Orexo Q2 2026 Interim Report
July 16, 2026
Building momentum for the next chapter
Financial summary April – June
- Total net revenues of SEK 3.5 m (4.8)
- Net earnings for the period is SEK -102.5 m (-97.5)
- Cash flow for the period is SEK -109.3 m (2.2)
- Earnings per share before and after dilution SEK -2.92 (-2.81)
- Net earnings for the period for discontinued operations is SEK 2.1 m (57.8).
Operational highlights April – June
- Izipry: Supportive stability and reliability data for the final commercial product were generated, supporting the planned NDA resubmission in Q3 2026. Potential FDA approval expected in Q1 2027
- OX640 advanced toward pivotal development, with commercial-scale manufacturing and study preparations progressing according to plan ahead of Q4 2026
- OX390 delivered positive proof-of-concept in vivo data and achieved further regulatory alignment with the FDA, supporting continued advancement of the program
- A scientific collaboration with a pharmaceutical organization was initiated to support the expansion of AmorphOX® into GLP‑1 agonists and other large molecule applications
- Growing external interest in AmorphOX generated multiple partnering discussions across small molecules, peptides and vaccines.
Significant events after the end of the period
- No significant events after the end of the period.
| SEK m unless otherwise stated | 2026 Apr-Jun | 2025 Apr-Jun | 2026 Jan-Jun | 2025 Jan-Jun | 2025 Jan-Dec |
| Net revenues | 3.5 | 4.8 | 8.5 | 17.9 | 26.0 |
| Cost of goods sold | -0.1 | -0.1 | -0.6 | -4.8 | -14.5 |
| Operating expenses | -106.7 | -89.9 | -186.2 | -174.6 | -364.3 |
| Of which research and development expenses/operating expenses, % | 46 | 59 | 49 | 57 | 64 |
| EBIT | -103.3 | -85.3 | -178.2 | -161.5 | -352.7 |
| EBIT margin % | neg. | neg. | neg. | neg. | neg. |
| EBITDA | -95.1 | -73.8 | -161.1 | -139.0 | -285.7 |
| Earnings per share before dilution, SEK | -2.92 | -2.81 | -5.95 | -5.44 | -11.65 |
| Earnings per share after dilution, SEK | -2.92 | -2.81 | -5.95 | -5.44 | -11.65 |
| Cash flow from operating activities | -93.3 | -53.4 | -126.8 | -95.0 | -195.4 |
| Cash and cash equivalents Orexo | 232.8 | 121.3 | 232.8 | 121.3 | 912.4 |
| Cash and cash equivalents payable to Dexcel | 44.1 | — | 44.1 | — | — |
| Total Cash and cash equivalents | 276.9 | 121.3 | 276.9 | 121.3 | 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 good progress across our portfolio of rescue medications, including OX640 for the treatment of anaphylaxis, Izipry™ for synthetic opioid overdose and OX390 for adulterated opioid overdose. We remain on track to reach important value inflection points, including the start of the pivotal trial for OX640 in fourth quarter of 2026 with read-out in the first quarter of 2027, and a potential FDA approval of Izipry in the first quarter of 2027 following the planned resubmission in the third quarter of this year.
For OX390, which is being developed in collaboration with BARDA, operating under the US Department of Health and Human Services, we reported successful in vivo study results during the quarter. At the same time, our strengthened business development team is seeing growing interest in the AmorphOX technology from external parties.
Following the divestment of Zubsolv® US, we continue to adapt and optimize the organization to support our new growth strategy. We are also intensifying our efforts to resolve the Department of Justice (DOJ) investigation.
To fully realize the value of our technology platform and development pipeline, while also removing the unresolved DOJ-related legal matters, we have initiated a process to evaluate opportunities for securing additional financing together with our financial advisor, DNB Carnegie.
Uppsala, Sweden, July 16, 2026
Nikolaj Sørensen
President and CEO
For full CEO Comments see PDF
Contact persons
Nikolaj Sørensen, President and CEO
Fredrik Järrsten, EVP and CFO
+46 18 780 88 00
ir@orexo.com
Presentation
July 16, 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-q2-report-2026
Prior to the call, presentation material will be available on the website under Investors/Rapport archive.
