UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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| Item 2.02 | Results of Operations and Financial Condition. |
On January 10, 2023, Amarin Corporation plc (the “Company”) issued a press release announcing its preliminary 2022 revenue results and year end cash position, and 2023 priorities (the “Press Release”). A copy of the Press Release is furnished herewith as Exhibit 99.1.
| Item 7.01 | Regulation FD Disclosure |
The Company will present further details on the matters noted above at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023 at 8:15 p.m. Eastern Time/5:15 Pacific Time, which presentation will be accessible by a live webcast through the Company’s website at https://investor.amarincorp.com/events-and-presentations/events. A copy of the Company’s investor deck, which will be referenced during the Company’s webcast presentation, is furnished herewith as Exhibit 99.2
The information set forth under Item 2.02, Item 7.01, and in the Press Release and the Investor Deck furnished as Exhibit 99.1 and Exhibit 99.2 herewith 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 shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | ||
| 99.2 | Investor Deck dated January 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: January 10, 2023 | Amarin Corporation plc | |||||
| By: | /s/ Karim Mikhail | |||||
| Karim Mikhail | ||||||
| President and Chief Executive Officer | ||||||
Exhibit 99.1
AMARIN PROVIDES PRELIMINARY FOURTH QUARTER AND FULL
YEAR 2022 REVENUE AND CASH POSITION AND PRIORITIES FOR 2023
— Company Delivers Fourth Consecutive Quarter of U.S. Revenue Stabilization, Positive Fourth
Quarter Cash Flow and Continued Progress on European Reimbursements —
— Amarin to Present at 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023 —
DUBLIN, Ireland and BRIDGEWATER, N.J., January 10, 2023 – 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 Events and Presentations at Events | Amarin Corporation plc.
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 States
Indications 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 DeFrancesco
Amarin Corporation plc
Media Inquiries:
Mark Marmur
Amarin Corporation plc
# # #
Exhibit 99.2 st 41 Annual J.P. Morgan Healthcare Conference Karim Mikhail President & CEO January 23
Forward Looking Statements & Disclaimer This presentation contains forward-looking statements, such as those relating to the commercial potential of VASCEPA® (VAZKEPA® in Europe), clinical and regulatory efforts and timelines, potential regulatory and pricing approvals, patent litigation, generic product launch, intellectual property, cash flow, research and development, and other statements that are forward-looking in nature and depend upon or refer to future events or conditions, including financial guidance and milestones. These statements involve known and unknown risks, uncertainties and other factors that can cause actual results to differ materially. Investors should not place undue reliance on forward-looking statements, which speak only as of the presentation date of this presentation. Please refer to the “Risk Factors” section in Amarin’s most recent Forms 10-K and 10-Q filed with the SEC and cautionary statements outlined in recent press releases for more complete AMARIN, VASCEPA, VAZKEPA and REDUCE-IT are trademarks descriptions of risks in an investment in Amarin. of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States. THIS PRESENTATION IS INTENDED FOR COMMUNICATION WITH INVESTORS AND NOT FOR DRUG PROMOTION.
