Exhibit 99.1

 

 

 

 

Intercept Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results, Issues 2020 Operating Expense Guidance and Provides Business Update

 

Worldwide Ocaliva net sales of $249.6 million for the full year 2019, representing 40% growth over the prior year

 

Our NDA was the first accepted by the FDA for liver fibrosis due to NASH

 

Completed enrollment of REVERSE, our Phase 3 study evaluating OCA for the treatment of compensated cirrhosis due to NASH

 

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

 

 

NEW YORK, February 25, 2020

– 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, 2019.

 

“2019 was a pivotal year for Intercept given the positive results in our Phase 3 REGENERATE study in liver fibrosis due to NASH and our subsequent filing for approval in both the U.S. and Europe,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “At the same time, our commercial team’s outstanding execution helped us deliver net sales of approximately $250 million for Ocaliva in 2019 and they continue to reach more PBC patients globally. As we enter 2020, we are focused on successfully completing the U.S. regulatory process and ensuring full readiness to launch the first approved therapy for patients suffering from fibrosis due to NASH.”

 

Ocaliva® (obeticholic acid) Commercial Highlights

 

Full year 2019 Ocaliva net sales were $249.6 million, which represented growth of 40% as compared to the prior year. Ocaliva net sales in 2019 were comprised of U.S. net sales of $187.5 million and ex-U.S. net sales of $62.1 million, as compared to U.S. net sales of $140.8 million and ex-U.S. net sales of $37.0 million in 2018.

 

We recognized $70.3 million of Ocaliva net sales in the fourth quarter of 2019, which represented growth of 33% as compared to the prior year quarter. Ocaliva net sales in the fourth quarter of 2019 were comprised of U.S. net sales of $53.5 million and ex-U.S. net sales of $16.8 million, as compared to U.S. net sales of $41.1 million and ex-U.S. net sales of $11.8 million in the prior year quarter.

 

Selected Fourth Quarter and Full Year 2019 Financial Results 

 

Revenues 

 

We recognized $71.5 million in total revenue in the fourth quarter of 2019, as compared to $53.3 million in total revenue in the prior year quarter. Total revenue in the fourth quarter of 2019 included $70.3 million of Ocaliva net sales and approximately $1.2 million of licensing revenue, as compared to $52.9 million and approximately $0.4 million, respectively, in the prior year quarter.

 


The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Tuesday, February 25, 2020 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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