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Annual Report 2011 - Boehringer Ingelheim

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Value through Innovation<br />

Corporate Magazine <strong>2011</strong>


corporate magazine <strong>2011</strong><br />

content<br />

value through innovation<br />

Solid foundations –<br />

flexibility and continuous<br />

change<br />

6 a n d r e a s B a r n e r i n c o n v e r s at i o n w i t h<br />

C h r i s t i a n B o e h r i n g e r<br />

corporate responsibility<br />

# 01<br />

Responsibility<br />

for future generations<br />

1 4 t r u s t, f a i r n e s s, d e v e l o p m e n t<br />

1 8 m a k e c h a n g e h a p p e n<br />

2 2 r e s p o n s i b l e D i a l o g u e<br />

2 4 p r e s e r v i n g b i o d i v e r s i t y<br />

2 6 G g r e e n A c t i v i t i e s<br />

2 9 r e s e a r c h a l l i a n c e s<br />

3 3 p r o m o t i n g e x c e l l e n c e l o n g - t e r m<br />

research & development<br />

# 02<br />

Innovation<br />

For The best medicIne<br />

3 8 D e d i c at e d t o I n n o vat i o n<br />

4 0 r e s e a r c h a n d D E V e l o p m e n t o f n e w b i o l o g i c a l e n t i t i e s<br />

4 4 t r a n s l at i n g R e s e a r c h , T r a n s f o r m i n g M e d i c i n e s<br />

4 8 B e t t e r m e d i c i n e s a n d va l u e f o r p at i e n t s<br />

5 0 B o e h r i n g e r I n g e l h e i m V e n t u r e F u n d


therapeutic areas<br />

# 03<br />

Health<br />

for a better quality of life<br />

[ prescription medicines ]<br />

5 5 a therapeutic breakthrough<br />

5 8 new treatment option for type 2 diabetes<br />

62 changing the way copd is treated<br />

[ consumer health care ]<br />

6 4 seeing the consumer’s point of view<br />

[ biopharmaceuticals and biosimilars ]<br />

69 connecting knowledge and innovation<br />

[ animal health ]<br />

73 taking prevention seriously<br />

76 H horses grow old as well<br />

future markets<br />

# 04<br />

Perspective<br />

For new markets<br />

8 0 e m e r g i n g m a r k e t s – g r o w i n g i m p o r ta n c e<br />

8 6 i n d i a – h i g h u n m e t m e d i c a l n e e d<br />

8 9 c h i n a – i n v e s t i n g i n h e a lt h c a r e<br />

9 2 B r a z i l – b e t t e r t r e at m e n t o p t i o n s<br />

production network<br />

# 05<br />

flexibility<br />

for strong networks<br />

9 6 s u p p ly c h a i n r e l i a b i l i t y a n d i n t e g r i t y<br />

9 8 s u c c e s s f u l P r o d u c t l a u n c h e s<br />

Content


Value through<br />

innovation<br />

We perceive ourselves as the patient ̒s partner,<br />

providing innovative medicines for better health.<br />

We thereby create Value through Innovation.<br />

[ photos on cover ]<br />

3d-structure of a monoclonal antibody<br />

biopharmaceutical production, biberach, germany<br />

the auditory cortex in the brain of a transgenic mouse


value through innovation<br />

extracts from our ‘leitbild’<br />

EXTRACTS FROM OUR<br />

Leitbild *<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has been a successful, family-owned business<br />

for more than 125 years and intends to remain so for the second<br />

century of its existence. Although it is impossible to predict the<br />

future precisely, we are actively and creatively facing the changing<br />

tasks and challenges, building on our experiences and achievements.<br />

This gives us the strength, direction and confidence to shape<br />

our future.<br />

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

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

and therapies. In this endeavour the future of our company will<br />

depend on its innovative capability.<br />

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

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

and promote environmental awareness. Parallel to pursuing these<br />

goals we seek to foster economic and social well-being in the countries<br />

and communities where we do business.<br />

In order to realise our goals, we must be financially successful,<br />

be willing to make the necessary changes, and be critically receptive<br />

to new ideas and developments. Maintaining and improving the<br />

performance of the company take precedence over maxi mising<br />

earnings in the short term.<br />

* guiding principles<br />

Extracts from our Leitbild<br />

5


SOLID FOUNDATIONS –<br />

FLEXIBILITY AND CONTINUOUS CHANGE<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>, like a tree, is firmly rooted in the ground. At the same time, the image of a tree<br />

also stands for flexibility and pliancy, two characteristics that allow it to remain able to adjust.<br />

And this is precisely how we behave. We constantly strive to renew ourselves and grow independently<br />

and from the inside. We thereby want to improve the established and develop the new our selves.<br />

We perceive <strong>Boehringer</strong> <strong>Ingelheim</strong> in the role of the partner of patients that produces innovative<br />

medicines for better health, thus creating value through innovation.<br />

Andreas Barner, Chairman of the Board of Managing Directors (left) in discussion<br />

with Christian <strong>Boehringer</strong>, Chairman of the Shareholders’ Committee<br />

6<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


value through innovation<br />

in conversation<br />

In conversation 7


What does<br />

“Be entrepreneurial”<br />

mean for us<br />

christian boehringer: “For me, as a member of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

shareholder family, to be entrepreneurial means the ability and readiness to<br />

continually innovate so that <strong>Boehringer</strong> <strong>Ingelheim</strong> can continue to grow on<br />

the basis of its innovative capacity and remain an independent family-run<br />

company.<br />

But because the pharmaceutical markets and healthcare systems change<br />

constantly, to be entrepreneurial also requires being prepared for continuous<br />

adjustment to new circumstances, such as the simultaneous feedback on the<br />

needs of patients, physicians and decision-makers in healthcare systems.<br />

Furthermore, the current challenges of the systemic financial, economic and<br />

political crisis also demand a reappraisal of our growth expectations, a return<br />

to past values and determination of what long-term growth over generations<br />

means for <strong>Boehringer</strong> <strong>Ingelheim</strong>.”<br />

What does “Improve the<br />

established” mean for us<br />

andreas barner: “If we want to continue to successfully develop new,<br />

innovative medicines, it is essential that we ask ourselves at regular intervals<br />

what the medical needs of tomorrow will be and how our processes in research,<br />

development and production, as well as marketing, can be further improved.<br />

Our attention will be increasingly directed towards earnings management,<br />

productivity and efficiency.<br />

A good example of this is how we have sharpened our view of markets and<br />

their future potential, and given a differentiated focus to our business<br />

development in the rapidly developing new markets. The recently implemented<br />

product launches in mature markets in what are for us new therapeutic areas<br />

are also an example of the effort to constantly improve in order to make better,<br />

innovative medicines available.”<br />

What does “Develop the<br />

new” mean for us<br />

andreas barner: “With its diversified, broad portfolio of innovative<br />

medicines for people and animals, <strong>Boehringer</strong> <strong>Ingelheim</strong> enjoys sustained<br />

success.<br />

To remain innovative and efficient in the future, we have built up our own<br />

network of independent, flexible research and development units in which we<br />

cover the complete value-added chain for research and development. Specialised<br />

scientists work together at seven locations in this worldwide network in order<br />

to convert their ideas into medicines. At the same time, we have further reinforced<br />

our traditional cooperation with academic centres and smaller companies.<br />

8<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


value through innovation<br />

in conversation<br />

The target of our research and development is to fulfil unmet medical needs.<br />

Our main goal is to research and develop the best-suited types of molecule,<br />

from either new chemical or biological active ingredients, for the treatment<br />

of diseases in our most important therapeutic areas. Initial approaches in<br />

translational medicine, such as the early development of biomarkers, should<br />

simplify the early development phases.<br />

Additionally, we are pursuing broader approaches to find new targets, often<br />

in cooperation with academic institutions. Furthermore, we have built up<br />

expertise in biopharmaceuticals over many years in the development and manufacture<br />

of biological medicines. We are thus not only well-positioned to<br />

develop, manufacture and market new biological active substances, but also<br />

have the possibility of successfully developing biosimilars.”<br />

Why are growth and<br />

renewal from the inside<br />

important for us<br />

christian boehringer: “To explain this, I frequently use the symbol<br />

of a tree. For <strong>Boehringer</strong> <strong>Ingelheim</strong> this means that the company, like a tree,<br />

must remain rooted in the ground and stable. At the same time, the image of a<br />

tree also stands for flexibility and pliancy, two characteristics that prevent the<br />

company from breaking in difficult times and always allow it to remain able<br />

to adjust.<br />

And this is precisely how we behave, unlike many of our competitors. We constantly<br />

strive to renew ourselves and grow independently and from the inside.<br />

We thereby want to improve the established and develop the new ourselves.”<br />

Why do we perceive<br />

ourselves as a partner<br />

for better health<br />

andreas barner: “The goal of all of our business activities is to make<br />

the best possible medicines available to people. We perceive <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> here in the role of the partner of patients that produces innovative<br />

medicines for better health. We create value through innovation.<br />

And this requires real partners: we cooperate trustingly, fairly and with mutual<br />

respect with our employees, our business partners and the public sector, be it<br />

government bodies or non-governmental organisations. In keeping with our<br />

fundamental principle, we encourage each individual to take responsibility for<br />

themselves and others in their actions. In this way, we make a logical connection<br />

in our company between a strong economic dynamic and social fairness.<br />

Increasingly often, especially in situations where we need external knowledge,<br />

medical or technical expertise in addition to our internal expertise, we enter<br />

into targeted cooperations and partnerships with other companies and academic<br />

organisations in order to achieve our goals.<br />

In conversation<br />

9


Partnerships in the field of research and development range from leading<br />

universities and basic research institutions to biotech companies. <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> has thus established itself as a reliable ally for our cooperation<br />

partners.”<br />

christian boehringer: “In addition, we have launched the ‘Making<br />

more health’ initiative which is designed to support social entrepreneurs in the<br />

healthcare sector. The goal of this initiative is to initiate new, innovative<br />

healthcare solutions and improve access to medical treatment worldwide.<br />

With the help of the non-governmental organisation Ashoka, we are searching<br />

for social entrepreneurs who are looking for new, innovative healthcare solutions<br />

or seeking to improve people’s access to medical treatment.<br />

What is particularly new in this approach is that social entrepreneurs should<br />

earn sufficient to finance their schemes, but, as not-for-profit organisations,<br />

no capital market return. These cooperations provide impetus and raise questions<br />

for us that give us food for thought and enable us to see things in a different<br />

light. The goal with these cooperations is not to earn money, but to learn from<br />

social entrepreneurs what the questions of the future are.”<br />

Why is a special corporate<br />

culture important for us<br />

christian boehringer: “We see <strong>Boehringer</strong> <strong>Ingelheim</strong> as a very special<br />

company in the pharmaceutical world. And why is that It is because, as a<br />

family-run company, we have a special cannon of values that forms our culture.<br />

Our actions are borne by mutual respect, trust, empathy and passion for our<br />

topics and targets. This special culture determines our actions and contributes<br />

decisively to firmly anchoring business processes and to retaining our innovative<br />

strength and efficiency.”<br />

andreas barner: “Our openness to change, in accordance with our<br />

Leitbild (guiding principles), productive, efficient research and development<br />

in new, innovative medicines for the benefit of people, while observing social<br />

and environmental standards, is for us the basis of company leadership. Our<br />

corporate culture, orientated toward and lived by ethical benchmarks and<br />

social and environmental standards, also contributes towards creating business<br />

adaptation processes that are constructive for our employees.<br />

For our employees are the most important asset in our company and the<br />

guarantors of its innovative strength and efficiency. Together with them we<br />

can succeed in realising our leitmotif ‘Value through Innovation’ in all our<br />

business activities.<br />

10<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


value through innovation<br />

in conversation<br />

The continuity of people in the workplace at <strong>Boehringer</strong> <strong>Ingelheim</strong> has created<br />

an environment of trust that makes it possible to work coherently and intelligently.<br />

We live out these values together with our employees. This corporate<br />

culture, which we live out to the same extent across national frontiers, is gaining<br />

importance for achieving our goals of raising the company‘s productivity<br />

and efficiency.”<br />

What are our tasks for the<br />

future<br />

christian boehringer: “<strong>Boehringer</strong> <strong>Ingelheim</strong> currently faces many<br />

challenges - and will face many challenges in the future too. Our company will<br />

be borne and taken forward together with our Board of Managing Directors<br />

and our employees.<br />

At the same time, we want to create the future for <strong>Boehringer</strong> <strong>Ingelheim</strong> early and<br />

on a sustainable basis. Only in this way will we actively counter the challenges<br />

and change and ensure that we are not driven by external developments.”<br />

andreas barner: “That calls for commitment, engagement, courage and<br />

creativity from everybody. With our organisational structure, our priorities, our<br />

focus on new fast-growing markets and our successful launches of new medicines<br />

in established markets, we are confident that we are on the right road to<br />

successfully developing the company further. Naturally, we must not slacken in<br />

these efforts now, as our environment is constantly changing and we should<br />

recognise and seize change as an opportunity for the future.”<br />

signed by<br />

christian boehringer<br />

chairman of the shareholders’ committee<br />

signed by<br />

andreas barner<br />

chairman of the board of managing directors<br />

In conversation<br />

11


# 01<br />

RESPONSIBILITY<br />

FOR FUTURE GENERATIONS<br />

Sustainability and future investment are our goals. And this requires real partners:<br />

we cooperate trustingly, fairly and with mutual respect with our employees,<br />

our business partners and the public sector, be it government bodies or nongovernmental<br />

organisations. We encourage each individual to take respon sibility<br />

for themselves and others in their actions. In this way, we combine economic,<br />

dynamic and social fairness.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

14 TRUST, FAIRNESS, DEVELOPMENT<br />

18 MAKE CHANGE HAPPEN<br />

22 RESPONSIBLE DIALOGUE<br />

24 PRESERVING BIODIVERSITY<br />

26 GREEN ACTIVITIES<br />

29 RESEARCHALLIANCES<br />

33 PROMOTING EXCELLENCE LONG-TERM<br />

12<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

Responsibility for future generations 13


TRUST, FAIRNESS, DEVELOPMENT<br />

Together with our employees, we are creating the future of <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>. Every individual is encouraged to take responsibility for<br />

themselves and others. Our corporate culture, guided by respect,<br />

mutual trust, fairness and passion for our tasks, contributes to constructively<br />

establishing entrepreneurial processes and maintaining<br />

our performance.<br />

Talent management<br />

Employee development is the foundation<br />

for talent management. And<br />

effectively managing talent is essential<br />

for our future success. In order to<br />

prepare our employees for constantly<br />

changing working conditions and<br />

requirements, we foster their ongoing<br />

development through our global talent<br />

management approach.<br />

“The first observation I made when I joined<br />

the company was that it invests in nurturing<br />

its talents. I have also recently seen the<br />

introduction of the Talent Management Net,<br />

a structured, systematic and transparent<br />

platform to support the talent management<br />

initiatives.”<br />

jonathan chin<br />

regional product manager - pradaxa®<br />

regional operating unit south east asia<br />

boehringer ingelheim singapore<br />

Supported by a global web-based<br />

talent management system, all of our<br />

employees worldwide can access,<br />

work on and execute their individual<br />

development plans. The objectives of<br />

the development plan, which is aligned<br />

with business needs, are discussed<br />

individually between the employee and<br />

supervisor and aim to keep employees<br />

up to date with current and future<br />

working conditions and job requirements.<br />

Furthermore, we develop our employees<br />

for challenging opportunities<br />

ahead, both nationally and internationally.<br />

We thereby secure robust<br />

14


corporate responsibility<br />

responsibility for future generations<br />

INDIVIDUAL DEVELOPMENT<br />

Our employees participate in diverse seminars<br />

within the framework of our management<br />

development programme. Measures are well-suited<br />

to their indi vidual needs in order to support them<br />

in different phases of their careers.<br />

succession planning, ensuring that<br />

the company has the right people in<br />

the right position at the right time at<br />

all levels in the organisation.<br />

Individual development planning for<br />

all employees at all levels will foster<br />

sustained employability and the sustainable<br />

competitiveness of our workforce.<br />

We believe that talent management<br />

needs to be built on a sound workforce<br />

plan linked with a business strategy<br />

highlighting the needs of future organisational<br />

and individual capacities<br />

and capabilities. A more anticipative<br />

approach is critical, not only in view<br />

of imminent demographic trends, but<br />

even more so because many parts of<br />

our organisation will continue to<br />

operate in dynamically changing<br />

environments.<br />

Leadership development<br />

To deliver on our talent management<br />

goals, our leaders must understand<br />

how to leverage employees as our<br />

most important resource.<br />

This requires<br />

leaders committed<br />

to developing and<br />

coaching employees<br />

and focusing on<br />

identifying, growing<br />

and developing future<br />

leaders.<br />

Our leadership development<br />

philo sophy is based<br />

upon self-awareness as the crucial<br />

foundation for leaders to deliver<br />

results and build the <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

of the future. The leadership<br />

development framework was established<br />

to support leaders by providing<br />

appropriate development, based on<br />

their individual needs at the different<br />

stages in their leadership careers.<br />

In <strong>2011</strong>, leadership development<br />

programmes for three target groups<br />

were rolled out: the Global Strategic<br />

Leader ship Programme (GSLP) for participants<br />

who lead at a global enterprise<br />

level, the Regional Leadership Develop-<br />

“<strong>Boehringer</strong> <strong>Ingelheim</strong> has provided me the<br />

opportunity to learn and to apply learnings<br />

in action. The experience of working with<br />

colleagues all around the world has been<br />

exciting, challenging and rewarding. I am<br />

grateful to the company for giving me an<br />

opportunity to make a difference to our<br />

consumers’ lives.”<br />

christopher l. salzo<br />

brand manager consumer health care<br />

boehringer ingelheim usa<br />

Trust, fairness, development<br />

15


LEADERSHIP DEVELOPMENT PROGRAMMES<br />

values, lead & learn, leadership competence<br />

long-term objectives<br />

strategy<br />

GSLP RLDP LLDP<br />

GMDP<br />

global strategic<br />

leadership<br />

programme<br />

regional leadership<br />

development<br />

programme<br />

local leadership<br />

development<br />

programme<br />

global management<br />

development<br />

programme<br />

lead & learn<br />

global leadership curriculum<br />

ment Programme (RLDP) for participants<br />

who lead a business or function,<br />

and the Global Management Development<br />

Programme (GMDP) for participants<br />

leading others and demonstrating<br />

potential to become future global leaders<br />

for the organi sation. The curriculum<br />

for all programmes is based on our<br />

Leitbild (guiding principles), vision and<br />

values as well as the global strategy of<br />

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

“Hard work, dedication and delivering results<br />

are strongly rewarded in the form of a variety of<br />

career and personal development opportunities.<br />

The constant search for the inspiring leaders<br />

of tomorrow means leadership can very soon<br />

be a part of your job!”<br />

sandra quintero<br />

head of order-to-cash,<br />

global department regional<br />

business services,<br />

boehringer ingelheim germany<br />

Our global leadership development<br />

programmes will develop leaders who<br />

• set direction<br />

• lead innovation<br />

• lead and manage change<br />

• lead people<br />

• deliver results<br />

to ensure the sustained growth and<br />

independence of the company.<br />

Diversity and inclusion<br />

Our employees are the source of our<br />

competitiveness. We believe that diversity<br />

in our workforce fosters innovation,<br />

supports decision-making and<br />

increases our attractiveness as an<br />

employer. Diversity represents the differences<br />

between people, be it regarding<br />

gender, culture, ethnicity, education,<br />

religion or other dimensions, such as<br />

diversity of thought. It recognises that<br />

no two people are alike and that each<br />

person brings to the company a unique<br />

set of talents.<br />

Inclusion brings together diversity to<br />

make the company better and stronger<br />

16


corporate responsibility<br />

responsibility for future generations<br />

“A working environment that gives men and<br />

women the same opportunities for personal<br />

development provides the necessary basis for<br />

a balanced representation of both genders in<br />

our management teams. There are many things<br />

that we can do to achieve this – what is crucial<br />

is that we really take it seriously.”<br />

dr sabine luik,<br />

head of corporate division quality<br />

regulatory, pharmacovigilance,<br />

epidemiology (qrpe) and member of<br />

the advisory council gender diversity,<br />

boehringer ingelheim germany<br />

because of each employee. It is a sense of<br />

belonging: feeling respected, valued for<br />

who you are; feeling a level of supportive<br />

energy and commitment from others<br />

so that you can bring your authentic self<br />

to work and do your best. To have them<br />

show their best, we encourage our employees<br />

to bring their uniqueness and<br />

potential into the company. To support<br />

a diverse and inclusive environment,<br />

where everyone can contribute, we have<br />

set up diversity and inclusion advisory<br />

groups. For example, two groups, Leaders<br />

of Diverse Nationalities and Gender<br />

Diversity, have already started to propose<br />

specific activities and measures.<br />

The Asian council group has set out a<br />

vision for their work: “By 2020, Asian<br />

leaders will play a prominent role<br />

within our global leadership team<br />

within and outside Asia.” The<br />

group will actively follow<br />

through to make their vision a<br />

reality through process<br />

excellence and specific programmes<br />

and interventions<br />

along our talent management<br />

cycle.<br />

As another example, the Gender<br />

Diversity group pursues the vision<br />

that, in the future, our culture will involve<br />

equal contribution from both<br />

genders at all levels. It will drive the<br />

visible monitoring of gender diversity<br />

by the company leadership, support for<br />

networking and role modelling for<br />

women, the provision of globally<br />

aligned mentoring framework and the<br />

amendment of the hiring, succession<br />

planning and staffing processes.<br />

“The opportunities within <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> to work on assignments<br />

diverse in terms of people, thought and<br />

culture has been greatly beneficial in<br />

developing myself as well as preparing<br />

for leadership roles in a global<br />

company.”<br />

rajeev sukumaran,<br />

information systems, service development<br />

& delivery, service management,<br />

boehringer ingelheim usa<br />

Trust, fairness, development<br />

17


Ashoka: The word “Ashoka” is Sanskrit and can be translated as “the<br />

active absence of sorrow”. The eponym was an Indian emperor around<br />

300 BC who unified the Indian subcontinent and committed himself<br />

to a policy of peace promotion and social welfare.<br />

MAKE CHANGE HAPPEN<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> and Ashoka are working together in a global<br />

partnership, “Making more health”, devoted to innovative health<br />

solutions and promoting social entrepreneurship.<br />

Ashoka is a global non-governmental<br />

organisation (NGO) of<br />

leading social entrepreneurs who<br />

are finding solutions to the world’s<br />

most urgent social problems in<br />

order to change society in the<br />

long run.<br />

Once social entrepreneurs are<br />

elected as “Ashoka Fellows,” they<br />

are provided with living stipends,<br />

professional support, and access<br />

to a global network of peers in 70<br />

countries.<br />

“Making more health” is the ambition<br />

to deliver new health care models –<br />

more health – to the world, that is to<br />

say, to individuals and society. More<br />

health means prevention, diagnosis<br />

and treatment. Promising solutions to<br />

challenging health problems worldwide<br />

are identified and approached in<br />

the course of the initiative.<br />

By 2014, Ashoka and <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> will support 50 so-called<br />

social entrepreneurs who advance<br />

sustainable health solutions with<br />

their concepts (for our first 13 elected<br />

entrepreneurs, see examples). The<br />

social entrepreneurs are selected at a<br />

national and international level by<br />

Ashoka and <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

We support them for three years,<br />

but afterwards their concepts should<br />

be self-sustaining. Our partnership<br />

forms a win-win situation. On the one<br />

hand, Ashoka displays competence in<br />

creating change and comes with the<br />

network and know-how to identify<br />

and to advance social innovators.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>, on the other<br />

hand, is competent in the healthcare<br />

and business sectors. We can provide<br />

the social entrepreneurs with a great<br />

MICHAELA NACHTRAB, VERBAVOICE<br />

[ germany ]<br />

her idea: a society in which open communication<br />

for citizens with hearing difficulties or<br />

deafness is the norm instead of the exception<br />

her approach: introducing a web-based<br />

service that reduces the cost<br />

of transcription services<br />

18<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

KRYSTIAN FIKERT, MYMIND<br />

[ ireland ]<br />

REBECCA ONIE, HEALTH LEADS<br />

[ usa ]<br />

her idea: doctors prescribing food or other basic<br />

resources necessary for families to be healthy<br />

her approach: training students to liaise<br />

between doctors, patients and community<br />

resources and to staff health desks in urban<br />

medical centres<br />

his idea: making mental healthcare available<br />

and affordable without stigma<br />

his approach: providing in-person and online<br />

psychological services, with quick and<br />

affordable access to a team of<br />

counsellors, psychotherapists<br />

and psychologists<br />

deal of experience in professional<br />

project management. Furthermore,<br />

we support the entrepreneurs with<br />

our skills, experience, and network.<br />

We would hereby like to achieve a<br />

change in the healthcare system. And<br />

we would like to give something to<br />

society, something that cannot be<br />

mea sured and solved monetarily.<br />

Changemakers competition<br />

As part of the partnership initiative,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> and Ashoka’s<br />

Changemakers launched their first<br />

online competition, the “Making more<br />

health Changemakers competition”, in<br />

July <strong>2011</strong>. In this way, we sought new<br />

ideas for improving the health and<br />

well-being of diverse communities<br />

around the world – rural and urban,<br />

developed and developing – and in<br />

different political and economic systems.<br />

Through the competition, we<br />

also “feed the pipeline” for future<br />

social entrepreneurs.<br />

Everybody has been able to use this<br />

platform to express their ideas. More<br />

than 470 entries from 82 countries<br />

were made, including those of our<br />

employees. Through the contributions<br />

we also established contact with people<br />

who think innovatively whom we<br />

would not have met in other ways and<br />

with whom we engage in active exchanges.<br />

Using the website, ideas could be submitted<br />

on how to improve services<br />

and treatment, on promoting prevention,<br />

early detection and diagnosis, on<br />

empowering individuals, families and<br />

GUILLAUME BAPST, A.N.D.E.S.<br />

[ france ]<br />

his idea: improving health and social integration<br />

by making better choices of food available<br />

for low-income families<br />

his approach: delivering food to the poor who<br />

can buy everyday products cheaper in<br />

so-called solidarity stores<br />

MARIANA ANGELERI,<br />

FUNDACIÓN EDUCACIONAL<br />

[ argentina ]<br />

her idea: attacking the problem of<br />

child obesity by focusing on health<br />

and wellness<br />

her approach: building<br />

healthy habits at schools for<br />

successful prevention<br />

Make change happen 19


LUH KETUT SURYANI,<br />

SURYANI INSTITUTE FOR MENTAL HEALTH<br />

[ indonesia ]<br />

her idea: expanding the definition of a mental<br />

healthcare provider – “everyone can be a self-healer”<br />

her approach: low-cost mental health treatment<br />

and rehabilitation, involving<br />

different groups in the<br />

recovery process<br />

JOSH NESBIT, MEDIC MOBILE<br />

[ usa ]<br />

his idea: transforming the efficacy of<br />

decentralised rural public health<br />

his approach: medical workers use mobile<br />

phones to gather health data efficiently<br />

MIA SUTANTO, ASOCIASI IBU<br />

MENYUSUI INDONESIA (AIMI)<br />

[ indonesia ]<br />

her idea: raising awareness about and<br />

promoting breastfeeding<br />

her approach: a support group for<br />

breastfeeding mothers, the<br />

Indonesian Breastfeeding<br />

Mothers Association (AIMI)<br />

Ashoka’s Changemakers is an<br />

online action community that connects<br />

social entrepreneurs around<br />

the globe to share ideas, inspire,<br />

and mentor each other. Through<br />

its online competitions, changemakers.com<br />

is one of the world’s<br />

most robust spaces for launching,<br />

discussing and scaling ideas to<br />

solve the world’s most pressing<br />

social problems. Changemakers<br />

builds on Ashoka’s history and<br />

vision for an “Everyone a Changemaker”<br />

world by creating a place<br />

where the best ideas in social innovation<br />

can be shared, refined<br />

and funded.<br />

www.changemakers.com<br />

communities to address their health<br />

issues and on targeting vulnerable<br />

and underserved populations.<br />

From 13 finalists chosen by the competition<br />

jury, the public then voted to<br />

select the three winners. Their innovations<br />

describe new healthcare delivery<br />

models for extremely impoverished<br />

communities, the novel use of<br />

GERALD KOLLER, RISFLECTING<br />

[ austria ]<br />

his idea: training individuals to develop responsible<br />

behaviour in risky settings. His focus:<br />

drug and alcohol consumption, gambling,<br />

extreme sports, etc.<br />

his approach: conveying risk competence as a<br />

central component of addiction<br />

pre vention and health promotion<br />

in workshops and training sessions<br />

local human resources to expand the<br />

capacity of rural and urban clinics,<br />

and holistic approaches to sustainable<br />

health. Each winner received a prize<br />

of USD 10,000.<br />

The winners were:<br />

• ColaLife, zambia: simple medicines<br />

are piggy backed on Coca-Cola supply<br />

chains, i. e. tucked into Cola<br />

boxes, to save lives in underserved<br />

rural areas in Africa.<br />

• Saúde Criança, brazil: families receive<br />

support for different areas in<br />

the favelas in Rio de Janeiro. This<br />

includes improving their living situation<br />

and education. The families<br />

shall be lifted out of poverty to live<br />

healthily in the long term.<br />

20


corporate responsibility<br />

responsibility for future generations<br />

DR FRANK HOFFMANN,<br />

DISCOVERING HANDS®<br />

[ germany ]<br />

CLAUS GOLLMANN,<br />

KIND IN DÜSSELDORF<br />

[ germany ]<br />

his idea: improving the quality of care for<br />

abused children<br />

his approach: opening an inpatient diagnostic<br />

centre where children stay for<br />

up to six months<br />

his idea: detecting breast cancer earlier<br />

his approach: training blind women to<br />

examine women’s breasts and introducing<br />

the profession of medical tactile<br />

examiner (Medizinische<br />

Tastunter sucherin - MTU)<br />

JORDI MARTI, DRY BLOOD SCREENING<br />

[ spain ]<br />

• Unite For Sight, ghana: the organisation<br />

is partnering with local eye<br />

clinics in poor regions all over the<br />

world. Patient barriers to care in<br />

rural villages, slums and refugee<br />

camps and preventable blindness<br />

shall be eliminated.<br />

his idea: enabling affordable detection of infectious<br />

and non-communicable diseases in disadvantaged<br />

communities and poorly funded health systems<br />

his approach: developing a new method to analyse<br />

biochemical parameters (uric acid,<br />

cholesterol, glucose, etc.) in dried<br />

blood samples<br />

Employees as changemakers<br />

Our employees not only participated<br />

in the changemakers competition by<br />

contributing their ideas. We are also<br />

matching the needs of social entrepreneurs<br />

with our employees’ skills and<br />

interests. Within their different functions,<br />

they engage where the Ashoka<br />

social entrepreneurs need some help<br />

with their projects.<br />

We can engage and develop individually<br />

and as a whole company by pursuing<br />

a common aim. By contributing<br />

to the projects voluntarily, we help to<br />

bring more health to the world as well<br />

– we also become changemakers at our<br />

workplace and in our community.<br />

www.makingmorehealth.org<br />

PHIL CONWAY, COOL 2 CARE<br />

[ united kingdom ]<br />

his idea: introducing a new type of personal<br />

assistant into the homecare industry<br />

his approach: modern recruitment techniques<br />

to bring new types of carers, namely energetic<br />

young people, to the disabled


PROVIDING INFORMATION<br />

Providing more information to patients is our ethical duty. On our social media channels, we<br />

illuminate different disease issues and provide information on our cooperations or disease<br />

awareness campaigns. By engaging in dialogue with our stakeholder groups, sustainable and<br />

innovative values and solutions can be found.<br />

For more information, visit our channels on Facebook, Twitter and YouTube.<br />

RESPONSIBLE DIALOGUE<br />

New communication channels, such as Facebook, Twitter and<br />

YouTube, enable us to engage with stakeholder groups. These<br />

social media channels allow rich interaction between the company,<br />

patients, scientists, physicians and other interested parties.<br />

Social media channels are two-way<br />

communication that is more intensive<br />

and more direct than traditional<br />

digital channels. This is important, as<br />

sustainable, innovative values and<br />

solutions can only be found through<br />

dialogue between different social<br />

groups, with people expressing their<br />

opinions and ideas. We appreciate discussion,<br />

criticism and open expression<br />

of opinion, so that we can benefit from<br />

the community’s wealth of ideas and<br />

stay up to date. With the right social<br />

media tools, we can also attract talents.<br />

Different issues on different channels<br />

On our YouTube channel, we have<br />

about 70 videos which illuminate different<br />

disease issues, provide information<br />

on projects and collaborations,<br />

and report on patients’ disease<br />

experiences. With Facebook and<br />

Twitter, we also want to be genuine<br />

and transparent, to engage more, to<br />

share more, to learn more, and to help<br />

more. Providing more information to<br />

patients is our ethical duty.<br />

PREVENTING STROKES<br />

The campaign “1 Mission 1 Million –<br />

Getting to the Heart of Stroke”<br />

started in <strong>2011</strong> to raise awareness<br />

of atrial fibrillation (AF) and its<br />

link to stroke. The public was empowered<br />

to decide how to spend<br />

EUR 1 million on projects to help<br />

to prevent as many as one million<br />

AF-related strokes. In August<br />

<strong>2011</strong>, the 32 best projects were<br />

announced in Paris, France.<br />

We were among the first pharmaceutical<br />

companies to use Twitter and<br />

we are one of the most engaged users.<br />

It enables us to tweet news, disease<br />

awareness slides, infographics and<br />

other information. And it allows us to<br />

engage in healthy dialogue, answering<br />

questions and solving problems, providing<br />

quick, accurate responses.<br />

Support for campaigns<br />

Our global initiative “1 Mission 1 Million<br />

– Getting to the Heart of Stroke”<br />

(box, left) was supported by our social<br />

media channels. The public submitted<br />

more than 200 projects. One of the<br />

winning projects suggested a social<br />

media platform to motivate stroke<br />

prevention.<br />

22<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

BETTER UNDERSTANDING<br />

Interest groups can with this game dive into<br />

the daily working process of a pharmaceutical<br />

company. This helps them to understand the<br />

process and points <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

employees have to work through before a<br />

product can be launched.<br />

The goal of our DRIVE4COPD campaign<br />

was to drive one million people to<br />

a website to fill out a diagnostic questionnaire<br />

to detect their risk of chronic<br />

obstructive pulmonary disease (COPD).<br />

We also support the “Making more<br />

health” project, a collaboration with<br />

Ashoka (see page 18), on our social<br />

media channels. They are integrated<br />

in all our cooperations and activities.<br />

Breaking new ground<br />

In the second half of 2012, we will<br />

launch a game played on Facebook.<br />

Based on research and development, we<br />

will use it to educate people about diseases<br />

or disease awareness. Players will<br />

equip and use a laboratory to discover<br />

new drugs and bring them to market<br />

with a view to increasing global health.<br />

The game provides an outstanding way<br />

of helping people to understand the different<br />

stages and obstacles of R&D, i. e.<br />

the challenges facing the pharmaceutical<br />

industry. It is also a great way of<br />

communicating with, educating and<br />

engaging with people.<br />

Alignment in future<br />

By striving to find new ways to reach<br />

our audiences, we can provide patients,<br />

customers and other stakeholder groups<br />

with up-to-date in formation. Disease<br />

awareness and interaction will advance<br />

the understanding and importance<br />

of health.<br />

DRIVE4COPD<br />

This was a campaign that aimed<br />

to raise awareness of and increase<br />

screening for COPD. It was an example<br />

of how to use social media<br />

effectively to drive social change.<br />

70<br />

On our YouTube channel about<br />

70 videos illuminate different disease<br />

issues, provide information on<br />

projects and collaborations, and<br />

report on patients’ disease experiences.<br />

Responsible dialogue<br />

23


2 3<br />

1<br />

1 The Jaborandi shrub is harvested from June to October.<br />

2 The registered gatherers receive a harvesting cutter and a<br />

personal identity card.<br />

3 Gatherers learning the correct harvesting technique, which is<br />

essential for the plant’s preservation.<br />

PRESERVING BIODIVERSITY<br />

In Brazil, <strong>Boehringer</strong> <strong>Ingelheim</strong> is engaged in a cooperation to pre -<br />

serve biodiversity and support families whose livelihoods depend<br />

on gathering Jaborandi leaves.<br />

JABORANDI:<br />

PILOCARPUS MICROPHYLLUS<br />

STAPF<br />

• shrub, 1.20 to 1.60 metres in<br />

height<br />

• grows mainly in Brazil’s Amazonas<br />

region<br />

• leathery leaves and greenyellow-coloured<br />

flowers<br />

• active substance pilocarpine<br />

is used to treat glaucoma and<br />

severe dry mouth<br />

• 0.8 % pilocarpine per leaf<br />

• threatened with extinction from<br />

past unsustainable harvesting<br />

Through a development partnership<br />

we actively promote fair and improved<br />

working conditions as well as sustainable<br />

cultivation of a native plant and<br />

the preservation of biodiversity.<br />

We work jointly with the Brazilian company<br />

Centroflora Group and the German<br />

Society for International Cooperation<br />

(Deutsche Gesell schaft für internationale<br />

Zusammenarbeit GmbH – GIZ) on<br />

realising a project for the sustainable<br />

use and preservation of the Jaborandi<br />

shrub in northeast and north Brazil<br />

in the protected forest of Carajás<br />

(Amazonas region). Furthermore, the<br />

social and economic integration of<br />

local Jaborandi gatherers is to be intensified.<br />

Project partners<br />

Centroflora uses Jaborandi leaves<br />

directly, which are employed to isolate<br />

the alkaloid pilocarpine, used to treat<br />

glaucoma and severe dry mouth.<br />

The GIZ supports people and societies<br />

in developing, fast-developing and industrialised<br />

countries to develop their<br />

own prospects and improve their living<br />

conditions. As a federal German organisation,<br />

its most important client is the<br />

German Federal Ministry for Economic<br />

Cooperation and Development (Bundesministerium<br />

für wirtschaftliche Zusammenarbeit<br />

und Entwicklung – BMZ).<br />

The GIZ also works for other German<br />

ministries, federal states and municipalities,<br />

as well as public and private sector<br />

clients in different countries. These include,<br />

for example, governments in other<br />

countries, the European Commission, the<br />

United Nations and the World Bank.<br />

Ensuring future harvests<br />

When harvesting Jaborandi leaves,<br />

special factors must be taken into consideration.<br />

Branch tops should only be<br />

24<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

DEVELOPMENT PARTNERSHIPS –<br />

BUSINESS FOR MORE RESPONSIBILITY<br />

JABORANDI GATHERING AREA<br />

IN BRAZIL<br />

manaus<br />

brazil<br />

pará<br />

maranhão<br />

piauí<br />

In development cooperation, partnerships<br />

between the public and private sectors are<br />

described as development partnerships.<br />

They link the business interests of companies<br />

to the development policy goals of<br />

the public sector in the mutual interest of<br />

both sides. The partners can thus jointly<br />

pursue their goals, which could only be<br />

realised poorly, or to an inadequate extent,<br />

if undertaken alone.<br />

The leaves are harvested in the<br />

northeastern and northern federal states<br />

of Pará, Maranhão and Piauí.<br />

harvested after the first fruit has ripened<br />

from a height above 50 centimetres.<br />

Moreover, cutters should be used<br />

to ensure propagation from seed, regeneration<br />

and further harvests in the years<br />

ahead.<br />

Harvesting takes place during the dry<br />

season from June to October. Illegal<br />

picking of the shrubs was widespread in<br />

the past. To harvest as much as possible<br />

to sell to dealers, pickers shortened the<br />

branches to the point where the species<br />

Pilocarpus microphyllus was threatened<br />

with extinction. The small payments that<br />

dealers made to gatherers was only<br />

enough for food during the harvest<br />

season, but not for the rest of the year.<br />

Helping to solve the problem<br />

The problem-solving approaches developed<br />

by the project partners first of<br />

all include gatherer registration in a<br />

land register in order to contain illegal<br />

gathering. After theoretical and<br />

practical instruction in harvesting<br />

guidelines and techniques, gatherers<br />

receive a harvesting cutter and a personal<br />

identity card. This card contains<br />

important information concerning<br />

harvest amounts, dates and locations.<br />

Centroflora will in future purchase<br />

Jaborandi leaves at fair prices from<br />

these gatherers only, securing their<br />

living for many months. Prices for<br />

dried Jaborandi leaves will, however,<br />

be renegotiated each season. To ensure<br />

the preservation of the shrub,<br />

and reforestation of the regions, gatherers<br />

also replant with seedlings. We<br />

support gatherers in organi sing themselves<br />

to become economically independent<br />

and to negotiate free of dealers<br />

to secure their living.<br />

As sustainable enterprise can only be<br />

achieved in the developing countries within<br />

a stable economic, ecological and social<br />

environment, both business and development<br />

cooperation organisations are interested<br />

in creating the corresponding preconditions.<br />

These include job creation and the<br />

improvement of production processes, environmental<br />

protection and technology.<br />

Private companies can benefit from the<br />

contacts, experiences and the expert network<br />

of the organisations that implement<br />

developmental policies. Furthermore, they<br />

gain access to new markets for their products<br />

and services. Public sector partners<br />

strive to integrate poorer social groups in<br />

markets, thereby improving their incomes<br />

and quality of life as well as contributing<br />

towards preserving natural resources.<br />

[ project partners ]<br />

Preserving biodiversity<br />

25


1 Reforestation project at our farm in Solana, Brazil<br />

2 By integrating three climate systems we save about 2,000 tons of<br />

CO 2<br />

per year at our site in Petersburg, USA.<br />

3 At our German sites we systematically identified the optimisation<br />

potential of energy efficiency measures in buildings. Here: biopharmaceutical<br />

production plant G 104 in Biberach<br />

1<br />

2 3<br />

GREEN ACTIVITIES<br />

Acting in an environmentally sustainable way is a global challenge.<br />

We owe it to our employees, customers and the whole society.<br />

For us, it means, for instance, reducing energy consumption and<br />

enhancing environmental protection. Furthermore, we make every<br />

effort to protect our employees and guarantee their health.<br />

SUSTAINABLE ENERGY<br />

CONCEPTS<br />

Energy concepts with time frames<br />

of up to 15 years ensure the sustainable<br />

use of energy at our sites.<br />

A scientific board of external advisors<br />

and internal specialists is<br />

engaged in working out sustainable<br />

energy supply strategies for<br />

Germany. Regular reviews ensure<br />

integration of the best available<br />

techniques in the concepts and<br />

tell us which energy resources and<br />

technologies to use in the future.<br />

Protecting the environment, conserving<br />

natural resources and promoting<br />

environmental awareness are valued<br />

principles at <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

This is reflected in our Leitbild (guiding<br />

principles), as well as our new<br />

Environment, Health and Safety (EHS)<br />

Policy and Strategy being rolled out<br />

in 2012.<br />

We investigate important “green strategies”<br />

that go further to improve the<br />

environmental impact of our operations.<br />

Embarking on greener paths<br />

will help us to manufacture clean,<br />

safe and efficient products through<br />

sensible component sourcing.<br />

Energy and emission savings<br />

For many years, projects reducing<br />

energy consumption and greenhouse<br />

gases have been implemented at our<br />

sites with the aim to improve our performance.<br />

We consider these issues a<br />

prerequisite to enjoying a competitive<br />

advantage and to being economically<br />

sustainable in the future. Some examples<br />

of energy- and emission-reducing<br />

projects in <strong>2011</strong> are:<br />

• The reforestation project at our<br />

farm in Solana, Brazil: we evaluated<br />

that the amount of CO 2<br />

that is<br />

absorbed by the plants in our reforestation<br />

activities broadly matches<br />

the CO 2<br />

emitted at our pharmaceutical<br />

production facility, farm<br />

and administrative buildings in<br />

Brazil.<br />

• At our plant in Petersburg, Virginia,<br />

USA: we integrated three existing<br />

process and heating, ventilation and<br />

air conditioning (HVAC) chilled<br />

water systems into a fully-controlled<br />

building automation system, saving<br />

an estimated 2,000 tons of CO 2<br />

per year.<br />

26<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

4 5<br />

4 The roll-out of BE SAFE took place at several sites in<br />

<strong>2011</strong>: Here: Fornovo, Italy<br />

5 <strong>Boehringer</strong> <strong>Ingelheim</strong> Germany receives the Responsible<br />

