Orexo (ORX) Q2 2026 earnings summary

Executive summary

• Advanced R&D pipeline with OX390 (positive in vivo data), Izipry (on track for Q3 2026 FDA filing), and OX640 (pivotal trial scheduled for Q4 2026), while divesting Zubsolv US business and focusing on AmorphOX platform.

• Strengthened business development by hiring a new Head/SVP of Business Development and expanding partnerships and collaborations, especially for AmorphOX technology.

• Underwent significant transformation post-Zubsolv sale, incurring one-time costs to exit contracts and reduce staff in both the U.S. and Sweden.

• Initiated early-stage collaborations for GLP-1 agonists and vaccines using AmorphOX.

• Ongoing settlement negotiations with the US DOJ regarding a multi-year investigation, with insurance expected to cover part of the settlement.

Financial highlights

• Q2 2026 net revenues were SEK 3.5m, down from SEK 4.8m year-over-year, mainly due to lower royalties from Abstral and Edluar, but higher Zubsolv ex-US royalties due to positive Q1 true-up.

• Operating expenses reached SEK 107m, inflated by SEK 20m in one-time settlement and legal fees; EBIT for Q2 2026 was SEK -103.3m.

• Net loss from continued operations was SEK -102.5m; discontinued operations contributed SEK 2.1m.

• Cash and cash equivalents at quarter-end were SEK 276.9m, with SEK 233m net cash position (excluding SEK 44m payable to Dexcel).

• Cash flow from operating activities was SEK -93.3m in Q2 2026.

Outlook and guidance

• Izipry FDA filing expected in Q3 2026, with approval targeted for Q1 2027.

• OX640 pivotal trial to start in Q4 2026, with results expected in Q1 2027; major investments focused on this program through 2028.

• Ongoing partnering efforts for OX640 (global) and Izipry (U.S.), aiming to secure partners for commercialization and late-stage development.

• Additional financing required to execute business plan and resolve DOJ investigation; options under evaluation.

• Expectation to reduce expenses further as legacy U.S. operations wind down and office move in Sweden halves office costs from next year.