Financ - Boehringer Ingelheim

Transcription

Financial Highlights
Boehringer Ingelheim group of companies
2005
2004
Change
9,535
8,157
17 %
Europe
33 %
32 %
Americas
48 %
48 %
Asia, Australasia, Africa
19 %
20 %
96 %
96 %
4 %
4 %
Research and development
1,360
1,232
10 %
Personnel costs
2,671
2,443
9 %
37,406
35,529
5 %
1,923
1,372
40 %
20.2 %
16.8 %
Amounts in millions of EUR, unless otherwise indicated
Net sales
by region
by business area
Human Pharmaceuticals
Boehringer Ingelheim
Animal Health
Operating income
Operating income as % of sales
Annual Report 2005
Income after taxes
1,514
908
15.9 %
11.1 %
4,609
4,363
34.2 %
23.1 %
2,069
1,430
45 %
Investments in tangible assets
532
427
25 %
Depreciation of tangible assets
439
377
16 %
Income after taxes as % of sales
Annual Report 2005
www.boehringer-ingelheim.com
Average number of employees*
Shareholders’ equity
Return on shareholders’ equity
Cash flow
*including the total number of employees in joint ventures included in the consolidation
Value through Innovation
nopq
67 %
6 %
2005
2004
Change
9,535
8,157
17 %
Europe
33 %
32 %
Americas
48 %
48 %
19 %
20 %
96 %
96 %
4 %
4 %
1,360
1,232
10 %
Personnel costs
2,671
2,443
9 %
37,406
35,529
5 %
1,923
1,372
40 %
20.2 %
16.8 %
Net sales
by region
by business area
Animal Health
Operating income
Annual Report 2005
Income after taxes
1,514
908
15.9 %
11.1 %
4,609
4,363
34.2 %
23.1 %
2,069
1,430
45 %
532
427
25 %
439
377
16 %
Annual Report 2005
Cash flow
nopq
67 %
6 %
Contents
8
22
40
56
62
70
Comparison of Balance Sheets/
Financial Data 1996—2005 (in millions of EUR)
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
89
508
452
400
344
322
302
242
267
233
Tangible assets
1,342
1,612
1,739
1,992
2,217
2,467
2,840
2,767
2,712
2,900
Financial assets
1,007
757
731
849
1,135
1,008
1,689
2,462
2,756
3,396
Fixed assets
2,438
2,877
2,922
3,241
3,696
3,797
4,831
5,471
5,735
6,529
Assets (as of 31.12.)
Intangible assets
Inventories
Accounts receivable (incl. deferred charges)
Cash and cash equivalents (incl. securities)
2 The Shareholders’ Perspective
627
794
806
944
1,021
1,014
971
1,000
1,085
1,229
1,057
1,211
1,255
1,870
1,938
2,314
2,360
2,537
2,477
3,013
156
134
299
459
477
1,002
1,055
1,134
1,333
1,247
Current assets
1,840
2,139
2,360
3,273
3,436
4,330
4,386
4,671
4,895
5,489
Total assets
4,278
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
383
399
441
332
211
200
178
178
178
178
Our Company
4 Key Aspects of 2005
8 Our Caring Culture
Boehringer Ingelheim is a research-driven group of companies
10 Our Commitment
dedicated to researching, developing, manufacturing and marketing
12 For Our Neighbours
pharmaceuticals that improve health and quality of life.
14 For Our People
18 For Our Environment
Our business consists largely of Prescription Medicines, Consumer Health
22 Our R&D Drive
Care, Biopharmaceuticals and Animal Health. We focus on the production 26 “HIV is Being Played Down”
of innovative drugs and treatments that represent major therapeutic
28 Our Strength in R&D + Medicine
advances.
Business Development
Excellence in innovation and technology guides our actions in all areas.
Prescription Medicines
Our products have long been highly successful in the treatment 40 A New Quality of Treatment, a New Quality of Life
of respiratory, cardiovascular, central nervous system, urological and 44 Overview Prescription Medicines
virological disorders. In addition we have intensified our research into Consumer Health Care
Liabilities and equity (as of 31.12.)
Shareholders’ capital
Reserves (incl. currency conversion difference)
1,307 1,461 1,651 1,982 2,362 2,753 2,818 3,139
3,297
2,940
Net income
167
212
229
320
379
401
537
529
888
1,491
Total equity
1,857
2,072
2,321
2,634
2,952
3,354
3,533
3,846
4,363
4,609
0
0
0
0
0
1
203
188
193
216
Group equity
1,857
2,072
2,321
2,634
2,952
3,355
3,736
4,034
4,556
4,825
Provisions (incl. deferred taxes)
1,841 1,982 2,012 2,631 2,932 3,150 3,568 3,963 4,172
4,958
Minority interests
580 962 949 1,249 1,248 1,622 1,913 2,145
1,902
2,235
Total liabilities
Liabilities (incl. deferred charges)
2,421
2,944
2,961
3,880
4,180
4,772
5,481
6,108
6,074
7,193
Total liabilities and equity
4,278
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
the immune system, metabolic diseases and cancer.
56 Let’s Talk About it
Boehringer Ingelheim, which currently has almost 37,500 employees, Summary of selected financial data
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
has 143 affiliated companies spread around the globe. We have research
Sales
3,623
4,201
4,474
5,086
6,188
6,694
7,580
7,382
8,157
9,535
62 Time is Critical
facilities in nine countries and production plants in more than 20. Operating income
333
350
336
655
800
980
1,082
901
1,372
1,923
66 Overview Biopharmaceuticals and Chemicals
Our pharmaceuticals research and development spending corresponds Operating income as % of sales
9.2
8.3
7.5
12.9
12.9
14.6
14.3
12.2
16.8
20.2
to about 18 % of net sales in Prescription Medicines.
Income after taxes
167
212
229
320
379
401
551
537
908
1,514
4.6
5.0
5.1
6.3
6.1
6.0
7.3
7.3
11.1
15.9
Our headquarters is at Ingelheim, the German town where the company
Return on equity (in %)
9.8
11.4
11.0
13.8
14.4
13.6
16.0
15.0
23.1
34.2
was founded in 1885.
Own capital resources (in %)
43.4
41.3
43.9
40.4
41.4
41.3
38.3
37.9
41.0
38.4
Cash flow
426
561
595
737
791
1,117
1,049
1,059
1,430
2,069
60 Overview Consumer Health Care
Biopharmaceuticals and Chemicals
Animal Health
70 Helping the Heart
74 Overview Animal Health
77 Group Management Report
Financial funds
Consolidated Financial Statements 2005
Personnel expenditure
966
722
858
1,055
1,094
1,645
2,645
3,516
4,015
4,585
1,153
1,270
1,409
1,527
1,749
1,916
2,175
2,252
2,443
2,671
30.5
29.9
28.0
34,221 35,529
37,406
90 Overview of the Major Consolidated Companies
Personnel expenditure as % of sales
92 Consolidated Balance Sheet
Average numbers of employees
93 Consolidated Profit and Loss Statement
Research and development costs
626
771
812
94 Cash Flow Statement
R&D as % of sales
17.3
18.4
18.1
95 Statement of Changes in Group Equity
346
455
421
96 Notes to the Consolidated Financial Statements
169
189
211
114 Auditor’s Report
116 Glossary
Flap Comparison of Balance Sheet/Financial Data 1996–2005
*As of the comparative financial statement
1999, accounting and evaluation methods were
brought closer into line with International
Accounting Standards (IAS), in particularly
with regard to deferred taxes and provisions
for pensions.
31.8
30.2
31.5
30.0
28.3
28.6
28.7
24,074
24,860
25,927
26,448
27,325
27,980
31,843
826
968
1,019
1,304
1,176
1,232
1,360
16.2
15.6
15.2
17.2
15.9
15.1
14.3
377
497
548
634
516
427
532
256
288
305
340
354
377
439
Contents
8
22
40
56
62
70
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
89
508
452
400
344
322
302
242
267
233
Tangible assets
1,342
1,612
1,739
1,992
2,217
2,467
2,840
2,767
2,712
2,900
Financial assets
1,007
757
731
849
1,135
1,008
1,689
2,462
2,756
3,396
Fixed assets
2,438
2,877
2,922
3,241
3,696
3,797
4,831
5,471
5,735
6,529
Intangible assets
Inventories
627
794
806
944
1,021
1,014
971
1,000
1,085
1,229
1,057
1,211
1,255
1,870
1,938
2,314
2,360
2,537
2,477
3,013
156
134
299
459
477
1,002
1,055
1,134
1,333
1,247
Current assets
1,840
2,139
2,360
3,273
3,436
4,330
4,386
4,671
4,895
5,489
Total assets
4,278
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
383
399
441
332
211
200
178
178
178
178
Our Company
10 Our Commitment
14 For Our People
22 Our R&D Drive
advances.
1,307 1,461 1,651 1,982 2,362 2,753 2,818 3,139
3,297
2,940
Net income
167
212
229
320
379
401
537
529
888
1,491
Total equity
1,857
2,072
2,321
2,634
2,952
3,354
3,533
3,846
4,363
4,609
0
0
0
0
0
1
203
188
193
216
Group equity
1,857
2,072
2,321
2,634
2,952
3,355
3,736
4,034
4,556
4,825
1,841 1,982 2,012 2,631 2,932 3,150 3,568 3,963 4,172
4,958
Minority interests
580 962 949 1,249 1,248 1,622 1,913 2,145
1,902
2,235
Total liabilities
2,421
2,944
2,961
3,880
4,180
4,772
5,481
6,108
6,074
7,193
4,278
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
Sales
3,623
4,201
4,474
5,086
6,188
6,694
7,580
7,382
8,157
9,535
62 Time is Critical
333
350
336
655
800
980
1,082
901
1,372
1,923
9.2
8.3
7.5
12.9
12.9
14.6
14.3
12.2
16.8
20.2
Income after taxes
167
212
229
320
379
401
551
537
908
1,514
4.6
5.0
5.1
6.3
6.1
6.0
7.3
7.3
11.1
15.9
9.8
11.4
11.0
13.8
14.4
13.6
16.0
15.0
23.1
34.2
43.4
41.3
43.9
40.4
41.4
41.3
38.3
37.9
41.0
38.4
Cash flow
426
561
595
737
791
1,117
1,049
1,059
1,430
2,069
Animal Health
Financial funds
966
722
858
1,055
1,094
1,645
2,645
3,516
4,015
4,585
1,153
1,270
1,409
1,527
1,749
1,916
2,175
2,252
2,443
2,671
30.5
29.9
28.0
34,221 35,529
37,406
626
771
812
R&D as % of sales
17.3
18.4
18.1
346
455
421
169
189
211
116 Glossary
for pensions.
31.8
30.2
31.5
30.0
28.3
28.6
28.7
24,074
24,860
25,927
26,448
27,325
27,980
31,843
826
968
1,019
1,304
1,176
1,232
1,360
16.2
15.6
15.2
17.2
15.9
15.1
14.3
377
497
548
634
516
427
532
256
288
305
340
354
377
439
Our vision drives us forward.
It helps us to foster value creation
through innovation throughout
our company and to look to the
future with constantly renewed
commitment and ambition.
The Shareholders’ Perspective
of the importance of our employees, and our
long-term thinking and commitment. Our
strength is founded on our stability. As a
The importance of family-owned companies in
family-owned company, we can transform the
Germany is repeatedly given prominence in the
parameters mentioned above into a well-
public debate over significant economic policy
balanced strategic approach along with a market-
issues, for instance, regarding the labour market
orientated growth strategy. We are not under
situation or taxation policy. Family-owned
pressure from the short-term demands of
companies represent a peculiarity in the German
anonymous investors or the capital market.
system. Of the 50 largest European companies of
this type, more than half come from Germany.
This does not, however, mean that we do not
comply with standards and norms that apply to
The results of investigations lead to the conclu-
companies listed on the stock market. In this
sion that such companies are, in terms of both
respect, we share the approach of those compa-
revenues and earnings development, more than
nies perceiving themselves as Good Corporate
competitive compared with companies listed on
Citizens. Social commitment, openness and
the stock exchange. Looking into the reasons for
transparency are of utmost importance for us.
this, you find features like long-term orientation
The principle of sustainability – applied to the
combined with higher attention to risk, personal
long-term, stable development of the company’s
commitment of the owners as well as a strong
value, applied to the selection and targeted
employee focus. These aspects also apply to
promotion and fair treatment of our employees,
Boehringer Ingelheim, which serves as a positive
and applied to environment-friendly and socially-
example with its successful business and
orientated economies – is reflected in our
corporate development.
Leitbild, the guiding principles for our corporate
behaviour. For us, sustainability is the basis of
We are frequently described as a company that
stability and success.
is “different” to its competitors. What is meant
by that? The criteria which mark us out and
Our company is growing dynamically. Indeed, in
form Boehringer Ingelheim’s identity are our
the last few years, it has clearly outpaced average
orientation towards values, such as reliability
growth of the pharmaceutical market. In 2005,
and predictability, the close alignment with the
the successful development continued once
needs of patients and physicians, the awareness
again. Once more we are in the top ranks of
the pharmaceutical companies with the strongest
growth. We have succeeded in providing new
therapeutic options for our patients with a row
Boehringer Ingelheim A n n u a l R e p o r t 2 0 0 5
of innovative medications. Our expectations for
In spite of such limitations, 2005 was once again
2005 have been achieved or were exceeded in a
a successful business year. The Shareholders and
whole number of areas. On all of these grounds,
the Board of Managing Directors of Boehringer
the Shareholders of Boehringer Ingelheim are
Ingelheim took or prepared the decisions to
very satisfied with the course and results of the
achieve the goals we have set in close coopera-
business year.
tion and coordination with the Advisory
Board. The decisions concerned the company’s
Nevertheless, we must not ignore the potential
strategic direction, important business matters or
risks the pharmaceutical industry is facing.
decisions on capital expenditure.
Developing new, innovative medicines is a
In regular joint sessions, the Advisory Board,
protracted and expensive process. Only a few
the Shareholders’ Committee and the Board of
research approaches end up as new medicines
Managing Directors have discussed the short
and make it to market approval. The healthcare
and medium-term development of the company
policy environment in most countries, which is
and the necessary decisions entailed.
afflicted with ever-increasing uncertainties and
continuously deteriorating, represents a
The Shareholders of Boehringer Ingelheim thank
considerable burden for our industry. For capital
all employees, the Board of Managing Directors
expenditure creating new jobs or developing
and the Advisory Board for their successful work
innovative medicines, we win many public
and commitment in 2005. The path Boehringer
plaudits. Sadly, these fine-sounding words are in
Ingelheim has taken as an independent family-
reality not often followed by corresponding
owned company also promises us growth and
deeds.
success for the future.
Instead of strengthening the power to innovate –
for which an appropriate risk premium is a
Dr Heribert Johann
pre-condition, that is to say, reasonable prices
Chairman of the Shareholders’ Committee
and adequate protection of innovations against
imitation – the precise opposite is happening.
Prices are being forced down, reimbursement
opportunities restricted and parallel imports
encouraged. In our opinion, supporting
economic progress in combating disease looks
different. When making future investment
decisions we will also have to take such aspects
into consideration.
The Shareholders’ Perspective
Key Aspects of 2005
position No. 14 worldwide in terms of sales,
with a market share of 2 %.
We are a research-driven pharmaceutical
Strong international brands
company that invests about 18 % of net sales of
In 2005, our net sales rose by around 17 % to EUR
our Prescription Medicines business every year in
9.5 billion. Currency effects played a secondary
the research and development of medicinal
role compared with previous years.
products. Our goal is to serve mankind through
research into different diseases and to create the
Our growth was primarily driven by our pre-
drugs and therapies to treat them. This principle
scription medicines products. spiriva®, for the
guides all our business activities. Our success
treatment of chronic obstructive pulmonary
to date and our future prospects are measured by
disease, and mobic®, for the treatment of arthri-
the degree of innovation of our new medicines
tis, both passed the blockbuster threshold of
now available to patients and by the innovative
more than USD 1 billion annual net sales.
potential of our product pipeline. We are proud
micardis®, our product for the treatment of
that in 2005 four million of patients worldwide
hypertension, and sifrol®/mirapex®, to treat
affected by chronic obstructive pulmonary
Parkinson’s disease, were significant growth
disease could benefit from our spiriva® and live
drivers too. flomax®/alna®, our drug for benign
a better life.
prostatic hyperplasia, also contributed to the
successful sales development.
For some years now, Boehringer Ingelheim has
been one of the fastest-growing companies in the
To measure our development in financial results
pharmaceutical industry. In 2005 again, we
is one thing. But of ultimate importance for us
maintained a fast pace of dynamic growth.
is the benefit we offer to the millions of patients
According to the market analysts IMS, employed
whom we have supported with our above
by all pharmaceutical companies, we achieved
mentioned drugs and for people infected with
the strongest growth of the top 20 pharma
HIV. Since it was first introduced in 1996, we
ceutical companies. We also outpaced the
have helped a million patients with our drug
average for the pharmaceutical market in all
viramune®. And the success of our viramune®
major regions of the world. This takes us to
Donation Programme to prevent the mother-tochild transmission of HIV in developing
Members of the Board
of Managing Directors:
Dr Hans-Jürgen Leuchs
Dr Andreas Barner
Dr Alessandro Banchi
Prof. Marbod Muff
(from left to right)
countries since 2000 encourages us to put even
We also market our own biotech products,
greater emphasis on our efforts to create value
metalyse® (heart attack) and actilyse® (stroke).
for patients and society. The launch of our new
Our overall biopharmaceuticals business,
HIV drug aptivus® in 2005 is thus another step
which grew by 40 % in 2005 to EUR 548 million,
towards fulfilling our commitment to ‘Value
is expected to play an increasingly important
through Innovation’.
role in combating many major and developing
diseases.
Prescription Medicines, by far our largest business area, accounting for 76 % of total net sales,
Our Animal Health business, which accounts for
increased its turnover by more than 17 % to
4 % of our net sales, has also grown above the
total EUR 7.2 billion. The share of our product
market average in recent years. In 2005, sales
portfolio which still enjoys patent protection or
rose by almost 8 % to EUR 361 million.
exclusivity rights rose to 59 %.
Our other business areas also achieved signifi-
A key factor for Boehringer Ingelheim’s sustained
cant growth. In Consumer Health Care (CHC),
success is our well-distributed presence in all
our self-medication business, net sales rose
important world markets. Our products are sold
by 8.5 % to almost EUR 1.1 billion. This was
in some 150 countries. The USA, again by far
mainly attributable to our flagship brands and
the most important market in 2005, generated
leading products in the cough & cold and gastro
36 % of our total net sales. Our US sales grew
intestinal indications, such as bisolvon®,
by 17 % to EUR 3.4 billion. Japan (+8 % to EUR
mucosolvan®, dulcolax® and buscopan®.
1.2 billion) and Europe (+19 % to EUR 3.1 billion)
In addition, pharmaton®, our well-established
also posted excellent development. Europe as a
international brand for the improvement and
region contributed 33 % of our total net sales.
maintenance of vitality and well-being, held the
second strongest position in our CHC product
The healthy business development of the past
portfolio.
business year led to a 40 % rise in operating
For some years, Boehringer Ingelheim has
EUR 1.9 billion and reflecting an operating
been one of the world’s largest manufacturers
margin of more than 20 %.
income (broadly comparable to EBIT), totalling
of biopharmaceuticals for industrial customers.
Key Aspects of 2005
Our successful business activities go hand in
Outlook
hand with increasing effectiveness in cost
The gratifying development of our business in
management through all areas of the corporation.
2005 reflects the strengths of our company.
Cost-effective pharmaceutical manufacture is
However, yesterday’s successes are today’s history
one of the key factors in attracting new partners
and the way ahead is uphill. The pharmapolitical
for third-party manufacture.
measures in a number of important countries,
starting with Germany, pose an increasing
Patented drugs or drugs with exclusivity con-
barrier to innovation and to patient’s access to
tinue to drive our growth. Our product pipeline
new and better therapies. Developing medicines
includes a number of promising substances
is a lengthy, costly and risky process. Short patent
in major indication areas such as respiratory,
lifetimes, frequent regulatory interventions,
cardiovascular and inflammatory diseases,
rigorous price containment measures and fierce
virology, urology and CNS. In addition, good
competition make it all the more difficult to
progress was made with development candidates
guarantee the financial basis required for R&D.
in oncology, metabolism and immunology. Our
areas of research are divided across the four main
We once again expect to grow faster than the
research sites in Germany (Biberach), Austria
pharmaceutical market in 2006, although we are
(Vienna), the USA (Ridgefield) and Canada
unlikely to match the growth rates posted in
(Laval), in line with their defined key areas.
2005. mobic®, for example, is expected to face
In addition, our activities and projects are
competition of the first generic versions in the
supported by strategic alliances and in-licensing
USA in 2006. However, our product portfolio
of new technologies. In 2005, we moved various
contains numerous branded medicines with
candidates into predevelopment and develop-
medium to long-term patent protection which
ment with promising prospects for the future.
still have significant potential for growth.
We are also pleased to have a number of interest-
In a continued move to support this strong
ing drug candidates for various indications
growth, we took the opportunity to increase our
in our promising pipeline. All in all, Boehringer
manpower by 5 % to total 37,400 employees in
Ingelheim is optimistic about the future.
the past year, mainly in the USA, Germany and
Spain.
Dr Andreas Barner
Prof. Marbod Muff
Shareholders’ Committee
Advisory Board
Board of Managing Directors
Dr Heribert Johann
Prof. Michael Hoffmann-Becking
Chairman of the
Attorney at Law, Düsseldorf
Corporate Board Division
Shareholders’ Committee
Chairman of the Advisory Board
Chairman of the Board
Albert Boehringer
Dr Rolf-E. Breuer
Christian Boehringer
Chairman of the Supervisory Board
Pharma Marketing and Sales
Deutsche Bank AG,
Dr Andreas Barner
Christoph Boehringer
Frankfurt (Main)
Vice-Chairman of the Board
Ferdinand von Baumbach
Prof. Fredmund Malik
Hubertus von Baumbach
Dr Mathias Boehringer
Managementzentrum
St. Gallen Holding AG
Prof. Axel Ullrich
Director of the Max Planck Institute
for Biochemistry, Martinsried
Dr Heinrich Weiss
SMS AG, Düsseldorf
Pharma Research,
Development and Medicine
Operations
Animal Health
Prof. Marbod Muff
Finance
Human Resources
Key Aspects of 2005
Our caring culture
The caring culture to which Boehringer Ingelheim has been committed
for well over a century embraces a broad range of stakeholders from
our patients, our employees and their families through neighbouring
communities and society at large to our natural environment.
Corporate responsibility as practised by our company takes many forms. Of paramount
importance for us are the needs of our patients. It is the quest for innovation and medical
breakthrough which drives all our activities. We understand that the importance of our
company directly depends on the value of the therapies which we can present to those in
need of medical help. And we fully grasp the central role of our employees in all our
endeavours.
Boehringer Ingelheim has been always regarded as an excellent employer. From the very
beginning, it has focused on providing employees with an attractive place to work, a place
in which they feel their contribution is fully recognised and properly rewarded. But our
sense of responsibility does not stop there. It has always reached out far beyond our factory
gates and today addresses many issues of a truly global nature.
Boehringer Ingelheim complies with the intention and basic principles of corporate
governance and corporate social responsibility as proposed by international organisations,
such as the United Nations (UN), the World Health Organization (WHO), the Organisation
for Economic Co-operation and Development (OECD) or the European Union (EU).
We regard ourselves as a good corporate citizen in all countries in which we operate, or
where our products are available. We fully comply with the principles set out in the Global
Compact in 1999 under a United Nations initiative.
Such principles are already fully integrated into our business activities around the world
and guide our strategy, corporate culture and day-to-day operations. Our aim is to provide
full transparency concerning our business and corporate conduct within the framework of
our annual report and other publications.
In order to sustain our corporate responsibility, we depend on our business success, driven
by product innovation and the morale of our people.
Photo: Young tsunami survivors gather at new school-cum-village hall in Krueng Raya, Indonesia,
supported by Boehringer Ingelheim.
Our caring culture
Our commitment
We have committed ourselves to the goal of serving mankind through
research into diseases and the development of new drugs and therapies.
In this endeavour the future of the Corporation will depend on its innovative
capability. Boehringer Ingelheim strives for medical breakthroughs and
invests heavily in research, development and medicine for therapies which
fulfil unmet medical needs.
In improving access to anti-AIDS drugs,
Boehringer Ingelheim strives to facilitate the
Boehringer Ingelheim acknowledges its special
access to life-saving nevirapine. Five voluntary
responsibility as a research-driven pharma
licenses to manufacture and market generic
ceutical company in the war on the pandemic.
nevirapine have been granted to companies in
It is engaged in wide-ranging initiatives to
South Africa, Nigeria, Egypt and Kenya.
combat AIDS. The company has increased efforts
Moreover, as a founding partner of the Accelerat-
in HIV/AIDS research, in supplying anti-AIDS
ing Access Initiative (AAI), Boehringer Ingelheim
drugs free of charge to treat the transmission of
offers developing countries considerable dis-
the disease from mother-to-child during birth,
counts in order to enable access to viramune®.
or providing them at substantially reduced prices
to developing countries for chronical treatment.
Some 6,000 of Papua New Guinea’s 5.3 million
It has furthermore increased its activities supply-
inhabitants are infected with HIV and the infec-
ing knowledge and training and supporting
tion rate is 1,000 per year. Very few infected
philanthropic initiatives via its affiliates in areas
people go to healthcare centres so the figures are
strongly affected by HIV/AIDS.
likely to be vastly underestimated. Apart from the
viramune® Donation Programme, Boehringer
Since 2000, Boehringer Ingelheim has given free
Ingelheim in partnership with other pharmaceu-
access to single-dose viramune® (nevirapine),
tical companies, the Catholic Aids Office, the
to be used alone or in combination with other
Australasian Society for HIV Medicine (ASHM)
drugs, to prevent mother-to-child transmission
and the government of Papua New Guinea
of the HI virus during birth. The company
(PNG), have designed and implemented a pilot
currently donates the product to some 140
project to train healthcare workers under the
programmes in around 60 countries in Africa,
auspices of the Collaboration for Health in Papua
Asia, Latin America and Eastern Europe. In total
New Guinea.
some 700,000 mother and child pairs have been
treated so far.
Unlike other programmes, this model used a
multi-disciplinary approach to train teams of
healthcare workers rather than doctors only.
10
Uganda has made strong progress in reducing the prevalence
rate of HIV. The key to this success has been public openness,
at all levels of society, in addressing the issue. Here, people
living with HIV in Uganda demonstrate their support
for treatment at the opening of a free AIDS clinic in Masaka,
close to where the pandemic is thought to have begun.
The teams consisted of physicians, nurses,
Among other initiatives was the Student
counsellors, social workers and technicians
Education Programme in collaboration with the
working in healthcare centres. Topics covered in
University of Cape Town, South Africa, which
workshops included basic infection control,
provides full financial support from Boehringer
infection prevention, record keeping, diagnosis
Ingelheim for medical students from disadvan-
and management of opportunistic infections.
taged backgrounds. The Boehringer Ingelheim
Lung Institute at the same university has been set
The collaboration for Health in PNG is an initia-
up as a centre of excellence to support clinical
tive of a group of pharmaceutical manufacturers
trial activities in the country with research
committed to the treatment and care of people
facilities in infectious and respiratory diseases.
living with HIV/AIDS.
In 2005, the Boehringer Ingelheim Training and
Facilitation Unit was opened in Botswana.
Addressing infrastructure needs
As improving access to treatment remains
seriously limited in many developing countries
due to local structural problems in healthcare,
Boehringer Ingelheim has also engaged increasingly in projects to improve education and
relevant infrastructure.
In addition to donation and increasing access to
drugs, the company continues to explore ways
to partner governments and NGOs to improve
healthcare in developing countries.
Initiatives the company has already undertaken
in South Africa include the “Turning the Tide”
programme of training and education for health
professionals in HIV and its management. This
has been extended into Swaziland and Botswana
and now reaches over 1,000 healthcare workers.
In 2005, Boehringer Ingelheim opened discussions with healthcare organisations in Uganda
with a view to possibly replicating schemes
which have been successful in other parts of
Africa.
Our commitment
11
For our neighbours
We are fundamentally committed to fostering economic and social wellbeing in the countries and communities where we operate. Working together
as a corporate entity and as individuals using their own time, we seek in a
people-orientated and inspirational way to deliver value through innovation
in all we do. We contribute actively to communities, charitable organisations, research, science, education, healthcare, environmental protection
and cultural projects.
