Biotherapies for Life TM

Transcription

1 Biotherapies for Life TM

2 Paul Perreault Chief Executive Officer and Managing Director, CSL Limited

3 MESSAGE FROM THE CEO

4 BIOTHERAPIES FOR LIFE CSL Behring is a global leader in the therapeutic protein industry. Committed to saving and improving the lives of people with rare and serious medical disorders, we research, develop, manufacture and market plasma-derived and recombinant biotherapies. Our biotherapies replace components missing in the blood of patients and are used around the world to treat coagulation disorders such as hemophilia and von Willebrand disease (VWD), primary immune deficiencies, hereditary angioedema and inherited respiratory disease, as well as neurological disorders in certain markets. We also manufacture products used in cardiac surgery, organ transplantation, and burn treatment, and to treat acquired bleeding, reverse the effects of warfarin, and prevent hemolytic disease of the newborn. U N I Q U E P R O D U C T S Our therapies differ from conventional, chemical-derived products in many ways. Most important, they are derived from human plasma, or produced as its recombinant equivalent. Our plasmaderived products undergo rigorous safety controls and are monitored throughout every step of the manufacturing process, from the collection of plasma to the final packaging and shipping of the finished product. We, and the patients we treat, are grateful to the many dedicated plasma donors who make these products possible. At CSL Behring we are committed to the people who rely on our products. We always remember that our therapies are essential to the health and well-being of every patient. Each of us brings that sense of purpose to work every day. Our Core Values customer focus, innovation, integrity, collaboration and superior performance underscore our purpose and our commitment to provide the best possible therapies and services. Customer Focus Patients come first in all we do. We are passionate about listening to and addressing the needs of people with life-threatening disorders and the professionals who serve them. We conduct and fund medical research, sponsor and support patient programs, improve and expand educational programs, and advocate with governmental authorities for patient access to care. Our patient-support initiatives and efforts to improve access to care would not be possible without the involvement of dedicated physicians, healthcare professionals and patient advocacy groups. Collectively, we facilitate awareness and are a powerful force for increasing access to treatment therapies. Innovation At CSL Behring, we continually leverage our medical and scientific expertise to develop new therapies, create new applications and innovative enhancements for our products, and identify underserved patient populations. We invest in emerging technologies to develop new products 2

5 and improve existing therapies, and we continually explore ways to expand and enhance the programs and services we offer. While many pharmaceutical companies have cut back or slowed the growth of their R&D spending, we continue to increase our investment, growing the R&D project portfolio and enhancing and expanding global capabilities where they can add the most value. CSL Behring has more than 1,000 R&D employees who work in global teams to maximize individual expertise while leveraging core capabilities at each site. We strive to ensure our manufacturing processes and facilities are state-of-theart and can meet a growing demand for immunoglobulin, albumin and other products. We also supply products to treat diseases for which there are no other available therapies. Our facilities combine highly effective virus inactivation processes, advanced industrial-scale filtration technology and advanced formulation to generate our innovative plasma-derived and recombinant therapies. Our innovative spirit also drives the many programs and services we offer patients with rare diseases. Integrity We are ethical and honest at all times. Our governance structure, employee training and a core sense of ethics ensures that we manage and operate our business as transparently as possible. Collaboration We work with patient groups, plasma donors, researchers, physicians, nurses, pharmacists and home healthcare companies to achieve better results. This includes promoting quality care, improving patient access to care, expanding educational and outreach efforts, and affecting public healthcare policy. Superior Performance CSL Behring is one of the largest and fastest growing plasma-protein therapeutics businesses in the world, in large part because we strive to be the best at what we do. Because our patients rely on us, we are driven to achieve exceptional, innovative results that have been recognized with awards by patient organizations such as the European Organization for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD). The Swiss government has recognized CSL Behring for exceptional innovations in state-of-the-art manufacturing in our Bern facility, and for novel protein therapies, with the Tell Award. Our consistently superior performance is driven by our ability to attract and retain talented individuals who have a passion for meeting the needs of people with rare and serious diseases. S A F E, E F F E C T I V E T H E R A P I E S The safety, quality and availability of our therapies are of the highest importance. Our products are manufactured at facilities in Bern, Switzerland; Marburg, Germany; Kankakee, United States; and Broadmeadows, Australia. Worldwide production mandates that our plasmaderived and recombinant therapies conform to rigorous international safety and quality standards. L E G A C Y O F I N N O V A T I O N CSL Behring and our parent company, CSL Limited, continue to build on a long legacy of innovation in patient care. CSL Behring traces its beginnings to the 1904 founding of Behringwerke in Marburg, Germany, a company established by Emil von Behring, the first recipient of the Nobel Prize in Physiology and Medicine. Dr. von Behring founded Behringwerke to produce sera and vaccines to combat infectious diseases. In 1916 our parent company, CSL Limited, was founded to supply biological medicines to the people of Australia. Later in the 20th century, leading companies came together to form CSL Behring. For more than 60 years, we have specialized in providing plasma therapies to improve the quality of life for people with rare and serious diseases worldwide. C O R P O R A T E R E S P O N S I B I L I T Y Ethical and responsible conduct is the foundation of a sustainable company and it defines who we are. At CSL Behring we live by the CSL Code of Responsible Business Practice. It sets the bar for the standard of behavior expected of all employees, and makes it clear what stakeholders, from patients to investors, can expect in their dealings with us; our relationships are built on trust and transparency. The CSL Corporate Responsibility Report is available at S T R O N G L E A D E R S H I P CSL Behring s management team is made up of exceptional professionals who are internationally recognized in the biotherapeutics industry. They are leaders with collective expertise acquired across the globe that well qualifies them for the privilege of serving people with rare and serious diseases.

