Animal Health

Pharmaceuticals

Medical Care

Consumer Care

Bayer HealthCare

Names Figures Facts 2012

Conten t s
Names Figures Facts 2012
Foreword

Bayer HealthCare Executive Committee

Key figures 2011

Active worldwide

Animal Health

10

Consumer Care

12

Medical Care

14

Pharmaceuticals

16

Research and development

20

Product Supply

24

Business development

26

Social commitment

28

Research milestones

30

Contacts

32

COVER:
Bayer HealthCare combines the global activities of its four divisions: Animal Health, Consumer Care, Medical Care
and Pharmaceuticals.

Imp ri
renstsum
Published by: Bayer HealthCare AG,
Communications & Public Affairs
Oliver Renner
51368 Leverkusen, Germany
English version: Language Service, Currenta
GmbH & Co. OHG, Germany
Edited by:
Christina Sehnert, christina.sehnert@bayer.com
Brbel Doormann, baerbel.doormann@bayer.com

Forward-Looking Statements
This brochure may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors
could lead to material differences between the actual future results,
financial situation, development or performance of the company and the
estimates given here. These factors include those discussed in Bayers
public reports which are available on the Bayer website at www.bayer.com.
The company assumes no liability
whatsoever to update these forwardlooking statements or to conform
them to future events or developments.
Product names are mostly registered
trademarks. All trademarks are printed
in italics.

Foreword
Science for A Better Life
Dear Readers,
Our mission as a company is to develop innovative products and solutions that improve the lives of
humans and animals. To this end, Bayer HealthCare researches and develops prescription medicines,
primarily in areas where there is a high level of medical need, such as cancer therapy or the treatment
of cardiovascular disease. Our Consumer Health segment includes non-prescription medicines, dermatology products, blood glucose meters, medical devices, contrast agents, and pharmaceuticals and
grooming products for companion animals and lifestock.
Bayer HealthCare is already one of the world's leading companies in the health care industry today,
and we plan to further extend this position in the coming years. At present, we believe that the greatest
opportunities for development can be found in the new growth markets in Asia and Latin America, but
also in Eastern Europe. In these regions in particular, the demand for innovative health care products is
continuing to rise strongly. In the United States and Western Europe, however, the situation is different.
In these markets that are equally important to us, public health care systems are facing the challenge of
increasing the efficiency of their medical care. To be economically successful in the future, we at Bayer
HealthCare must find ways to offer the right products and solutions that meet the specific needs of our
customers and create clear added value in both market environments.
The key to this is innovation. We at Bayer HealthCare have at our disposal excellent capabilities
in medical research and new product development. Thanks to the scientific know-how and
personal dedication of our employees in these areas, we currently have one of the strongest
pipelines of innovative products in the industry.
However, we must continue to work on developing new solutions that meet the needs of
our customers and will be successful on the market. Here, we benefit firstly from our
broad positioning in the health care sector and secondly from the great regard and trust
that the Bayer brand enjoys around the globe.
This brochure will give you an insight into the diversity and strength of our company.
I hope that this edition of Names Figures Facts will spur your fascination for
Bayer HealthCare and our mission - "Science For A Better Life".
Dr. Jrg Reinhardt
Chief Executive Officer Bayer HealthCare

Baye r Healt hCare

Bayer HealthCare Executive Committee
Bayer HealthCare is managed by its Executive Committee.
This body is composed of the four divisional heads, the
heads of Research and Development as well as the heads
of the cross-divisional platform functions Central Administration & Organization, Communications & Public Affairs,
Global Business Development & Licensing, Human
Resources, Law and Patents and Product Supply. The
Executive Committee sets the course for the companys
future. Its task is to make strategic decisions that lead to
a sustained increase in the companys value.
Dr. Jrg Reinhardt
Chief Executive Officer
Bayer HealthCare

Dr. Alexander Bey

Head of Law and
Patents and
Compliance Officer

Prof. Andreas Busch

Head of Global Drug
Discovery

Dr. Dirk Ehle

Head of the Animal
Health Division

Andreas Fibig
Head of the Pharmaceuticals Division

Andreas Gnther
Head of Human
Resources

Dr. Hartmut Klusik

Head of Product
Supply

Alan Main
Head of the Medical
Care Division

Dr. Kemal Malik

Head of Development
and Chief Medical
Officer of the Pharmaceuticals Division

Erica L. Mann
Head of the Consumer
Care Division

Oliver Renner
Head of Corporate
Communications &
Public Affairs

Nigel Sheail
Head of Global
Business Development & Licensing

Manfred Vehreschild
CFO and Head of
Central Administration & Organization

Key figures 2011

Sites of Bayer HealthCare
and its divisions

Monheim
(Animal Health)

Berlin (Pharmaceuticals)
Leverkusen (Bayer HealthCare)

Tarrytown (Medical Care)

Morristown (Consumer Care)
Sites:

Employees:

55,700

Sales:

17,169 million

Bayer HealthCare

2010

2011

million
Sales

Change
%

Fx (& p) adj. %
2.4

16,913

17,169

1.5

EBITDA

4,116

4,502

9.4

EBIT

1,861

3,191

71.5

Special items

(1,169)

(176)

