Exhibit 99.1

 

Intercept Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results, Issues 2019 Financial Guidance and Provides Business Update

 

Positive topline results from pivotal Phase 3 REGENERATE study of obeticholic acid in patients with liver fibrosis due to NASH: the largest and first successful pivotal Phase 3 NASH study

 

Worldwide Ocaliva net sales of $52.9 million in the fourth quarter of 2018 and $177.8 million in the full year 2018, consistent with previously issued guidance

 

Strong year-end cash position of approximately $436.2 million

 

2019 worldwide Ocaliva net sales projected between $225 million and $240 million and 2019 non-GAAP adjusted operating expenses projected between $450 million and $470 million

 

Conference call scheduled for 8:30 a.m. ET today

 

NEW YORK, February 28, 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 fourth quarter and full year ended December 31, 2018.

 

“This past year was a great year of execution 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. “We were thrilled to recently report positive topline data from our pivotal Phase 3 REGENERATE study, with OCA clearly meeting the study’s primary objective by demonstrating its anti-fibrotic benefit in patients with NASH, truly a first in the field. We intend to file for regulatory approval in the U.S. and Europe in the second half of this year and believe that the REGENERATE results support our long-held conviction that OCA will become the first approved medicine and backbone therapy for those living with liver fibrosis due to NASH. This underscores our ongoing commitment to drive scientific innovation to address the unmet medical needs of patients with progressive non-viral liver diseases, both large and small.”

 

Ocaliva® (obeticholic acid or OCA) Commercial Highlights

 

We recognized $52.9 million of Ocaliva net sales in the fourth quarter of 2018, as compared to $37.3 million in the prior year quarter. Ocaliva net sales in the fourth quarter of 2018 were comprised of U.S. net sales of $41.1 million and ex-U.S. net sales of $11.8 million, as compared to U.S. net sales of $32.0 million and ex-U.S. net sales of $5.3 million in the prior year quarter.

 

Full year 2018 Ocaliva net sales were $177.8 million, as compared to $129.2 million in 2017. Ocaliva net sales in 2018 were comprised of U.S. net sales of $140.8 million and ex-U.S. net sales of $37.0 million, as compared to U.S. net sales of $115.8 million and ex-U.S. net sales of $13.4 million in 2017.

 


The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Thursday, February 28, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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