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<strong>Bayer</strong> <strong>HealthCare</strong><br />

A Company Overview | 2013


Published by:<br />

<strong>Bayer</strong> <strong>HealthCare</strong> AG,<br />

Corporate Communications & Public Affairs<br />

Oliver Renner, 51368 Leverkusen, Germany<br />

English version:<br />

Language Service, Currenta GmbH & Co. OHG, Germany<br />

Edited by:<br />

Christina Sehnert, christina.sehnert@bayer.com<br />

Bärbel Doormann, baerbel.doormann@bayer.com<br />

6<br />

8<br />

10<br />

12<br />

Contents<br />

innovations in health care 3<br />

Animal Health 6<br />

Consumer Care 8<br />

Medical Care 10<br />

Pharmaceuticals 12<br />

research and development 16<br />

Product Supply 20<br />

Business development 22<br />

Social commitment 24<br />

Contacts 26<br />

Appendix<br />

Key fi gures 2012<br />

Headquarter sites / headcounts<br />

<strong>Bayer</strong> <strong>HealthCare</strong><br />

Executive Committee<br />

Cover:<br />

Aspirin – even after<br />

more than 110 years,<br />

this successful product<br />

is still undergoing further<br />

development.<br />

Forward-looking Statements<br />

This brochure may contain forward-looking statements based on current assumptions<br />

and forecasts made by <strong>Bayer</strong> Group or subgroup management. Various<br />

known and unknown risks, uncertainties and other factors could lead to material<br />

differences between the actual future results, fi nancial situation, development or<br />

performance of the company and the estimates given here. These factors include<br />

those discussed in <strong>Bayer</strong>’s public reports which are available on the <strong>Bayer</strong> website<br />

at www.bayer.com. The company assumes no liability whatsoever to update these<br />

forward-looking statements or to conform them to future events or developments.<br />

Product names are mostly registered trademarks. All trademarks are printed in<br />

italics. not all products are marketed by <strong>Bayer</strong> in all countries.


innovations in<br />

health care<br />

<strong>Bayer</strong> <strong>HealthCare</strong> is among the world’s foremost innovators in the<br />

fi eld of pharmaceutical and medical products. The subgroup’s<br />

mission is to research, develop, manufacture and market innovative<br />

products that improve the health of people and animals throughout<br />

the world.<br />

3


4<br />

“For me it was terrific that we developed three new cancer<br />

drugs within such a short period of time.” Dr. Dimitris<br />

Voliotis isn’t just saying this because he is in charge<br />

of clinical development activities in Oncology at <strong>Bayer</strong><br />

<strong>HealthCare</strong>. He also has a very personal relationship<br />

to this disease. “My father died of cancer when I was<br />

25.” As a scientist, he always keeps in mind that it is<br />

ultimately fathers, mothers, sons and daughters who<br />

suffer from – and often die of – cancer.<br />

Voliotis is one of more than 55,300 employees at<br />

<strong>Bayer</strong> <strong>HealthCare</strong>, and one of the approximately<br />

7,500 employees who work in research and de-<br />

velopment. Each of<br />

“ Science For A Better<br />

Life – medical progress<br />

for the benefit<br />

of patients”<br />

our employees, like<br />

Dimitris Voliotis, is<br />

driven by his or her<br />

own personal moti-<br />

vation. Their fundamental<br />

objective is<br />

always to alleviate people’s suffering, improve their<br />

well-being and extend their lives.<br />

For 150 years, <strong>Bayer</strong> has been developing products<br />

that help to improve people’s quality of life. <strong>Bayer</strong><br />

<strong>HealthCare</strong> – one of three <strong>Bayer</strong> subgroups – researches,<br />

develops and produces products that<br />

improve the health of people and animals worldwide,<br />

concentrating on innovations in areas where<br />

there is a high medical need.<br />

We are currently in the process of extending our<br />

range with five new products in quick succession:<br />

an anticoagulant, two cancer drugs, an eye medicine<br />

and a drug to treat pulmonary hypertension.<br />

And further innovations are in the pipeline – fully in<br />

line with our mission “<strong>Bayer</strong>: Science For A Better<br />

Life.”<br />

Many groundbreaking medicines have been created<br />

by <strong>Bayer</strong> over the past more than 100 years. Many<br />

of them are known around the world. For example,<br />

Aspirin has been on the market since 1899, yet<br />

scientists are still continually discovering new<br />

aspects of this once-in-a-century pharmaceutical.<br />

<strong>Bayer</strong>’s research into completely new principles of<br />

action has proven successful: not just in oncology,<br />

but also in the treatment of cardiovascular and<br />

infectious diseases as well. We offer therapeutic<br />

options for people with multiple sclerosis who are<br />

hoping to halt the progression of this disease of the<br />

central nervous system.<br />

We also have a broad range of contraceptives for<br />

women who want safe and convenient birth control,<br />

as well as products to alleviate menopause symptoms.<br />

In addition, we have solutions for people with<br />

diabetes who need to monitor their blood glucose.<br />

Our range of products also includes devices for<br />

diagnostic imaging and medical therapy.<br />

And we have products for people who want to<br />

choose their own medicines to prevent or treat<br />

everyday ailments, as well as dietary supplements<br />

to support a healthy diet.<br />

The health of animals is equally important to us,<br />

whether that of companion animals on the one hand


or farm animals for food production on the other.<br />

So no matter whether a dog is tormented by<br />

fleas or ticks, pigs have come down with a<br />

bacterial infection of the intestines, or a cat is<br />

suffering from infestation with worms – we<br />

can offer products to treat each of these<br />

cases.<br />

In order to concentrate optimally on the re-<br />

spective target areas and markets, we have<br />

divided our business into four divisions –<br />

Pharmaceuticals, Consumer Care, Medical<br />

Care and Animal Health. Our strategy is<br />

geared toward achieving above-average,<br />

profitable and sustainable growth.<br />

Our work is concentrated on innovation. Our<br />

research pipeline contains projects that have great<br />

potential, above all to produce innovative products<br />

capable of providing better treatment of the chronic<br />

diseases that are increasingly prevalent in the<br />

world’s aging population.<br />

In growth markets such as Brazil, China and<br />

Russia, we are working to further extend our port-<br />

folio. Furthermore, we want to further strengthen<br />

our business in the market for non-prescription<br />

medicines.<br />

As a global company with sites around the world<br />

and a differentiated portfolio, we are committed to a<br />

workforce characterized by diversity. The ingenuity<br />

of our employees is a cornerstone of our success.<br />

<strong>Bayer</strong> <strong>HealthCare</strong> therefore endeavors to attract the<br />

