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WHEN WE LOOK AT THE WORLD, WE SEE INFINITE POSSIBILITIES. AT LUPIN, WE ARE PRUDENTLY CHOOSING OUR OPTIONS AND CONVERTING THEM INTO REALITIES. LUPIN LIMITED Annual Report 2007-08 Corporate Information DIRECTORS Dr. Desh Bandhu Gupta Mr. D. K. Contractor Dr. K. U. Mada Mr. Marc Desaedeleer Mr. Sunil Nair Managing Director Mrs. Vinita Gupta Mr. Edward R. Roberts Mrs. M. D. Gupta Dr. Vijay Kelkar Chairman Dr. Kamal K. Sharma (up to April 2, 2008) Executive Director (up to December 31, 2007) Mr. R. A. Shah SENIOR MANAGEMENT TEAM Dr. Desh Bandhu Gupta COMPANY SECRETARY & COMPLIANCE OFFICER Mr. R. V. Satam SOLICITORS AZB & Partners Crawford Bayley & Co. DSK Legal Chairman Dr. Kamal K. Sharma Managing Director Mrs. Vinita Gupta President & Managing Director Lupin Pharmaceuticals Inc., USA Mr. Satish Khanna Group President - API Mr. Shakti Chakraborty President - India Region Formulations Dr. Ninad Deshpanday President - Pharma Research & Development Mr. Vinod Dhawan President - AAMLA & Business Development Mr. Rajan Dutta President - Human Resources Development Mr. Nilesh Gupta President - Advanced Markets Mr. Naresh Gupta President - API & Global TB Mr. Harish Narula President - Corporate AUDITORS Deloitte Haskins & Sells Chartered Accountants AUDIT COMMITTEE Dr. K. U. Mada Chairman Mr. D. K. Contractor Dr. Kamal K. Sharma INVESTORS' GRIEVANCES COMMITTEE Mr. D. K. Contractor Chairman Dr. K. U. Mada REMUNERATION/ COMPENSATION COMMITTEE Dr. K. U. Mada Chairman Mr. Sunil Nair (alternate - Mr. Marc Desaedeleer) Mr. R. A. Shah Mr. Ramesh Swaminathan President - Finance & Planning Mr. Sunil Makharia Executive Vice President - Finance Mr. Debabrata Chakravorty Executive Vice President - Supply Planning & Strategic Sourcing Mr. Andrew Macaulay Executive Vice President - Business Development REGISTERED OFFICE 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai-400 098. Tel:+ 91 22 6640 2323 Fax:+ 91 22 2652 8806 CORPORATE OFFICE Laxmi Towers, 'B' Wing, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051. Tel: + 91 22 6640 2222 Fax: + 91 22 6640 2130 www.lupinworld.com Mr. Alok Ghosh Executive Vice President - Global Dosage Form Manufacturing and Quality Assurance BANKERS Central Bank of India Bank of Baroda State Bank of India Citibank N.A. ICICI Bank Ltd. The Hongkong and Shanghai Banking Corporation Ltd. Standard Chartered Bank ABN AMRO Bank N.V. Forward-Looking Statement In this Annual Report, we have disclosed forward-looking information to enable investors to comprehend our prospects and take informed investment decisions. This report and other statements - written and oral that we periodically make, contain forward-looking statements that set out anticipated results based on the management's plans and assumptions. We have tried, wherever possible, to identify such statements by using words such as 'anticipate', 'estimate', 'expects', 'projects', 'intends', 'plans', 'believes' and words of similar substance in connection with any discussion of future performance. We cannot guarantee that these forward-looking statements will be realised, although we believe we have been prudent in assumptions. The achievement of results is subject to risks, uncertainties and even inaccurate assumptions. Should known or unknown risks or uncertainties materialise, or should underlying assumptions prove inaccurate, actual results could vary materially from those anticipated, estimated or projected. Readers should bear this in mind. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Our Vision TO BE TO BE AN INNOVATION AN INNOVATION LED LED TRANSNATIONAL TRANSNATIONAL PHARMACEUTICALCOMPANY COMPANY PHARMACEUTICAL CONTENTS 04 Financial Highlights 06 Business Highlights 08 Chairman's Message 12 Managing Director's Review Management Discussion and Analysis 16 Industry Overview 20 Formulations - Advanced Markets 26 India Region Formulations 32 Asia, Africa, Middle East and Latin America 36 CIS 40 API & Intermediates 44 Research & Development 54 Human Resources 58 Financial Overview 62 Corporate Social Responsibility 66 Five Year Financial Summary 68 Reports & Financials LUPIN LIMITED Annual Report 2007-08 04 Financial Highlights FY2007-08 4074.5 6423.0 Rs. in Mn Rs. in Mn 2255.0 2976.6 4912.8 5402.1 Profit Before Tax (PBT) EBIDTA 2005 - 06 2006 - 07 2005 - 06 2007 - 08 Consolidated Net Profit 2006 - 07 2007 - 08 Earnings Per Share (Basic) 50.01* 37.79* 42.24 2005 - 06 2006 - 07 Rs. Rs. in Mn 1729.9 3085.6 4082.5 * With effect of Bonus issue 2005 - 06 2007 - 08 Consolidated Gross Sales (Market Break-Down) 2006 - 07 2007 - 08 Consolidated Gross Sales (Business Mix) API Formulations 2005 - 06 2004 - 05 Anti - asthma Anti - diabetic CNS Cardiovasculars 61 52 2006 - 07 % Contribution 30 2005 - 06 2004 - 05 2007 - 08 Revenue Composition (%) Anti - TB 12 39 42 2007 - 08 Therapeutic Mix (%) Others 48 58 2006 - 07 % Contribution 23 16 22 35 65 77 78 84 70 Advanced Markets Emerging Markets API India 11 20 1 2 4 46 Cephalosporins API Emerging Markets 16 API Advanced Markets 3 33 15 3 Formulations Domestic 34 Formulations Advanced Markets Formulations Emerging Markets Our Values SUPERIOR PERFORMANCE Exports ENTREPRENEURSHIP 5260 5094 INTEGRITY 583 Rs. in Mn 3051 4938 5555 5921 10032 Formulations API 2004 - 05 2005 - 06 2006 - 07 2007 - 08 CUSTOMER ORIENTATION WORKING TOGETHER RESPECT FOR PEOPLE Consolidated Gross Sales (Geography Break-Down) 51 52 Domestic Exports - Advanced Markets Exports - Emerging Markets 2004 - 05 2005 - 06 Contribution (%) 20 25 23 27 16 22 34 35 45 50 05 2006 - 07 2007 - 08 100*** Dividend History 50 65 65 50** Dividend (%) 35 50* 65 * Including Interim Dividend @ 25% ** Dividend on enhanced capital, post bonus issue 1:1 *** Proposed Dividend, including a special dividend of 50% 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 LUPIN LIMITED Annual Report 2007-08 06 Business Highlights FORMULATIONS API ! 3 Fastest growing generic ! Volume growth in Cephalosporin rd pharma Company in the US by prescriptions ! 15 Generic products commercialised in the US with No.1 position in four ! Suprax® exhibits 55% prescription growth in the US ! Line extension of Suprax® Intermediates ! Maintained stability on Pen-G derived products despite volatility ! Continued thrust on Lisinopril and other Prils ! Steady increase in regulatory filings - DMFs, EDMFs and COS launched ! Cumulative Regulatory filings in key markets: US 62, UK 21, France 9, Australia 16 ! Received 'Best New Manufacturer of the Year, Generics Rx' Award from AmerisourceBergen ! Received 'Quality Supplier FACILITIES ! Jammu facility for Anti-TB, Anti-asthma and other oral solids commissioned ! First generic launch in France for ! Goa facility expanded ! Indore plant commissioning on ! UK Direct-to-Market starts with ! New Multi-Purpose Plant at Award' from Cardinal Health Cefpodoxime Proxetil promising market share gain in Lisinopril ! Australia - Sales commenced ! India Region Formulation th Ranked 6 Outpaces market and prescription growth rates Fastest growing Company amongst the top 10 in the IPM the Anvil Tarapur for advanced markets commissioned 07 R&D M&A FINANCE IP Strengths - ! Gateway to Japan - Acquisition ! Consolidated Sales (Gross) - ! Euro 20 Mn income from Servier of France for the sale of additional patent rights for Perindopril ! Introduction of Cefdinir, in the US, after a successful litigation and settlement with Abbott ! Court of Appeals ruled in favour of Lupin, finding the Aventis patent on Ramipril invalid product launched in the US ! NCE Research - Steady progressOne molecule in Phase III, Two molecules in Phase II and One molecule completed Phase I ! R&D Spend - 7.5% of Consolidated Net Sales of Kyowa Pharmaceutical Ind. Co. Ltd. ! Rubamin Laboratories Ltd (rechristened as Novodigm Ltd.) acquired, to emerge as part of global CRAMS strategy Growth 34% at Rs. 27,730 Mn Consolidated Net Profit growth 32% at Rs. 4,082.5 Mn ! Board recommends a dividend of 100% (including a special dividend @ 50%) ! Lupin's short-term debt programme receives the highest rating from ICRA ! Basic Earnings Per Share of Rs.50.01, up by 32% from the previous year ! Reserves and Surplus at Rs.11,976 Mn, up by 51% ! Debt Equity Ratio 0.78:1 ! FCCB conversion commenced HUMAN RESOURCES Initiatives undertaken for - ! ! ! ! Grooming future leaders Increasing employee productivity Optimisation of costs Employee engagement Chairman and MD reaching out to Lupinytes. LUPIN LIMITED Annual Report 2007-08 08 Chairman’s Message FROM A SIMPLE ASPIRATION TO GOING BEYOND US$1 Bn Dr. Desh Bandhu Gupta Chairman 09 I believe that every possibility harbours a reality and all we need is the vision to see it and the resolve to capitalise it. At Lupin, we live this belief and strive to convert every possibility into a reality. Dear Shareowners, I believe that every possibility harbours a reality and all we need is the vision to see it and the resolve to capitalise it. At Lupin, we live this belief and strive to convert every possibility into a reality. Today, we have come a long way from being a manufacturer and supplier of APIs, to becoming a fully integrated global pharmaceutical company. Behind us, we have left a trail that exemplifies our determination to turn possibilities into realities. Leveraging cutting edge technology to deliver innovative offerings, our journey has just begun… STRONG FINANCIAL PERFORMANCE The bygone fiscal was a momentous landmark in our journey. Impressive growth, noteworthy profits and meaningful acquisitions – 2007-08 has witnessed it all, to aptly qualify as an action-packed year. Chairman’s Message We closed the year 2007-08 with Consolidated Revenues at Rs. 27,730 Mn (Rs. 20,717 Mn-FY2006-07) recording a growth of 34%. Our Consolidated Net Profit for the year increased by 32 % to Rs. 4,083 Mn (Rs. 3,086 Mn-FY2006-07). I am happy to share that this year's performance was driven by all round robust growth recorded by each of the Company's business segments. The US as well as India business inparticular weresignificantgrowthdrivers this year. FORGINGAHEAD INTHEADVANCED MARKETS Our US business clocked in a stellar performance by more than doubling in size. The Company achieved the distinction of being rated as the third fastest growing company in the US for the year 2007 in terms of prescriptions. Lupin received two awards that demonstrate the quality of our products and strength of our marketing LUPIN LIMITED Annual Report 2007-08 10 in the world's largest pharma market. These were, the 'Best New Manufacturer of the Year Award' from AmerisourceBergen and 'Quality Supplier of the Year Award' by Cardinal Health. Services (CRAMS) space. The technological expertise, meaningful relationships and manufacturing capacity that Novodigm brings, are catalysts to our success in this arena. FOCUS ON SPECIALISED PRODUCTS GAINING STRONGHOLD IN THE DOMESTIC MARKET Consistently outperforming the industry growth, we are truly proud of what our India business has delivered. We continue to grow from strength to strength on the domestic th front. The 6 rank in the marketplace as per IMS ORG, up th from the 10 in 2006, truly substantiates our capability and determination in seeking domestic leadership. ACCELERATING PACE THROUGH STRATEGIC ACQUISITIONS I am proud that we have consistently outperformed the industry in terms of organic growth and this year we supplemented this with inorganic opportunities. The strategic acquisition of Kyowa, during 2007-08 has propelled Lupin directly into the elite league of the top 10 generic players in Japan, the second largest and one of the most stringent pharma markets of the world. Kyowa has brought with it a rich product portfolio, extensive market reach, a world class R&D setup and state of the art manufacturing capabilities. We are now focussed on consolidating our position in Japan as the acceptance for generics continually increases. Having tasted success in Japan, we are also scouting for meaningful acquisitions in the emerging markets of South East Asia, particularly Philippines, Middle East, South Africa and Europe. We have devised a two-pronged strategy to tap the lucrative US market. Much as we are developing a healthy pipeline of value-added generic products, we are also working towards the acquisition of strategic brands in the US, across various therapy segments. As I talk about acquisitions in select markets of the world, India is certainly no exception. The acquisition of Rubamin Laboratories Ltd. (rechristened as Novodigm) marks our foray into the Contract Research and Manufacturing Today, we are sufficiently broad-based in terms of our spectrum of product offerings and geographical reach. However, as we step into the next phase of our growth we are focussing on leveraging our existing technological capabilities to develop value added differentiated products that will further strengthen Lupin's position. During the year we have forayed into new therapeutic areas such as Anti-asthma, Biosimilars and Steroids. Having set up specialised laboratories as well as a dedicated production facility, we are making significant inroads into the Steroids arena. In the forthcoming fiscal, we will initiate commercial production. We have already achieved significant market share in the domestic Anti-asthma space. We are now working towards introducing these products in other markets around the world. I am confident that Lupin will make its presence felt globally in this therapeutic area. RESEARCH Our innovative research is focussed largely on four areas, New Chemical Entity Research, New Biological Entity Research, Advanced Drug Delivery Systems Research and Innovative Generics Research. In all these areas a sound base has been created including initiation in the Biotech area. We have planned to make substantial investments in this area as we believe Biotechnology is the frontier area of technology. Over 40% of all future discoveries in pharmaceuticals are expected from biologicals. I believe concrete outcome of our research work done should start getting market recognition soon. My confidence emerges from the powerful leadership and infrastructure created in the entire spectrum of research at Lupin. Innovation is at the heart of Lupin and is being continuously strengthened further. 