Presentation

Hansa Biopharma is a Swedish commercial-stage biopharmaceutical company with a proprietary IgG-cleaving enzyme technology platform for rare immunological conditions. The lead product Idefirix® (imlifidase) is a unique enzyme that specifically targets and cleaves all classes of IgG antibodies. Imlifidase has been granted conditional marketing authorisation by EMA for the desensitisation treatment of highly sensitised adult kidney transplant patients.

Recent highlights
Hansa Biopharma has solid sales growth in Q1 with SEK 24.2m in product sales and total revenue of SEK 30.3m. Commercial launch activities for Idefirix in EU continued to progress, with market access secured in France and Germany and ongoing efforts in 11 countries, including Spain, Italy and the UK. In addition, Hansa Biopharma announced marketing authorisation in Israel together with their partner Medison Pharma in March and temporary marketing authorisation in Switzerland in May. In June, NICE recommended use of Idefirix as desensitisation treatment for highly sensitised kidney transplant patients. The company also announced positive results of a Ph2 anti-GBM disease trial in March and FDA acceptance of IND for Ph3 shortly after. Lastly, the company recently announced first patient treated in the post-authorisation efficacy study of Idefirix in highly sensitised kidney transplant patients in July.

Outlook
The company aims to initiate the Ph3 study in patients with anti-GBM, complete patient enrolment of the pivotal trial in the US for kidney transplantation, read out Ph2 data of the antibody mediated kidney transplant rejection trial, and complete patient enrolment in the Ph2 Guillain Barré Syndrome trial in the second half of 2022.