Hansa Biopharma (HNSA) Økonomisk Ugebrev Life Science Conference presentation summary

Strategic highlights

• Achieved conditional EU approval for Idefirix® (imlifidase) in highly sensitized kidney transplant patients, with market access secured in nine European countries and ongoing procedures in eight more.

• Expanded commercialization through partnerships, including Medison Pharma for Central Eastern Europe and Israel, and collaborations with Sarepta and AskBio for gene therapy pre-treatment.

• Built a high-performance organization, tripling headcount in three years to 145 employees, and established a purpose-driven culture.

• Diversified shareholder base with ~40% foreign ownership and a market capitalization of ~$300m.

• Secured SEK ~70m in non-dilutive financing, extending cash runway through 2024.

Product and pipeline development

• Idefirix® is the first and only approved desensitization treatment for highly sensitized kidney transplant patients in Europe, targeting those unlikely to be transplanted under current allocation systems.

• Broad clinical pipeline includes programs in US kidney transplantation, anti-GBM disease, Guillain-Barré syndrome, AMR, and gene therapy pre-treatment.

• Ongoing pivotal US Confides study for highly sensitized kidney patients, with BLA submission targeted for 2024.

• Phase 2 AMR study completed enrollment, with first data readout expected in H2 2022.

• Exploring new indications in oncology, autoimmune diseases, and gene therapy, leveraging proprietary antibody-cleaving enzyme technology.

Financial performance

• Q3 2022 revenue reached SEK 67m, including SEK 23m in product sales.

• Net loss for Q3 2022 was SEK -136m, with cash and short-term investments at SEK 1.2bn at quarter end.

• Revenue for the first nine months of 2022 totaled SEK 124m, with product sales of SEK 55m.

• Financial guidance assumes no persistent COVID-19 impact on clinical trial operations.