Xspray Pharma (XSPRAY) Q4 2025 earnings summary

Executive summary

• Transitioned from a research-focused to a commercial-stage pharmaceutical company, preparing for US launches of two cancer drugs in 2026.

• Faced regulatory challenges, including an FDA Complete Response Letter for Dasynoc® due to manufacturing deficiencies not directly related to its production line.

• Continued engagement with FDA and key opinion leaders, with positive clinical feedback and strong market interest in product candidates.

Financial highlights

• Net sales were SEK 0 thousand for both Q4 and full year 2025, unchanged from the prior year.

• Loss before income tax improved to SEK -37,009 thousand in Q4 2025 (from -82,002) and SEK -171,546 thousand for the year (from -285,674).

• Earnings per share before dilution improved to SEK -0.89 in Q4 (from -2.36) and SEK -4.46 for the year (from -8.62).

• Cash and cash equivalents at year-end were SEK 153,745 thousand (down from 208,236).

• Cash flow from operating activities was SEK -41,370 thousand in Q4 and SEK -193,163 thousand for the year.

Outlook and guidance

• Preparing for potential US launches of Dasynoc® and XS003 nilotinib in the second half of 2026.

• Cash position expected to finance operations through autumn 2026; additional capital may be sought to support commercialization.

• Regulatory resubmission for Dasynoc® planned for Q1 2026; FDA decision on XS003 expected by June 18, 2026.