As 2005 began, the world was becoming aware of
The company made substantial donations
the enormous scale of the devastation wreaked
through its international and local organisations
by the tsunami that struck Southeast Asia.
to aid agencies involved in the 2005 disasters,
People from our operation in Indonesia reacted
the Asian tsunami and the devastating earth-
immediately, sending donations of clothes,
quake that hit Kashmir in October. In response
food, medication and toys to the Aceh region of
to the hurricane Katrina disaster in September,
Sumatra. A crisis team made up of volunteer
the company’s US organisation also funded a free
employees also went to Aceh to see how best to
mobile clinic to treat people in New Orleans in
further support the local population.
addition to making financial and product contri-
Among the displaced in Aceh were more than
relief efforts in the USA and elsewhere.
butions through MAP International to disaster
150,000 children, many traumatised by the
disaster. The company crisis team therefore
Our people taking the initiative
decided to fund the construction of a trauma
Our wide range of charitable activities in the
centre, which also serves as a school and village
USA heavily involves volunteering by employees.
hall in Krueng Raya village. Aksari Ibnu, who
A “Day of Caring” sponsored by the company,
co-headed the Boehringer Ingelheim Indonesia
gives employees at our Ridgefield, Connecticut,
tsunami task force, commenting on the school
USA, site the opportunity to volunteer for tasks
opening in July, said: “The smiling faces of young
to help the aged and deprived. In many ways,
children and the people of Krueng Raya was a
from decorating homes to reading to children at
huge reward for our team who had all dedicated
day care centres. Our US employees also partici-
themselves to this worthwhile project.”
pate in numerous sponsored events to raise funds
for good causes. At our Roxane, Ohio, USA, site
employees help the Salvation Army buy and
distribute Christmas presents for poor families.
12
Employees at Boehringer Ingelheim Portugal volunteered to
build houses for two families in need in Braga in the north of
the country in association with the humanitarian organisation
Habitat for Humanity. Miguel Moreira, Area Manager for
Prescription Medicines in Portugal, an active volunteer, said:
“I am very proud that the company where I work shares the
same concern: helping the ones most in need.”
In the Philippines, our employees stepped in to
In Colombia, we not only contribute to health-
help families made homeless when their shanties
care and schooling for people in our immediate
burned down at Baseco Compound in Tondo.
community, but also support two foundations:
Not only did the employees donate funds to build
the Padre Luna Farms, which help battered
eight new row houses for the homeless, they also
children and teach agricultural labourers; and
helped with the construction work in their free
Fundafidro, an organisation working with health-
time. The homes, built in cooperation with an
related issues in deprived neighbourhoods.
organisation dedicated to eradicating homelessness, were handed over to their new occupants in
Despite the extraordinary challenges of the
June.
tsunami disaster, Boehringer Ingelheim
Indonesia succeeded in October in continuing its
Promoting equal opportunity
established community-awareness programme,
In Latin America, the company has a long,
giving general medical treatment to hundreds of
solid tradition of charitable activities. In Brazil,
needy people near the company’s Bogor plant as
Boehringer Ingelheim launched a two-year social
well as fostering educational improvement.
responsibility programme, “Conectar”, directed at
disabled people to help them prepare for jobs
market (many have never been employed). An
employment assistance programme in the favelas
of São Paulo is another example of how we
actively promote fairness and equal opportunity.
The company’s human resources professionals,
voluntarily and in co-operation with those of
other organisations, provide youngsters with
poor prospects hands-on training and support in
employment counselling, identifying ways to
move forward and ensuring professional and
emotional back-up.
In Venezuela, the company gives training to the
doctors at the respiratory care centres in Chacao
neighbourhood and the Hospital Pérez de León
in Caracas. The hospital also receives free medicines and equipment.
For our neighbours
13
For our people
To achieve our corporate objectives we deploy flexible, mobile, self-confident
employees prepared to accept responsibility and capable of thinking and acting
globally. Our internal principles guide employee selection and assessment.
To attain continuous innovation in all we do, we apply our employees’ and
managers’ creativity, capability, commitment and willingness to learn and
change. The Corporation in this regard delegates responsibilities to employees
and acknowledges their success, performance and commitment in meeting
agreed goals. Remuneration and classification are based on the task,
performance, achievement and competitive comparison.
Successfully pursuing our vision, Value through
large number of apprentices in our extensive
Innovation, calls for the dedication, passion and
vocational programmes has won widespread
continuous powers of renewal of our more than
praise as a powerful encouragement to the labour
37,000 employees. They are our unique source of
market.
strength and inspiration.
Great place to work
Our persistent, combined efforts and resulting
We are proud of the attractive working environ-
achievements in pharmaceutical innovation have
ment that we have created and the status that we
enabled us to maintain growth and create new
enjoy as a preferred employer. Authoritative,
jobs. In many countries we have generated a
independent workplace surveys in many coun-
significant volume of employment opportunities,
tries have confirmed our position among the top
led by the USA, with a total of 1,000 new jobs.
companies in this area so vital to recruiting and
The increased employment prospects we offer
maintaining high quality employees (see box on
have been greeted extremely favourably in
page 17, list of awards).
countries where lowering unemployment is a
Such positive recognition of our company as
national challenge.
a great place to work spurs us on to enhance
On employment, Boehringer Ingelheim has
Ever responsive to the changing needs of our
our distinctive company culture still further.
received numerous accolades. In 2005, we were
employees, we at the same time call for everyone
awarded first price in “Arbeitsplätze absolut” for
to be personally engaged in improving our
being the company which generated the highest
working environment at the heart of which are
number of new jobs in Germany. We also gained
mutual respect, fairness, openness and space for
considerable public recognition in Germany for
both personal and professional development.
continuing to increase the number of apprenticeships which rose from 623 to 698. The relatively
14
Teamwork is a key element of Boehringer
Ingelheim’s corporate culture. In Istanbul,
our Turkish employees are here celebrating
the 2005 launch of Lead & Learn with
its implications for improved teamwork.
Development opportunities
International assignments are an integrated part
Our aspiration to continuously innovate requires
of our succession planning process and our
firm commitment from everyone in the company.
business and capability development.
Ongoing dialogue between our employees and
their supervisors is also essential to allow all
Our international assignees represent a large
parties to participate in our achievements and
number of our organisations and are uniformly
development. And our ability to progress coher-
distributed throughout our geographical regions.
ently towards realising our vision by developing
While the focus groups and purpose of the
and leveraging the immense diversity within the
assignment might differ from strategic positions
company is pivotal to our success.
to development measures or knowledge transfers,
Our annual employee – supervisor dialogue
these moves serve clearly as a vehicle to enhance
(Mitarbeitergespraech – MAG) is at the core of
cultural understanding and broadening a global
our performance and development culture.
mindset.
Engaging and stretching performance objectives
are mutually agreed and career aspirations and
The Boehringer Ingelheim Academy, encompass-
perspectives for professional development are
ing a variety of development courses and
addressed. Every individual is expected to have a
approaches in numerous countries, is designed to
valid and forward-looking development plan to
support and strengthen our core values and
meet the qualification needs of our rapidly
capabilities. Everyone at the company can access
changing business and work environment.
local and international development information
Career aspirations and prospects are also embed-
on our intranets. The Boehringer Ingelheim
ded in our global succession planning process.
Academy offers a wide spectrum of options from
Here we seek to guarantee a strong pipeline of
vocational subjects to leadership development
leadership talent for local and international key
programmes.
positions. Talent reviews linked to the succession
planning support the identification and development of leadership talent across the corporation.
Personnel costs in millions of EUR
Personnel costs as % of net sales
Number of employees (incl. apprentices)
2005
2004
2003
2002
2001
2,671
2,443
2,252
2,175
1,916
28.0
29.9
30.5
28.7
28.6
37,406
35,529
34,221
31,843
27,980
For our people
15
A key benefit for many employees is the provision by
the company of day care facilities for their children.
Here, (left) toddlers enjoy a meal at the kindergarten
in Ingelheim, Germany, set up in cooperation
with the local community. In the US, construction of
the Child Development Center on the Ridgefield,
USA, campus is in full swing.
We foster good leadership at all levels. Carefully
The way we work together
tailored local and international development
From the mid-1990s, our corporate culture has
approaches are applied to help our current and
built on our vision Value through Innovation
potential leaders to discover ways to create a
(VTI), which has given direction to all our activi-
context in which our people can excel and all of
ties. An annual VTI Day brings our organisations
us can continuously enhance our outcomes.
together to celebrate our achievements in line
with our vision and encourages and inspires our
Our third consecutive International Management
employees to participate in realising it in practi-
Development Programme, launched in 2005,
cal ways.
marked the beginning of 14 months of international, interdisciplinary learning and working for
Value through Innovation has guided and will
some 100 potentials. The programme involves
continue to guide our way of working together. It
participants in hands-on work on 14 strategically
helps us build on our strength and make the most
relevant projects, close professional mentoring
of our distinctive character, enabling us individu-
and frequent exposure to senior management in
ally and collectively to achieve great success.
various countries.
In 2005, Lead & Learn was introduced to outline
Benefits
ways in which we can enhance our culture of
Our benefits programmes, which vary from
working together to realise and deliver Value
country to country, include, amongst others,
through Innovation. The core principles of Lead
retirement benefits, health coverage, insurance
& Learn encourage increased questioning and
cover, company restaurants, kindergartens, child-
seizing opportunities while fostering a culture of
care centres and access to a variety of personal
shared leadership and learning.
and family support services.
VTI teams that fairly represent the diversity of
Numerous additional initiatives and programmes
our employees, together with our line manage-
are available for our employees and their fami-
ment, have commenced their challenge to
lies. These include international clubs, our Inter-
explore and realise complementary new ways to
national Cultural Student Exchange programmes,
support our aspired cultural development
local internships for family members and sum-
throughout the corporation.
mer camps for children.
16
Awards 2005
Country
Ranking Survey
Austria
13 Great Place to Work
Belgium
Brazil
< 150 Great Place to Work: The best companies to work for in Brazil
Brazil
Brazil
Denmark
Germany
Germany
Germany
Netherlands
Mexico
United Kingdom
USA (Roxane)
Great Place to Work: The best companies to work for in Latin America
< 50 Great Place to Work: The best companies to work for women
11 Denmark’s Best Place to Work
1 Germany’s Best Employers (VAA)
15 Germany’s Best Employers (Capital)
2 Germany’s Best Employers with more than 5,000 employees (Capital)
non given
The 49 Preferred Employers in the Netherlands
19 100 Best Companies to Work for (Sunday Times)
9 Business First Places to Work in Central Ohio
“Great Place to Work”®, USA, is an international initiative that has been undertaken for many years
in various countries to evaluate the world of work and employee satisfaction.
For our people
17
For our environment
In all our activities we will protect our employees, the facilities and the
environment from harmful influences, conserve natural resources and promote
environmental awareness.
These tenets, which are firmly established in our
examples show that we accept responsibility for
guiding principles (Leitbild) and formulated in
our products and attach great value to EHS,
our Principles on Safety, Quality and Environ-
not only at our own plants but also at those of
mental Protection, are put into practice through
our business partners.
systematic environmental protection, health
and safety (EHS) management. Global standards
Climate protection
are defined and enforced wherever they are
In the wake of disasters, such as those caused
indicated. Goals are set annually, while our
by the hurricanes Wilma and Katrina in 2005,
EHS status is checked regularly by Corporate
the subject of climate protection moved to centre-
Headquarters. In 2005 alone, this involved
stage in public debate.
twelve audits at various sites. Every plant
undertakes to set up a local management system
By converting the power station at our Ingelheim
and is free to have this certified or not. For fur-
site to burn a renewable source of energy, waste
ther details of our EHS management please visit
wood, Boehringer Ingelheim has already made
www.boehringer-ingelheim.com/ehs.
an active contribution to improving the carbon
dioxide (CO2) balance. Compared with the two
With our declared support for the concepts of
the Responsible Care® Initiative of the chemical
industry, we have undertaken to exceed the
minimum legal requirements wherever we
consider it appropriate. Consequently, each site
draws up its own programme for continuous
improvements in the EHS field.
Work accidents
■ Frequency rate =
accidents x 1 million hours / total labour hours
■ Severity rate =
lost labour days x 1 million hours / total labour hours
80
Frequently it is not only our employees and the
70
environment that benefit, but measures taken
60
can also have an economic impact, as illustrated
50
by the example of our wood-fired power station
4
in Ingelheim, Germany, described below. Other
3
40
2
1
’01
18
’02
’03
’04
’05
The safety checklist for vehicles carrying hazardous materials to
and from company sites is longer as that for a passenger
aircraft. Here the tyres on a truck are being examined at the
Ingelheim site in Germany as part of the comprehensive checks
made before it may leave the plant.
previous years, the balance has improved by
Another example of our responsible approach to
about 60,000 tonnes, or a quarter of the Corpo-
climate protection came within the framework of
ration’s total CO2 emissions.
a programme run by the Swiss national energy
A secondary benefit of the conversion has been a
authorities in 2003. Our Swiss site undertook to
major reduction in emissions of sulphur dioxide,
reduce CO2 emissions by 10 % by the year 2010
a contributor to acid rain.
and has already met interim goals.
In a move to reduce emissions of gases detrimental to the global climate, in accordance with the
Pharmaceuticals in the environment
Kyoto Protocol, the European Union introduced
We are not only responsible for clean production,
the Emissions Trading Scheme for CO2 in 2005.
but also for ensuring our products have minimal
Boehringer Ingelheim has joined this scheme.
impact on the environment.
Our heating power station in Ingelheim was
issued trading certificates on the basis of the
An environmental risk assessment is now
emissions in 2000–2002. Following the switch
required when registering new products. This is
to wood, a CO2-neutral power source, we can
prepared on the basis of studies on environmen-
now trade any certificates that we no longer need.
tal impact and ecotoxicological effects. We also
This project has allowed us to pursue both
assess the environmental data for products
ecological and economic goals at the same time.
already on the market and, where necessary, run
further voluntary studies to assess the ultimate
impact.
Energy
■ Energy consumption (in millions of gigajoules)
■ Energy consumption index (in %)
Water
■ Water consumption (in millions of m3)
■ Water consumption index (in %)
120
140
100
120
80
10
60
100
5
8
4
6
3
4
2
2
1
’01
’02
’03
’04
’05
’01
’02
’03
’04
’05
For our environment
19
Assessments to date show that our substances
Incidents
present no risk to man.
Our local and global crisis management
allows us to react rapidly to potential incidents.
Business partners
No major incidents occurred in 2005.
Our EHS management system guarantees that
all Boehringer Ingelheim sites satisfy set require-
Our performance
ments and make constant improvements.
The graphs show the EHS performance figures
However, we also attach great value to ensuring
for the last five years.
that our business partners likewise meet our
expectations in terms of EHS, while satisfying
Performance in the field of safety at work is
minimum requirements, in order to ensure the
measured by the number of accidents and their
continuity of our own business. For this reason,
rate adjusted for the number of employees.
we increasingly check EHS aspects as well as
As can be seen from the graph (page 18), the rate
quality during qualification of suppliers and
of accidents has fallen again since 2004.
contract manufacturers.
Our environmental impacts are shown both
Awards
as absolute values and relative to production –
In 2005, a number of sites were again awarded
represented in our production index. The index
prizes by external agencies for their efforts in
represents our overall production in all business
EHS. For the 6th time running, our site in
areas and is weighted to compensate for differ-
Colombia won an award for its excellent contri-
ences in environmental impact. Our baseline year
bution to long-term development. The local
is 1995. Since 2005 the figures include the values
agencies awarded the site in Toride, Japan, a
for the company microParts, Germany, which
prize for its exemplary efforts in the storage of
was acquired in 2004. They do not include
hazardous goods and fire safety, while the site in
SSP Co., Ltd. , Japan, which has also not been
Petersburg, Virginia, USA, was given an award
included in previous years.
for its modern wastewater treatment plant.
Our French chemical plant received first place
Over the last few years, most indicators have
in a countrywide external safety audit conducted
reached a relative stable level because many
prior technical or organisational improvements
to international standards.
resulted in a high performance standard. This is
Carbon dioxide (CO2)
■ CO2 by energy purchased (in 1,000 tonnes)
■ CO2 by process emissions (in 1,000 tonnes)
■ CO2 emissions index, direct emissions (in %)
(without company car park)
Volatile organic carbon (VOC)
■ VOC emissions, non-halogenated (in tonnes)
■ VOC emissions, halogenated (in tonnes)
■ VOC emissions index (in %)
120
80
100
60
40
80
500
60
400
800
300
600
200
400
100
200
’01
20
1,000
’02
’03
’04
’05
’01
’02
’03
’04
’05
reflected clearly in the respective indices com-
nitrogen removal by improving the nitrification/
pared with 1995. The production-adjusted
denitrification process, and will also target the
amount of pollutants in wastewater produced
specific halogen-containing wastewater which
has been reduced by 60 %, solvent emissions
can be difficult to treat when using only conven-
(volatile organic hydrocarbon – VOC) have been
tional technology.
halved and water consumption lowered by a
quarter. Our recycling rate has stabilised at a very
Our chemical sites in Malgrat, Spain, and
high level of about 80 %. Many of our ongoing
Fornovo, Italy, are seeking to have their environ-
efforts are therefore no longer reflected as
mental management systems certified in 2006
clearly as in earlier years. For a more detailed
in accordance with ISO 14001.
explanation of the individual graphs, please visit
www.boehringer-ingelheim.com/ehs
This report only mentions some of the activities
Our goals
Please visit the internet for further details about
We are aware that there is further potential for
our product responsibility, the safe handling
optimisation in terms of solvent emissions (VOC)
of highly potent substances in production and
into the air. We are making changes at our chemi-
other examples of our many safety activities.
cal site in Spain, where VOCs will be eliminated
www.boehringer-ingelheim.com/ehs
we engage in to fulfil our responsibilities.
in future through thermal oxidation rather than
by scrubbing with aqueous media. In Ingelheim,
Germany, too, additional plants are to be connected to the existing incinerator. Our goal for
2008 is to reduce VOC emissions by at least 50 %.
Our wastewater treatment plants are already
performing on a very high level. To maintain and
further improve this level and to adapt to
increasing loads, we started a major investment
in our Ingelheim wastewater treatment plant.
An additional state-of-the art treatment step will
make the process more effective, will increase
Disposed waste
■ Domestic waste (in tonnes)
■ Hazardous waste (in tonnes), incl. pharmaceutical waste
■ Disposed waste index (in %)
■ Recycling rate (in %)
Wastewater — chemical oxygen demand (COD)
■ COD load before treatment (in tonnes)
■ COD load after treatment (in tonnes)
■ COD load (after treatment) index (in %)
80
100
60
90
40
80
20
70
8,000
20,000
6,000
15,000
4,000
10,000
2,000
5,000
’01
’02
’03
’04
’05
’01
’02
’03
’04
’05
For our environment
21
22
Our R&D drive
Holger Pfister has been treated with almost all of the 22 currently
available HIV drugs. “But my doctors never managed to bring my viral
load under the detectable limit,” says Holger. The viral load, the number
of virus particles in the blood, measures a person’s HIV / AIDS status.
Owing to the failure to treat Holger’s virus effectively, it has become
resistant in his body to almost all AIDS medications. Resistance is
a very serious HIV issue. In 2003, Holger took part in the resist clinical
study for Boehringer Ingelheim’s novel protease inhibitor (PI) aptivus®
(tipranavir). “Since then I’ve been under the measurable limit for the
first time ever,” he says. Continuing the treatment, he is in good mental
and physical health.
Professor Schlomo Staszewski from Frankfurt university, a leading AIDS expert and the
first person in Germany to hold a professorship in HIV infections, hails aptivus®,
launched in the first markets in 2005, as “the most efficacious protease inhibitor so far”.
And it is not just a question of efficacy. “Tipranavir is the largest antiretroviral development
to date,” says Dr Paul Carter, who coordinated the project at Boehringer Ingelheim.
“This project has clearly shown that our closely integrated development network, which
links our R&D centres around the world, together with our well established interactions
with clinical investigators, gives us access to all the capabilities necessary to achieve
successful and timely development of even the most challenging drugs,” he notes. In only
five years, tipranavir was taken from a promising candidate to a potent new drug.
Tipranavir, in-licensed in phase II development from the former Pharmacia-Upjohn in
2000, is a non-peptidic PI. It works by inhibiting protease, an enzyme needed to complete
the HIV replication process. Based on available clinical and in vitro data, tipranavir is
active against most strains of HIV-1 that are resistant to commercially available protease
inhibitors. Tipranavir does not cure HIV infection/AIDS or prevent the transmission of HIV
to others. What it importantly offers is a treatment that benefits patients with limited
therapeutic options.
Our R&D drive
23
Since Holger Pfister was diagnosed with human
immune deficiency virus (HIV) infection in 1986, he has
been fighting AIDS (acquired immune deficiency
syndrome). “I am one of the few who survived,” he says.
AIDS drug resistance — a big issue
The resist programme examined the treatment
Since the initial detection of AIDS in the early
response of tipranavir boosted with ritonavir
1980s, viral resistance to drugs treating HIV has
versus a comparator group in which patients
become a crucial issue. The pharmaceutical
received one of several marketed ritonavir-
industry has thus sought to constantly develop
boosted PIs. The comparator PI was lopinavir,
new drugs. To date, a total of over 20 are avail-
indinavir, saquinavir or amprenavir. In addition,
able. However, the HI virus has proved to be a
patients received in both arms a personally
very dangerous master of metamorphosis, always
optimised background regimen of another
finding ways to change its genetic pattern and
antiretroviral.
thus ward off the attacks of antiviral drugs.
The results of the resist studies demonstrated
A recent six-year study demonstrated a high
that a statistically significant greater percentage
prevalence of drug-resistant virus in a European
of HIV-positive patients taking tipranavir
group of patients under treatment for HIV-1
boosted with ritonavir achieved a treatment
infection. Data from the United Kingdom indi-
response versus the comparator group (40 %
cate that the transmission of drug-resistant virus
compared to 18 %). Furthermore, more than
is on the rise, with 47 % of patients resistant to at
twice the number of patients receiving regimens
least one PI. The estimated prevalence of people
that contain boosted tipranavir were able to
with drug resistant virus in a recent large-scale
reduce the amount of HIV in their blood to
study in the United States was 78 % (Richmann et
undetectable levels than in the boosted compara-
al., 2001). For all of HIV infected, new and potent
tor group (viral load <400 virus copies/ml blood:
drugs, like aptivus®, are a last resort.
34 % compared to 15 %). Patients treated with
tipranavir boosted with ritonavir also experi-
The RESIST clinical programme
enced greater increases in the numbers of their
In 2003, the first patients were recruited for the
CD4+ immune cells than those treated with a
resist pivotal trial programmes. These involved
ritonavir-boosted comparator PI (34 cells vs. 4).
the most clinically advanced population ever
studied and included 1,500 patients with highly
However, as with all PIs, tipranavir boosted with
resistant virus in 270 hospitals in 21 countries.
ritonavir was also associated with side-effects,
Recruitment was completed in just eight months.
such as diarrhoea, nausea and vomiting as well
as increases in liver enzyme and lipid levels.
24
The development of effective treatments
for viral infections, such as human
immunodeficiency virus (HIV), presents
a significant scientific challenge.
A researcher studies an HIV-infected
T lymphocyte cell on-screen. T cells,
a type of white blood cell, are important
for protecting the immune system
against viral infections and are a prime
target for the HI virus that causes a
reduction in the number of T cells.
New data presented at the 10th European AIDS
A key indicator for Boehringer Ingelheim’s
Conference in Dublin demonstrate that through
strength in R&D is the ratio of products still
48 weeks, aptivus® provides a convincing and
patented or under exclusivity protection to
durable benefit, achieving and maintaining a
our net sales. It rose to 59 % in 2005.
superior treatment response in patients with
resistant HIV. A large number of further clinical
Speed and efficiency are key to successful
studies with tipranavir boosted with ritonavir
pharmaceutical development projects, as novel
are currently running or planned to start in the
medicines that bring real benefit in terms of
near future. Some of these are designed to inves-
health and well-being are taking longer and
tigate tipranavir’s safety and efficacy in other
longer to get to the market. And more time adds
patient populations such as children, women,
further expenditure to the enormous cost of
patients co-infected with hepatitis B or C and
developing modern medications.
naïve (previously untreated) patients. This range
of studies demonstrates Boehringer Ingelheim’s
Our R&D expenditure in 2005 amounted to
continuing commitment to fully understand the
18.2 % of our net sales in Prescription Medicines,
profile of aptivus®.
indicating the extent to which a modern researchdriven pharmaceutical company has to invest
Our development strength
in discovering and developing new products,
aptivus® is not the only AIDS drug to emerge
or extending the life and indication coverage of
from our development programmes. The now
existing drugs in its portfolio.
widely-used antiretroviral agent nevirapine
(viramune®) is a product of original Boehringer
Ingelheim R&D and was the first member of the
non-nucleoside reverse transcriptase inhibitor
(NNRTI) class of anti-HIV drugs. In many other
indication areas there are also new medications
discovered and developed in-house by
Boehringer Ingelheim, amongst them tiotropium
bromide (spiriva®), a treatment for chronic
obstructive pulmonary disease (COPD),
pramipexole (sifrol®/mirapex®) against
Parkinson’s disease or telmisartan (micardis®)
for treating essential hypertension.
Our R&D drive
25
‘HIV is being played down’
An interview with Prof. Schlomo Staszewski
Q: Prof. Staszewski, let’s start by discussing AIDS in the
new infections in European countries. In 2005,
industrialised world. Hasn’t the disease here to a consider-
they rose by about 10 %, in Germany, even by as
able extent already disappeared from public awareness,
much as 20 %.
even though it naturally remains with us? What’s your
experience with this issue?
Prof. Staszewski:
AIDS, or HIV infection, is the most
dangerous epidemic, and the one with the greatest
Q: What’s the reason?
Prof. Staszewski:
HIV is being played down.
Awareness of the therapies and their effects on the
consequences, in the latter part of the 20th
course of the disease HIV are removed and remote
century and the beginning of the 21st century.
from the real situation. This we have to correct.
According to the World Health Organization, we
We must say what kind of disease it is.
have more than 40 million infected people. Some
three million died of the disease in 2005. In the
same year, an additional five million were infected.
My criticism of the current trend is also that,
content with the possibility of individual therapy,
we’ve lost sight of the overall epidemic. People no
Most deaths occur in sub-Saharan Africa. AIDS is
longer regard HIV as a fatal disease.
really a deadly disease there. In our countries
nobody needs to die of AIDS any longer. With
Advertising by the pharmaceutical industry often
the appropriate treatment the progression of the
also contributes considerably to glossing over the
disease can be halted and patients can be
disease. It focuses the HIV disease to the
prevented from developing the manifestations
industrialised world and shows in its pictures and
of AIDS.
personal testimonials people who are well. It
presents things as though there is no problem
The dilemma with AIDS is, on the one hand, its
at all.
good treatability, and, on the other hand, that it’s
26
the most dangerous infectious disease of our time.
Q: A problem in the West is the development of drug-
The question is how do we deal with it?
resistance. How do we deal with this?
Naturally you can gloss over or keep AIDS secret,
Prof. Staszewski:
if you live in the western world, where patients can
enon. In the event of therapy failure or side-effects,
receive all the available medications. You can
the switch to a tolerable or effective therapy
conceal the fact that some things in the world are
is more difficult. When resistance has occurred,
not in order. You can also see that in the number of
you have to switch therapy to combine those
Resistance is a common phenom-
Thanks to new treatments and innovative drugs,
AIDS has become controllable in the developed
world. Although it is still a deadly disease,
HIV awareness has weakened, leading to
increasing infection rates. In Mainz, Germany,
with the support of Boehringer Ingelheim,
a group of teenage schoolchildren put on a play,
“Damned positive”, which highlights the dangers
of an HIV infection.
medications to which the virus is still sensitive.
viruses that are resistant to aptivus®. This, one has
Here, the right combination is decisive. If we use
to know. Because only then it becomes clear that
an effective medication in the wrong combination,
aptivus® must also be used sensibly. When I use it
there is a danger that it will be wasted because of
too late, or use it in the wrong combination,
resistance developing.
I waste the medication.
Q: Is aptivus® effective because of the very fact that it can
aptivus® has strengths and weaknesses.
also be used for patients who are already resistant to many
Basically, it has all the side-effects familiar to
protease inhibitors. As dosage-related side-effects
other medications? Is that its strength?
occur, it is a good idea to test lower doses in
Prof. Staszewski:
That’s currently the most important
patients whose disease is less advanced than the
indication area for aptivus®, as it is effective
dose necessary for the patient with PI-resistent
against viruses that have already become resistant
virus. This should though at present only occur
to other protease inhibitors (ed: PI). But there are
within a controlled clinical study.
Prof. Schlomo Staszewski
• First holder in Germany of a professorship dedicated
to AIDS, established in 2003 at Johann Wolfgang Goethe
University, Frankfurt am Main
• Director of the Out-Patient Clinic for the HIV-infected
Patients and the Antiretroviral Research Unit
• Principal investigator in several international
multi-centre studies with new HIV compounds.
Current editor of HIV-Medicine
• Executive Committee Member of the European
AIDS Clinical Society (EACS)
Our R&D drive
27
Our strength in R & D + Medicine
Research and Development has been the foundation of Boehringer Ingelheim’s
success so far and continues to be the major driver of innovative, new
medicines. We recognise the unique opportunities and challenges that medical
needs and the health environment present. We have consequently committed
ourselves to discovering, profiling and developing new products of high
therapeutic value for patients and healthcare systems.
