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Washington, D.C. 20549










Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934


Date of report (Date of earliest event reported): February 1, 2022




Intercept Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)





(State or Other Jurisdiction

of Incorporation)



File Number)


(IRS Employer

Identification No.)


10 Hudson Yards, 37th Floor

New York, NY 10001

(Address of Principal Executive Offices and Zip Code)


Registrant’s telephone number, including area code: (646) 747-1000




Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class   Trading
  Name of each exchange on which registered
Common Stock, par value $0.001 per share   ICPT   Nasdaq Global Select Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).


Emerging growth company ¨


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨







Item 8.01. Other Events.


On February 1, 2022, the French subsidiary of Intercept Pharmaceuticals, Inc. (the “Company”), Intercept Pharma France SAS (“ICPT France”), withdrew its application for reimbursement in France of Ocaliva for treatment of primary biliary cholangitis (“PBC”), on account of inability to reach mutually acceptable pricing terms with the Economic Committee for Health Products (“CEPS”), the French regulator for pricing and reimbursement of pharmaceuticals. ICPT France initiated sales of Ocaliva in France prior to finalization of reimbursement terms pursuant to a temporary use authorization (“ATU”). As required by French law, ICPT France intends to continue to provide Ocaliva in France for one year following the closure of the ATU period, for purposes of continuity of treatment for patients using Ocaliva. ICPT France will continue to work with the French regulators regarding ATU and post-ATU payback. The French market represents approximately 1% of global net sales for the Company and its consolidated affiliates.







Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


  By: /s/ Andrew Saik  
    Name: Andrew Saik  
    Title: Chief Financial Officer  


Date: February 7, 2022