Hansa Biopharma Reports Third Quarter and Interim January - September 2024 Financial Results

Q3 2024 marks highest ever in-market quarterly sales performance and fourth consecutive quarter of strong sales performance

LUND, Sweden, Oct. 17, 2024 /PRNewswire/ -- Hansa Biopharma today announced its interim report for January-September and third quarter 2024 financial results.

Søren Tulstrup, President and CEO, Hansa Biopharma said, "The third quarter of 2024 marks the highest ever IDEFIRIX® sales performance to date, resulting in four consecutive quarters of strong sales performance. The launch of IDEFIRIX in Europe continues to advance with adoption in international organ allocation systems and an increase in new and repeat utilization in leading transplant clinics. Equally, we see strong momentum in our clinical development programs in autoimmune, gene therapy and transplantation. Enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM has reached 86%. In the Post Authorization Efficacy and Safety (PAES) study in kidney transplant enrolment has reached 78%. Finally, just after quarter end, we communicated positive results from the 12-month analysis of NICE-01, demonstrating that HNSA-5487 can robustly and very rapidly reduce IgG levels, has clear redosing potential, and a favorable safety and tolerability profile. Initial clinical development will focus on neuromyelitis optica (NMO), myelin oligodendrocyte glycoprotein antibody disease (MOGAD), and myasthenia gravis (MG)."

Financial Performance

The Company recorded total revenue of 78.4 MSEK. Of this, 69.5 MSEK is attributed to IDEFIRIX sales, marking the highest ever quarterly in-market sales. This excludes the impact of a 29.7 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. Of the total provision only 4.9 MSEK was related to Q3 sales. Net of the provision, Q3 2024 IDEFIRIX sales were 39.8 MSEK and total year to date IDEFIRIX sales were 114.5 MSEK. Previously, the Company recorded a provision of 19.9 MSEK in Q2 2024. Of this, 2.0 MSEK was related to sales in Q2 2024. Of the total provision taken in Q2 and Q3 2024, 42.7 MSEK relates to previous periods since launch in 2020.

Pipeline Progress

Progress across the pipeline included the strong momentum in enrollment in the Phase 3 GOOD-IDES-02 study in anti-GBM (86%), and in the Post Authorization Efficacy and Safety (PAES) study in kidney transplantation (78%). Further efficacy data from the 15-HMedIdes-09 Phase 2 trial in Guillain-Barré Syndrome (GBS) is scheduled to read out by the end of 2024. The ConfIdeS trial continues to progress following completed randomization in May and data from the study is expected to provide the basis for a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in the second half of 2025. On 7 October 2024, Hansa announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential.

Financial Summary

MSEK, unless otherwise stated, unaudited

Q3 2024