11 INTELLECTUAL PROPERTY MANAGEMENT NURTURINGTHE FOUNDATIONS OFTHE SOCIETY Over the last few years the Company has demonstrated the success of its Intellectual Property Management through multiple developments. This year we received further income of Euro 20 Mn (Rs. 1,127 Mn) for the sale of additional IP on Perindopril, launched Cefdinir in the US after a successful litigation and settlement agreement and won the Ramipril litigation at the Federal circuit. These developments reflect the unique capabilities the Company has built in matters pertaining to Intellectual Property. We consider ourselves fortunate for having had the opportunity to serve society through the Lupin Human Welfare and Research Foundation (LHWRF). The social initiatives at Lupin are aimed at strengthening the very foundation of our society. Consequently, we lay emphasis on imparting education, facilitating employment generation, creating health awareness and efficient water management. Today LHWRF's efforts cover over 2.2 million villagers. AUGMENTING MANUFACTURING CAPACITIES BUSINESS OUTLOOK In order to meet the challenges of the future, the Company augmented manufacturing capacities this year at most of its plants. A state of the art Formulations facility at Jammu was fully commissioned while another green field project at Indore is well under way. This will be a highly specialised facility for both API's and Formulations. New technological initiatives were also taken for energy conservation and environment protection. As we move closer to our goal of US$ 1 Bn we are challenging ourselves to set new milestones. We are accelerating our pace to strongly establish Lupin in five of the top 10 pharmaceutical markets of the world. We are aiming at generating two thirds of our revenues from the global markets. We will continue to consolidate our market share position in the domestic market as we renew our vigour to keep growing ahead of the industry. The Company has incurred a capital expenditure of around Rs. 2,500 Mn augmenting its manufacturing capabilities and creating new projects this year. We believe this is a sound investment for our growth. Our focus on technology and differentiation will enable us to charter into new areas of business. Today we are well positioned to strengthen our formulations business in the Advanced Markets as we gear up to replicate the success of our US operations in Europe, Japan and Australia. MANAGEMENT BANDWIDTH At the heart of every successful organisation, lies its people and this holds true for Lupin as well. In strengthening our leadership team we look at bringing in the best talent the world has to offer. During the year we expanded our senior management team to include experts like Dr. Ninad Deshpanday, who joined us as President, Pharma R&D and Mr. Ramesh Swaminathan, as President, Finance and Planning. Soon joining us would be an eminent scientist in the area of New Chemical Entity Research who will steer our NCE discovery programme. Please join me in welcoming them and the leadership teams of Kyowa and Novodigm into the Lupin family. Chairman’s Message I would like to express my gratitude towards all our stakeholders for their continued support and belief in our capability. Your confidence drives us to aspire to even greater heights. With Best Wishes & Regards, Dr. Desh Bandhu Gupta Chairman LUPIN LIMITED Annual Report 2007-08 12 Managing Director’s Review FROM DOMESTIC STRONGHOLD TO GLOBAL FOOTPRINT Dear Shareowners, 'Promising' is the word that comes to my mind while describing the year 2007-08, at Lupin. With revenue and profit growth being way ahead of industry, we have definitely recorded impressive numbers. What is encouraging is that while every business of the Company has contributed towards this success, the performance turned out by the formulations business in the advanced markets (US and Europe) is rather commendable, registering a growth of 113%. I take pleasure in announcing that our consolidated topline recorded a growth of 34%, while the bottom line grew by 32 %. Our net profits stand at Rs. 4,083 Mn. The end of yet another successful fiscal has reaffirmed my faith in the famous maxim - 'Whatever the human mind can conceive and believe, it can achieve.' Four years ago, we embarked on a journey to move up the value chain. I'm proud to say that today, we've reached a significant milestone in our quest. Our formulations business has grown to account for 70% of our portfolio, up from 42% three years back - a clear indication of our value-added offerings. OUR STURDY FOUNDATIONS Standing tall on a firm R&D base, we are adapting latest technologies in developing innovative formulations to meet the needs of contemporary times. We have aptly demonstrated our capabilities to create and defend our intellectual property. We are continuously building our intellectual wealth and have strengthened our delivery research and drug discovery research during the year. We have also set up research and development for biologicals and this is going to further add to the momentum of creating sound intellectual properties. 13 We differentiate ourselves as a company which sets stretched goals and prides in achieving them Dr. Kamal K. Sharma Managing Director Managing Director’s Review LUPIN LIMITED Annual Report 2007-08 14 BIOTECHNOLOGY - ADDITIONAL LEVER OF GROWTH CHARTINGTHE INORGANIC ROUTE I strongly believe that perceptive strategies make all the difference. To be a successful pharmaceutical company, we recognize that biologicals will form an important component of our business. Based on our experience and understanding of the marketplace and taking advantage of the hindsight of a late entrant, we have put in place a detailed blue-print for establishing ourselves in this space. During the year, our biotechnology initiative gathered significant momentum. Today, we have already in-licensed five biologicals. Besides inhouse product development, we have entered into strategic arrangements for co-development. We are now in the process of establishing a cGMP certified manufacturing facility at Pune. Turning another leaf in our march towards globalisation, we commenced our forays into Japan, the second largest pharmaceutical market of the world. This has been facilitated through acquisition of Kyowa Pharmaceuticals. Kyowa among the top 10 generic companies presents a perfect mélange that assures bright prospects in the Japanese pharmaceutical market a robust product portfolio, state-of-the-art manufacturing facilities and R&D and strong brand equity. SPREADING OUR AMBIT Our plans for creating a global footprint have taken off extremely well. Currently, 55% of our revenues are contributed by international business. Lupin is fast forging its presence in selective markets across the world. During the year under review, advanced markets of US and Europe have contributed 30% to the topline. This year, we made our first launch in Europe through Cefopodoxime Proxetil in France followed by Lisinopril in the UK. While these two launches mark the beginning of our forays into Europe, we can look forward to promising prospects in this geography. I am also pleased to announce that Lupin is one of the few Indian companies to have a presence in Australia and Gulf Co-operative Council countries. Both these markets are of significance for the growth of generic business. The Government is doing everything possible to promote the use of generics and this indeed augurs well for our growth story. During the year we also acquired Rubamin Laboratories Ltd., now christened as Novodigm to provide desired impetus to CRAMS business. We believe this acquisition will add substantial weight to CRAMS through technology, manufacturing capacity and customer contacts. ONTHE HOME FRONT As I often say our team in the Indian market has made it a habit to beat the market growth. We continue to grow at almost twice the industry rate of growth. Lupin has graduated from the 10th position in year 2006 to occupy the 6th rank in the Indian Pharmaceutical sector, according to IMS ORG ( MAT March -08). This has been contributed by a combination of unique promotional strategies, judicious selection of products, and an extremely motivated team. We are committed to expand and grow on the strength of innovative products, additionofnewtherapies andenhancedmarketreach. 15 Turning another leaf in our march towards globalisation, we commenced our foray into Japan, the second largest pharmaceutical market of the world. BUILDING COMPETENCIES We are an ambitious Company and achievement of each milestone marks the beginning of a fresh journey for us. In pursuit of accelerated and profitable growth, we have to continuously build right competencies. We are undertaking introduction of 'assessment centers' as a development tool to assess current competencies and the gaps thereof. This will enable us to draw up requisite development plans for our people. We value our people; their commitment and contribution forms the core of our growth aspirations. A LOOK INTOTHE FUTURE At Lupin, profitable growth must remain the order of the day, everyday. We differentiate ourselves as a Company which sets stretched goals and prides in achieving them. We have lots to achieve. Going forward, you would see the Company consolidating and growing in all its chosen markets on the strength of its technology base and seamless execution. Best Wishes & Regards, Dr. Kamal K. Sharma Managing Director Managing Director’s Review LUPIN LIMITED Annual Report 2007-08 16 Industry Overview FROM KNOWING MARKETS TO CAPITALISING OPPORTUNITIES THE GLOBAL PHARMACEUTICAL MARKET* According to IMS Health (IMS), the global pharmaceutical market has recorded a growth of 95%, over the last 7 years, moving up from US$ 365 Bn (2000) to US$ 712 Bn (2007). 2001 712 649 605 560 499 US$ Bn 392 2000 428 365 Global Sales 2002 2003 2004 2005 2006 expected in the US pharma industry, with generics accounting for more than two-thirds of the overall prescriptions generated. Espicom Business Intelligence reports that the world generic pharmaceutical market was estimated to be valued around US$ 84.4 Bn in 2006, with USA, the world's largest generic market valued at US$ 31 Bn. 2007 The US continues to be the single largest pharma market, estimated at US$ 286.5 Bn. It, however, contributed only 25.5% of the total growth to the global market in 2007, which is the lowest level of contribution. A growth of 4-5% is The aggregate growth of the five major European markets, viz., France, Germany, UK, Italy and Spain, was 4.8% over the year. The rest of the European markets, valued at US$ 81.6 Bn, expanded by over 10%. The uptake of generic drugs in Western Europe varied from country to country, but there is a distinctive shift towards genericisation. This trend is most noticeable in Spain, France and Italy, where so far, generic consumption is dismally low, but on an increase. High-price markets such as, Germany, UK, and Netherlands, have encouraged the use of generics in order to bring down their healthcare expenditure . 17 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview > CSR It is not just about knowing the market. It is also about translating knowledge into value. At Lupin, it is a constant practice. Encouraged by our experience in serving the pharmaceutical arena, we have successfully traversed the distance between gaining knowledge and converting it into opportunities, to create shareholder value Global Market Share - Key Markets (% Feb’08) Latin America 5 Japan 9 AAA 9 46 Europe IMS reports that the Latin American markets continued their rapid expansion, registering a growth of 11.6% in 2007, with a market size, estimated at US$ 42.4 Bn. Similarly, the Japanese pharmaceutical market grew by 3.6% to reach US$ 65.2 Bn. The growth registered by the Japanese market during 2007, is higher than the compounded annual growth rate (CAGR) of the previous five years. The Asian markets experienced a double-digit growth, on account of a significant expansion of healthcare access in the region. These markets (excluding Japan, including Australia and New Zealand) grew collectively by 13.3% and represent close to 11% of the total global sales. In terms of revenue, the ten key markets constitute over 80% of the global pharmaceutical industry. The year 2008, is slated to witness a shift in growth from the top seven markets to emerging markets and from primary care-driven to specialty care-driven drugs. The markets of China, Brazil, Management Discussion & Analysis North America 31 Mexico, South Korea, India, Turkey and Russia are projected to experience growth at the rate of 12-13% to reach US$ 85-90 Bn. It is a favourable time for the generic manufacturers, mainly because a large number of top selling drugs are due for patent expiry in the US. Further, a large number of countries are promoting the use of generics as a means of containing healthcare costs. It is estimated that the generic market is currently growing faster than the pharmaceutical industry, as a whole. It is also further estimated that around 50% of US prescriptions are for generics and nearly 80% of UK NHS prescriptions are written generically. *(Source IMS Health) THE INDIAN PHARMACEUTICAL MARKET (IPM)** ORG IMS reports that the IPM has been valued at around US$ 7.8 Bn, and over the last four years, the IPM has grown at a CAGR of 13%. McKinsey & Company's recent research estimates indicate that the IPM is expected to grow to a size of US$ 20 Bn by LUPIN LIMITED Annual Report 2007-08 18 2015 and will be among the top 10 pharma markets of the world. Factors contributing to the above growth are: ! Increasing disposable incomes and the number of middle-class households ! Expansion of medical infrastructure ! Greater penetration of health insurance ! Rising prevalence of chronic diseases ! Aggressive market penetration, driven by the relatively small companies ! Adoption of product patent Their research further points out that growth in the Indian pharmaceuticals market is anticipated to be well distributed across urban and rural areas. Rural areas are expected to account for a third of the country's consumption growth, over the nexttwodecades. The Indian companies' contribution to the IPM is estimated to be around 80% and there are only 11 MNCs among the top 50 pharma companies. The chronic segments have shown a CAGR of 16% in terms of value, over the last four years, while acute segments exhibited a growth of 12% on a CAGR basis. The contribution of combination drugs is estimated to be around 46%. IPM - Leading Therapy Classes (% share) Others Anti-diabetic 12.9 4.9 Neuro/CNS 5.5 Derma 5.5 Gynaec Vitamins/Minerals/ Nutrients 11 5.6 10.7 9 8.3 8.9 **(Source ORG IMS) Anti-infective 17.7 Gastro Intestinal Cardiac Respiratory Pain/Analgesics LUPIN - ON A FAST TRACK Lupin has successfully positioned itself as a Transnational Pharmaceutical Company, with a wide global footprint. It has gained recognition as the world's largest manufacturer of Tuberculosis drugs. Over the years, the Company has moved up the value chain and has not only mastered the business of certain intermediates and APIs, but has also leveraged its strengths to build a formidable formulations business. Over the last four years, the Company's business mix has improved, with close to 70% of its revenues coming from formulations and 30% from APIs. In terms of geographies, the Company has retained a stronghold in India, growing ahead of the industry and has developed a sound branded and generic business in the US. In terms of overall revenues, the overseas business constitutes close to 55%, while the balance comes from the domestic market. The US is Lupin's largest market overseas. The Company aspires to replicate this success in other Advanced Markets such as, Europe, Japan and Australia. 19 Lupin has successfully positioned itself as a Transnational Pharmaceutical Company, with a wide global footprint. Over the years, the Company has moved up the value chain and has leveraged its strengths to build a formidable formulations business. The Company's business mix has improved, with close to 70% of its revenues coming from formulations and 30% from APIs. During the year, Lupin further fast tracked its growth trajectory through two acquisitions. While the acquisition of Kyowa positioned the Company amongst the top ten generic pharma companies in Japan; another acquisition in India provided it a springboard to leap ahead in the CRAMS space. Lupin's manufacturing facilities, spread across India, play a critical role in enabling the Company realise its global aspirations, benchmarked to international standards, these facilities are approved by international regulatory agencies such as US FDA, UK MHRA, TGA Australia, WHO and MCC South Africa. The Company's domestic formulation business has consistently exhibited a handsome growth, way ahead of the IPM. The Company has leveraged its strong vertical integration in building a global pharmaceutical powerhouse. The Company's Research prowess enables it to master cutting edge science and technology. Lupin is poised and well prepared to capitalise the opportunities that are set to unfurl in the global pharmaceutical space. This performance has translated into Lupin graduating to the sixth position in the IPM. From being a predominantly Anti-TB Company, today Lupin holds a wide product basket, spanning multiple therapy areas, with a focus on chronic segments. The Company is further augmenting its product offerings through in-licensing. Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 20 FormulationsAdvanced Markets (USA and Europe) FROM CONCEPTION TO CONVICTION A wide spectrum of products, vertical integration, perceptive marketing strategies and attractive prices have enabled us to develop a formidable presence in the Advanced Markets, a testimony to our flight from conception to conviction. The Company's Advanced Markets business in the US and Europe did extremely well during the year, recording sales of Rs. 8,430 Mn. (US$ 210.9 Mn) and registering a growth of 75%, over the previous year. This was led by the US contributing Rs. 7,657 Mn. (US$ 191.6 Mn) and Europe reporting sales of Rs. 773 Mn. (US$ 19.33 Mn). Ms. Vinita Gupta, President & MD - Lupin Pharmaceuticals Inc. USA 21 > Industry Overview > CIS > API > Advanced Markets > HR > R&D > IRF > AAMLA > CSR > Financial Overview The Company has built a strong foothold in the Branded market and is an emerging market leader in the generic space over the past 3-4 years in the US USA The Company's formulation business was the key growth driver, reporting a stellar growth of 103%, riding on the success of Direct-To-Market (DTM) and brand business. Intellectual Property (IP) based products, coupled with sound marketing, backed by world class manufacturing and research capabilities, have helped the Company emerge as a strong generic player in the US. 299 Rs. in Mn 3553 2240 7205 Formulations Revenue - US 2004-05 2005-06 2006-07 Management Discussion & Analysis 2007-08 The Company has built a strong foothold in the paediatric Branded market and is an emerging market leader in the generic space over the past 3-4 years in the US. LUPIN LIMITED Annual Report 2007-08 22 US Generics This year, the generics business in the US clocked sales of US$ 118Mn, recording an exponential growth of 127%. The key growth drivers were increased market share for Lisinopril and Lisinopril+HCTZ and the launches of Cefdinir, Trandolapril, Lovastatin, Amlodipine and rd Simvastatin. For the year 2007, Lupin was ranked as the 3 fastest growing Company in the US, in terms of prescriptions (as per IMS) and Lupin's Lisinopril was rated as the fastest growing product, in terms of prescriptions, having garnered leading market share position in field of 10 competitors. The Company has a product basket of 15 generic formulations in the market and it ranks in the top 3 in 10 of the 15 products. Lupin's prescription growth and penetration has been faster and deeper than any other large domestic player. The key factors contributing to the success of the Company's generic strategy in the US are: Wide Product Portfolio The Company has built significant expertise in identifying and developing the right products. It focusses on 'difficult to make' complex and innovative products, in addition to niche products. The Intellectual Property Management Group focusses on building a differentiated product pipeline, based on the Company's key strengths in the areas of APIs and formulations. Ramp-up By Lupin In Total US Market Prescriptions* 6000000 5000000 Caraco Pharm, Sun Pharmaceutical Dr. Reddy's Lab Ranbaxy Labs Lupin 4000000 3000000 2000000 1000000 0 April 2005 March 2008 During the year, the Company filed 11 ANDAs, taking its cumulative filings to 62, with 27 ANDA approvals received. Additionally, the cumulative DMF filings stand at 74, with 14 made during the year. The estimated market size of Lupin's ANDAs i.e., molecules for which it has got approval / submitted dossiers, is close to US$ 42.5 Bn. (source IMS MAT DEC 07). Lupin has developed a balanced pipeline, of Para III, Para IV filings, controlled release and other niche products. IP Based Products The Company has built strong capabilities in identifying and challenging unique opportunities. The IP team had two big wins this year. In the early part of the year, a significant achievement for the Company was the introduction of Cefdinir, after a successful litigation and settlement with Abbott Laboratories and Astellas Pharma Inc., in USA. Lupin was the first Company to receive an approval from the US FDA for Cefdinir and launched the products after the settlement. Similarly, in case of the Ramipril litigation, the Court of Appeals for the Federal Circuit reversed a district court decision, finding the Aventis patent on Ramipril invalid. Ramipril is one of the ACE inhibitors used for the treatment of high blood pressure. Lupin believes that it is a landmark decision and reflects the strength and maturity of the Company's IP capability. Market Share Gains By Lupin Across Several Products* Apr-07 70 60 50 40 30 20 10 0 Apr-08 (%) Cefprozil Tab. Cefprozil Susp. Lisinopril Lisinopril Meloxicam HCTZ Tabs Quinapril HCl Lovastatin *Source IMS (Featured in Lehman Brothers Global Equity Research Report) 23 Vertical Integration Lupin's success in the Advanced Markets is aided by the Company's strong vertically integrated operations spanning across intermediates, APIs and formulations which distinctly provide it the competitive edge needed in the increasingly competitive markets. Scale and cost has played a critical role in carving Lupin's market success. Lupin's cost efficient manufacturing of APIs and formulations in India, provides the Company the competitive edge needed in an otherwise crowded generic market. Quality The Company's presence in the market has been applauded by its customers. During the year, the Company received the 'Best New Manufacturer of the Year, Generics Rx' award from AmerisourceBergen, a leader in healthcare distribution in the US. The award recognises Lupin's contribution and commitment towards excellence as a generic drug supplier in the US. The Company also received the 'Quality Supplier Award' from Cardinal Health Inc., a leading wholesaler. This award is a recognition of the suppliers, who meet or exceed Cardinal's standards of quality in service levels, lead-times and customer service. Mr. Nilesh Gupta, President - Advanced Markets Intellectual Property based products, coupled with marketing muscle, backed by world class manufacturing capabilities and research, have helped the Company emerge as a strong global generic player Marketing Strategy The Company's carefully crafted marketing strategies have resulted in enhanced market penetration. Today, the Company has a presence across all major classes of trade such as, the chain drug stores, distributors, wholesalers and mail order houses. The mix of these channels is guided by the strength of the individual class of trade for a given molecule. The Company is engaged in developing strategic alliances with key trade partners, with the objective of achieving a sustainable long-term position in the market. 'Best New Manufacturer of the Year, Generics Rx' Award from AmerisourceBergen Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 24 US Branded The Company's foray in the US market, with the launch of 'Suprax®' as a brand for the paediatrics segment, was an outcome of innovative market strategy, which was unlike most other generic players. Driven by a blend of experience, deep market understanding and effective management of its 50-strong sales team to enhance productivity, Suprax® has evolved to become a US$ 40 Mn plus brand, over the last four years. During 2007-08, Suprax® continued to chart strong growth, recording a prescription growth of 55% and revenue growth of 52%. The Company, so far, participates only in 26% of the national market, leaving ample scope to further enhance the penetration of Suprax®. In order to further extend the brand franchise, the Company launched Suprax® Double Strength powder for suspension. The product has proved to be a success as evident from the rising prescriptions, which reflect a healthy trend towards the Double Strength products. Additionally, the Company recently introduced Suprax® 400 mg tablets that offer an additional value proposition to Paediatricians by covering the adolescent and teenage patient population. The incidence of urinary tract th infections is high in children and Paediatricians are the 5 Suprax's Double-dose Strength Gaining Market Share* Total Suprax TRx Share of Double Dose (%) 50,000 45,000 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 May 2005 45 40 35 30 25 20 15 10 5 0 April 2008 *Source IMS (Featured in Lehman Brothers Global Equity Research Report) largest specialty prescribing antibiotics for this indication. Suprax® tablets are well-positioned to fit into this niche segment. The Suprax® brand basket now includes, Suprax® (Cefixime for oral suspension 100 mg/ 5 ml, 200 mg/ 5ml and Suprax® 400 mg tablets ( Cefixime Tablets). Following the success of Suprax®, the Company is focussing on strengthening its portfolio with more valueadded, differentiated products and is constantly engaged in product development, using its proprietary controlled release and taste masking platforms. The Company is also aggressively pursuing in-licensing opportunities to add to its basket for paediatricians. EUROPE After making successful inroads in the US, the Company is working to replicate this success in the European markets. Today, the European pharmaceutical markets are witnessing deeper generic penetration as Governments accelerate their efforts towards encouraging the use of generic medicines, in order to contain burgeoning healthcare costs arising from an upsurge in the ageing population. The Company's product portfolio for Europe encompasses offerings in the Anti-infective, Cardiovascular and CNS segments. The accent is on leveraging the Company's development, manufacturing and commercialisation capabilities and offer complex products, which provide a natural hedge against competition and price erosion. 25 UK-Direct to Market Lupin launched its direct-to-market initiative under its own label during the year. Its flagship product Lisinopril has been well received and has achieved a market share of 15% in the first four months of product introduction. The Company has a strong pipeline of 21 MAAs for various products. The Company expects to repeat the successful launch of Lisinopril with a host of additional offerings. France and Other European Markets Lupin is forging ahead in France and other markets, leveraging its partnership business model. During the year, Cefpodoxime Proxetil tablets introduced in France through multiple partners garnered over 50% market share. The Company is looking forward to replicate this success with the launch of Cefpodoxime Proxetil powder for suspension, amongst other products. Packs Cefpodoxime Proxetil Tab. - France Generic Split: Lupin Vs. Others 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Lupin Others Aug-07 Sep-07 Oct-07 Nov-07 Management Discussion & Analysis Lupin launched its direct-to-market initiative in UK under its own label, during the year. Its flagship product Lisinopril has been well received and has achieved a market share of 15% in the first four months of product introduction. Additional Sale of IP In the year, Lupin also received Euro 20 Mn for the sale of additional patent applications on Perindopril to Laboratoires Servier of France. Having set its foot on European soil, the Company is considering every avenue of value creation. As a result, it has entered into several out-licensing arrangements for its products across the region. Lupin has planned 10-15 dossier filings and an estimated 5-7 launches in the European Union in the near term. Dec-07 LUPIN LIMITED Annual Report 2007-08 26 India Region Formulations (IRF) FROM INCISIVE STRATEGIES TO GAINING LEADERSHIP Our success on the domestic soil personifies our trek from devising strategies to breaking new ground. Profound understanding of the Indian pharmaceutical landscape has empowered us to forge ahead towards domestic leadership backed by consistent performance. Rs. in Mn 7530 6064 4944 9496 Domestic Formulations Sales 2004-05 2005-06 2006-07 2007-08 INDIA REGION FORMULATIONS (IRF) Lupin's IRF business has witnessed an exemplary growth over the last few years, growing well ahead of the industry. The Company has widened its product basket with a mix of branded generics and value added generics, getting into newer therapy areas, such as, gynaecology, oncology and wound management. Simultaneously, the Company has focussed on gaining further market share in Anti-asthma, cardiovascular, diabetic and other chronic segments, while maintaining its dominant position in Anti-TB and Antiinfective segments. During 2007-08, the domestic formulations business posted a robust performance with annual sales of Rs.9,496 Mn (7,530 Mn), reflecting a growth of over 26%, while the Indian Pharmaceutical Market (IPM) grew by 15%. Riding high on the success of its performance over the years, Lupin improved its ranking to number 6 in the IPM (ORG IMS MAR MAT 08) up from number 10 in 2006. Furthermore, for the month of March '08, it was placed at number 5. 27 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview > CSR The Company's high quality, reliable formulations have gained a wide market acceptance, resulting in several of its products being leaders in their respective segments. Top Ten Lupin Brands Product Therapeutic Segment Tonact R-Cinex AKT Ramistar Gluconorm Odoxil Rablet L-Cin Akurit Clopitab CVS Anti-TB Anti-TB CVS Anti-diabetic Anti-infective Gastro Intestinal Levofloxacin Anti-TB CVS Segment Ranking 2 1 1 2 3 1 2 1 1 1 Mr. Shakti Chakraborty, President - India Region Formulations While the prescription market of IPM grew by 4.7%, Lupin exhibited a healthy prescription growth of 9.3% for the year, thus attaining the status of the fastest growing company amongst the top 10 in the IPM. Captitalising on this growth, the Company improved its market share to 2.7% ( from 2.4% last year). The Company's high quality, reliable formulations have gained a wide market acceptance, resulting in several of its products being leaders in their respective segments. Currently, six Lupin products are among the top 300 products of the industry. 'Combitaz' an Anti-bacterial Management Discussion & Analysis th injection has been rated by ORG as the 7 best launch in the IPM, during 2007-08. GROWTH ENABLERS ! Leadership inAnti-TB and Anti-infectives It is estimated that 80% of the world's Tuberculosis (TB) cases are concentrated in 22 high-burden developing countries, including India. However, the disease is prevalent across geographies. The global eradication drive of this disease has gained momentum and Lupin is a frontrunner in this global LUPIN LIMITED Annual Report 2007-08 28 mission, as it produces the highest volume of TB drugs, APIs, as well as formulations. This year, Lupin maintained its leadership position in TB by commanding a 48% market share. ! ! Focus on the Chronic Segment The Company has made a conscious shift to focus on lifestyle segments and chronic therapies, such as, Diabetics, Cardiovasculars, Respiratory, Onocology, Wound management and CNS. The Company has also made significant inroads in the Anti-asthma segment, which is largely dominated by a single player and has achieved a double digit market share with a distinct No.2 position in the segment. Today, Lupin offers a comprehensive Respiratory therapy portfolio that addresses TB, Asthma, COPD, Allergy and Respiratory tract infections. Additionally, Tirofuse, belonging to GPIIb/IIIa class of inhibitors for the management of Acute Coronary Syndrome (ACS), was also introduced, which would help in saving lives of the critically ill patients. IRF - Therapeutic Contribution (%) 15 Gastro Intestinal Lupin has taken steps to enter the area of women healthcare and will focus on building a formidable presence in this new therapy area in the future. The Gynaecological market in India is estimated to be around Rs.18,061 Mn, growing at 19%. Anti - TB 17 26 Others Cephalosporins 6 Anti - asthma Anti - diabetic 8 CVS 5 4 19 CNS Segments in Which Lupin Outperformed The Market Segment Market growth Lupin growth rate (%) rate (%) Anti-asthma Anti-diabetic Neuro / CNS Cardiac Gastro Intestinal Anti-infectives Anti-TB Specialised Product Introductions Lupin has a formidable presence in the Anti-infectives segment. In order to further strengthen its portfolio in this category, several products for critical care segment were introduced, during the year. These were Gemifloxicin (GCIN), an advanced Quinolone; Eugraf, a biotech product for wound management; Percin, (Prulifloxacin) a superior Floroquinolone indicated for respiratory, urinary and gastrointestinal tract infections; Lupinem, a beta lactam Anti-bacterial aimed at treating critically ill patients in ICCUs and Voritrol, an advanced Anti-fungal product. All these products have been well received and have extended Lupin's franchise with the medical community. 