No Significant Impact on Intercept (ICPT) from France Withdrawal, Focus Remains on Future Data - H. C. Wainwright

H.C. Wainwright analyst Ed Arce reiterated a Neutral rating and $18.00 price target on Intercept Pharmaceuticals (NASDAQ: ICPT), following a recently announced withdrawal of application for Ocaliva's reimbursement for PBC in France.

The analyst quotes: "France represents a marginal opportunity; keeping our eyes on two Ocaliva clinical milestones in 1H22. Yesterday, Intercept announced that it has withdrawn its application for Ocaliva's reimbursement for PBC in France, as mutually acceptable pricing terms could not be reached between Intercept and the Economic Committee for Health Products (CEPS), the French regulatory agency that is primarily responsible for setting the prices of pharmaceutical products and medical devices and their reimbursement by health insurance in France. Intercept noted that sales of Ocaliva are ongoing in France by its French subsidiary, ICPT France, under a temporary use authorization (ATU), and is expected to continue for one year after the ATU period. We do not expect a significant impact from this withdrawal, as Intercept estimates that the French market to represent approximately 1% of global Ocaliva net sales. As the next significant catalysts for Intercept in 1H22, we continue to await Intercept to complete the data package prior to a pre-submission meeting with the FDA (expected in 1H22) to determine Ocaliva's path forward in NASH, and report top-line data from the Phase 3 REVERSE study of Ocaliva in NASH patients with compensated cirrhosis in 1Q22. Maintain Neutral."

For an analyst ratings summary and ratings history on Intercept Pharmaceuticals click here. For more ratings news on Intercept Pharmaceuticals click here.

Shares of Intercept Pharmaceuticals closed at $15.77 yesterday.

Written by Vlad Schepkov | [email protected]

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