Gross cash flow

2,948

3,254

10.4

Net cash flow

3,320

3,357

1.1

2010

2011

Fx (& p) adj. = currency- (and portfolio-) adjusted

Sales by division
million

Change
%

Fx (& p) adj. %

Animal Health Division

1,120

1,186

5.9

5.1

Consumer Care Division

3,371

3,534

4.8

7.1

Medical Care Division

2,468

2,500

1.3

2.4

Pharmaceuticals Division

9,954

9,949

-0.1

0.6

2010

2011

Fx (& p) adj. = currency- (and portfolio-) adjusted

Sales by region
million

Change
%

Fx adj. %

Europe

6,375

6,376

0.0

-0.1

North America

4,666

4,360

-6.6

-2.4

Asia/Pacific

3,269

3,656

11.8

9.4

Latin America/Africa/Middle East

2,603

2,777

6.7

10.1

Fx adj. = currency-adjusted

Bayerr Healt hCare

Baye
Key figures 2011
Best-Selling Pharmaceutical Products

2010

2011

million

Change
%

Fx adj. %

Betaferon/Betaseron (Specialty Medicine)

1,206

1,117

-7.4

-5.4

Kogenate (Specialty Medicine)

1,004

1,075

7.1

8.3

Yaz/Yasmin/Yasminelle (General Medicine)

1,111

1,070

-3.7

-2.9

Nexavar (Specialty Medicine)

705

725

2.8

3.5

Adalat (General Medicine)

664

640

-3.6

-4.8

Mirena (General Medicine)

539

581

7.8

10.7

Avalox/Avelox (General Medicine)

497

486

-2.2

-1.8

Aspirin Cardio (General Medicine)

358

404

12.8

12.6

Glucobay (General Medicine)

347

362

4.3

4.2

Levitra (General Medicine)

429

332

-22.6

-22.2

Cipro/Ciprobay (General Medicine)

262

232

-11.5

-11.4

Diane (General Medicine)

171

182

6.4

7.0

Zetia (General Medicine)

138

179

29.7

23.5

Kinzal/Pritor (General Medicine)

178

172

-3.4

-3.4

99

147

48.5

42.0

7,708

7,704

-0.1

0.5

77 %

77 %

2010

2011

Fosrenol (General Medicine)

Total
Proportion of Pharmaceuticals sales
Products are ranked by full year 2011 sales.
Fx adj. = currency-adjusted

Best-Selling Consumer Health Products

million

Fx adj. %

Contour (Medical Care)

602

640

6.3

7.7

Aspirin* (Consumer Care)

418

440

5.3

8.6

Advantage product line (Animal Health)

408

420

2.9

6.2

Ultravist (Medical Care)

313

316

1.0

2.0

Aleve/naproxen (Consumer Care)

273

285

4.4

9.1

Bepanthen/Bepanthol (Consumer Care)

212

235

10.8

10.6

Canesten (Consumer Care)

210

224

6.7

6.9

Magnevist (Medical Care)

215

187

-13.0

-11.8

Iopamiron (Medical Care)

185

185

0.0

-4.7

One A Day (Consumer Care)

178

174

-2.2

2.3

3,014

3,106

3.1

4.8

43 %

43 %

Total
Proportion of Consumer Health sales
Fx adj. = currency-adjusted

* Sales of Aspirin including Aspirin Cardio, which is reflected in the sales of the
Pharmaceuticals segment increased by 8.8 % (Fx adj. + 10.4 %) in 2011 to 844 million (2010: 776 million).

Change

Headcount according to country

0

200

400

600

800

1,000

2,000

3,000

8,000

Germany

12,952
8,205

USA

China

6,126

Japan

2,516

Mexico

2,208

Brazil

1,704

Italy

1,553

France

1,474

Spain

1,087

Turkey

1,056

Russian Federation

Xarelto production team in Leverkusen

Employees by Segment:
Consumer
Health*

Indonesia

667

Argentina

660

Canada

651

India

640
621

United Kingdom

601

Finland

582

Switzerland

564

Venezuela

526

El Salvador

500
483

United Arab Emirates

481

Pakistan

477

Colombia

394
390

37,100

*The Consumer Health segment comprises Bayer HealthCare's

Animal Health, Consumer Care and Medical Care Divisions.

Status: December 31, 2011

324

18,600

996

Republic of Korea

Pharmaceuticals

286
270
253

14,000

Australia
Poland

Morocco
Philippines
Guatemala

Republic of South Africa

Status: December 31, 2011

Acti ve worldwide

Bayer HealthCare and its divisions are represented in nearly all markets of the world.

Active worldwide
The aim of Bayer HealthCare is to research, develop, manufacture and market
innovative products that will improve the health of people and animals all over
the world. The products are used for the diagnosis, prevention and treatment of
diseases and help to enhance quality of life.
Bayer HealthCare is a globally operating company with sites on all five continents.
Approximately 55,700 people work for the Bayer subgroup in more than 100
countries at all stages of the value-added chain. The company has its headquarters in Germany (Leverkusen). Two divisions (Consumer Care and Medical Care)
are based in the United States (Morristown and Tarrytown). The headquarters of
the Animal Health and Pharmaceuticals Divisions are located in Germany (Monheim
and Berlin, respectively). Local companies belonging to Bayer HealthCare handle
product distribution and are in close contact with the customer and with the
authorities in the various countries.
As a global company with four divisions, sites all over the world and a differentiated portfolio, Bayer HealthCare is reliant on a diversely composed workforce. After
all, one of the cornerstones of Bayer HealthCares success is the creativity of its
employees. This is why Bayer HealthCare is keen to attract the most talented
candidates from all over the world to the company.
Diversity pays off in particular in the health care industry. The development of
innovative products in this field requires cooperation between many partners.
The more diverse the composition of those involved, the greater the creative
potential that can be generated by collaboration. Their diverse knowledge,
experiences and values can then be put to profitable use to produce innovative
customer solutions and meet global challenges.

