Xbrane Biopharma (XBRANE) Q4 2024 earnings summary

Executive summary

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

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

• Strategic partnerships with STADA (Europe), Valorum (U.S.), and Intas (global for Xdivane) drive commercialization and development; Intas agreement includes EUR 10m upfront, milestones, and royalties.

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

• Cash position strengthened to SEK 124.3m at year-end, supported by upfront and milestone payments.

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%.

• Q4 EBITDA: SEK -23.2m; full year EBITDA: SEK -182.8m.

• Q4 net loss: SEK 53.2m; full year net loss: SEK 266.2m.

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

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.

• Aims to close an out-licensing deal for XB003 in Q1 2025 to secure further working capital.

• Current liquidity estimated to finance operations until early Q2 2025, contingent on securing a licensing partner for XB003 and postponing certain activities.

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