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Hansa Biopharma's Financial Performance Overview

On April 24, 2025, Hansa Biopharma AB, listed on Nasdaq Stockholm under the ticker HNSA, released its interim financial report for the first quarter of 2025. The company reported total revenues of 66.3 million SEK, marking a 39% increase from the same quarter in the previous year, where revenues stood at 47.4 million SEK. Notably, product sales of IDEFIRIX® accounted for 65.7 million SEK, illustrating robust growth within this segment.

Peter Nicklin, the Chairman of the Board at Hansa Biopharma, discussed the company’s performance, stating, "Despite the unpredictable nature of the organ allocation market, which directly impacts our quarterly sales, we remain optimistic in achieving substantial year-over-year revenue growth. During Q1, we successfully completed enrollment in the Post Authorization Efficacy and Safety (PAES) study and extended access in three additional European markets. Furthermore, we witnessed a notable increase in repeat utilization of IDEFIRIX across leading centers in Europe."

Pipeline Developments

Hansa Biopharma has made significant headway with its clinical trials and product developments. The completion of enrollment in the PAES study showcases dedication to meeting regulatory obligations following conditional authorization by the European Commission for IDEFIRIX. This study is projected to yield results in the latter half of 2026 which will play a pivotal role in securing full marketing authorization in Europe.

Moreover, the company announced an anticipated data presentation at an upcoming medical congress regarding data from the 15-HMedIdeS-09 Phase 2 trial in Guillain-Barré Syndrome. These developments underline Hansa's forward momentum and commitment to addressing critical unmet medical needs.

Leadership Transition

Renée Aguiar-Lucander is now at the helm as the newly appointed Chief Executive Officer, stepping in immediately following Søren Tulstrup's departure after seven years in the role. This leadership shift aligns with the company's evolving strategy as it aims to enhance its market presence and expand its innovative treatment offerings.

Future Outlook

Looking ahead, Hansa Biopharma anticipates substantial milestones in the second half of 2025, including pivotal data readouts from the ConfIdeS Phase 3 trial evaluating imlifidase as a potential desensitization therapy for highly sensitized patients awaiting kidney transplants. In addition to this, progress continues for HNSA-5487, the next-generation molecule designed for repeat dosing, particularly in the treatment of myasthenia gravis (MG). Positive feedback has been received from the BfArM, confirming the clinical development plan for this new product line.

Financial Summary

Hansa Biopharma's financial summary for the first quarter of 2025 reflects a resilient operational framework:

• - Total Revenue: 66.3 million SEK
• - Product Sales: 65.7 million SEK
• - Loss from Operations: 93.4 million SEK (compared to a loss of 159.4 million SEK in Q1 2024)
• - Net Cash Used in Operations: 151.9 million SEK
• - Cash and Short-term Investments: 250.2 million SEK

These figures illustrate the company's strategic developments amidst the fluctuating nature of quarterly sales driven by variations in European kidney allocation systems.

Conclusion

Hansa Biopharma's first quarter results exhibit a commendable trajectory for 2025, backed by substantial revenue growth and optimistic pipeline advancements. With new leadership in place and a commitment to innovation, the company stands poised to enhance its impact within the biopharmaceutical landscape, addressing pressing medical needs in the process.

For further details and to follow Hansa Biopharma’s journey, please visit their official website for the latest updates.