most talented employees from around the world.<br />

The analgesic Aspirin was launched in 1899 and<br />

was one of the first successful drug products in the<br />

history of <strong>Bayer</strong>. Research into the medicine (left)<br />

continues to this day – for example, studies into<br />

new formulations of the active ingredient of Aspirin.<br />

Protecting, curing and caring for animals –<br />

<strong>Bayer</strong> Animal Health has been developing and<br />

producing medicinal and care products for farm<br />

and companion animals in line with this philosophy<br />

for years (center).<br />

Many diseases today remain difficult or impossible<br />

to treat. Scientists at <strong>Bayer</strong> <strong>HealthCare</strong> (right)<br />

are therefore looking for new active ingredients to<br />

treat diseases with a high level of medical need.<br />

Diversity is particularly valuable in the health care<br />

industry, and developing innovative products in<br />

this research-oriented field requires cooperation<br />

between numerous partners. The more diversified<br />

this team, the greater the creative potential released<br />

by the cooperation. In this way, the multifaceted<br />

knowledge, experience and values can be used to<br />

design innovative customer solutions and address<br />

global challenges.<br />

We hope this brochure will give you an insight into<br />

the diverse world and strengths of <strong>Bayer</strong> Health-<br />

Care. We wish you pleasant reading.<br />

Seeing is the<br />

most important<br />

sense for<br />

humans: 80 percent<br />

of what we<br />

perceive comes<br />

via the eyes. But<br />

when the visual<br />

cells in the center<br />

of the retina die off<br />

as a result of old<br />

age, the window<br />

on the world<br />

closes. An eye<br />

medicine has been<br />

co­developed with<br />

the U.S. company<br />

Regeneron for the<br />

treatment of wet<br />

age­related macular<br />

degeneration.<br />

5


Sick pets can also impair the health of humans, for example by<br />

transmitting disease pathogens.<br />

6<br />

Animal Health<br />

net sales 2012: approx. € 1.3 billion<br />

Headquarters: Monheim, Germany


The goals of the Animal Health Division are to maintain the health of animals and<br />

cure veterinary diseases, with the focus primarily on treating infectious diseases<br />

and repelling parasites. in livestock – animals that play a role in food production – the<br />

safety of drug and care products is paramount for food safety. Companion animals receive<br />

special attention in clinical practice: in view of the emotional ties that people have<br />

to them but also their close relationship to the family, it is vital that they receive dependable,<br />

easy-to-use and safe medication in order to safeguard both their well-being and<br />

that of their owners.<br />

With more than 100 different animal health and care products worldwide for livestock and<br />

companion animals, the division is one of the most successful suppliers in the field of<br />

veterinary medicine. Animal Health is well positioned in the steadily growing market for<br />

antiparasitic products for companion animals. The Advantage family of flea control<br />

products for dogs and cats was again one of <strong>Bayer</strong> <strong>HealthCare</strong>’s best-selling products<br />

in 2012, generating annual sales of roughly € 495 million.<br />

The innovative flea and tick collar Seresto for dogs and cats joined the portfolio of<br />

parasiticides for companion animals in 2012. The collar’s patented polymer matrix<br />

ensures controlled low-dose release of the tried and true active ingredients flumethrin<br />

and imidacloprid into the animal’s coat. Seresto provides effective protection for up to<br />

eight months from a single application, and is available on the market in Europe, the<br />

United States and new Zealand.<br />

The acquisition of the animal health business of Teva Pharmaceuticals in the United<br />

States has strengthened both the companion animals and farm animals businesses<br />

and means that <strong>Bayer</strong> is now represented in all major therapeutic areas. The companion<br />

animal products acquired comprise mainly a complete range of dermatological<br />

products but also a wide spectrum of dietary supplements to support joint and<br />

gastrointestinal functions and other whole body health care products, while the farm<br />

animal products acquired from Teva cover a wide range of anti-infectives, parasiticides,<br />

anti-inflammatories and reproduction hormones.<br />

<strong>Bayer</strong> has signed a distribution agreement with the Irish veterinary manufacturer<br />

norbrook in Germany and France with the objective of supplementing the existing<br />

portfolio so that customers can be offered comprehensive solutions.<br />

AniMAl HEAlTH DIVISIOn<br />

7


More and more people are taking<br />

responsibility for their own health.<br />

For this reason, self­medication<br />

is becoming increasingly<br />

important.<br />

8<br />

Consumer Care<br />

net sales 2012: approx. € 3.9 billion<br />

Headquarters: Morristown, new Jersey, uSA


A growing number of individuals worldwide select medicines themselves for the<br />

prevention or treatment of common ailments, as well as nutritional supplements to<br />

support a healthy diet. Many of them place their trust in tried-and-true non-prescription<br />

or over-the-counter (oTC) products from <strong>Bayer</strong> <strong>HealthCare</strong>’s Consumer Care Division.<br />

one example is Aspirin, a more than 110-year-old brand that enjoys an unsurpassed<br />

level of global familiarity.<br />

Consumer Care currently ranks among the top consumer health care companies in the world.<br />

The division operates in more than 100 countries and maintains 14 manufacturing<br />

sites and two product research and development centers.<br />

With more than 170 brands around the world and nine global brands generating<br />

annual sales of more than € 100 million each, the Consumer Care Division is<br />

well positioned to take advantage of the sustained growth forecast for the OTC<br />

market.<br />

The division holds a balanced portfolio of strong brands in all major categories,<br />

including analgesics, cardiovascular risk prevention, cough and cold, dermatology,<br />

gastrointestinals and nutritionals.<br />

In fact, some of the world’s best-known and most trusted over-the-counter medications<br />

and nutritional supplements including Aspirin, Aleve, Alka­Seltzer, Bepanthen/<br />

Bepanthol, Berocca, Canesten, Elevit, Redoxon, Rennie, Supradyn, Talcid and<br />

