| Item 7.01 | Regulation FD Disclosure. |
On August 19, 2022, Amarin Deutschland GmbH, a wholly-owned subsidiary of Amarin Corporation plc (“Amarin”), issued a press release in Germany titled “Amarin Provides Update on VAZKEPA® (icosapent ethyl) Pricing Negotiations in Germany.” An English translation of the press release is furnished herewith as Exhibit 99.1.
The information in this Item 7.01 and Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
In light of the developments in Germany whereby a viable agreement on the reimbursement price of Vazkepa® (icosapent ethyl) could not be reached, Amarin will cease commercial activities in Germany, effective September 1, 2022. Amarin estimates that it will incur a charge of approximately $4 million (USD), related to the outcome of German price negotiations, all of which are cash expenditures related to termination benefits and associated costs. Amarin expects to record this charge in the third quarter of 2022.
Forward-looking statement
This Current Report on Form 8-K and the press release furnished herewith contain forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements contained herein and therein which do not describe historical facts, including, among others, beliefs about the medical benefits of Vazkepa and Amarin’s efforts to secure acceptable reimbursement, the estimate of the restructuring charge and the expected timing of such charge, and our desire to re-submit a pricing and reimbursement dossier and advance in other key European markets, are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, the restructuring charge associated with the cessation of commercial activities in Germany may be higher than expected and Amarin’s ability to maintain and grow revenue from sales of Vazkepa in Europe may be materially adversely affected.
Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with administrative decisions and the bases for such decisions. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
