Hansa Biopharma Q3 and Jan-Sep 2024 Financial Results

Hansa Biopharma, based in Lund, Sweden, has released its interim report for January-September and the third quarter (Q3) of 2024. The company has recorded its highest ever in-market quarterly sales performance with IDEFIRIX®, marking the fourth consecutive quarter of strong sales. The achievement highlights the ongoing successful launch of IDEFIRIX in Europe, which continues to gain traction in international organ allocation systems and sees increasing use in leading transplant clinics.

Søren Tulstrup, President and CEO of Hansa Biopharma, expressed satisfaction with the remarkable sales performance of IDEFIRIX in Q3 2024. He emphasized the progress in their clinical development programs spanning autoimmune diseases, gene therapy, and transplantation. Notably, enrollment in the Phase 3 GOOD-IDES-02 study for anti-GBM disease has reached 86%, while the Post Authorization Efficacy and Safety (PAES) study for kidney transplantation has achieved 78% enrollment. Additionally, the company announced positive findings from the 12-month analysis of the NICE-01 trial for HNSA-5487, showcasing its potential to reduce IgG levels rapidly and sustainably, with a favorable safety profile. Initial clinical development for HNSA-5487 will target neuromyelitis optica (NMO), myelin oligodendrocyte glycoprotein antibody disease (MOGAD), and myasthenia gravis (MG).

Financially, Hansa Biopharma reported total revenue of 78.4 million Swedish kronor (MSEK) for Q3 2024. Of this, 69.5 MSEK stemmed from IDEFIRIX sales, setting a new record for quarterly in-market sales. However, a 29.7 MSEK provision related to potential price adjustments from cumulative sales since the 2020 launch of IDEFIRIX in Europe was accounted for, with only 4.9 MSEK attributed to Q3 sales. After considering the provision, Q3 2024 IDEFIRIX sales stood at 39.8 MSEK, and year-to-date sales reached 114.5 MSEK. Previously, a 19.9 MSEK provision was recorded in Q2 2024, of which 2.0 MSEK related to Q2 sales, and a total of 42.7 MSEK pertained to sales since the launch in 2020.

The company's pipeline saw significant progress with good momentum across various studies. The Phase 3 GOOD-IDES-02 study in anti-GBM reached 86% enrollment, and the PAES study in kidney transplantation achieved 78% enrollment. Further efficacy data from the Phase 2 15-HMedIdes-09 trial in Guillain-Barré Syndrome (GBS) is expected by the end of 2024. Additionally, the ConfIdeS trial, which completed randomization in May, is progressing and is anticipated 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 October 7, 2024, Hansa announced favorable results from a 12-month follow-up analysis of the NICE-01 trial for HNSA-5487, examining IgG recovery, immunogenicity, and redosing potential.

Hansa Biopharma is committed to advancing its pioneering work in developing innovative treatments for rare immunological conditions. Their focus on expanding research and development programs based on their proprietary IgG-cleaving enzyme technology platform aims to address unmet medical needs in transplantation, autoimmune diseases, gene therapy, and cancer.

The company, listed on Nasdaq Stockholm under the ticker HNSA, continues to enhance its presence in Europe and the U.S., striving to make a significant impact on patients' lives through its groundbreaking therapies.