Summary 01 The Amarin Journey Changing the Paradigm in Cardiovascular Care 02 Progress In 2022 Solid Execution Against Ambitious Objectives 03 The Next Chapter Becoming a Diversified, Global Cardiometabolic Player AMARIN, VASCEPA, VAZKEPA and REDUCE-IT are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending 04 registration in the United States. 2023 Key Priorities Positioned for Successful Execution
The Amarin Journey Changing the Paradigm in Cardiovascular Care
The Amarin Journey The Amarin Journey - Changing The Paradigm Amarin Delivered on Pursuing Cardiovascular Outcomes 2012 2009 2018 2020 FDA approval Focus on preventative cardiovascular care, Publication of REDUCE-IT® Launch of VASCEPA® with the start of Amarin’s Phase 3 clinical study results in New England in the United States to reduce cardiovascular risk beyond cholesterol program MARINE and ANCHOR studies Journal of Medicine (Nov ’18) lowering therapy in high-risk patients PART 1 - TARGETED U.S. COMMERICAL EFFORT PART 2 - PURSUING CARDIOVASCULAR OUTCOMES & U.S. COMMERCIALIZATION FOR NICHE HIGH TRIGLYCERIDES INDICATION 2011 2013 2019 2021 Start of the landmark Launch of VASCEPA® • FDA approval of Vascepa® Amarin loses patent protection to treat severe (≥500 mg/dL) hypertriglyceridemia, cardiovascular outcomes to reduce cardiovascular risk in the United States known as very high triglycerides (VHTG) REDUCE-IT® trial • EMA submission accepted • Icosapent ethyl in guidelines issued by European Society of Cardiology (ESC) & European Atherosclerosis Society (EAS) January 23 5
The Amarin Journey The Amarin Journey - Changing The Paradigm Becoming a Global, Diversified Cardiometabolic Player 2020 2022 Decision to self-launch in Europe H1 2022: reimbursement and build dedicated organization received in UK & Sweden PART 1 - GOING PART 2 - PURSUING AFTER HIGH CARDIOVASCULAR Part 3: GLOBALIZATION & COMMERCIALIZATION TRIGLYCERIDE OUTCOMES & U.S. COMMERCIALIZATION CHALLENGES 2021 BEYOND March ‘21: EC approves icosapent ethyl (branded VAZKEPA®) Multi-billion dollar ex-US opportunity April ‘21: MHRA approves icosapent ethyl in Great Britain Sept ‘21: Vazkepa® available in Germany January 23 6
2022 Progress Solid Execution Against Ambitious Objectives
2022 Solid Execution Against Ambitious Objectives We Made Progress Against All Three Strategic Pillars January 23 8 8 8
2022 Progress Managing The Dynamic U.S. Situation Maintaining Share Two Years Into Generic Competition Total IPE Norm TRx Trend Nov-20: Hikma Aug-21: Karim Mikhail Sep-21: AMRN announces Jun-22: $100mm cost launches icosapent appointed Amarin restructuring and focuses on reduction plan and revised 120,000 ethyl capsules; President and CEO on Go-to-market strategy Go-to-market strategy first generic announced Vascepa® launch U.S. Business has 100,000 maintained ~60% market share with 80,000 four generics on the market 60,000 40,000 20,000 0 Oct-20 Jan-21 Apr-21 Jul-21 Oct-21 Jan-22 Apr-22 Jul-22 Oct-22 Jan-23 Generic V Vascepa Total IPE JANUARY 23 9 Norm TRx
2022 Progress Significant Progress In Europe 1. Regulatory 2. Submission of Market Access 3. Scientific Evidence Assessm. 4. Reimbursement 5. Country Launch Approval & Reimbursement Dossiers / Recommendation Price Negotiations Pricing announcement & Publication Austria Denmark England/Wales Finland France Germany Entering 2022 we had Italy one market in price Netherlands negotiations… Norway Portugal Scotland Spain Sweden Switzerland Israel JANUARY 23 10
2022 Progress Significant Progress In Europe 1. Regulatory 2. Submission of Market Access 3. Scientific Evidence Assessm. 4. Reimbursement 5. Country Launch Approval & Reimbursement Dossiers / Recommendation Price Negotiations Pricing announcement & Publication Launched Austria Individual reimbursement > national reimbursement expansion 2023 (Individual Reimbursement) Launched Denmark Individual reimbursement > national reimbursement expansion 2023 (Individual Reimbursement) England/Wales National reimbursement Launched Finland National reimbursement Launched CEPS negotiations ongoing France Final Arbitration Decision Germany Amarin suspended VAZKEPA® supply and German business operations November 2022 At year end we had Positive CTS, CPR negotiations started Italy VAZKEPA® available in Netherlands Positive ZIN recommendation, MoH pricing negotiations ongoing 5 markets, and in the Norway Pending NOMA decision pricing negotiation stage in another 5 markets INFARMED submission ongoing Portugal SMC submission ongoing Scotland Spain Positive IPT recommendation, Pending MoH decision National reimbursement Sweden Launched Switzerland BAG submission ongoing Israel JANUARY 23 11
