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Conten t s
Names Figures Facts 2011
Foreword The Bayer HealthCare management team Facts and figures 2010 Active worldwide
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10 12 14 16
Research and development Product Supply Business development Social commitment Research milestones BHC in dialogue
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COVER: Bayer researcher Dr. Johannes-Peter Stasch (left) and Professor Hossein Ardeschir Ghofrani from Giessen University Hospital (Germany) work with a model of a lung.
Foreword
Innovation that reaches its target
Dear Readers, The global healthcare market is undergoing a transformation. While cost aspects are increasingly becoming the main priority in many state healthcare systems, in emerging markets such as China or Brazil there is a new, growing demand for healthcare products and services. Given these changes, innovation is and will remain a crucial success factor. For Bayer HealthCare, innovation means offering products that improve peoples lives. Excellence in research and development is essential for this. Furthermore, we must also understand peoples needs because innovation is only innovation if our customers view it as such and it provides them with true added value. Customer orientation in all phases of product development from research to marketing is a key success factor in this regard. In each of our four divisions Animal Health, Consumer Care, Medical Care and Pharmaceuticals we constantly work to offer our customers real innovations: Animal Health is our specialist for veterinary medicine for companion animals and livestock. Among our product innovations is Profender Dog, the first allwormer for dogs, which provides control of adult and all larval stages of the most relevant worm species in dogs. Our Consumer Care Division is a world leader in the over-the-counter or non-prescription drugs market. Through our Intendis business, we also place emphasis on new areas such as aesthetic dermatology, where we are working together with a partner to develop an injection to remove fat deposits under the chin. The Medical Care portfolio comprises blood glucose meters for people with diabetes and devices for diagnostic imaging and medical therapy. Cotavance, a drug-coated balloon catheter for the treatment of peripheral arterial disease, is one of the most important development projects in this division.
At Pharmaceuticals, we research and develop new therapies primarily in areas where there is a high level of medical need, such as cancer therapy, cardiovascular and hematological disorders, gynecological therapy and new molecular imaging processes. Among the promising candidates in our pipeline are the anticoagulant Xarelto and VEGF Trap-Eye for the treatment of wet age-related macular degeneration. Bayer HealthCare is thus prepared to create value through innovation in the future as well. This brochure provides insight into the diversity and strength of our company, and I hope that this edition of Names Figures Facts will spur your fascination for Bayer HealthCare and its innovative power. Dr. Jrg Reinhardt Chairman of the Bayer HealthCare Executive Committee
Dr. Alexander Bey Head of Law and Patents and Compliance Officer
Prof. Dr. Andreas Busch Head of Pharmaceuticals and Animal Health Research
Dr. Kemal Malik Head of Development and Chief Medical Officer of the Pharmaceuticals Division
16,913 million Monheim (Animal Health) Berlin (Pharmaceuticals) Leverkusen (Bayer HealthCare)
Bayer HealthCare million Sales EBITDA EBIT Special items Gross cash flow Net cash flow
2009
2010
Change %
- 6.5 -3.2
2009 1,214 1,278 888 604 633 490 460 360 315 315 262 331 219 199 164 7,732 74 %
2010 1,206 1,111 1,004 705 664 539 497 429 358 347 313 262 215 185 178 8,013 73 %
Change % -0.7 -13.1 13.1 16.7 4.9 10.0 8.0 19.2 13.7 10.2 19.5 -20.8 -1.8 -7.0 8.5 3.6
Best-Selling Consumer Health Products million Contour (Medical Care) Aspirin* (Consumer Care) Advantage product line (Animal Health) Aleve/naproxen (Consumer Care) Bepanthen/Bepanthol (Consumer Care) Canesten (Consumer Care) One A Day (Consumer Care) Baytril (Animal Health) Supradyn (Consumer Care) Breeze (Medical Care) Total Proportion of Consumer Health sales
2009 601 400 336 217 186 188 153 149 136 138 2,504 45 %
2010 602 418 408 273 212 210 178 166 138 125 2,730 45 %
Change % 0.2 4.5 21.4 25.8 14.0 11.7 16.3 11.4 1.5 -9.4 9.0
* Total Aspirin sales = 776 million (2010: 715 million), including Aspirin Cardio, which is reflected in sales of the Pharmaceuticals segment.
