Xbrane Biopharma (XBRANE) Q1 2026 earnings summary

Executive summary

• Ximluci, a LUCENTIS biosimilar, launched in 24 countries in Europe and the Middle East, maintaining an 8% market share by volume in Europe as of March 2026, with profit sharing through a partnership with STADA.

• Ximluci BLA was resubmitted to the FDA in April 2026 after addressing manufacturing site deficiencies, with a decision expected in November 2026.

• Xdivane, an OPDIVO biosimilar candidate, is progressing as planned, with clinical trials initiated and FDA submission targeted for H2/Q4 2027 and potential launch in early 2029.

• Agreement with Intas revised: Intas will partly finance Xdivane’s CMC activities at an 18% add-on, with costs deducted from future profit sharing or a one-time lump sum payment option.

• Independent valuation estimates Xdivane’s 10-year accumulated profit sharing at nearly SEK 10 billion, with a net present value of SEK 4.4 billion for the first four years or €408 million in January 2029 at a 15% discount rate.

Financial highlights

• Q1 2026 revenue was SEK 17.3 million, with SEK 17.2 million from Ximluci product sales to STADA and a gross margin of 39%.

• Profit sharing from STADA contributed SEK 13 million in Q1 2026, related to Q4 2025.

• Operating cash flow for Q1 2026 was SEK -8.5 million; closing cash balance was SEK 66.7 million at quarter-end.

• Administration expenses were SEK 7.6–17.6 million; R&D expenses were SEK 9.9 million, including SEK 2.7 million in amortization of intangibles.

• EBITDA for Q1 2026 was SEK -7.8 million, with an equity ratio of 82%.

Outlook and guidance

• Production cost reduction measures for Ximluci are expected to yield results from 2027 onwards, potentially unlocking further volume growth.

• Regulatory decision on Ximluci’s U.S. BLA resubmission is expected within six months, with hopes for approval in H2/November 2026.

• Xdivane’s clinical trial and CMC activities are on track, with anticipated U.S. launch in early 2029, pending timely approval.

• Management expects existing financial resources to be sufficient for ongoing operations, assuming development proceeds as planned.