6 THERAPIES WE PROVIDE CSL Behring s expertise and thorough understanding of bleeding disorders and coagulation factor replacement therapy have been honed over decades of focused commitment to the therapeutic category. B L E E D I N G D I S O R D E R S CSL Behring offers more than a dozen therapies to treat bleeding disorders. These include recombinant factor VIII and plasma- derived factors VIII that are used to treat hemophilia A, as well as two plasma-derived factor VIII/VWF concentrates for the treatment (and also prophylaxis in Europe) of bleeding in VWD. In some countries one of our FVIII/VWF products is also licensed for treatment of patients with antibodies against factor VIII. Our factor IX products are used for the prevention and control of bleeding in patients with hemophilia B. CSL Behring produces factor X for treating patients with factor X deficiency. With an incidence of one in million people, factor X deficiency is an especially rare disease. CSL Behring also offers factor XIII for treating individuals with factor XIII deficiency, and fibrinogen for treating congenital deficiency. Our site in Marburg developed, patented and introduced a special method for the pasteurization of plasma products to increase their virus safety. We made history in 1981 with the first pasteurized factor VIII product in the world, introducing technology to ensure our products are safe and effective. I M M U N O G L O B U L I N S Immunoglobulins (Ig) are antibodies or specific proteins of the immune system, key components in keeping us healthy. Through our global Ig franchise, CSL Behring offers one of the most comprehensive portfolios of safe, high-quality, technically advanced Ig products. We design products for patient convenience, choice and ease of administration. Our products are designed to be administered intravenously (IVIg) or subcutaneously (SCIg) to treat primary immunodeficiency diseases, secondary immunology disorders and neurological conditions, and intravenously for the treatment of idiopathic thrombocytopenic purpura. Our hyperimmune immunoglobulins are administered to treat infections such as tetanus, rabies or hepatitis B. In 1979, CSL Behring predecessor companies introduced the world s first native (intact or non-modified) immunoglobulin product for intravenous infusion. 4

