Annual Report 2005 - Boehringer Ingelheim
Annual Report 2005 - Boehringer Ingelheim
Annual Report 2005 - Boehringer Ingelheim
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Value through Innovation<br />
<strong>Annual</strong> <strong>Report</strong> <strong>2005</strong><br />
nopq
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