New biological entities (NBEs)
During 2005, we expanded our NBE discovery
We are widely recognised as a world leader in all
programme to include some 10 discovery projects,
aspects of biopharmaceutical manufacturing,
a first step towards a steady stream of innovative
from early process development to large-scale
NBE therapeutics feeding our development
commercial manufacturing in microbial as well
pipeline. While our key focus is on human mono-
as mammalian expression systems. Combined
clonal antibody projects, we are also exploring
with our disease expertise in key therapeutic
treatment options for cardiovascular and meta-
areas, our strategy is to create a comprehensive
bolic diseases with optimised bioactive therapeu-
NBE programme addressing unmet medical
tic proteins (OBTs). In-licensing promising NBE
needs in several indication areas, thus expanding
candidates is an important complement to
our proprietary NBE product portfolio beyond
in-house research activities and to this end we
actilyse® (first generation t-PA), metalyse®
have in-licensed AbGn-168, a humanised
(second generation t-PA), imukin® (interferon
monoclonal antibody that induces apoptosis of
gamma) and beromun® (tumour necrosis factor).
activated T cells, from AbGenomics Corporation,
Taiwan. AbGn-168 holds promise in delivering
In order to fully exploit the synergistic potential
long-lasting control of T cell mediated diseases,
of our internal capabilities, we have established
including autoimmune diseases.
centralised expertise in human antibody drug
discovery at our research site in Vienna, Austria,
Drug Discovery and Non-Clinical Development
facilitated by in-licensing of key technologies
Insight into the workings of diseases at a
from MorphoSys (phage display) and Medarex
molecular level is an important prerequisite for
(genetically modified mice). We have also
identifying promising targets for new drugs.
strengthened our protein technology infrastruc-
In this context, integrating state-of–the-art
ture across research sites and allocated dedicated
technologies to enhance the R&D value chain
biology resources in key therapeutic areas.
is the key to success in pharmaceutical R&D.
Despite significant progress in recent years,
unmet medical needs continue to be great and
growing due to changes in the environment and
people living longer.
28
Laboratory assistants at our Quality & Compliance Department,
Biopharmaceutical Manufacture, Biberach, Germany, undertake
visual assessment of biotechnically produced proteins using gel
electrophoresis.
Today, we carry out drug discovery in seven
At these sites, pharmaceutical development is
major therapeutic areas allocated to four major
focused on conventional dosage forms, whereas
R&D sites. Our R&D sites maintain strong
Ingelheim represents our centre of competence
responsibility and accountability for their thera-
for developing all inhalative dosage forms.
peutic areas locally and deploy their innovation
Boehringer Ingelheim has a particular focus on
and flexibility. International scientific reviews
the development of innovative inhalation devices.
and portfolio management ensure a sustainable,
handihaler® and respimat® Soft Mist™ Inhaler
competitive and risk-balanced discovery portfo-
offer us a very competitive platform in inhalation
lio. To further strengthen our R&D organisation
therapy and meet the challenges of drug develop-
we have international skill centres to improve
ment in a variety of indications. Added support
efficiency and to secure equal access to state-of-
on drug formulations and manufacturing clinical
the-art technologies and informatics platforms
trial supplies is provided by our sites in Kawa
for all sites. In Biberach, Germany, our largest
nishi and Buenos Aires, Argentina. Our coopera-
R&D centre, we concentrate on diseases of the
tions with biotech and academic groups provide
central nervous system (CNS), metabolic diseases
another key string to Boehringer Ingelheim’s
and respiratory diseases. Biberach is supported
bow in finding and developing innovative medi-
by our chemistry laboratories in Milan, Italy.
cines. A good example is the strategic research
Drug discovery in immunology & inflammation
collaboration initiated between our Biberach and
and cardiovascular diseases is carried out in
Ridgefield centres and Evotec OAI that enabled
Ridgefield, USA. Further fully-fledged drug
us to establish a novel research platform for
discovery centres are located in Laval, Canada,
elucidating innovative receptor-based drugs. This
carrying out research in virology, and in Vienna,
collaboration started on receptor targets involved
doing research in oncology. In Kawanishi, Japan,
in CNS diseases but now also addresses targets
we have an additional centre in molecular cell
of potential interest in other therapeutic areas,
biology, specialised in membrane receptor targets.
such as metabolic and immunological diseases.
Our non-clinical drug development activities are
The bridge between our R&D people and
concentrated in Europe and North America at
academia is reinforced by the strong link to
the sites Biberach and Ingelheim, Germany,
the renowned Research Institute of Molecular
and Ridgefield, USA. Biberach and Ridgefield are
Pathology (IMP) which we fund in Vienna.
conducting the full range of non-clinical development work packages including activities for
chemistry, manufacturing and control (CMC)
as well as relevant pharmacokinetic and safety
studies.
Our strength in R&D+Medicine
29
IMP scientists are at the forefront of discovery
only poorly controlled by current, widely-used
defining fundamental processes of cell division
anti-inflammatory drugs, such as corticosteroids.
and differentiation in healthy and diseased states.
Our research in asthma is aimed at new
A collaboration started in 2001 between the IMP
mechanisms and immunological paradigms
and the Institute of Molecular Biotechnology
which would allow us to replace or reduce the
Austria (IMBA) added a new dimension to our
doses of inhaled steroids by providing anti-
academic network. Intensified interactions with
inflammatory therapy better tolerated by patients.
IMBA began in 2005 in target identification
Another goal is to provide a new treatment for
using model organisms.
specific syndromes with high unmet medical
need, such as severe, steroid-resistant asthma.
The more than 3,000 scientists, technicians and
support personnel we employ in preclinical R&D
Virology
is complemented by about 2,100 clinical moni-
Antiviral therapies for many serious, life-threat-
tors, statisticians and data managers in clinical
ening chronic and acute viral diseases are lacking
development and medical departments.
or are unsatisfactory. Our Laval centre focuses on
the discovery and development of new antiviral
Respiratory diseases
therapeutics for the treatment of the human
Respiratory diseases have long been a major
immunodeficiency virus type 1 (HIV-1) and the
focus area for Boehringer Ingelheim and we
hepatitis C virus (HCV). These two devastating
dedicate ample resources for research in this field.
pathogens have each emerged epidemically in
Our main objective in pulmonary research is to
recent decades, afflicting millions globally.
provide still further improved treatment options
for chronic obstructive pulmonary disease
Our HCV research is directed toward identifying
(COPD) and severe asthma. COPD is currently
inhibitors targeting essential viral enzymes, such
the fourth most common cause of death, yet up
as the HCV serine protease and RNA polymerase.
to three quarters of sufferers in Europe go
Such new mechanisms offer the potential for
undiagnosed. This suggests a major unmet need
new therapies with improved safety and efficacy
for treatment for this debilitating lung disease
compared to current treatments of chronic
which often afflicts smokers. Our worldwide
hepatitis C. Our clinical studies with an HCV
launch of tiotropium (spiriva®) provided a
serine protease inhibitor provided the first proof
medication to improve COPD therapy, strength-
of clinical concept for this class of antiviral agent
ening our leading position in the bronchodilator
and we continue to make efforts to exploit this
field. This is being build up by developing
antiviral target together with other novel
bronchodilators with alternative mechanisms
approaches.
which additionally offer the opportunity
for combination with our anticholinergic
compounds.
Our R&D activities in HIV aim at developing new
treatment options, especially for HIV patients
who have failed prior therapy due to the develop-
Extending our product portfolio to drugs that
ment of drug resistance. Our research into the
target treatment of the underlying inflammation
rapidly growing resistance problem has identified
and the tissue remodelling process are the key
a promising new non-nucleoside reverse tran-
goals in our COPD research. Inflammation in
scriptase inhibitor (NNRTI) as a follow-up to our
COPD patients is provoked by an infiltration of
existing HIV treatment viramune® (nevirapine).
the lungs by macrophages and neutrophils. It is
Development is proceeding on this compound
which may become a treatment alternative for
patients who have failed first line NNRTI therapy.
30
Basic research plays an important role for Boehringer Ingelheim.
At the Research Institute of Molecular Pathology (IMP) in Vienna, Austria,
where the fundamental principles and mechanisms of living organisms
are analysed, about 200 researchers from all over the world investigate new
ways forward in science, novel approaches and targets, thereby enriching
applied research. The IMP enjoys a worldwide reputation in research in the
areas of developmental biology and molecular genetics.
In addition, our discovery efforts are addressing
Vienna oncology research centre have success-
several new targets for HIV therapy.
fully completed phase I studies in various cancer
indications. A novel type of triple angiokinase
Oncology
inhibitor, targeting endothelial cell receptors
Every year, more than 10 million people find
responsible for cancer neo-angiogenesis, has
themselves grappling with the medical uncer-
entered phase II of clinical development. A dual
tainties and emotional upheaval of a newly
kinase inhibitor targeting epidermal growth
diagnosed cancer. Fortunately, an increasing
factor receptor and HER2 kinase, has shown
number of patients benefit from surgery, radia-
promising results in patients with advanced solid
tion and medicines, but still there is recurrence of
tumours. And further, a first-in-class cell cycle/
the disease. Thus, there remains a therapeutic
polo-like kinase 1 inhibitor was applied in a
gap to be bridged with innovative and improved
single dose escalation study to patients with
treatments that enhances the quality of life.
advanced solid malignancies. In addition, we are
increasing our efforts in monoclonal antibody
The sequencing of the human genome mean-
based projects for treatment of both solid and
while promises to accelerate the emergence of
haematological neoplasias.
new cancer drugs. While not specifically
designed for cancer research, no other area of
Metabolic diseases
biomedicine has profited more from the Human
Health authorities and governments have been
Genome Project than cancer biology, with deep
alarmed by recent epidemiological data suggest-
insights into the fundamentals of how gene
ing that metabolic diseases, including obesity,
mutations and faulty cellular circuitry lie behind
diabetes mellitus type II and dyslipidemia, will
the aberrant growth, invasion, and metastasis of
grow worldwide by a much greater extent than
cancerous tissues in the body.
previously expected. This has been identified as a
major health problem not only for industrialised
Armed with such insights, we have embarked on
societies but also in, for example, South America,
a major drive to discover and develop innovative
India and China. Particularly worrisome is the
medicines for some of the most common cancers.
increasing prevalence of obesity in children
Cutting-edge research conducted at Boehringer
together with the onset of type II diabetes in
Ingelheim Austria has resulted in promising drug
young adults. This disturbing fact leads to the
candidates moving into clinical development.
forecast that today’s children may have a lower
As presented for the first time at the American
life expectancy than their parent generation.
Association for Cancer Research – European
We are therefore putting great efforts on the
Organisation for Research and Treatment of
metabolic disease field with particular focus on
Cancer meeting in Philadelphia in November
diabetes type II, obesity and dyslipidemia.
2005, three compounds originating from our
31
When Dr Barry Dickson talks about fruit flies, his eyes light up, as he has been working with
Drosophila melanogaster for most of his scientific life. “The focus of my research is to understand
the nervous system at the level of neural circuits and trying to understand how genes direct the
assembly and function of specific circuits. Just as many of today’s major therapeutic targets came
from studies of Drosophila development in the 70s and 80s, we anticipate that our work will open
up new opportunities for the future treatment of neurological disorders,” Dr Dickson says.
In January 2006, the 43-year old Australian, one of the world’s leading developmental neuro
biologists, became Scientific Director of the Boehringer Ingelheim-funded Research Institute of
Molecular Pathology (IMP) in Vienna. Work by his team at the Institute of Molecular Biotechnology
(IMBA) of the Austrian Academy of Sciences showed that a single gene determines the complex
mating ritual of Drosophila. This was a front-page story in the New York Times in 2005.
New therapeutic approaches for the treatment of
Boehringer Ingelheim has been at the forefront of
diabetes type II have the potential of delaying or
research and development in the cardiovascular
even inhibiting the progression of the disease.
disease area for decades, establishing its market
Several research projects even offer the possibil-
presence in the treatment of thromboembolic
ity of preventing manifestation of the illness.
diseases as well as hypertension and consequen-
We were successful in several of our research
tial diseases. Ongoing research efforts in the
projects and have achieved promising results in
thromboembolic area could be successfully
preclinical but also clinical trials. In obesity there
completed by advancing a new product into pre-
is a great need for new drugs that are more
clinical development. We will continue to
efficacious than the existing ones while provid-
develop our cardiovascular research platform
ing a high level of patient safety. Research in that
in the area of atherothrombosis and widen our
area is directed both at a reduction of appetite
research to include heart failure.
and food intake as well as increasing the metabolism of energy carriers. We have established
To address the ever-increasing unmet medical
state-of-the-art technologies to carefully profile
need for treating these cardiovascular diseases,
advanced compounds in vitro and in vivo.
our Ridgefield scientists are already focusing on
innovative approaches to identify novel and
Despite efficacious treatment for the lowering of
effective drugs that reach beyond current treat-
low-density lipoprotein (LDL) cholesterol, 60 %
ment regimes.
to 70 % of cardiovascular events still cannot be
prohibited. The role of low levels of high-density
These programmes will benefit from close inter-
lipoprotein (HDL) cholesterol and malfunction of
action with research scientists in our other drug
the reverse cholesterol transport are hence areas
discovery units. Targeting related human dis-
of increasing research interest. We have started
eases, such as metabolic and immunological/
several new research projects to address that
inflammatory disorders, will undoubtedly
therapeutic need.
increase the opportunities for developing novel,
innovative therapeutic agents in the fight against
Cardiovascular diseases
cardiovascular disease.
With cardiovascular diseases forecasted to be the
most common cause of premature death world-
Central nervous system diseases
wide within the next decade, according to the
According to WHO predictions, diseases of the
World Health Organization (WHO), we commit-
central nervous system will constitute an
ted ourselves to renewed efforts in this therapeu-
increasing medical need this century, attributable
tic area by moving our cardiovascular research to
to an exponential increase of these diseases after
Ridgefield in 2003.
32
Photo: IMP
the age of 65 combined with an aging population.
Immunology & inflammation
To date, available therapeutic treatments are still
Autoimmune diseases such as rheumatoid
unsatisfactory for the majority of CNS diseases.
arthritis, multiple sclerosis and psoriasis are
serious chronic inflammatory disorders with
Our research in CNS diseases therefore focuses
a large unmet medical need for safer and more
on novel treatment concepts for the major neuro-
efficacious treatments. At our Ridgefield site,
degenerative disorders, Alzheimer’s and Parkin-
our drug discovery efforts aim to regulate the
son’s disease, prominent consequences of the
processes involved in lymphocyte trafficking,
aging population. An additional focus lies on
immune cell signalling and the synthesis of
chronic pain, a condition for which medical
critical inflammatory mediators. Additionally,
attention is sought most frequently. New molecu-
we aim to deploy our knowledge about the
lar targets, such as ion channels and G-protein
influence of the immune and inflammatory
coupled receptors (GPCRs), which are involved
systems on diseases in other therapeutic areas.
in pain transduction pathways and have been
In that regard, small molecule inhibitors of
validated in neuropathic and inflammatory pain
immunological signalling are being tested for
models, form the basis for our drug discovery
their activities against inflammatory diseases
efforts in the chronic pain indication. Our drug
as well as respiratory diseases that have an
discovery activities in the indication migraine
inflammatory component. Small molecules,
address a new mechanism of action to interfere
able to inhibit inflammatory processes, have also
with cerebral vasodilation for which we have
advanced into pre-clinical development and
obtained clinical proof of concept.
others are currently being evaluated for key
Our research efforts to interfere with disease
rheumatoid arthritis has allowed our scientists
progression in Alzheimer’s and Parkinson’s
the identification of new approaches to under-
decisions. The mechanistic understanding of
disease focus on targets established by pathology
standing the biology of the disease that we hope
and genetics. Our activities in Alzheimer’s
will continue to lead to further innovation in the
disease are, for example, aimed at reducing
future. Given the recent success of biologics in
amounts of the amyloid-beta peptide, the major
autoimmune diseases, such as rheumatoid
mediator of this fatal disorder and additionally
arthritis and psoriasis, the focus of NBE research
searching for pro-cognitive therapies beyond
has been applied to these diseases. In order to
acetylcholine restoration in this disease.
maximise our portfolio, we have in-licensed an
Moreover, we are investigating approaches for
antibody from the biotechnology company
reducing treatment-induced motor complications
AbGenomics that targets activated T lymphocytes
(dyskinesias), a major medical problem for
patients with late stage Parkinson’s disease.
33
sparing the early immune response and therefore
collaboration with the German biotech company
shows promise as therapy for autoimmune
Evotec now also includes the joint identification
diseases. Progress has also been made in the
of novel ligands to selected Boehringer Ingel-
identification of antibodies targeting the inflam-
heim target proteins.
matory cascade, further building our NBE portfolio. Given the variety of approaches and the
In line with our vision to expand our R&D
focus on the mechanistic understanding of
portfolio of biopharmaceuticals, in particular
disease pathogenesis, we are confident that our
monoclonal antibodies, partnering in this area
research in immunology and inflammation will
was a very important goal in 2005. The biotech
result in improved treatment options for patients
companies MorphoSys and Medarex have devel-
who suffer from autoimmune diseases.
oped innovative and complementary technologies for the generation of fully human mono-
In-licensing and partnering
clonal antibodies. We have concluded collabora-
Our alliances range from early stage research to
tions with both companies enabling our
development and marketing or co-promotion
researchers to exploit these technologies in all of
collaborations. Complementing our in-house
our therapeutic areas. The collaboration with
R&D efforts, these tie-ups are a vital component
MorphoSys was extended and has already
of our search for novel therapeutics which pro-
resulted in the start of a new antibody project
vide new treatment options for patients.
against a novel target molecule involved in
cardiovascular diseases. In addition, we have
Reflecting the growing importance of alliances in
explored collaborations with companies highly
the pharmaceutical industry, Boehringer Ingel-
specialised in proteomics based identification of
heim has stepped up its partnering activities in
biomarkers (Caprion, Canada) and modulation of
recent years, particularly in early stage collabora-
delivery of bioactive proteins (Syntonix, USA).
tions. In its October 2005 issue, Nature Reviews
Furthermore, we have signed an exclusive licens-
Drug Discovery characterised Boehringer
ing agreement with the Taiwanese company
Ingelheim as one of the top ten pharmaceutical
AbGenomics for the worldwide rights to develop,
deal-makers worldwide. When deal activity was
manufacture and commercialise the human
adjusted against ethical sales, we even ranked
monoclonal antibody AbGn 168, discovered by
number one in the analysis.
AbGenomics in cooperation with the National
Taiwan University. Due to its innovative mode of
A key example of our partnerships in 2005 was
action, AbGn 168 has the potential to open up
the worldwide exclusive research and license
new avenues for the treatment of autoimmune
collaboration with the Swedish biotech company
disease, such as psoriasis, rheumatoid arthritis
Biolipox. Based on a new approach to the inhibi-
and multiple sclerosis. This agreement represents
tion of prostaglandin E2, an important endog-
the first R&D partnership between a Taiwanese
enous inflammatory mediator, the aim of the
biotech company and a multinational pharma-
collaboration is to develop a new class of drugs
ceutical corporation and illustrates our drive to
with a novel mechanism of action for the treat-
tap new R&D resources in emerging markets.
ment of pain and inflammation. In 2005, we also
It has also given a significant boost for Taiwan’s
extended two existing agreements with our
efforts to build up a biotechnology industry.
partners Evotec and Astex. In addition to a
substantial discovery programme to identify and
develop therapeutics acting on G-Protein
Coupled Receptors (GPCRs), the scope of our
34
Clinical development and registration
graphic territories outside of Western Europe
Both for clinical development and registration
and North America has supported the progress in
2005 was again very dynamic and resulted in
our clinical trial activities. Eastern Europe and
remarkable progress in many areas. Our clinical
Southeast Asia benefited most from our strength-
programmes in clinical phases I to IV added
ened clinical trial platform established in these
another 32,000 patients newly recruited on top
regions. We will continue to build on our
of the large programmes ongoing from last year.
extended reach and are encouraged by the
More than ever, the contribution from geo-
impressive quality delivered in these countries
(see table).
Boehringer Ingelheim Clinical Trial Statistics
During the period from 1996 to 2005, Boehringer Ingelheim conducted or sponsored 1,399 studies
with 142 substances in 59 countries from all regions of the world.
Study type
number of protocols
Phase I
344
Phase II
161
Phase III
229
Phase IV
115
PMS studies
183
Consumer health care
61
Other*
73
Co-sponsored studies
233
The studies enrolled approximately 1.2 million patients during this decade, of which 300,000 were in Phase I–IV studies
and over 700,000 in PMS studies (post-marketing surveillance). The term “patient” refers here in a wider sense to
patients receiving test medication, comparative medications, receiving placebo, marketed medication, or being healthy
volunteers. Detailing these numbers by region and clinical phases reveals a broad geographical distribution with
emphasis on North America and Western Europe.
Region
Africa
I—III
IV
Other
PMS
8,188
2,553
–
–
59,829
28,745
3,676
36,275
America, S & L
5,707
6,660
96
52,019
Asia (Japan)
7,531
1,890
–
16,924
Asia (other)
4,028
13,972
113
140,692
Australia
4,658
2,903
36
America, North
Europe, East
Europe, West
Near East
Total
–
5,705
11,367
296
3,065
105,485
36,254
166,636
482,476
582
436
–
–
201,713
104,780
170,853
731,451
February 2006
The category “other” includes, for example, compassionate use and methodological studies.
35
Before new drug candidates can be
given to patients in clinical studies
to test their efficacy, they are first
studied in healthy volunteers,
as here at the Human Pharma
cology Center at Biberach, Germany.
This provides valuable information
about the safety profile and
tolerability of the substances.
Important new registrations were also obtained
In the USA, mobic® was approved for juvenile
in 2005. The US Food and Drug Administration
rheumatoid arthritis. Our successful clinical
(FDA) granted accelerated approval for aptivus®
development in this paediatric indication is an
in June and European registration under excep-
important contribution towards a great medical
tional circumstances was granted in October.
need and was additionally honoured by an
Following these approvals, our second HIV drug
extension of US market exclusivity.
after viramune® has reached the market and
adds an important treatment option for heavily
cymbalta® a brand of duloxetine licensed from
pre-treated patients who have developed resistant
Eli Lilly & Company, co-developed in post-
virus and depend on new drugs with improved
registration studies and marketed for the treat-
resistance profile.
ment of depression, received registration in
spiriva®, the once daily maintenance treatment
Europe for the additional indication diabetic
for COPD was approved in France and is now
neuropathic pain.
approved in 97 countries. Fast worldwide registration and numerous excellent clinical trial
Without exception, all of our large-scale clinical
results have facilitated its rapid growth into the
outcome studies continued according to plan.
leading COPD treatment position. The phase III
The micardis® mega-trial ontarget™/
programme for spiriva® administered through
transcend with 31,000 patients recruited has
the innovative propellant-free soft mist inhaler
undergone repeated independent Drug Safety
respimat® was successfully completed and
Monitoring Board (DSMB) review and is in its
registration files are under development.
second year after last patient included. With a
As planned, we submitted sifrol® the leading
from similar trials, the likelihood that we
Parkinson’s medication simultaneously to the
will have results available as planned in 2008 is
patient retention rate clearly above that known
US FDA and the European Medicines Agency
further reinforced. A proof of concept study to
(EMEA) for approval in the new indication
investigate a newly identified pharmacologic
restless legs syndrome. We expect regulatory
mechanism of micardis® and its metabolic effect
review to be completed in 2006.
in patients with type II diabetes has been completed. Results will be available in early 2006.
The excellent and very rapid patient uptake for
the long-term factorial secondary stroke prevention study profess® comparing aggrenox®,
micardis® and clopidogrel allowed us to
36
increase the planned patient number to 18,500
metalyse®, our bolus injection thrombolytic,
and still expect the last patient to be included in
has been investigated in two exploratory settings:
early 2006.
lysis followed by routine primary percutaneous
uplift, our 6,000-patient long-term outcome
intervention (PCI) after myocardial infarction
study with spiriva®, is also in stable follow-up
(assent iv trial) and as rescue intervention
with DSMB review and approval and patients
during reanimation in cardiac arrest (troica
treated up to three years.
trial). While assent iv has been discontinued
Results from several well-controlled clinical
because routine combination of lysis and PCI
studies have become available, enhancing its
was inferior to PCI alone, troica is continuing
profile spiriva® was shown to improve and
and will complete recruitment in 2006.
extend the beneficial effect of pulmonary
rehabilitation in patients with moderate to severe
In all our therapeutic areas clinical pipeline
COPD. In a comparison of spiriva® combined
projects in phase I to III have been advanced.
with a long-acting beta agonist (LABA) versus
the combination of a LABA and an inhaled
Three new compounds entered clinical phase I,
steroid, the spiriva®-LABA combination resulted
two in respiratory, one in oncology.
in superior lung function improvements. This
confirms the international guideline recommen-
Phase I was successfully completed by our oral
dation to first combine long-acting bronchodila-
LFA antagonist with positive ex vivo signals
tors before adding a steroid. spiriva® also
suggestive of immune modulatory effects. We
confirmed its clinical efficacy in a selected Afro-
will therefore start phase II proof of concept
American patient population and demonstrated
studies in patients with psoriasis early next year.
excellent lung function improvements in a study
Already in an expedited phase I study we could
in patients with mild COPD. Earlier clinical trial
establish a clear proof of principle for a new oral
results on COPD exacerbation reduction and
anti-diabetic drug when given to type II diabetic
improvements in exercise performance have been
patients. Results from extended exposure in
submitted for registration in Europe.
diabetic patients will complete the clinical profile
and are expected for early 2006.
The robust clinical data base for sifrol® (prami-
In the important respiratory field, we advanced a
pexole) in the treatment of Parkinson’s disease
new anti-cholinergic compound to clinical phase
was acknowledged in a review article in the New
II in patients with COPD. We expect this com-
England Journal of Medicine where pramipexole
pound to provide beneficial effects through
was recommended as starting treatment of choice
increased target selectivity and maintenance of a
in early Parkinson’s disease.
very reliable 24-hour efficacy.
37
In addition to the first clinical administration of
The most exciting progress has been made for
a new cell cycle inhibitor in patients, our first
dabigatran, an orally available thrombin inhibi-
angiokinase inhibitor has achieved proof of
tor for the prevention and treatment of thrombo-
principle in phase I as an anti-cancer drug active
embolic diseases. The programme in the preven-
in patients suffering from a variety of different
tion of deep vein thrombosis (DVT) following
cancers. With this encouraging result we could
orthopaedic hip or knee replacement surgery has
move the first oncology compound from own
developed with impressive speed and recruited
research to clinical phase II.
more than 6,000 patients into controlled phase
III trials by the end of the year. We expect all
With NS 2330, a compound licensed from Neuro-
three international trials to close in the second
search, results of three well-performed proof of
half of 2006. In a large global cooperative
concept trials in early and advanced Parkinson’s
approach with leading academic centres we
disease and in Alzheimer’s disease were disap-
developed the final protocol for re-ly, the
pointing and did not meet our predefined efficacy
pivotal trial in the indication stroke prevention
criteria to justify a phase III development.
in patients with atrial fibrillation. The protocol
for this 15,000 patient warfarin controlled mega-
For flibanserine, a new therapeutic principle to
trial passed successful authority review and the
treat hyposexual desire disorder in females, the
first patients were randomised in December 2005.
final phase III development has been agreed with
The programmes for DVT treatment and long-
the FDA and several methodology studies in
term prevention are in preparation and sched-
support of the pivotal phase III studies have been
uled to start mid-2006.
performed. The first six months phase III study
Our capability to perform electronic remote data
to be conducted in North America is in final
capture in practically every country of the world
preparation and ready to initiate in QI 2006.
was strengthened in cooperation with a leading
computer technology provider. This enables us to
meet the challenges of our growing clinical
programmes, deliver quality data in an expedited
fashion and extend our clinical trials to geographic regions with new opportunities.
38
Our Businesses consist of Human
Pharmaceuticals and Animal Health.
We focus on the production of
innovative drugs and treatments
that represent major therapeutic
advances.
2005
Net sales (in EUR million)
2004
7,822
6,183
– Branded Prescription Medicines
5,743
6,712
969
17 %
440
535
95
22 %
Consumer Health Care
970
1,052
82
8 %
Industrial Customer
654
847
193
30 %
— and Manufacturing Pharma
262
299
37
14 %
— Biopharmaceuticals
392
548
156
40 %
15
28
13
87 %
335
361
26
8 %
8,157
9,535
1,378
17 %
– Non-Branded Prescription Medicines
Growth
in %
9,174
1,352
17 %
7,247
1,064
17 %
— Fine Chemicals
Others
Animal Health
Total
40
A new quality
of treatment,
a new quality
of life
“I long to run, but I actually make it a rule to go for a brisk walk around a park
twice a week since starting to take spiriva® in December 2004,” says Hiroshi Aida,
a 76-year-old man from Tokyo, who used to run out of breath even on the gentlest
slope due to chronic obstructive pulmonary disease (COPD). “Today, I can walk the
1,800-metre course twice without strain and my finishing time is quicker every time.
