Annual Report 2011 - Boehringer Ingelheim
Annual Report 2011 - Boehringer Ingelheim
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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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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 />
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<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 />
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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 />
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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 />
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<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 />
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<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
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Fax + 49 6132 72-3000<br />
Contact<br />
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