Orexo AB

Orexo reported net revenues of SEK 3.5 million in Q2. Continued-operations OpEx was SEK 107 million, and management said that excluding non-recurring transition items, the quarter would have been around SEK 60 million excluding depreciation, or about SEK 240 million annualized. Net profit from continued operations was -SEK 102.5 million; discontinued operations contributed +SEK 2.1 million. Cash flow from continued operations was -SEK 98 million, cash flow from discontinued operations was -SEK 14 million, and total negative cash flow was SEK 112 million. Cash at quarter-end was SEK 277 million, of which SEK 44 million belonged to Dexcel, leaving Orexo with SEK 233 million of its own cash. For guidance, management said Izipry is expected to be filed in September, with a six-month FDA review pointing to approval at the end of Q1 next year. OX640 remains on track for a Q4 nasal allergy challenge study and is expected to require roughly SEK 200 million from today until filing, with a filing currently discussed for 2028. The GLP-1 semaglutide in vivo study is expected in Q3.

The CEO framed the quarter as part of a deliberate cleanup and transformation after the Zubsolv sale, saying the company is trying to come through with a “clean slate” and redirect resources toward long-term value creation. He emphasized AmorphOX as the central platform behind all of the company’s programs, and repeatedly highlighted near-term milestones in OX390, Izipry, OX640, and the GLP-1 and vaccine-related work. His tone was optimistic but pragmatic: he stressed partnering, financing flexibility, and the need to keep the company well-funded while navigating the DOJ process and legacy costs.

The CFO focused on the financial impact of the transition, noting that Q2 OpEx of SEK 107 million was elevated mainly by the roughly SEK 20 million GAIA settlement, plus higher legal fees tied to the DOJ investigation and higher R&D spend on OX640 and OX390. He said BARDA reimbursed SEK 4.5 million of OX390-related costs, helping offset R&D, and that normalized OpEx excluding non-recurring transition and legal costs would have been about SEK 60 million for the quarter. He also highlighted that rebate payments tied to prior Zubsolv sales should decline sharply, with only SEK 3 million left to pay this year, and that SEK 44 million of cash on hand belongs to Dexcel under the transition services arrangement. He said the Swedish workforce was reduced by about 10% and that net finance items were positive at SEK 1 million due mainly to higher interest income.

Analysts focused on the DOJ process, asking whether management had received a settlement term sheet and whether equity financing would likely wait until the DOJ matter is resolved. Management said there is no written term sheet yet, but there have been concrete discussions about one, and that more clarity on DOJ would likely be needed before raising equity. On OX640, management explained that most of the SEK 200 million planned spend is not just the clinical trial itself but also stability, reliability, and manufacturing work; they also said the pivotal package includes a nasal allergy challenge study, a self-administration study, and possibly a repeat-dosing or pediatric study depending on results. Questions on the GLP-1 collaboration clarified that the industrial partner is providing know-how and some materials under confidentiality, but that Orexo is running and funding the study, and that any positive result would be more of a door-opener than an automatic partnership trigger.