20.4 22.3 16.6 23.4 14.1 15.2 4.5 48 42 38 34 31 28 8.3 ! Leveraging in-licensing to introduce niche products Lupin is capitalising on the in-licensing route to get specialised products for the patients in India. The Company has re-defined wound care management in India with the launch of Calgigraf Ag, a patented product of a well known wound care major, ADRI Technam, USA. This is the first of its kind product made available in India, by Lupin. Furthermore, its in-licensed product, Lupenox, an anti-Thrombotic drug, has been licensed from Italfarmaco (Italy). Lupenox was ranked No.1 amongst the new launches in the Indian cardiac nd market and 2 in the IPM (ORG IMS MAR MAT'08). Currently, it has a 20% market share, exhibiting a tremendous growth of 81%, as per ORG. 29 Following the success of its international programme a series of CME programmes on diabetes management for diabetologists in India, in collaboration with JDC, were held across the country. Eminent speakers from JDC and University of Texas Southwest Medical Centre, USA, were invited to preside over the programmes. Over, 2,000 doctors benefited from these programmes. Similarly, in the area of cardiology, an initiative with the American College of Cardiology was launched for the benefit of nearly 10,000 doctors in India. It is a unique knowledge sharing initiative through which, the Company is providing access to Cardiosource, an online Journal of American College of Cardiology. A special website www.epinnacleworld.com has been developed to work as a gateway to the world of cardiology for the doctors. BIOCLIN, a unique probiotic product, in-licensed from Lallemand (Institut Rosell), France, was also introduced during the year. ! Passionate field force In the area of Asthma, the Joint Airway Diseases Initiative (JAI), focussed on creating awareness about the disease amongst the masses, was started. During the year, the Company held several free diagnostic camps for the detection of Asthma and Chronic Obstructive Pulmonary Disease (COPD). As a part of incisive strategies to enhance market penetration, the Company periodically augments its field staff across all divisions. The over-2500-strong, passionate, productive and motivated field force is committed to further propel the Company's position in the IPM, in years to come. ! Growth in medical infrastructure and health care insurance The advent of healthcare insurance and improved medical infrastructure is opening up new opportunities for pharmaceutical companies and is expected to augment business further. ! Nurturing Relationships through initiatives for Excellence The Company extended its relationship with the medical fraternity by accelerating its knowledge sharing initiative to include renowned specialists from prominent global universities. Lupin targets at providing a platform to medical professionals to keep abreast with the latest happenings in the medical world, through interactions with key opinion makers and Continuous Medical Education (CME) programmes. A few of its initiatives during the year were: Similarly, in collaboration with John Hopkins University, Rablet Key Opinion Leaders (RKOL) programme was initiated to enhance relationships with the key opinion makers by partnering with them in their quest for knowledge. A distant learning 'certificate course' from John Hopkins University, USA, was offered to key gastroenterologists. ! StrategicApproach Lupin has several strategic marketing arms that focus on specific therapy segments. This approach provides impetus to the business through enhanced relationships with the doctors and better market penetration. The success of this model is reflected in the growing market share of Lupin in the domestic market. With undivided focus on the niche areas, the Company has successfully built a strong brand value amidst the medical community. It's divisions are: ² Lupin has partnered with Joslin Diabetes Care (JDC), Boston, USA for exclusively developing a quality educationalprogramme for Indian diabetologists. During the year, the Company held “Diabetes in 2008”, a one and half day training seminar for about 30 doctors at JDC. The programme covered current trends in diabetes, in both, research and clinical practice setting. Management Discussion & Analysis Lupin Respira This division is focussed on offering a comprehensive product basket and a complete range of Anti-asthma and COPD medicine. Within a short span of three years, the Respira division has helped Lupin attain a significant size and share in the Anti-asthma market. This year, the Company recorded 48% growth and achieved a double digit market share. The Company is currently positioned at No. 2 in the Anti-asthma market, which is estimated at Rs.4,592 Mn. with a growth rate of 20.4%. LUPIN LIMITED Annual Report 2007-08 ² 30 Key Products Of Lupin Respira Division Product Therapeutic Segment L-CIN Levofloxacin Esiflo Salmeterol+Fluticasone Budamate Formoterol+Budesonide Budate Budesonide Tiomate Tiotropium+Formoterol Telekast Montelukast Salbair Salbutamol ² Pinnacle The accent of the Company on chronic and lifestyle ailments is aided by this division. Through Pinnacle, the Company addresses chronic and lifestyle diseases, which are constantly on the rise. The division caters to a specialist's group comprising Cardiologists and Consulting Physicians. ORG IMS estimates the Cardiac Market in India to be around Rs.34,847 Mn with a growth rate of 23.4%. In the CVS segment, Lupin commands 5.1% of the market share and is positioned in the top 10 Companies for this segment. Key Products Of Pinnacle Division Product Therapeutic Segment Clopitab CVS Tonact CVS Ramistar CVS Lupenox CVS Nebistar CVS ² Segment Ranking 1 2 2 2 2 3 3 Segment Ranking 1 2 2 2 2 Lupin Diabetes Care The Lupin Diabetes Care division, launched in 2004, offers a distinctive product range, catering to the therapeutic areas of diabetes and diabetes related complications. Its core portfolio of offerings revolves around the Oral Diabetes Agents. The division also encompasses Diabetes Neuropathy Management. Additionally, the Company has strategically included specific cardio-products such as, Diabetic Antihypertensive and Diabetic Dislipidemic drugs, to better meet the needs of its target populace. ORG estimates the Diabetic market to be valued at Rs.11,128 Mn with a growth rate of 22.3%. Lupin has been growing faster than the market and has secured a position amongst the top 10 in the IPM in this segment. Key Products of Lupin Diabetes Care Division Product Therapeutic Segment Segment Ranking Misobit Miglitol 1 Telista Telmisartan 2 Gabastar Gabapentin 2 Matilda Mecobalamin 2 Lipril Lisinopril 2 Gluconorm Diabetics orals 3 ² Endeavour The Company's strengths in Cephalosporin and Antiinfectives, in particular, have been driven through Endeavour. Endeavour is a multi-specialty division, focussing on acute therapy areas and therefore, has a wide product portfolio comprising Antibiotics, Painmanagement, Gastrointestinal, Neutraceuticals and Anti-Osteoporosis products. The Endeavour team addresses leading Physicians, General Surgeons, General Practitioners, ENT, Gyneacologists and Paediatricians. The Anti-infective market is estimated at Rs.57,294 Mn, with a growth rate of 15%. Key Products Of Endeavour Division Product Therapeutic Segment Softovac Bulk Producers Cefaxone Ceftriaxone Injectables Doxcef Cefpodoxime Solids Signoflam Other Aceclofenac Comb. Segment Ranking 2 4 4 4 31 ² Lupin The Company's concerted focus on the semi-acute therapy is the crux of the Lupin division, which has enabled the Company to attain market leadership in the Anti-TB segment of IPM. In a Rs.3,162 Mn AntiTB market, Lupin commands 48% market share. As market leaders in this space, Lupin has embarked on an effort, which would redefine the treatment guidelines, based on conditions existing in India, under the aegis of Redefining Indian Expertise Based Tuberculosis Treatment (RIETT). Key Products Of Lupin Division Product Therapeutic Segment R-Cinex Anti-TB AKT Anti-TB Akurit Anti-TB R-CIN Anti-TB G-CIN Gemifloxacin Combutol Ethambutol & Comb. Pyzina Pyrazinamide Plain ² Segment Ranking 1 1 1 1 1 1 2 Maxter As the face of Lupin in the critical care segment and Anti-infectives, the Maxter division emulates the Company's objective of 'saving lives'. As a spin-off from the Endeavour, the division was launched in 2006-07. This division reaches out to interventionists and super-specialty doctors and has also ventured into the field of wound management. Key Products Of Maxter Division Product Therapeutic Segment Merotrol Meropenem Tazar Piperacillin+Tazobactam Ceff Cephalexin Oral Solids Cetil Cefuroxime Oral Solids Cefantral Cefotaxime Injectables Management Discussion & Analysis Segment Ranking 1 1 3 5 9 ² MindVision Lupin's forays into the burgeoning Neuro Psychiatry and Oncology segments are driven by this division. This year has been the first year of MindVision's operations since its spin off from the Pinnacle. Its brands fall under high growth therapeutic segments like epilepsy, stroke and migraine. CNS market is estimated to be Rs.17,590 Mn, growing at 17% and the Indian Oncology, market stands at Rs.1,900 Mn. Through this division the Company has ventured into Oncology which is the segment of tomorrow. Today, it is estimated that not more than 10-15% of people actually go for treatment of cancer as it is perceived to be expensive. However, with the growing infrastructure of insurance in the country, rising awareness and increasing availability of drugs, people are able to afford cancer treatment. Key Products Of MindVision Division Product Therapeutic Segment Stalopam Escitalopram Placidox Diazepam Arzu Aripiprazole Fibril Bulk Producers Dulot Duloxetine Citistar Citocholine ² Segment Ranking 2 3 3 5 6 6 Lupinova With its rural marketing initiative, through its Lupinova division, the Company is increasingly catering to the unmet needs of the rural populace that still constitutes around 70% of the Indian population. Looking at the challenges posed by these markets in terms of reach, the Company introduced a self sustained model that has helped it in successfully taking its products to 10 states, thus benefiting the rural patients in these areas. LUPIN LIMITED Annual Report 2007-08 32 Asia, Africa, Middle East and Latin America (AAMLA) FROM STRATEGISING TO CREATING GROWTH We aspire, we plan, we execute and we grow. Capitalising on the opportunities presented by the market, we have embraced inorganic growth as a strategy to re-inforce our presence in key pharmaceutical markets. 130 Rs. in Mn 329 478 1788 AAMLA Sales (Including Kyowa 07-08) 2004-05 2005-06 2006-07 2007-08 AAMLA During the year, AAMLA (including Kyowa for the period October 18, 2007 to March 31, 2008) recorded revenues of Rs.1,788 Mn. The division's most significant achievement of the year was the acquisition of Kyowa Pharmaceutical Industry Co. Ltd., in Japan, which successfully positioned Lupin amongst the top ten generic companies in the world's second largest pharma market. Lupin's focus in the AAMLA region is to introduce worldclass value-added products in multiple therapy areas. Its current basket of offerings comprises products from Anti- TB, Anti-infectives, Anti-asthma and the Cardiovascular segments. Over the last three-years, Lupin has built a presence in several key markets of these regions such as, Australia, UAE, Yemen, Kenya, Kuwait, Lebanon, Peru, Vietnam and Philippines. With 344 filings across the region during 2007, the AAMLA division is gearing for accelerated growth in years to come. Today, Lupin is one of the 3 Indian companies to have established a presence across the highly lucrative Gulf Cooperative Council (GCC) markets. 33 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview > CSR The acquisition of Kyowa in Japan successfully positioned Lupin in the top ten generic pharma companies in Japan 344 34 Number of Filings 243 220 321 AAMLA Regulatory Filings 2003-04 2004-05 2005-06 2006-07 2007-08 Mr. Vinod Dhawan, President - AAMLA & Business Development Japan - MajorAcquisition Currently estimated at US$ 65 Bn, Japan is the second largest pharmaceutical market in the world. While generic penetration presently is low (5-6% by value and 12-14% by volume) and entry barriers are high because of stringent regulatory guidelines, Japan specific molecules and a different patent environment, the potential is very large. With the ongoing pro-generic reforms being introduced by the government which encourage the use of generics in hospitals and substitution at the pharmacy level, the market is set to witness very significant growth in the future. Management Discussion & Analysis The government estimates that the generic market will grow to 30% by volume by 2012. The Japanese pharmaceutical market is unique. A number of molecules are developed and sold by Japanese companies only in Japan. Even blockbusters in other markets have different specifications, dosage forms and strengths in Japan. All these factors present entry barriers to potential entrants. LUPIN LIMITED Annual Report 2007-08 34 Taking into account this uniqueness, Lupin acquired Kyowa Pharmaceutical Industry Co. Ltd. in October 2007. Kyowa was established in 1954 as a pharmaceutical company predominantly selling over-the-counter (OTC) drugs. Today, it is amongst the top 10 generic companies in Japan, with over 50 years of history in manufacturing and marketing pharmaceutical products. For the period from October 18, 2007 to March 31, 2008, the consolidated sales of Kyowa was Yen 3,618.8 Mn (Rs. 1,315.4 Mn), with specialisation in CNS, cardiovascular, Gastro Intestinal and respiratory therapeutic segments. Kyowa is currently marketing more than 100 molecules in Japan. Kyowa has 58 Medical Representatives. They provide customers with comprehensive information on pharmaceutical products. Kyowa’s Manufacturing Facility One of Kyowa's key strategies is to become the leader in offering CNS generic drugs. Towards this goal, its field force numbering 58, covers 1,258 out of 1,379 psychiatry hospitals. Kyowa is recognised as an indispensable information provider in the CNS area. Kyowa has state-of-the-art research and manufacturing facilities and spends approximately 8% of its sales on R&D. With Lupin's support on various areas of R&D, regulatory, manufacturing and sourcing, coupled with Kyowa's experienced management team and infrastructure in Japan, the company is poised for accelerated growth in the years to come. 35 ROW Operations Concurrent to gaining momentum in US, Japan and Australia, Lupin has made significant inroads into the Rest of the World (ROW) markets. New launches and an expanded field force in the ROW regions were the key attributes. Africa The fiscal 2007-08 marks the first full year of the Company's operations in Nigeria. As part of its strategy to differentiate itself with complex products, the Company has achieved first to launch status on many products in the Nigerian market, thus facilitating access to quality medicines. With its basket of Antibiotics, Anti-asthma and Anti-TB drugs, the Company is primed to whittle a strong presence in the respiratory market of Nigeria. Today, Lupin is the only Company in this region to have a complete range of Metered Dose Inhalers. In line with its direct-to-market approach, it has already deployed 10 people on the ground in Nigeria. During the year, Lupin traversed beyond its already established presence in the Anti-TB segment in Kenya. The Company became the 'first to market' Cephalexin CEFF ER in the region. With the further expansion of its product portfolio, the Company looks forward to the opportunity of supplying to the Government of Kenya and NGOs in this region, such as Mission for Essential Drug Supplies, Kenya Medical and Supplies Agency as well as the Ministry of Health. Middle East Lupin has also made meaningful progress in the Middle East, in course of the year. Today, the Company is one amongst the few Indian entities present in this significant market. Management Discussion & Analysis Following the GCC accreditation of its facilities at Mandideep and Goa, the Company has received product approvals in Lebanon and Kuwait. The bygone fiscal also marked Lupin's foray into the markets of United Arab Emirates (UAE) and the Republic of Yemen. Subsequent to receiving approvals, the Company has launched 5 products in Yemen. Leveraging on its experience in serving international geographies, Lupin aims to reinforce its business in these markets through its value added Antibiotics and Cardiovascular products. It introduced rd the 3 generation antibiotic Cefdinir, as a first-to-market product. South EastAsia The bygone fiscal was the Company's first full year of onshore operations in Vietnam, one of the fastest growing st markets in South East Asia. Its 1 generation cephalosporin brand, Lucef, recorded an impressive performance during the year. The Company has also established its presence in the Anti-TB and Anti-asthma segments. Tuberculosis continues to remain a menace in Philippines. In December 2007, Lupin forayed into this high diseaseburdened country, through its Anti-TB brand 'Akurit'. With several filings in the Antibiotics space, the Company is already widening its horizons in this rich territory. Australia Strengthening Foothold Australia is one of the leading global markets with sales of A$ 10.5 Bn. Most of the world's major pharmaceutical companies are active in this market. All Australian citizens are covered under the Government's reimbursement plan called Pharmaceutical Benefits Scheme (PBS). Approximately one in every four prescriptions presented to pharmacists in Australia were filled with generic medicines in 2005. This level of use will almost LUPIN LIMITED Annual Report 2007-08 36 double in the next five years as more than half of the top 100 selling prescription medicines will come off patent. The generic pharmaceutical growth is supported by the Government's efforts for use of generic medicines through PBS reforms; ageing Australian population; and active substitution by pharmacists. Lupin established a wholly owned subsidiary in Australia to file its product registration and hold marketing authorisations. The Company has entered into alliances with some of the leading and fast growing players in the market. Lupin has filed 16 