Care Award for its BE SAFE activities<br />

6 Alternative engines: the new acquisitions for the<br />

German car fleet symbolise our requirement to reduce<br />

CO 2<br />

emissions effectively.<br />

6<br />

• At our plant in Yamagata, Japan: we<br />

installed a heat recovery chiller. It<br />

reduces the yearly consumption of<br />

energy and the emission of CO 2<br />

at<br />

the plant by more than 7 % (status<br />

October <strong>2011</strong>).<br />

• At our German sites: we systematically<br />

identified the optimisation<br />

potential of energy efficiency<br />

measures in buildings and initiated<br />

projects for implementation. These<br />

optimisation projects are scheduled<br />

from <strong>2011</strong> to 2014. Savings will<br />

amount to about 20 GWh per year,<br />

corresponding to about 4,500 tons<br />

of CO 2<br />

per year.<br />

• Our German car fleet: we are currently<br />

improving its environmental<br />

performance. Within the next few<br />

years, we are going to reduce the<br />

CO 2<br />

emission rates of our cars. The<br />

current average rate is 142 g. Reductions<br />

will be reached by switching<br />

to more efficient conventional<br />

cars, as well as by introducing alternative<br />

power resources. The<br />

number of electric cars is currently<br />

eight and is going to be increased to<br />

20 by end of 2012. Furthermore, a<br />

pilot project is ongoing, using a hydrogen-based<br />

car and the possibility<br />

of implementing our own hydrogen<br />

filling station is under<br />

evaluation.<br />

Our “Sustainable Use of Energy” team<br />

coordinates this kind of energy- and<br />

emission-reducing activities at an<br />

international level and fosters the<br />

knowledge exchange between our<br />

sites. This team has been integrated in<br />

our new project “BE GREEN”, which<br />

was started in <strong>2011</strong> with the aim of<br />

coordinating and optimising our<br />

green activities.<br />

Protection of employees’ health<br />

Since the start of the roll-out of the<br />

new <strong>Boehringer</strong> <strong>Ingelheim</strong> safety culture<br />

“BE SAFE - Zero by Choice” in<br />

May 2010, great effort has been made<br />

to systematically improve how we<br />

deal with our own safety. The aim is<br />

to encourage both the management<br />

and employees to pro-actively take on<br />

the responsibility of their own well-<br />

GREENHOUSE GAS REDUCTION<br />

A concept for calculating<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s corporate<br />

carbon footprint has been set<br />

up in accordance with the Greenhouse<br />

Gas Protocol, a multistakeholder<br />

initiative coordinated<br />

by the World Business Council<br />

for Sustainable Development and<br />

the World Resources Institute. We<br />

seek to minimise our footprint<br />

and have set a new goal to reduce<br />

our CO 2<br />

emission equivalents by<br />

20 % by 2020.<br />

Green activities<br />

27


SOIL CLEAN-UP AT OUR INGELHEIM SITE<br />

Until the beginning of the 1970s, it was common practice and<br />

legally permitted to fill exhausted sand, gravel and clay pits<br />

with chemical development and production waste. This is how,<br />

for example, the <strong>Ingelheim</strong> disposal site came about. We<br />

have already removed part of the contaminated deposits.<br />

In <strong>2011</strong>, observing nature conservation, some 45,000 m² of<br />

the soil at the disposal site was relocated and replenished, and<br />

the site secured with a surface barrier.<br />

If it is impossible to dispose of contaminated deposits completely,<br />

we extract groundwater in the immediate vicinity of<br />

the substances using protective boreholes in order to clean it<br />

in our wastewater treatment plant.<br />

1<br />

being and also look out for others<br />

working around them. The roll-out<br />

ensures that all functions go through<br />

a workflow comprised of various steps,<br />

such as self-assessments together with<br />

management and setting up specific<br />

improvement plans. By the end of<br />

<strong>2011</strong>, the roll-out of “BE SAFE” had<br />

been started in Germany, the USA,<br />

China, Austria, Spain, France, Italy,<br />

Mexico, Russia and other Eastern<br />

European countries. More countries<br />

will follow in 2012. In Germany, our<br />

activities in relation to this initiative<br />

have been rewarded by the German<br />

Chemical Association with the local<br />

Responsible Care Award.<br />

Care through protection<br />

In the interest of social responsibilty<br />

stretching over generations, and of<br />

sustainable environmental protection,<br />

the potential contamination of the<br />

soil at our sites should be eliminated<br />

wherever possible. For this purpose,<br />

we have started an extensive, global<br />

project for the inspection and, if necessary,<br />

clean-up of contaminated deposits<br />

in the soil at our company sites<br />

and in their immediate vicinity.<br />

We concentrate our efforts on longstanding<br />

sites. This approach is not<br />

stipulated by the authorities, but is<br />

undertaken voluntarily. We will bear<br />

all costs. Where pollution is identified,<br />

the soil will be returned as far as<br />

possible to a near-natural, geogenic<br />

state. Contaminated deposits should<br />

be disposed of such that they can<br />

cause no long-term damage.<br />

28<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

2<br />

Neurobiologists at the Research Institute of Molecular<br />

Pathology (IMP) in Vienna, Austria, study the mating ritual<br />

of flies to find out how the nervous system generates complex<br />

animal behaviour.<br />

1<br />

1 Fruit fly (Drosophila melanogaster).<br />

Copyright Solvin Zankl<br />

2 Picture of a fly brain. Digital atlas of the fruit fly brain,<br />

assembled from numerous individual images.<br />

Genetically defined neuronal networks are shown in<br />

various colours. Source IMP<br />

RESEARCH ALLIANCES<br />

We continue to support cooperations with academic research<br />

scientists to better define the underlying causes and molecular<br />

mechanisms of human disease. This is part of our involvement<br />

in public-private partnerships and guided by the notion of active<br />

citizenship and service to society.<br />

We have established a strong track<br />

record of working with academic scientists<br />

around the globe on drug discovery<br />

projects, ranging from the<br />

search for new drug targets to drug<br />

profiling and development. In addition,<br />

we have established a number<br />

of preferred, long-term partnerships<br />

with academic centres that transcend<br />

the scope of individual research projects.<br />

Examples include our involvement<br />

with the Institute of Molecular<br />

Pathology (IMP) in Vienna, Austria,<br />

and a newer partnership with the University<br />

of Ulm in Ulm, Germany.<br />

Networks: <strong>Boehringer</strong> <strong>Ingelheim</strong> and<br />

the Institute of Molecular Pathology<br />

The Institute of Molecular Pathology<br />

conducts basic research in molecular<br />

biology and engages in excellent networking<br />

for cutting-edge scientific<br />

research. The IMP is connected through<br />

cooperation at a scientific and administrative<br />

level to the Institute of<br />

Molecular Biotechnology of the Austrian<br />

Academy of Sciences (IMBA)<br />

and the neighbouring Gregor Mendel<br />

Institute. Numerous overlaps with the<br />

institutes of the University of Vienna<br />

and the Medical University of Vienna,<br />

as well as synergies with Austria-based<br />

biotechnology companies, characterise<br />

The Research Institute of Molecu -<br />

lar Pathology (IMP) conducts basic<br />

research in molecular biology and<br />

engages in excellent networking for<br />

cutting-edge scientific research.<br />

Research alliances 29


2<br />

1 At the Vienna Drosophila RNAi Center<br />

(VDRC), 32,000 transgenic lines of the<br />

fruit fly Drosophila melanogaster are bred<br />

and dispatched around the world when<br />

ordered by scientists and laboratories.<br />

Copyright Solvin Zankl<br />

1<br />

2 Elucidation of the infection apparatus<br />

of Salmonella using advanced cryoelectron<br />

microscopy. Pictured:<br />

a three-dimensional reconstruction<br />

of the needle complex with which<br />

Salmonella infects human cells.<br />

Source IMP-IMBA<br />

In <strong>2011</strong>, Jan-Michael Peters, biologist,<br />

received the Wittgenstein<br />

Award of the Austrian government,<br />

Austria’s most prestigious<br />

research prize. Together with his<br />

team at the IMP, he is studying<br />

the molecular mechanisms of cell<br />

division.<br />

the local network at the so-called<br />

Campus Vienna Biocenter site.<br />

IMP research is borne by <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> as well as Austrian and European<br />

research funding.<br />

Internationally networked<br />

Networks – whether virtual or real –<br />

leverage capabilities and give greater<br />

freedom of manoeuvre. The around<br />

200 IMP researchers are permanently<br />

in contact with working groups worldwide.<br />

The researchers are formally<br />

linked through major, international<br />

projects and informally through the<br />

active exchange of know-how and<br />

scientific material. There are also<br />

constant connections to Boeh ringer<br />

Ingel heim’s research and development<br />

teams. The researchers’ personal<br />

careers, that frequently switch<br />

between institutions and continents,<br />

weave the web tighter at an individual<br />

level.<br />

The goal of academic and extra-university<br />

basic research is to gain insights<br />

that are documented in scientific<br />

publications. IMP researchers<br />

annually publish some 80 specialist<br />

articles in peer-reviewed journals.<br />

Wittgenstein Prize for cutting-edge<br />

research<br />

In <strong>2011</strong>, Jan-Michael Peters received<br />

the Wittgenstein Prize, the most prestigious<br />

Austrian award for scientists,<br />

to become the sixth IMP winner.<br />

Since the European Research Council<br />

(ERC) was established in 2007, wellendowed<br />

support has also gone to<br />

six IMP researchers. In <strong>2011</strong>, Group<br />

Leaders Andrew Straw and Manuel<br />

Zimmer both received approval for<br />

an ERC starting grant and Meinrad<br />

Busslinger, Senior Scientist at IMP,<br />

for an advanced grant.<br />

Securing this funding is extremely<br />

competitive and is exclusively related<br />

to the quality and potential of the research.<br />

The funds make it possible to<br />

address questions that can only be answered<br />

with major personnel and<br />

technical expenditure.<br />

30<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

4<br />

RESEARCH INTO CELL DIVISION IS ONE OF THE CORE AREAS AT THE IMP.<br />

3 Human cells dividing. The chromosomes are grey, the spindle apparatus protein<br />

(tubulin) coloured blue or red, depending on intensity (pseudo-colours). Source IMP<br />

4 The course of cell division in human HeLA cells. Chromosomes in blue, spindle apparatus<br />

in green. Points of contact for spindle fibres (kinetochores) shown in red. Source IMP<br />

3<br />

Unlocking the immune system’s<br />

regulatory network<br />

Meinrad Busslinger researches the<br />

adaptive immune system with the<br />

goal of unlocking the regulatory network<br />

that controls the development<br />

of the blood’s B and T lymphocytes<br />

from stem cells. A significant factor,<br />

the PAX5 gene, was identified by<br />

his group some years ago. In <strong>2011</strong>,<br />

the team described new regulatory<br />

elements that control the formation<br />

of millions of different immunoglobulins.<br />

Networking with basic research<br />

institutes<br />

Networking is also essential for Jan-<br />

Michael Peters’s group in elucidating<br />

the structural mechanism of the anaphase<br />

promoting complex (APC),<br />

which initiates cell division. While<br />

the IMP-team is specialised in biochemical<br />

methods, Holger Stark of<br />

the Max Planck Institute for Biophysical<br />

Chemistry in Göttingen,<br />

Germany, contributes his expertise in<br />

three-dimensional cryo-electron microscopy.<br />

Structural biologists at the Howard<br />

Hughes Medical Institute in Memphis,<br />

Tennessee, USA, complement the<br />

analyses through crystallographic<br />

methods. This cooperation between<br />

several teams is exemplary for the<br />

modern approach to complex biological<br />

questions.<br />

With its three new group leaders in<br />

<strong>2011</strong>, the IMP also imported their<br />

networks. Physician Johannes Zuber<br />

previously conducted research at Cold<br />

Spring Harbor Laboratory in New<br />

York, USA. In Scott Lowe’s laboratory<br />

he investigated novel therapeutic approaches<br />

for leukaemia and in <strong>2011</strong>,<br />

in a joint publication, described a new<br />

active ingredient against acute myeloid<br />

leukaemia. In Vienna, he collaborates<br />

with the Medical University and<br />

Oncology Research at <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>.<br />

At the IMP research is conducted,<br />

inter alia, into the mechanisms<br />

underlying the development of B<br />

and T lymphocytes from blood<br />

stem cells. B and T lymphocytes<br />

are white blood cells that are responsible<br />

for acquired immunity.<br />

Research alliances 31


BOEHRINGER INGELHEIM ULM<br />

UNIVERSITY BIOCENTER<br />

In <strong>2011</strong>, the University of Ulm, Germany,<br />

and <strong>Boehringer</strong> <strong>Ingelheim</strong> signed a research<br />

cooperation agreement which is<br />

also being supported by the Baden-Württemberg<br />

government. The new research<br />

alliance is called “<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Ulm University Biocenter” (BIU) with a<br />

funding volume of around EUR 4.5 million<br />

for an initial period of three years. We<br />

will contribute EUR 2.25 million and, as<br />

a global research-driven company, will<br />

also bring to the cooperation the experience<br />

and stability needed to accomplish<br />

projects that are multi-disciplinary and<br />

require scientific persistence.<br />

The auditory cortex in the brain of a transgenic<br />

mouse. Individual nerve cells are displayed<br />

using special colouring techniques, with different<br />

cell types defined by various colours.<br />

Signing of the agreement: Prof. Gerd<br />

Schnorrenberg (lower left) Head of Research<br />

Germany, at <strong>Boehringer</strong> <strong>Ingelheim</strong> in<br />

Biberach, Germany and President of Ulm<br />

University, Prof. Karl Joachim Ebeling (lower<br />

right). Prof. Andreas Barner, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> (upper left), Theresia Bauer,<br />

Science minister, Baden-Württemberg (upper<br />

right)<br />

Picture by BioRegionUlm<br />

Structural biologist Thomas Marlovits<br />

cooperates closely with researchers in<br />

the USA on investigating the details of<br />

the infection apparatus of Salmonellae.<br />

Using advanced methods of<br />

cryo-electron microscopy, he has also<br />

resolved the structure of the needlecomplex<br />

on a near atomic level. A<br />

team of Yale researchers contributed<br />

expertise in bacterial genetics.<br />

Besides addressing questions of cell<br />

biology and mechanisms of disease,<br />

the IMP also focuses on research into<br />

neuronal networks. Powerful new<br />

tools in optogenetics, imaging and<br />

electrophysiology make it possible to<br />

measure and manipulate neural activity<br />

within genetically-defined circuits<br />

and causally link them to behaviour.<br />

The young discipline circuit neuroscience<br />

has a highly interdisciplinary<br />

character.<br />

Neurobiologists around IMP Director<br />

Barry Dickson investigate which elements<br />

of the nervous system control<br />

the reproductive behaviour in fruit<br />

flies. With newly developed thermogenetic<br />

methods, they can target individual<br />

nerve networks and, for example,<br />

trigger the mating song of the male fly<br />

“remotely”. Together with visual computing<br />

experts of the Center for Virtual<br />

Reality and Visualisation (VRVis) in<br />

Vienna, the neurobiologists developed<br />

“BrainGazer” – a software that produces<br />

an interactive 3D atlas of the<br />

fly’s brain from tens of thousands of<br />

confocal microscope images.<br />

32<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

The Institute of Molecular Biology (IMB) in Mainz,<br />

Germany, was opened in March <strong>2011</strong>. It is exemplary<br />

for our approach to foster excellent research.<br />

PROMOTING EXCELLENCE<br />

LONG-TERM<br />

The <strong>Boehringer</strong> <strong>Ingelheim</strong> Foundation is an independent, non-profit<br />

organisation committed to the promotion of the medical, biological,<br />

chemical and pharmaceutical sciences. In particular, we support<br />

outstanding young scientists. Our commitment to the Institute of<br />

Molecular Biology (IMB) in Mainz, Germany, is exemplary of our<br />

approach to fostering excellent research.<br />

A number of high-ranking representatives<br />

of science and politics attended<br />

the opening ceremony of the Institute<br />

of Molecular Biology (IMB) at the<br />

University of Mainz in March <strong>2011</strong>.<br />

The institute is contrived as a publicprivate<br />

partnership between the<br />

public sector and a private foundation.<br />

The <strong>Boehringer</strong> <strong>Ingelheim</strong> Foundation<br />

pledged itself to endow the scientific<br />

running of the IMB – and thus<br />

promote excellence on a long-term<br />

basis – by financing it with a total<br />

of EUR 100 million over a period of<br />

10 years. The federal state government<br />

of Rhineland-Palatinate financed the<br />

building of this modern research institute<br />

to the tune of EUR 45.5 million.<br />

The IMB and its affiliation with<br />

the Johannes Gutenberg University<br />

aim to strengthen the international<br />

biomedical research in Mainz and, as<br />

such, to attract leading scientists as<br />

well as outstanding up-and-coming<br />

young researchers.<br />

In addition to the group of IMB’s<br />

founding director, Prof. Christof<br />

Promoting excellence long-term 33


Awarding of the Heinrich-Wieland-Prize <strong>2011</strong><br />

(from left to right: Christoph <strong>Boehringer</strong>, prize<br />

winner Prof. Franz-Ulrich Hartl, Prof. Konrad<br />

Sandhof).<br />

1<br />

HEINRICH WIELAND PRIZE<br />

The international prize is named<br />

after the German chemist and Nobel<br />

Prize laureate Heinrich Otto<br />

Wieland (1877 – 1957) and has<br />

been awarded annually since<br />

1964 by an independent board<br />

of trustees. Since <strong>2011</strong>, the<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Foundation<br />

has endowed the international<br />

Heinrich Wieland Prize with EUR<br />

50,000. The prize honours outstanding<br />

research on biologically<br />

active molecules and systems and<br />

its clinical impact in the areas of<br />

chemistry, biochemistry and<br />

physiology.<br />

Niehrs, several Junior Researcher<br />

Groups and two Senior Research<br />

Groups have already taken up their<br />

work at the IMB. Two further directors<br />

are soon to be appointed. A total<br />

of three directors` groups and 8 – 10<br />

smaller research groups are planned,<br />

all of which will have the institute’s<br />

core facilities for bioinformatics,<br />

cytometry, histology, high-end microscopy,<br />

microarray analysis and next<br />

generation sequencing at their disposal.<br />

Research at the IMB concentrates on<br />

three areas: developmental biology,<br />

epigenetics and DNA repair. The<br />

knowledge gained about these fundamental<br />

biological phenomena from<br />

basic research will provide more insight<br />

into processes such as ageing<br />

and the development of diseases like<br />

cancer. The IMB thus combines longterm<br />

basic research with its potential<br />

to be of benefit to patients.<br />

Heinrich Wieland Prize <strong>2011</strong><br />

In <strong>2011</strong>, the Heinrich Wieland Prize<br />

went to Professor Franz-Ulrich Hartl,<br />

director at the Max Planck Institute<br />

of Biochemistry in Martinsried, Germany.<br />

He and his colleagues discovered<br />

that proteins do not fold spontaneously<br />

within cells, but require the<br />

assistance of other proteins known as<br />

chaperones. Misfolded, aggregated<br />

proteins play, for instance, a central<br />

role in neuro degenerative diseases<br />

such as Morbus Alzheimer, Chorea<br />

Huntington and Morbus Parkinson.<br />

Hartl’s pioneering work could therefore<br />

paved the way for new approaches<br />

for the prevention, diagnosis and<br />

therapy of these illnesses.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Fonds:<br />

Passion for science<br />

The <strong>Boehringer</strong> <strong>Ingelheim</strong> Fonds (BIF),<br />

a non-profit foundation for basic biomedical<br />

research, was called into<br />

existence in 1983. The foundation is<br />

known for its international Titisee<br />

Conferences and, above all, for its<br />

PhD fellowships for the promotion of<br />

scientific excellence in international<br />

basic research. It supports 120 outstanding<br />

PhD students of all national-<br />

34<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


corporate responsibility<br />

responsibility for future generations<br />

1 BPA endothelial cells, coloured. Visible are the cell nucleus,<br />

mitochondria and actin filaments.<br />

2 Research on developmental biology: sperm production in mice;<br />

coloured histological preparations of mice sperm precursors.<br />

3 The “Doctor of Medicine” (MD) Fellowship Programme of the<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Fonds supports ongoing doctors of medicine<br />

studying inGermany.<br />

2<br />

3<br />

ities at any one time. The fellows, who<br />

work in Europe and the USA, receive a<br />

competitive monthly stipend, personal<br />

support and participate in seminars.<br />

Less than 10 per cent of all applicants<br />

are admitted to the programme after<br />

a challenging selection procedure. In<br />

<strong>2011</strong>, applications for two of BIF’s programmes<br />

reached an all-time high;<br />

525 applications for PhD fellowships<br />

and almost 200 for travel grants were<br />

received by the administrative headquarters.<br />

Bridging the gap between basic<br />

research and medicine<br />

For a few years now, the BIF has been<br />

running a programme to support ongoing<br />

doctors of medicine who have<br />

opted to study in Germany and change<br />

their workplace for their dissertation.<br />

These “Doctor of Medicine” (MD)<br />

fellow ships are designed to enable<br />

talented young medical students to<br />

pursue a challenging experimental<br />

MD thesis in biomedical basic research<br />

under state-of-the-art conditions.<br />

They are given the opportunity<br />

to learn new methods and techniques<br />

under the auspices of leading scientists<br />

in internationally renowned laboratories.<br />

In addition to the financial<br />

aspect of the fellowship, MD fellows<br />

also receive the all-round personal<br />

support that is one of BIF’s hallmarks.<br />

Up to now, the BIF has awarded<br />

fellowships to about 40 MD students,<br />

the majority of which choose to do<br />

research in the USA. The first MD<br />

fellows have since published their<br />

scientific results in renowned<br />

scientific journals such as Science,<br />

Molecular Cell or EMBO Journal and<br />

some have already gone on to do a<br />

doctorate in a scientific discipline<br />

(PhD) after completing their MD.<br />

RESEARCH SUBJECT OF THE<br />

HEINRICH WIELAND PRIZE<br />

WINNER <strong>2011</strong>:<br />

PROTEIN FOLDING<br />

The spatial structure of the cellular<br />

protein factories (polyribosomes)<br />

helps to prevent misfolding – a<br />

polyribosome consists of several<br />

individual ribosomes, which are<br />

made of small (yellow) and large<br />

(blue) subunits. Newly formed<br />

proteins (red cones) maintain the<br />

greatest possible distance from<br />

one another to prevent aggregation<br />

of neighbouring proteins.<br />

Promoting excellence long-term<br />

35


# 02<br />

INNOVATION<br />

FOR THE BEST MEDICINE<br />

Our goal is to research and develop the best-suited types of molecule, from either<br />

new chemical or biological active ingredients, for the treatment of diseases.<br />

Pioneering approaches in translational medicine, such as the early identification<br />

of biomarkers, should simplify the early development phases. Additionally,<br />

we are pursuing broader approaches to find new targets, often in cooperation with<br />

academic institutions. In biopharmaceuticals, we have over many years built<br />

up expertise in the development and manufacture of biologicals, such as proteins<br />

and monoclonal antibodies.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

38 DEDICATED TO INNOVATION<br />

40 RESEARCH AND DEVELOPMENT OF NEW BIOLOGICAL ENTITIES<br />

44 TRANSLATING RESEARCH, TRANSFORMING MEDICINES<br />

48 BETTER MEDICINES AND VALUE FOR PATIENTS<br />

50 THE BOEHRINGER INGELHEIM VENTURE FUND<br />

36<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

Innovation for the best medicine 37


RESEARCH AREAS<br />

boehringer ingelheim’s research and development focuses on six major areas:<br />

respiratory<br />

diseases<br />

cardio-metabolic<br />

diseases<br />

oncology<br />

diseases of the<br />

central nervous<br />

system (cns)<br />

immunology<br />

infectious<br />

diseases<br />

DEDICATED TO INNOVATION<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has always defined itself as a researchdriven<br />

pharmaceutical company with one aim: bringing better<br />

health to more people. We have committed ourselves to the<br />

goal of serving humankind through research into diseases and<br />

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

studying human diseases, the subsets<br />

of each disease, and establishing target-disease<br />

relationships which enables<br />

us to ask the right and impactful<br />

questions. Our ambition is to gain an<br />

early insight into new therapeutic<br />

concepts and thereby be actively involved<br />

in the provision of therapeutic<br />

options of tomorrow.<br />

THE BOEHRINGER INGELHEIM PIPELINE<br />

[ 84 projects in development ]<br />

16<br />

respiratory<br />

diseases<br />

5<br />

immunology<br />

8<br />

cns diseases<br />

5<br />

infectious<br />

diseases<br />

24<br />

oncology<br />

26<br />

cardiometabolic<br />

diseases<br />

For us the simple answer to the question,<br />

“Why are we conducting our<br />

own research and development” is<br />

that the efforts across all areas of activity<br />

are aimed at creating compounds<br />

and treatments which offer<br />

significant therapeutic benefits to patients.<br />

We continue to be a major driver<br />

of innovative, new medicines for<br />

the treatment of diseases with unmet<br />

therapeutic need.<br />

Bringing medical innovation to patients<br />

is the shared vision of our scientists.<br />

A better understanding of human<br />

diseases is the basis for selection<br />

of innovative targets and therapeutic<br />

modalities. We therefore focus on<br />

We have a strong commitment to current<br />

and increased investment in R&D<br />

and wish to work, in our areas of<br />

therapeutic focus, with partners in industry<br />

and science, as science is progressing<br />

rapidly with increasingly<br />

specialist knowledge.<br />

We firmly believe in the expertise of<br />

leading academic groups, public research<br />

institutes and biotech companies,<br />

and we collaborate with partners<br />

across the entire value chain of drug<br />

discovery.<br />

38<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

SUCCESSFUL PRESCRIPTION MEDICINES<br />

from our own research & development<br />

sifrol® / mirapex® / mirapexin®<br />

pramipexole<br />

Parkinson’s disease<br />

pradaxa®<br />

dabigatran etexilate<br />

Prevention of venous thrombo-embolic events<br />

(VTE) after hip or knee replacement surgery<br />

twynsta®<br />

telmisartan and<br />

amlodipine<br />

Essential<br />

hypertension<br />

pradaxa®<br />

dabigatran etexilate<br />

Prevention of stroke and<br />

systemic embolism in<br />

adults with non-valvular<br />

atrial fibrillation (SPAF)<br />

viramune®<br />

nevirapine<br />

HIV/AIDS<br />

micardis®<br />

telmisartan<br />

Essential hypertension<br />

spiriva®<br />

tiotropium<br />

Chronic obstructive pulmonary<br />

disease (COPD)<br />

sifrol®<br />

pramipexole<br />

Restless legs<br />

syndrome (RLS)<br />

spiriva® respimat soft<br />

mist inhaler<br />

tiotropium<br />

COPD<br />

trajenta ©<br />

linagliptin<br />

Type 2 diabetes mellitus<br />

1996 2000 2005 2010<br />

Our activities in R&D include both<br />

new chemical entities (NCEs) and new<br />

biological entities (NBEs) with the<br />

aim of identifying and validating new<br />

and innovative mechanisms of action<br />

and targets.<br />

Therapeutic benefit for patients<br />

Basic research findings are of fundamental<br />

importance. Furthermore, it is<br />

vital to focus more on existing indication<br />

areas and on diseases with an<br />

unmet medical need. As the understanding<br />

of many human diseases is<br />

still very limited, our research concentrates<br />

on relevant questions, bedside-tobench<br />

research.<br />

We will optimise the development of<br />

drugs and identify biomarkers to expand<br />

the therapeutic scope of our<br />

medications with the aim of filling<br />

existing therapeutic gaps.<br />

Breakthroughs, in genetic research,<br />

for example, are resulting in a new<br />

era of personalised medicine and, of<br />

course, have an impact on the drug<br />

discovery and development process.<br />

A deeper understanding of the genetic<br />

information at the individual level<br />

is enabling new methods of detecting,<br />

treating, and preventing diseases that<br />

are tailored to the needs of each patient.<br />

our research and development sites<br />

1 ridgefield, usa<br />

2 laval, canada<br />

3 buenos aires, argentina<br />

2<br />

1<br />

3<br />

4<br />

5<br />

6<br />

4 biberach and ingelheim, germany<br />

5 milan, italy<br />

6 vienna, austria<br />

7 kobe, japan<br />

7<br />

Dedicated to innovation<br />

39


1 2<br />

1 New Safety Assessment Building (computer animation)<br />

2 R&D site in Ridgefield, USA<br />

3 Automated high throughput screening platform<br />

3<br />

RESEARCH AND DEVELOPMENT OF<br />

NEW BIOLOGICAL ENTITIES<br />

One of our pillars in research and development is to produce<br />

innovative medicines by discovering and developing new biological<br />

entities (NBEs) against human diseases.<br />

Integrated network<br />

To ensure the successful execution of<br />

our NBE projects three NBE skill centers<br />

were established in 2010 in our business<br />

units Research, Development and Biopharmaceuticals.<br />

Both the NBE skill<br />

centers for research and for non-clinical<br />

development are located in Ridgefield,<br />

Connecticut, USA.<br />

40<br />

Over the past 18 months, our global<br />

portfolio has grown from 25 to<br />

over 40 NBE research projects.<br />

Our focus on new biological entities<br />

Our vision is to produce innovative<br />

medicines by implementing new technologies<br />

and to develop differentiated<br />

NBEs with superior efficacy profiles.<br />

Over the past few years, we have been<br />

investing in enhancing our own research<br />

and development capabilities for<br />

the discovery of NBEs.<br />

In this area, we profit from the expertise<br />

of several years working as a<br />

contract manufacturing organisation<br />

(CMO) in the field of NBE drugs.<br />

As a result, the portfolio of biological<br />

projects has grown steadily in both<br />

preclinical and clinical stages.<br />

The NBE skill center for Biopharmaceuticals<br />

is located in Biberach (Germany)<br />

and Vienna (Austria). These three NBE<br />

skill centers share a common goal of developing<br />

and implementing strategies,<br />

driving cross-functional initiatives, and<br />

capitalising on effectiveness from lessons<br />

learned, all of which are the essence<br />

of successful drug development.<br />

NBE research<br />

We have the competence to discover<br />

novel therapeutic molecules, including<br />

monoclonal antibodies and related<br />

antibody-based formats. This enables<br />

us to employ a diversity of molecular<br />

platforms to produce specific and<br />

40<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

NBE SKILL CENTERS<br />

Each NBE skill center – Research, Development and<br />

Biopharmaceuticals – consists of a pool of scientists<br />

with specific expertise. By working together<br />

effectively, the three skill centers will bring more<br />

health to patients and their families.<br />

nbe skill center<br />

research<br />

nbe skill center<br />

non-clinical<br />

development<br />

nbe skill center<br />

interface<br />

nbe skill center<br />

biopharmaceuticals<br />

effective treatments for life-threatening<br />

diseases within our therapeutic areas.<br />

NBE Research is comprised of an integrated<br />

network of the Research NBE<br />

skill centre as well as in the NBE<br />

pharmacology departments located in<br />

Biberach (Germany), Laval (Canada),<br />

Ridgefield (USA) and Vienna (Austria).<br />

The skill center specialises in the<br />

generation, design, characterisation<br />

and optimisation of lead molecules.<br />

The NBE pharmacology scientists<br />

work in collaboration with therapeutic<br />

area specialists to perform diseaserelevant<br />

assays. Members of the skill<br />

center as well as the pharmacologists<br />

participate in research project teams,<br />

thereby providing their expertise to<br />

guide the design and testing of candidate<br />

therapeutic molecules.<br />

Search for multi-specific NBEs<br />

We strive to implement new and innovative<br />

approaches to meet the challenge<br />

of treating diseases in ways<br />

which achieve better therapeutic out-<br />

comes. As our understanding of human<br />

disease improves, it has become<br />

clear that multiple pathways contribute<br />

to disease pathogenesis. Thus, molecules<br />

that target multiple pathways<br />

offer the opportunity to deliver superior<br />

benefits for our patients.<br />

To achieve this goal, multi-specific molecules<br />

capable of modulating multiple<br />

biological pathways are beginning to<br />

emerge as a core platform for the next<br />

generation of NBE products.<br />

Development of NBE drugs<br />

When an NBE drug candidate is identified<br />

by Research, either by our own<br />

researchers or as a result of an external<br />

cooperation, a multifaceted process<br />

starts, involving specialists within the<br />

non-clinical Development organisation<br />

and the Biopharmaceuticals organisation.<br />

The non-clinical Development<br />

NBE skill center offers access to the expertise<br />

of Non-clinical Drug Safety,<br />

Drug Metabolism and Pharmacokinetics,<br />

and Analytical Development.<br />

building on partnerships<br />

To strengthen our research portfolio and expertise<br />

in developing NBEs binding to two targets<br />

(bispecific therapeutics), we are building<br />

on our partnership with Ablynx NV. The aim is<br />

the discovery of therapeutic Nanobodies®. We<br />

have also entered into separate global strategic<br />

collaborations with MacroGenics, Inc., and<br />

f-star, Biotechnologische Forschungs- und Entwicklungsges.<br />

m. b. H.<br />

MacroGenics has developed the Dual-Affinity<br />

Re-Targeting (DART) platform technology<br />

that is focused on dual specificity “antibodylike”<br />

therapeutic proteins capable of targeting<br />

multiple pathways with a single recombinant<br />

molecule.<br />

DART-based molecules are currently being<br />

evaluated within our organisation for modulating<br />

targets focused on the treatment of rheumatoid<br />

arthritis. f-star is focused on developing<br />

bispecific molecules based on its unique<br />

Modular Antibody Technology® which allows<br />

engineering of additional specific binding sites<br />

within novel regions of an antibody.<br />

Additionally, we work together with Micromet,<br />

Inc., to develop and commercialise a BiTE®<br />

(Bispecific T-cell Engager) for the treatment of<br />

multiple myeloma. BiTE®s represent a novel<br />

class of therapeutic antibody fragments designed<br />

to specifically direct the body’s cell-destroying<br />

T-cells against target cancer cells.<br />

Research and development of new biological entities<br />

41


RESEARCH & DEVELOPMENT VALUE CHAIN<br />

target<br />

selection<br />

lead identification/<br />

optimisation<br />

pre-clinical<br />

development<br />

phase i/ii/iii registration launch<br />

cmc development value chain for drug substance and drug product<br />

cell line development/<br />

host screening<br />

process development/<br />

pre-clinical material supply<br />

clinical & commercial<br />

material supply<br />

academia and industry<br />

We are one of the founding corporate<br />

members of the Biomolecular Interactions<br />

Technologies Center (BITC), a consortium<br />

in which academic and industrial<br />

researchers can interact to transfer advanced<br />

biophysical technologies and methods.<br />

EUR 31m<br />

As part of dealing with the rapid<br />

growth in the number of NBE development<br />

projects, we are investing<br />

EUR 31m in a new drug<br />

safety assessment building in<br />

Ridgefield.<br />

More specifically, this is the assessment<br />

of the drug safety of all NBEs<br />

that are being developed at<br />

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

Non-clinical NBE development<br />

Another task in non-clinical development<br />

of NBEs is the definition of the<br />

pathway of a drug after it enters the<br />

body and its relationship to safety and<br />

efficacy. The techniques used to fulfil<br />

these activities are in vitro and in vivo<br />

investigations, computational techniques<br />

that assess the pathway of new<br />

molecular entities. Furthermore, studies<br />

determine the time-dependent<br />

drug concentration (pharmacokinetics<br />

or PK) and drug efficacy profiles<br />

(pharmacodynamics or PD). Biotherapeutic<br />

Bioanalysis has the primary<br />

goal of providing all required bioanalytical<br />

support for NBEs. This includes<br />

measurement of drug concentration<br />

in plasma as well as characterisation<br />

of anti-drug antibody responses.<br />

Besides the usual challenges in drug<br />

development, selection of species for<br />

pharmacology and non-clinical safety<br />

assessment, intravenous and/or subcutaneous<br />

formulation development,<br />

demonstration of drug product comparability,<br />

immunogenicity risk assessment<br />

and the selection of optimal dose<br />

levels for the clinic are considered<br />

unique challenges for development of<br />

NBEs. The Biopharmaceutical skill<br />

centre covers Chemistry, Manufacturing<br />

and Control (CMC) development<br />

for mammalian and microbial products<br />

from DNA to filled vials.<br />

CMC development<br />

Typically 3 - 5 lead candidates identified<br />

in Research are further assessed<br />

regarding their physico-chemical and<br />

manufacturability properties within<br />

the Biopharmaceuticals organisation.<br />

The comprehensive data package from<br />

Research and Biopharmaceuticals will<br />

guide the final selection of the lead<br />

candidate.<br />

CMC development starts with cell line<br />

development and initial process development<br />

for early supply of repre-<br />

42<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

BIOPHARMACEUTICAL PRODUCTION<br />

1 Automated filling plant<br />

2 Cell expansion<br />

3 Cell proliferation in inoculum<br />

1<br />

2<br />

3<br />

sentative material for assessment in<br />

pre-clinical assays (non-clinical drug<br />

profiling: drug safety, pharmacokinetic<br />

and pharmaco-dynamic) by applying<br />

proprietary technology platforms, such<br />

as the BI-HEX® expression system,<br />

high-throughput rapid clone screening<br />

and rapid screening of purification<br />

conditions (RAPPTor®). Comprehensive<br />

and parallel analytical, drug substance<br />

and drug product development assure<br />

rapid and high-quality process development<br />

to ensure fast track supplies of<br />

material for good laboratory practice<br />

(GLP) toxicology studies and clinical<br />

trials. Our excellence in process science<br />

and technology accelerates time to<br />

clinical development as well as time<br />

to market.<br />

Two phases of development<br />

A lean, back-loading approach focusing<br />

on the basic process elements to<br />

support early clinical studies is followed<br />

by a process optimisation phase<br />

to ensure robust and economic clinical<br />

phase III and commercial supplies.<br />

This includes process productivity increase<br />

(fermentation and purification),<br />

final formulation and selection of<br />

commercial application and delivery<br />

device.<br />

The final, commercial process format<br />

is transferred into our large scale<br />

cGMP (current Good Manufacturing<br />

Practice) manufacturing plants which<br />

are multi-product facilities. The Biologics<br />

Licence Application (BLA) is received<br />

on the basis of runs in the final<br />

scale and generated product stability<br />

data. Usually process validation is performed<br />

in parallel to prove the robustness,<br />

quality and replicability of<br />

the commercial process.<br />

Key for success<br />

At <strong>Boehringer</strong> <strong>Ingelheim</strong> this is truly<br />

an exciting time for NBE Research<br />

and Development. While much<br />

progress has already been achieved,<br />

even greater mutual cooperation,<br />

innovation, and dedication will be<br />

the key for success for our endeavours<br />

in the development of drugs, based<br />

on NBEs.<br />

Research and development of new biological entities<br />

43


HOW TRANSLATIONAL MEDICINE AND PRODUCT & PIPELINE SCIENTIFIC SUPPORT (PPSS) WORK<br />

drug<br />

characteristics<br />

comparator<br />

information<br />

biomarkers/<br />

pharmacogenomics<br />

disease<br />

information<br />

patients´<br />

attributes<br />

data/information<br />

integration models<br />

clinical response<br />

of the drug<br />

TRANSLATING RESEARCH,<br />

TRANSFORMING MEDICINES<br />

streamlining early clinical development<br />

programmes and earlier decision<br />

points based on biomarkers and surrogate<br />

endpoints.<br />

With a focus on expanding knowledge of disease biologies,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> aims to develop new personalised treatment<br />

approaches that provide more benefit for patients.<br />

PERSONALISING HEALTHCARE<br />

Which compound prolongs life<br />

best in a patient suffering from<br />

lung cancer How do you predict<br />

the effectiveness of a medication<br />

Questions like these are the<br />

basis for the integrated approaches<br />

of our Translational Medicine<br />

(TransMed) and Product & Pipeline<br />

Scientific Support (PPSS).<br />

Their mission: to identify the<br />

most promising compounds from<br />

the research pipeline to bring<br />

them to the right patients as fast<br />

as possible.<br />

Our approach to innovation includes<br />

Translational Medicine (TransMed)<br />

and Product & Pipeline Scientific Support<br />

(PPSS, Translational Research) in<br />

the area of translational research. Both<br />

aim to help develop the most promising<br />

compounds from the research<br />

pipeline to bring them to the right patients<br />

as fast as possible.<br />

Society expects innovative medicines<br />

at affordable prices. At the same time,<br />

and rightly so, it has increasing demands<br />

on their safety and efficacy. Our Translational<br />

Medicine group, together with<br />

the clinical development teams, aims<br />

to revise development paradigms by<br />

A classic example is to measure effects<br />

on blood sugar in the early testing of<br />

new diabetes drugs instead of having<br />

to deal with the consequences of diabetes,<br />

which can only be assessed in<br />

subsequent long-lasting studies.<br />

The selection of new markers and<br />

endpoints is facilitated by internal<br />

and external research to strengthen<br />

the mechanistic understanding of the<br />

clinical drug candidates, organised<br />

and executed by the PPSS group.<br />

Asking the right questions<br />

Important parts of this streamlining<br />

are two questions:<br />

• Which compound is most promising<br />

clinically<br />

• Which patient is most likely to benefit<br />

from this treatment<br />

The definitive answer to these questions,<br />

e. g., which compound prolongs<br />

44<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

BEDSIDE TO BENCH APPROACH<br />

Identification<br />

of biomarkers<br />

Diagnosis of<br />

disease subtype<br />

patient disease disease subtype identification<br />

of drugable<br />

target<br />

Patient-specific<br />

therapy<br />

specific<br />

medication<br />

life best in a lung cancer patient, can<br />

only be found in comprehensive and<br />

long-lasting clinical studies. However,<br />

it is ethically necessary and, furthermore,<br />

commercially prudent, to focus<br />

exposure to a new cancer drug on<br />

those patients most likely to benefit<br />

from such treatment.<br />

Identifying the right compound and<br />

the right patient requires biomarkers,<br />

which predict therapeutic response.<br />

These can include parameters measured<br />

in blood samples or images generated<br />

by techniques, such as magnetic<br />

resonance imaging (MRI), positron<br />

emission tomography (PET scan) or<br />

computer tomography (CT). In the case<br />

of non-small-cell lung cancer (NSCLC),<br />

a mathematical model based on four<br />

large registration trials was developed<br />

that linked survival to risk factors and<br />

changes in tumour size measured by<br />

imaging technologies after eight<br />

weeks of treatment.<br />

Such a disease model, that can link an<br />

early biomarker response to a clinical<br />

endpoint, is independent of the drug<br />

and uses quantitative data from previous<br />

studies to facilitate future development<br />

of anti-NSCLC drugs.<br />

Another type of biomarker relates to<br />

the genetic makeup, which can differ<br />

in subtle but nevertheless important<br />

ways between individuals. These gene<br />

variations are termed polymorphisms.<br />

While they cannot be used to follow<br />

treatment effects, they can help to stratify<br />

patient groups and identify those<br />

most likely to benefit from treatment.<br />

Thus, genotypes are essential parts of<br />

a comprehensive understanding of<br />

new drugs.<br />

Partnerships with academia<br />

Identifying optimal biomarkers is facilitated<br />

by our continued investment<br />

in internal and external experimental<br />

research related to its drug candidates<br />

in clinical development and on the<br />

market. This involves partnerships<br />

with leading academic institutions,<br />

such as Stanford University (USA), the<br />

Karolinska Institute (Sweden) and<br />

Translating research, transforming medicines<br />

45


NON-SMALL-CELL LUNG CANCER<br />

1 The border between malignant growth and the still<br />

normal, ciliated epithelium in the bronchus of a<br />

45-year-old heavy smoker.<br />

2 Cancer cells and normal, ciliated cells in the<br />

bronchial tree of a heavy smoker.<br />

3 A squamous cell carcinoma in the bronchial tree.<br />

1<br />

2 3<br />

Our investment in internal and<br />

external experimental research<br />

involves partnerships with leading<br />

academic institutions, such as<br />

Stanford University, the Karolinska<br />

Institute and Johannes Gutenberg<br />

University.<br />

Johannes Gutenberg University Mainz<br />

(Germany).<br />

While the value of biomarkers is obvious,<br />

their usefulness at the group<br />

or individual level requires careful<br />

validation. It needs to be demonstrated<br />

that a change in a given biomarker,<br />

such as levels of a protein in blood, is<br />

indeed predictive for a change in a<br />

clinically relevant outcome, for instance,<br />

extended survival.<br />

Partnerships with organisations<br />

To identify and validate biomarkers,<br />

we work with internal and external<br />

partners including consortia of academic<br />

institutions, governmental<br />

agencies and pharmaceutical companies,<br />

e. g. the ‘Innovative Medicines<br />

Initiative’ by the European Union and<br />

the pharmaceutical industry association<br />

EFPIA. Collaboration with external<br />

partners will also help to make results<br />

available to as many patients as<br />

possible. These specific steps will contribute<br />

to the establishment of personalised<br />

medicine.<br />

Identification of patient characteristics<br />

Moreover, patient characteristics (e.g.<br />

renal function, often assessed as creatinine<br />

clearance) can have a relevant<br />

impact on finding the right dose for<br />

the right patient. An example of this is<br />

pradaxa® (dabigatran etexilate), our<br />

innovative drug for preventing stroke<br />

in patients with atrial fibrillation (AF).<br />

Some of the patients potentially benefitting<br />

from dabigatran suffer from<br />

severe renal failure, a population that<br />

was not explicitly tested during the<br />

clinical development. Nevertheless, it<br />

is necessary to develop a dose and<br />

dosing regimen for these patients. We<br />

therefore developed a model based on<br />

the data from 9,522 patients from the<br />

pivotal phase III study RE-LY®. The<br />

resulting data showed that AF patients<br />

with a markedly reduced renal function<br />

(creatinine clearance of ≥ 15 to<br />

< 30 mL/min as compared to > 90 mL/<br />

min), treated with a dose of 75 mg dabigatran<br />

etexilate twice daily, have target<br />

plasma level and exposure data<br />

largely within the concentration range<br />

proven to be safe and effective in pa-<br />

46<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

BENCH TO BEDSIDE APPROACH<br />

cancer<br />

studies<br />

cancer<br />

treatment<br />

compound<br />

oncology<br />

experimental +<br />

clinical<br />

lung studies<br />

lung fibrosis<br />

treatment<br />

new<br />

indication<br />

tients with less reduced or normal<br />

renal function (creatinine clearance<br />

> 30 mL/min) receiving 150 mg twice<br />

a day. This dosing schedule was also<br />

confirmed and supported by the regulatory<br />

authorities in the USA.<br />

Thus, the systematic use of various<br />

sources of knowledge in mathematical<br />

models and subsequent computer<br />

simulations to investigate “what-if”<br />

scenarios of interest (e. g. to inform new<br />

study designs, to develop dosing<br />

recommendations for sub-populations)<br />

allows rational data-driven decisionmaking<br />

in drug development, regulatory<br />

submission and pharmacotherapy.<br />

Better understanding of drug action<br />

Our applied research also aims to<br />

better understand the diseases we<br />

wish to treat and the drugs we use to<br />

do so. A better understanding of drug<br />

action may lead to the identification<br />

of additional uses of new and existing<br />

drugs, which then can be developed<br />

more quickly based on the existing<br />

experience with that drug. For example,<br />

we are developing nintedanib for the<br />

treatment of some types of cancer.<br />

During such investigations it emerged<br />

that nintedanib may also be useful<br />

in treating lung fibrosis, where lung<br />

tissue is replaced by rigid scar tissue.<br />

Lung fibrosis is an often fatal condition<br />

in some patients for unknown<br />

reasons, but can also develop secondary<br />

to some types of cancer treatments.<br />

We are therefore currently<br />

studying the anti-fibrotic mechanisms<br />

of nintedanib in more detail. Concomitantly,<br />

we have performed groundbreaking<br />

clinical studies demonstrating<br />

that nintedanib can indeed have<br />

beneficial effects in patients with idiopathic<br />

lung fibrosis and is currently<br />

undergoing phase III studies.<br />

Luca Richeldi, M.D., Ph.D., Ulrich Costabel,<br />

M.D., Moises Selman, M.D., Dong Soon<br />

Kim, M.D., David M. Hansell, M.D., Andrew<br />

G. Nicholson, D.M., Kevin K. Brown, M.D.,<br />

Kevin R. Flaherty, M.D., Paul W. Noble,<br />

M.D., Ganesh Raghu, M.D., Michèle Brun,<br />

M.Sc., Abhya Gupta, M.D., Nolwenn Juhel,<br />

M.Sc., Matthias Klüglich, M.D., and Roland<br />

M. du Bois, M.D.<br />

THE NEW ENGLAND JOURNAL<br />

OF MEDICINE<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> studies<br />

showed that nintedanib may not<br />

only be useful in oncology but<br />

also for the treatment of lung<br />

fibrosis.<br />

Translating research, transforming medicines<br />

47


sweden<br />

2<br />

3<br />

finland<br />

1 united<br />

kingdom<br />

THE INNOVATIVE MEDICINES INITIATIVE<br />

partners and funding<br />

4 germany<br />

26<br />

partners<br />

eur<br />

32.6m<br />

budget<br />

5<br />

italy<br />

19<br />

academic<br />

centres<br />

1<br />

sme *<br />

[ finland]<br />

* Small and medium enterprise<br />

6<br />

pharma<br />

companies<br />

[ academic centres ]<br />

1 University of Cambridge<br />

University of Oxford<br />

University of Dundee<br />

University of Exeter<br />

University of Edinburgh<br />

2 University of Lund<br />

Karolinska Institute,<br />

Stockholm<br />

University of Gothenburg<br />

3 Folkhälsan Institute, University of Helsinki<br />

University of Eastern Finland<br />

University of Turku<br />

National Institute for Health and Welfare,<br />

Helsinki<br />

4 Helmholtz Centre Munich<br />

5 University of Padova<br />

University of Pavia<br />

University of Pisa<br />

Catholic University Rome<br />

Mario Negri Institute Bergamo<br />

University of Florence<br />

BETTER MEDICINES AND VALUE<br />

FOR PATIENTS<br />

The Innovative Medicines Initiative (IMI) is a public-private partnership<br />

established by the European Commission and the European<br />

Federation of Pharmaceutical Industries and Associations (EFPIA).<br />

The IMI funds pre-competitive collaboration projects with the aim<br />

of addressing some of the fundamental scientific challenges in the<br />

search for new medicines.<br />

EUR 1bn<br />

E U R 2 bn<br />

partnership<br />

EUR 1bn<br />

It brings together large pharmaceutical<br />

companies, small and medium-sized<br />

enterprises (SME), patient organisations,<br />

academia, hospitals and public authorities.<br />

The projects cover the entire<br />

value chain from discovery, through<br />

preclinical and clinical research, to<br />

health technology assessment and<br />

pharmacovigilance. The ultimate goal<br />

is to provide better medicines which<br />

bring value to patients, healthcare<br />

systems and society.<br />

A substantial funding of EUR 2 billion<br />

has been made available jointly by<br />

the European Commission and EFPIA.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is committed<br />

to supporting the initiative through<br />

monetary as well as in-kind contributions,<br />

such as personnel, laboratory<br />

equipment and consumables, or specialised<br />

knowledge.<br />

The IMI research agenda identifies<br />

the principal research bottlenecks in<br />

the biopharmaceutical research and<br />

development process and sets forth<br />

recommendations to overcome them<br />

by focusing on four areas: predicting<br />

safety, predicting efficacy, more effective<br />

utilisation of available knowledge<br />

as well as enhanced education and<br />

training.<br />

Some of the examples of current<br />

projects include leveraging expertise<br />

in new technologies for identification<br />

48<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


esearch & development<br />

innovation for the best medicine<br />

THE SUMMIT CONSORTIUM<br />

overview of the work packages<br />

new animal models<br />

PATIENT OVERLAP<br />

genetic<br />

marker<br />

biomarker<br />

imaging<br />

technologies<br />

data mining &<br />

in silico modeling<br />

and evaluation of biomarkers, managing<br />

and organising data to predict<br />

benefit and risk of new therapies,<br />

thereby contributing to the three Rs<br />

(refinement, reduction, and replacement)<br />

for animal studies, improving<br />

the dialogue with regulators during<br />

development prior to regulatory approval<br />

by helping to reduce requests<br />

for additional data and regulatory<br />

questions following submission, and<br />

building and supporting pre-competitive<br />

research centres and a European<br />

network of centres of excellence.<br />

Supporting IMI projects<br />

The IMI launches a new set of research<br />

and training projects every year.<br />

Project participants are recruited<br />

through open and competitive calls<br />

for proposals. Since its inception<br />

in 2007 IMI has launched four calls<br />

for proposals. And a further two<br />

calls are scheduled for 2012.<br />

with an overall in-kind commitment<br />

of around EUR 19 million in Research,<br />

Development and Medicine.<br />

SUMMIT consortium<br />

One example is the SUMMIT consortium<br />

coordinated by <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

and the University of Lund in<br />

Sweden (see graphic). The aim of the<br />

26 different partners is to identify susceptibility<br />

markers that can be used to<br />

define patients at high risk to develop<br />

diabetic micro and macrovascular<br />

complications in organs such as the<br />

kidney, eye, heart, skin or nerve tissue,<br />

and use them to monitor the progression<br />

of disease, thereby potentially<br />

serving as surrogate endpoints in clinical<br />

trials.<br />

FOCUS ON:<br />

[ type 1 and type 2 diabetes ]<br />

Diabetic nephropathy<br />

Diabetic retinopathy<br />

[ type 2 diabetes ]<br />

Cardiovascular diseases<br />

THREE PROJECT PHASES:<br />

1 Discovery of novel genetic and<br />

biomarkers for diabetic complications<br />

(existing bio-samples)<br />

2 Validation of these biomarkers<br />

in appropriate cohorts<br />

3 Translation of these findings<br />

into clinically relevant settings.<br />

Predict and monitor progression<br />

of complications<br />

Thus far, <strong>Boehringer</strong> <strong>Ingelheim</strong> has<br />

significantly contributed to the initiative<br />

by participating in 20 projects<br />

Better medicines and value for patients 49


BOEHRINGER INGELHEIM VENTURE FUND (BIVF)<br />

is investing in novel technology platforms and new therapy concepts,<br />

which are ahead of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s current research and<br />

development focus.<br />

BOEHRINGER INGELHEIM<br />

VENTURE FUND<br />

The fund’s goal is to enable the therapeutic opportunities of<br />

tomorrow - our mission is to validate and develop emerging<br />

concepts that have the potential to bring breakthrough therapies<br />

for diseases with a high unmet medical need.<br />

VALUE FOR BOEHRINGER<br />

INGELHEIM<br />

The primary goal of the <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Venture Fund is to add<br />

value to the companies we have<br />

invested in. If we are successful,<br />

a strategic alliance between a<br />

portfolio company and <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> is a possibility, but not<br />

an obligation, as we are not asking<br />

for option rights.<br />

We are exploring new fields, in which<br />

we are investing in a few, selected biotechnology<br />

companies. The selection<br />

criteria are: the innovativeness of the<br />

scientific approach and the quality of<br />

the management team. Opportunities<br />

are being sought on a world wide basis.<br />

We are investing up to EUR 10 million<br />

per company over its life, with staged<br />

investments based on the company’s<br />

progress. Besides financing, the members<br />

of our team, who all have a successful<br />

track record in discovering new<br />

drugs, are helping scientific entrepreneurs<br />

refine their strategies and develop<br />

their approaches towards clinical<br />

proof of concept.<br />

Our investment focus<br />

Our investment focus is on technology<br />

platforms with a potentially broad<br />

application across various indications<br />

and therapeutic areas. We aim at:<br />

• Addressing the so-called “undrugable”<br />

targets, such as intracellular<br />

protein-protein interactions, that are<br />

currently poorly accessible with either<br />

small molecules or monoclonal<br />

antibodies<br />

• Discovering the new generation of<br />

new biological entities (NBEs), i. e.<br />

therapeutic proteins and peptides),<br />

with a main focus on technologies<br />

supporting a more targeted NBEdriven<br />

oncolysis and/or the delivery<br />

of therapeutic proteins to the brain<br />

• Discovering the new generation<br />

of vaccines, with a main focus on<br />

T cell vaccines, including therapeutic<br />

vaccines<br />

• Opening new target or biomarker<br />

space<br />

• Entering the field of regenerative<br />

medicine, including cell-based<br />

therapy, but also drug-based<br />

50<br />

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esearch & development<br />

innovation for the best medicine<br />

FOCUS OF INVESTMENTS BY THE BOEHRINGER INGELHEIM VENTURE FUND<br />

entering<br />

underexplored<br />

targets/indications<br />

addressing<br />

“undrugable”<br />

targets<br />

new generation<br />

nbes<br />

new generation<br />

vaccines<br />

opening new<br />

target/<br />

biomarker space<br />

regenerative<br />

medicine<br />

Hearing loss,<br />

lysosomal storage diseases,<br />

antibiotics resistance<br />

Intracellular proteinprotein<br />

interaction<br />

Brain-penetrating NBEs,<br />

NBE-driven oncolysis<br />

T cell vaccines<br />

Epigenetics, ubiquitines,<br />

phosphatases<br />

NME: Activation of<br />

resident stem cell,<br />

cell-based therapy<br />

approaches for recruiting or activating<br />

tissue resident progenitor<br />

cells<br />

• Discovery programmes in indications<br />

that are not part of <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>’s current R&D focus,<br />

such as antibiotics resistance, hearing<br />

loss and orphan indications<br />

such as lysosomal storage diseases.<br />

A practical example: T cell vaccines<br />

We want to discover vaccines against<br />

diseases that normally escape the immune<br />

system and cannot be addressed<br />

with conventional vaccines. Conventional<br />

vaccines are based on the protective<br />

action of neutralising antibodies,<br />

the so-called humoral immune<br />

response. However, for several infectious<br />

diseases and for cancer, this is<br />

largely ineffective. In this context, a<br />

new generation of vaccines is needed<br />

that stimulate not only the humoral,<br />

but also and most importantly, the<br />

T cell immune response, in order to<br />

directly kill the pathogens or the transformed<br />

cells. In order to activate T cells,<br />

the endogenous pathway for antigen<br />

presentation needs to be mimiked.<br />

This can be achieved by using viral<br />

vectors that transfer the genes coding<br />

for the selected antigens into host<br />

cells. The infected cells then produce<br />

the antigens which are recognised as<br />

endogenous proteins, thereby facilitating<br />

antigen processing and presentation<br />

towards a T cell response.<br />

NEW GENERATION VACCINES<br />

We have invested in the biotechnology<br />

company Okairos Srl<br />

whose technology platform is<br />

based on the use of non-human<br />

primate adenoviruses as vectors.<br />

Of course, such viral vectors have<br />

been genetically modified to prevent<br />

their proliferation in the host.<br />

The Okairos vaccine technology<br />

has been shown to induce a strong<br />

T cell response both pre-clinically<br />

and clinically. A T cell vaccine technology<br />

platform has the potential<br />

to address infectious diseases for<br />

which traditional vaccines are<br />

largely ineffective, for example,<br />

HCV, HIV, malaria, as well as the<br />

possibility to develop therapeutic<br />

cancer vaccines.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Venture Fund<br />

