It’s always exciting when a stock quadruples in value, as Intercept Pharmaceuticals (ICPT) has this year. But are investors too excited? FBR’s Andrew Berens and Thomas Smith think they are:
Steve Remich We are initiating coverage of Intercept Pharmaceuticals, Inc. with an Underperform rating and a 12-month price target of $172 per share. We believe investors are much too optimistic about the accessibility of the nonalcoholic steatohepatitis (NASH) market and the regulatory pathway to commercialization. We agree that NASH is a highly prevalent disease globally but see this potential market as facing significant challenges before it can be accessed. We think payors are unlikely to embrace intervention for NASH, especially given the anticipated hepatitis C (HCV) burden on the system. NASH would be competing with HCV for payor dollars and provider access, as both diseases are treated by hepatologists.
Furthermore, unlike HCV, which is cured after one course of treatment, NASH is likely to require chronic therapy. NASH is also a relatively unrecognized disease with no treatment paradigms, necessitating building the market. Despite compelling efficacy, we do not think the FDA is likely to approve obeticholic acid (OCA) without an adequate safety database, making an accelerated approval unlikely in the time frame expected by investors. The co-morbidities in this patient population are too significant, and the lipid changes with OCA are concerning, especially in light of the reported cardiovascular events disclosed in the top-line FLINT data release.
Shares of Intercept Pharmaceuticals have dropped 3.2% to $286.78 at 2:40 p.m. today.
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