One A Day are part of the Consumer Care portfolio.<br />

The division has a strong track record of growth in emerging markets and continues<br />

to invest in fast-growing regions around the world to increase its global footprint and<br />

advance its international portfolio of products.<br />

In addition to focusing its growth in emerging markets, Consumer Care continues to<br />

seek Merger & Acquisition (M&A) opportunities to deepen its pipeline and diversity of<br />

product offerings.<br />

ConSuMEr CArE DIVISIOn<br />

9


egular blood glucose monitoring helps<br />

people with diabetes keep their blood sugar levels<br />

normal.<br />

10<br />

Medical Care<br />

net sales 2012: approx. € 2.7 billion<br />

Headquarters: Tarrytown, new york, uSA


<strong>Bayer</strong> <strong>HealthCare</strong>’s Medical Care Division is comprised of two business units – radiology<br />

& interventional and Diabetes Care. The radiology & interventional unit was formed in 2012<br />

through the combination of <strong>Bayer</strong> <strong>HealthCare</strong>’s contrast agent and medical devices<br />

businesses.<br />

radiology & interventional is a global leader in developing and manufacturing contrast<br />

agents used in X-ray, computed tomography (CT) and magnetic resonance imaging<br />

(MRI), as well as injection systems for diagnostic and therapeutic medical proce-<br />

dures in CT, MRI and cardiovascular and peripheral vascular disease. The unit also<br />

provides service support for the systems as well as medical data management<br />

products.<br />

Products include the contrast agents Ultravist, Magnevist and Gadovist/Gadavist;<br />

the injection systems Stellant D and Spectris Solaris EP; the thrombectomy system<br />

AngioJet Ultra; the atherectomy system JetStream; and the Certegra Informatics<br />

Platform.<br />

The products are provided to cardiologists, radiologists and vascular surgeons in<br />

hospitals and out-patient clinical sites through a global direct sales organization,<br />

supplemented in some locations by local distributors.<br />

The Diabetes Care unit is one of the leading providers of blood glucose monitoring<br />

systems, monitors to test glycated hemoglobin (HbA1c), lancing devices and diabetes<br />

management software.<br />

The portfolio of blood glucose meters includes Contour, Contour XT, Contour Next EZ,<br />

Contour Link* and Contour Next Link* (*International alliance with Medtronic, Inc. to<br />

develop innovative next generation diabetes management solutions for patients<br />

worldwide), Contour USB, Contour Next USB, Contour TS and Breeze 2.<br />

Monitors for measurement of glycated hemoglobin include the A1CNow+ monitor for<br />

health care providers and A1CNow Selfcheck for home use.<br />

Outside Europe, these products are generally sold to consumers through pharmacies,<br />

drugstores, mass merchants, hospitals or wholesalers. In Europe, they are sold mainly<br />

through pharmacies.<br />

MEDiCAl CArE DIVISIOn<br />

11


More and more doctors and patients rely on innovative<br />

drugs from <strong>Bayer</strong> <strong>HealthCare</strong>’s Pharmaceuticals Division.<br />

12<br />

Pharmaceuticals<br />

net sales 2012: approx. € 10.8 billion<br />

Headquarters: Berlin, Germany


<strong>Bayer</strong> <strong>HealthCare</strong>’s success story in the pharmaceuticals business began 125 years<br />

ago. The first product marketed by the “Pharmaceutical Department” of <strong>Bayer</strong> was<br />

the antipyretic Phenacetin in 1888. <strong>Bayer</strong> also quickly developed a reputation espe-<br />

cially in the treatment of infectious diseases. <strong>Bayer</strong> researcher Gerhard Domagk, who<br />

discovered the antibacterial effect of sulfonamides, was awarded the nobel Prize in<br />

Medicine in 1939.<br />

<strong>Bayer</strong> <strong>HealthCare</strong> Pharmaceuticals today holds a worldwide leading position in its main<br />

therapeutic areas. The focus on specialty pharmaceuticals and the opportunities<br />

for growth in the field of general medicine offer an outstanding basis for sustainable<br />

expansion. The division combines its strengths in two business units: General<br />

Medicine and Specialty Medicine.<br />

The General Medicine Business Unit develops and markets products that are prescribed<br />

by both general practitioners and medical specialists. Our extensive range<br />

of products in this segment – for the control of high blood pressure, prevention of<br />

myocardial infarction and stroke, and for diabetes management – offer doctors and<br />

patients options in both the treatment and prevention of acute disease conditions.<br />

The company also markets effective drug products to treat bacterial infections, such<br />

as respiratory tract and urinary tract infections. In the field of Men’s Health, the division<br />

offers a wide range of therapeutic options, including treatments for erectile dysfunction<br />

and testosterone deficiency. In 2008, <strong>Bayer</strong> <strong>HealthCare</strong> launched a novel oral Factor<br />

Xa inhibitor for the prevention of life-threatening blood clots that is taken once daily in<br />

most indications. This product is now registered in more than 120 countries for the<br />

prevention of thrombosis after elective hip or knee replacement surgery; further<br />

indications have since also been added.<br />

In the field of Women’s Healthcare, the company is currently concentrating on three<br />

areas: contraception, menopause management and the development of gyneco-<br />

logical treatments. <strong>Bayer</strong> is the world leader in the field of female hormonal contra-<br />

ception, in particular in the area of oral contraception. The “pill” has been helping<br />

women plan their families for more than 50 years.<br />

<strong>Bayer</strong> <strong>HealthCare</strong> offers a wide range of different contraceptives to meet individual<br />

needs, including a low-dosage contraceptive which is the first product from a new<br />

class of oral contraceptives whose estrogen component has the same action as<br />

estradiol, an estrogen that is produced by the female body. For women who do not<br />

wish to take a daily contraceptive pill, the company offers long-term intrauterine<br />

contraceptive systems with a duration of action of up to five years. The range also<br />

includes products to relieve the symptoms associated with menopause. In the gynecological<br />

therapy segment, <strong>Bayer</strong> <strong>HealthCare</strong> is working to develop new therapeutic<br />

options for conditions with a high level of unmet medical need such as uterine fibroids<br />

(myomas) and endometriosis, a condition in which endometrial cells grow outside<br />

PHArMACEuTiCAlS DIVISIOn<br />

13


14<br />

in 2008, <strong>Bayer</strong> <strong>HealthCare</strong> launched a novel oral<br />

Factor Xa inhibitor for the prevention of life­threatening<br />

blood clots. <strong>Bayer</strong> scientist Dr. Susanne<br />

Röhrig (above) has been conducting research into<br />

the active ingredient for several years.<br />

<strong>Bayer</strong> researchers Professor Johannes­Peter<br />

Stasch (right), Dr. Stephan Vettel (center) and<br />

Dr. Dieter Neuser in the laboratory in Wuppertal<br />

(photo left) with a model of a lung.<br />

The active ingredient aflibercept is another promising<br />

new product in ophthalmology (below). It is<br />

now available in the world’s main markets for the<br />

treatment of wet age­related macular degeneration.


