Orexo (ORX) DNB Carnegie Småbolagsdag summary

Key business highlights

• Focus on developing improved pharmaceuticals using proprietary drug delivery technologies, with 30 years of experience and a strong commercial platform in the US addressing opioid use disorder (OUD).

• Lead product Zubsolv® and digital support program MODIA® target OUD, generating SEK 5.85 billion in net revenue since 2013 US launch.

• AmorphOX® technology offers improved stability and shelf life for sensitive molecules, validated in multiple clinical trials and applied to both internal and partnered projects.

• Commercial platform robustly addresses the opioid crisis, with medication-assisted treatment, digital support, and rescue medications.

• US commercial net revenues for YTD 2025 reached SEK 246 million, with an EBIT margin of 33%.

Product pipeline and innovation

• Zubsolv® remains a key product for OUD, while new products like Izipry™ (naloxone, registration phase) and OX640 (adrenaline, clinical phase) expand the portfolio.

• AmorphOX® enables development of intranasal rescue medications and expansion into large molecules, with ongoing partnerships to broaden scope and reduce risk.

• Izipry™ is designed for high-dose efficacy against synthetic opioid overdoses, offering improved stability and insurance coverage potential.

• OX640 aims to transform emergency anaphylaxis treatment with superior absorption, fast action, and longer shelf life; partnering for global commercialization is ongoing.

• AmorphOX® platform validated for a wide range of molecules, including small molecules, peptides, and biologics, with strong chemical stability data.

Market trends and financial outlook

• Buprenorphine/naloxone market showed 4% YoY and 2% QoQ growth in Q2 2025, with commercial segment up 11% as patients switched from Medicaid.

• Medicaid segment growth stagnated at 1%, while cash segment declined by 11%.

• Full-year 2025 financial forecast confirmed, targeting positive EBITDA; YTD 2025 net revenues at SEK 264.5 million.

• Lower OPEX due to reduced SG&A and R&D costs, with positive EBITDA of SEK 4.7 million when excluding non-recurring rebate.

• Legal update: ongoing resolution negotiations regarding a subpoena related to past marketing campaigns, with no filed cases known.