Xbrane Biopharma (XBRANE) Q2 2024 earnings summary

Executive summary

• Focused on biosimilar development, with a portfolio targeting four major biologics, including Ximluci (Lucentis biosimilar), late pre-clinical candidates for Cimzia and Opdivo, and a new US licensing deal for ranibizumab biosimilar.

• Ximluci is launched in 18 European countries, showing strong net sales and volume growth in Q2 2024, with market share exceeding 1% of a €300m market.

• Regulatory progress includes ongoing FDA discussions for US approval, BLA resubmission planned for Q4 2024, and preparation for a prefilled syringe launch in Europe in 2025.

• Out-licensing processes for XB003 (Cimzia biosimilar) and Xdivane (Opdivo biosimilar) are active, with the goal to close deals by end of October 2024, now critical for near-term funding.

• Biogen terminated the XB003 licensing agreement, returning full rights and impacting expected income.

Financial highlights

• Q2 2024 total revenues reached SEK 52 million, with net profit from Ximluci at SEK 22 million and a SEK 27 million milestone from Valorum.

• Q2 2024 EBITDA improved to SEK -54.7m from SEK -81.1m, reflecting cost controls and favorable product mix.

• Q2 2024 net loss was SEK 70.5m; cash and cash equivalents at quarter-end were SEK 73 million.

• Gross margin benefited from declining marketing and sales costs, positive production variances, and retroactive price adjustment.

• Equity ratio at June 30, 2024 was 36%.

Outlook and guidance

• Expectation of 20–30% quarterly growth in Ximluci sales to continue into Q3 2024.

• Out-licensing of XB003 and Xdivane is essential to secure funding from November 2024 onward and reduce financial risk.

• Prefilled syringe for Ximluci planned for European launch in 2025, pending approval.

• Regulatory submissions in Middle East ongoing, with launches expected in 2025.

• Positive operating cash flow expected if FDA approval for Ximluci is achieved in Q2 2025.