Exhibit 99.1

 

 

 

Intercept Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update

 

Positive results from pivotal Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH

 

New Drug Application (NDA) filing in the U.S. for OCA in NASH projected in the third quarter of 2019

 

Worldwide Ocaliva net sales of $51.8 million in the first quarter of 2019 representing 47% growth versus the prior year quarter

 

Increasing 2019 Ocaliva net sales guidance range to between $235 and $245 million

 

Updating 2019 non-GAAP adjusted operating expenses guidance range to between $470 and $500 million in connection with acceleration of NASH NDA filing and launch preparation activities

 

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

 

NEW YORK, May 8, 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 quarter ended March 31, 2019.

 

“Our Phase 3 REGENERATE readout demonstrating OCA’s anti-fibrotic benefit in patients with NASH has been a watershed moment for the liver community and underscores our unique competitive opportunity to become the first approved NASH therapy,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “I’m very pleased with the acceleration of our NASH NDA filing and launch preparations, as well as our continued strong commercial performance in PBC resulting in our increased 2019 Ocaliva net sales guidance.”

 

OCA in NASH

 

In February 2019, we announced positive topline results from the pivotal Phase 3 REGENERATE study demonstrating that once-daily obeticholic acid (“OCA”) 25 mg met the primary endpoint of ‘fibrosis improvement by at least one stage with no worsening of NASH’ in the planned 18-month interim analysis with high statistical significance (p=0.0002 vs placebo). Adverse events were generally mild-to-moderate in severity and the most common were consistent with the known profile of OCA. In April 2019, additional supportive REGENERATE data were presented during the Opening Ceremony of the International Liver Congress™ 2019, the 54th Annual Meeting of the European Association for the Study of the Liver (“EASL”). The data presented at EASL showed that OCA demonstrated robust efficacy across a range of additional histologic and biochemical parameters.

 


The following information was filed by on Wednesday, May 8, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one quarter to another to evaluate 's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by .

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Log in with your credentials

or    

Forgot your details?

Create Account