Vienna, Austria – 9 April 2025 - CSL Behring Austria today announced that the first haemophilia B patient in Austria was treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at the Comprehensive Care Center of the University Hospital of Medicine Vienna.HEMGENIX® is the first one-time gene therapy approved in Europe for the treatment of adults with severe and moderately severe haemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1“It is a great opportunity for people with hemophilia B to live a symptom-free life for many years,” explains hematologist Univ.-Prof. Priv.-Doz. Dr Cihan Ay from the Medical University of Vienna, University Clinic for Internal Medicine I Clinical Department for Hematology and Hemostaseology."For the community of affected patients and their families, this represents an enormously significant milestone: the ability to treat hemophilia with gene therapy, and the fact that this option is now available in Austria, is something our community has been eagerly anticipating and hoping for over decades," says Thomas Schindl, MA, Chairman of the Austrian Hemophilia Society (ÖHG)."We are proud and grateful to offer haemophilia B patients in Austria a treatment option that has the potential to transform their lives," said Dr Beate Natmessnig, Managing Director of CSL Behring Austria. "This achievement is the result of outstanding regional and national collaboration among all parties involved and is a strong testament to Austria's innovative capabilities."HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022

Marburg, Germany, 2 April 2025 – CSL Behring and the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) have successfully concluded negotiations on the reimbursement price of HEMGENIX®. This agreement marks the availability of the first gene therapy approved in Europe for haemophilia B under an innovative, national, success-based reimbursement model, being implemented for the first time in Germany.HEMGENIX® represents significant progress in the treatment of haemophilia B. The aim of this one-time gene therapy is to eliminate the need for regular factor IX infusions, thereby offering patients the possibility of more freedom from prophylaxis and significantly improving their quality of life.1-4 This development not only provides substantial relief for those affected but also has the potential to reduce long-term costs for the healthcare system.‘The performance-based payment model at national level which was agreed with the GKV-Spitzenverband is unique in Germany. It addresses key reimbursement challenges, such as the question of long-term efficacy, which is inherent for any one-time therapy. Reimbursement is linked to treatment success of the individual patient,’ explains Stefan Neudoerfer, CSL Behring's chief negotiator in Germany.Moreover, this reimbursement model reflects the high therapeutic and innovative value of HEMGENIX® and sets new standards for integrating innovative gene therapies into the German healthcare system.‘The agreement on the reimbursement price of HEMGENIX® is a decisive step for the care of people with haemophilia B in Germany. It enables access to a groundbreaking therapy and recognises the long-term medical and economic benefits of gene therapy,’ explains Christian Wieszner, Managing Director of CSL Behring Germany.With this agreement, CSL Behring is underlining its commitment to innovative therapies that sustainably improve the lives of patients