Xbrane Biopharma (XBRANE) Q4 2024 earnings summary

Executive summary

• Ximluci sales volume grew over 225% year-over-year in Q4 and 20% sequentially from Q3, now launched in 21 countries with a 3% market share in Europe’s EUR 1.2bn ranibizumab market.

• Exclusive global licensing and development agreement signed with Intas for Xdivane, with EUR 10m upfront, milestones, and profit-sharing; Intas finances clinical/regulatory development and commercialization.

• BLA for Ximluci resubmitted to FDA in December 2024; FDA decision expected by April 2025, with US launch preparations underway.

• XB003 out-licensing process ongoing, with non-binding proposals received and target to finalize in Q1 2025.

• Focused on biosimilar development, targeting a EUR 26 billion originator market with key products including Ximluci, XB003, and Xdivane.

Financial highlights

• Q4 2024 revenue: SEK 66 million; gross profit: SEK 61 million; gross margin: 93%.

• Full-year 2024 revenue: SEK 198.7 million; gross profit: SEK 180.5 million; gross margin: 91%.

• Operating cash flow positive SEK 94 million in Q4, driven by upfront payments from Intas and Biogen milestones.

• R&D expenses: SEK 80.8 million in Q4, SEK 391.8 million for the year, mainly for Xdivane and XB003 development.

• Cash and cash equivalents at year-end: SEK 124.3 million.

Outlook and guidance

• FDA decision on Ximluci BLA resubmission expected in April 2025; US launch preparations ongoing.

• Clinical studies for Xdivane expected to begin in Q2 2025, with US launch targeted for December 2028 upon patent expiry.

• Focus on finalizing a partnership for XB003 by end of Q1 2025 to meet capital needs.

• Expects continued strong Ximluci sales growth in Europe and additional launches in new territories.