51


# 03<br />

HEALTH<br />

FOR A BETTER QUALITY OF LIFE<br />

This is our heart and lifeblood of our entrepreneurial activities.<br />

We seek sustained success with our diversified, broad portfolio<br />

of innovative medicines for people and animals.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

[ prescription medicines ]<br />

55 A THERAPEUTIC BREAKTHROUGH<br />

58 NEW TREATMENT OPTION FOR TYPE 2 DIABETES<br />

62 CHANGING THE WAY COPD IS TREATED<br />

[ consumer health care ]<br />

64 SEEING THE CONSUMER’S POINT OF VIEW<br />

[ biopharmaceuticals and biosimilars ]<br />

69 CONNECTING KNOWLEDGE AND INNOVATION<br />

[ animal health ]<br />

73 TAKING PREVENTION SERIOUSLY<br />

76 HORSES GROW OLD AS WELL<br />

52<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

Health for a better quality of life 53


#3.1<br />

BETTER TREATMENTS<br />

FOR PEOPLE<br />

If you want to successfully invent new, innovative medicines, you have to regularly<br />

ask yourself which therapies will meet tomorrow‘s requirements. We have to<br />

continuously adjust to the changing needs of patients, physicians and decisionmakers<br />

in healthcare systems.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

54<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

A THERAPEUTIC BREAKTHROUGH<br />

The approval of pradaxa® marks an important milestone in our<br />

research and development and also in the continuing fight for<br />

improved prevention and treatment of acute and chronic thromboembolic<br />

diseases, which continue to have a great unmet medical need.<br />

pradaxa® (dabigatran etexilate) was<br />

the first novel anticoagulant therapy<br />

in 50 years. It represents a therapeutic<br />

pro gress for patients around the world.<br />

Since 2008, it has been approved in<br />

over 80 countries for the primary prevention<br />

of venous thrombo-embolic<br />

events (blood clots) in adults who<br />

have undergone elective total hip or<br />

knee replacement surgery. Since 2010<br />

it has been approved for prevention<br />

of stroke and systemic embolism in<br />

adults with non-valvular atrial fibrillation<br />

(SPAF) in over 60 countries.<br />

Breakthrough therapy<br />

pradaxa® offers a new treatment option<br />

for preventing thrombo-embolic<br />

diseases, a leading cause of morbidity<br />

and mortality worldwide. This new<br />

generation of oral anticoagulants,<br />

known as direct thrombin inhibitors<br />

(DTIs), achieves potent anti-thrombotic<br />

effects by specifically blocking<br />

the activity of thrombin (both free<br />

and clot-bound), the central enzyme<br />

in the process responsible for thrombus<br />

formation.<br />

Thrombo-embolic diseases are caused<br />

when a blood vessel is obstructed by<br />

a blood clot (embolus) that has been<br />

carried in the bloodstream from the<br />

site of its formation. Thrombo-embolic<br />

disease includes both venous thromboembolism<br />

(VTE) and arterial thromboembolism.<br />

Arterial embolism is a frequent<br />

complication in patients with<br />

atrial fibrillation (AF) and can lead<br />

to stroke or systemic embolism. AF<br />

is the most common sustained heart<br />

rhythm condition, with one in four<br />

adults over the age of 40 developing<br />

the condition in their lifetime.<br />

Reducing the risk of stroke<br />

AF increases the risk of stroke by up<br />

to five times. Studies have shown that<br />

4,500 of every 100,000 patients with<br />

AF may suffer a stroke each year, if<br />

they do not receive anticoagulation<br />

therapy. Those strokes tend to be especially<br />

severe and disabling with<br />

half of the people dying within a year.<br />

Reducing the risk of stroke is therefore<br />

the primary goal of anticoagulation<br />

in AF.<br />

Registration study RE-LY®<br />

The RE-LY® study was a PROBE (prospective,<br />

randomized, open-label with<br />

blinded endpoint evaluation) trial. It<br />

showed that, compared to the long-time<br />

standard of care, vitamin K antagonist<br />

warfarin, pradaxa® 150 mg (twice<br />

daily) reduced the risk of stroke and<br />

systemic embolism by 35 %. Major<br />

bleeds were comparable to those in<br />

3D structure of dabigatran<br />

in complex with thrombin<br />

(“ball and stick”)<br />

A therapeutic breakthrough<br />

55


1<br />

FROM A THROMBUS IN THE ATRIUM OF THE HEART TO<br />

A STROKE IN ATRIAL FIBRILLATION<br />

1 Macroscopic picture of a thrombus in the left atrium of the<br />

heart as a consequence of atrial fibrillation<br />

2 Microscopic picture of a thrombus. Red blood cells, platelets<br />

and fibrin threads leading to the formation of a blood clot<br />

2<br />

56,000<br />

GLORIA-AF (Global Registry on Long-<br />

Term Anti-thrombotic Treatment in<br />

Patients with Atrial Fibrillation) is a<br />

large, international Registry Program<br />

in which 56,000 patients are planned<br />

to be enrolled through 2,200 sites in<br />

up to 50 countries worldwide.<br />

Sources Atrial fibrillation and RE-LY® p 55 and p 56:<br />

Atrial fibrillation investigators. Ann Intern Med 1994;<br />

154:1449-1457.<br />

Pradaxa®, Summary of Product Characteristics, <strong>2011</strong>.<br />

Europe.<br />

Di Nisio M, et al. Direct Thrombin Inhibitors. N Engl J<br />

Med 2005; 353:1028-40.<br />

Connolly SJ, et al. Dabigatran versus Warfarin in Patients<br />

with Atrial Fibrillation. N Engl J Med 2009;<br />

361:1139-51.<br />

Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin<br />

L: Newly identified events in the RE-LY® trial. N<br />

Engl J Med 2010; 363(19): 1875-1876.<br />

FDA Advisory Committee Briefing Document, September<br />

2010, http://www.fda.gov/downloads/Advisory-<br />

Committees/CommitteesMeetingMaterials/Drugs/<br />

CardiovascularandRenalDrugsAdvisory Committee/<br />

UCM226009.pdf<br />

the warfarin study arm. pradaxa®<br />

110 mg (twice daily), indicated for<br />

specific patients, demonstrated similar<br />

reductions in stroke and systemic embolism<br />

while delivering significantly<br />

fewer major and fatal bleeds.<br />

Reduced burden for patients<br />

With no international normalised<br />

ratio (INR) monitoring, limited drugdrug<br />

interactions and no food interactions,<br />

it represents a lower overall<br />

burden to the patient and their loved<br />

ones compared to current therapy options.<br />

Global Registry Program<br />

GLORIA-AF (Global Registry on Long-<br />

Term Anti-thrombotic Treatment in<br />

Patients with Atrial Fibrillation) is a<br />

large, international Registry Program<br />

with up to 2,200 sites and 50 participating<br />

countries worldwide. Its purpose is<br />

to characterise patients who are newly<br />

diagnosed with non-valvular AF at risk<br />

of stroke and to study patterns, predictors<br />

and outcomes of different treatment<br />

regimens for stroke prevention in a<br />

real-world setting. The major benefit<br />

of the GLORIA-AF Registry Program<br />

will be to further increase our scientific<br />

know ledge on the safety and effectiveness<br />

of established as well as new<br />

anti-thrombotic treatments for stroke<br />

prevention in AF patients.<br />

Pharmacoeconomic aspects<br />

Following the regulatory approvals, the<br />

product has been reviewed by many<br />

health technology assessment (HTA)<br />

and reimbursement agencies worldwide.<br />

Their role is to provide recommendations<br />

on whether the added clinical<br />

value, especially compared to<br />

vitamin K antagonists, is worth its added<br />

costs, which is often assessed in a<br />

cost-effectiveness analysis. Given the<br />

outstanding clinical data and the fact<br />

that no monitoring of the anticoagulation<br />

effect has to be performed, most<br />

agencies came to the conclusion that<br />

pradaxa® is a cost-effective use of<br />

healthcare resources. Several agencies,<br />

including the National Institute for<br />

Health and Clinical Excellence (NICE)<br />

for England and Wales, stated that<br />

56<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

3 The cerebral artery at the base of a patient’s brain. The middle<br />

cerebral artery has been occluded by a thrombus dislodged from<br />

the atrium of the heart, which caused a large cerebral infarction.<br />

4 Macroscopic picture of an infarction of the brain (after a stroke) in<br />

the occipital part of the left hemisphere of the brain.<br />

“The new medication<br />

can be taken easily and<br />

means improved quality<br />

of life to me.”<br />

michael firth<br />

patient suffering from<br />

atrial fibrillation<br />

3 4<br />

pradaxa® should receive funding in<br />

this indication. However, given the<br />

current worldwide economic crisis and<br />

financial constraints, the affordability<br />

of innovations such as pradaxa® has<br />

become a struggle, especially in indications<br />

with a large number of patients<br />

who would benefit from the treatment.<br />

As a result, positive reimbursement<br />

1 mission 1 million<br />

“1 Mission 1 Million – Getting to the Heart of<br />

Stroke“ is a first-of-its-kind initiative that<br />

has set a new industry benchmark in disease<br />

awareness. ”1 Mission 1 Million“ empowered<br />

the public to decide which awareness projects<br />

should receive a share of EUR 1 million to<br />

help prevent AF-related strokes through an<br />

online competition.<br />

Supported by over 45 third-party organisations,<br />

this global initiative saw the submission<br />

of 184 projects from 36 countries by individuals,<br />

patient and professional groups<br />

and healthcare centres. Awareness was<br />

decisions, and hence patient access to<br />

the product, has in some countries<br />

not been as quick as expected and desired.<br />

We are committed to work with<br />

the key decision-makers to find solutions<br />

that grant patients access to<br />

pradaxa®, whilst recognising the current<br />

budgetary constraints of healthcare<br />

systems.<br />

raised on a global and national scale, leading<br />

to over 2 million votes for projects, showcased<br />

in 10 languages. In order to raise significant<br />

awareness of the condition, 32 projects will<br />

now be implemented around the world to<br />

prevent AF-related strokes.<br />

www.heartofstroke.com<br />

PRADAXA®, PRADAX®, PRAZAXA®<br />

belongs to a new generation of oral<br />

anticoagulants/direct thrombin inhibitors<br />

(DTIs) targeting a high unmet<br />

medical need in the prevention<br />

and treatment of acute and chronic<br />

thrombo-embolic diseases. The<br />

medication is approved for stroke<br />

prevention in atrial fibrillation.<br />

It is also approved for the primary<br />

prevention of venous thromboembolic<br />

events (blood clots) in<br />

adults who have undergone elec -<br />

tive total hip or elective total knee<br />

replacement surgery.<br />

A therapeutic breakthrough<br />

57


2<br />

1<br />

1 Microvascular complications of diabetes:<br />

nephropathy (kidney disease). Glomeruli<br />

of an 85-year old patient.<br />

2 Pancreas: Islets of Langerhans (yellow)<br />

of a male diabetes patient.<br />

NEW TREATMENT OPTION FOR<br />

TYPE 2 DIABETES<br />

Diabetes is a pandemic of the modern era, affecting an estimated<br />

366 million people worldwide. trajenta®, our innovative type 2<br />

diabetes medication, is providing a new therapeutic option.<br />

Type 2 diabetes<br />

Diabetes, a chronic progressive condition,<br />

occurs when the body either does<br />

not properly produce, or use, the hormone<br />

insulin. As the most common<br />

form of diabetes, type 2 diabetes accounts<br />

for up to 95 % of all cases in developed<br />

countries. It is characterised<br />

by increased insulin resistance and impaired<br />

beta-cell function resulting in<br />

inadequate insulin response.<br />

366m<br />

People worldwide are affected by<br />

diabetes. The most common form,<br />

type 2 diabetes, accounts for up<br />

to 95 % of all diabetes cases in<br />

developed countries.<br />

trajenta® (linagliptin) is a one-dosage<br />

strength anti-diabetes treatment<br />

without the need for dose adjustment<br />

or additional monitoring, even for<br />

elderly patients with type 2 diabetes<br />

and patients who are at high risk of<br />

declining renal function.<br />

Clinical studies with trajenta® showed<br />

a meaningful, durable and reliable<br />

blood sugar reduction. trajenta®<br />

was well-tolerated with an overall adverse<br />

event rate similar to placebo<br />

which does not cause weight gain or<br />

hypoglycaemia (low blood sugar).<br />

If left uncontrolled, this can result in<br />

serious medical complications in all<br />

parts of the body, especially where<br />

nerves and blood vessels play a vital<br />

role. Patients with hyperglycaemia<br />

have a higher risk of developing longterm<br />

complications, such as:<br />

• declining renal function leading to<br />

kidney failure<br />

• visual impairment or blindness<br />

• damage to nerves, leading to loss of<br />

feeling (neuropathy)<br />

• increased risk of stroke and heart<br />

attack<br />

58<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

COMPLICATIONS AND CONSEQUENCES IN DIABETES<br />

diabetic<br />

retinopathy<br />

declining kidney<br />

function<br />

diabetic neuropathy /<br />

foot wounds and ulces<br />

cardiovascular<br />

risk<br />

risk of<br />

stroke<br />

going blind kidney failure amputation heart attack cerebral infarction<br />

Disease management<br />

Good diabetes control means not only<br />

reducing but also maintaining blood<br />

glucose at as normal a level as possible.<br />

Sometimes, this can be achieved<br />

through a combination of diet and<br />

exercise. More often, people with<br />

diabetes require medication to achieve<br />

glucose control in the long term.<br />

However, many traditional treatments<br />

are not successful in helping patients<br />

with type 2 diabetes to reach their<br />

blood glucose targets. Often they may<br />

be associated with adverse effects, such<br />

as increased risk of hypo glycemia,<br />

weight gain, increased cardio vascular<br />

risk and gastrointestinal side effects,<br />

such as vomiting and abdominal pain.<br />

The kidneys matter in type 2 diabetes<br />

Most patients with type 2 diabetes<br />

are at risk of declining renal function,<br />

which itself carries a greater risk of<br />

diabetes-related disease and death.<br />

Some currently available treatments<br />

are mainly excreted via the kidneys<br />

and may not be recommended in<br />

those patients.<br />

A modern type of diabetes medication<br />

trajenta® is an oral antidiabetes<br />

treatment which belongs to the class<br />

of dipeptidyl peptidase-4 (DPP-4) inhibitors,<br />

a modern type of medication<br />

used to treat type 2 diabetes to effectively<br />

reduce blood sugar levels both<br />

before and after eating.<br />

Unlike other DPP-4 inhibitors, trajenta®<br />

is primarily excreted unmetabolised<br />

via the bile and the gut – meaning<br />

no dose adjustment is needed in<br />

patients with declining kidney or liver<br />

function.<br />

trajenta® lowers blood sugar in a<br />

glucose-dependent manner by increasing<br />

incretin levels, which increase<br />

insulin levels and decrease<br />

glucagon levels after meals and<br />

throughout the day. It can be used as<br />

monotherapy or in combination with<br />

other commonly prescribed medica-<br />

TRAJENTA®, TRADJENTA®,<br />

TRAZENTA®, TRAYENTA®<br />

is approved for the treatment of<br />

type 2 diabetes mellitus to improve<br />

glycaemic control in adults.<br />

It may be used as monotherapy or<br />

combination therapy.<br />

The compound is primarily excreted<br />

unmetabolised via the bile<br />

and the gut. No dose adjustment<br />

is needed in patients with declining<br />

kidney or liver function.<br />

New treatment option for type 2 diabetes<br />

59


RISK FACTORS FOR DEVELOPING<br />

TYPE 2 DIABETES<br />

age<br />

physical<br />

inactivity<br />

obesity<br />

diabetes during<br />

pregnancy<br />

ethnicity<br />

positive family<br />

history<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> and Eli Lilly<br />

and Company have formed an<br />

alliance in the field of diabetes.<br />

By joining forces, we are striving<br />

to offer pharmacological solutions<br />

that will assist physicians in<br />

choosing the most appropriate<br />

treatment for their patients.<br />

tions for type 2 diabetes — metformin,<br />

sulfonylurea or pioglitazone — and<br />

demonstrates mean reductions in hemoglobin<br />

A1C (HbA1C or A1C) levels<br />

of up to 0.7 %, compared to placebo.<br />

In early 2012, the US Food and Drug<br />

Administration (FDA) approved<br />

jentadueto (linagliptin/metformin<br />

HCl). It is the first pill combining the<br />

dipeptidyl peptidase-4 (DPP-4) inhibitor<br />

linagliptin and metformin. Taken as<br />

a single tablet twice daily jentadueto<br />

is used along with diet and exercise to<br />

lower blood glucose in adults with<br />

type 2 diabetes when treatment with<br />

both linagliptin and metformin is<br />

appropriate.<br />

The diabetes alliance with Eli Lilly<br />

Discovered by <strong>Boehringer</strong> <strong>Ingelheim</strong>,<br />

trajenta® represents the first pipeline<br />

compound to be developed and commercialised<br />

together with our alliance<br />

partner Eli Lilly and Company. The<br />

approval in several markets marked a<br />

major regulatory milestone for our<br />

strategic diabetes alliance announced<br />

in January <strong>2011</strong>.<br />

Included in the alliance are our two<br />

oral diabetes agents — the DPP-4 inhibitor,<br />

linagliptin and the SGLT-2<br />

inhibitor, empagliflozin — as well as<br />

Eli Lilly’s two basal insulin analogues<br />

(LY2605541, a novel basal insulin analog<br />

and LY2963016, a new insulin<br />

glargine product).<br />

Clinical outcome study - Carolina®<br />

The cardiovascular safety profile of<br />

linagliptin is currently being investigated<br />

in 6,000 patients through the<br />

CAROLINA® trial (Cardiovascular<br />

Outcome Study of Linagliptin Versus<br />

Glimepiride in Patients With type 2<br />

diabetes). It is the first cardiovascular<br />

outcome study in the DPP-4 class to<br />

include an active comparator and is<br />

part of a joint long-term commitment<br />

to evaluate the effectiveness of our<br />

treatments.<br />

60<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

WORLD DIABETES DAY ON 14 NOVEMBER <strong>2011</strong><br />

Our contribution included an employee-led “Run for<br />

diabetes“. More than 700 of our employees sprinted to the<br />

finish line for the 3km fundraising run. This activity was<br />

converted into a EUR 15,000 contribution for the ‘Life for a<br />

Child’ programme, an innovative and sustainable scheme<br />

to help children with diabetes in developing countries.<br />

Making Trajenta® available for patients<br />

Our teams are working hard to make<br />

trajenta® available as quickly as possible<br />

to people with type 2 diabetes<br />

across the world: within three months<br />

trajenta® gained approval in the<br />

USA, in Europe and in Japan – an impressive<br />

achievement we are proud of.<br />

The medication is meanwhile marketed<br />

in global markets, including the<br />

USA, a number of EU member states<br />

and Japan. It is currently not made<br />

available to patients in Germany, as<br />

the AMNOG (Act on the Reform of<br />

the Market for Medicinal Products)<br />

process leads to inadequate consideration<br />

of the positive characteristics of<br />

linagliptin.<br />

the pharma policy environment in germany<br />

The German Act on the Reform of the Market<br />

for Medicinal Products (Arzneimittelmarktneuordnungsgesetz)<br />

led in <strong>2011</strong> to a paradigm<br />

shift in price formation for medicines in Germany.<br />

After a preliminary evaluation, medicines<br />

receive either a maximum reimbursement<br />

amount (fixed reference price) or the<br />

manufacturer has to negotiate the reimbursement<br />

amount with the National Association of<br />

Statutory Health Insurance Funds (GKVS-<br />

Spitzenverband). If no agreement is reached,<br />

an arbitration board decides. The reimbursement<br />

amount applies for the Statutory Health<br />

Insurance (GKV) and the Private Health Insurance<br />

(PKV) after 13 months at the latest.<br />

For manufacturers there is no possibility of demanding<br />

a different price. Price deductions in<br />

Germany can thereby lead to price erosion in<br />

other countries that use Germany as a reference<br />

within the framework of their own price<br />

formation. There is therefore a risk that medicines<br />

are withdrawn from the market or not<br />

even launched in Germany. The question of<br />

which price is appropriate on the basis of the<br />

evaluation, and how expenditure on research<br />

and development should be refinanced, remains<br />

unresolved.<br />

Given the great uncertainty, unrestricted price<br />

formation in year one can be seen in a new<br />

light. Depending on its concrete application,<br />

the new price formation can represent a considerable<br />

threat to the supply of innovative<br />

medicines as well as to research, development<br />

and employment in Germany.<br />

This has also led to <strong>Boehringer</strong> <strong>Ingelheim</strong> and<br />

Eli Lilly and Company not marketing trajenta®<br />

in Germany, as long as the evaluation and<br />

price-setting has not been concluded. Something<br />

new in Germany is that a medication that<br />

passed examination by the European registration<br />

authority straight away on the basis of<br />

good, extensive clinical study results is not<br />

marketed in Germany; one of the countries<br />

where new medicines have hitherto mostly<br />

been very rapidly available; physicians and<br />

patients are still having to wait for this new<br />

therapy option. The reason is that while other<br />

countries have been guided in their benefit<br />

evaluation and price-setting for trajenta® by<br />

medications from the same substance group,<br />

in Germany the substance has to be compared<br />

with generics that stand elsewhere in the scheme<br />

of therapies or apply to another patient group.<br />

New treatment option for type 2 diabetes<br />

61


1 Lung tissue with alveoli<br />

2 Key visual of the SPIRIVA® campaign<br />

‘Life can’t wait’<br />

START SPIRIVA ®<br />

when COPD symptoms<br />

impact everyday life<br />

1 2<br />

CHANGING THE WAY COPD IS<br />

TREATED<br />

spiriva® has helped to transform how COPD patients are treated<br />

around the world during the last ten years of its availability. The full<br />

potential of tiotropium – the molecule of spiriva® – is now also<br />

explored in asthma and in combination with olodaterol, a novel<br />

bronchodilator, in COPD.<br />

SPIRIVA®– THE SUCCESS STORY<br />

CONTINUES<br />

spiriva® was first launched in the<br />

Netherlands in 2002 and is now<br />

available in 110 countries around<br />

the world. It has demonstrated over<br />

10 years of clinical experience with<br />

over 25 million patient-years.<br />

spiriva® is the first and still the only<br />

once-daily long-acting anticholinergic<br />

indicated for COPD maintenance<br />

treatment. It is available in<br />

HandiHaler® and Respimat® device<br />

in several markets. spiriva® provides<br />

clinically meaningful improvement<br />

of breathlessness and lung function,<br />

reduces the risk of COPD exacerbations<br />

and demontrates improved<br />

health-related quality of life.<br />

COPD - one of the top five leading<br />

causes of death worldwide<br />

According to the World Health Organization<br />

(WHO), 65 million patients suffer<br />

from chronic obstructive pulmonary<br />

disease (COPD) worldwide. Despite<br />

that knowledge and the fact that COPD<br />

is a leading cause of death, disease<br />

awareness and diagnosis rates are still<br />

extremely low. A significant number of<br />

patients who suffer from COPD symptoms<br />

are either not treated at all or undertreated.<br />

The direct and indirect<br />

costs to society is estimated to amount<br />

to EUR 50 billion per year. Worldwide<br />

spending on COPD drugs amounts to<br />

EUR 9.33 billion in the major markets.<br />

EmPower COPD awareness<br />

programme<br />

We not only made spiriva® available,<br />

but also provided medical-specific<br />

programmes to increase COPD awareness<br />

and diagnosis rates. The EmPower<br />

programme was one of the largest<br />

education programmes solely dedicated<br />

to increasing diagnosis and treatment<br />

standards. More than 35,000<br />

healthcare providers in over 25 countries<br />

have been successfully trained<br />

and educated on COPD.<br />

Despite the success of spiriva® in recent<br />

years, a great number of COPD<br />

patients still suffer from COPD symptoms<br />

and require maintenance treatment.<br />

spiriva® provides clinically meaningful<br />

benefits to COPD patients. Among<br />

other therapeutic effects, spiriva® significantly<br />

reduces the risk of COPD<br />

exacerbations – sudden worsening of<br />

symptoms that can result in hospitalisation<br />

and than can even be lethal.<br />

62<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

3 spiriva® is indicated for COPD<br />

maintenance treatment.<br />

4 Production site for respimat® Soft<br />

Mist TM Inhaler: <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

microParts in Dortmund, Germany<br />

3<br />

4<br />

Cornerstone for our future respiratory<br />

franchise<br />

We continue to explore potential new<br />

ways in which patients with respiratory<br />

diseases can benefit further from<br />

tiotropium. Based on the pharmacological<br />

profiles and already proven<br />

clinical benefits of tiotropium in COPD,<br />

we are undertaking the following programmes<br />

which are all in phase III of<br />

clinical development:<br />

• tiotropium in asthma<br />

• tiotropium in cystic fibrosis<br />

• tiotropium + olodaterol in COPD<br />

Tiotropium Respimat® in asthma<br />

The tiotropium in asthma development<br />

programme is conducted in the<br />

respimat® Soft Mist TM Inhaler (SMI).<br />

The first set of trials of the phase III<br />

programme, testing the efficacy and<br />

safety of tiotropium delivered via SMI<br />

in patients suffering from severe asthma,<br />

are under evaluation and will be<br />

published in the near future.<br />

The full development programme<br />

is planned to comprise additional<br />

studies including moderate asthma<br />

patients and a full paediatric programme.<br />

Tiotropium + olodaterol Respimat®<br />

in COPD<br />

We have decided to move the oncedaily<br />

fixed-dose combination of<br />

tiotropium plus olodaterol into the<br />

TOviTO® Phase III trial programme.<br />

It will investigate this combination<br />

for the treatment of COPD.<br />

The TOviTO® programme includes<br />

several trials that will provide important<br />

evidence to improve patients’ lives<br />

beyond optimal bronchodilation. The<br />

first two trials will be TOnado® 1 and<br />

TOnado® 2, evaluating the safety and<br />

efficacy of the fixed-dose combination<br />

for the treatment of COPD patients,<br />

with 5,000 patients at more than 500<br />

trial sites in 40 countries.<br />

5,000 patients at more than<br />

500 trial sites in 40 countries<br />

are participating in the first two<br />

trials of the TOviTO® programme.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> will continue<br />

to build on its expertise<br />

to research, develop and market<br />

products that fulfil high unmet<br />

medical needs in respiratory<br />

disease.<br />

We would like to thank all our<br />

partners and patients involved<br />

in our clinical trials in asthma,<br />

COPD and cystic fibrosis.<br />

Changing the way COPD is treated<br />

63


“Today’s consumers are more savvy than ever.<br />

They look for very specific solutions for their<br />

problems. By basing all our developments on<br />

consumer insights, we ensure that our product<br />

pipeline is sustainable and relevant to our<br />

consumer.”<br />

DULCOLAX®<br />

the brand for relief of<br />

acute constipation.<br />

anke schick<br />

consumer insight manager<br />

boehringer ingelheim consumer health care<br />

germany<br />

SEEING THE CONSUMER’S<br />

POINT OF VIEW<br />

Listening to consumers drives and grows the momentum<br />

of our brands. Whatever we develop is based on knowledge<br />

about the consumer.<br />

Trends are indicators of the changing<br />

needs of our consumers. Change can<br />

be complicated, even overwhelming,<br />

and trends help to provide a structure<br />

for understanding complexity. They<br />

deliver explanations and answers<br />

about market developments and help<br />

us to understand why brands become<br />

more or less relevant to consumers.<br />

On the other hand, consumer trends<br />

also act as a spur for new thoughts<br />

and ideas.<br />

To understand long-term consumer<br />

needs better, trends are a powerful<br />

working tool. One of the strategic pillars<br />

of our Consumer Health Care<br />

(CHC) business is excellence in<br />

developing sustainable and relevant<br />

solutions for consumers. Our vision<br />

to create and drive inspiring global<br />

brands reflects our will to lead.<br />

Inspirati on for effective<br />

information<br />

Listening to consumers is our guiding<br />

principle to ensure development of<br />

the right health solution for people.<br />

One part of our expertise is using consumer<br />

trends as a powerful lever that<br />

allows us to understand consumers’<br />

lives and to provide them with relevant<br />

information.<br />

Trends help us to consider new possibilities.<br />

We are able to use them for<br />

our brands across different activities,<br />

for awareness-building, product innovation<br />

and information campaigns.<br />

Based on research, The Futures Company<br />

analysed and structured trends.<br />

Here are some examples of how consumer<br />

trends underpin our brands’ activities.<br />

64<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

A COLONOSCOPY CAN BE A<br />

LIFESAVER<br />

2<br />

I DID I T<br />

FOR MY<br />

GRANDCHILD<br />

1<br />

I did it for<br />

my wife<br />

I did it for<br />

my friends<br />

I did it for<br />

my brother<br />

1 & 2 The “Lifesaver ad” of the dulcolax®<br />

Colon Cancer Awareness campaign.<br />

T lk<br />

d<br />

Dulcolax® and the Colon Cancer<br />

Alliance<br />

Our team for dulcolax®, our brand<br />

for relief from acute constipation,<br />

partnered with the Colon Cancer<br />

Alliance (CCA) in the USA, realising<br />

that there is a public health issue: in<br />

the USA, colon cancer receives very<br />

little public attention, despite being a<br />

leading cause of cancer-related deaths<br />

and up to 90 % being preventable<br />

when detected early.<br />

A multi-channel disease awareness<br />

campaign with the motto “A Colonoscopy<br />

Can Be a Lifesaver” was developed<br />

to raise awareness of the disease<br />

and the need to be screened. The campaign<br />

led to a significant increase in<br />

awareness of colon cancer and colonoscopy.<br />

The partnership also gave additional<br />

value to dulcolax®.<br />

The campaign is a good example of<br />

the trend of navigating health and<br />

well-being. Consumers feel that there<br />

are more health risks today than ever<br />

before and that there is a heightened<br />

sense of responsibility for managing<br />

their own health. We would like to<br />

help them in doing so.<br />

Access to information and improved<br />

diagnostic technologies are allowing<br />

consumers to find the best solutions.<br />

The campaign “I did it for my ...” is<br />

based on the insight that consumers<br />

wish to safeguard their health also for<br />

their family or friends and this helps<br />

to overcome the taboo topic of colonoscopy.<br />

Innovation – new product features<br />

buscopan®, our brand for abdominal<br />

pain, entered the Italian heartburn<br />

market with an important innovation.<br />

What is unique about the new buscopan®<br />

antiacido is that it lasts for<br />

12 hours.<br />

The dual action of buscopan® antiacido,<br />

and the fact that it was the<br />

first over-the-counter (OTC) heartburn<br />

remedy offering, was also a<br />

differentiating product feature for<br />

physicians.<br />

COMMITMENT HONOURED<br />

The Colon Cancer Alliance (CCA)<br />

honoured <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

with the Corporate Championship<br />

Award for our commitment to<br />

raising awareness about colon<br />

cancer.<br />

Seeing the customer’s point of view<br />

65


“The Dulcolax® colon cancer awareness campaign has been run<br />

across all media, including packaging, print and online advertising.<br />

More than two million boxes of Dulcolax® products co-branded<br />

with the Colon Cancer Alliance have been distributed. Partnerships<br />

with national retailers in circulars, in-store displays<br />

and at-home mailers delivered an additional 75 million<br />

messages for the cause. This ensured that the whole<br />

nation could see it.“<br />

PHARMATON®<br />

the multivitamin brand of<br />

boehringer ingelheim<br />

gerard fernandes<br />

international brand manager dulcolax®<br />

boehringer ingelheim, germany<br />

FOCUS ON CONSUMERS<br />

People with a busy lifestyle, under<br />

stress and often eating on the go,<br />

suffer more often from heartburn.<br />

With a very specific informationadvertising<br />

campaign, buscopan®<br />

antiacido focuses on where the<br />

consumer is: often travelling in<br />

trains or planes. Tailor-made messages<br />

ensure high relevance within<br />

this target group and provokes<br />

their awareness.<br />

The innovation buscopan® anti acido<br />

is building on the trend “professional<br />

consumers”: ever more consumers<br />

are becoming increasingly demanding<br />

in their consumption patterns. A clear<br />

benefit or difference that makes a<br />

product worth buying is essential.<br />

In addition, consumers also look<br />

for reassurance on a products’ value<br />

from expert advisors to avoid poor<br />

choices. In the case of heartburn,<br />

physicians are important expert advisors<br />

and they see buscopan®<br />

antiacido as a relevant remedy.<br />

Information campaign<br />

For pharmaton®, our multivitamin<br />

brand, the consumer trend “keeping<br />

it real” was one crucial element<br />

on the way to a new TV spot. Consumers<br />

are seeking the reassurance<br />

and trust provided by those things<br />

that are honest, genuine and true.<br />

Consumers trust in things that stay<br />

true to original recipes and values.<br />

They want to know where products<br />

come from and who makes them.<br />

This trend initiated the following<br />

thought: our pharmaton® product<br />

is the “real” one in many South<br />

American markets where copycat<br />

products populate the market. The<br />

trend was interpreted as “real =<br />

genuine, original product”.<br />

This thought then came to life in<br />

the description of the consumer<br />

need in the communication concept<br />

“I have an active life style and I like it.<br />

But everyday life stress and tiredness<br />

may stop me from enjoying it to the<br />

full. That’s why I need a reliable and<br />

effective product that won’t let me<br />

down.”<br />

The concept was the basis for the<br />

global pharmaton® TV spot “Videogame”,<br />

which is now used in eight<br />

countries – proof that consumer<br />

needs and insights are international.<br />

66<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

2 3<br />

1 Key visual of the pharmaton® videospot<br />

2 Image from TV spot for buscopan® antiacido in Italy<br />

3 silomat® for irritable cough<br />

1<br />

Guidance on coughs<br />

The trend towards consumers feeling<br />

increasingly responsible for their<br />

health, and seeking information in<br />

the media to find the best solutions<br />

for themselves, has led to a service<br />

offering from silomat®, our brand in<br />

Germany for irritable, non-productive<br />

cough.<br />

A representative survey showed that<br />

consumers have great difficulty telling<br />

the difference between non-productive<br />

and productive cough and<br />

most consumers do not therefore use<br />

different cough treatments. It is precisely<br />

the irritable, non-productive<br />

cough that well-informed sufferers<br />

consider to be an annoying nuisance.<br />

In order to intensify information<br />

about both types of cough, the silomat®<br />

Team offers guidance so that<br />

sufferers themselves can better classify<br />

their coughs: the Silometer. This<br />

is a cough detector which was developed<br />

from scratch in cooperation<br />

with the Fraunhofer Institute for<br />

Digital Media Technology. All it<br />

takes is a telephone call to the free<br />

cough hotline. After listening to the<br />

automatic response, you cough into<br />

the receiver and are told whether<br />

you could be suffering from a congested<br />

cough or from a dry cough.<br />

The Silometer is no substitute for a<br />

physician or a pharmacist, but is<br />

helpful for making an initial assessment<br />

of a cough’s classification.<br />

There are many examples of how<br />

trends are a constant source of inspiration<br />

for all kinds of projects. Major<br />

trends remain stable over a certain<br />

time and slowly grow, so that they<br />

are always an attractive inspiration<br />

for our CHC business.<br />

SILOMETER COUGH HOTLINE<br />

In cooperation with the Fraunhofer<br />

Institute for Digital Media Technology<br />

in Ilmenau, Germany, we<br />

have developed software in combination<br />

with a free-of-charge<br />

hotline which identifies the type<br />

of cough a caller suffers from. This<br />

is the so-called Silometer. When a<br />

caller coughs into the phone, the<br />

software identifies the kind of<br />

cough and diagnoses whether it is<br />

a smoker’s cough or a normal or a<br />

dry cough which needs to be<br />

treated by a doctor. The Silometer<br />

cannot replace a physician, but it<br />

can provide patients with initial<br />

assistance and diagnosis.<br />

Seeing the customer’s point of view<br />

67


# 3.2<br />

BIOPHARMACEUTICALS AND BIOSIMILARS –<br />

EXPERTISE, TECHNOLOGY, PROCESSES<br />

The innovative potential of biotechnological products is undoubtedly a<br />

significant driver of medicinal progress. With more than 30 years experience<br />

in biopharmaceuticals, we develop, manufacture and market biological<br />

products from our own research as well as additional products under contract<br />

for other companies.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

68<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

CONNECTING KNOW LEDGE<br />

AND INNOVATION<br />

With our expertise and world-class technology we are also wellplaced<br />

to create, develop and manufacture high-quality biosimilars.<br />

Biosimilars will improve patient access to biologics.<br />

As a research-driven company, we<br />

serve patient needs and are eager to<br />

always identify new ways of achieving<br />

this. We therefore decided to expand<br />

our Biopharmaceuticals business for<br />

the development and manufacture of<br />

new and innovative biopharmaceuticals<br />

into the development of biosimilars.<br />

Our biopharmaceutical network<br />

As a pioneer in the development and<br />

manufacturing of biopharmaceuticals<br />

for more than 30 years, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> is one of the leading companies<br />

in this field and offers the entire<br />

production technology chain. We have<br />

the expertise in process and analytical<br />

sciences for the development and<br />

manu facture of biopharmaceuticals, either<br />

for our own R&D purposes, or for<br />

the needs of our customers.<br />

From high expression systems to fill<br />

and finish and even patient-convenient<br />

injection systems, all product elements<br />

can be found within our one-stop-shop<br />

Biopharmaceuticals division. To date,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has successfully<br />

manufactured 19 recombinantbiopharmaceutical<br />

products for the<br />

global market.<br />

A well-filled R&D pipeline<br />

Our biopharmaceutical network is<br />

located in Vienna (Austria), Biberach<br />

(Germany) and, since <strong>2011</strong>, in Fremont<br />

(California), where we acquired a biopharmaceutical<br />

facility in the Bay<br />

area biotech cluster that complements<br />

our existing facilities.<br />

One of our major efforts is the development<br />

of NBEs for the treatment of diseases<br />

in our core therapeutic areas.<br />

Strong basis for successful products –<br />

our excellent network<br />

We benefit from our cooperations with<br />

research-orientated companies, our<br />

commercial partners, and leading academic<br />

networks. Working in partnership<br />

with us provides access to the<br />

state-of-the-art biopharmaceutical<br />

manufacturing. Specific franchise technologies<br />

for either microbial or mammalian<br />

processes have been established<br />

and represent competitive assets for our<br />

biopharmaceutical business.<br />

What are biopharmaceuticals<br />

Biopharmaceuticals are inherently<br />

bio logical in nature, as their technologically<br />

sophisticated manufacturing<br />

process utilises live organisms.<br />

19<br />

Biopharmaceutical products have<br />

been successfully manufactured<br />

by <strong>Boehringer</strong> <strong>Ingelheim</strong> for the<br />

global market.<br />

Connecting know ledge and innovation<br />

69


1 In fermenters, genetically<br />

modified bacteria, yeasts<br />

or mammalian cells produce<br />

either recombinant<br />

proteins or monoclonal<br />

antibodies.<br />

2 Structure of a monoclonal<br />

antibody<br />

1 2<br />

In fermenters, genetically modified<br />

bacteria, yeasts or mammalian cells<br />

produce either recombinant proteins<br />

or monoclonal antibodies. Their biological<br />

effect depends on many factors:<br />

growth conditions in the host cells,<br />

growth media, fermentation processes,<br />

temperature and many other physical<br />

conditions.<br />

In turn, therapeutic proteins produced<br />

in this way form highly complex threedimensional<br />

structures. The extent to<br />

which these proteins ultimately bind<br />

to receptors in the human body, or interact<br />

with other proteins, depends on<br />

the precise development of these tertiary<br />

structures. The therapeutic effect of a<br />

biopharmaceutical can only be evaluated<br />

in extensive clinical studies.<br />

Development of biosimilars<br />

A biosimilar is a close but non-identical<br />

copy of a biological drug that has lost<br />

patent protection or exclusivity. The<br />

development of a biosimilar, especially<br />

a very large and complex monoclonal<br />

antibody, is challenging for any<br />

firm, given that the end-point is predetermined<br />

by the originator. With<br />

our world-class expertise,<br />

technology and processes in biopharmaceutical<br />

development, we are<br />

well-placed to create, develop and<br />

manufacture high-quality biosimilars.<br />

Biologics can range from relatively<br />

simple molecules, such as insulin, to<br />

complex monoclonal antibody drugs.<br />

Unlike generics from small molecules,<br />

where the generic product is an exact<br />

chemical copy of the innovator product,<br />

bio similars are derived from the<br />

same gene sequence, but produced using<br />

a different cell line than that used<br />

for the originator product.<br />

As with an original biopharmaceutical,<br />

biosimilar product quality is determined<br />

by the production organisms<br />

and process. In the absence of the<br />

originator cell banks, the molecular<br />

clone used, and the exact fermentation<br />

and purification processes for the<br />

originator product, our scientists develop<br />

their own process, clones and<br />

70<br />

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our businesses<br />

health for a better quality of life<br />

3 4<br />

3 Biopharmaceuticals site in Fremont (USA):<br />

cell culture and fill and finish<br />

4 Biopharmaceuticals site in Biberach (Germany):<br />

cell culture and fill and finish<br />

5 Biopharmaceuticals site in Vienna (Austria):<br />

microorganism fermentation<br />

5<br />

cell banks. The selected cell line is<br />

used to produce the final bio similar,<br />

which will in turn be compared to the<br />

originator product in clinical trials,<br />

designed to demonstrate clinical and<br />

safety equivalence.<br />

biopharmaceutical sites<br />

2<br />

3<br />

Cost savings from biosimilars<br />

Once the drug is developed, the challenge<br />

is in getting the products to the<br />

patients who need them. Several biosimilars<br />

to four originator products<br />

have been launched in the European<br />

Union. Experience with these biosimilars<br />

has slowly increased, resulting in<br />

drug budget savings. The inclusion of<br />

biosimilar drug budget savings is also<br />

part of the US healthcare reforms introduced<br />

by the current US administration<br />

in 2009. In addition, given the<br />

drugs budget stress felt in other regions,<br />

for example, emerging markets,<br />

such as Brazil, Mexico, Russia and China,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> anticipates that<br />

these markets will welcome the introduction<br />

of high-quality, lower-priced<br />

biosimilars.<br />

1<br />

1 fremont, usa<br />

2 biberach, germany<br />

3 vienna, austria<br />

OUR BUSINESS UNIT BIOSIMILARS<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s centres of biopharmaceutical<br />

production excellence in Vienna,<br />

Biberach and Fremont will be the backbone<br />

supporting our newly established<br />

Biosimilars Business Unit.<br />

We are working closely with key regulatory<br />

and development bodies to ensure that we<br />

meet all requirements to successfully develop<br />

and register high-quality biosimilars.<br />

Biosimilars will become a major part of the<br />

biopharmaceutical market and will improve<br />

patient access to life-saving and life-changing<br />

medicines at affordable prices. Our new business<br />

unit will provide us the opportunity to<br />

bring high quality biosimilars to patients worldwide.<br />

Connecting know ledge and innovation<br />

71


# 3.3<br />

ANIMAL HEALTH –<br />

BETTER TREATMENTS<br />

Innovation is the backbone of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s Animal Health business.<br />