Ani mal Healt h

Sick pets can also impair the health of humans, for example by transmitting disease pathogens.

10

Ou r A r e as o f f o cus t h e f o u r d i v i s i o n s

Net sales 2011: approx. 1.2 billion

Site: Monheim, Germany

The Animal Health Division

The goals of the Animal Health Division are to maintain the health of animals and
cure veterinary diseases, with the focus primarily on treating infectious diseases
and repelling parasites. In livestock animals that play a role in food production
the safety of drug and care products is paramount for food safety. Companion
animals receive special attention in clinical practice: in view of the emotional ties
that people have to them but also their physical closeness to the family, it is vital
that they receive dependable, easy-to-use and safe medication in order to
safeguard both their well-being and that of their owners.
With more than 100 different animal health and care products worldwide for
livestock and companion animals, the division is one of the most successful
suppliers in the field of veterinary medicine. Animal Health is well positioned in
the steadily growing market for antiparasitic products for companion animals. The
Advantage family of flea control products for dogs and cats was again one of Bayer
HealthCares best-selling consumer health products in 2011, generating annual
sales of roughly 420 million. The Baytril antibiotic for the treatment of serious
infectious diseases in livestock and companion animals has been setting standards
for many years. Veraflox, the first next-generation veterinary fluoroquinolone for
the treatment of infections in dogs and cats, was launched in 2011. Thanks to its
special mechanism of action, it exerts a stronger bacterial action than existing
fluoroquinolones. The product has been granted regulatory approval in Europe
and - according to the terms of the regulatory approval - can be used to treat
different infections caused by specific bacterial pathogens.
The 2010 acquisition and integration of the New Zealand-based Bomac Group
into Animal Health was followed in 2011 by the construction of a new Center for
Innovation and Development in Auckland where products with a special focus on
the needs of the Asia/Pacific region will be developed. The first products have
already been re-registered and launched in the region. More than 200 other
registration dossiers are currently being reviewed by the authorities.
With sales of approximately 1.2 billion in 2011, the Animal Health Division
contributed 6.9 percent to Bayer HealthCares total sales.

11

Cons umer Care

More and more people are taking responsibility for

their own health. For this reason, self-medication is
becoming increasingly important.

12

Ou r a r e as o f f o cus t h e f o u r d i v i s i o n s

Net sales 2011: approx. 3.5 billion

Site: Morristown, New Jersey, USA

The Consumer Care Division

A growing number of individuals worldwide select medicines themselves for
the prevention or treatment of common ailments, as well as nutritional supplements to support a healthy diet. Many of them place their trust in tried-and-true
non-prescription or over-the-counter (OTC) products from Bayer HealthCare's
Consumer Care Division. One example is Aspirin, a more than 110-year-old
brand that enjoys an unsurpassed level of global familiarity.
Consumer Care currently ranks among the top consumer healthcare companies
in the world. The division operates in more than 140 countries and maintains
14 manufacturing sites and two product research and development centers.
With more than 170 brands around the world and eight global brands generating
annual sales of more than 100 million each, Consumer Care is well positioned
to take advantage of the sustained growth forecast for the OTC market.
The division holds a balanced portfolio of strong brands in all major categories,
including analgesics, cardiovascular risk prevention, cough and cold, dermatology, gastrointestinals and nutritionals.
In fact, some of the worlds best-known and most trusted over-the-counter
medications and nutritional supplements including Aspirin, Aleve, Alka Seltzer,
Bepanthen/Bepanthol, Berocca, Canesten, Elevit, Redoxon, Rennie, Supradyn,
Talcid and One A Day are part of the Consumer Care portfolio.
The division has a strong track record of growth in emerging markets and continues to invest in fast-growing regions around the world to increase its global
footprint and advance its international portfolio of products. In addition to
focusing its growth in emerging markets, Consumer Care continues to seek
Merger & Acquisition (M&A) opportunities to deepen its pipeline and diversity
of product offerings.

13

Medi cal Care

In a laboratory in Minneapolis (USA) Bayer researchers Diana Dutcher and Mark Hilse demonstrate on a model of blood vessels how thrombi
and deposits can be removed by a minimally invasive procedure using a catheter.

