Plot No. 2, Maitri Vihar, Ameerpet, Hyderabad - 500 038. www.aurobindo.com
Delive ring on promises
Annual Report 2005-2006
Concept, Research & Design - CAPRICORN Printed at Kala Jyothi, Ph : 040-27645539 A Glossary Some of the terms used in the annual report are briefly explained below:
ANDA Abbreviated New Drug ERP Enterprise Resource Planning Application (to the %DA) %CCB %oreign Currency Convertible ANVISA Agência Nacional de Vigilância Bond Sanitária (National Health %D% %inished dosage form Surveillance Agency Brazil) HIV Human Immunodeficiency Virus API Active Pharmaceutical Ingredient IPR Intellectual Property Rights ARD Analytical Research Department MCC Medicines Control Council, South ART Antiretroviral Therapy (HIV) Africa ARV Antiretroviral MTCT Mother to child transmission Bioequivalence performs in the same manner as NDA New Drug Application the innovator drug PEP%AR President's Emergency Plan for CNS Central nervous system AIDs Relief CoS Certificate of Suitability QA/QC Quality assurance/Quality control CPD Clinical Pharmacology Department SSP Semi-synthetic penicillins CRD Chemical Research Department UK MHRA The Medicines and Healthcare CVS Cardiovascular system products Regulatory Agency, U.K. DM% Drug Master %ile UNICE% United Nations Children's %und EBIDTA Earnings before Interest, Taxes, UNDP United Nations Development Depreciation and Amortization Program EDQM European Directorate for the US %DA U. S. %ood and Drug Quality of Medicines Administration EHS Environmental Health and Safety USP United States Pharmacopeia EPS Earnings per Share WHO World Health Organization
Contents o r w a r d L o o k i n g S t a t e m e n t s Message from the Chairman 2 Report on Corporate Governance 45 This communication contains statements that constitute forward looking statements including, without limitation, statements relating to the implementation of strategic initiatives and other %rom the desk of the Managing Director 6 Auditors Report 57 statements relating to our future business developments and economic performance. R&D interface makes the difference 10 Balance Sheet 62 While these forward looking statements represent our judgements and future expectations We kept our promises 12 Profit & Loss Account 63 concerning the development of our business, a number of risks, uncertainties and other important factors could cause actual developments and results to differ materially from our expectations. Growth is our Dharma 14 Cash %low Statement 64 These factors include, but are not limited to, general market, macro-economic, governmental and Chairman's address at the United Nations 16 Schedules 66 regulatory trends, movements in currency exchange and interest rates, competitive pressures, Board of Directors 18 Statement relating to subsidiary companies 95 technological developments, changes in the financial conditions of third parties dealing with us, legislative developments, and other key factors that we have indicated could adversely affect our Notice 19 Consolidated %inancial Statements 96 business and financial performance. Directors Report 29 Admission Slip / Proxy 131 Aurobindo undertakes no obligation to publicly revise any forward looking statements to reflect Management Discussion and Analysis 40 %orward Looking Statements IBC future events or circumstances. We have constructed a solid strategic foundation. The business is organised to remain close to the customers, sharing products, values and best practices. This is leveraged on high-level researchers and technology combined to provide world-class performance, unbeatable value for money and the ability to deliver large basket of products.
This did not happen overnight. It came out of a commitment to excel at the best markets. They were not mere promises, but a passion to make an impact in the most competitive markets.
Our businesses are performing well. We are working for strong growth, and shall sustain the momentum.
We shall sharpen our focus on international expansion, even as we consolidate and build on the strengths of our base business in the domestic and emerging markets.
Aurobindo is a high-energy pharmaceutical company and the vibrancy in the organisation gives confidence to make fresh commitment to deliver. To deliver the Earth for our customers, shareholders and in fact, all our stakeholders.