14,000
2,000
3,000
8,000
1,000
Employees
Germany 12,976 8,618 5,012 2,455 2,361 1,587 1,560 1,461 1,121 1,085 910 691 683 672 669 641 616 601 592 583 563 505 Columbia 479 United Arab Emirates 432 Poland 432 Pakistan 356 Australia 325 Morocco 290 Philippines 289 Guatemala 279 Republic of South Africa
USA
200
400
600
800
Consumer Health*
17,700
China Japan Mexico Brazil Italy France Spain Turkey Russian Federation Republic of Korea India Argentina Indonesia Canada Finland United Kingdom El Salvador Switzerland Venezuela
38,000 Sales
Consumer Care 3,371 million Medical Care 1,514 million
*The Consumer Health segment comprises Bayer HealthCare's Animal Health, Consumer Care and Medical Care Divisions.
Pharmaceuticals
Acti ve worldwide
Bayer HealthCare and its divisions are represented in nearly all markets of the world.
Active worldwide
The aim of Bayer HealthCare is to research, develop, manufacture and market innovative products that will improve the health of people and animals all over the world. The products are used for the diagnosis, prevention and treatment of diseases and help to enhance quality of life. Bayer HealthCare is a globally operating company with sites on all five continents. Approximately 55,700 people work for the Bayer subgroup in more than 100 countries at all stages of the value-added chain. The company has its headquarters in Germany (Leverkusen). Two divisions (Consumer Care and Medical Care) are based in the United States (Morristown and Tarrytown). The headquarters of the Animal Health and Pharmaceuticals Divisions are also located in Germany (Monheim and Berlin, respectively). Local companies handle product distribution and are in close contact with the customer and with the authorities in the various countries. As a global company with four divisions, sites all over the world and a differentiated portfolio, Bayer HealthCare is reliant on a diversely composed workforce. After all, one of the cornerstones of Bayer HealthCares success is the innovative strength of its employees. This is why Bayer HealthCare is keen to attract the most promising talent from all over the world to the company. Overall, diversity pays off. In addition to a better understanding of customer requirements, an enhanced image and greater appeal as an employer, diversity as a business case is also gaining importance in day-to-day business: the more diverse the workforce, the greater the creative potential released through cooperation. Working together, men and women, different age groups and nationalities, and people with different ways of thinking can have a more well-rounded approach to challenges and may find solutions which would not have even occurred to a group with a more homogeneous composition. Only in this way can the diverse knowledge, experience and values of employees be put to profitable use to produce innovative customer solutions and meet global challenges.
When pets become ill, they can also impair the health of humans - for example by spreading disease pathogens.
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Net sales 2010: 1.1 billion Global ranking: 4 Headquarters: Monheim, Germany
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neues F
More and more people are taking responsibility for their own health. For this reason, self-medication is becoming increasingly important.
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Foto
Net sales 2010: 3.4 billion Global ranking: 2 Headquarters: Morristown, NJ, USA
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Regular blood glucose monitoring helps people with diabetes to keep their blood sugar levels normal. This in turn can considerably reduce the risk of complications.
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Net sales 2010: Medical Care 1.5 billion Global ranking: Blood glucose monitoring systems: 3 Fluid injection systems and thrombectomy devices: 1 Headquarters: Tarrytown, NY, USA
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Pharmaceuticals
More and more doctors and patients rely on innovative drugs from Bayer HealthCare's Pharmaceuticals Division.
