Hansa Biopharma (HNSA) Ökonomisk Ugebrev presentation summary

Company overview and strategy

• Founded in 2007 in Lund, Sweden, with ~80 employees and operations in Sweden, US, and Europe.

• Market cap of SEK 11bn (~$1.25bn) as of September 2020; listed on Nasdaq OMX Stockholm.

• Focuses on immunomodulatory enzymes for rare IgG-mediated diseases, with a broad pipeline in transplantation and autoimmune diseases.

• Controls the full value chain from drug discovery to commercialization, aiming for multiple income streams including sales, milestones, and royalties.

Lead product and clinical development

• Imlifidase, an IgG antibody-cleaving enzyme, enables rapid inactivation of IgG and has been studied in five clinical trials for kidney transplantation.

• Conditional EU approval granted for Idefirix (imlifidase) in highly sensitized kidney transplant patients; US pivotal trial protocol submitted, with first patient dosing expected H1 2021.

• Pooled analysis from four Phase 2 trials showed successful transplantation in 46 highly sensitized patients, with 94% graft survival at six months.

• Additional indications in Phase 2 include anti-GBM disease, antibody-mediated rejection (AMR), and Guillain-Barré syndrome (GBS).

Market opportunity and commercialization

• Approximately 15,000 annual kidney transplants in EU5, with additional 2,000 in other European countries.

• Idefirix targets highly sensitized patients unlikely to be transplanted under current allocation systems.

• Launch strategy focuses on centers of excellence in Europe, expanding in waves to broader EU, ROW, and US markets post-BLA submission (2023).

• Early launch targets leading transplant clinics with experience in desensitization.