dossiers of generic products, which have a total market size of about A$ 850 Mn. Until 31st May 2008, eleven of these have received approval. The Company launched its business in Australia, during the last quarter of the financial year 2007-08. The products, which have been approved are Ceftriaxone, Cefotaxime, Cephalexin, Lisinopril, Simvastatin, Sertraline, Quinapril, Perindopril, Ramipril, Zolpidem and Amlodipine. Lupin has also participated in local government tenders and has been awarded tender for supply of injectable cephalosporin, during the year. CIS FROM ENTRY STEPS TO CONSOLIDATING OUR PRESENCE The CIS region is a fragmented but lucrative market , estimated at US$ 15.5 Bn. Since 2000, the Company has been building its business in the region with a focus on Russia (estimated market US$ 10.8 Bn) and Ukraine (estimated market US$ 2 Bn). During the year, the Company extended its footprint in Tajikistan, with the introduction of a herbal cough formulation, Dr. Kashel. The fast emerging economies of Russia, Ukraine, Kazakhstan and Azerbaijan in particular, are rich in natural resources and have been steadily increasing their per capita income. This propensity to spend on healthcare is ever increasing. All these factors, coupled with an ageing population, changing lifestyle and increased government spend, enhance the opportunity in this region. The CIS region also displays very strong brand preferences and loyalty. The region has also demonstrated ready and preferred acceptance for herbal based products. Lupin has bolstered its onshore presence, with teams focussed on each of these specific regions. The Company adopts a mix of DTM and partnered relationships, customised to the unique requirements of each country. To support its expanding business, the Company has 37 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview Having glimpsed the potential, we have already made significant inroads into the fertile Russian market. However, driven by our innate nature to grow to the next level, today, we are fast spreading our footprint to consolidate our presence across the opportunityrich CIS region. > CSR strengthened its field force, which will help improve market penetration and reach in these markets. The Company has 98 representatives working in the CIS region. The Company, through its supplies to local partners, also participates in the government tender business. The accent of the Company is on building strong brands, which would drive value for the Company in the years to come. During the year, the Company strengthened its presence in the Russian market through its brand 'Ribavin', an Anti-viral formulation. The Company is poised to build its other branded formulations viz. Softovac, One-Be, Ixime and Dr. Kashel. Leveraging its deep market understanding, Lupin is set to launch a new line of products catering to lifestyle ailments and herbals. The Company's business in CIS countries for the year 200708 clocked Rs.348 Mn. Six products were launched, during the year, in this region. Mr. Harish Narula, President - Corporate Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 38 Global Manufacturing, Quality & Supply Chain APIs - India Ankleshwar Mandideep Tarapur Vadodara 39 Formulations - India Japan Aurangabad Mandideep Sanda Goa Jammu Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 40 Active Pharmaceutical Ingredients (API) and Intermediates FROM BACKWARD INTEGRATION TO STRENGTHENING THE CORE A resilient foundation goes a long way in sustaining success. Having established a strong integration model, we are engaged in nurturing the API business to deliver superior quality products. Mr. Satish Khanna, Group President - API 41 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF Attaining a global scale of operations is the underlying principle, governing Lupin's API business model. It is only natural that the Company is a global leader in its chosen therapy areas > AAMLA > Financial Overview Sustainable growth in API and Intermediates has always been a significant contributor to the success of the Company. With sound process research and Intellectual Property management skills, Lupin has the ability to build expertise in developing and commercialising processes and products. During 2007-08, Lupin maintained its global leadership status in its key APIs and intermediates. Several complex, difficult to make APIs were also developed successfully. The Company's API business during the year, clocked in Rs.8,202 Mn with Rs.7,495 Mn from developing markets (including India), reporting a growth of 9%. > CSR THE LUPIN EDGE Attaining a global scale of operations is the underlying principle governing Lupin's API business model. Consequently, it is only natural that the Company is a global leader in its chosen therapy areas. Today, the Company has sculpted an enduring presence in the Anti-TB and Cephalosporins space. API Sales (Therapeutic Contribution %) 12 Others 2 13 Anti - TB CVS 73 Management Discussion & Analysis Cephalosporin LUPIN LIMITED Annual Report 2007-08 42 The Company's manufacturing capabilities are truly international standards. As many as 9 of the Company's API plants are US FDA approved. The year 2007-08 witnessed significant expansionintheTarapurandMandideepcapacities. Furthermore, the year under review also witnessed a steady increase in the filing of DMFs, EDMFs and COSs. GLOBALTB -AN INSIGHT Today, Multi Drug Resistant (MDR TB) and Extensively Drug Resistant TB (XDR TB) are emerging as major threats for high TB burden regions like Asia, Africa and Latin America. Funding from newer sources is pouring in for the treatment of MDR TB and Paediatric TB. TheCompanyisexpandingitsspectrumofofferingsin the Anti-TB range to include APIs in the MDR TB category. The twin areas of MDR TB and Paediatric TB provide avenues for Lupin to strengthen itsgloballeadershipandbecometheone-stop-shopfor globalTBsolutions. Lupin's Anti-TB products such as, Rifampicin, Pyrazinamide and Ethambutol as well as Cephalosporins such as, Cephalexin, CefaclorandtheirintermediatesarekeypillarsoftheCompany's success.In2007-08, two mainstay intermediates, 7ADCA and 7ACCA recorded significant growth in volumes. Additionally the Company continued its steady progress on developing Optically Active Building Blocks (OABB). The Company also maintained its thrust in Lisinopril and other Prils. Having directed a concerted focus on building Statins, it is optimistic about establishing a leadership position for these products in the yearstocomeaswell. Anti-TB units produced Units in Mn During 2007-08, the Company improved its margins through operational improvement and better product and business mix, which helped it sustain the adverse pricing pressures on Pen G. The Company has filed a total of 27 dossiers across various countries through GDF in 2007-08. Lupin's close association with the Revised National Tuberculosis Control Programme an initiative of the Government of India, continues as the Company is one of the chief suppliers of patient kits for this programme. 2788 ENCORE PERFORMANCE 2101 Mr. Naresh Gupta, President - API & Global TB As a pre-qualified supplier to the Global Drug Facility (GDF), Lupin was awarded a major long term contract for the supply ofFirstLine TBproducts, during theyear. 2004-06 2006-08 43 CRAMS The Contract Research and Manufacturing Services (CRAMS) market, in India, is on the threshold of exponential growth. The global CRAMS space is projected to touch US$ 64 billion by 2010 from US$ 34 billion in 2006. India's contribution to the total outsourcing market is slated to increase to 5.8% by 2010 from 2.2% in 2006, a CAGR of 46%. India has always been a preferred outsourcing hub. The following factors are responsible for driving the domestic CRAMSmarket: ! State-of-the-art infrastructure ! Advanced research proficiency ! A sustained and reliable regulatory environment ! Availability of trained manpower Additionally, the country is already moving up the value chaintoofferthe nextlevelofservices. North America, Japan and other parts of the world. Novodigm utilises a stage-gate methodology to increase focus on selected projects. It also created strong IP for several cost-effective and non-infringing processes. With strong in-house analytical development capabilities, Novodigm is proficient in the development and validation of the analytical method as well. These analytical development capabilities aid in new product development as well as stability studies and impurity profile studies.Ithaswell-equippedcGMPfacilitywhich is ISO14001 andOHAS18001compliant. In addition to focussing on the acquired offerings, the Company is keen on shifting some of its synergistic products to Novodigm. It is deploying Novodigm's manufacturing capabilities to produce intermediates such as OABB. The Company is now focussing on expanding the business of Novodigm through alliances, JVs and strategic partnerships. With a proven track record in APIs and intermediates, Lupin is confident of replicating its success in the CRAMS space. NOVODIGM - MAJOR ACQUISITION Lupin's foray into this segment was marked by its acquisition of Rubamin Laboratories Ltd., now rechristened Novodigm Ltd. Novodigm brings with itself, manufacturing and research assets as well as valuable relationships that help fuel Lupin's growth aspirations in this space. The Company exports over 90% of its products to global pharmaceuticals and specialty chemical companies in EU, Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 44 Research and Development FROM INVENTIONS TO INNOVATION We continuously hone our expertise to fuel the development of innovative, difficult-to-replicate entities as well as processes. With innovation brewing in our laboratories, we identify and adapt new technologies as well as scientific approaches to deliver sophisticated medicines. Scientific Pool - LRP Others 17% 48% MSc and M. Tech M. Pharm and Ph.D 35% The Company's Research and Development programme progressed well during the year. Guided by its mission to become an innovation led transnational pharmaceutical company, Lupin's scientific pool of over 440 researchers constantly strive to develop new technologies and products. Lupin Research Park (LRP) located at Pune, spread across 19 acres is the hub of the Company's research activities. The Centre harbours a culture that fosters innovation and helps shape inventions into innovative commercial products. Mr. Nilesh Gupta, President - Advanced Markets 45 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview > CSR The Company has the proficiency to develop a wide range of pharmaceuticals, across the value chain Today, the Company has the proficiency to develop a wide range of pharmaceuticals, across the value chain encompassing complex APIs to value-added difficult to develop formulations. During 2007-08 the total investment of the Company in R & D (excluding depreciation) was Rs.2,037.5 Mn, 7.5% of consolidated net sales. Lupin's research and development initiatives are spread across: ! Generics Research £ Process Research and Development £ Formulations Research and Development ! Advanced Drug Delivery Systems (ADDS) ! Intellectual Property Management ! New Chemical Entity Research ! Biotechnology Research Management Discussion & Analysis PROCESS RESEARCHAND DEVELOPMENT Lupin's success in the global generic pharmaceutical market can be attributed to its process research capabilities that has helped Lupin build a robust backward integrated model for complex and difficult to develop APIs. The synthesis of APIs today is governed by stringent norms as the process chemistry employed needs to be costeffective, hazard-free, non-infringing, adhering to pharmacopoeial quality and eco-friendly. In order to develop safe processes the Company deploys various emergent synthetic tools such as biocatalysis, metal-mediated chemistry, use of water as reaction media, as far as possible and novel separation techniques. LUPIN LIMITED Annual Report 2007-08 46 To sustain its competitiveness in the international market, Lupin has broadened its scope of activity of process research, for better understanding and expertise in the synthesis and characterisation of solids. It has developed expertise in the science of crystallisation. Lupin, today produces cost-effective APIs for different regulatory markets of the world in time, with acceptable and dependable quality. The Company's productivity is evidenced from the DMF filings made so far. During 200708, the Company filed 14 DMFs in the US and Five EDMFs/COS in Europe for APIs taking the cumulative number to 74 DMFs (US), 92 EDMFs (EU) and 16 COS (EU). The Company has initiated research in the highly specialised area of steroidal hormones. Towards this, Lupin has established high-tech infrastructure, in both research and manufacturing involving stringent safety and operational norms. FORMULATIONS RESEARCHAND DEVELOPMENT During 2007-08, 11 ANDAs in the US, seven MAAs in UK/Europe and two dossiers in Australia were filed. The cumulative bank of 62 ANDAs with several Para IV filings and 1938 dossiers for formulations for rest of the world bears testimony to Lupin's finished products research capabilities. The Company's ANDA focus has shifted to complex and difficult to develop molecules that offers a unique niche position. The Company's fast growing finished products business in Advanced Markets is strong testimony to its formulations research capabilities. ANDAApprovals Received DuringTheYear Sr. No. Molecule Therapy Area 1 Cefixime for Oral Suspension 200 mg/5 ml Cephalosporin Antibiotic 2 Simvastatin Tablets CVS 3 Ziprasidone Capsules (Tentative) CNS 4 Cefadroxil Capsules Cephalosporin Antibiotic 5 Amlodipine Tablets CVS 6 Carvedilol Tablets CVS 7 Lovastatin Tablets CVS 8 Pravastatin Tablets CVS 9 Cefadroxil for Oral Suspension Cephalosporin Antibiotic Aided by a wide product portfolio, the Company is consolidating its presence in the global generics space. Following the acquisition of Kyowa Pharmaceutical Industry Co. Ltd., Lupin now has a dedicated team focussing on the development of generics exclusively for the Japanese market. ADVANCED DRUG DELIVERY SYSTEMS (ADDS) In its journey towards becoming a specialty pharma company, Lupin has identified ADDS to be an important building block for its research initiatives and recognises this Cumulative Filings - Formulation Key Markets DMF (US) EDMF (EU) COS (EU) USA UK FRANCE (EU others) No. of Filings 9 9 21 No. of Filings 16 74 62 92 Cumulative Filings - API Key Markets During the year, the Company received ANDA approvals for nine products for the US market. The UK MHRA approval for Lisinopril underpins the Company's ability to submit high quality dossiers and gain approval in good stead. 