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Net sales 2010: 10.9 billion Global ranking: Leading positions in key therapeutic categories Headquarters: Berlin, Germany
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Pharmaceuticals
Dr. Peter Kolkhof checks a slide before examining it under the microscope in one of the laboratories of Bayer HealthCare's Pharmaceuticals Division in Wuppertal (Germany).
large-scale clinical development program is investigating the suitability of the drug product in the prevention and treatment of various types of acute and chronic blood coagulation disorders. The Womens Healthcare segment of the General Medicine Business Unit is a pioneer in its field, concentrating on three areas: contraception, menopause management and gynecological therapies. Bayer is the world leader in the field of female hormonal contraception, in particular in the area of oral contraception. The pill has been enabling women to engage in conscious family planning for 50 years. Womens Healthcare offers a wide range of different contraceptives to meet individual needs, including lowdosage contraceptives with additional indications. One product that was first launched in the European Union in 2009 is the first product from a new class of oral contraceptives whose estrogen component is based on estradiol,
the same estrogen that is produced by the female body. In addition, Womens Healthcare develops products to relieve the symptoms associated with menopause. In the gynecological therapy segment, Bayer HealthCare is working to develop new therapeutic options for conditions with a high level of unmet medical need such as uterine fibroids (myomas) and endometriosis, a condition in which endometrial cells grow outside of the uterus. Indeed, a drug for the treatment of endometriosis was launched in Europe in the second quarter of 2010. The Specialty Medicine Business Unit offers innovative therapeutic options to markedly improve the quality of life for people suffering from severe, chronic and life-threatening diseases. Thanks to the contrast agents from Diagnostic Imaging, precise and early diagnosis can play a crucial role in the selection of optimal treatment and therefore has a positive effect on the therapeutic course.
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Oemur Capar conducts a visual inspection of Nexavar tablets at Bayer HealthCare's Leverkusen site.
Some 2.5 million people worldwide suffer from multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system usually occurring in episodes. Bayer HealthCare was one of the first companies to offer a causal treatment for this autoimmune disease that reduces the frequency of attacks and in this way can slow progression of the disease considerably. Hemophilia A is a rare genetic blood coagulation disorder that can be effectively treated with blood coagulation Factor VIII. The Pharmaceuticals Division is one of the worlds most important manufacturers of drug products to treat this hereditary disease. Crucial improvements have been achieved in selective cancer treatments therapies that inhibit cell division and simultaneously disrupt the blood supply to the tumor. A state-of-the-art oral drug product containing the active ingredient sorafenib has been granted regulatory approval
for the treatment of renal cell carcinoma and hepatocellular carcinoma in many countries and is now undergoing studies to investigate its suitability for a large number of other forms of cancer such as breast cancer, colorectal cancer and lung cancer. Today, medicine relies not only on conventional X-rays but also employs various diagnostic methods such as computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound. Diagnostic Imaging is one of the worlds leading providers of X-ray and MRI contrast agents for in vivo diagnostics. These products are used to make tissues and organs visible in their natural position inside the body. Work is also focused on the development of markers (tracers) for positron emission tomography (PET). The PET tracer florbetaben in Bayer's pipeline makes it possible to recognize beta Amyloid, one of the pathological hallmarks of Alzheimer's disease, with high accuracy very early on and while the patient is still alive.
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fanny Knoth, stefan stargard and Dr. antje stratmann examine cell cultures under microscopes to investigate the efficacy of a substance.
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Dr. Klemens Krieger and sabrina schwartzkopff from the research department of the animal Health Division apply droplets of Advocate to a cat.
BHC's scientists' profound knowledge of human and veterinary medicine, accompanied by their expertise in inter-disciplinary technologies, forms the basis for innovative products.
