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Annual Report 2005 - Boehringer Ingelheim

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Value through Innovation<br />

<strong>Annual</strong> <strong>Report</strong> <strong>2005</strong><br />

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Financial Highlights<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> group of companies<br />

Amounts in millions of EUR, unless otherwise indicated <strong>2005</strong> 2004 Change<br />

Net sales 9,535 8,157 17 %<br />

by region<br />

Europe 33 % 32 %<br />

Americas 48 % 48 %<br />

Asia, Australasia, Africa 19 % 20 %<br />

by business area<br />

Human Pharmaceuticals 96 % 96 %<br />

Animal Health 4 % 4 %<br />

Research and development 1,360 1,232 10 %<br />

Personnel costs 2,671 2,443 9 %<br />

Average number of employees* 37,406 35,529 5 %<br />

Operating income 1,923 1,372 40 %<br />

Operating income as % of sales 20.2 % 16.8 %<br />

Income after taxes 1,514 908 67 %<br />

Income after taxes as % of sales 15.9 % 11.1 %<br />

Shareholders’ equity 4,609 4,363 6 %<br />

Return on shareholders’ equity 34.2 % 23.1 %<br />

Cash flow 2,069 1,430 45 %<br />

Investments in tangible assets 532 427 25 %<br />

Depreciation of tangible assets 439 377 16 %<br />

* including the total number of employees<br />

in joint ventures included in the consolidation


Contents<br />

2 The Shareholders’ Perspective<br />

4 Key Aspects of <strong>2005</strong><br />

8 Our Caring Culture<br />

10 Our Commitment<br />

12 For Our Neighbours<br />

14 For Our People<br />

18 For Our Environment<br />

22 Our R&D Drive<br />

26 “HIV is Being Played Down”<br />

28 Our Strength in R&D + Medicine<br />

Business Development<br />

Prescription Medicines<br />

40 A New Quality of Treatment, a New Quality of Life<br />

44 Overview Prescription Medicines<br />

Consumer Health Care<br />

56 Let’s Talk About it<br />

60 Overview Consumer Health Care<br />

Biopharmaceuticals and Chemicals<br />

62 Time is Critical<br />

66 Overview Biopharmaceuticals and Chemicals<br />

Animal Health<br />

70 Helping the Heart<br />

74 Overview Animal Health<br />

77 Group Management <strong>Report</strong><br />

Consolidated Financial Statements <strong>2005</strong><br />

90 Overview of the Major Consolidated Companies<br />

92 Consolidated Balance Sheet<br />

93 Consolidated Profit and Loss Statement<br />

94 Cash Flow Statement<br />

95 Statement of Changes in Group Equity<br />

96 Notes to the Consolidated Financial Statements<br />

114 Auditor’s <strong>Report</strong><br />

116 Glossary<br />

Flap Comparison of Balance Sheet/Financial Data 1996–<strong>2005</strong>


8 22 40 56 62 70<br />

Our Company<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is a research-driven group of companies<br />

dedicated to researching, developing, manufacturing and marketing<br />

pharmaceuticals that improve health and quality of life.<br />

Our business consists largely of Prescription Medicines, Consumer Health<br />

Care, Biopharmaceuticals and Animal Health. We focus on the production<br />

of innovative drugs and treatments that represent major therapeutic<br />

advances.<br />

Excellence in innovation and technology guides our actions in all areas.<br />

Our products have long been highly successful in the treatment<br />

of respiratory, cardiovascular, central nervous system, urological and<br />

virological disorders. In addition we have intensified our research into<br />

the immune system, metabolic diseases and cancer.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>, which currently has almost 37,500 employees,<br />

has 143 affiliated companies spread around the globe. We have research<br />

facilities in nine countries and production plants in more than 20.<br />

Our pharmaceuticals research and development spending corresponds<br />

to about 18 % of net sales in Prescription Medicines.<br />

Our headquarters is at <strong>Ingelheim</strong>, the German town where the company<br />

was founded in 1885.


Value through Innovation<br />

Our vision drives us forward.<br />

It helps us to foster value creation<br />

through innovation throughout<br />

our company and to look to the<br />

future with constantly renewed<br />

commitment and ambition.


The Shareholders’ Perspective<br />

The importance of family-owned companies in<br />

Germany is repeatedly given prominence in the<br />

public debate over significant economic policy<br />

issues, for instance, regarding the labour market<br />

situation or taxation policy. Family-owned<br />

companies represent a peculiarity in the German<br />

system. Of the 50 largest European companies of<br />

this type, more than half come from Germany.<br />

The results of investigations lead to the conclu-<br />

sion that such companies are, in terms of both<br />

revenues and earnings development, more than<br />

competitive compared with companies listed on<br />

the stock exchange. Looking into the reasons for<br />

this, you find features like long-term orientation<br />

combined with higher attention to risk, personal<br />

commitment of the owners as well as a strong<br />

employee focus. These aspects also apply to<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>, which serves as a positive<br />

example with its successful business and<br />

corporate development.<br />

We are frequently described as a company that<br />

is “different” to its competitors. What is meant<br />

by that? The criteria which mark us out and<br />

form <strong>Boehringer</strong> <strong>Ingelheim</strong>’s identity are our<br />

orientation towards values, such as reliability<br />

and predictability, the close alignment with the<br />

needs of patients and physicians, the awareness<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

of the importance of our employees, and our<br />

long-term thinking and commitment. Our<br />

strength is founded on our stability. As a<br />

family-owned company, we can transform the<br />

parameters mentioned above into a well-<br />

balanced strategic approach along with a market-<br />

orientated growth strategy. We are not under<br />

pressure from the short-term demands of<br />

anonymous investors or the capital market.<br />

This does not, however, mean that we do not<br />

comply with standards and norms that apply to<br />

companies listed on the stock market. In this<br />

respect, we share the approach of those compa-<br />

nies perceiving themselves as Good Corporate<br />

Citizens. Social commitment, openness and<br />

transparency are of utmost importance for us.<br />

The principle of sustainability – applied to the<br />

long-term, stable development of the company’s<br />

value, applied to the selection and targeted<br />

promotion and fair treatment of our employees,<br />

and applied to environment-friendly and socially-<br />

orientated economies – is reflected in our<br />

Leitbild, the guiding principles for our corporate<br />

behaviour. For us, sustainability is the basis of<br />

stability and success.<br />

Our company is growing dynamically. Indeed, in<br />

the last few years, it has clearly outpaced average<br />

growth of the pharmaceutical market. In <strong>2005</strong>,<br />

the successful development continued once<br />

again. Once more we are in the top ranks of<br />

the pharmaceutical companies with the strongest<br />

growth. We have succeeded in providing new<br />

therapeutic options for our patients with a row


of innovative medications. Our expectations for<br />

<strong>2005</strong> have been achieved or were exceeded in a<br />

whole number of areas. On all of these grounds,<br />

the Shareholders of <strong>Boehringer</strong> <strong>Ingelheim</strong> are<br />

very satisfied with the course and results of the<br />

business year.<br />

Nevertheless, we must not ignore the potential<br />

risks the pharmaceutical industry is facing.<br />

Developing new, innovative medicines is a<br />

protracted and expensive process. Only a few<br />

research approaches end up as new medicines<br />

and make it to market approval. The healthcare<br />

policy environment in most countries, which is<br />

afflicted with ever-increasing uncertainties and<br />

continuously deteriorating, represents a<br />

considerable burden for our industry. For capital<br />

expenditure creating new jobs or developing<br />

innovative medicines, we win many public<br />

plaudits. Sadly, these fine-sounding words are in<br />

reality not often followed by corresponding<br />

deeds.<br />

Instead of strengthening the power to innovate –<br />

for which an appropriate risk premium is a<br />

pre-condition, that is to say, reasonable prices<br />

and adequate protection of innovations against<br />

imitation – the precise opposite is happening.<br />

Prices are being forced down, reimbursement<br />

opportunities restricted and parallel imports<br />

encouraged. In our opinion, supporting<br />

economic progress in combating disease looks<br />

different. When making future investment<br />

decisions we will also have to take such aspects<br />

into consideration.<br />

In spite of such limitations, <strong>2005</strong> was once again<br />

a successful business year. The Shareholders and<br />

the Board of Managing Directors of <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> took or prepared the decisions to<br />

achieve the goals we have set in close coopera-<br />

tion and coordination with the Advisory<br />

Board. The decisions concerned the company’s<br />

strategic direction, important business matters or<br />

decisions on capital expenditure.<br />

In regular joint sessions, the Advisory Board,<br />

the Shareholders’ Committee and the Board of<br />

Managing Directors have discussed the short<br />

and medium-term development of the company<br />

and the necessary decisions entailed.<br />

The Shareholders of <strong>Boehringer</strong> <strong>Ingelheim</strong> thank<br />

all employees, the Board of Managing Directors<br />

and the Advisory Board for their successful work<br />

and commitment in <strong>2005</strong>. The path <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> has taken as an independent family-<br />

owned company also promises us growth and<br />

success for the future.<br />

Dr Heribert Johann<br />

Chairman of the Shareholders’ Committee<br />

The Shareholders’ Perspective


Key Aspects of <strong>2005</strong><br />

We are a research-driven pharmaceutical<br />

company that invests about 18 % of net sales of<br />

our Prescription Medicines business every year in<br />

the research and development of medicinal<br />

products. Our goal is to serve mankind through<br />

research into different diseases and to create the<br />

drugs and therapies to treat them. This principle<br />

guides all our business activities. Our success<br />

to date and our future prospects are measured by<br />

the degree of innovation of our new medicines<br />

now available to patients and by the innovative<br />

potential of our product pipeline. We are proud<br />

that in <strong>2005</strong> four million of patients worldwide<br />

affected by chronic obstructive pulmonary<br />

disease could benefit from our spiriva® and live<br />

a better life.<br />

For some years now, <strong>Boehringer</strong> <strong>Ingelheim</strong> has<br />

been one of the fastest-growing companies in the<br />

pharmaceutical industry. In <strong>2005</strong> again, we<br />

maintained a fast pace of dynamic growth.<br />

According to the market analysts IMS, employed<br />

by all pharmaceutical companies, we achieved<br />

the strongest growth of the top 20 pharma-<br />

ceutical companies. We also outpaced the<br />

average for the pharmaceutical market in all<br />

major regions of the world. This takes us to<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

position No. 14 worldwide in terms of sales,<br />

with a market share of 2 %.<br />

Strong international brands<br />

In <strong>2005</strong>, our net sales rose by around 17 % to EUR<br />

9.5 billion. Currency effects played a secondary<br />

role compared with previous years.<br />

Our growth was primarily driven by our pre-<br />

scription medicines products. spiriva®, for the<br />

treatment of chronic obstructive pulmonary<br />

disease, and mobic®, for the treatment of arthri-<br />

tis, both passed the blockbuster threshold of<br />

more than USD 1 billion annual net sales.<br />

micardis®, our product for the treatment of<br />

hypertension, and sifrol®/mirapex®, to treat<br />

Parkinson’s disease, were significant growth<br />

drivers too. flomax®/alna®, our drug for benign<br />

prostatic hyperplasia, also contributed to the<br />

successful sales development.<br />

To measure our development in financial results<br />

is one thing. But of ultimate importance for us<br />

is the benefit we offer to the millions of patients<br />

whom we have supported with our above<br />

mentioned drugs and for people infected with<br />

HIV. Since it was first introduced in 1996, we<br />

have helped a million patients with our drug<br />

viramune®. And the success of our viramune®<br />

Donation Programme to prevent the mother-to-<br />

child transmission of HIV in developing


countries since 2000 encourages us to put even<br />

greater emphasis on our efforts to create value<br />

for patients and society. The launch of our new<br />

HIV drug aptivus® in <strong>2005</strong> is thus another step<br />

towards fulfilling our commitment to ‘Value<br />

through Innovation’.<br />

Prescription Medicines, by far our largest busi-<br />

ness area, accounting for 76 % of total net sales,<br />

increased its turnover by more than 17 % to<br />

total EUR 7.2 billion. The share of our product<br />

portfolio which still enjoys patent protection or<br />

exclusivity rights rose to 59 %.<br />

Our other business areas also achieved signifi-<br />

cant growth. In Consumer Health Care (CHC),<br />

our self-medication business, net sales rose<br />

by 8.5 % to almost EUR 1.1 billion. This was<br />

mainly attributable to our flagship brands and<br />

leading products in the cough & cold and gastro-<br />

intestinal indications, such as bisolvon®,<br />

mucosolvan®, dulcolax® and buscopan®.<br />

In addition, pharmaton®, our well-established<br />

international brand for the improvement and<br />

maintenance of vitality and well-being, held the<br />

second strongest position in our CHC product<br />

portfolio.<br />

Members of the Board<br />

of Managing Directors:<br />

Dr Hans-Jürgen Leuchs<br />

Dr Andreas Barner<br />

Dr Alessandro Banchi<br />

Prof. Marbod Muff<br />

(from left to right)<br />

For some years, <strong>Boehringer</strong> <strong>Ingelheim</strong> has<br />

been one of the world’s largest manufacturers<br />

of biopharmaceuticals for industrial customers.<br />

We also market our own biotech products,<br />

metalyse® (heart attack) and actilyse® (stroke).<br />

Our overall biopharmaceuticals business,<br />

which grew by 40 % in <strong>2005</strong> to EUR 548 million,<br />

is expected to play an increasingly important<br />

role in combating many major and developing<br />

diseases.<br />

Our Animal Health business, which accounts for<br />

4 % of our net sales, has also grown above the<br />

market average in recent years. In <strong>2005</strong>, sales<br />

rose by almost 8 % to EUR 361 million.<br />

A key factor for <strong>Boehringer</strong> <strong>Ingelheim</strong>’s sustained<br />

success is our well-distributed presence in all<br />

important world markets. Our products are sold<br />

in some 150 countries. The USA, again by far<br />

the most important market in <strong>2005</strong>, generated<br />

36 % of our total net sales. Our US sales grew<br />

by 17 % to EUR 3.4 billion. Japan (+8 % to EUR<br />

1.2 billion) and Europe (+19 % to EUR 3.1 billion)<br />

also posted excellent development. Europe as a<br />

region contributed 33 % of our total net sales.<br />

The healthy business development of the past<br />

business year led to a 40 % rise in operating<br />

income (broadly comparable to EBIT), totalling<br />

EUR 1.9 billion and reflecting an operating<br />

margin of more than 20 %.<br />

Key Aspects of <strong>2005</strong>


Our successful business activities go hand in<br />

hand with increasing effectiveness in cost<br />

management through all areas of the corporation.<br />

Cost-effective pharmaceutical manufacture is<br />

one of the key factors in attracting new partners<br />

for third-party manufacture.<br />

Patented drugs or drugs with exclusivity con-<br />

tinue to drive our growth. Our product pipeline<br />

includes a number of promising substances<br />

in major indication areas such as respiratory,<br />

cardiovascular and inflammatory diseases,<br />

virology, urology and CNS. In addition, good<br />

progress was made with development candidates<br />

in oncology, metabolism and immunology. Our<br />

areas of research are divided across the four main<br />

research sites in Germany (Biberach), Austria<br />

(Vienna), the USA (Ridgefield) and Canada<br />

(Laval), in line with their defined key areas.<br />

In addition, our activities and projects are<br />

supported by strategic alliances and in-licensing<br />

of new technologies. In <strong>2005</strong>, we moved various<br />

candidates into predevelopment and develop-<br />

ment with promising prospects for the future.<br />

In a continued move to support this strong<br />

growth, we took the opportunity to increase our<br />

manpower by 5 % to total 37,400 employees in<br />

the past year, mainly in the USA, Germany and<br />

Spain.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Outlook<br />

The gratifying development of our business in<br />

<strong>2005</strong> reflects the strengths of our company.<br />

However, yesterday’s successes are today’s history<br />

and the way ahead is uphill. The pharmapolitical<br />

measures in a number of important countries,<br />

starting with Germany, pose an increasing<br />

barrier to innovation and to patient’s access to<br />

new and better therapies. Developing medicines<br />

is a lengthy, costly and risky process. Short patent<br />

lifetimes, frequent regulatory interventions,<br />

rigorous price containment measures and fierce<br />

competition make it all the more difficult to<br />

guarantee the financial basis required for R&D.<br />

We once again expect to grow faster than the<br />

pharmaceutical market in 2006, although we are<br />

unlikely to match the growth rates posted in<br />

<strong>2005</strong>. mobic®, for example, is expected to face<br />

competition of the first generic versions in the<br />

USA in 2006. However, our product portfolio<br />

contains numerous branded medicines with<br />

medium to long-term patent protection which<br />

still have significant potential for growth.<br />

We are also pleased to have a number of interest-<br />

ing drug candidates for various indications<br />

in our promising pipeline. All in all, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> is optimistic about the future.<br />

Dr Alessandro Banchi Dr Andreas Barner Dr Hans-Jürgen Leuchs<br />

Prof. Marbod Muff


Shareholders’ Committee<br />

Dr Heribert Johann<br />

Chairman of the<br />

Shareholders’ Committee<br />

Albert <strong>Boehringer</strong><br />

Christian <strong>Boehringer</strong><br />

Christoph <strong>Boehringer</strong><br />

Ferdinand von Baumbach<br />

Hubertus von Baumbach<br />

Dr Mathias <strong>Boehringer</strong><br />

Advisory Board<br />

Prof. Michael Hoffmann-Becking<br />

Attorney at Law, Düsseldorf<br />

Chairman of the Advisory Board<br />

Dr Rolf-E. Breuer<br />

Chairman of the Supervisory Board<br />

Deutsche Bank AG,<br />

Frankfurt (Main)<br />

Prof. Fredmund Malik<br />

Chairman of the Board<br />

Managementzentrum<br />

St. Gallen Holding AG<br />

Prof. Axel Ullrich<br />

Director of the Max Planck Institute<br />

for Biochemistry, Martinsried<br />

Dr Heinrich Weiss<br />

Chairman of the Board<br />

SMS AG, Düsseldorf<br />

Board of Managing Directors<br />

Dr Alessandro Banchi<br />

Corporate Board Division<br />

Chairman of the Board<br />

Corporate Board Division<br />

Pharma Marketing and Sales<br />

Dr Andreas Barner<br />

Vice-Chairman of the Board<br />

Corporate Board Division<br />

Pharma Research,<br />

Development and Medicine<br />

Dr Hans-Jürgen Leuchs<br />

Corporate Board Division<br />

Operations<br />

Corporate Board Division<br />

Animal Health<br />

Prof. Marbod Muff<br />

Corporate Board Division<br />

Finance<br />

Corporate Board Division<br />

Human Resources<br />

Key Aspects of <strong>2005</strong>


Our caring culture<br />

The caring culture to which <strong>Boehringer</strong> <strong>Ingelheim</strong> has been committed<br />

for well over a century embraces a broad range of stakeholders from<br />

our patients, our employees and their families through neighbouring<br />

communities and society at large to our natural environment.<br />

Corporate responsibility as practised by our company takes many forms. Of paramount<br />

importance for us are the needs of our patients. It is the quest for innovation and medical<br />

breakthrough which drives all our activities. We understand that the importance of our<br />

company directly depends on the value of the therapies which we can present to those in<br />

need of medical help. And we fully grasp the central role of our employees in all our<br />

endeavours.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has been always regarded as an excellent employer. From the very<br />

beginning, it has focused on providing employees with an attractive place to work, a place<br />

in which they feel their contribution is fully recognised and properly rewarded. But our<br />

sense of responsibility does not stop there. It has always reached out far beyond our factory<br />

gates and today addresses many issues of a truly global nature.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> complies with the intention and basic principles of corporate<br />

governance and corporate social responsibility as proposed by international organisations,<br />

such as the United Nations (UN), the World Health Organization (WHO), the Organisation<br />

for Economic Co-operation and Development (OECD) or the European Union (EU).<br />

We regard ourselves as a good corporate citizen in all countries in which we operate, or<br />

where our products are available. We fully comply with the principles set out in the Global<br />

Compact in 1999 under a United Nations initiative.<br />

Such principles are already fully integrated into our business activities around the world<br />

and guide our strategy, corporate culture and day-to-day operations. Our aim is to provide<br />

full transparency concerning our business and corporate conduct within the framework of<br />

our annual report and other publications.<br />

In order to sustain our corporate responsibility, we depend on our business success, driven<br />

by product innovation and the morale of our people.<br />

Photo: Young tsunami survivors gather at new school-cum-village hall in Krueng Raya, Indonesia,<br />

supported by <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

Our caring culture


10<br />

Our commitment<br />

We have committed ourselves to the goal of serving mankind through<br />

research into diseases and the development of new drugs and therapies.<br />

In this endeavour the future of the Corporation will depend on its innovative<br />

capability. <strong>Boehringer</strong> <strong>Ingelheim</strong> strives for medical breakthroughs and<br />

invests heavily in research, development and medicine for therapies which<br />

fulfil unmet medical needs.<br />

In improving access to anti-AIDS drugs,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> acknowledges its special<br />

responsibility as a research-driven pharma-<br />

ceutical company in the war on the pandemic.<br />

It is engaged in wide-ranging initiatives to<br />

combat AIDS. The company has increased efforts<br />

in HIV/AIDS research, in supplying anti-AIDS<br />

drugs free of charge to treat the transmission of<br />

the disease from mother-to-child during birth,<br />

or providing them at substantially reduced prices<br />

to developing countries for chronical treatment.<br />

It has furthermore increased its activities supply-<br />

ing knowledge and training and supporting<br />

philanthropic initiatives via its affiliates in areas<br />

strongly affected by HIV/AIDS.<br />

Since 2000, <strong>Boehringer</strong> <strong>Ingelheim</strong> has given free<br />

access to single-dose viramune® (nevirapine),<br />

to be used alone or in combination with other<br />

drugs, to prevent mother-to-child transmission<br />

of the HI virus during birth. The company<br />

currently donates the product to some 140<br />

programmes in around 60 countries in Africa,<br />

Asia, Latin America and Eastern Europe. In total<br />

some 700,000 mother and child pairs have been<br />

treated so far.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> strives to facilitate the<br />

access to life-saving nevirapine. Five voluntary<br />

licenses to manufacture and market generic<br />

nevirapine have been granted to companies in<br />

South Africa, Nigeria, Egypt and Kenya.<br />

Moreover, as a founding partner of the Accelerat-<br />

ing Access Initiative (AAI), <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

offers developing countries considerable dis-<br />

counts in order to enable access to viramune®.<br />

Some 6,000 of Papua New Guinea’s 5.3 million<br />

inhabitants are infected with HIV and the infec-<br />

tion rate is 1,000 per year. Very few infected<br />

people go to healthcare centres so the figures are<br />

likely to be vastly underestimated. Apart from the<br />

viramune® Donation Programme, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> in partnership with other pharmaceu-<br />

tical companies, the Catholic Aids Office, the<br />

Australasian Society for HIV Medicine (ASHM)<br />

and the government of Papua New Guinea<br />

(PNG), have designed and implemented a pilot<br />

project to train healthcare workers under the<br />

auspices of the Collaboration for Health in Papua<br />

New Guinea.<br />

Unlike other programmes, this model used a<br />

multi-disciplinary approach to train teams of<br />

healthcare workers rather than doctors only.


Uganda has made strong progress in reducing the prevalence<br />

rate of HIV. The key to this success has been public openness,<br />

at all levels of society, in addressing the issue. Here, people<br />

living with HIV in Uganda demonstrate their support<br />

for treatment at the opening of a free AIDS clinic in Masaka,<br />

close to where the pandemic is thought to have begun.<br />

The teams consisted of physicians, nurses,<br />

counsellors, social workers and technicians<br />

working in healthcare centres. Topics covered in<br />

workshops included basic infection control,<br />

infection prevention, record keeping, diagnosis<br />

and management of opportunistic infections.<br />

The collaboration for Health in PNG is an initia-<br />

tive of a group of pharmaceutical manufacturers<br />

committed to the treatment and care of people<br />

living with HIV/AIDS.<br />

Addressing infrastructure needs<br />

As improving access to treatment remains<br />

seriously limited in many developing countries<br />

due to local structural problems in healthcare,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has also engaged increas-<br />

ingly in projects to improve education and<br />

relevant infrastructure.<br />

In addition to donation and increasing access to<br />

drugs, the company continues to explore ways<br />

to partner governments and NGOs to improve<br />

healthcare in developing countries.<br />

Initiatives the company has already undertaken<br />

in South Africa include the “Turning the Tide”<br />

programme of training and education for health<br />

professionals in HIV and its management. This<br />

has been extended into Swaziland and Botswana<br />

and now reaches over 1,000 healthcare workers.<br />

In <strong>2005</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong> opened discus-<br />

sions with healthcare organisations in Uganda<br />

with a view to possibly replicating schemes<br />

which have been successful in other parts of<br />

Africa.<br />

Among other initiatives was the Student<br />

Education Programme in collaboration with the<br />

University of Cape Town, South Africa, which<br />

provides full financial support from <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> for medical students from disadvan-<br />

taged backgrounds. The <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Lung Institute at the same university has been set<br />

up as a centre of excellence to support clinical<br />

trial activities in the country with research<br />

facilities in infectious and respiratory diseases.<br />

In <strong>2005</strong>, the <strong>Boehringer</strong> <strong>Ingelheim</strong> Training and<br />

Facilitation Unit was opened in Botswana.<br />

Our commitment 11


1<br />

For our neighbours<br />

We are fundamentally committed to fostering economic and social wellbeing<br />

in the countries and communities where we operate. Working together<br />

as a corporate entity and as individuals using their own time, we seek in a<br />

people-orientated and inspirational way to deliver value through innovation<br />

in all we do. We contribute actively to communities, charitable organisations,<br />

research, science, education, healthcare, environmental protection<br />

and cultural projects.<br />

As <strong>2005</strong> began, the world was becoming aware of<br />

the enormous scale of the devastation wreaked<br />

by the tsunami that struck Southeast Asia.<br />

People from our operation in Indonesia reacted<br />

immediately, sending donations of clothes,<br />

food, medication and toys to the Aceh region of<br />

Sumatra. A crisis team made up of volunteer<br />

employees also went to Aceh to see how best to<br />

further support the local population.<br />

Among the displaced in Aceh were more than<br />

150,000 children, many traumatised by the<br />

disaster. The company crisis team therefore<br />

decided to fund the construction of a trauma<br />

centre, which also serves as a school and village<br />

hall in Krueng Raya village. Aksari Ibnu, who<br />

co-headed the <strong>Boehringer</strong> <strong>Ingelheim</strong> Indonesia<br />

tsunami task force, commenting on the school<br />

opening in July, said: “The smiling faces of young<br />

children and the people of Krueng Raya was a<br />

huge reward for our team who had all dedicated<br />

themselves to this worthwhile project.”<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

The company made substantial donations<br />

through its international and local organisations<br />

to aid agencies involved in the <strong>2005</strong> disasters,<br />

the Asian tsunami and the devastating earth-<br />

quake that hit Kashmir in October. In response<br />

to the hurricane Katrina disaster in September,<br />

the company’s US organisation also funded a free<br />

mobile clinic to treat people in New Orleans in<br />

addition to making financial and product contri-<br />

butions through MAP International to disaster<br />

relief efforts in the USA and elsewhere.<br />

Our people taking the initiative<br />

Our wide range of charitable activities in the<br />

USA heavily involves volunteering by employees.<br />

A “Day of Caring” sponsored by the company,<br />

gives employees at our Ridgefield, Connecticut,<br />

USA, site the opportunity to volunteer for tasks<br />

to help the aged and deprived. In many ways,<br />

from decorating homes to reading to children at<br />

day care centres. Our US employees also partici-<br />

pate in numerous sponsored events to raise funds<br />

for good causes. At our Roxane, Ohio, USA, site<br />

employees help the Salvation Army buy and<br />

distribute Christmas presents for poor families.


In the Philippines, our employees stepped in to<br />

help families made homeless when their shanties<br />

burned down at Baseco Compound in Tondo.<br />

Not only did the employees donate funds to build<br />

eight new row houses for the homeless, they also<br />

helped with the construction work in their free<br />

time. The homes, built in cooperation with an<br />

organisation dedicated to eradicating homeless-<br />

ness, were handed over to their new occupants in<br />

June.<br />

Promoting equal opportunity<br />

In Latin America, the company has a long,<br />

solid tradition of charitable activities. In Brazil,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> launched a two-year social<br />

responsibility programme, “Conectar”, directed at<br />

disabled people to help them prepare for jobs<br />

market (many have never been employed). An<br />

employment assistance programme in the favelas<br />

of São Paulo is another example of how we<br />

actively promote fairness and equal opportunity.<br />

The company’s human resources professionals,<br />

voluntarily and in co-operation with those of<br />

other organisations, provide youngsters with<br />

poor prospects hands-on training and support in<br />

employment counselling, identifying ways to<br />

move forward and ensuring professional and<br />

emotional back-up.<br />

In Venezuela, the company gives training to the<br />

doctors at the respiratory care centres in Chacao<br />

neighbourhood and the Hospital Pérez de León<br />

in Caracas. The hospital also receives free medi-<br />

cines and equipment.<br />

Employees at <strong>Boehringer</strong> <strong>Ingelheim</strong> Portugal volunteered to<br />

build houses for two families in need in Braga in the north of<br />

the country in association with the humanitarian organisation<br />

Habitat for Humanity. Miguel Moreira, Area Manager for<br />

Prescription Medicines in Portugal, an active volunteer, said:<br />

“I am very proud that the company where I work shares the<br />

same concern: helping the ones most in need.”<br />

In Colombia, we not only contribute to health-<br />

care and schooling for people in our immediate<br />

community, but also support two foundations:<br />

the Padre Luna Farms, which help battered<br />

children and teach agricultural labourers; and<br />

Fundafidro, an organisation working with health-<br />

related issues in deprived neighbourhoods.<br />

Despite the extraordinary challenges of the<br />

tsunami disaster, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Indonesia succeeded in October in continuing its<br />

established community-awareness programme,<br />

giving general medical treatment to hundreds of<br />

needy people near the company’s Bogor plant as<br />

well as fostering educational improvement.<br />

For our neighbours 1


1<br />

For our people<br />

To achieve our corporate objectives we deploy flexible, mobile, self-confident<br />

employees prepared to accept responsibility and capable of thinking and acting<br />

globally. Our internal principles guide employee selection and assessment.<br />

To attain continuous innovation in all we do, we apply our employees’ and<br />

managers’ creativity, capability, commitment and willingness to learn and<br />

change. The Corporation in this regard delegates responsibilities to employees<br />

and acknowledges their success, performance and commitment in meeting<br />

agreed goals. Remuneration and classification are based on the task,<br />

performance, achievement and competitive comparison.<br />

Successfully pursuing our vision, Value through<br />

Innovation, calls for the dedication, passion and<br />

continuous powers of renewal of our more than<br />

37,000 employees. They are our unique source of<br />

strength and inspiration.<br />

Our persistent, combined efforts and resulting<br />

achievements in pharmaceutical innovation have<br />

enabled us to maintain growth and create new<br />

jobs. In many countries we have generated a<br />

significant volume of employment opportunities,<br />

led by the USA, with a total of 1,000 new jobs.<br />

The increased employment prospects we offer<br />

have been greeted extremely favourably in<br />

countries where lowering unemployment is a<br />

national challenge.<br />

On employment, <strong>Boehringer</strong> <strong>Ingelheim</strong> has<br />

received numerous accolades. In <strong>2005</strong>, we were<br />

awarded first price in “Arbeitsplätze absolut” for<br />

being the company which generated the highest<br />

number of new jobs in Germany. We also gained<br />

considerable public recognition in Germany for<br />

continuing to increase the number of apprentice-<br />

ships which rose from 623 to 698. The relatively<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

large number of apprentices in our extensive<br />

vocational programmes has won widespread<br />

praise as a powerful encouragement to the labour<br />

market.<br />

Great place to work<br />

We are proud of the attractive working environ-<br />

ment that we have created and the status that we<br />

enjoy as a preferred employer. Authoritative,<br />

independent workplace surveys in many coun-<br />

tries have confirmed our position among the top<br />

companies in this area so vital to recruiting and<br />

maintaining high quality employees (see box on<br />

page 17, list of awards).<br />

Such positive recognition of our company as<br />

a great place to work spurs us on to enhance<br />

our distinctive company culture still further.<br />

Ever responsive to the changing needs of our<br />

employees, we at the same time call for everyone<br />

to be personally engaged in improving our<br />

working environment at the heart of which are<br />

mutual respect, fairness, openness and space for<br />

both personal and professional development.


