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Intercept Pharmaceuticals Reports Third
Quarter 2019 Financial Results
and Provides Business Update
Worldwide Ocaliva net sales of $61.5 million in the third quarter of 2019 representing 32% growth versus the prior year quarter; increasing full year 2019 worldwide Ocaliva net sales guidance range to between $245 million and $250 million
U.S. NDA for NASH submitted; EU MAA submission for NASH planned for fourth quarter of 2019
New NASH and PBC clinical data to be presented at The Liver Meeting® 2019
Conference call scheduled for 8:30 a.m. ET today
NEW YORK, November 5, 2019 – 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, 2019.
“During the third quarter, we submitted our NDA seeking accelerated approval of OCA for NASH in the U.S., a historic achievement for our company and a critically important milestone for the many patients currently without an approved treatment,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “With the submission behind us, we are actively preparing to launch the first therapy for advanced fibrosis due to NASH and our pre-launch disease state educational activities are accelerating with the continued expansion of our sales, medical and market access teams. In addition, we are looking forward to the presentation of important new data from the interim analysis of our ongoing Phase 3 REGENERATE study at the upcoming AASLD Liver Meeting. Based on our team’s strong commercial execution in the third quarter, I am also pleased to announce that we are increasing our 2019 net sales guidance for Ocaliva to between $245 million and $250 million.”
Ocaliva® (obeticholic acid) Commercial Highlights
We recognized $61.5 million of worldwide Ocaliva net sales in the third quarter of 2019, as compared to $46.6 million in the prior year quarter. Ocaliva net sales in the third quarter of 2019 were comprised of U.S. net sales of $45.2 million and ex-U.S. net sales of $16.3 million, as compared to U.S. net sales of $36.7 million and ex-U.S. net sales of $9.9 million in the prior year quarter.
Ocaliva was approved in the United States by the FDA in May 2016 and by the European Commission in December 2016 for the treatment of primary biliary cholangitis (“PBC”) in combination with ursodeoxycholic acid (“UDCA”) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Since December 2016, Ocaliva has also received regulatory approval in several of our target markets outside the United States and Europe, including Canada, Israel and Australia.
The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Tuesday, November 5, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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