7 P U L M O N A R Y Alpha-1 Antitrypsin Deficiency (AATD), commonly called Alpha-1, is a disorder caused by low levels of the protein alpha-1 antitrypsin. This protein is made in the liver and protects the lungs from damage caused by infection and inhaled irritants such as smoke. People with Alpha-1 have very low levels of alpha-1 antitrypsin, meaning their lungs do not have the same protection as people without the disorder. CSL Behring s alpha-1 proteinase inhibitor product increases the levels of alpha-1 antitrypsin protein in patients with alpha-1-related emphysema. C R I T I C A L C A R E CSL Behring s critical care products are used to treat life-threatening conditions including hereditary angioedema, shock, burns or fluid loss. Factor concentrates control bleeding and are used for management of perioperative bleeding complications and emergency bleeding. Prothrombin complex concentrate restores specific coagulation factors that are missing or depleted. Fibrinogen concentrates replace a major protein involved in clot formation and help control bleeding. Albumin is used to support blood volume and blood pressure in the treatment of shock or sepsis and to replace blood proteins lost from severe burns. It is also used during cardiac surgery, to augment fluid replacement therapy, and to treat certain liver disorders. CSL Behring s surgical hemostatics include fibrin agents containing certain plasma-derived coagulation factors: fibrinogen and thrombin and the anti-fibrinolytic agent, aprotinin. Surgical hemostatics are used to speed up healing during surgery and to control bleeding. Our surgical hemostatics are used during a wide range of surgical procedures. R E C O M B I N A N T F A C T O R T H E R A P I E S CSL Behring s expertise and thorough understanding of bleeding disorders and coagulation factor replacement therapy have been honed over decades of focused commitment to the therapeutic category. We have developed therapeutic approaches for a broad range of coagulation disorders, including hemophilia. Because of our insights into the issues surrounding bleeding disorders, we can be counted on to provide innovative thinking and improved methods for the therapeutic management of these conditions. We continue to develop therapeutic solutions through innovative recombinant technologies, including albumin fusion to extend the half-life of coagulation factors. Our commitment to improving quality of life for hemophilia patients is also reflected in our investment in stateof-the-art manufacturing facilities for the production of recombinant fusion albumin proteins.

8 INNOVATION AND EXPANSION We leverage our medical knowledge and scientific expertise in researching promising drug compounds and developing new products to treat rare and serious disorders. This is vital to the patients we serve and to our business. Our integrated global research and development organization is driven by an experienced team of talented scientists who work collaboratively at worldwide locations. I N V E S T M E N T I N R & D CSL Behring and the collective group of CSL companies have a heritage of outstanding contributions to medicine and human health that spans more than a century. These contributions have been possible because we continually grow our investment in R&D, making balanced investments in life cycle management and market development of existing products. We also make strategic investments in longer term, new product development activities in areas aligned with our core capabilities and commercial strengths. The company advocates with other stakeholders for public policies that foster innovation and the development and licensing of new therapies. G R O W I N G O U R I N F R A S T R U C T U R E Maintaining state-of-the-art facilities that support research and development, efficient plasma collection and production of high-quality products is critical to delivering novel plasma-derived products to patients. For our recombinant developments, our new world-class cell culture facility in G L O B A L R & D S I T E M A P Marburg Germany CSL Behring R&D, Manufacturing Bern Switzerland CSL Behring R&D, Manufacturing Tokyo Japan CSL Behring R&D Melbourne Australia Parkville CSL Limited Group HQ, R&D biocsl R&D, Manufacturing Broadmeadows CSL Behring R&D, Manufacturing 6

9 Melbourne, Australia and recombinant purification facility in Marburg, Germany will add to the supply chain for material to enable Phase I, II and III clinical trials, and play a key role in developing recombinant products for cancer and bleeding disorders, along with other new therapies progressing through our product pipeline. We have expanded our manufacturing capacity to keep pace with the growing demand for immunoglobulin and albumin, including construction of new facilities at our Broadmeadows, Australia and Kankakee, United States sites. We are committed to ensuring the continued availability of these important products. CSL Behring operates one of the world s largest plasma collection networks in the world through its subsidiary, CSL Plasma. New collection centers are continually being opened to meet the demand for plasma. Information about the innovations in CSL Behring s product pipeline can be viewed at research-development. Learn about CSL Behring clinical trials at C S L R & D I N V E S T M E N T G R O W T H In millions of U.S. dollars $278 $226 $203 $323 $368 New Product Development activities focus on innovative new therapies for life-threatening diseases. Market Development Strategies seek to bring therapies to new markets and new indications Life Cycle Management ensures continuous improvement of existing products. King of Prussia U.S. CSL Behring Corporate HQ, R&D Kankakee U.S. CSL Behring R&D, Manufacturing