The company is committed to providing the best solutions for the prevention and<br />

treatment of diseases in animals. Striving for this goal is the best preparation for<br />

sustainable success in the future.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

72<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


our businesses<br />

health for a better quality of life<br />

TAKING PREVENTION SERIOUSLY<br />

Vaccines are undeniably some of the most important active tools<br />

in the field of modern veterinary medicine. Our Animal Health<br />

business is committed to continue bringing innovative medications<br />

to farmers, animals, veterinarians and consumers.<br />

A growing world population and continued<br />

economic growth, especially in<br />

the fast-evolving developing markets,<br />

entail higher protein consumption,<br />

and meat is considered a major source<br />

of protein in the nutrition plan.<br />

The need for safe and nutritious food<br />

is even more urgent. In this context<br />

too, sustainability is an important issue<br />

and animal health companies<br />

need to consider this. Concepts, such<br />

as animal welfare, development of resistance<br />

to antimicrobials and food<br />

safety, are important and require adequate<br />

solutions.<br />

Committed to prevention and<br />

innovation<br />

In <strong>2011</strong>, we were the leading company<br />

in swine vaccines worldwide. We<br />

consider it our responsibility to foster<br />

the health and well-being of mankind<br />

by contributing to an adequate supply<br />

of safe and nutritious food.<br />

Moreover, vaccines are becoming increasingly<br />

important for all species.<br />

Over recent years, our Animal Health<br />

business has been particularly active<br />

in the area of disease prevention. In<br />

the past, the company’s scientists succeeded<br />

in providing solutions for<br />

emerging pathogens through the<br />

timely development of modern vaccines.<br />

We are committed to strengthening<br />

this leading role with regard to<br />

innovations in the future. This will be<br />

achieved by introducing vaccines<br />

against novel diseases and further improving<br />

vaccines with enhanced efficacy<br />

against established pathogens.<br />

The value of vaccination<br />

Our Animal Health business provides<br />

leading swine vaccines, such as ingelvac<br />

circoflex®, ingelvac mycoflex®,<br />

ingelvac® prrs mlv and enterisol®<br />

ileitis. The value of vaccination is clearly<br />

obvious.<br />

Taking prevention seriously supports<br />

the idea that, whenever possible, prevention<br />

is preferable to therapeutic<br />

intervention. The use of vaccines<br />

helps to prevent illnesses before they<br />

occur. Consequently, the need for antibiotic<br />

treatment and the risk of antibiotic<br />

resistance can be reduced.<br />

To date, the PRRS virus remains<br />

one of the major challenges for<br />

pig farmers.<br />

In 1994, our Animal Health business<br />

introduced ingelvac® prrs,<br />

the first PRRS vaccine.<br />

Taking prevention seriously<br />

73


OUR GLOBAL SCIENTIFIC NET WORK IN ANIMAL HEALTH<br />

2<br />

1<br />

3<br />

5<br />

4<br />

1 2<br />

1 fort dodge/ames/st. joseph, usa<br />

2 guadalajara, mexico<br />

3 ingelheim/hanover, germany<br />

4 tokyo, japan<br />

5 shanghai, china<br />

3 34<br />

Participants at the <strong>2011</strong> <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Swine Academy (BISA)<br />

(Photo: Dani Ausen, Iowa State University)<br />

VALUE THROUGH EDUCATION<br />

As an employer of choice, our<br />

Animal Health business is serious<br />

about investing in promising talent.<br />

Internally and externally, the<br />

company brings together young<br />

and established researchers and<br />

provides global platforms to encourage<br />

communication and foster<br />

scientific exchange.<br />

Young researchers and senior scientists<br />

mutually benefit from discussing<br />

the latest results in the<br />

field of prevention and leading<br />

vaccine solutions.<br />

Responding to consumer demands<br />

By focusing on prevention, our Animal<br />

Health business can confidently meet<br />

consumers’ demands of today and tomorrow.<br />

Healthy nutrition is an important<br />

factor which determines quality<br />

of life now and in the future.<br />

Increasingly, consumers not only pay<br />

attention to the price of what they<br />

buy, but also consider aspects, such as<br />

animal welfare, food safety and environmental<br />

protection. This being said,<br />

prevention of disease through immunisation<br />

with our innovative vaccines<br />

is effective in meeting these demands.<br />

Our global research network<br />

Innovation is the key to resolving unmet<br />

medical needs and making a difference<br />

in the health and life of animals.<br />

High-level research generates<br />

novel ideas that result in innovative<br />

products for both humans and animals.<br />

Recent technological progress<br />

has significantly enhanced our ability<br />

to generate vaccines with better and<br />

more predictable efficacy.<br />

This includes the integration of sophisticated<br />

molecular biology and the<br />

decoding of the genome of target<br />

pathogens. The company further believes<br />

that the early identification of<br />

emerging diseases, coupled with tools<br />

for their control, will help to protect<br />

animals and farmers in the future.<br />

Numerous partnerships with academic<br />

institutions all around the world<br />

and <strong>Boehringer</strong> <strong>Ingelheim</strong>’s R&D in<br />

Human Pharmaceuticals provide a<br />

unique and effective scientific environment.<br />

International teams are<br />

working together in the worldwide<br />

network to bring innovative solutions<br />

to the marketplace for the benefit of<br />

our customers.<br />

Activities have started at the state-ofthe-art<br />

European Vaccine Research<br />

Facility in Hanover, Germany, where<br />

the company will identify and develop<br />

innovative vaccines against livestock<br />

diseases. Moreover, this research centre<br />

will further strengthen our relationship<br />

and collaboration with the<br />

74<br />

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our businesses<br />

health for a better quality of life<br />

1 Hanover, Germany<br />

2 Shanghai, China<br />

3 St. Joseph, USA<br />

4 Guadalajara, Mexico<br />

5 Scientists working in the cell culture<br />

lab at AVRDC in Shanghai.<br />

5<br />

major EU academic research institutes<br />

active in veterinary medicine.<br />

The boom city of Shanghai, China, is<br />

the location of the Asian Veterinary<br />

Research and Development Center<br />

(AVRDC) where we will develop innovative<br />

vaccine solutions for the Asian<br />

market.<br />

Together with global research sites in<br />

St. Joseph, Missouri, USA, and Guadalajara,<br />

Mexico, we provide a unique<br />

scientific network in which young and<br />

ambitious scientists can grow.<br />

Our Animal Health business provides<br />

excellent opportunities for learning<br />

and experience, allowing their scientists<br />

to gain an insight into the whole<br />

process, from research and development,<br />

production, to receiving customers’<br />

feedback through Marketing<br />

and Sales.<br />

Our approach of focusing on prevention<br />

pays off in so many different<br />

ways. We will ensure that, in the future<br />

too, it will deliver leading vaccines<br />

for a better quality of life for animals<br />

and those who care for them.<br />

“In a fast-changing environment<br />

we are well prepared. In<br />

the future too, we will deliver<br />

innovative solutions to our<br />

customers. Highly competitive<br />

markets require that we transform<br />

and adapt continuously<br />

in order to be successful. Our<br />

teams are our assets on which<br />

we build.”<br />

george heidgerken<br />

managing director<br />

boehringer ingelheim animal<br />

health<br />

Ideal research environment<br />

Researchers from a diverse range of<br />

backgrounds find an ideal environment<br />

to develop their skills and contribute<br />

to the company’s future.<br />

Taking prevention seriously<br />

75


2<br />

1<br />

1 Horse suffering from Equine Crushing’s<br />

disease (PPID)<br />

2 Curly hair coat is a clinical sign of PPID and<br />

appears even in summer time.<br />

HORSES GROW OLD AS WELL<br />

Nowadays, not only humans are living longer. The same is true of<br />

horses too. With the launch of prascend®, we have added another<br />

important solution to the equine portfolio and are expanding our<br />

expertise to the field of endocrinology and the geriatric horse.<br />

include laminitis, a painful and frequently<br />

uncurable disease of the hoof,<br />

but also immunosuppression, poor<br />

body condition and loss of performance.<br />

The disease is not curable and,<br />

following diagnosis, requires a daily,<br />

lifelong treatment.<br />

76 %<br />

PRASCEND® FIELD<br />

EFFECTIVENESS SURVEY<br />

CLEARLY SHOWS POSITIVE<br />

EFFECT FOR PPID HORSES<br />

Horses benefit from an adequate<br />

therapeutic treatment. <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Animal Health has<br />

conducted a substantial field<br />

study, which demonstrate that the<br />

condition of 76 % of the treated<br />

animals has improved after treatment<br />

with prascend®.<br />

The “geriatric horse” segment is steadily<br />

growing due to improved medical<br />

care and an increasing number of people<br />

who keep their horses as family<br />

members or sports partners.<br />

prascend® is approved in a number of<br />

countries for the treatment of clinical<br />

signs associated with pituitary pars<br />

intermedia dysfunction (PPID), also<br />

known as Equine Cushing’s disease,<br />

which is one of the most common diseases<br />

in horses older than 15 years.<br />

Horses suffering from PPID for many<br />

years are mostly recognised by the<br />

owner or veterinarian due to the long,<br />

curly hair coat even in the summer<br />

time. Other, more unspecific signs,<br />

Awareness for equine endocrinology<br />

Equine endocrinology has long been<br />

a neglected scientific area. Up to now,<br />

owners thought that signs of illness<br />

were just a natural part of the aging<br />

process. However, even more information<br />

is required to raise awareness in<br />

the public in order to better understand<br />

which measures can be taken.<br />

Thanks to modern diagnostic methods,<br />

it is now possible to treat horses<br />

with some endocrinological diseases<br />

that we previously hardly knew.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is the first company<br />

to offer a registered therapeutic<br />

solution against PPID, which affects<br />

at least 15 - 30 % of horse older than<br />

15 years.<br />

76<br />

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our businesses<br />

health for a better quality of life<br />

degenerated neuron<br />

DEGENERATED NEURON<br />

prascend® is a dopamine mimetic and acts<br />

to replace the dopamine that is missing in<br />

horses with PPID. By binding to the receptor,<br />

prascend® decreases the secretion of the<br />

pituitary hormones (below) to a normal level,<br />

leading to an improvement in the signs of the<br />

disease.<br />

end – endorphine<br />

acth – adrenocorticotropine hormone<br />

msh – melanocyte stimulating hormone<br />

prascend®<br />

Health management is very important<br />

Once its days of successful competition<br />

are over, the horse takes on the<br />

role of a companion and family member.<br />

At this stage of the horse’s life,<br />

sound health management becomes<br />

increasingly important.<br />

Encourage active dialogue<br />

Taking this into account, and treating<br />

a greater number of horses, a veterinarian<br />

can even measure the extent of<br />

the disease. We foster the dialogue<br />

bet ween veterinarians and horse<br />

owners in order to facilitate early detection<br />

of PPID and to save horses<br />

that would otherwise have been put<br />

down.<br />

Elderly horses may suffer from health<br />

impairments that require regular<br />

check-ups and careful monitoring,<br />

which means that the importance of<br />

equine geriatric medicine becomes increasingly<br />

significant.<br />

prascend® ensures that veterinarians<br />

can respond to these requirements.<br />

Refined diagnostic methods are<br />

worthwhile considering as they lead<br />

to a greater awareness of health issues<br />

due to advancing age. Consequently,<br />

horses and their owners benefit from<br />

these findings.<br />

The horse owner is also encouraged to<br />

actively participate in preventative<br />

health management routines. Paying<br />

particular attention to dentistry, hoof<br />

care and worming can provide valuable<br />

information for the veterinarian,<br />

who plays a pivotal role in this health<br />

management by initiating the dialogue<br />

with the owner.<br />

So, in the future, owners and horses<br />

will be enjoying a longer and happier<br />

time together thanks to future-orientated<br />

therapeutic solutions which we<br />

offer for companion animals.<br />

“Zippity Do Dah, our 29-yearold<br />

Quarter Horse mare who is<br />

a special part of our family, has<br />

PPID and has benefited greatly<br />

from therapy, including fewer<br />

secondary infections, improved<br />

hair coat and overall vitality.<br />

She enjoys carrying our son,<br />

Evan, and other children just<br />

learning to ride.”<br />

dr kate christmas,<br />

dvm veterinarian and owner<br />

of a geriatric horse<br />

Horses grow old as well<br />

77


# 04<br />

PERSPECTIVE<br />

FOR NEW MARKETS<br />

Economic, demographic and lifestyle changes will further increase the attractiveness and<br />

importance of the emerging markets as important geographies for <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

Our innovative product portfolio, research and development and manufacturing capabilities,<br />

regulatory know-how, as well as our workforce in these key regions, are important success<br />

factors for us in embracing the opportunities and in satisfying the great need of medical<br />

treatment in these growing and still flexible market environments.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

80 EMERGING MARKETS – GROWING IMPORTANCE<br />

86 INDIA – HIGH UNMET MEDICAL NEED<br />

89 CHINA – INVESTING IN HEALTHCARE<br />

92 BRAZIL – BETTER TREATMENT OPTIONS<br />

78<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective for new markets<br />

Perspective for new markets 79


85 % of the United Arab Emirates’ population live in the capital city<br />

Dubai. Here, the whole economic, social, cultural and political life of<br />

the Emirates takes place.<br />

EMERGING MARKETS –<br />

GROWING IMPORTANCE<br />

The emerging markets are characterised by high gross domestic<br />

product (GDP) growth rates and huge, growing populations, as well<br />

as healthcare spending that is mainly out-of-pocket. This makes it<br />

hard for the poorer population to get access to medicines.<br />

Strong growth rates can be observed<br />

in regions such as the BRIC economies<br />

– Brazil, Russia, India and China<br />

(some of which we highlight on pages<br />

86 to 93). But there are also less classical,<br />

new emerging markets, such as<br />

several countries in the Middle East,<br />

Asia, Africa or Latin America which<br />

have achieved a considerable level of<br />

economic development and growth<br />

potential. These regions will gain increasingly<br />

in importance in the immediate<br />

future. Some examples of countries<br />

with <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

facilities can be found on the following<br />

pages.<br />

Chances and challenges<br />

Although the emerging markets provide<br />

considerable opportunities, there<br />

are also challenges that have to be met.<br />

They are particularly vulnerable to<br />

any economic downturn, high inflation<br />

rates and legislative as well as<br />

political changes.<br />

Differences among them include<br />

intellectual property rights, levels of<br />

protectionism, disease patterns, economic<br />

and demographic developments<br />

as well as the history of reimbursement<br />

for healthcare expenditures. In<br />

this context, a correlation between<br />

the willingness to pay an out-of-pocket<br />

premium for pharmaceutical products<br />

and the existence of reimbursement<br />

systems has to be noted.<br />

80<br />

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future markets<br />

perspective for new markets<br />

1 Buenos Aires, the capital of Argentina, is the second-largest metropolitan<br />

area in South America (on the picture Plaza del Congreso).<br />

2 Jakarta is located on the northwest coast of Java, Indonesia, and has a<br />

population of about 10 million.<br />

3 Johannesburg is the provincial capital of Gauteng, the wealthiest province<br />

in South Africa and the largest economy in the Sub-Saharan region.<br />

1 2 3<br />

Pharmaceutical markets<br />

Due to changes in lifestyle, there is a<br />

great need for medical treatment. The<br />

majority of the healthcare spend in the<br />

emerging markets is out-of-pocket.<br />

People’s ability to pay for medicines<br />

varies significantly. The affordability<br />

of medicines and vaccines is one of<br />

many barriers to accessing healthcare.<br />

Varying standards exist and many of<br />

the poorest do not have access to<br />

hospitals or clinics.<br />

Emerging markets undergo constant<br />

change in different areas. There is an<br />

increasing incidence of non-communicable<br />

diseases such as asthma and diabetes.<br />

With increased access to healthcare<br />

facilities, the population is more<br />

likely to receive prescriptions and purchase<br />

drugs. Moreover, patients will have<br />

wider access to drugs through expanded<br />

reimbursement in the public health system.<br />

As public healthcare systems are<br />

extended, given their expected financial<br />

constraints, there will be increased opportunities<br />

for generics which are generally<br />

favoured over innovative and<br />

usually much higher priced originator<br />

drugs. Nevertheless, originator products<br />

will still have a place. The goal – which<br />

is a challenge at the same time – must be<br />

to deliver medicines and vaccines to as<br />

many people as possible. As a researchdriven<br />

pharmaceutical company, we<br />

therefore provide a broad portfolio of<br />

medicines that can be offered across the<br />

emerging markets’ varied healthcare<br />

systems. Because of the different conditions<br />

in the individual countries, a diverse<br />

range of needs must be taken into<br />

account.<br />

Sources chapter Perspective for new markets:<br />

Asian International Vocational Center 2012<br />

Business Wire 2010<br />

Datamonitor 2010<br />

dpa <strong>2011</strong><br />

Federal Foreign Office (Germany) 2010<br />

International Monetary Fund 2010, <strong>2011</strong><br />

McKinsey 2010<br />

World Bank 2010<br />

Emerging markets – growing importance<br />

81


[ mena countries ]<br />

dubai<br />

regional head office<br />

BOEHRINGER INGELHEIM<br />

IN MENA<br />

We manage this area from our Regional<br />

Operative Unit Near East in Dubai, United<br />

Arab Emirates.<br />

331m<br />

population<br />

USD 1.07tn<br />

gdp<br />

There is significant volatility in the market<br />

due to the p olitical unrest in <strong>2011</strong>. Despite<br />

the turmoil caused by the Arab Spring, we<br />

have seen continued high performance<br />

and we were recognised as one of the<br />

fastest-growing companies in Saudi Arabia,<br />

Lebanon and Algeria. Established products,<br />

such as spiriva®, micardis® and<br />

metalyse®, have made a significant contribution.<br />

With full confidence and commitment to<br />

the region, we invested in new office<br />

premises in Egypt in <strong>2011</strong>. We have local<br />

manufacturing arrangements with about<br />

35 partners in the region.<br />

Middle East and North Africa<br />

[ mena countries ]<br />

The MENA region is an economically<br />

diverse region that includes both the<br />

oil-rich economies in the Gulf and<br />

countries that are resource-poor in relation<br />

to population, such as Egypt,<br />

Morocco, and Yemen. The region has<br />

vast reserves of oil and natural gas.<br />

About 331 million people live in the<br />

Middle East and North Africa. The<br />

combined GDP is over USD 1 trillion.<br />

Due to the region’s growth, infrastructure<br />

development and rapidly changing<br />

regulations are evident.<br />

The highest growth potential of the<br />

MENA pharmaceutical market can be<br />

seen in Algeria, Saudi Arabia, Egypt,<br />

Lebanon, United Arab Emirates and<br />

Iran. The pharmaceutical market consists<br />

of private, public and institution<br />

business. The main products dominating<br />

the market include antirheumatics,<br />

antibiotics, vitamins and antidiabetics.<br />

The market is highly dependent on<br />

imported pharmaceutical products and<br />

therapeutics.<br />

Association of Southeast Asian<br />

Nations<br />

[ asean countries ]<br />

The ASEAN region is the world’s<br />

largest regional emerging market,<br />

encompassing 600 million people.<br />

The demographics of the ten countries<br />

vary considerably. Indonesia is by<br />

far the largest country with 39 % of<br />

the ASEAN population. There is a<br />

large population in the region aged<br />

between 15 and 60 years of age.<br />

The ASEAN countries will have a<br />

growing presence and future role<br />

in the world economy. Overall, the<br />

region has a GDP of USD 1.84 trillion.<br />

ASEAN economies are diverse, both<br />

in levels of development and the<br />

institutional and commercial policy<br />

environment.<br />

82<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective for new markets<br />

[ asean countries ]<br />

600m<br />

population<br />

USD 1.84tn<br />

gdp<br />

jakarta<br />

regional head office<br />

bogor<br />

production site<br />

BOEHRINGER INGELHEIM<br />

IN ASEAN<br />

One of the countries in this region in<br />

which we are present is Indonesia. Our<br />

head office is in Jakarta (above) and our<br />

production plant in Bogor.<br />

Health facilities and services are<br />

different within individual countries<br />

as well. Ageing demographics in the<br />

more mature Asian countries represent<br />

a challenge. The increasing wealth<br />

and the intention of governments to<br />

increase access to healthcare for their<br />

population support the expansion of<br />

the pharmaceutical markets in all<br />

countries. There is a growing penetration<br />

of generics in most markets, due<br />

to increasing acceptance and usage<br />

of these products, as well as strong<br />

promotion, allowing improved availability<br />

and accessibility of medicines.<br />

Continuing pressure on prices is<br />

expected as governments strive to<br />

manage increasing healthcare costs.<br />

This especially applies to unreimbursed<br />

markets, and where the patients<br />

pay out-of-pocket for their medicines,<br />

increased price competition is expected.<br />

The possibility of further price reductions,<br />

including voluntary cuts, is<br />

expected.<br />

Indonesia is the dominant economy<br />

within the ASEAN region. Two thirds<br />

of Indonesia’s GDP is driven by domestic<br />

consumption, making it less<br />

susceptible to global economic turbulence.<br />

However, lack of infrastructure,<br />

terrorism, corruption, and natural<br />

disasters remain a threat to this young<br />

but stable democracy with its growing<br />

middle class.<br />

Government funding for healthcare is<br />

low, but strong economic growth has<br />

led to increased healthcare expenditure.<br />

The dominance of local players<br />

is reflected in the highest share of<br />

generic drugs across Southeast Asia.<br />

Price cuts for current products and<br />

the pricing of newly developed innovative<br />

medicines still remains to be a<br />

major challenge. With the governmentinitiated<br />

transition from an out-ofpocket<br />

market to a largely reimbursed<br />

market by 2014, drastic changes can<br />

be foreseen.<br />

<strong>2011</strong> has been a successful year for us<br />

and, for the first time, Indonesia became<br />

the highest-selling country in Southeast<br />

Asia. Our three equally strong businesses<br />

Prescription Medicines, Consumer Health<br />

Care (CHC), and Industrial Customer Business<br />

are joined by an emerging Animal<br />

Health business.<br />

We launched pradaxa® in <strong>2011</strong> and launches<br />

of trajenta® and twynsta® are anticipated<br />

in 2012. pharmaton®, bisolvon®<br />

and dulcolax® are the three strong brands<br />

of our CHC portfolio in Indonesia.<br />

The importance of our pharmaceutical production<br />

increased as an export hub within<br />

our Operations network serving most<br />

countries in the ASEAN free trade zone and<br />

beyond. Investments continue to be made<br />

in the manufacturing plant in order to supply<br />

additional countries in the near future.<br />

We are also a trusted business partner for<br />

several multinational companies.<br />

Emerging markets – growing importance<br />

83


[ sub-saharan africa ]<br />

BOEHRINGER INGELHEIM<br />

IN SUB-SAHARAN AFRICA<br />

Since 2007, <strong>Boehringer</strong> <strong>Ingelheim</strong> in<br />

South Africa (established in 1966) has<br />

managed the business for the whole Sub-<br />

Saharan Africa region. The focus for our<br />

business remains predominantly East and<br />

West Africa where our lead countries are<br />

currently Kenya and Nigeria. The year<br />

2012 will see further launches of pradaxa®<br />

and twynsta® being initiated throughout<br />

Southern and Sub-Saharan African countries,<br />

following its first African launch in<br />

Namibia in <strong>2011</strong>.<br />

Improving access to treatment and quality<br />

healthcare remains seriously limited<br />

in many African countries. We are engaged<br />

in combating the AIDS pandemic<br />

through our initiative for the prevention<br />

of mother-to-child transmission (PMTCT)<br />

of HIV/AIDS. We have granted non-assert<br />

declarations to generic manufacturers,<br />

prequalified by the World Health Organization<br />

(WHO) to manufacture products<br />

containing the active pharmaceutical ingredient<br />

nevirapine and tipranavir respectively.<br />

Our activities in the training and education<br />

of healthcare professionals and primary<br />

healthcare workers remain a focus<br />

in several African countries. In Botswana<br />

we have a <strong>Boehringer</strong> <strong>Ingelheim</strong> Training<br />

Center in Gaborone and further investments<br />

include the HIV Treatment Facility<br />

in Gumare which caters for around 60,000<br />

people. Access to treatment was further<br />

advanced through the building of the<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Lung Institute<br />

(above) in Cape Town, South Africa, a<br />

partnership with the local university.<br />

Our longstanding commitment in facilitating<br />

the medical education of underprivileged<br />

African students has delivered<br />

over 30 qualified doctors and physicians<br />

over the past years.<br />

854m<br />

population<br />

USD 1.10tn<br />

gdp<br />

Sub-Saharan Africa<br />

The region of Sub-Saharan Africa<br />

includes Southern, East, West and<br />

Central Africa, i. e. the area of the continent<br />

that lies south of the Sahara.<br />

About 854 million people are living in<br />

47 countries. With exception of South<br />

Africa, more than 40 % of the population<br />

are below 15 years in most Sub-<br />

Saharan countries. Africa is considered<br />

the world’s poorest inhabited<br />

continent with low life expectancy<br />

and high infant mortality, violence<br />

and instability.<br />

South Africa is by far the continent’s<br />

wealthiest state in total GDP terms<br />

and is seen as the economic gateway<br />

to Sub-Saharan Africa. There is considerable<br />

variation in wealth in most<br />

African countries. The upper class has<br />

a much higher income than the majority<br />

of the population. Africa is also<br />

the least industrialised continent: in<br />

the Sub-Saharan region it is only<br />

South Africa which has substantial<br />

manufacturing sectors. Despite readily<br />

available cheap labour, nearly all<br />

randburg<br />

regional head office<br />

of the continent’s natural resources<br />

are exported for secondary refining<br />

and manufacturing. The investment<br />

in infrastructure contributed to more<br />

than half of Africa’s improved growth<br />

performance in the last 20 years.<br />

Increased investment is necessary to<br />

maintain growth and tackle poverty.<br />

The pharmaceutical sector underwent<br />

substantial governmental reforms<br />

over the last decade, including legislation<br />

banning discounts and samples,<br />

enforcing generic substitution at<br />

pharmacy level and setting pricing for<br />

pharmaceutical products. Due to the<br />

social climate in South Africa, healthcare<br />

is high on the government’s<br />

agenda with plans to introduce national<br />

health insurance over the next<br />

20 years. The government’s short to<br />

medium-term goals are focused on<br />

non-communicable diseases, including<br />

hypertension and diabetes,<br />

through encouraging lifestyle changes.<br />

The biggest healthcare issue remains<br />

HIV/AIDS. The pandemic disease<br />

has decimated or will decimate<br />

84<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective for new markets<br />

mexico city<br />

regional head office<br />

[ latin america ]<br />

590m<br />

population<br />

USD 4.97tn<br />

gdp<br />

BOEHRINGER INGELHEIM<br />

IN LATIN AMERICA<br />

the working-age population<br />

of many states.<br />

buenos aires<br />

regional head office<br />

Latin America<br />

Latin America has a combined GDP<br />

of almost USD 5 trillion and a population<br />

of over 590 million. The inhabitants<br />

are of a variety of ancestries,<br />

ethnic groups and races which makes<br />

the region one of the most diverse in<br />

the world. One of the region’s main<br />

challenges continues to be poverty.<br />

The cost of drugs is too high for many<br />

people in Latin America and they often<br />

do without. Generics are typically<br />

favoured over brands. Health and<br />

drug programmes by the governments<br />

are complicated and ineffective for remote<br />

communities yet. Nevertheless,<br />

the annual growth rate of the pharmaceutical<br />

market is over 10 % and<br />

will probably remain at this or a higher<br />

level over the coming years. There<br />

is a shift in population and the number<br />

of people over 65 years continues<br />

to grow. Age-related illnesses, such<br />

as Alzheimer’s disease, represent a<br />

challenge and corresponding drugs<br />

are needed. Moreover, the middle-class<br />

is no longer immune to non-communicable<br />

diseases as obesity, diabetes and<br />

cardiovascular diseases.<br />

One of the countries in which we are<br />

present in Latin America is Mexico. We are<br />

the only FDA/EMA (Food and Drug Administration/European<br />

Medicines Agency)-<br />

approved facility to manufacture prescription<br />

medicines and over-the-counter<br />

(OTC) products in the country. Guatemala,<br />

Honduras, El Salvador, Nicaragua, Panama,<br />

Dominican Republic and Cuba are<br />

controlled from our Mexican location.<br />

pradaxa® was launched in June, trayenta®<br />

in September <strong>2011</strong>. sifrol® is the number<br />

one product in the Parkinson segment<br />

and the most prescribed product by neurologists.<br />

The region of the ROPU South America<br />

(Argentina, Colombia, Venezuela, Ecuador,<br />

Peru, Chile, Paraguay and Uruguay) is<br />

managed from Buenos Aires. Regulatory<br />

authorities in the region vary greatly in<br />

their infrastructure, resources and expertise.<br />

Each country has its national procedures<br />

for the regulation of medicines but<br />

they are at different stages of development.<br />

Drug registration timelines in the<br />

region generally range from 4 to 18 months.<br />

Our core brands in the Regional Operative<br />

Unit in <strong>2011</strong> included buscapina®, pharmaton®<br />

and bisolvon® within the OTC<br />

business and micardis®, secotex® and<br />

spiriva® within the prescription medicines<br />

business.<br />

Emerging markets – growing importance<br />

85


View of Mumbai, one of the world's most<br />

populous cities. It is located at the west<br />

coast of India.<br />

INDIA – HIGH UNMET<br />

MEDICAL NEED<br />

India is the second most populous country in the world. A shift<br />

from communicable to more chronic “western” diseases represents<br />

a challenge to the pharmaceutical industry.<br />

The pharmaceutical market<br />

In the past five years, the Indian pharmaceutical<br />

market has been growing by<br />

12 % to 14 %. Market agencies and consultancy<br />

firms predict that this growth<br />

rate can be maintained in future, or<br />

even surpassed by a few percent.<br />

1.73tn<br />

SUSTAINED GROWTH<br />

In 2010, the Indian gross domestic<br />

product (GDP) reached USD 1.73<br />

trillion. In the 2010 – <strong>2011</strong> financial<br />

year, the Indian economy grew by<br />

over 8 %. As the economy is mainly<br />

driven by domestic consumption,<br />

it still achieved respectable positive<br />

growth during the recent financial<br />

crisis. During the decade 2010 – 2020,<br />

120 million young people will be added<br />

to the Indian workforce. This poses a<br />

very big challenge to the government<br />

in attracting enough investment to<br />

provide employment opportunities<br />

for this large pool of people.<br />

India’s population is 1.21 billion.<br />

40 % are under the age of 19. As the<br />

birthrate remains high, India will<br />

soon have the largest population in<br />

the world. Nevertheless, the number<br />

of elderly people is still increasing,<br />

which is likely to compound the<br />

healthcare challenge facing India<br />

in the coming years.<br />

India belongs to the world’s strongest-expanding<br />

economies. Over the<br />

years, the country has consistently<br />

posted exceptionally high GDP<br />

growth rates.<br />

The market is dominated by branded<br />

generics, as patent legislation was only<br />

introduced at the beginning of 2005.<br />

With this legislation, the international<br />

pharmaceutical industry started to intensify<br />

its focus on the Indian market.<br />

Effects of lifestyle changes<br />

A gradual shift is taking place in India<br />

from communicable diseases to more<br />

chronic, non-communicable diseases,<br />

like hypertension and diabetes. This<br />

change in epidemiology means that<br />

the demand will switch to high-value<br />

medicines.<br />

86<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective – for new markets<br />

1<br />

2<br />

1 A view of celebrations in the Indian federal state Rajasthan<br />

2 The Taj Mahal, one of the seven wonders of the world, is located in Agra in the<br />

Indian federal state Uttar Pradesh.<br />

3 Its well-educated workforce is India’s greatest strength.<br />

3<br />

The rapid emergence of cardiovascular<br />

and metabolic diseases has created<br />

a situation where we, as an international<br />

pharmaceutical company, can<br />

act as a partner to provide the latest<br />

innovations for the treatment of such<br />

diseases.<br />

Out-of-pocket payment<br />

As Indian patients pay for medicines<br />

mainly out-of-pocket, the market is<br />

extremely price-sensitive. Growth<br />

drivers, besides lifestyle-related diseases,<br />

are increased affordability of<br />

drugs, due to sustained income growth<br />

and increased medical insurance.<br />

Greater government spending, rapid<br />

expansion of medical infrastructure<br />

and the introduction of patented, innovative<br />

products are additional factors<br />

contributing to market growth.<br />

All these factors, combined with high<br />

unmet medical need, changed the<br />

attractiveness of this market considerably.<br />

Recent new introductions of innovative<br />

products by international<br />

companies have demonstrated that<br />

sensible pricing can lead to major in-<br />

roads into local patient potential with<br />

a viable commercial model. Nevertheless,<br />

branded generics will remain<br />

the largest market sector for the next<br />

20 years at least.<br />

Cardiovascular diseases and neurology<br />

Until now, our business has, for the most<br />

part, been institutionally orientated,<br />

with our main products actilyse® and<br />

metalyse®. Registration of pradaxa®<br />

is expected in early 2012. Our market<br />

studies have confirmed a high unmet<br />

medical need. In order to bring the<br />

benefits of pradaxa® to as many patients<br />

as possible, we, together with<br />

physicians, provide consistent medical<br />

education by the SPAF Academy<br />

(see right). And with actilyse® and<br />

aggrenox®, we are able to provide our<br />

target customers with a comprehensive<br />

product range for the treatment of<br />

acute and secondary prevention of<br />

stroke.<br />

Metabolism<br />

As India already has more than 50 million<br />

patients suffering from diabetes,<br />

this therapeutic area will form the<br />

SPAF ACADEMY – MEDICAL<br />

EDUCATION TO PREVENT<br />

STROKES<br />

We initiated this educational programme<br />

to spread awareness of<br />

medical progress in the area of<br />

stroke prevention in atrial fibrillation<br />

(SPAF). It educates physicians<br />

in India for the pradaxa®<br />

launch. The programme has been<br />

positioned as an extension of the<br />

global initiative with the same<br />

mission: to prevent at least one<br />

million strokes due to atrial fibrillation.<br />

It is led by a body of top<br />

electrophysiologists and neurologists<br />

and aims at targeting some<br />

5,000 physicians.<br />

India – high unmet medical need<br />

87


BOEHRINGER INGELHEIM IN INDIA<br />

As one of the first wholly foreignowned<br />

pharmaceutical companies,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> India was registered<br />

in late 2003. In the initial years,<br />

we focused on establishing market<br />

channels and contacts with government<br />

agencies. In 2010, Clinical Operations<br />

started to build a major hub for<br />

its activities.<br />

mumbai<br />

head office<br />

1,21bn<br />

population<br />

USD 1,73tn<br />

gdp<br />

In prescription medicines, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> India is now active in three<br />

therapeutic areas: cardiovascular,<br />

metabolic diseases and diseases of<br />

the central nervous system.<br />

backbone of our future market presence.<br />

In order to successfully enter this<br />

new, potential, but very competitive,<br />

therapeutic area, we formed a local<br />

partnership with Eli Lilly in October<br />

<strong>2011</strong>. Since January 2012, we have<br />

been co-promoting Eli Lilly’s Humalog<br />

(injectable insulin). With the introduction<br />

of trajenta® in the second<br />

half of 2012, and subsequent combination<br />

with Metformin, Eli Lilly will<br />

co-promote these products with us.<br />

Consumer Health Care<br />

The Indian consumer market has<br />

vast potential and is expected to be<br />

amongst the top ten in a few years.<br />

We are currently not in this market<br />

segment. Our two flagship products,<br />

dulcolax® and buscopan®, have been<br />

out-licensed for the past 40 years to a<br />

local partner that currently promotes<br />

the products to physicians.<br />

categories of potential interest are<br />

multivitamins and cough and cold.<br />

Animal Health<br />

Animal Health started its activities in<br />

India in 2009. The animal health market<br />

in India concentrates largely on<br />

dairy cattle. With 55 million head, India<br />

has the largest dairy cattle population<br />

in the world, as well as a poultry<br />

sector, which is amongst the largest.<br />

However, due to regulatory timelines,<br />

Animal Health in India started business<br />

operations in early 2010 in the still<br />

niche equine segment. Meanwhile, we<br />

achieved marketing authorisations for<br />

a number of poultry vaccines and the<br />

launch of our poultry business began<br />

in the fourth quarter of <strong>2011</strong>. The next<br />

step for us is to enter the dairy cattle<br />

segment in 2012–2013.<br />

We see a great potential in shifting the<br />

promotion of these brands to overthe-counter<br />

(OTC) and in selectively<br />

adding line extensions. Other product<br />

88<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective for new markets<br />

A glance at Puhdong, an area of Shanghai, located<br />

along the east side of the Huangpu River. Shanghai is<br />

the largest city by population in China.<br />

CHINA – INVESTING<br />

IN HEALTHCARE<br />

China, the most populous country in the world, is facing increased<br />

pressure on healthcare and growing death rates from chronic diseases.<br />

1.35bn<br />

China’s population increased<br />

from 1.31 billion in 2005 to 1.35<br />

billion in 2010. By 2050, it is<br />

estimated that more than 30 %<br />

of the population will be 60 or<br />

older, creating additional pressure<br />

on healthcare.<br />

Shanghai is the epitome of China’s<br />

development in recent decades; however,<br />

such dramatic changes are happening<br />

all over the country. China’s<br />

gross domestic product (GDP) growth<br />

has been among the world’s highest<br />

since it adopted its reform and opening-up<br />

policy in 1979. In the second<br />

quarter of <strong>2011</strong>, China overtook Japan<br />

to become the world’s second largest<br />

economy. In 2010, the GDP grew by<br />

10.3 % to USD 5.88 trillion and is<br />

expected to have grown by 9.5 % in<br />

<strong>2011</strong>.<br />

Increasing access to healthcare<br />

Health outcomes in China have improved<br />

tremendously over the past<br />

three decades. Although some infectious<br />

diseases signifi cantly decreased,<br />

death rates from chronic diseases have<br />

been rising due to changes in lifestyle<br />

and environmental conditions.<br />

The absence of a primary care system<br />

and a tiered public hospital system,<br />

with uneven distribution of resources<br />

and physicians’ capabilities, has led to<br />

over-crowding in major hospitals. The<br />

government continuously introduces<br />

healthcare reforms and is investing in<br />

In spite of its great economic<br />

progress, China’s GDP per capita is<br />

still low. Improving the stan dard<br />

of living and stimulating domestic<br />

consumption has become a key<br />

focus in the government’s new<br />

five-year plan.<br />

China – investing in healthcare<br />

89


1 Zhangjiang High-Tech Park in Shanghai, where our production plant is located<br />

2 View of a Chinese chemist's shop: traditional medicine is valued highly<br />

(19 % of the medications market)<br />

3 The city wall of Xi’an: tradition and modernity are side by side in China<br />

4 Packaging of ampules in Zhangjiang production plant in Shanghai<br />

1 3 4<br />

2<br />

THE PHARMACEUTICAL MARKET<br />

IN CHINA<br />

19 %<br />

traditional<br />

chinese<br />

medicine<br />

18 %<br />

over-thecounter<br />

Source: IMS Health CHPA Q3 <strong>2011</strong><br />

62 %<br />

prescription<br />

medicines<br />

improving healthcare provision, providing<br />

medical insurance and ensuring<br />

basic drug delivery.<br />

It is estimated that China will overtake<br />

Germany and France as the<br />

world’s third-largest prescription<br />

medicines market in <strong>2011</strong>, after the<br />

USA and Japan. Prescription medicines<br />

comprised 62 % of the total<br />

pharmaceutical market (graphic, left:<br />

market composition). Over half of the<br />

overall value in prescription medicines<br />

is generated in the anti-infective,<br />

metabolism, cardiovascular and<br />

oncology segments.<br />

Strong partner for health<br />

Our existing product portfolio provides<br />

health in several leading therapeutic<br />

areas, including our core<br />

products spiriva® (COPD), sifrol®<br />

(Parkinson’s disease), actilyse®<br />

(stroke) and micardis® (hypertension).<br />

Numerous disease awareness<br />

and patient education initiatives contri-bute<br />

to gaining more knowledge in<br />

these areas:<br />

• More than 40 million patients suffer<br />

from COPD in China. On average,<br />

2.5 people die of COPD every<br />

minute. To increase disease awareness<br />

and prevention, we are partnering<br />

with academics and experts<br />

in a six-year research programme<br />

called Tie-COPD aimed at observing<br />

COPD patients in the long term.<br />

• Channels to obtain disease information<br />

for the approximately two million<br />

patients with Parkinson’s disease<br />

are very limited in China.<br />

Together with leading experts, we<br />

launched China’s first professional<br />

patient website for Parkinson’s disease<br />

(www.pajo.cn). It aims to improve<br />

the life of patients and their<br />

care-givers by providing comprehensive,<br />

professional information,<br />

such as disease knowledge sharing,<br />

suggestions for daily life and hospital<br />

and physician profiles, as well<br />

as online communication platforms<br />

between patients, care-givers and<br />

physicians.<br />

90<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective for new markets<br />

[ china ]<br />

1.35bn<br />

population<br />

USD 5.88tn<br />

gdp<br />

• In cooperation with China’s Parkinson’s<br />

disease and Movement Disorder<br />

Society, we supported the promotion<br />

of “Parkinson’s Disease<br />

Healthy Home”, the first educational<br />

tool providing lifestyle tips for<br />

patient care.<br />

shanghai<br />

head office<br />

R&D+Medicine<br />

China is a key contributor to our global<br />

clinical development programmes<br />

and has entered 3,510 patients in<br />

about 33 pivotal studies in <strong>2011</strong>, covering<br />

the diabetes, oncology and respiratory<br />

therapeutic areas.<br />

BOEHRINGER INGELHEIM<br />

IN CHINA<br />

The branch office was set up in March<br />

1994. A year later, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

International Trade (Shanghai) Co. Ltd.<br />

was registered. In 1995 <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Shanghai Pharmaceuticals Ltd.<br />

was established as a joint venture with a<br />

local Chinese pharmaceutical company,<br />

and in 2000 it became a wholly-owned<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> company. The company<br />

set up its production plant in Shanghai<br />

Zhangjiang High-Tech park in 2002.<br />

In <strong>2011</strong>, the expansion project of<br />

Zhangjiang plant began and the facility is<br />

to become the supply centre for China and<br />

also in future for the Asia-Pacific region.<br />

• Together with the Chinese Hypertension<br />

League, we initiated and<br />

sup ported a campaign to roll out<br />

new hypertension treatment guidelines<br />

covering more than 50 cities<br />

across China.<br />

Innovative medicine<br />

The introduction of innovative products<br />

will strengthen our presence in<br />

the leading therapeutic areas. Products<br />

in diabetes, stroke prevention in<br />

atrial fibrillation and oncology will<br />

provide more health in China’s biggest<br />

and fastest growing healthcare<br />

segments over the next five years. Our<br />

newest innovations, pradaxa® and<br />

trajenta®, will be launched in China<br />

in 2013.<br />

Animal Health<br />

China is the world’s largest producer<br />

of meat products. Strong economic<br />

growth and increased income are<br />

driving higher local consumption of<br />

meat. China currently ranks third in<br />

the global animal health market and<br />

second in the swine health segment.<br />

In 2010, we were leading in the swine<br />

segment, especially with our vaccines,<br />

such as ingelvac circoflex®.<br />

EUR 79m<br />

We are investing EUR 79 million<br />

to expand our production plant in<br />

the Zhangjiang High-Tech Park in<br />

Shanghai into a strategically important<br />

supply centre for China<br />

and the Asia-Pacific region. By<br />

increasing the number of employees<br />

and doubling production<br />

capacity, we will bring health to<br />

more patients.<br />

China – investing in healthcare<br />

91


PHYTOCHEMICALS – PART OF OUR GLOBAL NETWORK<br />

Phytochemistry concerns research into chemicals derived from plants. On our farms in Australia<br />

and Brazil, we grow our own plants and extract and purify the active substances. We ensure<br />

that raw material production for our pharmaceutical ingredients, as well as for our Industrial<br />

Customer business, is conducted in a sustainable way.<br />

BRAZIL – BETTER<br />

TREATMENT OPTIONS<br />

The Brazilian pharmaceutical market is mainly out-of-pocket and<br />

hard to afford for most of the public. To grant access to medicines<br />

to a broader section of the population and to provide them with<br />

better treatment options, we are developing innovative business<br />

models together with the public sector.<br />

With a population of 196 million,<br />

Brazil is the fifth most populous<br />

country in the world and covers about<br />

half of the area of South America. A<br />

gross domestic product (GDP) of over<br />

USD 2 trillion made Brazil the seventh<br />

largest national economy in 2010. In<br />

<strong>2011</strong> it reached sixth place. Brazil is a<br />

relatively young country with around<br />

half of the population under 29 years<br />

of age. This population bonus means<br />

that there is a large pool of young<br />

workers – an asset to a growing economy.<br />

The jobless rate was reduced to<br />

6 % in <strong>2011</strong>. Social, political and economic<br />

stability is turning Brazil into<br />

one of the main destinations for foreign<br />

investment, benefiting from its<br />

young labour force.<br />

The pharmaceutical market<br />

The healthcare system in Brazil represents<br />

a continuous challenge for the<br />

government and stakeholders, as most<br />

of the active pharmaceutical ingredients<br />

(API) are imported and most of<br />

the population cannot afford out-ofpocket<br />

spending (which accounts for<br />

80 % of the market). For this reason,<br />

generics and low-price pharmaceutical<br />

products are growing strongly.<br />

The greatest need is to offer good prices<br />

and good quality. The government has<br />

set up the Brazilian popular pharmacy<br />

programme (Programa Farmácia Popular<br />

do Brasil) to increase the supply of<br />

medicines to the poor, but many patients<br />

still do not have access to medicines and<br />

92<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


future markets<br />

perspective for new markets<br />

[ brazil ]<br />

196m<br />

population<br />

USD 2.09tn<br />

gdp<br />

are therefore increasingly demanding<br />

access to innovative drugs from the<br />

government for which they previously<br />

had to pay out-of-pocket.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> in Brazil –<br />

knowledge transfer<br />

To provide a broader part of the population<br />

with better treatment options,<br />

we are developing new business models<br />

in Brazil. In signing a five-year<br />

partnership with the Brazilian government<br />

in <strong>2011</strong>, we chose one such<br />

model. On the one hand, we are<br />

granting the supply of sifrol®, for the<br />

treatment of Parkinson’s disease, for<br />

government purchase, in order to provide<br />

patients with a high-class product.<br />

On the other hand, we will transfer<br />

knowledge and technology on how<br />

to produce the API pramipexole for<br />

the drug to a local public production<br />

site after the five years.<br />

Better access to medicines<br />

spiriva® for the treatment of chronic<br />

obstructive pulmonary disease (COPD),<br />

is another example of our growing<br />

são paulo<br />

head office<br />

presence in the public sector. The future<br />

of spiriva® looks even more promising,<br />

as it has been newly listed in several<br />

states of Brazil. We thus facilitate access<br />

to better treatment opportunities for patients<br />

with COPD. The disease can be<br />

diagnosed by means of spirometry and<br />

we can help thousands of patients who<br />

depend on public assistance to get adequate<br />

access to therapies and to acquire<br />

their medication.<br />

Education<br />

Moreover, the Brazilian government<br />

decided to include our products actilyse®<br />

and metalyse® in the federal<br />

protocol of reimbursement in 2012.<br />

Stroke is the number one cause of death<br />

in Brazil. The government recognises<br />

the enormous human suffering caused<br />

by stroke and acute myocardial infarction<br />

(AMI), and the impact they have<br />

on the national economy. We offer a<br />

training and education programme,<br />

“Educar para Salvar” (Educate to Save),<br />

for public health agents to build up<br />

awareness of the early symptoms of<br />

stroke and AMI.<br />

BOEHRINGER INGELHEIM<br />

IN BRAZIL<br />

Our first subsidiary over the Atlantic,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> do Brasil Química e<br />

