Orexo (ORX) Q3 2026 earnings summary

Executive summary

• Transformation focused on AmorphOX development, cost restructuring and partnerships to share future development costs and fund later-stage programs.

• Izipry was resubmitted to the FDA, OX640’s IND was accepted and commercial-scale units were manufactured, and an initial oral semaglutide formulation showed comparable bioavailability to the reference tablet.

• BARDA extended OX390 support, while a non-binding DOJ settlement in principle and a proposed ~SEK 250m rights issue shaped financing plans.

Financial highlights

• Q3 net revenue was SEK 0.8m versus SEK 4.8m; Jan–Sep revenue was SEK 9.3m versus SEK 22.8m, mainly reflecting lower Abstral and Edluar royalties.

• Q3 operating expenses were SEK 99.3m, including a SEK 34.6m DOJ settlement provision and nearly SEK 24m in external OX640 and Izipry costs.

• Normalized Q3 OpEx was SEK 55.3m, or SEK 18m per month, excluding the DOJ provision and other adjustments.

• Continued-operations net loss was SEK 117.9m; consolidated net loss was SEK 96.4m, including SEK 21.5m earnings from discontinued operations.

• Q3 net financial items were SEK +2.7m, supported by positive unrealized FX and higher bank interest income.

Outlook and guidance

• Izipry was resubmitted on September 29; FDA review is expected to take six months, with approval targeted for Q1 2027 subject to FDA confirmation. US commercialization is expected to rely on a partner.

• OX640’s first pivotal trial is planned for Q4 2026, with results expected in H1 2027; partnering discussions are ongoing.

• Normalized OpEx is expected to fall in 2027 as staff reductions and lower facility costs take effect; cash flow is expected to move closer to EBITDA.

• Zubsolv earn-out proceeds are expected in Q1 2027, while BARDA reimbursements for OX390 costs are expected to catch up in Q4 2026.