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1 Annual Report 2007 Value Value through through Innovation nopq

2 Financial Highlights Boehringer Ingelheim group of companies Amounts in millions of EUR, unless otherwise indicated change Net sales 10,952 10,574 4 % by region Europe 33 % 31 % Americas 50 % 51 % Asia, Australasia, Africa 17 % 18 % by business Human Pharmaceuticals 96 % 96 % Animal Health 4 % 4 % Research and development 1,730 1, % Personnel costs 2,886 2,836 2 % Average number of employees 39,800 38,428 4 % Operating income 2,100 2,140-2 % Operating income as % of sales 19.2 % 20.2 % Income after taxes 1,812 1,729 5 % Income after taxes as % of sales 16.5 % 16.4 % Shareholders equity 3,372 5, % Return on shareholders equity 35.0 % 37.4 % Cash flow 2,392 2,317 3 % Investments in tangible assets % Depreciation of tangible assets % Top 5 products Prescription Medicines Net sales 2007 in millions of EUR change spiriva 1, % micardis 1, % flomax 1, % combivent % sifrol % Top 5 products Consumer Health Care Net sales 2007 in millions of EUR change dulcolax % mucosolvan % zantac 111 > 100 % pharmaton % buscopan 77 9 %

3 Contents 1 Value through Innovation 2 The shareholders perspective 6 Key aspects of Corporate bodies 12 Our caring culture 15 Our conviction 18 Caring for our neighbours 21 Our people 24 Our environment, health and employee safety 28 Research & Development 30 Our R&D strategy 32 Our R&D sites 34 Treating and preventing thrombo-embolic diseases 36 Addressing a taboo disorder Decreased sexual desire 38 Managing a daily burden Living with diabetes type II 40 Lung cancer Our current focus in oncology 42 Our business in figures 44 Human Pharmaceuticals * 48 Prescription Medicines 48 Branded Prescription Medicines 66 Generic Prescription Medicines 69 Consumer Health Care 73 Product Supply and Industrial Customer 75 Biopharmaceuticals 78 Pharmaceuticals Production 80 Pharma Chemicals 83 Animal Health 89 Our products 99 Group Management Report Consolidated Financial Statements Overview of the major consolidated companies 118 Consolidated balance sheet 119 Consolidated profit and loss statement 120 Cash flow statement 121 Statement of changes in group equity 122 Notes to the consolidated financial statements Auditor s Report Flap Comparison of balance sheets / financial data Our driving force Research & Development Our own research and development continues to be the major driver of innovative, new medicines. page 28 For humans and animals Animal Health With innovative veterinary medicines that accommodate the needs of both man and animal, we are a reliable partner for animal owners and veterinarians. page 83 Our caring culture The ethical principles that guide our company have created a culture of social responsibility and commitment. page 12 Serving patients Human Pharmaceuticals* We are committed to the goal of serving humankind through new drugs and therapies. page 44 Serving customers Product Supply and Industrial Customer We produce drugs for our own Human Pharmaceuticals business in a globally coordinated production network. Furthermore, we offer customised manufacturing services to our industrial customers. page 73 * The patient reports are authentic reports which refer to personal experience only. Please note that other patients may experience different treatment results. Individual treatment schemes have always to be discussed between patient and physician case by case. please turn over

4 Value through Innovation Our vision drives us forward. It helps us to foster value creation through innovation in our company and to look to the future with constantly renewed commitment and ambition. Boehringer Ingelheim is a research-driven group of companies dedicated to researching and developing, manufacturing and marketing pharmaceuticals that improve health and quality of life. Our business consists of Human Pharmaceuticals and Animal Health. We focus on innovative drugs and treatments that represent major therapeutic advances. Excellence in innovation and technology guides our actions in all areas. Our products have long been highly successful in the treatment of central nervous system, respiratory, cardiovascular, urological and virological disorders. In addition, we have successfully advanced our research in thrombo-embolic, metabolic and oncological diseases. Boehringer Ingelheim has 39,800 employees in 135 affiliated companies worldwide. We have research and development facilities in ten countries and production plants in more than 20 countries. Expenditure on research and development in Prescription Medicines corresponds to more than 19 % of net sales in this business segment. Our headquarters is at Ingelheim, the German town where the familyowned company was founded in 1885.