Development opportunities<br />

Our aspiration to continuously innovate requires<br />

firm commitment from everyone in the company.<br />

Ongoing dialogue between our employees and<br />

their supervisors is also essential to allow all<br />

parties to participate in our achievements and<br />

development. And our ability to progress coher-<br />

ently towards realising our vision by developing<br />

and leveraging the immense diversity within the<br />

company is pivotal to our success.<br />

Our annual employee – supervisor dialogue<br />

(Mitarbeitergespraech – MAG) is at the core of<br />

our performance and development culture.<br />

Engaging and stretching performance objectives<br />

are mutually agreed and career aspirations and<br />

perspectives for professional development are<br />

addressed. Every individual is expected to have a<br />

valid and forward-looking development plan to<br />

meet the qualification needs of our rapidly<br />

changing business and work environment.<br />

Career aspirations and prospects are also embed-<br />

ded in our global succession planning process.<br />

Here we seek to guarantee a strong pipeline of<br />

leadership talent for local and international key<br />

positions. Talent reviews linked to the succession<br />

planning support the identification and develop-<br />

ment of leadership talent across the corporation.<br />

Teamwork is a key element of <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>’s corporate culture. In Istanbul,<br />

our Turkish employees are here celebrating<br />

the <strong>2005</strong> launch of Lead & Learn with<br />

its implications for improved teamwork.<br />

International assignments are an integrated part<br />

of our succession planning process and our<br />

business and capability development.<br />

Our international assignees represent a large<br />

number of our organisations and are uniformly<br />

distributed throughout our geographical regions.<br />

While the focus groups and purpose of the<br />

assignment might differ from strategic positions<br />

to development measures or knowledge transfers,<br />

these moves serve clearly as a vehicle to enhance<br />

cultural understanding and broadening a global<br />

mindset.<br />

The <strong>Boehringer</strong> <strong>Ingelheim</strong> Academy, encompass-<br />

ing a variety of development courses and<br />

approaches in numerous countries, is designed to<br />

support and strengthen our core values and<br />

capabilities. Everyone at the company can access<br />

local and international development information<br />

on our intranets. The <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Academy offers a wide spectrum of options from<br />

vocational subjects to leadership development<br />

programmes.<br />

00 2004 2003 2002 2001<br />

Personnel costs in millions of EUR 2,671 2,443 2,252 2,175 1,916<br />

Personnel costs as % of net sales 28.0 29.9 30.5 28.7 28.6<br />

Number of employees (incl. apprentices) 37,406 35,529 34,221 31,843 27,980<br />

For our people 1


1<br />

We foster good leadership at all levels. Carefully<br />

tailored local and international development<br />

approaches are applied to help our current and<br />

potential leaders to discover ways to create a<br />

context in which our people can excel and all of<br />

us can continuously enhance our outcomes.<br />

Our third consecutive International Management<br />

Development Programme, launched in <strong>2005</strong>,<br />

marked the beginning of 14 months of interna-<br />

tional, interdisciplinary learning and working for<br />

some 100 potentials. The programme involves<br />

participants in hands-on work on 14 strategically<br />

relevant projects, close professional mentoring<br />

and frequent exposure to senior management in<br />

various countries.<br />

Benefits<br />

Our benefits programmes, which vary from<br />

country to country, include, amongst others,<br />

retirement benefits, health coverage, insurance<br />

cover, company restaurants, kindergartens, child-<br />

care centres and access to a variety of personal<br />

and family support services.<br />

Numerous additional initiatives and programmes<br />

are available for our employees and their fami-<br />

lies. These include international clubs, our Inter-<br />

national Cultural Student Exchange programmes,<br />

local internships for family members and sum-<br />

mer camps for children.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

A key benefit for many employees is the provision by<br />

the company of day care facilities for their children.<br />

Here, (left) toddlers enjoy a meal at the kindergarten<br />

in <strong>Ingelheim</strong>, Germany, set up in cooperation<br />

with the local community. In the US, construction of<br />

the Child Development Center on the Ridgefield,<br />

USA, campus is in full swing.<br />

The way we work together<br />

From the mid-1990s, our corporate culture has<br />

built on our vision Value through Innovation<br />

(VTI), which has given direction to all our activi-<br />

ties. An annual VTI Day brings our organisations<br />

together to celebrate our achievements in line<br />

with our vision and encourages and inspires our<br />

employees to participate in realising it in practi-<br />

cal ways.<br />

Value through Innovation has guided and will<br />

continue to guide our way of working together. It<br />

helps us build on our strength and make the most<br />

of our distinctive character, enabling us individu-<br />

ally and collectively to achieve great success.<br />

In <strong>2005</strong>, Lead & Learn was introduced to outline<br />

ways in which we can enhance our culture of<br />

working together to realise and deliver Value<br />

through Innovation. The core principles of Lead<br />

& Learn encourage increased questioning and<br />

seizing opportunities while fostering a culture of<br />

shared leadership and learning.<br />

VTI teams that fairly represent the diversity of<br />

our employees, together with our line manage-<br />

ment, have commenced their challenge to<br />

explore and realise complementary new ways to<br />

support our aspired cultural development<br />

throughout the corporation.


Awards 00<br />

Country Ranking Survey<br />

Austria 1 Great Place to Work<br />

Belgium 11 Great Place to Work<br />

Brazil < 1 0 Great Place to Work: The best companies to work for in Brazil<br />

Brazil Great Place to Work: The best companies to work for in Latin America<br />

Brazil < 0 Great Place to Work: The best companies to work for women<br />

Denmark 11 Denmark’s Best Place to Work<br />

Germany 1 Germany’s Best Employers (VAA)<br />

Germany 1 Germany’s Best Employers (Capital)<br />

Germany Germany’s Best Employers with more than 5,000 employees (Capital)<br />

Netherlands non given The 49 Preferred Employers in the Netherlands<br />

Mexico Great Place to Work<br />

United Kingdom 1 100 Best Companies to Work for (Sunday Times)<br />

USA (Roxane) Business First Places to Work in Central Ohio<br />

“Great Place to Work”®, USA, is an international initiative that has been undertaken for many years<br />

in various countries to evaluate the world of work and employee satisfaction.<br />

For our people 1


1<br />

For our environment<br />

In all our activities we will protect our employees, the facilities and the<br />

environment from harmful influences, conserve natural resources and promote<br />

environmental awareness.<br />

These tenets, which are firmly established in our<br />

guiding principles (Leitbild) and formulated in<br />

our Principles on Safety, Quality and Environ-<br />

mental Protection, are put into practice through<br />

systematic environmental protection, health<br />

and safety (EHS) management. Global standards<br />

are defined and enforced wherever they are<br />

indicated. Goals are set annually, while our<br />

EHS status is checked regularly by Corporate<br />

Headquarters. In <strong>2005</strong> alone, this involved<br />

twelve audits at various sites. Every plant<br />

undertakes to set up a local management system<br />

and is free to have this certified or not. For fur-<br />

ther details of our EHS management please visit<br />

www.boehringer-ingelheim.com/ehs.<br />

With our declared support for the concepts of<br />

the Responsible Care® Initiative of the chemical<br />

industry, we have undertaken to exceed the<br />

minimum legal requirements wherever we<br />

consider it appropriate. Consequently, each site<br />

draws up its own programme for continuous<br />

improvements in the EHS field.<br />

Frequently it is not only our employees and the<br />

environment that benefit, but measures taken<br />

can also have an economic impact, as illustrated<br />

by the example of our wood-fired power station<br />

in <strong>Ingelheim</strong>, Germany, described below. Other<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

examples show that we accept responsibility for<br />

our products and attach great value to EHS,<br />

not only at our own plants but also at those of<br />

our business partners.<br />

Climate protection<br />

In the wake of disasters, such as those caused<br />

by the hurricanes Wilma and Katrina in <strong>2005</strong>,<br />

the subject of climate protection moved to centrestage<br />

in public debate.<br />

By converting the power station at our <strong>Ingelheim</strong><br />

site to burn a renewable source of energy, waste<br />

wood, <strong>Boehringer</strong> <strong>Ingelheim</strong> has already made<br />

an active contribution to improving the carbon<br />

dioxide (CO2) balance. Compared with the two<br />

Work accidents<br />

■ Frequency rate =<br />

accidents x 1 million hours / total labour hours<br />

■ Severity rate =<br />

lost labour days x 1 million hours / total labour hours<br />

4<br />

3<br />

2<br />

1<br />

’01 ’02 ’03 ’04 ’05<br />

80<br />

70<br />

60<br />

50<br />

40


The safety checklist for vehicles carrying hazardous materials to<br />

and from company sites is longer as that for a passenger<br />

aircraft. Here the tyres on a truck are being examined at the<br />

<strong>Ingelheim</strong> site in Germany as part of the comprehensive checks<br />

made before it may leave the plant.<br />

previous years, the balance has improved by<br />

about 60,000 tonnes, or a quarter of the Corpo-<br />

ration’s total CO2 emissions.<br />

A secondary benefit of the conversion has been a<br />

major reduction in emissions of sulphur dioxide,<br />

a contributor to acid rain.<br />

In a move to reduce emissions of gases detrimen-<br />

tal to the global climate, in accordance with the<br />

Kyoto Protocol, the European Union introduced<br />

the Emissions Trading Scheme for CO2 in <strong>2005</strong>.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has joined this scheme.<br />

Our heating power station in <strong>Ingelheim</strong> was<br />

issued trading certificates on the basis of the<br />

emissions in 2000–2002. Following the switch<br />

to wood, a CO2-neutral power source, we can<br />

now trade any certificates that we no longer need.<br />

This project has allowed us to pursue both<br />

ecological and economic goals at the same time.<br />

Water<br />

■ Water consumption (in millions of m 3 )<br />

■ Water consumption index (in %)<br />

10<br />

8<br />

6<br />

4<br />

2<br />

’01 ’02 ’03 ’04 ’05<br />

120<br />

100<br />

80<br />

60<br />

Another example of our responsible approach to<br />

climate protection came within the framework of<br />

a programme run by the Swiss national energy<br />

authorities in 2003. Our Swiss site undertook to<br />

reduce CO2 emissions by 10 % by the year 2010<br />

and has already met interim goals.<br />

Pharmaceuticals in the environment<br />

We are not only responsible for clean production,<br />

but also for ensuring our products have minimal<br />

impact on the environment.<br />

An environmental risk assessment is now<br />

required when registering new products. This is<br />

prepared on the basis of studies on environmen-<br />

tal impact and ecotoxicological effects. We also<br />

assess the environmental data for products<br />

already on the market and, where necessary, run<br />

further voluntary studies to assess the ultimate<br />

impact.<br />

Energy<br />

■ Energy consumption (in millions of gigajoules)<br />

■ Energy consumption index (in %)<br />

5<br />

4<br />

3<br />

2<br />

1<br />

’01 ’02 ’03 ’04 ’05<br />

140<br />

120<br />

100<br />

For our environment 1


0<br />

Assessments to date show that our substances<br />

present no risk to man.<br />

Business partners<br />

Our EHS management system guarantees that<br />

all <strong>Boehringer</strong> <strong>Ingelheim</strong> sites satisfy set require-<br />

ments and make constant improvements.<br />

However, we also attach great value to ensuring<br />

that our business partners likewise meet our<br />

expectations in terms of EHS, while satisfying<br />

minimum requirements, in order to ensure the<br />

continuity of our own business. For this reason,<br />

we increasingly check EHS aspects as well as<br />

quality during qualification of suppliers and<br />

contract manufacturers.<br />

Awards<br />

In <strong>2005</strong>, a number of sites were again awarded<br />

prizes by external agencies for their efforts in<br />

EHS. For the 6th time running, our site in<br />

Colombia won an award for its excellent contri-<br />

bution to long-term development. The local<br />

agencies awarded the site in Toride, Japan, a<br />

prize for its exemplary efforts in the storage of<br />

hazardous goods and fire safety, while the site in<br />

Petersburg, Virginia, USA, was given an award<br />

for its modern wastewater treatment plant.<br />

Our French chemical plant received first place<br />

in a countrywide external safety audit conducted<br />

to international standards.<br />

Carbon dioxide (CO2)<br />

■ CO2 by energy purchased (in 1,000 tonnes)<br />

■ CO2 by process emissions (in 1,000 tonnes)<br />

■ CO2 emissions index, direct emissions (in %)<br />

(without company car park)<br />

500<br />

400<br />

300<br />

200<br />

100<br />

’01 ’02 ’03 ’04 ’05<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

120<br />

100<br />

80<br />

60<br />

Incidents<br />

Our local and global crisis management<br />

allows us to react rapidly to potential incidents.<br />

No major incidents occurred in <strong>2005</strong>.<br />

Our performance<br />

The graphs show the EHS performance figures<br />

for the last five years.<br />

Performance in the field of safety at work is<br />

measured by the number of accidents and their<br />

rate adjusted for the number of employees.<br />

As can be seen from the graph (page 18), the rate<br />

of accidents has fallen again since 2004.<br />

Our environmental impacts are shown both<br />

as absolute values and relative to production –<br />

represented in our production index. The index<br />

represents our overall production in all business<br />

areas and is weighted to compensate for differ-<br />

ences in environmental impact. Our baseline year<br />

is 1995. Since <strong>2005</strong> the figures include the values<br />

for the company microParts, Germany, which<br />

was acquired in 2004. They do not include<br />

SSP Co., Ltd. , Japan, which has also not been<br />

included in previous years.<br />

Over the last few years, most indicators have<br />

reached a relative stable level because many<br />

prior technical or organisational improvements<br />

resulted in a high performance standard. This is<br />

Volatile organic carbon (VOC)<br />

■ VOC emissions, non-halogenated (in tonnes)<br />

■ VOC emissions, halogenated (in tonnes)<br />

■ VOC emissions index (in %)<br />

1,000<br />

800<br />

600<br />

400<br />

200<br />

’01 ’02 ’03 ’04 ’05<br />

80<br />

60<br />

40


eflected clearly in the respective indices com-<br />

pared with 1995. The production-adjusted<br />

amount of pollutants in wastewater produced<br />

has been reduced by 60 %, solvent emissions<br />

(volatile organic hydrocarbon – VOC) have been<br />

halved and water consumption lowered by a<br />

quarter. Our recycling rate has stabilised at a very<br />

high level of about 80 %. Many of our ongoing<br />

efforts are therefore no longer reflected as<br />

clearly as in earlier years. For a more detailed<br />

explanation of the individual graphs, please visit<br />

www.boehringer-ingelheim.com/ehs<br />

Our goals<br />

We are aware that there is further potential for<br />

optimisation in terms of solvent emissions (VOC)<br />

into the air. We are making changes at our chemi-<br />

cal site in Spain, where VOCs will be eliminated<br />

in future through thermal oxidation rather than<br />

by scrubbing with aqueous media. In <strong>Ingelheim</strong>,<br />

Germany, too, additional plants are to be con-<br />

nected to the existing incinerator. Our goal for<br />

2008 is to reduce VOC emissions by at least 50 %.<br />

Our wastewater treatment plants are already<br />

performing on a very high level. To maintain and<br />

further improve this level and to adapt to<br />

increasing loads, we started a major investment<br />

in our <strong>Ingelheim</strong> wastewater treatment plant.<br />

An additional state-of-the art treatment step will<br />

make the process more effective, will increase<br />

Wastewater — chemical oxygen demand (COD)<br />

■ COD load before treatment (in tonnes)<br />

■ COD load after treatment (in tonnes)<br />

■ COD load (after treatment) index (in %)<br />

8,000<br />

6,000<br />

4,000<br />

2,000<br />

’01 ’02 ’03 ’04 ’05<br />

80<br />

60<br />

40<br />

20<br />

nitrogen removal by improving the nitrification/<br />

denitrification process, and will also target the<br />

specific halogen-containing wastewater which<br />

can be difficult to treat when using only conven-<br />

tional technology.<br />

Our chemical sites in Malgrat, Spain, and<br />

Fornovo, Italy, are seeking to have their environ-<br />

mental management systems certified in 2006<br />

in accordance with ISO 14001.<br />

This report only mentions some of the activities<br />

we engage in to fulfil our responsibilities.<br />

Please visit the internet for further details about<br />

our product responsibility, the safe handling<br />

of highly potent substances in production and<br />

other examples of our many safety activities.<br />

www.boehringer-ingelheim.com/ehs<br />

Disposed waste<br />

■ Domestic waste (in tonnes)<br />

■ Hazardous waste (in tonnes), incl. pharmaceutical waste<br />

■ Disposed waste index (in %)<br />

■ Recycling rate (in %)<br />

20,000<br />

15,000<br />

10,000<br />

5,000<br />

’01 ’02 ’03 ’04 ’05<br />

100<br />

90<br />

80<br />

70<br />

For our environment 1


Our R&D drive<br />

Holger Pfister has been treated with almost all of the 22 currently<br />

available HIV drugs. “But my doctors never managed to bring my viral<br />

load under the detectable limit,” says Holger. The viral load, the number<br />

of virus particles in the blood, measures a person’s HIV / AIDS status.<br />

Owing to the failure to treat Holger’s virus effectively, it has become<br />

resistant in his body to almost all AIDS medications. Resistance is<br />

a very serious HIV issue. In 2003, Holger took part in the resist clinical<br />

study for <strong>Boehringer</strong> <strong>Ingelheim</strong>’s novel protease inhibitor (PI) aptivus®<br />

(tipranavir). “Since then I’ve been under the measurable limit for the<br />

first time ever,” he says. Continuing the treatment, he is in good mental<br />

and physical health.<br />

Professor Schlomo Staszewski from Frankfurt university, a leading AIDS expert and the<br />

first person in Germany to hold a professorship in HIV infections, hails aptivus®,<br />

launched in the first markets in <strong>2005</strong>, as “the most efficacious protease inhibitor so far”.<br />

And it is not just a question of efficacy. “Tipranavir is the largest antiretroviral development<br />

to date,” says Dr Paul Carter, who coordinated the project at <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

“This project has clearly shown that our closely integrated development network, which<br />

links our R&D centres around the world, together with our well established interactions<br />

with clinical investigators, gives us access to all the capabilities necessary to achieve<br />

successful and timely development of even the most challenging drugs,” he notes. In only<br />

five years, tipranavir was taken from a promising candidate to a potent new drug.<br />

Tipranavir, in-licensed in phase II development from the former Pharmacia-Upjohn in<br />

2000, is a non-peptidic PI. It works by inhibiting protease, an enzyme needed to complete<br />

the HIV replication process. Based on available clinical and in vitro data, tipranavir is<br />

active against most strains of HIV-1 that are resistant to commercially available protease<br />

inhibitors. Tipranavir does not cure HIV infection/AIDS or prevent the transmission of HIV<br />

to others. What it importantly offers is a treatment that benefits patients with limited<br />

therapeutic options.<br />

Our R&D drive


AIDS drug resistance — a big issue<br />

Since the initial detection of AIDS in the early<br />

1980s, viral resistance to drugs treating HIV has<br />

become a crucial issue. The pharmaceutical<br />

industry has thus sought to constantly develop<br />

new drugs. To date, a total of over 20 are avail-<br />

able. However, the HI virus has proved to be a<br />

very dangerous master of metamorphosis, always<br />

finding ways to change its genetic pattern and<br />

thus ward off the attacks of antiviral drugs.<br />

A recent six-year study demonstrated a high<br />

prevalence of drug-resistant virus in a European<br />

group of patients under treatment for HIV-1<br />

infection. Data from the United Kingdom indi-<br />

cate that the transmission of drug-resistant virus<br />

is on the rise, with 47 % of patients resistant to at<br />

least one PI. The estimated prevalence of people<br />

with drug resistant virus in a recent large-scale<br />

study in the United States was 78 % (Richmann et<br />

al., 2001). For all of HIV infected, new and potent<br />

drugs, like aptivus®, are a last resort.<br />

The RESIST clinical programme<br />

In 2003, the first patients were recruited for the<br />

resist pivotal trial programmes. These involved<br />

the most clinically advanced population ever<br />

studied and included 1,500 patients with highly<br />

resistant virus in 270 hospitals in 21 countries.<br />

Recruitment was completed in just eight months.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Since Holger Pfister was diagnosed with human<br />

immune deficiency virus (HIV) infection in 1986, he has<br />

been fighting AIDS (acquired immune deficiency<br />

syndrome). “I am one of the few who survived,” he says.<br />

The resist programme examined the treatment<br />

response of tipranavir boosted with ritonavir<br />

versus a comparator group in which patients<br />

received one of several marketed ritonavir-<br />

boosted PIs. The comparator PI was lopinavir,<br />

indinavir, saquinavir or amprenavir. In addition,<br />

patients received in both arms a personally<br />

optimised background regimen of another<br />

antiretroviral.<br />

The results of the resist studies demonstrated<br />

that a statistically significant greater percentage<br />

of HIV-positive patients taking tipranavir<br />

boosted with ritonavir achieved a treatment<br />

response versus the comparator group (40 %<br />

compared to 18 %). Furthermore, more than<br />

twice the number of patients receiving regimens<br />

that contain boosted tipranavir were able to<br />

reduce the amount of HIV in their blood to<br />

undetectable levels than in the boosted compara-<br />

tor group (viral load


New data presented at the 10th European AIDS<br />

Conference in Dublin demonstrate that through<br />

48 weeks, aptivus® provides a convincing and<br />

durable benefit, achieving and maintaining a<br />

superior treatment response in patients with<br />

resistant HIV. A large number of further clinical<br />

studies with tipranavir boosted with ritonavir<br />

are currently running or planned to start in the<br />

near future. Some of these are designed to inves-<br />

tigate tipranavir’s safety and efficacy in other<br />

patient populations such as children, women,<br />

patients co-infected with hepatitis B or C and<br />

naïve (previously untreated) patients. This range<br />

of studies demonstrates <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

continuing commitment to fully understand the<br />

profile of aptivus®.<br />

Our development strength<br />

aptivus® is not the only AIDS drug to emerge<br />

from our development programmes. The now<br />

widely-used antiretroviral agent nevirapine<br />

(viramune®) is a product of original <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> R&D and was the first member of the<br />

non-nucleoside reverse transcriptase inhibitor<br />

(NNRTI) class of anti-HIV drugs. In many other<br />

indication areas there are also new medications<br />

discovered and developed in-house by<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>, amongst them tiotropium<br />

bromide (spiriva®), a treatment for chronic<br />

obstructive pulmonary disease (COPD),<br />

pramipexole (sifrol®/mirapex®) against<br />

Parkinson’s disease or telmisartan (micardis®)<br />

for treating essential hypertension.<br />

A key indicator for <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

strength in R&D is the ratio of products still<br />

patented or under exclusivity protection to<br />

our net sales. It rose to 59 % in <strong>2005</strong>.<br />

Speed and efficiency are key to successful<br />

pharmaceutical development projects, as novel<br />

medicines that bring real benefit in terms of<br />

health and well-being are taking longer and<br />

longer to get to the market. And more time adds<br />

further expenditure to the enormous cost of<br />

developing modern medications.<br />

Our R&D expenditure in <strong>2005</strong> amounted to<br />

18.2 % of our net sales in Prescription Medicines,<br />

indicating the extent to which a modern research-<br />

driven pharmaceutical company has to invest<br />

in discovering and developing new products,<br />

or extending the life and indication coverage of<br />

existing drugs in its portfolio.<br />

The development of effective treatments<br />

for viral infections, such as human<br />

immunodeficiency virus (HIV), presents<br />

a significant scientific challenge.<br />

A researcher studies an HIV-infected<br />

T lymphocyte cell on-screen. T cells,<br />

a type of white blood cell, are important<br />

for protecting the immune system<br />

against viral infections and are a prime<br />

target for the HI virus that causes a<br />

reduction in the number of T cells.<br />

Our R&D drive


‘HIV is being played down’<br />

An interview with Prof. Schlomo Staszewski<br />

Q: Prof. Staszewski, let’s start by discussing AIDS in the<br />

industrialised world. Hasn’t the disease here to a consider-<br />

able extent already disappeared from public awareness,<br />

even though it naturally remains with us? What’s your<br />

experience with this issue?<br />

Prof. Staszewski: AIDS, or HIV infection, is the most<br />

dangerous epidemic, and the one with the greatest<br />

consequences, in the latter part of the 20th<br />

century and the beginning of the 21st century.<br />

According to the World Health Organization, we<br />

have more than 40 million infected people. Some<br />

three million died of the disease in <strong>2005</strong>. In the<br />

same year, an additional five million were infected.<br />

Most deaths occur in sub-Saharan Africa. AIDS is<br />

really a deadly disease there. In our countries<br />

nobody needs to die of AIDS any longer. With<br />

the appropriate treatment the progression of the<br />

disease can be halted and patients can be<br />

prevented from developing the manifestations<br />

of AIDS.<br />

The dilemma with AIDS is, on the one hand, its<br />

good treatability, and, on the other hand, that it’s<br />

the most dangerous infectious disease of our time.<br />

The question is how do we deal with it?<br />

Naturally you can gloss over or keep AIDS secret,<br />

if you live in the western world, where patients can<br />

receive all the available medications. You can<br />

conceal the fact that some things in the world are<br />

not in order. You can also see that in the number of<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

new infections in European countries. In <strong>2005</strong>,<br />

they rose by about 10 %, in Germany, even by as<br />

much as 20 %.<br />

Q: What’s the reason?<br />

Prof. Staszewski: HIV is being played down.<br />

Awareness of the therapies and their effects on the<br />

course of the disease HIV are removed and remote<br />

from the real situation. This we have to correct.<br />

We must say what kind of disease it is.<br />

My criticism of the current trend is also that,<br />

content with the possibility of individual therapy,<br />

we’ve lost sight of the overall epidemic. People no<br />

longer regard HIV as a fatal disease.<br />

Advertising by the pharmaceutical industry often<br />

also contributes considerably to glossing over the<br />

disease. It focuses the HIV disease to the<br />

industrialised world and shows in its pictures and<br />

personal testimonials people who are well. It<br />

presents things as though there is no problem<br />

at all.<br />

Q: A problem in the West is the development of drug-<br />

resistance. How do we deal with this?<br />

Prof. Staszewski: Resistance is a common phenom-<br />

enon. In the event of therapy failure or side-effects,<br />

the switch to a tolerable or effective therapy<br />

is more difficult. When resistance has occurred,<br />

you have to switch therapy to combine those


Thanks to new treatments and innovative drugs,<br />

AIDS has become controllable in the developed<br />

world. Although it is still a deadly disease,<br />

HIV awareness has weakened, leading to<br />

increasing infection rates. In Mainz, Germany,<br />

with the support of <strong>Boehringer</strong> <strong>Ingelheim</strong>,<br />

a group of teenage schoolchildren put on a play,<br />

“Damned positive”, which highlights the dangers<br />

of an HIV infection.<br />

medications to which the virus is still sensitive.<br />

Here, the right combination is decisive. If we use<br />

an effective medication in the wrong combination,<br />

there is a danger that it will be wasted because of<br />

resistance developing.<br />

Q: Is APTIvuS® effective because of the very fact that it can<br />

also be used for patients who are already resistant to many<br />

other medications? Is that its strength?<br />

Prof. Staszewski: That’s currently the most important<br />

indication area for aptivus®, as it is effective<br />

against viruses that have already become resistant<br />

to other protease inhibitors (ed: PI). But there are<br />

viruses that are resistant to aptivus®. This, one has<br />

to know. Because only then it becomes clear that<br />

aptivus® must also be used sensibly. When I use it<br />

too late, or use it in the wrong combination,<br />

I waste the medication.<br />

aptivus® has strengths and weaknesses.<br />

Basically, it has all the side-effects familiar to<br />

protease inhibitors. As dosage-related side-effects<br />

occur, it is a good idea to test lower doses in<br />

patients whose disease is less advanced than the<br />

dose necessary for the patient with PI-resistent<br />

virus. This should though at present only occur<br />

within a controlled clinical study.<br />

Prof. Schlomo Staszewski<br />

• First holder in Germany of a professorship dedicated<br />

to AIDS, established in 2003 at Johann Wolfgang Goethe<br />

University, Frankfurt am Main<br />

• Director of the Out-Patient Clinic for the HIV-infected<br />

Patients and the Antiretroviral Research Unit<br />

• Principal investigator in several international<br />

multi-centre studies with new HIV compounds.<br />

Current editor of HIV-Medicine<br />

• Executive Committee Member of the European<br />

AIDS Clinical Society (EACS)<br />

Our R&D drive


Our strength in R & D + Medicine<br />

Research and Development has been the foundation of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

success so far and continues to be the major driver of innovative, new<br />

medicines. We recognise the unique opportunities and challenges that medical<br />

needs and the health environment present. We have consequently committed<br />

ourselves to discovering, profiling and developing new products of high<br />

therapeutic value for patients and healthcare systems.<br />

New biological entities (NBEs)<br />

We are widely recognised as a world leader in all<br />

aspects of biopharmaceutical manufacturing,<br />

from early process development to large-scale<br />

commercial manufacturing in microbial as well<br />

as mammalian expression systems. Combined<br />

with our disease expertise in key therapeutic<br />

areas, our strategy is to create a comprehensive<br />

NBE programme addressing unmet medical<br />

needs in several indication areas, thus expanding<br />

our proprietary NBE product portfolio beyond<br />

actilyse® (first generation t-PA), metalyse®<br />

(second generation t-PA), imukin® (interferon<br />

gamma) and beromun® (tumour necrosis factor).<br />

In order to fully exploit the synergistic potential<br />

of our internal capabilities, we have established<br />

centralised expertise in human antibody drug<br />

discovery at our research site in Vienna, Austria,<br />

facilitated by in-licensing of key technologies<br />

from MorphoSys (phage display) and Medarex<br />

(genetically modified mice). We have also<br />

strengthened our protein technology infrastructure<br />

across research sites and allocated dedicated<br />

biology resources in key therapeutic areas.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

During <strong>2005</strong>, we expanded our NBE discovery<br />

programme to include some 10 discovery projects,<br />

a first step towards a steady stream of innovative<br />

NBE therapeutics feeding our development<br />

pipeline. While our key focus is on human monoclonal<br />

antibody projects, we are also exploring<br />

treatment options for cardiovascular and metabolic<br />

diseases with optimised bioactive therapeutic<br />

proteins (OBTs). In-licensing promising NBE<br />

candidates is an important complement to<br />

in-house research activities and to this end we<br />

have in-licensed AbGn-168, a humanised<br />

monoclonal antibody that induces apoptosis of<br />

activated T cells, from AbGenomics Corporation,<br />

Taiwan. AbGn-168 holds promise in delivering<br />

long-lasting control of T cell mediated diseases,<br />

including autoimmune diseases.<br />

Drug Discovery and Non-Clinical Development<br />

Insight into the workings of diseases at a<br />

molecular level is an important prerequisite for<br />

identifying promising targets for new drugs.<br />

In this context, integrating state-of–the-art<br />

technologies to enhance the R&D value chain<br />

is the key to success in pharmaceutical R&D.<br />

Despite significant progress in recent years,<br />

unmet medical needs continue to be great and<br />

growing due to changes in the environment and<br />

people living longer.


Laboratory assistants at our Quality & Compliance Department,<br />

Biopharmaceutical Manufacture, Biberach, Germany, undertake<br />

visual assessment of biotechnically produced proteins using gel<br />

electrophoresis.<br />

Today, we carry out drug discovery in seven<br />

major therapeutic areas allocated to four major<br />

R&D sites. Our R&D sites maintain strong<br />

responsibility and accountability for their thera-<br />

peutic areas locally and deploy their innovation<br />

and flexibility. International scientific reviews<br />

and portfolio management ensure a sustainable,<br />

competitive and risk-balanced discovery portfo-<br />

lio. To further strengthen our R&D organisation<br />

we have international skill centres to improve<br />

efficiency and to secure equal access to state-of-<br />

the-art technologies and informatics platforms<br />

for all sites. In Biberach, Germany, our largest<br />

R&D centre, we concentrate on diseases of the<br />

central nervous system (CNS), metabolic diseases<br />

and respiratory diseases. Biberach is supported<br />

by our chemistry laboratories in Milan, Italy.<br />

Drug discovery in immunology & inflammation<br />

and cardiovascular diseases is carried out in<br />

Ridgefield, USA. Further fully-fledged drug<br />

discovery centres are located in Laval, Canada,<br />

carrying out research in virology, and in Vienna,<br />

doing research in oncology. In Kawanishi, Japan,<br />

we have an additional centre in molecular cell<br />

biology, specialised in membrane receptor targets.<br />

Our non-clinical drug development activities are<br />

concentrated in Europe and North America at<br />

the sites Biberach and <strong>Ingelheim</strong>, Germany,<br />

and Ridgefield, USA. Biberach and Ridgefield are<br />

conducting the full range of non-clinical devel-<br />

opment work packages including activities for<br />

chemistry, manufacturing and control (CMC)<br />

as well as relevant pharmacokinetic and safety<br />

studies.<br />

At these sites, pharmaceutical development is<br />

focused on conventional dosage forms, whereas<br />

<strong>Ingelheim</strong> represents our centre of competence<br />

for developing all inhalative dosage forms.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has a particular focus on<br />

the development of innovative inhalation devices.<br />

handihaler® and respimat® Soft Mist Inhaler<br />

offer us a very competitive platform in inhalation<br />

therapy and meet the challenges of drug develop-<br />

ment in a variety of indications. Added support<br />

on drug formulations and manufacturing clinical<br />

trial supplies is provided by our sites in Kawa-<br />

nishi and Buenos Aires, Argentina. Our coopera-<br />

tions with biotech and academic groups provide<br />

another key string to <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

bow in finding and developing innovative medi-<br />

cines. A good example is the strategic research<br />

collaboration initiated between our Biberach and<br />

Ridgefield centres and Evotec OAI that enabled<br />

us to establish a novel research platform for<br />

elucidating innovative receptor-based drugs. This<br />

collaboration started on receptor targets involved<br />

in CNS diseases but now also addresses targets<br />

of potential interest in other therapeutic areas,<br />

such as metabolic and immunological diseases.<br />

The bridge between our R&D people and<br />

academia is reinforced by the strong link to<br />

the renowned Research Institute of Molecular<br />

Pathology (IMP) which we fund in Vienna.<br />

Our strength in R&D+Medicine


0<br />

IMP scientists are at the forefront of discovery<br />

defining fundamental processes of cell division<br />

and differentiation in healthy and diseased states.<br />

A collaboration started in 2001 between the IMP<br />

and the Institute of Molecular Biotechnology<br />

Austria (IMBA) added a new dimension to our<br />

academic network. Intensified interactions with<br />

IMBA began in <strong>2005</strong> in target identification<br />

using model organisms.<br />

The more than 3,000 scientists, technicians and<br />

support personnel we employ in preclinical R&D<br />

is complemented by about 2,100 clinical moni-<br />

tors, statisticians and data managers in clinical<br />

development and medical departments.<br />

Respiratory diseases<br />

Respiratory diseases have long been a major<br />

focus area for <strong>Boehringer</strong> <strong>Ingelheim</strong> and we<br />

dedicate ample resources for research in this field.<br />

Our main objective in pulmonary research is to<br />

provide still further improved treatment options<br />

for chronic obstructive pulmonary disease<br />

(COPD) and severe asthma. COPD is currently<br />

the fourth most common cause of death, yet up<br />

to three quarters of sufferers in Europe go<br />

undiagnosed. This suggests a major unmet need<br />

for treatment for this debilitating lung disease<br />

which often afflicts smokers. Our worldwide<br />

launch of tiotropium (spiriva®) provided a<br />

medication to improve COPD therapy, strength-<br />

ening our leading position in the bronchodilator<br />

field. This is being build up by developing<br />

bronchodilators with alternative mechanisms<br />

which additionally offer the opportunity<br />

for combination with our anticholinergic<br />

compounds.<br />

Extending our product portfolio to drugs that<br />

target treatment of the underlying inflammation<br />

and the tissue remodelling process are the key<br />

goals in our COPD research. Inflammation in<br />

COPD patients is provoked by an infiltration of<br />

the lungs by macrophages and neutrophils. It is<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

only poorly controlled by current, widely-used<br />

anti-inflammatory drugs, such as corticosteroids.<br />

Our research in asthma is aimed at new<br />

mechanisms and immunological paradigms<br />

which would allow us to replace or reduce the<br />

doses of inhaled steroids by providing anti-<br />

inflammatory therapy better tolerated by patients.<br />

Another goal is to provide a new treatment for<br />

specific syndromes with high unmet medical<br />

need, such as severe, steroid-resistant asthma.<br />

virology<br />

Antiviral therapies for many serious, life-threat-<br />

ening chronic and acute viral diseases are lacking<br />

or are unsatisfactory. Our Laval centre focuses on<br />

the discovery and development of new antiviral<br />

therapeutics for the treatment of the human<br />

immunodeficiency virus type 1 (HIV-1) and the<br />

hepatitis C virus (HCV). These two devastating<br />

pathogens have each emerged epidemically in<br />

recent decades, afflicting millions globally.<br />

Our HCV research is directed toward identifying<br />

inhibitors targeting essential viral enzymes, such<br />

as the HCV serine protease and RNA polymerase.<br />

Such new mechanisms offer the potential for<br />

new therapies with improved safety and efficacy<br />

compared to current treatments of chronic<br />

hepatitis C. Our clinical studies with an HCV<br />

serine protease inhibitor provided the first proof<br />

of clinical concept for this class of antiviral agent<br />

and we continue to make efforts to exploit this<br />

antiviral target together with other novel<br />

approaches.<br />

Our R&D activities in HIV aim at developing new<br />

treatment options, especially for HIV patients<br />

who have failed prior therapy due to the develop-<br />

ment of drug resistance. Our research into the<br />

rapidly growing resistance problem has identified<br />

a promising new non-nucleoside reverse tran-<br />

scriptase inhibitor (NNRTI) as a follow-up to our<br />

existing HIV treatment viramune® (nevirapine).<br />

Development is proceeding on this compound<br />

which may become a treatment alternative for<br />

patients who have failed first line NNRTI therapy.