10 COMMITMENT TO PATIENTS People with rare diseases are our community. MIGUEL ANGEL GUTIÉRREZ Patient Miguel Angel Gutiérrez family realized he had hemophilia A when he was a child. Growing up with this disorder caused hardships for Miguel, such as being overly cautious during playtime and frequently missing school. Today, when he experiences a bleeding episode, he administers a therapy that replaces the missing factor VIII in his blood, helping it to clot. Miguel is a swimming coach at the Municipal Institute of Physical Culture and Sport of Nicolas Romero. He also works with the Mexican Hemophilia Federation where he participated in the 2012 Caribbean Challenge, training patients with hemophilia to swim three kilometers in the open sea. By effectively managing my condition, I can lead a healthy and normal life, Miguel said. Living with hemophilia has helped me to develop a determination that doesn t let me give up on any obstacles. LYNNE SZOTT Mother of two children with PI and CSL Behring employee Lynne Szott is the mother of two children with primary immunodeficiency (PI). When her second-born was 20 months, he experienced a severe upper respiratory infection. After seeing multiple physicians, her son took a turn for the worse and had to be airlifted to a medical center 200 miles from home. An immunologist in the ICU diagnosed him with PI. After her youngest child was also diagnosed with PI, Lynne switched careers and earned a nursing degree, then worked in case management for children with special healthcare needs. She was also active in the PI community and established a local chapter of a national patient organization. Today, Lynne works for CSL Behring as a national reimbursement manager. This original work of art called FingerSmears was created by patients under the guidance of Kelli Sullivan, an artist from the San Francisco Bay Area, during a National Hemophilia Foundation meeting. The participants used dabs of paint to fill in the outline of the painting. This creative endeavor is symbolic of the caring and collaborative dynamic between CSL Behring and the patients who use our therapies, and who benefit from the programs and services we offer. 8

11 terrible lack of knowledge about bleeding disorders, Wilhelm s father noted. Today, Wilhelm says, I want to carry on living a normal active life. He seems to be doing just that. After five seasons playing football in the Finnish National League, Wilhelm now plays football in Sweden. JUTTA KOHAUT and KARIN WEIDE Patients Twin sisters Jutta Kohaut and Karin Weide were born with Hereditary Angioedema (HAE). This inherited condition is potentially life-threatening, and consists of substantial and painful swelling in specific areas of the body. HAE symptoms are similar to those associated with other conditions, making HAE difficult to diagnose. The disease was first identified in Karin at age 18. In the beginning, doctors tested me for rheumatism, because my joints were swollen, although the cause of the swellings was HAE, Karin reported. It didn t take long before HAE was identified in me, too, Jutta added. More than two decades after they first began treating HAE with C1-Esterase Inhibitor, Jutta and Karin can now selfadminister their therapy when they experience symptoms of an attack. When not running their party service/catering company, Karin and Jutta frequently garden and jog. WILHELM INGVES Patient Being born with a bleeding disorder doesn t stop Wilhelm Ingves. This native Finlandian has Type 3 von Willebrand disease, the most severe form of this hereditary bleeding disorder. Having him diagnosed at eight months, and meeting other parents of children with bleeding disorders, Wilhelm s family learned several of those families endured similar false accusations of child abuse. On the one hand this showed an important alertness to the signs of child abuse, but on the other, a THE NIXON FAMILY Patients and their parents All three children in the Nixon family were born with the same rare medical condition. Benjamin, Hannah and Daniel have primary immunodeficiency, a disorder that makes it extremely difficult to fight off germs and infections and often causes the siblings to become ill, impacting their everyday lives. Finding the right therapy has made a huge difference in our family s lifestyle, says their father Eric. Our daughter and sons no longer have to miss as much school, vacations or social activities.