14

Ou r a r e as o f f o cus t h e f o u r d i v i s i o n s

Net sales 2011: approx. 2.5 billion

Site: Tarrytown, New York, USA

The Medical Care Division

Bayer HealthCares Medical Care Division is comprised of two business units -Radiology and Interventional (R&I) and Diabetes Care. The R&I unit, established
on January 1, 2012, merged Bayer HealthCare's contrast agent and medical
devices businesses.
Radiology & Interventional is a world leader in developing and manufacturing
contrast agents used in X-ray, computed tomography (CT) and magnetic resonance
imaging (MRI), as well as injection systems for diagnostic and therapeutic medical
procedures in CT, MRI and cardiovascular and peripheral vascular disease.
The unit also provides service support for the systems as well as medical data
management products. Product examples from the business unit include contrast
agents Ultravist, Magnevist and Gadovist/Gadavist; injection systems Stellant D
and Spectris Solaris EP; thrombectomy system AngioJet Ultra, and the Certegra
Informatics Platform. The products are marketed to cardiologists, radiologists and vascular surgeons in hospitals and
out-patient clinical sites through a global direct sales organization, supplemented in some locations by local distributors.
The Diabetes Care unit is one of the leading providers of blood
glucose monitoring systems, monitors to test glycated hemoglobin (HbA1c), lancing devices, diabetes management software
and patient education and lifestyle support services.
The portfolio of blood glucose meters includes Contour,
Contour XT, Contour Link (with Medtronic), Contour USB,
Contour TS and Breeze 2. Monitors for measurement of
glycated hemoglobin include the A1CNow+ monitor for healthcare providers, and A1CNow SELFCHECK for home use.
Outside Europe, these products are generally sold to consumers
through pharmacies, drugstores, mass merchants, hospitals or wholesalers. In
Europe, they are sold mainly through pharmacies.

15

Pharmaceuticals

More and more doctors and patients rely on innovative drugs from Bayer HealthCare's Pharmaceuticals Division.

16

O u r a r e a s o f f oc u s th e f o u r d i v i s i ons

Net sales 2011: approx. 9.9 billion

Site: Berlin, Germany

The Pharmaceuticals
Division
Bayer HealthCares success story in the pharmaceuticals business goes back
almost 125 years. The first product marketed by the Pharmaceutical Department of Bayer was the antipyretic Phenacetin in 1888. Bayer also quickly
developed a reputation especially in the treatment of infectious diseases.
Bayer researcher Gerhard Domagk, who discovered the antibacterial effect of
sulfonamides, was awarded the Nobel Prize in Medicine in 1939.
Bayer HealthCare Pharmaceuticals holds a worldwide leading position in its main
therapeutic areas. The focus on specialty pharmaceuticals and the opportunities
for growth in the field of general medicine offer an outstanding basis for prospering in the increasingly competitive pharmaceuticals market. The division combines its strengths in two business units: General Medicine and Specialty
Medicine.
The General Medicine Business Unit develops and markets products that are
prescribed by both general practitioners and medical specialists. The extensive
range of products in this segment for the control of high blood pressure,
prevention of myocardial infarction and stroke, and for diabetes management offer doctors and patients options in both the treatment and prevention of acute
disease conditions.
The company also markets effective drug products to treat bacterial infections,
such as respiratory tract and urinary tract infections. In the field of Mens Health,
the division offers a wide range of therapeutic options, including treatments for
erectile dysfunction and testosterone deficiency.
Bayer HealthCare has launched a novel Factor Xa inhibitor for the treatment of
life-threatening blood clots that is taken once daily in tablet form. This product is
now registered in more than 110 countries for the prevention of thrombosis after
elective hip or knee replacement surgery.

17

Pharmaceuticals

Dr. Peter Kolkhof checks a slide before examining it under the microscope in one of the laboratories of Bayer HealthCare's
Pharmaceuticals Division in Wuppertal (Germany).

It was recently also granted regulatory approval in Europe,

the United States and Japan for the prevention of stroke
in patients with atrial fibrillation. In Europe, it also received approval in the treatment of deep vein thrombosis
and the prevention of recurrent deep vein thrombosis and
pulmonary embolism in late 2011.
The Womens Healthcare segment of the General Medicine Business Unit is a pioneer in its field, concentrating
on three areas: contraception, menopause management
and the development of gynecological treatments.
Bayer is the world leader in the field of female hormonal
contraception, in particular in the area of oral contraception. The pill has been enabling women to engage
in conscious family planning for more than 50 years.
Bayer HealthCare offers a wide range of different contraceptives to meet individual needs, including a low-dosage
contraceptive which is the first product from a new class
of oral contraceptives whose estrogen component has the

18

same action as estradiol, an estrogen that is produced by

the female body.
The range also includes products to relieve the symptoms
associated with menopause. In the gynecological therapy
segment, the company is working to develop new therapeutic options for conditions with a high level of unmet
medical need such as uterine fibroids (myomas) and
endometriosis, a condition in which endometrial cells
grow outside of the uterus. Indeed, Bayer HealthCare has
already launched a drug product for the treatment of
endometriosis in Europe.
The Specialty Medicine Business Unit offers innovative
therapeutic options to markedly improve the quality of life
for people suffering from severe, chronic and life-threatening diseases.
Some 2.5 million people worldwide suffer from multiple
sclerosis (MS), a chronic inflammatory disease of the
central nervous system usually occurring in episodes.

O u r a r e a s o f f oc u s th e f o u r d i v i s i ons

Gisela Niepraschk conducts a visual inspection of blisters

containing Nexavar tablets.

Bayer scientist Dr. Xin Ma prepares a drug development study at the Global Drug Discovery
Innovation Center in Beijing (China).

Bayer HealthCare was one of the first companies to

offer a causal treatment for this autoimmune disease
that reduces the frequency of attacks and in this way
can slow progression of the disease considerably.

The pharmaceutical products are primarily distributed

through wholesalers, pharmacies and hospitals. In addition, products are also co-developed and co-marketed in
partnerships with other companies.

