Xbrane Biopharma (XBRANE) Q2 2024 earnings summary

Executive summary

• Ximluci (Lucentis biosimilar) launched in 18 European countries, with net sales up nearly 40% in Q2 2024 and value market share above 1% in a €300 million market.

• Portfolio includes late pre-clinical candidates for Cimzia and Opdivo, with successful upscaling and analytical similarity for Xdivane and XB003.

• Regained global rights to XB003 after Biogen terminated the partnership, with out-licensing processes for XB003 and Xdivane targeting closure by end of October 2024.

• Out-licensing of Xdivane and XB003 is now critical for near-term funding and financial stability.

• Regulatory progress includes ongoing FDA discussions for US approval and preparation for a prefilled syringe launch in Europe in 2025.

Financial highlights

• Q2 2024 revenues reached SEK 52 million, with Ximluci net profit at SEK 21.7 million and SEK 27.2 million upfront from Valorum Biologics.

• Gross margin improved due to favorable market mix, retroactive contract manufacturer price adjustment, and positive production variances.

• Q2 2024 EBITDA improved to SEK -54.7 million from SEK -81.1 million, reflecting cost controls.

• Cash and cash equivalents at June 30, 2024, were SEK 73 million, with operating cash flow around SEK -100 million.

• SEK 299.8 million net raised via rights issue in H1 2024; SEK 62.5 million bond repayment in Q2.

Outlook and guidance

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

• Out-licensing of XB003 and Xdivane targeted by October 2024 to secure upfront payments and reduce financial risk.

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

• Ximluci BLA resubmission to FDA planned for Q4 2024, with potential US launch in 2025.

• Preparation underway for clinical trials of XB003 and Xdivane in 2025.