The drug works like a charm.” Mr Aida now has a dream of walking from Tokyo
to Kyoto, about 510 kilometres, before his 100th birthday. Recently, he successfully
completed a 10-kilometre walk.
41
“spiriva® has obviously improved Mr Aida’s
Around 80 % of cases are attributed to smoking
quality of life,” comments Mr Aida’s family doctor,
tobacco. In fact, smokers are 10 times more likely
Dr Kozui Kida, Professor and Director of the Res-
to die of COPD than non-smokers. Another cause
piratory Care Clinic, Nippon Medical School. Six
of COPD is exposure to indoor or outdoor pollut-
million people are estimated to suffer from COPD
ants. Workers exposed to toxic chemicals and
in Japan alone, but only some 20,000 are currently
pollutants have increased odds of developing
receiving treatment for the condition. This mis-
COPD. A recent study found that some 20 % of
match is not just a Japanese issue. “COPD stays
COPD was attributed in part to work-related
undiagnosed in many cases,” says Professor Bart
exposure.
Celli, Head of Pulmonary and Critical Care Medicine, St Elizabeth’s Medical Center, Boston. “This
is presenting a very serious problem.”
“spiriva® has obviously improved
Mr Aida’s quality of life.”
Millions of people around the globe suffer from
COPD which the World Health Organization
expects to be the third most common cause of
death worldwide by 2020. This debilitating lung
condition makes it increasingly difficult to breathe.
For many patients even walking or performing
simple daily tasks is difficult. It can affect both
men and women from their early 40s.
42
spiriva® (tiotropium bromide), discovered, developed and manufactured by Boehringer Ingelheim
has further strengthened the company’s position
as a world leader in COPD treatment. The novel,
once daily inhaled medication is recommended
for the first line maintenance treatment of COPD.
The disease is characterised by chronic airflow
limitation, shortness of breath (dyspnoe), cough,
wheezing and increased sputum production.
spiriva® helps to relax narrowed muscles in the
airways inside the lungs or prevent them from
Revolutionising
drug delivery
narrowing (and to release trapped air), enabling
sufferers to exhale more easily.
Boehringer Ingelheim is revolutionising inhaler therapy
spiriva® is already the world’s most prescribed
inhaler device successfully launched in 2004 with
drug for COPD. The highly favourable reception it
berodual®, a drug for treating asthma and chronic
has had since its initial launch in mid-2002
obstructive pulmonary diseases (COPD).
with the respimat® Soft Mist™ Inhaler (SMI), a unique
secured it blockbuster status (a pharmaceutical
brand with annual sales exceeding USD 1 billion)
“As a world leader in the treatment of COPD, we are
as expected, in 2005, with net sales of 951 million.
committed to developing the respimat® SMI as the gold
It is co-promoted with the US pharmaceutical
standard for the administration of respiratory inhalation
company, Pfizer Inc. Following the launch in
medications,” says Allan Hillgrove, head of Boehringer
Japan, the world’s second largest pharmaceutical
Ingelheim’s Respiratory Marketing.
market, and in China in 2005, the medication is
now available in almost all important markets.
After the acquisition of the Dortmund (Germany) based
microParts GmbH, a leading company in micro-system
Kim Jong-Hyun, a South Korean farmer and
technology, Boehringer Ingelheim is currently developing
former heavy smoker, now in his early 60s, recalls
several substances for use with respimat®. Boehringer
his situation when, after suffering from cold
Ingelheim microParts will meanwhile be built up as an
symptoms, heavy sputum and difficulties in
international centre of excellence for inhaler technology.
breathing for months, he decided to visit the
general hospital in Seoul. “When I was working,
For more information on respimat®
walking and even doing minor things, I had
please visit www.respimat.com
difficulties in breathing. I thought that I could not
ignore the symptoms any longer.” Mr Kim feared
his life was slowly coming to an end after he was
told that he had COPD.
Initial medication failed to restore any normality
to his life, but on switching to spiriva® in early
2005 he got much better. “Now I can work on the
farm and take care of my cows. I feel like I have a
second new life when walking in the sunshine.”
Real improvement has also been confirmed in
clinical studies, such as the tiphon* study, presented to the American Thoracic Society in 2005.
Fifteen times finer than human hair, the micro-channels (5 μm)
Dr André-Bernard Tonnel, Service de Pneumolo-
inside the respimat® Soft Mist™ Inhaler are responsible for the highly
gie et Immuno-Allergologie, Centre Hospitalier
effective distribution in the human lung of the mist containing
Regional et Universitaire de Lille and the study’s
respiratory medication. The inhalers are manufactured in Dortmund,
lead investigator, said: “The tiphon study results
Germany, by microParts, a Boehringer Ingelheim subsidiary.
are encouraging because they show that treatment
with spiriva® can result in clinically significant
and sustained improvements in health–related
quality of life for patients with COPD.” n
43
Boehringer Ingelheim’s product range is mainly focused on human pharma
ceuticals, which contribute the largest share of the turnover of our group of
companies, accounting for 96 % of net sales in 2005. Human Pharmaceuticals
covers the following business segments: Branded Prescription Medicines
(BPM), Generic Prescription Medicines (GPM), Consumer Health Care (CHC)
and Industrial Customers, which is sub-divided into Biopharmaceuticals,
Chemicals and Manufacturing Pharma. Our Human Pharmaceuticals business
developed very dynamically in 2005. World sales rose by 17 % compared with
the previous year to EUR 9.2 billion, primarily due to our innovative patented
medications. The successful growth reinforces our approach of continuing
intensive research into new drugs that offer relief and improvement for
patients.
Branded Prescription
Medicines (BPM)
Therapeutic areas
BPM, which accounts for almost 70 % of our sales,
Chronic obstructive pulmonary disease (COPD),
expanded markedly in 2005, with worldwide
a chronic progressive respiratory disease charac-
sales rising by 17 % to EUR 6.7 billion.
terised by chronic airflow limitation, shortness of
Respiratory diseases
breath, cough, wheezing and increased sputum
Sales growth was mainly driven by the growth of
production, can restrict a patient’s ability to
our more recent drugs micardis®, spiriva® and
perform normal daily activities. It is the fourth
sifrol®/mirapex® but more mature products,
leading cause of death in the world.
such as aggrenox® and mobic®, continued to
contribute to the excellent development too.
spiriva® (tiotropium bromide), a novel once daily
Meanwhile, the launch of new products – aptivus®
inhaled medication recommended for first line
and cymbalta®/xeristar® – contributed to the
maintenance treatment of COPD, works by
further rejuvenation of our product portfolio.
targeting a dominant reversible mechanism of
Top 10 products
Branded Prescription Medicines
44
Sales Branded Prescription Medicines
by Therapeutic Area
Net sales 2005
in millions of EUR
change
1. spiriva®
951
+81.2 %
2. mobic®
848
+26.1 %
3. micardis®
724
+27.3 %
4. flomax®
721
–2.0 %
5. combivent®
561
+9.8 %
6. sifrol®
434
+52.2 %
7. viramune®
288
+2.0 %
8. atrovent®
248
+0.7 %
9. catapresan® 176
–2.1 %
10. aggrenox®
172
+17.8 %
Gastrointestinal/
Metabolic 3.4 % Others 1.6 %
HIV 4.6 %
Central Nervous System
9.3 %
Respiratory
34.8 %
Muscoloskeletal/
Rheumatology
13.0 %
Urology
11.4 %
Cardiovascular
21.9 %
COPD – cholinergic constriction. It helps patients
spiriva®, currently delivered to patients via our
breathe more easily by opening narrowed airways
HandiHaler® device, will be used in the future
and helping to keep them open for 24 hours.
with respimat® Soft Mist™ Inhaler (SMI). This
spiriva®, globally co-promoted with Pfizer Inc,
propellant-free, new generation inhaler, which
is now available to patients in most of the world.
generates a slow-moving, long-lasting cloud with
In France the launch is planned in 2006.
a high fine particle fraction, represents a major
The benefits which spiriva® provides to patients
travels more slowly and lasts longer than aerosol
step forward in inhalation therapy. The soft mist
are reflected in sales of EUR 951 million in 2005
clouds from pressurised metered dose inhalers
and market shares of 20 % or even more on a
(pMDIs). Scintigraphic studies have shown that
country basis. It has achieved blockbuster status.
these properties increase drug deposition in the
More importantly, spiriva® is now the world’s
lungs where desired and reduce unwanted deposi-
No. 1 prescribed product for COPD.
tion in the mouth and throat compared to pMDIs.
It is important that patients feel comfortable with
The spiriva® clinical trials programme has
inhalers as this may influence adherence to treat-
recruited over 25,000 patients so far. The drug has
ment. Patients with obstructive lung diseases
demonstrated significant and sustained broncho
prefer respimat® SMI to pMDIs, expressing a
dilation (opening of the airways) and reduction in
high level of satisfaction.
markers of air trapping. It has also demonstrated
superior and sustained improvements in lung
function (FEV1) over atrovent® (ipratropium
bromide) Inhalation Aerosol, which were main-
Cardiovascular diseases
tained over one year. Further, it has demonstrated
Hypertension (high blood pressure) is a serious
superior improvement in key lung function
cardiovascular risk, linked to stroke and heart
parameters over salmeterol. In addition, in
attack as well as other conditions.
placebo-controlled studies, patients treated with
spiriva® required fewer doses of rescue medica-
It is vitally important that therapy controls this
tions, had fewer exacerbations and COPD-related
high blood pressure, but, despite available
hospitalisations.
treatment options, hypertension is still not well
controlled. An estimated 45–73 % of hypertensive
In another part of the clinical trial programme the
patients in the USA remain uncontrolled. This is
influence of spiriva® on the exercise endurance
of particular concern as hypertension increases
has been studied. It improved the capability of
the risk of cardiovascular events and reducing
patients to exercise in a consistent way in 6-24
blood pressure may prevent cardiovascular
week studies and showed a reduction in hospi-
mortality and morbidity. Among patients with
talisation as well as an improved quality of life.
stage 1 hypertension, a reduction of 12 mmHg in
systolic blood pressure for 10 years prevents one
death for every 12 treated patients with diabetes or
cardiovascular diseases. Even small reductions of
3 to 5 mmHg produce significant reductions in
stroke or heart failure (Source: American Journal
of Medicines, 2005, 118: 695-705).
With micardis® (telmisartan), our angiotensin II
receptor blocker (ARB), and micardisplus®
(telmisartan in a fixed-dose combination with the
diuretic hydrochlorothiazide), Boehringer Ingelheim offers two innovative options and flexibility
for the treatment of essential hypertension.
45
Protection
around the clock
micardis® has the longest half-life in the ARB
“In treating hypertension, the early morning hours are
powerful blood pressure reductions.
class, providing effective blood pressure control
over 24 hours with a once daily dosage, including
the early morning hours when blood pressure
surges. At this critical time of day, it delivers
critical, as blood pressure is known to surge at that
time. This surge corresponds to a sharp increase in the
micardis®/micardisplus® posted net sales of
risk of having a heart attack or stroke. Studies have
EUR 724 million in 2005, representing growth of
shown an estimated 40 % more people suffer a heart
27 % and making it our third biggest BPM product.
attack and 50 % more people suffer a stroke between
Having grown above the market average for anti-
6 a.m. and 12 noon,” says Professor Bryan Williams,
hypertensives (34 %), its global market share
University of Leicester and lead investigator of the
improved to 7.6 %.
prisma studies.
In the protection programme of clinical trials
micardis® (telmisartan), Boehringer Ingelheim’s
with micardis®, five trials versus main competi-
successful, highly efficacious drug for treating essential
tors have provided new important clinical data for
hypertension, offers 24-hour blood pressure control,
micardis® and micardisplus® in hypertension,
and also provides superior blood pressure lowering
showing clear clinical superiority over ramipril,
compared to ramipril in the early hours. It is being
losartan, valsartan, and amlodipine + HCTZ. The
evaluated for its potential to protect end-organs, such
detail study, published in the New England Jour-
as the kidneys or the brain, as well as the potential to
nal of Medicine in November 2004 in diabetic
delay the onset of diabetes II in patients with increased
nephropathy has put micardis® in the map of
risk, in the ontarget™ trial.
nephro-protection. The trendy study reported in
major congresses in 2005 supported the nephroprotective benefits of micardis® and three addi-
Systolic blood pressure (in mmHg)
in relation to time (wakening hours)
(0 = wake-up time)
tional renal trials will consolidate the profile of
the brand in this area in 2006.
160
The landmark trials ontarget™ (in patients of
high cardiovascular risk, with 31,700 randomised
150
patients) and profess® (in patients with previous
140
aiming to prove the cardio and cerebro-vascular
stroke with 15,000 patients already recruited),
protection properties of micardis®, are proceeding on schedule. Results of these trials are expected
130
-4
-2
0
2
4
6
8
10
12
14
16
18
hours
in 2008.
The good acceptance of the product in 2005 provide an excellent platform to put micardis® on
track to become another blockbuster.
For additional information please visit our
websites at
www.micardis.com / www.ontarget-micardis.com
Every year, approximately three million people
worldwide suffer from acute myocardial infarction (AMI), or heart attack. However, only about
47 % are diagnosed and treated. About 53 % are
46
either not recognised or are beyond treatment.
actilyse® (alteplase), is indicated for the thrombo
The most important factor for a successful treat-
lytic treatment in AMI as well as in thrombolytic
ment of AMI is time to treatment. Thrombolytic
treatment in acute massive pulmonary embolism
therapy, established as one of the most successful
with haemodynamic instability. It has also a
modern AMI treatment options, is easy to apply,
conditional license for the treatment of acute
available in all hospitals and considered safe in
ischemic stroke (see below).
view of the serious nature of the disease.
metalyse® (tenecteplase), the only thrombolytic
to be administered as single shot injection, is also
registered for the thrombolytic treatment in AMI
for patients, in whom a coronary intervention
cannot be performed within 90 minutes of onset.
With its ease of administration, metalyse® is
very well-suited for pre-hospital and in-hospital
thrombolysis to keep the time from onset of
symptoms to effective treatment as short as
possible.
Both products continued to be leaders in their
The Stroke Lysis Box from Boehringer Ingelheim
class and posted combined net sales of EUR 151
enables hospital emergency departments to provide
million, giving a 57.7 % market share in this com-
rapid clot-busting treatment.
bined class of fibrinolytics.
Telemedicine helps stroke victims
Acute ischaemic stroke is caused by blood clots in the brain and requires urgent specialist attention.
those in rural areas do not always have access to specialist care. New technologies can link rural
hospitals with specialist centres. Remote patient interviewing, data transmission and video
conferencing are available 24 hours a day to all hospitals linked in the network. The benefit to the
patients is twofold: they now have access to this modern treatment and the treatment is started
by very experienced people. This allows a greater proportion of acute stroke patients to be assessed
for thrombolysis with Boehringer Ingelheim’s actilyse® (alteplase), the only medication available
Photo: Lennart Nilsson
However, only 30 % of acute stroke patients reach hospital within the first three hours. Particularly
for the treatment of acute stroke.
47
Stroke treatment and prevention
Stroke is the third leading cause of death and the
most important reason for medical disability. In
industrialised countries some five people in every
1,000, and three in every 100 people aged 65 years
and above, suffer a stroke. A stroke occurs when a
blood clot blocks a vessel or artery in the brain
(ischaemic stroke), or when a blood vessel ruptures
(haemorrhagic stroke), interrupting blood flow to
an area of the brain. A stroke kills brain cells in
the immediate area within a few minutes or a few
hours.
actilyse® is the first and only treatment indicated
for acute ischaemic stroke within three hours after
onset of symptoms. With sits most and sits
istr, Boehringer Ingelheim is sole sponsor of the
largest international stroke registry, providing
Diseases of the central
nervous system (CNS)
Parkinson’s disease affects approximately 1 % of
people over 60, but Parkinson’s can also afflict
people much younger. It is caused by a slow,
gradual loss of specific cells in the brain that
produce a chemical called dopamine which is
ultimately necessary for normal muscle function.
The disease is characterised by three main symptoms: slowness of motion, stiffness and shaking of
arms, legs or head.
Pramipexole, a dopamine agonist, is indicated for
the symptomatic treatment of Parkinson’s disease,
alone or in combination, throughout all stages of
the disease.
stroke experts worldwide with a valuable tool for
documenting and monitoring stroke patients.
For more information please visit the website:
www.stroke-forum.com
aggrenox® / asasantin® / asasantin retard®
(dipyridamole/ASA) is indicated to reduce the risk
of secondary stroke in patients who have had
transient ischaemia of the brain or completed
ischaemic stroke due to thrombosis. It posted net
sales of EUR 172 million in 2005, with growth of
18 %.
With profess®, the world’s largest trial in secondary stroke prevention, Boehringer Ingelheim
is aiming to prove that aggrenox® is superior to
clopidogrel. The trial, conducted since 2002, will
involve 18,500 patients in 32 countries. The outcome is expected in 2008.
The compound is internationally marketed as
mirapex®, mirapexin®, sifrol® or pexola®.
mirapex®/sifrol® continued to show strong
growth in 2005, in part due to the launch in Japan.
At the end of 2005, it ranked No. 6 among our bestselling products, with total net sales of EUR 430
million, up 52 % against 2004. It is the world’s
best-selling brand for Parkinson’s disease, with a
market share of more than 20 %.
The clinical development of mirapex®/sifrol®
has been completed for restless legs syndrome
(RLS), a sensorimotor disorder characterised by a
distressing urge to move the legs and sometimes
other parts of the body. It is usually accompanied
by a marked sense of discomfort or pain in affected
body parts. A comprehensive clinical development
programme with more than 1,000 patients in the
USA and six European countries, completed in
48
2005, showed significant improvements in RLS
symptoms, rapid onset of action and an excellent
tolerability profile. Regulatory dossiers for the
approval of mirapex®/sifrol® for RLS were filed
in 2005 in the USA and the EU.
Major depressive disorder (MDD), a common disorder of complex, often recurring symptoms
affecting mind and body, can be life-threatening
and certainly disabling, according to World Health
Organization (WHO) research. The neuropathology of depression is not fully understood but the
two neurotransmitters serotonin and norepine
phrine seem to play a major role in the develop-
Stilling
restless legs
“The feeling is very irritating and I cannot sit
still. It is frustrating because I can feel the
‘bubbles’, but I cannot make them disappear.
The only way I can stop this feeling in my
legs is to move them and to walk,” says
Katrin Scherman from Sweden, who spent
25 years of her life enduring the symptoms
of RLS before seeking treatment. Restless
legs syndrome (RLS) is a neurological
disorder characterised by an uncontrollable
urge to move the legs, usually accompanied
by unpleasant and sometimes painful
sensations which worsen at night. Social
activities, including travelling, can also be
severely affected by RLS, as sufferers can
find sitting still very painful or difficult, espe-
ment and course of the disease.
In November 2002, Eli Lilly and Company and
Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialise
duloxetine hydrochloride. Duloxetine for MDD
and diabetic peripheral neuropathic pain (DPNP)
is internationally marketed under the brand
names cymbalta® and for Boehringer Ingelheim
in Greece, Italy and Spain as xeristar®.
cymbalta®/xeristar® is a potent and balanced
dual reuptake inhibitor of both serotonin and
norepinephrine that provides rapid, sustained
relief of the emotional and painful physical symptoms of depression and gives patients a better
chance of getting well and staying well. In 2005,
major milestones were achieved with marketing
authorisation for MDD in the EU and other parts
of the world. cymbalta® had been launched in 20
countries by December 2005.
cially in the evening. Recent clinical studies
showed that pramipexole, with its fastacting effect on a broad range of RLS
symptoms, cannot only provide rapid relief
from RLS symptoms, but also suggest
significant sustained efficacy. Pramipexole,
a compound from Boehringer Ingelheim
research, was first approved in 1997 and is
available in major countries worldwide under
the trade names sifrol®, mirapex® and
mirapexin® for the symptomatic treatment
of idiopathic Parkinson’s disease. Boehringer
Ingelheim anticipates approval in 2006 in
Europe and the USA for the treatment of RLS.
49
Serotonin and norepinephrine also play a major
results in wake-up several times at night with
role in the neuronal modulation of pain signals.
urgent need to urinate (nocturia), one of the most
cymbalta®/xeristar® has been successfully
bothersome symptoms of BPH.
developed for the treatment of DPNP, which
occurs in approximately 30 % of patients suffering
Stress urinary incontinence
from diabetes mellitus. Symptoms of DPNP
Stress urinary incontinence (SUI) is the involun-
include lancinating pain, paraesthesia and dys-
tary loss of urine with an increase in abdominal
aesthesia as well as pain produced by a normally
pressure caused by a physical activity such as
non-painful stimulus. By effectively de-amplify-
coughing, laughing, sneezing, lifting or exercising.
ing the pain signalling, duloxetine offers a new
Around 97 % of SUI patients are female, but less
approach in the treatment of DPNP patients.
than half of the women suffering from this condition seek treatment.
In November 2002, Eli Lilly and Company and
Urologic diseases
Benign prostate hyperplasia (BPH), a common
Boehringer Ingelheim signed a long-term agree
ment to jointly develop and commercialise
y entreve®/ariclaim® (duloxetine) for treating
disease that occurs in about 25 % of men aged 40
SUI. This partnership covers most countries world
years or over and in more than 30 % of men over
wide.
50, results in lower urinary tract symptoms (LUTS)
In mid-August 2004, EU approval was received
related to obstructions of the urethra and gradual
for yentreve®/ariclaim® for the treatment of
loss of bladder function. These symptoms, such as
women with moderate to severe SUI. In 2005,
frequent need to urinate (particularly at night),
yentreve®/ariclaim® was launched in Greece
urgency, leaking, or dribbling, disrupt the activity
and Italy (by Boehringer Ingelheim as ariclaim®)
and sleep patterns of sufferers, drastically affect-
and in Mexico.
ing their quality of life.
alna®/flomax® (tamsulosin), an alpha receptor
antagonist, is indicated for the treatment of func-
Virologic diseases
tional symptoms of BPH, significantly improving
Boehringer Ingelheim aims to improve HIV/AIDS
symptoms and quality of life. The product was in-
therapy by providing physicians and patients with
licensed in and jointly developed together with
innovative antiretroviral drugs.
Astellas Pharma and is marketed under a license
For more information, please visit the website:
from Astellas Pharma. It achieved net sales of
www.boehringer-ingelheim.com/hiv
EUR 721 million in 2005 and maintained its
market leadership in the USA, where a co-promo-
aptivus® (tipranavir), a non-peptidic protease
tion collaboration with Astellas Pharma started in
inhibitor, works by blocking the viral protease, an
2004.
enzyme needed to complete HIV replication.
Due to its unique chemical structure, aptivus®
In 2005, a new formulation of
preserves activity against viruses which have lost
alna®/flomax® using the ocas®
susceptibility to other treatment options – a sig-
(Oral Controlled Absorption System)
nificant advantage compared to other commer-
technology, was launched in several
cially available protease inhibitors (PI).
European countries. This allows a
50
smoother 24-hour drug release with
When co-administered with low dose ritonavir, it
reduced plasma peaks independent
is indicated for combined antiretroviral treatment
of food intake, resulting in an even
of HIV infection in highly treatment experienced
better safety profile and favourable
(HTE) patients.
Teamwork sets
benchmark
It took only 168 hours after market approval by the US
regulatory authority, the Food and Drug Administration
(FDA), for the first packages of Boehringer Ingelheim’s
novel anti-AIDS-drug aptivus® (tipranavir) to leave the
warehouse for US distribution. Due to the long manufacturing processes, the wheels of our supply chain began
aptivus®, which complements viramune® in our
HIV portfolio, was launched in the USA in July
2005 and in the EU in November 2005.
viramune® (nevirapine) was the first compound
of the new class of non-nucleoside reverse transcriptase inhibitors (NNRTI) to be launched in
1996 as a powerful component of combination
therapy for HIV-1. This product is now available
in about 100 countries which makes it one of the
most widely used compounds in chronic HIV-1
therapy worldwide.
turning well before approval starting with chemical
production of the active ingredient tipranavir and pharmaceutical production. These two different manufacturing
steps were conducted on two continents at Boehringer
Ingelheim’s company site in Ingelheim, Germany and a
third party site – Cardinal Health, USA. After the FDA had
endorsed and released all detailed drug-related information, the company was on the home straight. Printing the
packages and leaflets, packaging, shipment and distribution under refrigerated conditions: the cogs – coordinated by Boehringer Ingelheim’s packaging site Roxane
(Columbus, Ohio, USA) – meshed perfectly. Even with
another step added – release testing and distribution
via our product release site in Ingelheim – aptivus® was
available to patients in Germany and the United Kingdom
within a few days after the subsequent approval in Europe
in October was granted. Early involvement of Operations during the development process was a key success
factor. Numerous challenges arose which called for close
communication between the company’s Research &
Development and Operations divisions as well as with the
external US manufacturing partner to develop the appropriate chemical and pharmaceutical processes. “Seam-
viramune® has also been demonstrated to be
beneficial to prevent transmission from the HIV-1
infected mother to her infant. A single dose to the
mother during labour and a single dose to the
infant after birth has shown to significantly reduce
less cooperation between multi-faceted teams across the
Boehringer Ingelheim development and supply chain, and
beyond, played a key role in the successful initial launch of
aptivus®,” Operations teamleader Joerg Hefer said.
“A new benchmark has been set.”
the HIV transmission rate. This simple and effective treatment, also tested successfully in combination with zidovudine/lamivudine, has particular value in the healthcare setting of developing
countries, and, as such, is recommended by the
WHO. viramune® posted sales of EUR 288
million in 2005.
51
Rheumatologic diseases
Osteoarthritis is the most commonly diagnosed
degenerative joint disease affecting the joints,
especially in elderly people. Signs and symptoms
of osteoarthritis might include joint stiffness and
discomfort often with a sensation of a grinding in
the affected joint. Rheumatoid arthritis, an autoimmune disease that affects the body as a whole,
may also lead to joint destruction.
mobic®/mobec® (meloxicam) is indicated for the
symptomatic treatment of osteoarthritis and
rheumatoid arthritis as well
as ankylosing spondylitis
(Morbus Bechterew). The
drug which became our second blockbuster drug in
2005, posted net sales of EUR
848 million, with a market
share of 14.9 % in the IMS
anti-rheumatic market.
The debate about cost containment, rebates and
reimbursement payments (“Medicare” and “Medic
aid”) continuously put pressure on prices and may
render patient access to innovative products more
difficult. But the ongoing healthcare reform
initiative (“Medicare Drug Benefit”) will provide
access to health services for additional patients.
The impact of this initiative on pharmaceutical
sales volumes and price levels will be seen over
the the next years.
spiriva® was our biggest growth driver in the
region, achieving net sales of EUR 379 million, up
120 % from the previous year. Additional growth
drivers in 2005 were mobic®, combivent® and
sifrol®.
In 2005, Boehringer Ingelheim continued to
increase its field force in the USA and a customer
relationship management (CRM) programme was
successfully implemented. An additional phase of
increased focus on the specific needs of physicians
and their need for individual information will
continue to improve the service level during the
coming years.
In Latin America, economic growth slowed in
Economic Regions
2005 to a more sustainable level compared to the
sharp increase in 2004. Inflation in the region
Americas
stabilised, but remains volatile, with highly fluctuating commodity prices. The currencies of the
The economic environment in the Americas
main countries stabilised against the Euro. Some,
Region developed favourably during 2005. The
like the Brazilian real, even strengthened.
region posted sales of EUR 3.7 billion with a
growth rate of 17 %, representing a 51 % share of
The total pharmaceutical market, including
Boehringer Ingelheim’s Prescription Medicines
branded and generic products, continued to grow,
business. The USA achieved net sales of EUR 3.1
with Mexico up 12.0 %, Brazil up 14.6 % and
billion, corresponding to 18 % growth.
Argentina 12.2 %. However, a stable and dependable development of our BPM business in this
The USA remains the worldwide motor for eco-
region is still hampered by the lack of binding
nomic growth in the innovative pharmaceutical
patent laws, except in Brazil and Mexico.
industry. A highly competitive environment with
free market price development and rapid market
Total net sales of our BPM business in Latin
acceptance for innovations, it offers patients quick
America amounted to EUR 200 million in 2005,
comprehensive access to improved treatments.
an increase of 26 % against the previous year.
The USA will remain the most important market
Growth drivers were mobic®, micardis® and
for Boehringer Ingelheim’s innovative pharma-
selected local products. Currency revaluations
ceuticals for the foreseeable future.
52
The USA remained the
by far most important
market for our drugs.
Europe
2,037
of which: Germany
455
(which accounted for 76 %
of our net sales) had a
turnover of more than EUR
Americas
3,670
of which:
USA branded
2,592
USA non-branded
535
Asia, Australasia,
Africa
1,312
of which: Japan
801
7.2 billion to which US sales
contributed 43 %.
