Hansa Biopharma Q2 2024 Financial Results and Business Update

LUND, Sweden, July 18, 2024 -- Hansa Biopharma recently published its financial results for the first half and second quarter of 2024, along with a business update. President and CEO Søren Tulstrup highlighted the company's robust sales performance of IDEFIRIX® for the third consecutive quarter, particularly in major European markets. Additionally, significant progress was made in their clinical trials, specifically the pivotal Phase 3 US trial for kidney transplantation, ConfIdeS. The company anticipates presenting data in the latter half of 2025 and aims to submit a Biologics License Application (BLA) to the US FDA. Furthermore, advancements were noted in the Phase 3 trial for anti-glomerular basement membrane (anti-GBM) disease and the European Post Authorization Efficacy Study (PAES) in kidney transplantation, both of which are on track for completion.

From a financial perspective, Hansa Biopharma reported strong performance with a total revenue of 54.2 MSEK for the quarter, 47.1 MSEK of which was from IDEFIRIX sales. However, after accounting for a 20 MSEK provision related to possible price adjustments since the European launch in 2020, the net IDEFIRIX sales stood at 27.2 MSEK. The expansion of IDEFIRIX into key European markets has been a significant driver of this revenue, and the company has secured reimbursement in 14 European countries.

During the second quarter of 2024, Hansa Biopharma successfully completed a directed share issue, generating gross proceeds of 372 MSEK (US $34.6 million). This capital was primarily raised from esteemed international healthcare specialist investors.

In terms of its pipeline, Hansa Biopharma achieved several milestones. The randomization phase for the ConfIdeS pivotal Phase 3 US trial in kidney transplantation was completed. The European Post Approval Efficacy Study in kidney transplantation reached 70% enrollment and is expected to conclude by 2025. Similarly, the GOOD-IDES-12 Phase 3 trial for anti-GBM disease also reached 70% enrollment, with data anticipated to be available in 2025.

Hansa Biopharma is committed to advancing its pipeline and achieving several key milestones in the second half of the year. Notable among these is the further analysis of the Phase 1 study data for HNSA-5487, the company's second-generation IgG cleaving enzyme intended for repeated dosing.

Hansa Biopharma is a forward-thinking biopharmaceutical company focused on developing and commercializing innovative treatments for patients with rare immunological conditions. The company's flagship product, IDEFIRIX, is a groundbreaking IgG antibody cleaving enzyme therapy that facilitates kidney transplantation in highly sensitized patients. The company's research and development efforts are centered on its proprietary IgG-cleaving enzyme technology platform, which targets unmet medical needs in transplantation, autoimmune diseases, gene therapy, and cancer.

Based in Lund, Sweden, Hansa Biopharma operates across Europe and the U.S. and is listed on Nasdaq Stockholm under the ticker HNSA.