2022 Progress $1 Billion Opportunity - Plans To Bring Unique Cardioprotective Benefits Of VASCEPA®/VAZKEPA® To 20 Additional Markets ST 1 WAVE Switzerland ND 2 WAVE 2023 UP TO China 9 COUNTRIES Bahrain Hong Kong (CVRR) Saudi Arabia Puerto Rico RD 3 WAVE 2024 UP TO 5 COUNTRIES Australia 6 ACHIEVED New Zealand Including… Australia, Switzerland, Hong Kong, Saudi Arabia, Bahrain; Additional markets Supported by REDUCE-IT® Study pending including New Zealand and China and U.S. FDA and EMA Filings Note: The company is pursuing expansion into these various additional markets and the status of regulatory and/or patent approval will vary market to market. JANUARY 23 12
2022 Progress 2022 Solid Execution Against Ambitious Objectives Transformed Amarin Through Focus on Operational Excellence SIGNIFICANT PROGRESS ON CASH TRANSFORMED LEADERSHIP PRESERVATION INITIATIVES TEAM AND BOARD • Added global, pharma, leadership • Cost savings plans to achieve $100 million and financial expertise in annual savings by mid-2023 on target • Built a leading European leadership team • Renegotiations of supply agreements to best execute on significant continue to progress resulting in commercial opportunity reduction of inventory purchases • 70% of executive leadership team new in 2022 JANUARY 23 13
2022 Progress Full Year 2022 Preliminary Results Support Solid Foundation For Future Growth Q1 Q2 Q3 Q4 160 Stabilization Of 140 U.S. Revenue Drives 120 Strong Performance Est • Fourth quarter 2022 $88-90 100 million revenues expected between $88 and $90 million 80 • Despite ongoing generic competition, experienced 60 stable revenue trends 40 throughout 2022 for VASCEPA® in the U.S. 20 0 2021 2022 January 23 14 Total Net Revenues $M
2022 Progress Operational Excellence 2022 Solid Execution Against Ambitious Objectives Significant Efforts Taken To Control Costs And Lower Cash Burn 2022 Quarterly Cash Burn 20 Preliminary 4Q Results Fourth Quarter Cash Flow Positive ~$4 Million 0 Cash Flow Positive • Cash balance at 12/31 -20 approximately $310 million -40 • $100 million cost reduction plans announced in June on- -60 track • Significant progress -80 renegotiating supply purchase -100 agreements - process ongoing -120 Q1 2022 Q2 2022 Q3 2022 Q4 2022 January 23 15
2022 Progress Transformed And Strengthened Leadership Team 25+ 45+ 100+ CV & RELATED DIFFERENT YEARS PRODUCTS LAUNCHED MARKETS IN CV Caroline Maraval Laurent Abuaf Dr. Nabil Abadir Tom Reilly Lisa DeFrancesco David Keenan Jordan Zwick Aaron Berg Steven Ketchum, PhD Donna Pasek VP, Chief of Staff SVP, President SVP, Chief SVP, Chief SVP, Corporate SVP, Technical SVP, Corporate EVP, President-U.S. EVP, Chief Scientific SVP, Human March 2022 of Europe Medical Officer Financial Officer Affairs and Operations Business November 2012 Officer Resources August 2021 April 2022 June 2022 Investor Relations May 2022 Development February 2012 May 2012 January 2022 May 2022 JANUARY 23 16
2022 Progress Established Best-in-Class European Leadership Team 30+ 40+ 125+ CV & RELATED DIFFERENT YEARS PRODUCTS LAUNCHED MARKETS IN CV Laurent Abuaf Scott Curley Luca Ruffini Henrik Salvador Lopez Hakima Laurent Josse, PhD Tamara Barghout David Jakouloff, MD Christos SVP, President UK – General Italy – General Asmussen Iberia – General Hannachi France – General Head of Head of Market Papadopoulos of Europe Manager Manager Mid Europe & Manager Head of Medical Manager Marketing & Access CCE – General Nordics – Affairs Europe Launch Lead Manager General Manager JANUARY 23 17
