Intercept Pharmaceuticals Reports Third Quarter 2016 Financial Results And Provides Business Update

  • Net Ocaliva ® (obeticholic acid or OCA) 3Q sales of $4.7 million
  • Positive opinion adopted by Committee of Medicinal Products in Human Use (CHMP) for Ocaliva in Primary Biliary Cholangitis (PBC) in EU
  • Enrollment in Phase 2 CONTROL trial complete in Nonalcoholic Steatohepatitis (NASH) patients with fibrosis
  • Enrollment in Phase 2 AESOP trial complete in primary sclerosing cholangitis (PSC)

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

NEW YORK, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today reported financial results for the three and nine months ended September 30, 2016 and provided other general business updates.

"The third quarter marked another key milestone for our company, representing our first full quarter as a commercial organization," said Mark Pruzanski, M.D., President and CEO of Intercept. "Initial prescribing interest for Ocaliva has been strong and we believe there is substantial long-term potential for Ocaliva in PBC."

"In addition to our commercial launch in the U.S., the third quarter was marked by several key accomplishments that have strengthened Intercept's position strategically and financially," added Dr. Pruzanski. "These include the publication of our Phase 3 POISE trial in the New England Journal of Medicine, the positive CHMP opinion recommending European regulatory approval of Ocaliva in PBC, and the completion of enrollment in two placebo-controlled Phase 2 trials of OCA in NASH and PSC. We also completed a $460 million convertible notes offering, leaving us with a strong balance sheet. These achievements put Intercept on an excellent footing as we look toward 2017."

Ocaliva Commercial Update

Net U.S. Ocaliva sales for the quarter were $4.7 million.

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