could support earlier and more precise diagnosis of cancer or dementia in the future. Bayer HealthCare's Pharmaceuticals Division is also carrying out research and development in the field of womens healthcare, to offer a wide spectrum of contraceptive options. This ranges from the clinical testing of a contraceptive patch through to oral contraceptives which are intended for authorization in additional indications besides contraception. A new class of oral contraceptives with an estrogen component based on estradiol the estrogen which is also produced naturally by the female body was granted regulatory approval in the EU in 2009. Gynecological therapies are another R&D focus of Womens Healthcare. The company launched Visanne, a new treatment option for endometriosis, in Europe in the second quarter of 2010. Endometriosis is a chronic gynecological disease in which endometrial-like tissue appears and flourishes in areas outside the uterine cavity, which leads to chronic inflammatory reactions. The Medical Care Division conducts proprietary R&D into next-generation advances in diabetes monitoring, radiology and interventional cardiology, improving the current portfolio of marketed products as well as entering into strategic alliances with other companies to share technology and expertise. The current R&D focus in the field of blood glucose monitoring includes ease-ofuse, meter accuracy, and e-health initiatives to simplify
data capture and analysis. In the field of medical devices, the division is focused on developing alternative fluid delivery mechanisms, vascular intervention systems for treating constricted or blocked blood vessels (such as Cotavance, a drug-coated balloon catheter), customer workflow efficiencies and patient-specific contrast administration, as well as molecular imaging and healthcare informatics. The acquisition of the Bomac Group with its headquarters in Auckland, New Zealand, has strengthened the Animal Health Divisions research activities in the livestock sector. Auckland will join Monheim (Germany) and Shawnee (Kansas, USA) as a new, regional development center. The growing demand for animal protein necessitates innovative solutions for food-producing animals. Another important research area is the treatment of age-related diseases in companion animals. Further efforts are devoted to developing new formulations and user-friendly applications for established active ingredients. The Consumer Care Division is concentrating its research and development activities on developing existing brands through expanded indications and optimized delivery forms. In addition, Consumer Care actively seeks opportunities to switch prescription pharmaceuticals that could be marketed as over-the-counter products.
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Research
Preclinical
Clinical studies
Application submitted
Approved
Phase I
up to substances
Phase II
substances
Testing in a small number of patients
Phase III
substances
Testing generally in several thousand patients
10,000
substances
Efficacy and safety tests, animal testing with the final 10 to 20 substances
250
substances
Tolerability testing in healthy human subjects
4.7
3.3
1.5
substances
Documentation examined by regulatory authorities
1.2
substance
Only one substance receives marketing authorization: On average, the development of a pharmaceutical product to market maturity takes about 10 to 12 years and costs roughly half a billion euros. Generally only one out of every 5,000 to 10,000 examined substances ultimately receives marketing authorization.
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12 years
Research and Development Projects (Phase III)* alemtuzumab Alpharadin aTX-101 fC Patch low florbetaben Gadovist LCs (uLD LNG contraceptive system) Nexavar Nexavar Nexavar regorafenib (DasT inhibitor) regorafenib (DasT inhibitor) riociguat (sGC stimulator) riociguat (sGC stimulator) Xarelto Xarelto Xarelto Vaginorm veGf Trap-eye veGf Trap-eye veGf Trap-eye
* as of February 15, 2011 PAH = pulmonary arterial hypertension; CTEPH = chronic thromboembolic pulmonary hypertension The nature of drug discovery and development is such that not all coumpounds can be expected to meet the pre-defined project goals. It is possible that any or all of the projects listed above may have to be discontinued due to scientific and/or commercial reasons and will not result in commercialized products. It is also possible that the requisite FDA, European Medicines Agency (EMA) or other regulatory approvals will not be granted for these compounds.
Multiple sclerosis Treatment of bone metastases in hormone-refractory prostate cancer Reduction of submental fat Contraception PET imaging in diagnosis of Alzheimers disease Magnetic resonance imaging Contraception Breast cancer Thyroid cancer Non-small-cell lung cancer Treatment of metastatic or inoperable gastrointestinal stromal tumors Colon cancer Pulmonary hypertension (CTEPH) Pulmonary hypertension (PAH) Prevention of venous thromboembolism in medically ill, immobilized patients Treatment and secondary prevention of venous thromboembolism Secondary prevention of acute coronary syndrome / myocardial infarction Vulvovaginal atrophy and female sexual dysfunction (FSD) Wet age-related macular degeneration Abnormal retinal angiogenesis following pathological myopia Central retinal vein occlusion
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Product supply employee Christian Otulak fills active pharmaceutical ingredients in the supply Center in Bergkamen (Germany).
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Global partnerships enable Bayer HealthCare to secure access to innovative research technologies, systematically expand its product portfolio and strengthen its regional market presence.
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soc i al commitment
Dr. Luis alberto Benios, a doctor in the san Marcos de sierra hospital in Honduras, explains how to take Lampit tablets to Yadira and her mother Catalina Nuez. Yadira suffers from Chagas disease.
Bayer HealthCare's Pharmaceuticals Division has many years of experience and great expertise in the field of family planning. The company is dedicated to ensuring that people in developing countries in particular can engage in conscious family planning free of charge or at reasonable prices.