47 area as an important growth driver for the future. Consequently, during the year sizeable investments were directed towards strengthening the Company's ADDS capability. The Company's ADDS initiative is guided by a Scientific Advisory Board comprising of internationally acclaimed scientists. The focus of ADDS research is on: ! Invasive and non-invasive Systems ! Oral Controlled Release Systems (OCRS) ! Solubilisation / Bioavailability Enchancing Technologies ! Pulmonary Drug Delivery Systems ! Taste Masking Technologies Lupin's research proficiency and experience have empowered the Company to deploy sophisticated technologies to offer contemporary solutions to the marketplace. Consequently, the Company is working towards setting up an in-house nano technology capability among several other technologies. This enabling technology is expected to further empower Lupin in developing unique solutions. In 2007-08, Lupin continued its concerted efforts in developing ADDS based products that are truly unique from a global perspective. These new products under development will offer added patient convenience, improve compliance and may also improve therapeutic efficacy in various disease states. The Company's 'Innovation Cell' comprising a pool of highly qualified scientists is engaged in shaping novel ideas into innovative technologies for developing value added products. Its primary focus areas are: ! Developing and enhancing the branded pipeline for the US Paediatrics business ! Using ADDS creating product-specific platform technologies for out-licensing ! Developing ADDS for the India Region Formulations and Rest of the World markets ! Providing support to the NCE Group for pharma development during Pre-clinical and Clinical stages Management Discussion & Analysis Dr. Ninad Deshpanday, President - Pharma R & D The Company is also in the process of setting up cGCP and cGLP clinical and laboratory facilities to conduct BioAvailability and Bio-Equivalence (BA BE) clinical studies, along with the requisite Bio-Analytical laboratory infrastructure. Lupin is progressing with ambitious plans. As a catalyst to achieving its growth aspirations, Lupin is also considering inorganic growth. The Company is actively scouting for strategic acquisitions, in-licensing agreements and alliances in the drug delivery space. ANALYTICAL RESEARCH Lupin has a state of the art analytical facility at LRP, with analysts supporting both API Process Research and Formulations Research. Besides analysis of samples during process and formulation development and stability studies, the Company has built a centre of excellence to study physical properties like polymorphism in both API and drug products, using Powder X-ray Diffraction, Solid State NMR and Differential Scanning Calorimetery. In addition, isolation/synthesis and characterisation of impurities in APIs and drug products is conducted with the latest LC/MS-MS and automated preparative high performance chromatography techniques and instrumentation. The Analytical Research Group also ensures that all processes and products transferred to plants meet regulatory requirements and expectations. LUPIN LIMITED Annual Report 2007-08 48 INTELLECTUAL PROPERTY MANAGEMENT At Lupin, creating intellectual property assets is an ongoing endeavour. Research is driven by scientists having expertise in IP management. Located at LRP, the Company's Intellectual Property Management Group (IPMG) plays a significant role in constantly evaluating its research portfolio to identify wealth creation opportunities. Lupin's wide spectrum of products comprising niche generic products, Para IV filings and diversification into newer therapy areas like oral contraceptives is all driven by IPMG. PATENTS FILED 600 Process 230 Pending 162 Granted 68 Formulations 168 NCE 202 Pending 177 Granted 25 Pending 155 Granted 13 NEW CHEMICAL ENTITY RESEARCH The process of creating intellectual wealth starts with judicious product identification, based on technological complexity, patent challenges and emerging opportunities. The Company believes that its NCE programme can be truly transformational and is committed to develop new and innovative healthcare products catering to different disease areas. The functional objective of this group is in tandem with Lupin's strategy of developing differentiated, value added products. Lupin has created a creditable pipeline of four Investigational New Drugs (IND) that focus on three different disease areas of Migraine, Psoriasis and Tuberculosis. The year 2007-08 witnessed significant progress in the development of these drug candidates. Additionally, noteworthy advances were made in the novel drug discovery programmes related to Type-2 Diabetes and Rheumatoid Arthritis. The IP team is responsible for the Company's patent challenges across the globe. Its key achievements during the year were reflected in the Ramipril and Cefdinir litigations and in the Perindopril outlicensing. The Company introduced its Cefdinir generic following a sucessful litigation and settlement with Abbott Laboratories and Astellas Pharma Inc., related to District Court litigation proceedings. Similarly, in the case of Ramipril litigation, the Court of Appeals for the Federal Circuit reversed a District Court decision on Ramipril and found the Aventis patent on Ramipril invalid. Ramipril is one of the ACE inhibitors used for the treatment of high blood pressure. Subsequently, the Company launched Ramipril in June 2008. During 2007-08, the Company received Euro 20 Mn from Laboratoires Servier, France for the sale of additional patents rights for Perindopril. The Company also believes in protecting its inventions and has developed a healthy basket of patents over the years. During the fiscal year the Company filed 97 patent applications and received patent grants for 37 patents, with five patents related to formulations and drug delivery technologies, 10 patents related to chemical processes and 22 patents related to new chemical entities. LL 2011 (AMIGRA) Lupin has developed a safe and non-toxic nasal spray for the prophylactic treatment of migraine. Encouraged by the compound's efficacy and safety profile during Phase II trials, the Phase III trial was initiated in eight centres in India. The New Drug Application would be filed after the review of Phase III findings. LL 3348 (DESORIS) In a bid to create an orally active curative that is efficacious and safe, Lupin has developed a herbal formulation for the treatment of psoriasis. The formulation has completed Phase I and Phase IIa clinical trials. Phase IIb clinical trials, spread over seven centres are in progress. Concomitantly, Lupin is also in the process of filing an IND with the US FDA to conduct clinical trials in USA. This project is being developed in collaboration with CSIR's NMITLI programme. 49 LL 4218 (DESOSIDE-P) As an extension to its Psoriasis programme, Lupin has also identified a novel molecule from a plant source. Being orally bioavailable, this pure compound has displayed promising anti-psoriatic activity in preclinical studies. This drug candidate has completed Phase I clinical trials. Currently, the compound is undergoing Phase II evaluation across seven centres in India. LL 3858 (SUDOTERB) The Company has successfully completed Phase I studies for its lead TB molecule (LL 3858) alone and in combination with standard Anti-TB drugs (LL 4858). Having submitted Phase I report to the DCGI in March 2008, the Company is awaiting permission for conducting Phase IIa studies. PRECLINICAL RESEARCH The Company's ongoing Novel Drug Discovery and Development efforts are directed towards identifying and developing new therapeutic leads for the treatment of metabolic diseases and inflammatory disorders. Metabolic Diseases PPAR Modulators: This programme has resulted in the identification of a novel PPAR modulator, with PPARa dominant agonist efficacy. Having displayed a good efficacy and safety profile, the compound LL 6531 has NCE Pipeline LL 2011 Anti-migraine (Amigra) LL 3348 Anti-psoriasis, Herbal (Desoris) LL 4218 Anti-psoriasis (Desoside-P) LL 3858 Anti-TB (Sudoterb) LL 6531 Anti-diabetic, PPAR Modulators Dr. B. N. Roy, Technical Advisor been selected for further development. Preparations are underway to take this molecule through an exploratory IND (eIND) with the DCGI, to further evaluate it in humans. DPP-IV Inhibitors: Lupin's DPP-IV programme has resulted in the identification of compounds with efficacy and selectivity profiles which are either comparable or superior to those of competitor molecules. PTP1B Inhibitors: The programme to identify inhibitors of protein tyrosine phosphatase 1b (PTP-1B), a drug target for Type-2 Diabetes and obesity, is progressing well with the identification of several compounds that are potent and highly selective. Preclinical Phase I Phase II Phase III Market Anti-diabetic, DPP-IV Inhibitors Anti-diabetic, PTP1B Inhibitors Anti-inflammatory, p38aMAPK Inhibitors Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 50 Cutting Edge Research Regulatory, Intellectual Property, Process, Formulation, Analytical and NCE Research Team 51 Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 52 Inflammatory Disorders The enzyme p38a mitogen-activated protein kinase (p38aMAPK) is a drug target involved in the etiology of rheumatoid arthritis. Lupin has identified several compounds which are now being evaluated in chronic arthritis models. Partnerships with Institutions Lupin is closely associated with an extensive network of CSIR laboratories and other academic institutions in India and abroad on various research projects. The Department of Science and Technology (DST), Government of India and Lupin have joined hands for the clinical development of Lupin's Migraine and Psoriasis molecules. The DST has selected the above two clinical development programmes of Lupin for funding and has committed over Rs. 100 Mn to support the said projects. BIOTECHNOLOGY In line with the Company's decision to foray into Biotechnology last year, further progress was made during this year. A dedicated team of scientists specialising in Biotech research have been working constantly to develop a basket of proteins. In order to sharpen the focus in this area a new independent Biotech facility is in the process of being set up in Pune, Lupin is also exploring collaborative arrangements to expedite its business in this segment. The Company is targeting both Biosimilars and New Biological Entities (NBEs), in order to develop cost effective products, free from side effects and in compliance with the existing regulatory guidelines. Biotech research will be the new engine of differentiation for the Company. Worldwide, as the NCE pipeline is drying up Biotech is fast emerging as the future growth driver. Going forward, it is estimated that over 40% of new entities will originate through the Biotech route. At Lupin, we take considerable pride in the quality that we ensure and assure The importance of quality cannot be undermined in any organisation. The customers, both in India and overseas, are becoming increasingly demanding with respect to cost, quality and delivery performance. Achieving these three, require imbibing the philosophy of 'Total Quality Management' into the organisation's culture. It has to become the very essence of the organisation. The Pharma industry is subject to strict quality control and scrutiny. India has the largest number of US FDA approved plants, outside of the US which exemplifies the increasing focus on quality assurance of the industry. At Lupin, we believe that quality is the mainstay of competitiveness. We have thus been working towards creating an environment of Quality and Compliance in line with global best practices. We believe that quality has to be built into the product and therefore employ practices to instill this culture throughout the organisation. Lupin's Corporate Quality Assurance (CQA) works as a link between manufacturing and its customers for ensuring that quality is built into the product itself. It ensures that the Company has a common quality system ensuring consistency, effectiveness and efficiency, during the manufacture of APIs and formulations at all sites. 53 Quality Control FROM QUALITY CONTROL TO INSTILLING QUALITY The CQA focusses on: ! ! ! ! ! Establishing Quality Standards Developing processes to achieve those standards Monitoring to ensure Compliance Upgrading technology standards Training personnel on quality aspects A team of 12 people is engaged in driving the quality philosophy of the organisation and assuring that global standards of good manufacturing are implemented in the best manner at every facility of the Company. The team also develops and implements Quality Policy and Guidelines for key systems and processes. CQA is supported by a team of over 500 people comprising the quality functions at sites responsible for implementing the policy and the guidelines laid down by CQA, ensuring complianceto regulatory requirements. Management Discussion & Analysis ON SITE QUALITY The CQA group monitors effectiveness of the site Quality functions through periodic quality reviews, periodic audits and review of compliance to regulatory inspections and customer audits. CQA also supports the site Quality organisation by providing necessary resources, technical guidance and training. The Company also continuously endeavours to upgrade skills and competence levels in QC / QA function by introducing advanced technologies and techniques. Enterprises that exemplify leadership in quality not only deliver quality products and services, but also effectively set industry benchmarks and redefine standards for those, who share their mission. At Lupin, we set our quality standards above and beyond regulatory and customer requirements and take considerable pride in the quality that we ensure and assure. LUPIN LIMITED Annual Report 2007-08 54 Human Resources FROM COMPETENCE TO EXCELLENCE Our yearning to deliver brilliance has compelled us to have by our side, the best-in-class talent that aligns its strides to our objectives. Our distinguished pool of intellectuals is impregnated with the right elements that drive success - competence as well as excellence. Mr. Rajan Dutta, President - Human Resources Development 55 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview At Lupin, we believe, our people are our biggest strength. We continuously nurture and motivate our human assets. We attribute our success so far, to the efficient and committed workforce of close to 9,000 Lupinytes across the globe. The Company's clear business goals are well entrenched amidst our people and each employee is proud to contribute towards the overall mission of the Company. The HR function is constantly engaged in providing opportunities to our people to equip them with the right skills to enable them to learn, perform and succeed. Coupled with guidance and motivation, we aim to groom the leaders for the Lupin of tomorrow. During the year, the Company's HR initiatives were focussed on: Increasing employee productivity ! Optimisation of costs ! Enhancing employee retention ! Management Discussion & Analysis > CSR ! The Company's clear business goals are well entrenched amidst our people and each employee is proud to contribute towards the overall mission of the Company Augmenting operational excellence and successful wage settlements THE ETHICAL SPINE Lupin's moral fiber rests on a strong set of values. The Company's workforce has truly imbibed the values comprising integrity, superior performance, entrepreneurship, customer orientation, working together and respect for people. We have designed exhaustive induction programmes to instill these values amongst new recruits. Through repeated interactions and communication with its employees, the Company further ensures that the essence of its values is not only understood but is also implemented. As an extension of the organisation culture, Lupin offers a high degree of empowerment and the LUPIN LIMITED Annual Report 2007-08 56 freedom to work as entrepreneurs. UDBHAV is one such programme, aimed at value coaching for new recruits in Operations and R&D. It orients new talent towards 'Workforce / Workplace Preparedness', before one is put on the job. RECRUITINGTALENT Given the competitive market scenario, Lupin's primary challenge is to develop a team that can sustain high growth. The Company has succeeded in creating a strong brand image in the marketplace. Lupin is an active recruiter at most leading technical and management institutes across the country, selecting only the best to add to its pool. Furthermore, the Company has built meaningful relationships with HR agencies and consultants to induct the best talent in the Company, globally. HR plays a close, well co-ordinated role in addressing the recruitment needs of the Company. ENSURINGTHE RIGHT ORIENTATION Cultivating young talent into leaders is an ongoing process. In its endeavour to create a reservoir of leaders, the Company has developed several customised training programmes. These initiatives are aimed at training, imparting product knowledge as well as the overall personal development. Some of these programs are : ACE :A CUTTING EDGE ACE is a result of Lupin's strategic tie-up with Indian Institute of Management, Ahmedabad (IIM A). This initiative imparts training in two phases of 4 days each, scheduled at a gap of a month and a half. It comprises interactive discussions, case studies, cross-functional sharing of experiences and field projects, and addresses the developmental needs of the Company's High Performing/ High Potential managers. LEAP LEAP is 4-day training programme for High Potential & High Performing executives, conducted in two phases of 2days each, scheduled at a month's gap. This has been designed to enhance the skill and competence level of executives, so that they can take on higher responsibilities. I LEAD As a learning intervention for Managers, it focusses on increasing self-productivity; enhancing strategic leadership input and building as well as leading diverse teams. EXCELL Aimed at executives, Excell focusses on personality development through self-understanding; selfmanagement and communication skills; organisation alignment and implementation of effectiveness, efficiency and productivity. FINANCE FOR NON-FINANCE This is a 2-day finance training for non-finance managers, which focuses on building fiscal awareness and understanding. FIRSTTIME MANAGERS This initiative is aimed at grooming individuals to take up managerial roles and responsibilities, enhancing their efficiency and productivity. 