Xbrane Biopharma (XBRANE) Q2 2025 earnings summary

Executive summary

• Ximluci, a Lucentis biosimilar, is commercialized in 24 countries, achieving 11% volume growth in Europe in Q2 2025 versus Q1, and holds an 8% market share by volume in Europe.

• U.S. regulatory process for Lucumsi (Ximluci) is ongoing, with FDA decision expected October 21, 2025; launch preparations with Valorum Biologics are underway.

• Xtovane/Xdivane, an Opdivo biosimilar, is progressing as planned with a clinical trial initiated, EUR 2 million milestone recognized, and launch targeted post-patent expiry in 2028.

• Alvotech transaction finalized, generating SEK 275 million, reducing debt, and improving liquidity; directed share issue of SEK 240 million completed in July.

• Significant financial turnaround in H1 2025 driven by asset sale, cost reductions, and strengthened financial position.

Financial highlights

• Q2 2025 revenue was SEK 39.9 million, entirely from the Xtovane/Xdivane license agreement; no revenue from Ximluci shipments or profit sharing due to revenue recognition model.

• Gross margin for Q2 2025 was 100%.

• Profit from discontinued operations (Alvotech divestment) was SEK 185 million; EBITDA from discontinued operations was SEK 210 million.

• R&D expenses for Q2 2025 were SEK 26.3 million; SEK 48.9 million capitalized in ongoing programs.

• Cash and cash equivalents at period end were SEK 6 million; operating cash flow for Q2 2025 was -SEK 65 million.

Outlook and guidance

• Shipments of Ximluci to STADA to resume in Q3 2025 and are expected to continue each quarter for the next 6–8 quarters, converting SEK 170 million in inventory to cash by end of 2027.

• FDA approval for Lucumsi in the U.S. is a key milestone; launch expected six months post-approval.

• Xtovane/Xdivane clinical trial is on track, with U.S. submission targeted for Q4 2027 and launch post-patent expiry in 2028.

• Fixed costs expected at SEK 12.5 million per quarter from Q3 2025 onward; additional SEK 200 million investment in Xtovane/Xdivane process development through 2027.

• Cash from share issue and asset sale expected to fund operations until positive cash flow is achieved.