Xbrane Biopharma (XBRANE) investor relations material

Executive summary

• XimluciⓇ maintained a 7% volume market share in Europe, launched in 24 countries, and resumed shipments, generating SEK 127 million in profit sharing with STADA.

• Regulatory resubmission for U.S. approval (as Lucamzi™) completed, with FDA decision expected by October 29, 2026, and U.S. launch preparations underway.

• Xdivane™ (OPDIVO biosimilar) development is on track, targeting BLA submission to FDA in H2 2027, with Intas financing ongoing activities.

• Co-development agreement signed with JOINN Biologics for Xdarzane™ (DARZALEX biosimilar), enabling continued development with minimal or no further direct investment.

• Strategic partnerships and revised financing agreements advanced, supporting the biosimilar pipeline.

Financial highlights

• Q2 2026 revenue reached SEK 46.8 million, mainly from resumed XimluciⓇ shipments to STADA.

• Gross margin for Q2 was 5%, impacted by SEK 5.5 million profit sharing and SEK 5.7 million inventory adjustments; adjusted gross margin would have been 26%.

• Fixed costs included SEK 7 million administration, SEK 10.1 million R&D, and SEK 2.7 million amortization.

• Cash and cash equivalents at end of June 2026 were SEK 49.5 million; operating cash flow for Q2 was minus SEK 4.8 million.

• Net loss for Q2 was SEK -11.4 million, with EBITDA at SEK -6.3 million.

Outlook and guidance

• Production cost reduction measures for XimluciⓇ expected to yield a 50% decrease, improving margins from mid-2027 onward.

• Continued deliveries to STADA expected in upcoming quarters, with XimluciⓇ sales projected for Q3 and Q4 2026.

• Cash resources are expected to be sufficient for ongoing operations, excluding loan repayment and potential U.S. income.

• Lucamzi™ U.S. launch contingent on FDA approval, with commercialization preparations underway.

• Xdivane™ BLA submission targeted for H2 2027, supported by positive regulatory feedback.