Orexo (ORX) investor relations material

Strategic transformation and platform focus

• Transitioning from a single-product model to a scalable platform company centered on the AmorphOX technology, which has demonstrated versatility across over 20 molecules and multiple delivery methods.

• AmorphOX platform offers unique stability and bioavailability advantages, with patent protection potentially extending to 2047 and robust process know-how.

• Manufacturing processes for AmorphOX are established in FDA-inspected facilities in Switzerland and Canada, supporting reliability and regulatory compliance.

• The company is actively pursuing partnerships to leverage AmorphOX in both internal and external projects, aiming to reduce risk and expand market reach.

• Business model now emphasizes out-licensing, royalties, and milestone payments, with a focus on divesting late-stage projects and securing external funding.

Pipeline and product development

• Pipeline includes three main projects: OX124 (Izipry) for opioid overdose, OX640 for anaphylaxis, and OX390 for adulterated opioid overdose, with OX124 FDA filing imminent and OX640 pivotal trial results expected in Q1 next year.

• OX640 demonstrates exceptional stability and rapid action in anaphylaxis, outperforming current nasal and injectable competitors in preliminary studies.

• Izipry targets the growing high-dose naloxone market, addressing fentanyl overdoses where higher doses are increasingly required.

• OX390 is largely funded by the U.S. government to address overdoses involving potent alpha-2 agonists mixed with fentanyl.

• Early-stage projects include oral semaglutide and vaccine formulations, with ongoing in vivo studies and partnership discussions.

Financial and operational updates

• Sale of the U.S. entity and ZUBSOLV product generated $91 million plus potential earn-outs, with restructuring efforts underway to streamline operations and exit legacy contracts.

• Earn-out payments from ZUBSOLV sales are expected over the next two years, with European relaunch facilitated by local manufacturing.

• Royalties from legacy products ABSTRAL and EDLUAR continue at low levels.

• Focus on cost reduction and risk-sharing through early-stage partnerships and external funding, including BARDA support.