In addition, our discovery efforts are addressing<br />

several new targets for HIV therapy.<br />

Oncology<br />

Every year, more than 10 million people find<br />

themselves grappling with the medical uncer-<br />

tainties and emotional upheaval of a newly<br />

diagnosed cancer. Fortunately, an increasing<br />

number of patients benefit from surgery, radia-<br />

tion and medicines, but still there is recurrence of<br />

the disease. Thus, there remains a therapeutic<br />

gap to be bridged with innovative and improved<br />

treatments that enhances the quality of life.<br />

The sequencing of the human genome mean-<br />

while promises to accelerate the emergence of<br />

new cancer drugs. While not specifically<br />

designed for cancer research, no other area of<br />

biomedicine has profited more from the Human<br />

Genome Project than cancer biology, with deep<br />

insights into the fundamentals of how gene<br />

mutations and faulty cellular circuitry lie behind<br />

the aberrant growth, invasion, and metastasis of<br />

cancerous tissues in the body.<br />

Armed with such insights, we have embarked on<br />

a major drive to discover and develop innovative<br />

medicines for some of the most common cancers.<br />

Cutting-edge research conducted at <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Austria has resulted in promising drug<br />

candidates moving into clinical development.<br />

As presented for the first time at the American<br />

Association for Cancer Research – European<br />

Organisation for Research and Treatment of<br />

Cancer meeting in Philadelphia in November<br />

<strong>2005</strong>, three compounds originating from our<br />

Basic research plays an important role for <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

At the Research Institute of Molecular Pathology (IMP) in Vienna, Austria,<br />

where the fundamental principles and mechanisms of living organisms<br />

are analysed, about 200 researchers from all over the world investigate new<br />

ways forward in science, novel approaches and targets, thereby enriching<br />

applied research. The IMP enjoys a worldwide reputation in research in the<br />

areas of developmental biology and molecular genetics.<br />

Vienna oncology research centre have success-<br />

fully completed phase I studies in various cancer<br />

indications. A novel type of triple angiokinase<br />

inhibitor, targeting endothelial cell receptors<br />

responsible for cancer neo-angiogenesis, has<br />

entered phase II of clinical development. A dual<br />

kinase inhibitor targeting epidermal growth<br />

factor receptor and HER2 kinase, has shown<br />

promising results in patients with advanced solid<br />

tumours. And further, a first-in-class cell cycle/<br />

polo-like kinase 1 inhibitor was applied in a<br />

single dose escalation study to patients with<br />

advanced solid malignancies. In addition, we are<br />

increasing our efforts in monoclonal antibody<br />

based projects for treatment of both solid and<br />

haematological neoplasias.<br />

Metabolic diseases<br />

Health authorities and governments have been<br />

alarmed by recent epidemiological data suggest-<br />

ing that metabolic diseases, including obesity,<br />

diabetes mellitus type II and dyslipidemia, will<br />

grow worldwide by a much greater extent than<br />

previously expected. This has been identified as a<br />

major health problem not only for industrialised<br />

societies but also in, for example, South America,<br />

India and China. Particularly worrisome is the<br />

increasing prevalence of obesity in children<br />

together with the onset of type II diabetes in<br />

young adults. This disturbing fact leads to the<br />

forecast that today’s children may have a lower<br />

life expectancy than their parent generation.<br />

We are therefore putting great efforts on the<br />

metabolic disease field with particular focus on<br />

diabetes type II, obesity and dyslipidemia.<br />

Our strength in R&D+Medicine 1


New therapeutic approaches for the treatment of<br />

diabetes type II have the potential of delaying or<br />

even inhibiting the progression of the disease.<br />

Several research projects even offer the possibil-<br />

ity of preventing manifestation of the illness.<br />

We were successful in several of our research<br />

projects and have achieved promising results in<br />

preclinical but also clinical trials. In obesity there<br />

is a great need for new drugs that are more<br />

efficacious than the existing ones while provid-<br />

ing a high level of patient safety. Research in that<br />

area is directed both at a reduction of appetite<br />

and food intake as well as increasing the metabo-<br />

lism of energy carriers. We have established<br />

state-of-the-art technologies to carefully profile<br />

advanced compounds in vitro and in vivo.<br />

Despite efficacious treatment for the lowering of<br />

low-density lipoprotein (LDL) cholesterol, 60 %<br />

to 70 % of cardiovascular events still cannot be<br />

prohibited. The role of low levels of high-density<br />

lipoprotein (HDL) cholesterol and malfunction of<br />

the reverse cholesterol transport are hence areas<br />

of increasing research interest. We have started<br />

several new research projects to address that<br />

therapeutic need.<br />

Cardiovascular diseases<br />

With cardiovascular diseases forecasted to be the<br />

most common cause of premature death world-<br />

wide within the next decade, according to the<br />

World Health Organization (WHO), we commit-<br />

ted ourselves to renewed efforts in this therapeu-<br />

tic area by moving our cardiovascular research to<br />

Ridgefield in 2003.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

When Dr Barry Dickson talks about fruit flies, his eyes light up, as he has been working with<br />

Drosophila melanogaster for most of his scientific life. “The focus of my research is to understand<br />

the nervous system at the level of neural circuits and trying to understand how genes direct the<br />

assembly and function of specific circuits. Just as many of today’s major therapeutic targets came<br />

from studies of Drosophila development in the 70s and 80s, we anticipate that our work will open<br />

up new opportunities for the future treatment of neurological disorders,” Dr Dickson says.<br />

In January 2006, the 43-year old Australian, one of the world’s leading developmental neuro-<br />

biologists, became Scientific Director of the <strong>Boehringer</strong> <strong>Ingelheim</strong>-funded Research Institute of<br />

Molecular Pathology (IMP) in Vienna. Work by his team at the Institute of Molecular Biotechnology<br />

(IMBA) of the Austrian Academy of Sciences showed that a single gene determines the complex<br />

mating ritual of Drosophila. This was a front-page story in the New York Times in <strong>2005</strong>.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has been at the forefront of<br />

research and development in the cardiovascular<br />

disease area for decades, establishing its market<br />

presence in the treatment of thromboembolic<br />

diseases as well as hypertension and consequen-<br />

tial diseases. Ongoing research efforts in the<br />

thromboembolic area could be successfully<br />

completed by advancing a new product into pre-<br />

clinical development. We will continue to<br />

develop our cardiovascular research platform<br />

in the area of atherothrombosis and widen our<br />

research to include heart failure.<br />

To address the ever-increasing unmet medical<br />

need for treating these cardiovascular diseases,<br />

our Ridgefield scientists are already focusing on<br />

innovative approaches to identify novel and<br />

effective drugs that reach beyond current treat-<br />

ment regimes.<br />

These programmes will benefit from close inter-<br />

action with research scientists in our other drug<br />

discovery units. Targeting related human dis-<br />

eases, such as metabolic and immunological/<br />

inflammatory disorders, will undoubtedly<br />

increase the opportunities for developing novel,<br />

innovative therapeutic agents in the fight against<br />

cardiovascular disease.<br />

Central nervous system diseases<br />

According to WHO predictions, diseases of the<br />

central nervous system will constitute an<br />

increasing medical need this century, attributable<br />

to an exponential increase of these diseases after


the age of 65 combined with an aging population.<br />

To date, available therapeutic treatments are still<br />

unsatisfactory for the majority of CNS diseases.<br />

Our research in CNS diseases therefore focuses<br />

on novel treatment concepts for the major neuro-<br />

degenerative disorders, Alzheimer’s and Parkin-<br />

son’s disease, prominent consequences of the<br />

aging population. An additional focus lies on<br />

chronic pain, a condition for which medical<br />

attention is sought most frequently. New molecu-<br />

lar targets, such as ion channels and G-protein<br />

coupled receptors (GPCRs), which are involved<br />

in pain transduction pathways and have been<br />

validated in neuropathic and inflammatory pain<br />

models, form the basis for our drug discovery<br />

efforts in the chronic pain indication. Our drug<br />

discovery activities in the indication migraine<br />

address a new mechanism of action to interfere<br />

with cerebral vasodilation for which we have<br />

obtained clinical proof of concept.<br />

Our research efforts to interfere with disease<br />

progression in Alzheimer’s and Parkinson’s<br />

disease focus on targets established by pathology<br />

and genetics. Our activities in Alzheimer’s<br />

disease are, for example, aimed at reducing<br />

amounts of the amyloid-beta peptide, the major<br />

mediator of this fatal disorder and additionally<br />

searching for pro-cognitive therapies beyond<br />

acetylcholine restoration in this disease.<br />

Moreover, we are investigating approaches for<br />

reducing treatment-induced motor complications<br />

(dyskinesias), a major medical problem for<br />

patients with late stage Parkinson’s disease.<br />

Photo: IMP<br />

Immunology & inflammation<br />

Autoimmune diseases such as rheumatoid<br />

arthritis, multiple sclerosis and psoriasis are<br />

serious chronic inflammatory disorders with<br />

a large unmet medical need for safer and more<br />

efficacious treatments. At our Ridgefield site,<br />

our drug discovery efforts aim to regulate the<br />

processes involved in lymphocyte trafficking,<br />

immune cell signalling and the synthesis of<br />

critical inflammatory mediators. Additionally,<br />

we aim to deploy our knowledge about the<br />

influence of the immune and inflammatory<br />

systems on diseases in other therapeutic areas.<br />

In that regard, small molecule inhibitors of<br />

immunological signalling are being tested for<br />

their activities against inflammatory diseases<br />

as well as respiratory diseases that have an<br />

inflammatory component. Small molecules,<br />

able to inhibit inflammatory processes, have also<br />

advanced into pre-clinical development and<br />

others are currently being evaluated for key<br />

decisions. The mechanistic understanding of<br />

rheumatoid arthritis has allowed our scientists<br />

the identification of new approaches to under-<br />

standing the biology of the disease that we hope<br />

will continue to lead to further innovation in the<br />

future. Given the recent success of biologics in<br />

autoimmune diseases, such as rheumatoid<br />

arthritis and psoriasis, the focus of NBE research<br />

has been applied to these diseases. In order to<br />

maximise our portfolio, we have in-licensed an<br />

antibody from the biotechnology company<br />

AbGenomics that targets activated T lymphocytes<br />

Our strength in R&D+Medicine


sparing the early immune response and therefore<br />

shows promise as therapy for autoimmune<br />

diseases. Progress has also been made in the<br />

identification of antibodies targeting the inflam-<br />

matory cascade, further building our NBE port-<br />

folio. Given the variety of approaches and the<br />

focus on the mechanistic understanding of<br />

disease pathogenesis, we are confident that our<br />

research in immunology and inflammation will<br />

result in improved treatment options for patients<br />

who suffer from autoimmune diseases.<br />

In-licensing and partnering<br />

Our alliances range from early stage research to<br />

development and marketing or co-promotion<br />

collaborations. Complementing our in-house<br />

R&D efforts, these tie-ups are a vital component<br />

of our search for novel therapeutics which pro-<br />

vide new treatment options for patients.<br />

Reflecting the growing importance of alliances in<br />

the pharmaceutical industry, <strong>Boehringer</strong> Ingel-<br />

heim has stepped up its partnering activities in<br />

recent years, particularly in early stage collabora-<br />

tions. In its October <strong>2005</strong> issue, Nature Reviews<br />

Drug Discovery characterised <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> as one of the top ten pharmaceutical<br />

deal-makers worldwide. When deal activity was<br />

adjusted against ethical sales, we even ranked<br />

number one in the analysis.<br />

A key example of our partnerships in <strong>2005</strong> was<br />

the worldwide exclusive research and license<br />

collaboration with the Swedish biotech company<br />

Biolipox. Based on a new approach to the inhibi-<br />

tion of prostaglandin E2, an important endog-<br />

enous inflammatory mediator, the aim of the<br />

collaboration is to develop a new class of drugs<br />

with a novel mechanism of action for the treat-<br />

ment of pain and inflammation. In <strong>2005</strong>, we also<br />

extended two existing agreements with our<br />

partners Evotec and Astex. In addition to a<br />

substantial discovery programme to identify and<br />

develop therapeutics acting on G-Protein<br />

Coupled Receptors (GPCRs), the scope of our<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

collaboration with the German biotech company<br />

Evotec now also includes the joint identification<br />

of novel ligands to selected <strong>Boehringer</strong> Ingel-<br />

heim target proteins.<br />

In line with our vision to expand our R&D<br />

portfolio of biopharmaceuticals, in particular<br />

monoclonal antibodies, partnering in this area<br />

was a very important goal in <strong>2005</strong>. The biotech<br />

companies MorphoSys and Medarex have devel-<br />

oped innovative and complementary technolo-<br />

gies for the generation of fully human mono-<br />

clonal antibodies. We have concluded collabora-<br />

tions with both companies enabling our<br />

researchers to exploit these technologies in all of<br />

our therapeutic areas. The collaboration with<br />

MorphoSys was extended and has already<br />

resulted in the start of a new antibody project<br />

against a novel target molecule involved in<br />

cardiovascular diseases. In addition, we have<br />

explored collaborations with companies highly<br />

specialised in proteomics based identification of<br />

biomarkers (Caprion, Canada) and modulation of<br />

delivery of bioactive proteins (Syntonix, USA).<br />

Furthermore, we have signed an exclusive licens-<br />

ing agreement with the Taiwanese company<br />

AbGenomics for the worldwide rights to develop,<br />

manufacture and commercialise the human<br />

monoclonal antibody AbGn 168, discovered by<br />

AbGenomics in cooperation with the National<br />

Taiwan University. Due to its innovative mode of<br />

action, AbGn 168 has the potential to open up<br />

new avenues for the treatment of autoimmune<br />

disease, such as psoriasis, rheumatoid arthritis<br />

and multiple sclerosis. This agreement represents<br />

the first R&D partnership between a Taiwanese<br />

biotech company and a multinational pharma-<br />

ceutical corporation and illustrates our drive to<br />

tap new R&D resources in emerging markets.<br />

It has also given a significant boost for Taiwan’s<br />

efforts to build up a biotechnology industry.


Clinical development and registration<br />

Both for clinical development and registration<br />

<strong>2005</strong> was again very dynamic and resulted in<br />

remarkable progress in many areas. Our clinical<br />

programmes in clinical phases I to IV added<br />

another 32,000 patients newly recruited on top<br />

of the large programmes ongoing from last year.<br />

More than ever, the contribution from geo-<br />

graphic territories outside of Western Europe<br />

and North America has supported the progress in<br />

our clinical trial activities. Eastern Europe and<br />

Southeast Asia benefited most from our strength-<br />

ened clinical trial platform established in these<br />

regions. We will continue to build on our<br />

extended reach and are encouraged by the<br />

impressive quality delivered in these countries<br />

(see table).<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Clinical Trial Statistics<br />

During the period from 1996 to <strong>2005</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong> conducted or sponsored 1,399 studies<br />

with 142 substances in 59 countries from all regions of the world.<br />

Study type number of protocols<br />

Phase I 344<br />

Phase II 161<br />

Phase III 229<br />

Phase IV 115<br />

PMS studies 183<br />

Consumer health care 61<br />

Other* 73<br />

Co-sponsored studies 233<br />

The studies enrolled approximately 1.2 million patients during this decade, of which 300,000 were in Phase I–IV studies<br />

and over 700,000 in PMS studies (post-marketing surveillance). The term “patient” refers here in a wider sense to<br />

patients receiving test medication, comparative medications, receiving placebo, marketed medication, or being healthy<br />

volunteers. Detailing these numbers by region and clinical phases reveals a broad geographical distribution with<br />

emphasis on North America and Western Europe.<br />

Region I—III Iv Other PMS<br />

Africa 8,188 2,553 – –<br />

America, North 59,829 28,745 3,676 36,275<br />

America, S & L 5,707 6,660 96 52,019<br />

Asia (Japan) 7,531 1,890 – 16,924<br />

Asia (other) 4,028 13,972 113 140,692<br />

Australia 4,658 2,903 36 –<br />

Europe, East 5,705 11,367 296 3,065<br />

Europe, West 105,485 36,254 166,636 482,476<br />

Near East 582 436 – –<br />

Total 201,713 104,780 170,853 731,451<br />

February 2006<br />

The category “other” includes, for example, compassionate use and methodological studies.<br />

Our strength in R&D+Medicine


Important new registrations were also obtained<br />

in <strong>2005</strong>. The US Food and Drug Administration<br />

(FDA) granted accelerated approval for aptivus®<br />

in June and European registration under excep-<br />

tional circumstances was granted in October.<br />

Following these approvals, our second HIV drug<br />

after viramune® has reached the market and<br />

adds an important treatment option for heavily<br />

pre-treated patients who have developed resistant<br />

virus and depend on new drugs with improved<br />

resistance profile.<br />

spiriva®, the once daily maintenance treatment<br />

for COPD was approved in France and is now<br />

approved in 97 countries. Fast worldwide regis-<br />

tration and numerous excellent clinical trial<br />

results have facilitated its rapid growth into the<br />

leading COPD treatment position. The phase III<br />

programme for spiriva® administered through<br />

the innovative propellant-free soft mist inhaler<br />

respimat® was successfully completed and<br />

registration files are under development.<br />

As planned, we submitted sifrol® the leading<br />

Parkinson’s medication simultaneously to the<br />

US FDA and the European Medicines Agency<br />

(EMEA) for approval in the new indication<br />

restless legs syndrome. We expect regulatory<br />

review to be completed in 2006.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Before new drug candidates can be<br />

given to patients in clinical studies<br />

to test their efficacy, they are first<br />

studied in healthy volunteers,<br />

as here at the Human Pharma-<br />

cology Center at Biberach, Germany.<br />

This provides valuable information<br />

about the safety profile and<br />

tolerability of the substances.<br />

In the USA, mobic® was approved for juvenile<br />

rheumatoid arthritis. Our successful clinical<br />

development in this paediatric indication is an<br />

important contribution towards a great medical<br />

need and was additionally honoured by an<br />

extension of US market exclusivity.<br />

cymbalta® a brand of duloxetine licensed from<br />

Eli Lilly & Company, co-developed in post-<br />

registration studies and marketed for the treat-<br />

ment of depression, received registration in<br />

Europe for the additional indication diabetic<br />

neuropathic pain.<br />

Without exception, all of our large-scale clinical<br />

outcome studies continued according to plan.<br />

The micardis® mega-trial ontarget/<br />

transcend with 31,000 patients recruited has<br />

undergone repeated independent Drug Safety<br />

Monitoring Board (DSMB) review and is in its<br />

second year after last patient included. With a<br />

patient retention rate clearly above that known<br />

from similar trials, the likelihood that we<br />

will have results available as planned in 2008 is<br />

further reinforced. A proof of concept study to<br />

investigate a newly identified pharmacologic<br />

mechanism of micardis® and its metabolic effect<br />

in patients with type II diabetes has been com-<br />

pleted. Results will be available in early 2006.<br />

The excellent and very rapid patient uptake for<br />

the long-term factorial secondary stroke preven-<br />

tion study profess® comparing aggrenox®,<br />

micardis® and clopidogrel allowed us to


increase the planned patient number to 18,500<br />

and still expect the last patient to be included in<br />

early 2006.<br />

uplift, our 6,000-patient long-term outcome<br />

study with spiriva®, is also in stable follow-up<br />

with DSMB review and approval and patients<br />

treated up to three years.<br />

Results from several well-controlled clinical<br />

studies have become available, enhancing its<br />

profile spiriva® was shown to improve and<br />

extend the beneficial effect of pulmonary<br />

rehabilitation in patients with moderate to severe<br />

COPD. In a comparison of spiriva® combined<br />

with a long-acting beta agonist (LABA) versus<br />

the combination of a LABA and an inhaled<br />

steroid, the spiriva®-LABA combination resulted<br />

in superior lung function improvements. This<br />

confirms the international guideline recommen-<br />

dation to first combine long-acting bronchodila-<br />

tors before adding a steroid. spiriva® also<br />

confirmed its clinical efficacy in a selected Afro-<br />

American patient population and demonstrated<br />

excellent lung function improvements in a study<br />

in patients with mild COPD. Earlier clinical trial<br />

results on COPD exacerbation reduction and<br />

improvements in exercise performance have been<br />

submitted for registration in Europe.<br />

The robust clinical data base for sifrol® (prami-<br />

pexole) in the treatment of Parkinson’s disease<br />

was acknowledged in a review article in the New<br />

England Journal of Medicine where pramipexole<br />

was recommended as starting treatment of choice<br />

in early Parkinson’s disease.<br />

metalyse®, our bolus injection thrombolytic,<br />

has been investigated in two exploratory settings:<br />

lysis followed by routine primary percutaneous<br />

intervention (PCI) after myocardial infarction<br />

(assent iv trial) and as rescue intervention<br />

during reanimation in cardiac arrest (troica<br />

trial). While assent iv has been discontinued<br />

because routine combination of lysis and PCI<br />

was inferior to PCI alone, troica is continuing<br />

and will complete recruitment in 2006.<br />

In all our therapeutic areas clinical pipeline<br />

projects in phase I to III have been advanced.<br />

Three new compounds entered clinical phase I,<br />

two in respiratory, one in oncology.<br />

Phase I was successfully completed by our oral<br />

LFA antagonist with positive ex vivo signals<br />

suggestive of immune modulatory effects. We<br />

will therefore start phase II proof of concept<br />

studies in patients with psoriasis early next year.<br />

Already in an expedited phase I study we could<br />

establish a clear proof of principle for a new oral<br />

anti-diabetic drug when given to type II diabetic<br />

patients. Results from extended exposure in<br />

diabetic patients will complete the clinical profile<br />

and are expected for early 2006.<br />

In the important respiratory field, we advanced a<br />

new anti-cholinergic compound to clinical phase<br />

II in patients with COPD. We expect this com-<br />

pound to provide beneficial effects through<br />

increased target selectivity and maintenance of a<br />

very reliable 24-hour efficacy.<br />

Our strength in R&D+Medicine


In addition to the first clinical administration of<br />

a new cell cycle inhibitor in patients, our first<br />

angiokinase inhibitor has achieved proof of<br />

principle in phase I as an anti-cancer drug active<br />

in patients suffering from a variety of different<br />

cancers. With this encouraging result we could<br />

move the first oncology compound from own<br />

research to clinical phase II.<br />

With NS 2330, a compound licensed from Neuro-<br />

search, results of three well-performed proof of<br />

concept trials in early and advanced Parkinson’s<br />

disease and in Alzheimer’s disease were disap-<br />

pointing and did not meet our predefined efficacy<br />

criteria to justify a phase III development.<br />

For flibanserine, a new therapeutic principle to<br />

treat hyposexual desire disorder in females, the<br />

final phase III development has been agreed with<br />

the FDA and several methodology studies in<br />

support of the pivotal phase III studies have been<br />

performed. The first six months phase III study<br />

to be conducted in North America is in final<br />

preparation and ready to initiate in QI 2006.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

The most exciting progress has been made for<br />

dabigatran, an orally available thrombin inhibi-<br />

tor for the prevention and treatment of thrombo-<br />

embolic diseases. The programme in the preven-<br />

tion of deep vein thrombosis (DVT) following<br />

orthopaedic hip or knee replacement surgery has<br />

developed with impressive speed and recruited<br />

more than 6,000 patients into controlled phase<br />

III trials by the end of the year. We expect all<br />

three international trials to close in the second<br />

half of 2006. In a large global cooperative<br />

approach with leading academic centres we<br />

developed the final protocol for re-ly, the<br />

pivotal trial in the indication stroke prevention<br />

in patients with atrial fibrillation. The protocol<br />

for this 15,000 patient warfarin controlled mega-<br />

trial passed successful authority review and the<br />

first patients were randomised in December <strong>2005</strong>.<br />

The programmes for DVT treatment and long-<br />

term prevention are in preparation and sched-<br />

uled to start mid-2006.<br />

Our capability to perform electronic remote data<br />

capture in practically every country of the world<br />

was strengthened in cooperation with a leading<br />

computer technology provider. This enables us to<br />

meet the challenges of our growing clinical<br />

programmes, deliver quality data in an expedited<br />

fashion and extend our clinical trials to geo-<br />

graphic regions with new opportunities.


Business Development<br />

Our Businesses consist of Human<br />

Pharmaceuticals and Animal Health.<br />

We focus on the production of<br />

innovative drugs and treatments<br />

that represent major therapeutic<br />

advances.<br />

Net sales (in EUR million) 2004 00 Growth in %<br />

Human Pharmaceuticals , ,1 1, 1 %<br />

Prescription Medicines<br />

– Branded Prescription Medicines<br />

– Non-Branded Prescription Medicines<br />

6,183<br />

5,743<br />

440<br />

7,247<br />

6,712<br />

535<br />

1,064<br />

Consumer Health Care 970 1,052 82 8 %<br />

Industrial Customer<br />

— Fine Chemicals<br />

— and Manufacturing Pharma<br />

— Biopharmaceuticals<br />

Others 15 28 13 87 %<br />

Animal Health 1 %<br />

Total ,1 , 1, 1 %<br />

654<br />

262<br />

392<br />

847<br />

299<br />

548<br />

969<br />

95<br />

193<br />

37<br />

156<br />

17 %<br />

17 %<br />

22 %<br />

30 %<br />

14 %<br />

40 %


Human Pharmaceuticals<br />

A new quality<br />

of treatment,<br />

a new quality<br />

of life<br />

“I long to run, but I actually make it a rule to go for a brisk walk around a park<br />

twice a week since starting to take spiriva® in December 2004,” says Hiroshi Aida,<br />

a 76-year-old man from Tokyo, who used to run out of breath even on the gentlest<br />

slope due to chronic obstructive pulmonary disease (COPD). “Today, I can walk the<br />

1,800-metre course twice without strain and my finishing time is quicker every time.<br />

The drug works like a charm.” Mr Aida now has a dream of walking from Tokyo<br />

to Kyoto, about 510 kilometres, before his 100th birthday. Recently, he successfully<br />

completed a 10-kilometre walk.<br />

1


“spiriva® has obviously improved Mr Aida’s<br />

quality of life,” comments Mr Aida’s family doctor,<br />

Dr Kozui Kida, Professor and Director of the Res-<br />

piratory Care Clinic, Nippon Medical School. Six<br />

million people are estimated to suffer from COPD<br />

in Japan alone, but only some 20,000 are currently<br />

receiving treatment for the condition. This mis-<br />

match is not just a Japanese issue. “COPD stays<br />

undiagnosed in many cases,” says Professor Bart<br />

Celli, Head of Pulmonary and Critical Care Medi-<br />

cine, St Elizabeth’s Medical Center, Boston. “This<br />

is presenting a very serious problem.”<br />

Millions of people around the globe suffer from<br />

COPD which the World Health Organization<br />

expects to be the third most common cause of<br />

death worldwide by 2020. This debilitating lung<br />

condition makes it increasingly difficult to breathe.<br />

For many patients even walking or performing<br />

simple daily tasks is difficult. It can affect both<br />

men and women from their early 40s.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Around 80 % of cases are attributed to smoking<br />

tobacco. In fact, smokers are 10 times more likely<br />

to die of COPD than non-smokers. Another cause<br />

of COPD is exposure to indoor or outdoor pollut-<br />

ants. Workers exposed to toxic chemicals and<br />

pollutants have increased odds of developing<br />

COPD. A recent study found that some 20 % of<br />

COPD was attributed in part to work-related<br />

exposure.<br />

“spiriva® has obviously improved<br />

Mr Aida’s quality of life.”<br />

spiriva® (tiotropium bromide), discovered, devel-<br />

oped and manufactured by <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

has further strengthened the company’s position<br />

as a world leader in COPD treatment. The novel,<br />

once daily inhaled medication is recommended<br />

for the first line maintenance treatment of COPD.<br />

The disease is characterised by chronic airflow


limitation, shortness of breath (dyspnoe), cough,<br />

wheezing and increased sputum production.<br />

spiriva® helps to relax narrowed muscles in the<br />

airways inside the lungs or prevent them from<br />

narrowing (and to release trapped air), enabling<br />

sufferers to exhale more easily.<br />

spiriva® is already the world’s most prescribed<br />

drug for COPD. The highly favourable reception it<br />

has had since its initial launch in mid-2002<br />

secured it blockbuster status (a pharmaceutical<br />

brand with annual sales exceeding USD 1 billion)<br />

as expected, in <strong>2005</strong>, with net sales of 951 million.<br />

It is co-promoted with the US pharmaceutical<br />

company, Pfizer Inc. Following the launch in<br />

Japan, the world’s second largest pharmaceutical<br />

market, and in China in <strong>2005</strong>, the medication is<br />

now available in almost all important markets.<br />

Kim Jong-Hyun, a South Korean farmer and<br />

former heavy smoker, now in his early 60s, recalls<br />

his situation when, after suffering from cold<br />

symptoms, heavy sputum and difficulties in<br />

breathing for months, he decided to visit the<br />

general hospital in Seoul. “When I was working,<br />

walking and even doing minor things, I had<br />

difficulties in breathing. I thought that I could not<br />

ignore the symptoms any longer.” Mr Kim feared<br />

his life was slowly coming to an end after he was<br />

told that he had COPD.<br />

Initial medication failed to restore any normality<br />

to his life, but on switching to spiriva® in early<br />

<strong>2005</strong> he got much better. “Now I can work on the<br />

farm and take care of my cows. I feel like I have a<br />

second new life when walking in the sunshine.”<br />

Real improvement has also been confirmed in<br />

clinical studies, such as the tiphon* study, pre-<br />

sented to the American Thoracic Society in <strong>2005</strong>.<br />

Dr André-Bernard Tonnel, Service de Pneumolo-<br />

gie et Immuno-Allergologie, Centre Hospitalier<br />

Regional et Universitaire de Lille and the study’s<br />

lead investigator, said: “The tiphon study results<br />

are encouraging because they show that treatment<br />

with spiriva® can result in clinically significant<br />

and sustained improvements in health–related<br />

quality of life for patients with COPD.” n<br />

Revolutionising<br />

drug delivery<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is revolutionising inhaler therapy<br />

with the respimat® Soft Mist Inhaler (SMI), a unique<br />

inhaler device successfully launched in 2004 with<br />

berodual®, a drug for treating asthma and chronic<br />

obstructive pulmonary diseases (COPD).<br />

“As a world leader in the treatment of COPD, we are<br />

committed to developing the respimat® SMI as the gold<br />

standard for the administration of respiratory inhalation<br />

medications,” says Allan Hillgrove, head of <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>’s Respiratory Marketing.<br />

After the acquisition of the Dortmund (Germany) based<br />

microParts GmbH, a leading company in micro-system<br />

technology, <strong>Boehringer</strong> <strong>Ingelheim</strong> is currently developing<br />

several substances for use with respimat®. <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> microParts will meanwhile be built up as an<br />

international centre of excellence for inhaler technology.<br />

For more information on respimat®<br />

please visit www.respimat.com<br />

Fifteen times finer than human hair, the micro-channels (5 μm)<br />

inside the respimat® Soft Mist Inhaler are responsible for the highly<br />

effective distribution in the human lung of the mist containing<br />

respiratory medication. The inhalers are manufactured in Dortmund,<br />

Germany, by microParts, a <strong>Boehringer</strong> <strong>Ingelheim</strong> subsidiary.<br />

Human Pharmaceuticals


Prescription Medicines<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s product range is mainly focused on human pharmaceuticals,<br />

which contribute the largest share of the turnover of our group of<br />

companies, accounting for 96 % of net sales in <strong>2005</strong>. Human Pharmaceuticals<br />

covers the following business segments: Branded Prescription Medicines<br />

(BPM), Generic Prescription Medicines (GPM), Consumer Health Care (CHC)<br />

and Industrial Customers, which is sub-divided into Biopharmaceuticals,<br />

Chemicals and Manufacturing Pharma. Our Human Pharmaceuticals business<br />

developed very dynamically in <strong>2005</strong>. World sales rose by 17 % compared with<br />

the previous year to EUR 9.2 billion, primarily due to our innovative patented<br />

medications. The successful growth reinforces our approach of continuing<br />

intensive research into new drugs that offer relief and improvement for<br />

patients.<br />

Branded Prescription<br />

Medicines (BPM)<br />

BPM, which accounts for almost 70 % of our sales,<br />

expanded markedly in <strong>2005</strong>, with worldwide<br />

sales rising by 17 % to EUR 6.7 billion.<br />

Sales growth was mainly driven by the growth of<br />

our more recent drugs micardis®, spiriva® and<br />

sifrol®/mirapex® but more mature products,<br />

such as aggrenox® and mobic®, continued to<br />

contribute to the excellent development too.<br />

Meanwhile, the launch of new products – aptivus®<br />

and cymbalta®/xeristar® – contributed to the<br />

further rejuvenation of our product portfolio.<br />

Top 10 products<br />

Branded Prescription Medicines<br />

Net sales <strong>2005</strong> in millions of EUR change<br />

1. spiriva® 951 +81.2 %<br />

2. mobic® 848 +26.1 %<br />

3. micardis® 724 +27.3 %<br />

4. flomax® 721 –2.0 %<br />

5. combivent® 561 +9.8 %<br />

6. sifrol® 434 +52.2 %<br />

7. viramune® 288 +2.0 %<br />

8. atrovent® 248 +0.7 %<br />

9. catapresan® 176 –2.1 %<br />

10. aggrenox® 172 +17.8 %<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Therapeutic areas<br />