Continued from page 13<br />

of the uterus. In Europe, <strong>Bayer</strong> <strong>HealthCare</strong> has<br />

launched a drug product for the treatment of endometriosis<br />

which is also approved in some countries<br />

in Latin America and Asia/Pacific.<br />

The Specialty Medicine Business Unit offers innovative<br />

therapeutic options to markedly improve the<br />

quality of life for people suffering from severe, chronic<br />

and life-threatening diseases. Some 2.5 million<br />

people worldwide suffer from multiple sclerosis (MS),<br />

a chronic inflammatory disease of the central nervous<br />

system usually occurring in episodes. <strong>Bayer</strong> Health-<br />

Care was one of the first companies to offer a causal<br />

treatment for this automimmune disease that reduces<br />

the frequency of attacks and in this way can slow<br />

progression of the disease considerably.<br />

Hemophilia A is a rare genetic blood coagulation<br />

disorder that can be effectively treated with blood<br />

coagulation Factor VIII. The Pharmaceuticals Division<br />

is one of the world’s leading manufacturers of drug<br />

products to treat this hereditary disease.<br />

Crucial improvements have been achieved in tar-<br />

geted cancer treatments – therapies that inhibit cell<br />

division and simultaneously disrupt the blood supply<br />

to the tumor. Nexavar, an oral drug containing the<br />

active ingredient sorafenib, is approved for the<br />

treatment of renal cell carcinoma and hepatocellular<br />

carcinoma in many countries. It is also undergoing<br />

studies to investigate its suitability in other forms of<br />

cancer such as breast and thyroid cancer or as an<br />

adjuvant therapy in renal cell carcinoma and hepatocellular<br />

carcinoma.<br />

Another promising cancer drug is regorafenib, which<br />

was granted regulatory approval in the United States<br />

for treatment of metastatic colorectal cancer in Sep-<br />

tember 2012 and for the treatment of gastrointestinal<br />

stromal tumors (GIST) in February 2013. Here, too,<br />

further therapeutic options are being investigated.<br />

Radium-223 dichloride is an investigational alpha<br />

particle-emitting pharmaceutical in development for<br />

the treatment of castrate-resistant prostate cancer<br />

with bone metastases. It was filed for regulatory<br />

approval in the United States and Europe in<br />

December 2012.<br />

Another promising drug that was recently launched<br />

is Eylea, a solution for intravitreal injection containing<br />

the active ingredient aflibercept and used for the<br />

treatment of wet age-related macular degeneration,<br />

which is now available in this indication on the<br />

world’s main markets. Another important indication<br />

for which the drug has been filed for regulatory<br />

approval in Europe is occlusion of the central retinal<br />

vein, which can lead to blood clots and edema in the<br />

retina. Other studies are being conducted to investigate<br />

the use of aflibercept in various diseases of the<br />

ocular fundus.<br />

The Pharmaceutical Division’s products are primarily<br />

distributed through wholesalers, pharmacies and<br />

hospitals. In addition, products are also co-developed<br />

and co-marketed in partnerships with other<br />

companies.<br />

PHArMACEuTiCAlS DIVISIOn<br />

15


Every tumor is unique. Biology lab assistant<br />

Kirsten Steiner­Hahn fi rst inspects tissue specimens<br />

with the naked eye. The tumor samples then<br />

undergo numerous further analyses.<br />

16<br />

research and<br />

development


€1,962 million of the <strong>Bayer</strong> Group’s total research and development (r&D) spending<br />

went to <strong>Bayer</strong> <strong>HealthCare</strong> in 2012, corresponding to 65.1 percent of the group’s entire<br />

research expenditure, or 10.5 percent of <strong>Bayer</strong> <strong>HealthCare</strong>’s sales. Some 7,500 employees<br />

research and develop innovative active ingredients for the treatment of diseases<br />

where there is a high level of medical need.<br />

Drug discovery in <strong>Bayer</strong> <strong>HealthCare</strong>’s Pharmaceuticals Division is concentrated on the areas of<br />

Cardiology, Oncology, Hematology and Women’s Healthcare, while the corresponding<br />

mechanisms of inflammation and the development of new therapeutic options in oph-<br />

thalmology are also of interest. The division aims to identify low-molecular-weight sub-<br />

stances as well as to develop new biologics. It also evolves products that have already<br />

been granted regulatory approval, for example by developing novel formulations. In<br />

many of these projects, <strong>Bayer</strong>’s scientists work together in close collaboration with<br />

external cooperation partners.<br />

rESEArCH AnD DEvEloPMEnT<br />

One example of an innovative active ingredient is the anticoagulant Xarelto (rivaroxaban)<br />

which was invented in <strong>Bayer</strong>’s laboratories in Wuppertal and co-developed with<br />

Janssen Pharmaceuticals. The extensive clinical trial program conducted for rivaroxaban<br />

which will have involved more than 100,000 patients once all studies are completed<br />

makes it the most studied oral, direct Factor Xa inhibitor in the world today. The<br />

clinical development program investigated the inhibitor’s potential in the prevention and<br />

treatment of a broad spectrum of acute and chronic thromboembolic disorders,<br />

including stroke prevention in patients with atrial fibrillation, treatment of deep vein<br />

thrombosis and pulmonary embolism, prevention of recurrent deep vein thrombosis or<br />

pulmonary embolism, and finally secondary prevention of acute coronary syndrome.<br />

Another innovative substance from <strong>Bayer</strong>’s research laboratories is riociguat, the first<br />

drug from a new class of vasodilatative substances. This oral product is being developed<br />

for the treatment of various forms of pulmonary hypertension, a rare but lifethreatening<br />

disease. Further priorities in cardiology research are heart failure and kidney<br />

disorders. The functions of the heart and kidneys are mutually interdependent and<br />

heart and kidney diseases often share common underlying disease mechanisms.<br />

