Orexo (ORX) investor relations material

Platform and partnering

• AmorphOX is a scalable amorphous-powder platform tested for nasal delivery of small and large molecules, including proteins and vaccines.

• Platform kept sensitive molecules stable at 50°C for a month, although some normally require storage at -70°C; potential formats include nasal, inhaled and reconstituted injectable delivery.

• Manufacturing capabilities include meeting 99.999% reliability requirements for U.S. emergency products; the platform has human and CMC validation.

• Semaglutide work showed up to 7x higher bioavailability nasally than RYBELSUS; an oral tablet reached a level comparable to an advanced marketed tablet in an initial trial.

• Partnerships cover semaglutide and vaccines, including Swedish and U.S. collaborators and academic institutions; the aim is to develop these into commercial partnerships with milestones and revenues.

Development programs and catalysts

• IZIPRY, a naloxone overdose treatment, was filed with the FDA; its PDUFA date is March 29 next year, with approval expected early next year.

• OX640, a nasal anaphylaxis treatment, had a good second quarter; pivotal trial results are expected early next year, with market development underway in the U.S. and Europe.

• OX640 completed an upscale manufacturing run of 12,000 units during the summer, with final quality control underway; its bioavailability profile showed faster, extended uptake under nasal rhinitis conditions.

• OX390 targets overdose involving adulterated opioids, including xylazine; BARDA awarded up to $54 million, nearly fully funding development, while commercial rights remain with the developer.

• Late-stage programs target markets exceeding $4 billion; one is filed and another could be filed as early as 2028, with several catalysts expected within six months.

Financing and operating changes

• Rights issue proceeds are primarily intended for late-stage pipeline investment and also to support early-stage programs; subscription and guarantees cover 70%, representing SEK 175 million before transaction costs.

• The U.S. business was closed after the U.S. marketed product was sold at the end of last year; streamlining included staff reductions, contract exits and legacy rebate commitments.

• More than SEK 50 million from the ZUBSOLV earnout is expected in Q1; European ZUBSOLV royalties and smaller royalties from two other products also contribute, alongside partner funding for development.