Sweden · Delayed Price · Currency is SEK Xbrane Biopharma AB Earnings Call Transcripts
Fiscal Year 2025
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Ximluci saw strong year-over-year growth and profit contribution, but faces increased price pressure and competition in Europe. Cost reduction measures and FDA resubmission are key focuses, while Xdivane development remains on track for a 2027 US launch.
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Ximluci maintained stable market share and revenue in Q3, with resumed shipments and a strong cash position following a directed share issue. FDA approval for U.S. launch is delayed, while Xdivane development progresses on track for a 2028 launch.
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Biosimilars are gaining market share due to regulatory changes and growing acceptance. Ximluci, a Lucentis biosimilar, is performing well in Europe and preparing for a U.S. launch, while Xdivane, an Opdivo biosimilar, targets a 2029 launch. Recent restructuring and partnerships have improved financial stability and global reach.
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Ximluci saw 11% volume growth in Europe in Q2, with U.S. FDA approval for Lucumsi expected in October. Xtovane's clinical trial is underway, and the Alvotech deal improved liquidity and reduced debt. SEK 240 million was raised in a directed share issue.
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Divestment of the XB003 program and R&D to Alvotech will strengthen the financial position, reduce costs, and allow focus on Ximluci and Xdivane. Q1 2025 saw strong Ximluci growth, with SEK 93.2 million revenue and 57% gross margin.
Fiscal Year 2024
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Q4 2024 saw strong revenue and margin growth, driven by Ximluci's European expansion and new licensing deals. Regulatory progress continues for U.S. approval, while out-licensing and milestone payments are key to future cash flow.
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Q3 2024 saw SEK 67 million in revenue and a 45% gross margin, driven by Ximluci's strong volume growth in Europe and ongoing out-licensing negotiations for Xdivane and XB003. Cash position ended at SEK 31 million, with significant R&D and cost-saving measures in place.
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Q2 2024 saw strong Ximluci sales growth and improved margins, with active out-licensing of pipeline assets to secure financial stability. Cost controls and regulatory progress support a positive outlook, but success depends on closing new partnerships by October 2024.