Despite major progress in the fight against cancer, there is still a high medical need for<br />

therapies to prolong life and improve the quality of life. The development pipeline in<br />

Oncology comprises various targeted antibodies, antibody-drug conjugates as well as<br />

low-molecular-weight substances. These include, in addition to Nexavar (sorafenib), a<br />

co-development with Onyx Pharmaceuticals, the substance regorafenib, which inhibits<br />

various enzymes involved in tumor growth and the formation of new blood vessels<br />

(neoangiogenesis), and radium-223 dichloride, a novel alpha-pharmaceutical drug<br />

which is being co-developed with the norwegian company Algeta ASA for the treatment<br />

of tumor types which have already formed metastases in the bones. Radium-223<br />

dichloride emits targeted alpha radiation to eliminate cancer cells in the bones. It was<br />

filed for regulatory approval for the treatment of castration-resistant prostate<br />

17


Team analysis: Tanja Wesarg and Marco Jaspers use a mass<br />

spectrometer to analyze protein structures.<br />

on average, the<br />

development of<br />

a pharmaceutical<br />

product to market<br />

maturity takes about<br />

10 to 12 years<br />

and costs roughly<br />

half a billion euros.<br />

Generally only one<br />

out of every 5,000<br />

to 10,000 examined<br />

substances ultimately<br />

receives marketing<br />

authorization.<br />

18<br />

cancer patients with bone metastases in Europe and<br />

the United States in 2012. Together with its partner<br />

OncoMed Pharmaceuticals, <strong>Bayer</strong> <strong>HealthCare</strong> is<br />

working in the innovative research area of cancer<br />

stem cell research. Cancer stem cells are believed to<br />

play a signifi cant role in the development, metastasis<br />

and recurrence of cancer. The objective is to jointly<br />

develop new therapeutic options to target cancer<br />

stem cells.<br />

Eylea (afl ibercept), a drug product that is being developed<br />

in collaboration with Regeneron Pharmaceuticals<br />

Inc., could make an important contribution in the treatment<br />

of eye diseases. The product, which is injected<br />

into the vitreous body of the eye, is registered in various<br />

countries and regions for the treatment of wet agerelated<br />

macular degeneration and in the United States<br />

also for the treatment of macular edema due to central<br />

retinal vein occlusion. Further clinical trials on the treatment<br />

of additional diseases of the ocular fundus are<br />

currently ongoing.<br />

Development of a pharmaceutical product: The long road<br />

research<br />

up to 10,000<br />

substances<br />

In vitro efficacy<br />

tests<br />

250<br />

substances<br />

oscillating, disposable bioreactor: Dr. Uwe Langer from Biotechnology<br />

Development at <strong>Bayer</strong> <strong>HealthCare</strong>, developer Jörg Kauling and Annette Waldhelm<br />

from <strong>Bayer</strong> Technology Services (left to right) check the product quality.<br />

4.7<br />

substances<br />

0 2 4 6 8 10<br />

In the fi eld of women’s health care, <strong>Bayer</strong> <strong>HealthCare</strong><br />

conducts research to discover innovative approaches to<br />

treat gynecological disorders such as endometriosis and<br />

uterine fi broids. The company has launched Visanne<br />

(dienogest), a new treatment option for endometriosis, in<br />

Europe. <strong>Bayer</strong> <strong>HealthCare</strong> is also working on further developing<br />

the broad spectrum of contraceptives, ranging<br />

from the development of new, low-dose oral contraceptives<br />

with a fl exible extended dosing regimen through to<br />

a new, low-dose intrauterine system. This long-term<br />

contraceptive with a duration of action of up to three<br />

years was granted regulatory approval in the European<br />

Union (trade name: Jaydess) in December 2012 and in<br />

the United States (trade name: Skyla) in early 2013.<br />

The Medical Care Division conducts R&D into nextgeneration<br />

advances in diabetes monitoring, radiology/<br />

interventional radiology and cardiology to improve the<br />

current portfolio of marketed products. The division<br />

conducts proprietary R&D and also forms strategic<br />

alliances with other companies to share technology and<br />

Preclinical Clinical studies Application<br />

Phase i Phase ii Phase iii<br />

submitted<br />

Efficacy and safety tests,<br />

animal testing with<br />

the final 10 to 20<br />

substances<br />

Tolerability<br />

testing in<br />

healthy human<br />

subjects<br />

3.3<br />

substances<br />

Testing in a<br />

small<br />

number of<br />

patients<br />

1.5<br />

substances<br />

Testing<br />

generally in<br />

several thousand<br />

patients<br />

1.2<br />

substances<br />

Documentation<br />

examined by<br />

regulatory<br />

authorities<br />

Approved<br />

1<br />

substance<br />

12 years


expertise. The current R&D focus in blood glucose<br />

monitoring includes ease-of-use, meter accuracy,<br />

and software to simplify data capture and analysis. In<br />

radiology and interventional, the division is focused on<br />

investments in informatics, contrast media, fluid delivery<br />

systems, interventional therapeutic catheters and other<br />

accessories to deliver innovative integrated solutions to<br />

customers. R&D activities focus on contrast agents for<br />

high field MRI and low radiation CT; solutions to improve<br />

diagnostic outcome and radiology workflow efficiency;<br />

equipment service; and vascular intervention systems for<br />

treating constricted or blocked blood vessels. The<br />

division’s expanded global network of leading clinical<br />

researchers supports R&D activities through innovative<br />

clinical studies.<br />

Research and development in the Animal Health Division<br />

is concentrated on the identification and registration of<br />

new active ingredients for applications in companion<br />

and farm animals. Another priority is the development of<br />

innovative formulations and new applications for existing<br />

research and Development Projects (Phase iii)*<br />

Aflibercept Treatment of diabetic macular edema<br />

active ingredients. The close collaboration with the re-<br />

search departments of <strong>Bayer</strong> <strong>HealthCare</strong> Pharma and<br />

