Hansa Biopharma (HNSA) Q2 2026 earnings summary

Executive summary

• Entered a transformative out-licensing agreement for IDEFIRIX/Idefirix in Europe, UK, Switzerland, Norway, Liechtenstein, Iceland, and MENA with SERB Pharmaceuticals, valued at €115–150 million, including a €110 million upfront payment and €5 million milestone upon EMA filing acceptance, strengthening financial position and enabling focus on US launch and R&D advancement.

• Reported positive topline data from the European confirmatory PAES trial, supporting conversion from conditional to full approval in Europe, with 92% graft survival and 98% patient survival at 12 months.

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

• Strengthened executive team with new CFO and VP Business Development; completed corporate transition with focus on US commercialization and European business transfer to SERB.

• Q2 2026 revenues were SEK 48.1 million (MSEK), nearly flat year-over-year but up 39% sequentially from Q1, with strong performance in Spain and France.

Financial highlights

• Q2 2026 revenue: SEK 48.1 million; product sales: SEK 46.8 million, down 2% year-over-year but up 39% sequentially; trailing twelve months product sales: SEK 171.9 million.

• SG&A expenses rose to SEK 119 million, up 31% year-over-year, reflecting US launch preparations and deal-related costs.

• R&D expenses decreased 29% year-over-year to SEK 68 million due to winding down clinical trials and restructuring.

• Loss from operations was SEK 174 million, compared to SEK 155 million in Q2 2025.

• Cash and equivalents at quarter-end were SEK 553 million (MSEK), not including the SERB upfront payment, which would bring pro forma cash to SEK 1.8 billion.

Outlook and guidance

• Focused on completing the transition to SERB, filing for full approval in Europe, and preparing for US launch pending FDA approval, with PDUFA date set for December 19, 2026.

• Exploring additional collaborations in gene therapy and geographic out-licensing opportunities in H2 2026.

• IND filing for HNSA-5487 in GBS targeted before year-end 2026, with ongoing FDA discussions on trial design.

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

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