Respiratory diseases<br />

Chronic obstructive pulmonary disease (COPD),<br />

a chronic progressive respiratory disease charac-<br />

terised by chronic airflow limitation, shortness of<br />

breath, cough, wheezing and increased sputum<br />

production, can restrict a patient’s ability to<br />

perform normal daily activities. It is the fourth<br />

leading cause of death in the world.<br />

spiriva® (tiotropium bromide), a novel once daily<br />

inhaled medication recommended for first line<br />

maintenance treatment of COPD, works by<br />

targeting a dominant reversible mechanism of<br />

Sales Branded Prescription Medicines<br />

by Therapeutic Area<br />

Central Nervous System<br />

9.3 %<br />

Muscoloskeletal/<br />

Rheumatology<br />

13.0 %<br />

Gastrointestinal/<br />

Metabolic 3.4 %<br />

HIV 4.6 %<br />

Urology<br />

11.4 %<br />

Others 1.6 %<br />

Cardiovascular<br />

21.9 %<br />

Respiratory<br />

34.8 %


COPD – cholinergic constriction. It helps patients<br />

breathe more easily by opening narrowed airways<br />

and helping to keep them open for 24 hours.<br />

spiriva®, globally co-promoted with Pfizer Inc,<br />

is now available to patients in most of the world.<br />

In France the launch is planned in 2006.<br />

The benefits which spiriva® provides to patients<br />

are reflected in sales of EUR 951 million in <strong>2005</strong><br />

and market shares of 20 % or even more on a<br />

country basis. It has achieved blockbuster status.<br />

More importantly, spiriva® is now the world’s<br />

No. 1 prescribed product for COPD.<br />

The spiriva® clinical trials programme has<br />

recruited over 25,000 patients so far. The drug has<br />

demonstrated significant and sustained broncho-<br />

dilation (opening of the airways) and reduction in<br />

markers of air trapping. It has also demonstrated<br />

superior and sustained improvements in lung<br />

function (FEV1) over atrovent® (ipratropium<br />

bromide) Inhalation Aerosol, which were main-<br />

tained over one year. Further, it has demonstrated<br />

superior improvement in key lung function<br />

parameters over salmeterol. In addition, in<br />

placebo-controlled studies, patients treated with<br />

spiriva® required fewer doses of rescue medica-<br />

tions, had fewer exacerbations and COPD-related<br />

hospitalisations.<br />

In another part of the clinical trial programme the<br />

influence of spiriva® on the exercise endurance<br />

has been studied. It improved the capability of<br />

patients to exercise in a consistent way in 6-24<br />

week studies and showed a reduction in hospi-<br />

talisation as well as an improved quality of life.<br />

spiriva®, currently delivered to patients via our<br />

HandiHaler® device, will be used in the future<br />

with respimat® Soft Mist Inhaler (SMI). This<br />

propellant-free, new generation inhaler, which<br />

generates a slow-moving, long-lasting cloud with<br />

a high fine particle fraction, represents a major<br />

step forward in inhalation therapy. The soft mist<br />

travels more slowly and lasts longer than aerosol<br />

clouds from pressurised metered dose inhalers<br />

(pMDIs). Scintigraphic studies have shown that<br />

these properties increase drug deposition in the<br />

lungs where desired and reduce unwanted deposi-<br />

tion in the mouth and throat compared to pMDIs.<br />

It is important that patients feel comfortable with<br />

inhalers as this may influence adherence to treat-<br />

ment. Patients with obstructive lung diseases<br />

prefer respimat® SMI to pMDIs, expressing a<br />

high level of satisfaction.<br />

Cardiovascular diseases<br />

Hypertension (high blood pressure) is a serious<br />

cardiovascular risk, linked to stroke and heart<br />

attack as well as other conditions.<br />

It is vitally important that therapy controls this<br />

high blood pressure, but, despite available<br />

treatment options, hypertension is still not well<br />

controlled. An estimated 45–73 % of hypertensive<br />

patients in the USA remain uncontrolled. This is<br />

of particular concern as hypertension increases<br />

the risk of cardiovascular events and reducing<br />

blood pressure may prevent cardiovascular<br />

mortality and morbidity. Among patients with<br />

stage 1 hypertension, a reduction of 12 mmHg in<br />

systolic blood pressure for 10 years prevents one<br />

death for every 12 treated patients with diabetes or<br />

cardiovascular diseases. Even small reductions of<br />

3 to 5 mmHg produce significant reductions in<br />

stroke or heart failure (Source: American Journal<br />

of Medicines, <strong>2005</strong>, 118: 695-705).<br />

With micardis® (telmisartan), our angiotensin II<br />

receptor blocker (ARB), and micardisplus®<br />

(telmisartan in a fixed-dose combination with the<br />

diuretic hydrochlorothiazide), <strong>Boehringer</strong> Ingel-<br />

heim offers two innovative options and flexibility<br />

for the treatment of essential hypertension.<br />

Prescription Medicines


Protection<br />

around the clock<br />

“In treating hypertension, the early morning hours are<br />

critical, as blood pressure is known to surge at that<br />

time. This surge corresponds to a sharp increase in the<br />

risk of having a heart attack or stroke. Studies have<br />

shown an estimated 40 % more people suffer a heart<br />

attack and 50 % more people suffer a stroke between<br />

6 a.m. and 12 noon,” says Professor Bryan Williams,<br />

University of Leicester and lead investigator of the<br />

prisma studies.<br />

micardis® (telmisartan), <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

successful, highly efficacious drug for treating essential<br />

hypertension, offers 24-hour blood pressure control,<br />

and also provides superior blood pressure lowering<br />

compared to ramipril in the early hours. It is being<br />

evaluated for its potential to protect end-organs, such<br />

as the kidneys or the brain, as well as the potential to<br />

delay the onset of diabetes II in patients with increased<br />

risk, in the ontarget trial.<br />

Systolic blood pressure (in mmHg)<br />

in relation to time (wakening hours)<br />

(0 = wake-up time)<br />

160<br />

150<br />

140<br />

130<br />

-4 -2 0 2 4 6 8 10 12 14 16 18<br />

hours<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

micardis® has the longest half-life in the ARB<br />

class, providing effective blood pressure control<br />

over 24 hours with a once daily dosage, including<br />

the early morning hours when blood pressure<br />

surges. At this critical time of day, it delivers<br />

powerful blood pressure reductions.<br />

micardis®/micardisplus® posted net sales of<br />

EUR 724 million in <strong>2005</strong>, representing growth of<br />

27 % and making it our third biggest BPM product.<br />

Having grown above the market average for anti-<br />

hypertensives (34 %), its global market share<br />

improved to 7.6 %.<br />

In the protection programme of clinical trials<br />

with micardis®, five trials versus main competi-<br />

tors have provided new important clinical data for<br />

micardis® and micardisplus® in hypertension,<br />

showing clear clinical superiority over ramipril,<br />

losartan, valsartan, and amlodipine + HCTZ. The<br />

detail study, published in the New England Jour-<br />

nal of Medicine in November 2004 in diabetic<br />

nephropathy has put micardis® in the map of<br />

nephro-protection. The trendy study reported in<br />

major congresses in <strong>2005</strong> supported the nephro-<br />

protective benefits of micardis® and three addi-<br />

tional renal trials will consolidate the profile of<br />

the brand in this area in 2006.<br />

The landmark trials ontarget (in patients of<br />

high cardiovascular risk, with 31,700 randomised<br />

patients) and profess® (in patients with previous<br />

stroke with 15,000 patients already recruited),<br />

aiming to prove the cardio and cerebro-vascular<br />

protection properties of micardis®, are proceed-<br />

ing on schedule. Results of these trials are expected<br />

in 2008.<br />

The good acceptance of the product in <strong>2005</strong> pro-<br />

vide an excellent platform to put micardis® on<br />

track to become another blockbuster.<br />

For additional information please visit our<br />

websites at<br />

www.micardis.com / www.ontarget-micardis.com<br />

Every year, approximately three million people<br />

worldwide suffer from acute myocardial infarction<br />

(AMI), or heart attack. However, only about<br />

47 % are diagnosed and treated. About 53 % are


either not recognised or are beyond treatment.<br />

The most important factor for a successful treat-<br />

ment of AMI is time to treatment. Thrombolytic<br />

therapy, established as one of the most successful<br />

modern AMI treatment options, is easy to apply,<br />

available in all hospitals and considered safe in<br />

view of the serious nature of the disease.<br />

The Stroke Lysis Box from <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

enables hospital emergency departments to provide<br />

rapid clot-busting treatment.<br />

actilyse® (alteplase), is indicated for the thrombo-<br />

lytic treatment in AMI as well as in thrombolytic<br />

treatment in acute massive pulmonary embolism<br />

with haemodynamic instability. It has also a<br />

conditional license for the treatment of acute<br />

ischemic stroke (see below).<br />

metalyse® (tenecteplase), the only thrombolytic<br />

to be administered as single shot injection, is also<br />

registered for the thrombolytic treatment in AMI<br />

for patients, in whom a coronary intervention<br />

cannot be performed within 90 minutes of onset.<br />

With its ease of administration, metalyse® is<br />

very well-suited for pre-hospital and in-hospital<br />

thrombolysis to keep the time from onset of<br />

symptoms to effective treatment as short as<br />

possible.<br />

Both products continued to be leaders in their<br />

class and posted combined net sales of EUR 151<br />

million, giving a 57.7 % market share in this com-<br />

bined class of fibrinolytics.<br />

Telemedicine helps stroke victims<br />

Acute ischaemic stroke is caused by blood clots in the brain and requires urgent specialist attention.<br />

However, only 30 % of acute stroke patients reach hospital within the first three hours. Particularly<br />

those in rural areas do not always have access to specialist care. New technologies can link rural<br />

hospitals with specialist centres. Remote patient interviewing, data transmission and video-<br />

conferencing are available 24 hours a day to all hospitals linked in the network. The benefit to the<br />

patients is twofold: they now have access to this modern treatment and the treatment is started<br />

by very experienced people. This allows a greater proportion of acute stroke patients to be assessed<br />

for thrombolysis with <strong>Boehringer</strong> <strong>Ingelheim</strong>’s actilyse® (alteplase), the only medication available<br />

for the treatment of acute stroke.<br />

Photo: Lennart Nilsson<br />

Prescription Medicines


Stroke treatment and prevention<br />

Stroke is the third leading cause of death and the<br />

most important reason for medical disability. In<br />

industrialised countries some five people in every<br />

1,000, and three in every 100 people aged 65 years<br />

and above, suffer a stroke. A stroke occurs when a<br />

blood clot blocks a vessel or artery in the brain<br />

(ischaemic stroke), or when a blood vessel ruptures<br />

(haemorrhagic stroke), interrupting blood flow to<br />

an area of the brain. A stroke kills brain cells in<br />

the immediate area within a few minutes or a few<br />

hours.<br />

actilyse® is the first and only treatment indicated<br />

for acute ischaemic stroke within three hours after<br />

onset of symptoms. With sits most and sits<br />

istr, <strong>Boehringer</strong> <strong>Ingelheim</strong> is sole sponsor of the<br />

largest international stroke registry, providing<br />

stroke experts worldwide with a valuable tool for<br />

documenting and monitoring stroke patients.<br />

For more information please visit the website:<br />

www.stroke-forum.com<br />

aggrenox® / asasantin® / asasantin retard®<br />

(dipyridamole/ASA) is indicated to reduce the risk<br />

of secondary stroke in patients who have had<br />

transient ischaemia of the brain or completed<br />

ischaemic stroke due to thrombosis. It posted net<br />

sales of EUR 172 million in <strong>2005</strong>, with growth of<br />

18 %.<br />

With profess®, the world’s largest trial in sec-<br />

ondary stroke prevention, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

is aiming to prove that aggrenox® is superior to<br />

clopidogrel. The trial, conducted since 2002, will<br />

involve 18,500 patients in 32 countries. The out-<br />

come is expected in 2008.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Diseases of the central<br />

nervous system (CNS)<br />

Parkinson’s disease affects approximately 1 % of<br />

people over 60, but Parkinson’s can also afflict<br />

people much younger. It is caused by a slow,<br />

gradual loss of specific cells in the brain that<br />

produce a chemical called dopamine which is<br />

ultimately necessary for normal muscle function.<br />

The disease is characterised by three main symp-<br />

toms: slowness of motion, stiffness and shaking of<br />

arms, legs or head.<br />

Pramipexole, a dopamine agonist, is indicated for<br />

the symptomatic treatment of Parkinson’s disease,<br />

alone or in combination, throughout all stages of<br />

the disease.<br />

The compound is internationally marketed as<br />

mirapex®, mirapexin®, sifrol® or pexola®.<br />

mirapex®/sifrol® continued to show strong<br />

growth in <strong>2005</strong>, in part due to the launch in Japan.<br />

At the end of <strong>2005</strong>, it ranked No. 6 among our best-<br />

selling products, with total net sales of EUR 430<br />

million, up 52 % against 2004. It is the world’s<br />

best-selling brand for Parkinson’s disease, with a<br />

market share of more than 20 %.<br />

The clinical development of mirapex®/sifrol®<br />

has been completed for restless legs syndrome<br />

(RLS), a sensorimotor disorder characterised by a<br />

distressing urge to move the legs and sometimes<br />

other parts of the body. It is usually accompanied<br />

by a marked sense of discomfort or pain in affected<br />

body parts. A comprehensive clinical development<br />

programme with more than 1,000 patients in the<br />

USA and six European countries, completed in


Stilling<br />

restless legs<br />

“The feeling is very irritating and I cannot sit<br />

still. It is frustrating because I can feel the<br />

‘bubbles’, but I cannot make them disappear.<br />

The only way I can stop this feeling in my<br />

legs is to move them and to walk,” says<br />

Katrin Scherman from Sweden, who spent<br />

25 years of her life enduring the symptoms<br />

of RLS before seeking treatment. Restless<br />

legs syndrome (RLS) is a neurological<br />

disorder characterised by an uncontrollable<br />

urge to move the legs, usually accompanied<br />

by unpleasant and sometimes painful<br />

sensations which worsen at night. Social<br />

activities, including travelling, can also be<br />

severely affected by RLS, as sufferers can<br />

find sitting still very painful or difficult, especially<br />

in the evening. Recent clinical studies<br />

showed that pramipexole, with its fastacting<br />

effect on a broad range of RLS<br />

symptoms, cannot only provide rapid relief<br />

from RLS symptoms, but also suggest<br />

significant sustained efficacy. Pramipexole,<br />

a compound from <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

research, was first approved in 1997 and is<br />

available in major countries worldwide under<br />

the trade names sifrol®, mirapex® and<br />

mirapexin® for the symptomatic treatment<br />

of idiopathic Parkinson’s disease. <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> anticipates approval in 2006 in<br />

Europe and the USA for the treatment of RLS.<br />

<strong>2005</strong>, showed significant improvements in RLS<br />

symptoms, rapid onset of action and an excellent<br />

tolerability profile. Regulatory dossiers for the<br />

approval of mirapex®/sifrol® for RLS were filed<br />

in <strong>2005</strong> in the USA and the EU.<br />

Major depressive disorder (MDD), a common dis-<br />

order of complex, often recurring symptoms<br />

affecting mind and body, can be life-threatening<br />

and certainly disabling, according to World Health<br />

Organization (WHO) research. The neuropathol-<br />

ogy of depression is not fully understood but the<br />

two neurotransmitters serotonin and norepine-<br />

phrine seem to play a major role in the develop-<br />

ment and course of the disease.<br />

In November 2002, Eli Lilly and Company and<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> signed a long-term agree-<br />

ment to jointly develop and commercialise<br />

duloxetine hydrochloride. Duloxetine for MDD<br />

and diabetic peripheral neuropathic pain (DPNP)<br />

is internationally marketed under the brand<br />

names cymbalta® and for <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

in Greece, Italy and Spain as xeristar®.<br />

cymbalta®/xeristar® is a potent and balanced<br />

dual reuptake inhibitor of both serotonin and<br />

norepinephrine that provides rapid, sustained<br />

relief of the emotional and painful physical symptoms<br />

of depression and gives patients a better<br />

chance of getting well and staying well. In <strong>2005</strong>,<br />

major milestones were achieved with marketing<br />

authorisation for MDD in the EU and other parts<br />

of the world. cymbalta® had been launched in 20<br />

countries by December <strong>2005</strong>.<br />

Prescription Medicines


0<br />

Serotonin and norepinephrine also play a major<br />

role in the neuronal modulation of pain signals.<br />

cymbalta®/xeristar® has been successfully<br />

developed for the treatment of DPNP, which<br />

occurs in approximately 30 % of patients suffering<br />

from diabetes mellitus. Symptoms of DPNP<br />

include lancinating pain, paraesthesia and dys-<br />

aesthesia as well as pain produced by a normally<br />

non-painful stimulus. By effectively de-amplify-<br />

ing the pain signalling, duloxetine offers a new<br />

approach in the treatment of DPNP patients.<br />

urologic diseases<br />

Benign prostate hyperplasia (BPH), a common<br />

disease that occurs in about 25 % of men aged 40<br />

years or over and in more than 30 % of men over<br />

50, results in lower urinary tract symptoms (LUTS)<br />

related to obstructions of the urethra and gradual<br />

loss of bladder function. These symptoms, such as<br />

frequent need to urinate (particularly at night),<br />

urgency, leaking, or dribbling, disrupt the activity<br />

and sleep patterns of sufferers, drastically affect-<br />

ing their quality of life.<br />

alna®/flomax® (tamsulosin), an alpha receptor<br />

antagonist, is indicated for the treatment of func-<br />

tional symptoms of BPH, significantly improving<br />

symptoms and quality of life. The product was in-<br />

licensed in and jointly developed together with<br />

Astellas Pharma and is marketed under a license<br />

from Astellas Pharma. It achieved net sales of<br />

EUR 721 million in <strong>2005</strong> and maintained its<br />

market leadership in the USA, where a co-promo-<br />

tion collaboration with Astellas Pharma started in<br />

2004.<br />

In <strong>2005</strong>, a new formulation of<br />

alna®/flomax® using the ocas®<br />

(Oral Controlled Absorption System)<br />

technology, was launched in several<br />

European countries. This allows a<br />

smoother 24-hour drug release with<br />

reduced plasma peaks independent<br />

of food intake, resulting in an even<br />

better safety profile and favourable<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

results in wake-up several times at night with<br />

urgent need to urinate (nocturia), one of the most<br />

bothersome symptoms of BPH.<br />

Stress urinary incontinence<br />

Stress urinary incontinence (SUI) is the involun-<br />

tary loss of urine with an increase in abdominal<br />

pressure caused by a physical activity such as<br />

coughing, laughing, sneezing, lifting or exercising.<br />

Around 97 % of SUI patients are female, but less<br />

than half of the women suffering from this condi-<br />

tion seek treatment.<br />

In November 2002, Eli Lilly and Company and<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> signed a long-term agree-<br />

ment to jointly develop and commercialise<br />

yentreve®/ariclaim® (duloxetine) for treating<br />

SUI. This partnership covers most countries world-<br />

wide.<br />

In mid-August 2004, EU approval was received<br />

for yentreve®/ariclaim® for the treatment of<br />

women with moderate to severe SUI. In <strong>2005</strong>,<br />

yentreve®/ariclaim® was launched in Greece<br />

and Italy (by <strong>Boehringer</strong> <strong>Ingelheim</strong> as ariclaim®)<br />

and in Mexico.<br />

virologic diseases<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> aims to improve HIV/AIDS<br />

therapy by providing physicians and patients with<br />

innovative antiretroviral drugs.<br />

For more information, please visit the website:<br />

www.boehringer-ingelheim.com/hiv<br />

aptivus® (tipranavir), a non-peptidic protease<br />

inhibitor, works by blocking the viral protease, an<br />

enzyme needed to complete HIV replication.<br />

Due to its unique chemical structure, aptivus®<br />

preserves activity against viruses which have lost<br />

susceptibility to other treatment options – a sig-<br />

nificant advantage compared to other commer-<br />

cially available protease inhibitors (PI).<br />

When co-administered with low dose ritonavir, it<br />

is indicated for combined antiretroviral treatment<br />

of HIV infection in highly treatment experienced<br />

(HTE) patients.


aptivus®, which complements viramune® in our<br />

HIV portfolio, was launched in the USA in July<br />

<strong>2005</strong> and in the EU in November <strong>2005</strong>.<br />

viramune® (nevirapine) was the first compound<br />

of the new class of non-nucleoside reverse tran-<br />

scriptase inhibitors (NNRTI) to be launched in<br />

1996 as a powerful component of combination<br />

therapy for HIV-1. This product is now available<br />

in about 100 countries which makes it one of the<br />

most widely used compounds in chronic HIV-1<br />

therapy worldwide.<br />

viramune® has also been demonstrated to be<br />

beneficial to prevent transmission from the HIV-1<br />

infected mother to her infant. A single dose to the<br />

mother during labour and a single dose to the<br />

infant after birth has shown to significantly reduce<br />

the HIV transmission rate. This simple and effec-<br />

tive treatment, also tested successfully in combi-<br />

nation with zidovudine/lamivudine, has particu-<br />

lar value in the healthcare setting of developing<br />

countries, and, as such, is recommended by the<br />

WHO. viramune® posted sales of EUR 288<br />

million in <strong>2005</strong>.<br />

Teamwork sets<br />

benchmark<br />

It took only 168 hours after market approval by the US<br />

regulatory authority, the Food and Drug Administration<br />

(FDA), for the first packages of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

novel anti-AIDS-drug aptivus® (tipranavir) to leave the<br />

warehouse for US distribution. Due to the long manufac-<br />

turing processes, the wheels of our supply chain began<br />

turning well before approval starting with chemical<br />

production of the active ingredient tipranavir and pharma-<br />

ceutical production. These two different manufacturing<br />

steps were conducted on two continents at <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>’s company site in <strong>Ingelheim</strong>, Germany and a<br />

third party site – Cardinal Health, USA. After the FDA had<br />

endorsed and released all detailed drug-related informa-<br />

tion, the company was on the home straight. Printing the<br />

packages and leaflets, packaging, shipment and distribu-<br />

tion under refrigerated conditions: the cogs – coordi-<br />

nated by <strong>Boehringer</strong> <strong>Ingelheim</strong>’s packaging site Roxane<br />

(Columbus, Ohio, USA) – meshed perfectly. Even with<br />

another step added – release testing and distribution<br />

via our product release site in <strong>Ingelheim</strong> – aptivus® was<br />

available to patients in Germany and the United Kingdom<br />

within a few days after the subsequent approval in Europe<br />

in October was granted. Early involvement of Opera-<br />

tions during the development process was a key success<br />

factor. Numerous challenges arose which called for close<br />

communication between the company’s Research &<br />

Development and Operations divisions as well as with the<br />

external US manufacturing partner to develop the appro-<br />

priate chemical and pharmaceutical processes. “Seam-<br />

less cooperation between multi-faceted teams across the<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> development and supply chain, and<br />

beyond, played a key role in the successful initial launch of<br />

aptivus®,” Operations teamleader Joerg Hefer said.<br />

“A new benchmark has been set.”<br />

Prescription Medicines 1


Rheumatologic diseases<br />

Osteoarthritis is the most commonly diagnosed<br />

degenerative joint disease affecting the joints,<br />

especially in elderly people. Signs and symptoms<br />

of osteoarthritis might include joint stiffness and<br />

discomfort often with a sensation of a grinding in<br />

the affected joint. Rheumatoid arthritis, an auto-<br />

immune disease that affects the body as a whole,<br />

may also lead to joint destruction.<br />

mobic®/mobec® (meloxicam) is indicated for the<br />

symptomatic treatment of osteoarthritis and<br />

Economic Regions<br />

Americas<br />

rheumatoid arthritis as well<br />

as ankylosing spondylitis<br />

(Morbus Bechterew). The<br />

drug which became our sec-<br />

ond blockbuster drug in<br />

<strong>2005</strong>, posted net sales of EUR<br />

848 million, with a market<br />

share of 14.9 % in the IMS<br />

anti-rheumatic market.<br />

The economic environment in the Americas<br />

Region developed favourably during <strong>2005</strong>. The<br />

region posted sales of EUR 3.7 billion with a<br />

growth rate of 17 %, representing a 51 % share of<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s Prescription Medicines<br />

business. The USA achieved net sales of EUR 3.1<br />

billion, corresponding to 18 % growth.<br />

The USA remains the worldwide motor for eco-<br />

nomic growth in the innovative pharmaceutical<br />

industry. A highly competitive environment with<br />

free market price development and rapid market<br />

acceptance for innovations, it offers patients quick<br />

comprehensive access to improved treatments.<br />

The USA will remain the most important market<br />

for <strong>Boehringer</strong> <strong>Ingelheim</strong>’s innovative pharma-<br />

ceuticals for the foreseeable future.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

The debate about cost containment, rebates and<br />

reimbursement payments (“Medicare” and “Medic-<br />

aid”) continuously put pressure on prices and may<br />

render patient access to innovative products more<br />

difficult. But the ongoing healthcare reform<br />

initiative (“Medicare Drug Benefit”) will provide<br />

access to health services for additional patients.<br />

The impact of this initiative on pharmaceutical<br />

sales volumes and price levels will be seen over<br />

the the next years.<br />

spiriva® was our biggest growth driver in the<br />

region, achieving net sales of EUR 379 million, up<br />

120 % from the previous year. Additional growth<br />

drivers in <strong>2005</strong> were mobic®, combivent® and<br />

sifrol®.<br />

In <strong>2005</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong> continued to<br />

increase its field force in the USA and a customer<br />

relationship management (CRM) programme was<br />

successfully implemented. An additional phase of<br />

increased focus on the specific needs of physicians<br />

and their need for individual information will<br />

continue to improve the service level during the<br />

coming years.<br />

In Latin America, economic growth slowed in<br />

<strong>2005</strong> to a more sustainable level compared to the<br />

sharp increase in 2004. Inflation in the region<br />

stabilised, but remains volatile, with highly fluc-<br />

tuating commodity prices. The currencies of the<br />

main countries stabilised against the Euro. Some,<br />

like the Brazilian real, even strengthened.<br />

The total pharmaceutical market, including<br />

branded and generic products, continued to grow,<br />

with Mexico up 12.0 %, Brazil up 14.6 % and<br />

Argentina 12.2 %. However, a stable and depend-<br />

able development of our BPM business in this<br />

region is still hampered by the lack of binding<br />

patent laws, except in Brazil and Mexico.<br />

Total net sales of our BPM business in Latin<br />

America amounted to EUR 200 million in <strong>2005</strong>,<br />

an increase of 26 % against the previous year.<br />

Growth drivers were mobic®, micardis® and<br />

selected local products. Currency revaluations


Americas<br />

3,670<br />

also contributed positively. spiriva® and the<br />

recently launched product cymbalta® performed<br />

strongly and continued to gain market share.<br />

In Latin America, we implemented a new regional<br />

business concept by implementing a regional<br />

operative unit located in Argentina.<br />

Europe<br />

Our business developed highly satisfactorily in<br />

Europe in <strong>2005</strong>. With a growth rate of 15 % and<br />

net sales of EUR 2 billion, we grew about twice as<br />

fast as the market. Our market share increased to<br />

2 %, ranking us as No. 12 in the European pharma-<br />

ceutical market. This success is based on the good<br />

acceptance of our innovative products by physi-<br />

cians and patients.<br />

Europe<br />

2,037<br />

of which:<br />

USA branded<br />

2,592<br />

USA non-branded<br />

535<br />

However, the pharma-political environment in<br />

Europe remained challenging during <strong>2005</strong> and<br />

patient access to new innovative medicines was<br />

often delayed. In addition, cost containment<br />

measures in national healthcare systems mainly<br />

target pharmaceutical spending with mandatory<br />

rebates, repayments and parallel trade.<br />

The main growth driver in <strong>2005</strong> is spiriva®.<br />

Net sales reached EUR 459 million, an increase of<br />

54 % over 2004. spiriva® developed very positively<br />

of which: Germany<br />

455<br />

Asia, Australasia,<br />

Africa<br />

1,312<br />

Sales Prescription Medicines <strong>2005</strong>, excluding licenses (in millions of EUR)<br />

in all major markets, reaching market shares of<br />

10–15 % and even up to 20 %.<br />

micardis® / micardisplus® became our second<br />

leading product in Europe, growing with net sales<br />

of EUR 191 million. Newly published data on its<br />

benefits, not only in hypertension but specifically<br />

new benefits for nephroprotection in hypertensive<br />

diabetic patients, is expected to support further<br />

growth.<br />

of which: Japan<br />

801<br />

sifrol®, our leading Parkinson’s medicine, more<br />

than doubled its turnover to EUR 183 million.<br />

Currently it is under registration for RLS. Three<br />

important new introductions to the European<br />

market came in <strong>2005</strong>. cymbalta® for MDD. alna<br />

ocas®, a tablet version of our market-leading BPH<br />

product and aptivus®, our HIV treatment.<br />

With the exception of France, all major European<br />

markets gained considerable growth momentum<br />

in <strong>2005</strong>. After a difficult year 2004, our German<br />

business developed quite satisfactorily due to the<br />

new introductions of cymbalta®, aptivus® and<br />

alna® ocas® as well as the high market accept-<br />

ance of spiriva®, micardis® and sifrol®.<br />

Dynamic growth was achieved in Central and<br />

Eastern Europe, especially in Russia. Double-digit<br />

growth rates were recorded in Italy, Spain and the<br />

United Kingdom.<br />

The USA remained the<br />

by far most important<br />

market for our drugs.<br />

Prescription Medicines<br />

(which accounted for 76 %<br />

of our net sales) had a<br />

turnover of more than EUR<br />

7.2 billion to which US sales<br />

contributed 43 %.<br />

The Europe Region<br />

achieved 28 % of PM net<br />

sales.<br />

Prescription Medicines


Asia, Australasia, Africa<br />

In all major markets in our Asia, Australasia,<br />

Africa (AAA) Region – Japan, Australia, Turkey<br />

and South Korea – we experienced strong<br />

growth.<br />

This is particularly remarkable considering the<br />

business environment of our industry in the region<br />

was in <strong>2005</strong> determined by a continuation of cost<br />

containment initiatives and governmental restric-<br />

tions. The development in AAA must therefore be<br />

considered against a background of mandatory<br />

price reductions, governmental prescription rec-<br />

ommendations, such as positive lists, and, in<br />

almost every country, strong encouragement of<br />

generic prescribing.<br />

In Japan, Nippon <strong>Boehringer</strong> <strong>Ingelheim</strong> had the<br />

fastest growing business among the leading<br />

25 pharmaceutical companies. Net sales grew by<br />

12 % to EUR 800 million, driven in particular<br />

by micardis®, due to a continuation of our highly<br />

successful cooperation with Astellas. micardis®,<br />

now our leading product in Japan, achieved a<br />

market share of 10.6 % within two years of<br />

launch.<br />

Although sifrol® and spiriva® also contributed<br />

to the excellent development in Japan, much of<br />

the Nippon <strong>Boehringer</strong> <strong>Ingelheim</strong>’s sales growth<br />

can be explained by a range of field force effi-<br />

ciency improvements in <strong>2005</strong>.<br />

In Australia, above-market performance achieved<br />

in the last few years continued in <strong>2005</strong>, with net<br />

sales growing by 25 % to EUR 120 million, the<br />

main contribution coming from spiriva®. The<br />

situation in Turkey was similar. Our sales, driven<br />

by spiriva®, flomax® and micardis®, achieved<br />

a growth of 54 % to achieve net sales of EUR 80<br />

million.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

South Africa, AAA’s sixth largest country, also<br />

showed positive development. Here, however, the<br />

largest sales contribution came from viramune®.<br />

Our company in China celebrated its tenth anni-<br />

versary. Net sales reached more than EUR 40<br />

million. In India, besides our licensing agreement<br />

with Cadila Healthcare Ltd., we have started our<br />

own subsidiary.<br />

In the region Near East / Middle East, we imple-<br />

mented a new regional business concept at the<br />

end of <strong>2005</strong> by creating a regional operative unit<br />

located in Dubai.<br />

Generic Prescription<br />

Medicines (GPM)<br />

In the USA, <strong>Boehringer</strong> <strong>Ingelheim</strong> Corporation’s<br />

GPM business consists of its subsidiaries Ben<br />

Venue Laboratories with its separate division<br />

Bedford Laboratories, based in Columbus, Ohio.<br />

Bedford Laboratories is dedicated to the market-<br />

ing of a select line of liquid and lyophilised sterile<br />

injectables from Ben Venue. Roxane Laboratories<br />

and Bedford Laboratories, generated 6 % of<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s sales.<br />

With respect to generic drugs, the US pharmaceu-<br />

tical market is currently in a change process.<br />

It is expected that demand for pharmaceuticals<br />

and generics in particular, will continue to<br />

increase due to pressure to reduce healthcare<br />

costs, the aging population, and the 2006 Medi-<br />

care Prescription Drug Benefit.<br />

However, as the size of the generic market<br />

increases, there is increased competition for<br />

revenues coming from traditional brand pharma-<br />

ceutical companies with a renewed interest in<br />

generics, from extremely large multinational<br />

generic companies that have grown through<br />

merger and acquisition, and from Indian, Eastern<br />

European, and very soon Chinese companies.


