Unlocking the potential of the AmorphOX® technology
Q3 2025 highlights
› Total net revenues of SEK 118.7 m (136.5)
› EBITDA of SEK -9.8 m (-0.7), including a negative impact from costs associated with LTIP programs of SEK -12.9 m
› Net earnings of SEK -29.8 m (-41.9)
› US Commercial segment net revenues of SEK 113.9 m (131.0), in local currency USD 12.0 m (12.6)
› Cash flow from operating activities of SEK -10.3 m (-13.4), cash and cash equivalents of SEK 105.6 m (114.9)
› Earnings per share before dilution and after dilution amounted to SEK -0.86 (-1.21)
› Positive in-vivo data showed for a powder-based intranasal GLP-1 agonist medication supported by the AmorphOX® technology
› The subsidiary, Orexo US Inc., awarded approx. SEK 75 m (USD 8 m) by BARDA for the development of OX390, an intranasal rescue medication for adulterated overdoses. Pending milestones and deliverables the award is valued up to approx. SEK 480 m (USD 50.9 m).
› 2025 financial outlook reiterated.
Important events after the end of the period
› No important events after the end of the period.
| SEK m unless otherwise stated | 2025 Jul-Sep | 2024 Jul-Sep | 2025 Jan-Sep | 2024 Jan-Sep | 2024 Jan-Dec |
| Net revenues | 118.7 | 136.5 | 383.2 | 429.7 | 590.0 |
| Cost of goods sold | -7.1 | -20.1 | -36.3 | -49.7 | -72.1 |
| Operating expenses | -132.7 | -138.1 | -394.7 | -422.3 | -658.2 |
| EBIT | -21.1 | -21.7 | -47.8 | -42.2 | -140.3 |
| EBIT margin % | neg. | neg. | neg. | neg. | neg. |
| EBITDA | -9.8 | -0.7 | -14.0 | 20.2 | 48.9 |
| Earnings per share, before dilution, SEK | -0.86 | -1.21 | -2.47 | -2.51 | -5.89 |
| Earnings per share, after dilution, SEK | -0.86 | -1.21 | -2.47 | -2.51 | -5.89 |
| Cash flow from operating activities | -10.3 | -13.4 | 21.9 | -38.8 | -32.6 |
| Cash and cash equivalents | 105.6 | 114.9 | 105.6 | 114.9 | 123.3 |
CEO Comments in brief
Orexo has a strong track record of turning platform technologies into approved medicines. Our sublingual platform enabled multiple FDA-approved products, including Zubsolv® and Abstral®, that generated significant revenues for the company. Building on that success, we are now concentrating resources on the AmorphOX® platform, our next-generation formulation engine designed to unlock proprietary products and expand our pipeline.
During the quarter, we reached two key milestones that reinforce the scalability of the AmorphOX platform. The breakthrough with the GLP-1 agonist and the BARDA¹ financing secured for the OX390 project both strengthen the platform and its future potential. I am encouraged by the enthusiasm these developments have generated among our key stakeholders, and by the growing recognition of AmorphOX's long-term value.
From a financial perspective, EBITDA was negative, however, we would have reported positive EBITDA for the quarter absent provisions for social security fees related to the long-term incentive program following the positive share price development in the quarter. Zubsolv demand is stable, but top line sales were impacted by foreign exchange rate headwinds and significantly lower inventory levels with the wholesalers. We expect Zubsolv sales to improve in the fourth quarter consistently with historical seasonal patterns and we maintain our full-year guidance.
Uppsala, Sweden, October 23, 2025
Nikolaj Sørensen
President and CEO
Contact persons interim report
Nikolaj Sørensen, President and CEO
Fredrik Järrsten, EVP and CFO
Lena Wange, IR & Communications Director
Tel: +46 18 780 88 00, +1 855 982 7658,
E-mail: ir@orexo.com.
Presentation
On October 23, 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-2025
Prior to the call, presentation material will be available on the website under Investors/Rapport archive.
This information is information that Orexo AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-10-23 08:00 CEST.