— Ocaliva net sales jumped by 33% to $70.3 million from last year. US sales increased by 30% and ex-US sales climbed by 42%.
— Research and development expenses increased by 2% primarily due to increases in development program expenses relating to its lead candidate, obeticholic acid (OCA), for liver fibrosis due to nonalcoholic steatohepatitis (NASH) and costs associated with the submission of new drug application.
— The FDA has set a Prescription Drug User Fee Act target action date of June 26, 2020, for the completion of its review of its NDA seeking approval of obeticholic acid for liver fibrosis due to NASH. The NDA was first accepted by the FDA for live fibrosis due to NASH.
— Looking ahead into full-year 2020, adjusted operating expenses are expected to be $560-600 million. This reflects its investments to support the launch of OCA for liver fibrosis due to NASH, commercial efforts in primary biliary cholangitis, clinical development and pipeline programs and other operating activities.
— During the fourth quarter, the company completed enrollment of Reverse, its phase 3 study evaluating OCA for the treatment of compensated cirrhosis due to NASH.