Farmacêutica Ltda., was founded in 1956.<br />

Our main product portfolio consists of<br />

buscopan®, spiriva®, anador®, micardis®,<br />

sifrol® and secotex®. pradaxa® and<br />

trajenta® were launched in <strong>2011</strong>, four to<br />

six months earlier than originally planned,<br />

thanks to the innovation-friendly government.<br />

Since the pharmaceutical market is mainly<br />

out-of-pocket, our over-the-counter business<br />

is of great worth and represents 48 %<br />

of our Human Pharmaceuticals business<br />

value. buscopan® is among the top ten<br />

brands in Brazil – with strong growth rates.<br />

The main product of our Animal Health<br />

Business is ingelvac circoflex®, which<br />

combats porcine circovirus type 2.<br />

Brazil – better treatment options<br />

93


# 05<br />

FLEXIBILITY<br />

FOR STRONG NETWORKS<br />

Through our production network we supply the global market with our active<br />

pharmaceutical ingredients and high-quality medicines. Here, we give the<br />

highest priority to quality and reliability from the start of a product’s life cycle<br />

as well as to supplying the market with established products. As our network<br />

covers all the regions worldwide, we are able to adapt flexibly to the local requirements<br />

of each region. With our product launch record, innovative technologies<br />

and cost-effectiveness, we satisfy both internal and external customers.<br />

Please see<br />

annualreport.boehringer-ingelheim.com<br />

96 SUPPLY CHAIN RELIABILITY AND INTEGRITY<br />

98 SUCCESSFUL PRODUCT LAUNCHES<br />

94<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


production network<br />

flexibility for strong networks<br />

Flexibility for strong networks 95


2<br />

1<br />

1 Increasingly globalised pharmaceutical supply chains demand excellent management.<br />

2 The product pradaxa® is packed in boxes at the LogiPack-Center in <strong>Ingelheim</strong>, Germany.<br />

3 A growing number of counterfeit drugs on the worldwide pharmaceutical market is a threat<br />

for patients.<br />

4 One of our production sites is in Koropi, Greece.<br />

SUPPLY CHAIN RELIABILITY<br />

AND INTEGRITY<br />

An increasing number of counterfeited medical products can be<br />

observed today. We ensure supply chain integrity and the supply<br />

of original high-quality products.<br />

Operations at <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

have established a reliable supply<br />

plan for product launches. However,<br />

when growing market demands and<br />

associated risks are gauged, additional<br />

measures have to be designed into<br />

launch planning. Setting up contingency<br />

launch sites has therefore become<br />

part of the plan execution. The<br />

originating launch site will thus receive<br />

support shortly after launch<br />

through a second or third production<br />

site.<br />

Site transfers at such an early stage in<br />

the product life cycle are more challenging<br />

compared to the transfer of<br />

already established products, as less<br />

process experience exists at the beginning.<br />

Such transfers offer the chance<br />

of a significant increase in operational<br />

supply chain reliability and flexibility.<br />

Patient security and safety<br />

Management of increasingly globalised<br />

pharmaceutical supply chains has become<br />

a top public health concern regarding<br />

patient safety. We are firmly<br />

committed to delivering safe and efficacious<br />

products to our patients and<br />

customers around the globe.<br />

The traditional supply chain of a medicinal<br />

product used to be short and<br />

transparent. Pharmaceutical manufacturers<br />

sourced from local or regional<br />

raw material suppliers and sold<br />

finished products via certain wholesalers<br />

to pharmacies where customers<br />

obtained the products.<br />

Today, an increasing number of counterfeited<br />

medical products can be observed,<br />

falsified regarding their identity,<br />

history or source. Adulterated active<br />

pharmaceutical ingredients (API) are<br />

foisted into regular supply chains and<br />

96<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


production network<br />

flexibility for strong networks<br />

PRADAXA® – VARIOUS PRODUCT<br />

PACKAGINGS<br />

3<br />

In August <strong>2011</strong>, pradaxa® was approved in the<br />

indication stroke prevention in atrial fibrillation<br />

(SPAF) in Europe. All European member countries<br />

obtained marketing authorisation simultaneously.<br />

The main complexity for this launch<br />

was the magnitude of the various product<br />

packagings per country, presentations based<br />

on differing languages, pack sizes and dosage<br />

strengths. Because of the innovative character<br />

of pradaxa®, time was essential to make the<br />

product widely available to offer treatment<br />

alternatives for patients.<br />

4<br />

the theft and distribution of finished<br />

pharmaceutical products via questionable<br />

or even illegal channels is on<br />

the rise.<br />

Better control by networking<br />

In this new environment, traditional<br />

control mechanisms no longer suffice.<br />

All members need to be involved in<br />

the pharmaceutical supply chain and<br />

our efforts are extended beyond the<br />

point of product sale. Supply chain integrity<br />

is the responsibility of all actors<br />

involved in sourcing, manufacturing,<br />

packaging and distributing<br />

raw materials, intermediates and final<br />

products. Open dialogue and networking<br />

with external stakeholders<br />

are essential to achieve a safe supply<br />

chain with integrity, as one company<br />

alone cannot solve the issue.<br />

Product protection<br />

Full end-to-end supply chain transparency<br />

from initial materials to patients<br />

is recognised as the key enabler<br />

to ensure product integrity globally<br />

and trigger rapid action. Product pro-<br />

tection concepts must comply with<br />

regulations and be concrete to achieve<br />

the target. They differentiate between<br />

genuine and counterfeited products.<br />

Mass serialisation is currently considered<br />

to be the most effective enabler<br />

to ensure public health and safety.<br />

Collaboration with customs and police<br />

to support prosecution of criminal<br />

activities is important. Thus, we<br />

thoroughly investigate all incidents<br />

leading to a violation of supply chain<br />

integrity. The combination of serialisation,<br />

tamper-evident closure and<br />

point-of-dispense verification helps to<br />

guarantee that patients receive the<br />

prescribed original, high-quality medication.<br />

COUNTERFEIT DRUGS —<br />

HEALTH THREAT<br />

Supplying patients with genuine<br />

medications has become an important<br />

topic, as counterfeiting is<br />

an increasing threat to patient<br />

health and thereby to the pharmaceutical<br />

industry. Commitment<br />

to patient safety has been the<br />

foundation of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

business activities. Our<br />

“Product Safety and Security”<br />

(PSS) initiative is an important<br />

part of our overall anti-counterfeiting<br />

strategy. The scope of PSS<br />

is to manufacture serialised medicinal<br />

products to ensure that<br />

nobody has manipulated the box.<br />

Supply chain reliability and integrity<br />

97


1 Nozzles for the respimat® Soft Mist TM inhaler<br />

are produced in Dortmund, Germany.<br />

2 Final quality control at our plant in<br />

Yamagata, Japan<br />

3 Japanese blister packaging machine<br />

4 Launching team that produced the first<br />

boxes for the Japanese market<br />

1<br />

2<br />

SUCCESSFUL PRODUCT LAUNCHES<br />

Launching a new medicine to supply the market is highly complex.<br />

Once a novel drug has proven its effectiveness and passed all<br />

the regulatory approval stages, a robust product launch process<br />

becomes critical to ensure market success.<br />

This launch process must address<br />

all necessary steps, from aligning resources<br />

and managing production<br />

volumes against forecast to developing<br />

the required documentation and<br />

executing sales and marketing activities.<br />

A stable launch process results in<br />

a faster time-to-market for the product<br />

and, hence, time-to-profit. Activities<br />

are better planned, coordinated<br />

and more tightly integrated across the<br />

various functions.<br />

Strong commitment and flexibility<br />

Operations is well prepared for future<br />

launch challenges. Even dramatically<br />

shortened timelines for some countryspecific<br />

product introductions, or the<br />

implementation of last-minute information,<br />

such as local trade names,<br />

are supported in a highly efficient and<br />

effective way. The close interactions<br />

between launch sites in the USA and<br />

Germany, and alignment with the local<br />

supply chain organisations, are the<br />

guaranty for a successful launch.<br />

TRAJENTA® — DIABETES<br />

ALLIANCE<br />

trajenta® (linagliptin) is the first<br />

product of our diabetes alliance<br />

with Eli Lilly and Company, first<br />

launched in the USA. Over the<br />

next five years, we plan to launch<br />

numerous innovative products<br />

from our diabetes portfolio worldwide.<br />

Several of them will be<br />

based on two new chemical entities<br />

discovered by our research<br />

team. Another product in our diabetes<br />

portfolio is jentadueto TM<br />

(linagliptin/metformin), the fixed<br />

dose combination of linagliptin<br />

with metformin approved by the<br />

US Food and Drug Administration.<br />

Applying such a process methodology,<br />

we succeeded in launching several<br />

new products in <strong>2011</strong>. A great example<br />

is trajenta® for the treatment of<br />

diabetes (see box left).<br />

The launch of Trajenta®<br />

In <strong>Ingelheim</strong>, Germany, preparations<br />

for the launch of trajenta® began in<br />

early 2010 with the start of drug substance<br />

manufacturing for initial market<br />

supply. In February <strong>2011</strong>, the first<br />

drug product tablets for launch were<br />

produced at Roxane, one of our global<br />

launch sites for prescription medicines<br />

in Columbus, Ohio, USA.<br />

The trajenta® launch was unique,<br />

due to almost simultaneous new drug<br />

application submissions in the USA,<br />

98<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


production network<br />

flexibility for strong networks<br />

JAPAN – SUCCESSFUL LAUNCHES DESPITE<br />

THE EARTHQUAKE AND TSUNAMI<br />

3<br />

Despite the natural catastrophe in March <strong>2011</strong>,<br />

the team based at our Japanese plant in<br />

Yamagata successfully launched trajenta®<br />

(Japanese trade name trazenta®), pradaxa®<br />

(trade name in Japan prazaxa®) and sifrol® er<br />

(mirapex® la) on the Japanese market. pradaxa®<br />

was even launched almost one year earlier<br />

than expected.<br />

4<br />

the European Union and Japan, followed<br />

soon after by additional<br />

launches in 18 countries, including<br />

India and China. Noteworthy was<br />

Roxane’s use of process analytical<br />

technology (PAT) to ensure a reliable,<br />

high-quality supply of trajenta®.<br />

This is our first global submission using<br />

PAT at product launch. These<br />

techniques are now being transferred<br />

throughout our network all over the<br />

world as best practice. In the USA,<br />

launch and shipping of tradjenta®<br />

took place less than ten days after the<br />

date of approval. As a result, 120 distribution<br />

centres for 21 direct US<br />

wholesalers received enough products<br />

that day to ensure coverage across the<br />

country. Over 29,000 pharmacies<br />

across the USA stocked at least one<br />

bottle of trajenta® within a week of<br />

launch.<br />

from <strong>Ingelheim</strong>. The first release for<br />

the EU launch was carried out in September<br />

<strong>2011</strong> in <strong>Ingelheim</strong>.<br />

Innovative dosage forms<br />

At <strong>Boehringer</strong> <strong>Ingelheim</strong>, launch<br />

preparations are not only limited to<br />

active ingredients and medications.<br />

Our goal is also to make innovative<br />

dosage forms, such as the precision<br />

inhaler respimat® Soft Mist TM Inhaler,<br />

available to the market. The inhaler<br />

system is manufactured in Dortmund,<br />

Germany, and the cartridges and<br />

medication at the Launch & Strategic<br />

Products (LSP) site in <strong>Ingelheim</strong>.<br />

combivent® respimat®, which will<br />

become available to patients in the USA<br />

by mid 2012, is another example where<br />

our innovative device technology is<br />

used.<br />

In <strong>2011</strong>, our launch site Roxane,<br />

Inc. also launched viramune® xr,<br />

a once-a-day formulation of nevirapine<br />

for use in combination<br />

with other antiretrovirals for the<br />

treatment of HIV-1 infections in<br />

adults. It was the first product to<br />

move directly from development<br />

to operations.<br />

For the European market, <strong>Ingelheim</strong>,<br />

Germany, was established as the port<br />

of entry for trajenta®. Also the European<br />

countries require local release,<br />

so products for Europe are distributed<br />

Successful launches<br />

99


www.boehringer-ingelheim.com<br />

annualreport.boehringer-ingelheim.com


Value through Innovation<br />

Business Year <strong>2011</strong>


usiness year <strong>2011</strong><br />

content<br />

our company<br />

our company<br />

0 6 t h e s h a r e h o l d e r s ’ p e r s p e c t i v e<br />

1 0 K e y a s p e c t s 2 0 1 1<br />

1 5 c o r p o r at e b o d i e s<br />

group management report <strong>2011</strong><br />

group management report <strong>2011</strong><br />

1 8 B u s i n e s s a n d o p e r at i n g e n v i r o n m e n t<br />

2 9 n e t a s s e t s, f i n a n c i a l p o s i t i o n a n d r e s u lt s f r o m o p e r at i o n s<br />

3 3 r e p o r t o n p o s t - b a l a n c e s h e e t d at e e v e n t s<br />

3 3 r i s k r e p o r t<br />

3 4 r e p o r t o n e x p e c t e d d e v e l o p m e n t s


consolidated financial statements <strong>2011</strong><br />

consolidated financial<br />

statements <strong>2011</strong><br />

3 8 o v e r v i e w o f t h e m a j o r c o n s o l i d at e d c o m p a n i e s<br />

4 0 c o n s o l i d at e d b a l a n c e s h e e t<br />

4 1 c o n s o l i d at e d p r o f i t a n d l o s s s tat e m e n t<br />

4 2 c a s h f l o w s tat e m e n t<br />

4 3 s tat e m e n t o f c h a n g e s i n g r o u p e q u i t y<br />

4 4 n o t e s t o t h e c o n s o l i d at e d f i n a n c i a l s tat e m e n t s 2 0 1 1<br />

6 3 a u d i t o r ’ s r e p o r t<br />

product portfolio<br />

product portfolio –<br />

a selection<br />

[ branded prescription medicines ]<br />

6 8 r e s p i r at o r y d i s e a s e s<br />

7 0 d i s e a s e s o f t h e c e n t r a l n e r v o u s s y s t e m<br />

7 2 c a r d i o va s c u l a r d i s e a s e s<br />

7 6 m e ta b o l i c d i s e a s e s<br />

7 6 i n f e c t i o u s d i s e a s e s<br />

[ consumer health care ]<br />

7 8 c o u g h a n d c o l d<br />

7 8 s o r e t h r o at<br />

8 0 g a s t r o i n t e s t i n a l d i s e a s e s<br />

8 2 v i ta m i n s a n d s u p p l e m e n t s<br />

8 2 u r o l o g i c a l d i s e a s e s<br />

8 4 l e g v e i n h e a lt h<br />

8 4 p a i n<br />

[ animal health ]<br />

8 6 f o o d p r o d u c i n g a n i m a l s – s w i n e<br />

8 8 f o o d p r o d u c i n g a n i m a l s – c at t l e<br />

9 0 c o m p a n i o n a n i m a l s – s m a l l a n i m a l s<br />

9 2 c o m p a n i o n a n i m a l s – h o r s e<br />

Content


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

financial highlights<br />

Amounts in millions of EUR, unless otherwise indicated <strong>2011</strong> 2010 Change<br />

Net sales 13,171 12,586 5 %<br />

by region<br />

Europe 31 % 32 %<br />

Americas 46 % 45 %<br />

Asia, Australasia, Africa 23 % 23 %<br />

by business<br />

Human Pharmaceuticals 93 % 93 %<br />

Animal Health 7 % 7 %<br />

Research and development 2,516 2,453 3 %<br />

Personnel costs 3,664 3,358 9 %<br />

Average number of employees 44,094 42,224 4 %<br />

Operating income 2,272 1,896 20 %<br />

Operating income as % of net sales 17.3 % 15.1 %<br />

Income after taxes 1,476 888 66 %<br />

Income after taxes as % of net sales 11.2 % 7.1 %<br />

Shareholders‘ equity 7,466 6,474 15 %<br />

Return on shareholders‘ equity 22.8 % 15.0 %<br />

Cash flow 2,378 2,234 6 %<br />

Investments in tangible assets 458 519 — 12 %<br />

Depreciation of tangible assets 535 498 7 %<br />

Top 4 products — Prescription Medicines<br />

Net sales <strong>2011</strong> in millions of EUR change<br />

spiriva® 3,153 + 10 %<br />

micardis® 1,593 + 2 %<br />

combivent® 766 + 5 %<br />

pradaxa® 629 + 915 %<br />

Top 4 products — Consumer Health Care<br />

Net sales <strong>2011</strong> in millions of EUR change<br />

buscopan® 180 + 34 %<br />

dulcolax® 171 + 8 %<br />

mucosolvan® 160 + 8 %<br />

pharmaton® 137 + 5 %<br />

[ photo on cover ]<br />

boehringer ingelheim center (headquarters, ingelheim, germany)


usiness year <strong>2011</strong><br />

our company<br />

OUR COMPANY<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is a research-driven company dedicated to<br />

resear ching and developing, manufacturing and marketing pharmaceuticals<br />

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

Our businesses are Human Pharmaceuticals and Animal Health.<br />

We focus on innovative drugs and treatments that represent major<br />

therapeutic advances.<br />

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

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

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

disorders. We have successfully launched two new and innovative<br />

products in thrombo-embolic and metabolic diseases. In addition, we<br />

have successfully advanced our research in oncological and infectious<br />

diseases.<br />

We have more than 44,000 employees in 145 affiliated companies and<br />

operate global networks of research and development (R&D) facilities<br />

at seven sites and 20 production sites in 13 countries. R&D expenditure<br />

in the business area Prescription Medicines corresponds to 23.5 %<br />

of its net sales.<br />

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

company was founded in 1885.<br />

5


THE SHAREHOLDERS’ PERSPECTIVE<br />

christian boehringer<br />

chairman of the shareholders’ committee<br />

Why do we attach great value to our company, <strong>Boehringer</strong> <strong>Ingelheim</strong>, being private and independent<br />

And why do we deliberately call ourself a family-owned company<br />

First, because we, the owner family, are a visible and noticeable part of our company, and<br />

secondly, because our company’s history is inseparably linked to our family history. And like<br />

a family, <strong>Boehringer</strong> <strong>Ingelheim</strong> was and will be marked by its identity and way of life.<br />

Social commitment is our nature<br />

As the shareholder family, we feel especially committed to society and general welfare. Beside<br />

our core business of helping people with innovative medicines, three <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

foundation projects promoting art and culture, as well as partnerships with academic basic<br />

research, have developed. <strong>Boehringer</strong> <strong>Ingelheim</strong> and the non-governmental organisation<br />

Ashoka have also recently entered into a partnership to support social entrepreneurs in the<br />

health sector. We, the shareholder family of <strong>Boehringer</strong> <strong>Ingelheim</strong>, have fostered and given<br />

shape to this social and cultural commitment over four generations.<br />

We, the shareholder family, the Board of Managing Directors and our employees seek interaction<br />

with society, as it provides stimuli for us and the company, gives us new perspectives<br />

and helps us to fulfil our vision “Value through Innovation”.<br />

6<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

the shareholders’ perspective<br />

Deep breath makes space<br />

A family-owned company like <strong>Boehringer</strong> <strong>Ingelheim</strong> works continually with time. This<br />

means continuing the company’s successful history and leading the company, its employees<br />

and also our customers into the future.<br />

In everything we do, in all that we plan, <strong>Boehringer</strong> <strong>Ingelheim</strong> acts independently of shortterm<br />

commercial considerations in periods of time that extend over generations. The company’s<br />

continued existence is for us worth far more than short-term profit maximisation.<br />

Profit is for us an important key figure, but only one of many from which we can see whether<br />

the path we have taken has been successful or promises success. A high equity ratio, in<br />

order to withstand times of crisis, considerable investment in the company and organic growth<br />

are for us the strategies where we take this information into account. It is also highly relevant<br />

to us to be attractive to our current and prospective employees.<br />

Innovations that help people are our core. In our business these innovations do not happen<br />

“overnight”. That is why we plan long term. That gives us precisely the space and freedom<br />

for our own decisions in research and development and leads to our own successful dynamic<br />

over many decades. Most of all, this means important support for our employees in research<br />

and development in their work in pursuit of our supreme goal of helping people with innovations.<br />

With people, for people<br />

Our employees are the most important asset in our company and the guarantors of its innovative<br />

strength and efficiency. Only together with them can we succeed in realising our leitmotif<br />

“Value through Innovation” in all our activities. That is why fostering and further developing<br />

our employees is part of how we see ourselves.<br />

The shareholders’ perspective<br />

7


We shareholders experience and live out these values together with the Board of Managing<br />

Directors and our employees. We work together with mutual respect, trust and empathy.<br />

And together we commit ourselves with passion to <strong>Boehringer</strong> <strong>Ingelheim</strong> and our customers.<br />

Balance between necessary change and stabilising continuity<br />

Family-owned companies, such as <strong>Boehringer</strong> <strong>Ingelheim</strong>, are no islands. We too operate in a<br />

highly competitive environment. Processes of change in the economy and society, in the<br />

value systems of groups and individuals, are accelerating.<br />

Rapidly changing global markets, the systemic financial, economic and political crisis worldwide<br />

calling for globally coordinated solutions, and new regulations and complex legislation<br />

in the healthcare sector, all present challenges for us. Not only with regard to uncertainties<br />

that being entrepreneurial inevitably entails, but also with regard to these global processes<br />

of change, we must, as a family-owned company, show great flexibility in the face of uncertainties.<br />

Under these conditions our main focus is to ensure the continuity of our highly capable<br />

family-owned company.<br />

Outlook<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> faces, and will continue to face, many challenges. Our company will<br />

be borne and taken forward together with the Board of Managing Directors and our employees.<br />

It is all of these courageous, life-affirming people who dare to undertake something<br />

responsibly, who put their trust in their many-sided competences and their colleagues.<br />

8<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

the shareholders’ perspective<br />

Be entrepreneurial, improve the established, develop the new! With this orientation, we, as<br />

the family-owned company <strong>Boehringer</strong> <strong>Ingelheim</strong>, have every reason to go our own way<br />

with self-confidence.<br />

I would not like to end without expressing my heartfelt gratitude on behalf of the shareholders<br />

to all those mentioned for their contribution to our business success in <strong>2011</strong>. You<br />

have contributed to what we are: a successful and internationally respected pharmaceutical<br />

company with a distinct corpor ate culture.<br />

signed by<br />

christian boehringer<br />

chairman of the shareholders’ committee<br />

The shareholders’ perspective<br />

9


KEY ASPECTS <strong>2011</strong><br />

andreas barner, engelbert tjeenk willink, wolfram carius,<br />

hubertus von baumbach (from left to right)<br />

the board of managing directors<br />

10<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong> key aspects <strong>2011</strong><br />

<strong>2011</strong> was a successful year, but also a year filled with challenges for <strong>Boehringer</strong> <strong>Ingelheim</strong>. A year in<br />

which we were able to maintain our chosen course and, as expected, embarked on a new phase of<br />

growth.<br />

Start of a new growth phase<br />

A year ago, we looked at the new tasks in <strong>2011</strong> with optimism and confidence and announced the start<br />

of a new, organic, mid-single digit growth phase. And we have achieved this: net sales in local currency<br />

terms rose by +6.2 % (+ 4.6 % on a euro basis) to EUR 13,171 million.<br />

Furthermore, we were able in the past business year to increase the operating profit to EUR 2,272 million<br />

(EUR 1,896 million the previous year) and also the operating margin to 17.3 % (2010: 15.1 %).<br />

This is a very satisfactory business result. We have thereby established a good starting position for the<br />

coming years and see this confirming the merits of our long-term orientation.<br />

Our business: core products as the basis – new registrations with potential for the future<br />

The positive development of net sales was mainly borne by our Human Pharmaceuticals business. Our<br />

core prescription medicine products, such as spiriva® (chronic obstructive pulmonary disease – COPD),<br />

as well as combivent® (asthma) and micardis®/twynsta® (hypertension), form the stable basis for this<br />

gratifying growth.<br />

After very rapid registration, we successfully launched on the market two new, innovative products<br />

from our own research and development for stroke prevention in atrial fibrillation and diabetes. The<br />

growth rates of our novel oral anticoagulant pradaxa® (dabigatran etexilate) and trajenta® (linagliptin)<br />

for the treatment of type 2 diabetes had contributed decisively to <strong>Boehringer</strong> <strong>Ingelheim</strong>’s growth<br />

last year and, with their sales, will also shape the growth period that has now begun.<br />

The registration of trajenta® at the same time achieved the first milestone of the strategic alliance between<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> and Eli Lilly and Company for the joint development and marketing of active<br />

substances for diabetes. This long-term orientated cooperation also encompasses three other active<br />

substances and an option to jointly develop and market a further substance.<br />

Key aspects <strong>2011</strong><br />

11


Our Consumer Health Care (over-the-counter, OTC) medication business also developed positively, especially<br />

in the emerging markets, our strategically important growth markets. Once again, our established<br />

products buscopan®, dulcolax®, mucosolvan® and pharmaton® were <strong>Boehringer</strong> <strong>Ingelheim</strong>’s bestselling<br />

OTC products.<br />

Our Industrial Customer business, which is made up of our third-party business in biopharmaceuticals<br />

and pharmaceutical production and contract business in pharmaceutical chemicals, also registered<br />

gratifying growth. This growth is based on the favourable development in the biopharmaceutical area.<br />

Our Animal Health business too achieved gratifying growth. Swine vaccines with the bestselling product<br />

ingelvac circoflex® and also ingelvac® prrs were the main substantial growth drivers.<br />

Challenges for <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

For <strong>Boehringer</strong> <strong>Ingelheim</strong>, <strong>2011</strong> was also coupled with many different, unforeseeable challenges. These<br />

include the natural catastrophe in Japan and the reactor accident at Fukushima with inestimable consequences<br />

for people and the environment. We have followed these events with great sympathy. Our employees<br />

in Japan were unhurt and we are proud of how they successfully met the huge challenges with<br />

courage and determination. The systemic financial, economic and political crisis worldwide also had a<br />

burdening influence on healthcare systems and the pharmaceutical market.<br />

But internal extraordinary factors have also burdened the development of our business. These include<br />

the temporary – and in our view necessary – suspension of production at our US subsidiary Ben Venue<br />

Laboratories, Inc. to allow comprehensive renovation and corrective action, so that the medicines produced<br />

there can be made available again to patients as soon as possible. We are confident of being able<br />

to address the regulatory issues.<br />

Legislative interventions in price formation for prescription medicines in different markets also had a<br />

negative impact. In Germany, our new medicine trajenta®, for the treatment of type 2 diabetes, will<br />

not be available until the end of the evaluation process and the associated determination of the reimbursement<br />

amount for the therapy.<br />

12<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong> key aspects <strong>2011</strong><br />

Promoting our competitiveness<br />

We invest continuously in expanding our functions, such as our own research and development, supported<br />

by various research cooperations and our own production network. The paramount goal in so<br />

doing is to promote our competitiveness in order to secure our long-term independence as a familyowned<br />

company.<br />

New and innovative medicines from our own research and development, supported by various research<br />

cooperations with biotech companies, will enable <strong>Boehringer</strong> <strong>Ingelheim</strong> to maintain in the future the<br />

growth period that began in <strong>2011</strong>.<br />

We therefore in <strong>2011</strong> also once again increased the investments in our research and development. Our<br />

well-filled product pipeline with promising study outcomes for substances under development, as well<br />

as significant sales potential, justifies our high investments in R&D.<br />

We are convinced that this successful, innovative pipeline from our own research and development is a<br />

good basis for our sustainable company development.<br />

Future challenges<br />

The major challenges facing the research-driven pharmaceutical industry, besides patent expiry and<br />

patent infringement, are growing investments in the R&D area and greater obstacles and raised expenditure<br />

in product registration. In this context, special mention must be made of increased cost pressure<br />

in healthcare systems, which increasingly less lead to appropriate account being taken of the high<br />

investment expenditure in the development of new medicines. Legislative interventions in price formation<br />

for prescription medicines also have a negative impact in different markets.<br />

This will continue to be a challenge for <strong>Boehringer</strong> <strong>Ingelheim</strong> in future. This is a challenge we face<br />

gladly and with confidence. We will reach our demanding goals with our great, innovative strength<br />

based on a successful pipeline of our own products in research and development.<br />

This will succeed in close cooperation with the efficiency of our highly qualified and committed employees<br />

who are for us the company’s greatest asset and its fundamental success factor. They deserve<br />

thanks for the success of the past year.<br />

Key aspects <strong>2011</strong><br />

13


Outlook<br />

We are convinced that the basis of our established product portfolio, new introductions and the successful<br />

launch of more new products from our own research and development will enable us to sustainably<br />

strengthen and expand our position on the world market for human and veterinary pharmaceuticals.<br />

For 2012, we expect to boost growth and expect a high single-digit increase in sales. This will also positively<br />

impact profit growth.<br />

signed by<br />

andreas barner<br />

signed by<br />

hubertus von baumbach<br />

signed by<br />

wolfram carius<br />

signed by<br />

engelbert tjeenk willink<br />

14<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

corporate bodies<br />

CORPORATE BODIES<br />

Shareholders’ Committee<br />

Board of Managing Directors<br />

christian boehringer<br />

Chairman of the Shareholders’ Committee<br />

albert boehringer (until 30.09.<strong>2011</strong>)<br />

christoph boehringer<br />

erich von baumbach jr.<br />

ferdinand von baumbach<br />

isabel boehringer (from 01.10.<strong>2011</strong>)<br />

dr mathias boehringer<br />

prof.* dr dr andreas barner<br />

Chairman of the Board<br />

Corporate Board Division Pharma Research,<br />

Development and Medicine<br />

hubertus von baumbach<br />

Corporate Board Division<br />

Finance and Animal Health<br />

prof. h.c. dr wolfram carius<br />

Corporate Board Division<br />

Human Resources and Operations<br />

Advisory Board<br />

prof. dr michael hoffmann-becking<br />

Attorney at Law, Düsseldorf<br />

Chairman of the Advisory Board<br />

engelbert tjeenk willink<br />

Corporate Board Division<br />

Marketing and Sales Human Pharma<br />

egbert appel<br />

Trustee, Martin Hilti Family Trust<br />

Member of the Board and Managing Director<br />

Hilti Foundation<br />

dr andreas kreimeyer<br />

Member of the Board of Executive Directors<br />

and Research Executive Director<br />

BASF SE<br />

prof. dr fredmund malik<br />

Chairman of the Board<br />

Malik Management Zentrum St. Gallen AG<br />

Jan Rinnert<br />

Vice Chairman of the Board of Management<br />

Heraeus Holding GmbH (from 01.09.<strong>2011</strong>)<br />

*Republic of Austria<br />

Corporate bodies<br />

15


16<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

<strong>2011</strong><br />

GROUP MANAGEMENT REPORT<br />

18 BUSINESS AND OPERATING ENVIRONMENT<br />

29 NET ASSETS, FINANCIAL POSITION AND<br />

RESULTS FROM OPERATIONS<br />

33 REPORT ON POST BALANCE SHEET DATE EVENTS<br />

33 RISK REPORT<br />

34 REPORT ON EXPECTED DEVELOPMENTS<br />

Group Management <strong>Report</strong> 17


GROUP MANAGEMENT REPORT <strong>2011</strong><br />

BUSINESS AND<br />

OPERATING ENVIRONMENT<br />

Economic environment<br />

In the <strong>2011</strong> calendar year, the global economy continued<br />

the growth trend started in the previous year. However,<br />

the pace of global economic growth tailed off to 2.7%<br />

compared with the previous year (+ 4.1%). This decrease<br />

is largely due to uncertainty over the mounting sovereign<br />

debt crisis in Europe, turbulence on the financial markets,<br />

the impact of the natural and nuclear disaster in Japan<br />

and the rise in raw material prices. The main sources of<br />

growth momentum for the global economy were emerging<br />

countries, such as China and India, with growth<br />

rates of around 9.1% and 6.7% respectively.<br />

Germany’s economic upturn continued in <strong>2011</strong> with a<br />

growth rate of 3%. The main growth components were<br />

the positive global economic environment and the positive<br />

labour market development, which fostered consistently<br />

high domestic consumption. A new high of more<br />

than 41 million people in employment was reached in<br />

<strong>2011</strong>. The average number of unemployed during the<br />

year was 2.5 million. Due to further programmes to cut<br />

public sector budgets in 2012 and a worsening external<br />

environment, economic growth is expected to fall significantly<br />

to 0.7%.<br />

With an average inflation rate of 2.3%, price rises in<br />

Germany more than doubled year-on-year in <strong>2011</strong>,<br />

measured with the consumer price index. The main<br />

Another slight slowdown in global economic growth to<br />

2.5% is expected for the 2012 financial year. The reasons<br />

for this are uncertainty over the further impact of the<br />

debt crisis in Europe and lower growth in countries, such<br />

as China, Brazil and India. Whilst the emerging and developing<br />

countries are likely to post economic growth of<br />

5.4%, growth in the region of just 1.4% is expected for<br />

the industrialised nations.<br />

Within the eurozone, there were sharp contrasts in economic<br />

development in <strong>2011</strong>. Even so, at 1.6%, growth<br />

remained virtually unchanged compared with the previous<br />

year (+ 1.7%). However, some countries in southern<br />

Europe had to reduce public spending due to budgetary<br />

tightening, thus ruling out new growth momentum. For<br />

the 2012 financial year, the World Bank forecasts a 0.3%<br />

decline in economic growth within the eurozone, as economic<br />

growth is also tailing off noticeably in the other<br />

euro states.<br />

Net sales by business (in millions of EUR)<br />

Prescription Medicines<br />

<strong>2011</strong><br />

10,096<br />

2010 9,702<br />

Consumer Health Care<br />

<strong>2011</strong><br />

1,396<br />

2010 1,318<br />

Biopharmaceuticals<br />

<strong>2011</strong> 519<br />

2010 422<br />

Pharma Chemicals and Pharmaceuticals Production<br />

<strong>2011</strong> 178<br />

2010 216<br />

Animal Health<br />

<strong>2011</strong> 976<br />

2010 921<br />

18<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

Net sales by region (in millions of EUR)<br />

Americas 6,087 5,724<br />

<strong>2011</strong> 2010<br />

Europe 4,037 4,089<br />

<strong>2011</strong> 2010<br />

Asia,<br />

Australasia,<br />

Africa<br />

(AAA) 3,047 2,773<br />

<strong>2011</strong> 2010<br />

reason for this was the sharp rise in raw material prices.<br />

There was a similar picture for the entire eurozone, with<br />

an inflation rate of 2.7%.<br />

In addition to the euro, the other key currencies for the<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> group of companies are the US<br />

dollar (USD) and the Japanese yen (JPY). The latter two<br />

currencies fluctuated significantly in the <strong>2011</strong> financial<br />

year. In relation to the US dollar, the euro ranged between<br />

1.29 USD/EUR and 1.49 USD/EUR in <strong>2011</strong>. After<br />

a brief period of decline the exchange rate continuously<br />

rose until the middle of the second quarter, reaching an<br />

interim high of 1.49 USD/EUR. After moving sideways<br />

between 1.40 and 1.45 USD/EUR at the beginning of<br />

second half of the year, the euro started to decline markedly<br />

at the beginning of September, due to the European<br />

debt crisis and the resulting uncertainty. The financial<br />

year ended with an exchange rate of 1.29 USD/EUR.<br />

Compared with 31 December 2010, the euro was down<br />

3% against the US dollar.<br />

In the <strong>2011</strong> financial year, the exchange rate of the euro<br />

against the Japanese yen ranged between 100 JPY/EUR<br />

and 123 JPY/EUR, which equates to a change of more<br />

than 20%. Up until the start of the second quarter of<br />

<strong>2011</strong>, the euro steadily gained in value against the yen,<br />

also due to the earthquake and nuclear catastrophe in<br />

Japan, reaching its high for the year of 123 JPY/EUR. After<br />

this, the euro began to fall steadily until the end of<br />

the third quarter. A brief rally until mid-October was not<br />

maintained. The <strong>2011</strong> financial year ended with an exchange<br />

rate of 100 JPY/EUR (also the annual low). Compared<br />

with 31 December 2010, the euro was down<br />

around 8% against the yen.<br />

The global pharmaceutical market remained stable in<br />

<strong>2011</strong>, recording growth of around 4.6%, which was<br />

slightly higher than in 2010 (4%). This development was<br />

influenced by health policy measures and price regulations,<br />

mainly in Europe and the USA, as well as higher<br />

cost pressure on health systems, which had a negative<br />

impact on the pharmaceutical sector, particularly in established<br />

industrialised nations, and led to lower sales.<br />

Growth in the world pharmaceutical market was therefore<br />

largely driven by high growth rates in emerging markets<br />

(including China, Brazil, Russia, India, Mexico and<br />

Turkey). For <strong>2011</strong>, market researchers are forecasting<br />

slightly weakening growth of around 3% for the global<br />

pharmaceutical market, with growth rates still expected<br />

to continue to vary widely on the different pharmaceutical<br />

markets around the world.<br />

Business at <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

<strong>2011</strong> was a successful year for <strong>Boehringer</strong> <strong>Ingelheim</strong>,<br />

but also a challenging one. Following the transitional<br />

year of 2010, which was characterised by patent expiries,<br />

regulatory changes on the markets and preparations for<br />

new product launches, we initiated a new period of organic<br />

growth in the <strong>2011</strong> financial year. <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

generated sales of EUR 13,171 million in the<br />

<strong>2011</strong> financial year. As expected, the previous year’s<br />

figure of EUR 12,586 million was exceeded with sales<br />

growth of 4.6%. After a very quick registration, we successfully<br />

launched two new products arising from our<br />

own research and development for prevention of stroke<br />

in patients with atrial fibrillation (pradaxa®) and diabetes<br />

( trajenta®), which are new indication areas for us.<br />

The growth rates of these new products, pradaxa® and<br />

trajenta®, made a major contribution to the growth of<br />

Business and operating environment 19


<strong>Boehringer</strong> <strong>Ingelheim</strong>, and they will continue to be key<br />

factors in the growth phase that is now underway. Our<br />

established core products, such as spiriva® for chronic<br />

obstructive pulmonary disease (COPD), micardis®/<br />

twynsta® for high blood pressure and combivent® for<br />

COPD and Asthma also propelled this positive growth.<br />

A well-filled product pipeline will enable <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> to continue the growth phase initiated in<br />

<strong>2011</strong> into the future.<br />

As part of our corporate strategy, we are focusing our<br />

business activities on the successful research and development<br />

of innovative medications. By concentrating on<br />

our strengths in this way, we are laying the foundations<br />

for continuous organic growth. In areas where we require<br />

new expertise, or if meaningful market opportunities<br />

arise, <strong>Boehringer</strong> <strong>Ingelheim</strong> will also evaluate opportunities<br />

for external growth.<br />

In January <strong>2011</strong>, <strong>Boehringer</strong> <strong>Ingelheim</strong> and Eli Lilly announced<br />

the start of a strategic alliance for joint development<br />

and marketing of diabetes active ingredients. A<br />

first milestone was achieved in this new indication area<br />

for <strong>Boehringer</strong> <strong>Ingelheim</strong> with the approval of our medication<br />

trajenta® (active ingredient linagliptin) in the<br />

USA, Europe and Japan during <strong>2011</strong>. The long-term alliance<br />

covers three more active ingredients as well as an<br />

option for joint development and marketing of an additional<br />

substance.<br />

In addition, at the beginning of the year, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> and Amgen Inc. agreed the acquisition of the<br />

biotechnological development and production site in<br />

Fremont, USA. The site was integrated into the existing<br />

biopharmaceutical network in the first half of <strong>2011</strong>, and<br />

reflects the great strategic importance of biotechnology<br />

within the <strong>Boehringer</strong> <strong>Ingelheim</strong> group of companies as<br />

well as the importance of the US market.<br />

In the past financial year, our business was negatively<br />

affected by the in our view necessary temporary suspension<br />

of production at our US subsidiary Ben Venue Laboratories,<br />

Inc. to allow comprehensive renovation and<br />

corrective actions as well as the reorganisation measures<br />

at our Japanese subsidiary SSP Co., Ltd. in the Consumer<br />

Health Care area.<br />

The positive development of sales was driven by the two<br />

regions of the Americas and Asia/Australasia/Africa (AAA).<br />

Year-on-year growth of 6.3% was generated in the Americas<br />

region with sales of EUR 6,087 million. With a 46%<br />

share of group sales, this region remains <strong>Boehringer</strong> <strong>Ingelheim</strong>’s<br />

most important sales market. As expected,<br />

the AAA region posted the strongest growth with 9.9%.<br />

With net sales of EUR 3,047 million, this increasingly<br />

significant region accounted for around 23% of group<br />

sales. The Europe region posted a slight decline in sales<br />

(– 1.3%) to EUR 4,037 million. This region thus accounted<br />

for around 31% of group sales.<br />

Net sales by region<br />

(in millions of EUR) <strong>2011</strong> 2010 Change<br />

Americas 6,087 5,724 6.3%<br />

Europe 4,037 4,089 — 1.3%<br />

Asia, Australasia, Africa (AAA) 3,047 2,773 9.9%<br />

With gratifying growth of around 4.6% we generated<br />

sales of EUR 12,195 million in the Human Pharmaceuticals<br />

business in the <strong>2011</strong> financial year. Consequently,<br />

this business accounted for around 93% of group sales.<br />

Within the Human Pharmaceuticals business, the Prescription<br />

Medicines business generated sales of EUR 10,096 million<br />

with growth of 4.1%. In addition, our Consumer<br />

Health Care division achieved sales of EUR 1,396 million<br />

with growth of 5.9%. Our Animal Health business<br />

also showed positive development in the <strong>2011</strong> financial<br />

year. With year-on-year growth of 6.0%, it achieved sales<br />

of EUR 976 million. This division’s share in our total sales<br />

increased to around 7%. Sales growth is largely attributable<br />

to the positive development of our animal vaccines,<br />

especially ingelvac circoflex®.<br />

20<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

Net sales by businesses<br />

(in millions of EUR) <strong>2011</strong> 2010 Change<br />

Prescription Medicines 10,096 9,702 4.1%<br />

Consumer Health Care (CHC) 1,396 1,318 5.9%<br />

Biopharmaceuticals 519 422 23.0%<br />

Pharma Chemicals and<br />

Pharmaceutical Production 178 216 — 17.6%<br />

Animal Health 976 921 6.0%<br />

Our encouraging sales performance in <strong>2011</strong> serves to<br />

affirm our actions as a company. Following the difficult<br />

transitional year of 2010, we have been able to initiate a<br />

new growth phase on the back of the strong development<br />

of our established products and successful new<br />

product launches.<br />

Our committed employees and positive results in research<br />

and development form the basis for the continuation<br />

of our long-term growth. At EUR 2,272 million,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s operating income corresponded<br />

to a return on net sales of 17.3%.<br />

Key figures (in millions of EUR) <strong>2011</strong> 2010 Change<br />

Net sales 13,171 12,586 4.6%<br />

Operating income 2,272 1,896 19.8%<br />

Return on net sales 17.3% 15.1%<br />

Research and development (R&D)<br />

On the basis of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s guiding principles,<br />

our company’s research and development activities<br />

are focused on developing medications and treatments<br />

for diseases that cannot yet be treated in a satisfactory<br />

manner. We are constantly striving to make an important<br />

contribution in areas where the need for treatment<br />

is high and to attain a leading position in the major indication<br />

areas. In order to achieve this goal, we ensure that<br />

we are up-to-date with strategically important technologies<br />

and systematically research new key technological<br />

approaches.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s successful research and development<br />

activities and associated innovative strength<br />

have always provided the basis for our positive economic<br />

development in previous years. In-house research and<br />

development will remain a top priority in the future.<br />

It represents the cornerstone of the <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

group of companies and will continue to be our main<br />

growth driver. An example of the consistent implementation<br />

of our strategy is the investment of around<br />

EUR 80 million for the construction of new research and<br />

development facilities at our site in Ridgefield, Connecticut,<br />

USA.<br />

In the <strong>2011</strong> financial year, we employed an average of<br />

7,159 staff at our R&D sites. With a total investment of<br />

around EUR 2,516 million in research and development<br />

activities, <strong>Boehringer</strong> <strong>Ingelheim</strong> once again slightly increased<br />

its investment in this field compared with the<br />

previous year. In total, <strong>Boehringer</strong> <strong>Ingelheim</strong> thus invested<br />

19.1% of group sales in the research and development<br />

of new medicines in <strong>2011</strong>.<br />

Independent research and development of medications is<br />

of fundamental importance to <strong>Boehringer</strong> <strong>Ingelheim</strong>. In<br />

addition, we are expanding our own product portfolio<br />

through cooperation agreements and targeted in-licensing<br />

of technologies and products.<br />

Research and development <strong>2011</strong> 2010 2009 2008 2007<br />

Expenditure in millions of EUR 2,516 2,453 2,215 2,109 1,900<br />

– as % of net sales 19.1 19.5 17.4 18.2 17.3<br />

Prescription Medicines expenditure in millions of EUR 2,372 2,306 2,100 2,016 1,818<br />

– as % of Prescription Medicines net sales 23.5 23.8 20.9 22.1 21.0<br />

Average number of employees 7,159 7,093 6,934 6,788 6,405<br />

Investments in tangible assets (without investments in infrastructure) in millions of EUR 112 83 125 145 157<br />

Business and operating environment<br />

21


Human Pharmaceuticals<br />

Our four large research sites in Germany (Biberach), the<br />

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

are focused on the following indication areas:<br />

• Respiratory diseases<br />

• Cardiometabolic disorders<br />

(cardiovascular and metabolic diseases)<br />

• Oncology<br />

• Neurological diseases<br />

• Immunology<br />

• Infectious diseases<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> again made substantial progress<br />

in terms of new substances in clinical research in the<br />

<strong>2011</strong> financial year. Our innovations in the therapeutic<br />

area of oncology with our substances afatinib and nintedanib<br />

as well as in the virology segment with our active<br />

ingredients BI 201335 and BI 207127 are particularly<br />

worthy of mention here.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is one of the world’s leading pharmaceutical<br />

companies in the treatment of respiratory<br />

diseases. Our research and development are particularly<br />

focused on chronic obstructive pulmonary disease<br />

(COPD), asthma and idiopathic pulmonary fibrosis. To<br />

improve the treatment outcomes of our product spiriva®<br />

(active ingredient tiotropium), a long-acting anticholinergic<br />

(LAMA) for inhalation, daily single administration<br />

of the fixed-dose combination of tiotropium and olodaterol,<br />

a long-acting β2-agonist (LABA), is being examined<br />

in the context of the extensive phase III study programme<br />

“TOviTO®”. The study programme started with<br />

the “TOnado® 1” and “TOnado® 2” studies, in which the<br />

efficacy and safety of the fixed-dose combination of tiotropium<br />

and olodaterol are being compared with the respective<br />

single active substances in the treatment of<br />

COPD patients. Furthermore, the initial results of a<br />

phase III study regarding the efficacy of olodaterol monotherapy<br />

are expected in the first half of 2012.<br />

with the active ingredients of our product combivent®<br />

at the beginning of October <strong>2011</strong>. The respimat® inhaler<br />

is a propellant gas-free soft-mist nebuliser, which acts as<br />

a standard application for our future respiratory system<br />

products.<br />

After our product pradaxa® (active ingredient dabigatran<br />

etexilate) obtained approval in the USA and Canada<br />

in the indication stroke prevention in patients with atrial<br />

fibrillation back in 2010, approvals in Europe and Japan<br />

followed in the <strong>2011</strong> financial year.<br />

Our oral anticoagulant pradaxa® has been approved for<br />

prevention of venous thrombo-embolism (VTE) following<br />

hip and knee replacement operations since 2008. The<br />

indication area for dabigatran etexilate has now been extended,<br />

delivering significant therapeutic added value<br />

from a medical viewpoint, as this is the first approval in<br />

the field of oral anticoagulants for 50 years.<br />

Receiving the “Prix Galien”, an award for cutting-edge<br />

pharmacological research, in Canada in November <strong>2011</strong><br />

in the “innovative products” category for our medication<br />

pradaxa®, was further confirmation of the high quality<br />

of our research and development activities.<br />

In the indication area metabolic diseases, research and<br />

development work is focused on active ingredients for<br />

the treatment of diabetes. A first milestone in the diabetes<br />

alliance between <strong>Boehringer</strong> <strong>Ingelheim</strong> and Eli Lilly<br />

was reached in the USA, Japan and Europe during <strong>2011</strong><br />

with the approval of our medication trajenta® (active<br />

ingredient linagliptin). Linagliptin is a dipeptidyl peptidase-4<br />

inhibitor (DPP-4 inhibitor) for the treatment of<br />

type 2 diabetes and is approved as monotherapy and<br />

combination therapy with metformin or with a sulfonylurea<br />

and metformin. In addition, linagliptin is the only<br />

DPP-4 inhibitor on the market that can be used in patients<br />

with type 2 diabetes and restricted kidney or liver<br />

function without adjusting the dose.<br />

In addition to this, our respimat® technology obtained<br />

approval for treatment of COPD in the USA in conjunction<br />

In the indication area oncology, <strong>Boehringer</strong> <strong>Ingelheim</strong> focuses<br />

on research and development of novel cancer treat-<br />

22<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

ments that give patients therapeutic added value, thus<br />

helping to improve their quality of life. The research field<br />

covers the development of targeted treatments for solid<br />

tumours as well as haematological cancers.<br />

In the context of our LUX® study programme, the effectiveness<br />

of our substance afatinib (BIBW 2992) on various<br />

solid tumours (including non-small-cell bronchial<br />

carcinoma, breast cancer and carcinoma of the head and<br />

neck) is being examined in several studies taking place<br />

worldwide. Our active ingredient afatinib is an innovative<br />

tyrosine kinase inhibitor (TKI) that leads to irreversible<br />

inhibition of two tyrosine kinase receptors involved<br />

in the growth and spread of tumours.<br />

In addition to the “LUX®-Breast-1” clinical phase III approval<br />

study started last year to assess the effectiveness<br />

of afatinib in breast cancer, two more phase II studies,<br />

“LUX®-Breast-2” and the “1200.89” study, were started<br />

during <strong>2011</strong>, examining the effectiveness of our substance<br />

afatinib on other forms of breast cancer. This<br />

potential extension of the range of applications is a key<br />

milestone on the path towards extending our developments<br />

in oncology beyond lung cancer.<br />

The active ingredient ninte danib is the second leading<br />

substance in our oncology pipeline. This is a triple angiokinase<br />

inhibitor for the treatment of patients with advanced<br />

non-small-cell bronchial carcinoma. In relation<br />

to this, the first results of the extensive LUME® study<br />

programme are now available. In the context of the<br />

clinical phase III study “LUME®-Lung-1”, a longer progression-free<br />

survival was established in patients with<br />

advanced or relapsing non-small-cell bronchial carcinoma.<br />

Furthermore, an additional clinical phase III study<br />

is being conducted with our active ingredient nintedanib<br />

for the treatment of patients suffering from ovarian<br />

cancer.<br />

Our third oncology active ingredient is volasertib (BI 6727).<br />

This is a specific inhibitor of Polo-like kinase-1 (Plk-1),<br />

which is currently going through a large-scale clinical<br />

phase II study programme. In addition, two new chemical<br />

molecules and two antibodies were added to the oncology<br />

portfolio in <strong>2011</strong>.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s research and development activities<br />

in the therapeutic area infectious diseases are focused<br />

on viral diseases with high, previously unmet<br />

medical needs. Focus here is on treatment of hepatitis C<br />

viruses (HCV). In the <strong>2011</strong> financial year, further significant<br />

progress was made here with our substances<br />

BI 201335, an orally administered HCV-NS3/4A protease<br />

inhibitor, and BI 207127, an NS5B-RNA-dependent<br />

polymerase inhibitor. <strong>Boehringer</strong> <strong>Ingelheim</strong> published<br />

promising results of two phase II studies from the<br />

SILEN-C® study programme for the active ingredient<br />

BI 201335 (protease inhibitor) in November <strong>2011</strong>. A reduction<br />

in the period of treatment for hepatitis C and an<br />

increase in the likelihood of virological healing compared<br />

with the traditional standard treatment were observed<br />

in the context of the SILEN-C®3 study. In addition,<br />

the study “SILEN-C®1” showed that our protease<br />

inhibitor can also lead to an improvement in the clinical<br />

picture in patients with hard-to-treat HCV genotypes.<br />

Building on these results, an extensive study programme<br />

consisting of three phase III studies evaluating<br />

BI 201335 in combination with standard treatment has<br />

been launched. The results are likely to be available in<br />

the first half of 2013.<br />

An interim analysis of the phase IIb study “SOUND-<br />

C®21” also showed a high virological response rate in<br />

therapy-naive patients for the combination of our active<br />

ingredients BI 201335 and BI 207127 with and without<br />

additional administration of Ribavirin. As this active ingredient<br />

combination does not contain any pegylated interferon,<br />

it could enable a significant reduction in treatment-related<br />

negative effects in many HCV patients.<br />

The second focal point of research in this indication area<br />

is the treatment of HIV/AIDS. In the course of the year,<br />

our medication viramune® (active ingredient nevirapine),<br />

previously approved as a tablet with immediate active<br />

ingredient release to be taken twice daily, obtained<br />

approval in the USA and Europe as a tablet with delayed<br />

Business and operating environment 23


elease of nevirapine to be taken once daily. viramune®<br />

is a non-nucleoside reverse transcriptase inhibitor (NNRTI)<br />

approved for combination therapy with other antiretroviral<br />

substances for the treatment of HIV infections.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has granted the global exclusive<br />

rights for research, development and marketing of<br />

the innovative non-catalytic site integrase inhibitors<br />

(NCINIs) in HIV to the US company Gilead. This includes<br />

the active ingredient BI 224436, which was evaluated<br />

in a phase 1a dose-finding study to assess its bioavailability<br />

and pharmacokinetic properties in healthy<br />

volunteers.<br />

Animal Health<br />

In our Animal Health business, research and development<br />

work is focused on innovative vaccines, primarily<br />

to protect food-producing and companion animals, and<br />

pharmaceutical products. With around EUR 96 million,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> invested approximately 10% of<br />

the net sales of the Animal Health business in the <strong>2011</strong><br />

financial year in the research and development of new<br />

products and in establishing new research and development<br />

sites (Hanover and Shanghai).<br />

pimobendan can also delay the initial onset of the clinical<br />

symptoms of this disease.<br />

Cooperations<br />

At the beginning of the year, <strong>Boehringer</strong> <strong>Ingelheim</strong> and<br />

