Intercept Pharma to restructure

The Company will promptly begin the process of closing out the REGENERATE study. The Company expects to substantially complete the trial shut-down process by the end of 2023. In addition to closing out REGENERATE, Intercept is quickly winding down all other NASH-related spending within the Company’s R&D, commercial, medical affairs and administrative functions. Actions taken by Intercept to reduce its operating expenses are projected to result in a workforce reduction of approximately one third of the Company. Intercept expects to initiate workforce reductions in the third quarter of 2023, with the vast majority completed by the end of 2023. Intercept plans to maintain the scale of its current field sales organization to support the growth potential of Ocaliva (obeticholic acid or OCA).Intercept will continue its strong investment to support Ocaliva, the only FDA-approved second-line treatment for people living with primary biliary cholangitis (PBC). The Company has generated meaningful new data with innovative studies that leverage real-world evidence and will continue to do so going forward. Intercept remains on track for a planned regulatory submission to the FDA in 2023 in support of fulfilling post-marketing requirements for Ocaliva in PBC. Intercept will prioritize R&D investment on its fixed-dose combination of OCA and bezafibrate, a peroxisome proliferator-activated receptor agonist. The first Phase II interim analysis for the OCA-bezafibrate combination was presented at the 2023 European Association for the Study of the Liver Congress.