<strong>Bayer</strong> CropScience offers a unique competitive advantage<br />

thanks to the opportunities to share data and<br />

research results. In all of <strong>Bayer</strong> Animal Health’s developments,<br />

the focus is always on user friendliness and<br />

safety for both humans and animals. The division’s main<br />

development sites are located in Monheim (Germany),<br />

Shawnee (USA) and Auckland (new Zealand).<br />

In the Analgesics category, <strong>Bayer</strong> Aspirin has been<br />

a leader in pain relief for over 110 years. The new <strong>Bayer</strong><br />

Advanced Aspirin represents the most exciting Aspirin<br />

innovation to date in the United States. Launched by the<br />

Consumer Care Division in 2011, the product was the<br />

result of more than five years of research and development<br />

and uses breakthrough patented technology to<br />

reduce the Aspirin particles into micro-particles. This<br />

next generation of Aspirin targets younger, more active<br />

consumers.<br />

Aflibercept Prevention of abnormal retinal angiogenesis following<br />

pathological myopia<br />

BAY 86-6150 (rFVIIa mutein) Treatment of hemophilia A (Phase II/III)<br />

BAY 94-9027 (rFVIII mutein) Treatment of hemophilia A<br />

Ciprofloxacin Inhale Treatment of pulmonary infections<br />

LCS-16 (ULD LnG Contraceptive System) Intrauterine contraception, duration of use: up to 5 years<br />

Prasterone ** Treatment of vulvovaginal atrophy<br />

Rivaroxaban Prevention of major adverse cardiac events (MACE)<br />

Sodium deoxycholate *** Injection for reduction of submental fat<br />

Sorafenib Treatment of breast cancer<br />

Sorafenib Treatment of liver cancer, adjuvant therapy<br />

Sorafenib Treatment of kidney cancer, adjuvant therapy<br />

Sorafenib Treatment of thyroid cancer<br />

Tedizolid Treatment of complicated skin and lung infections<br />

rESEArCH AnD DEvEloPMEnT<br />

* as of February 11, 2013<br />

** prasterone = vaginorm<br />

*** sodium deoxycholate =<br />

ATX-101<br />

The nature of drug discovery and<br />

development is such that not all<br />

compounds can be expected to<br />

meet the predefined project<br />

goals. It is possible that any or all<br />

of the projects listed above may<br />

have to be discontinued due to<br />

scientific and / or commercial<br />

reasons and will not result in<br />

commercialized products. It is also<br />

possible that the requisite Food<br />

and Drug Administration (FDA),<br />

European Medicines Agency<br />

(EMA) or other regulatory<br />

approvals will not be granted for<br />

these compounds.<br />

19


High-quality active ingredients are<br />

fi lled at the Supply Center in<br />

Bergkamen.<br />

20<br />

Product Supply


<strong>Bayer</strong> <strong>HealthCare</strong> manufactures products at almost 60 sites around the world which<br />

are managed by Product Supply. The production of active ingredients for prescription<br />

medicines is conducted primarily at the production sites in Wuppertal and Bergkamen<br />

(Germany) and Berkeley and Emeryville (united States). They are processed and packaged<br />

as finished pharmaceuticals in plants around the world.<br />

A broad spectrum of different pharmaceutical presentations is covered: solid formulations such<br />

as tablets, sugar-coated tablets and powders, semi-solid ointments and creams, and<br />

liquid drug products for application, for example, as injections or infusions. Hormonal<br />

contraceptives are produced as sugar- or film-coated tablets but also, for example, as<br />

intrauterine systems. These formulation and packaging activities are based in Berlin,<br />

Leverkusen and Weimar (Germany), Garbagnate (Italy), Turku (Finland), São Paulo<br />

(Brazil), Beijing (China), as well as various other sites in Europe, Asia and Latin America.<br />

Kogenate, a drug product for the treatment of hemophilia, is manufactured in Berkeley<br />

(United States) using a biotechnology process, while Betaferon/Betaseron for the<br />

treatment of multiple sclerosis is produced in Emeryville (United States).<br />

The main production sites for non-prescription (over-the-counter) drug products are<br />

located in Bitterfeld-Wolfen and Grenzach-Wyhlen (Germany), Cimanggis (Indonesia),<br />

Lerma (Mexico), Myerstown (United States) and Madrid (Spain). The globally marketed<br />

animal health products are mainly manufactured at the sites in Kiel (Germany) and<br />

Shawnee (United States).<br />

In addition to drug products for humans and animals, medical devices for diagnosis<br />

and therapy are produced in the United States. <strong>Bayer</strong> <strong>HealthCare</strong> supplies a total of<br />

more than 20,000 articles. The reason for this large number is the different presentations<br />

of individual products and packaging – for example, different formulations,<br />

dosages, pack sizes and language versions.<br />

<strong>Bayer</strong> <strong>HealthCare</strong> Product Supply steers the subgroup’s entire supply chain, from raw<br />

material sourcing through manufacturing to distribution, utilizing a global production<br />

network consisting of its own sites and those of contract manufacturers. In this way<br />

the company aims for continuous improvement of costs, flexibility and delivery reliability,<br />

maintaining high standards of quality, health, safety and environmental protection on<br />

a global basis.<br />

The manufacture of pharmaceutical products is subject to extraordinarily stringent<br />

quality standards. These standards are known collectively as “Good Manufacturing<br />

Practice” (GMP). Compliance with these requirements is regularly audited by internal<br />

experts, regulatory authorities and external consultants.<br />

ProDuCT SuPPly<br />

21


Fostering real partnerships which offer both sides the opportunity<br />

to develop and grow – that is the partnering philosophy of <strong>Bayer</strong><br />

<strong>HealthCare</strong>.<br />

Business development


As an innovation- and growth-oriented company, <strong>Bayer</strong> <strong>HealthCare</strong> also invests in<br />

setting up and maintaining collaborations with external partners. These partnerships<br />

cover a broad variety of models ranging from r&D collaborations, licensing and co-<br />

marketing agreements to regional alliances and acquisitions.<br />

Strategic alliances with international partners from academia are an important pillar of the<br />

company’s R&D strategy. Examples are the joint research center for innovative therapeutic<br />

approaches at Tsinghua University (China) and the collaboration with the<br />

German Cancer Research Center (Heidelberg). Other collaborations at earlier stage<br />

include the multi-target drug discovery alliance with Evotec AG from Germany in the<br />

area of endometriosis.<br />

With the targeted anticancer drug Nexavar (sorafenib), the Pharmaceuticals Division<br />

and Onyx Pharmaceuticals, Inc., USA, have gone all the way from drug discovery to<br />

market. Another example in the area of Oncology is the successful co-development of<br />

radium-223 dichloride with Algeta ASA from norway. <strong>Bayer</strong> <strong>HealthCare</strong> just recently<br />

submitted this substance for marketing authorization in the EU and the United States<br />

for the treatment of castration-resistant prostate cancer patients with bone metastases.<br />

