Xbrane Biopharma (XBRANE) Q3 2024 earnings summary

Executive summary

• Focused on biosimilar development with four candidates targeting a €26–27 billion reference market by 2026–2028.

• Ximluci (Lucentis biosimilar) launched in 18–19 European countries, progressing toward US approval; other programs (Xcimzane, Xdivane, XB003) advancing toward clinical trials and out-licensing.

• Out-licensing negotiations for Xdivane and XB003 are at advanced stages, with deals needed by end of November 2024 to secure working capital.

• Aim to reach positive operational cash flow by Q2 2025.

Financial highlights

• Q3 2024 revenue was SEK 67 million, up from SEK 59 million in Q3 2023; gross margin improved to 45–67% from 4–7% year-over-year.

• Q3 EBITDA: SEK -28.9 million, a significant improvement from SEK -81.6 million in Q3 2023.

• Net profit share from Ximluci was SEK 16 million, lower than Q2 due to one-time marketing costs and a less favorable price mix.

• Operating cash flow for the quarter was SEK 15 million; quarter-end cash position was SEK 30.6–31 million.

• Realized SEK 22 million in cost savings from a cost-saving scheme, with staff reductions of 35 out of 40 planned.

Outlook and guidance

• Expecting to resubmit Ximluci BLA to FDA in Q4 2024, with a potential US approval decision in Q2 2025.

• Out-licensing of Xdivane and XB003 expected in Q4 2024 to support working capital, with upfront payments potentially exceeding $10 million combined.

• Positive operational cash flow targeted by Q2 2025.

• R&D spend expected to remain significant in the next two quarters, with potential reduction after Q2 2025 as major development milestones are completed.