12 COMMITMENT TO PATIENTS We offer therapies that meet the needs of patients because we listen to them and understand what they want. We also believe that our role extends beyond just developing and manufacturing therapies for rare and serious diseases. CSL Behring offers comprehensive support for patients and their families. This includes innovative programs and services to help families better manage the daily challenges of living with a chronic disorder. In addition, we work with government authorities to ensure patients have access to care, while also funding medical research. P A T I E N T S U P P O R T CSL Behring s Gettin in the Game SM Junior National Championship is a patient support program in the U.S. that encourages and teaches young people with bleeding disorders to take part in healthy athletic activities. We also developed the My Steps for Healthy Living program to help patients with alpha-1 antitrypsin deficiency walk their way toward a healthier lifestyle. These are just two of the many programs we have in place to support patients. A C C E S S T O C A R E Even the most innovative therapies are meaningless if people are not able to obtain them. CSL Behring offers a broad range of programs and services to assist patients and physicians with reimbursement support and ways to ensure access to their therapies. We partner with patient associations to advocate for legislation that protects patient and physician choice of therapy, appropriate standards of care, appropriate reimbursement and other topics that impact the rare disease communities we serve. CSL Behring also works to promote availability and access to safe and effective plasma protein therapeutics for all patients, and we are developing a system that would allow for simultaneous new drug submissions in Europe, Japan and the United States. A D V O C A C Y D E V E L O P M E N T CSL Behring has a long history of working closely with patient organizations to develop programs in awareness, diagnosis, testing, education, advocacy, research and more. We believe that successful advocacy results from the empowerment of those who are impacted by a particular issue. We partner with patient advocacy organizations across Europe and the U.S. to promote improved awareness and diagnosis, quality medical care and services, and to improve and expand educational and outreach efforts. The advocacy initiatives we support in Europe include Policy Forum events on key issues faced by the European primary immune deficiency community, sponsored by the International Patient Organization for Primary Immunodeficiencies. We also support the European Haemophilia Consortium s Stakeholder Round Tables on key issues faced by the hemophilia community, and the European Platform for Patient Organizations, Science and Industry and the European Patients Forum. Our Local Empowerment for Advocacy Development (LEAD) program assists local patient organizations in the U.S. in developing their advocacy capabilities through the LEAD grant and Raise Your Voice! initiatives. 10

13 COMMITMENT TO SAFETY AND QUALITY CSL Behring s steadfast commitment to product safety is driven by an integrated system of safety that spans four critical areas of the company s operations: plasma selection, product manufacturing, monitoring and testing, and pharmacovigilance. I N T E G R A T E D S A F E T Y S Y S T E M Donor Selection The company monitors every step involved in the plasma collection process from rigorous on-site donor selection and donation screening, through freezing to transporting plasma units that have tested non-reactive in virus screening assays to the manufacturing sites. We meet very stringent international standards for plasma product purity, safety and quality in accordance with regulatory agencies worldwide. CSL Behring applies effective and robust pathogen inactivation and removal processes, including pasteurization and virus filtration, resulting in final products with a high margin of safety. CSL personnel are rigorously trained to ensure strict adherence to demanding regulations and to the company s own quality standards. Multiple methodologies are applied to evaluate the safety and quality of all our products throughout the manufacturing and formulation processes. All processes are thoroughly validated to demonstrate that consistently high-quality products are delivered. Quality Assurance personnel monitor each step of the manufacturing process to assure that the finished product meets all quality attributes. Final products are released to the market only when they meet all pre-defined specifications based on a thorough batch record review. Post-marketing surveillance and reporting for marketed products is conducted on an ongoing basis so that CSL maintains visibility over the safety and efficacy of our products after they enter the market. Pasteurized plasma derivatives produced according to Good Manufacturing Practice have not had a confirmed case of virus transmission in over 30 years. T O L E A R N M O R E To learn more about how CSL Behring builds quality and safety into our therapies from start to finish, visit Plasma Testing Protein Purification Virus Inactivation/ Removal and Prion Removal Batch Release Pharmacovigilance P R O D U C T S A F E T Y