The Europe Region
achieved 28 % of PM net
sales.
Sales Prescription Medicines 2005, excluding licenses (in millions of EUR)
also contributed positively. spiriva® and the
in all major markets, reaching market shares of
recently launched product cymbalta® performed
10–15 % and even up to 20 %.
strongly and continued to gain market share.
micardis® / micardisplus® became our second
In Latin America, we implemented a new regional
leading product in Europe, growing with net sales
business concept by implementing a regional
of EUR 191 million. Newly published data on its
operative unit located in Argentina.
benefits, not only in hypertension but specifically
new benefits for nephroprotection in hypertensive
diabetic patients, is expected to support further
Europe
growth.
Our business developed highly satisfactorily in
sifrol®, our leading Parkinson’s medicine, more
Europe in 2005. With a growth rate of 15 % and
than doubled its turnover to EUR 183 million.
net sales of EUR 2 billion, we grew about twice as
Currently it is under registration for RLS. Three
fast as the market. Our market share increased to
important new introductions to the European
2 %, ranking us as No. 12 in the European pharma-
market came in 2005. cymbalta® for MDD. alna
ceutical market. This success is based on the good
ocas®, a tablet version of our market-leading BPH
acceptance of our innovative products by physi-
product and aptivus®, our HIV treatment.
cians and patients.
With the exception of France, all major European
However, the pharma-political environment in
markets gained considerable growth momentum
Europe remained challenging during 2005 and
in 2005. After a difficult year 2004, our German
patient access to new innovative medicines was
business developed quite satisfactorily due to the
often delayed. In addition, cost containment
new introductions of cymbalta®, aptivus® and
measures in national healthcare systems mainly
alna® ocas® as well as the high market accept-
target pharmaceutical spending with mandatory
ance of spiriva®, micardis® and sifrol®.
rebates, repayments and parallel trade.
Dynamic growth was achieved in Central and
Eastern Europe, especially in Russia. Double-digit
The main growth driver in 2005 is spiriva®.
growth rates were recorded in Italy, Spain and the
Net sales reached EUR 459 million, an increase of
United Kingdom.
54 % over 2004. spiriva® developed very positively
53
In all major markets in our Asia, Australasia,
Africa (AAA) Region – Japan, Australia, Turkey
and South Korea – we experienced strong
growth.
This is particularly remarkable considering the
business environment of our industry in the region
was in 2005 determined by a continuation of cost
containment initiatives and governmental restrictions. The development in AAA must therefore be
considered against a background of mandatory
South Africa, AAA’s sixth largest country, also
showed positive development. Here, however, the
largest sales contribution came from viramune®.
Our company in China celebrated its tenth anniversary. Net sales reached more than EUR 40
million. In India, besides our licensing agreement
with Cadila Healthcare Ltd., we have started our
own subsidiary.
In the region Near East / Middle East, we implemented a new regional business concept at the
end of 2005 by creating a regional operative unit
located in Dubai.
price reductions, governmental prescription recommendations, such as positive lists, and, in
almost every country, strong encouragement of
generic prescribing.
In Japan, Nippon Boehringer Ingelheim had the
Generic Prescription
Medicines (GPM)
fastest growing business among the leading
In the USA, Boehringer Ingelheim Corporation’s
25 pharmaceutical companies. Net sales grew by
GPM business consists of its subsidiaries Ben
12 % to EUR 800 million, driven in particular
Venue Laboratories with its separate division
by micardis®, due to a continuation of our highly
Bedford Laboratories, based in Columbus, Ohio.
successful cooperation with Astellas. micardis®,
Bedford Laboratories is dedicated to the market-
now our leading product in Japan, achieved a
ing of a select line of liquid and lyophilised sterile
market share of 10.6 % within two years of
injectables from Ben Venue. Roxane Laboratories
launch.
and Bedford Laboratories, generated 6 % of
Boehringer Ingelheim’s sales.
Although sifrol® and spiriva® also contributed
to the excellent development in Japan, much of
With respect to generic drugs, the US pharmaceu-
the Nippon Boehringer Ingelheim’s sales growth
tical market is currently in a change process.
can be explained by a range of field force efficiency improvements in 2005.
It is expected that demand for pharmaceuticals
and generics in particular, will continue to
In Australia, above-market performance achieved
increase due to pressure to reduce healthcare
in the last few years continued in 2005, with net
costs, the aging population, and the 2006 Medi-
sales growing by 25 % to EUR 120 million, the
care Prescription Drug Benefit.
main contribution coming from spiriva®. The
situation in Turkey was similar. Our sales, driven
However, as the size of the generic market
by spiriva®, flomax® and micardis®, achieved
increases, there is increased competition for
a growth of 54 % to achieve net sales of EUR 80
revenues coming from traditional brand pharma-
million.
ceutical companies with a renewed interest in
generics, from extremely large multinational
generic companies that have grown through
merger and acquisition, and from Indian, Eastern
European, and very soon Chinese companies.
54
As the size of the market increases, competition is
putting downward pressure on prices and margins. Many companies are moving, or looking to
move manufacturing off-shore.
Roxane
Roxane Laboratories focuses on developing,
manufacturing and packaging more than 400
medications, including oral liquids, tablets, and
capsules.
The business posted sales of EUR 194 million
(USD 241 million), representing an increase of
14 %.
Roxane launched nine new generic drugs in 2005,
High value
injectables
including the antibiotic clarithromyin and almost
20 new abbreviated new drug applications
Over the past 12 years, Bedford Laboratories has focused
(ANDAs) were filed.
its efforts on improving and advancing high-quality
Bedford Laboratories
for select specialty injectables, many not available from
Bedford posted net sales of EUR 341 million (USD
any other source. Bedford currently offers 84 inject-
424 million), a growth rate of 26 %. Key products
able products in 229 different configurations, covering a
products that offer value to its customers. It is renowned
for 2005 included propofol, octreotide, GlucaGen®,
wide variety of therapeutic classes, mainly in the areas of
paclitaxel and Adriamycin®.
oncology, cardiology, anaesthesia and antipsychotics.
In 2005, Bedford launched six new products,
including propofol, an anaesthesia product, and
octreotide, an oncology adjunct. Propofol entered
the US market as one of two generics. Octreotide
entered the US market as the sole generic with 180
days exclusivity. These two products accounted
for USD 94 million sales. With these six new
products, Bedford has solidified its position in the
generic market and remains one of the largest US
suppliers of speciality injectable pharmaceuticals
to hospitals and clinics.
Bedford’s recent partnership with an intravenous
(IV) bag manufacturer will provide Bedford’s customers with a wider variety of drug deliver choices.
Bedford will also continue to file 10 to 12 ANDAs
each year to create a pipeline of products that will
allow us to maintain a leadership position.
55
Let’s talk about it
“Constipation is a widespread and sensitive disorder. Many
sufferers often feel guilty and responsible for their symptoms,
believing that their lifestyle is to blame,” according to the
gastroenterologist Professor Stefan A. Müller-Lissner of ParkKlinik Weissensee, Humboldt University, Berlin.
56
57
A review that he led on constipation, published in
While diet and lifestyle should not be assumed to
the American Journal of Gastroenterology (AJG)
be the main cause of constipation, it is advisable
in 2005, provided sufferers and healthcare profes-
to remain healthy overall by eating a balanced
sionals with strong, legitimate grounds to remove
diet, drinking enough water and taking regular
such feelings of guilt. Boehringer Ingelheim’s
exercise. As a proven, safe and effective laxative,
long-standing contribution to relieving this com-
dulcolax® can be taken as a first-line treatment
mon, very uncomfortable condition is dulcolax®,
to help restart the natural rhythm.
the world’s leading laxative brand.
Our communication initiatives
The independent paper, “Myths and Misconcep-
The review in AJG prompted Boehringer Ingel-
tions About Chronic Constipation”, which
heim to launch a major campaign in 24 countries
appeared in the AJG, concluded that many aspects
to communicate its key findings in order to con-
of constipation, including the use of laxatives, are
tribute to a better understanding of constipation
based on traditional views and misunderstand-
and laxatives’ role in treatment options.
ings. It clarified many wrongly held beliefs and
showed that often they are not based on hard fact
The scientists too had a good opportunity to make
or medical evidence.
their findings known. Professor Carmelo Scarpignato, University of Parma, Italy, co-author of the
AJG paper called the health education campaign a
“great success”.
The international
dulcolax® website,
locally implemented,
underlines the
global presence
of the brand.
The review’s key findings were that diet and life-
Significantly, new constipation treatment guide-
style should not be assumed to be the main cause
lines for pharmacy staff were, for instance, pub-
of constipation. For some, a fibre-rich diet may be
lished in the United Kingdom after the review in
helpful, however, in many people with more
the AJG with the endorsement of the College of
severe constipation, fibre intake can make symp-
Pharmacy Practice, which followed the recom-
toms even worse. Increased fluid intake will not
mendations in the paper.
provide significant relief from constipation, except
if you are dehydrated. Further findings relate to
Boehringer Ingelheim’s commitment to raising
the use of laxatives that have wrongly been associ-
disease and treatment awareness was also evident
ated with a number of unsubstantiated claims.
in the USA where the dulcolax® Guide for
The review found, for instance, that there is no
Healthy Living, a national educational pro-
evidence that laxative use might cause damage to
gramme, was launched by the Hispanic talk show
the colon and that it is uncommon for most laxa-
host Cristina Saralegui in 2004. “Constipation
tive users to develop a level of tolerance.
sufferers need to listen to their bodies and take
action by becoming aware of the things they
are doing and not doing to alleviate symptoms,”
she said. n
58
Gentle and effective
dulcolax® forms a key part of Boehringer Ingelheim’s self-medication heritage. On the market for over 50
years, dulcolax® is available as sugar-coated tablets and suppositories containing the active ingredient
bisacodyl as well as pearls and drops containing the active ingredient sodium picosulphate. A unique comfort
coating prevents the tablet from being dissolved until it reaches the colon, where its active ingredient is
released exactly in the right place. Today, this gentle and effective laxative is marketed in over 90 countries,
both on prescription and over-the-counter (OTC). It is recognised as the top selling contact laxative
(influence on the motility of the colon by direct contact with the colon wall). And the new thinking about
constipation has had a real impact. Shailesh Amin, a retail pharmacist in the UK, noted: “I have already made
a monumental shift in prescribing advice and sale for constipation products. Out goes lactulose and fibre and
in come the contact laxatives.”
For more information visit www.dulcolax.com
59
Our Consumer Health Care (CHC) segment achieved net sales of EUR 1.1 billion
in 2005 (+8,5 % against the previous year). Both our Americas and Europe
Regions achieved strong double-digit growth. Boehringer Ingelheim is ranked
No. 8 worldwide among CHC companies and in 2005 enhanced its position
primarily through line-extensions and switching prescription-only medicines
to over-the-counter (OTC) products. Our key international brands continued
to develop positively.
dulcolax® – our leading laxative brand –
Development by brand
successfully marketed in more than 100 countries,
maintained its No. 1 market position in 2005. In
buscopan® – a medication against abdominal
the Americas it continues to reinforce its strong
discomfort and cramping – is the worldwide No. 1
category position. Good performances were
antispasmodic brand, according to IMS data. The
achieved in Europe and Asia, with dulcolax®
buscopan® franchise produced strong double-
holding a strong lead position in important
digit growth in 2005, mainly due to successful
markets, such as Germany and South Korea. Plans
switches in Mexico, Brazil, Argentina, Colombia
to strengthen this brand into a worldwide OTC
and Venezuela.
laxative leader over the forthcoming years is a key
focus of our strategic development.
The product is now marketed in more
than 100 countries. The development of
antistax® – our brand for the prevention and
a validated international brand platform
treatment of chronic leg vein weakness – suc-
was started in 2005 and is expected to be
ceeded in further accelerating growth in 2005,
implemented from 2006, helping to
with Italy, Belgium and Germany the main con-
capitalise on the brand’s strong medical
tributors to this positive performance. In Germany,
heritage and build a robust OTC umbrella
antistax® extended its leadership in the leg vein
as a basis for future line-extensions.
Top 10 products
Net sales 1. dulcolax®
Sales Consumer
Health Care
in millions of EUR
2. mucosolvan®
1,000
800
600
’03 ’04 ’05
60
114.8
+18.8 %
91.3
+226.6 %
88.4
+4.5 %
4. bisolvon®
66.9
+8.4 %
5. buscopan®
59.5
+38.2 %
6. laxoberal®
31.8
+126.6 %
7. thomapyrin®
30.0
–15.3 %
8. anador®
25.3
+13.0 %
9. antistax®
22.6
+2.5 %
18.6
–12.1 %
549.2
21.1 %
others
964
change
3. geriatric pharmaton®
10.frubienzym®
400
200
in millions of EUR
970
For information about indications,
1,052
see our Glossary on pages 116–118.
health market.
With
2006. This will help capitalise on the strong brand
sales of almost 30 % in
image/market position that pharmaton® com-
the market, Italy made a
mands in many markets. pharmaton® kiddi
very substantial contri-
(children’s supplement) produced strong growth
bution to the perform-
in Mexico in 2005, boosted by the launch of
ance of antistax® in
galenic line extensions in late 2004.
2005.
mucoangin® – our sore throat brand – achieved
satisfactory growth in the major markets Germany
Development by region
and Mexico. New product launches were made in
Europe
Denmark and Sweden.
In 2005, the region reported sales growth as of
14 % compared to the previous year, as a result of
mucosolvan® – the world’s
a favourable seasonal demand for cough & cold
leading cough expectorant –
brands combined with several line extension
strengthened its position with
launches, switches and healthy, above-market
good growth of 14 %, compared
growth. Activities in 2005 were intensively
with 2004. New marketing
focused on our international brands. Germany,
campaigns were initiated in
Spain, Italy and Russia, our major markets in
Mexico, Brazil and Germany
Europe, were the prime drivers of the positive
during the year.
development.
bisolvon® – the cough remedy
Americas
– consolidated its position as one of the leading
The year 2005 was a very positive one for the
brands in the world OTC
CHC business in the Americas Region, which
expectorant market. In
achieved growth of 19 % against previous year.
2005, it successfully sus-
The main growth driver was Mexico.
tained its strong position
in many markets, particu-
Asia, Australasia, Africa (AAA)
larly in South America
SSP Co. Ltd. – the No. 3 OTC company in Japan,
and Europe, achieving
whose major shareholder is Nippon Boehringer
double-digit growth.
Ingelheim Co. Ltd. – strengthened its position in a
highly competitive market environment. The AAA
pharmaton® – our umbrella brand for the
Region, excluding Japan, achieved strong growth
improvement and maintenance of vitality and
of +16 % against the previous year. Our interna-
well-being – performed well in 2005, with strong
tional core brands pharmaton®, bisolvon® and
growth in the key markets in Latin America –
dulcolax® showed overall sales growth of 86 %.
Mexico, Brazil and Argentina.
IMS figures put pharmaton®
as world No. 2 in its category.
In 2005, development of a validated international brand platform was started, with implementation expected to start in
61
Margareta Ebelt collapsed in her bathroom, struck down by a severe heart attack.
Walking her dog, she had felt a twinge in her chest but had not taken any notice.
Fortunately, her husband alerted the emergency services immediately.
Otherwise, the incident could have been fatal. Margareta lives to tell her story,
thanks to right in time treatment with Boehringer Ingelheim’s metalyse®.
Time is extremely critical when suffering a heart attack. In the ideal scenario,
treatment can begin aboard the ambulance or as in Margareta’s case in the
patient’s home. The probability of patients recovering fully then rises to around 70 %.
Biopharmaceuticals
62
Time
is critical
63
“I did not want to become one of those helpless folk,” Margareta Ebelt says.
And she certainly is not. As before, Margareta is now managing the accounts of
the company she and her husband own in Dueren, Germany. Besides the human
suffering, cardiovascular diseases have a major financial and social impact.
Many people who survive a stroke or a heart attack need long-term care. It is
estimated that stroke accounts for 4–6 % of healthcare budgets, excluding the
costs of social services and care. metalyse® (tenecteplase) is the first and only
clot-dissolving medication administered as a five-second injection. This bio
pharmaceutical, manufactured and marketed by Boehringer Ingelheim, is today
considered the first line treatment for heart attack (acute myocardial infarction).
Early leadership in biotechnology
morphine and codeine, and later, atropine, theo-
In the rapidly expanding field of biopharmaceuti-
bromine and ergot alkaloids – all clinically impor-
cals Boehringer Ingelheim is one of the world’s
tant agents.
leading players, building on a wealth of expertise
that the company has generated since 1885.
Drugs for the 21st century
In biopharmaceuticals the active substances are
The company began using bacteria for the produc-
extracted from natural materials, from cells or
tion of lactic acid in commercial quantities as
plants, and not through chemical synthesis. It is
early as 1895. This was the world’s first successful
widely accepted today that a wide range of diseases,
use of micro-organisms for large-scale product
such as diabetes, autoimmune diseases or cancer,
manufacturing. In 1933, the company successfully
are better treated with medicines produced using
developed a process for manufacturing citric acid
biotechnology.
through the fermentation of fungi. Our competence in fermentation processes provided valuable
64
Reflecting this, the importance of biotechnology
support in the 1970s for the manufacture of
has grown significantly since 1990, when not even
numerous new antibiotics, including amicleno-
1 % of all drugs were produced biologically. Now
mycin, epidermin and gunacin, lead substances
they account for 8 % and are on a rising trend. It is
for chemically optimizing medications. After first
estimated that by 2018 half of all pharmaceutical
extracting alkaloids from plants in 1905,
turnover will be generated by biopharmaceutical
Boehringer Ingelheim increased production con-
medicines. For newly launched medicines, the
siderably from the 1960s onwards. This led to the
figure is already as high as 35 %. For Boehringer
commercial introduction of products, such as
Ingelheim the modern era of biotechnology began
at the end of the 1970s with the manufacture of
The company has maintained its early technologi-
therapeutically active proteins by genetic engi-
cal lead to the present day. At the Biberach site,
neering. Again, the company was among the
the company has the world’s second largest plant
pioneers. Our output included interferon beta,
for manufacturing biopharmaceuticals. Its 12 fer-
interferon omega, Namalwa interferon, interferon
menters each have a capacity of 15,000 litres.
alpha, interferon gamma and manganese super-
Mammalian cell cultures are here turned into
oxide dismutase.
highly efficacious drugs, such as metalyse® or
actilyse®, a medication indicated against stroke.
Successful cooperations
Our technical lead in biopharmaceutical manu-
To maintain our strong performance in microbial
facture and competence across the whole devel-
production of biopharmaceuticals a new plant
opment and production chain led in the early
was inaugurated in April 2005 at our site in
1980s to the highly successful cooperation with
Vienna, Austria.
the California-based Genentech Inc. This resulted
in the development of drugs such as actilyse®
In addition, we provide know-how to our
(rt-PA), metalyse (TNK-tPA), imukin® (inter-
commercial partners, companies such as Amgen,
feron gamma) and beromun® (tumour necrosis
Pfizer or Schering, for which we do contract
factor alpha).
manufacturing. n
Biopharmaceuticals
65
Our Biopharmaceuticals division is a leader in time-to-market development for
efficient and robust large-scale production of high quality biopharmaceuticals.
Its major sites in Vienna, Austria, and Biberach, Germany, have both established
a strong track record in development and regulatory approval during the last
25 years. In our Industrial Customer business for global marketing and sales
of third parties, we provide the entire biopharmaceutical process chain with
our own intellectual property from cell-line development, fermentation,
downstream processing, formulation as well as fill and finish in state-of-the-art
application systems, including global registration and marketing support for
biopharmaceuticals.
Biopharmaceuticals
In order to further accommodate our high-yield
fermentation processes for mammalian cell
cultures, additional investments are being made
Ground-breaking for a brighter future
at the Biberach site, groundbreaking for competi-
The year 2005 represents the most successful
tive manufacturing costs.
business year so far for Biopharmaceuticals.
To address patient convenience, an investment
To maintain our strong performance in microbial
into an aseptic filling line for pre-filled syringes
production of biopharmaceuticals a new plant
has been given the go-ahead. This should
was inaugurated in April 2005 at our site in
strengthen our leading position in the develop-
Vienna, where the capacity is now doubled with
ment of application systems for therapeutic pro-
an investment of EUR 80 million, raising total
teins and in future for gene therapeutics too.
capacity of 12,300 litres fermentation volume in
three parallel operating facilities and created 200
new highly qualified jobs.
The full operation of our new facility for cell culture-derived products in Biberach, high-yield
processes, extraordinary success rates and our
demanding long-term contracts contributed to a
sales increase of more than 40 % to EUR 548 million. Our investment in a brighter future was fully
materialised, due to very substantial synergies
with existing onsite plants in Vienna and Biberach
and skilled, highly-experienced employees.
66
Moreover, for Boehringer Ingelheim’s own bio
targets and estimated lower treatment cost. We
pharmaceutical products – actilyse®, metalyse®,
are already prepared to take up such processes in
beromun® and imukin® – sales amounted to
our Industrial Customer business and for in-
EUR 163 million. metalyse® gained significant
licensing for our own R&D pipeline. One of our
market share over actilyse®, indicating that
partners in this field is Avidia.
second generation products with improved
efficacy pay off in the market.
Short half-life and parental application of bio
pharmaceuticals can be compensated, for example,
Cost of goods is a key issue in a competitive envi-
by pegylation of the protein therapeutic. Expertise
ronment. For our gene therapy production line at
in this technology led in 2005 to new business.
our microbial plant in Vienna improvements in
For mammalian cell cultures, a monoclonal anti-
expression yields up to 1.2 g pDNA/litre were
body titer of more than 4g/litre has been reached
obtained through culture media development and
successfully in process development.
optimised feeding strategies. Our proprietary
microbial expression system for the production of
Major investments in increased capacity combined
therapeutic proteins was also advanced signifi-
with achievements in process sciences and manu-
cantly during 2005 to 12 g protein-inclusion
facturing, together with improved business proc-
bodies/litre fermentation volume and 80 % yield
esses, provide potential for improved profitability
in the following refolding step.
in manufacturing and strengthen Biopharmaceuticals’ competitiveness on the world market.
Comparable with our franchise in manufacturing
gene therapeutics, an economic manufacturing
The year 2005 marked the 10th anniversary of our
process for protein scaffolds has been established.
mammalian cell culture multi-product US Food
It is believed that protein scaffolds will be a second
and Drug Administration (FDA) license. During
wave of immuno-therapeutics with certain advan-
the FDA’s 2005 biannual inspection, all of our
tages over monoclonal antibodies such as brain
facilities and products were certified. In the new
penetration, suitability for specific intracellular
cell culture facility with 6 x 15,000 litre capacity a
67
second manufacturing process has been successfully implemented. The facility was also licensed
Chemicals
as a multi-product facility by the FDA in 2005,
just one year after initial licensing as a monoproduct facility.
Our new biological entity (NBE) pipeline strategy
has been implemented to fuel Boehringer Ingelheim’s R&D pipeline with biopharmaceuticals. In
this context, a monoclonal antibody for the treatment of psoriasis was in-licensed from AbGenomics. A research collaboration for natriuretic peptide
receptor fusion proteins with Syntonix has been
commenced. Medarex and MorphoSys technologies have been licensed in 2005. All these efforts
are designed to create added value for Boehringer
Ingelheim’s NBE development.
Chemical Production
In recent years, our production network Chemicals has been developed into a globally-orientated
organisation, developing and producing active
pharmaceutical ingredients (APIs) for Boehringer
Ingelheim.
By focusing our chemical sites – Germany, France,
Italy, Spain and the USA – on specific predefined
roles within the network, flexible and highly
competitive production of active pharmaceutical
ingredients (APIs) has been secured for captive
use and industrial customers.
In 2005, the launch of aptivus® was supported by
API production at the launch site Ingelheim,
Germany. To satisfy constantly growing demand
for micardis®, the Petersburg, Virginia, USA, site
commenced production of telmisartan. In addition, the Malgrat, Spain, site hosted an international workshop, where members of the
“Telmisartan Expert Teams” from Ingelheim,
Petersburg and Malgrat met to establish best practices at all sites through an intensive exchange of
experiences and accessing opportunities for continuous improvement.
Investments
Worldwide investments in property, plant and equipment accelerated at Boehringer Ingelheim in 2005. They increased
by about 25 % compared to 2004 to EUR 532 million. “These investments mirror our dynamic business growth,” says
Dr Hans-Jürgen Leuchs, Board Member responsible for Operations. The most important project completed in 2005
was the new biopharmaceutical production plant in Vienna, Austria (inauguration in Vienna 2005, picture on the right),
an investment of some EUR 80 million, which will also create 200 new jobs. The company is strongly expanding its
biopharmaceutical investments in order to maintain its leading edge in this field. EUR 70 million will be invested to
modernise (de-bottleneck) one of the high capacity biopharmaceutical plants in Biberach, Germany. Further investment
projects in 2005 were the starts of a new logistics centre in Ingelheim, and a physical science building in Ridgefield,
Connecticut, USA. The expansion of the chemical production plant in Petersburg, Virginia, USA is ongoing, and also the
expansion of the production lines at our companies Roxane Laboratories, Inc., Columbus, Ohio/USA, and Ben Venue
Laboratories, Bedford, Ohio.
68
Pioneering college course
in biotechnology
In a unique educational venture Boehringer Ingelheim is participating in a pioneering public-private partnership in Biberach,
Germany, to create a college course in pharmaceutical biotechnology. The groundbreaking ceremony for the technical
college building that will house the course took place in June 2005. The first group of 35 students is scheduled to start
the bachelor of science course in the winter semester 2006-7, but ultimately the number of students will total 200.
Prof. Rolf Werner, head of the division Biopharmaceuticals at Boehringer Ingelheim, described the venture as an
“investment in the future” for the Baden-Wuertemberg region, for Germany and for Boehringer Ingelheim. Biberach is the
main site of the company’s biopharmaceutical activities. The partners in the project are the local, regional and federal
authorities, a local bank and the biotechnology company Rentschler. The degree course will cover everything from the basic
science and analytical techniques in biopharmaceuticals through process development and plant technology to business
economics and medical law.
Fine Chemicals
A highlight of 2005 was the performance of
The sales figures of our worldwide Fine Chemicals
phenylephrine. Volumes doubled due to sales
business developed very well. Despite difficult
restrictions on an alternative API in the USA.
market conditions, arising, for example, from
Controlled substances also showed gratifying
Indian competition surplus capacities, they
growth in the USA. Sales from new business
attained the same level as in 2004. Consolidated
development projects performed very well, too.
sales amounted to EUR 140 million in 2005, just
matching the 2004 level, irrespective of the
substantial loss of a custom synthesis product.
The importance of the US market increased
further.
69
Animal Health
Helping the
70
heart
When her Labrador Buster
fell ill, he could no longer play with
little Anna Kingston. “Our dog was frail and
apathetic,” says Anna’s mother, Liz. Buster was
unresponsive, weak and lacked his usual spirit.
Like the one in ten dogs with heart disease, he was suffering from what the
experts call dilated cardiomyopathy (DCM) which produces changes in the heart,
reducing its capacity, leading to congestive heart failure. This at first causes
breathing difficulties and exhaustion, later leading to premature death.
71
Fortunately for Buster and the Kingston family, vetmedin®, a breakthrough
treatment developed by Boehringer Ingelheim for treating heart failure in dogs,
was available. Buster has been part of the Kingston family for the past five
years. “He won our hearts in an instant and bonded particularly strongly with
our little daughter Anna,” says Liz Kingston. “They would tumble around
all the time, playing with a ball or exploring their surroundings. In winter, we
suddenly noticed that Buster at night paced to and fro nervously. His breathing
was difficult and he developed a cough. At first we thought it was just a cold,
but Buster would lay on his blanket all day and not even want to go for walkies.”
The family finally turned to their veterinarian, Dr Henry Norfolk, who diagnosed
that Buster had DCM, a disorder which, if untreated, means an average life
expectancy for the dog of only a few weeks or months. “This news hit us very
hard, but thankfully Dr Norfolk knew that vetmedin® (pimobendan) has been
shown to be a highly effective medication for this condition,” Liz Kingston
recalls. After hearing about the favourable results of various studies involving
the treatment, the family had renewed hope for their much-loved pet. Their
hope was fulfilled when, shortly after treatment began, Buster was much better
and almost back to his old playful self. That was over a year ago and Buster is
still going strong. “We’ve been so thankful for every extra day that we’ve had
with Buster,” Liz concludes.