2022 Progress Highly Qualified New Board Members With the Right Skills Needed to Guide Amarin Through EU Commercialization INTERNATIONAL PRICING AND CARDIOVASCULAR BUSINESS YEARS FINANCE GOVERNANCE (EU / GLOBAL) REIMBURSEMENT EXPERIENCE DEVELOPMENT EXPERTISE 30+ Per Wold-Olsen PHARMA AND üüüüüü Chairman since May 2022 COMMERCIAL 30+ Geraldine Murphy PHARMA COMMERCIAL üüüü Board member since Oct 2022 AND MANUFACTURING 30+ Alfonso “Chito” Zulueta PHARMA, COMMERCIAL üüü ü Board member since May 2022 AND GOVERNANCE 30+ Adam Berger OF FINANCIAL üüüüü Board member since Oct 2022 EXPERTISE 29+ Erin Enright FINANCIAL AND üüü Board member since May 2022 GOVERNANCE 27+ Murray Stewart MEDICAL, CARDIO, üüü ü Board member since January 2023 GOVERNANCE 26+ Karim Mikhail PHARMA AND üüüü President & CEO since Aug 2021 COMMERCIAL NEW BOARD MEMBERS’ BREADTH AND DEPTH OF EXPERIENCE üüüüüü 175+ JANUARY 23 18
The Next Chapter Becoming a Diversified, Global Cardiometabolic Player
The Next Chapter Becoming a Diversified, Global Cardiometabolic Player OPERATIONAL PORTFOLIO EVOLUTION DIVERSIFICATION GEOGRAPHIC EXPANSION Solid foundation entering growth and expansion period JANUARY 23 20
The Next Chapter The Next Chapter - Becoming A Global 1. Regulatory 4. Reimbursement 5. Country Launch Cardiometabolic Player 2. Submission of Dossiers 3. Scientific Evidence Pricing announcement & Publication Approval Price Negotiations Underway Austria November 2022 (National) Underway Denmark April 2022 (National) We will enter the England/Wales Completed October 2022 final stages of price Finland Completed December 2022 negotiations in all France Underway 2023/2024 key markets in Italy Underway Europe this year 2023 Netherlands Underway 2023 COMPLETED Norway Underway 2023 Portugal 2023 2023 Scotland 2023 2023 Spain Underway 2023 Sweden Completed Launch Underway Switzerland Underway 2023 Israel 2023 2023 JAN JANU UAR ARY 2 Y 23 3 21
The Next Chapter International Expansion A Significant Focus – 20 Markets By 2024 Switzerland China NEXT WAVE UP TO Bahrain Hong Kong (CVRR) Saudi Arabia Puerto Rico 14 BY YEAR END 2024 Additional markets pending including China, New Zealand Australia ST Negotiate Partnership Opportunities 1 WAVE New Zealand to Drive Access While Maintaining Flexibility 6 COMPLETE Supported by REDUCE-IT® Study and U.S. FDA and EMA Filings JANUARY 23 22
The Next Chapter We Will Continue To Focus On Operational Excellence As Part Of Our Evolution FOCUS ON PROFITABILITY IN THE US Continue to anticipate and manage effectively to market dynamics MAINTAIN FINANCIAL DISCIPLINE Identify additional cost savings opportunities SEQUENCED INVESTMENTS IN GROWTH Staged investment approach to launch activities in Europe JANUARY 23 23
The Next Chapter The Next Chapter – Becoming A Diversified Cardiometabolic Player Explore Strategic Opportunities to Leveraging our Strengths for Future Success Scientific R&D Commercial Strong Expertise Capabilities Cardiovascular Network REDUCE-IT®, US Commercial Cardiovascular Capabilities and Building Global Medical Affairs Development and EU Commercial Team and Advocacy Global Regulatory JANUARY 23 24
The Next Chapter The Next Chapter – Becoming A Diversified Cardiometabolic Player Rationale for Development of an FDC Portfolio Life Cycle Management Greater Patient Enhance The Of VAZKEPA® Convenience And Adherence Value Proposition An FDC launch can potentially Reduced pill burden, meaning If successful, the FDC product bring a significant value to greater convenience which would carry the most significant the VASCEPA® /VAZKEPA® translates into increased adherence CV risk outcome benefit label franchise globally with a positive impact on patient and potentially additional outcome but also commercially protection for patients Process underway to seek Scientific Advice from EMA JANUARY 23 25
2023 Priorities Positioned for Successful Execution
2023 Priorities The Next Chapter – Becoming A Diversified Cardiometabolic Player 2023 KEY PRIORITIES Progress all Obtain additional Advance the Continue Maintain reimbursements regulatory development to focus on profitability to focus on approvals of FDC and operational in US launching and partner explore excellence in Europe international additional markets diversification opportunities through BD JANUARY 23 27
Leading a new paradigm in preventive cardiovascular care and growing our impact for patients globally AMBITIONS for
THANK YOU JANUARY 23