Orexo (ORX) Seminar Presentation summary

Business overview and strategy

• Focuses on developing improved pharmaceuticals using proprietary drug delivery technologies, with 30 years of experience in the field.

• Addresses unmet needs in opioid use disorder (OUD) and other therapeutic areas.

• Operates a commercial platform in the US, with Zubsolv® as the lead product and MODIA® as a digital support program for OUD patients.

• AmorphOX® platform enables expansion beyond OUD, supporting both internal and partnered projects.

• Recognized for sustainability, ranking in the top 5% by EcoVadis in June 2024.

Product portfolio and pipeline

• Zubsolv® targets OUD with a differentiated position, broad dose range, and strong reimbursement coverage.

• Pipeline includes OX124 (naloxone, registration phase), OX125 (nalmefene), and OX640 (adrenaline, clinical phase), all leveraging AmorphOX® technology.

• AmorphOX® platform validated in multiple clinical trials, offering improved stability and bioavailability for small molecules, peptides, and biologics.

• OX124 NDA filed with FDA in 2023, addressing synthetic opioid overdoses; OX640 shows positive clinical data for anaphylaxis treatment.

• Active partnering process for AmorphOX® and OX640, with ongoing collaborations in vaccines and protein-based products.

Market dynamics and commercial performance

• US OUD market shows accelerating growth, with Zubsolv® maintaining stable revenues and strong presence in commercial and public payer segments.

• New US legislation and opioid litigation funding support increased access to treatment and branded products.

• Zubsolv® achieved SEK 578m net revenue and SEK 177m EBITDA in 2024, with 98% commercial payer reimbursement.

• Settlement with Sun Pharmaceuticals removes near-term IP litigation risk, maintaining Zubsolv® exclusivity until at least September 2030.

• Market for opioid overdose rescue and anaphylaxis treatments projected to grow at 10% and 8% CAGR, respectively.