5 The Shareholders Perspective The shareholders perspective Scientific research into family-owned companies lends support in its analyses to the financial and strategic success of such companies. The question is why. First of all, the causes mainly rest on a foundation of committed shareholders who, with their creative drive, actively concern themselves about the fortunes of their company. On this, as a bearing pillar, stands the shareholders intensive and conscious discussion and evaluation of corporate risk. They constantly take well-calculated corporate risks to further develop and enhance the innovative strength of their company, without putting at risk the overall existence of their company. And as an additional pillar, the shareholders long-term and sustainable perspective is given emphasis. Our commitment And it is precisely in this sense that we see ourselves as committed shareholders in our company, Boehringer Ingelheim. We actively concern ourselves about our company s interests. As shareholders, we have a vision that drives us. We have committed ourselves to the goal of serving mankind through research into diseases and the development of new drugs and therapies. As committed shareholders, actively concerning ourselves with our company in concrete terms means that we engage in intensive dialogue at all levels and continuously introduce topics of fundamental importance to our company, without intervening in the operative management of the company, which is the sole responsibility of the Board of Managing Directors. And ultimately commitment for us means: we make an active contribution to our corporate culture by walking the talk for our employees on ethical values. Boehringer Ingelheim A n n u a l R e p o r t

6 Christian Boehringer By intensive cooperation between the Shareholders Committee and the Board of Managing Directors, we jointly assess the necessary corporate risks to the dynamic development of our company. Our decisions adhere to the principle of well-calculated and balanced risk and, at the same time, secure in each case our company s long-term independence. These conditions for our company make our long-term and sustainable way of thinking imperative. As shareholders, we must recognise the economic cycles of the pharmaceutical market from far off and steer our company on a calm course through changing external market conditions beyond our influence, between the dynamic growth coordinates of net sales and profitability on the one hand and ensuring financial stability on the other. Our results provide confirmation Our outstanding market position was further extended once again in Our core products offer real therapeutic benefit for patients. The volume of prescriptions tells us how much patients use our medications. Examples of the social commitment in our company are our worldwide promotion of projects and programmes focused on the health of people, not commercial success. Under our viramune Donation Programme, it pleased us greatly when, in summer 2007, we supplied the millionth dose of viramune for the prevention of mother-to-child transmission (pmtct) of HIV during birth. To date, 165 pmtct programmes are running in 59 countries. Our committed employees Our innovative strength is directed decisively by the driving force of our employees who we need to achieve the excellence and increased productivity at all stages in our value The shareholders perspective

7 creation chain. We build on their integrity, their expertise and their sustained commitment. We are proud of our employees and what they attain. But the social commitment of our employees is also valued highly in our company. Many of our employees have made our programmes and projects focused on people their own and adopted the idea of helping by volunteering. Examples of this are the refurbishment of a shelter for street children in South Africa and the construction of environmentally friendly wood-burning stoves in the homes of poor people in Mexico. For this social commitment we would like to express our heartfelt thanks to these employees. They support our company philosophy. It is also important for us that we are an outstanding employer for our employees and are attractive for interested people outside the company. Boehringer Ingelheim is considered to be one of the most interesting and desirable employers and that is what independent opinion polls are saying too. Moreover, in 2007, for the sixth time in a row, we were selected as the most preferred employer in a survey conducted among executives in the German chemical and pharmaceutical industries. In the annual Top Employers survey by the highly regarded magazine Science for scientists in pharmaceuticals and biopharmaceuticals, we in 2007 came No. 1 for the first time. Our contributions to success We, the shareholders of Boehringer Ingelheim, have in 2007 once again provided for a financially stable and strategically predictable overall framework. With this additional participation and commitment outside the Shareholders Committee, the family was again able in the reporting year to make its contribution within the given framework. We thank all our employees for their motivation and innovative strength in their shared efforts. With confidence in their own capabilities and identification with their work, they create the basis for the sustained optimal performance essential to our company s wellbeing. In maintaining our company s success, we have confidence in the competence and experience of the Board of Managing Directors and the Advisory Board s constructive support of our company. Boehringer Ingelheim A n n u a l R e p o r t

