Intercept:: Now sees NASH data in Q3

 Worldwide Ocaliva® net sales of $92.4 million and $363.5 million for the fourth quarter and full year 2021, representing 11% and 16% growth over the prior year

Company provides 2022 Ocaliva net sales guidance of $375 million to $405 million and non-GAAP adjusted operating expense guidance of $360 million to $390 million

Data package from REGENERATE Phase 3 study in fibrosis due to NASH being generated; targeting potential pre-submission meeting with FDA in 1H 2022

Topline results from REVERSE Phase 3 study in compensated cirrhosis due to NASH now expected in Q3

Company to host conference call today at 8:30 a.m. ET

“In 2021, our team was focused on continuing to grow our foundational PBC business; executing on our clinical and regulatory goals in PBC and NASH; and advancing our pipeline while also taking important steps to significantly strengthen our financial position,” said Jerry Durso, President and Chief Executive Officer of Intercept. “Our team delivered strong double-digit revenue growth for Ocaliva, despite the challenges associated with the pandemic and the U.S. label update. Looking ahead, we continue to see long-term potential for Ocaliva given the number of patients with PBC who are eligible for second-line therapy.”

“We also made important progress in generating what will ultimately be the largest data set in the NASH field,” Durso continued. “We remain focused on delivering the new data package from our Phase 3 REGENERATE study, and if we believe these data support accelerated approval, we will continue to target a potential pre-submission meeting with FDA in the first half of this year. We also look forward to communicating topline results from the Phase 3 REVERSE study, the only active late-stage study in compensated cirrhosis due to NASH, a disease with no approved therapies. Given the magnitude and complexity of these analyses, we now expect to deliver these data in the third quarter of this year. Taken together, REGENERATE and REVERSE continue to represent the most robust, active clinical development program to date in NASH and include more than 3,300 patients across both studies.”

2022 Financial Guidance

We are announcing 2022 Ocaliva net sales guidance of $375 million to $405 million. In addition, we are announcing 2022 non-GAAP adjusted operating expense guidance of $360 million to $390 million. See “Non-GAAP Financial Measures” below. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense.

Conference Call on March 2, 2022 at 8:30 a.m. ET

We are hosting our fourth quarter and full year 2021 financial results conference call and webcast on March 2, 2022 at 8:30 a.m. ET. The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free) with passcode 3258502. A replay of the call will be available on our website shortly following the completion of the call and will be available for two weeks.

https://finance.yahoo.com/news/intercept-pharmaceuticals-reports-fourth-quarter-120000739.html