Eli Lilly and Company signed a long-term global strategic<br />

partnership on the joint development and marketing<br />

of diabetes active ingredients that are currently in advanced<br />

phases of clinical development. <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> is set to introduce the two oral anti-diabetic<br />

agents linagliptin and BI 10773. Linagliptin is an innovative<br />

dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor),<br />

which obtained approvals for the USA, Japan and Europe<br />

during <strong>2011</strong>. The active ingredient BI 10773 is currently<br />

in clinical phase III, and is one of the innovative class of<br />

SGLT-2 inhibitors that inhibit glucose reabsorption in<br />

the kidneys. Eli Lilly is set to introduce the structurally<br />

innovative basal insulin analogue LY 2605541 and the<br />

insulin glargine active ingredient LY 2963016, which are<br />

also in an advanced phase of clinical development. There<br />

is also an option to jointly develop and market a monoclonal<br />

TGF-beta antibody that is currently in phase II of<br />

clinical development for patients with diabetes and<br />

chronic kidney conditions.<br />

Our product prascend® obtained approval in <strong>2011</strong> in<br />

many countries for the treatment of equine Cushing’s<br />

syndrome, one of the most common hormonal disorders<br />

in horses. prascend® is the first preparation with the<br />

dopamine antagonist pergolide mesylate to be approved<br />

for horses, and causes the symptoms to wane within a<br />

few weeks. The approval for the combination therapy of<br />

mycoflex® and circoflex®, a swine vaccine, was given<br />

for the USA and Japan during the first quarter of <strong>2011</strong>.<br />

In the research area of small animals, the recruitment<br />

phase for the extensive EPIC® study was started. In the<br />

context of this study, veterinary cardiologists are examining<br />

whether, above and beyond its effectiveness in the<br />

treatment of dogs with congestive failure as a result of<br />

chronic mitral valve disease, our active ingredient<br />

In <strong>2011</strong>, we signed a licensing agreement with ProBio-<br />

Gen AG (Germany) on the use of its GlymaxX® technology<br />

to extend our technology portfolio. This is employed<br />

in biopharmaceutical contract development and production<br />

to increase ADCC activity (antibody-dependent cellmediated<br />

cytotoxicity) of antibodies. It can be used in<br />

existing antibody-producing cell lines without impairing<br />

their productivity. In addition, it can be easily integrated<br />

into <strong>Boehringer</strong> <strong>Ingelheim</strong>’s CHO-based high-expression<br />

system, BI-HEX®.<br />

Production<br />

Our global Human Pharmaceuticals production network<br />

comprised 20 sites in 13 countries in <strong>2011</strong>. Spread over<br />

these production sites, the group operates 13 pharmaceutical<br />

units, five chemical units, three biopharmaceutical<br />

units and one unit for medical products. Our many<br />

24<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

years of experience at these production sites enable us to<br />

provide reliable and high-quality product supply for both<br />

internal group customers and third party industrial customers.<br />

The pharmaceutical and chemical production sites combined<br />

in the Launch & Strategic Products division (LSP)<br />

ensure adherence to our high quality requirements for<br />

new product launches as well as the technologically and<br />

procedurally challenging manufacture of these innovative<br />

products during the first years of their life cycle. The<br />

division thus acts as an interface between our development<br />

activities and series production. It is also responsible<br />

for taking on preparatory tasks for the market launch<br />

of new products at a very early stage.<br />

Our Established Products (ESP) division, which is focused<br />

on the manufacture of established products in the advanced<br />

stages of their life cycle, accounts for more than<br />

half of our total production volume. A global presence in<br />

all growth markets allows us maximum flexibility in our<br />

ESP production network, so that we can react optimally<br />

to local requirements. We can therefore manufacture not<br />

only our proprietary drugs, but also products for industrial<br />

customers cost-effectively and reliably to high quality<br />

standards.<br />

In the LSP division, the resomer® business was sold to<br />

Evonik Indutries at the beginning of <strong>2011</strong>. This involves<br />

the entire product range of standard and customer-specific<br />

polymers for the manufacture of medical applications<br />

and pharmaceutical formulations.<br />

The new pradaxa® production facility in <strong>Ingelheim</strong> was<br />

inaugurated with the completion of two further modules.<br />

With an overall investment of EUR 156 million, an<br />

existing plant was converted into a modern production<br />

facility, a project which started in 2009. Around 116 new<br />

jobs have been created at the new plant at our group<br />

headquarters in <strong>Ingelheim</strong>. This investment has tripled<br />

the previous capacity for pradaxa® capsule manufacture<br />

to 1.5 billion capsules per year, meaning that global demand<br />

for dabigatran etexilate (pradaxa®) can be met.<br />

The opening of a new high-containment production<br />

facility at our site in Columbus, Ohio, USA for around<br />

EUR 36 million is another investment in our LSP production<br />

network to ensure innovative, state-of-the-art production<br />

technologies.<br />

To build up our presence in key emerging countries,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> announced back in 2009 that it<br />

would be investing up to EUR 100 million in China over<br />

the next few years. Back in 2010, around EUR 11 million<br />

was invested in the creation of a new centre of competence<br />

in Shanghai. This new facility specialises in quality<br />

control for pharmaceutical active ingredients and<br />

chemical intermediate products procured in China. A<br />

decision was made in the <strong>2011</strong> financial year to expand<br />

our production site at the Zhangjiang Hi-Tech Park in<br />

Shanghai into a supply centre for China with investment<br />

of EUR 79 million. This expansion includes an increase<br />

in the number of employees from 240 at present to<br />

around 400 and doubling the existing production capacity.<br />

A new packaging centre for ampoules, tablets and<br />

capsules and an automated storage facility will be built<br />

in the first phase of the investment project. In the second<br />

phase, the existing production facility will be converted<br />

and modernised.<br />

In addition to the manufacture of proprietary products<br />

(actilyse®, metalyse®, imukin® and beromun®), the<br />

bio pharmaceutical production arm of <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

is a globally respected contract manufacturer for<br />

industrial customers. In December <strong>2011</strong>, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> and the US company AVEO Pharmaceuticals<br />

Inc. signed an agreement on the contract manufacturing<br />

of ficlatuzumab, an novel inhibitory antibody for the<br />

treatment of non-small-cell bronchial carcinoma. With<br />

more than 25 years’ experience, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

covers the entire biopharmaceutical process chain<br />

from development of new biological active ingredients<br />

through manufacture to market launch. The existing<br />

biopharmaceutical network, consisting of the sites in<br />

Biberach, Germany and Vienna, Austria, has been expanded<br />

following the purchase of a modern development<br />

and production site in Fremont, California, USA<br />

Business and operating environment 25


from Amgen Inc. The site was integrated into the existing<br />

biopharmaceutical network in the first half of <strong>2011</strong>,<br />

and reflects the great strategic importance of biotechnology<br />

for <strong>Boehringer</strong> <strong>Ingelheim</strong>.<br />

Environmental and employee protection<br />

An important element of our company’s guiding principle<br />

and of key concern to <strong>Boehringer</strong> <strong>Ingelheim</strong>, is the<br />

protection of our employees, our facilities and the environment.<br />

This goes hand in hand with sustainable use of<br />

natural resources and promoting environmental awareness.<br />

We have long taken care to ensure that social and<br />

ecological concerns are firmly anchored at the heart of<br />

our corporate philosophy. In all of our activities, we do<br />

our utmost to protect our employees, neighbouring communities<br />

and the environment. The company endeavours<br />

to conserve natural resources and works hard to promote<br />

environmental awareness both internally and externally.<br />

The Environment, Health and Safety department (EHS)<br />

is responsible for implementing and reviewing our groupwide<br />

standards for environmental protection, health and<br />

occupational safety. Our internal guidelines are geared<br />

towards the respective country-specific legal requirements,<br />

although they exceed them in many cases. We<br />

ensure adherence to these and identification of possible<br />

potential for improvement in our internal environmental<br />

and occupational safety guidelines by means of regular<br />

internal audits. In this way, 14 internal audits were performed<br />

throughout the group in the <strong>2011</strong> financial year.<br />

In addition, we continuously review our measures in the<br />

above areas on the basis of defined key figures. Inter -<br />

action between these various measures forms the basis<br />

for the high standards in the areas of environmental<br />

protection, health and occupational safety at <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has been involved in the Responsible<br />

Care® initiative of the World Chemicals Association<br />

since 1995. In line with our company’s mission statement,<br />

we, as a member of this initiative, always gear our<br />

actions towards attaining improvements in the areas of<br />

environment, health and safety. We are well aware that<br />

consideration of social and environmental aspects is a<br />

key factor for our sustainable success.<br />

The certification of our production sites by external organisations<br />

also remained a key element of our environmental<br />

and safety management processes in <strong>2011</strong>. Once<br />

again our commitment was rewarded by the receipt of an<br />

ISO 14001 certificate for environmental management at<br />

our pharmaceutical production plant in Narita, Japan. In<br />

gaining this certificate, the Narita plant is following in<br />

the footsteps of our certified chemical plants in France,<br />

Italy and Spain.<br />

To play our part in reducing global CO2 emissions, in<br />

the context of the “BE Green” initiative, we have set ourselves<br />

the ambitious target of reducing our CO2 emissions<br />

by 20% compared with 2010 levels by 2020. We will<br />

achieve this reduction through a large number of different<br />

projects, including in the areas of energy efficiency,<br />

business travel and fleet management.<br />

We began systematically examining buildings for their<br />

energy efficiency at our sites in Germany in the <strong>2011</strong><br />

financial year. Optimisation projects were derived<br />

from these projects which should be completed by<br />

2014. 20 GWh or 4,500 tonnes of CO 2<br />

emissions can<br />

be saved each year as a result of these projects. In the<br />

context of a further project at our production site in<br />

Petersburg, Virginia, USA, the previously separate systems<br />

for heating, ventilation and air conditioning<br />

were bundled in a single building automation system.<br />

We can save around 2,000 tonnes of CO 2<br />

emissions per<br />

year with this measure.<br />

The health and safety of our employees enjoys the highest<br />

priority at <strong>Boehringer</strong> <strong>Ingelheim</strong>. This is reflected in<br />

our stringent global safety standards and guidelines. The<br />

accident rate fell again in the last financial year as a result<br />

of rigorous implementation of our “Zero by Choice”<br />

initiative, in which management and employees proactively<br />

take responsibility for their own safety and that of<br />

their colleagues. With 2.3 accidents per million hours<br />

26<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

worked, we are on the right track to achieving our goal of<br />

reducing the rate to below 1 in 2014.<br />

Employee reporting<br />

As in previous years, the average number of employees<br />

at <strong>Boehringer</strong> <strong>Ingelheim</strong> increased once more in the<br />

<strong>2011</strong> financial year. The average number of employees<br />

for the year was 44,094. This represents an increase of<br />

4.4% on the previous year.<br />

Average number of employees by region <strong>2011</strong> 2010<br />

Americas 14,300 13,491<br />

Europe 21,380 21,016<br />

Asia, Australasia, Africa (AAA) 8,414 7,717<br />

44,094 42,224<br />

An important success factor for the ongoing positive development<br />

of <strong>Boehringer</strong> <strong>Ingelheim</strong> are its innovative,<br />

committed and dependable employees. With this in<br />

mind, we support our employees in various life situations<br />

and create appropriate conditions for achieving a<br />

healthy work/life balance. Flexible working hours, parttime<br />

working and teleworking, nursery places, individual<br />

employee support and preventive health programmes<br />

are measures that enable a balance between career and<br />

private life. For the second time, we won the Corporate<br />

Health Award for “Best Occupational Health Management<br />

in the Chemicals/Pharmaceuticals Segment” for<br />

our occupational health management. Following basic<br />

certification in 2005, we went through the re-auditing<br />

process for the “Work and Family audit” of the Hertie<br />

Foundation in the <strong>2011</strong> financial year. This certificate illustrates<br />

our self-imposed obligation to enhance our family-orientated<br />

human resources policy.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has a long tradition of giving<br />

school-leavers the opportunity to start a skilled career.<br />

With 676 trainees in 29 different occupations, we gave<br />

approximately as many young people a start in their professional<br />

life at our sites in Germany as in the previous<br />

year. We also enable people with disabilities to integrate<br />

into professional life, thanks to the versatility of our<br />

occupations requiring training. In addition to the acquisition<br />

of technical skills and knowledge, we also attach<br />

great importance in the context of integrated training<br />

to fostering the social skills and personality of our employees.<br />

Talent management is of great importance as a fundamental<br />

part of our corporate strategy. Our aim is to have<br />

the right employees available in the right place at the<br />

right time. This ensures the employability and professional<br />

development of every single employee. In addition,<br />

employees with development potential are to be<br />

identified and specifically fostered for strategically important<br />

positions from an early stage. To this end, the<br />

conduct and performance of each employee are evaluated<br />

and differentiated appropriately in terms of both remuneration<br />

and professional development opportunities.<br />

Besides a strong corporate culture, this approach<br />

enables us to recruit highly qualified employees and<br />

bind them to <strong>Boehringer</strong> <strong>Ingelheim</strong> in the long term,<br />

even in an intensely competitive business environment.<br />

We believe that we are in a strong competitive position<br />

with our remuneration system. In addition to the basic<br />

salary that is usual for the market, we have integrated<br />

variable salary components that are geared towards the<br />

commercial success of the company and the attainment<br />

of individual targets of each employee. Individual targets<br />

for each year are agreed as part of a continuous<br />

process of communication between manager and employee<br />

at the beginning of the year in question. Individual<br />

target attainment during the year has a direct effect<br />

on the employee’s variable salary component. Our attractive<br />

remuneration system is rounded off by extensive<br />

voluntary benefits, such as our company pension scheme<br />

and preventive health checks.<br />

In addition, a remuneration component linked with the<br />

long-term success of the company has been in place for<br />

senior management at <strong>Boehringer</strong> <strong>Ingelheim</strong> for several<br />

years now. This variable salary component is geared to<br />

the attainment of long-term company targets and not<br />

short-term targets.<br />

Business and operating environment<br />

27


As in previous years, surveys have confirmed that<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is a highly attractive employer.<br />

Positive results in countries like the USA in the “Top<br />

Employers” competition of Science magazine, Australia<br />

and New Zealand in the “Aon Hewitt Best Employer<br />

Award” and Brazil and Denmark in the “Great Place to<br />

Work” competition are special recognition of our employee-friendly<br />

working environment, our respectful<br />

employee management and our outstanding research<br />

work.<br />

In addition, <strong>Boehringer</strong> <strong>Ingelheim</strong> was named “company<br />

of the year” by Medical Marketing & Media magazine.<br />

Special mention was given to the rigorous focus on independent<br />

research and development and the smooth market<br />

launch of new products in <strong>2011</strong>.<br />

Corporate citizenship<br />

We regard commitment to society and an awareness of<br />

social responsibility as key components of our corporate<br />

culture. In a wide range of projects, we exercise our social<br />

responsibility to our patients and employees and<br />

their families as well as those in need of help in countries<br />

and regions in which we do business.<br />

A major part of our social commitment in the <strong>2011</strong> financial<br />

year was the start of the three-year global partnership<br />

“Making More Health” between <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

and Ashoka, an international non-governmental<br />

organisation (NGO). The aim of this initiative is to promote<br />

the health of people, their families and their social<br />

environment all over the world by identifying and implementing<br />

promising solutions to overcoming health<br />

problems. To achieve this aim, support is being given to<br />

50 selected social entrepreneurs who are advancing sustainable<br />

healthcare solutions with novel concepts. A<br />

web-based “change-maker competition” has also been<br />

launched, in which the public is asked to put forward<br />

new ideas for how healthcare can be improved in an<br />

environment with inadequate provision. In addition to<br />

this, in the context of the “Youth Venture” initiative,<br />

young people have been asked to draw up healthcare<br />

solutions for their specific environment. During <strong>2011</strong>,<br />

13 selected social entrepreneurs in the healthcare sector<br />

received support. Examples of sponsored projects include<br />

improved early detection of breast cancer in Germany<br />

and an initiative for holistic healthcare solutions<br />

for families in the favelas of Brazil.<br />

Another project was the worldwide initiative “1 Mission<br />

1 Million – Getting to the Heart of Stroke”. In this project,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> sponsored projects aimed at improving<br />

the understanding of atrial fibrillation and the<br />

associated risk of stroke, as well as public perception.<br />

Over 40 independent organisations worldwide took part<br />

in the information initiative. In Germany, the initiative<br />

was supported by the German Cardiac Society (DGK). Of<br />

the approximately 180 projects submitted, 32 were selected,<br />

receiving funding of up to EUR 1 million between<br />

them. The projects selected include various print-based<br />

and web-based information campaigns and protection<br />

programmes.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> has been an active supporter of<br />

research, science and culture for many years. In the <strong>2011</strong><br />

financial year, <strong>Boehringer</strong> <strong>Ingelheim</strong> and the University<br />

of Ulm signed a cooperation agreement on the foundation<br />

of the <strong>Boehringer</strong> <strong>Ingelheim</strong> Ulm University Biocenter<br />

(BIU), which is to receive around EUR 2 million in<br />

funding from <strong>Boehringer</strong> <strong>Ingelheim</strong>. Research is focused<br />

on neurodegenerative and cardiometabolic diseases as<br />

well as pulmonary diseases. This cooperation is directed<br />

towards basic research and <strong>Boehringer</strong> <strong>Ingelheim</strong>’s research<br />

and development expertise is further proof of the<br />

group’s firm commitment to research and development.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> also supported Mainz City Council<br />

as the main sponsor of the Germany-wide “City of<br />

Science <strong>2011</strong>” competition. This consisted of a series of<br />

lectures by experts from a wide range of fields, such as<br />

health research for people and animals and a tangible<br />

corporate culture.<br />

28<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

NET ASSETS, FINANCIAL<br />

POSITION AND RESULTS<br />

FROM OPERATIONS<br />

Results from operations<br />

Generating sustainable income in order to ensure longterm,<br />

successful corporate development forms the basis<br />

for the group’s independence and is at the centre of<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s strategic orientation. As in previous<br />

years, we based our actions on these principles in<br />

the last financial year. The launch of new, innovative<br />

products in the <strong>2011</strong> financial year allowed us to initiate<br />

a new period of sustainable growth. According to<br />

preliminary market research figures, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

has a market share of 1.9%, making it the 15th<br />

largest pharmaceutical company in the world.<br />

In <strong>2011</strong>, the Group improved its net sales by 4.6% yearon-year<br />

to EUR 13,171 million. Exchange rate developments<br />

on the currency markets and the resulting exchange<br />

rate effects had a negative impact on net sales of<br />

– 1.6% or approximately EUR – 187 million.<br />

Prescription Medicines<br />

With a share of sales of around 83%, Prescription Medicines<br />

is the key pillar of our activities in the Human<br />

Pharmaceuticals business area. Net sales increased by<br />

4.1% to EUR 10,096 million in <strong>2011</strong> (after adjustment<br />

for exchange rate effects: 5.3%).<br />

Net sales (in millions of EUR) <strong>2011</strong> 2010 Change<br />

spiriva® 3,153 2,863 10.1%<br />

micardis® 1,593 1,555 2.4%<br />

combivent® 766 727 5.4%<br />

pradaxa® 629 62 914.5%<br />

Continuous growth in our core products from the spiriva®<br />

and micardis® product family has made a positive contribution<br />

to our Prescription Medicines business. As in<br />

the previous years, our best-selling product was spiriva®,<br />

which is used to treat chronic obstructive pulmonary<br />

disease (COPD). In the reporting period, it generated<br />

sales in excess of EUR 3 billion for the first time (EUR<br />

3,153 million), corresponding to year-on-year growth<br />

of 10.1%. In its largest sales market, the USA, sales increased<br />

to EUR 1,497 million.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s activities are divided into the<br />

two business areas of Human Pharmaceuticals and Animal<br />

Health. Our Human Pharmaceuticals business is<br />

further subdivided into Prescription Medicines, Consumer<br />

Health Care and Industrial Customers.<br />

In <strong>2011</strong>, our Human Pharmaceuticals business generated<br />

net sales of EUR 12,195 million, corresponding to sales<br />

growth of 4.6% compared with the previous year and<br />

accounting for around 93% of total sales.<br />

Our second-largest product, micardis®, a drug for the<br />

treatment of high blood pressure, also enjoyed positive<br />

development, with sales rising by 2.4% to EUR 1,593 million.<br />

Our new oral anticoagulant pradaxa® is the fastestgrowing<br />

product in our portfolio, generating sales of<br />

EUR 629 million (previous year: EUR 62 million).<br />

Components of growth in net sales (as %) <strong>2011</strong> 2010 2009 2008 2007<br />

Price/quantity/new introductions + 6.3 — 6.2 + 6.6 + 9.7 + 7.9<br />

Acquisitions and sale of business — 0.1 + 0.2 + 0.1 — 0.2 + 0.9<br />

Currency effect — 1.6 + 4.9 + 3.0 — 3.6 — 5.2<br />

Net assets, financial position and results from operations<br />

29


Regional development in our Prescription Medicines<br />

business was varied, with growth in the Americas and<br />

Asia /Australasia /Africa (AAA) regions against falling<br />

sales in Europe.<br />

In the Americas, <strong>Boehringer</strong> <strong>Ingelheim</strong>’s largest sales<br />

region for prescription medicines, sales amounted to<br />

EUR 4,831 million in the past financial year (+ 5.3% as<br />

against the previous year). This growth was driven in<br />

particular by the USA, which recorded the highest sales,<br />

up 6.4% year-on-year to EUR 3,977 million.<br />

The AAA region achieved sales growth of 13.5% to<br />

EUR 2,380 million. Within this development, sales on<br />

the important Japanese market rose by 13.6% to EUR<br />

1,498 million, while the growth market China saw sales<br />

growth around 34% to EUR 195 million.<br />

By contrast, sales in the Europe region declined (by 4.6%<br />

to EUR 2,671 million); this was attributable in particular<br />

to the sifrol® patent expiry in Germany and the resulting<br />

drop in sales of 13.4% on the German market.<br />

Net sales by region<br />

(in millions of EUR) <strong>2011</strong> 2010 Change<br />

Americas 4,831 4,587 5.3%<br />

Europe 2,671 2,801 — 4.6%<br />

Asia, Australasia, Africa (AAA) 2,380 2,097 13.5%<br />

Consumer Health Care<br />

Our business with non-prescription drugs also developed<br />

positively, particularly in our strategically important<br />

growth markets. In <strong>2011</strong>, net sales increased by<br />

5.9% year-on-year to EUR 1,396 million.<br />

Our established products buscopan®, dulcolax®,<br />

mucosolvan® and pharmaton® each generated sales of<br />

more than EUR 100 million, making them <strong>Boehringer</strong><br />

<strong>Ingelheim</strong>’s best-selling non-prescription products. All<br />

four enjoyed growth compared to the previous year.<br />

buscopan® recorded the highest absolute sales and<br />

year-on-year growth, at EUR 180 million and 34.3% respectively.<br />

The development of our Consumer Health<br />

Care business is extremely encouraging against the background<br />

of the difficult business environment.<br />

Net sales (in millions of EUR) <strong>2011</strong> 2010 Change<br />

buscopan® 180 134 34.3%<br />

dulcolax® 171 159 7.5%<br />

mucosolvan® 160 148 8.1%<br />

pharmaton® 137 130 5.4%<br />

The performance of the Consumer Health Care business<br />

varied from region to region. Europe, the largest region<br />

in terms of sales, generated sales growth of 7.3% to<br />

around EUR 540 million. Germany, which is the most<br />

important sales market in Europe, enjoyed a solid 2.2%<br />

increase in sales to EUR 134 million. The highest growth<br />

rate in the <strong>2011</strong> financial year was in the Americas region,<br />

where sales increased by 14.8% to EUR 430 million.<br />

This growth was driven in particular by the extremely<br />

positive development in Brazil, where sales amounted to<br />

EUR 115 million (+ 56.6% year-on-year). Sales in the<br />

AAA region declined by 3.4% to around EUR 427 million;<br />

this was largely due to the performance of the Japanese<br />

market (– 7.6%).<br />

Industrial Customers<br />

The Industrial Customers business encompasses our<br />

third-party business in the fields of Biopharmaceuticals<br />

and Pharmaceutical Production and our commission<br />

business for Pharma Chemicals. Sales in this business<br />

amounted to EUR 697 million in <strong>2011</strong>, up 9.2% year-onyear.<br />

This was attributable to the positive development<br />

in the Biopharmaceuticals business, where sales reached<br />

EUR 519 million (+ 23% as against 2010). In contrast, the<br />

difficult market environment led to a reduction in sales<br />

in both Pharma Chemicals and Pharmaceutical Production<br />

(EUR 178 million, – 17.6%).<br />

Animal Health<br />

With growth of around 6% and sales of EUR 976 million,<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong>’s Animal Health business again<br />

enjoyed a successful year. Porcine vaccines were the<br />

main growth driver. The best-selling product, ingelvac<br />

circoflex®, generated sales of EUR 257 million (up<br />

30<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

7.5% as against 2010). ingelvac® prrs recorded the<br />

second-highest year-on-year growth rate of 29.5%. In<br />

addition to livestock products, our products in the companion<br />

animal segment also developed positively. In particular,<br />

our products in the metacam® family recorded<br />

sales growth compared with the previous year.<br />

In terms of growth rates, our Animal Health business<br />

again took first place among the ten leading companies<br />

in the sector. With a market share of 6.1%, <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> is ranked sixth among the companies in this<br />

market segment, according to provisional market research<br />

figures.<br />

Net sales (in millions of EUR) <strong>2011</strong> 2010 Change<br />

ingelvac circoflex® 257 239 7.5%<br />

metacam® 96 95 1.1%<br />

ingelvac® prrs 57 44 29.5%<br />

vetmedin® 46 42 9.5%<br />

At around 29%, the AAA region enjoyed the highest<br />

growth rate, generating sales of EUR 178 million. This<br />

positive development was driven in particular by China<br />

(+ 30%), Japan (+ 17%) and South Korea (+ 16%). The<br />

Europe region recorded sales of EUR 315 million, corresponding<br />

to solid growth of around 5%. In our largest<br />

sales market, the Americas region, sales remained almost<br />

unchanged year-on-year at EUR 477 million.<br />

things, this cost block includes commission and licence<br />

payments, which are dependent on sales.<br />

Both the operating income and return on net sales were<br />

increased in the past financial year. Operating income<br />

reached a new high of EUR 2,272 million (previous year:<br />

EUR 1,896 million), while the return on net sales<br />

climbed to 17.3% (previous year: 15.1%).<br />

At EUR – 198 million, the financial result for the period<br />

under review was down EUR 44 million on the previous<br />

year. The lower income from plan assets for pensions<br />

and similar obligations was only partially offset by the<br />

higher level of interest income. Income before taxes developed<br />

in line with the result from operating activities,<br />

improving by 19.6% year-on-year to EUR 2,043 million.<br />

Driven by the positive income development, tax expense<br />

amounted to EUR 567 million in the period under review,<br />

up 150.9% on the previous year. Here, it must be<br />

taken into consideration that, under the provisions of<br />

German commercial law, shareholders’ personal taxes<br />

arising from group business activities may not be recognised<br />

in tax expense. Instead, these taxes are presented<br />

as part of withdrawals from group equity. Taking this extraordinary<br />

effect into account, the actual tax ratio is<br />

markedly higher than the figure shown in the profit and<br />

loss statement.<br />

Expenditure and income<br />

At EUR 12,256 million, <strong>Boehringer</strong> <strong>Ingelheim</strong>’s operating<br />

expenses in the <strong>2011</strong> financial year remained largely<br />

unchanged as against the previous year. Material costs<br />

declined by around 6.9% year-on-year to EUR 1,679 million<br />

(previous year: EUR 1,803 million), meaning that<br />

the ratio of material costs to total sales was 12.7%. Personnel<br />

expenses increased by 9.1% year-on-year to EUR<br />

3,664 million, corresponding to 27.8% of total sales<br />

(2010: 26.7%).<br />

Depreciation and amortisation rose by 6.5% to EUR<br />

637 million. Other operating expenses declined by EUR<br />

149 million (– 2.3%) to EUR 6,276 million. Among other<br />

On the back of the positive development of the <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> Group, net income for the <strong>2011</strong> financial year<br />

increased by 66.2%, from EUR 888 million in the previous<br />

year, burdened by the special effect of changes in<br />

German accounting rules (BiLMoG), to EUR 1,476 million<br />

in <strong>2011</strong>.<br />

Financial position<br />

At the heart of <strong>Boehringer</strong> <strong>Ingelheim</strong>’s financial management<br />

are safeguarding liquidity, minimising or limiting<br />

financial and economic risks, and ensuring an appropriate<br />

capital structure that optimises the cost of<br />

capital. Our financial activities are therefore geared towards<br />

supporting the business strategy.<br />

Net assets, financial position and results from operations<br />

31


As an internationally orientated company, exchange rate<br />

fluctuations have a considerable influence on our financial<br />

position. The importance of our US business and the<br />

associated supply relationships means that the US dollar<br />

exchange rate constitutes the largest individ ual risk. Due<br />

to the global nature of our business activities, exchange<br />

rate risks are calculated within the framework of our<br />

groupwide financial reporting and hedged using derivative<br />

financial instruments. The nature and scope of these<br />

measures are set out in our group guidelines and are regularly<br />

discussed and decided upon by the relevant committee<br />

in a standardised process.<br />

Investments are of great strategic importance to <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> when it comes to securing the group’s longterm<br />

success and further development. Continuous investment<br />

forms the basis for future profitable growth.<br />

A total of EUR 512 million was invested in tangible and<br />

intangible assets in the <strong>2011</strong> financial year. Two new<br />

production modules for pradaxa® were inaugurated at<br />

our headquarters in <strong>Ingelheim</strong>. This increased capacity<br />

serves to ensure the supply of our active ingredient dabigatran<br />

etexilate. At our Biberach site, an expansion investment<br />

was made in a new research laboratory building<br />

that will house various research disciplines that were<br />

previously performed in separate facilities. In Spain, an<br />

additional ampoule production line was commissioned<br />

in order to meet rising global demand. Investment activities<br />

in the field of veterinary medicine focused on the<br />

further expansion of research and development capacities,<br />

with examples including additional investments in<br />

the <strong>Boehringer</strong> <strong>Ingelheim</strong> Veterinary Research Center at<br />

our Hanover site and the construction of a new research<br />

and development facility in Shanghai.<br />

In <strong>2011</strong>, net cash flow amounted to EUR 2,378 million, up<br />

6.4% on 2010. Due to the higher net income for the period<br />

under review compared with 2010, cash flow from operating<br />

activities increased by EUR 514 million to EUR 2,570 million.<br />

This means that, as in previous years, investments were<br />

financed entirely from funds generated by the company itself.<br />

Cash flow from financing activities included an outflow of<br />

funds of EUR 502 million as a result of payments to group<br />

shareholders, mainly to settle tax debt attributable to the income<br />

of the group. All in all, this development led to an increase<br />

in the group’s cash and cash equivalents of EUR 1,598<br />

million to EUR 7,711 million (+ 26.1%).<br />

In summary, it is clear that, with the available liquidity, the<br />

current financial structure and the high cash flow from our<br />

operating activities, all of the prerequisites for the solid<br />

continuation of our business activities and the successful<br />

implementation of our strategy remain fulfilled.<br />

Net assets<br />

In the <strong>2011</strong> financial year, total assets increased by EUR<br />

2,425 million to EUR 18,658 million, corresponding to<br />

year-on-year growth of 14.9%. Tangible and intangible<br />

assets totalled EUR 4,152 million and were fully covered<br />

by consolidated equity.<br />

As of 31 December <strong>2011</strong>, financial assets amounted to<br />

EUR 3,953 million, up EUR 785 million (+ 24.8%) on the<br />

previous year. Inventories increased by EUR 148 million<br />

to EUR 1,998 million, while receivables rose by 15.3% to<br />

EUR 3,126 million. Liquid funds including current securities<br />

increased sharply by EUR 785 million to total EUR<br />

3,903 million (+ 25.2% year-on-year).<br />

Group equity amounted to EUR 7,466 million at year-end,<br />

up EUR 992 million or 15.3% on the previous year. This<br />

increase was primarily attributable to retained net income<br />

for the period. Consolidated long-term disposable capital<br />

(equity, pension provisions and long-term liabilities) increased<br />

to EUR 11,384 million (2010: EUR 10,408 million),<br />

thereby corresponding to 61% of total assets. This<br />

meant that, as in the previous year, intangible and tangible<br />

assets, inventories and trade accounts receivable are<br />

covered in full by long-term disposable capital.<br />

Other provisions increased by 11.3% year-on-year to<br />

EUR 3,166 million. Liabilities remained largely unchanged<br />

at EUR 3,280 million (+ 4.9%).<br />

The balance sheet and the respective balance sheet ratios<br />

round off the positive picture already shown in the finan-<br />

32<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

cial position and results from operations. A combined<br />

evaluation of the net assets, financial position and results<br />

from operations shows that <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

is a soundly financed and profitable company. In the<br />

<strong>2011</strong> financial year, we established a sound basis for our<br />

further business development.<br />

REPORT ON POST-BALANCE<br />

SHEET DATE EVENTS<br />

On 30 January 2012, <strong>Boehringer</strong> <strong>Ingelheim</strong> announced<br />

the disposal of its subsidiary Nutrichem to B. Braun Melsungen<br />

AG. Nutrichem diät+pharma GmbH has 285 employees<br />

and specialises in the development, production,<br />

filling and packaging of products for special nutritional<br />

requirements, particularly enteral nutrition, food supplements<br />

and sports nutrition.<br />

RISK REPORT<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> uses an established risk management<br />

system that has proved itself over the last few years<br />

and was not modified in the <strong>2011</strong> financial year.<br />

The aim of risk management is to identify businessspecific<br />

risks and, in particular, risks that jeopardise the<br />

continued existence of the company as early as possible,<br />

to assess them and to reduce them to a reasonable level<br />

by means of suitable measures. When assessing the risks<br />

in the context of holistic risk management, we also endeavour<br />

to take into account the resulting opportunities<br />

and incorporate them into the analysis.<br />

The persons responsible for the key business areas and<br />

functions are included in the process of calculating and<br />

assessing risks. With the groupwide risk and information<br />

system, we ensure that all identified risks are analysed<br />

and assessed carefully. Following appropriate classification,<br />

adequate countermeasures are commenced and<br />

their implementation is consistently monitored.<br />

In the year under review, Internal Auditing performed<br />

targeted routine audits as well as extraordinary audits<br />

worldwide. In addition to adherence to legal requirements<br />

and group-internal guidelines, the main focal<br />

points here were the functionality of systems, the effectiveness<br />

of internal controls for the prevention of loss<br />

of assets, and the efficiency of structures and processes.<br />

An audit plan approved by the Board of Managing Directors<br />

was consistently followed.<br />

Currency risks resulting from the global orientation of<br />

our business activities are monitored at regular intervals<br />

and limited by means of corresponding hedging strategies<br />

with appropriate financial instruments, such as forward<br />

exchange contracts. From the portfolio of trade<br />

accounts receivable and trade accounts payable, we did<br />

not identify any extraordinary risks beyond the usual<br />

level in the sector for the group. The same applies to<br />

possible default risks for receivables, which are largely<br />

hedged against economic and political risks. We will<br />

continue to carefully track macroeconomic and industry-specific<br />

risks in order to allow us to respond to negative<br />

changes in a timely manner.<br />

The group pursues a conservative investment strategy in<br />

the management of its financial assets. This is reflected<br />

in the defensive orientation of its portfolio, which is focused<br />

on EMU government bonds with top credit ratings<br />

and short-term investments at selected banks. A large<br />

proportion of cash and cash equivalents have a shortterm<br />

investment horizon.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is exposed to risks arising from<br />

legal disputes and proceedings as well as official investigations.<br />

As the legal or administrative decisions in ongoing<br />

or future proceedings cannot be predicted, we have<br />

made appropriate provisions for resultant risks.<br />

Protection of innovations through trademark, brand and<br />

patent rights is of particular importance to <strong>Boehringer</strong><br />

Ingel heim as a research company. These commercial protective<br />

rights are increasingly the target of attacks and<br />

breaches. We have taken precautions so that we can de-<br />

<strong>Report</strong> on post-balance sheet date events / Risk report 33


tect threats at an early stage and, by commencing appropriate<br />

countermeasures, defend our legal position using<br />

all legal means available to us, if applicable.<br />

Risks in the area of Environment, Health and Safety are<br />

minimised preventively by adherence to our own very<br />

high safety standards. Appropriate emergency plans have<br />

been drawn up for possible incidents of any kind and are<br />

practised and subjected to comprehensive quality testing<br />

at regular intervals. To provide protection against the financial<br />

impact of potential damage or loss events and<br />

liability risks, <strong>Boehringer</strong> <strong>Ingelheim</strong> has appropriate insurance<br />

coverage for the company’s risk profile. Its scope<br />

and amount are regularly monitored.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> is also exposed to business risks<br />

specific to the pharmaceutical industry. In addition to<br />

the loss of exclusivity of products established on the<br />

market and risks associated with the development and<br />

registration of new products, these risks increasingly include<br />

changing and restrictive requirements relating to<br />

pricing and reimbursement on many sales markets. Frequently,<br />

the prices of pharmaceutical products are not<br />

only subject to state monitoring and regulation, but also<br />

to price pressure from cheaper generic drugs caused by<br />

the state reimbursement systems.<br />

been aware of for some time and planned for – and the<br />

impact on operating income from the extensive investments<br />

in research and development as well as marketing<br />

for the planned new product launches, we successfully<br />

initiated a new period of organic growth in the <strong>2011</strong> financial<br />

year.<br />

In addition to the blockbusters in our stable product portfolio<br />

(spiriva® and micardis®), this upturn was driven<br />

by the launch of our innovative oral anticoagulant<br />

pradaxa® (active ingredient dabigatran etexilate) for the<br />

indication of stroke prevention in patients with atrial fibrillation<br />

in Europe and Japan. We had already obtained<br />

approval in the USA and Canada in the last quarter of<br />

2010.<br />

trajenta® (active ingredient linagliptin), which was approved<br />

for the treatment of type 2 diabetes in the USA,<br />

Europe and Japan in <strong>2011</strong>, also offers significant sales<br />

potential. The approval of trajenta® also marked the first<br />

milestone in the strategic alliance between <strong>Boehringer</strong><br />

<strong>Ingelheim</strong> and Eli Lilly for the joint development and<br />

marketing of active ingredients for diabetes treatment.<br />

The long-term cooperation covers a further three active<br />

ingredients as well as an option for the joint development<br />

and marketing of an additional substance.<br />

There are currently no indications of any risks going beyond<br />

this which could jeopardise the continued existence<br />

of the <strong>Boehringer</strong> <strong>Ingelheim</strong> group.<br />

REPORT ON EXPECTED<br />

DEVELOPMENTS<br />

Our extremely satisfactory business performance in the<br />

<strong>2011</strong> financial year confirmed our long-term orientation<br />

and provided us with a strong starting point for the coming<br />

years.<br />

In the Biopharmaceuticals business, we have many years<br />

of expertise in the development and production of biological<br />

medicines. This gives us a good basis for the development,<br />

production and marketing of biosimilars, a line of<br />

business that we will enter for the first time in 2012.<br />

The temporary suspension of production at our US subsidiary<br />

Ben Venue Laboratories, Inc. has been necessary<br />

in our view to allow comprehensive renovation and corrective<br />

actions, to thereby make medicines produced<br />

there available to patients as soon as possible . We are<br />

confident of being able to address the regulatory issues.<br />

Following the transitional year of 2010 with the expiry<br />

of exclusivity protection for our blockbuster products<br />

flomax® and mirapex® in the USA – something we had<br />

We are convinced that our established product portfolio<br />

and the successful launch of new products will help us<br />

to sustainably strengthen and expand our position on<br />

34<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

group management report<br />

the global pharmaceutical market. We expect to record<br />

growth in 2012 and are forecasting a high single-digit increase<br />

in sales compared with the year under review. As<br />

this positive trend will be reinforced by additional product<br />

launches, we are also confident that we will be able to<br />

further improve our sales year-on-year in 2013.<br />

We have increased our investment budget once again,<br />

thereby underlining our strategic approach of driving<br />

growth and product supply primarily through products<br />

from our own research and development. We are confident<br />

that this sustainably generated organic growth will<br />

secure the basis for our long-term success.<br />

We intend to address these challenges and are confident<br />

in our ability to master them. With great innovative<br />

strength based on a well-filled pipeline and the support<br />

of our highly qualified and committed employees, who<br />

are a key factor in our success, we will achieve our ambitious<br />

targets. <strong>Boehringer</strong> <strong>Ingelheim</strong>’s declared aim remains<br />

to continue to develop the company competitively<br />

and successfully as an independent, family-owned enterprise.<br />

For us, long-term and sustainable organic growth<br />

still takes precedence over short-term profit targets. We<br />

will also continue to stand by our vision “Value through<br />

Innovation”, researching and developing innovations<br />

that offer medical benefits and bringing them to the<br />

market with the aim of providing patients with the best<br />

treatments possible.<br />

We believe that our well-filled product pipeline, with<br />

promising results for our development products in trials<br />

and significant sales potential, serves to justify our high<br />

level of research and development investment.<br />

In addition to patent expiries and challenges, the major<br />

challenges facing the research-driven pharmaceutical industry<br />

are rising investments in R&D and tougher barriers<br />

and increased expenditure for product approvals.<br />

One particular factor is the intensification of cost pressure<br />

in healthcare systems, which are increasingly unwilling<br />

to reward the high level of investment in new<br />

drugs to an appropriate extent. Legislative intervention<br />

in the pricing of prescription drugs is having a negative<br />

impact on various markets. For example, our new antidiabetes<br />

agent trajenta® will not be available for use in<br />

treatment in Germany until the Act on the Reform of the<br />

Market for Medicinal Products (AMNOG) assessment<br />

procedure is complete and the reimbursable amount has<br />

been fixed.<br />

<strong>Report</strong> on expected developments 35


36<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

<strong>2011</strong><br />

CONSOLIDATED FINANCIAL<br />

STATEMENTS<br />

38 OVERVIEW OF THE MAJOR CONSOLIDATED COMPANIES<br />

40 CONSOLIDATED BALANCE SHEET<br />

41 CONSOLIDATED PROFIT AND LOSS STATEMENT<br />

42 CASH FLOW STATEMENT<br />

43 STATEMENT OF CHANGES IN GROUP EQUITY<br />

44 NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS <strong>2011</strong><br />

63 AUDITOR’S REPORT<br />

Consolidated Financial Statements<br />

37


OVERVIEW OF THE MAJOR CONSOLIDATED COMPANIES<br />

C. H. <strong>Boehringer</strong> Sohn AG & Co. KG*<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Europe GmbH<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

International GmbH<br />

germany D P R<br />

austria D P R<br />

austria<br />

R<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><br />

microParts GmbH, Dortmund<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> RCV<br />

GmbH & Co. KG, Vienna<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Pharma Ges.m.b.H., Vienna<br />

czech republic<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> s.r.o.,<br />

Prague<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 />

poland<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Sp.zo.o.,<br />

Warsaw<br />

D<br />

D<br />

D<br />

D<br />

Forschungsinstitut für Molekulare<br />

Pathologie Gesellschaft mbH,<br />

Vienna<br />

belgium<br />

D<br />

SCS <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Comm. V., Brussels<br />

china D P<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 />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

(Phil.), Inc., Manila<br />

south korea<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Korea Ltd., Seoul<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Vetmedica<br />

Korea Ltd., Seoul<br />

D Distribution<br />

P Production<br />

R Research and Development<br />

* sole general partner:<br />

<strong>Boehringer</strong> AG<br />

38<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH & Co. KG<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Auslandsbeteiligungs GmbH<br />

argentina D R<br />

greece D P<br />

portugal<br />

D<br />

united kingdom<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> S.A.,<br />

Buenos Aires<br />

australia<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Pty. Ltd.,<br />

North Ryde<br />

brazil D P<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 D R<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

(Canada) Ltd., Burlington<br />

chile<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ltda.,<br />

Santiago de Chile<br />

D<br />

columbia D P<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> S.A.,<br />

Bogotá<br />

denmark D P<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Danmark A/S, Copenhagen<br />

ecuador<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> del<br />

Ecuador<br />

Cia. Ltda., Quito<br />

france D P<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

France S.A.S., Paris<br />

Labso Chimie Fine S.A.R.L.,<br />

Blanquefort<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ellas AE,<br />

Athens<br />

indonesia D P<br />

PT <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Indonesia, Jakarta<br />

italy D P R<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Italia S.p.A., Reggello<br />