57 ICEBERG Iceberg is a specially designed programme for Managers and General Managers. It is about knowing and managing oneself in a demanding work environment; managing relationships with people, processes and customers, in a complex workplace; managing emotions and the art of dealing with others for productive results and ultimately, achieving the desired outlook. REACHING OUT Apart from induction programmes, SAMPARK is another initiative that facilitates communication between the senior management and the employees. Through this programme, the Chairman and the Managing Director address Lupinytes every quarter, to motivate them and reiterate the corporate philosophy. As the Company moves forward to achieve new milestones, it is constantly building its competencies through acquisition, training and further development of the best talent available in the industry. Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 58 Financial Overview FROM MANAGING FINANCE TO OPTIMISING FINANCIALS At Lupin, we have brought about a paradigm shift in the strength of our financial base. We have leveraged our financial expertise to propel the Company to achieve its future aspirations and development needs. Lupin recorded a 34% rise in consolidated revenues, up from Rs. 20,717 Mn in FY2006-07, to Rs. 27,730 Mn, in FY200708. The Company also generated Rs. 4,083 Mn in net profit, a 32% increase over the previous year's Rs. 3,086 Mn. Profit growth was triggered by the Company's sound performance in the Advanced Markets; success within the domestic market and Intellectual Property based revenues. These factors contributed towards the growth in Earnings before Interest, Depreciation, Tax and Amortisation (EBIDTA) by 31%, from Rs. 4,913 Mn in the previous year, to Rs. 6,423 Mn. EBIDTA margins were also higher at 23.7% of the net sales, despite a considerable drop in realisation, due to rupee appreciation. ROBUST GROWTH IN THE ADVANCED MARKET OF USA Lupin Pharmaceuticals Inc., (LPI) the Company's subsidiary reported a stellar performance, recording Formulation sales of Rs. 7,205 Mn, reflecting a growth of 103%. The Company has displayed a commendable performance in the US, both in the branded and generics space. The Company has commercialised 15 generic products, of which, four are market leaders. Consolidated Net Profit Rs. in Mn Rs. in Mn 3086 4083 27730 20717 Consolidated Sales (Gross) The triggers for the impressive performance in the FY 2007-08 inter-alia were : 2006-07 2007-08 2006-07 2007-08 59 > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview > CSR rd LPI has been reported by IMS health as the 3 fastest growing generic pharma company by prescriptions in 2007. In the branded segment, Suprax® prescriptions for the period grew by 55%. The Suprax® franchise was expanded with the addition of the Double Strength suspension and tablets, both of which, have been well received by the market. INDIA REGION GROWTH The Company has successfully broken its dependence on Acute therapy segments by developing its presence in the Chronic therapy area as well. The Company, while consolidating its strengths in Anti-TB and Cephalosporins also reflected strong growth in new therapy areas of Asthma, Diabetics and CVS. Additionally, it also successfully in-licensed products into the domestic Profit growth was triggered by the Company's sound performance in the Advanced markets; success within the domestic market and Intellectual Property based revenues formulation business to supplement its portfolio of products. The domestic formulation business continued to post a robust performance, with sales of Rs. 9,496 Mn, reflecting a growth of 26% - a rate higher than the IPM. During this period, the Company improved its market share from 2.4% to 2.7%. The domestic formulation business accounted for 34% of the Company's consolidated gross sales and continued to be a strong performer in FY 2007-08. SIGNIFICANT STEPS IN JAPAN During 2007-08, Lupin acquired Kyowa Pharmaceutical Industry Co. Ltd., Japan. This marks the Company's foray into a market, which it believes, would be very lucrative in the years to come. The prudential acquisition policies of the Company are also reflected in the cost of acquiring a SBU Wise Sales Rest of the World US & Europe 9% API Emerging Markets 30% 27% 34% IRF Mr. Ramesh Swaminathan, President - Finance & Planning Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 60 'critical mass' in a market that holds much potential for the future. The acquisition was EPS neutral, right from the start and would be accretive in years to follow. capacity at Indore. In line with its strategy of being vertically integrated, Lupin has put up various multi purpose plants for APIs. REST OFTHEWORLD MARKET EFFECTIVE RESOURCE PLANNING The Company continued to increase the filings related to product registrations in other parts of the world. While the operations grew modestly during the current year, it is expected that with the approvals clicking in, the turnover from these parts would grow in years to come. During the year, the Company commenced generating revenues through its subsidiary in Australia. The Company's borrowing increased negligibly, consequent to robust cash flows and judicious financial planning. The total cost of interest stood at Rs.373.5 Mn, representing about 5% average cost of borrowing, during the year. The total debt at the year-end stood at Rs.10,303 Mn, net of FCCB deposits. Debts excluding FCCBs, which are likely to be converted, were at Rs. 8,341.9 Mn. The debt-equity ratio was 0.78:1. Lupin's short-term debt programme received the highest rating from ICRA. STRATEGIC INITIATIVE The API and Intermediates business, which is based on a resilient business model, continued maintaining steady progress. During the year, Lupin acquired Novodigm Ltd., (erstwhile Rubamin Laboratories Ltd.) Vadodara. This acquisition would enable the Company to set up its strategic initiative in the CRAMS segment. The Company recorded basic Earnings Per Share of Rs. 50.01, up 32% from the previous year. The Board has recommended a dividend of 100% i.e. Rs.10/- per equity share of the face value of Rs.10/- each (including a special dividend @ 50% i.e. Rs. 5/- per equity share) absorbing a sum of Rs. 960.3 Mn, inclusive of tax on dividend. INTELLECTUAL PROPERTY BASED REVENUES The tax obligations of the Company, including FBT, were higher at Rs. 1,318.0 Mn, compared to Rs. 988.1 Mn in the previous year. However, the effective rate for current tax on a stand alone basis stood at 14.8%, as against 19% in the previous year. The Company has increased its reserves and surplus by Rs.4,046.3 Mn to Rs.11,976.0 Mn. Lupin earned a significant income from the sale of additional patent rights for Perindopril from Laboratoires Servier, France. Euro 20 Mn were added to the Company's total revenues on this count. This follows the pattern set in the previous year, when similar revenues were generated. It is an endorsement of the Company's Research and IP prowess. R&D SPEND Lupin has allocated 7.5% of its overall consolidated net sales for its R&D operation. With an increase in sales, the R&D spend of the Company is on a rise. The total expenditure (excluding depreciation) on Research and Development, during the year stood at Rs.2,037.5 Mn. CAPACITY EXPANSIONS During 2007-08, the capital expenditure, including assets (net) acquired on acquisition of subsidiaries, was Rs. 3,650.6 Mn. The Company commissioned its formulations plant at Jammu and is now developing fresh CHALLENGES Price erosion in the US is one of the biggest threats faced by Lupin. The FOREX markets continue to remain volatile. However, the Company has appropriate hedging strategies in place to sustain its overall margins. Given price and cost related pressures, margin maintenance and improvement thereon, warrant increased focus. Lupin is also encountering the Drug Price Control Order challenge, which has encompassed the entire Indian pharmaceutical space. INTERNAL CONTROL SYSTEMS The Company has a sound internal control system commensurate to its size, scale of business and complexity 61 of operations. Clearly defined policies, procedures and inbuilt checks and controls supplement the internal control procedures. A well established and empowered system of internal audit independently reviews the financial and operational controls and reports deviations, if any, and further enables course correction, as required. The Company is constantly engaged in practicing the best financial and operational control systems, as per international practices and standards. The Company operates on the 'SAP' platform, which is a well-acclaimed ERP solution. Mr. Sunil Makharia, Executive Vice President - Finance A reputed firm of Chartered Accountants M/s Khimji Kunverji & Co., are engaged as the internal auditors who submit their reports to the Audit Committee of the Board, which reviews the same and provides guidance on measures to be initiated to further enhance the efficiency and effectiveness of this vital control system. RISKS,CONCERNS &THREATS The Company has adopted a risk management system that is designed to identify, analyse and mitigate the operational and business risks. The executives implement measures for risk mitigation, in consultation with the management and continually review the corrective actions to enhance the efficacy of the system. The Company had appointed Deloitte Touche Tohmatsu India Pvt Ltd (Deloitte) to assist in designing the Risk Management Framework and related process. The risk of over dependence on few markets is being addressed by the Company through its prudent business strategy of identifying and penetrating other potential pharma markets across the globe. The Company's global footprint extends to most of the large pharma markets of the world, with its products available in over 50 countries, including advanced markets such as, North America and Europe. The Company also pursues a prudent policy of growing and obtaining a position in critical markets of the world through the inorganic route, subject to the acquisition offering strategic fit to its operations. Having established its leadership in the Anti-TB and oral Cephalosporin segments, the Company has progressed towards a robust formulations business comprising a wide Management Discussion & Analysis product mix, covering critical and chronic disease areas. It has circumvented the risk of overdependence on few products/therapy areas, through its wide portfolio offerings. The Company develops, manufactures and markets a wide range of quality, affordable generic and branded generic formulations and APIs for the developed and developing markets of the world. It is amongst the world's largest manufacturers of drugs that combat tuberculosis bacterial infections, with significant presence in the areas of Diabetics and Asthma. In the India Region, the Company is focussed on enhancing its offerings for the Chronic Therapy areas. Through its strengths in backward integration, ability to master complex chemistry, process and products, global scale, skills in sterile manufacturing, synthetic process development, fermentation and through its global reach with long terms contracts, its expertise and competencies are leveraged to counter the highly price sensitive API and Intermediates markets. Its strengths in API and Intermediates play a crucial role in maintaining the competitive positioning of its Formulation offerings to the advanced markets. The threats of price erosion of generics in the advanced markets is countered through the prudent selection of the product portfolio, accent on value added and complex products, strict vigil and control over cost, sharpening the supply chain management, leveraging its strengths in backward integration, economies of scale and quality differentiation. The Company positioned itself as a quality supplier, with impeccable service standards, thereby, providing itself the lever of being the 'supplier of choice'. LUPIN LIMITED Annual Report 2007-08 62 The Company believes that its focussed, productive and dedicated sales team for the branded space in the US and innovative promotional campaigns, together with the introduction of line extensions, would further extend the brand franchise of Suprax®. The Company has a dedicated regulatory cell comprising experienced, qualified and trained personnel, conversant with regulatory requirements, working in close proximity with the Research team. The accent is on attaining quality filings tuned to the diverse needs, requirements and expectations of varied regulatory authorities, across the world and thereby, aim at speedier approvals. Lupin has, over the years, built a relationship driven, multisupplier model for its raw materials, services and finished goods needs that provides a natural hedge against the failure or inability of any supplier. Procurements by a focussed and specialised team ensures that the benefit of competitive pricing is obtained, while maintaining the highest quality standards. The cost competitiveness, ability to provide high quality and niche products covering wide therapeutic areas, long term alliances and partnerships ensuring stable orders, provide the naturalhedgeagainstsalesrisk. The Company's business can be affected by foreign exchange fluctuations. The Company hedges its risk through forward exchange contracts and derivatives. Lupin believes that it has the requisite competencies to handle varied risks and is continually evolving proactive strategies to counter the same and emerge successfuly. OPPORTUNITIES,STRENGTHSAND OUTLOOK With its strengths in APIs, formulations, R&D, vertical integration, cost competencies, economics of scale, world class manufacturing facilities, marketing and distributions prowess, the Company is well equipped to capitalise the opportunities that are set to arise in future. Lupin looks at the future with confidence, as it moves along its journey of excellence and superior performance. As a socially responsible organisation, we strive to take care of the less privileged sections of our society. We extend our expertise to transform the lives of our people and make a difference to the society. Lupin is committed to the challenging task of becoming a proactive partner in nation building through the Lupin Human Welfare & Research Foundation (LHWRF). Initiating the programme of Rural Development within a small number of 35 villages, LHWRF has now succeeded in revitalising, revamping and recreating life in 2,200 villages in Rajasthan, Madhya Pradesh, Maharashtra and Uttarakhand States of India, which has led to LHWRF emerging as one of the largest NGOs in the country. The Foundation has been successful in making a big difference in the development of poverty-ridden villages, and especially in the life of the poorest of the poor and empowermentofa large number ofwomeninthese areas. Today, LHWRF, on its part, is a catalyst and an observer of a self-evolving, self-sustaining spectacular transformation. At LHWRF, the Company has learnt far more from rustic traditional wisdom and the villagers will to develop together in a converged and cooperative manner, than it could teach them. 63 Corporate Social Responsibility FROM PROVIDING HELP TO TRANSFORMING LIVES > Industry Overview > CIS > API > Advanced Markets > R&D > HR > IRF > AAMLA > Financial Overview > CSR THE KEY FOCUSAREAS OFTHE FOUNDATIONARE: SIGNIFICANT UNDERTAKINGS ! Lupin is working towards developing two major programmes, one targeting the youth and the other, the landless as well as the poor by empowering them through Animal Husbandry. Both these programmes are aimed at uplifting 21,000 BPL (Below Poverty Line) families to above the poverty line, to lead prosperous lives. ! Economic Development Agriculture + Animal Husbandry + Rural Industry & Microfinance + Social Development Health + Education + Women Empowerment + Infrastructure Development + Today, LHWRF is indeed recognised as a pioneer in undertaking several unique initiatives, within its key focus areas. ANOTHERYEAR OF SERVING THE COMMUNITY ESTABLISHMENT OF KAUSHAL INSTITUTE The Ministry of Rural Development, Government of India, has agreed, in principle, to sanction a massive project worth Rs.15 crore to train 15,000 youngsters and ensure the employment of 80% of them. The programme will also provide self-employment to 20% youth in seven districts across the State of Rajasthan. This initiative is aimed at addressing the unemployment issue prevalent in these districts and kindle a ray of hope in the minds of youth towards their future. During 2007-08, the Foundation has undertaken significant steps towards improving the quality of life of farmers in the country. Management Discussion & Analysis LUPIN LIMITED Annual Report 2007-08 64 DAIRY DEVELOPMENT ADDRESSINGWATER CRISIS LHWRF has undertaken this initiative to provide sustainable income through out the year, against the vagaries of the monsoon. The programme, costing nearly Rs. 8.5 crore, is expected to provide 6,000 buffaloes, along with vermi-compost and chilling plant to bring about 6,000 most vulnerable families into the main stream of life. LHWRF has embarked on an ambitious initiative of restoration of traditional tanks and ponds in the Bharatpur district. As a majority of wells are located near ponds, de-silting of these ponds will not only provide water for multiple uses, but it will also generate the requisite awareness for water conservation for the future. LHWRF has setup a target to dig 55 ponds in one block of the district. PUBLIC PRIVATE PARTNERSHIPS LHWRF has signed MoUs with Mother Dairy and National Dairy Development Board. According to the agreement, Mother Dairy plans to set up chilling plants and bulk coolers in villages. LHWRF is expected to ensure a minimum of 2,000 litres milk collection to these chilling centers. These chilling centers will be monitored by Lupin and run by trained women members and Mother Dairy will offer performance based incentives. Over Rs.5 crore is expected to be invested to promote this activity in the Bharatpur District. Additionally, LHWRF has also undertaken two water resource development projects at its Pune center. The Government has already sanctioned one of the two projects, costing Rs. 2 crore, for providing drinking water in the rural areas of the Pune district. The development of a watershed is the other project , with an estimated cost of Rs. 1.8 crore, which is being undertaken in association with NABARD. This project is going to capture the run-off water for conservation and gainful utilisation. “I had never imagined that I would become a successful dairy owner with only 2 acres of land. Currently, my earning through this integrated model dairy is Rs.15,000 to Rs. 20,000 per month. Earlier, my source of income was sufficient only for producing cereals for my family consumption. Mr. Sohan Singh Today, the situation has changed and my sources of income are Dairy, Vermi-compost, Bio-gas, natural insemination, milk collection center and animal feed. This has been possible because of the motivational, technical and financial support from Lupin.” 