72
According to the American Veterinary Medical
Association (AVMA), canine heart disease is one of
Beneficial alliance
the leading causes of death in pet dogs. Of the 10 %
of dogs which develop congestive heart failure,
Boehringer Ingelheim Animal Health cares for pet animals,
DCM is the second most frequent cause.
for a longer and happier life together. This is one of the
cornerstones of our mission. Boehringer Ingelheim has for
Studies prove efficacy
the past half century cared for the benefit of animals and
Veterinarians have increasingly recognised
people, discovering and developing a wide range of novel,
v etmedin® as a first-line treatment for canine
practical treatments for cats and dogs.
congestive heart failure due to both DCM and
mitral valve disease (MVD). vetmedin® differs
The company is dedicated to fostering a beneficial alliance
from previous treatments by helping the heart
between man and animals by uniting research expertise
pump more easily and efficiently, often bringing
and human pharmaceutical excellence. Our pets are living
dramatic clinical improvement within days of
longer, healthier and happier lives through improved
initiating treatment.
nutrition and healthcare. This has created a real demand
for effective and safe treatments for chronic and geriatric
In contrast to other commonly used heart drugs
conditions, such as heart disease, osteoarthritis and
that only attack the disorder with a single mode of
cancer.
action, vetmedin® combines two favourable
actions. It dilates the blood vessels, thereby reducing the effort the heart has to make to circulate
blood. At the same time, vetmedin® works to
increase contractility by helping the heart to pump
more strongly and more efficiently. The first of a
new class of compounds, this inodilator’s unique
dual action, makes it an optimum treatment for
MVD and DCM, the two most common forms of
heart disease in dogs.
Clinical studies have independently confirmed the
significant superiority of vetmedin®. Boehringer
Ingelheim aims with the long-term study quest
(QUality of Life and Extension of Survival Time),
initiated two years ago, to further research the
important parameters of quality of life and life
vetmedin® helps
the heart to pump
more strongly and
more efficiently.
expectancy. Based on this study, one of the world’s
largest independent studies in companion animal
veterinary medicine, a new benchmark will be set
for treating heart failure in dogs. n
Animal Health
73
Animal Health
Our Animal Health division celebrated its 50th anniversary in 2005.
While this makes Boehringer Ingelheim one of the long-established companies
in this industry, it stands out as one of the most innovative and dynamic.
The anniversary year saw generally very satisfactory business development.
Sales rose by 8 % to around EUR 360 million in local currency. Our focus
in 2005 continued to be on the core segments livestock vaccines and chronic
diseases in companion animals and on optimisation of organisational
and marketing structures. This further consolidated our position among the
top 10 leading animal health companies in the world, giving us a global market
share of 3 %.
Regional differences
management of pigs. In Germany, some produc-
Growth in 2005 varied greatly from one region to
ers’ associations have already declared the use of
another. Once again, Europe, the growth engine
the oral vaccine to be mandatory, only one year
behind the Animal Health division, posted excel-
after launch. enterisol® ileitis is thus well on
lent business development in the market with an
the way to becoming another of Animal Health’s
7 % increase in sales. The NAFTA region posted
top products.
sound growth of 9 %, but the year was marked by
special factors, such as the sale of the antibiotic
It is noteworthy that we received marketing
denagard® to Novartis. Asia also had a success-
authorisation for enterisol® ileitis in Australia.
ful year. Sales in China and Thailand more than
Not only is this the first Boehringer Ingelheim
doubled, while the registration of ingelvac® prrs
vaccine to be introduced in Australia, but it is also
in these countries paved the way for continued
the first imported modified live vaccine to be given
strong growth. In Japan, the restructuring process,
marketing authorisation there.
aimed at streamlining the product portfolio and
concentrating on our core segments, is practically
Our flagship product ingelvac® prrs showed
complete. The launch of our porcine vaccine range
extraordinary development, particularly in South
in Latin America and Eastern Europe is currently
Korea where sales doubled. Our best-selling
being prepared.
vaccine is now also available in China, the largest
swine market in the world, allowing us to
consolidate further our No. 1 position there among
Food-producing animals
the international suppliers of porcine vaccines.
Swine
ingelvac® m. hyo also posted strong growth. This
The key event in the swine segment in 2005 was
enabled our young company in Thailand to
the pan-European launch in Barcelona in October
become market leader in this indication in a very
2005 of enterisol® ileitis, the first and only
short time. Excellent results were also achieved in
vaccine in the world for the widespread dis-
France where ingelvac® m. hyo improved
ease ileitis that is associated with diar-
by 36 % in a flat market, thus securing a
rhoea. Our experience in practice to date
market share of 31 %.
has been extraordinarily positive. In the
USA, every third pig was vaccinated
74
On the whole, 2005 saw excellent progress
against ileitis in 2005, while control of
with our porcine vaccines, one of our core
the disease was established as an essential
target segments, putting us well on the way
element
to becoming global market leader.
of
professional
healthcare
Cattle
There were two highly gratifying developments in
the cattle segment. First, the food-producing
animal industry is becoming increasingly aware
that healthy animals also produce healthy meat
and higher milk yields. More and more farmers
Half a century
keeping animals
healthy
therefore attach value to effective treatment of
their animals’ pain and inflammation, thus help-
Boehringer Ingelheim has been committed to maintaining
ing our metacam® progress towards becoming
and improving the health of companion and farm animals
the gold standard in this area. The drug continued
since the mid-1950s. The following milestones show the
its double-digit growth in the cattle segment in
launch years for key veterinary medicines from our own
2005.
research and development.
Secondly, our mastitis products not only main-
1955
tained their excellent market position in 2005,
pecusanol® (lindane) – a treatment for ectoparasitic
but were also able to step up market penetration
infestation of all types of animals
in the developing markets, a positive trend that is
likely to be consolidated further. An international
congress in Maastricht provided
impressive evidence of the
excellent efficacy of our classical product mamyzin® in sub-
1956
lobelin® (lobelin HCl) – a treatment for airway diseases
in horses, especially used as a stimulant for newborn foals,
based on the active principle of lobelia inflata (Indian
tobacco plant)
clinical mastitis. The vaccine
1964
portfolio continues to represent
voren® (dexamethasone-21-isonicotinate) – a long-
one of the strongholds of our
acting catabolic steroid used to treat metabolic disorders,
cattle business in the NAFTA
inflammation and allergic reactions in cattle, swine,
region.
horses, dogs, and cats
1966
buscopan compositum® (N-butyl scopolamonium
bromide + metamizole) – a spasmolytic and pain inhibitor
for treating colic in horses, based on active substance
Companion animals
from the Duboisia (Corkwood) plant
1967
Small animals
bisolvon® (bromhexine) – a mucolytic for treating
The small animals segment can look back on a
respiratory disease in cattle, swine and small animals
highly successful year. With consistent growth of
where mucus is a complicating factor
our existing products we confirmed our leading
market position in many key countries. The
extraordinary performance of vetmedin® is
particularly promising, with worldwide growth of
24 %. This drug secured first or second position on
all the leading markets in Europe. The outstanding growth rates in Canada (82 %) and France
(27 %) give us every reason to be
extremely optimistic about the next
few years when the product will be
registered in other key markets.
1980
ventipulmin® (clenbuterol HCl) – an equine respiratory
treatment that relieves the breathing difficulty of horses
with conditions characterised by reversible broncho
spasm, or mucus accumulation, including heaves or
chronic obstructive pulmonary disease (COPD)
1989
ingelvac® aujeszky mlv (Bartha strain K-61) – the first
of the ingelvac® series of products to immunize swine
against a range of viral infections
continued on next page ➤
Animal Health
75
➤ continued from page before
1995
ingelvac® prrs mlv (Porcine respiratory & reproductive
syndrom virus, modified live virus)
1998
metacam® (meloxicam) – initially launched for dogs, this
treatment is now licensed for alleviating pain and reducing
inflammation in many indications in dogs, cats, horses,
cattle and pigs
1999
vetmedin® (pimobendan) – a treatment for congestive
heart failure in dogs
2001 (US)
enterisol® ileitis (Lawsonia intracellularis a virulent
live culture) – first vaccine against Lawsonia intracellularis
worldwide
2002 (EU)
ingelvac® m. hyo (Mycoplasma hyopneumoniae bacterin)
– novel technique allows a one shot only vaccination
metacam® also achieved a strong increase in sales
Business with our non-prescription products
which highlights the excellent performance once
canosan®, seraquin® and viatop®, a new
again in 2005. With double-digit global growth
product for skin disorders, showed a gratifying
rates, we effectively maintained our position in
trend throughout the entire companion animals
Europe, Canada, and Australia, in spite of fierce
segment.
competition. The new small animals team in the
USA achieved striking success, advancing in
record time to take 3rd position in the market.
Horses
76
We once again maintained our strong position in
True to our company vision Value through Inno-
the horse segment in the European and American
vation, we invested around 12 % of our Animal
markets. With the introduction of the intravenous
Health sales in research and development in 2005,
solution for injection, metacam® horse, in
a high percentage for the international industry.
Europe, we extended our portfolio with a
The focus was primarily on the development of
frequently demanded product. At the same time,
new pharmaceutical solutions for small animals
two launches in the USA, the world’s largest
and preventive measures for the large animals
equine market, provided further impetus for
sector. These efforts have culminated in several
growth: buscopan®, the classical treatment for
interesting projects in the current pipeline and
equine colic, and sedivet®, a drug used to sedate
good progress in the development of innovative
animals.
pharmaceutical molecules and vaccines.
Group Management Report
Business and operating
environment
remains very difficult due to high unemployment
and stagnating domestic demand. Stimulation for
the German economy came substantially from
exports.
Overview
The development of the world economy in 2005,
Global conditions for research-driven pharma-
compared with the previous year, was character-
ceutical companies did not improve last year.
ised by a marked increase in raw material prices.
Regulatory interventions are no positive signal
At the same time, generally low capital market
for the development of innovative medicines.
interest rates, a rather expansion-orientated
Despite these trends, Boehringer Ingelheim will
monetary policy and the corporate earnings
continue to do its best in researching new,
position had an overall positive influence on the
innovative pharmaceuticals for the benefit of
economic cycle.
patients.
Regionally, the USA and China were the growth
The world pharmaceutical market grew by 6.3 %
centres of the world economy. The Japanese
in the financial year 2005, discounting currency
economic situation also developed favourably
effects. With an increase of 23.9 % in this period,
and it is to be hoped that the stagnation phase is
Boehringer Ingelheim clearly exceeded average
now overcome for good. The development of the
market growth. It is noteworthy that Boehringer
economic cycle in Europe was rather restrained.
Ingelheim outpaced the pharmaceutical market
In Germany in particular the economic situation
in every region, reflecting the global orientation
Net Net
sales
sales
by businesses
by businesses
2005
2005
(in millions
(in millions
of EUR)
of EUR)
Medicines
Medicines
Prescription
Prescription
6,183
6,183
7,247
7,247
CareCare
Health
Health
Consumer
Consumer
970 970
1,052
1,052
Biopharmaceuticals
Biopharmaceuticals
392 392
and and
Chemicals
Chemicals
Fine Fine
Pharma
Pharma
Manufacturing
Manufacturing
262 262
Health
Health
Animal
Animal
335 335
Net Net
sales
sales
by region
by region
2005
2005
(in millions
(in millions
of EUR)
of EUR)
548 548
299 299
9,5359,535
’04 ’05
’04 ’05
78
4,559
4,559
Europe
Europe
2,622
2,622
3,117
3,117
Total Total
Total Total
8,1578,157
361 361
Americas
Americas
3,905
3,905
Australasia,
Australasia,
Asia,Asia,
Africa
Africa
1,630
1,630
8,1578,157
1,859
1,859 9,5359,535
’04 ’05
’04 ’05
and strength of the group. The greatest stimulus
disease HIV, was remarkable in two senses. First,
for growth in 2005 came once again from
the medication was developed to market maturity
America, the most important market for
in a very short time. Secondly, only seven days
research-driven pharmaceutical manufacturers.
after approval by the US Food and Drug Admin-
Here, we gained additional benefit from the
istration (FDA) in June 2005, aptivus® was
positive commercial development of our product
already commercially available. Thus, patients
mobic®.
have access to a new, highly efficacious therapy
option for the treatment of HIV disease. In
Boehringer Ingelheim’s growth on the pharma-
November, the product was launched in Germany
ceuticals market consequently led to a marked
and the United Kingdom.
increase in group turnover. In 2005, Boehringer
Ingelheim generated net sales of EUR 9.5 billion,
The very positive uptake of already established,
corresponding to an increase of 17 %. The positive
innovative pharmaceutical products in our
development of business in 2004 was thereby
markets also contributed to the success in 2005.
continued further. A comparative analysis of
spiriva® is already the most commonly
the business results for the years 2004 and 2005
prescribed product for the treatment of chronic
can virtually ignore the influence of foreign
obstructive pulmonary disease (COPD).
exchange, as this only accounts for a factor of
The launch of spiriva® in Japan in December
< 0.1%.
2004 made it possible for the first time for
patients to be treated with this innovative medi-
The business segment Prescription Medicines
cation in almost all important pharmaceutical
(PM) was responsible for the largest share of the
markets. The cooperation with Pfizer Inc. on
success achieved in the past financial year.
marketing the product has proved its worth.
In addition, our other segments also developed
very satisfactorily:
Sales of micardis®, a treatment for hyper
tension, have also shown very gratifying development. Clinical studies which were concluded in
Net sales
(in millions of EUR)
2005
2004
Change
7,247
6,183
+17 %
1,052
970
+9 %
Biopharmaceuticals
548
392
+40 %
Animal Health
361
335
+8 %
2005 have confirmed our high expectations
concerning the efficacy of micardis®. Despite
intensive competition in this market segment,
we still anticipate further growth potential for
this product.
Our business success in previous years was also
The development of net sales in the segments
founded on the vision Value through Innovation
Consumer Health Care (CHC) and Animal Health
(VTI) embedded in our corporate culture. With
is noteworthy, as both businesses had to main-
the introduction in 2005 of the initiative Lead &
tain their position in a very difficult market
Learn we have given the VTI concept fresh
environment. The outstanding business develop-
stimulus. We thereby ensure that the VTI princi-
ment of Biopharmaceuticals was the main
ples will also be secured in the company in future
growth driver of our Industrial Customer
and continue to be translated into reality.
business and maintained the growth rates of the
previous year.
To sum up, 2005 was for Boehringer Ingelheim
a highly successful year in which we laid solid
For the business segment Prescription Medicines,
foundations for the further development of the
the market launch of aptivus®, a protease inhib-
group of companies.
itor for the treatment of immunodeficiency
79
The most important key figures for earnings are
These areas of research are divided according to
as follows:
their defined focus between four main research
sites in Germany, the USA, Austria and Canada.
2005
2004 Change
Net sales
9,535
8,157
+17 %
Operating income
1,923
1,372
+40 %
20.2
16.8
Return on net sales (as %)
In the area of respiratory diseases, 2005 saw the
successful launch of spiriva® in Japan. Further
studies have long confirmed the efficacy of this
medication. Research in the disease COPD is
being consistently continued.
A focus of research in virology is a new non-
Research and Development
nucleoside reverse transcriptase inhibitor
Boehringer Ingelheim sees its objective as devel-
(NNRTI) which can be applied particularly when
oping new medicines and therapies, thereby
resistance to hitherto used therapeutic regimes
helping the sick. This strategic orientation is
occurs. In addition, this concerns the consistent
shown in both actual projects and initiatives and
further development of the class of drugs to
in the worldwide expenditure on research and
which the successfully launched viramune®
development. In the financial year 2005,
belongs.
Boehringer Ingelheim invested EUR 1,360
In oncology, new active ingredients have been
million in R&D.
discovered which promise new therapeutic
approaches and opportunities to cure various
R&D expenditure as percentage of net sales
types of tumour. These are currently in phase I
amounted to 14.3 % in 2005 (2004: 15.1 %).
of clinical development. The first results were
The focus of our R&D activities is Prescription
presented to the scientific community in the USA
Medicines. In this segment, the R&D expenditure
in late autumn last year.
as a share of net sales stood at 18.2 % in 2005
In metabolic diseases, new therapeutic
(2004: 19.3 %).
approaches to treating diabetes mellitus type II
are in the foreground, especially in conjunction
Boehringer Ingelheim supports this focus with
with associated secondary diseases. Some
its own research that is concentrated on the
projects show promising therapeutic approaches
following therapeutic areas:
and are at present in the pre-clinical or clinical
• respiratory diseases
phases.
• virology
Studies in the area of central nervous system
• oncology
diseases have confirmed that mirapex®/sifrol®
• metabolic diseases
can be used to treat restless legs syndrome.
• cardiovascular diseases
In addition to its efficacy, its good tolerability
• central nervous system diseases
in particular was confirmed. Applications for
• immunology and inflammation
market approval for this indication were
submitted in the USA and Europe in 2005.
2005
2004
2003
2002
2001
Expenditure (in millions of EUR)
1,360
1,232
1,176
1,304
1,019
14.3
15.1
15.9
17.2
15.2
– as % of net sales
Human Pharma. expend. (in millions of EUR)
– as % of net sales of HP
Average number of employees
Investments in tangible assets (in millions of EUR)
80
1,318
1,140
1,264
984
14.4
1,195
15.3
16.1
17.4
15.4
5,678
5,471
5,362
5,205
4,828
116
97
93
97
99
cymbalta®, the anti-depressive in-licensed
help people with our products. This helping
from Eli Lilly & Co., received in the meantime
stance is only credible if Boehringer Ingelheim
approval as a treatment in 20 countries, thereby
takes an active part in preserving the environ-
reinforcing our therapy area central nervous
ment.
system.
It goes without saying that Boehringer Ingelheim
On top of our own research efforts, our activities
respects and observes each country’s legal
and projects are complemented by strategic
regulations. Beyond that it is our aim to exceed
alliances and in-licensing technologies. In the
the environmental requirements where we
past financial year, technologies were, for exam-
consider this purposeful and necessary. Our
ple, in-licensed from MorphoSys and Medarex
established processes in the field of Environmen-
that should support our research activities in
tal, Health & Safety (EHS) form the foundation
the field of biotechnologically manufactured
for successful implementation of the fundamen-
pharmaceuticals. This also applies for a mono-
tal principles of environmental policy. Thus we
clonal antibody in-licensed from AbGenomics.
carried out environmental audits at 11 different
sites in 2005. The purpose was to see whether the
From today’s perspective, Boehringer Ingelheim’s
environmental guidelines we have set out were
R&D pipeline provides a very good foundation to
being observed. In 2005, Boehringer Ingelheim
support and enable the further development of
was also awarded various prizes in the EHS field.
our company on a lasting basis.
The award received by the chemical site
Petersburg,Virginia, USA, hailed its new waste-
Production
water plant as exemplary.
Boehringer Ingelheim’s production activities are
divided into three areas:
Employee reporting
• chemical production (five sites worldwide):
The favourable business development of the past
this encompasses both the manufacture of
year is also expressed in the marked increase in
active ingredients for our own pharmaceutical
the number of employees. Averaged over the year,
production and chemical active ingredients for
37,406 people were employed at Boehringer
customers outside the Boehringer Ingelheim
Ingelheim, corresponding to an increase of 5 %
group.
against the previous year. In Germany, we
• pharmaceutical production (19 sites world-
received first prize for the highest number of new
wide): pharmaceutical production concentrates
people hired in 2005 in our reference group.
on manufacturing finished products.
We are particularly proud that in 2005 we clearly
Production is structured in technological
increased our offer of apprenticeships at our
centres of competence, which operate in a
German subsidiaries compared to 2004.
production alliance.
• biopharmaceutical production (two sites in
An essential goal for our human resources work
Europe): as for chemicals, biopharmaceuticals
is to hire the best employees and retain them
are produced for both Boehringer Ingelheim
long-term. Various personnel and leadership
medications and for third parties.
development paths are available in order to
consistently develop further the talents of our
Environmental reporting
employees.
According to the guiding principles (Leitbild) of
Boehringer Ingelheim, the preservation and
protection of the environment has a very high
priority. This derives ultimately from our claim to
81
Social responsibility
Boehringer Ingelheim’s net sales increased by
Boehringer Ingelheim takes an active part in the
17 % in 2005 to EUR 9,535 million. This gratify-
overall social responsibility with great care and
ing development reflects the favourable market
considerable enthusiasm.
uptake of the pharmaceuticals, which we produce
For example, since the year 2000, programmes
and sell. The currency effect of EUR 3.3 million
have been supported that substantially reduce
only had insignificant influence when the finan-
the transmission of HIV from mother to child
cial years 2004 and 2005 are compared. The full
during birth through antiretroviral therapy. The
consolidation of our South Korean subsidiary
viramune® necessary for this purpose is made
since 2005 has a one-off effect of EUR 18 million
available free of charge by Boehringer Ingelheim.
on net sales. Comparing growth rates in 2005
In calendar year 2005, Boehringer Ingelheim
and 2004, an additional extraordinary effect due
supported about 140 programmes in around 60
to the product sifrol® has to be considered.
countries.
Except for the USA, exclusive worldwide market-
In addition, Boehringer Ingelheim fosters the
ing rights were returned to Boehringer Ingelheim
development of healthcare systems in defined
by Pfizer Inc. on 15 October 2004.
countries. In Botswana, for instance, a training
unit was opened to promote medical education.
Boehringer Ingelheim’s activities are concen-
Our overall social responsibility is expressed in
trated on the two businesses Human Pharma
additional international initiatives. For example,
ceuticals and Animal Health. Net sales in Human
we gave rapid and unbureaucratic support with
Pharmaceuticals, with activities grouped under
money and materials to the victims of the natural
the segments Prescription Medicines, Consumer
catastrophes in Southeast Asia and Pakistan.
Health Care and Industrial Customer, amounted
In this context, it is important to point out that,
corresponds to 96% of total group net sales.
to EUR 9,174 million in 2005 (+17 %). This
in addition to the engagement of our company,
many of our employees voluntarily use their free
Prescription Medicines (PM)
time to involve themselves in social projects.
Within the Human Pharmaceuticals business,
For this, we would like to express our heartfelt
PM accounts for 79 % of net sales, forming the
thanks to all our employees. Actively helping
centrepiece of our activities. In 2005, we
people is for us an expression of an attitude that
achieved net sales of EUR 7,247 million in this
reflects the way Boehringer Ingelheim perceives
segment (2004: EUR 6,183 million). A currency
itself and which we support as much as possible.
effect of EUR 6 million must be taken into
account when analysing the figures.
Results from operations,
financial position and
net assets
Results from operations
perspective, the following products were the
strongest growth drivers:
Net sales
2005
2004
Growth
Based on currently available market data,
spiriva®
951
525
+81 %
Boehringer Ingelheim was last year the fastest-
sifrol®/mirapex®
434
285
+52 %
growing pharmaceutical company in the world
micardis®
724
568
+27 %
within its benchmark group. Our company is
mobic®
848
672
+26 %
now ranked No.14 among the largest pharma
ceutical companies, with a worldwide market
share of 2 %.
82
From a worldwide business development
2005
2004
2003
2002
2001
Price/quantity/new introductions
17.4
16.1
7.8
10.1
8.9
Acquisition and sale of businesses
–0.5
–0.5
–0.2
7.1
–0.7
0
–5.1
–10.2
–4.0
0.0
Components of growth in net sales (as %)
Currency effect
spiriva®, our new medication for the treatment
Germany was very gratifying compared to the
of COPD, has developed very satisfactorily.
previous year. Growth in our home country was
Net sales for cymbalta®, the product in-licensed
mainly achieved with our innovative medications
from Eli Lilly & Co. and launched in 2004,
spiriva®, sifrol®, micardis® and cymbalta®.
performed as expected.
In addition, there was the launch in Germany of
The positive uptake by patients and the market of
the product alna® ocas®, which allows benign
aptivus®, a protease inhibitor for the treatment
prostatic hyperplasia (BPH) to be treated with a
of the immunodeficiency disease HIV, will also
single dose per day.
strengthen the development of our innovative
product portfolio in the coming financial year.
Despite increasing regulatory restrictions too, the
In addition, products that are already established
Asia, Australasia, Africa (AAA) Region achieved
on the market will support the business develop-
double-digit growth in net sales, contributing to
ment in the future.
group success with net sales of EUR 1,312
million. With its 61 % share, Japan is for us the
Analysing the regions in which we operate
largest market in this region. In 2005, our
around the world, it can be observed that
Japanese subsidiary attained net sales growth of
Boehringer Ingelheim has clearly grown more
12 % to EUR 801 million in this market, largely
strongly than the respective regional pharma
attributable to the highly favourable develop-
ceutical markets.
ment of micardis®. The Australian market also
performed above average, with a EUR 24 million,
The Americas Region, with a share of 51 %,
or 25 %, increase in growth. Overall, we achieved
contributes the largest part of net sales in PM.
net sales of EUR 120 million in this market.
Compared to the previous year, growth of 17%
In India, we have started to build up our own
was achieved here, corresponding to net sales of
subsidiary.
EUR 3,670 million. The USA, with its 85 % share
of net sales, is the largest and thereby the most
important country for Boehringer Ingelheim in
this region. Our products spiriva® and mobic®
in particular were responsible for the positive
US business development, increasing net sales
by EUR 345 million (+58 %) compared to the
previous year.
Foreign exchange development
■ EUR 1 in USD (average exchange rates)
■ EUR 1 in YEN (average exchange rates)
1.30
150
1.25
The Europe Region’s share of net sales in this
1.20
market segment stands, with a volume of EUR
1.10
2,037 million, at 28 %. It contributed to the
1.05
success in 2005 with a 15 % increase in net sales
0.95
compared to the previous year. With net sales
growth of over 22 %, business development in
140
1.15
130
1.00
120
0.90
’01
110
’02
’03
’04
’05
83
Consumer Health Care (CHC)
difficult business environment in Japan.
In the business segment CHC we raised our net
Overall, in the financial year 2005, we achieved
sales by 9 % to EUR 1,052 million (discounting
the following net sales figures for each region:
currency effects: EUR 1,056 million). Consistent
Americas EUR 222 million, Europe EUR 436
orientation towards core brands defined in our
million and AAA EUR 394 million.
strategy continues. Non-prescription products,
whose patent protection has expired, will be
Industrial Customer
integrated into existing product lines, and,
The third party business in pharmaceutical
wherever possible and purposeful, an umbrella
production and the fine chemicals area broadly
brand strategy will be built up.
matched the previous year’s level with net sales
of EUR 298 million.
Worldwide growth was achieved by the following
product groups in particular:
Alongside the important role that Biopharma
ceuticals has in developing and manufacturing
Net sales
medications for the Boehringer Ingelheim group,
2005
2004
Growth
mucosolvan®
91
40
+228 %
buscopan®
59
43
+37 %
dulcolax®
115
97
+19 %
88
85
+4 %
pharmaton®
last year it was highly successful with regard to
producing biopharmaceuticals for other pharmaceutical companies. Net sales of biotechno
logically produced medications for third parties
rose from EUR 392 million to EUR 548 million,
corresponding to growth of 40 %. Increased
customer demand indicates the market success of
The distinct increase in net sales for
the products our group manufactures for third
mucosolvan® resulted, on the one hand, from
parties. The commissioning of our new produc-
a major cold outbreak at the beginning of 2005,
tion facility in Vienna, Austria, and the marked
and on the other hand, from product group
improvement in productivity of the existing
switches in some countries from prescription-
production plant in Biberach, Germany, enabled
only pharmaceuticals to the CHC business
us to fulfil market demand.
segment.
Routine inspections carried out by the FDA last
year resulted in certification of our production
buscopan®, as a result of product switches in
facilities and processes by the auditors.
certain countries in the Americas Region, also
benefited from this special effect, which explains
Animal Health
part of the double-digit growth in net sales.
Compared to the previous year, the Animal
Based on available market data, the buscopan®
Health business developed very positively in an
brand has secured No. 1 position worldwide in
intensely competitive market, with net sales
antispasmodics.
growth of 8 %. Total net sales in the last financial
Business development differed greatly from
year amounted to EUR 361 million (discounting
region to region. While in the Americas (+19 %)
currency effects EUR 360 million).
and Europe (+14 %) marked net sales increases
were achieved, net sales in AAA fell slightly
(-1.8 %). This was because we were able to maintain, but not expand, our market share in a very
84
Worldwide growth was achieved by the following
Again, in 2005, Boehringer Ingelheim made
product groups in particular:
further efforts to secure the future of the group
of companies through appropriate investments.
Net sales
Taking into account the newly initiated projects
2005
2004
Growth
vetmedin®
16
13
+23 %
ventipulmin®
13
11
+18 %
metacam®
68
58
+17 %
ingelvac® m. hyo
21
18
+17 %
in 2005, depreciations increased by EUR 60
million to EUR 531 million, corresponding to an
increase of 13 %. Other operating expenses rose
by EUR 414 million (13 %). The amount of
EUR 3,573 million includes expenditures arising
from the termination of a sales cooperation with
Abbott.
enterisol® ileitis was successfully launched
Overall, this produces a EUR 551 million higher
in Europe in October 2005. This is an oral
operating income of EUR 1,923 million, that aptly
vaccine for preventing the bacterium Lawsonia
records the success of the past financial year. The
intracellularis. This bacterium triggers inflamma-
Boehringer Ingelheim group’s return on net sales
tion in the gut of domestic pigs that hitherto
rose distinctly from 16.8 % to 20.2 %.
could only be treated with an antibiotic therapy.