Hemophilia A is a rare genetic blood coagulation disorder

that can be effectively treated with blood coagulation
Factor VIII. The Pharmaceuticals Division is one of the
worlds most important manufacturers of drug products
to treat this hereditary disease.
Crucial improvements have been achieved in selective
cancer treatments therapies that inhibit cell division
and simultaneously disrupt the blood supply to the tumor.
A state-of-the-art oral drug product containing the active
ingredient sorafenib has been granted regulatory approval
for the treatment of renal cell carcinoma and hepatocellular carcinoma in many countries and is now undergoing
studies to investigate its suitability for a large number of
other forms of cancer such as breast cancer, thyroid
cancer and lung cancer.

19

Research and development

Samples for future medical research such as tissue specimens are stored in biobanks. They are cross-referenced to various disease stages and
examination findings in a central database.

20

Research and development

at Bayer HealthCare
1,948 million of the Bayer Groups total research and development (R&D)
spending went to Bayer HealthCare in 2011, corresponding to 66.4 percent
of the groups entire research expenditure, or 11.3 percent of Bayer HealthCare's sales. 7,700 employees research and develop innovative active ingredients for the treatment of diseases where there is a high level of medical
need.
Active ingredient discovery research at Bayer HealthCare Pharmaceuticals
is concentrated on the areas of Cardiology & Hematology, Oncology and
Womens Healthcare, while the inflammation mechanisms and therapeutic
options in ophthalmology are also of interest. The division aims to identify
and optimize low-molecular-weight substances and develop new biologics. In
many of these projects, Bayer's scientists work together in close collaboration with external cooperation partners. One example of an innovative active
ingredient is the anticoagulant rivaroxaban (trade name: Xarelto), which was
invented in Bayer's laboratories in Wuppertal. The extensive clinical trial
program supporting rivaroxaban makes it the most studied oral, direct Factor
Xa inhibitor in the world today, with the most scientific publications. More
than 75,000 patients in total are taking part in the clinical development
program to investigate the preparations potential in the prevention and
treatment of a broad spectrum of acute and chronic thromboembolic
disorders, including stroke prevention in patients with atrial fibrillation,
treatment of deep vein thrombosis, prevention of recurrent deep vein
thrombosis or pulmonary embolism, and finally secondary prevention of
acute coronary syndrome.
One of the many other innovative substances in the pipeline is riociguat, an
active ingredient for the treatment of pulmonary hypertension which is the
first drug from a new class of vasodilatative substances. Other priorities in
cardiology research are heart failure and kidney disorders, as heart disease
and chronic kidney disease often share a common disease mechanism. The
division also evolves products that have already been granted regulatory
approval, for example by developing novel formulations.
Despite major advances in the fight against cancer, there is still a high level
of medical need for therapies to prolong survival and improve the quality of
life. The development pipeline in Oncology comprises various targeted
antibodies and low-molecular-weight substances. In addition to the active
ingredient sorafenib (trade name: Nexavar), these include regorafenib, a

21

Research and development

develo pment
contraceptive patch and a new, low-dose intrauterine
system through to the further development of oral
contraceptives.

Dr. Christoph Schatz checks a slide with tissue samples.

development substance that inhibits various enzymes

stimulating tumor growth and angiogenesis, and Alpharadin, a novel alpha-pharmaceutical agent that has produced positive results in a Phase III study for the treatment
of prostate cancer and which is scheduled to be filed for
regulatory approval in mid 2012. Another innovative field
in oncology research at Bayer HealthCare is cancer stem
cell research. Cancer stem cells are believed to play a
significant role in the development, metastasis and recurrence of cancer. The objective is to develop new
therapeutic options for cancer stem cells.
Aflibercept (VEGF Trap-Eye) could make an important contribution in the treatment of serious eye diseases. The
active ingredient has exhibited promising results in two
clinical Phase III trials in the treatment of wet age-related
macular degeneration. The product was granted regulatory
approval in the United States in November 2011 and is
expected to receive authorization in Europe in the second
half of 2012.
Bayer HealthCare's Pharmaceuticals Division is also active
in the field of womens healthcare, conducting research
into innovative approaches to treat gynecological disorders
such as endometriosis and uterine fibroids. Visanne, a
new treatment option for endometriosis, was launched in
Europe in 2010. Bayer HealthCare is also working on
further developing the broad spectrum of contraception
options, ranging from the development of an innovative

22

The Medical Care Division conducts proprietary R&D

into next-generation advances in diabetes monitoring,
radiology and interventional cardiology, improving the
current portfolio of marketed products as well as entering
into strategic alliances with other companies to share
technology and expertise. The current R&D focus in the
field of blood glucose monitoring includes ease-of-use,
meter accuracy, and e-health initiatives to simplify data
capture and analysis. In the field of radiology and interventional, the division is focused on investments in informatics,
contrast media, fluid delivery and other accessories to
deliver innovative integrated solutions to customers.
Investment areas include high field MR, low radiation CT,
radiology workflow, equipment service in addition to
vascular intervention systems for treating constricted or
blocked blood vessels (such as Cotavance, a drug-coated
balloon catheter). The divisions expanded global network
of leading clinical researchers will contribute to research
that supports innovative clinical studies.
The acquisition of the Bomac Group with its headquarters
in Auckland, New Zealand, has strengthened the Animal
Health Divisions research activities in the livestock sector.
Auckland joins Monheim (Germany) and Shawnee (United
States) as a new, regional development center. The growing demand for animal protein necessitates innovative
solutions for food-producing animals. Another important
segment is the treatment of age-related diseases in companion animals. Further efforts are devoted to developing
new formulations and user-friendly applications for familiar
active ingredients.
One recent innovation within the Consumer Care business includes the launch of Bayer Advanced Aspirin in the
United States. A combination of Bayers commitment to
technological advances in medicine along with its rich
analgesic heritage resulted in the introduction of the product that offers consumers faster, tough pain relief. Bayer
Advanced Aspirin was first introduced in the United
States in 2011 and plans are under way for launches in
other countries.