As the size of the market increases, competition is<br />

putting downward pressure on prices and mar-<br />

gins. Many companies are moving, or looking to<br />

move manufacturing off-shore.<br />

Roxane<br />

Roxane Laboratories focuses on developing,<br />

manufacturing and packaging more than 400<br />

medications, including oral liquids, tablets, and<br />

capsules.<br />

The business posted sales of EUR 194 million<br />

(USD 241 million), representing an increase of<br />

14 %.<br />

Roxane launched nine new generic drugs in <strong>2005</strong>,<br />

including the antibiotic clarithromyin and almost<br />

20 new abbreviated new drug applications<br />

(ANDAs) were filed.<br />

Bedford Laboratories<br />

Bedford posted net sales of EUR 341 million (USD<br />

424 million), a growth rate of 26 %. Key products<br />

for <strong>2005</strong> included propofol, octreotide, GlucaGen®,<br />

paclitaxel and Adriamycin®.<br />

In <strong>2005</strong>, Bedford launched six new products,<br />

including propofol, an anaesthesia product, and<br />

octreotide, an oncology adjunct. Propofol entered<br />

the US market as one of two generics. Octreotide<br />

entered the US market as the sole generic with 180<br />

days exclusivity. These two products accounted<br />

for USD 94 million sales. With these six new<br />

products, Bedford has solidified its position in the<br />

generic market and remains one of the largest US<br />

suppliers of speciality injectable pharmaceuticals<br />

to hospitals and clinics.<br />

Bedford’s recent partnership with an intravenous<br />

(IV) bag manufacturer will provide Bedford’s cus-<br />

tomers with a wider variety of drug deliver choices.<br />

Bedford will also continue to file 10 to 12 ANDAs<br />

each year to create a pipeline of products that will<br />

allow us to maintain a leadership position.<br />

High value<br />

injectables<br />

Over the past 12 years, Bedford Laboratories has focused<br />

its efforts on improving and advancing high-quality<br />

products that offer value to its customers. It is renowned<br />

for select specialty injectables, many not available from<br />

any other source. Bedford currently offers 84 inject-<br />

able products in 229 different configurations, covering a<br />

wide variety of therapeutic classes, mainly in the areas of<br />

oncology, cardiology, anaesthesia and antipsychotics.<br />

Prescription Medicines


Consumer Health Care<br />

Let’s talk about it<br />

“Constipation is a widespread and sensitive disorder. Many<br />

sufferers often feel guilty and responsible for their symptoms,<br />

believing that their lifestyle is to blame,” according to the<br />

gastroenterologist Professor Stefan A. Müller-Lissner of Park-<br />

Klinik Weissensee, Humboldt University, Berlin.


A review that he led on constipation, published in<br />

the American Journal of Gastroenterology (AJG)<br />

in <strong>2005</strong>, provided sufferers and healthcare profes-<br />

sionals with strong, legitimate grounds to remove<br />

such feelings of guilt. <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

long-standing contribution to relieving this com-<br />

mon, very uncomfortable condition is dulcolax®,<br />

the world’s leading laxative brand.<br />

The independent paper, “Myths and Misconcep-<br />

tions About Chronic Constipation”, which<br />

appeared in the AJG, concluded that many aspects<br />

of constipation, including the use of laxatives, are<br />

based on traditional views and misunderstand-<br />

ings. It clarified many wrongly held beliefs and<br />

showed that often they are not based on hard fact<br />

or medical evidence.<br />

The review’s key findings were that diet and life-<br />

style should not be assumed to be the main cause<br />

of constipation. For some, a fibre-rich diet may be<br />

helpful, however, in many people with more<br />

severe constipation, fibre intake can make symp-<br />

toms even worse. Increased fluid intake will not<br />

provide significant relief from constipation, except<br />

if you are dehydrated. Further findings relate to<br />

the use of laxatives that have wrongly been associ-<br />

ated with a number of unsubstantiated claims.<br />

The review found, for instance, that there is no<br />

evidence that laxative use might cause damage to<br />

the colon and that it is uncommon for most laxa-<br />

tive users to develop a level of tolerance.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

While diet and lifestyle should not be assumed to<br />

be the main cause of constipation, it is advisable<br />

to remain healthy overall by eating a balanced<br />

diet, drinking enough water and taking regular<br />

exercise. As a proven, safe and effective laxative,<br />

dulcolax® can be taken as a first-line treatment<br />

to help restart the natural rhythm.<br />

Our communication initiatives<br />

The review in AJG prompted <strong>Boehringer</strong> Ingel-<br />

heim to launch a major campaign in 24 countries<br />

to communicate its key findings in order to con-<br />

tribute to a better understanding of constipation<br />

and laxatives’ role in treatment options.<br />

The scientists too had a good opportunity to make<br />

their findings known. Professor Carmelo Scarpig-<br />

nato, University of Parma, Italy, co-author of the<br />

AJG paper called the health education campaign a<br />

“great success”.<br />

The international<br />

dulcolax® website,<br />

locally implemented,<br />

underlines the<br />

global presence<br />

of the brand.<br />

Significantly, new constipation treatment guide-<br />

lines for pharmacy staff were, for instance, pub-<br />

lished in the United Kingdom after the review in<br />

the AJG with the endorsement of the College of<br />

Pharmacy Practice, which followed the recom-<br />

mendations in the paper.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s commitment to raising<br />

disease and treatment awareness was also evident<br />

in the USA where the dulcolax® Guide for<br />

Healthy Living, a national educational pro-<br />

gramme, was launched by the Hispanic talk show<br />

host Cristina Saralegui in 2004. “Constipation<br />

sufferers need to listen to their bodies and take<br />

action by becoming aware of the things they<br />

are doing and not doing to alleviate symptoms,”<br />

she said. n


Gentle and effective<br />

dulcolax® forms a key part of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s self-medication heritage. On the market for over 50<br />

years, dulcolax® is available as sugar-coated tablets and suppositories containing the active ingredient<br />

bisacodyl as well as pearls and drops containing the active ingredient sodium picosulphate. A unique comfort<br />

coating prevents the tablet from being dissolved until it reaches the colon, where its active ingredient is<br />

released exactly in the right place. Today, this gentle and effective laxative is marketed in over 90 countries,<br />

both on prescription and over-the-counter (OTC). It is recognised as the top selling contact laxative<br />

(influence on the motility of the colon by direct contact with the colon wall). And the new thinking about<br />

constipation has had a real impact. Shailesh Amin, a retail pharmacist in the UK, noted: “I have already made<br />

a monumental shift in prescribing advice and sale for constipation products. Out goes lactulose and fibre and<br />

in come the contact laxatives.”<br />

For more information visit www.dulcolax.com<br />

Consumer Health Care


0<br />

Consumer Health Care<br />

Our Consumer Health Care (CHC) segment achieved net sales of EUR 1.1 billion<br />

in <strong>2005</strong> (+8,5 % against the previous year). Both our Americas and Europe<br />

Regions achieved strong double-digit growth. <strong>Boehringer</strong> <strong>Ingelheim</strong> is ranked<br />

No. 8 worldwide among CHC companies and in <strong>2005</strong> enhanced its position<br />

primarily through line-extensions and switching prescription-only medicines<br />

to over-the-counter (OTC) products. Our key international brands continued<br />

to develop positively.<br />

Development by brand<br />

buscopan® – a medication against abdominal<br />

discomfort and cramping – is the worldwide No. 1<br />

antispasmodic brand, according to IMS data. The<br />

buscopan® franchise produced strong double-<br />

digit growth in <strong>2005</strong>, mainly due to successful<br />

switches in Mexico, Brazil, Argentina, Colombia<br />

and Venezuela.<br />

The product is now marketed in more<br />

than 100 countries. The development of<br />

a validated international brand platform<br />

was started in <strong>2005</strong> and is expected to be<br />

implemented from 2006, helping to<br />

capitalise on the brand’s strong medical<br />

heritage and build a robust OTC umbrella<br />

as a basis for future line-extensions.<br />

Sales Consumer<br />

Health Care<br />

in millions of EUR<br />

1,000<br />

800<br />

600<br />

400<br />

200<br />

’03 ’04 ’05<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

964<br />

970<br />

1,052<br />

dulcolax® – our leading laxative brand –<br />

successfully marketed in more than 100 countries,<br />

maintained its No. 1 market position in <strong>2005</strong>. In<br />

the Americas it continues to reinforce its strong<br />

category position. Good performances were<br />

achieved in Europe and Asia, with dulcolax®<br />

holding a strong lead position in important<br />

markets, such as Germany and South Korea. Plans<br />

to strengthen this brand into a worldwide OTC<br />

laxative leader over the forthcoming years is a key<br />

focus of our strategic development.<br />

antistax® – our brand for the prevention and<br />

treatment of chronic leg vein weakness – suc-<br />

ceeded in further accelerating growth in <strong>2005</strong>,<br />

with Italy, Belgium and Germany the main con-<br />

tributors to this positive performance. In Germany,<br />

antistax® extended its leadership in the leg vein<br />

Top 10 products<br />

Consumer Health Care<br />

Net sales in millions of EUR change<br />

1. dulcolax® 114.8 +18.8 %<br />

2. mucosolvan® 91.3 +226.6 %<br />

3. geriatric pharmaton® 88.4 +4.5 %<br />

4. bisolvon® 66.9 +8.4 %<br />

5. buscopan® 59.5 +38.2 %<br />

6. laxoberal® 31.8 +126.6 %<br />

7. thomapyrin® 30.0 –15.3 %<br />

8. anador® 25.3 +13.0 %<br />

9. antistax® 22.6 +2.5 %<br />

10. frubienzym® 18.6 –12.1 %<br />

others 549.2 21.1 %<br />

For information about indications,<br />

see our Glossary on pages 116–118.


health market. With<br />

sales of almost 30 % in<br />

the market, Italy made a<br />

very substantial contri-<br />

bution to the perform-<br />

ance of antistax® in<br />

<strong>2005</strong>.<br />

mucoangin® – our sore throat brand – achieved<br />

satisfactory growth in the major markets Germany<br />

and Mexico. New product launches were made in<br />

Denmark and Sweden.<br />

mucosolvan® – the world’s<br />

leading cough expectorant –<br />

strengthened its position with<br />

good growth of 14 %, compared<br />

with 2004. New marketing<br />

campaigns were initiated in<br />

Mexico, Brazil and Germany<br />

during the year.<br />

bisolvon® – the cough remedy<br />

– consolidated its position as one of the leading<br />

brands in the world OTC<br />

expectorant market. In<br />

<strong>2005</strong>, it successfully sus-<br />

tained its strong position<br />

in many markets, particu-<br />

larly in South America<br />

and Europe, achieving<br />

double-digit growth.<br />

pharmaton® – our umbrella brand for the<br />

improvement and maintenance of vitality and<br />

well-being – performed well in <strong>2005</strong>, with strong<br />

growth in the key markets in Latin America –<br />

Mexico, Brazil and Argentina.<br />

IMS figures put pharmaton®<br />

as world No. 2 in its category.<br />

In <strong>2005</strong>, development of a vali-<br />

dated international brand plat-<br />

form was started, with imple-<br />

mentation expected to start in<br />

2006. This will help capitalise on the strong brand<br />

image/market position that pharmaton® com-<br />

mands in many markets. pharmaton® kiddi<br />

(children’s supplement) produced strong growth<br />

in Mexico in <strong>2005</strong>, boosted by the launch of<br />

galenic line extensions in late 2004.<br />

Development by region<br />

Europe<br />

In <strong>2005</strong>, the region reported sales growth as of<br />

14 % compared to the previous year, as a result of<br />

a favourable seasonal demand for cough & cold<br />

brands combined with several line extension<br />

launches, switches and healthy, above-market<br />

growth. Activities in <strong>2005</strong> were intensively<br />

focused on our international brands. Germany,<br />

Spain, Italy and Russia, our major markets in<br />

Europe, were the prime drivers of the positive<br />

development.<br />

Americas<br />

The year <strong>2005</strong> was a very positive one for the<br />

CHC business in the Americas Region, which<br />

achieved growth of 19 % against previous year.<br />

The main growth driver was Mexico.<br />

Asia, Australasia, Africa (AAA)<br />

SSP Co. Ltd. – the No. 3 OTC company in Japan,<br />

whose major shareholder is Nippon <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Co. Ltd. – strengthened its position in a<br />

highly competitive market environment. The AAA<br />

Region, excluding Japan, achieved strong growth<br />

of +16 % against the previous year. Our interna-<br />

tional core brands pharmaton®, bisolvon® and<br />

dulcolax® showed overall sales growth of 86 %.<br />

Consumer Health Care<br />

1


Margareta Ebelt collapsed in her bathroom, struck down by a severe heart attack.<br />

Walking her dog, she had felt a twinge in her chest but had not taken any notice.<br />

Fortunately, her husband alerted the emergency services immediately.<br />

Otherwise, the incident could have been fatal. Margareta lives to tell her story,<br />

thanks to right in time treatment with <strong>Boehringer</strong> <strong>Ingelheim</strong>’s metalyse®.<br />

Time is extremely critical when suffering a heart attack. In the ideal scenario,<br />

treatment can begin aboard the ambulance or as in Margareta’s case in the<br />

patient’s home. The probability of patients recovering fully then rises to around 70 %.<br />

Biopharmaceuticals<br />

Time


is critical


“I did not want to become one of those helpless folk,” Margareta Ebelt says.<br />

And she certainly is not. As before, Margareta is now managing the accounts of<br />

the company she and her husband own in Dueren, Germany. Besides the human<br />

suffering, cardiovascular diseases have a major financial and social impact.<br />

Many people who survive a stroke or a heart attack need long-term care. It is<br />

estimated that stroke accounts for 4–6 % of healthcare budgets, excluding the<br />

costs of social services and care. metalyse® (tenecteplase) is the first and only<br />

clot-dissolving medication administered as a five-second injection. This biopharmaceutical,<br />

manufactured and marketed by <strong>Boehringer</strong> <strong>Ingelheim</strong>, is today<br />

considered the first line treatment for heart attack (acute myocardial infarction).<br />

Early leadership in biotechnology<br />

In the rapidly expanding field of biopharmaceuti-<br />

cals <strong>Boehringer</strong> <strong>Ingelheim</strong> is one of the world’s<br />

leading players, building on a wealth of expertise<br />

that the company has generated since 1885.<br />

The company began using bacteria for the produc-<br />

tion of lactic acid in commercial quantities as<br />

early as 1895. This was the world’s first successful<br />

use of micro-organisms for large-scale product<br />

manufacturing. In 1933, the company successfully<br />

developed a process for manufacturing citric acid<br />

through the fermentation of fungi. Our compe-<br />

tence in fermentation processes provided valuable<br />

support in the 1970s for the manufacture of<br />

numerous new antibiotics, including amicleno-<br />

mycin, epidermin and gunacin, lead substances<br />

for chemically optimizing medications. After first<br />

extracting alkaloids from plants in 1905,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> increased production con-<br />

siderably from the 1960s onwards. This led to the<br />

commercial introduction of products, such as<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

morphine and codeine, and later, atropine, theo-<br />

bromine and ergot alkaloids – all clinically impor-<br />

tant agents.<br />

Drugs for the 1st century<br />

In biopharmaceuticals the active substances are<br />

extracted from natural materials, from cells or<br />

plants, and not through chemical synthesis. It is<br />

widely accepted today that a wide range of diseases,<br />

such as diabetes, autoimmune diseases or cancer,<br />

are better treated with medicines produced using<br />

biotechnology.<br />

Reflecting this, the importance of biotechnology<br />

has grown significantly since 1990, when not even<br />

1 % of all drugs were produced biologically. Now<br />

they account for 8 % and are on a rising trend. It is<br />

estimated that by 2018 half of all pharmaceutical<br />

turnover will be generated by biopharmaceutical<br />

medicines. For newly launched medicines, the<br />

figure is already as high as 35 %. For <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> the modern era of biotechnology began


at the end of the 1970s with the manufacture of<br />

therapeutically active proteins by genetic engi-<br />

neering. Again, the company was among the<br />

pioneers. Our output included interferon beta,<br />

interferon omega, Namalwa interferon, interferon<br />

alpha, interferon gamma and manganese super-<br />

oxide dismutase.<br />

Successful cooperations<br />

Our technical lead in biopharmaceutical manu-<br />

facture and competence across the whole devel-<br />

opment and production chain led in the early<br />

1980s to the highly successful cooperation with<br />

the California-based Genentech Inc. This resulted<br />

in the development of drugs such as actilyse®<br />

(rt-PA), metalyse (TNK-tPA), imukin® (inter-<br />

feron gamma) and beromun® (tumour necrosis<br />

factor alpha).<br />

The company has maintained its early technologi-<br />

cal lead to the present day. At the Biberach site,<br />

the company has the world’s second largest plant<br />

for manufacturing biopharmaceuticals. Its 12 fer-<br />

menters each have a capacity of 15,000 litres.<br />

Mammalian cell cultures are here turned into<br />

highly efficacious drugs, such as metalyse® or<br />

actilyse®, a medication indicated against stroke.<br />

To maintain our strong performance in microbial<br />

production of biopharmaceuticals a new plant<br />

was inaugurated in April <strong>2005</strong> at our site in<br />

Vienna, Austria.<br />

In addition, we provide know-how to our<br />

commercial partners, companies such as Amgen,<br />

Pfizer or Schering, for which we do contract<br />

manufacturing. n<br />

Biopharmaceuticals


Biopharmaceuticals and Chemicals<br />

Our Biopharmaceuticals division is a leader in time-to-market development for<br />

efficient and robust large-scale production of high quality biopharmaceuticals.<br />

Its major sites in Vienna, Austria, and Biberach, Germany, have both established<br />

a strong track record in development and regulatory approval during the last<br />

25 years. In our Industrial Customer business for global marketing and sales<br />

of third parties, we provide the entire biopharmaceutical process chain with<br />

our own intellectual property from cell-line development, fermentation,<br />

downstream processing, formulation as well as fill and finish in state-of-the-art<br />

application systems, including global registration and marketing support for<br />

biopharmaceuticals.<br />

Biopharmaceuticals<br />

Ground-breaking for a brighter future<br />

The year <strong>2005</strong> represents the most successful<br />

business year so far for Biopharmaceuticals.<br />

To maintain our strong performance in microbial<br />

production of biopharmaceuticals a new plant<br />

was inaugurated in April <strong>2005</strong> at our site in<br />

Vienna, where the capacity is now doubled with<br />

an investment of EUR 80 million, raising total<br />

capacity of 12,300 litres fermentation volume in<br />

three parallel operating facilities and created 200<br />

new highly qualified jobs.<br />

The full operation of our new facility for cell cul-<br />

ture-derived products in Biberach, high-yield<br />

processes, extraordinary success rates and our<br />

demanding long-term contracts contributed to a<br />

sales increase of more than 40 % to EUR 548 mil-<br />

lion. Our investment in a brighter future was fully<br />

materialised, due to very substantial synergies<br />

with existing onsite plants in Vienna and Biberach<br />

and skilled, highly-experienced employees.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

In order to further accommodate our high-yield<br />

fermentation processes for mammalian cell<br />

cultures, additional investments are being made<br />

at the Biberach site, groundbreaking for competi-<br />

tive manufacturing costs.<br />

To address patient convenience, an investment<br />

into an aseptic filling line for pre-filled syringes<br />

has been given the go-ahead. This should<br />

strengthen our leading position in the develop-<br />

ment of application systems for therapeutic pro-<br />

teins and in future for gene therapeutics too.


Moreover, for <strong>Boehringer</strong> <strong>Ingelheim</strong>’s own bio-<br />

pharmaceutical products – actilyse®, metalyse®,<br />

beromun® and imukin® – sales amounted to<br />

EUR 163 million. metalyse® gained significant<br />

market share over actilyse®, indicating that<br />

second generation products with improved<br />

efficacy pay off in the market.<br />

Cost of goods is a key issue in a competitive envi-<br />

ronment. For our gene therapy production line at<br />

our microbial plant in Vienna improvements in<br />

expression yields up to 1.2 g pDNA/litre were<br />

obtained through culture media development and<br />

optimised feeding strategies. Our proprietary<br />

microbial expression system for the production of<br />

therapeutic proteins was also advanced signifi-<br />

cantly during <strong>2005</strong> to 12 g protein-inclusion<br />

bodies/litre fermentation volume and 80 % yield<br />

in the following refolding step.<br />

Comparable with our franchise in manufacturing<br />

gene therapeutics, an economic manufacturing<br />

process for protein scaffolds has been established.<br />

It is believed that protein scaffolds will be a second<br />

wave of immuno-therapeutics with certain advan-<br />

tages over monoclonal antibodies such as brain<br />

penetration, suitability for specific intracellular<br />

targets and estimated lower treatment cost. We<br />

are already prepared to take up such processes in<br />

our Industrial Customer business and for in-<br />

licensing for our own R&D pipeline. One of our<br />

partners in this field is Avidia.<br />

Short half-life and parental application of bio-<br />

pharmaceuticals can be compensated, for example,<br />

by pegylation of the protein therapeutic. Expertise<br />

in this technology led in <strong>2005</strong> to new business.<br />

For mammalian cell cultures, a monoclonal anti-<br />

body titer of more than 4g/litre has been reached<br />

successfully in process development.<br />

Major investments in increased capacity combined<br />

with achievements in process sciences and manu-<br />

facturing, together with improved business proc-<br />

esses, provide potential for improved profitability<br />

in manufacturing and strengthen Biopharmaceu-<br />

ticals’ competitiveness on the world market.<br />

The year <strong>2005</strong> marked the 10th anniversary of our<br />

mammalian cell culture multi-product US Food<br />

and Drug Administration (FDA) license. During<br />

the FDA’s <strong>2005</strong> biannual inspection, all of our<br />

facilities and products were certified. In the new<br />

cell culture facility with 6 x 15,000 litre capacity a<br />

Biopharmaceuticals and Chemicals


second manufacturing process has been success-<br />

fully implemented. The facility was also licensed<br />

as a multi-product facility by the FDA in <strong>2005</strong>,<br />

just one year after initial licensing as a mono-<br />

product facility.<br />

Our new biological entity (NBE) pipeline strategy<br />

has been implemented to fuel <strong>Boehringer</strong> Ingel-<br />

heim’s R&D pipeline with biopharmaceuticals. In<br />

this context, a monoclonal antibody for the treat-<br />

ment of psoriasis was in-licensed from AbGenom-<br />

ics. A research collaboration for natriuretic peptide<br />

receptor fusion proteins with Syntonix has been<br />

commenced. Medarex and MorphoSys technolo-<br />

gies have been licensed in <strong>2005</strong>. All these efforts<br />

are designed to create added value for <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>’s NBE development.<br />

Investments<br />

Chemicals<br />

Chemical Production<br />

In recent years, our production network Chemi-<br />

cals has been developed into a globally-orientated<br />

organisation, developing and producing active<br />

pharmaceutical ingredients (APIs) for <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>.<br />

By focusing our chemical sites – Germany, France,<br />

Italy, Spain and the USA – on specific predefined<br />

roles within the network, flexible and highly<br />

competitive production of active pharmaceutical<br />

ingredients (APIs) has been secured for captive<br />

use and industrial customers.<br />

In <strong>2005</strong>, the launch of aptivus® was supported by<br />

API production at the launch site <strong>Ingelheim</strong>,<br />

Germany. To satisfy constantly growing demand<br />

for micardis®, the Petersburg, Virginia, USA, site<br />

commenced production of telmisartan. In addi-<br />

tion, the Malgrat, Spain, site hosted an interna-<br />

tional workshop, where members of the<br />

“Telmisartan Expert Teams” from <strong>Ingelheim</strong>,<br />

Petersburg and Malgrat met to establish best prac-<br />

tices at all sites through an intensive exchange of<br />

experiences and accessing opportunities for con-<br />

tinuous improvement.<br />

Worldwide investments in property, plant and equipment accelerated at <strong>Boehringer</strong> <strong>Ingelheim</strong> in <strong>2005</strong>. They increased<br />

by about 25 % compared to 2004 to EUR 532 million. “These investments mirror our dynamic business growth,” says<br />

Dr Hans-Jürgen Leuchs, Board Member responsible for Operations. The most important project completed in <strong>2005</strong><br />

was the new biopharmaceutical production plant in Vienna, Austria (inauguration in Vienna <strong>2005</strong>, picture on the right),<br />

an investment of some EUR 80 million, which will also create 200 new jobs. The company is strongly expanding its<br />

biopharmaceutical investments in order to maintain its leading edge in this field. EUR 70 million will be invested to<br />

modernise (de-bottleneck) one of the high capacity biopharmaceutical plants in Biberach, Germany. Further investment<br />

projects in <strong>2005</strong> were the starts of a new logistics centre in <strong>Ingelheim</strong>, and a physical science building in Ridgefield,<br />

Connecticut, USA. The expansion of the chemical production plant in Petersburg, Virginia, USA is ongoing, and also the<br />

expansion of the production lines at our companies Roxane Laboratories, Inc., Columbus, Ohio/USA, and Ben Venue<br />

Laboratories, Bedford, Ohio.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5


Pioneering college course<br />

in biotechnology<br />

In a unique educational venture <strong>Boehringer</strong> <strong>Ingelheim</strong> is participating in a pioneering public-private partnership in Biberach,<br />

Germany, to create a college course in pharmaceutical biotechnology. The groundbreaking ceremony for the technical<br />

college building that will house the course took place in June <strong>2005</strong>. The first group of 35 students is scheduled to start<br />

the bachelor of science course in the winter semester 2006-7, but ultimately the number of students will total 200.<br />

Prof. Rolf Werner, head of the division Biopharmaceuticals at <strong>Boehringer</strong> <strong>Ingelheim</strong>, described the venture as an<br />

“investment in the future” for the Baden-Wuertemberg region, for Germany and for <strong>Boehringer</strong> <strong>Ingelheim</strong>. Biberach is the<br />

main site of the company’s biopharmaceutical activities. The partners in the project are the local, regional and federal<br />

authorities, a local bank and the biotechnology company Rentschler. The degree course will cover everything from the basic<br />

science and analytical techniques in biopharmaceuticals through process development and plant technology to business<br />

economics and medical law.<br />

Fine Chemicals<br />

The sales figures of our worldwide Fine Chemicals<br />

business developed very well. Despite difficult<br />

market conditions, arising, for example, from<br />

Indian competition surplus capacities, they<br />

attained the same level as in 2004. Consolidated<br />

sales amounted to EUR 140 million in <strong>2005</strong>, just<br />

matching the 2004 level, irrespective of the<br />

substantial loss of a custom synthesis product.<br />

The importance of the US market increased<br />

further.<br />

A highlight of <strong>2005</strong> was the performance of<br />

phenylephrine. Volumes doubled due to sales<br />

restrictions on an alternative API in the USA.<br />

Controlled substances also showed gratifying<br />

growth in the USA. Sales from new business<br />

development projects performed very well, too.<br />

Biopharmaceuticals and Chemicals


Animal Health<br />

Helping the<br />

0


heartWhen<br />

her Labrador Buster<br />

fell ill, he could no longer play with<br />

little Anna Kingston. “Our dog was frail and<br />

apathetic,” says Anna’s mother, Liz. Buster was<br />

unresponsive, weak and lacked his usual spirit.<br />

Like the one in ten dogs with heart disease, he was suffering from what the<br />

experts call dilated cardiomyopathy (DCM) which produces changes in the heart,<br />

reducing its capacity, leading to congestive heart failure. This at first causes<br />

breathing difficulties and exhaustion, later leading to premature death.<br />

1


Fortunately for Buster and the Kingston family, vetmedin®, a breakthrough<br />

treatment developed by <strong>Boehringer</strong> <strong>Ingelheim</strong> for treating heart failure in dogs,<br />

was available. Buster has been part of the Kingston family for the past five<br />

years. “He won our hearts in an instant and bonded particularly strongly with<br />

our little daughter Anna,” says Liz Kingston. “They would tumble around<br />

all the time, playing with a ball or exploring their surroundings. In winter, we<br />

suddenly noticed that Buster at night paced to and fro nervously. His breathing<br />

was difficult and he developed a cough. At first we thought it was just a cold,<br />

but Buster would lay on his blanket all day and not even want to go for walkies.”<br />

The family finally turned to their veterinarian, Dr Henry Norfolk, who diagnosed<br />

that Buster had DCM, a disorder which, if untreated, means an average life<br />

expectancy for the dog of only a few weeks or months. “This news hit us very<br />

hard, but thankfully Dr Norfolk knew that vetmedin® (pimobendan) has been<br />

shown to be a highly effective medication for this condition,” Liz Kingston<br />

recalls. After hearing about the favourable results of various studies involving<br />

the treatment, the family had renewed hope for their much-loved pet. Their<br />

hope was fulfilled when, shortly after treatment began, Buster was much better<br />

and almost back to his old playful self. That was over a year ago and Buster is<br />

still going strong. “We’ve been so thankful for every extra day that we’ve had<br />

with Buster,” Liz concludes.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5


According to the American Veterinary Medical<br />

Association (AVMA), canine heart disease is one of<br />

the leading causes of death in pet dogs. Of the 10 %<br />

of dogs which develop congestive heart failure,<br />

DCM is the second most frequent cause.<br />

Studies prove efficacy<br />

Veterinarians have increasingly recognised<br />

vetmedin® as a first-line treatment for canine<br />

congestive heart failure due to both DCM and<br />

mitral valve disease (MVD). vetmedin® differs<br />

from previous treatments by helping the heart<br />

pump more easily and efficiently, often bringing<br />

dramatic clinical improvement within days of<br />

initiating treatment.<br />

In contrast to other commonly used heart drugs<br />

that only attack the disorder with a single mode of<br />

action, vetmedin® combines two favourable<br />

actions. It dilates the blood vessels, thereby reduc-<br />

ing the effort the heart has to make to circulate<br />

blood. At the same time, vetmedin® works to<br />

increase contractility by helping the heart to pump<br />

more strongly and more efficiently. The first of a<br />

new class of compounds, this inodilator’s unique<br />

dual action, makes it an optimum treatment for<br />

MVD and DCM, the two most common forms of<br />

heart disease in dogs.<br />

Clinical studies have independently confirmed the<br />

significant superiority of vetmedin®. <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> aims with the long-term study quest<br />

(QUality of Life and Extension of Survival Time),<br />

initiated two years ago, to further research the<br />

important parameters of quality of life and life<br />

expectancy. Based on this study, one of the world’s<br />

largest independent studies in companion animal<br />

veterinary medicine, a new benchmark will be set<br />

for treating heart failure in dogs. n<br />

Beneficial alliance<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Animal Health cares for pet animals,<br />

for a longer and happier life together. This is one of the<br />

cornerstones of our mission. <strong>Boehringer</strong> <strong>Ingelheim</strong> has for<br />

the past half century cared for the benefit of animals and<br />

people, discovering and developing a wide range of novel,<br />

practical treatments for cats and dogs.<br />

The company is dedicated to fostering a beneficial alliance<br />

between man and animals by uniting research expertise<br />

and human pharmaceutical excellence. Our pets are living<br />

longer, healthier and happier lives through improved<br />

nutrition and healthcare. This has created a real demand<br />

for effective and safe treatments for chronic and geriatric<br />

conditions, such as heart disease, osteoarthritis and<br />

cancer.<br />

vetmedin® helps<br />

the heart to pump<br />

more strongly and<br />

more efficiently.<br />

Animal Health


Animal Health<br />

Our Animal Health division celebrated its 50th anniversary in <strong>2005</strong>.<br />

While this makes <strong>Boehringer</strong> <strong>Ingelheim</strong> one of the long-established companies<br />

in this industry, it stands out as one of the most innovative and dynamic.<br />

The anniversary year saw generally very satisfactory business development.<br />

Sales rose by 8 % to around EUR 360 million in local currency. Our focus<br />

in <strong>2005</strong> continued to be on the core segments livestock vaccines and chronic<br />

diseases in companion animals and on optimisation of organisational<br />

and marketing structures. This further consolidated our position among the<br />

top 10 leading animal health companies in the world, giving us a global market<br />

share of 3 %.<br />

Regional differences<br />

Growth in <strong>2005</strong> varied greatly from one region to<br />

another. Once again, Europe, the growth engine<br />

behind the Animal Health division, posted excellent<br />

business development in the market with an<br />

7 % increase in sales. The NAFTA region posted<br />

sound growth of 9 %, but the year was marked by<br />

special factors, such as the sale of the antibiotic<br />

denagard® to Novartis. Asia also had a successful<br />

year. Sales in China and Thailand more than<br />

doubled, while the registration of ingelvac® prrs<br />

in these countries paved the way for continued<br />

strong growth. In Japan, the restructuring process,<br />

aimed at streamlining the product portfolio and<br />

concentrating on our core segments, is practically<br />

complete. The launch of our porcine vaccine range<br />

in Latin America and Eastern Europe is currently<br />

being prepared.<br />

Food-producing animals<br />

Swine<br />

The key event in the swine segment in <strong>2005</strong> was<br />

the pan-European launch in Barcelona in October<br />

<strong>2005</strong> of enterisol® ileitis, the first and only<br />

vaccine in the world for the widespread dis-<br />

ease ileitis that is associated with diar-<br />

rhoea. Our experience in practice to date<br />

has been extraordinarily positive. In the<br />

USA, every third pig was vaccinated<br />

against ileitis in <strong>2005</strong>, while control of<br />

the disease was established as an essential<br />

element of professional healthcare<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

management of pigs. In Germany, some produc-<br />

ers’ associations have already declared the use of<br />

the oral vaccine to be mandatory, only one year<br />

after launch. enterisol® ileitis is thus well on<br />

the way to becoming another of Animal Health’s<br />

top products.<br />

It is noteworthy that we received marketing<br />

authorisation for enterisol® ileitis in Australia.<br />

Not only is this the first <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

vaccine to be introduced in Australia, but it is also<br />

the first imported modified live vaccine to be given<br />

marketing authorisation there.<br />

Our flagship product ingelvac® prrs showed<br />

extraordinary development, particularly in South<br />

Korea where sales doubled. Our best-selling<br />

vaccine is now also available in China, the largest<br />

swine market in the world, allowing us to<br />

consolidate further our No. 1 position there among<br />

the international suppliers of porcine vaccines.<br />

ingelvac® m. hyo also posted strong growth. This<br />

enabled our young company in Thailand to<br />

become market leader in this indication in a very<br />

short time. Excellent results were also achieved in<br />

France where ingelvac® m. hyo improved<br />

by 36 % in a flat market, thus securing a<br />

market share of 31 %.<br />

On the whole, <strong>2005</strong> saw excellent progress<br />

with our porcine vaccines, one of our core<br />

target segments, putting us well on the way<br />

to becoming global market leader.


