Current Report Filing (8-k)
23 Junio 2023 - 5:36AM
Edgar (US Regulatory)
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2023-06-22
2023-06-22
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date
of report (Date of earliest event reported): June 22, 2023
Intercept
Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | |
001-35668 | |
22-3868459 |
(State or other jurisdiction | |
(Commission | |
(IRS Employer |
of incorporation) | |
File Number) | |
Identification No.) |
305 Madison Avenue, Morristown, NJ 07960
(Address of principal executive offices) (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
Symbol(s) |
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 2.05 | Costs Associated with Exit or Disposal Activities. |
On June 22, 2023, Intercept Pharmaceuticals, Inc. (the “Company”)
adopted a workforce reduction and expense reduction plan (the “Restructuring Plan”).
The Restructuring Plan was adopted on account of the Company’s
previously announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”)
in regard to its New Drug Application (“NDA”) for obeticholic acid (“OCA”) for the treatment of pre-cirrhotic
liver fibrosis due to nonalcoholic steatohepatitis (“NASH”), and the Company’s intention to strengthen its focus on
the treatment of rare and serious liver diseases, discontinue NASH-related investment, and achieve profitability. The Restructuring Plan
seeks to significantly reduce operating expenses, while maintaining the ability to drive growth in the Company’s primary biliary
cholangitis (“PBC”) business and continue to develop innovative new medicines.
The Restructuring Plan will result in a workforce reduction of approximately
one third. The Company expects to incur approximately $16 million in restructuring costs, including approximately $15 million in cash
severance pay and related personnel termination costs and less than $1 million in non-cash stock-based compensation. The Company expects
the Restructuring Plan to be implemented during the second half of 2023, with workforce reductions initiated in the third quarter of 2023,
and for the majority of the restructuring, including the workforce reduction, to be completed by the end of 2023. The Company expects
the majority of restructuring costs to be incurred during the third quarter of 2023.
This Current Report on Form 8-K contains forward-looking statements
(“FLS”), including regarding a planned corporate restructuring, restructuring timing and implementation, corporate strategy
and priorities, expense reductions, restructuring costs, workforce size, growth in product sales, profitability, and investments in new
drug development. Important factors could cause actual results to differ materially from the FLS. For example, we may be less effective
than expected in implementing strategic changes, restructuring and clinical trial wind-down may be slower and have greater costs than
expected, Ocaliva sales may be lower than expected, and we may fail to achieve profitability.
Item 7.01 | Regulation FD Disclosure. |
On June 23, 2023, the Company issued a press release, which is attached
hereto as Exhibit 99.1 and is incorporated by reference, announcing the Restructuring Plan.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit Number | |
Description |
99.1 | |
Press Release |
104 | |
Cover Page Interactive Data File (embedded as Inline XBRL document) |
The information in Item 7.01 and Exhibit 99.1 is being furnished, not
filed.
SIGNATURES
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.
|
INTERCEPT PHARMACEUTICALS,
INC. |
|
|
|
|
By: |
/s/ Jerome Durso |
|
Name: |
Jerome Durso |
|
Title: |
President and CEO |
Date: June 23, 2023
Intercept Pharmaceuticals (NASDAQ:ICPT)
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