Uppsala, Sweden – September 04, 2026 -- Orexo AB has reached a non-binding agreement in principle with the US Department of Justice to pay USD 4 million in installments over several years, closing a federal investigation that began in 2020.
Orexo agrees to capped contingent payment tied to 2030-2031 sales thresholds
Beyond the fixed USD 4 million payment, Orexo would accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales-related thresholds are met in 2030 and 2031 and Orexo's commercial products perform successfully in the market. The company is in the final stages of negotiating the settlement but cautions there is no assurance the deal will be finalized on these terms.
Settlement structure avoids admission of wrongdoing via Non-Prosecution Agreement
The arrangement would take the form of a Non-Prosecution Agreement combined with a separate civil settlement, with no admission of wrongdoing by Orexo or any current or former employees. Once finalized, the agreements would resolve the DOJ investigation entirely, eliminating further legal exposure for the company on the matters covered.
Two former US employees separately settle civil claims with DOJ
Orexo said it understands that two former Orexo US employees have reached their own agreements in principle with the DOJ to resolve civil claims. The company intends to seek insurance coverage to cover the full settlement amount for these former employees.
Orexo books USD 4 million provision ahead of final agreement
As a result of the progress in talks, Orexo expects to recognize a provision of USD 4 million for the anticipated liability. Further financial details will be disclosed separately once a final settlement agreement is signed with the DOJ.
President and CEO Nikolaj Sørensen said the investigation had run for more than six years and that the decision to settle reflects the significant costs of a continued legal process rather than any admission of fault, allowing the company to focus on its research and development pipeline.