Investment themes
1. Commercial presence in the US with extensive synergies
One of the key strategic priorities for growth is to capitalize on the company's commercial position in the US. Orexo's US subsidiary, Orexo US Inc. has long experience in pricing and reimbursement, sales and marketing, phase IW and RWE clinical trials focusing on one of the largest health crises in the US in modern times - opioid use disorder (OUD). Today Orexo is commercializing Zubsolv for OUD. Adding additional products to the US commercial platform offers significant synergistic benefits.
2. Strong cash generation from US Commercial business segment
Orexo's lead drug Zubsolv® is an important cash generator. In 2023, EBITDA for US Commercial, which is entirely related to Zubsolv sales, amounted to SEK 196 million. Revenue from Zubsolv is an important addition to the operation of the business. Zubsolv has patent protection until 2032 and Orexo will continue to optimize operations around Zubsolv maintain and improve profit contribution.
3. Orexo’s next generation drug delivery technology, AmorphOX®, unlocks a broad range of new opportunities
AmorphOX is a unique innovative new powder-based drug delivery technology.
- AmorphOX has repeatedly proven to have superior bio-availability compared to other nasal delivery technologies
- AmorphOX enables nasal delivery for small molecules, peptides and biologics previously thought to be impossible to formulate for alternative routes of administration
- AmorphOX can significantly improve shelf life and reduce need for cold chains, even in very fragile and sensitive bio-molecules, through outstanding chemical and physical stability
- AmorphOX offers cost efficient large scale manufacturing
- AmorphOX initial patents protect the formulation technology until 2039-2044 and additional patent protection is expected with new molecules.
4. AmorphOX paves the way for continued pipeline growth of Orexo led projects
AmorphOX is a scalable technology and is the cornerstone in Orexo’s current internal pipeline. AmorphOX is used in the drug candidates OX124 (registration phase) and OX125, both developed to offer an improved treatment of opioid overdose. AmorphOX is used in OX640 (clinical stage) for treatment of anaphylaxis and have proved to have unparalleled stability and bio-availability compared to other formulations of epinephrine. AmorphOX will be the backbone in the future development of new innovative drugs targeting large unmet needs.
5. AmorphOX enables partnership with both established leading biotech companies and new companies with ground breaking therapies
Orexo continue to seek partnerships with companies with exciting molecules where AmorphOX enable new drug delivery pathway for their molecules and improve stability of the finished product. Orexo has already entered early stage partnerships with several companies to evaluate AmorphOX ability to improve their product properties such as the leading Swedish biotech company, Sobi. These partnerships will be based on a combination of fee for service and future royalty payments from the license to use AmorphOX.