8 On behalf of the shareholders, allow me to express our heartfelt thanks to all those mentioned for their contribution to our corporate success in You have all contributed to making us what we are: a successful and highly respected international pharmaceutical company with a unique corporate culture. We look forward to continuing to work closely with our employees, the Board of Managing Directors and the Advisory Board. We are confident in the path we have taken and, despite a difficult environment, aim to build up our position as one of the world s leading research-driven pharmaceutical companies. Christian Boehringer Chairman of the Shareholders Committee The shareholders perspective

9 Key aspects of 2007 Key Aspects of 2007 We can look back once again on a successful year. We note with satisfaction that our medications are benefiting patients worldwide. Again in 2007, we have grown above average and outpaced the world market for the eighth consecutive year. The acceptance of our core products was very good, resulting in a continuous improvement of their market position. Some of our major clinical studies are coming to completion in We are confident that we will further profile the great clinical benefits of our new products and already launched medications. We have thereby maintained and reinforced Boehringer Ingelheim s successful path as an independent, family-owned pharmaceutical company and we have been able to offer new job opportunities worldwide. The basis and the main reason for our excellent performance are our employees and our unique corporate culture. This is characterised by mutual trust, by goals set in open and constructive dialogue and by identification with our work. The focus on people We are proud of our employees and of what they achieve. Boehringer Ingelheim has long sought to create the preconditions within the company for fostering employee development. To this end we offer many initiatives and programmes from professional qualifications to healthcare. Our corporate environment is excellent. This is also the finding of several independent opinion polls. In many countries around the world Boehringer Ingelheim belongs to the most highly regarded employers. In the annual Top Employers survey of scientists in pharmaceuticals and biopharmaceuticals conducted by the prestigious magazine Science in 2007, we achieved No. 1 position for the first time. Our Leitbild (guiding principles) and vision have created a working environment in which trust and cooperation can flourish. In spring 2007, we conducted the first-ever worldwide survey (Your view on our culture) of our 39,800 employees. Participation was very high: almost 33,000 people worldwide, or over 80 % of the total workforce. The results confirmed that we are working well together with high ethical standards and are focused on delivering innovative medications to patients. This translates into our business success. Boehringer Ingelheim A n n u a l R e p o r t

10 Dr Alessandro Banchi Dr Andreas Barner Dr Hans-Jürgen Leuchs Prof. Marbod Muff Value through Innovation We seek to help people by researching diseases and developing new medicines and therapies. In 2007, we again took a substantial step forward in this endeavour. In 2007, our corporation-wide net sales rose to EUR 10,952 million. In local currency terms, we recorded very gratifying 8.8 % growth. Due to the weakness of the US dollar and the Japanese yen, net sales increased by 3.6 % in euro terms versus the previous year. We also see this, from our point of view, as a very positive development of net sales against the background of the mobic patent expiry in 2006, which required a EUR 340 million decline in net sales to be offset. In our prime strategic business area, Human Pharmaceuticals, Prescription Medicines net sales rose by 9.9 % in local currency terms against 2006 to EUR 8,660 million (+4.2 % in euro terms), making by far the largest contribution to our turnover growth and enabling us for the eighth year in succession to grow markedly faster than the pharmaceutical market. We achieved a 1.9 % share of the world market 1, thereby securing our solid position among the leading international pharmaceutical companies. Our operating income of EUR 2,100 million was broadly in line with the previous year. This corresponds to a return on sales of 19.2 %. All our core products achieved distinct growth in 2007 and improved their market position. spiriva attained net sales of EUR 1,792 million (+29.8 %). Furthermore, the respimat Soft Mist Inhaler with spiriva was launched in autumn 2007 in Germany, Denmark, the Netherlands and the United Kingdom. The high level of patient and physician demand shows that we have potentially achieved another breakthrough with the spiriva respimat Soft Mist Inhaler. micardis (EUR 1,123 million, %), flomax /alna (EUR 1,020 million, %), sifrol /mirapex (EUR 644 million, %) and aggrenox (EUR 278 million, %) also developed very satisfactorily. In our portfolio we now have three blockbusters, all with further growth potential. Our Consumer Health Care (CHC) self-medication business also developed positively with turnover growth of 11.7 % in local currency terms (7.2 % in euro terms) in 2007 to EUR 1,141 million, with our international core brands dulcolax and buscopan continuing their 1) IMS Health Database Key aspects of 2007