Aurobindo Pharma Ltd. Annual Report 2006 1 Delive ring on promises Message from the Chairman
Dear friends,
We at Aurobindo have been actively creating a platform for growth. We pursued a well-laid road map and added to our marketing reach. In particular, we made a strategic entry into the regulated markets of US and Europe. We ensured that we had a marketing strategy and a large number of regulatory approved APIs and BOTH IN US AND EUROPE, WE HAVE STARTED formulations. EXECUTING REPEAT ORDERS. EQUALLY We made a good beginning and I SIGNIICANT WAS OUR BEING PART O THE am happy to report that many of the PRESTIGIOUS PEPAR PROGRAM. initiatives undertaken in the recent past to scale up the organization have through challenging circumstances that we have earned over many years. started to bear fruit. Both in US and and environment. Our endeavor is to retain this Europe, we have started executing Since we did a calibrated entry leadership position in the base repeat orders. Equally significant was into such markets, our learning cost business, and make inroads into the our being part of the prestigious and lag-time was lower. We had sized regulated markets. PEP+AR program initiated by the up the breadth and depth of the +Y06 was characterised by severe Government of USA. market, we are better positioned to competitive pressure, shortage of
We had planned well; we knew deliver larger volume and service raw materials, higher input costs and our strengths; were clear on where we wider boundaries. challenges latent in entering some of wanted to go; what we wanted to Our Members are aware, that we the most quality conscious markets. deliver; were sure of our milestones at Aurobindo have been a dominant We needed to be better than market and the efforts that we needed to put player in the domestic API market expectations, and I am glad to share in to make things happen. We did as and a significant player in the less with you, that the professional team well as we planned and navigated regulated markets. This is a strength at Aurobindo anticipated and
2 Annual Report 2006 Aurobindo Pharma Ltd. AUROBINDO'S STRENGTHS ARE ITS ABILITY market, from our own experiences, TO OER WHAT THE CUSTOMERS WANT and in the process, have fine tuned AND BE THE LOWEST COST PRODUCER. our growth plans and momentum. I shall share a few pointers which worked to a game plan. We found it Aurobindo has some of the best have helped us gain clarity in our much easier to market our products, skills in the industry, especially in business. Some of the basic questions at affordable prices. critical functions such as research, that we ask ourselves include: Who are
Aurobindo's strengths are its manufacturing and marketing. we competing? How would we ability to offer what the customers Going forward, the Company succeed in a market made of leaders want and be the lowest cost has the clarity of its future revenue in the industry? What should we do producer. We give them quality that flows and has the capability to to gain larger presence, market share, they want, service them especially protect and improve margins. We improved business mix and with delivery deadline, and meet the have mapped with milestones our sustainable long-term growth? needs of customers at prices that give future course of managing market We at Aurobindo believe that we them value. We see long-term needs and are progressively are not competing against MNCs, relationships, and plan to tie up with improving the presence of our innovators or other competitors. We some of the best names in the products. believe those equipped to deliver
industry. Over the years, Aurobindo has better will demonstrate sustained It is a matter of pride for us that taken care to keep its commitments, long term growth. two of our ARV and deliver better than what was My colleagues and I believe, our We are working products coupled with earlier estimated. Our team has fight is against ailments, disease and towards revenues of the analytical methods gained strength and has converted ill-health. We work the same market half-a-billion in are becoming the basis challenges into opportunities. Seen in with other players, and together we Y07 and one for the USP perspective, we have delivered better are challenging the spread of billion in three monographs. A few to all our stakeholders. ailments such as HIV; providing years, designated in dollar terms. of our talented Often, we have deliberated within support to patients to recover from scientists have been the Company to take stock of our diabetes, migraine, cardiovascular recognised by awards and citations by progress, as well as on what need be ailments; and help them with our industry associations. Indeed, done. We have learnt from the drugs to control several lifestyle
Aurobindo Pharma Ltd. Annual Report 2006 3 material as well. Aurobindo straddles the value chain. London We bring to the market, consistency of products, reliability of sources, ability to produce at shorter time-lag and cost effectiveness. We believe this competitive edge will be maintained and improved upon as we gain stronger foot-prints in the markets.
Our endeavor as in the past, will WE BELIEVE THE WINNERS WILL BE THOSE WHO be to remain the most cost effective ARE EQUIPPED TO OER EECTIVE PRODUCTS producer of the best pharmaceutical AT PRICES THAT ARE COMPETITIVE. products, gain volume and market share and be a dependable resource disorders. We have a stake in patients products at prices that are for patients and medical fraternity.
regaining their health. competitive. We believe our efforts will lead to While there are many players in This is where we are distinctive sustainable growth of the Company the same market, with similar and different. Aurobindo is and wealth creation for our facilities, manufacturing systems, backward integrated, manufactures stakeholders. Our portfolio of product approvals and skill sets, we most of the APIs that go into its investments, assets, capacities, believe the winners will be those who formulation products; and, in many products and people talents are are equipped to offer effective instances, manufactures the key raw reassuring, and we at Aurobindo
OUR VISION
Aspire to be a leading provider of pharmaceuticals to both brand and generic pharma industry Shall achieve it by creating a competitive advantage in chemistry through innovation, cost structure and constructive partnerships.
