INTERCEPT PHARMACEUTICALS, INC. (NASDAQ:ICPT) Files An 8-K Results of Operations and Financial ConditionItem 2.02 Results of Operations and Financial Condition.
On July 31, 2017, Intercept Pharmaceuticals, Inc. (the “Company”) announced its financial results for the three and six months ended June 30, 2017 and provided other general business updates. A copy of the Company’s press release (the “Press Release”) containing such announcement is attached hereto as Exhibit 99.1. The information in the Press Release is incorporated by reference into this Item 2.02 of this Current Report on Form 8-K.
Except as shall be expressly set forth by specific reference, the information contained or incorporated by reference in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Bifurcation of Role of David Shapiro, M.D.
On July 31, 2017, the Company announced that the role of David Shapiro, M.D., the Company’s Chief Medical Officer and Executive Vice President, Development, will be bifurcated into two separate roles. Dr. Shapiro will remain with the Company and continue to serve as its Chief Medical Officer. Until the Company has filled the position of head of research and development, Dr. Shapiro will continue to lead the Company’s research and development organization.
Item 7.01. Regulation FD Disclosure.
On July 31, 2017, the Company announced top-line results from the Phase 2 AESOP trial in primary sclerosing cholangitis (“PSC”) which evaluated the effects of 24 weeks of treatment with varying doses of obeticholic acid (“OCA”) compared to placebo. This trial achieved its primary endpoint, which the Company believes establishes a proof-of-concept of OCA in a second cholestatic liver disease. The press release is attached hereto as Exhibit 99.2.
On July 31, 2017, the Company announced top-line results from the CONTROL trial which characterized the lipid metabolic effects of OCA and cholesterol management effects of concomitant statin administration in nonalcoholic steatohepatitis patients. This trial achieved its primary endpoint. The press release is attached hereto as Exhibit 99.3.
Except as shall be expressly set forth by specific reference, the information contained or incorporated by reference in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibits are filed with this Current Report on Form 8-K:
| Exhibit 99.1 | Press Release of Intercept Pharmaceuticals, Inc. on financial results dated July 31, 2017 |
| Exhibit 99.2 | Press Release of Intercept Pharmaceuticals, Inc. on AESOP trial dated July 31, 2017 |
| Exhibit 99.2 | Press Release of Intercept Pharmaceuticals, Inc. on CONTROL trial dated July 31, 2017 |
INTERCEPT PHARMACEUTICALS INC ExhibitEX-99.1 2 v471909_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Intercept Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update ·Worldwide net Ocaliva® (obeticholic acid or OCA) 2Q 2017 sales of $30.4 million ·AESOP Phase 2 trial in patients with PSC met its primary endpoint ·CONTROL trial met its objective,…To view the full exhibit click here
About INTERCEPT PHARMACEUTICALS, INC. (NASDAQ:ICPT)
Intercept Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of therapeutics to treat non-viral, progressive liver diseases. The Company’s product candidates have the potential to treat orphan and more prevalent diseases for which there are limited therapeutic solutions. The Company’s product candidate, obeticholic acid (OCA), is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid that selectively binds to and activates the farnesoid X receptor (FXR). The Company is developing OCA for the treatment of liver diseases, such as primary biliary cirrhosis (PBC), non-alcoholic steatoheptitis (NASH), primary sclerosing cholangitis (PCS) and biliary atresia. The Company is also developing other products INT-767 for the treatment of fibrosis and INT-777 for the treatment of type 2 diabetes.
