Zubsolv^® divestment unlocks financial strength and sharpens strategic focus

The decision to divest all US rights to Zubsolv was not taken lightly but has been an option assessed as part of a strategic review starting with the successful closure of the patent litigation with Sun Pharmaceuticals (Sun). The settlement with Sun triggered interest from other companies to acquire Zubsolv. After receiving concrete proposals we decided to initiate a competitive process leading to the divestment of Zubsolv for an upfront consideration of USD 91 million and additional potential through an Earn-Out of up to USD 16.8 million. With this transaction we have secured most of the expected EBIT contribution from Zubsolv until patent expiry, enabling the company to redeem the corporate bond and become debtfree. However, more importantly, the transaction enables Orexo to continue investments in the AmorphOX^® platform and our expanding pipeline of development programs.

The performance of the AmorphOX technology has already established it as the most advanced nasal powder technology in the world. It has unique properties to improve bioavailability and stability for both large and small molecules, enabling new approaches to administration, manufacturing, and distribution. This combined with an established manufacturing process for nasal administration and patent protection until 2044, means we have the potential to expand into several new promising and fast-growing therapeutic areas.

With the proceedings from the Zubsolv^® transaction we will invest in three areas. 

1. We will continue developing the platform to enable new applications and generate the proof-of-concept data needed, for example in peptides such as GLP-1 agonists and proteins such as vaccines. To generate data, we will collaborate with leading pharmaceutical companies, contract manufacturers and academia.
2.  We will develop our proprietary projects until key valueinflection points, such as pivotal clinical data or approval. Thereafter, consider the appropriate commercialization strategy, which will primarily be based on partnerships, but with the possibility for more direct involvement from Orexo in the commercialization in the US.
3. The third area is to enter into partnerships with pharmaceutical companies that utilize AmorphOX in their projects, with Orexo being compensated through payment for work performed as well as future commercial royalties and milestone payments

During the quarter we have continued to advance our formulation work applying AmorphOX to GLP-1 agonists and specifically to semaglutide. The first in-vivo study was promising, but to be competitive we see opportunities to improve bioavailability through optimization of the formulation. We are also convinced AmorphOX has potential in vaccines and are working to expand the testing into a broader scope in collaboration with leading vaccine experts.

We are on track with our OX640 program, for nasal treatment of anaphylaxis, to initiate the first pivotal trial in Q4 this year. The pivotal trial program requires products manufactured at commercial scale, and we are making the final preparations for production, utilizing the manufacturing process established for Izipry™, our opioid overdose rescue medication. The first trial, in patients undergoing an allergy challenge, is very important as a value inflexion point in partnership discussions and an enabler to secure an agreement with attractive upfront, milestone and royalty payments.

OX390, for the treatment of patients overdosing with opioids adulterated by alpha-2 agonists, has had an intensive start. The project involves colleagues from both the US and Sweden and is co-developed with BARDA,¹ who cover the majority of the expenses with funding up to a value of USD 51 million. The focus in Q4 has been on formulation development and in-vitro testing to ensure we have the best possible opportunity to meet the desired endpoints in the first in-vivo proof-of-concept study starting early in 2026.

Finally, Izipry is making good progress towards a resubmission in Q3, and we are planning for the testing of the new batches that are currently undergoing stability studies. Due to the divestment of Zubsolv we intend to find a partner for commercialization of Izipry in the US.

_{1. Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Administration for Strategic Preparedness and Response in the US Department of Health and Human Services}

Making AmorphOX available to partners is a core element of our updated strategy. These partnerships will be based on Orexo’s documentation and proof‑of‑concept data from molecules similar to those the potential partner company is working with. In recent years, we have conducted several studies together with potential partners in this category, where Orexo has been partially compensated for the work performed while the partner has covered most of the external costs. This is a growth area and one we will work intensively to further develop.

2026 will be exciting for Orexo, but it will also be a year with high expectations to show concrete progress with AmorphOX, the development pipeline and partnering. Key priorities will be to initiate the first pivotal trial for OX640, analyzing in-vivo data from OX390, resubmit Izipry with the FDA and to progress within peptides and vaccines. We  will outline more detailed plans at our upcoming R&D Day, on March 24, as well as providing deeper insight into our updated strategy.

We begin 2026 as a transformed company, and have started a process to optimize our organization and expenses in light of the new strategy. During a transition period parts of Orexo’s continued operations will support Dexcel and we aim to have the restructuring completed during the autumn of 2026.

I want to take this opportunity to show my appreciation and gratitude to the colleagues who are now leaving the company. Most have left to join Dexcel, but unfortunately some will need to leave as we are downsizing our operations related to Zubsolv and reducing our US presence to a small office focused on the development programs. I am impressed with the engagement and loyalty many colleagues have shown, even when their future at Orexo was at risk. Closing the deal with Dexcel on New Year´s Eve, was symbolic of our new start. It also took extraordinary effort from many Orexo colleagues and our advisors to make this happen and I want to thank all of you for your strong efforts.