4 Annual Report 2006 Aurobindo Pharma Ltd. have set short and long term targets. We are working towards revenues of half-a-billion in +Y07 and one billion in three years, designated in dollar terms.
We are committed in this mission and shall deliver results that will exceed expectations. I look forward to the future with confidence.
Warm regards
P. V. Ramaprasad Reddy Chairman
Leadership in chosen segments
Steriles Betalactams Anti-virals Life style drugs
Market size: US$ 6.1 bn Market size: US$ 6.1 bn Market size: US$ 6.6 bn Market size: US$ 110 bn
A high margin segment Strongest player with ull range of portfolio Broad portfolio in economies of scale immediate release and Protected by entry barriers US DA approved API and sustained release generics Larger capacities and better finished form facilities IPR capabilities, vertically cost structure than any Both plain and combination integrated product base and Aggressively participating in competitor products process add to strengths PEPAR Vertically integrated and a Strong pipeline to balance Strong portfolio of 27 Large basket of 17 products leader in the category portfolio in developing products markets Competitive cost structure Large manufacturing Offer potential for global capacities to meet single outsourcing umbrella needs of global distribution
Most ANDAs are sourced from Company’s DMFs –
Aurobindo Pharma Ltd. Annual Report 2006 5 Exe cuting strate gies and making an impact
+rom the desk of the Managing Director
Each quarter was better than the earlier one. We did significantly better on every measure - entered into newer markets, delivered larger volumes, improved top and bottom lines and recorded higher operating margins. In every activity we progressed as planned.
+or instance, we submitted larger number of ANDAs, received expeditious regulatory approvals, commercialised more products for THE "SPEED-TO-MARKET" IS ONE O THE the US & European markets, and ACTORS THAT GIVES US A DISTINCTIVE more important, participated in the ADVANTAGE. prestigious PEP+AR program.
The Company's strength has to-market", or the ability to cut short product approvals and their launch in always been manufacturing the time between developing a the addressable markets, has now cost effective active pharmaceutical product, get it registered and created a healthy platform for much ingredients (APIs). We leverage this commercialise it, is one of the factors stronger foray of newer products.
capability to produce generic that gives us a distinctive advantage. Members are aware, we at formulations for the regulatory These are powerful drivers, Aurobindo were confident of markets. especially while entering markets participating in the global attempt at We are vertically integrated, and which have leading players in the making available larger volume of we do add value end-to-end. Our industry. Our scaling up to make antiretroviral products to help HIV dynamics are different as compared meaningful presence in regulatory affected people. The Company to competition. We offer products at markets, as well as the fast tracking successfully bid and became competitive prices, and the "speed- with hardly any time loss between authorised vendors to the US
6 Annual Report 2006 Aurobindo Pharma Ltd. government sponsored PEP+AR fresh momentum, we maintained yet to reach optimum viability. We are program. Supplies commenced our focus and grew in segments such confident that the volume and prices during the year, helped mainly by the as CNS, SSP and semi-synthetic would improve, while the cost of fact that Aurobindo has system cephalosporins. Efforts made were production can be We have acquired a inspected manufacturing facilities, successful because of the strong reigned in. marketing outfit in large basket of approved products basket of products, potential Considerable U.K. and a US DA and the ability to respond fast with opportunities and existing managerial efforts approved the experienced in-house scientists. relationships with customers, both are being made to manufacturing Aurobindo's large product mix in international and domestic improve the facility in U.S.A. makes it convenient for organisations markets. economics of the which gives us a platform to such as UNICE+ to source their While the business mix units under accelerate growth. supplies of ARV products from us. improved and duly got reflected in pressure. Its a single window resource to the financials, we have challenges in Capacity utilisation at our API procure drugs for many institutional the profitability of some of the production units have been customers. overseas production branches. In consistently improving. We are While our ARV products got particular, our ventures at China are working to de-bottleneck some of
Every quarter... an improvement
Q1 Q2 Q3 Q4 Y06 Rs. Millions
Revenues 2842.4 3271.0 4169.7 4742.4 15025.5
PBDIT 266.3 291.0 661.5 827.8 2046.6
PBT 13.2 25.2 364.0 526.6 929.0
PAT 20.1 36.4 261.9 375.3 693.7
EPS (Rs.) 0.39 0.66 4.49 6.44 12.46
Aurobindo Pharma Ltd. Annual Report 2006 7 THERE WAS GROWTH IN VOLUMES AS It is a matter of pride that global WELL AS IMPROVEMENT IN MARGINS, IN investors participated and helped us THE INTERNATIONAL BUSINESS. WE SEE place two +CCB issues, one for US$ 60 THIS AS A RESULT O OUR COORDINATED million in August 2005 and another for US$ 200 million in May 2006. We APPROACH, WHERE RESEARCH, are particular that the funds are best PRODUCTION AND MARKETING ARE utilised to gain strong foothold for our HORIZONTALLY INTEGRATED. products in the premium markets.
