Resolving issues, unlocking more 
flexibility 

The market for daily treatment of buprenorphine/naloxone has continued to improve and grew 2 percent in Q4 over last year and full year growth is 3 percent, which is within the guidance of 2-5 percent for the year. The market growth supports the stable demand of Zubsolv year over year and I am pleased to see both demand and revenues grow from Q3. Despite the strong ­recovery of revenues in the fourth quarter, sales in USD are slightly lower both in the quarter and across the full year comparing to 2023. Our 2024 guidance was sales in USD “in line with 2023”, and with a deviation of 2.6 percent, we were relatively close to meeting the target. 

The market growth is driven by continued double-digit growth in the Commercial segment, whereas Medicaid continues the negative trend seen since mid-last year. The Commercial ­segment is the most important for Zubsolv sales and growth in the Commercial segment is likely to have a positive impact on sales and margins over time. The price of Zubsolv was increased by January 1st and will support ­continued stable sales in 2025. The main uncertainty in the year is related to Medicare where a new pricing and rebate system was implemented by January 1, 2025. The new system is likely to have a positive net price impact on ­Zubsolv, but some payers have implemented policies to favor generic alternatives for certain patient groups which might have a negative impact primarily on volume and, to a lesser extent, net sales. 

During the quarter we have worked intensively with our ­legal ­advisors to find a resolution to the subpoena and DOJ ­investigation initiated in 2020. Orexo maintains the position that Zubsolv has been promoted in a compliant and ­r­esponsible manner, but the legal expenses and uncertainty associated with a court case make a settlement a more attractive option for Orexo. 

For OX124, our rescue medication for opioid overdose with ­naloxone, we have worked extensively to address the issues raised by the FDA and have presented a comprehensive plan to the agency to strengthen the documentation related to the reliability and stability of the device. A meeting has been completed with the FDA discussing the plan presented by Orexo, but the FDA has reserved the rights to review if the data is comprehensive enough when submitted. Unfortunately, the timeline of the submission of the new data remains uncertain. This is primarily related to delays in the supply of necessary components of the product from one of our suppliers. When we receive the delivery, we will immediately start the commercial manufacturing of OX124 and initiate the necessary testing. Thus, the final timeline for approval of OX124 is dependent on when the supplier can deliver the parts, our completion of the tests and the FDA´s review time, which will be communicated after the data submission is complete. 

With OX640 we are aiming at developing a nasal epinephrine product for anaphylaxis and in Q4 we reached an important development milestone as we conducted a new clinical study that showed strong data which was communicated in the beginning of the new year. The study improved our evidence of the impact on bioavailability of epinephrine in OX640 in patients with allergic rhinitis, but also provided more information about the dose required to ensure we have a competitive product. With the results it is evident the bioavailability of OX640 improves with allergic rhinitis, which is important since this is a common reaction to anaphylaxis. We will use this new data in our discussions with potential partners and it enable us to prepare our next step in the development, which is upscaling of the manufacturing of OX640 to  commercial scale. 

We have also started a collaboration with Abera Bioscience to develop nasal powder vaccines based on the AmorphOX^® technology. Abera has an innovative and promising vaccine platform for the development of mucosal vaccines, as confirmed by their recent funding from CEPI (the Coalition for Epidemic Preparedness Innovation). The collaboration is fully in line with our strategic development of the AmorphOX platform and through the collaboration we will develop data that can be used to showcase the potential and value of our technology in vaccines. . 

From an EBITDA perspective, 2024 is the best year for Orexo since  2019, but from a net earnings perspective the year finishes with a  negative result. This is to a large degree explained by the impairment of intangibles and has no cash impact. With the review of the balance sheet and changes to the corporate structure, Orexo is in a much more  stable position with a positive equity in the parent company, limited exposure to impairment and more focused operations. 

Solving many issues in 2024 enables us to focus our efforts to continue to develop the best strategy to ensure our commercial opioid use disorder products and pipeline products have a platform to thrive from and to create value for our shareholders.

I want to take this opportunity to thank my colleagues at Orexo for their commitment to the company. We have been forced to address unexpected issues with short notice and, for more than four years, we have worked with the uncertainty of a patent litigation risking the main source of funds for the company. In light of these challenges, it is with immense pride that I and the managers continue to receive feedback from our annual employee engagement survey placing Orexo in the top tier of companies in terms of job satisfaction and commitment to Orexo.