Page 1

Intercept Intercept Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update May 6 , 2021 Worldwide OcalivaⓇnet sales of $ 81.7M , representing 12 % growth over the prior year quarter Company narrows 2021 financial guidance ; now expects worldwide Ocaliva net sales guidance of $ 325 million to $ 340 million and reiterates Non - GAAP adjusted operating expense guidance of $ 380 to $ 410 million Process between Intercept and FDA remains ongoing regarding updates to the Ocaliva U.S. Prescribing Information Intercept continues to work toward potential resubmission of OCA in NASH fibrosis in the U.S. Company to host conference call today at 8:30 a.m. ET NEW YORK , May 06 , 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 March 31 , 2021 . " Our global commercial strategy and our continued progress in educating specialists including gastroenterologists have produced another quarter of double - digit sales growth for Ocaliva , " said Jerry Durso , President and Chief Executive Officer of Intercept . " As we continue our dialogue with FDA , which is reaching its conclusion regarding updates to the Ocaliva U.S. Prescribing Information , we expect that the final label will restrict Ocaliva in patients with decompensated cirrhosis and in a subset of patients with compensated cirrhosis . Following this label update , Ocaliva will remain an important option for the significant majority of second line PBC patients . " We are currently preparing for a NASH safety update from the ongoing Phase 3 REGENERATE study that will reflect more than twice the patient exposure to OCA relative to our first submission . We are also planning to generate additional data pursuant to upcoming discussions with the agency . While we are making progress , significant work remains and alignment with FDA on the necessary elements will be a key dependency for a potential resubmission in support of accelerated approval . So at this time we cannot reiterate our potential filing timing for this year and expect to provide an update in the third quarter of this year , " Durso continued . " We have also formally received a 6 - month clock stop of the review of OCA for development of NASH fibrosis in the EU in order to allow us to focus on executing on the feedback we have received . Additionally , our Phase 3 REVERSE study in NASH patients with compensated cirrhosis is ongoing and we expect to have top - line data by end - of - year , and we continue to make progress on our pipeline programs including our combination program with bezafibrate . " Program Highlights Primary Biliary Cholangitis • Process with FDA regarding updates to the U.S. Prescribing Information is nearing completion . Final label will restrict Ocaliva in patients with decompensated cirrhosis and in a subset of patients with compensated cirrhosis . • Discussion remains ongoing with FDA and EMA regarding the COBALT post - marketing trial . NASH • Held multiple formal interactions with FDA regarding our NASH fibrosis development program and are preparing for a safety update that will reflect a doubling of patient exposure to OCA relative to our first submission . We are also gathering data that will be the subject of upcoming interactions . • The REVERSE Phase 3 study in patients with compensated cirrhosis due to NASH remains ongoing and a top - line readout is expected to be available by the end of 2021 . • We have formally received a 6 - month clock stop of the review of OCA for development of NASH fibrosis in the EU to allow us to focus on executing on the feedback we have received and the data we are developing for potential U.S. resubmission . Additional Pipeline • The Company continues to enroll the OCA / bezafibrate combination trial outside the U.S. and will provide updates when enrollment is complete . Intercept now has an open IND for the combination in the U.S. • Intercept intends to initiate first - in - human work with INT - 787 in 2021 . Financial Results Revenue • We recognized $ 81.7 million in total revenue in the first quarter of 2021 , as compared to $ 72.7 million in total revenue in