them, as well as exiting non- our coordinated approach, where We have acquired a marketing remunerative products. As business research, production and marketing outfit in U.K. and a US +DA grows, the management will ensure are horizontally integrated. Our approved manufacturing facility in U.S.A. which gives us a platform to capacities are adequate and optimise ability to respond to the market, accelerate growth. We shall continue their utilisation. reach out to customers as well as to pursue similar opportunities, in The state-of-the-art formulation meet their needs, offer affordable the best interest of Aurobindo. units were specially created to cater to prices, and flexibility of operations regulatory markets, and with has been enhanced. These strengths We shall progress with caution. increasing demand from the markets, enable superior decision making Operational excellence will be are now expected to move towards process and better control of matched by our focus on compliance optimum utilisation. The economics operations, which translate into standards, adherence to EHS norms of scale would be better business and strong and raising the bar on system We hope to keep visible in the fundamentals. implementation. Our ERP system is improving our foreseeable future. R&D efforts were focused dynamic, and fine tuned to protect, volume sales, There was growth towards creating a product pipeline assist and reflect the business. market share, revenues, operating in volumes as well as and obtaining regulatory approvals. More than ever before, we remain margins and net improvement in The large basket of non-infringing very confident about the future of earnings. margins, in the process patents would further Aurobindo. +ollowing our vision, international enhance the ability of the Company we will master the challenges ahead business. We see this as a result of to widen product portfolio. of us. We shall pursue success since
8 Annual Report 2006 Aurobindo Pharma Ltd. we believe we are well equipped for conscious of the need for increased focused efforts can be expected to future growth. We shall accelerate and API capacities, and shall add full- deliver better performance results and improve our presence in the fledged blocks where necessary. help cross newer milestones. premium markets of US & Europe. Simultaneously, we shall review our We are in the business of good basket on an on-going basis, and Product approvals from health, and in this endeavor we are shed non-remunerative products. regulatory authorities on hand and supported by our competent and the marketing strategies in place will We hope to keep improving our capable staff at all levels. As a team, fast track our volume and top line volume sales, market share, revenues, we shall leverage our excellence in growth. In addition, we shall operating margins and net earnings. sustained execution in key continue to submit dossiers for newer There will be targeted sales and result operational areas of sourcing raw products and seek regulatory oriented approach to business. Our materials, production efficiencies and approvals to ensure a healthy pipeline. Q1+Y07 result has demonstrated the marketing thrust. It is expected that with higher trend of improving performance, formulation sales, in-house capacities and we shall maintain the K. Nityananda Reddy of APIs will be better utilised. We are momentum of growth. Such Managing Director
Product portfolio in both conventional and high entry barrier dosage forms
Orally disintegrating tablets Lyophilized sterile injectables
Sustained/controlled release generics Liquids/dry syrups
Sterile injectables Immediate release generics (tablets/capsules/chewable)
Aurobindo Pharma Ltd. Annual Report 2006 9 R&D interface makes the difference
Every organization has an engine of growth. Aurobindo saw its potential in being a knowledge-based company, finding challenging solutions to complex chemistry and a business built on a strong intellectual property foundation.