The financial income diminished by EUR 20
Some producer associations in Germany have
million to EUR -35 million compared to the
already made vaccination mandatory for their
previous year. The reasons for this decline were
members’ farms.
mainly losses on transactions in foreign
metacam® has developed favourably for all types
exchange derivatives.
of animal. vetmedin®, a pharmaceutical for the
Holding income, with a contribution EUR
treatment of degenerative heart failure in dogs,
0 million, was EUR 2 million lower than the
has exceeded our commercial expectations.
previous year. In the past financial year, the
extraordinary effect arising from the disposal
Business developed very well in all three Regions.
of a holding was not repeated.
Europe, with a 45 % share of net sales, is just
ahead of the Americas Region (42 %). In the
Taking into account the individual income
Americas, extraordinary effects have to be taken
components, income before taxes was EUR 1,888
into account. For example, the sale of the anti
million, a significant increase of EUR 529 million
biotic denagard® to Novartis in the NAFTA
or 39 % above the previous year.
region produced a fall in net sales, which had a
correspondingly negative impact on the business.
Tax expenses amounted to EUR 374 million,
The 8 % growth in net sales achieved in 2005
corresponding to a tax ratio of 20 % (2004: 33 %).
must therefore be regarded as all the more grati-
Here, it must be taken into consideration that,
fying.
due to regulations in the German commercial
In the AAA Region net sales growth of 7 % also
code, personal taxes on group activities levied on
contributed to the success of the Animal Health
the shareholders may not be shown as tax
business.
expenses. These are presented as withdrawals
from accumulated group equity. Taking this effect
Expenditure and income
into consideration, the actual tax ratio is
Total operating costs of EUR 8,388 million were
markedly higher than the value shown in the
14 % above the previous year (EUR 7,362 million).
profit and loss statement.
Material costs (EUR 1,613 million) by comparison
increased above average, with growth of 25 %,
mainly due to changes in the product mix.
The increase in the average headcount led to a
9 % rise in personnel costs to EUR 2,671 million.
85
The clear decline in the tax ratio compared to
To summarise, it can be noted that, because of
financial year 2004 is a result of the restructur-
the existing liquidity, the given capital structure
ing of inter-company relationships at group level.
and the available funding potential, the financial
This has full effect for the first time in 2005.
preconditions for successfully realising our
In 2004, the tax ratio was negatively impacted by
strategy remain in place. The goals we set within
a one-off extraordinary effect amounting to EUR
our financial strategy have been fulfilled.
121 million which arose from changes to the tax
tariff applied in the calculation of deferred taxes.
Investments are necessary and important for
securing our future development. We have there-
Taking into account the described tax effects,
fore increased our investment activity in 2005 to
net income rose from EUR 888 million to EUR
EUR 532 million (2004: EUR 427 million), which
1,491 million.
registered as a distinct increase in our tangible
assets. The bulk of the investments were made in
Financial position
implementing new technologies, expanding our
Boehringer Ingelheim’s financial management is
capacity and rationalisation projects.
in its instruments and methods aligned with the
international standards for a modern industrial
At our German research site in Biberach the new
company. The goal of the financial management
galenics building was commissioned. Further-
is to support the business strategy of our com-
more, funds were released for a packaging centre
pany by providing or investing financial assets,
(LogiPack Center) and a new works canteen
taking account of the foreign exchange risk
at the Ingelheim site. In future, products manu-
which arises from our international business
factured in Germany will receive their final
relations.
finishing in our LogiPack Center. The canteen’s
capacity will be in line with the markedly
For the financial year 2005, Boehringer Ingel
increased number of employees in recent years
heim’s very good economic development is also
and the expected increase.
reflected in its further improved financial position compared to the previous year. The cash
In the USA, we have also commenced important
flow in 2005 amounted to EUR 2,069 million,
investment projects. Good examples are the
corresponding to 45 % growth compared to the
expansion of production facilities at our sub
previous year. The cash flow from operating
sidiary Ben Venue Laboratories in Bedford, Ohio,
activities rose to EUR 2,390 million and is
and additional research capacity at Ridgefield,
thereby markedly higher than funds used for
Connecticut.
investment activities in the past year. Financial
activities yielded an outflow of EUR 1,334 million
Net assets
from changes in equity as well as credits raised
Total assets rose by 13 % in 2005 to EUR 12,018
with financial institutions.
million. The long-term, secured assets are
Securities and liquid funds increased by 14 % to
covered by Boehringer Ingelheim’s total equity.
EUR 4,585 million. The complete presentation of
the cash flow calculation is to be found in the
By actively managing our receivables, and
financial section of the annual report.
discounting currency effects, we achieved a
development that was disproportionately small
relative to the expansion of our business.
86
Liquid assets declined by 12 % compared to the
previous year to EUR 1,167 million due to the
transfer of liquid funds into the financial assets.
Group equity increased to EUR 4,825 million
(2004: EUR 4,556 million) because of the favourable business development compared to the
previous year.
Long-term disposable capital rose by EUR 281
million compared to the previous year to stand
at EUR 7,052 million, corresponding to 59 %
of the balance sheet total. This year again, this
item covers all intangible and tangible assets,
inventories and liabilities as well as nearly half
of the liquid assets.
The balance sheet and the related balance sheet
ratios round off the altogether favourable picture
that the earnings and financial position have
already drawn.
The combined evaluation of the net assets,
financial position and results of operations
shows that Boehringer Ingelheim is a soundly
financed and profitable company. In 2005,
we created a firm basis for our further business
development.
Risk report
The risk management system of the Boehringer
Ingelheim group has proved effective and the
concept was unchanged in the financial year
2005. Business-specific risks are reported
and systematically monitored. Our strategy
and planning processes also form a significant
element in our active risk management.
Hereby, we ensure that all risks known to us are
thoroughly analysed. Following the appropriate
classification, counter-measures from the risk
management system are commenced and their
implementation consistently monitored.
Within the framework of the audit plan approved
by the Board of Managing Directors, internal
auditing conducted routine and extraordinary
audits worldwide during the reporting year.
The focus was the efficiency of structures and
processes, securing assets, adherence to legal
requirements and guidelines, the functionality
of systems and the effectiveness of internal
controls.
Currency and interest rate risks, which arise
Report on post-balance
sheet date events
Since the end of the financial year 2005, we are
not aware of any events that are of material
significance to the group of companies or could
lead to a reappraisal of its asset, financial or
earnings position.
because of our group’s international business
relationships, are constantly examined and
limited by appropriate hedging strategies.
Risks in the area of Environmental Health &
Safety (EHS) are minimised preventively by
adherence to our own very high safety standards.
For possible incidents, appropriate emergency
plans are in place that are regularly tested and
trained. Furthermore, Boehringer Ingelheim has
risk-adjusted insurance coverage in case damage
occurs, despite the high safety standards.
In addition to the general business risks associated with the industry, we are not currently
aware of any risks that substantially threaten the
further development of Boehringer Ingelheim’s
business.
87
Report on expected
developments
For the financial year 2006, we assume that the
vigorous growth rates of 2005 will not be maintained. One reason for this is the anticipated
stronger generic competition for mobic® that will
In the financial year 2005, we updated our
affect our business development during the first
strategy according to our defined planning
half of the year in some European countries.
processes. The newly defined milestones and
The USA will feel the effect in the second half of
targets of our reworked strategy make us all the
the current year.
more determined to consistently continue to
Based on present planning, we expect net sales
pursue the course we have chosen and build
in 2006 of around EUR 10 billion and predict
on our strengths.
that Boehringer Ingelheim’s business development will again exceed that of the world pharma-
We will make every effort to launch our new
ceutical market.
pharmaceuticals aptivus®, cymbalta® and
spiriva® in additional markets. For sifrol® we
In the financial year 2006, we plan to invest
expect registration for the new indication restless
EUR 660 million in fixed assets. The focus for
legs syndrome. The spiriva® respimat® Soft
this expenditure will be in the areas of produc-
Mist™ Inhaler (SMI) will also be submitted for
tion and research. We want to ensure that our
registration. Studies show that the spiriva®
production can deliver an optimal response to
respimat® SMI is preferred by our patients
the demands of new products, at the same time
compared to other dosage forms. It is free of gas
exploiting opportunities to rationalise.
propellant and furthermore allows improved
Adequately equipping research will also make a
uptake of the active ingredient via the lungs.
significant contribution in 2006 to building
alna® ocas® was successfully launched in three
potential for future success.
European countries last year. This involves a
retard tablet of the already launched active
It is our declared goal to manage Boehringer
ingredient tamsulosin, in-licensed from Astellas
Ingelheim long-term as an independent family-
Pharma. The launch of this dosage form is
owned company. Our endeavour in this context is
planned for additional European markets.
to achieve above-average growth in the market
that will deliver a corresponding increase in the
Important studies are entering their decisive
value of the company. To this end, we will also
phases and we are confident that they will bring
continue to keep a close eye on the profitability
positive results for our company.
of our group. This is for no other reason than our
Noteworthy, for example, are the uplift
being highly aware of the risks concerning the
(spiriva®) und ontarget (micardis®) studies.
success rate for our research pipeline and that
At the beginning of 2006, we initiated the
sustainable financing of the required research
biggest-ever clinical study programme for
projects can only be ensured in this way.
thrombo-embolic diseases. In the study programme re-volution™, 27,000 patients world-
For reaching this demanding goal, we have in
wide are expected to take part. The study will
the financial year 2005 created a very good basis.
investigate Dabigatran (rendix™) the novel,
We will also continue to use every means to
orally available thrombin inhibitor researched
enable Boehringer Ingelheim to achieve its
and developed by Boehringer Ingelheim for the
ambitious goals and develop successfully further
prevention and treatment of thrombo-embolic
as a company. We consider this a duty towards all
conditions.
stakeholders, especially towards all patients for
whom we also want to provide efficacious and
safe medicines in the future as well.
88
Consolidated
Financial Statements 2005
Overview of the major consolidated companies
C. H. Boehringer Sohn*
Boehringer Ingelheim GmbH
Deutschland GmbH
International GmbH
Germany
Finland
Austria
Pharma GmbH & Co. KG,
Ingelheim
Finland Ky, Espoo
Forschungsinstitut für Molekulare
Pathologie Gesellschaft mbH,
Vienna
Vetmedica GmbH, Ingelheim
Norway
Norway KS, Asker
Belgium
Coordination Centre S.C.S.,
Brussels
China
International Trading (Shanghai)
Co. Ltd., Shanghai
Boehringer Ingelheim Shanghai
Pharmaceuticals Co. Ltd.,
Shanghai
Philippines
Boehringer Ingelheim (Phil.) Inc.,
Manila
South Korea
Boehringer Ingelheim Korea Ltd.,
Seoul (50 %)
Boehringer Ingelheim Vetmedica
Korea Ltd., Seoul
Distribution
Production
Research
*sole general partner:
Boehringer AG
90
Boehringer Ingelheim a n n u a l r e p o r t 2 0 0 5
C. H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG
Auslandsbeteiligungs GmbH
Pharma Investment Ltd.,
Burlington, Canada
Argentina
France
South Africa
Mexico
Boehringer Ingelheim S.A.,
Buenos Aires
France S.A.S., Paris
Boehringer Ingelheim (Pty.) Ltd.,
Randburg
Promeco S.A. de C.V., Mexico City
Australia
Labso Chimie Fine S.A.R.L.,
Blanquefort
Ingelheim Pharmaceuticals (Pty.)
Ltd., Randburg
Boehringer Ingelheim Vetmedica
S.A. de C.V., Guadalajara
Boehringer Ingelheim Pty. Ltd.,
North Ryde
Austria
Boehringer Ingelheim Austria
GmbH, Vienna
Greece
Spain
USA
Boehringer Ingelheim Ellas AE,
Athens
Boehringer Ingelheim España S.A.,
Barcelona
Boehringer Ingelheim Corp.,
Ridgefield, Connecticut
Indonesia
Boehringer Ingelheim S.A.,
Barcelona
Pharmaceuticals, Inc.,
Ridgefield, Connecticut
Pharma Ges.m.b.H., Vienna
PT Boehringer Ingelheim
Indonesia, Jakarta
Belgium
Italy
N.V. Boehringer Ingelheim S.A.,
Brussels
Boehringer Ingelheim Italia S.p.A.,
Reggello
Brazil
Bidachem S.p.A.,
Fornovo S. Giovanni
Boehringer Ingelheim do Brasil
Quimica e Farmaceutica Ltda.,
São Paulo
Solana Agro Pecuaria Ltda.,
Arapongas
Canada
Boehringer Ingelheim (Canada)
Ltd., Burlington
Chile
Boehringer Ingelheim Ltda.,
Santiago de Chile
Colombia
Pharmaton S.A., Lugano
Nippon Boehringer Ingelheim
Co. Ltd., Kawanishi
Taiwan
SSP Co. Ltd., Tokio (57 %)
Boehringer Ingelheim Taiwan Ltd.,
Taipei
Vetmedica Japan Co. Ltd.,
Kawanishi
Seiyaku Co., Ltd., Yamagata
Boehringer Ingelheim B. V.,
Alkmaar
Ecuador
Boehringer Ingelheim del Ecuador
Cia. Ltda., Quito
Switzerland
Japan
Czech Republic
Boehringer Ingelheim Danmark
A/S, Copenhagen
Sweden
Boehringer Ingelheim AB,
Stockholm
(Schweiz) GmbH, Basel
Netherlands
Denmark
Laboratorios Fher S.A., Barcelona
Istituto De Angeli srl,
Reggello
Boehringer Ingelheim S.A., Bogotá
Boehringer Ingelheim s.r.o.,
Prague
Europharma S.A., Barcelona
Poland
Boehringer Ingelheim Sp.zo.o.,
Warsaw
Portugal
Boehringer Ingelheim Lda.,
Lisbon
Ben Venue Laboratories, Inc.,
Bedford, Ohio
Roxane Laboratories, Inc.,
Columbus, Ohio
Vetmedica, Inc.,
St. Joseph, Missouri
Roxane, Inc., Columbus, Ohio
Chemicals, Inc.,
Petersburg, Virginia
Thailand
Boehringer Ingelheim (Thai) Ltd.,
Bangkok
Turkey
Boehringer Ingelheim Ilac
Ticaret A.S., Istanbul
United Kingdom
Boehringer Ingelheim Ltd.,
Bracknell
Venezuela
Boehringer Ingelheim C.A.,
Caracas
Unilfarma Lda., Lisbon
91
C. H. Boehringer Sohn, Ingelheim
Consolidated balance sheet
Assets (in millions of EUR)
Notes1)
31.12.2004
Intangible assets
(3.1)
233
267
Tangible assets
(3.2)
2,900
2,712
Financial assets
(3.3)
Fixed assets
3,396
2,756
6,529
5,735
Inventories
(3.4)
1,229
1,085
Accounts receivable
(3.5)
2,143
1,814
80
1
Securities
Cash and cash equivalents
1,167
1,332
Current assets
4,619
4,232
Deferred taxes
821
619
49
44
12,018
10,630
31.12.2005
31.12.2004
178
178
3,001
3,465
–61
–168
Deferred charges and prepaid expenses
Total assets
Liabilities and equity (in millions of EUR)
Notes1)
Group reserves
Balance sheet currency conversion difference
Net income
1,491
888
Equity
4,609
4,363
216
193
4,825
4,556
4,754
3,979
Minority interests
Group equity
Provisions
(3.6)
Accounts payable
(3.7)
Liabilities
Deferred taxes
Deferred charges
1)
92
31.12.2005
For explanation, see relevant section in the Notes to the Consolidated Financial Statements.
2,174
1,886
6,928
5,865
204
193
61
16
12,018
10,630
Consolidated profit and loss statement
Notes1)
2005
2004
Net sales
(4.1)
9,535
8,157
175
91
Changes in inventories
Other internal work performed and capitalised
Other operating income
Total revenues
3
3
598
483
10,311
8,734
Material costs
(4.2)
–1,613
–1,289
Personnel costs
(4.3)
–2,671
–2,443
Amortisation of intangible and depreciation of tangible assets
(4.4)
–531
–471
Other operating expenses
(4.5)
–3,573
–3,159
1,923
1,372
–35
–15
Operating income
Financial income
(4.6)
Holding income
(4.7)
Income before taxes
Taxes2)
(4.8)
Income after taxes
Third-party share
Net income
1)
(4.9)
0
2
1,888
1,359
–374
–451
1,514
908
–23
–20
1,491
888
For explanation, see relevant section in the Notes to the Consolidated Financial Statements.
Due to legal requirements the disclosure of the shareholders’ personal taxes arising from
consolidated business activities as tax expenses is not allowed. These taxes are shown as
withdrawels from the accrued group capital.
2)
93
Cash flow statement
2005
2004
1,514
908
529
467
26
55
2,069
1,430
561
256
Other non-cash income and expenses
43
–17
Gain/loss on disposals of fixed assets
–4
3
–90
–110
–385
–20
196
–123
2,390
1,419
Income after taxes
Write-downs/write-ups on fixed assets
1)
Change in provisions for pensions
Cash flow
Change in other provisions
Increase of inventories
Increase of accounts receivable and other assets not related to
investing or financing activities
Increase/decrease of trade accounts payable and other liabilities
not related to investing or financing activities
Cash flow from operating activities
Investments in intangible assets
–57
–115
–532
–450
Investments in non-current financial assets1)
–6
–11
Proceeds from disposals of intangible assets
2
0
43
50
Investments in property, plant and equipment
Proceeds from disposals of property, plant and equipment
Proceeds from disposals of non-current financial assets
21
16
–529
–510
–1,360
–295
26
–59
–1,334
–354
527
555
0
0
43
–56
Securities and liquid funds 2) as of 1. 1.
4,015
3,516
Securities and liquid funds as of 31. 12.
4,585
4,015
1)
Cash flow from investing activities
Cash payments to shareholders and minority shareholders
Cash proceeds from borrowings/repayments of loans
Cash flow from financing activities
Change in liquid funds from cash relevant transactions
Changes in liquid funds due to changes in scope of consolidation
Changes in liquid funds due to exchange rate movements
2)
excl. fixed-asset securities
2)
liquid funds, securities within fixed and current assets
(+) = source of funds, (–) = use of funds
1)
94
Statement of changes in group equity
Shareholders’
capital1)
Accrued
group
capital
of which
currency
effects
Equity
Minority
interests
of which
currency
effects
Group
equity
Group Equity
178
3,668
–84
3,846
188
–22
4,034
Contributions
Balance as of 31. 12. 2003
0
0
0
0
0
0
0
Withdrawals
0
–286
0
–286
0
0
–286
Net income
0
888
0
888
20
0
908
Change of scope of consolidation
0
0
0
0
–4
0
–4
Other changes
0
–85
–84
–85
–11
–7
–96
178
4,185
–168
4,363
193
–29
4,556
Contributions
0
0
0
0
0
0
0
Withdrawals
0
–1,352
0
–1,352
0
0
–1,352
Net income
0
1,491
0
1,491
23
0
1,514
Change of scope of consolidation
0
0
0
0
7
0
7
0
107
107
107
–7
2
100
178
4,431
–61
4,609
216
–27
4,825
Other changes
1)
The shareholders’ capital consists of the equity of C. H. Boehringer Sohn and C. H. Boehringer Sohn Grundstücksverwaltung
GmbH & Co. KG. The balance as of 31.12. 2005 consists only of capital of the limited partners. The shareholders’ personal taxes
arising from consolidated business activities are shown as withdrawals from the accrued group capital.
95
Notes to the consolidated financial statements 2005
1 Principles and methods
1.1 General principles
The consolidated financial statements of Boehringer Ingelheim for the fiscal year 2005 have been
prepared pursuant to section 264a German Commercial Code (HGB) by applying the group accounting
regulations of section 290 to 314 HGB.
In accordance with section 297, paragraph 1 HGB, the consolidated financial statements are composed
of the consolidated balance sheet, the consolidated profit and loss statement, notes to the consolidated
financial statement, the consolidated cash flow statement and the statement on changes in equity.
1.2 Companies included in the consolidation
The ultimate parent of boehringer ingelheim is c. h. boehringer sohn. Boehringer AG is the sole
unlimited managing partner of this company.
Besides c. h. boehringer sohn there is c. h. boehringer sohn grundstücksverwaltung GmbH
& Co. KG whose unlimited partner is under the unified management of c. h. boehringer sohn.
boehringer ingelheim consists of 143 affiliated companies in and outside Germany. In addition to
c. h. boehringer sohn and c. h. boehringer sohn grundstücksverwaltung GmbH & Co. KG,
a further 109 companies in which c. h. boehringer sohn holds directly or indirectly the majority of
voting shares are included in the consolidated financial statements. One company, hitherto included
on a proportional consolidation basis, has since fiscal 2005 been wholly consolidated.
30 companies were not consolidated in the reporting year, as the net assets, financial position and
results of operations of these companies were insignificant to Boehringer Ingelheim. Combined they
represent less than 1% of the Group’s net sales, equity and net profit. A further two companies are
subject to bylaws containing enduring restrictions.
Compared to the previous year, the total number of affiliated companies was reduced by one. In the
past year, three companies established, two companies were sold and a further two companies were
dissolved due to mergers. Two existing subsidiaries hitherto not included due to insignificance were
taken up in the consolidation. In this context, one company was no longer consolidated as it was
below the materiality threshold.
A separate statement of interests held by Boehringer Ingelheim will be filed with the Register of
Companies of the District Court in Mainz.
96
The following subsidiaries were exempted from the reporting and disclosure obligations in accordance
with section 264, paragraph 4 HGB in conjunction with section 264, paragraph 3 HGB:
• Boehringer Ingelheim GmbH, Ingelheim
• Boehringer Ingelheim International GmbH, Ingelheim
• Dr. Karl Thomae GmbH, Biberach
• Boehringer Ingelheim Deutschland GmbH, Ingelheim
• Boehringer Ingelheim Vetmedica GmbH, Ingelheim
• Boehringer Ingelheim Secura Versicherungsvermittlungs GmbH, Ingelheim
• Boehringer Ingelheim Grundstücks-GmbH, Ingelheim
• Boehringer Ingelheim Finanzierungs GmbH, Ingelheim.
Exempted from reporting and disclose obligations of annual financial statements according to HGB
regulations for joint stock companies under section 264b HGB are:
• C.H. Boehringer Sohn, Ingelheim
• C.H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG, Ingelheim
• Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim.
1.3 Consolidation methods
For inventories, accounts receivable and payable, and the income and expense items, business
transactions between the companies consolidated were eliminated as part of the debt consolidation,
according to section 303 HGB, the elimination of inter-company profits according to section 304 HGB,
and the income and expense consolidation according to section 305 HGB.
The purchase method of accounting was used for the capital consolidation of those subsidiaries that
were included for the first time in the consolidated financial statements. First-time consolidation takes
place at the time of the respective company becoming a subsidiary.
The goodwill of two major companies wholly acquired in 1997 is being amortised according to plan
over 10 years.
Credit balances from capital consolidation primarily represent retained earnings during group membership; they therefore have the characteristics of equity and are included in group reserves. Negative
goodwill arising from the first-time consolidation of a subsidiary was further amortised in the fiscal
year in accordance with section 309, paragraph 2, clause 1 HGB to the amount of the share of the
losses (EUR 0.6 million).
97
1.4 Currency conversions
The financial statements prepared in foreign currencies were translated into euros, the functional
currency of the group parent company, C. H. Boehringer Sohn, according to the year-end method.
All assets and liabilities have been converted at the year-end rate. The profit and loss statement and,
consequently, net income, were converted at the average annual rate for the reporting year.
Translation differences due to the conversion of foreign currencies are shown as a balancing item in
the equity without impact on income.
Inflation effects in high inflation countries were eliminated by separate hard currency financial
statements (in US dollars or euros) drawn up by the respective local subsidiaries.
The most important currencies for Boehringer Ingelheim reflect the following changes in the reporting
year (base 1 euro):
year-end rate
US dollar
Japanese yen
98
average annual rate
31.12.2005
31.12.2004
2005
2004
1.18
1.36
1.24
1.24
138.90
139.83
136.87
134.40
Pound sterling
0.69
0.71
0.68
0.68
Canadian dollar
1.37
1.64
1.51
1.61
2 Accounting and evaluation methods
2.1 Fixed assets
Intangible and tangible assets are shown at purchase or manufacturing cost, net of regular straightline depreciation, according to the technical and economic situation. The following periods of use
were applied:
Buildings
20 years
Technical facilities and machinery
10 years
Other facilities, operating and business equipment
3 to 10 years
Diverging from the declining-balance method of depreciation applied in the individual financial
statements of C. H. Boehringer Sohn the straight-line method of depreciation is used in the
consolidated financial statements for the purpose of uniformity in group-wide measurement.
Anticipated long-term losses in the value of investments were accounted for by unscheduled writeoffs. Appropriate portions of material and production overheads were taken into consideration for the
determination of manufacturing costs. Fully amortised goodwill that is more than five years old, or is
materially insignificant, is shown under disposals.
All capitalised intangible assets have a limited useful life.
The financial assets were valued at the lower of either purchase cost or fair market value.
2.2 Current assets
Inventories were valued at purchase or manufacturing cost using the weighted average cost
flow method as the group-wide uniform method of measurement, whereas for tax purposes,
C. H. Boehringer Sohn applies the LIFO Method in its individual financial statements. Appropriate
portions of material and production overheads were taken into consideration for the determination
of the manufacturing costs. Necessary reductions were made for inventory risks.
Accounts receivable were stated at their nominal value net of any individual valuation allowances
required. The general credit risk was covered by a general valuation allowance for bad debt.
Other assets were stated at the lower of either purchase cost or fair market value.
Foreign currency items were recorded at the year-end rate of exchange.
2.3 Group reserves
Group reserves include the retained earnings of the consolidated subsidiaries from prior years,
consolidation entries that affect earnings, where they relate to prior years, and credit balances arising
from capital consolidation.
99
2.4 Provisions
The provisions include required amounts to cover any perceptible obligations and risks, including
provisions for contingent losses from pending contracts. The valuation is made at the amount that is
necessary on the basis of reasonable commercial judgement. Provisions with an implied interest were
shown on a discounted basis (e. g. certain personnel provisions).
2.5 Liabilities
Liabilities are shown in the balance sheet at the repayable amount. Liabilities in foreign currencies
were recorded at the year-end rate of exchange.
2.6 Deferred taxes
The deferred tax assets and liabilities represent the tax deferral in accordance with section 274 and
306 HGB, which arise because of temporary differences between the tax balance sheets of the individual companies and the consolidated balance sheet (including differences arising from adjustments
for conformity in group-wide reporting and evaluation as well as consolidation measures).
Quasi-permanent differences between the consolidated balance sheet and the tax balance sheet are
treated as temporary differences in accordance with German Accounting Standard 10 (GAS 10).
Deferred tax assets and liabilities are offset in accordance with GAS 10.
In the individual balance sheets (i.e. the financial statements II) the consolidated companies made use
of their option to capitalise assets to the amount of probable tax savings in the following years in
accordance with section 274, paragraph 2 HGB. The calculation of deferred taxes is based on the tax
rates that are expected to be valid at the time of their realisation.
The capitalisation of deferred tax assets on tax loss carryforwards is carried out if it is sufficiently
probable that the tax benefits can be realised.
