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Intercept Pharmaceuticals Reports Second
Quarter 2018 Financial Results
and Provides Business Update
|·||Worldwide Ocaliva net sales of $43.2 million in the second quarter of 2018|
|·||Leading Phase 3 NASH program continues to advance: REGENERATE trial in NASH patients with advanced liver fibrosis expected to report data in the first half of 2019|
Conference call scheduled for 8:30 a.m. ET today
NEW YORK, August 2, 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 announced its financial results for the quarter ended June 30, 2018.
“During the first half of 2018, we made good progress executing against our key strategic priorities in our Phase 3 NASH program and our PBC commercial efforts,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “Our leadership position in NASH is supported by what we believe to be the most comprehensive dataset of any ongoing development program and we remain on track to report top line data from the Phase 3 REGENERATE trial in first half of 2019. On the commercial front, the expansion of our U.S. sales and commercial infrastructure is expected to further enhance our capacity to provide access to Ocaliva to eligible PBC patients and the healthcare providers who treat them.”
Ocaliva® (obeticholic acid or OCA) Commercial Highlights
We recorded $43.2 million of Ocaliva net sales in the second quarter of 2018, as compared to $30.4 million in the prior year quarter. Ocaliva net sales in the second quarter of 2018 were comprised of U.S. net sales of $34.5 million and ex-U.S. net sales of $8.7 million, as compared to U.S. net sales of $27.9 million and ex-U.S. net sales of $2.6 million in the prior year quarter.
Ocaliva was approved in the United States 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. We commenced sales and marketing of Ocaliva in the United States shortly after receiving marketing approval, and Ocaliva is now available to patients primarily through a network of specialty pharmacy distributors.
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, and we commenced our European commercial launch in January 2017. Since January 2017, 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 Thursday, August 2, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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