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Intercept Intercept Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update November 3 , 2021 Worldwide Ocaliva® net sales of $ 92.8 million , representing 17 % growth over the prior year quarter Company increases 2021 guidance of Ocaliva net sales to $ 355 million to $ 370 million and narrows Non - GAAP adjusted operating expense guidance to $ 380 to $ 395 million NASH data generation remains on track New PBC POISE long - term data accepted in a late - breaking presentation at The Liver Meeting® next month Completed successful debt exchange and share buy back Company to host conference call today at 8:30 a.m. ET NEW YORK , Nov. 03 , 2021 ( GLOBE NEWSWIRE ) -- Intercept Pharmaceuticals , Inc. ( Nasdaq : ICPT ) , a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non - viral liver diseases , today announced its financial results for the quarter ended September 30 , 2021 . " Our results in Q3 2021 demonstrate the underlying strength of our PBC business and we are raising sales guidance for Ocaliva , " said Jerry Durso , President and Chief Executive Officer of Intercept . " We are also lowering the top end of our operating expense guidance as we focus on maintaining a strong cash position . Additionally , we remain committed to generating important PBC data , and look forward to sharing a late - breaking podium presentation at The Liver Meeting® this month titled , ' Patients with primary biliary cholangitis treated with long - term obeticholic acid in a trial - setting demonstrate better transplant - free survival than external controls from the GLOBAL PBC and UK - PBC study groups " . " " As we approach 2022 , we are also entering a pivotal phase for our NASH clinical development program , " Durso continued . " We expect topline results from the Phase 3 REVERSE study in compensated cirrhosis due to NASH to be available near the end of the year . We are also on track with compiling a new data package from the Phase 3 REGENERATE study in fibrosis due to NASH to support a potential resubmission meeting with FDA in the first half of 2022. I'm pleased with the progress our R & D team is making under the leadership of Dr. Michelle Berrey and expect we will have the necessary data to drive our strategic decisions and regulatory dialogue . As we continue to advance our pipeline and explore opportunities to leverage our strong commercial foundation , Intercept is well positioned for success in 2022 and beyond . " Financial Results Revenue • We recognized $ 92.8 million in total revenue in the third quarter of 2021 , as compared to $ 79.5 million in total revenue in the prior year quarter . Ocaliva net sales in the third quarter of 2021 were comprised of U.S. net sales of $ 66.6 million and ex - U.S . net sales of $ 26.2 million , as compared to U.S. net sales of $ 58.6 million and ex - U.S . net sales of $ 20.9 million in the prior year quarter . Operating Expenses • In the quarters ended September 30 , 2021 and 2020 , we recorded $ 99.0 million and $ 134.7 million , respectively , in total operating expenses and $ 89.6 million and $ 118.1 million , respectively , in non - GAAP adjusted operating expenses , which excludes non - cash stock - based compensation expense of $ 8.6 million and $ 15.8 million , respectively , and depreciation expense of $ 0.8 million and $ 0.7 million , respectively . • References in this press release to " non - GAAP adjusted operating expenses " mean our total operating expenses , as calculated and presented in accordance with U.S. Generally Accepted Accounting Principles ( “ GAAP ” ) , adjusted for the effects of two non - cash items : stock - based compensation and depreciation . See " Non - GAAP Financial Measures " below . A reconciliation of non - GAAP adjusted operating expenses to total operating expenses for all historical periods presented is included below under the heading " Reconciliation of Non - GAAP Adjusted Operating Expenses to Total Operating Expenses . " Cost of Sales • Our cost of sales was $ 0.7 million in the third quarter of 2021 , as compared to $ 1.8 million in the prior year quarter . Our cost of sales for the quarters ended September 30 , 2021 and 2020 consisted primarily of packaging , labeling , materials and related expenses . Sales , General & Administrative Expenses