Orexo (ORX) Q4 2025 earnings summary

Executive summary

• Completed divestment of all US rights to Zubsolv to Dexcel Pharma for USD 91 million plus inventory, with potential earn-outs up to USD 16.8 million, significantly strengthening financial position and enabling debt redemption and future investments.

• Strategic focus shifts to the AmorphOX technology platform, with plans to expand proprietary and partnered projects, especially in large molecule drug delivery, peptides, and vaccines.

• Organizational restructuring underway, with most US commercial staff moving to Dexcel and a leaner structure planned for continued operations.

• Met adjusted financial objectives for 2025, achieving positive EBITDA when excluding the Zubsolv transaction.

• Transition phase includes supporting Dexcel and organizational adjustments, with Orexo reimbursed for transition services.

Financial highlights

• Year-end cash position of SEK 912.4 million, up significantly due to the Zubsolv sale.

• Net proceeds from the transaction were SEK 814 million after transaction costs.

• EBITDA for continued operations was negative SEK 70 million in Q4; full-year EBITDA positive at SEK 3.2 million after adjustments.

• Discontinued operations contributed SEK 840 million to net earnings, mainly from the Zubsolv sale.

• Net earnings for Q4: SEK 724.8 million, with SEK -115.6 million from continued and SEK 840.4 million from discontinued operations.

Outlook and guidance

• Focus on advancing AmorphOX-based projects, with pivotal OX640 trial planned for Q4 and IZIPRY resubmission in Q3.

• 2025 outlook metrics (excluding Zubsolv transaction effects) were met: Zubsolv net sales USD 50.8 million, OPEX SEK 467.6 million, and positive EBITDA of SEK 3.2 million.

• Runway of at least two years expected, with potential extension through partnerships.

• Guidance for R&D expenses in 2026 remains uncertain, as costs depend on clinical trial timing and potential partnerships.

• 2026 priorities include advancing AmorphOX platform, initiating pivotal OX640 trial, analyzing OX390 in-vivo data, and expanding peptide/vaccine programs.