Development of a pharmaceutical product: The long road

Research

Phase I

10,000

250

up to
substances

substances

In vitro efficacy tests

Efficacy and safety tests, animal

testing with the final 10 to 20
substances

Application
submitted

Clinical studies

Preclinical

Phase II

4.7

3.3

1.5

1.2

substances

substances

substances

Tolerability testing
in healthy human
subjects

Testing in a small
number of patients

Testing generally in
several thousand
patients

Documentation
examined by
regulatory
authorities

Approved

Phase III

substances

On average, the development of a pharmaceutical

product to market maturity
takes about 10 to 12 years
and costs roughly half a
billion euros. Generally only
one out of every 5,000 to
10,000 examined substances
ultimately receives
marketing authorization.

10

substance

12 years

Research and Development Projects (Phase III)*

Alemtuzumab**

Multiple sclerosis

Alpharadin

Treatment of bone metastases in hormone-refractory/castration-resistant prostate cancer

ATX-101

Reduction of submental fat

FC Patch low

Contraception

Florbetaben

PET imaging in diagnosis of Alzheimers disease

Gadovist

Magnetic resonance imaging

LCS-16 (ULD LNG

contraceptive system)

Contraception, duration of use: 5 years

Nexavar

Breast cancer

Nexavar

Adjuvant therapy of liver cancer

Nexavar

Non-small-cell lung cancer

Nexavar

Adjuvant therapy of kidney cancer

Nexavar

Thyroid cancer

Regorafenib (DAST inhibitor)

Colorectal cancer

Regorafenib (DAST inhibitor)

Treatment of metastatic or inoperable gastrointestinal stromal tumors

Riociguat (sGC stimulator)

Pulmonary hypertension (CTEPH)

Riociguat (sGC stimulator)

Pulmonary hypertension (PAH)

Tedizolid

Complicated skin infections and pneumonia

Vaginorm

Vulvovaginal atrophy

Aflibercept (VEGF Trap-Eye)

Diabetic macular edema

Aflibercept (VEGF Trap-Eye)

Abnormal retinal angiogenesis following pathological myopia

Aflibercept (VEGF Trap-Eye)

Central retinal vein occlusion

Xarelto

Treatment and secondary prevention of venous thromboembolism

* as of February 14, 2012

**co-promotion
PET = positron emission tomography; CTEPH = chronic thromboembolic pulmonary hypertension; PAH = pulmonary arterial hypertension
The nature of drug discovery and development is such that not all coumpounds can be expected to meet the pre-defined project goals. It is
possible that any or all of the projects listed above may have to be discontinued due to scientific and/or commercial reasons and will not
result in commercialized products. It is also possible that the requisite FDA, European Medicines Agency (EMA) or other regulatory approvals will not be granted for these compounds.

23

Prod uct Supply

Andreas Werner (left) and Francesco Lo Grande clean and inspect the stirring rods of an ointment mixer used to manufacture Bepanthen
antiseptic cream at the Grenzach-Wyhlen production site.

24

From sourcing to
the finished product
Bayer HealthCare manufactures products at almost 60 sites around the world.
The active ingredients for prescription medicines are manufactured primarily at
the production sites in Wuppertal and Bergkamen (Germany) and Berkeley and
Emeryville (United States). They are processed and packaged as finished pharmaceuticals in plants around the world using sophisticated technology. A broad
spectrum of different pharmaceutical presentations is covered: solid formulations
such as tablets, sugar-coated tablets and powders, semi-solid ointments and
creams, and liquid drug products for application, for example, as injections or
infusions. Hormonal contraceptives are produced as sugar- or film-coated tablets
but also, for example, as intrauterine systems. These formulation and packaging
activities are based in Berlin, Leverkusen and Weimar (Germany), Garbagnate (Italy),
Turku (Finland), So Paulo (Brazil), Beijing (China), as well as various other sites in
Europe, Asia and Latin America. Kogenate, a drug product for the treatment of
hemophilia, is manufactured in Berkeley (United States) using a biotechnology
process, while Betaferon for the treatment of multiple sclerosis is produced in
Emeryville (United States).
The main production sites for non-prescription (over-the-counter) drug products are
located in Bitterfeld-Wolfen and Grenzach-Wyhlen (Germany), Cimanggis (Indonesia), Myerstown (USA) and Madrid (Spain). The globally marketed animal health
products are mainly manufactured at the sites in Kiel (Germany) and Shawnee
(United States). In addition to drug products for humans and animals, medical
devices for diagnosis and therapy are produced in the United States. Bayer HealthCare supplies a total of more than 20,000 articles. The reason for this large number
is the different presentations of individual products and packaging for example,
different formulations, dosages, pack sizes and language versions.
Bayer HealthCare Product Supply steers the subgroups entire supply chain, from
raw material sourcing through manufacturing to distribution, utilizing a global
production network consisting of its own sites and those of contract manufacturers.
In this way the company aims for continuous improvement of costs, flexibility and
delivery reliability, maintaining high standards of quality, safety and environmental
protection on a global basis. The manufacture of pharmaceutical products is subject
to extraordinarily stringent quality standards. These standards are known collectively as Good Manufacturing Practice (GMP). Compliance with these requirements
is regularly inspected by internal experts, regulatory authorities and external
consultants.