In collaboration with Regeneron Pharmaceuticals, Inc., Eylea (aflibercept) has<br />

been successfully launched for the treatment of wet age-related macular degenera-<br />

tion and central retinal vein occlusion. Another example of a fruitful partnership is the<br />

co-development and co-promotion agreement with Janssen Pharmaceuticals for the<br />

anticoagulant Xarelto (rivaroxaban). This collaboration has led to launches in multiple<br />

locations worldwide.<br />

<strong>Bayer</strong> <strong>HealthCare</strong> Animal Health recently acquired the U.S. animal health business of<br />

Teva Pharmaceutical Industries. This transaction reinforces <strong>Bayer</strong>’s product offering in<br />

the USA with anti-infectives for livestock and adds reproductive hormones to the<br />

existing portfolio. The acquisition also strengthens the company’s companion animal<br />

franchise with the addition of dermatological, pet wellness and nutraceutical products.<br />

The Consumer Care Division continues to focus its business development efforts to<br />

strengthen its position in the United States and to accelerate growth in emerging<br />

markets including Brazil, China and Russia. In addition, the division will expand its<br />

portfolio into adjacent business categories, as well as Rx to OTC switch opportunities.<br />

BuSinESS DEvEloPMEnT<br />

23


in developing countries in particular, <strong>Bayer</strong> <strong>HealthCare</strong><br />

is committed to giving people access to conscious family<br />

planning.<br />

24<br />

Social commitment


in the 21st century, the world will be strongly shaped by the effects of population growth<br />

in developing countries and emerging markets and by demographic change in numerous<br />

industrialized countries. Developing countries in particular are home to increasing numbers<br />

of people who lack access to the necessary pharmaceutical products and medical<br />

care. <strong>Bayer</strong> <strong>HealthCare</strong> is committed to the principles of sustainable development and<br />

accepts responsibility in society. At the center of all our employees’ actions are human<br />

and animal health and environmental protection.<br />

in the context of the company’s “access to medicine” strategy, <strong>Bayer</strong> <strong>HealthCare</strong> provides<br />

medicines free of charge to combat the neglected tropical diseases that affect<br />

around 1 billion people worldwide. For example, in 2012 <strong>Bayer</strong> <strong>HealthCare</strong> doubled<br />

the number of Lampit tablets that it will donate for the treatment of Chagas disease,<br />

a widespread disease in Latin America, to one million tablets per year over the next five<br />

years. <strong>Bayer</strong> also collaborates with the WHO in programs to combat African sleeping<br />

sickness, malaria and multiresistant tuberculosis. The company is participating in the<br />

Global Alliance for TB Drug Development to develop a new therapy that will shorten<br />

the treatment period for tuberculosis from at present at least six months to four<br />

months.<br />

As the market leader in the field of hormonal contraceptives, <strong>Bayer</strong> <strong>HealthCare</strong> has<br />

been supporting family planning programs in a global network of governmental and<br />

non-governmental organizations (nGOs) worldwide for more than 50 years.<br />

The company has initiated new partnerships to ensure long-term access to hormonal<br />

contraceptives for women in developing countries. In late 2012, for example, <strong>Bayer</strong><br />

<strong>HealthCare</strong> and the Bill & Melinda Gates Foundation signed an agreement guaranteeing<br />

access to safe and reversible contraception for at least 27 million women in<br />

developing countries over a six-year period.<br />

Medical Care supports patient and other non-governmental organizations, including<br />

the International Diabetes Federation (IDF), the Foundation of European nurses in<br />

Diabetes (FEnD) and the Juvenile Diabetes Research Foundation (JDRF).<br />

Consumer Care supports a range of social initiatives focused on education and<br />

