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Hansa Biopharma's Financial Performance: Q4 and Full Year 2025

Hansa Biopharma AB, trading on Nasdaq Stockholm under the ticker symbol HNSA, recently revealed its financial outcomes for the fourth quarter and full year of 2025. The report highlighted substantial revenue growth, strong product sales, and strategic advancements in their pipeline, particularly concerning their leading product, Idefirix.

Key Highlights

The fourth quarter of 2025 marked a significant achievement for Hansa Biopharma, with revenue reaching 76.0 million SEK, a remarkable increase of 135% compared to the same period in 2024. Product sales for Idefirix, which totaled 61.1 million SEK, represented a striking 139% rise from the previous year.

For the entire year, total revenue reached 222.3 million SEK, reflecting a 30% growth from 171.3 million SEK in 2024. This growth is largely attributed to Hansa’s successful reach across major European markets, solidifying its reputation as a leader in immunomodulatory therapies for kidney transplantation.

CEO Remarks

Renée Aguiar-Lucander, CEO of Hansa Biopharma, emphasized the remarkable year the company had, punctuated by the timely submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). This application is crucial for imlifidase, aimed at helping highly sensitized patients awaiting kidney transplants. Aguiar-Lucander noted, “Filing our BLA with the FDA just three months after announcing Phase 3 results highlights the strength of our team and execution focus.”

Pipeline Advancements

In December, alongside their financial results, Hansa Biopharma submitted their BLA for imlifidase aimed at significantly enhancing the outcomes for patients who are heavily sensitized. The FDA’s potential granting of Priority Review could expedite their approval process, setting a target date for August 2026.

Additionally, data from initial trials concerning imlifidase’s use in gene therapy showcased promising results, indicating its ability to effectively eliminate AAV antibodies. This advancement could pave the way for gene therapy treatments for patients suffering from Crigler–Najjar syndrome.

The company is also making strides forward with its next-generation enzyme, HNSA-5487, which is aimed at treating Guillain-Barré syndrome. Interactions with the FDA are planned for the first half of 2026 as part of their agreement on the clinical development pathway.

Financial Summary Overview

The company's consistent growth is reflected in their financial summaries as well:

• - Q4 2025 Revenue: 76.0 million SEK (compared to 32.3 million SEK in Q4 2024)
• - 12M 2025 Revenue: 222.3 million SEK (up from 171.3 million SEK in 2024)
• - Net Cash Used in Operations: 177.5 million SEK, with cash and short-term investments totaling 701.1 million SEK at year-end.

While operational losses were recorded, the company is focused on sustaining its growth trajectory, investing in research and development, and in securing pivotal approvals for their lead products.

Looking Ahead

As 2026 unfolds, Hansa Biopharma's priorities are clear: securing FDA approval for imlifidase, ensuring a successful U.S. market launch, and promoting commercial uptake across Europe. The company’s continued momentum in addressing the unmet medical needs of vulnerable patient populations remains a driving force behind its strategic initiatives.

The earnings call, scheduled for February 11, 2026, promises to provide additional insights into Hansa’s future plans and further elaborate on their financial performance.

For more updates, interested parties can join the webcast available on Hansa Biopharma’s official website during the earnings call.