Hansa Biopharma AB (STU:24H) Q4 2025 Earnings Call Highlights: Robust Revenue Growth and …

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Thu, February 12, 2026 at 4:02 AM GMT+9 3 min read

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Release Date: February 11, 2026

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

Hansa Biopharma AB (STU:24H) reported a strong revenue growth of 135% in Q4 2025 compared to the same quarter last year.

The company successfully closed an equity round of SEK671.5 million, securing funding for operations into 2027.

Hansa Biopharma AB submitted a BLA application to the FDA in December 2025, with expectations of a PUFA date announcement soon.

The company announced plans to develop Hansa 5,487 for Guillain-Barre Syndrome, with trials expected to start before the end of the year.

Reorganization of the European commercial organization aims to improve transparency and accountability, potentially enhancing future performance.

Negative Points

The company expects a relatively weak revenue development in Q1 2026 due to ongoing change management implementations.

Challenges in the German market persist, with a pause in participation in the Eurotransplant priority program affecting operations.

The phase 3 study in anti-GBM disease did not meet its primary and key secondary endpoints, leading to no further planned trials in this area.

SG&A expenses increased by 15% in Q4 2025 compared to the same period in 2024, indicating rising operational costs.

The company faces uncertainties in the US market regarding reimbursement pathways and pricing strategies for the upcoming product launch.

Q & A Highlights

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Q: For the US launch, do you have any initial feedback from payers on reimbursement policies, and can you provide any revenue guidance for the year? A: We are not providing revenue guidance at this stage. Regarding reimbursement, the pathway is well-established in the US as an inpatient drug covered by medical insurance. We are applying for NTAP, which would allow an extra payment for Medicare, and engaging with hospitals to understand their expertise in this area. (Maria Toornson, Chief Operating Officer and President, US)

Q: Can you elaborate on the addressable patient population for the US launch and the pricing flexibility? A: In the US, there are 15,000 patients on the waitlist with a CPRA over 80%, and 3,500 in the most sensitized group. We have detailed data on these patients. Pricing in the US is expected to be higher than in Europe due to higher healthcare costs. (Maria Toornson, Chief Operating Officer and President, US; Renee Aguiar Lukander, CEO)

Story continues  

Q: How will outlier payments cover the cost of the drug, and what is your policy on free goods for early clinical experience? A: Outlier payments are already used by hospitals for additional costs. The exact coverage depends on various factors, including state and hospital submissions to CMS. We are confident in working with hospitals to ensure access. We do not have a policy on free goods yet, but it will be assessed closer to launch. (Maria Toornson, Chief Operating Officer and President, US)

Q: Can you update us on the manufacturing and distribution plans for the US, and the decision in France to expand reimbursement to lung transplants? A: Our drug is manufactured in Europe, and we are finalizing our US distribution network. In France, a KOL initiated the reimbursement for lung transplants, which is not an approved indication but was granted due to special circumstances. (Maria Toornson, Chief Operating Officer and President, US)

Q: What are the similarities or differences in the future GBS study compared to other trials, and what feedback are you seeking from the FDA? A: We are exploring various design options for the GBS study and will discuss these with the FDA. We aim to learn from other trials while leveraging our previous study data to optimize patient benefit. (Richard Phillipson, Chief Medical Officer)

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

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