14 HISTORY OF INNOVATIVE FIRSTS 1954 Europe s first human plasma fractionation Behringwerke, CSL Behring s predecessor company, is the first in Europe to begin fractionating plasma proteins from human plasma on an industrial scale. First pasteurized plasma protein solution ZLB, another CSL Behring predecessor company, produces the first pasteurized plasma protein solution Researchers discover Alpha-1 Alpha-1 antitrypsin, a proteinase inhibitor, is discovered, purified and characterized for the first time by researchers of Behringwerke Japan s first IVIg Behringwerke launches Gamma-Venin, the first intravenous immune globulin (IVIg) product in Japan Launch of first non-modified IVIg ZLB and Sandoz AG, Switzerland, launch Sandoglobulin, the world s first native (intact or non-modified) immunoglobulin product for intravenous infusion First pasteurized factor VIII therapy launched Behringwerke introduces Haemate human plasma coagulation factor VIII/von Willebrand factor complex, first marketed in Europe for the treatment of patients with hemophilia A. It is the first pasteurized factor VIII product in the world First intravenous immunoglobulin approved in U.S. ZLB receives approval for polyvalent immunoglobulin the first intravenous immunoglobulin product to be approved in the U.S Mononine approved in U.S. FDA approves Mononine, a monoclonal antibody purified Factor IX product for treatment of hemophilia B. Mononine, the first highly purified FIX in the U.S. market, is still the gold standard Launch of first virus-filtered liquid anti-d immunoglobulin Rhophylac, the first virus-filtered liquid anti-d immunoglobulin for the prevention of hemolytic diseases of the newborn due to Rh factor incompatibility, launched in Switzerland First von Willebrand factor in U.S. FDA approves Humate-P human coagulation factor VIII/von Willebrand factor complex for treatment of von Willebrand disease, the most common hereditary bleeding disorder New formulation of recombinant Factor VIII Helixate FS/Helixate NexGen recombinant coagulation factor VIII, formulated with sucrose for the treatment of hemophilia A, is approved by the FDA for use in U.S. and by the EMA for use in 15 countries First virus-filtered human normal immunoglobulin for intravenous (IV) administration Carimune NF approved for marketing in the U.S Vivaglobin, first FDA-approved subcutaneous immunoglobulin treatment Vivaglobin licensed for use in adults and children who require antibody replacement due to primary immunodeficiency in the U.S and U.K First proline-stabilized intravenous immunoglobulin (IVIg) approved Privigen approved in U.S. for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura Berinert, first therapy for acute attacks of HAE in U.S. FDA grants marketing approval for CSL Behring s Berinert C1- esterase inhibitor, the country s first therapy for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) Hizentra, first and only 20 percent SCIg, approved by FDA and EMA FDA and EMA grant marketing approval for Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg). Stabilized with L-proline, Hizentra is ready to use; it requires no refrigeration throughout its 30-month shelf-life, offering patients and physicians convenience and portability FDA approves Corifact, first and only FXIII concentrate approved in U.S. FDA grants marketing approval for Corifact for the treatment of congenital factor XIII (FXIII) deficiency. Congenital FXIII deficiency is a rare and potentially life-threatening bleeding disorder. Corifact is also available in 12 countries under the trade name Fibrogammin Kcentra approved in U.S. FDA approves first non-activated 4-factor prothrombin complex concentrate (PCC) in the U.S. for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy. 12

15 O U R V A L U E S Customer Focus We are passionate about meeting the needs of our customers Innovation We seek better ways of doing things Integrity We are ethical and honest at all times Collaboration We work together to achieve better results Superior Performance We strive to be the best at what we do

