Amarin Corporation plc (NASDAQ:AMRN) today provided a business
update, including preliminary fourth quarter and full-year 2022
revenue and its year end cash position, in addition to its 2023
priorities to investors at the 41st Annual J.P. Morgan Healthcare
Conference in San Francisco.
Amarin Announces Preliminary (Unaudited)
Fourth-Quarter and Full-Year 2022 Revenues and Cash
Position
Revenues: For the fourth quarter and full year
2022, Amarin estimates total net revenue, subject to audit, to be
between $88 to $90 million and $367 to $369 million, respectively.
These results continue to reflect ongoing stabilization of the U.S.
business for VASCEPA® (icosapent ethyl).
Cash Position: Amarin ended 2022 with
approximately $310 million in cash and investments, with positive
cash flow of approximately $4 million in the fourth quarter of
2022.
Management Commentary
“As we enter 2023, and continuing into the next
chapter for Amarin, we will advance on our vision of becoming a
global, diversified cardiometabolic player. We will do this with a
clear focus on geographic expansion, operational excellence and
portfolio diversification,” said Karim Mikhail, president and chief
executive officer, Amarin. “We are well-equipped and
well-positioned to face head-on the headwinds from the global
macroeconomic environment and the challenges for governments and
payers. We have the right team in Europe with the expertise to
continue to drive reimbursement efforts and launches matched with a
molecule in VASCEPA®/VAZKEPA® with demonstrated evidence across
multiple studies, including the recent results from RESPECT-EPA.
With these elements in place, we are confident that 2023 will be a
year of important execution as we continue to advance our
strategy.”
2022 Key Achievements & 2023
Priorities
Europe
- In 2022, Amarin
secured positive pricing and reimbursement decisions in five
European markets: England & Wales, Sweden, Austria, Denmark and
Finland.
- Reimbursement negotiations continue
to progress in all remaining markets including Spain, Italy,
France, Norway and the Netherlands.
- In 2023, we will
focus on opportunities to accelerate revenues in Europe in key
launched markets including England & Wales, Northern Ireland,
Finland and Sweden and further price negotiations in all
markets.
United States
- The Amarin team
achieved four consecutive quarters of revenue stabilization in the
U.S. business despite additional generic competition.
- In 2023, we will
maintain our focus on profitability while evaluating and adapting
to market conditions.
International
- Secured six
International regulatory approvals, including Hong Kong, Bahrain,
Puerto Rico, Saudi Arabia, Australia and Switzerland.
- In 2023, we will
continue to progress international regulatory filings and support
approval processes in up to 9 countries, including China and New
Zealand.
Data Evidence & Pipeline
Advancement
- Amarin made
progress with our fixed-dose combination (FDC) program for
icosapent ethyl, including initiating the process to seek
scientific advice from the European Medicines Agency and we look
forward to sharing additional updates in 2023.
J.P. Morgan Presentation
Details
Amarin’s president and chief executive officer Karim Mikhail is
scheduled to participate at the 41st Annual J.P. Morgan Healthcare
Conference on January 10, 2023.
41st Annual J.P. Morgan Healthcare Conference (January 9th-12th,
2023; San Francisco, California)
Date/Time: January 10, 2023, 5:15 p.m. PST / 8:15 p.m. ET
Webcast:
https://jpmorgan.metameetings.net/events/healthcare23/sessions/43879-amarin-corporation-plc/webcast?gpu_only=true&kiosk=true
The conference presentation will be webcast live and archived on
the Company’s website in the Investor Relations section under
Upcoming Events and Latest Presentations.
2023 Financial Outlook
Amarin reiterates its belief that current cash
and investments and other assets are adequate to support continued
operations, including European launch activities.About
Amarin
Amarin 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®/VAZKEPA® (icosapent ethyl)
Capsules
VASCEPA capsules are the first prescription treatment approved
by the U.S. Food and Drug Administration (FDA) comprised solely of
the active ingredient, icosapent ethyl, a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after 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 over 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 the United Kingdom, Canada,
Austria, Denmark, Finland, Lebanon, Germany, Sweden 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. In April 2021 marketing
authorization for VAZKEPA (icosapent ethyl) was granted in Great
Britain. The Great Britain Marketing Authorization for VAZKEPA
applies to England, Scotland and Wales.United
StatesIndications and Limitation of
Use
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.
Europe
For further information about the Summary of Product
Characteristics (SmPC) for VAZKEPA® in Europe, please click
here.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
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, including beliefs about
Amarin’s key achievements in 2022 and the potential impact and
outlook for achievements in 2023 and beyond; Amarin’s 2023
financial outlook and cash position; Amarin’s overall efforts to
expand access and reimbursement to VAZKEPA across global markets;
and the overall potential and future success of VASCEPA/VAZKEPA and
Amarin generally. These forward-looking statements are not promises
or guarantees and involve substantial risks and uncertainties. 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 Amarin’s annual report on Form 10-K for the full year
ended 2021. 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 and FAQs, Securities and Exchange Commission
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 DeFrancescoAmarin Corporation
plc IR@amarincorp.com Media
Inquiries: Mark Marmur Amarin Corporation
plc PR@amarincorp.com
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