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Intercept Pharmaceuticals Reports Full Year 2016 Financial Results and Provides Business Update
|·||Net Ocaliva® (obeticholic acid or OCA) 4Q16 sales of $13.4 million, full year 2016 net sales of $18.2 million|
|·||Enrollment of Phase 3 REGENERATE interim analysis cohort anticipated completion by mid-2017|
|·||Data expected from two Phase 2 trials for OCA in 2017|
|·||Planned initiation of Phase 2 trial of INT-767 in 2017|
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NEW YORK, February 23, 2017 -- 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, 2016 and provided other general business updates.
“2016 was a truly momentous year for Intercept, marked by the U.S. and European approvals of Ocaliva for the treatment of primary biliary cholangitis (PBC),” said Mark Pruzanski, M.D., President and CEO of Intercept. “We successfully transitioned to a commercial organization with our U.S. launch for PBC in June 2016 that generated net sales of $18.2 million for the year, while making solid progress in our clinical development programs.”
“We believe 2017 has the potential to be another transformative year for Intercept," added Dr. Pruzanski. "We are dedicated to bringing Ocaliva to more PBC patients in need, not only in the U.S, but now also internationally. We intend to complete enrollment of the interim analysis cohort in our Phase 3 REGENERATE trial in nonalcoholic steatohepatitis (NASH) patients with fibrosis by mid-2017, an important milestone given our intention to seek regulatory approval based on its results. In addition, we plan to report data for two placebo-controlled Phase 2 trials of OCA, one designed to advance our understanding of OCA’s lipid effects in NASH patients taking statins and the second to evaluate OCA in patients with primary sclerosing cholangitis, a devastating cholestatic liver disease with no approved treatment options. Finally, we will be initiating a Phase 2 trial of our second product candidate, INT-767, in NASH patients with fibrosis.”
Ocaliva Commercial Update
Net U.S. Ocaliva sales were $18.2 million for the full year 2016, and $13.4 million for the fourth quarter.
Ocaliva was approved by the U.S. Food and Drug Administration (FDA) in May 2016 for the treatment of 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.
Ocaliva was granted conditional approval by the European Commission in December 2016 for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. We commenced our European commercial launch in January 2017.
The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Thursday, February 23, 2017 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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