25

Busi n es s develop ment

Bayer HealthCare has expanded its life science partnership activities in the Bay Area of California. The company makes laboratory space
available to start-up companies for their research work under the project name CoLaborator.

26

Partnerships for
innovative products
Bayer HealthCare is an innovation- and growth-oriented enterprise investing across
its divisions not only in own R&D activities, but also in external collaborations. In
order to secure access to innovative research and technologies, expand the product
portfolio and strengthen its regional market presence, the company is constantly
searching for opportunities to collaborate. Partnerships cover a broad range of
models from R&D collaborations, licensing agreements, co-marketing agreements
and regional alliances to acquisitions. The philosophy is that successful transactions
must meet the needs of both partners.
With the innovative anticancer drug Nexavar, the Pharmaceuticals Division and Onyx
Pharmaceuticals, Inc., USA have gone all the way from drug discovery to market.
The co-development and co-promotion agreement with Janssen Pharmaceuticals for
the anticoagulant Xarelto has led to multiple joint launches. In collaboration with
Regeneron Pharmaceuticals, Inc. Aflibercept (VEGF Trap-Eye) has successfully completed Phase III trials in wet age-related macular degeneration and central retinal
vein occlusion. In Oncology, a Phase III trial for the cancer drug Alpharadin was
successfully completed together with Algeta ASA from Norway. Collaborations at
earlier stages include very innovative approaches, such as the one with OncoMed
Pharmaceuticals investigating new approaches to block cancer stem cells. Strategic
alliances with international innovation partners from academia are another pillar of
the companys R&D strategy, such as the joint research center for innovative therapeutic approaches at Tsinghua University (China) and a cooperation with the German Cancer Research Center. Bayer HealthCare is also striving to build its regional
portfolio in the core growth markets where partners can leverage Bayers marketing
presence and local knowledge, as demonstrated through the in-licensing of tedizolid,
an antibiotic from Trius Therapeutics for China, Japan and other emerging markets.
The Animal Health Division will focus on Mergers & Acquisitions and licensing activity in developing markets to complement recent transactions in the United States
(Piedmont Pharmaceuticals, KMG Chemicals) and Asia/Pacific (Bomac). The
Consumer Care Division continues to focus its business development resources in
the growth markets. The recent acquisitions of Sagmel (Russia) and Topsun (China)
are examples of the successful implementation of this strategy. In addition, the
division will expand its portfolio into adjacent business categories, as well as Rx to
OTC switch opportunities. In the Medical Care Division, recent investments including
the acquisitions of Possis Medical and Pathway Medical are excellent examples of
Bayers long-term commitment to growing its cardiovascular therapy franchise.
Bayer Diabetes Care has recently extended existing alliances with both the Medtronic and Becton Dickinson corporations to better serve the needs of people
treating their diabetes with insulin.

27

Soci al commitment

Dr. Concepcin Ziga Valeriano, head of

the national Chagas program in Honduras,
explains to visitors to the hospital how to
protect against Chagas disease.

Bayer HealthCare's Pharmaceuticals Division has many

years of experience and great expertise in the field of
family planning. The company is dedicated to ensuring
that people in developing countries in particular can
engage in conscious family planning free of charge or at
reasonable prices.

28

Bayer HealthCare is engaged in social projects around the

world, many of which are devoted to improving the
supply of health care in developing countries.

Global initiatives
for better healthcare
Bayer HealthCare is committed to the principles of sustainable development and
accepts responsibility in society. At the center of all our employees actions are
human and animal health and environmental protection. Our Guidelines for
responsible care in environmental protection and safety ensure that all of our
products for humans and animals are well tolerated and can be safely disposed
of and decomposed after use. The sustainability program also makes concrete
contributions to the United Nations Millennium Development Goals.
As the market leader in hormonal contraception, Bayer HealthCare has supported family planning around the world for 50 years. In 2010, for example,
the company marketed an oral contraceptive at a reduced price in Ethiopia in
collaboration with the USAID (United States Agency for International Development) so that low-income women can also afford this product. Further launches
followed in Uganda and Tanzania in 2011, with other eight states in sub-Saharan
Africa scheduled to follow by 2014. In addition, Bayer HealthCare is working
together with partners to improve knowledge of sexuality, health and contraception in developing countries.
More than 3.3 billion people are affected by so-called neglected diseases. In
cooperation with the World Health Organization (WHO), Bayer HealthCare provides medicines free of charge to treat African sleeping sickness and Chagas
disease in Latin America. Bayer HealthCare reaffirmed this commitment in early
2012: it plans to work together with partners from the public and private sectors,
such as the WHO and the Bill & Melinda Gates Foundation, to speed up the
progress being made in fighting tropical diseases by 2020. The company is also
working together with the Global Alliance for TB Drug Development on a new
treatment for tuberculosis that will shorten the duration of therapy. Should the
studies prove successful, the new treatment will be made available at reduced
prices, particularly in developing countries.
Medical Care continues to support patient and other non-governmental
organizations (NGOs), including the International Diabetes Federation (IDF),
Foundation of European Nurses in Diabetes (FEND) and the Juvenile Diabetes
Research Foundation (JDRF). The Division also supports the International
Diabetes Federations Young Leaders in Diabetes Programme to foster the
development of leadership skills and connections to achieve tangible improvements in the lives of young people with diabetes in their countries and regions.