Bidachem S.p.A.,<br />

Fornovo S. Giovanni<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Research<br />

Italia S.a.S., Milano<br />

japan D P R<br />

Nippon <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Co. Ltd., Tokyo<br />

SSP Co. Ltd., Tokyo<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Vetmedica Japan Co. Ltd.,<br />

Tokyo<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Seiyaku Co. Ltd., Yamagata<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Japan, Inc., Tokyo<br />

mexico D P R<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Promeco S.A. de C.V.,<br />

Mexico City<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Vetmedica,<br />

S.A. de C.V., Guadalajara<br />

the<br />

netherlands<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> B.V.,<br />

Alkmaar<br />

new zealand<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Lda.,<br />

Lisbon<br />

Unilfarma Lda., Lisbon<br />

south africa<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> (Pty.) Ltd.,<br />

Randburg<br />

<strong>Ingelheim</strong> Pharmaceuticals (Pty.)<br />

Ltd., Randburg<br />

spain D P<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

España S.A., 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 />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> AB,<br />

Stockholm<br />

switzerland<br />

D<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><br />

Taiwan Ltd., Taipei<br />

thailand<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

(Thai) Ltd., Bangkok<br />

turkey<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ilac<br />

Ticaret A.S., Istanbul<br />

D<br />

D<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> Ltd.,<br />

Bracknell<br />

usa D P R<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 />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

USA Corporation,<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 />

venezuela<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> C.A.,<br />

Caracas<br />

D<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong><br />

(N.Z.) Ltd., Auckland<br />

Overview of the major consolidated companies<br />

39


C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong><br />

CONSOLIDATED BALANCE SHEET<br />

Assets (in millions of EUR) Notes 1) 31.12.<strong>2011</strong> 31.12.2010<br />

Intangible assets (3.1) 710 736<br />

Tangible assets (3.2) 3,442 3,314<br />

Financial assets (3.3) 3,953 3,168<br />

Fixed assets 8,105 7,218<br />

Inventories (3.4) 1,998 1,850<br />

Accounts receivable and other assets (3.5) 3,126 2,712<br />

Securities 1,932 1,095<br />

Cash and cash equivalents 1,971 2,023<br />

Current assets 9,027 7,680<br />

Deferred charges and prepaid expenses 69 54<br />

Deferred taxes 1,457 1,281<br />

Total assets 18,658 16,233<br />

Liabilities and equity (in millions of EUR) Notes 1) 31.12.<strong>2011</strong> 31.12.2010<br />

Shareholders‘ capital 178 178<br />

Group reserves 5,806 5,413<br />

Balance sheet currency conversion difference 6 — 5<br />

Net income 1,476 888<br />

Group equity 7,466 6,474<br />

Negative difference from acquisition of companies 157 0<br />

Provisions (3.6) 7,128 6,411<br />

Accounts payable (3.7) 3,280 3,127<br />

Liabilities 10,408 9,538<br />

Deferred charges 353 34<br />

Deferred taxes 274 187<br />

Total liabilities and equity 18,658 16,233<br />

1)<br />

For explanation, see relevant section in the Notes to the consolidated financial statements.<br />

40<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong><br />

CONSOLIDATED PROFIT AND LOSS STATEMENT<br />

(in millions of EUR) Notes 1) <strong>2011</strong> 2010<br />

Net sales (4.1) 13,171 12,586<br />

Changes in inventories — 101 7<br />

Other internal work performed and capitalised 4 5<br />

Other operating income (4.2) 1,454 1,482<br />

Total revenues 14,528 14,080<br />

Material costs (4.3) — 1,679 — 1,803<br />

Personnel costs (4.4) — 3,664 — 3,358<br />

Amortisation of intangible and depreciation of tangible assets (4.5) — 637 — 598<br />

Other operating expenses (4.6) — 6,276 — 6,425<br />

Operating income 2,272 1,896<br />

Financial income (4.7) — 198 — 154<br />

Holding income (4.8) — 31 — 34<br />

Income before taxes 2,043 1,708<br />

Extraordinary result (4.9) 0 — 594<br />

Taxes 2) (4.10) — 567 — 226<br />

Income after taxes (4.11) 1,476 888<br />

1)<br />

For explanation, see relevant section in the Notes to the consolidated financial statements.<br />

2)<br />

Due to legal requirements the disclosure of the shareholders‘ personal taxes arising from consolidated business activities as tax expenses is not<br />

allowed. These taxes are shown as withdrawals from the accrued group capital.<br />

Consolidated balance sheet / Consolidated profit and loss statement<br />

41


C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong><br />

CASH FLOW STATEMENT<br />

(in millions of EUR) <strong>2011</strong> 2010<br />

Income after taxes 1,476 888<br />

Write-downs/write-ups on fixed assets 1) 659 631<br />

Change in provisions for pensions 243 715<br />

Cash flow 2,378 2,234<br />

Change in other provisions 382 — 46<br />

Other non-cash income and expenses 287 1<br />

Loss on disposals of fixed assets 20 72<br />

Change in inventories — 136 25<br />

Change in accounts receivable and other assets not related to investing or financing activities — 515 — 141<br />

Change in trade accounts payable and other liabilities not related to investing or financing<br />

activities 154 — 89<br />

Cash flow from operating activities 2,570 2,056<br />

Investments in intangible assets — 54 — 57<br />

Investments in property, plant and equipment — 458 — 519<br />

Investments in non-current financial assets 1) — 14 — 14<br />

Proceeds from disposals of tangible assets 17 21<br />

Proceeds from disposals of non-current financial assets 1) 7 4<br />

Cash flow from investing activities — 502 — 565<br />

Cash receipts from/cash payment to owners and minority shareholders — 498 — 837<br />

Cash proceeds from borrowings/repayments of loans 32 31<br />

Cash flow from financing activities — 466 — 806<br />

Change in liquid funds from cash relevant transactions 1,602 685<br />

Changes in liquid funds due to exchange rate movements — 4 44<br />

Financial funds 2) as of 1.1. 6,113 5,384<br />

Financial funds 2) as of 31.12. 7,711 6,113<br />

1)<br />

Excl. fixed-asset securities<br />

2)<br />

Liquid funds, securities within fixed and current assets<br />

(+) = source of funds, (-) = use of funds<br />

42<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <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 />

thereof<br />

currency<br />

effects<br />

Equity<br />

Minority<br />

interests<br />

thereof<br />

currency<br />

effects<br />

Group equity<br />

Balance as of 31.12.2009 178 5,723 — 244 5,901 179 — 20 6,080<br />

Withdrawals 0 — 456 0 — 456 0 0 — 456<br />

Net income 0 888 0 888 0 0 888<br />

Change of scope of consolidation 0 0 0 0 0 0 0<br />

Other changes 0 141 239 141 — 179 20 — 38<br />

Balance as of 31.12.2010 178 6,296 — 5 6,474 0 0 6,474<br />

Withdrawals 0 — 495 0 — 495 0 0 — 495<br />

Net income 0 1,476 0 1,476 0 0 1,476<br />

Change of scope of consolidation 0 0 0 0 0 0 0<br />

Other changes 0 11 11 11 0 0 11<br />

Balance as of 31.12.<strong>2011</strong> 178 7,288 6 7,466 0 0 7,466<br />

1)<br />

The shareholders‘ capital consists of the equity of C. H. <strong>Boehringer</strong> Sohn AG & Co. KG and C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH & Co. KG. As of<br />

31.12.<strong>2011</strong>, the capital consists only of the limited partner‘s capital contribution. The shareholders‘ personal taxes arising from consolidated business activities are<br />

shown as withdrawals from the accrued group capital.<br />

Cash flow statement / Statement of changes in group equity<br />

43


C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong><br />

NOTES TO THE CONSOLIDATED FINANCIAL<br />

STATEMENTS <strong>2011</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 <strong>2011</strong> financial year were prepared<br />

in accordance with section 264a of the Handelsgesetzbuch (HGB – German Commercial Code), in line<br />

with the requirements of group accounting of sections 290 et seq. HGB.<br />

In accordance with section 297 paragraph 1 HGB, the consolidated financial statements consist of the consolidated<br />

balance sheet, the consolidated profit and loss statement, the notes to the consolidated financial<br />

statements, the cash flow statement and the statement of changes in equity.<br />

The consolidated financial statements were prepared in euro in accordance with section 298 paragraph 1<br />

in conjunction with section 244 HGB.<br />

To improve the clarity of the consolidated financial statements, individual items of the consolidated balance<br />

sheet and the consolidated profit and loss statement have been combined. These items are presented<br />

and explained separately in the notes. The additional disclosures required for the individual items can also<br />

be found in the notes.<br />

1.2 Information on companies included in consolidation<br />

The parent company of the <strong>Boehringer</strong> <strong>Ingelheim</strong> Group is C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong>.<br />

<strong>Boehringer</strong> AG, <strong>Ingelheim</strong>, is the sole, personally liable, managing shareholder of this company.<br />

Besides C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, there is C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH<br />

& Co. KG, the general partner which is controlled by C. H. <strong>Boehringer</strong> Sohn AG & Co. KG.<br />

The <strong>Boehringer</strong> <strong>Ingelheim</strong> Group consists of a total of 145 affiliated companies in Germany and abroad. In<br />

addition to C. H. <strong>Boehringer</strong> Sohn AG & Co. KG and C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH<br />

& Co. KG, a further 111 companies in which C. H. <strong>Boehringer</strong> Sohn AG & Co. KG directly or indirectly<br />

holds the majority of voting rights have been fully consolidated in the consolidated financial statements.<br />

30 companies were not included in consolidation in accordance with section 296 paragraph 2 HGB in the<br />

reporting year, as they are individually and collectively insignificant to the net assets, financial position<br />

and results of operations of the Group. The total amount of the sales, equity and net income of the companies<br />

not included in consolidation account for less than 1% of the aggregated group financial statements<br />

totals. These companies were also not classified as associates in accordance with section 311 paragraph 2<br />

HGB on account of immateriality. There are ongoing restrictions on disposal at two other companies on ac-<br />

44<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

count of their articles of association. These were not included in consolidation in accordance with section<br />

296 paragraph 1 sentence 1 HGB.<br />

The total number of affiliated companies remained unchanged as against the previous year:<br />

• Two companies were liquidated<br />

• Two companies were founded<br />

The following subsidiaries were exempted from the reporting and disclosure obligations of section 264<br />

paragraph 3 HGB:<br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Europe 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> Grundstücksgesellschaft mbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Finanzierungs GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> R&D Beteiligungs GmbH, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Venture Fund GmbH, <strong>Ingelheim</strong><br />

Exempt from the duty to prepare and disclose annual financial statements and management reports in accordance<br />

with HGB provisions for corporations under section 264b HGB are:<br />

• C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong><br />

• C. H. <strong>Boehringer</strong> Sohn Grundstücksverwaltung GmbH & Co. KG, <strong>Ingelheim</strong><br />

• C. H. <strong>Boehringer</strong> Sohn Selbstmedikation KG, Biberach<br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Pharma GmbH & Co. KG, <strong>Ingelheim</strong><br />

• <strong>Boehringer</strong> <strong>Ingelheim</strong> Veterinary Research Center GmbH & Co. KG, Hanover<br />

1.3 Consolidation methods<br />

For inventories and fixed assets, receivables, liabilities and income and expense items, transactions between<br />

the companies included in consolidation were eliminated as part of debt consolidation in accordance with<br />

section 303 HGB, the elimination of intercompany profits in accordance with section 304 HGB and the<br />

consolidation of income and expenses in accordance with section 305 HGB.<br />

The revaluation method of section 301 HGB was applied in acquisition accounting for the first-time consolidation<br />

of subsidiaries. First-time consolidation occurred on the date at which the company became a<br />

subsidiary.<br />

The carrying amount of the shares held by the parent company was offset against the corresponding equity<br />

of the subsidiary. Equity is carried at the amount of the fair value of the assets, liabilities, prepaid expenses<br />

and deferred income and special reserves included in the consolidated financial statements as at the time<br />

of consolidation. Any remaining balance after offsetting was reported as goodwill.<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

45


1.4 Currency translation<br />

Assets and liabilities resulting from foreign currency transactions were translated using the middle spot<br />

exchange rate as at the balance sheet date. The realisation principle (section 298 paragraph 1 in conjunction<br />

with section 252 paragraph 1 no. 4, 2nd half-sentence HGB) and the historical cost convention (section<br />

298 paragraph 1 in conjunction with section 253 paragraph 1 sentence 1 HGB) were complied with<br />

for remaining terms of more than one year.<br />

In these consolidated financial statements, the financial statements of foreign subsidiaries domiciled in a<br />

state outside the euro zone and denominated in foreign currency have been converted into euro in accordance<br />

with section 308a HGB using the modified closing rate method.<br />

Using the modified closing date rate method, the asset, equity and liability items of the annual financial<br />

statements prepared in foreign currency were translated into euro using the middle spot exchange rate as at<br />

the closing date, with the exception of equity, which was translated using the historical rate. The items of<br />

the profit and loss statement were translated into euro using the average rate. The resulting translation difference<br />

was reported within consolidated equity below the reserves within “Difference in equity from<br />

currency translation”. The most important currencies for the Group developed as follows in the reporting<br />

year (basis: EUR 1):<br />

Year-end rate<br />

Average annual rate<br />

31.12.<strong>2011</strong> 31.12.2010 <strong>2011</strong> 2010<br />

US dollar 1.29 1.34 1.39 1.33<br />

Japanese yen 100.20 108.65 111.03 116.46<br />

Pound sterling 0.84 0.86 0.87 0.86<br />

Canadian dollar 1.32 1.33 1.38 1.37<br />

46<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

2 ACCOUNTING POLICIES<br />

2.1 Fixed assets<br />

Acquired intangible assets and tangible assets were carried at cost less straight-line amortisation and<br />

depreciation respectively in line with technical and economic circumstances. This is based on the following<br />

useful lifes:<br />

Intangible assets<br />

Buildings<br />

Technical equipment and machinery<br />

Other equipment, operating and office equipment<br />

2 to 15 years<br />

20 years<br />

10 years<br />

3 to 10 years<br />

Only straight-line depreciation and amortisation is used in the consolidated financial statements. Anticipated<br />

permanent impairment was shown by write-offs. Direct costs of materials and labour costs, appropriate<br />

portions of materials and labour overheads and the depreciation of fixed assets (if caused by production)<br />

were taken into account in determining production costs.<br />

All capitalised, intangible assets have a limited useful life.<br />

Goodwill from the first-time consolidation of shares is usually being amortised over a period of five years.<br />

A useful life of ten years was applied to the goodwill for <strong>Boehringer</strong> <strong>Ingelheim</strong> Korea Ltd., acquired in<br />

2007, as past experience of products, sales markets and the business conditions of <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Korea Ltd. has shown that this presents a true and fair view.<br />

Financial assets essentially included shareholder rights, securities and loans and are carried at the lower of<br />

cost or fair market value, if impaired.<br />

2.2 Current assets and prepaid expenses<br />

Inventories were carried at the lower of cost and fair market value.<br />

Raw materials, consumables and supplies were capitalised at the lower of average acquisition prices or fair<br />

market value on the balance sheet date.<br />

Finished goods and work in progress were measured at production cost on the basis of individual calculations,<br />

taking into account the directly attributable costs of materials, direct labour costs, special direct<br />

costs, appropriate shares of production and materials overheads and depreciation.<br />

Goods for resale are valued at the lower of either purchase cost or fair market value.<br />

All identifiable risks in inventory assets arising from above-average storage periods, diminished marketability<br />

and lower replacement costs were taken into account by appropriate valuation adjustments.<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

47


Inventories are valued loss-free, i.e. discounts were recognised on the expected sales prices for costs yet to<br />

be incurred.<br />

Receivables and other assets were recognised at cost less allowances for specific risks and general credit<br />

risk. Low-interest or non-interest-bearing receivables with a term of more than one year were discounted.<br />

Securities classified as current assets include other securities and were recognised at the lower of cost or<br />

quoted/market prices on the reporting date.<br />

Cash and cash equivalents were recognised at the lower of cost or fair market value.<br />

Deferred charges and prepaid expenses in accordance with section 250 paragraph 1 HGB include expenses<br />

paid in advance for a certain period after the balance sheet date.<br />

Deferred charges in accordance with section 250 paragraph 2 HGB includes proceeds for a certain period<br />

after the balance sheet date.<br />

2.3 Negative difference from acquisition of companies<br />

The negative difference from acquisition of companies was recognised as a result of the net assets of a<br />

company acquired as of 31 March <strong>2011</strong> exceeding the purchase price. The release of the negative difference<br />

from acquisition of companies (by EUR 18 million from EUR 175 million to EUR 157 million) is shown in<br />

other operating income; the amount of the release of the negative difference from acquisition of companies<br />

is in line with the amortisation of the excess net assets as of the time of acquisition. The period of amortisation<br />

is currently estimated at ten years.<br />

2.4 Group reserves<br />

Group reserves include the retained earnings of the consolidated subsidiaries from prior years and consolidation<br />

entries that affect earnings related to prior years.<br />

2.5 Provisions<br />

Tax provisions and other provisions include all uncertain liabilities and expected losses from executory<br />

contracts. They were carried at the amount required to settle the obligation based on reasonable business<br />

judgement in accordance with the prudence principle (i.e. including future cost and price increases). Provisions<br />

with a remaining term of more than one year are discounted using the matched-term, average market<br />

interest rate for the last seven years (in accordance with the Rückstellungsabzinsungsverordnung – German<br />

Regulation on the Discounting of Provisions).<br />

2.6 Liabilities<br />

Liabilities are recognised at settlement amount.<br />

48<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

2.7 Deferred taxes<br />

To calculate deferred taxes on temporary or quasi-permanent differences between the accounting carrying<br />

amounts of assets, liabilities, prepaid expenses and deferred income and their tax carrying amounts or on<br />

tax loss carryforwards, the amounts of the resulting tax benefits and expenses at the time of reversal were<br />

measured using tax rates specific to the respective consolidated company (10% - 40%) and not discounted.<br />

Differences due to consolidation measures in accordance with sections 300 to 305 HGB were also measured<br />

using company-specific tax rates at the time of the expected reversal of the difference. Deferred tax<br />

assets on loss carryforwards were taken into account, if it is likely that they will be used within the next<br />

five years.<br />

Deferred tax assets and liabilities were reported without being netted.<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

49


3 NOTES TO THE CONSOLIDATED BALANCE SHEET<br />

3.1 Intangible assets<br />

(in millions of EUR)<br />

Acquired<br />

concessions/<br />

similar rights<br />

Goodwill<br />

Advance<br />

payments<br />

Total<br />

Procurement/manufacturing costs<br />

Balance as of 1.1.2010 1,293 572 13 1,878<br />

Currency conversion difference 67 0 2 69<br />

Additions due to first consolidation 0 0 0 0<br />

Additions 42 0 15 57<br />

Disposals — 78 0 0 — 78<br />

Reclassifications 10 0 — 3 7<br />

Balance as of 31.12.2010 1,334 572 27 1,933<br />

Currency conversion difference 30 1 0 31<br />

Additions due to first consolidation 0 0 0 0<br />

Additions 44 0 10 54<br />

Disposals — 15 0 — 1 — 16<br />

Reclassifications 26 0 — 22 4<br />

Balance as of 31.12.<strong>2011</strong> 1,419 573 14 2,006<br />

Accumulated depreciation<br />

Balance as of 1.1.2010 597 536 0 1,133<br />

Currency conversion difference 20 0 0 20<br />

Additions due to first consolidation 0 0 0 0<br />

Additions 95 5 0 100<br />

Write-ups 0 0 0 0<br />

Disposals — 56 0 0 — 56<br />

Reclassifications 0 0 0 0<br />

Balance as of 31.12.2010 656 541 0 1,197<br />

Currency conversion difference 12 0 0 12<br />

Additions due to first consolidation 0 0 0 0<br />

Additions 97 5 0 102<br />

Write-ups 0 0 0 0<br />

Disposals — 15 0 0 — 15<br />

Reclassifications 0 0 0 0<br />

Balance as of 31.12.<strong>2011</strong> 750 546 0 1,296<br />

Book value as of 31.12.2010 678 31 27 736<br />

Book value as of 31.12.<strong>2011</strong> 669 27 14 710<br />

50<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

3.2 Tangible assets<br />

Land and Technical Other Advance Total<br />

buildings facilities facilities/ payments/<br />

and machines operating construction<br />

(in millions of EUR) equipment in progress<br />

Procurement/manufacturing costs<br />

Balance as of 1.1.2010 2,510 2,611 1,867 402 7,390<br />

Currency conversion difference 163 102 71 20 356<br />

Additions due to first consolidation 0 0 0 0 0<br />

Additions 31 82 123 283 519<br />

Disposals — 82 — 109 — 150 — 8 — 349<br />

Reclassifications 33 96 52 — 188 — 7<br />

Balance as of 31.12.2010 2,655 2,782 1,963 509 7,909<br />

Currency conversion difference 62 41 22 6 131<br />

Additions due to first consolidation 0 8 1 0 9<br />

Additions 61 214 137 218 630<br />

Disposals — 15 — 60 — 93 — 2 — 170<br />

Reclassifications 63 140 30 — 237 — 4<br />

Balance as of 31.12.<strong>2011</strong> 2,826 3,125 2,060 494 8,505<br />

Accumulated depreciation<br />

Balance as of 1.1.2010 1,262 1,581 1,328 0 4,171<br />

Currency conversion difference 89 70 51 0 210<br />

Additions due to first consolidation 0 0 0 0 0<br />

Additions 106 202 190 0 498<br />

Write-ups 0 0 0 0 0<br />

Disposals — 55 — 96 — 133 0 — 284<br />

Reclassifications 0 0 0 0 0<br />

Balance as of 31.12.2010 1,402 1,757 1,436 0 4,595<br />

Currency conversion difference 36 21 18 0 75<br />

Additions due to first consolidation 0 6 2 0 8<br />

Additions 113 235 187 0 535<br />

Write-ups — 3 — 6 0 0 — 9<br />

Disposals — 13 — 49 — 79 0 — 141<br />

Reclassifications 0 0 0 0 0<br />

Balance as of 31.12.<strong>2011</strong> 1,535 1,964 1,564 0 5,063<br />

Book value as of 31.12.2010 1,253 1,025 527 509 3,314<br />

Book value as of 31.12.<strong>2011</strong> 1,291 1,161 496 494 3,442<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

51


3.3 Financial assets<br />

(in millions of EUR)<br />

Investments Loans Investments Investment Other Total<br />

in affiliated to affiliated in related securities loans<br />

companies companies companies<br />

Procurement/manufacturing costs<br />

Balance as of 1.1.2010 65 7 104 1,521 20 1,717<br />

Currency conversion difference 11 0 — 1 8 0 18<br />

Additions due to first consolidation 0 0 0 0 0 0<br />

Additions 7 0 2 1,542 5 1,556<br />

Disposals — 4 0 0 — 64 — 6 — 74<br />

Reclassifications 0 0 0 0 0 0<br />

Balance as of 31.12.2010 79 7 105 3,007 19 3,217<br />

Currency conversion difference 4 0 1 8 0 13<br />

Additions due to first consolidation 0 0 0 0 0 0<br />

Additions 0 0 8 853 6 867<br />

Disposals — 2 — 7 0 — 46 — 5 — 60<br />

Reclassifications 0 0 0 0 0 0<br />

Balance as of 31.12.<strong>2011</strong> 81 0 114 3,822 20 4,037<br />

Accumulated amortisation<br />

Balance as of 1.1.2010 0 0 1 14 3 18<br />

Currency conversion difference 0 0 0 1 0 1<br />

Additions due to first consolidation 0 0 0 0 0 0<br />

Additions 0 0 33 1 0 34<br />

Write-ups 0 0 0 0 0 0<br />

Disposals 0 0 0 — 4 0 — 4<br />

Reclassifications 0 0 0 0 0 0<br />

Balance as of 31.12.2010 0 0 34 12 3 49<br />

Currency conversion difference 2 0 0 1 0 3<br />

Additions due to first consolidation 0 0 0 0 0 0<br />

Additions 18 0 13 2 0 33<br />

Write-ups 0 0 0 0 0 0<br />

Disposals 0 0 0 — 1 0 — 1<br />

Reclassifications 0 0 0 0 0 0<br />

Balance as of 31.12.<strong>2011</strong> 20 0 47 14 3 84<br />

Book value as of 31.12.2010 79 7 71 2,995 16 3,168<br />

Book value as of 31.12.<strong>2011</strong> 61 0 67 3,808 17 3,953<br />

As in the previous year, the “Other loans” item does not include any loans to shareholders.<br />

52<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

3.4 Inventories<br />

(in millions of EUR) 31.12.<strong>2011</strong> 31.12.2010<br />

Raw materials and supplies 427 381<br />

Unfinished products 872 817<br />

Finished products and goods for resale 694 649<br />

Advance payments to suppliers 5 3<br />

1,998 1,850<br />

3.5 Accounts receivable and other assets<br />

Residual<br />

term over<br />

Residual<br />

term over<br />

(in millions of EUR) 31.12.<strong>2011</strong> 1 year 31.12.2010 1 year<br />

Trade accounts receivable 2,531 6 2,156 4<br />

Receivables from affiliated companies 12 0 7 0<br />

Receivables from related companies 19 0 17 0<br />

Other assets 564 12 532 12<br />

3,126 18 2,712 16<br />

The “Other assets” item includes receivables from shareholders of EUR 1 million (previous year:<br />

EUR 28 million).<br />

Receivables from affiliated companies, as in the previous year, exclusively consist of receivables from<br />

loans.<br />

Receivables from related companies only consist of trade accounts receivable.<br />

3.6 Provisions<br />

(in millions of EUR) 31.12.<strong>2011</strong> 31.12.2010<br />

Pension provisions 3,283 3,007<br />

Tax provisions 679 559<br />

Other provisions 3,166 2,845<br />

7,128 6,411<br />

Provisions for pensions and similar obligations<br />

The provisions for pensions and similar obligations were determined on the basis of actuarial calculations<br />

using the projected unit credit method, taking into account future adjustments in salaries and pensions.<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

53


In addition to local biometric data (e.g. Prof Heubeck’s 2005 G mortality tables in Germany), pension obligations<br />

in the significant countries were calculated on the basis of the following actuarial parameters:<br />

(in % as of 31 December <strong>2011</strong>) Germany USA Japan<br />

Discount rate 5.13 5.53 2.06<br />

Salary increase 4.0 5.0 4.2 – 4.9<br />

Pension increase 3.5 3.0 0.0<br />

Provisions for pensions and similar obligations were discounted using the average market interest rate on a<br />

remaining term of 15 years in accordance with the German Regulation on the Discounting of Provisions of<br />

18 November 2009. The interest rates used to discount significant foreign pension obligations (US, Japan)<br />

were determined with comparable parameters, in line with the German Regulation on the Discounting of<br />

Provisions of 18 November 2009.<br />

The plan assets intended solely to cover pension and similar obligations that are unavailable to all other<br />

creditors (cover assets within the meaning of section 246 paragraph 2 sentence 2 HGB) were measured at<br />

fair market value which is essentially derived from stock market prices and offset against the underlying<br />

pension and similar obligations.<br />

The fair market value of the plan assets on balance sheet date was EUR 920 million. The corresponding<br />

present value of the pension and similar obligations was EUR 4,203 million.<br />

Gains and losses from plan assets and interest expense relating to pension and similar obligations were<br />

offset in accordance with section 246 paragraph 2 sentence 2 HGB.<br />

In total, EUR 12 million losses from plan assets and EUR 224 millions interest expense relating to pension<br />

and similar obligations are included in the financial income.<br />

54<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

3.7 Accounts payable<br />

(in millions of EUR)<br />

Residual term Residual term<br />

less than<br />

1 - 5<br />

over 31.12. 31.12. less than<br />

1 year<br />

years 5 years<br />

<strong>2011</strong><br />

2010<br />

1 year<br />

Bank loans 479 747 493 1,719 1,740 237<br />

Other accounts payable 1,362 57 142 1,561 1,387 1,261<br />

of which:<br />

- Trade accounts payable 899 1 0 900 803 802<br />

- Advance payments 27 16 0 43 41 23<br />

- Accounts payable<br />

to affiliated companies 24 0 0 24 29 29<br />

- Accounts payable<br />

to related companies 2 0 0 2 1 1<br />

- Other liabilities* 410 40 142 592 513 406<br />

1,841 804 635 3,280 3,127 1,498<br />

* Of which:<br />

- from taxes (EUR million) 65 76<br />

- social security liabilities (EUR million) 15 14<br />

As in the previous year, there were no liabilities secured by mortgages or similar collateral rights on the<br />

balance sheet date.<br />

At the end of the year, there were liabilities to shareholders of EUR 26 million (previous year: EUR 0 million).<br />

Payables to affiliated companies consist of payables from loans amounting to EUR 19 million (previous year:<br />

EUR 18 million) and trade accounts payable amounting to EUR 5 million (previous year: EUR 11 million).<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

55


4 NOTES TO THE CONSOLIDATED PROFIT AND LOSS<br />

STATEMENT<br />

The structure of the consolidated profit and loss statement was based on the total cost format.<br />

4.1 Net sales<br />

by business and business segment (in millions of EUR) <strong>2011</strong> 2010<br />

Human Pharmaceuticals 12,195 11,665<br />

of which: Prescription Medicines 10,096 9,702<br />

Consumer Health Care 1,396 1,318<br />

Industrial Customers 697 638<br />

Other Sales 6 7<br />

Animal Health 976 921<br />

13,171 12,586<br />

by geographic region (in millions of EUR) <strong>2011</strong> 2010<br />

Europe 4,037 4,089<br />

of which: Germany 950 977<br />

Americas 6,087 5,724<br />

of which: USA 4,820 4,511<br />

Asia / Australasia / Africa 3,047 2,773<br />

of which: Japan 1,831 1,695<br />

13,171 12,586<br />

4.2 Other operating income<br />

Other operating income includes income from currency translation of EUR 546 million (previous year:<br />

EUR 715 million).<br />

4.3 Material costs<br />

(in millions of EUR) <strong>2011</strong> 2010<br />

Costs of raw material, supplies and goods for resale 1,231 1,375<br />

Expenditure on services 448 428<br />

1,679 1,803<br />

56<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

4.4 Personnel costs<br />

(in millions of EUR) <strong>2011</strong> 2010<br />

Salaries and wages 2,875 2,713<br />

Social benefits and retirement benefits 789 645<br />

of which: retirement benefits 306 177<br />

3,664 3,358<br />

All interest effects of the measurement of the provision for pensions and similar obligations were shown as<br />

a separate item of the financial income.<br />

Average headcount <strong>2011</strong> 2010<br />

Production 13,076 12,647<br />

Administration 5,217 5,242<br />

Marketing and sales 17,945 16,543<br />

Research and development 7,159 7,093<br />

Apprentices 697 699<br />

44,094 42,224<br />

4.5 Amortisation of intangible assets and depreciation of tangible assets<br />

Amortisation of intangible fixed assets and depreciation of tangible fixed assets include extraordinary<br />

write-downs of EUR 34 million (previous year: EUR 23 million).<br />

4.6 Other operating expenses<br />

Other operating expenses include expenses from currency translation of EUR 497 million (previous year:<br />

EUR 796 million).<br />

Other operating expenses essentially include third-party services in the areas of research, development,<br />

medicine and marketing plus administrative expenses, fees and contributions, commissions, rent, freight<br />

and expenses for third-party repairs.<br />

4.7 Financial income<br />

(in millions of EUR) <strong>2011</strong> 2010<br />

Interest expense relating to pensions and similar obligations and other provisions — 247 — 147<br />

Other interest expense and similar expenditure — 130 — 115<br />

Interest expense and similar expenditure — 377 — 262<br />

Amortisation of and loss on disposal on financial assets and short-term investments — 2 — 4<br />

Income from other investment securities and from long-term loans 113 80<br />

Other interest income and similar proceeds 68 32<br />

— 198 — 154<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

57


4.8 Holding income<br />

(in millions of EUR) <strong>2011</strong> 2010<br />

Write-offs on financial assets — 31 — 33<br />

Expense from loss allocation 0 — 1<br />

of which from affiliated companies 0 — 1<br />

— 31 — 34<br />

4.9 Extraordinary result<br />

In the previous year, the adoption of section 66 and section 67 paragraph 1 to paragraph 5 EGHGB (transitional<br />

BilMoG regulations) resulted in extraordinary expenses of EUR 587 million from the addition to provisions<br />

for pensions and similar obligations and EUR 20 million from the addition to other long-term provisions.<br />

Also in the previous year, the adoption of section 66 and section 67 paragraph 1 to paragraph 5<br />

EGHGB resulted in extraordinary income of EUR 13 million from the reversal of provisions for pensions<br />

and similar obligations also included in this item.<br />

4.10 Taxes<br />

(in millions of EUR) <strong>2011</strong> 2010<br />

Income taxes 630 369<br />

Deferred taxes — 63 — 143<br />

567 226<br />

Current income taxes essentially include the costs of corporation and trade tax for the companies included<br />

in consolidation.<br />

As a result of the conclusion of profit transfer agreements, significant German corporations have been included<br />

in the trade and corporation tax group of the parent company C. H. <strong>Boehringer</strong> Sohn AG & Co. KG<br />

since 1 January 2004. As the income taxes of the shareholders of C. H. <strong>Boehringer</strong> Sohn AG & Co. KG incurred<br />

on operating income cannot be reported in the consolidated profit and loss statement, only the<br />

trade income tax of the companies concerned and other fully consolidated German partnerships is shown<br />

as tax expenses.<br />

Total deferred tax assets amounted to EUR 1,457 million as of the balance sheet date. Deferred tax assets<br />

essentially relate to the different carrying amounts of provisions, fixed assets and inventories. Deferred tax<br />

liabilities were recognised in the amount of EUR 274 million. They mainly relate to the differences in the<br />

carrying amounts of tangible assets, inventories and provisions.<br />

4.11 Net income<br />

The net income for <strong>2011</strong> was positively influenced by prior-period operating income (essentially from the<br />

reversal of other provisions) of EUR 166 million (previous year: EUR 99 million) and negatively influenced<br />

by prior-period operating expenses of EUR 99 million (previous year: EUR 37 million).<br />

58<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

5 NOTES TO THE CASH FLOW STATEMENT<br />

The cash flow statement shows how the cash and cash equivalents (cash and long-term securities and investments<br />

classified as current assets that can be sold at any time) of the <strong>Boehringer</strong> <strong>Ingelheim</strong> Group<br />

changed as a result of cash inflows and outflows in the reporting year. In accordance with German Accounting<br />

Standard 2 on the cash flow statement (GAS 2), this has been broken down according to cash<br />

flows from operating activities and cash flows from investing and financing activities.<br />

The changes in the balance sheet items of the affiliated companies included were translated using average<br />

rates for the year. As in the balance sheet, cash and cash equivalents are carried at the closing rate. The<br />

e ffect of exchange rate changes on cash and cash equivalents has been shown separately.<br />

In the financial year, EUR 164 million were received from interests; EUR 83 million (previous year: EUR<br />

89 million) were paid for interests while EUR 407 million (previous year: EUR 347 million) were paid for<br />

taxes.<br />

6 OTHER DISCLOSURES<br />

6.1 Contingent liabilities<br />

(EUR million) 31.12.<strong>2011</strong> 31.12.2010<br />

Liabilities from guarantees,<br />

bills and cheque guarantees, warranties<br />

and the granting of security for third-party liabilities 34 21<br />

The risk of utilisation of the individual contingent liabilities is estimated as follows:<br />

The risk of utilisation of guarantees for the liabilities to banks of affiliated companies is rated as low on account<br />

of the solid net assets, financial position and results of operations of the subsidiaries in question.<br />

6.2 Other financial commitments<br />

(in millions of EUR) 31.12.<strong>2011</strong> 31.12.2010<br />

Rental and leasing obligations 320 249<br />

Purchase commitment 768 563<br />

1,088 812<br />

There are obligations from rental and lease agreements of EUR 320 million (previous year: EUR 249 million),<br />

EUR 34 million of which (previous year: EUR 39 million) relating to long-term rental agreements<br />

with subsidiaries not included in consolidation.<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

59


The purpose of the lease agreements is the lower capital commitment compared to buying property and the<br />

absence of the resale risk. Risks could arise from the term of the lease, if it were no longer possible to fully<br />

utilise the properties, of which there are no indications at this time.<br />

Other financial commitments include future expenses from follow-up investments, investments already<br />

initiated and future major repairs. As at the balance sheet date, purchase commitments include future cash<br />

investments of EUR 645 million (previous year: EUR 449 million) in other off-balance sheet transactions.<br />

6.3 Derivative financial instruments and hedges<br />

Owing to its extensive international structure, the <strong>Boehringer</strong> <strong>Ingelheim</strong> Group is highly dependent on developments<br />

in the world’s currencies and interest rates. To hedge these risks, particularly those emerging<br />

from goods, services and financing, currency forwards and options are generally used for currency risks<br />

and interest rate swaps and options are used for interest rate risks.<br />

The use of derivative financial instruments and the organisational processes are set out in internal guidelines.<br />

There is a strict separation of trading, processing, documentation and control.<br />

Risk positions are regularly tracked, analysed and measured in a special consolidated financial report. The<br />

positions entered into are periodically re-evaluated and monitored. The fair market values of the derivative<br />

financial instruments are calculated using standard market measurement methods (currency and interest<br />

forwards using the net present value method, currency and interest options using recognised option<br />

pricing models) on the basis of the market data available on the balance sheet date.<br />

Currency and interest options are recognised at fair market value not exceeding the option premium paid<br />

or received. They are derecognised on maturity.<br />

Provisions of EUR 42 million were recognised for currency forwards not included in hedge accounting for<br />

which there was a negative fair market value within a currency as at the balance sheet date. In line with<br />

the imparity principle, positive fair market values within a currency are not recognised.<br />

On the balance sheet date, there were the following derivative financial instruments not included in hedge<br />

accounting:<br />

Nominal value<br />

Market value<br />

(in millions of EUR) 31.12.<strong>2011</strong> 31.12.2010 31.12.<strong>2011</strong> 31.12.2010<br />

Foreign exchange forward contracts 1,866 1,892 — 42 — 1<br />

Interest options 0 1 0 0<br />

If the requirements for hedge accounting of foreign exchange forward contracts with highly probable forecasted<br />

transactions in accordance with section 254 HGB are met, the foreign exchange forward contracts<br />

are not recognised in the balance sheet in line with the net hedge presentation method.<br />

60<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

consolidated financial statements<br />

The following accounting policies apply in the recognition of hedges in accordance with 254 HGB:<br />

Economic hedges are accounted for by hedge accounting. Hedges are recognised per foreign currency from<br />

the net amount of highly probable forecasted transactions and currency forwards that match the forecasted<br />

net cash flow in terms of maturity, nominal amount and foreign currency (macro hedge). The highly<br />

probable forecasted transactions (incoming and outgoing payments for planned sales and purchases) are<br />

derived from company planning. Ex-post analysis of planning has shown that the planned transactions are<br />

highly probable.<br />

As the critical terms (maturity, nominal amount, foreign currency) match, the opposing changes in value of<br />

the hedged item and the hedging instrument are fully offset. An effective hedge can therefore be assumed<br />

both prospectively and retrospectively. The critical term match method is exclusively used to measure prospective<br />

and retrospective hedge effectiveness.<br />

As of 31 December <strong>2011</strong>, hedges for highly probable forecast net cash flows were recognised as follows:<br />

January to December 2012:<br />

Net cash flow (in millions of EUR) FX forward contracts (in millions of EUR)<br />

Nominal value Nominal value Market value<br />

USD 1,014 USD — 713 USD — 47<br />

JPY 780 JPY — 698 JPY — 81<br />

January to December 2013:<br />

Net cash flow (in millions of EUR) FX forward contracts (in millions of EUR)<br />

Nominal value Nominal value Market value<br />

USD 1,099 USD — 366 USD — 25<br />

JPY 782 JPY — 345 JPY — 36<br />

January to December 2014:<br />

Net cash flow (in millions of EUR) FX forward contracts (in millions of EUR)<br />

Nominal value Nominal value Market value<br />

USD 1,123 USD — 168 USD — 5<br />

JPY 831 JPY — 180 JPY — 16<br />

January, February 2015:<br />

Net cash flow (in millions of EUR) FX forward contracts (in millions of EUR)<br />

Nominal value Nominal value Market value<br />

USD 185 USD — 18 USD 0<br />

JPY 155 JPY — 29 JPY — 2<br />

Notes to the consolidated financial statements <strong>2011</strong><br />

61


The amount of the hedged foreign currency risk correlates to the relative change in the exchange rate<br />

between the planning date and the realisation date of the forecasted transactions. If all currencies were to<br />

appreciate or depreciate against the euro by 10.0%, there would be a foreign currency risk of plus or minus<br />

EUR 597 million without hedging.<br />

As of the <strong>2011</strong> balance sheet date, there are two floating-rate loans amounting to EUR 516 million. Interest<br />

rate swaps with matching amounts and matching maturities were concluded to hedge the interest rate<br />

risk associated with this. As this only involves transforming the floating-rate loan portions into a fixed interest<br />

rate, use is made of hedge accounting (micro hedges). The opposing changes in value of the hedged<br />

item and the hedging instrument are fully offset until 2016. As of the balance sheet date, the interest rate<br />

swaps including accrued interest had a fair market value of minus EUR 16 million. The carrying amount<br />

(equal to deferred accrued interest) was EUR 2 million and is reported under liabilities to banks. The net<br />

hedge presentation method was used.<br />

6.4 Research and development expenses<br />

(in millions of EUR ) <strong>2011</strong> 2010<br />

Research & development expenses 2.516 2.453<br />

The research and development expenses not capitalised include costs for phase IV clinical studies.<br />

6.5 Total auditor fees<br />

The total fee charged by the auditor for the financial year was EUR 2.5 million. EUR 0.9 million of this relates<br />

to audits of financial statements, EUR 0.1 million to other assurance or valuation services and EUR<br />