100
3 Notes to the consolidated balance sheet
3.1 Intangible assets
Concessions/
Similar rights
Goodwill
Advance
payments
Total
432
–6
807
3
1,242
–1
0
–7
Procurement/manufacturing costs
Currency conversion difference
Additions due to first consolidation
5
0
0
5
Additions
98
10
3
111
Disposals
–9
0
0
–9
6
0
–3
3
526
816
3
1,345
11
3
0
14
0
0
0
0
Reclassifications
Additions
50
0
7
57
Disposals
–18
–13
0
–31
4
0
–4
0
573
806
6
1,385
Reclassifications
Accumulated depreciations
Additions
Value adjustments
Disposals
Reclassifications
336
664
0
1,000
–6
–1
0
–7
1
0
0
1
36
58
0
94
0
0
0
0
–9
0
0
–9
–1
0
0
–1
357
721
0
1,078
9
2
0
11
0
0
0
0
44
48
0
92
0
0
0
0
–16
–13
0
–29
0
0
0
0
394
758
0
1,152
Book value as of 31. 12. 2004
169
95
3
267
179
48
6
233
Additions
Value adjustments
Disposals
Reclassifications
101
3.2 Tangible assets
Property and
Technical
plants facilities and
machines
Other
Advance
facilities/
payments/
operating construction
equipment
in progress
Total
2,055
1,900
1,113
383
5,451
–60
–47
–30
–7
–144
1
21
11
4
37
Additions
30
59
134
204
427
Disposals
–45
–53
–79
–5
–182
41
102
163
–309
–3
2,022
1,982
1,312
270
5,586
96
82
61
15
254
3
2
2
0
7
Reclassifications
Additions
37
77
140
278
532
Disposals
–31
–42
–89
–8
–170
Reclassifications
56
98
49
–203
0
2,183
2,199
1,475
352
6,209
890
942
852
0
2,684
–25
–24
–20
0
–69
0
7
7
0
14
81
151
145
0
377
Additions
Value adjustments
Disposals
Reclassifications
0
–4
0
–4
–48
–69
0
–129
–1
2
0
0
1
933
1,030
911
0
2,874
42
43
40
0
125
2
1
2
0
5
125
163
151
0
439
0
–2
0
0
–2
–13
–37
–82
0
–132
0
0
0
0
0
1,089
1,198
1,022
0
3,309
1,089
952
401
270
2,712
1,094
1,001
453
352
2,900
Additions
Value adjustments
Disposals
Reclassifications
102
0
–12
3.3 Financial assets
Investments
in affilated
companies
Loans
to affiliated
companies
Related
companies
Loans to
related
companies
Investment
securities
Other loans
Total
21
6
10
6
2,391
49
2,483
–1
0
0
0
–2
0
–3
0
0
0
0
0
0
0
Additions
1
2
0
0
679
8
690
Disposals
0
0
0
0
–382
–16
–398
Reclassifications
0
0
0
0
0
0
0
21
8
10
6
2,686
41
2,772
0
0
0
0
3
0
3
0
0
0
0
0
0
0
Additions
0
1
0
0
674
5
680
Disposals
–1
0
0
0
–7
–21
–29
Reclassifications
0
0
0
0
0
0
0
20
9
10
6
3,356
25
3,426
3
0
3
3
9
3
21
0
0
0
0
1
0
1
0
0
0
0
0
0
0
Additions
0
0
0
0
0
0
0
Value adjustments
0
0
0
0
–1
0
–1
Disposals
0
0
0
0
–5
0
–5
Reclassifications
0
0
0
0
0
0
0
3
0
3
3
4
3
16
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Additions
0
0
0
0
14
0
14
Value adjustments
0
0
0
0
0
0
0
Disposals
0
0
0
0
0
0
0
Reclassifications
0
0
0
0
0
0
0
3
0
3
3
18
3
30
18
8
7
3
2,682
38
2,756
17
9
7
3
3,338
22
3,396
The item “other loans” includes no loans to the shareholders (2004: EUR 12 million).
103
3.4 Inventories
31.12.2005
31.12.2004
Raw materials and supplies
225
217
Unfinished products
537
444
Finished products and goods for resale
460
416
7
8
1,229
1,085
Advance payments to suppliers
3.5 Accounts receivable
Trade accounts receivable
Receivables from affiliated companies
Receivables from related companies
Other assets
31.12.2005
Residual term
over 1 year
31.12.2004
Residual term
over 1 year
1,854
71
1,543
6
2
0
4
0
5
0
6
0
282
12
261
11
2,143
83
1,814
17
The item “other assets” contains no receivables from the shareholders (2004: EUR 2 million).
3.6 Provisions (in millions of EUR)
31.12.2005
31.12.2004
Pension provisions
2,035
1,983
Tax provisions
Other provisions
104
548
380
2,171
1,616
4,754
3,979
Pension provisions
Boehringer Ingelheim’s pension schemes are based on various defined contribution plans as well as
defined benefit plans.
Pension obligations arising from direct or indirect defined benefit plans are determined on the basis of
the projected unit credit method, taking future salary and pension increases into consideration.
The actuarial calculation of the pension obligation from defined benefit plans is based on countryspecific biometric data (in Germany the “generation tables” issued in 2005 by Professor Klaus Heubeck
were used) and actuarial assumptions. The main countries applied the following parameters:
Germany
USA
Japan
2005
2004
2005
2004
2005
2004
4.1
5.0
5.5
5.75
1.5
1.5
Expected return on assets
6.0
6.0
8.0
8.5 2.2–3.0
3.0
Salary increase
2.5
3.0
5.5
5.5 2.4–4.7
3.9
Pension increase
1.7
1.7
3.0
3.0
0.0
Parameter (in %)
Discount rate
0.0
At the balance sheet date, the present value of the expected pension obligation was netted with the fair
value of the respective pension plan assets (funding status).
Based on this, pension provisions are determined by deducting unrealised transition amounts as well
as unrealised actuarial gains and losses from the funding status. Based on the “corridor approach”,
unrealised gains and losses are amortised over the expected average service periods of the respective
active employees. At balance sheet date, pension commitments (including total unrealised transition
amounts and actuarial gains and losses) of EUR 698 million (2004: EUR 343 million) were not recognised as part of pension provisions.
In conjunction with defined contribution plans, group companies paid contributions to state or
private insurers on the basis of legal or contractual regulations. On payment of the contributions the
companies no longer have any performance obligations. Contributions are recognised as personnel
costs upon payment.
105
3.7 Accounts payable
Bank loans
Residual term
less than 1 year
Residual term
1–5 years
Residual term
over 5 years
31.12.2005
Residual term
31.12.2004 less than 1 year
216
221
43
480
441
190
1,549
–
145
1,694
1,445
1,271
775
–
–
775
516
516
–Advance payments
45
–
–
45
66
66
–Notes payable
14
–
–
14
17
17
8
–
–
8
7
7
related companies
1
–
–
1
6
6
–Other liabilities (*)
706
–
145
851
833
659
1,765
221
188
2,174
1,886
1,461
– taxes
24
35
– social security contributions
22
17
Other accounts payable
of which:
–Trade accounts payable
–Accounts payable to
affiliated companies
– Accounts payable to
(*) of which:
There were no liabilities secured by mortgages or similar rights on the balance sheet date consistent
with the previous year.
Liabilities due to shareholders amounted to EUR 215 million (2004: EUR 190 million) at year-end.
These were disclosed under “other liabilities”. They stem from the shareholders’ personal taxes arising
from consolidated business activities.
Payments received from the ABS partners in conjunction with the ABS transaction are shown as
short-term loans under “other liabilities” until the underlying accounts receivable are paid off.
106
4 Notes to the consolidated profit and loss statement
The consolidated profit and loss statement is presented in line with the total cost method.
4.1 Net sales by business and business segment (in millions of EUR)
2005
2004
9,174
7,822
of which: Prescription Medicines
7,247
6,183
1,052
970
Industrial Customer
847
654
Other sales
28
15
361
335
9,535
8,157
by geographic region (in millions of EUR)
2005
2004
Europe
3,117
2,622
Animal Health
of which: Germany
Americas
816
656
4,559
3,905
of which: USA/Canada/Mexico
4,219
3,625
1,859
1,630
of which: Japan
1,232
1,142
9,535
8,157
2005
2004
Costs of raw material, supplies and goods for resale
1,351
1,076
262
213
1,613
1,289
2005
2004
Salaries and wages
4.2 Material costs
Expenditure on services
4.3 Personnel costs
2,087
1,913
Social benefits and retirement benefits
584
530
of which: retirement benefits
155
154
2,671
2,443
The interest component with respect to the increase in pensions and similar obligations is included in
financial income rather than in personnel costs and is, therefore, not included in the operating result
of the company.
107
Average headcount
Production
Administration
Marketing and Sales
Research and Development
Apprentices
2005
2004
12,044
10,614
4,742
5,670
14,257
13,151
5,678
5,471
685
623
37,406
35,529
0
245
This includes:
Average number of employees in joint ventures,
proportionately consolidated
Regarding 2005, transfers from “administration” to “production” caused by changes in organisational
structure have to be considered.
4.4 Amortisation of intangible and depreciation of tangible assets
The amortisation of intangible assets and depreciation of tangible assets includes unscheduled writeoffs of EUR 2 million (2004: EUR 1 million).
4.5 Other operating expenses
Other operating expenses include third-party services in research, development, medicine, and
marketing, in addition to administration costs, fees, contributions, commissions, rents, freight costs,
and expenses for third-party repairs as well as expenses incurred by restructuring measures.
4.6 Financial income
2005
2004
Interest expense relating to pensions and similar obligations
–108
–111
Other interest expense and similar expenditure
–70
–49
–178
–160
Amortisation of other financial assets and short-term investments
–14
–4
Income from other investment securities and from long-term loans
110
103
Interest expense and similar expenditure
Other interest income and similar proceeds
108
47
46
–35
–15
4.7 Holding income
2005
2004
0
2
2005
2004
Income taxes
504
360
Deferred taxes
–154
72
Gains from the sale of investments
4.8 Taxes
Other taxes
24
19
374
451
By concluding profit transfer agreements, significant German corporations have since 1 January
2004 belonged to the trade and corporate taxation group of integrated companies of the parent
company C. H. Boehringer Sohn. As income tax levied on operating income of the shareholders of
C. H. Boehringer Sohn may not be shown in the consolidated profit and loss statement, only the trade
tax of the relevant companies is shown as a tax expense.
As a consequence of the conclusion of profit transfer agreements in the previous year, the deferred
taxes of these corporations as of 31 December 2004 were no longer calculated at a profit tax rate of
37.6 % but at a trade tax rate of around 15 %. In 2004, this change led to a one-off deferred tax expense
of EUR 121 million.
In the effective tax-rate reconciliation an expected tax expense for Boehringer Ingelheim is calculated
on a profit tax rate for corporations (corporate tax, solidarity levy and trade tax). As in the profit and
loss statement tax expenses related to the income tax for partnerships and integrated companies of
C. H. Boehringer Sohn are limited to showing trade tax, the expected tax expense in the effective
tax-rate reconciliation is in this respect adjusted for fictive current and deferred corporate tax expenses
in order to link to the profit tax expense shown in the profit and loss statement. This elimination of
fictive corporate tax (including the solidarity levy) is shown in the items Fictive Corporation.
109
The expected tax expense derived by using a fictive tax rate of 37.6 % (average tax rate for a German
corporation at a municipal trade tax levy rate of 360 %) can be related to the actual tax expense as
follows:
2005
Income before taxes minus other taxes
2004
1,864
Expected tax expense (current and deferred)
1,340
701
37.6 %
504
37.6 %
–378 –20.3 %
–191
–14.3 %
2.6 %
18
1.3 %
Decrease/increase in expected tax by
–Fictive Corporation current taxes
–Fictive Corporation deferred taxes
49
0
0.0 %
121
9.0 %
–34
–1.8 %
–41
–3.1 %
–6
–0.3 %
–6
–0.4 %
–One-off effect of profit transfer agreements
–Local tax rate divergences
–Non-taxable income
–Non-tax-deductible expense
34
1.8 %
36
2.7 %
–Taxes related to prior periods
–35
–1.9 %
–19
–1.4 %
18
1.0 %
21
1.6 %
7
0.4 %
9
0.7 %
–Amortisation of goodwill
–Changes in applicable tax rates
–Withholding taxes not subject to tax credits
–Tax credits for research activities
20
1.1 %
18
1.3 %
–19
–1.0 %
–36
–2.7 %
–7
–0.4 %
–2
–0.1 %
350
18.8 %
432
32.2 %
–Other effects
Actual tax expense (current and deferred)
The deferred taxes can be attributed to the following balance sheet items:
31.12.2005
Intangible assets
Liabilities
Assets
Liabilities
7
2
7
1
Tangible assets
32
132
18
125
Financial assets
15
24
16
23
Inventories
104
19
88
21
Receivables
38
9
22
7
600
16
448
9
14
2
15
7
Provisions
Liabilities
Tax loss carryforwards and tax credits
110
Assets
31.12.2004
11
0
5
0
821
204
619
193
Other mandatory disclosures according to GAS 10.39:
2005
2004
Deferred tax expense from changes in law
0
–4
Deferred tax expense relating to the write-off of deferred tax assets
in fiscal year
5
0
The absence of changes in accounting and evaluation methods results, as in the previous year,
in no deferred tax income.
Potential corporate tax reductions in accordance with section 37, paragraph 2 corporation tax law
(KStG) amount to EUR 22 million.
The valuation allowances relating to deferred tax assets amount to EUR 19 million.
Unused tax loss carryforwards, on which no deferred tax assets are recognised in the balance sheet,
amount to EUR 51 million at year-end, EUR 30 million of which can be carried forward without
time limits. The remainder expire after five years (EUR 11 million) and 10 years (EUR 10 million)
respectively.
4.9 Net income
Net income for the year 2005 includes operating income unrelated to the accounting period
(mainly the release of other provisions) amounting to EUR 81 million (2004: EUR 92 million).
Operating expenditure unrelated to the accounting period (mainly increase of other provisions)
amounted to EUR 27 million (2004: EUR 47 million).
111
5 Notes to the cash flow statement
The cash flow statement shows how the total securities and liquid funds (liquid assets and securities in
fixed and current assets) of the Boehringer Ingelheim Group have changed during the reporting year
through inflow and outflow of cash and cash equivalents.
In accordance with German Accounting Standard No. 2, (GAS 2), Cash Flow Statements, cash flows are
classified by operating, investing or financing activities.
Changes reported by consolidated companies are converted at the average annual rate. Securities and
liquid funds are converted, as shown in the balance sheet, according to the year-end rate method.
The influence of exchange rate changes on securities and liquid assets is provided separately.
6 Other information
6.1 Derivative financial instruments
Boehringer Ingelheim is, due to its extensive international structure, highly dependent on the
development of the major world currencies and interest rates. In order to hedge against the risks,
particularly those inherent in supplies and services and financial funding, use is generally made
of foreign exchange forward contracts in the case of currency risks. Regarding interest rate risks,
use is made of interest rate swaps and interest rate options.
The risk positions are recorded, analysed and assessed regularly in a special consolidated financial
report.
The use of derivative financial instruments and the organisational procedure are laid down in internal
guidelines. Trade, processing, documentation, and control are kept strictly separate.
The items are periodically re-evaluated and monitored. Derivative financial instruments are only
agreed on with banks of sound financial standing.
As of 31 December 2005, the nominal value of all foreign currency and interest rate hedging
transactions amounted to EUR 3,618 million (2004: 2,179 million). The corresponding market values
amounted to EUR -63 million (2004: EUR 85 million).
112
Derivative financial instruments at year-end were as follows:
Nominal value
Market value
31.12.2005
31.12.2004
31.12.2005
31.12.2004
3,355
1,906
–62
86
263
273
–1
–1
Foreign exchange forward contracts
Interest instruments
The nominal value is the sum of all purchases and sales. The market value is calculated on the basis of
quoted prices or derived values for derivative instruments.
6.2 Contingent liabilities to the benefit of third parties (in millions of EUR)
31.12.2005
31.12.2004
176
154
31.12.2005
31.12.2004
741
752
Liabilities from guarantees, guarantees for bills and cheques,
warranties and provisions of collateral for third-party liabilities
6.3 Other financial obligations
To third parties
At year-end, other financial obligations included capital investments of EUR 552 million (2004:
EUR 593 million). Furthermore EUR 182 million (2004: EUR 146 million) from renting and leasing
contracts are included, of which EUR 87 million concern long-term rent contracts with subsidiaries
not included in the consolidation.
6.4 Research and development expenses
2005
2004
Expenditures for Research and Development
1,360
1,232
113
Auditor’s Report
We have audited the consolidated financial
We conducted our audit of the consolidated
statements prepared by C. H. Boehringer Sohn,
annual financial statements in accordance with
Ingelheim – comprising the balance sheet, the
section 317 HGB and the generally accepted
income statement, the statement of changes in
standards for the audit of financial statements
equity, the cash flow statement and the notes to
promulgated by the Institut der Wirtschaftsprüfer
the consolidated financial statements – together
in Deutschland (IDW). Those standards require
with the group management report for the busi-
that we plan and perform the audit such that
ness year from 1 January to 31 December 2005.
misstatements materially affecting the presenta-
The preparation of the consolidated financial
tion of the net assets, financial position and
statements and the group management report in
results of operations in the consolidated financial
accordance with German commercial law are the
statements in accordance with German princi-
responsibility of the Management Board of the
ples of proper accounting and in the group
Managing Corporate Partnership-AG. Our
management report are detected with reasonable
responsibility is to express an opinion on the
assurance. Knowledge of the business activities
consolidated financial statements and the group
and the economic and legal environment of the
management report based on our audit.
Company and evaluations of possible misstatements are taken into account in the determination of audit procedures. The effectiveness of the
accounting-related internal control system and
the evidence supporting the disclosures in the
consolidated financial statements and the group
management report are examined primarily on a
test basis within the framework of the audit.
The audit includes assessing the annual financial
statements of the companies included in consolidation, the determination of the companies to be
included in consolidation, the accounting and
consolidation principles used and significant
estimates made by the Management Board of the
Managing Corporate Partnership-AG, as well as
evaluating the overall presentation of the consolidated financial statements and the group
management report. We believe that our audit
provides a reasonable basis for our opinion.
114
With the following exception, our audit has not
led to any reservations: contrary to section 314
paragraph 1 number 6 HGB compensation of the
members and former members of the board of
managing directors have not been disclosed.
In our opinion based on the findings of our audit
the consolidated financial statements with the
exception mentioned comply with the legal
requirements. The consolidated financial statements give a true and fair view of the net assets,
financial position and results of operations of
the Group in accordance with German principles
of proper accounting. The group management
report is consistent with the consolidated
financial statements and as a whole provides
a suitable view of the Group’s position and
suitably presents the opportunities and risks of
future development.
Frankfurt am Main, 15 February 2006
PricewaterhouseCoopers
Aktiengesellschaft
Wirtschaftsprüfungsgesellschaft
(E.-W. Frings)
(P. Marshall)
Wirtschaftsprüfer
Wirtschaftsprüfer
(German Certified
(German Certified
Public Accountant)
Public Accountant)
115
Glossary
Product name
116
Active ingredient
Indication
actilyse®
alteplase
Fibrinolytic treatment of acute myocardial
infarction, acute massive pulmonary embolism
and ischaemic stroke
aggrenox® asasantin® persantin®
ASA / dipyridamole
extended release
Prevention of stroke following a first stroke
or for transient ischaemic attacks
As above and adjunct to coumarin anticoagulants
in the prevention of postoperative thrombo
embolic complications of cardiac valve
replacement
alesion® flurinol® talerc®
epinastine
Antiallergic agent
antistax®
standardized
red wine leaf extract AS195®
Prevention and treatment of symptoms of chronic
venous insufficiency – such as painful swollen,
heavy or tired legs
aptivus®
tipranavir
Available as capsules for adults – used coadministered with 200 mg of ritonavir,
is indicated for combination antiretroviral
treatment of HIV-1 infected adult patients with
evidence of viral replication, who are highly
treatment-experienced or have HIV-1 strains
resistant to multiple protease inhibitors
atrovent®
ipratropium bromide
Bronchodilator for maintenance treatment
of bronchospasm associated with chronic
obstructive pulmonary disease, including chronic
bronchitis, emphysema and asthma
berotec® dosberotec®
fenoterol
a) Symptomatic treatment of acute asthma
attacks
b) Prophylaxis of exercise induced asthma
c) Symptomatic treatment of bronchial asthma
and other conditions with reversible airway
narrowing e.g. chronic obstructive bronchitis.
Concomitant anti-inflammatory therapy should
be considered for patients with bronchial asthma
and steroid responsive chronic obstructive
pulmonary disease (COPD)
bisolvon®
bromhexine
Mucolytic for the treatment of acute and chronic
bronchopulmonary diseases associated with
impaired formation and transport of mucus
buscopan® buscapina®
butylscopolamine
Treatment of abdominal discomfort and pain due
to intestinal cramps
catapresan® catapres® catapressan® atensina®
clonidine
All forms of high blood pressure,
unless caused by phaeochromocytoma
Product name
Active ingredient
Indication
combivent®
ipratropium bromide/ salbutamol
Treatment of bronchospasms associated with
reversible obstructive airways diseases in patients
requiring more than one bronchodilator
cymbalta® xeristar®
duloxetine
Major depressive disorder (MDD),
Diabetic peripheral neuropathic pain (DPNP)
dulcolax®
bisacodyl Laxative for the treatment of constipation
(tablets, suppositories), sodium picosulphate
(drops, pearls, tablets)
duovent® bronchodual® berodual®
fenoterol / ipratropium bromide
Prevention and treatment of symptoms
in asthmic and chronic obstructive pulmonary
disease (COPD) patients with reversible
bronchospasm
flomax® alna® josir® pradif® secotex® urolosin®
tamsulosin
ydrochloride
h
Lower urinary tract symptoms (LUTS) associated
with benign prostatic hyperplasia (BPH)
flomax® cr alna® ocas® pradif® t urolosin® ocas®
tamsulosin
ydrochloride, h
Oral Controlled
Absorption System
Lower urinary tract symptoms (LUTS) associated
with benign prostatic hyperplasia (BPH)
inflammide®
budesonide
Bronchial asthma
laxoberal®
sodium picosulphate (drops, pearls and
tablets)
Laxative for the treatment of constipation
lendormin® lendorm® lindormin® sintonal®
brotizolam
Short-term treatment of disorders of initiating
and maintaining sleep
metalyse®
tenecteplase
Fibrinolytic treatment of acute myocardial
infarction
mexitil® mexitilen®
mexiletine
Serious symptomatic ventricular tachycardic
heart rhythm disturbances
micardis® micardisplus® micardis® hct co-micardis®
telmisartan telmisartan / hydro
chlorothiazide
Treatment of essential hypertension
Glossary
117
Product name
118
Active ingredient
Indication
mobic® mobec® movalis® movatec®
meloxicam
Symptomatic treatment of rheumatic diseases
motens® caldine® tens® midotens®
lacidipine
Treatment of essential hypertension
mucoangin®
ambroxol hydrochloride
Pain relief in acute sore throat
mucosolvan® motosol® mucosan® surbronc®
ambroxol
Mucolytic treatment of acute and chronic
bronchopulmonary diseases associated with
impaired formation and transport of mucus
pharmaton® pharmaton® capsules geriavit pharmaton® pharmaton® caplets
standardized ginseng
extract G115®, vitamins, minerals, trace elements
To improve physical and mental performance
and well-being
sifrol®
pramipexole
Symptomatic treatment of idiophathic
arkinson’s disease
P
silomat®
clobutinol
ydrochloride
h
Symptomatic treatment of irritable,
non-productive cough
spiriva®
tiotropium bromide
Maintenance treatment of patients with COPD
(including chronic bronchitis and emphysema),
the maintenance treatment of associated
dyspnoea and for prevention of exacerbations
thomapyrin®
ASA, paracetamol,
caffeine
Pain
viramune®
nevirapine
Available as tablets for adults and suspension
for children – for the combination therapy of HIV
infection and for the prevention of
mother-to-child transmission of HIV
yentreve® ariclaim®
duloxetine
Moderate to severe stress urinary
incontinence (SUI) in women
Animal Health
Product name
Active ingredient
Indication
buscopan®
compositum
N-butyl scopolamonium Spasmolitic and pain inhibitor for the treatment
bromide + metamizole
of colic (horse and cattle)
enterisol® ileitis
attenuated life vaccine
(Lawsonia
intracellularis)
lyophilised
express®
attenuated life vaccine For prevention of reproductive and respiratory
(IBRV, BVDV, PI3V, BRSV) diseases in cattle
ingelvac® m.hyo
inactivated ycoplasma
M
hyopneumoniae
ingelvac® prrs mlv
modified live PRRS virus, For the active immunization of clinically healthy
grown in a permanent
swine against the respiratory and
cell line freeze-dried
reproductive form of PRRS virus infection
(porcine reproductive respiratory
syndrome)
mamyzin®
penethamate
ydroiodide
h
For the treatment of mastitis caused by
Gram-positive pathogens
metacam®
meloxicam
Dog, horse: alleviation of pain and inflammation
associated with acute or chronic musculoskeletal disorders
Cat, dog: reduction of postoperative pain
Cattle: respiratory infection, diarrhoea,
acute mastitis
Swine: non-infectious locomoter disorders,
mastitis-metritis-agalactic-syndrome
ventipulmin®
clenbuterol
Bronchodilator for the treatment of acute and
chronic obstructive airway disease in horses
vetmedin®
pimobendan
For the treatment of congestive heart failure
in dogs
voren®
dexamethasone-21isonicotinate
For the treatment of metabolic disorders,
i nflammation and allergic reactions in cattle,
swine, horses, dogs and cats
For active immunisation of pigs to reduce
intestinal lesions caused by Lawsonia intracel
lularis infection and to reduce growth variability
and loss of weight gain associated with the
disease
For the active immunization of swine from three
weeks of age to reduce lung lesions
following infection with Mycoplasma
hyopneumoniae
Glossary
119
Corporate Head Office
Binger Strasse 173
55216 Ingelheim
Germany
Telephone + 49 / 6132 / 77-0
Fax + 49 / 6132 / 77-3000
Contacts
CD Communications
Telephone + 49 / 6132 / 77-2012
Fax + 49 / 6132 / 77-6601
Internet www.boehringer-ingelheim.com
Issued by
Design and layout
Neufrankfurt Corporate Design GmbH, Offenbach am Main
Photos on title page
Jens Wunderlich, Lennart Nilsson
Printed by
Süddeutsche Verlagsgesellschaft, Ulm
Copyright
© Boehringer Ingelheim GmbH, 2006
All rights reserved. No part of this Annual Report 2005
may be reproduced or transmitted in any form or
by any means, electronic or photocopy, without permission
in writing from Boehringer Ingelheim GmbH.
Contents
8
22
40
56
62
70
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
89
508
452
400
344
322
302
242
267
233
Tangible assets
1,342
1,612
1,739
1,992
2,217
2,467
2,840
2,767
2,712
2,900
Financial assets
1,007
757
731
849
1,135
1,008
1,689
2,462
2,756
3,396
Fixed assets
2,438
2,877
2,922
3,241
3,696
3,797
4,831
5,471
5,735
6,529
Intangible assets
Inventories
627
794
806
944
1,021
1,014
971
1,000
1,085
1,229
1,057
1,211
1,255
1,870
1,938
2,314
2,360
2,537
2,477
3,013
156
134
299
459
477
1,002
1,055
1,134
1,333
1,247
Current assets
1,840
2,139
2,360
3,273
3,436
4,330
4,386
4,671
4,895
5,489
Total assets
4,278
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
383
399
441
332
211
200
178
178
178
178
Our Company
10 Our Commitment
14 For Our People
22 Our R&D Drive
advances.
1,307 1,461 1,651 1,982 2,362 2,753 2,818 3,139
3,297
2,940
Net income
167
212
229
320
379
401
537
529
888
1,491
Total equity
1,857
2,072
2,321
2,634
2,952
3,354
3,533
3,846
4,363
4,609
0
0
0
0
0
1
203
188
193
216
Group equity
1,857
2,072
2,321
2,634
2,952
3,355
3,736
4,034
4,556
4,825
1,841 1,982 2,012 2,631 2,932 3,150 3,568 3,963 4,172
4,958
Minority interests
580 962 949 1,249 1,248 1,622 1,913 2,145
1,902
2,235
Total liabilities
2,421
2,944
2,961
3,880
4,180
4,772
5,481
6,108
6,074
7,193
4,278
5,016
5,282
6,514
7,132
8,127
9,217
10,142
10,630
12,018
1996
1997
1998
1999*
2000
2001
2002
2003
2004
2005
Sales
3,623
4,201
4,474
5,086
6,188
6,694
7,580
7,382
8,157
9,535
62 Time is Critical
333
350
336
655
800
980
1,082
901
1,372
1,923
9.2
8.3
7.5
12.9
12.9
14.6
14.3
12.2
16.8
20.2
Income after taxes
167
212
229
320
379
401
551
537
908
1,514
4.6
5.0
5.1
6.3
6.1
6.0
7.3
7.3
11.1
15.9
9.8
11.4
11.0
13.8
14.4
13.6
16.0
15.0
23.1
34.2
43.4
41.3
43.9
40.4
41.4
41.3
38.3
37.9
41.0
38.4
Cash flow
426
561
595
737
791
1,117
1,049
1,059
1,430
2,069
Animal Health
Financial funds
966
722
858
1,055
1,094
1,645
2,645
3,516
4,015
4,585
1,153
1,270
1,409
1,527
1,749
1,916
2,175
2,252
2,443
2,671
30.5
29.9
28.0
34,221 35,529
37,406
626
771
812
R&D as % of sales
17.3
18.4
18.1
346
455
421
169
189
211
116 Glossary
for pensions.
31.8
30.2
31.5
30.0
28.3
28.6
28.7
24,074
24,860
25,927
26,448
27,325
27,980
31,843
826
968
1,019
1,304
1,176
1,232
1,360
16.2
15.6
15.2
17.2
15.9
15.1
14.3
377
497
548
634
516
427
532
256
288
305
340
354
377
439
2005
2004
Change
9,535
8,157
17 %
Europe
33 %
32 %
Americas
48 %
48 %
19 %
20 %
96 %
96 %
4 %
4 %
1,360
1,232
10 %
Personnel costs
2,671
2,443
9 %
37,406
35,529
5 %
1,923
1,372
40 %
20.2 %
16.8 %
Net sales
by region
by business area
Animal Health
Operating income
Annual Report 2005
Income after taxes
1,514
908
15.9 %
11.1 %
4,609
4,363
34.2 %
23.1 %
2,069
1,430
45 %
532
427
25 %
439
377
16 %
Annual Report 2005
Cash flow
nopq
67 %
6 %

Financ - Boehringer Ingelheim

Transcription

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