Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) recently revealed its plans for a strategic restructuring aimed at strengthening its focus on rare and serious liver diseases while significantly reducing operating expenses. The company's President and CEO, Jerry Durso, emphasized the decision's objective to drive long-term growth, support innovative medicines, and achieve profitability by 2024.

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Planned Actions and Financial Impacts

Closing out the REGENERATE study

Intercept will initiate the process of closing out the REGENERATE study promptly. The company anticipates completing the trial shut-down process by the end of 2023, thereby discontinuing nonalcoholic steatohepatitis (NASH)-related investment.

Winding down NASH-related spending

Intercept is swiftly winding down all NASH-related spending across its research and development (R&D), commercial, medical affairs, and administrative functions.

Workforce reduction

As part of the expense reduction measures, Intercept plans to implement a workforce reduction of approximately one third of the company. These layoffs are projected to begin in the third quarter of 2023, with the majority expected to be completed by year-end. The company will maintain the scale of its current field sales organization to support the growth potential of Ocaliva®, its FDA-approved second-line treatment for primary biliary cholangitis (PBC).

Cost savings and financial targets

Intercept aims to achieve a net reduction of approximately $140 million in annual non-GAAP adjusted operating expenses. This reduction will be relative to updated 2023 non-GAAP adjusted operating expense guidance and will be effective upon completion of the restructuring and the close-out of the REGENERATE study. The company has revised its 2023 non-GAAP adjusted operating expense guidance to $350 million to $370 million.

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Strengthened Focus on Rare and Serious Liver Diseases

Support for Ocaliva

Intercept will continue its strong investment in Ocaliva, the FDA-approved second-line treatment for PBC. The company is dedicated to generating meaningful data through innovative studies that leverage real-world evidence.

Regulatory submission and R&D investment

Intercept remains on track to submit data to the FDA in 2023 to fulfill post-marketing requirements for Ocaliva in PBC. The submission will include data from the post-marketing study COBALT and supplementary real-world evidence from large datasets in the U.S. and Europe. Moreover, Intercept will prioritize research and development investment in the fixed-dose combination of OCA and bezafibrate to further improve the treatment of PBC.

Advancement of INT-787

The company continues to advance the Phase 2a FRESH study for INT-787, a next-generation farnesoid X receptor (FXR) agonist. The goal is to establish a proof-of-concept in severe alcohol-associated hepatitis.