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Orexo (ORX) investor relations material
Orexo Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary23 Oct, 2025
Executive summary
Significant R&D progress with BARDA funding up to USD 51 million for OX390 and strong preclinical data for GLP-1 (OX472); commercial manufacturing of Izipry™ (OX124) completed and OX640 upscaled, though market uncertainty affects partnerships.
Q3 revenues declined year-over-year due to SEK 11 million FX headwind and lower US Commercial sales, but gross margin improved and net loss narrowed.
2025 financial outlook reaffirmed, with positive EBITDA expected and continued focus on pipeline and US commercial performance.
Ongoing US DOJ investigation and legal risks, but no civil or criminal case filed as of report date.
Market and investor interest increased following GLP-1 and OX390 developments.
Financial highlights
Q3 net revenues: SEK 118.7 million (down from SEK 136.5 million); 96% from US Commercial segment.
EBITDA: SEK -9.8 million, mainly due to SEK 12.9 million LTIP provision; adjusted EBITDA would be positive.
Gross margin improved to 94% (Q3 2023: 85%), driven by favorable FX and lower production costs.
Cash and cash equivalents at quarter-end: SEK 106 million; negative cash flow of SEK 14.9 million for the period.
Net loss for Q3: SEK -29.8 million, improved from SEK -41.9 million last year.
Outlook and guidance
2025 outlook reaffirmed: buprenorphine/naloxone market expected to grow 2–5%, Zubsolv net sales guidance USD 50–55 million, opex (excl. D&A) SEK 460–500 million.
Positive EBITDA forecast for FY 2025, with risks from non-budgeted one-time items and FX volatility.
Q4 inventory build anticipated to support sales and EBITDA targets.
BARDA funding expected to positively impact Q4 and 2025 results.
Currency sensitivity: 10% USD/SEK depreciation would reduce EBIT by ~20% of the change in net revenues.
How will AmorphOX GLP-1 data impact R&D focus?
Zubsolv: long-term commercial strategy?
Beyond Q4, how will Orexo ensure financial capacity?
When will OX390's active ingredient be disclosed?
What is the OX472 partnering strategy?
How will OX640 market research inform strategy?
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Q4 20255 Feb, 2026
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Frequently asked questions
Orexo AB, a specialty pharmaceutical company, develops and commercializes pharmaceuticals and digital therapies in the United States. The Company's strategy is to focus on developing products that reduce the risk of opioid dependence, misuse and accidental ingestion by chronic pain patients in need of effective pain management for long-lasting pain, who have been historically underserved. Furthermore, the company is differentiated by their scientifically-validated medications that treat lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The company's mission is to improve the lives of patients through acquisition, development and commercialization of new therapies as quickly as possible, with a focus on digital health technologies to rapidly deliver greater access to leading edge therapies.
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