Our Research & Development initiatives are giving us re-engineered processes with appropriate chemistry. We will always have better technology and non-infringing processes. We are also patenting some of them, to retain the exclusivity with the Company. ILINGS AND THEIR MANAGEMENT AND +ilings and their management ENSURING NON-INRINGING PROCESSES HAVE and ensuring non-infringing BEEN OLLOWED THROUGH TO RESPECTING processes have been followed INNOVATORS AND THEIR IP RIGHTS. through to respecting innovators and their IP rights. Adding value to the business
Introducing products
Assist in improving yields Building product pipeline
Resource for QA/QC Regulatory compliance/interface
Support in training operations staff Leveraging Intellectual Property
10 Annual Report 2006 Aurobindo Pharma Ltd. Vertically integrated across the processes
Develop & patent Production Chemical ile DM Research non-infringe in approved process for API facility
Develop Production in ormulation & patent, approved research non-infringing facility formulation ORMULATIONS Prove ile ANDA/ APIS Bio- regulatory Approval equivalence management INTERMEDIATES API/ D R&D Enter CLINICAL generic PHARMACOLOGY market
The research center capabilities possibly maximum number of This close coordination in include executing all the related work approvals under the PEP+AR operations is aimed at greater customer required for filing ANDAs in-house programme. Two of our ARV satisfaction. Operational efficiencies under one roof. The CRD, ARD, products coupled with the analytical need to be perceived in the delivery and Regulatory, IPR and the CPD methods are becoming the basis for value that we add to the product. departments of the Research Center the USP monographs. Given the reservoir of talents in together act like the fountainhead to R&D resources of the Company the Company, Aurobindo will meet the organisation's goals. are not numbers driven; even if over consolidate its knowledge of the The evidence is in the large 630 scientists have as a team filed customer needs, as well as market number of filings of DM+s and large numbers of dossiers, obtained opportunities. Contract research is a ANDAs and inspections with hardly patents or have enabled meeting potential area of business that would any observations/deviations and the regulatory norms. add to income stream and help number of patents filed. The in- The in-house scientists have develop long-term relationship with house expertise in R&D is to work added value by the business interface, large players in the industry. on widest range of therapeutic areas strengthened pipelines to business; The horizontal integration from thus creating a robust platform for supported and supplemented lab-to-market makes Aurobindo a expedited future filings. quality assurance; helped improve yields and minimise much stronger player in the market. A couple of achievements waste; and, more important, showcase this effort. Aurobindo has trained the production floor.
Aurobindo Pharma Ltd. Annual Report 2006 11 We k ept our promises
At Aurobindo, we always search Distinct manufacturing sites for for a better way to do everything we different segments
do. Over the years, we have Unit Segments Certifications developed new knowledge and APIs competencies that have given us Unit I CVS, CNS, Anti-allergics US +DA, WHO competitive edge and path-breaking Unit I A Cephs US +DA performance. This comes out of Unit VI Cephs US +DA, WHO, Health Canada promises that we make to ourselves. Unit VIII CNS, CVS, US +DA, WHO Gastroentrological, ARVs The growth trajectory was Unit XI ARVs US +DA, WHO
mapped with strategic entry into the ormulations regulated markets. The Company Unit III Multi-purpose US +DA, UK MHRA, WHO, Non-Betalactums Health Canada, MCC (SA) & had taken care to have facilities and ANVISA (Brazil) products readied and ensure that the Unit VI B Cephs US +DA, Health Canada, MCC (SA) delivery mechanisms are in place. & ANVISA (Brazil) Unit XII SSPs US +DA, UK MHRA, This needed multi-tasking of Health Canada, MCC (SA) & ANVISA (Brazil) activities, and implement them simultaneously. +or that matter, Bio-equivalence centre US +DA, WHO, ANVISA (Brazil) every segment of the business was refashioned, with the intent to be the Status of regulatory filings best pharmaceutical player of the iled Approved future. DMs/CoS US DA 86 * CoS/EDQM 50 * ANDAs 102 48 US DA 62 29 Europe 21 3 WHO 19 16 Patents 205 29 * No statutory approval required for DM+ As on July 31, 2006
12 Annual Report 2006 Aurobindo Pharma Ltd. What was the agenda?