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 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 positive surprise of 0.82% 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 $3.57, while the company reported a loss of $4.43.
Revenue: Intercept Pharma posted revenues of $37.7 million which also fell short of our consensus estimate of $38.4 million.
Key Stats: Ocaliva sales came in at $37.9 million, down from $40.9 million in the third quarter of 2017. Sales of the drug for 2017 came in at $129.2 million. There has been a lot of debates regarding the drug’s safety. Prescription demand softened following the Dear Health Care Provider letter and the FDA safety communication on Ocaliva.
Check back later for our full write up on this ICPT earnings report later!
Don’t Even Think About Buying Bitcoin Until You Read This
The most popular cryptocurrency skyrocketed last year, giving some investors the chance to bank 20X returns or even more. Those gains, however, came with serious volatility and risk. Bitcoin sank 25% or more 3 times in 2017.
Zacks’ has just released a new Special Report to help readers capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 4 crypto-related stocks now >>