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Intercept Pharmaceuticals Reports Full Year and Fourth Quarter 2017 Financial Results and Provides Business Update
|·||Worldwide Net Ocaliva® (obeticholic acid or OCA) full year 2017 net sales of $129.2 million, fourth quarter 2017 sales of $37.3 million|
|·||U.S. Prescribing Information for Ocaliva® updated to reinforce appropriate dosing in PBC patients with advanced cirrhosis|
|·||Continuing to advance industry leading NASH Phase 3 program: REGENERATE trial in NASH fibrosis on track to report data in 1H19; REVERSE trial in NASH cirrhosis enrolling|
Conference call scheduled for 8:30 a.m. ET today
NEW YORK, February 14, 2018 – 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 reported financial results for the three months and full year ended December 31, 2017 and provided other business updates.
“With an updated label that will help ensure correct dosing of Ocaliva in PBC patients with advanced cirrhosis, we are now pouring renewed energy into our efforts to bring our much-needed treatment to people living with this liver disease,” said Mark Pruzanski, M.D., President and CEO of Intercept. “At the same time, we are focused on advancing our leading NASH Phase 3 program, supported by the most robust safety and efficacy data of any drug in development. With our flagship REGENERATE trial and recently announced REVERSE trial both underway, we are well on our way to cementing OCA’s potential to treat NASH patients at the highest risk of progressing to liver failure.”
“Our confidence in our ability to help people living with PBC has never been greater, and our collaborative approach during the recent months has further strengthened our relationships with our customers,” said Richard Kim, Senior Vice President, U.S. Commercial at Intercept. “While we expect a transitional first quarter, we are actively re-engaging with physicians and patients and expect to reinvigorate growth in the PBC business throughout 2018, as we work diligently on physician education and broadening our reach among the large number of PBC patients who could benefit from Ocaliva.”
Ocaliva Commercial Highlights
Intercept recorded $129.2 million of worldwide net Ocaliva sales for the full year 2017, and $37.3 million for the fourth quarter of 2017.
Net U.S. Ocaliva sales were $115.8 million for the full year 2017 and $32.0 million for the fourth quarter of 2017.
Ocaliva was approved by the U.S. Food and Drug Administration (FDA) in May 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. Intercept commercially launched Ocaliva in the United States in June 2016 and in conjunction launched Interconnect®, a comprehensive, personalized program that connects patients with dedicated care coordinators who help them understand their disease and provides treatment support and, for eligible patients, financial assistance options. Earlier this month, the Prescribing Information in the United States was updated to reinforce appropriate dosing in PBC patients with Child-Pugh Class B or C or decompensated cirrhosis.
The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Wednesday, February 14, 2018 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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