Orexo (ORX) Q1 2026 earnings summary

Executive summary

• Completed the divestment and transition of Zubsolv, with a smooth handover to Dexcel and no market interruptions, impacting balance sheet and P&L through bond redemption, rebates, and restructuring costs.

• Transitioned to a new phase post-Zubsolv US divestment, focusing on proprietary development, exploratory research, and expanding technology partnerships, especially leveraging AmorphOX.

• Ongoing collaborations and preparations for clinical trials in key pipeline assets, including Izipry, OX640, and OX390.

• Q1 2026 marked by significant cash outflows due to bond redemption and restructuring, but left with a strong net cash position.

• Cash position at SEK 334 million as of March 31, 2026, excluding SEK 52 million attributable to Dexcel.

Financial highlights

• Net revenues for Q1 2026 were SEK 5 million, down from SEK 13.2 million year-over-year, mainly due to lower Zubsolv ex-US and Abstral royalties.

• EBIT for Q1 2026 was SEK -75.0 million (Q1 2025: SEK -76.3 million); EBITDA was SEK -66.1 million (Q1 2025: SEK -65.2 million).

• Net loss from continued operations was SEK -105.2 million (Q1 2025: SEK -90.6 million); discontinued operations posted SEK -28.7 million (Q1 2025: SEK 74.7 million).

• Cash and cash equivalents at quarter-end were SEK 386.2 million, with SEK 52 million attributable to Dexcel.

• SEK 490 million used for bond amortization, significantly impacting cash flow from financing activities.

Outlook and guidance

• NDA resubmission for Izipry™ planned for Q3 2026, with FDA approval targeted for Q1 2027.

• OX640 pivotal clinical trial expected to start in Q4 2026, with results anticipated in H1 2027.

• OX390 in vivo study results expected in Q2 2026, with a Type C FDA meeting and further BARDA financing anticipated.

• Annual normalized OpEx (excluding transition and DOJ costs) estimated at SEK 250 million.

• Transition period for the divested business expected to conclude by September or October 2026.