Orexo (ORX) Investing in Life Science 2025 summary

Commercial performance and financials

• Achieved sales close to SEK 600 million last year with positive EBITDA, expecting similar results this year.

• Zubsolv generates stable sales over $50 million in the U.S., with European expansion through Accord and cost reductions underway.

• Over 90% of revenue is dollar-denominated, with most expenses also in dollars, minimizing currency impact on profitability.

• Focus remains on maintaining stable financials and exploring value-maximizing options for Zubsolv, including partnerships.

• U.S. market access and reimbursement are key priorities for both current and future products.

Pipeline and product development

• Izipry (OX124), a high-dose naloxone rescue medication, is expected to file next year after resolving FDA issues and generating required stability data.

• OX125 (nalmefene) is on hold pending market developments, while OX390 targets mixed-substance overdoses, including xylazine, in collaboration with U.S. authorities.

• OX640, a nasal epinephrine powder, shows faster uptake and greater stability than current products, with ongoing global partnership discussions.

• The competitive OTC shift in naloxone markets is prompting a focus on institutional and niche sales for prescription products.

• Commercial plans for small molecules are being adapted to evolving U.S. market dynamics and increased competition.

AmorphOX technology platform

• AmorphOX enables stable encapsulation and nasal delivery of both small and large molecules, including mRNA and vaccines, maintaining stability at high temperatures.

• Demonstrated higher bioavailability and faster uptake for nasal powders compared to other delivery forms.

• Animal studies with semaglutide powder show seven times higher uptake than oral tablets and more consistent bioavailability.

• The platform eliminates the need for cold chain logistics, attracting significant attention and partnership interest.

• Ongoing efforts to secure platform partnerships, with announcements expected once deals are signed.