11 gratifying development. Our newly acquired product zantac also extended its market position very well. Overall, our CHC business contributes some 10 % to Boehringer Ingelheim s total net sales. In 2007, we undertook the market withdrawal of our well-established self-medication active ingredient clobutinol, as a study had indicated possible risks to patients. While the risk potential was deemed to be extremely limited, we nevertheless decided, given the indication and the availability of alternative treatments, to withdraw the clobutinolcontaining form of silomat. This decision is in line with our high ethical standards. Boehringer Ingelheim s strategic business areas include Animal Health. Here the gratifying growth path of the past few years was continued with an increase in net sales of 13.1 % in local currency (9.1 % in euro terms) to EUR 408 million. This makes us one of the leading suppliers of veterinary medicine products worldwide. The year 2007 was marked by ingelvac circoflex, our new vaccine against weakness of the immune system in pigs caused by the porcine circovirus-2 (PCV-2). Strong demand for this vaccine resulted in pleasing net sales of EUR 37 million. The porcine vaccines enterisol ileitis and ingelvac prrs also achieved substantial growth. We are thereby well on our way to becoming world market leader in the porcine vaccines segment. As planned, turnover in our business segment Biopharmaceuticals declined by 7.9 % to EUR 463 million, due to expansion and modernisation investments at our plants in Biberach, Germany, one of which was out of action for three months. A well-filled pipeline 2007 saw important progress in the development of our innovative product pipeline, with our clinical studies running to plan, supported by high patient interest. This allowed several compounds in development from different therapeutic areas to be moved towards the next clinical research phase, including phase III. Foremost was pradaxa (dabigatran etexilate), a novel compound from our own research and development. It is an orally available anticoagulant which acts through direct thrombin inhibition. It is in clinical development to prevent or to treat thrombo-embolic events. Registration documentation was submitted in 2007 in its initial indication (prevention of deep vein thrombosis after total hip or total knee replacement surgery). In January 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion to recommend marketing authorisation of pradaxa in this indication. We are also developing pradaxa in other important indications, including the prevention of stroke in patients with atrial fibrillation. Clinical studies in this indication are far advanced. Boehringer Ingelheim A n n u a l R e p o r t

12 Our oncology development portfolio showed further progress last year. Our frontrunner compound tovok (bibw 2992) is a compound which belongs to the group of signal transduction inhibitors. It will enter phase III clinical development in a subgroup of nonsmall cell lung cancer patients in Our second oncology compound, vargatef (bibf 1120), has successfully shown a good safety-benefit ratio in phase I and II trials and will also move forward into phase III clinical development in advanced lung cancer patients in In the disease area metabolism, we have made substantial progress with our diabetes type II programme. For our diabetes frontrunner compound bi 1356, which belongs to the novel class of DPP-IV inhibitors, a large phase III clinical programme was planned to start in We are developing flibanserin in clinical phase III for the treatment of premenopausal women suffering from hypoactive sexual desire disorder (HSDD), which can frequently cause substantial distress and interpersonal difficulties, and made major progress during Three phase III trials, with almost 4,000 patients, are ongoing. Our investments in research and development in Prescription Medicines increased again in 2007, rising by 9.9 % to EUR 1,649 million, corresponding to more than 19 % of our net sales in Prescription Medicines. Product launches and landmark studies in will be an exceptionally important year for the further development of our company. In the first half of 2008, we plan to launch pradaxa in the first indication: prevention of deep vein thrombosis after total hip or total knee replacement surgery. Furthermore, 2008 will be marked by the publication of some of our numerous landmark trials (phase IV studies). The micardis trials ontarget and transcend have reached their close-out phase in cooperation with the academic clinical research centres with which we have conducted the programme. With data from more than 31,000 patients we are compiling the analyses to make initial results available to the public in the first half of Other trials coming to completion and disclosure include the profess trial which investigates the efficacy of aggrenox in the prevention of secondary stroke. Here the medical world expects the results in the first half of Important initial results are also expected from the uplift study, which should be published in autumn This trial investigates whether spiriva can slow the progression of chronic obstructive pulmonary disease. Key aspects of 2007

