Hansa Biopharma Charts US Expansion Following Record Revenue and Pivotal FDA Submission

LUND, Sweden – February 11, 2026 – Hansa Biopharma has capped a transformative year with robust financial growth and a landmark regulatory filing in the United States, signaling a new chapter for the company and potentially for thousands of transplant patients. The Swedish biopharmaceutical firm announced a remarkable 135% increase in fourth-quarter revenue, driven by surging sales of its flagship product, IDEFIRIX (imlifidase), and confirmed the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

The submission seeks approval for imlifidase as a desensitization treatment for highly sensitized patients awaiting a kidney transplant, a move that could unlock a life-saving option in a market with significant unmet needs. This strategic push into the U.S. comes on the heels of a successful capital raise of 671.5 MSEK (approx. $71.3M), fortifying the company's financial position for the crucial year ahead.

"Q4 capped a strong year for Hansa Biopharma," stated Renée Aguiar-Lucander, CEO of Hansa Biopharma, in the company's announcement. "As we enter 2026, our focus is clear: secure FDA approval, ensure a successful U.S. launch of imlifidase, and progress commercial adoption across Europe."

A New Frontier for U.S. Kidney Transplants

The BLA submission for imlifidase represents a major milestone for Hansa and a beacon of hope for a particularly vulnerable patient population. In the United States, an estimated 7,000 to 11,000 patients on the kidney transplant waitlist are considered "highly sensitized." These individuals have developed high levels of antibodies that can attack a donor organ, making it exceedingly difficult to find a compatible match. Many wait for years, with some never receiving the transplant they need.

Imlifidase offers a novel approach to this challenge. It is an enzyme that rapidly cleaves and inactivates Immunoglobulin G (IgG) antibodies, creating a window of opportunity for a successful transplant. This mechanism is distinct from current desensitization protocols, such as plasmapheresis and intravenous immunoglobulin (IVIg), which are often less effective in patients with the highest antibody burdens.

The BLA is supported by data from the pivotal U.S. Phase 3 ConfIdeS trial, which demonstrated statistically significant improvements in kidney function for highly sensitized patients. Hansa has also requested a Priority Review from the FDA. If granted, this could shorten the review timeline from the standard ten months to just six, potentially leading to a PDUFA (Prescription Drug User Fee Act) target date in August 2026 and a market launch before the end of the year. With no other FDA-approved desensitization treatments in the U.S., imlifidase is positioned to address a critical gap in care.

Financial Firepower Fuels Expansion

Hansa's ambitious U.S. strategy is underpinned by a year of exceptional financial performance. The company reported fourth-quarter 2025 revenue of 76.0 MSEK, a 135% increase over the same period in 2024. This was driven by IDEFIRIX product sales, which soared 139% to 61.1 MSEK. For the full year, product sales grew 46% to 204.7 MSEK.

This commercial momentum is complemented by a strengthened balance sheet. The directed share issue completed in the fourth quarter brought in 671.5 MSEK from institutional investors, bolstering the company's cash and short-term investments to 701.1 MSEK. This infusion provides a crucial cash runway projected to last into 2027, funding not only the planned U.S. launch infrastructure but also the company's ongoing research and development efforts.

While demonstrating strong top-line growth, Hansa has also shown fiscal discipline. The company improved its full-year operating loss to 521 MSEK from 637 MSEK in 2024, partly due to a 19% reduction in R&D expenses as major clinical trials reached completion. This combination of rising revenue, a strong cash position, and managed expenses places Hansa on solid footing as it prepares for the significant costs associated with entering the competitive U.S. pharmaceutical market.

European Success Paves the Way

The strong performance in Europe serves as a powerful proof-of-concept for imlifidase's clinical value and commercial potential. The 46% year-over-year sales growth reflects increasing adoption and market penetration across key European countries. The company noted that sales were achieved across all its major European markets in the fourth quarter, highlighting broadening acceptance.

Securing reimbursement and market access has been a key focus. Recent progress, such as securing temporary funding for IDEFIRIX in the Catalunya region of Spain, has led to a clear increase in demand from transplant centers. This real-world experience in navigating complex European healthcare systems and demonstrating the drug's value to payers provides invaluable lessons as the company builds out its U.S. commercial and market access teams.

Further validation is expected in mid-2026 with the readout from the Post-Approval Efficacy Study (PAES), which will provide additional long-term data on the drug's performance and safety in a real-world setting, likely bolstering its case with clinicians and health authorities on both sides of the Atlantic.

Beyond Transplants: A Platform for Broader Cures

While the immediate focus is on kidney transplantation, Hansa is actively demonstrating the broader potential of its IgG-cleaving enzyme technology platform. The company is advancing its next-generation enzyme, HNSA-5487, into clinical development for Guillain-Barré syndrome (GBS), a rare and serious autoimmune disorder that attacks the nervous system. This decision was supported by promising data from a previous Phase 2 trial with imlifidase in GBS, and the company plans to meet with the FDA in the first half of 2026 to align on the clinical development path.

Furthermore, the imlifidase platform is showing promise in the burgeoning field of gene therapy. In many gene therapies that use adeno-associated virus (AAV) vectors, pre-existing antibodies to AAV can render the treatment ineffective. Initial data presented at a major scientific conference showed that a pre-treatment with imlifidase successfully cleared these AAV antibodies in a patient with Crigler–Najjar syndrome, potentially enabling a much wider patient population to benefit from these cutting-edge therapies.

By leveraging its core technology across transplantation, autoimmune diseases, and gene therapy, Hansa Biopharma is building a diversified pipeline that extends far beyond its initial success, positioning itself to tackle some of medicine's most complex immune challenges.