65 The Foundation is the architect of diverse programmes targeted at the overall upliftment of the village through economic, social and infrastructure development EMPOWERINGWOMEN Having formed women Self Help Groups (SHG) in each adopted village, Lupin has begun its drive towards providing women with their worthy status in the society at social and economical levels. These SHGs are linked with banks for financial assistance and are provided with the required technical know-how to start income generation activities. Today, LHWRF has formed as many as 2,500 Self-Help Groups (SHGs), with a total membership of about 28,750 women. While all the members of SHGs are insured, 70% of them are linked with income generation activities. Additionally, Lupin's initiative under Janni Suraksha Yojna of the Central Government, promotes institutional delivery to reduce Infant Mortality Rate (IMR) and Mother Mortality Rate (MMR). Another programme, “Beti Ek Anmol Ratan”, addresses the issue of gender disparity. This concept is already gaining popularity and is expected to eradicate gender discrimination. The Foundation is the architect of diverse programmes targeted at the overall upliftment of the village through economic, social and infrastructure development. These programmes assist impoverished families to become self-reliant and live a happy and prosperous lives. UNESCO Team visits Mr. Sohan Singh's Dairy farm FARMER’S SUCCESS STORY Sohan Singh's 2 acres of land was hardly enough to produce cereals for meeting his families consumption needs. Having received timely aid from LHWRF, today Sohan enjoys a sustainable means of income that has paved the way for a life of dignity. LHWRF established one model dairy for Sohan Singh. After ensuring sufficient production of milk, a cooling plant with a capacity of 2,000 liters has been commissioned by Mother Dairy. With this initiative, Sohan Singh draws a commission of Rs. 0.70 per litre. A latest Management Discussion & Analysis Chinese model biogas plant was also installed that ensures optimum utilisation of cow dung to provide cooking gas for women, slurry for soil enrichment and light for children to read. Furthermore, the Foundation also arranged for a loan from Rashtriya Mahila Kosh to purchase Murrah buffaloes, which alone ensured a monthly income of Rs. 5,000-6,000. Hidden in the success of Sohan Singh, is the fact that LHWRF presents a model for the farmers of the country to come out of their distress. LUPIN LIMITED Annual Report 2007-08 66 Five Years Financial Summary CONSOLIDATED BALANCE SHEET As at March 31, (Rs. in million) 2004 2005 2006 2007 2008 401.4 3,906.2 4,307.6 401.4 4,492.4 4,893.8 401.4 5,831.4 6,232.8 803.4 7,929.7 8,733.1 820.8 11,976.0 12,796.8 3,042.5 905.6 3,948.1 3,972.0 600.1 4,572.1 4,409.5 4,839.5 9,249.0 3,911.2 4,736.4 8,647.6 7,080.6 4,948.2 12,028.8 941.8 934.6 956.1 1,027.2 1,248.0 8.2 12.0 15.8 9,205.7 10,412.5 16,453.7 18,407.9 26,168.1 6,600.4 1,389.8 5,210.6 171.7 5,382.3 7,346.6 1,717.7 5,628.9 698.1 6,327.0 8,561.3 2,095.6 6,465.7 252.1 6,717.8 9,527.9 2,382.1 7,145.8 825.5 7,971.3 14,858.8 4,697.5 10,161.3 963.8 11,125.1 - - - - 1,872.3 26.4 26.4 28.0 28.0 58.2 - - 17.1 1.3 141.2 2,309.9 2,276.1 301.6 2,003.8 6,891.4 2,614.7 2,549.5 270.7 1,754.3 7,189.2 3,429.1 3,111.6 4,774.2 1,999.6 13,314.5 4,298.1 4,038.5 3,844.5 2,448.2 14,629.3 7,893.4 7,439.0 2,741.8 2,367.0 20,441.2 2,344.6 749.8 3,094.4 3,797.0 9,205.7 2,735.9 394.2 3,130.1 4,059.1 10,412.5 3,146.9 476.8 3,623.7 9,690.8 16,453.7 3,515.2 706.8 4,222.0 10,407.3 18,407.9 6,018.8 1,451.1 7,469.9 12,971.3 26,168.1 I. SOURCES OF FUNDS Shareholders' Funds Equity Share Capital Reserves and Surplus Loan Funds Secured Loans Unsecured Loans Deferred Tax Liabilities (Net) Minority Interest [31.03.2007 Rs.27/-] Total 94.5 II. APPLICATION OF FUNDS Fixed Assets Gross Block Less: Depreciation and Amortisation Net Block Capital Work-in-Progress Goodwill on Consolidation Investments Deferred Tax Assets (Net) Current Assets, Loans and Advances Inventories Sundry Debtors Cash and Bank Balances Loans and Advances Less: Current Liabilities and Provisions Current Liabilities Provisions Net Current Assets Total 67 CONSOLIDATED PROFIT AND LOSS ACCOUNT Year ended March 31, (Rs. in million) 2004 2005 2006 2007 2008 12,638.5 13,122.8 17,503.4 20,716.5 27,730.1 486.5 511.4 549.4 579.4 666.4 12,152.0 12,611.4 16,954.0 20,137.1 27,063.7 Other Income 513.5 234.1 741.0 1,990.5 2,064.5 Total Income 12,665.5 12,845.5 17,695.0 22,127.6 29,128.2 Cost of Materials 6,224.6 6,441.0 8,259.2 9,320.8 11,638.0 Personnel Expenses 1,100.5 1,329.1 1,689.6 2,199.9 3,076.0 Manufacturing and Other Expenses 2,608.1 3,507.1 4,769.6 5,694.1 7,991.2 9,933.2 11,277.2 14,718.4 17,214.8 22,705.2 2,732.3 1,568.3 2,976.6 4,912.8 6,423.0 Interest and Finance Charges 525.9 282.5 312.8 372.2 373.5 Depreciation and Amortisation 295.3 336.2 408.8 466.1 647.4 1,911.1 949.6 2,255.0 4,074.5 5,402.1 Current Tax 471.7 34.6 402.6 779.6 1,022.6 Deferred Tax 46.3 (7.2) 28.0 128.5 180.6 - - 90.7 80.0 114.8 1,393.1 922.2 1,733.7 3,086.4 4,084.1 Extraordinary Items (Net of Tax) 508.9 - - - - Net Profit before Minority Interest and Share of Loss in Associate 884.2 922.2 1733.7 3,086.4 4,084.1 16.2 3.8 3.8 0.8 1.3 - - - - 0.3 868.0 918.4 1,729.9 3,085.6 4,082.5 PARTICULARS Sales (Gross) Less: Excise Duty Sales (Net) Total Expenses Profit before Interest, Depreciation, Tax and Extraordinary Items Profit before Tax and Extraordinary Items Fringe Benefit Tax Net Profit before Extraordinary Items Minority Interest Share of Loss in Associate Net Profit Note: Figures for the previous years have been suitably regrouped to make them comparable. Five Year Financial Summary LUPIN LIMITED Annual Report 2007-08 68 Reports & Financials 69 Directors' Report 79 Corporate Governance Report 96 Auditors' Certificate on Corporate Governance 97 Auditors' Report 100 Financial Statements 141 Auditors' Report on Consolidated Financial Statements 142 Consolidated Financial Statements 182 Section 212 Statement 183 Financial Information of Subsidiary Companies 104 Schedules Forming Part of the Balance Sheet SCHEDULE 1 - SHARE CAPITAL Authorised 100,000,000 (previous year 100,000,000) Equity Shares of Rs 10/- each TOTAL Issued, Subscribed and Paid-up 82,080,895 (previous year 80,344,564) Equity Shares of Rs 10/each fully paid up TOTAL As at 31.03.2008 Rs. in million As at 31.03.2007 Rs. in million 1,000.0 1,000.0 1,000.0 1,000.0 820.8 803.4 820.8 803.4 Note : Of the above equity sharesi) 37,311,048 (previous year 37,311,048) Equity Shares of Rs. 10/- each were allotted as fully paid-up without payment being received in cash, pursuant to the Scheme of Amalgamation with erstwhile Lupin Laboratories Limited. ii) 40,152,494 (previous year 40,152,494) Equity shares of Rs 10/- each have been allotted as fully paid-up bonus shares by way of capitalisation of General Reserve. iii) 131,167 (previous year 50,936) Equity Shares of Rs. 10/- each, fully paid-up have been allotted pursuant to " Lupin Employees Stock Option Plans". [Refer note no.14(a) of Schedule 17(B)]. Particulars of options on unissued share capital [Refer note no.14(a) of Schedule 17(B)]. iv) 1,656,100 (previous year Nil) Equity Shares of Rs. 10/- each, fully paid-up have been allotted on conversion of Foreign Currency Convertible Bonds in accordance with the terms of issue. [Refer note no.20(a) of Schedule 17(B)]. Schedules (Rs. in million) **** 58.1 9,527.9 8,561.3 176.3 2,779.2 4.9 0.4 2,226.8 1,200.0 37.8 2,382.1 2,095.6 147.8 1,493.7 - 0.9 21.0 649.1 466.1 (0.1) (13.2) (172.6) 179.6 1.0 219.8 4,697.5 2,382.1 4.2 32.0 10,161.3 7,145.8 963.8 11,125.1 825.5 7,971.3 **** 20.3 7,145.8 Particulars Gross Block # Depreciation # Freehold Land (79.9) Buildings (79.9) (40.3) Plant , Machinery and Equipments (223.7) (170.0) Furniture and Fixtures (4.9) (4.2) Vehicles (0.3) ## Intangible Assets Goodwill (0.3) (0.1) Computer softwares (29.4) (25.6) # Previous Year Rs. Nil ## Rs. 20,168/8. Depreciation for the year includes Rs. 1.7 million (previous year Rs. Nil) being depreciation capitalised as pre operative expenses [Refer note no. 4 (b) of Schedule 17 (B)]. 6. Vehicle of a subsidiary company located in Australia is under a lien towards loan taken from bank. 7. Deductions/adjustments in the Gross Block and Depreciation and Amortisation include adjustments on account of exchange gain on translation into INR as under: (Rs. in million) (0.3) 5.2 (17.0) 251.8 (324.9) 14,858.8 233.4 9,527.9 Gross Block Depreciation and Amortisation Net Block As at Additions on Additions Deductions/ As at Up to Additions on For the Deductions/ Upto As at As at April 01, acquisition of Adjustments March 31, March 31, acquistion of Year Adjustments March 31, March 31, March 31, 2007 subsidiary 2008 2007 subsidiary 2008 2008 2007 companies*** companies*** 27.5 471.5 (79.9) 578.9 578.9 27.5 148.3 86.8 235.1 11.9 3.9 15.8* ** 219.3 136.4 2,235.0 554.0 571.3 (79.6) 3,439.9 361.0 243.0 90.2 (40.3) 734.5 2,705.4 1,874.0 6,858.8 1,534.6 1,514.9 (145.2) 10,053.5 1,915.3 1,075.5 512.3 (115.8) 3,618.9 6,434.6 4,943.5 179.4 36.9 46.5 (4.2) 267.0 51.6 25.3 18.5 (3.9) 99.3 167.7 127.8 20.8 5.9 2.0 1.3 27.4 4.5 2.1 2.3 0.7 8.2 19.2 16.3 * Amounts written off in respect of Leasehold Land for the period of lease which has expired. ** Rs. 45,166/-. *** Refer note no. 19 (a) of Schedule 17 (B) **** Rs.35/Notes : 1. Cost of Buildings include cost of shares in co-operative societies of Rs.1,000/- (previous year Rs.1,000/-). 2. Capital Work-in-Progress include capital advances paid, machinery under installation/in transit and construction and erection materials (including those lying with contractors) and pre-operative expenses. 3. Capital Work-in-Progress includes for project under construction of an Indian subsdiairy : a) Rs. 86.8 million ( previous year Rs Nil ) on account of Advances against Project Contracts. b) Rs. 8.7 million ( previous year Rs Nil ) on account of Project Development Expenditure Account. [Refer note no.4 (b) in Schedule 17(B)] c) Rs. 97.2 million ( previous year Rs. Nil ) on account of building under construction, construction material and machinery equipments at site. 4. Additions to Fixed Assets and Capital Work-in-Progress includes Rs. Nil [ previous year Rs. 1.3 million] on account of exchange differences (net). 5. Additions to Fixed Assets include items of fixed assets aggregating to Rs. 296.5 million (previous year Rs. 112.2 million) located at Research and Development Centres of the Company. Freehold Land Leasehold Land Buildings Plant, Machinery and Equipments Furniture and Fixtures Vehicles Intangible Assets - Goodwill - Computer softwares TOTAL Previous Year Capital Work-in-Progress TOTAL Particulars SCHEDULE 5 - FIXED ASSETS 149 LUPIN LIMITED Annual Report 2007-08 154 Schedules Forming Part of the Consolidated Profit and Loss Account Year Ended 31.03.2008 Rs. in million Year Ended 31.03.2007 Rs. in million 367.5 62.6 87.5 1,127.2 139.0 56.4 32.9 1,143.2 0.2 1.5 1.4 147.6 1.4 205.8 20.3 13.9 11.7 143.8 8.8 192.2 SCHEDULE 12 - OTHER INCOME Export Benefits and Other Incentives Income from Research Services Income from Product Registration Services (Dossiers) Income from Sale of Patent Applications Dividend on Long Term Investments - Trade [31.03.2008 - Rs. 8,820/- ; 31.03.2007 - Rs.6,615/-] Dividend on Long Term Investments - Non Trade Dividend on Short Term Investments - Non Trade Interest on Long Term Investments - Non Trade Interest on Fixed Deposits with Banks [Tax Deducted at Source Rs. 1.5 million (previous year Rs. 0.7 million)] Other Interest (net) [Tax Deducted at Source Rs.0.5 million (previous year Rs. 0.5 million)] Insurance Claims Compensation received [Refer note no.15 of Schedule 17(B)] Exchange Rate Diffference on translation (net) Credit balances written back Provision for Doubtful Debts/Advances no longer required written back Profit on Sale/Disposal of Investment in a subsidiary company Miscellaneous Income [Tax Deducted at Source Rs.0.4 million (previous year Rs.0.6 million)] TOTAL 40.3 0.2 1.4 51.3 15.1 55.1 18.2 21.1 87.4 2,064.5 1,990.5 SCHEDULE 13 - COST OF MATERIALS Raw and Packing Materials Consumed Purchase of Traded Goods 10,195.1 3,574.9 7,369.0 2,461.6 2,422.6 1,912.8 748.4 - 5,303.0 2,422.6 (2,132.0) (509.8) 11,638.0 9,320.8 2,627.0 257.0 192.0 3,076.0 1,898.5 162.2 139.2 2,199.9 Opening stock of Finished Goods (including Traded Goods) and Work-in-Process Add: Stock Acquired on Acquisition of subsidiaries [Refer note no. 19(a) of Schedule 17(B)] Less: Closing stock of Finished Goods (including Traded Goods) and Work-in-Process Increase in Stock of Finished Goods (including Traded Goods) and Work-in-Process TOTAL SCHEDULE 14 - PERSONNEL EXPENSES Salaries, Wages and Bonus Contribution to Provident and Other Funds, Gratuity Welfare Expenses TOTAL 155 SCHEDULE 15 - MANUFACTURING AND OTHER EXPENSES Processing Charges Consumable Stores and Spares Repairs and Maintenance: - Buildings - Plant and Machinery - Others Rent Rates and Taxes Insurance Power and Fuel Contract Labour Charges Excise Duty (net) Selling and Promotion Expenses Commission, Brokerage and Discounts [Including cash discount of Rs.3.8 million (previous year Rs.4.7 million)] Freight and Forwarding Lease Rent and Hire Charges Postage and Telephone Expenses Travelling and Conveyance Legal and Professional Charges Donations Clinical and Analytical Charges Loss on Sale/Discard of Fixed Assets (net) Bad Debts Export Incentive receivable written off [Refer note no. 18 of Schedule 17(B)] Provision for Doubtful Debts Provision for Diminution in value of Long Term Investments Directors Sitting Fees Exchange Rate Difference (net) Miscellaneous Expenses (includes Printing and Stationery, Vehicle Expenses Product Registration Fees, Audit Fees, etc.) TOTAL SCHEDULE 16 - INTEREST AND FINANCE CHARGES Interest on Debentures Interest on Fixed Loans Others TOTAL Schedules Year Ended 31.03.2008 Rs. in million Year Ended 31.03.2007 Rs. in million 256.4 669.8 182.9 488.5 61.2 161.5 110.1 124.5 54.8 128.7 1,129.4 205.8 201.3 1,518.5 448.9 56.4 113.7 87.2 44.9 47.5 95.9 905.2 164.1 79.7 1,002.2 345.2 396.3 92.3 100.5 507.5 563.2 45.0 320.8 23.7 4.5 134.5 329.3 46.1 80.4 397.6 461.1 40.0 337.5 12.9 17.0 - 13.0 3.5 0.8 287.8 426.9 0.9 95.8 262.1 7,991.2 5,694.1 10.4 50.5 312.6 373.5 5.8 56.4 310.0 372.2 LUPIN LIMITED Annual Report 2007-08