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Intercept Intercept Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update July 29 , 2021 Worldwide Ocaliva net sales of $ 96.6 million , representing 25 % growth over the prior year quarter Company reiterates 2021 financial guidance of Ocaliva net sales guidance of $ 325 million to $ 340 million and Non - GAAP adjusted operating expense guidance of $ 380 to $ 410 million Updates to the Ocaliva U.S. Prescribing Information complete Company provides regulatory update on NASH fibrosis program in the U.S. Company to host conference call today at 8:30 a.m. ET NEW YORK , July 29 , 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 June 30 , 2021 . " In the second quarter , we reported double digit sales growth driven by strong business performance both in the U.S. and our International Region and the company achieved its first cash positive quarter . In the U.S. , we worked with the FDA to finalize important changes to the Ocaliva Prescribing Information , allowing us to now focus on the long - term growth of our foundational PBC business , " said Jerry Durso , President and Chief Executive Officer of Intercept . " We are executing a comprehensive campaign to educate healthcare providers , patients and other key stakeholders on the updates to the Ocaliva label . Five years after the initial accelerated approval of Ocaliva , there are still many eligible patients who have the potential to benefit from second - line therapy , and we look forward to resuming our long - term strategy of expansion into the community gastroenterology setting in Q3 . " " We continue to make progress on our development program in NASH fibrosis , " Durso continued . " Since the beginning of 2021 , we have had frequent exchanges with FDA to gain alignment and feedback on safety , biopsy methodology and efficacy data . We have now gained enough insight from FDA in these critical areas to move forward on our plan , and with the right team in place , we have begun to generate what will ultimately be the largest data package ever produced in the NASH field . We will be evaluating available data internally to inform decision - making and expect that process to continue into the early part of next year , with a goal of holding our pre - submission meeting to review the data with FDA during the first half of 2022. The regulatory review of OCA in the EU remains on pause as we evaluate the potential to include additional data that may support our application . As we continue to advance our regulatory dialogue in NASH fibrosis , we also look forward to delivering the next major Phase 3 data readout in the field with REVERSE , our study evaluating OCA in patients with compensated cirrhosis due to NASH . This is a population with significant unmet need , and we expect topline results by end - of - year . We also continue to make progress on our pipeline programs including our OCA - bezafibrate fixed dose combination in PBC and our next - generation FXR agonist INT - 787 . We recently initiated first - in - human studies of INT - 787 and look forward to sharing additional details about this compound in the future . " Financial Results Revenue • We recognized $ 96.6 million in total revenue in the second quarter of 2021 , as compared to $ 77.2 million in total revenue in the prior year quarter . Ocaliva net sales in the second quarter of 2021 were comprised of U.S. net sales of $ 68.2 million and ex - U.S . net sales of $ 28.4 million , as compared to U.S. net sales of $ 59.6 million and ex - U.S . net sales of $ 17.6 million in the prior year quarter . Operating Expenses • In the quarters ended June 30 , 2021 and 2020 , we recorded $ 95.8 million and $ 129.3 million , respectively , in total operating and $ 86.5 million and $ 112.4 million , respectively , in non - GAAP adjusted operating expenses , which excludes non - cash stock - based compensation expense of $ 8.4 million and $ 16.1 million , respectively , and depreciation expense of $ 0.9 million and $ 0.8 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