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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