Xbrane Biopharma (XBRANE) Q4 2025 earnings summary

Executive summary

• Ximluci, a Lucentis biosimilar, is now launched in 24 countries, maintaining an 8% volume market share in Europe since May 2025, with sales to end customers up 63% year-over-year and a 60% year-over-year volume growth.

• Ximluci profit contribution reached SEK 160 million, with over SEK 100 million received in cash from STADA; total profit since launch was SEK 116 million, with SEK 102 million paid in cash.

• Xdivane, a biosimilar to Opdivo, is progressing on schedule, with clinical trial recruitment on track and BLA submission targeted for Q4/H2 2027.

• Lucamzi (ranibizumab biosimilar) FDA approval delayed due to manufacturing site issues; resubmission planned for March 2026.

• Completed divestment of XB003 and related assets to Alvotech, resulting in a gain of SEK 168.9 million after tax.

Financial highlights

• Q4 2025 revenue was SEK 9.1 million, with SEK 8.9 million from product sales to STADA; full-year revenue reached SEK 152.4 million.

• COGS was SEK 7.4 million in Q4, higher due to production issues, resulting in an 18% gross margin (would have been 39% without the issue); full-year gross margin was 59%.

• Administrative expenses were SEK 6.6 million; R&D expenses were SEK 17.8 million in Q4, including SEK 3.5 million in non-recurring R&D.

• SEK 24.3 million was capitalized as intangible assets in Q4 2025.

• Operating cash flow for Q4 2025 was SEK -68 million; cash and cash equivalents at year-end were SEK 86.6 million.

Outlook and guidance

• Majority of SEK 170 million Ximluci inventory expected to convert to cash by end of 2027.

• Cost reduction measures for Ximluci to start materializing in 2027.

• Fixed costs expected to remain around SEK 80 million per quarter in 2026, with only marginal reductions.

• BLA resubmission for Ximluci to FDA planned for March 2026, with a decision expected by September 2026.

• Xdivane clinical trial recruitment is on track, aiming for FDA submission by Q4/H2 2027.