Orexo AB (publ)

Orexo reported net revenues of SEK 3.5 million from continued operations in Q2. OpEx was SEK 107 million, and net profit for continued operations was -SEK 102.5 million; discontinued operations contributed +SEK 2.1 million. Fredrik Järrsten said the quarter’s OpEx would have been about SEK 60 million excluding non-recurring transition and legal items, or about SEK 240 million annualized. 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. End-of-quarter cash was SEK 277 million, including SEK 44 million belonging to Dexcel, leaving Orexo with SEK 233 million of its own cash. Management said OX124/Izipry is expected to be filed in September, with FDA review taking six months and approval expected by the end of Q1. For OX640, management reiterated a target to start the nasal allergy challenge study in Q4 and said the program could be filed in 2028, with approval either late that year or early the following year. OX640’s remaining external spend was described as around SEK 200 million from now until filing.

Nikolaj Sørensen framed the quarter as part of a deliberate transformation after the Zubsolv U.S. divestment, saying the company is cleaning up legacy issues, exiting contracts, and reducing staff to reset the cost base. He emphasized that Orexo is concentrating on an AmorphOX-based pipeline rather than trying to become a vaccine or biologics company itself, while using collaborations and partners to advance the platform. His tone was upbeat on the scientific progress and upcoming catalysts, especially Izipry, OX640, and GLP-1 and vaccine-related interest in AmorphOX.

Fredrik Järrsten said continued-operations revenue was SEK 3.5 million, with royalties pressured by expiring Abstral agreements, Middle East disruption, and generic launch pressure on Edluar in Canada, partly offset by higher Zubsolv ex-U.S. royalties. He detailed OpEx of SEK 107 million, driven mainly by a roughly SEK 20 million GAIA settlement, higher legal fees tied to the DOJ process, and higher R&D spend for OX640 and OX390, partly offset by SEK 4.5 million of BARDA reimbursement for OX390. He also noted SEK 3 million remains to be paid for rebate provisions over the last two quarters of the year, that SEK 44 million of cash is payable to Dexcel, and that the company reduced the Swedish workforce by about 10%.

Analysts focused on the DOJ process, asking whether the company had received a settlement term sheet and whether equity financing would wait for DOJ resolution; management said there is no written term sheet yet, but discussions are concrete, and that more clarity on the DOJ is needed before raising capital. Questions also probed OX640, where management said the majority of the SEK 200 million expected spend is for stability, reliability, and manufacturing work rather than the clinical trial itself, and that the first study is meant to differentiate the product from neffy by showing a more extended epinephrine profile. On GLP-1, management clarified the industrial collaboration is limited to scientific input, methods, and some materials under confidentiality, and is not yet a partnership, though positive results could lead to deeper discussions.