13 The medical world and Boehringer Ingelheim are eagerly awaiting the results of ontarget, transcend, profess and uplift. Positive outcomes from our studies mean further medical insights and expanded, new indications for our medications to benefit patients. Our goals for 2008 We, the Board of Managing Directors, will continue to do our utmost to ensure the reinforcing of the company s innovative power in order to achieve our demanding goals and to fulfil the company s long-term vision. Sustaining and raising the productivity of our research and development further is of particular importance to us. At the same time, we will ensure and extend the successful marketing of our products in a challenging market environment so that we can continue to offer patients the best possible products for treating their conditions. Dr Alessandro Banchi Dr Andreas Barner Dr Hans-Jürgen Leuchs Prof. Marbod Muff 10 Boehringer Ingelheim A n n u a l R e p o r t

14 Corporate bodies Shareholders Committee Advisory Board Board of Managing Directors Christian Boehringer Chairman of the Shareholders Committee Albert Boehringer Christoph Boehringer Erich von Baumbach jr. (from ) Ferdinand von Baumbach Hubertus von Baumbach (until ) Dr Mathias Boehringer Prof. Michael Hoffmann-Becking Attorney at Law, Düsseldorf Chairman of the Advisory Board Dr Rolf-E. Breuer Frankfurt (Main) Prof. Fredmund Malik Chairman of the Board Malik Management Zentrum St. Gallen AG Dr Heinrich Weiss (until ) Chairman of the Board SMS GmbH, Düsseldorf Dr Alessandro Banchi Corporate Board Division Chairman of the Board Corporate Board Division Pharma Marketing and Sales Dr Andreas Barner Vice-Chairman of the Board Corporate Board Division Pharma Research, Development and Medicine Dr Hans-Jürgen Leuchs Corporate Board Division Operations Corporate Board Division Animal Health Prof. Marbod Muff Corporate Board Division Finance Corporate Board Division Human Resources Key aspects of 2007 / Corporate bodies 11

15 People are at the heart of all we do. 12 Boehringer Ingelheim A n n u a l R e p o r t

16 Our caring culture

17 We can only defeat AIDS if all stakeholders and all members of society contribute their share. Heidemarie Wieczorek-Zeul, German Federal Minister for Economic Cooperation and Development 14 Boehringer Ingelheim A n n u a l R e p o r t

18 our caring culture Our conviction The ethical principles that have guided our company for well over a century have created a culture of social responsibility and commitment. Our social activities encompass patients, employees, neighbouring communities and society at large, with the needs of patients of paramount importance. In improving access to anti-aids drugs, Boehringer Ingelheim acknowledges its special responsibility as a researchdriven pharmaceutical company in the fight against the HIV/AIDS pandemic. Our viramune Donation Programme (VDP), set up in 2000 to help the countries most in need of support in combating HIV/AIDS, targets the prevention of mother-to-child transmission (pmtct) of the HIV-1 virus during birth. The amount of drugs supplied under the VDP is now over 1 million doses, with the millionth dose going to Malawi in The first supplies of viramune (nevirapine), researched and developed by Boehringer Ingelheim to prevent mothers passing on the virus to their babies during birth, were delivered to the Republic of Congo (Brazzaville) and Senegal in Since then, 57 more countries have joined the VDP and the number of individual support programmes now totals 165. Boehringer Ingelheim strives to donate drugs in conjunction with comprehensive pmtct programmes. Mothers are treated not only during delivery, but that they also have access to HIV treatment with antiretrovirals on a continuous basis as an integral part of individual government programmes. The VDP is an excellent example of how the private sector can deliver active help in developing countries. We can only defeat AIDS if all stakeholders, all members of society, contribute their share, Heidemarie Wieczorek-Zeul, the German Federal Minister for Economic Cooperation and Development, said in conjunction with the viramune delivery to Malawi. In addition to making drugs freely available for patients who need it for pmtct, this offer acts as a catalyst for other organisations, e. g. NGOs, which benefit from the already developed infrastructure. Community education and awareness of HIV/AIDS, voluntary counselling and testing, and other healthcare provisions, have been put in place on-site in order to take advantage of the donation offer. The needs of individual countries and programmes designed to combat the spread of HIV vary. There is no one size fits all solution. Local programmes differ both in capacity and resources; this is a recognised principle upon which the World Health Organization (WHO) Guidelines for Drug Donations were established. Boehringer Ingelheim strictly adheres to these guidelines. In addition, viramune must be approved by the regulatory Our conviction 15