16 GLOBAL PRODUCT PORTFOLIO * THERAPY PRODUCT NAME NON- PROPRIETARY NAME PRODUCT DESCRIPTION Coagulation Helixate FS, Helixate NexGen Recombinant coagulation factor VIII Freeze-dried recombinant factor VIII RiaSTAP Human coagulation factor I Freeze-dried factor I concentrate Monoclate P Human coagulation factor VIII Freeze-dried monoclonal antibody purified factor VIII concentrate Beriate Human coagulation factor VIII Freeze-dried factor VIII concentrate Humate P, Haemate P Human coagulation factor VIII / Freeze-dried factor VIII: C and von Willebrand von Willebrand factor complex factor concentrate Stimate Desmopressin Synthetic desmopressin acetate nasal spray Mononine Human coagulation factor IX Freeze-dried monoclonal antibody purified factor IX concentrate Berinin P Human coagulation factor IX Freeze-dried factor IX concentrate Factor X P Behring Human coagulation factor IX and X Freeze-dried factor IX and factor X concentrate Fibrogammin P, Corifact Human coagulation factor XIII Freeze-dried factor XIII concentrate Octostim Desmopressin Synthetic desmopressin acetate nasal spray Critical Care Beriplex P/N, Kcentra Human prothrombin complex Freeze-dried prothrombin complex concentrate Haemocomplettan P, RiaSTAP Human fibrinogen Freeze-dried fibrinogen (factor I) concentrate Kybernin P Human antithrombin III concentrate Freeze-dried antithrombin III concentrate AlbuRx, Alburex, Human Human albumin solution 5%, 20% or 25% human albumin solutions Albumin Behring, Albuminar 25 Berinert Human C 1 -esterase inhibitor Freeze-dried C 1 -esterase inhibitor concentrate Streptase Streptokinase Freeze-dried streptokinase Immunology Hizentra Human normal immunoglobulin Liquid 20% immunoglobulin solution, ready-touse for SC administration Privigen Human polyvalent immunoglobulin Liquid 10% solution for IV injection Carimune NF, Sandoglobulin, Human normal immunoglobulin Freeze-dried immunoglobulin formulations for Sanglopor IV administration Rhophylac Human anti-d immunoglobulin Prefilled syringes of highly purified anti-rhesus factor D IgG for IV administration and IM injection Cytogam Human cytomegalovirus Liquid immunoglobulin containing a standardimmunoglobulin ized amount of antibody to cytomegalovirus Berirab P Human rabies immunoglobulin Liquid 16% solution for IM injection Beriglobin P Human hepatitis A immunoglobulin Liquid 16% solution for IM injection Hepatitis B Immunoglobulin Human hepatitis B immunoglobulin Liquid 16% solution for IM injection P Behring Tetagam P Human tetanus immunoglobulin Liquid 16% solution for IM injection Varicellon P Human varicella immunoglobulin Liquid 16% solution for IM injection Pulmonology Zemaira Human Alpha 1 -proteinase inhibitor Freeze-dried Alpha 1 -proteinase inhibitor (A 1 -PI) Wound Beriplast P Combi-Set Fibrin sealant kit Freeze-dried fibrin sealant for topical application Healing Fibrogammin P Human coagulation factor XIII Freeze-dried factor XIII concentrate TachoComb Fibrin sealant fleece-type Fleece-type collagen preparations coated with fibrin glue components *Product availability varies from country to country, depending on registration status. Please contact your CSL Behring representative. CSL Behring is a company of CSL Limited. August 2013

17 CSL BEHRING AT A GLANCE Marburg CSL Behring is a global leader in the plasma-protein biotherapeutics industry, providing life-saving treatments that include recombinant biotherapies for a range of rare and serious medical disorders. CSL Behring also operates one of the world s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. E M P L O Y E E S 10,500+ employees in 30 countries H E A D Q U A R T E R S King of Prussia, Pennsylvania, United States 400+ employees M A N U F A C T U R I N G F A C I L I T I E S Marburg, Germany 2,000+ employees Core products: coagulation factors, critical care products and immunoglobulins Bern, Switzerland 1,100+ employees Core product: immunoglobulins Kankakee, Illinois, United States 900+ employees Core products: coagulation factors, Alpha-1 proteinase inhibitor, albumin Broadmeadows, Australia 650+ employees Core products: immunoglobulin, critical care therapies, coagulation factors, toll manufacturing Significant capital investments have made our facilities among the most modern in the industry. R E S E A R C H A N D D E V E L O P M E N T CSL integrated research and development includes facilities in Marburg, Germany; Bern, Switzerland; Kankakee, Illinois, United States; King of Prussia, Pennsylvania, United States; Tokyo, Japan; and Broadmeadows and Parkville, Australia. C S L P L A S M A Headquartered in Boca Raton, Florida, United States Testing laboratories in Knoxville, Tennessee, United States; and Göttingen, Germany Plasma logistics centers in Indianapolis, Indiana and Mesquite, Texas, United States 80+ collection centers in the United States and eight in Germany 5,000+ employees Product availability and approved indications vary from country to country, depending on registration status. Please contact your CSL Behring representative for details. Bern Kankakee Broadmeadows CSL PLasma CSL Behring is a company of CSL Limited. August 2013