29

Research milesto nes

History

More than 100 years ago, Aspirin was already known

beyond the borders of Germany as an effective pain
reliever.

Professor Gerhard Domagk, discoverer of the sulfonamides and Nobel Prize winner in 1939, in his laboratory.

In 1961, Anovlar became the first hormonal contraceptive on the market in Europe.

30

1888
Phenacetin

Bayer enters the pharmaceuticals

business with this antipyretic medicine

1890
Piperazin

Anti-aging product and later gout

medicine

1899
Aspirin

Pain reliever containing the active

ingredient acetylsalicylic acid

1923
Germanin

Medicine to treat African sleeping

sickness

1928
Progynon

The first hormonal drug to treat menopause

symptoms

1930
Uroselectan

The first injectable renal contrast agent for

X-ray images

1935
Prontosil

Chemotherapeutic drug to treat bacterial

infections

1950
Resochin

Globally successful malaria drug

1961
Anovlar

First European hormonal contraceptive

1969
Ames Reflec-
tance Meter

First portable blood

glucose meter

1975
Adalat

Drug to treat coronary heart disease

1987
Ciprobay

Antibiotic to treat bacterial infections

1987
Magnevist

Contrast agent for magnetic resonance

imaging

1987
Baytril

Medicine to treat severe infectious diseases in livestock and companion animals

1990
Glucobay

New therapy principle for diabetics

1991
Fludara

Drug for the specific treatment of chronic

lymphocytic leukemia (CLL)

1992
Glucometer
Elite

Blood glucose meter

1993
Kogenate

The first recombinant Bayer drug product to

treat hemophilia

1993
Betaferon/
Betaseron

The first multiple sclerosis drug to be

registered in the United States

1994
Aspirin Pro-
tect/Cardio

For prevention of a second myocardial

infarction or stroke

1996
Advantage

Long-acting flea control product for dogs

and cats

1997
Mirena

Novel hormonal intrauterine contraceptive

system

1999
Avalox/
Avelox

Respiratory tract antibiotic

2000
Yasmin

The first oral contraceptive based on the

novel gestagen drospirenone

2003
Levitra

Erectile dysfunction medicine

2003
Advantix

Flea, tick and mosquito control product

for dogs

2004
Animal health product to combat
Advocate/
internal and external parasites
Advantage Multi in dogs and cats
2005
Nexavar

Marketing authorization granted for treatment of advanced kidney cancer

Xarelto is a drug product to prevent and treat lifethreatening blood clots. Bayer scientists Dr. Alexander
Straub and Dr. Susanne Rhrig were involved in its
research and development.

2005
Deworming agent for cats
Profender Cat
2007
Nexavar

Marketing authorization granted for

treatment of liver cancer

2008
Xarelto

Prevention of venous thrombosis after

elective knee or hip replacement surgery

2008
Qlaira

First oral contraceptive whose estrogen component has the same action as estradiol, an
estrogen that is produced by the female body

2008
Renalzin

Dietary supplement to support kidney

function in cats with chronic kidney failure

2008
Intego

First automated PET (positron emission

tomography) infusion system in the U.S.

2009
Contour USB

First blood glucose meter with

integrated software

2009
Drug to control coccidiosis, a parasitic
Baycox Sheep infectious disease, in lambs

Oemuer Capar conducts a visual inspection of Nexavar

tablets at Bayer HealthCare's Leverkusen site.

2009
Deworming agent for dogs
Profender Dog
2011
Veraflox

First next-generation veterinary fluorquinolone for the

treatment of bacterial infections in cats and dogs

2011
Procox

Combination treatment against roundworms

and coccidia in dogs

2011
Seresto

Flea and tick collar for cats and dogs with an

innovative polymer matrix that releases the needed
amount of active ingredient for up to eight months

2011
Bayer
Advanced
Aspirin

A tablet with breakthrough Pro-Release

technology is launched in the United States

2011
Innovative blood glucose sensors for highly accurate
Contour Next blood glucose measurement
2011
Xarelto

Approval in Europe, the United States and Japan for the

prevention of stroke in patients with atrial fibrillation

2011
Xarelto

Approval in Europe for the treatment of deep vein

thrombosis and the prevention of recurrent deep vein
thrombosis and pulmonary embolism

Seresto provides sustained protection against ticks and

fleas for dogs and cats.

31

Cont acts

BAYER HEALTHCARE
Oliver Renner
oliver.renner@bayer.com

Pharmaceuticals Division
Oliver Renner
oliver.renner@bayer.com

Animal Health Division

Astrid Khler
astrid.koehler@bayer.com
Consumer Care Division
Tricia McKernan
tricia.mckernan@bayer.com
Medical Care Division
Meredith Fischer
meredith.fischer@bayer.com

A comprehensive overview of Bayer HealthCare

is available on the Internet at
www.bayerhealthcare.com