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Xbrane Biopharma (XBRANE) investor relations material
Xbrane Biopharma Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary24 Oct, 2025
Executive summary
Ximluci launched in 24 countries, maintaining an 8% market share in Europe and leading among biosimilars in Italy and Germany; FDA approval in the US is delayed due to manufacturing site issues, with resubmission targeted for Q1 2026.
Xdivane clinical trial was initiated, targeting a $14 billion originator market, with full patient recruitment expected within 12 months and FDA submission planned for Q4 2027; launch is planned immediately post-patent expiry in December 2028.
Directed share issue raised SEK 240 million, significantly reducing debt, improving liquidity, and strengthening the cash position.
Divestment of XB003 and part of the organization to Alvotech completed, resulting in a SEK 168.9 million post-tax gain.
Financial highlights
Q3 2025 net revenue was SEK 10 million, including SEK 9–9.2 million profit share and a SEK -10 million adjustment for future profit sharing due to price pressure.
Administration expenses were SEK 8 million and R&D expenses SEK 10 million in Q3 2025, with SEK 2.8 million amortization of intangible assets.
Operating cash flow was SEK -49 million in Q3 2025; cash and cash equivalents at quarter-end were SEK 93.6–94 million.
Gross margin turned negative in Q3 2025 due to market price pressure; Jan–Sep 2025 gross margin was 61% (down from 90% year-over-year).
Profit for Jan–Sep 2025 was SEK 153.7 million, mainly due to the Alvotech divestment.
Outlook and guidance
Shipments to STADA are expected to continue in Q4 2025 and throughout 2026, converting inventory into cash.
Growth in Ximluci volumes is anticipated to resume in 2026, with a long-term goal of 20% market share in Europe.
Xdivane is expected to generate SEK 1 billion annually post-launch, with SEK 200 million in remaining development expenditure.
Current cash and a SEK 60 million loan facility are expected to sustain operations through 2026, but material uncertainty remains regarding long-term going concern.
Initiatives are underway to reduce Ximluci production costs for long-term competitiveness.
Ximluci FDA CRL resolution timeline?
Ximluci EU price pressure mitigation strategy?
Going concern risk mitigation plans?
Ximluci US resubmission timeline confirmation?
Update on Ximluci prefilled syringe launch.
Xdivane financing and manufacturing site selection.
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Next Xbrane Biopharma earnings date
Q4 202531 Mar, 2026
Next Xbrane Biopharma earnings date
Q4 202531 Mar, 2026
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Frequently asked questions
Xbrane Biopharma is a biotechnology company that develops, manufactures and sells biosimilars worldwide. Many of the company's products are approved to treat cancer patients. Xbrane Biopharma AB (publ) was founded in 2008 and is headquartered in Solna, Sweden.
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