Intercept Pharmaceuticals, Inc. Announces Restructuring to Focus on Rare and Serious Liver Diseases
Intercept Pharmaceuticals, Inc. has announced a restructuring plan to strengthen its focus on rare and serious liver diseases, reduce operating expenses, and discontinue all nonalcoholic steatohepatitis (NASH)-related investment. The measures are aimed at reinforcing the company’s ability to drive growth in primary biliary cholangitis (PBC) business and continue developing innovative new medicines.
Planned Actions and Financial Impacts:
– The company will promptly begin the process of closing out the REGENERATE study.
– 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 is targeting a net reduction in annual non-GAAP adjusted operating expenses of approximately $140 million.
– The company has lowered 2023 non-GAAP adjusted operating expense guidance to $350 million to $370 million.
– Intercept reiterated its full-year 2023 Ocaliva net sales guidance of $310 million to $340 million.
Strengthened Focus on Rare and Serious Liver Diseases:
– Intercept will continue its strong investment to support Ocaliva, the only U.S. Food and Drug Administration (FDA)-approved second-line treatment for people living with primary biliary cholangitis (PBC).
– Intercept will prioritize R&D investment on its fixed-dose combination of OCA and bezafibrate, a peroxisome proliferator-activated receptor agonist.
– The company continues to advance the Phase 2a FRESH study for INT-787, a next-generation farnesoid X receptor (FXR) agonist, to establish a proof-of-concept in severe alcohol-associated hepatitis.
The company will host a conference call on Friday, June 23, 2023, at 8:30 a.m. ET to address the restructuring and provide updated financial guidance.
Jerry Durso, President and Chief Executive Officer of Intercept, said, “We are taking decisive actions that we believe will improve our ability to drive long-term growth and maintain leadership with our PBC business, continue to develop innovative new medicines, and achieve profitability beginning in 2024.”