Xbrane Biopharma (XBRANE) Q3 2025 earnings summary

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.