Orexo (ORX) investor relations material

Strategic transformation and platform focus

• Transitioning from a single-product model to a scalable platform company centered on AmorphOX technology, which has demonstrated versatility across over 20 molecules and multiple delivery methods, and has over 500 formulations developed over 8 years.

• AmorphOX platform offers unique stability, bioavailability, and needle-free delivery benefits, with patent protection extending to 2047 and robust process know-how that is difficult to replicate.

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

• The company is actively pursuing partnerships and out-licensing opportunities for AmorphOX-enabled projects, aiming to reduce risk, expand market reach, and drive value growth.

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

Pipeline and product development

• Pipeline includes OX640 (nasal epinephrine for anaphylaxis), Izipry (OX124, naloxone for opioid overdose), OX390 (atipamezole for adulterated opioid overdose), and OX472 (semaglutide for obesity), with OX124 FDA filing imminent and OX390 largely funded by BARDA.

• OX640 demonstrates exceptional stability and rapid action, with pivotal trial results expected in Q1 next year and pivotal trials entering Q4 2026.

• Izipry targets the high-dose naloxone market, with manufacturing completed in Q4 2025 and FDA resubmission expected in Q3 2026; commercialization partnership sought.

• Early-stage projects include oral and nasal formulations for GLP-1 agonists (semaglutide) and thermostable vaccines, with promising initial bioavailability and preclinical results.

• Legacy products like ZUBSOLV continue to generate royalties, with European manufacturing now established to improve cost efficiency.

Financial and operational updates

• Sale of the U.S. entity and ZUBSOLV generated $91 million upfront and up to $16.8 million in earn-outs, with first payments expected next year.

• Cash position of SEK 233m as of June 30, 2026, with additional funding from product divestments and BARDA contributions.

• Restructuring involved significant layoffs and contract exits in both Sweden and the U.S., with remaining rebate and return obligations from ZUBSOLV sales expected to fade after Q3.

• Royalties from commercial products and partner-funded R&D are key financing sources, with ongoing evaluation of long-term capital market financing.

• Headquarters in Uppsala, Sweden, with a US subsidiary in New Jersey and listings on Nasdaq Stockholm and OTCQX.