New York-based Intercept Pharmaceuticals, Inc. (ICPT - Free Report) focused on bringing novel therapeutics to treat chronic liver diseases to market.
Intercept received a major boost with the FDA approval (in May 2016) of its lead drug, Ocaliva, in combination with ursodeoxycholic (UDCA), for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
The FDA has approved Ocaliva under its accelerated approval program based on a reduction in alkaline phosphatase (ALP), since an improvement in survival or disease-related symptoms has not been established yet. Continued approval in this indication may be contingent upon the verification and description of clinical benefit in confirmatory studies.
In Dec 2016, the European Commission granted conditional approval to Ocaliva for the same indication. Meanwhile, Ocaliva is being evaluated for other indications including non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
Intercept’s track record has been mixed so far, with the company surpassing expectations in three of the last four quarters. The company has posted an average negative earnings surprise of 0.06% over this period.
Currently, Intercept Pharma has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Earnings: Our consensus called for a loss of $3.62, while the company reported a loss of $3.46.
Revenue: Intercept Pharma posted revenues of $30.9 million beating our consensus estimate of $27 million.
Key Stats: Intercept launched Ocaliva in June 2016 and the initial uptake of the drug has been encouraging. Ocaliva sales came in at $30.4 million, up from $20.6 million in the first quarter of 2017.
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