| 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