Report
Karen Andersen
EUR 850.00 For Business Accounts Only

Morningstar | ICPT Updated Forecasts and Estimates from 19 Mar 2019

Intercept reported fourth-quarter product sales of about $53 million, slightly above our expectations and representing 42% growth from last year. While quarterly sales growth was lumpy this year, full-year sales of $178 million were up 38% from last year, within our expectations and management guidance. The company reported a net loss of $88 million for the quarter and $309 million for the full year, an improvement from $111 million and $360 million last year. We don't anticipate any material changes to our fair value estimate of $150 per share, and we're maintaining our no-moat rating, given that the firm's prospects largely rest on one drug with a questionable side effect profile.

These fourth-quarter results closely follow last week's announcement of positive top-line results from the phase 3 trial of obeticholic acid, or OCA, in patients with liver fibrosis due to nonalcoholic steatohepatitis, NASH. Share prices swung on the results, initially climbing on the positive news and later plunging on liver-related safety concerns. However, the liver-related serious side effects reported last week were minimal and largely consistent with previous studies, and management reaffirmed this on the earnings call. We maintain our long-term thesis for Intercept, which is that OCA offers efficacy that could give the firm first-mover status if approved, but the safety profile leaves room for competitors. We continue to model a 65% probability of approval in patients with liver fibrosis due to NASH, as well as declining market share as potential competitors with more attractive safety profiles enter the market. With this dynamic explicitly modeled, we still see upside potential, given current share prices.
Underlying
Intercept Pharmaceuticals Inc.

Intercept Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat progressive non-viral liver diseases. The company's marketed product, Ocaliva? (obeticholic acid or OCA), is an farnesoid X receptor agonist approved in the U.S., the European Union and several other jurisdictions for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. In addition to, the company is developing OCA for multiple indications, including nonalcoholic steatohepatitis.

Provider
Morningstar
Morningstar

Morningstar, Inc. is a leading provider of independent investment research in North America, Europe, Australia, and Asia. The company offer an extensive line of products and services for individual investors, financial advisors, asset managers, and retirement plan providers and sponsors.

Morningstar provides data on approximately 530,000 investment offerings, including stocks, mutual funds, and similar vehicles, along with real-time global market data on more than 18 million equities, indexes, futures, options, commodities, and precious metals, in addition to foreign exchange and Treasury markets. Morningstar also offers investment management services through its investment advisory subsidiaries and had approximately $185 billion in assets under advisement and management as of June 30, 2016.

We have operations in 27 countries.

Analysts
Karen Andersen

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