Cattle<br />

There were two highly gratifying developments in<br />

the cattle segment. First, the food-producing<br />

animal industry is becoming increasingly aware<br />

that healthy animals also produce healthy meat<br />

and higher milk yields. More and more farmers<br />

therefore attach value to effective treatment of<br />

their animals’ pain and inflammation, thus help-<br />

ing our metacam® progress towards becoming<br />

the gold standard in this area. The drug continued<br />

its double-digit growth in the cattle segment in<br />

<strong>2005</strong>.<br />

Secondly, our mastitis products not only main-<br />

tained their excellent market position in <strong>2005</strong>,<br />

but were also able to step up market penetration<br />

in the developing markets, a positive trend that is<br />

likely to be consolidated further. An international<br />

congress in Maastricht provided<br />

impressive evidence of the<br />

excellent efficacy of our classi-<br />

cal product mamyzin® in sub-<br />

clinical mastitis. The vaccine<br />

portfolio continues to represent<br />

one of the strongholds of our<br />

cattle business in the NAFTA<br />

region.<br />

Companion animals<br />

Small animals<br />

The small animals segment can look back on a<br />

highly successful year. With consistent growth of<br />

our existing products we confirmed our leading<br />

market position in many key countries. The<br />

extraordinary performance of vetmedin® is<br />

particularly promising, with worldwide growth of<br />

24 %. This drug secured first or second position on<br />

all the leading markets in Europe. The outstand-<br />

ing growth rates in Canada (82 %) and France<br />

(27 %) give us every reason to be<br />

extremely optimistic about the next<br />

few years when the product will be<br />

registered in other key markets.<br />

Half a century<br />

keeping animals<br />

healthy<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has been committed to maintaining<br />

and improving the health of companion and farm animals<br />

since the mid-1950s. The following milestones show the<br />

launch years for key veterinary medicines from our own<br />

research and development.<br />

1<br />

pecusanol® (lindane) – a treatment for ectoparasitic<br />

infestation of all types of animals<br />

1<br />

lobelin® (lobelin HCl) – a treatment for airway diseases<br />

in horses, especially used as a stimulant for newborn foals,<br />

based on the active principle of lobelia inflata (Indian<br />

tobacco plant)<br />

1<br />

voren® (dexamethasone-21-isonicotinate) – a longacting<br />

catabolic steroid used to treat metabolic disorders,<br />

inflammation and allergic reactions in cattle, swine,<br />

horses, dogs, and cats<br />

1<br />

buscopan compositum® (N-butyl scopolamonium<br />

bromide + metamizole) – a spasmolytic and pain inhibitor<br />

for treating colic in horses, based on active substance<br />

from the Duboisia (Corkwood) plant<br />

1<br />

bisolvon® (bromhexine) – a mucolytic for treating<br />

respiratory disease in cattle, swine and small animals<br />

where mucus is a complicating factor<br />

1 0<br />

ventipulmin® (clenbuterol HCl) – an equine respiratory<br />

treatment that relieves the breathing difficulty of horses<br />

with conditions characterised by reversible bronchospasm,<br />

or mucus accumulation, including heaves or<br />

chronic obstructive pulmonary disease (COPD)<br />

1<br />

ingelvac® aujeszky mlv (Bartha strain K-61) – the first<br />

of the ingelvac® series of products to immunize swine<br />

against a range of viral infections<br />

continued on next page ➤<br />

Animal Health


➤ continued from page before<br />

1<br />

ingelvac® prrs mlv (Porcine respiratory & reproductive<br />

syndrom virus, modified live virus)<br />

1<br />

metacam® (meloxicam) – initially launched for dogs, this<br />

treatment is now licensed for alleviating pain and reducing<br />

inflammation in many indications in dogs, cats, horses,<br />

cattle and pigs<br />

1<br />

vetmedin® (pimobendan) – a treatment for congestive<br />

heart failure in dogs<br />

001 (US)<br />

enterisol® ileitis (Lawsonia intracellularis a virulent<br />

live culture) – first vaccine against Lawsonia intracellularis<br />

worldwide<br />

00 (EU)<br />

ingelvac® m. hyo (Mycoplasma hyopneumoniae bacterin)<br />

– novel technique allows a one shot only vaccination<br />

metacam® also achieved a strong increase in sales<br />

which highlights the excellent performance once<br />

again in <strong>2005</strong>. With double-digit global growth<br />

rates, we effectively maintained our position in<br />

Europe, Canada, and Australia, in spite of fierce<br />

competition. The new small animals team in the<br />

USA achieved striking success, advancing in<br />

record time to take 3rd position in the market.<br />

Horses<br />

We once again maintained our strong position in<br />

the horse segment in the European and American<br />

markets. With the introduction of the intravenous<br />

solution for injection, metacam® horse, in<br />

Europe, we extended our portfolio with a<br />

frequently demanded product. At the same time,<br />

two launches in the USA, the world’s largest<br />

equine market, provided further impetus for<br />

growth: buscopan®, the classical treatment for<br />

equine colic, and sedivet®, a drug used to sedate<br />

animals.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Business with our non-prescription products<br />

canosan®, seraquin® and viatop®, a new<br />

product for skin disorders, showed a gratifying<br />

trend throughout the entire companion animals<br />

segment.<br />

Research and development<br />

True to our company vision Value through Inno-<br />

vation, we invested around 12 % of our Animal<br />

Health sales in research and development in <strong>2005</strong>,<br />

a high percentage for the international industry.<br />

The focus was primarily on the development of<br />

new pharmaceutical solutions for small animals<br />

and preventive measures for the large animals<br />

sector. These efforts have culminated in several<br />

interesting projects in the current pipeline and<br />

good progress in the development of innovative<br />

pharmaceutical molecules and vaccines.


Group Management <strong>Report</strong>


Group Management <strong>Report</strong><br />

Business and operating<br />

environment<br />

Overview<br />

The development of the world economy in <strong>2005</strong>,<br />

compared with the previous year, was character-<br />

ised by a marked increase in raw material prices.<br />

At the same time, generally low capital market<br />

interest rates, a rather expansion-orientated<br />

monetary policy and the corporate earnings<br />

position had an overall positive influence on the<br />

economic cycle.<br />

Regionally, the USA and China were the growth<br />

centres of the world economy. The Japanese<br />

economic situation also developed favourably<br />

and it is to be hoped that the stagnation phase is<br />

now overcome for good. The development of the<br />

economic cycle in Europe was rather restrained.<br />

In Germany in particular the economic situation<br />

Net Net sales sales by businesses by businesses <strong>2005</strong> <strong>2005</strong><br />

(in millions (in millions of EUR) of EUR)<br />

Prescription Medicines Medicines<br />

6,183 6,183<br />

Consumer Consumer Health Health Care Care<br />

970 970<br />

Biopharmaceuticals<br />

392 392<br />

Fine Fine Chemicals Chemicals and and<br />

Manufacturing Pharma Pharma<br />

262 262<br />

Animal Animal Health Health<br />

335 335<br />

’04 ’05 ’04 ’05<br />

7,247 7,247<br />

1,052 1,052<br />

548 548<br />

299 299<br />

361 361<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Total Total<br />

8,157 8,157<br />

9,535 9,535<br />

remains very difficult due to high unemployment<br />

and stagnating domestic demand. Stimulation for<br />

the German economy came substantially from<br />

exports.<br />

Global conditions for research-driven pharma-<br />

ceutical companies did not improve last year.<br />

Regulatory interventions are no positive signal<br />

for the development of innovative medicines.<br />

Despite these trends, <strong>Boehringer</strong> <strong>Ingelheim</strong> will<br />

continue to do its best in researching new,<br />

innovative pharmaceuticals for the benefit of<br />

patients.<br />

The world pharmaceutical market grew by 6.3 %<br />

in the financial year <strong>2005</strong>, discounting currency<br />

effects. With an increase of 23.9 % in this period,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> clearly exceeded average<br />

market growth. It is noteworthy that <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> outpaced the pharmaceutical market<br />

in every region, reflecting the global orientation<br />

Net Net sales sales by region by region <strong>2005</strong> <strong>2005</strong><br />

(in millions (in millions of EUR) of EUR)<br />

Americas Americas<br />

3,905 3,905<br />

Europe Europe<br />

2,622 2,622<br />

Asia, Asia, Australasia,<br />

Africa Africa<br />

1,630 1,630<br />

’04 ’05 ’04 ’05<br />

4,559 4,559<br />

3,117 3,117<br />

1,859 1,859<br />

Total Total<br />

8,157 8,157<br />

9,535 9,535


and strength of the group. The greatest stimulus<br />

for growth in <strong>2005</strong> came once again from<br />

America, the most important market for<br />

research-driven pharmaceutical manufacturers.<br />

Here, we gained additional benefit from the<br />

positive commercial development of our product<br />

mobic®.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s growth on the pharma-<br />

ceuticals market consequently led to a marked<br />

increase in group turnover. In <strong>2005</strong>, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> generated net sales of EUR 9.5 billion,<br />

corresponding to an increase of 17 %. The positive<br />

development of business in 2004 was thereby<br />

continued further. A comparative analysis of<br />

the business results for the years 2004 and <strong>2005</strong><br />

can virtually ignore the influence of foreign<br />

exchange, as this only accounts for a factor of<br />

< 0.1%.<br />

The business segment Prescription Medicines<br />

(PM) was responsible for the largest share of the<br />

success achieved in the past financial year.<br />

In addition, our other segments also developed<br />

very satisfactorily:<br />

Net sales<br />

(in millions of EUR) 00 2004 Change<br />

Prescription Medicines 7,247 6,183 +17 %<br />

Consumer Health Care 1,052 970 +9 %<br />

Biopharmaceuticals 548 392 +40 %<br />

Animal Health 361 335 +8 %<br />

The development of net sales in the segments<br />

Consumer Health Care (CHC) and Animal Health<br />

is noteworthy, as both businesses had to maintain<br />

their position in a very difficult market<br />

environment. The outstanding business development<br />

of Biopharmaceuticals was the main<br />

growth driver of our Industrial Customer<br />

business and maintained the growth rates of the<br />

previous year.<br />

For the business segment Prescription Medicines,<br />

the market launch of aptivus®, a protease inhib-<br />

itor for the treatment of immunodeficiency<br />

disease HIV, was remarkable in two senses. First,<br />

the medication was developed to market maturity<br />

in a very short time. Secondly, only seven days<br />

after approval by the US Food and Drug Admin-<br />

istration (FDA) in June <strong>2005</strong>, aptivus® was<br />

already commercially available. Thus, patients<br />

have access to a new, highly efficacious therapy<br />

option for the treatment of HIV disease. In<br />

November, the product was launched in Germany<br />

and the United Kingdom.<br />

The very positive uptake of already established,<br />

innovative pharmaceutical products in our<br />

markets also contributed to the success in <strong>2005</strong>.<br />

spiriva® is already the most commonly<br />

prescribed product for the treatment of chronic<br />

obstructive pulmonary disease (COPD).<br />

The launch of spiriva® in Japan in December<br />

2004 made it possible for the first time for<br />

patients to be treated with this innovative medi-<br />

cation in almost all important pharmaceutical<br />

markets. The cooperation with Pfizer Inc. on<br />

marketing the product has proved its worth.<br />

Sales of micardis®, a treatment for hyper-<br />

tension, have also shown very gratifying develop-<br />

ment. Clinical studies which were concluded in<br />

<strong>2005</strong> have confirmed our high expectations<br />

concerning the efficacy of micardis®. Despite<br />

intensive competition in this market segment,<br />

we still anticipate further growth potential for<br />

this product.<br />

Our business success in previous years was also<br />

founded on the vision Value through Innovation<br />

(VTI) embedded in our corporate culture. With<br />

the introduction in <strong>2005</strong> of the initiative Lead &<br />

Learn we have given the VTI concept fresh<br />

stimulus. We thereby ensure that the VTI princi-<br />

ples will also be secured in the company in future<br />

and continue to be translated into reality.<br />

To sum up, <strong>2005</strong> was for <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

a highly successful year in which we laid solid<br />

foundations for the further development of the<br />

group of companies.<br />

Group Management <strong>Report</strong>


0<br />

The most important key figures for earnings are<br />

as follows:<br />

(in millions of EUR) 00 2004 Change<br />

Net sales 9,535 8,157 +17 %<br />

Operating income 1,923 1,372 +40 %<br />

Return on net sales (as %) 20.2 16.8<br />

Research and Development<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> sees its objective as devel-<br />

oping new medicines and therapies, thereby<br />

helping the sick. This strategic orientation is<br />

shown in both actual projects and initiatives and<br />

in the worldwide expenditure on research and<br />

development. In the financial year <strong>2005</strong>,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> invested EUR 1,360<br />

million in R&D.<br />

R&D expenditure as percentage of net sales<br />

amounted to 14.3 % in <strong>2005</strong> (2004: 15.1 %).<br />

The focus of our R&D activities is Prescription<br />

Medicines. In this segment, the R&D expenditure<br />

as a share of net sales stood at 18.2 % in <strong>2005</strong><br />

(2004: 19.3 %).<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> supports this focus with<br />

its own research that is concentrated on the<br />

following therapeutic areas:<br />

• respiratory diseases<br />

• virology<br />

• oncology<br />

• metabolic diseases<br />

• cardiovascular diseases<br />

• central nervous system diseases<br />

• immunology and inflammation<br />

These areas of research are divided according to<br />

their defined focus between four main research<br />

sites in Germany, the USA, Austria and Canada.<br />

In the area of respiratory diseases, <strong>2005</strong> saw the<br />

successful launch of spiriva® in Japan. Further<br />

studies have long confirmed the efficacy of this<br />

medication. Research in the disease COPD is<br />

being consistently continued.<br />

A focus of research in virology is a new nonnucleoside<br />

reverse transcriptase inhibitor<br />

(NNRTI) which can be applied particularly when<br />

resistance to hitherto used therapeutic regimes<br />

occurs. In addition, this concerns the consistent<br />

further development of the class of drugs to<br />

which the successfully launched viramune®<br />

belongs.<br />

In oncology, new active ingredients have been<br />

discovered which promise new therapeutic<br />

approaches and opportunities to cure various<br />

types of tumour. These are currently in phase I<br />

of clinical development. The first results were<br />

presented to the scientific community in the USA<br />

in late autumn last year.<br />

In metabolic diseases, new therapeutic<br />

approaches to treating diabetes mellitus type II<br />

are in the foreground, especially in conjunction<br />

with associated secondary diseases. Some<br />

projects show promising therapeutic approaches<br />

and are at present in the pre-clinical or clinical<br />

phases.<br />

Studies in the area of central nervous system<br />

diseases have confirmed that mirapex®/sifrol®<br />

can be used to treat restless legs syndrome.<br />

In addition to its efficacy, its good tolerability<br />

in particular was confirmed. Applications for<br />

market approval for this indication were<br />

submitted in the USA and Europe in <strong>2005</strong>.<br />

Research and development 00 2004 2003 2002 2001<br />

Expenditure (in millions of EUR) 1,360 1,232 1,176 1,304 1,019<br />

– as % of net sales 14.3 15.1 15.9 17.2 15.2<br />

Human Pharma. expend. (in millions of EUR) 1,318 1,195 1,140 1,264 984<br />

– as % of net sales of HP 14.4 15.3 16.1 17.4 15.4<br />

Average number of employees 5,678 5,471 5,362 5,205 4,828<br />

Investments in tangible assets (in millions of EUR) 116 97 93 97 99<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5


cymbalta®, the anti-depressive in-licensed<br />

from Eli Lilly & Co., received in the meantime<br />

approval as a treatment in 20 countries, thereby<br />

reinforcing our therapy area central nervous<br />

system.<br />

On top of our own research efforts, our activities<br />

and projects are complemented by strategic<br />

alliances and in-licensing technologies. In the<br />

past financial year, technologies were, for exam-<br />

ple, in-licensed from MorphoSys and Medarex<br />

that should support our research activities in<br />

the field of biotechnologically manufactured<br />

pharmaceuticals. This also applies for a mono-<br />

clonal antibody in-licensed from AbGenomics.<br />

From today’s perspective, <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

R&D pipeline provides a very good foundation to<br />

support and enable the further development of<br />

our company on a lasting basis.<br />

Production<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s production activities are<br />

divided into three areas:<br />

• chemical production (five sites worldwide):<br />

this encompasses both the manufacture of<br />

active ingredients for our own pharmaceutical<br />

production and chemical active ingredients for<br />

customers outside the <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

group.<br />

• pharmaceutical production (19 sites worldwide):<br />

pharmaceutical production concentrates<br />

on manufacturing finished products.<br />

Production is structured in technological<br />

centres of competence, which operate in a<br />

production alliance.<br />

• biopharmaceutical production (two sites in<br />

Europe): as for chemicals, biopharmaceuticals<br />

are produced for both <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

medications and for third parties.<br />

Environmental reporting<br />

According to the guiding principles (Leitbild) of<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>, the preservation and<br />

protection of the environment has a very high<br />

priority. This derives ultimately from our claim to<br />

help people with our products. This helping<br />

stance is only credible if <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

takes an active part in preserving the environ-<br />

ment.<br />

It goes without saying that <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

respects and observes each country’s legal<br />

regulations. Beyond that it is our aim to exceed<br />

the environmental requirements where we<br />

consider this purposeful and necessary. Our<br />

established processes in the field of Environmen-<br />

tal, Health & Safety (EHS) form the foundation<br />

for successful implementation of the fundamen-<br />

tal principles of environmental policy. Thus we<br />

carried out environmental audits at 11 different<br />

sites in <strong>2005</strong>. The purpose was to see whether the<br />

environmental guidelines we have set out were<br />

being observed. In <strong>2005</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

was also awarded various prizes in the EHS field.<br />

The award received by the chemical site<br />

Petersburg,Virginia, USA, hailed its new waste-<br />

water plant as exemplary.<br />

Employee reporting<br />

The favourable business development of the past<br />

year is also expressed in the marked increase in<br />

the number of employees. Averaged over the year,<br />

37,406 people were employed at <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>, corresponding to an increase of 5 %<br />

against the previous year. In Germany, we<br />

received first prize for the highest number of new<br />

people hired in <strong>2005</strong> in our reference group.<br />

We are particularly proud that in <strong>2005</strong> we clearly<br />

increased our offer of apprenticeships at our<br />

German subsidiaries compared to 2004.<br />

An essential goal for our human resources work<br />

is to hire the best employees and retain them<br />

long-term. Various personnel and leadership<br />

development paths are available in order to<br />

consistently develop further the talents of our<br />

employees.<br />

Group Management <strong>Report</strong> 1


Social responsibility<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> takes an active part in the<br />

overall social responsibility with great care and<br />

considerable enthusiasm.<br />

For example, since the year 2000, programmes<br />

have been supported that substantially reduce<br />

the transmission of HIV from mother to child<br />

during birth through antiretroviral therapy. The<br />

viramune® necessary for this purpose is made<br />

available free of charge by <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

In calendar year <strong>2005</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

supported about 140 programmes in around 60<br />

countries.<br />

In addition, <strong>Boehringer</strong> <strong>Ingelheim</strong> fosters the<br />

development of healthcare systems in defined<br />

countries. In Botswana, for instance, a training<br />

unit was opened to promote medical education.<br />

Our overall social responsibility is expressed in<br />

additional international initiatives. For example,<br />

we gave rapid and unbureaucratic support with<br />

money and materials to the victims of the natural<br />

catastrophes in Southeast Asia and Pakistan.<br />

In this context, it is important to point out that,<br />

in addition to the engagement of our company,<br />

many of our employees voluntarily use their free<br />

time to involve themselves in social projects.<br />

For this, we would like to express our heartfelt<br />

thanks to all our employees. Actively helping<br />

people is for us an expression of an attitude that<br />

reflects the way <strong>Boehringer</strong> <strong>Ingelheim</strong> perceives<br />

itself and which we support as much as possible.<br />

Results from operations,<br />

financial position and<br />

net assets<br />

Results from operations<br />

Based on currently available market data,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> was last year the fastest-<br />

growing pharmaceutical company in the world<br />

within its benchmark group. Our company is<br />

now ranked No.14 among the largest pharma-<br />

ceutical companies, with a worldwide market<br />

share of 2 %.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s net sales increased by<br />

17 % in <strong>2005</strong> to EUR 9,535 million. This gratifying<br />

development reflects the favourable market<br />

uptake of the pharmaceuticals, which we produce<br />

and sell. The currency effect of EUR 3.3 million<br />

only had insignificant influence when the financial<br />

years 2004 and <strong>2005</strong> are compared. The full<br />

consolidation of our South Korean subsidiary<br />

since <strong>2005</strong> has a one-off effect of EUR 18 million<br />

on net sales. Comparing growth rates in <strong>2005</strong><br />

and 2004, an additional extraordinary effect due<br />

to the product sifrol® has to be considered.<br />

Except for the USA, exclusive worldwide marketing<br />

rights were returned to <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

by Pfizer Inc. on 15 October 2004.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s activities are concentrated<br />

on the two businesses Human Pharmaceuticals<br />

and Animal Health. Net sales in Human<br />

Pharmaceuticals, with activities grouped under<br />

the segments Prescription Medicines, Consumer<br />

Health Care and Industrial Customer, amounted<br />

to EUR 9,174 million in <strong>2005</strong> (+17 %). This<br />

corresponds to 96% of total group net sales.<br />

Prescription Medicines (PM)<br />

Within the Human Pharmaceuticals business,<br />

PM accounts for 79 % of net sales, forming the<br />

centrepiece of our activities. In <strong>2005</strong>, we<br />

achieved net sales of EUR 7,247 million in this<br />

segment (2004: EUR 6,183 million). A currency<br />

effect of EUR 6 million must be taken into<br />

account when analysing the figures.<br />

From a worldwide business development<br />

perspective, the following products were the<br />

strongest growth drivers:<br />

Net sales<br />

(in millions of EUR) 00 2004 Growth<br />

spiriva® 951 525 +81 %<br />

sifrol®/mirapex® 434 285 +52 %<br />

micardis® 724 568 +27 %<br />

mobic® 848 672 +26 %


Components of growth in net sales (as %) 00 2004 2003 2002 2001<br />

Price/quantity/new introductions 17.4 16.1 7.8 10.1 8.9<br />

Acquisition and sale of businesses –0.5 –0.5 –0.2 7.1 –0.7<br />

Currency effect 0 –5.1 –10.2 –4.0 0.0<br />

spiriva®, our new medication for the treatment<br />

of COPD, has developed very satisfactorily.<br />

Net sales for cymbalta®, the product in-licensed<br />

from Eli Lilly & Co. and launched in 2004,<br />

performed as expected.<br />

The positive uptake by patients and the market of<br />

aptivus®, a protease inhibitor for the treatment<br />

of the immunodeficiency disease HIV, will also<br />

strengthen the development of our innovative<br />

product portfolio in the coming financial year.<br />

In addition, products that are already established<br />

on the market will support the business develop-<br />

ment in the future.<br />

Analysing the regions in which we operate<br />

around the world, it can be observed that<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has clearly grown more<br />

strongly than the respective regional pharmaceutical<br />

markets.<br />

The Americas Region, with a share of 51 %,<br />

contributes the largest part of net sales in PM.<br />

Compared to the previous year, growth of 17%<br />

was achieved here, corresponding to net sales of<br />

EUR 3,670 million. The USA, with its 85 % share<br />

of net sales, is the largest and thereby the most<br />

important country for <strong>Boehringer</strong> <strong>Ingelheim</strong> in<br />

this region. Our products spiriva® and mobic®<br />

in particular were responsible for the positive<br />

US business development, increasing net sales<br />

by EUR 345 million (+58 %) compared to the<br />

previous year.<br />

The Europe Region’s share of net sales in this<br />

market segment stands, with a volume of EUR<br />

2,037 million, at 28 %. It contributed to the<br />

success in <strong>2005</strong> with a 15 % increase in net sales<br />

compared to the previous year. With net sales<br />

growth of over 22 %, business development in<br />

Germany was very gratifying compared to the<br />

previous year. Growth in our home country was<br />

mainly achieved with our innovative medications<br />

spiriva®, sifrol®, micardis® and cymbalta®.<br />

In addition, there was the launch in Germany of<br />

the product alna® ocas®, which allows benign<br />

prostatic hyperplasia (BPH) to be treated with a<br />

single dose per day.<br />

Despite increasing regulatory restrictions too, the<br />

Asia, Australasia, Africa (AAA) Region achieved<br />

double-digit growth in net sales, contributing to<br />

group success with net sales of EUR 1,312<br />

million. With its 61 % share, Japan is for us the<br />

largest market in this region. In <strong>2005</strong>, our<br />

Japanese subsidiary attained net sales growth of<br />

12 % to EUR 801 million in this market, largely<br />

attributable to the highly favourable development<br />

of micardis®. The Australian market also<br />

performed above average, with a EUR 24 million,<br />

or 25 %, increase in growth. Overall, we achieved<br />

net sales of EUR 120 million in this market.<br />

In India, we have started to build up our own<br />

subsidiary.<br />

Foreign exchange development<br />

■ EUR 1 in USD (average exchange rates)<br />

■ EUR 1 in YEN (average exchange rates)<br />

1.30<br />

1.25<br />

1.20<br />

1.15<br />

1.10<br />

1.05<br />

1.00<br />

0.95<br />

0.90<br />

’01 ’02 ’03 ’04 ’05<br />

Group Management <strong>Report</strong><br />

150<br />

140<br />

130<br />

120<br />

110


Consumer Health Care (CHC)<br />

In the business segment CHC we raised our net<br />

sales by 9 % to EUR 1,052 million (discounting<br />

currency effects: EUR 1,056 million). Consistent<br />

orientation towards core brands defined in our<br />

strategy continues. Non-prescription products,<br />

whose patent protection has expired, will be<br />

integrated into existing product lines, and,<br />

wherever possible and purposeful, an umbrella<br />

brand strategy will be built up.<br />

Worldwide growth was achieved by the following<br />

product groups in particular:<br />

Net sales<br />

(in millions of EUR) 00 2004 Growth<br />

mucosolvan® 91 40 +228 %<br />

buscopan® 59 43 +37 %<br />

dulcolax® 115 97 +19 %<br />

pharmaton® 88 85 +4 %<br />

The distinct increase in net sales for<br />

mucosolvan® resulted, on the one hand, from<br />

a major cold outbreak at the beginning of <strong>2005</strong>,<br />

and on the other hand, from product group<br />

switches in some countries from prescription-<br />

only pharmaceuticals to the CHC business<br />

segment.<br />

buscopan®, as a result of product switches in<br />

certain countries in the Americas Region, also<br />

benefited from this special effect, which explains<br />

part of the double-digit growth in net sales.<br />

Based on available market data, the buscopan®<br />

brand has secured No. 1 position worldwide in<br />

antispasmodics.<br />

Business development differed greatly from<br />

region to region. While in the Americas (+19 %)<br />

and Europe (+14 %) marked net sales increases<br />

were achieved, net sales in AAA fell slightly<br />

(-1.8 %). This was because we were able to maintain,<br />

but not expand, our market share in a very<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

difficult business environment in Japan.<br />

Overall, in the financial year <strong>2005</strong>, we achieved<br />

the following net sales figures for each region:<br />

Americas EUR 222 million, Europe EUR 436<br />

million and AAA EUR 394 million.<br />

Industrial Customer<br />

The third party business in pharmaceutical<br />

production and the fine chemicals area broadly<br />

matched the previous year’s level with net sales<br />

of EUR 298 million.<br />

Alongside the important role that Biopharmaceuticals<br />

has in developing and manufacturing<br />

medications for the <strong>Boehringer</strong> <strong>Ingelheim</strong> group,<br />

last year it was highly successful with regard to<br />

producing biopharmaceuticals for other pharmaceutical<br />

companies. Net sales of biotechnologically<br />

produced medications for third parties<br />

rose from EUR 392 million to EUR 548 million,<br />

corresponding to growth of 40 %. Increased<br />

customer demand indicates the market success of<br />

the products our group manufactures for third<br />

parties. The commissioning of our new production<br />

facility in Vienna, Austria, and the marked<br />

improvement in productivity of the existing<br />

production plant in Biberach, Germany, enabled<br />

us to fulfil market demand.<br />

Routine inspections carried out by the FDA last<br />

year resulted in certification of our production<br />

facilities and processes by the auditors.<br />

Animal Health<br />

Compared to the previous year, the Animal<br />

Health business developed very positively in an<br />

intensely competitive market, with net sales<br />

growth of 8 %. Total net sales in the last financial<br />

year amounted to EUR 361 million (discounting<br />

currency effects EUR 360 million).


Worldwide growth was achieved by the following<br />

product groups in particular:<br />

Net sales<br />

(in millions of EUR) 00 2004 Growth<br />

vetmedin® 16 13 +23 %<br />

ventipulmin® 13 11 +18 %<br />

metacam® 68 58 +17 %<br />

ingelvac® m. hyo 21 18 +17 %<br />

enterisol® ileitis was successfully launched<br />

in Europe in October <strong>2005</strong>. This is an oral<br />

vaccine for preventing the bacterium Lawsonia<br />

intracellularis. This bacterium triggers inflamma-<br />

tion in the gut of domestic pigs that hitherto<br />

could only be treated with an antibiotic therapy.<br />

Some producer associations in Germany have<br />

already made vaccination mandatory for their<br />

members’ farms.<br />

metacam® has developed favourably for all types<br />

of animal. vetmedin®, a pharmaceutical for the<br />

treatment of degenerative heart failure in dogs,<br />

has exceeded our commercial expectations.<br />

Business developed very well in all three Regions.<br />

Europe, with a 45 % share of net sales, is just<br />

ahead of the Americas Region (42 %). In the<br />

Americas, extraordinary effects have to be taken<br />

into account. For example, the sale of the antibiotic<br />

denagard® to Novartis in the NAFTA<br />

region produced a fall in net sales, which had a<br />

correspondingly negative impact on the business.<br />

The 8 % growth in net sales achieved in <strong>2005</strong><br />

must therefore be regarded as all the more gratifying.<br />

In the AAA Region net sales growth of 7 % also<br />

contributed to the success of the Animal Health<br />

business.<br />

Expenditure and income<br />

Total operating costs of EUR 8,388 million were<br />

14 % above the previous year (EUR 7,362 million).<br />

Material costs (EUR 1,613 million) by comparison<br />

increased above average, with growth of 25 %,<br />

mainly due to changes in the product mix.<br />

The increase in the average headcount led to a<br />

9 % rise in personnel costs to EUR 2,671 million.<br />

Again, in <strong>2005</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong> made<br />

further efforts to secure the future of the group<br />

of companies through appropriate investments.<br />

Taking into account the newly initiated projects<br />

in <strong>2005</strong>, depreciations increased by EUR 60<br />

million to EUR 531 million, corresponding to an<br />

increase of 13 %. Other operating expenses rose<br />

by EUR 414 million (13 %). The amount of<br />

EUR 3,573 million includes expenditures arising<br />

from the termination of a sales cooperation with<br />

Abbott.<br />

Overall, this produces a EUR 551 million higher<br />

operating income of EUR 1,923 million, that aptly<br />

records the success of the past financial year. The<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> group’s return on net sales<br />

rose distinctly from 16.8 % to 20.2 %.<br />

The financial income diminished by EUR 20<br />

million to EUR -35 million compared to the<br />

previous year. The reasons for this decline were<br />

mainly losses on transactions in foreign<br />

exchange derivatives.<br />

Holding income, with a contribution EUR<br />

0 million, was EUR 2 million lower than the<br />

previous year. In the past financial year, the<br />

extraordinary effect arising from the disposal<br />

of a holding was not repeated.<br />

Taking into account the individual income<br />

components, income before taxes was EUR 1,888<br />

million, a significant increase of EUR 529 million<br />

or 39 % above the previous year.<br />

Tax expenses amounted to EUR 374 million,<br />

corresponding to a tax ratio of 20 % (2004: 33 %).<br />

Here, it must be taken into consideration that,<br />

due to regulations in the German commercial<br />

code, personal taxes on group activities levied on<br />

the shareholders may not be shown as tax<br />

expenses. These are presented as withdrawals<br />

from accumulated group equity. Taking this effect<br />

into consideration, the actual tax ratio is<br />

markedly higher than the value shown in the<br />

profit and loss statement.<br />

Group Management <strong>Report</strong>


The clear decline in the tax ratio compared to<br />

financial year 2004 is a result of the restructur-<br />

ing of inter-company relationships at group level.<br />

This has full effect for the first time in <strong>2005</strong>.<br />

In 2004, the tax ratio was negatively impacted by<br />

a one-off extraordinary effect amounting to EUR<br />

121 million which arose from changes to the tax<br />

tariff applied in the calculation of deferred taxes.<br />

Taking into account the described tax effects,<br />

net income rose from EUR 888 million to EUR<br />

1,491 million.<br />

Financial position<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s financial management is<br />

in its instruments and methods aligned with the<br />

international standards for a modern industrial<br />

company. The goal of the financial management<br />

is to support the business strategy of our com-<br />

pany by providing or investing financial assets,<br />

taking account of the foreign exchange risk<br />

which arises from our international business<br />

relations.<br />

For the financial year <strong>2005</strong>, <strong>Boehringer</strong> Ingel-<br />

heim’s very good economic development is also<br />

reflected in its further improved financial posi-<br />

tion compared to the previous year. The cash<br />

flow in <strong>2005</strong> amounted to EUR 2,069 million,<br />

corresponding to 45 % growth compared to the<br />

previous year. The cash flow from operating<br />

activities rose to EUR 2,390 million and is<br />

thereby markedly higher than funds used for<br />

investment activities in the past year. Financial<br />

activities yielded an outflow of EUR 1,334 million<br />

from changes in equity as well as credits raised<br />

with financial institutions.<br />

Securities and liquid funds increased by 14 % to<br />

EUR 4,585 million. The complete presentation of<br />

the cash flow calculation is to be found in the<br />

financial section of the annual report.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

To summarise, it can be noted that, because of<br />

the existing liquidity, the given capital structure<br />

and the available funding potential, the financial<br />

preconditions for successfully realising our<br />

strategy remain in place. The goals we set within<br />

our financial strategy have been fulfilled.<br />

Investments are necessary and important for<br />

securing our future development. We have there-<br />

fore increased our investment activity in <strong>2005</strong> to<br />

EUR 532 million (2004: EUR 427 million), which<br />

registered as a distinct increase in our tangible<br />

assets. The bulk of the investments were made in<br />

implementing new technologies, expanding our<br />

capacity and rationalisation projects.<br />

At our German research site in Biberach the new<br />

galenics building was commissioned. Further-<br />

more, funds were released for a packaging centre<br />

(LogiPack Center) and a new works canteen<br />

at the <strong>Ingelheim</strong> site. In future, products manu-<br />

factured in Germany will receive their final<br />

finishing in our LogiPack Center. The canteen’s<br />

capacity will be in line with the markedly<br />

increased number of employees in recent years<br />

and the expected increase.<br />

In the USA, we have also commenced important<br />

investment projects. Good examples are the<br />

expansion of production facilities at our subsidiary<br />

Ben Venue Laboratories in Bedford, Ohio,<br />

and additional research capacity at Ridgefield,<br />

Connecticut.<br />

Net assets<br />

Total assets rose by 13 % in <strong>2005</strong> to EUR 12,018<br />

million. The long-term, secured assets are<br />

covered by <strong>Boehringer</strong> <strong>Ingelheim</strong>’s total equity.<br />

By actively managing our receivables, and<br />

discounting currency effects, we achieved a<br />

development that was disproportionately small<br />

relative to the expansion of our business.