18 CSL BEHRING LOCATIONS WORLDWIDE Argentina CSL Behring SA Fray Justo Sarmiento 2350 B1636AKJ Olivos Buenos Aires Argentina Phone: Fax: /9578 Asia Region CSL Behring Asia Pacific Ltd Units , AIA Tower, 183 Electric Road, North Point Hong Kong Phone: Fax: Austria CSL Behring GmbH Altmannsdorfer Strasse 104 A-1120 Wien Austria Phone: Fax: Belgium / Luxemburg CSL Behring NV Technologielaan 13 B-3001 Leuven Belgium Phone: Fax: Brazil CSL Behring Brazil Ltda R. Olimpiadas 134 9th floor, Vila Olimpia São Paulo SP Brazil Phone: Fax: Canada CSL Behring Canada Inc 55 Metcalfe Street, Suite 1460 Ottawa, Ontario K1P 6L5 Canada Phone: Fax: China CSL Biotherapies (Shanghai) Consulting Limited Room 2101, The Center 989 Changle Road Shanghai , P.R. China Phone: Fax: Czech Republic CSL Behring s.r.o. BB Centrum, budova Alpha Vyskocilova 2a/1461 Praha 4, Czech Republic Phone: Denmark CSL Behring ApS Lyngby Hovedgade 70A, 1 DK-2800 Kgs. Lyngby Denmark Phone: Fax: France CSL Behring SA 30 rue Cambronne Paris France Phone: Fax: Germany CSL Behring GmbH Philipp-Reis-Strasse Hattersheim am Main Germany Phone: Fax: Greece CSL Behring MEPE 5 Hatziyianni Mexi Str Athens Greece Phone: , 1 Fax: Hungary CSL Behring Kft. Alkotás u.53. MOM Park, D. épület 4. emelet 1123 Budapest, Hungary Phone Fax Italy CSL Behring SpA Viale del Ghisallo n.20 I Milano Italy Phone: Fax: Japan CSL Behring KK KDX Toyosu Grandsquare Shinonome, Koto-ku Tokyo Japan Phone: Fax: Mexico CSL Behring SA de CV Torre Esmeralda II Blvd. Manuel Avila Camacho #36 Piso 14 Lomas de Chapultepac C.P México D.F. México Phone: Fax: Netherlands Bijster HX Breda Nederland Phone: +31 (0) Fax: +31 (0) Nordic Region P.O. Box 712 Berga Backe Danderyd Sweden Phone: Fax: Poland CSL Behring sp. Z o.o. ul. A. Branickiego Warszawa Poland Portugal CSL Behring Ltda Av.ª 5 de Outubro 198-3º Esqº Lisboa Portugal Phone: Fax: Spain CSL Behring, S.A. Av. dels Països Catalans, 34 3 a planta Esplugues de Llobregat Spain Phone: Fax: Switzerland CSL Behring AG Wankdorfstrasse 10 CH-3014 Bern Switzerland Phone: Fax: United Kingdom CSL Behring UK Ltd Market Place, Hayworth House Haywards Heath West Sussex RH16 1DB United Kingdom Phone: +44(0) Fax: +44(0) United States Corporate Headquarters CSL Behring LLC 1020 First Avenue P.O. Box King of Prussia, PA USA Phone: Fax: Manufacturing Sites CSL Behring (Australia) Pty Ltd Camp Road Broadmeadows Vic 3047 Australia Phone: Fax: CSL Behring GmbH Emil-von-Behring-Strasse Marburg Germany Phone: Fax: CSL Behring AG Wankdorfstrasse 10 CH-3014 Bern Switzerland Phone: Fax: CSL Behring LLC P.O. Box 511 Kankakee, IL USA Phone: Fax: Plasma Services CSL Plasma 900 Broken Sound Parkway Suite 400 Boca Raton, FL USA Phone: Fax: CSL Plasma Services GmbH Emil-von-Behring-Strasse Marburg Germany Phone: Fax: CSL Limited CSL Limited 45 Poplar Road Parkville, Victoria 3052 Australia Phone: Fax: First Avenue, P.O. Box 61501, King of Prussia, PA USA 2013 CSL Behring LLC 13GLOBCORPBRO