research, health and social needs as well as cultural initiatives.<br />

SoCiAl CoMMiTMEnT<br />

25


ConTACTS AT BAYER HEALTHCARE CoRPoRATE CoMMUnICATIonS & PUBLIC AFFAIRS<br />

BAYER HEALTHCARE<br />

Oliver Renner<br />

oliver.renner@bayer.com<br />

DIVISIONS<br />

Animal Health<br />

Jessica Federer<br />

jessica.federer@bayer.com<br />

Consumer Care<br />

Tricia McKernan<br />

tricia.mckernan@bayer.com<br />

Medical Care<br />

Dr. Gisela Lenz<br />

gisela.lenz@bayer.com<br />

Pharmaceuticals<br />

Oliver Renner<br />

oliver.renner@bayer.com<br />

REGIONS<br />

Europe/Canada<br />

Alexander Siedler<br />

alexander.siedler@bayer.com<br />

Asia/Pacific<br />

Su Ngoh Lee<br />

sungoh.lee@bayer.com<br />

China<br />

Yan Lin<br />

yan.lin@bayer.com<br />

Japan<br />

Miho Oka<br />

miho.oka@bayer.com<br />

Latin America/Africa/Middle East<br />

Diana Panqueva<br />

diana.panqueva@bayer.com<br />

North America<br />

Rosemarie Yancosek<br />

rosemarie.yancosek@bayer.com<br />

Status: April 2013


<strong>Bayer</strong> <strong>HealthCare</strong><br />

names – Figures – Facts | 2013


Key fi gures 2012<br />

<strong>Bayer</strong> <strong>HealthCare</strong> 2011 2012 Change<br />

€ million % Fx(& p) adj. %<br />

Sales 17,169 18,612 8.4 4.2<br />

EBITDA 4,502 3,815 -15.3<br />

Special items ­200 ­1,253<br />

EBIT 3,191 2,154 -32.5<br />

Special items ­176 ­1,582<br />

Gross cash fl ow 3,254 2,614 -19.7<br />

net cash fl ow 3,357 3,543 5.5<br />

Sales by division 2011 2012 Change<br />

€ million % Fx(& p) adj. %<br />

Animal Health 1,186 1,303 9.9 4.2<br />

Consumer Care 3,534 3,853 9.0 5.6<br />

Medical Care 2,500 2,653 6.1 2.2<br />

Pharmaceuticals 9,949 10,803 8.6 4.2<br />

Sales by region 2011 2012 Change<br />

€ million % Fx adj. %<br />

Europe 6,376 6,484 1.7 0.9<br />

north America 4,360 4,961 13.8 5.5<br />

Asia/Pacifi c 3,656 4,203 15.0 6.2<br />

Latin America/Africa/Middle East 2,777 2,964 6.7 5.6<br />

Best-Selling Pharmaceuticals Products 2011 2012 Change<br />

€ million % Fx adj. %<br />

Betaferon/Betaseron 1,117 1,216 8.9 4.2<br />

Kogenate 1,075 1,182 10.0 5.2<br />

YAZ/Yasmin/Yasminelle 1,070 1,045 -2.3 -5.0<br />

Nexavar 725 792 9.2 4.2<br />

Mirena 581 677 16.5 9.4<br />

Adalat 640 670 4.7 -2.3<br />

Avalox/Avelox 486 486 0.0 -5.0<br />

Aspirin Cardio 404 476 17.8 12.3<br />

Glucobay 362 408 12.7 3.6<br />

Xarelto 86 322 274.4 265.9<br />

Levitra 332 307 -7.5 -9.1<br />

Cipro/Ciprobay 232 229 -1.3 -5.1<br />

Zetia 179 207 15.6 7.5<br />

Diane 182 194 6.6 4.9<br />

Fosrenol 147 187 27.2 18.0<br />

Total 7,618 8,398 10.2 5.2<br />

Proportion of Pharmaceuticals sales 77 % 78 %<br />

Best-Selling Consumer Health Products 2011 2012 Change<br />

€ million % Fx adj. %<br />

Contour (Medical Care) 640 722 12.8 8.5<br />

Advantage product line (Animal Health) 420 495 17.9 10.6<br />

Aspirin* (Consumer Care) 471 494 4.9 1.3<br />

Ultravist (Medical Care) 316 324 2.5 -1.5<br />

Aleve/naproxen (Consumer Care) 285 323 13.3 5.4<br />

Bepanthen/Bepanthol (Consumer Care) 235 269 14.5 13.9<br />

Canesten (Consumer Care) 224 250 11.6 7.8<br />

Gadovist/Gadavist (Medical Care) 160 209 30.6 27.2<br />

One A Day (Consumer Care) 174 196 12.6 4.0<br />

Iopamiron (Medical Care) 185 174 -5.9 -12.3<br />

Total 3,110 3,456 11.1 6.2<br />

Proportion of Consumer Health sales 43 % 44 % Fx (& p) adj. = currency- (and portfolio-)adjusted | Fx adj. = currency-adjusted<br />

* Sales of Aspirin (including Aspirin Complex) – including Aspirin Cardio, which is refl ected in sales of the<br />

Pharmaceuticals segment – increased by 10.9% (Fx adj. +6.4%) in 2012 to €970 million (2011: €875 million).


Germany<br />

United States<br />

China<br />

Japan<br />

Mexico<br />

Brazil<br />

Italy<br />

Russian Fed.<br />

France<br />

Spain<br />

Turkey<br />

Argentina<br />

Indonesia<br />

India<br />

Canada<br />

Finland<br />

Colombia<br />

United Kingdom<br />

Switzerland<br />

Venezuela<br />

Pakistan<br />

Republic Korea<br />

United Arab. Emir.<br />

El Salvador<br />

Australia<br />

Poland<br />

Guatemala<br />

Philippines<br />

Netherlands<br />

Headquarter sites of <strong>Bayer</strong> <strong>HealthCare</strong> and its divisions<br />

Tarrytown (Medical Care)<br />

Morristown (Consumer Care)<br />

Headcount according to country<br />

1,210<br />

1,140<br />

1,100<br />

1,068<br />

2,077<br />

1,927<br />

1,637<br />

765<br />

741<br />

693<br />

671<br />

668<br />

644<br />

629<br />

615<br />

553<br />

525<br />

507<br />

478<br />

456<br />

417<br />

377<br />

269<br />

260<br />

256<br />

2,620<br />

Monheim (Animal Health)<br />

Leverkusen (<strong>Bayer</strong> <strong>HealthCare</strong>)<br />

7,103<br />

7,755<br />

Berlin (Pharmaceuticals)<br />

Employees by segment<br />

Total number of employees: 55,300<br />

Consumer<br />

Health<br />

17,600<br />

Pharmaceuticals<br />

37,700<br />

13,301


<strong>Bayer</strong> <strong>HealthCare</strong> Executive Committee<br />

<strong>Bayer</strong> <strong>HealthCare</strong> is managed by its Executive Committee. This body is com-<br />

posed of the four divisional heads, the heads of Research and Development as<br />

well as the heads of the cross-divisional platform functions Central Administration<br />

& Organization, Corporate Communications & Public Affairs, Global Business<br />

Development & Licensing, Human Resources, Law and Patents and Product<br />

Supply. The Executive Committee sets the course for the company’s future.<br />

Its task is to make strategic decisions that lead to a sustained increase in the<br />

company’s value.<br />

Prof. Andreas Busch<br />

Head of Global Drug<br />

Discovery<br />

Andreas Günther<br />

Head of Human<br />

Resources<br />

Erica L. Mann<br />

Head of the Consumer<br />

Care Division<br />

Dr. Dirk Ehle<br />

Head of the Animal<br />

Health Division<br />

Dr. Hartmut Klusik<br />

Head of Product<br />

Supply<br />

Oliver Renner<br />

Head of Corporate<br />

Communications &<br />

Public Affairs<br />

Andreas Fibig<br />

Head of the Pharmaceuticals<br />

Division<br />

Alan Main<br />

Head of the Medical<br />

Care Division<br />

Nigel Sheail<br />

Head of Global<br />

Business Development<br />

& Licensing<br />

Prof. Wolfgang Plischke<br />

Member of the Board of<br />

Management of <strong>Bayer</strong> AG<br />

and interim Chairman of<br />

<strong>Bayer</strong> <strong>HealthCare</strong><br />

Dr. Stefan Gehring<br />

Head of Law and<br />

Patents and Compliance<br />

Officer<br />

Dr. Kemal Malik<br />

Head of Development<br />

and Chief Medical<br />

Officer of the Pharmaceuticals<br />

Division<br />

Manfred Vehreschild<br />

CFO and Head of<br />

Central Administration<br />

& Organization<br />

Status: April 2013

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