Liquid assets declined by 12 % compared to the<br />

previous year to EUR 1,167 million due to the<br />

transfer of liquid funds into the financial assets.<br />

Group equity increased to EUR 4,825 million<br />

(2004: EUR 4,556 million) because of the favour-<br />

able business development compared to the<br />

previous year.<br />

Long-term disposable capital rose by EUR 281<br />

million compared to the previous year to stand<br />

at EUR 7,052 million, corresponding to 59 %<br />

of the balance sheet total. This year again, this<br />

item covers all intangible and tangible assets,<br />

inventories and liabilities as well as nearly half<br />

of the liquid assets.<br />

The balance sheet and the related balance sheet<br />

ratios round off the altogether favourable picture<br />

that the earnings and financial position have<br />

already drawn.<br />

The combined evaluation of the net assets,<br />

financial position and results of operations<br />

shows that <strong>Boehringer</strong> <strong>Ingelheim</strong> is a soundly<br />

financed and profitable company. In <strong>2005</strong>,<br />

we created a firm basis for our further business<br />

development.<br />

<strong>Report</strong> on post-balance<br />

sheet date events<br />

Since the end of the financial year <strong>2005</strong>, we are<br />

not aware of any events that are of material<br />

significance to the group of companies or could<br />

lead to a reappraisal of its asset, financial or<br />

earnings position.<br />

Risk report<br />

The risk management system of the <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> group has proved effective and the<br />

concept was unchanged in the financial year<br />

<strong>2005</strong>. Business-specific risks are reported<br />

and systematically monitored. Our strategy<br />

and planning processes also form a significant<br />

element in our active risk management.<br />

Hereby, we ensure that all risks known to us are<br />

thoroughly analysed. Following the appropriate<br />

classification, counter-measures from the risk<br />

management system are commenced and their<br />

implementation consistently monitored.<br />

Within the framework of the audit plan approved<br />

by the Board of Managing Directors, internal<br />

auditing conducted routine and extraordinary<br />

audits worldwide during the reporting year.<br />

The focus was the efficiency of structures and<br />

processes, securing assets, adherence to legal<br />

requirements and guidelines, the functionality<br />

of systems and the effectiveness of internal<br />

controls.<br />

Currency and interest rate risks, which arise<br />

because of our group’s international business<br />

relationships, are constantly examined and<br />

limited by appropriate hedging strategies.<br />

Risks in the area of Environmental Health &<br />

Safety (EHS) are minimised preventively by<br />

adherence to our own very high safety standards.<br />

For possible incidents, appropriate emergency<br />

plans are in place that are regularly tested and<br />

trained. Furthermore, <strong>Boehringer</strong> <strong>Ingelheim</strong> has<br />

risk-adjusted insurance coverage in case damage<br />

occurs, despite the high safety standards.<br />

In addition to the general business risks associ-<br />

ated with the industry, we are not currently<br />

aware of any risks that substantially threaten the<br />

further development of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

business.<br />

Group Management <strong>Report</strong>


<strong>Report</strong> on expected<br />

developments<br />

In the financial year <strong>2005</strong>, we updated our<br />

strategy according to our defined planning<br />

processes. The newly defined milestones and<br />

targets of our reworked strategy make us all the<br />

more determined to consistently continue to<br />

pursue the course we have chosen and build<br />

on our strengths.<br />

We will make every effort to launch our new<br />

pharmaceuticals aptivus®, cymbalta® and<br />

spiriva® in additional markets. For sifrol® we<br />

expect registration for the new indication restless<br />

legs syndrome. The spiriva® respimat® Soft<br />

Mist Inhaler (SMI) will also be submitted for<br />

registration. Studies show that the spiriva®<br />

respimat® SMI is preferred by our patients<br />

compared to other dosage forms. It is free of gas<br />

propellant and furthermore allows improved<br />

uptake of the active ingredient via the lungs.<br />

alna® ocas® was successfully launched in three<br />

European countries last year. This involves a<br />

retard tablet of the already launched active<br />

ingredient tamsulosin, in-licensed from Astellas<br />

Pharma. The launch of this dosage form is<br />

planned for additional European markets.<br />

Important studies are entering their decisive<br />

phases and we are confident that they will bring<br />

positive results for our company.<br />

Noteworthy, for example, are the uplift<br />

(spiriva®) und ontarget (micardis®) studies.<br />

At the beginning of 2006, we initiated the<br />

biggest-ever clinical study programme for<br />

thrombo-embolic diseases. In the study pro-<br />

gramme re-volution, 27,000 patients world-<br />

wide are expected to take part. The study will<br />

investigate Dabigatran (rendix) the novel,<br />

orally available thrombin inhibitor researched<br />

and developed by <strong>Boehringer</strong> <strong>Ingelheim</strong> for the<br />

prevention and treatment of thrombo-embolic<br />

conditions.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

For the financial year 2006, we assume that the<br />

vigorous growth rates of <strong>2005</strong> will not be main-<br />

tained. One reason for this is the anticipated<br />

stronger generic competition for mobic® that will<br />

affect our business development during the first<br />

half of the year in some European countries.<br />

The USA will feel the effect in the second half of<br />

the current year.<br />

Based on present planning, we expect net sales<br />

in 2006 of around EUR 10 billion and predict<br />

that <strong>Boehringer</strong> <strong>Ingelheim</strong>’s business develop-<br />

ment will again exceed that of the world pharma-<br />

ceutical market.<br />

In the financial year 2006, we plan to invest<br />

EUR 660 million in fixed assets. The focus for<br />

this expenditure will be in the areas of produc-<br />

tion and research. We want to ensure that our<br />

production can deliver an optimal response to<br />

the demands of new products, at the same time<br />

exploiting opportunities to rationalise.<br />

Adequately equipping research will also make a<br />

significant contribution in 2006 to building<br />

potential for future success.<br />

It is our declared goal to manage <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> long-term as an independent family-<br />

owned company. Our endeavour in this context is<br />

to achieve above-average growth in the market<br />

that will deliver a corresponding increase in the<br />

value of the company. To this end, we will also<br />

continue to keep a close eye on the profitability<br />

of our group. This is for no other reason than our<br />

being highly aware of the risks concerning the<br />

success rate for our research pipeline and that<br />

sustainable financing of the required research<br />

projects can only be ensured in this way.<br />

For reaching this demanding goal, we have in<br />

the financial year <strong>2005</strong> created a very good basis.<br />

We will also continue to use every means to<br />

enable <strong>Boehringer</strong> <strong>Ingelheim</strong> to achieve its<br />

ambitious goals and develop successfully further<br />

as a company. We consider this a duty towards all<br />

stakeholders, especially towards all patients for<br />

whom we also want to provide efficacious and<br />

safe medicines in the future as well.


Consolidated<br />

Financial Statements <strong>2005</strong>


90<br />

Overview of the major consolidated companies<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Distribution<br />

Production<br />

Research<br />

*sole general partner:<br />

<strong>Boehringer</strong> AG<br />

Germany<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Pharma GmbH & Co. KG,<br />

<strong>Ingelheim</strong><br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Vetmedica GmbH, <strong>Ingelheim</strong><br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5<br />

C. H. <strong>Boehringer</strong> Sohn*<br />

Deutschland GmbH<br />

Finland<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Finland Ky, Espoo<br />

Norway<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Norway KS, Asker<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

International GmbH<br />

Austria<br />

Forschungsinstitut für Molekulare<br />

Pathologie Gesellschaft mbH,<br />

Vienna<br />

Belgium<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Coordination Centre S.C.S.,<br />

Brussels<br />

China<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

International Trading (Shanghai)<br />

Co. Ltd., Shanghai<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Shanghai<br />

Pharmaceuticals Co. Ltd.,<br />

Shanghai<br />

Philippines<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> (Phil.) Inc.,<br />

Manila<br />

South Korea<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Korea Ltd.,<br />

Seoul (50 %)<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Vetmedica<br />

Korea Ltd., Seoul


C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH & Co. KG<br />

Argentina<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> S.A.,<br />

Buenos Aires<br />

Australia<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Pty. Ltd.,<br />

North Ryde<br />

Austria<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Austria<br />

GmbH, Vienna<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Pharma Ges.m.b.H., Vienna<br />

Belgium<br />

N.V. <strong>Boehringer</strong> <strong>Ingelheim</strong> S.A.,<br />

Brussels<br />

Brazil<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> do Brasil<br />

Quimica e Farmaceutica Ltda.,<br />

São Paulo<br />

Solana Agro Pecuaria Ltda.,<br />

Arapongas<br />

Canada<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> (Canada)<br />

Ltd., Burlington<br />

Chile<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ltda.,<br />

Santiago de Chile<br />

Colombia<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> S.A., Bogotá<br />

Czech Republic<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> s.r.o.,<br />

Prague<br />

Denmark<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Danmark<br />

A/S, Copenhagen<br />

Ecuador<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> del Ecuador<br />

Cia. Ltda., Quito<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Auslandsbeteiligungs GmbH<br />

France<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

France S.A.S., Paris<br />

Labso Chimie Fine S.A.R.L.,<br />

Blanquefort<br />

Greece<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ellas AE,<br />

Athens<br />

Indonesia<br />

PT <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Indonesia, Jakarta<br />

Italy<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Italia S.p.A.,<br />

Reggello<br />

Bidachem S.p.A.,<br />

Fornovo S. Giovanni<br />

Istituto De Angeli srl,<br />

Reggello<br />

Japan<br />

Nippon <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Co. Ltd., Kawanishi<br />

SSP Co. Ltd., Tokio (57 %)<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Vetmedica Japan Co. Ltd.,<br />

Kawanishi<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Seiyaku Co., Ltd., Yamagata<br />

Netherlands<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> B. V.,<br />

Alkmaar<br />

Poland<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Sp.zo.o.,<br />

Warsaw<br />

Portugal<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Lda.,<br />

Lisbon<br />

Unilfarma Lda., Lisbon<br />

South Africa<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> (Pty.) Ltd.,<br />

Randburg<br />

<strong>Ingelheim</strong> Pharmaceuticals (Pty.)<br />

Ltd., Randburg<br />

Spain<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> España S.A.,<br />

Barcelona<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> S.A.,<br />

Barcelona<br />

Europharma S.A., Barcelona<br />

Laboratorios Fher S.A., Barcelona<br />

Sweden<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> AB,<br />

Stockholm<br />

Switzerland<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

(Schweiz) GmbH, Basel<br />

Pharmaton S.A., Lugano<br />

Taiwan<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Taiwan Ltd.,<br />

Taipei<br />

Thailand<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> (Thai) Ltd.,<br />

Bangkok<br />

Turkey<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ilac<br />

Ticaret A.S., Istanbul<br />

United Kingdom<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ltd.,<br />

Bracknell<br />

Venezuela<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> C.A.,<br />

Caracas<br />

Pharma Investment Ltd.,<br />

Burlington, Canada<br />

Mexico<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Promeco S.A. de C.V., Mexico City<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Vetmedica<br />

S.A. de C.V., Guadalajara<br />

USA<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Corp.,<br />

Ridgefield, Connecticut<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Pharmaceuticals, Inc.,<br />

Ridgefield, Connecticut<br />

Ben Venue Laboratories, Inc.,<br />

Bedford, Ohio<br />

Roxane Laboratories, Inc.,<br />

Columbus, Ohio<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Vetmedica, Inc.,<br />

St. Joseph, Missouri<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Roxane, Inc., Columbus, Ohio<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Chemicals, Inc.,<br />

Petersburg, Virginia<br />

Consolidated Financial Statements <strong>2005</strong><br />

91


92<br />

C. H. <strong>Boehringer</strong> Sohn, <strong>Ingelheim</strong><br />

Consolidated balance sheet<br />

Assets (in millions of EUR) Notes 1) 31.12.<strong>2005</strong> 31.12.2004<br />

Intangible assets (3.1) 233 267<br />

Tangible assets (3.2) 2,900 2,712<br />

Financial assets (3.3) 3,396 2,756<br />

Fixed assets 6,529 5,735<br />

Inventories (3.4) 1,229 1,085<br />

Accounts receivable (3.5) 2,143 1,814<br />

Securities 80 1<br />

Cash and cash equivalents 1,167 1,332<br />

Current assets 4,619 4,232<br />

Deferred taxes 821 619<br />

Deferred charges and prepaid expenses 49 44<br />

Total assets 12,018 10,630<br />

Liabilities and equity (in millions of EUR) Notes 1) 31.12.<strong>2005</strong> 31.12.2004<br />

Shareholders’ capital 178 178<br />

Group reserves 3,001 3,465<br />

Balance sheet currency conversion difference –61 –168<br />

Net income 1,491 888<br />

Equity 4,609 4,363<br />

Minority interests 216 193<br />

Group equity 4,825 4,556<br />

Provisions (3.6) 4,754 3,979<br />

Accounts payable (3.7) 2,174 1,886<br />

Liabilities 6,928 5,865<br />

Deferred taxes 204 193<br />

Deferred charges 61 16<br />

Total liabilities and equity 12,018 10,630<br />

1) For explanation, see relevant section in the Notes to the Consolidated Financial Statements.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


C. H. <strong>Boehringer</strong> Sohn, <strong>Ingelheim</strong><br />

Consolidated profit and loss statement<br />

(in millions of EUR) Notes 1) <strong>2005</strong> 2004<br />

Net sales (4.1) 9,535 8,157<br />

Changes in inventories 175 91<br />

Other internal work performed and capitalised 3 3<br />

Other operating income 598 483<br />

Total revenues 10,311 8,734<br />

Material costs (4.2) –1,613 –1,289<br />

Personnel costs (4.3) –2,671 –2,443<br />

Amortisation of intangible and depreciation of tangible assets (4.4) –531 –471<br />

Other operating expenses (4.5) –3,573 –3,159<br />

Operating income 1,923 1,372<br />

Financial income (4.6) –35 –15<br />

Holding income (4.7) 0 2<br />

Income before taxes 1,888 1,359<br />

Taxes 2) (4.8) –374 –451<br />

Income after taxes 1,514 908<br />

Third-party share –23 –20<br />

Net income (4.9) 1,491 888<br />

1) For explanation, see relevant section in the Notes to the Consolidated Financial Statements.<br />

2) Due to legal requirements the disclosure of the shareholders’ personal taxes arising from<br />

consolidated business activities as tax expenses is not allowed. These taxes are shown as<br />

withdrawels from the accrued group capital.<br />

Consolidated Financial Statements <strong>2005</strong><br />

93


94<br />

C. H. <strong>Boehringer</strong> Sohn, <strong>Ingelheim</strong><br />

Cash flow statement<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Income after taxes 1,514 908<br />

Write-downs/write-ups on fixed assets 1) 529 467<br />

Change in provisions for pensions 26 55<br />

Cash flow 2,069 1,430<br />

Change in other provisions 561 256<br />

Other non-cash income and expenses 43 –17<br />

Gain/loss on disposals of fixed assets –4 3<br />

Increase of inventories –90 –110<br />

Increase of accounts receivable and other assets not related to<br />

investing or financing activities –385 –20<br />

Increase/decrease of trade accounts payable and other liabilities<br />

not related to investing or financing activities 196 –123<br />

Cash flow from operating activities 2,390 1,419<br />

Investments in intangible assets –57 –115<br />

Investments in property, plant and equipment –532 –450<br />

Investments in non-current financial assets 1) –6 –11<br />

Proceeds from disposals of intangible assets 2 0<br />

Proceeds from disposals of property, plant and equipment 43 50<br />

Proceeds from disposals of non-current financial assets 1) 21 16<br />

Cash flow from investing activities –529 –510<br />

Cash payments to shareholders and minority shareholders –1,360 –295<br />

Cash proceeds from borrowings/repayments of loans 26 –59<br />

Cash flow from financing activities –1,334 –354<br />

Change in liquid funds from cash relevant transactions 527 555<br />

Changes in liquid funds due to changes in scope of consolidation 0 0<br />

Changes in liquid funds due to exchange rate movements 43 –56<br />

Securities and liquid funds 2) as of 1. 1. 4,015 3,516<br />

Securities and liquid funds 2) as of 31. 12. 4,585 4,015<br />

1) excl. fixed-asset securities<br />

2) liquid funds, securities within fixed and current assets<br />

(+) = source of funds, (–) = use of funds<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


C. H. <strong>Boehringer</strong> Sohn, <strong>Ingelheim</strong><br />

Statement of changes in group equity<br />

(in millions of EUR)<br />

Shareholders’<br />

capital 1)<br />

Accrued<br />

group<br />

capital<br />

of which<br />

currency<br />

effects<br />

Group Equity<br />

Equity<br />

Minority<br />

interests<br />

of which<br />

currency<br />

effects<br />

Balance as of 31. 12. 2003 178 3,668 –84 3,846 188 –22 4,034<br />

Contributions 0 0 0 0 0 0 0<br />

Withdrawals 0 –286 0 –286 0 0 –286<br />

Net income 0 888 0 888 20 0 908<br />

Change of scope of consolidation 0 0 0 0 –4 0 –4<br />

Other changes 0 –85 –84 –85 –11 –7 –96<br />

Balance as of 31. 12. 2004 178 4,185 –168 4,363 193 –29 4,556<br />

Contributions 0 0 0 0 0 0 0<br />

Withdrawals 0 –1,352 0 –1,352 0 0 –1,352<br />

Net income 0 1,491 0 1,491 23 0 1,514<br />

Change of scope of consolidation 0 0 0 0 7 0 7<br />

Other changes 0 107 107 107 –7 2 100<br />

Balance as of 31. 12. <strong>2005</strong> 178 4,431 –61 4,609 216 –27 4,825<br />

1) The shareholders’ capital consists of the equity of C. H. <strong>Boehringer</strong> Sohn and C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung<br />

GmbH & Co. KG. The balance as of 31.12. <strong>2005</strong> consists only of capital of the limited partners. The shareholders’ personal taxes<br />

arising from consolidated business activities are shown as withdrawals from the accrued group capital.<br />

Group<br />

equity<br />

Consolidated Financial Statements <strong>2005</strong> 95


96<br />

C. H. <strong>Boehringer</strong> Sohn, <strong>Ingelheim</strong><br />

Notes to the consolidated financial statements <strong>2005</strong><br />

1 Principles and methods<br />

1.1 General principles<br />

The consolidated financial statements of <strong>Boehringer</strong> <strong>Ingelheim</strong> for the fiscal year <strong>2005</strong> have been<br />

prepared pursuant to section 264a German Commercial Code (HGB) by applying the group accounting<br />

regulations of section 290 to 314 HGB.<br />

In accordance with section 297, paragraph 1 HGB, the consolidated financial statements are composed<br />

of the consolidated balance sheet, the consolidated profit and loss statement, notes to the consolidated<br />

financial statement, the consolidated cash flow statement and the statement on changes in equity.<br />

1.2 Companies included in the consolidation<br />

The ultimate parent of boehringer ingelheim is c. h. boehringer sohn. <strong>Boehringer</strong> AG is the sole<br />

unlimited managing partner of this company.<br />

Besides c. h. boehringer sohn there is c. h. boehringer sohn grundstücksverwaltung GmbH<br />

& Co. KG whose unlimited partner is under the unified management of c. h. boehringer sohn.<br />

boehringer ingelheim consists of 143 affiliated companies in and outside Germany. In addition to<br />

c. h. boehringer sohn and c. h. boehringer sohn grundstücksverwaltung GmbH & Co. KG,<br />

a further 109 companies in which c. h. boehringer sohn holds directly or indirectly the majority of<br />

voting shares are included in the consolidated financial statements. One company, hitherto included<br />

on a proportional consolidation basis, has since fiscal <strong>2005</strong> been wholly consolidated.<br />

30 companies were not consolidated in the reporting year, as the net assets, financial position and<br />

results of operations of these companies were insignificant to <strong>Boehringer</strong> <strong>Ingelheim</strong>. Combined they<br />

represent less than 1% of the Group’s net sales, equity and net profit. A further two companies are<br />

subject to bylaws containing enduring restrictions.<br />

Compared to the previous year, the total number of affiliated companies was reduced by one. In the<br />

past year, three companies established, two companies were sold and a further two companies were<br />

dissolved due to mergers. Two existing subsidiaries hitherto not included due to insignificance were<br />

taken up in the consolidation. In this context, one company was no longer consolidated as it was<br />

below the materiality threshold.<br />

A separate statement of interests held by <strong>Boehringer</strong> <strong>Ingelheim</strong> will be filed with the Register of<br />

Companies of the District Court in Mainz.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


The following subsidiaries were exempted from the reporting and disclosure obligations in accordance<br />

with section 264, paragraph 4 HGB in conjunction with section 264, paragraph 3 HGB:<br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> International GmbH, <strong>Ingelheim</strong><br />

• Dr. Karl Thomae GmbH, Biberach<br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Deutschland GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Vetmedica GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Secura Versicherungsvermittlungs GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Grundstücks-GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Finanzierungs GmbH, <strong>Ingelheim</strong>.<br />

Exempted from reporting and disclose obligations of annual financial statements according to HGB<br />

regulations for joint stock companies under section 264b HGB are:<br />

• C.H. <strong>Boehringer</strong> Sohn, <strong>Ingelheim</strong><br />

• C.H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH & Co. KG, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Pharma GmbH & Co. KG, <strong>Ingelheim</strong>.<br />

1.3 Consolidation methods<br />

For inventories, accounts receivable and payable, and the income and expense items, business<br />

transactions between the companies consolidated were eliminated as part of the debt consolidation,<br />

according to section 303 HGB, the elimination of inter-company profits according to section 304 HGB,<br />

and the income and expense consolidation according to section 305 HGB.<br />

The purchase method of accounting was used for the capital consolidation of those subsidiaries that<br />

were included for the first time in the consolidated financial statements. First-time consolidation takes<br />

place at the time of the respective company becoming a subsidiary.<br />

The goodwill of two major companies wholly acquired in 1997 is being amortised according to plan<br />

over 10 years.<br />

Credit balances from capital consolidation primarily represent retained earnings during group mem-<br />

bership; they therefore have the characteristics of equity and are included in group reserves. Negative<br />

goodwill arising from the first-time consolidation of a subsidiary was further amortised in the fiscal<br />

year in accordance with section 309, paragraph 2, clause 1 HGB to the amount of the share of the<br />

losses (EUR 0.6 million).<br />

Consolidated Financial Statements <strong>2005</strong> 97


98<br />

1.4 Currency conversions<br />

The financial statements prepared in foreign currencies were translated into euros, the functional<br />

currency of the group parent company, C. H. <strong>Boehringer</strong> Sohn, according to the year-end method.<br />

All assets and liabilities have been converted at the year-end rate. The profit and loss statement and,<br />

consequently, net income, were converted at the average annual rate for the reporting year.<br />

Translation differences due to the conversion of foreign currencies are shown as a balancing item in<br />

the equity without impact on income.<br />

Inflation effects in high inflation countries were eliminated by separate hard currency financial<br />

statements (in US dollars or euros) drawn up by the respective local subsidiaries.<br />

The most important currencies for <strong>Boehringer</strong> <strong>Ingelheim</strong> reflect the following changes in the reporting<br />

year (base 1 euro):<br />

year-end rate average annual rate<br />

31.12.<strong>2005</strong> 31.12.2004 <strong>2005</strong> 2004<br />

US dollar 1.18 1.36 1.24 1.24<br />

Japanese yen 138.90 139.83 136.87 134.40<br />

Pound sterling 0.69 0.71 0.68 0.68<br />

Canadian dollar 1.37 1.64 1.51 1.61<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


2 Accounting and evaluation methods<br />

2.1 Fixed assets<br />

Intangible and tangible assets are shown at purchase or manufacturing cost, net of regular straight-<br />

line depreciation, according to the technical and economic situation. The following periods of use<br />

were applied:<br />

Buildings 20 years<br />

Technical facilities and machinery 10 years<br />

Other facilities, operating and business equipment 3 to 10 years<br />

Diverging from the declining-balance method of depreciation applied in the individual financial<br />

statements of C. H. <strong>Boehringer</strong> Sohn the straight-line method of depreciation is used in the<br />

consolidated financial statements for the purpose of uniformity in group-wide measurement.<br />

Anticipated long-term losses in the value of investments were accounted for by unscheduled write-<br />

offs. Appropriate portions of material and production overheads were taken into consideration for the<br />

determination of manufacturing costs. Fully amortised goodwill that is more than five years old, or is<br />

materially insignificant, is shown under disposals.<br />

All capitalised intangible assets have a limited useful life.<br />

The financial assets were valued at the lower of either purchase cost or fair market value.<br />

2.2 Current assets<br />

Inventories were valued at purchase or manufacturing cost using the weighted average cost<br />

flow method as the group-wide uniform method of measurement, whereas for tax purposes,<br />

C. H. <strong>Boehringer</strong> Sohn applies the LIFO Method in its individual financial statements. Appropriate<br />

portions of material and production overheads were taken into consideration for the determination<br />

of the manufacturing costs. Necessary reductions were made for inventory risks.<br />

Accounts receivable were stated at their nominal value net of any individual valuation allowances<br />

required. The general credit risk was covered by a general valuation allowance for bad debt.<br />

Other assets were stated at the lower of either purchase cost or fair market value.<br />

Foreign currency items were recorded at the year-end rate of exchange.<br />

2.3 Group reserves<br />

Group reserves include the retained earnings of the consolidated subsidiaries from prior years,<br />

consolidation entries that affect earnings, where they relate to prior years, and credit balances arising<br />

from capital consolidation.<br />

Consolidated Financial Statements <strong>2005</strong> 99


100<br />

2.4 Provisions<br />

The provisions include required amounts to cover any perceptible obligations and risks, including<br />

provisions for contingent losses from pending contracts. The valuation is made at the amount that is<br />

necessary on the basis of reasonable commercial judgement. Provisions with an implied interest were<br />

shown on a discounted basis (e. g. certain personnel provisions).<br />

2.5 Liabilities<br />

Liabilities are shown in the balance sheet at the repayable amount. Liabilities in foreign currencies<br />

were recorded at the year-end rate of exchange.<br />

2.6 Deferred taxes<br />

The deferred tax assets and liabilities represent the tax deferral in accordance with section 274 and<br />

306 HGB, which arise because of temporary differences between the tax balance sheets of the individual<br />

companies and the consolidated balance sheet (including differences arising from adjustments<br />

for conformity in group-wide reporting and evaluation as well as consolidation measures).<br />

Quasi-permanent differences between the consolidated balance sheet and the tax balance sheet are<br />

treated as temporary differences in accordance with German Accounting Standard 10 (GAS 10).<br />

Deferred tax assets and liabilities are offset in accordance with GAS 10.<br />

In the individual balance sheets (i.e. the financial statements II) the consolidated companies made use<br />

of their option to capitalise assets to the amount of probable tax savings in the following years in<br />

accordance with section 274, paragraph 2 HGB. The calculation of deferred taxes is based on the tax<br />

rates that are expected to be valid at the time of their realisation.<br />

The capitalisation of deferred tax assets on tax loss carryforwards is carried out if it is sufficiently<br />

probable that the tax benefits can be realised.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


3 Notes to the consolidated balance sheet<br />

3.1 Intangible assets<br />

(in millions of EUR)<br />

Procurement/manufacturing costs<br />

Balance as of 1. 1. 2004<br />

Concessions/<br />

Similar rights<br />

Goodwill Advance<br />

payments<br />

Total<br />

432 807 3 1,242<br />

Currency conversion difference –6 –1 0 –7<br />

Additions due to first consolidation 5 0 0 5<br />

Additions 98 10 3 111<br />

Disposals –9 0 0 –9<br />

Reclassifications 6 0 –3 3<br />

Balance as of 31. 12. 2004 526 816 3 1,345<br />

Currency conversion difference 11 3 0 14<br />

Additions due to first consolidation 0 0 0 0<br />

Additions 50 0 7 57<br />

Disposals –18 –13 0 –31<br />

Reclassifications 4 0 –4 0<br />

Balance as of 31. 12. <strong>2005</strong> 573 806 6 1,385<br />

Accumulated depreciations<br />

Balance as of 1. 1. 2004 336<br />

664<br />

0<br />

1,000<br />

Currency conversion difference –6 –1 0 –7<br />

Additions due to first consolidation 1 0 0 1<br />

Additions 36 58 0 94<br />

Value adjustments 0 0 0 0<br />

Disposals –9 0 0 –9<br />

Reclassifications –1 0 0 –1<br />

Balance as of 31. 12. 2004 357 721 0 1,078<br />

Currency conversion difference 9 2 0 11<br />

Additions due to first consolidation 0 0 0 0<br />

Additions 44 48 0 92<br />

Value adjustments 0 0 0 0<br />

Disposals –16 –13 0 –29<br />

Reclassifications 0 0 0 0<br />

Balance as of 31. 12. <strong>2005</strong> 394 758 0 1,152<br />

Book value as of 31. 12. 2004 169 95 3 267<br />

Book value as of 31. 12. <strong>2005</strong> 179 48 6 233<br />

Consolidated Financial Statements <strong>2005</strong> 101


102<br />

3.2 Tangible assets<br />

(in millions of EUR)<br />

Procurement/manufacturing costs<br />

Property and<br />

plants<br />

Balance as of 1. 1. 2004 2,055<br />

Technical<br />

facilities and<br />

machines<br />

1,900<br />

Other<br />

facilities/<br />

operating<br />

equipment<br />

1,113<br />

Advance<br />

payments/<br />

construction<br />

in progress<br />

383<br />

Total<br />

5,451<br />

Currency conversion difference –60 –47 –30 –7 –144<br />

Additions due to first consolidation 1 21 11 4 37<br />

Additions 30 59 134 204 427<br />

Disposals –45 –53 –79 –5 –182<br />

Reclassifications 41 102 163 –309 –3<br />

Balance as of 31. 12. 2004 2,022 1,982 1,312 270 5,586<br />

Currency conversion difference 96 82 61 15 254<br />

Additions due to first consolidation 3 2 2 0 7<br />

Additions 37 77 140 278 532<br />

Disposals –31 –42 –89 –8 –170<br />

Reclassifications 56 98 49 –203 0<br />

Balance as of 31. 12. <strong>2005</strong> 2,183 2,199 1,475 352 6,209<br />

Accumulated depreciations<br />

Balance as of 1. 1. 2004 890 942 852 0 2,684<br />

Currency conversion difference –25 –24 –20 0 –69<br />

Additions due to first consolidation 0 7 7 0 14<br />

Additions 81 151 145 0 377<br />

Value adjustments 0 0 –4 0 –4<br />

Disposals –12 –48 –69 0 –129<br />

Reclassifications –1 2 0 0 1<br />

Balance as of 31. 12. 2004 933 1,030 911 0 2,874<br />

Currency conversion difference 42 43 40 0 125<br />

Additions due to first consolidation 2 1 2 0 5<br />

Additions 125 163 151 0 439<br />

Value adjustments 0 –2 0 0 –2<br />

Disposals –13 –37 –82 0 –132<br />

Reclassifications 0 0 0 0 0<br />

Balance as of 31. 12. <strong>2005</strong> 1,089 1,198 1,022 0 3,309<br />

Book value as of 31. 12. 2004 1,089 952 401 270 2,712<br />

Book value as of 31. 12. <strong>2005</strong> 1,094 1,001 453 352 2,900<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


3.3 Financial assets<br />

(in millions of EUR)<br />

Procurement/manufacturing costs<br />

Investments<br />

in affilated<br />

companies<br />

Loans<br />

to affiliated<br />

companies<br />

Related<br />

companies<br />

Loans to<br />

related<br />

companies<br />

Investment<br />

securities<br />

Other loans<br />

Balance as of 1. 1. 2004 21 6 10 6 2,391 49 2,483<br />

Currency conversion difference –1 0 0 0 –2 0 –3<br />

Additions due to first consolidation 0 0 0 0 0 0 0<br />

Additions 1 2 0 0 679 8 690<br />

Disposals 0 0 0 0 –382 –16 –398<br />

Reclassifications 0 0 0 0 0 0 0<br />

Balance as of 31. 12. 2004 21 8 10 6 2,686 41 2,772<br />

Currency conversion difference 0 0 0 0 3 0 3<br />

Additions due to first consolidation 0 0 0 0 0 0 0<br />

Additions 0 1 0 0 674 5 680<br />

Disposals –1 0 0 0 –7 –21 –29<br />

Reclassifications 0 0 0 0 0 0 0<br />

Balance as of 31. 12. <strong>2005</strong> 20 9 10 6 3,356 25 3,426<br />

Accumulated depreciations<br />

Balance as of 1. 1. 2004 3 0 3 3 9 3 21<br />

Currency conversion difference 0 0 0 0 1 0 1<br />

Additions due to first consolidation 0 0 0 0 0 0 0<br />

Additions 0 0 0 0 0 0 0<br />

Value adjustments 0 0 0 0 –1 0 –1<br />

Disposals 0 0 0 0 –5 0 –5<br />

Reclassifications 0 0 0 0 0 0 0<br />

Balance as of 31. 12. 2004 3 0 3 3 4 3 16<br />

Currency conversion difference 0 0 0 0 0 0 0<br />

Additions due to first consolidation 0 0 0 0 0 0 0<br />

Additions 0 0 0 0 14 0 14<br />

Value adjustments 0 0 0 0 0 0 0<br />

Disposals 0 0 0 0 0 0 0<br />

Reclassifications 0 0 0 0 0 0 0<br />

Balance as of 31. 12. <strong>2005</strong> 3 0 3 3 18 3 30<br />

Book value as of 31. 12. 2004 18 8 7 3 2,682 38 2,756<br />

Book value as of 31. 12. <strong>2005</strong> 17 9 7 3 3,338 22 3,396<br />

The item “other loans” includes no loans to the shareholders (2004: EUR 12 million).<br />