Bayer HealthCare is engaged in social projects around the world, many of which are devoted to improving the supply of health care in developing countries.
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Histo r y
research milestones
1888 Phenacetin 1890 Piperazin 1899 Aspirin
More than 100 years ago, Aspirin was already known beyond the borders of Germany as an effective pain reliever.
Bayer enters the pharmaceuticals business with this antipyretic medicine Anti-aging product and later gout medicine Pain reliever containing the active ingredient acetylsalicylic acid Medicine to treat African sleeping sickness The first hormonal drug to treat menopause symptoms The first injectable renal contrast agent for X-ray images Chemotherapeutic drug to treat bacterial infections Globally successful malaria drug First European hormonal contraceptive First portable blood glucose meter Drug to treat coronary heart disease Antibiotic to treat bacterial infections Contrast agent for magnetic resonance imaging Medicine to treat severe infectious diseases in livestock and companion animals New therapy principle for diabetics Drug for the specific treatment of chronic lymphocytic leukemia (CLL) Blood glucose meter
1994 Aspirin Protect/ Cardio 1996 Advantage 1997 Mirena 1999 Avalox/ Avelox 2000 Yasmin 2003 Levitra 2003 Advantix
For prevention of a second myocardial infarction or stroke Long-acting flea control product for dogs and cats Novel hormonal intrauterine contraceptive system Respiratory tract antibiotic
1923 Germanin 1928 Progynon 1930 Uroselectan 1935 Prontosil 1950 Resochin 1961 Anovlar 1969 Ames Reflectance Meter 1975 Adalat 1987 Ciprobay 1987 Magnevist 1987 Baytril 1990 Glucobay 1991 Fludara
The first oral contraceptive based on the novel gestagen drospirenone Erectile dysfunction medicine Flea, tick and mosquito control product for dogs
2004 Animal health product to combat Advocate/ internal and external parasites Advantage Multi in dogs and cats 2005 Nexavar Marketing authorization granted for treatment of advanced kidney cancer
in 1961, Anovlar became the first hormonal contraceptive on the market in europe.
2005 Deworming agent for cats Profender Cat 2007 Nexavar 2008 Xarelto 2008 Qlaira 2008 Renalzin 2008 Intego 2009 Contour USB 2009 Baycox Sheep Marketing authorization granted for treatment of liver cancer Prevention of venous thrombosis after elective knee or hip replacement surgery First oral contraceptive based on estradiol, the same estrogen as is produced by the female body Dietary supplement to support kidney function in cats with chronic kidney failure First automated PET (positron emission tomography) infusion system in the U.S. First blood glucose meter with integrated software Drug to control coccidiosis, a parasitic infectious disease, in lambs
The winners of the German innovation Prize: Bayer researchers Dr. elisabeth Perzborn (left), Dr. frank Misselwitz (2nd right) and Dr. Dagmar Kubitza (right) with the then German federal President Horst Khler.
The first recombinant Bayer drug product to treat hemophilia The first multiple sclerosis drug to be registered in the United States
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BHC i n dialogue
Contacts:
BaYer HeaLTHCare Dr. Markus Pickel markus.pickel@bayer.com aNiMaL HeaLTH DivisiON Astrid Khler astrid.koehler@bayer.com PHarMaCeuTiCaLs DivisiON Oliver Renner oliver.renner@bayer.com CONsuMer Care DivisiON Tricia McKernan tricia.mckernan@bayer.com
MeDiCaL Care DivisiON Meredith Fischer meredith.fischer@bayer.com CONsuMer HeaLTH eurOPe Helmut Schfers helmut.schaefers@bayer.com
imp ri nt
Published by: Bayer HealthCare AG Communications Dr. Markus Pickel 51368 Leverkusen Germany English version: Language Service, Currenta GmbH & Co. OHG, Germany Edited by: Christina Sehnert christina.sehnert@bayer.com Brbel Doormann baerbel.doormann@bayer.com
fOrWarD-LOOKiNG sTaTeMeNTs This brochure may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayers public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Product names are mostly registered trademarks. All trademarks are printed in italics.
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