19 authorities for use for mothers and their babies in each country. The drug component is a substantial part of resources required for a comprehensive pmtct programme. Challenges include: community education and awareness of HIV and pmtct functional programme management training of dedicated and skilled medical staff voluntary counselling and testing of pregnant women and spouses ante-natal and post-natal care a clear policy on breastfeeding Until now, only 10 % of mother-child pairs in need receive preventative therapy as offered by Boehringer Ingelheim. The challenge is to achieve areawide effectiveness of the pmtct interventions. In this context, Boehringer Ingelheim works actively with partner institutions such as ministries of health, UNICEF, the German Institute for Technical Cooperation (GTZ), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), churches, NGOs and charitable organisations. In the past, Boehringer Ingelheim granted voluntary licences to several companies in Africa, enabling them to produce generic nevirapine for low income countries. To further improve and facilitate access to nevirapine, Boehringer Ingelheim has decided not to enforce its patents and offers non-assert declarations to interested manufacturers on the WHO prequalification list. These allow them to supply nevirapine to all low income countries according to the World Bank classification, all countries classified as least developed countries (LDCs) by the United Nations, and all African states not classified as low income or LDCs, such as South Africa, Botswana, Namibia and Gabun, without having to pay license fees. Our other initiatives to assist healthcare systems in emerging economies include adjusted pricing for chronic treatment, which provides viramune at substantially reduced prices for chronic therapy to all low income countries, LDCs and all of Africa, and at a preferential price to middle income countries, such as Brazil and Russia. l Boehringer Ingelheim strives to donate viramune under comprehensive programmes for preventing mother-to-child transmisson of HIV. 16 Boehringer Ingelheim A n n u a l R e p o r t

20 our caring culture Malawi is making significant progress in preventing the transmission of HIV from mother to child. Aida Girma, UNICEF Representative Aida Girma, United Nations Children s Fund (UNICEF) Representative in Malawi. Miss Girma, what is the HIV/AIDS situation in Malawi? The HIV prevalence rate among adults aged years was 14 % in An estimated one million people are living with HIV/AIDS. Mother-to-child transmission (MTCT) accounts for close to 30,000 infections among newborns annually, and less than 15 % of pregnant women attending antenatal clinics are accessing services to prevent it. What is the government doing to combat this dreadful situation? A rapid roll-out of the national AIDS treatment programme helped to put a total of 85,000 patients on antiretroviral treatment free of charge by January 2007, reaching 50 % of those in need of treatment. However, with regard to children, only 7 % of children in need of treatment are currently receiving it. Of Malawi s one million orphans, 500,000 have lost one or both parents to AIDS. Without parental protection, these children are exposed to neglect, abuse and exploitation and lack access to basic necessities and services. UNICEF is embarking on a special programme in Malawi to prevent motherto-child transmission of the AIDS virus during birth. What is being done to save the next generation from being infected so early in life? Malawi is making significant progress in preventing the transmission of HIV from mother to child. From 2003 to 2005, there were only 36 sites providing the prevention of MTCT, compared to 119 sites by the end of This already indicates a strong political commitment within the context of national health policy and the government aims at a rapid scale-up to all 542 healthcare sites in the country by June With support from partners in Malawi, as well as abroad, such as Boehringer Ingelheim s viramune Donation Programme (VDP), we are confident that the supply of drugs and HIV test kits will go a long way to helping Malawi meet the new targets. The response from Boehringer Ingelheim has been invaluable and the supplies have reached the health facilities where the need is overwhelming. Our conviction 17

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