1.5 million to other services.<br />

62<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


usiness year <strong>2011</strong><br />

auditor’s report<br />

AUDITOR’S REPORT<br />

We have audited the consolidated financial statements<br />

prepared by C.H. <strong>Boehringer</strong> Sohn AG &<br />

Co. KG, <strong>Ingelheim</strong> - comprising the balance<br />

sheet, the income statement, statement of changes<br />

in equity, cash flow statement and the notes to the<br />

consolidated financial statements, together with<br />

the group management report for the business<br />

year from 1 January to 31 December <strong>2011</strong>. The<br />

preparation of the consolidated financial statements<br />

and the group management report in accordance<br />

with German commercial law is the responsibility<br />

of the Managing Directors of the<br />

managing corporate general partner. Our responsibility<br />

is to express an opinion on the consolidated<br />

financial statements and the group management<br />

report based on our audit.<br />

We conducted our audit of the consolidated financial<br />

statements in accordance with § (Article)<br />

317 HGB (German Commercial Code) and<br />

German generally accepted standards for the audit<br />

of financial statements promulgated by the Institut<br />

der Wirtschaftsprüfer (Institute of Public<br />

Auditors in Germany) (IDW). Those standards require<br />

that we plan and perform the audit such<br />

that misstatements materially affecting the presentation<br />

of the net assets, financial position and<br />

results of operations in the consolidated financial<br />

statements in accordance with (German) principles<br />

of proper accounting and in the group management<br />

report are detected with reasonable assurance.<br />

Knowledge of the business activities and<br />

the economic and legal environment of the<br />

Group and expectations as to possible misstatements<br />

are taken into account in the determination<br />

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. The<br />

audit includes assessing the annual financial<br />

statements of the companies included in consolidation,<br />

the determination of the companies to be<br />

included in consolidation, the accounting and<br />

consolidation principles used and significant estimates<br />

made by the Managing Directors of the<br />

managing corporate general partner, as well as<br />

evaluating the overall presentation of the consolidated<br />

financial statements and the group management<br />

report. We believe that our audit provides<br />

a reasonable basis for our opinion.<br />

Auditor’s report<br />

63


With the exception of the following qualification,<br />

our audit has not led to any reservations: Contrary<br />

to § (Article) 314 (1) Nos.6 (a) and (b) HGB the<br />

total remuneration granted to the members and<br />

the former members of the board of managing directors<br />

as well as the pension provisions recognized<br />

and not recognized for the former members<br />

of the board of managing directors are not disclosed<br />

in the notes to the consolidated financial<br />

statements.<br />

In our opinion based on the findings of our audit,<br />

with the qualification mentioned above, the consolidated<br />

financial statements comply with the<br />

legal requirements. The consolidated financial<br />

statements give a true and fair view of the net assets,<br />

financial position and results of operations<br />

of the Group in accordance with (German) principles<br />

of proper accounting. The group management<br />

report is consistent with consolidated financial<br />

statements that comply with the legal<br />

requirements and as a whole provides a suitable<br />

view of the Group’s position and suitably<br />

presents the opportunities and risks of future development.<br />

Frankfurt am Main, 23 February 2012<br />

PricewaterhouseCoopers<br />

Aktiengesellschaft<br />

Wirtschaftsprüfungsgesellschaft<br />

/s/ Philip Marshall<br />

Wirtschaftsprüfer<br />

(German Certified<br />

Public Accountant)<br />

/s/ Georg Wolfgang Wegener<br />

Wirtschaftsprüfer<br />

(German Certified<br />

Public Accountant)<br />

64<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

branded prescription medicines<br />

<strong>2011</strong><br />

PRODUCT PORTFOLIO<br />

A SELECTION<br />

68 BRANDED PRESCRIPTION MEDICINES<br />

78 CONSUMER HEALTH CARE<br />

86 ANIMAL HEALTH<br />

67


Respiratory diseases<br />

Chronic obstructive pulmonary disease (COPD) and<br />

asthma are among the most prevalent chronic diseases<br />

affecting the lungs, and cause significant morbidity and<br />

premature deaths worldwide.<br />

COPD<br />

COPD is a chronic disease of the lung in which the airways<br />

become narrowed. This leads to a limitation of airflow<br />

causing shortness of breath and other respiratory<br />

symptoms. The airflow limitation is only partially reversible<br />

and usually worsens gradually over time. Destruction<br />

of lung tissue (mainly affecting the alveoli and<br />

thus gas exchange) and excessive mucus in the airways<br />

inducing chronic cough contribute to the burden of disease.<br />

These manifestations of COPD are designated as<br />

emphysema or chronic bronchitis.<br />

Asthma<br />

Asthma is a chronic disease involving airway inflammation<br />

in response to exposure to asthma triggers such as<br />

allergens. Airway inflammation causes airways to narrow,<br />

in some patients mucus to increase, and chronic dry<br />

cough may be an asthma symptom. Quite variable<br />

breathing difficulties may occur. In the early stages of<br />

the disease, this airflow limitation is fully reversible and<br />

patients can be free of symptoms between attacks.<br />

COPD is caused by noxious stimuli such as cigarette<br />

smoke or air pollution. The course of COPD is characterised<br />

by an accelerated loss of lung function compared<br />

to normal aging and occasional sudden worsening of<br />

symptoms and functions called acute exacerbations.<br />

68<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

branded prescription medicines<br />

Indications Brand names Active ingredients<br />

• Chronic obstructive pulmonary<br />

disease (COPD)<br />

spiriva®<br />

tiotropium bromide<br />

Maintenance treatment of patients with<br />

COPD (chronic obstructive pulmonary<br />

disease, including chronic bronchitis<br />

and emphysema), the maintenance<br />

treatment of associated dyspnoea and<br />

for prevention of exacerbations.<br />

• Bronchospasms associated<br />

with reversible obstructive<br />

airway diseases<br />

combivent®<br />

ipratropium bromide,<br />

salbutamol<br />

Management of reversible bronchospasms<br />

associated with obstructive<br />

airway diseases in patients requiring<br />

more than one bronchodilator.<br />

• Chronic obstructive<br />

pulmonary disease (COPD)<br />

• Chronic bronchitis<br />

• Asthma<br />

atrovent®<br />

ipratropium bromide<br />

Bronchodilator for maintenance treatment<br />

of bronchospasm associated with<br />

chronic obstructive pulmonary disease,<br />

including chronic bronchitis, emphysema<br />

and asthma.<br />

• Bronchial asthma<br />

• Chronic bronchitis<br />

berodual®<br />

bronchodual®<br />

duovent®<br />

fenoterol,<br />

ipratropium<br />

bromide<br />

For prevention and treatment of symptoms<br />

in chronic obstructive airway disorders<br />

with reversible air flow limitations,<br />

such as bronchial asthma, and<br />

especially chronic bronchitis, with or<br />

without emphysema.<br />

• Bronchial asthma<br />

berotec®<br />

dosberotec®<br />

fenoterol<br />

Symptomatic treatment of acute asthma<br />

attacks and other conditions with reversible<br />

airway narrowing, e. g. chronic<br />

obstructive bronchitis, prophylaxis of<br />

exercise-induced asthma.<br />

• Bronchial asthma<br />

inflammide®<br />

budesonide<br />

Chronic control of symptoms of bronchial<br />

asthma.<br />

• Bronchial asthma<br />

• Allergic rhinitis<br />

alesion®<br />

flurinol®<br />

epinastine<br />

Prophylactic treatment of bronchial<br />

asthma. Prophylaxis and symptomatic<br />

treatment of allergic rhinitis.<br />

Respiratory diseases<br />

69


Diseases of the central nervous system<br />

Mental and neurological diseases, such as depression<br />

and Parkinson’s disease, significantly impact patients<br />

and their families, and are a substantial burden to society.<br />

Parkinson’s disease<br />

Parkinson’s disease (PD) is a degenerative disorder of<br />

the central nervous system. Patients usually notice motor<br />

symptoms, like hand tremor (shaking), as their first<br />

sign of the disease, which progresses eventually to include<br />

shaking of the arms, legs or head. Other motor<br />

symptoms that may develop over time include stiffness<br />

that often results in loss of facial expression and a<br />

gradual slowing or loss of motion or “freezing”. About<br />

30 – 40 % of patients also suffer from non-motor symptoms<br />

associated with PD, such as dementia, depression<br />

and sleep disorders. The primary symptoms are the<br />

result of a lack of the neurotransmitter dopamine in<br />

distinct areas of the human brain.<br />

Restless legs syndrome (RLS)<br />

Restless legs syndrome (RLS) is a common neurological<br />

disorder characterised by an uncontrollable urge to<br />

move the legs, primarily occuring in the evening and<br />

night hours, usually accompanied by unpleasant and<br />

sometimes painful sensations in the legs as well as disturbed<br />

sleep resulting in daytime tiredness or sleepiness.<br />

The sensations are felt deep within the legs and are<br />

described as creeping, crawling or aching.<br />

70<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

branded prescription medicines<br />

Indications Brand names Active ingredients<br />

• Parkinson’s disease (PD)<br />

• Restless legs syndrome (RLS)<br />

sifrol®<br />

sifrol® er<br />

mirapex®<br />

mirapex® er<br />

mirapex er®<br />

mirapexin®<br />

mirapexin® er<br />

pexola®<br />

pramipexole<br />

Symptomatic treatment of idiopathic<br />

Parkinson’s disease. It may be used as<br />

monotherapy or in combination with<br />

levodopa. Symptomatic treatment of<br />

idiopathic moderate to severe restless<br />

legs syndrome.<br />

• Sleep disorders<br />

lendormin®<br />

lendorm®<br />

lindormin®<br />

sintonal®<br />

brotizolam<br />

Short-term treatment of disorders of<br />

initiating and maintaining sleep.<br />

Diseases of the central nervous system<br />

71


Cardiovascular diseases<br />

Cardiovascular diseases are the leading causes of death<br />

in many countries, and are still increasing in prevalence.<br />

Stroke<br />

Stroke is the rapidly developing loss of brain functions<br />

due to a blockage of the blood flow to the affected brain<br />

tissue. This can be due to ischaemia (lack of blood supply)<br />

caused by thrombosis or embolism, or due to a<br />

bleeding. As a result, the affected area of the brain is<br />

unable to function and the damage quickly becomes<br />

permanent, if untreated. Stroke is an acute event requiring<br />

emergency diagnosis and intervention. Stroke is one<br />

of the leading causes of death and long-term disability<br />

in the developed world. Symptoms of a transient ischaemic<br />

attack (TIA) are similar to stroke, but last for only<br />

a few minutes or hours. As a TIA may precede a stroke,<br />

emergency medical care and subsequent preventive<br />

treatment is necessary.<br />

Acute myocardial infarction<br />

An acute myocardial infarction, or heart attack, is an<br />

acute event that occurs when a thrombus or clot suddenly<br />

prevents blood flow to an area of the heart muscle.<br />

Unless the blood flow is restored quickly, the affected<br />

section of heart muscle becomes permanently<br />

damaged. Heart attack is a leading cause of death in all<br />

developed countries.<br />

72<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

branded prescription medicines<br />

Indications Brand names Active ingredients<br />

• Essential hypertension<br />

• Cardiovascular prevention<br />

micardis®<br />

micardisplus®<br />

micardis® plus<br />

micardis® hct<br />

co-micardis®<br />

telmisartan;<br />

telmisartan, hydrochlorothiazide<br />

Treatment of essential hypertension.<br />

For the reduction of the risk of myocardial<br />

infarction (heart attack), stroke or<br />

death from cardiovascular (CV) causes in<br />

patients 55 years of age or older at high<br />

risk of developing major CV events who<br />

are unable to take ACE inhibitors (USA).<br />

For the reduction of cardiovascular morbidity<br />

in patients with manifest atherothrombotic<br />

cardiovascular disease (history<br />

of coronary heart disease, stroke or<br />

peripheral arterial disease), or type 2<br />

diabetes mellitus with documented target<br />

organ damage (EU).<br />

• Hypertension<br />

twynsta®<br />

micamlo®<br />

telmisartan, amlodipine<br />

Treatment of hypertension alone or with<br />

other antihypertensive agents. As initial<br />

therapy in patients likely to need multiple<br />

antihypertensive agents to achieve<br />

their blood pressure goals (USA).<br />

Add on therapy in adult patients with not<br />

adequately controlled blood pressure on<br />

amlodipine and replacement therapy in<br />

adult patients receiving telmisartan and<br />

amlodipine from separate tablets (EU).<br />

• Secondary prevention of<br />

stroke or transient ischaemic<br />

attacks (TIA)<br />

aggrenox®<br />

asasantin®<br />

asasantin® retard<br />

dipyridamole,<br />

acetylsalicylic acid<br />

Prevention of stroke following a first<br />

stroke or transient ischaemic attacks.<br />

• Hypertension<br />

catapresan®<br />

catapres®<br />

catapressan®<br />

atensina®<br />

clonidine<br />

All forms of high blood pressure, unless<br />

caused by phaeochromocytoma.<br />

• Acute ischaemic stroke<br />

• Acute myocardial infarction<br />

• Acute massive pulmonary<br />

embolism<br />

• Catheter clearance due to<br />

thrombotic occlusion<br />

actilyse®<br />

actilyse® cathflo® 2mg<br />

alteplase<br />

Fibrinolytic treatment of acute ischaemic<br />

stroke, acute myocardial infarction,<br />

acute massive pulmonary embolism and<br />

for catheter clearance due to thrombotic<br />

occlusion.<br />

Cardiovascular diseases<br />

73


Cardiovascular diseases (continued)<br />

Hypertension and cardiovascular disease<br />

Hypertension, also referred to as high blood pressure, is<br />

a chronic disease in which the blood pressure is chronically<br />

elevated. Hypertension is one of the major risk factors<br />

for strokes, heart attacks, heart failure and chronic<br />

renal failure.<br />

About one billion people worldwide are affected by hypertension.<br />

The prevalence of essential hypertension increases<br />

steadily with age. As the world population ages<br />

and preventive strategies in terms of lifestyle changes are<br />

so far failing, the prevalence of hypertension is set to increase<br />

even further.<br />

Hypertension is a major risk factor for cardiovascular<br />

morbidity and mortality. The organs at risk are primarily<br />

the heart, the main blood vessels, the brain and the kidneys.<br />

The primary goal of any antihypertensive treatment<br />

is to prevent cardiovascular events, such as heart<br />

attacks or strokes, and finally to reduce cardiovascular<br />

mortality. Cardiovascular disease (CVD) is responsible<br />

for nearly one in three deaths worldwide and is the<br />

number one cause of death.<br />

Venous thrombo-embolism<br />

Patients undergoing orthopaedic surgery are at considerable<br />

risk of developing deep vein thrombosis in the legs<br />

or a potentially fatal pulmonary embolism. Both are also<br />

known as venous thrombo-embolism (VTE). In the longer<br />

term, thrombo-embolic events may recur and chronic<br />

venous insufficiency and/or pulmonary hypertension<br />

may occur. To prevent VTE events and their consequences,<br />

patients should receive some kind of thromboprophylaxis.<br />

Atrial fibrillation<br />

Patients with atrial fibrillation (AF) are at higher risk of<br />

developing blood clots, which can cause a disabling<br />

stroke if the clots travel to the brain. AF is the most common<br />

type of arrhythmia. It is associated with a hypercoagulable<br />

state which predisposes to stroke and systemic<br />

embolism, which can be prevented by effective chronic<br />

anticoagulation.<br />

Proper control of treatable risk factors and disease are<br />

vital for the prevention of cardiovascular events.<br />

74<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

branded prescription medicines<br />

Indications Brand names Active ingredients<br />

• Acute myocardial infarction<br />

metalyse®<br />

tenecteplase<br />

Fibrinolytic treatment of acute myocardial<br />

infarction.<br />

• Ventricular tachycardia<br />

mexitil®<br />

mexiletine<br />

Serious symptomatic ventricular tachycardic<br />

heart rhythm disturbances.<br />

• Hypertension<br />

motens®<br />

caldine®<br />

tens®<br />

midotens®<br />

lacidipine<br />

Treatment of essential hypertension.<br />

• Primary prevention of venous<br />

thrombo-embolic events<br />

after orthopaedic surgery<br />

pradaxa®<br />

pradax®<br />

pradaxar®<br />

dabigatran<br />

etexilate<br />

Primary prevention of venous thromboembolic<br />

events (VTE) in adults after<br />

elective total hip or knee replacement<br />

surgery.<br />

• Stroke prevention in atrial<br />

fibrillation<br />

pradaxa®<br />

pradax®<br />

prazaxa®<br />

dabigatran<br />

etexilate<br />

Prevention of stroke and blood clots in<br />

patients with abnormal heart rhythm<br />

(atrial fibrillation).<br />

Cardiovascular diseases<br />

75


Metabolic diseases<br />

Type 2 diabetes is a chronic, progressive condition that<br />

can damage the human body severely.<br />

Every year, 3.8 million deaths worldwide are linked directly<br />

to long-term effects of diabetes. As the most common<br />

form of diabetes, type 2 diabetes accounts for up<br />

to 95 % of all diabetes cases in the developed world: it<br />

now affects 366 million people worldwide and is imposing<br />

an enormous burden on healthcare systems globally.<br />

Without effective prevention and management, it is estimated<br />

that the number of cases will reach 440 million<br />

by 2030.<br />

Long-term complications of diabetes include:<br />

Retinopathy with potential loss of vision, an increased incidence<br />

of stroke and cardiovascular disease, peripheral<br />

neuropathy with the risk of foot ulcers, foot and leg<br />

amputations, autonomic neuropathy causing gastrointestinal,<br />

genitourinary and cardiovascular symptoms and<br />

sexual dysfunction and nephropathy leading to renal failure<br />

with potential risk for dialysis.<br />

Infectious diseases<br />

HIV infection/acquired immune deficiency syndrome<br />

(AIDS)<br />

Acquired immune deficiency syndrome (AIDS) is a set of<br />

symptoms and infections resulting from the damage to<br />

the human immune system caused by the human immunodeficiency<br />

virus (HIV). If untreated, this condition<br />

progressively reduces the effectiveness of the immune<br />

system and leaves individuals susceptible to opportunistic<br />

infections and tumours. Babies of infected mothers<br />

are at risk of getting the virus during pregnancy, childbirth<br />

or breastfeeding.<br />

76<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

branded prescription medicines<br />

Indications Brand names Active ingredients<br />

• Type 2 diabetes mellitus<br />

trajenta®<br />

tradjenta®<br />

trazenta®<br />

trayenta®<br />

linagliptin<br />

Treatment of type 2 diabetes mellitus to<br />

improve glycaemic control in adults. It<br />

may be used as monotherapy or in combination<br />

therapy.<br />

• Type 2 diabetes mellitus<br />

jentadueto tm<br />

linagliptin, metformin hydrochloride<br />

Treatment of type 2 diabetes mellitus to<br />

improve glycaemic control in adults<br />

when treatment with both linagliptin<br />

and metformin is appropriate.<br />

Indications Brand names Active ingredients<br />

• HIV/AIDS<br />

viramune® xr<br />

viramune xr®<br />

viramune® prolonged<br />

release tablets<br />

nevirapine<br />

Available as tablets and suspension for<br />

adults and children – for the combination<br />

therapy of HIV-1 infection and (in<br />

several countries) for the prevention of<br />

mother-to-child transmission of HIV-1<br />

in pregnant women who are not taking<br />

antiretroviral therapy at time of labour.<br />

Prolonged release tablets for once-daily<br />

dosing within combination therapy.<br />

• HIV/AIDS<br />

aptivus®<br />

tipranavir<br />

Capsule and oral solution – co-administered<br />

with 200 mg of ritonavir, is indicated<br />

for combination antiretroviral<br />

treatment of HIV-1-infected patients<br />

with evidence of viral replication, who<br />

are treatment-experienced and infected<br />

with HIV-1 strains resistant to more than<br />

one protease inhibitor.<br />

Metabolic diseases / Infectious diseases<br />

77


Cough and cold<br />

mucosolvan® (ambroxol) and bisolvon® (bromhexine)<br />

are both indicated for secretolytic therapy in bronchopulmonary<br />

diseases associated with abnormal mucus<br />

secretion and impaired mucus transport.<br />

Cough is the most common symptom of clinical importance<br />

and a frequent reason for consulting a doctor or<br />

visiting a pharmacy. The clinical symptoms of cough<br />

and expectoration have led to the development of drugs<br />

that affect respiratory mucus, i. e. the mucoactive agents.<br />

mucosolvan® (ambroxol), which promotes mucus clearance,<br />

facilitates expectoration and eases productive<br />

cough, allowing patients to breathe freely and deeply, is<br />

the world’s leading cough brand. It is available in many<br />

different product forms and formulations.<br />

body’s natural defence mechanisms. Ambroxol also<br />

stimulates synthesis and release of surfactant by type II<br />

pneumocytes.<br />

bisolvon® (bromhexine), available for all age groups,<br />

has been on the market since 1963. Bromhexine is contained<br />

in various formulations of bisolvon®. There are<br />

high and low strength syrups 8 mg/5 ml, 4 mg/5ml,<br />

tablets and soluble tablets (both with 8 mg bromhexine)<br />

and solution for oral use (10 mg/5 ml), adapted to patients’<br />

needs. Bromhexine is a synthetic derivative of the<br />

herbal active ingredient vasicine. It has been shown to<br />

increase the proportion of serious bronchial secretion,<br />

making it more easily expectorated. Bromhexine also<br />

enhances mucus transport by reducing mucus viscosity<br />

and by activating the ciliated epithelium.<br />

Ambroxol is a mucoactive drug with several properties,<br />

including secretolytic and secretomotoric actions that<br />

restore the physiological clearance mechanisms of the<br />

respiratory tract, which play an important role in the<br />

Sore throat<br />

mucoangin® is the best documented product in its category<br />

of pain relief in acute sore throat.<br />

Pain in sore throat is the hallmark of acute pharyngitis,<br />

usually caused by a viral infection. The infection is as a<br />

rule self-limited and the patient normally recovers in a<br />

couple of days. What is most bothersome for the patient<br />

is the continuous pain in the throat, which is maximised<br />

when swallowing. The main goal of the treatment is<br />

thus to reduce pain.<br />

In addition to its secretolytic activity, ambroxol is a very<br />

potent inhibitor of the neuronal sodium channels.<br />

Therefore mucoangin® (ambroxol) has a strong local<br />

anaesthetic effect, described first in the late 1970s, but<br />

explained and confirmed in more recent work.<br />

78<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

consumer health care<br />

Indications Brand names Active ingredients<br />

• Acute and chronic bronchopulmonary<br />

diseases<br />

mucosolvan®<br />

mucosan®<br />

surbronc®<br />

lasolvan®<br />

mucopect®<br />

ambroxol<br />

Secretolytic therapy in acute and chronic<br />

bronchopulmonary diseases associated<br />

with abnormal mucus secretion and impaired<br />

mucus transport.<br />

• Acute and chronic bronchopulmonary<br />

diseases<br />

bisolvon®<br />

bromhexine<br />

Secretolytic therapy in acute and chronic<br />

bronchopulmonary diseases associated<br />

with abnormal mucus secretion and impaired<br />

mucus transport.<br />

• Irritable cough<br />

silomat® dmp<br />

bisoltussin®<br />

bisolvon® dry<br />

bisolsek®<br />

bisolvon® antitusivo<br />

dextrometorphan<br />

Symptomatic treatment of irritable, nonproductive<br />

cough.<br />

Indications Brand names Active ingredients<br />

• Sore throat<br />

mucoangin®<br />

lysopadol®<br />

lysopain® dol<br />

isodinemint®<br />

zerinol® gola<br />

ambroxol<br />

Pain relief in acute sore throat.<br />

Cough and cold / Sore throat<br />

79


Gastrointestinal diseases<br />

In our gastrointestinal portfolio, we offer several brands<br />

such as dulcolax®, surulac®, laxoberal®, guttalax®,<br />

buscopan® as well as the heartburn brands zantac®<br />

and buscopan® antiacido.<br />

Constipation is a common problem. dulcolax® is the<br />

leading over-the-counter (OTC) laxative remedy for<br />

constipation relief worldwide.<br />

Within the dulcolax® franchise, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

markets a range of products for the treatment, regulation<br />

and prevention of intestinal irregularity and disruption.<br />

The primary ailment within this area is constipation,<br />

for which dulcolax® tablets are today the main<br />

method of treatment.<br />

dulcolax® tablets have a special enteric “comfort<br />

coating” which ensures that the active ingredient in<br />

dulcolax® tablets, bisacodyl, is taken to where it needs<br />

to act – the colon. Here, in the colon, the colonic juices<br />

activate the key ingredient, which then relieves constipation.<br />

It stimulates the natural movement of the bowels<br />

to provide gentle, predictable relief within 6 –12 hours.<br />

One to two tablets taken before going to bed will still<br />

provide relief the next morning.<br />

dulcolax® is specifically formulated to provide effective,<br />

predictable relief for constipation. dulcolax® offers<br />

a reliable range of products.<br />

Abdominal cramping, pain and discomfort are common<br />

ailments. Approximately one in four persons worldwide<br />

suffers on a regular basis.<br />

buscopan® is an antispasmodic product with the active<br />

ingredient hyoscine butylbromide. The product is<br />

basically a natural substance extracted from Duboisia<br />

plant species as scopolamine (hyoscine) and chemically<br />

modified to the quaternary ammonium compound<br />

hyoscine butylbromide. As an antispasmodic product,<br />

buscopan® acts directly on the site of abdominal pain by<br />

relaxing the muscles of the gastrointestinal tract.<br />

This means buscopan® relieves abdominal pain by directly<br />

treating its main cause – abdominal cramp or<br />

spasm.<br />

Several buscopan® line extensions are available today<br />

– the mono-variant and different combinations with analgesics<br />

(paracetamol, ibuprofen and metamizol/dipyrone)<br />

– and different formulations (tablets, drops, suppositories,<br />

syrup and solutions for intravenous<br />

injection).<br />

The umbrella brand buscopan® now also offers buscopan®<br />

antiacido for heartburn relief. The buscopan®<br />

antiacido effervescent tablets is giving quickly powerful<br />

soothing relief for even tough heartburn that lasts<br />

for a full 12 hours.<br />

Other products within the dulcolax® range include<br />

dulcoease® (stool softener), dulcoenema®,<br />

dulcobalance® and the new launch dulcogas®.<br />

surulac® is the constipation brand in Japan. It offers<br />

consumers surulac® as a laxative tablet. laxoberal®<br />

and guttalax® are the brands offering consumers constipation<br />

relief with a unique and flexible dosage format –<br />

namely drops.<br />

80<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

consumer health care<br />

Indications Brand names Active ingredients<br />

• Constipation<br />

dulcolax®<br />

surulac® s<br />

bisacodyl, sennoside<br />

Laxative for use in patients suffering<br />

from constipation. In preparation for<br />

diagnostic procedures, in pre- and postoperative<br />

treatment, and in conditions<br />

which require defecation to be facilitated.<br />

• Constipation<br />

laxoberal®<br />

laxoberon®<br />

guttalax®<br />

dulcolax® np<br />

sodium picosulphate<br />

Laxative for use in cases of constipation<br />

and in conditions which require defecation<br />

to be facilitated.<br />

• Constipation<br />

dulcolax® balance<br />

dulcolax® m balance<br />

dulcobalance®<br />

macrogol<br />

Symptomatic treatment of constipation<br />

for adults and children from eight years<br />

onwards.<br />

• Gas & bloating<br />

dulcogas®<br />

simethicone<br />

Fast-acting granules that relieve gas,<br />

bloating and prevent flatulence.<br />

• Abdominal cramping<br />

buscopan®<br />

buscapina®<br />

hyoscine butylbromide<br />

Treatment for the relief of abdominal<br />

cramping, pain and discomfort.<br />

• Heartburn<br />

zantac® (*)<br />

buscopan® antiacido<br />

ranitidine<br />

Relieves heartburn associated with acid<br />

indigestion and sour stomach. Prevents<br />

heartburn associated with acid indigestion<br />

and sour stomach brought on by<br />

certain foods and beverages.<br />

* only available in the USA<br />

Gastrointestinal diseases<br />

81


Vitamins and supplements<br />

pharmaton® capsules/tablets is a multivitamin and mineral<br />

supplements brand developed to support physical<br />

and mental well-being. A full range of products adapted<br />

to the needs of different target audiences has been developed<br />

that work in harmony with the body.<br />

pharmaton® vitality, a range of products for adults,<br />

contains a selected blend of vitamins, minerals and trace<br />

elements and standardised Ginseng extract G115®. The<br />

main target indications are: exhaustion, tiredness, decreasing<br />

concentration and mental alertness, as well as in<br />

cases of deficient nutrition, loss of appetite, debility due<br />

to illness and convalescence. Numerous clinical studies<br />

have shown that a regular intake of pharmaton® has a<br />

positive effect on mental and physical performance and<br />

well-being.<br />

pharmaton® matruelle® is indicated for active planning,<br />

pregnant and lactating women, containing all important<br />

micronutrients for mother and baby, such as vitamins,<br />

minerals and omega-3 fatty acids, to cover the increased<br />

needs for these substances in those particular periods.<br />

Moreover, it helps to protect against embryonal neural<br />

tube diseases of the foetus and against iron and folic acid<br />

anaemia during pregnancy.<br />

pharmaton® cardioactive, a product designed for<br />

adults over 40 years, contains a blend of vitamins and<br />

minerals combined with omega-3 fatty acids to help<br />

maintain cardiovascular health.<br />

pharmaton® kiddi®, a range of products designed for<br />

children, contains selected vitamins, minerals and the essential<br />

amino acid lysine that are important during the<br />

period of growth. It is also recommended in the preventive<br />

treatment of vitamin deficiencies.<br />

Urological diseases<br />

Benign prostate hyperplasia (BPH) refers to an enlargement<br />

of the prostate in middle-aged and elderly men,<br />

which can lead to lower urinary tract symptoms (LUTS)<br />

such as frequent nighttime urination, urge to urinate<br />

every few hours, weak flow and feeling of unfinished<br />

urinating.<br />

82<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

consumer health care<br />

Indications Brand names Active ingredients<br />

• Tiredness, decreasing concentration,<br />

in cases of deficient<br />

nutrition, loss of appetite,<br />

debility due to illness<br />

and convalescence<br />

pharmaton® vitality<br />

standardised ginseng<br />

extract, vitamins,<br />

minerals, trace<br />

elements<br />

To improve general well-being.<br />

• Increased demand for vitamins<br />

in childhood<br />

pharmaton® kiddi®<br />

vitamins,<br />

minerals,<br />

amino acids<br />

Increasing demand for vitamins, minerals<br />

and amino acids, especially during<br />

the period of growth. Preventive treatment<br />

in cases of vitamin deficiencies,<br />

e. g. restricted diets, convalescence, loss<br />

of appetite, following illness, infection<br />

or surgery.<br />

• Prophylaxis of iron and folic<br />

acid deficiency during<br />

pregnancy<br />

pharmaton®<br />

matruelle®<br />

vitamins, minerals,<br />

trace elements,<br />

omega-3 fatty acids<br />

[docosahexaenoic<br />

acid (DHA)]<br />

For women of child-bearing age intending<br />

to become pregnant, already pregnant<br />

and lactating, to cover the increased<br />

needs for vitamins, minerals,<br />

trace elements and DHA. To provide protection<br />

against embryonal neural tube<br />

diseases of the foetus, and prophylaxis<br />

of iron and folic acid anaemia during<br />

pregnancy.<br />

• Maintenance of cardiovascular<br />

health<br />

pharmaton®<br />

cardioactive<br />

pharmaton®<br />

coractive<br />

vitamins, minerals, trace elements<br />

and fish oil (omega-3 fatty acids rich<br />

in EPA and DHA)<br />

Helps to maintain cardiovascular health.<br />

Covers the daily needs for vitamins,<br />

minerals, trace elements and fish oil<br />

(omega-3 fatty acids rich in EPA and<br />

DHA), by acting complementary to daily<br />

nutrition.<br />

Indications Brand names Active ingredients<br />

• Benign prostate hyperplasia<br />

(BPH)<br />

flomax relief® (*)<br />

tamsulosin<br />

Treatment of lower urinary tract symptoms<br />

(LUTS) of a common condition<br />

called benign prostate hyperplasia<br />

(BPH).<br />

* only available in UK<br />

Vitamins and supplements/ Urological diseases<br />

83


Leg vein health<br />

Under the brand name antistax®, <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

markets a range of products developed for the prevention<br />

and treatment of symptoms attributable to<br />

known venous insufficiency. The most common symptoms<br />

of venous insufficiency observable for consumers<br />

are varicose veins, oedema of the lower leg, heavy or<br />

tired legs, sensation of tension, tingling and pain.<br />

antistax® capsules and tablets are scientifically proven<br />

to help maintain healthy leg vein circulation.<br />

Heavy, aching and tired legs often occur after long periods<br />

of standing or sitting, and increase at the end of the<br />

day or during the summer when outdoor temperatures<br />

rise. antistax® tablets and antistax® capsules offer effective<br />

treatment of the described symptoms. antistax®<br />

helps to keep the fluid that flows out of the capillaries<br />

into the surrounding tissue at normal levels, even when<br />

standing or sitting for a long time.<br />

Red vine leaf extract, the active ingredient in antistax®<br />

products, works on the endothelium inside the veins by<br />

sealing them from the inside, thereby reducing the<br />

swelling and the sensation of pain and heaviness.<br />

Products available in the antistax® range include<br />

antistax® tablets, antistax® capsules and antistax®<br />

creme.<br />

Two cosmetic products, antistax® leg chilling gel<br />

and antistax® leg cooling spray, complete the range.<br />

Pain<br />

The brand thomapyrin® comprises products for the<br />

treatment of acute pain of mild to intermediate intensity.<br />

thomapyrin® classic is the core product, which is<br />

composed of a triple combination of acetylsalicylic acid,<br />

paracetamol and caffeine. The three components suppress<br />

pain synergistically via interaction with several pain-related<br />

molecular mechanisms. As a result thomapyrin®<br />

classic disposes of a fast and superior efficacy compared<br />

with its single components which is, amongst<br />

others, well proven by state-of-the-art clinical studies.<br />

For this reason, the triple combination is recommended<br />

by many national and international medical societies as<br />

first choice acute treatment for tension-type headaches<br />

and migraines. thomapyrin® is positioned as the expert<br />

treatment for headaches. Several line extensions are<br />

available: thomapyrin® classic for normal headache,<br />

thomapyrin® intensiv for stronger headaches,<br />

thomapyrin® medium for milder headache, and<br />

thomapyrin® effervescent as a galenic alternative.<br />

Next to thomapyrin®, <strong>Boehringer</strong> <strong>Ingelheim</strong> offers<br />

analgesics as well in a combination of ibuprofen, allylisopropylacetylurea,<br />

dehydrated caffeine and magnesium<br />

oxide in Japan and South Korea under the tradename<br />

eve® and as a mono active ingredient with<br />

metamizol in Brazil under the tradename anador®.<br />

84<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

consumer health care<br />

Indications Brand names Active ingredients<br />

• Chronic venous insufficiency<br />

antistax®<br />

red vine leaf extract<br />

Prevention and treatment of symptoms<br />

of chronic venous insufficiency; varicose<br />

veins, leg oedema, painful swollen legs,<br />

tingling legs, tired and heavy legs.<br />

• Heavy, tired legs<br />

antistax®<br />

leg chilling gel<br />

antistax®<br />

leg cooling spray<br />

cooling,<br />

caring<br />

substances,<br />

red vine leaf<br />

extract<br />

Symptomatic treatment of heavy, tired<br />

legs.<br />

Indications Brand names Active ingredients<br />

• Pain<br />

thomapyrin® classic<br />

thomapyrin® intensiv (*)<br />

acetylsalicylic acid,<br />

paracetamol, caffeine<br />

For adults and adolescents older than<br />

twelve years for acute treatment of mild<br />

to moderate headache, migraine attacks,<br />

with and without aura, and for the treatment<br />

of tension-type headache.<br />

* only available in Germany.<br />

• Pain<br />

eve® a (*)<br />

eve® quick (*)<br />

ibuprofen;<br />

allylisopropylacetylurea, dehydrated<br />

caffeine, magnesium oxide *<br />

For adults (15 years and older) for the<br />

reduction of fever and the temporary<br />

relief of mild to moderate aches and<br />

pains associated with: headache, menstrual<br />

pain and other body pains.<br />

* only available in Japan and<br />

South Korea.<br />

* only in eve® quick<br />

• Pain<br />

anador® (*)<br />

metamizol<br />

For adults and adolescents older than 12<br />

years for acute treatment of mild to moderate<br />

headache.<br />

* only available in Brazil.<br />

Leg vein health / Pain<br />

85


Food producing animals – swine<br />

Infectious respiratory diseases<br />

ingelvac circoflex® is the first one-dose piglet vaccine<br />

for the control of porcine circovirus disease (PCVD).<br />

This vaccine provides significant reduction of mortality<br />

in the acute phase of PCVD as well as improved growth<br />

rates in the chronic phase of the disease. ingelvac<br />

circoflex® protects with minimal systemic adverse reactions<br />

or injection site swellings. The mixing of ingelvac<br />

circoflex® with ingelvac mycoflex® was approved by<br />

the European Commission. ingelvac®prrs mlv is licensed<br />

for the active immunisation against the respiratory<br />

and reproductive form of porcine reproductive and<br />

respiratory syndrome (PRRS).<br />

Infectious enteric diseases<br />

enterisol®ileitis is the first and only vaccine against<br />

ileitis caused by Lawsonia intracellularis. It is licensed<br />

to improve weight gain and to reduce growth variability<br />

associated with the disease. enterisol®ileitis helps to<br />

reduce the total antimicrobial use in pork production.<br />

ingelvac mycoflex® is licensed for the active immunisation<br />

of pigs against enzootic pneumonia (EP) in a onedose<br />

regimen. Through its advanced adjuvant system,<br />

it provides long-lasting and effective protection until<br />

slaughter, proven even in high-challenge situations.<br />

86<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

animal health<br />

Indications Brand names Active ingredients<br />

• Infectious respiratory<br />

diseases<br />

ingelvac circoflex®<br />

recombinant vaccine<br />

(porcine circovirus<br />

type 2, PCV 2)<br />

For the active immunisation of pigs over<br />

the age of two weeks against porcine<br />

circovirus type 2 to reduce mortality,<br />

clinical signs – including weight loss –<br />

and lesions in lymphoid tissues associated<br />

with porcine circovirus diseases<br />

(PCVD).<br />

In addition, vaccination has been shown<br />

to reduce PCV 2 nasal shedding, viral<br />

load in blood and lymphoid tissues, and<br />

duration of viraemia.<br />

• Infectious respiratory<br />

diseases<br />

ingelvac® prrs mlv<br />

attenuated live vaccine<br />

(PRRS virus)<br />

For the active immunisation of swine<br />

from three weeks of age against the respiratory<br />

and reproductive form of PRRS<br />

virus infection (porcine reproductive and<br />

respiratory syndrome).<br />

• Infectious respiratory<br />

diseases<br />

ingelvac mycoflex®<br />

inactivated vaccine<br />

(Mycoplasma<br />

hyopneumoniae)<br />

For active immunisation of pigs from<br />

three weeks of age to reduce lung<br />

lesions following infections with Mycoplasma<br />

hyopneumoniae.<br />

• Infectious enteric diseases<br />

enterisol® ileitis<br />

attenuated live<br />

vaccine (Lawsonia<br />

intracellularis)<br />

For active immunisation of pigs from<br />

three weeks of age and older to reduce<br />

intestinal lesions caused by Lawsonia<br />

intracellularis infection and to reduce<br />

growth variability and loss of weight gain<br />

associated with the disease.<br />

Food producing animals – swine<br />

87


Food producing animals – cattle<br />

Mastitis<br />

mamyzin® Injection contains penethamate hydroiodide,<br />

a prodrug of penicillin G which offers a unique pharmacokinetic<br />

profile.<br />

Achieving very high absorption and accumulation rates<br />

of its active principle in the udder, mamyzin® is an excellent<br />

first line treatment of (penase negative)<br />

Staphylo coccus aureus and Streptococcus spp. Highly<br />

suitable for combination therapy, mamyzin® is additionally<br />

an ideal tool in whole herd sanitation programmes<br />

where it is used to control subclinical mastitis during<br />

lactation, as initial dry-off treatment in problem herds,<br />

and for metaphylaxis in heifers.<br />

Pain and inflammatory diseases<br />

metacam® as a member of the class of non-steroidal<br />

anti-inflammatory drugs (NSAIDs) combines the need<br />

for maintained profitability and the concern for animal<br />

welfare in animal production.<br />

Due to its long-acting feature and its outstanding efficacy<br />

in controlling inflammatory symptoms, it helps to<br />

minimise losses from inflammation and maintaining<br />

profitability in animals suffering from disease. At the<br />

same time metacam® effectively controls pain and supports<br />

the restoration of well-being in farm animals. The<br />

use of metacam® is convenient and inflicts no stress on<br />

animals due to its low-volume, one-shot feature.<br />

benestermycin® is a broad spectrum and long-acting<br />

antibiotic preparation designed to effectively treat existing<br />

infections at dry-off and to prevent new infections<br />

during the dry period in dairy cattle.<br />

metacam® is licensed for use in cattle suffering from<br />

respiratory disease. Also, it is indicated in calves affected<br />

by diarrhoea and as adjunctive therapy in the treatment<br />

of mastitis in lactating cattle.<br />

ubrolexin® delivers enhanced bactericidal activity<br />

through a specifically designed combination of two<br />

complementary targeted antibiotics working in synergy.<br />

ubrolexin® marks a new quality of broad spectrum<br />

mastitis treatment because it achieves uncompromised<br />

efficacy on both ends of the pathogen spectrum. This<br />

makes ubrolexin® a simple-to-use, “no compromise”<br />

product for the routine treatment of clinical mastitis.<br />

88<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

animal health<br />

Indications Brand names Active ingredients<br />

• Mastitis<br />

mamyzin®<br />

penethamate hydroiodide<br />

For the treatment of mastitis in dairy<br />

cows caused by Gram-positive pathogens.<br />

• Mastitis<br />

benestermycin®<br />

penethamate hydroiodide<br />

benethamine penicillin<br />

framycetin sulphate<br />

Treatment of subclinical infections<br />

present at drying off and assistance in<br />

preventing new infections as well as<br />

acute clinical mastitis during the dry<br />

period.<br />

• Mastitis<br />

ubrolexin®<br />

cefalexin (as monohydrate),<br />

kanamycin (as monosulphate)<br />

Treatment of clinical mastitis in lactating<br />

dairy cows for bacteria susceptible to<br />

the combination of cefalexin and kanamycin<br />

such as Staphylococcus aureus,<br />

Streptococcus dysgalactiae, Streptococcus<br />

uberis and Escherichia coli.<br />

• Pain and inflammatory diseases<br />

metacam®<br />

meloxicam<br />

Alleviation of inflammation and pain in<br />

muscolo-skeletal disorders (dog, cat,<br />

pigs, horse) after surgery (dog, cat, pigs)<br />

and during colic (horse).<br />

As adjunctive treatment of diarrhoea,<br />

respiratory disease and acute mastitis<br />

(cattle) as well as mastitis-metritis-agalactia<br />

syndrome (pigs).<br />

• Cattle infectious diseases<br />

pyramid®<br />

presponse®<br />

attenuated vaccine against bovine<br />

rhinotracheitis-virus, diarrhea,<br />

parainfluenza 3, respiratory syncytial<br />

virus, Mannheimia haemolytica toxoid<br />

For vaccination of healthy dairy or beef<br />

cattle as an aid in prevention of diseases<br />

caused by included antigens (US and<br />

Canada only).<br />

Food producing animals – cattle<br />

89


Companion animals – small animals<br />

The main small animal products of <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Animal Health address major chronic diseases:<br />

heart failure and osteoarthritis.<br />

prozinc® is an aqueous protamine zinc (PZI) suspension<br />

of recombinant human insulin that is used to reduce<br />

hyperglycaemia in cats with diabetes mellitus.<br />

As the first of a new class of heart treatments termed inodilators,<br />

vetmedin® has been shown to significantly<br />

improve clinical signs and extend life expectancy in<br />

dogs with congestive heart failure originating from dilated<br />

cardiomyopathy or valvular insufficiency (mitral<br />

and/or tricuspid regurgitation). vetmedin® works<br />

through two complementary modes of action; it opens<br />

up the blood vessels taking blood to and away from the<br />

heart, thereby lowering the pressure on the heart and<br />

reducing the work the heart has to do to pump blood<br />

around the dog’s body. At the same time, vetmedin® has<br />

a direct effect on the heart muscle, helping it to beat<br />

stronger and pump blood more efficiently.<br />

The duramune® and fel-o-vax® brands are vaccines<br />

designed to aid in the prevention of a wide spectrum of<br />

infectious diseases in dogs and cats. These common diseases<br />

can be very serious and in some cases even fatal.<br />

Effective prevention including appropriate vaccination<br />

reduces the impact of these diseases on dogs and cats.<br />

metacam® is a non-steroidal anti-inflammatory drug<br />

(NSAID). It is available as oral suspension, tablets and<br />

injectable solution for dogs and as oral suspension and<br />

injectable solution for cats. In dogs, the indications include<br />

the alleviation of inflammation and pain in both<br />

acute and chronic musculo-skeletal disorders as well as<br />

the reduction of post-operative pain following surgery.<br />

In cats, the indications include the alleviation of inflammation<br />

and pain in acute and chronic musculo-skeletal<br />

disorders as well as for alleviation of mild to moderate<br />

post-operative pain following surgical procedures. The<br />

variety of formulations offers veterinarians and owners<br />

the flexibility to use the formulations they prefer to<br />

manage the various levels of inflammation and pain associated<br />

with the licensed indications.<br />

90<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

animal health<br />

Indications Brand names Active ingredients<br />

• Congestive heart failure<br />

vetmedin®<br />

pimobendan<br />

Treatment of canine congestive heart<br />

failure originated from dilatative cardiomyophathy<br />

or valvular insufficiency (mitral<br />

and/or tricuspid regurgitation).<br />

• Pain and inflammatory diseases<br />

metacam®<br />

meloxicam<br />

In dogs, the indications include the alleviation<br />

of inflammation and pain in both<br />

acute and chronic musculo-skeletal disorders<br />

as well as the reduction of postoperative<br />

pain following surgery.<br />

In cats, the indications include the alleviation<br />

of inflammation and pain in<br />

acute and chronic musculo-skeletal disorders<br />

as well as the alleviation of mild<br />

to moderate post-operative pain following<br />

surgical procedures.<br />

• Feline diabetes mellitus<br />

prozinc® (*)<br />

protamine zinc<br />

recombinant<br />

human insulin<br />

For the reduction of hyperglycaemia and<br />

hyperglycaemia associated clinical signs<br />

in cats with diabetes mellitus.<br />

* currently only available in<br />

USA.<br />

• Canine infectious diseases<br />

duramune®<br />

inactivated and attenuated vaccine<br />

against canine distemper, canine<br />

adenovirus type 2, coronavirus,<br />

parainfluenza-, parvovirus, borrelia<br />

Burgdorferi, leptospira canicola,<br />

-grippotyphosa, -icterohaemorrhagiae,<br />

-pomona<br />

For vaccination of healthy dogs as an aid<br />

in the prevention of diseases caused by<br />

included antigens (US, Canada and Australia<br />

only).<br />

• Feline infectious diseases<br />

fel-o-vax®<br />

inactivated vaccine against feline<br />

leukemia, rhinotracheitis, calici,<br />

panleukopenia, chlamydia psittaci<br />

For vaccination of healthy cats as an aid<br />

in the prevention of diseases caused by<br />

included antigens (US, Canada and Australia<br />

only).<br />

Companion animals – small animals<br />

91


Companion animals – horse<br />

The main horse products of <strong>Boehringer</strong> <strong>Ingelheim</strong><br />

Animal Health focus on the therapeutic areas respiratory<br />

disease, lameness and colic and newly hormonal disorders.<br />

ventipulmin® is a treatment of acute and chronic respiratory<br />

disease where airway obstruction due to bronchospasm<br />

and/or mucus accumulation is a contributing<br />

factor and improved mucociliary clearance is desirable.<br />

ventipulmin® can be used alone or as adjunctive therapy<br />

in chronic obstructive pulmonary disease (COPD)<br />

and in acute, sub-acute and chronic respiratory allergic<br />

conditions.<br />

prascend® is indicated for the treatment of pituitary<br />

pars intermedia dysfunction (PPID) also known as<br />

Equine Cushing’s disease. prascend® substitutes the<br />

lack of dopamine in the pituitary pars intermedia. Clinical<br />

signs are hypertrichiosis, laminitis, change in body<br />

confirmation, lack of performance. Treatment with<br />

prascend® is life-long.<br />

92<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> annual report <strong>2011</strong>


product portfolio<br />

animal health<br />

Indications Brand names Active ingredients<br />

• Acute and chronic obstructive<br />

respiratory diseases<br />

ventipulmin®<br />

clenbuterol<br />

Respiratory diseases attended by bronchial<br />

spasms, like subacute and chronic<br />

bronchiolitis, chronic-obstructive pulmonary<br />

disease (COPD), auxillary with acute<br />

bronchitis and pneumonia of bronchia.<br />

• Pituitary pars intermedia<br />

dysfunction (PPID)<br />

prascend®<br />

pergolide mesylate<br />

For the treatment of clinical signs associated<br />

with pituitary pars intermedia<br />

dysfunction (PPID) (Equine Cushing’s<br />

disease).<br />

Companion animals – horse<br />

93


C. H. <strong>Boehringer</strong> Sohn AG & Co. KG, <strong>Ingelheim</strong><br />

Comparison of Balance sheets 2002 – <strong>2011</strong><br />

(in millions of EUR)<br />

Assets (as of December 31) 2002 2003 2004<br />

Intangible assets 302 242 267<br />

Tangible assets 2,840 2,767 2,712<br />

Financial assets 1,689 2,462 2,756<br />

Fixed assets 4,831 5,471 5,735<br />

Inventories 971 1,000 1,085<br />

Accounts receivable (incl. deferred charges and deferred taxes) 2,360 2,537 2,477<br />

Liquid funds 1,055 1,134 1,333<br />

Current assets (incl. deffered charges and deferred taxes) 4,386 4,671 4,895<br />

Total assets 9,217 10,142 10,630<br />

Liabilities and equity (as of December 31) 2002 2003 2004<br />

Shareholders’ capital 178 178 178<br />

Reserves (incl. currency conversion difference) 2,818 3,139 3,297<br />

Net income 537 529 888<br />

Total equity 3,533 3,846 4,363<br />

Minority interests 203 188 193<br />

Group equity 3,736 4,034 4,556<br />

Negative difference from acquisition of companies 0 0 0<br />

Provisions (incl. deferred taxes) 3,568 3,963 4,172<br />

Liabilities (incl. deferred charges) 1,913 2,145 1,902<br />

Total liabilities (incl. deferred taxes and deferred charges) 5,481 6,108 6,074<br />

Total liabilities and equity 9,217 10,142 10,630<br />

Summary of selected financial data 2002 2003 2004<br />

Net sales 7,580 7,382 8,157<br />

Operating income 1,082 901 1,372<br />

Operating income as % of net sales 14.3 12.2 16.8<br />

Income after taxes 551 537 908<br />

Income after taxes as % of net sales 7.3 7.3 11.1<br />

Return on shareholders’ equity (in %) 16.0 15.0 23.1<br />

Equity ratio (in %) 38.3 37.9 41.0<br />

Cash flow 1,049 1,059 1,430<br />

Financial funds 2,645 3,516 4,015<br />

Personnel costs 2,175 2,252 2,443<br />

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

Average number of employees 31,843 34,221 35,529<br />

Research and development costs 1,304 1,176 1,232<br />

R & D as % of net sales 17.2 15.9 15.1<br />

Investments in tangible assets 634 516 427<br />

Depreciation of tangible assets 340 354 377<br />

Comparison of Balance sheets<br />

2002 — <strong>2011</strong>


usiness year <strong>2011</strong><br />

financial data<br />

2005 2006 2007 2008 2009 2010 <strong>2011</strong><br />

233 554 547 539 745 736 710<br />

2,900 2,886 2,972 3,177 3,219 3,314 3,442<br />

3,396 3,043 1,638 1,739 1,699 3,168 3,953<br />

6,529 6,483 5,157 5,455 5,663 7,218 8,105<br />

1,229 1,280 1,387 1,561 1,801 1,850 1,998<br />

3,013 3,137 2,912 3,496 3,663 4,047 4,652<br />

1,247 945 1,015 1,312 3,877 3,118 3,903<br />

5,489 5,362 5,314 6,369 9,341 9,015 10,553<br />

12,018 11,845 10,471 11,824 15,004 16,233 18,658<br />

2005 2006 2007 2008 2009 2010 <strong>2011</strong><br />

178 178 178 178 178 178 178<br />

2,940 3,275 1,385 3,101 3,964 5,408 5,812<br />

1,491 1,722 1,809 1,424 1,759 888 1,476<br />

4,609 5,175 3,372 4,703 5,901 6,474 7,466<br />

216 188 167 190 179 0 0<br />

4,825 5,363 3,539 4,893 6,080 6,474 7,466<br />

0 0 0 0 0 0 157<br />

4,958 4,641 4,726 5,120 5,731 6,598 7,402<br />

2,235 1,841 2,206 1,811 3,193 3,161 3,633<br />

7,193 6,482 6,932 6,931 8,924 9,759 11,035<br />

12,018 11,845 10,471 11,824 15,004 16,233 18,658<br />

2005 2006 2007 2008 2009 2010 <strong>2011</strong><br />

9,535 10,574 10,952 11,595 12,721 12,586 13,171<br />

1,923 2,140 2,100 1,980 2,239 1,896 2,272<br />

20.2 20.2 19.2 17.1 17.6 15.1 17.3<br />

1,514 1,729 1,812 1,428 1,764 888 1,476<br />

15.9 16.4 16.5 12.3 13.9 7.1 11.2<br />

34.2 37.4 35.0 42.2 37.4 15.0 22.8<br />

38.4 43.7 32.2 39.8 39.3 39.9 40.0<br />

2,069 2,317 2,392 1,997 2,409 2,234 2,378<br />

4,585 3,934 2,581 2,932 5,384 6,113 7,711<br />

2,671 2,836 2,886 3,004 3,221 3,358 3,664<br />

28.0 26.8 26.4 25.9 25.3 26.7 27.8<br />

37,406 38,428 39,800 41,300 41,534 42,224 44,094<br />

1,360 1,574 1,900 2,109 2,215 2,453 2,516<br />

14.3 14.9 17.3 18.2 17.4 19.5 19.1<br />

532 596 654 665 630 519 458<br />

439 419 432 453 470 498 535


IF YOU HAVE ANY QUERIES OR COMMENTS,<br />

PLEASE CONTACT US.<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH<br />

Binger Strasse 173<br />

55216 <strong>Ingelheim</strong><br />

Germany<br />

Telephone + 49 6132 77-0<br />

Fax + 49 6132 72-3000<br />

Contact<br />

Corporate Division Communications<br />

Dr Bernd Mann<br />

Telephone + 49 6132 77-92300<br />

Fax + 49 6132 72-92300<br />

E-mail webmaster@boehringer-ingelheim.com<br />

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Copyright<br />

©<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH, 2012<br />

All rights reserved. No part of this <strong>Annual</strong> <strong>Report</strong> <strong>2011</strong> may be reproduced or transmitted<br />

in any form or by any means, electronic or photocopy, without permission in writing from<br />

<strong>Boehringer</strong> <strong>Ingelheim</strong> GmbH. Figures from third parties used in the annual report are based<br />

on data available at the time the financial statement was drawn up.


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