Amarin Corporation plc (NASDAQ:AMRN) today provided a business
update, including preliminary unaudited fourth quarter 2023 revenue
and its year-end cash position, its 2023 progress and 2024
priorities and its plan to initiate a share repurchase program,
ahead of its presentation to investors at the 42nd Annual J.P.
Morgan Healthcare Conference in San Francisco.
Amarin Announces Preliminary (Unaudited)
Fourth-Quarter and Full-Year 2023 Revenues and Cash
Position
Revenues: For the fourth quarter, Amarin
estimates total revenue between $72 to $74 million (Europe ~$1.5
million; U.S. $64 - $65 million; RoW $7 - $8 million – including
supply shipments and milestone achievement) and between $304 to
$306 million for the full year 2023.
Cash Position: Amarin ended 2023 with
approximately $321 million in cash and investments, with positive
cash flow of approximately $10 million for the full year. The
Company has now reported six consecutive quarters of cash positive
or neutral operations.
Management Commentary
“In 2023, our team focused and delivered on our
priorities that advanced our strategy,” said Patrick Holt,
President & CEO of Amarin. “We enter 2024 with a number of
positives: we have a solid cash position and no debt; our European
business is showing early signs of progress following new
leadership and a new strategy; our U.S. business continues to
retain IPE market leadership and is in a solid position with
exclusive contracts to start 2024; and our partners in the Rest of
World (ROW) are advancing commercialization and market access
efforts. As we begin this year and in-line with this morning’s
announced share repurchase program, we have confidence in the
business and we are focused on delivering value for
shareholders.”
2023 Key Achievements & 2024
Priorities
Europe
- In 2023, Amarin
secured pricing and reimbursement and launched VAZKEPA in 3
additional markets, including Spain and the Netherlands. VAZKEPA is
now available in 9 markets across Europe. Amarin delivered
approximately 65% growth in the fourth quarter versus the third
quarter 2023.
- In 2024, we will
focus on opportunities to accelerate revenue in Europe in key
launched markets including Spain and the United Kingdom, and
advance pricing and reimbursement processes in key markets
including Italy, France, and Germany.
United States
- In 2023, the
Amarin team continued to retain its IPE market share leadership in
the U.S. at 57%, despite additional generic competition.
- In 2024, we will
focus on maintaining IPE market share leadership and profitability
while continuing to adapt to dynamic market conditions.
Rest of World
- In 2023, the
Amarin team secured 5 Rest of World regulatory approvals, including
China (VHTG), and entered into marketing and commercialization
agreements in key markets and regions, including Australia &
New Zealand and ASEAN/South Korea.
- In 2024, we will
support pricing and reimbursement and commercialization efforts
across key markets, including Australia and China, and continue to
progress Rest of World regulatory filings.
Amarin Announces Plan to Initiate Share Repurchase
Program of Up to $50 Million
On January 9, 2024, Amarin entered into a conditional share
repurchase agreement with Cantor Fitzgerald & Co. (“Cantor”) to
purchase up to $50 million of Amarin’s ordinary shares held in the
form of American depository shares (ADSs). The implementation of
the share repurchase program will require Amarin shareholder
approval as well as UK High Court approval, as required under UK
company law. The Company intends to call its 2024 annual general
meeting of shareholders early in the second quarter of 2024 to seek
shareholder approval of the program, which would be followed by the
UK High court process. Amarin anticipates that these steps could be
completed by the end of the second quarter of 2024, with share
repurchases commencing shortly thereafter.
Additional details regarding the share repurchase agreement can
be found in the appendix of this press release and corresponding
financial filings.
2024 Financial Outlook
Amarin continues to make progress on reducing operating expenses
and managing its cash position and is on-track to deliver $40
million of annual savings based on the reduction in force announced
in July 2023. With the recent cash preservation initiatives, Amarin
reiterates its belief that current cash and investments and other
assets are adequate to support continued operations including the
share repurchase program. We will continue to focus on cash
preservation and prudently invest in the right opportunities which
are value additive.
J.P. Morgan Presentation
Details
Amarin’s president and chief executive officer Patrick Holt is
scheduled to participate at the 42nd Annual J.P. Morgan Healthcare
Conference on January 10, 2024.
42nd Annual J.P. Morgan Healthcare Conference (January 8th-11th,
2024; San Francisco, California)
Date/Time: January 10, 2024, 4:30 p.m. ET/ 1:30 p.m. PST
Webcast:
https://jpmorgan.metameetings.net/events/healthcare24/sessions/49593-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
Events and Presentations at Amarin Corporation plc.
About
Amarin
Amarin is an innovative pharmaceutical company leading a new
paradigm in cardiovascular disease management. We are committed to
increasing the scientific understanding of the cardiovascular risk
that persists beyond traditional therapies and advancing the
treatment of that risk for patients worldwide. 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.
About VASCEPA®/VAZKEPA® (icosapent ethyl)
Capsules
VASCEPA (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 twenty million times. VASCEPA
is covered by most major medical insurance plans. In addition to
the United States, VASCEPA is approved and sold in Canada, China,
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. In April 2021 marketing authorization for VAZKEPA
(icosapent ethyl) was granted in Great Britain (applying to
England, Scotland and Wales). VAZKEPA (icosapent ethyl) is
currently approved and sold in Europe in Sweden, Denmark, Finland,
Austria, the UK, Spain and the Netherlands.
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.
Additional Information Regarding Amarin Share Repurchase
Agreement
The implementation of the repurchase agreement is conditional
upon shareholder and UK court approval, as required under UK
company law. The Company intends to accelerate its annual general
meeting of shareholders early in the second quarter of 2024 in
order to seek such shareholder approval, following which it will
proceed with the requisite court process to undertake a reduction
of capital in order to create the necessary distributable profits
for the funding of the repurchases. Amarin anticipates that these
steps could be completed by the end of the second quarter of 2024,
with share repurchases commencing shortly thereafter. Following
receipt of the requisite approvals, Cantor will purchase such ADSs
in compliance with the safe harbor provisions of Rule 10b-18 of the
U.S. securities laws and the terms of the approved repurchase
contract. The repurchase program will conclude at such time as
Cantor has purchased $50 million of ADSs, unless terminated earlier
by either Amarin or Cantor, as provided for in the repurchase
agreement. Subject to the necessary shareholder and court
approvals being obtained, the repurchases will be funded out of
distributable profits utilizing the Company’s existing cash
resources. The repurchase program was approved by the Amarin board
in compliance with UK company law regarding distributions and the
maintenance of capital. A copy of the repurchase agreement will be
available for inspection by Amarin’s shareholders at the registered
office address of Amarin in the run up to the 2024 annual general
meeting and, once entered into, will be available for inspection
for at least 10 years from the date of such
agreement.
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 2023 and the potential impact and
outlook for achievements in 2024 and beyond; Amarin’s 2024
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 2022. 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.
Implementation of the share repurchase program is subject to
shareholder and UK court approval, which may not be obtained in a
timely manner or at all; Cantor may be unable to repurchase some or
all of the ADSs within the parameters provided for in the share
repurchase agreement; and the share repurchase may not have the
expected results.
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 (amarincorp.com/investor-relations), 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
& Media Inquiries: Mark Marmur Amarin
Corporation plc PR@amarincorp.com
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