Total<br />

Consolidated Financial Statements <strong>2005</strong> 103


104<br />

3.4 Inventories<br />

(in millions of EUR) 31.12.<strong>2005</strong> 31.12.2004<br />

Raw materials and supplies 225 217<br />

Unfinished products 537 444<br />

Finished products and goods for resale 460 416<br />

Advance payments to suppliers 7 8<br />

3.5 Accounts receivable<br />

1,229 1,085<br />

Residual term<br />

Residual term<br />

(in millions of EUR) 31.12.<strong>2005</strong> over 1 year 31.12.2004 over 1 year<br />

Trade accounts receivable 1,854 71 1,543 6<br />

Receivables from affiliated companies 2 0 4 0<br />

Receivables from related companies 5 0 6 0<br />

Other assets 282 12 261 11<br />

2,143 83 1,814 17<br />

The item “other assets” contains no receivables from the shareholders (2004: EUR 2 million).<br />

3.6 Provisions<br />

(in millions of EUR) 31.12.<strong>2005</strong> 31.12.2004<br />

Pension provisions 2,035 1,983<br />

Tax provisions 548 380<br />

Other provisions 2,171 1,616<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5<br />

4,754 3,979


Pension provisions<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s pension schemes are based on various defined contribution plans as well as<br />

defined benefit plans.<br />

Pension obligations arising from direct or indirect defined benefit plans are determined on the basis of<br />

the projected unit credit method, taking future salary and pension increases into consideration.<br />

The actuarial calculation of the pension obligation from defined benefit plans is based on country-<br />

specific biometric data (in Germany the “generation tables” issued in <strong>2005</strong> by Professor Klaus Heubeck<br />

were used) and actuarial assumptions. The main countries applied the following parameters:<br />

Germany USA Japan<br />

Parameter (in %) <strong>2005</strong> 2004 <strong>2005</strong> 2004 <strong>2005</strong> 2004<br />

Discount rate 4.1 5.0 5.5 5.75 1.5 1.5<br />

Expected return on assets 6.0 6.0 8.0 8.5 2.2–3.0 3.0<br />

Salary increase 2.5 3.0 5.5 5.5 2.4–4.7 3.9<br />

Pension increase 1.7 1.7 3.0 3.0 0.0 0.0<br />

At the balance sheet date, the present value of the expected pension obligation was netted with the fair<br />

value of the respective pension plan assets (funding status).<br />

Based on this, pension provisions are determined by deducting unrealised transition amounts as well<br />

as unrealised actuarial gains and losses from the funding status. Based on the “corridor approach”,<br />

unrealised gains and losses are amortised over the expected average service periods of the respective<br />

active employees. At balance sheet date, pension commitments (including total unrealised transition<br />

amounts and actuarial gains and losses) of EUR 698 million (2004: EUR 343 million) were not recog-<br />

nised as part of pension provisions.<br />

In conjunction with defined contribution plans, group companies paid contributions to state or<br />

private insurers on the basis of legal or contractual regulations. On payment of the contributions the<br />

companies no longer have any performance obligations. Contributions are recognised as personnel<br />

costs upon payment.<br />

Consolidated Financial Statements <strong>2005</strong> 105


106<br />

3.7 Accounts payable<br />

Residual term Residual term Residual term<br />

Residual term<br />

(in millions of EUR) less than 1 year 1–5 years over 5 years 31.12.<strong>2005</strong> 31.12.2004 less than 1 year<br />

Bank loans 216 221 43 480 441 190<br />

Other accounts payable 1,549 – 145 1,694 1,445 1,271<br />

of which:<br />

– Trade accounts payable 775 – – 775 516 516<br />

– Advance payments 45 – – 45 66 66<br />

– Notes payable 14 – – 14 17 17<br />

– Accounts payable to<br />

affiliated companies 8 – – 8 7 7<br />

– Accounts payable to<br />

related companies 1 – – 1 6 6<br />

– Other liabilities (*) 706 – 145 851 833 659<br />

(*) of which:<br />

1,765 221 188 2,174 1,886 1,461<br />

– taxes 24 35<br />

– social security contributions 22 17<br />

There were no liabilities secured by mortgages or similar rights on the balance sheet date consistent<br />

with the previous year.<br />

Liabilities due to shareholders amounted to EUR 215 million (2004: EUR 190 million) at year-end.<br />

These were disclosed under “other liabilities”. They stem from the shareholders’ personal taxes arising<br />

from consolidated business activities.<br />

Payments received from the ABS partners in conjunction with the ABS transaction are shown as<br />

short-term loans under “other liabilities” until the underlying accounts receivable are paid off.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


4 Notes to the consolidated profit and loss statement<br />

The consolidated profit and loss statement is presented in line with the total cost method.<br />

4.1 Net sales<br />

by business and business segment (in millions of EUR) <strong>2005</strong> 2004<br />

Human Pharmaceuticals 9,174 7,822<br />

of which: Prescription Medicines 7,247 6,183<br />

Consumer Health Care 1,052 970<br />

Industrial Customer 847 654<br />

Other sales 28 15<br />

Animal Health 361 335<br />

9,535 8,157<br />

by geographic region (in millions of EUR) <strong>2005</strong> 2004<br />

Europe 3,117 2,622<br />

of which: Germany 816 656<br />

Americas 4,559 3,905<br />

of which: USA/Canada/Mexico 4,219 3,625<br />

Asia, Australasia, Africa 1,859 1,630<br />

of which: Japan 1,232 1,142<br />

4.2 Material costs<br />

9,535 8,157<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Costs of raw material, supplies and goods for resale 1,351 1,076<br />

Expenditure on services 262 213<br />

4.3 Personnel costs<br />

1,613 1,289<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Salaries and wages 2,087 1,913<br />

Social benefits and retirement benefits 584 530<br />

of which: retirement benefits 155 154<br />

2,671 2,443<br />

The interest component with respect to the increase in pensions and similar obligations is included in<br />

financial income rather than in personnel costs and is, therefore, not included in the operating result<br />

of the company.<br />

Consolidated Financial Statements <strong>2005</strong> 107


108<br />

Average headcount<br />

<strong>2005</strong> 2004<br />

Production 12,044 10,614<br />

Administration 4,742 5,670<br />

Marketing and Sales 14,257 13,151<br />

Research and Development 5,678 5,471<br />

Apprentices 685 623<br />

This includes:<br />

Average number of employees in joint ventures,<br />

proportionately consolidated<br />

37,406 35,529<br />

Regarding <strong>2005</strong>, transfers from “administration” to “production” caused by changes in organisational<br />

structure have to be considered.<br />

4.4 Amortisation of intangible and depreciation of tangible assets<br />

The amortisation of intangible assets and depreciation of tangible assets includes unscheduled write-<br />

offs of EUR 2 million (2004: EUR 1 million).<br />

4.5 Other operating expenses<br />

Other operating expenses include third-party services in research, development, medicine, and<br />

marketing, in addition to administration costs, fees, contributions, commissions, rents, freight costs,<br />

and expenses for third-party repairs as well as expenses incurred by restructuring measures.<br />

4.6 Financial income<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Interest expense relating to pensions and similar obligations –108 –111<br />

Other interest expense and similar expenditure –70 –49<br />

Interest expense and similar expenditure –178 –160<br />

Amortisation of other financial assets and short-term investments –14 –4<br />

Income from other investment securities and from long-term loans 110 103<br />

Other interest income and similar proceeds 47 46<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5<br />

0<br />

245<br />

–35 –15


4.7 Holding income<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Gains from the sale of investments 0 2<br />

4.8 Taxes<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Income taxes 504 360<br />

Deferred taxes –154 72<br />

Other taxes 24 19<br />

374 451<br />

By concluding profit transfer agreements, significant German corporations have since 1 January<br />

2004 belonged to the trade and corporate taxation group of integrated companies of the parent<br />

company C. H. <strong>Boehringer</strong> Sohn. As income tax levied on operating income of the shareholders of<br />

C. H. <strong>Boehringer</strong> Sohn may not be shown in the consolidated profit and loss statement, only the trade<br />

tax of the relevant companies is shown as a tax expense.<br />

As a consequence of the conclusion of profit transfer agreements in the previous year, the deferred<br />

taxes of these corporations as of 31 December 2004 were no longer calculated at a profit tax rate of<br />

37.6 % but at a trade tax rate of around 15 %. In 2004, this change led to a one-off deferred tax expense<br />

of EUR 121 million.<br />

In the effective tax-rate reconciliation an expected tax expense for <strong>Boehringer</strong> <strong>Ingelheim</strong> is calculated<br />

on a profit tax rate for corporations (corporate tax, solidarity levy and trade tax). As in the profit and<br />

loss statement tax expenses related to the income tax for partnerships and integrated companies of<br />

C. H. <strong>Boehringer</strong> Sohn are limited to showing trade tax, the expected tax expense in the effective<br />

tax-rate reconciliation is in this respect adjusted for fictive current and deferred corporate tax expenses<br />

in order to link to the profit tax expense shown in the profit and loss statement. This elimination of<br />

fictive corporate tax (including the solidarity levy) is shown in the items Fictive Corporation.<br />

Consolidated Financial Statements <strong>2005</strong> 109


110<br />

The expected tax expense derived by using a fictive tax rate of 37.6 % (average tax rate for a German<br />

corporation at a municipal trade tax levy rate of 360 %) can be related to the actual tax expense as<br />

follows:<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Income before taxes minus other taxes 1,864 1,340<br />

Expected tax expense (current and deferred) 701 37.6 % 504 37.6 %<br />

Decrease/increase in expected tax by<br />

– Fictive Corporation current taxes<br />

–378<br />

–20.3 %<br />

–191<br />

–14.3 %<br />

– Fictive Corporation deferred taxes 49 2.6 % 18 1.3 %<br />

– One-off effect of profit transfer agreements 0 0.0 % 121 9.0 %<br />

– Local tax rate divergences –34 –1.8 % –41 –3.1 %<br />

– Non-taxable income –6 –0.3 % –6 –0.4 %<br />

– Non-tax-deductible expense 34 1.8 % 36 2.7 %<br />

– Taxes related to prior periods –35 –1.9 % –19 –1.4 %<br />

– Amortisation of goodwill 18 1.0 % 21 1.6 %<br />

– Changes in applicable tax rates 7 0.4 % 9 0.7 %<br />

– Withholding taxes not subject to tax credits 20 1.1 % 18 1.3 %<br />

– Tax credits for research activities –19 –1.0 % –36 –2.7 %<br />

– Other effects –7 –0.4 % –2 –0.1 %<br />

Actual tax expense (current and deferred) 350 18.8 % 432 32.2 %<br />

The deferred taxes can be attributed to the following balance sheet items:<br />

31.12.<strong>2005</strong> 31.12.2004<br />

(in millions of EUR) Assets Liabilities Assets Liabilities<br />

Intangible assets 7 2 7 1<br />

Tangible assets 32 132 18 125<br />

Financial assets 15 24 16 23<br />

Inventories 104 19 88 21<br />

Receivables 38 9 22 7<br />

Provisions 600 16 448 9<br />

Liabilities 14 2 15 7<br />

Tax loss carryforwards and tax credits 11 0 5 0<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5<br />

821 204 619 193


Other mandatory disclosures according to GAS 10.39:<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Deferred tax expense from changes in law 0 –4<br />

Deferred tax expense relating to the write-off of deferred tax assets<br />

in fiscal year<br />

The absence of changes in accounting and evaluation methods results, as in the previous year,<br />

in no deferred tax income.<br />

Potential corporate tax reductions in accordance with section 37, paragraph 2 corporation tax law<br />

(KStG) amount to EUR 22 million.<br />

The valuation allowances relating to deferred tax assets amount to EUR 19 million.<br />

Unused tax loss carryforwards, on which no deferred tax assets are recognised in the balance sheet,<br />

amount to EUR 51 million at year-end, EUR 30 million of which can be carried forward without<br />

time limits. The remainder expire after five years (EUR 11 million) and 10 years (EUR 10 million)<br />

respectively.<br />

4.9 Net income<br />

Net income for the year <strong>2005</strong> includes operating income unrelated to the accounting period<br />

(mainly the release of other provisions) amounting to EUR 81 million (2004: EUR 92 million).<br />

Operating expenditure unrelated to the accounting period (mainly increase of other provisions)<br />

amounted to EUR 27 million (2004: EUR 47 million).<br />

5<br />

Consolidated Financial Statements <strong>2005</strong> 111<br />

0


112<br />

5 Notes to the cash flow statement<br />

The cash flow statement shows how the total securities and liquid funds (liquid assets and securities in<br />

fixed and current assets) of the <strong>Boehringer</strong> <strong>Ingelheim</strong> Group have changed during the reporting year<br />

through inflow and outflow of cash and cash equivalents.<br />

In accordance with German Accounting Standard No. 2, (GAS 2), Cash Flow Statements, cash flows are<br />

classified by operating, investing or financing activities.<br />

Changes reported by consolidated companies are converted at the average annual rate. Securities and<br />

liquid funds are converted, as shown in the balance sheet, according to the year-end rate method.<br />

The influence of exchange rate changes on securities and liquid assets is provided separately.<br />

6 Other information<br />

6.1 Derivative financial instruments<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is, due to its extensive international structure, highly dependent on the<br />

development of the major world currencies and interest rates. In order to hedge against the risks,<br />

particularly those inherent in supplies and services and financial funding, use is generally made<br />

of foreign exchange forward contracts in the case of currency risks. Regarding interest rate risks,<br />

use is made of interest rate swaps and interest rate options.<br />

The risk positions are recorded, analysed and assessed regularly in a special consolidated financial<br />

report.<br />

The use of derivative financial instruments and the organisational procedure are laid down in internal<br />

guidelines. Trade, processing, documentation, and control are kept strictly separate.<br />

The items are periodically re-evaluated and monitored. Derivative financial instruments are only<br />

agreed on with banks of sound financial standing.<br />

As of 31 December <strong>2005</strong>, the nominal value of all foreign currency and interest rate hedging<br />

transactions amounted to EUR 3,618 million (2004: 2,179 million). The corresponding market values<br />

amounted to EUR -63 million (2004: EUR 85 million).<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5


Derivative financial instruments at year-end were as follows:<br />

Nominal value Market value<br />

(in millions of EUR) 31.12.<strong>2005</strong> 31.12.2004 31.12.<strong>2005</strong> 31.12.2004<br />

Foreign exchange forward contracts 3,355 1,906 –62 86<br />

Interest instruments 263 273 –1 –1<br />

The nominal value is the sum of all purchases and sales. The market value is calculated on the basis of<br />

quoted prices or derived values for derivative instruments.<br />

6.2 Contingent liabilities to the benefit of third parties<br />

(in millions of EUR) 31.12.<strong>2005</strong> 31.12.2004<br />

Liabilities from guarantees, guarantees for bills and cheques,<br />

warranties and provisions of collateral for third-party liabilities<br />

6.3 Other financial obligations<br />

(in millions of EUR) 31.12.<strong>2005</strong> 31.12.2004<br />

To third parties 741 752<br />

At year-end, other financial obligations included capital investments of EUR 552 million (2004:<br />

EUR 593 million). Furthermore EUR 182 million (2004: EUR 146 million) from renting and leasing<br />

contracts are included, of which EUR 87 million concern long-term rent contracts with subsidiaries<br />

not included in the consolidation.<br />

6.4 Research and development expenses<br />

(in millions of EUR) <strong>2005</strong> 2004<br />

Expenditures for Research and Development 1,360 1,232<br />

176<br />

154<br />

Consolidated Financial Statements <strong>2005</strong> 113


114<br />

Auditor’s <strong>Report</strong><br />

We have audited the consolidated financial<br />

statements prepared by C. H. <strong>Boehringer</strong> Sohn,<br />

<strong>Ingelheim</strong> – comprising the balance sheet, the<br />

income statement, the statement of changes in<br />

equity, the cash flow statement and the notes to<br />

the consolidated financial statements – together<br />

with the group management report for the busi-<br />

ness year from 1 January to 31 December <strong>2005</strong>.<br />

The preparation of the consolidated financial<br />

statements and the group management report in<br />

accordance with German commercial law are the<br />

responsibility of the Management Board of the<br />

Managing Corporate Partnership-AG. Our<br />

responsibility is to express an opinion on the<br />

consolidated financial statements and the group<br />

management report based on our audit.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> a n n u a l r e p o r t 2 0 0 5<br />

We conducted our audit of the consolidated<br />

annual financial statements in accordance with<br />

section 317 HGB and the generally accepted<br />

standards for the audit of financial statements<br />

promulgated by the Institut der Wirtschaftsprüfer<br />

in Deutschland (IDW). Those standards require<br />

that we plan and perform the audit such that<br />

misstatements materially affecting the presenta-<br />

tion of the net assets, financial position and<br />

results of operations in the consolidated financial<br />

statements in accordance with German princi-<br />

ples of proper accounting and in the group<br />

management report are detected with reasonable<br />

assurance. Knowledge of the business activities<br />

and the economic and legal environment of the<br />

Company and evaluations of possible misstate-<br />

ments are taken into account in the determina-<br />

tion of audit procedures. The effectiveness of the<br />

accounting-related internal control system and<br />

the evidence supporting the disclosures in the<br />

consolidated financial statements and the group<br />

management report are examined primarily on a<br />

test basis within the framework of the audit.<br />

The audit includes assessing the annual financial<br />

statements of the companies included in consoli-<br />

dation, the determination of the companies to be<br />

included in consolidation, the accounting and<br />

consolidation principles used and significant<br />

estimates made by the Management Board of the<br />

Managing Corporate Partnership-AG, as well as<br />

evaluating the overall presentation of the consoli-<br />

dated financial statements and the group<br />

management report. We believe that our audit<br />

provides a reasonable basis for our opinion.


With the following exception, our audit has not<br />

led to any reservations: contrary to section 314<br />

paragraph 1 number 6 HGB compensation of the<br />

members and former members of the board of<br />

managing directors have not been disclosed.<br />

In our opinion based on the findings of our audit<br />

the consolidated financial statements with the<br />

exception mentioned comply with the legal<br />

requirements. The consolidated financial state-<br />

ments give a true and fair view of the net assets,<br />

financial position and results of operations of<br />

the Group in accordance with German principles<br />

of proper accounting. The group management<br />

report is consistent with the consolidated<br />

financial statements and as a whole provides<br />

a suitable view of the Group’s position and<br />

suitably presents the opportunities and risks of<br />

future development.<br />

Frankfurt am Main, 15 February 2006<br />

PricewaterhouseCoopers<br />

Aktiengesellschaft<br />

Wirtschaftsprüfungsgesellschaft<br />

(E.-W. Frings) (P. Marshall)<br />

Wirtschaftsprüfer Wirtschaftsprüfer<br />

(German Certified (German Certified<br />

Public Accountant) Public Accountant)<br />

Consolidated Financial Statements <strong>2005</strong> 115


116<br />

Glossary<br />

Human Pharmaceuticals<br />

Product name Active ingredient Indication<br />

actilyse® alteplase Fibrinolytic treatment of acute myocardial<br />

infarction, acute massive pulmonary embolism<br />

and ischaemic stroke<br />

aggrenox®<br />

asasantin®<br />

persantin®<br />

alesion®<br />

flurinol®<br />

talerc®<br />

ASA / dipyridamole<br />

extended release<br />

antistax® standardized<br />

red wine leaf extract<br />

AS195®<br />

epinastine Antiallergic agent<br />

Prevention of stroke following a first stroke<br />

or for transient ischaemic attacks<br />

As above and adjunct to coumarin anticoagulants<br />

in the prevention of postoperative thromboembolic<br />

complications of cardiac valve<br />

replacement<br />

Prevention and treatment of symptoms of chronic<br />

venous insufficiency – such as painful swollen,<br />

heavy or tired legs<br />

aptivus® tipranavir Available as capsules for adults – used coadministered<br />

with 200 mg of ritonavir,<br />

is indicated for combination antiretroviral<br />

treatment of HIV­1 infected adult patients with<br />

evidence of viral replication, who are highly<br />

treatment­experienced or have HIV­1 strains<br />

resistant to multiple protease inhibitors<br />

atrovent® ipratropium bromide Bronchodilator for maintenance treatment<br />

of bronchospasm associated with chronic<br />

obstructive pulmonary disease, including chronic<br />

bronchitis, emphysema and asthma<br />

berotec®<br />

dosberotec®<br />

fenoterol a) Symptomatic treatment of acute asthma<br />

attacks<br />

b) Prophylaxis of exercise induced asthma<br />

c) Symptomatic treatment of bronchial asthma<br />

and other conditions with reversible airway<br />

narrowing e.g. chronic obstructive bronchitis.<br />

Concomitant anti­inflammatory therapy should<br />

be considered for patients with bronchial asthma<br />

and steroid responsive chronic obstructive<br />

pulmonary disease (COPD)<br />

bisolvon® bromhexine Mucolytic for the treatment of acute and chronic<br />

bronchopulmonary diseases associated with<br />

impaired formation and transport of mucus<br />

buscopan®<br />

buscapina®<br />

catapresan®<br />

catapres®<br />

catapressan®<br />

atensina®<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

butylscopolamine Treatment of abdominal discomfort and pain due<br />

to intestinal cramps<br />

clonidine All forms of high blood pressure,<br />

unless caused by phaeochromocytoma


Product name Active ingredient Indication<br />

combivent® ipratropium bromide/<br />

salbutamol<br />

cymbalta®<br />

xeristar®<br />

dulcolax® bisacodyl<br />

(tablets, suppositories),<br />

sodium picosulphate<br />

(drops, pearls, tablets)<br />

duovent®<br />

bronchodual®<br />

berodual®<br />

flomax®<br />

alna®<br />

josir®<br />

pradif®<br />

secotex®<br />

urolosin®<br />

flomax® cr<br />

alna® ocas®<br />

pradif® t<br />

urolosin® ocas®<br />

Treatment of bronchospasms associated with<br />

reversible obstructive airways diseases in patients<br />

requiring more than one bronchodilator<br />

duloxetine Major depressive disorder (MDD),<br />

Diabetic peripheral neuropathic pain (DPNP)<br />

fenoterol /<br />

ipratropium bromide<br />

tamsulosin<br />

hydrochloride<br />

tamsulosin<br />

hydrochloride,<br />

Oral Controlled<br />

Absorption System<br />

inflammide® budesonide Bronchial asthma<br />

laxoberal® sodium picosulphate<br />

(drops, pearls and<br />

tablets)<br />

lendormin®<br />

lendorm®<br />

lindormin®<br />

sintonal®<br />

Laxative for the treatment of constipation<br />

Prevention and treatment of symptoms<br />

in asthmic and chronic obstructive pulmonary<br />

disease (COPD) patients with reversible<br />

bronchospasm<br />

Lower urinary tract symptoms (LUTS) associated<br />

with benign prostatic hyperplasia (BPH)<br />

Lower urinary tract symptoms (LUTS) associated<br />

with benign prostatic hyperplasia (BPH)<br />

Laxative for the treatment of constipation<br />

brotizolam Short­term treatment of disorders of initiating<br />

and maintaining sleep<br />

metalyse® tenecteplase Fibrinolytic treatment of acute myocardial<br />

infarction<br />

mexitil®<br />

mexitilen®<br />

micardis®<br />

micardisplus®<br />

micardis® hct<br />

co-micardis®<br />

mexiletine Serious symptomatic ventricular tachycardic<br />

heart rhythm disturbances<br />

telmisartan<br />

telmisartan / hydrochlorothiazide<br />

Treatment of essential hypertension<br />

Glossary 117


118<br />

Product name Active ingredient Indication<br />

mobic®<br />

mobec®<br />

movalis®<br />

movatec®<br />

motens®<br />

caldine®<br />

tens®<br />

midotens®<br />

meloxicam Symptomatic treatment of rheumatic diseases<br />

lacidipine Treatment of essential hypertension<br />

mucoangin® ambroxol hydrochloride Pain relief in acute sore throat<br />

mucosolvan®<br />

motosol®<br />

mucosan®<br />

surbronc®<br />

pharmaton®<br />

pharmaton® capsules<br />

geriavit pharmaton®<br />

pharmaton® caplets<br />

ambroxol Mucolytic treatment of acute and chronic<br />

bronchopulmonary diseases associated with<br />

impaired formation and transport of mucus<br />

standardized ginseng<br />

extract G115®,<br />

vitamins, minerals,<br />

trace elements<br />

To improve physical and mental performance<br />

and well­being<br />

sifrol® pramipexole Symptomatic treatment of idiophathic<br />

Parkinson’s disease<br />

silomat® clobutinol<br />

hydrochloride<br />

Symptomatic treatment of irritable,<br />

non­productive cough<br />

spiriva® tiotropium bromide Maintenance treatment of patients with COPD<br />

(including chronic bronchitis and emphysema),<br />

the maintenance treatment of associated<br />

dyspnoea and for prevention of exacerbations<br />

thomapyrin® ASA, paracetamol,<br />

caffeine<br />

viramune® nevirapine Available as tablets for adults and suspension<br />

for children – for the combination therapy of HIV<br />

infection and for the prevention of<br />

mother­to­child transmission of HIV<br />

yentreve®<br />

ariclaim®<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> A n n u A l R e p o R t 2 0 0 5<br />

Pain<br />

duloxetine Moderate to severe stress urinary<br />

incontinence (SUI) in women


Animal Health<br />

Product name Active ingredient Indication<br />

buscopan®<br />

compositum<br />

N­butyl scopolamonium<br />

bromide + metamizole<br />

enterisol® ileitis attenuated life vaccine<br />

(Lawsonia<br />

intracellularis)<br />

lyophilised<br />

express® attenuated life vaccine<br />

(IBRV, BVDV, PI3V, BRSV)<br />

ingelvac® m.hyo inactivated<br />

Mycoplasma<br />

hyopneumoniae<br />

ingelvac® prrs mlv modified live PRRS virus,<br />

grown in a permanent<br />

cell line freeze­dried<br />

mamyzin® penethamate<br />

hydroiodide<br />

Spasmolitic and pain inhibitor for the treatment<br />

of colic (horse and cattle)<br />

For active immunisation of pigs to reduce<br />

intestinal lesions caused by Lawsonia intracellularis<br />

infection and to reduce growth variability<br />

and loss of weight gain associated with the<br />

disease<br />

For prevention of reproductive and respiratory<br />

diseases in cattle<br />

For the active immunization of swine from three<br />

weeks of age to reduce lung lesions<br />

following infection with Mycoplasma<br />

hyopneumoniae<br />

For the active immunization of clinically healthy<br />

swine against the respiratory and<br />

reproductive form of PRRS virus infection<br />

(porcine reproductive respiratory<br />

syndrome)<br />

For the treatment of mastitis caused by<br />

Gram­positive pathogens<br />

metacam® meloxicam Dog, horse: alleviation of pain and inflammation<br />

associated with acute or chronic musculoskeletal<br />

disorders<br />

Cat, dog: reduction of postoperative pain<br />

Cattle: respiratory infection, diarrhoea,<br />

acute mastitis<br />

Swine: non­infectious locomoter disorders,<br />

mastitis­metritis­agalactic­syndrome<br />

ventipulmin® clenbuterol Bronchodilator for the treatment of acute and<br />

chronic obstructive airway disease in horses<br />

vetmedin® pimobendan For the treatment of congestive heart failure<br />

in dogs<br />

voren® dexamethasone­21isonicotinate<br />

For the treatment of metabolic disorders,<br />

inflammation and allergic reactions in cattle,<br />

swine, horses, dogs and cats<br />

Glossary 119


Corporate Head Office<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH<br />

Binger Strasse 173<br />

55216 <strong>Ingelheim</strong><br />

Germany<br />

Telephone + 49 / 6132 / 77­0<br />

Fax + 49 / 6132 / 77­3000<br />

Contacts<br />

CD Communications<br />

Telephone + 49 / 6132 / 77­2012<br />

Fax + 49 / 6132 / 77­6601<br />

Internet www.boehringer­ingelheim.com<br />

Issued by<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH<br />

Design and layout<br />

Neufrankfurt Corporate Design GmbH, Offenbach am Main<br />

Photos on title page<br />

Jens Wunderlich, Lennart Nilsson<br />

Printed by<br />

Süddeutsche Verlagsgesellschaft, Ulm<br />

Copyright<br />

© <strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH, 2006<br />

All rights reserved. No part of this <strong>Annual</strong> <strong>Report</strong> <strong>2005</strong><br />

may be reproduced or transmitted in any form or<br />

by any means, electronic or photocopy, without permission<br />

in writing from <strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH.


Comparison of Balance Sheets/<br />

Financial Data 1996—<strong>2005</strong> (in millions of EUR)<br />

Assets (as of 31.12.) 1996 1997 1998 1999 * 2000 2001 2002 2003 2004 <strong>2005</strong><br />

Intangible assets 89 508 452 400 344 322 302 242 267 233<br />

Tangible assets 1,342 1,612 1,739 1,992 2,217 2,467 2,840 2,767 2,712 2,900<br />

Financial assets 1,007 757 731 849 1,135 1,008 1,689 2,462 2,756 3,396<br />

Fixed assets 2,438 2,877 2,922 3,241 3,696 3,797 4,831 5,471 5,735 6,529<br />

Inventories 627 794 806 944 1,021 1,014 971 1,000 1,085 1,229<br />

Accounts receivable (incl. deferred charges) 1,057 1,211 1,255 1,870 1,938 2,314 2,360 2,537 2,477 3,013<br />

Cash and cash equivalents (incl. securities) 156 134 299 459 477 1,002 1,055 1,134 1,333 1,247<br />

Current assets 1,840 2,139 2,360 3,273 3,436 4,330 4,386 4,671 4,895 5,489<br />

Total assets 4,278 5,016 5,282 6,514 7,132 8,127 9,217 10,142 10,630 12,018<br />

Liabilities and equity (as of 31.12.) 1996 1997 1998 1999 * 2000 2001 2002 2003 2004 <strong>2005</strong><br />

Shareholders’ capital 383 399 441 332 211 200 178 178 178 178<br />

Reserves (incl. currency conversion difference) 1,307 1,461 1,651 1,982 2,362 2,753 2,818 3,139 3,297 2,940<br />

Net income 167 212 229 320 379 401 537 529 888 1,491<br />

Total equity 1,857 2,072 2,321 2,634 2,952 3,354 3,533 3,846 4,363 4,609<br />

Minority interests 0 0 0 0 0 1 203 188 193 216<br />

Group equity 1,857 2,072 2,321 2,634 2,952 3,355 3,736 4,034 4,556 4,825<br />

Provisions (incl. deferred taxes) 1,841 1,982 2,012 2,631 2,932 3,150 3,568 3,963 4,172 4,958<br />

Liabilities (incl. deferred charges) 580 962 949 1,249 1,248 1,622 1,913 2,145 1,902 2,235<br />

Total liabilities 2,421 2,944 2,961 3,880 4,180 4,772 5,481 6,108 6,074 7,193<br />

Total liabilities and equity 4,278 5,016 5,282 6,514 7,132 8,127 9,217 10,142 10,630 12,018<br />

Summary of selected financial data 1996 1997 1998 1999 * 2000 2001 2002 2003 2004 <strong>2005</strong><br />

Sales 3,623 4,201 4,474 5,086 6,188 6,694 7,580 7,382 8,157 9,535<br />

Operating income 333 350 336 655 800 980 1,082 901 1,372 1,923<br />

Operating income as % of sales 9.2 8.3 7.5 12.9 12.9 14.6 14.3 12.2 16.8 20.2<br />

Income after taxes 167 212 229 320 379 401 551 537 908 1,514<br />

Income after taxes as % of sales 4.6 5.0 5.1 6.3 6.1 6.0 7.3 7.3 11.1 15.9<br />

Return on equity (in %) 9.8 11.4 11.0 13.8 14.4 13.6 16.0 15.0 23.1 34.2<br />

Own capital resources (in %) 43.4 41.3 43.9 40.4 41.4 41.3 38.3 37.9 41.0 38.4<br />

Cash flow 426 561 595 737 791 1,117 1,049 1,059 1,430 2,069<br />

Financial funds 966 722 858 1,055 1,094 1,645 2,645 3,516 4,015 4,585<br />

Personnel expenditure 1,153 1,270 1,409 1,527 1,749 1,916 2,175 2,252 2,443 2,671<br />

Personnel expenditure as % of sales 31.8 30.2 31.5 30.0 28.3 28.6 28.7 30.5 29.9 28.0<br />

Average numbers of employees 24,074 24,860 25,927 26,448 27,325 27,980 31,843 34,221 35,529 37,406<br />

Research and development costs 626 771 812 826 968 1,019 1,304 1,176 1,232 1,360<br />

R&D as % of sales 17.3 18.4 18.1 16.2 15.6 15.2 17.2 15.9 15.1 14.3<br />

Investments in tangible assets 346 455 421 377 497 548 634 516 427 532<br />

Depreciation of tangible assets 169 189 211 256 288 305 340 354 377 439<br />

*As of the comparative financial statement<br />

1999, accounting and evaluation methods were<br />

brought closer into line with International<br />

Accounting Standards (IAS), in particularly<br />

with regard to deferred taxes and provisions<br />

for pensions.


www.boehringer-ingelheim.com

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