Hansa Biopharma (HNSA) Q2 2026 earnings summary

Executive summary

• Entered a €115 million out-licensing agreement with SERB Pharmaceuticals for Idefirix in Europe, UK, and MENA, strengthening financial position and enabling focus on US launch and R&D portfolio advancement.

• Reported positive topline data from the European confirmatory PAES trial, supporting full marketing authorization submission to EMA.

• Showcased pivotal US Phase 3 ConfideS data at ATC 2026, highlighting clinical relevance for highly sensitized kidney transplant patients.

• Q2 revenues were 48.1 MSEK, nearly flat year-over-year, but up 39% sequentially from Q1; H1 product revenue declined 29% year-over-year.

• Commercial execution improved in Q2, with strong performance in France and Spain and new reimbursement in Catalonia.

Financial highlights

• Q2 2026 revenue: 48.1 MSEK (Q2 2025: 49.1 MSEK); H1 2026 revenue: 82.7 MSEK (H1 2025: 115.5 MSEK).

• Q2 Idefirix product sales: 46.8 MSEK, down 2% year-over-year; H1 product sales: 80.7 MSEK, down 29% year-over-year.

• Q2 SG&A expenses: 118.9 MSEK (Q2 2025: 90.5 MSEK), reflecting US launch preparations and deal costs.

• Q2 R&D expenses: 67.9 MSEK (Q2 2025: 95.8 MSEK), lower due to finalization of key studies and restructuring.

• Q2 operating loss: 174.1 MSEK (Q2 2025: 154.5 MSEK); Q2 net loss: 260.5 MSEK (Q2 2025: 197.0 MSEK).

• Cash and short-term investments at June 30, 2026: 552.8 MSEK (June 30, 2025: 354.4 MSEK).

Outlook and guidance

• Submission to EMA for full marketing authorization of Idefirix planned for Q4 2026.

• US PDUFA date for imlifidase set for December 19, 2026.

• Publication of ConfideS Phase 3 data expected in H2 2026.

• IND submission for HNSA-5487 in GBS planned before year-end 2026.

• Current cash position expected to support operations well into 2028.