Orexo Q3 2026 Interim Report
October 22, 2026
Orexo in transformation
Financial summary July – September
- Total net revenues of SEK 0.8 m (4.8)
- Net earnings for the period are SEK -117.9 m (-99.7)
- Cash flow for the period is SEK -124.3 m (-15.7)
- Earnings per share before and after dilution SEK -3.36 (-2.87)
- Net earnings for the period for discontinued operations is SEK 21.5 m (69.8).
Operational highlights July – September
- Izipry™: The NDA resubmission to the FDA was completed on 29 September, addressing the items identified in the Complete Response Letter. Potential FDA approval expected in the first half of 2027
- OX640: The FDA accepted the IND application for the treatment of anaphylaxis, enabling initiation of the pivotal clinical program planned for Q4 2026
- OX390: BARDA provided an additional USD 2.99 million, extending the initial development stage to the end of 2027 and supporting further FDA-required activities
- A non-binding agreement in principle was reached with the US Department of Justice (DOJ) to settle the investigation ongoing since 2020
Significant events after the end of the period
- On October 6, the Board resolved on a rights issue of approximately SEK 250 million, subject to approval by an extraordinary general meeting on November 6, 2026
- Orexo reports encouraging bioavailability in first in vivo study of oral semaglutide formulation based on AmorphOX®
| SEK m unless otherwise stated | 2026 Jul-Sep | 2025 Jul-Sep | 2026 Jan-Sep | 2025 Jan-Sep | 2025 Jan-Dec |
| Net revenues | 0.8 | 4.8 | 9.3 | 22.8 | 26.0 |
| Cost of goods sold | -0.1 | -0.1 | -0.6 | -4.9 | -14.5 |
| Operating expenses | -99.3 | -92.8 | -285.4 | -267.4 | -364.3 |
| Of which research and development expenses/operating expenses, % | 48 | 62 | 49 | 59 | 64 |
| EBIT | -98.5 | -88.0 | -276.8 | -249.5 | -352.7 |
| EBIT margin % | neg. | neg. | neg. | neg. | neg. |
| EBITDA | -90.4 | -76.8 | -251.5 | -215.7 | -285.7 |
| Earnings per share before dilution, SEK | -3.36 | -2.87 | -9.31 | -8.32 | -11.65 |
| Earnings per share after dilution, SEK | -3.36 | -2.87 | -9.31 | -8.32 | -11.65 |
| Cash flow from operating activities | -118.1 | -70.1 | -244.7 | -165.1 | -195.4 |
| Cash and cash equivalents Orexo | 62.1 | 105.6 | 62.1 | 105.6 | 912.4 |
| Outstanding rebates related to the Dexcel agreement | 25.9 | — | 25.9 | — | — |
| Cash and cash equivalents payable to Dexcel | 64.6 | — | 64.6 | — | — |
| Total Cash and cash equivalents | 152.6 | 105.6 | 152.6 | 105.6 | 912.4 |
| Unless otherwise stated, all data refers to continued operations post Zubsolv US divestment as of Dec. 31 2025. Discontinued operations are presented in Note 10. | |||||
CEO comments in brief
During the quarter, we made strong progress in transforming Orexo, resolving long-standing matters and advancing our future growth. In August, after six years of investigation, we announced a settlement in principle with the DOJ. In September, we submitted Izipry™ to the US Food and Drug Administration (FDA). Our other programs also advanced: the FDA accepted the IND for OX640, and BARDA increased funding for OX390 by USD 2.99 million, bringing the total contract value to USD 53.8 million.
In early October, we announced a rights issue to strengthen our financial position, enhance our position in potential partnership discussions, and provide the resources needed to execute our business plan.
Uppsala, Sweden, October 22, 2026
Nikolaj Sørensen
President and CEO
Contact persons
Nikolaj Sørensen, President and CEO
Fredrik Järrsten, EVP and CFO
+46 18 780 88 00
ir@orexo.com
Presentation
October 22, at 2 pm CEST analysts, investors and media are invited to attend a presentation, incl. a Q&A. Participants may access the event via live webcast or teleconference through the following link:
https://investorcaller.com/events/orexo/orexo-q3-report-2026
Prior to the call, presentation material will be available on the website under Investors/Rapport archive.
