Amarin Announces Comprehensive Cost Reduction Plan to Address Market Dynamics in U.S. Business
June 06 2022 - 8:30AM
Amarin Corporation plc (NASDAQ: AMRN) today announced important and
critical actions including a comprehensive cost and organizational
restructuring plan to address current shifts within the Company’s
U.S. business. The Company expects these actions will reduce
operating costs by approximately $100 million over the next 12
months* and enable Amarin to maintain a positive contribution
margin in the U.S. while continuing to invest in its imminent
European market launches and global expansion for VASCEPA/VAZKEPA.
“Our management team, with the guidance of our Board, conducted
a comprehensive review of the business to ensure we are addressing
the realities within our U.S. business while we focus on our global
growth opportunities with efficiency and discipline,” said Karim
Mikhail, Amarin’s president and chief executive officer. “While we
continue to see value in branded VASCEPA in the U.S., the current
operating landscape remains challenging with uncertainty related to
future revenue from the U.S. business. As a result, today we are
taking critical, proactive steps to reduce our U.S. commercial team
by approximately 90% of our pre-pandemic and pre-generic
competition levels. These reductions are necessary as we invest in
our European launches while maintaining a strong, core U.S.
Commercial team to support branded VASCEPA revenues in the U.S.
These proactive steps also allow us to maintain a positive
contribution margin for the U.S. business and continue our
investments in other markets and our Fixed-Dose Combination (FDC)
program to ensure we are positioned for a stronger future as we
execute our European and global expansion plans.”
Mr. Mikhail added, “We have completely reshaped our investment
plan for the future. We have tremendous confidence in our
multi-billion dollar revenue opportunity for VASCEPA/VAZKEPA
globally where we remain on track to launch in six markets and
receive up to eight reimbursement decisions this year. These
comprehensive actions will enable us to better serve patients while
creating value for shareholders over the long-term.”
The Company will reduce its total operational expenditure by
approximately $100 million over the next 12 months* while
continuing its investments in European expansion. The Company’s
cost reduction plan includes:
- U.S. workforce reduction: The majority of
the cost savings will result from a significant workforce reduction
across the Company’s U.S. field force and corporate positions.
Amarin will reduce its U.S. commercial team by approximately 65%
from current levels and approximately 90% of pre-pandemic and
pre-generic competition levels, resulting in a core team able to
support branded VASCEPA revenues in the U.S. In total, these
actions will result in a reduction of the total company employee
base by over 40% from current levels.
- Streamlined operational expenditures: Includes
reductions and reallocations in overall selling, general and
administrative (SG&A) expenses as well as savings related to
refining the Company’s R&D strategy to a more focused, stepwise
approach for its FDC program.
Mr. Mikhail concluded, “We value the tremendous contributions of
our colleagues – whose dedication to our mission has helped build
this Company and enabled us to launch an innovative product that
has improved cardiovascular health for millions of patients. These
changes, while difficult, are necessary to support our ability to
continue bringing VASCEPA/VAZKEPA to patients around the
world.”
*Compared to 2021 full year GAAP operating expenses and excludes
restructuring charges.
About AmarinAmarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our foundation in scientific research to
our focus on clinical trials, and now our commercial expansion, we
are evolving and growing rapidly. Amarin has offices in
Bridgewater, New Jersey in the United States, Dublin in Ireland,
Zug in Switzerland, and other countries in Europe as well as
commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (icosapent ethyl) capsules are the first
prescription treatment approved by the U.S. Food and Drug
Administration (FDA) comprised solely of the active ingredient,
icosapent ethyl (IPE), a unique form of eicosapentaenoic acid.
VASCEPA was launched in the United States in January 2020 as the
first drug approved by the U.S. FDA for treatment of the studied
high-risk patients with persistent cardiovascular risk despite
being on statin therapy. VASCEPA was initially launched in the
United States in 2013 based on the drug’s initial FDA approved
indication for use as an adjunct therapy to diet to reduce
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. Since launch, VASCEPA has been prescribed
more than 18 million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States,
icosapent ethyl is approved and sold in Canada, Germany, Lebanon
and the United Arab Emirates. In Europe, in March 2021 marketing
authorization was granted to icosapent ethyl in the European Union
for the reduction of risk of cardiovascular events in patients at
high cardiovascular risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United
States)
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2%
vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Forward-Looking Statements This press release
contains 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 which do not describe historical facts, including, among
others, statements regarding, plans and expectations for the cost
reduction and restructuring plan, including the anticipated
operating cost reduction of $100 million over the next 12 months
and the ability to maintain a positive contribution margin in the
United States and expand in Europe; beliefs about the value and
potential for VASCEPA (marketed as VAZKEPA in Europe), including
that there is a multi-billion dollar revenue opportunity for
VASCEPA/VAZKEPA globally; expectations regarding a stronger future
and European and global expansion; plans and expectations,
including timing, regarding launch and reimbursement outside of the
United States; and beliefs that the cost reduction and
restructuring plan will allow Amarin to better serve patients while
creating value for shareholders over the long-term. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Such risks and
uncertainties include, among others, risks and uncertainties
related to the implementation of the cost reduction and
restructuring plan, including that Amarin may be unsuccessful in
implementing the plan or, even if successful, may not achieve the
expected results of such efforts, or that there will be
unanticipated and adverse consequences from implementation of the
plan; the risk that Amarin has overestimated the market potential
for VASCEPA in the United States, Europe and other geographies; and
the possibility that Amarin may be unsuccessful in achieving its
expansion goals, including launches and reimbursements in Europe or
other geographies on the expected timelines or at all. A further
list and description of risks and uncertainties associated with an
investment in Amarin can be found in Amarin's filings with the U.S.
Securities and Exchange Commission (SEC), including Amarin’s annual
report on Form 10-K for the full year ended 2021 and its quarterly
report on Form 10-Q for the first quarter of 2022, and in any
subsequent filings, including on current reports on Form 8-K, with
the SEC, which are available at the SEC’s website at www.sec.gov.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date they are made. Amarin undertakes no obligation to
update or revise the information contained in its forward-looking
statements, whether as a result of new information, future events
or circumstances or otherwise. Amarin’s forward-looking statements
do not reflect the potential impact of significant transactions the
company may enter into, such as mergers, acquisitions,
dispositions, joint ventures or any material agreements that Amarin
may enter into, amend or terminate.
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the
company website (www.amarincorp.com) and the investor relations
website (investor.amarincorp.com), including but not limited to
investor presentations, SEC filings, press releases, public
conference calls and webcasts. The information that Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the media
and others interested in Amarin to review the information that is
posted on these channels, including the investor relations website,
on a regular basis. This list of channels may be updated from time
to time on Amarin’s investor relations website and may include
social media channels. The contents of Amarin’s website or these
channels, or any other website that may be accessed from its
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
Amarin Contact Information
Investor Inquiries:Lisa DeFrancescoInvestor Relations Amarin
Corporation plcinvestor.relations@amarincorp.com (investor
inquiries)
Media Inquiries:Mark MarmurCorporate Communications, Amarin
Corporation plcPR@amarincorp.com (media inquiries)
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