Is This the End of the Growth Phase for Intercept?

By Chris Lange Published May 19, 2:00PM EDT

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Investors are not too happy with Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) after it released the terms for its most recent clinical trial. Over the course of 2015, shares have nearly doubled, but this seemingly has come to a screeching halt after this trial was initiated.

For some background, nonalcoholic steatohepatitis (NASH) is nonalcoholic fatty liver disease (NAFLD) and is associated with excessive fat in the liver. Intercept is a biopharmaceutical company focused on the development of treatment for chronic liver disease using its expertise in bile acid chemistry. The lead product candidate, obeticholic acid (OCA), is heading into registration for the treatment of primary biliary cirrhosis (PBC) and proceeding into Phase 3 trials for the larger NASH opportunity.

The study will initiate in the third quarter of 2015 and will enroll up to a total of 2,500 patients at 250 centers. An interim analysis will be completed after 72 weeks of treatment in about 1,400 stage 2/3 fibrosis (F2/F3) patients to support an accelerated approval in the United States and European Union.

The Regenerate Phase 3 trial in NASH will remain blinded after the interim analysis at 72 weeks and will continue until a pre-specified number of liver-related clinical events (progression to cirrhosis, liver transplant, all-cause mortality, etc.) are met. OCA could be the first approved treatment for NASH; however, a number of other NASH therapies are under development.

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Merrill Lynch estimates that it will take about a year to complete enrollment, which suggests potential interim results in the first half of 2018. For a positive trial, both co-primary endpoints will need to be met by the overall study population, but not on an individual patient basis.

Merrill Lynch further described its thoughts on the trial:

We view the overall trial design as expected though the trial size is larger than the 1,000-2,000 patients management had previously communicated. The revelation of this Phase 3 trial design was the most anticipated catalyst for ICPT this year and with its passing, we see a lack of catalysts going forward to drive shares meaningfully higher. The focus will now turn to the PBC approval and launch (anticipated 1H16), which we believe is already reflected in ICPT’s valuation.

As a result, Merrill Lynch downgraded Intercept to Neutral and maintained its estimates and $315 price objective. The firm described its investment thesis as:

We believe current shares appropriately reflect the PBC and NASH opportunities for OCA. With the passing of the phase 3 design announcement, we see a lack of meaningful catalysts to drive shares higher going forward.

Shares of Intercept were down 13% at $273.50 on Tuesday. The stock has a consensus analyst price target of $414.56 and a 52-week trading range of $128.50 to $349.08.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.