Amarin Corporation plc (NASDAQ:AMRN) Q4 2022 Results Conference Call March 1, 2023 8:00 AM ET Company Participants Lisa DeFrancesco - Senior Vice President, Corporate Affairs and Investor Relations Karim Mikhail - President and Chief Executive Officer Tom Reilly - Chief Financial Officer Conference Call Participants Roanna Ruiz - SVB Leerink Louise Chen - Cantor Cade Cruz - Goldman Sachs Naresh Chouhan - Intron Health Operator Welcome to Amarin Corporation's Conference Call to Discuss its Fourth Quarter and ...

Commercialization and Market Presence - VASCEPA has been commercially available since 2013, with over 20 million estimated normalized total prescriptions reported by Symphony Health[444]. - The company has received marketing authorization for VAZKEPA in the EU, with national reimbursement secured in several countries, including Sweden, Finland, and the United Kingdom[452]. - In China, the regulatory review for VASCEPA commenced in February 2021, with expected approval by mid-2023 following delays due to COVID-19[455]. - The company has entered into agreements for VASCEPA commercialization in the MENA region, with launches in Lebanon, UAE, and Qatar[458]. - The company has filed thirteen dossiers for market access in European countries, with reimbursement negotiations being critical for commercial success[451]. - The company plans to resubmit a pricing and reimbursement dossier in Germany after previous negotiations concluded without agreement[454]. - The company is implementing a hybrid commercial model in Europe to balance digital and face-to-face approaches for market launches[452]. - The company launched commercial operations in five European countries in 2022 and received regulatory approval in seven countries outside of EMA[496]. - The company aims to secure partnerships for VASCEPA in international markets where it receives local regulatory approval[460]. Financial Performance - Total revenue, net decreased by $214.0 million, or 37%, to $369.2 million in 2022 from $583.2 million in 2021, primarily due to a $218.0 million decrease in U.S. product revenue[492]. - Product revenue, net fell by $213.8 million, or 37%, to $366.5 million in 2022, driven by a 38% decrease in VASCEPA sales in the U.S. due to generic competition[493]. - Licensing and royalty revenue decreased by $0.2 million, or 6%, to $2.7 million in 2022, reflecting the timing of milestone payments[497]. - Cost of goods sold increased by $5.4 million, or 4%, to $126.7 million in 2022, including a $18.1 million charge related to restructuring inventory[499]. - VASCEPA branded prescriptions decreased by 19% in 2022 compared to 2021, indicating a decline in demand[494]. - The overall icosapent ethyl market in the U.S. increased by 7% in 2022, but the company's market share decreased to approximately 60% from 85% in 2021[494]. - Gross margin on product sales decreased from 79% in 2021 to 65% in 2022, with a gross margin of 73% when excluding restructuring inventory[501]. - Selling, general and administrative expenses decreased by $103.9 million, or 25%, from $408.3 million in 2021 to $304.4 million in 2022[501]. - Net cash used in operating activities increased from $66.5 million in 2021 to $180.1 million in 2022, primarily due to decreased U.S. product revenue[510]. - The accumulated deficit as of December 31, 2022, was $1.5 billion, reflecting ongoing annual operating losses since inception[512]. Research and Development - Research and development expenses primarily include costs for clinical trials and independent monitoring, with a focus on VASCEPA[473]. - Total research and development expense, excluding non-cash expense, was $25.9 million in 2022 compared to $25.0 million in 2021[505]. - Research and development expenses increased by $1.1 million, or 4%, from $29.3 million in 2021 to $30.4 million in 2022[504]. - The company has updated 30 clinical treatment guidelines recommending the use of icosapent ethyl in at-risk patients based on REDUCE-IT results[462]. - The REDUCE-IT study demonstrated a 34% reduction in cardiovascular death and events in patients with a history of percutaneous coronary intervention[464]. - The company initiated development of a fixed-dose combination product containing both icosapent ethyl and a statin[465]. Inventory and Restructuring - As of December 31, 2022, the company had inventory valued at $392.4 million, with 90% approved for use in North America[467]. - In 2022, VASCEPA's cost of goods sold included $18.1 million related to restructuring inventory to align supply with market demand[470]. - Restructuring expenses remained relatively stable, with a slight decrease from $13.7 million in 2021 to $13.5 million in 2022[506]. - The company is focusing on engaging top prescribers and maintaining exclusive formulary coverage amid pressure from generic competitors[447]. Cash and Investments - Cash and cash equivalents as of December 31, 2022, were $217.7 million, with total liquidity sources of approximately $311.2 million[509]. - The company anticipates that quarterly net cash outflows will continue to be variable due to factors such as API purchases and generic competition in the U.S.[512]. - The company monitors investments with the objective of minimizing concentrations of credit risks[519]. - Short-term investments consist of held-to-maturity securities due in one year or less[519]. - Long-term investments consist of held-to-maturity securities due in more than one year[519]. - Cash is invested in accordance with an investment policy that limits amounts in any one type of investment[519]. - Investments must maintain minimum ratings from Nationally Recognized Statistical Rating Organizations to achieve liquidity and capital preservation[519]. - The investment policy mandates investment only in institutions that meet high credit quality and diversification standards[519]. - Established limits on the amount and time to maturity of investments are part of the investment policy[519].

SVB Securities Global Biopharma Conference Karim Mikhail President & CEO February 14, 2023 Forward Looking Statements & Disclaimer This presentation contains forward-looking statements which are made pursuant to U.S. federal securities law, 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; strategies to ensure profit maximization; Amarin's strategic direction and actions manag ...

41st 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 na ...

Amarin Corporation plc (NASDAQ:AMRN) 41st Annual J.P. Morgan Healthcare Conference January 10, 2023 8:15 PM ET Company Participants Karim Mikhail - President and Chief Executive Officer Tom Reilly - Chief Financial Officer [Call Starts Abruptly] -- in Europe. And the Board took upon itself to refresh itself also. So, they have initiated a process, in October, of 2021. And for now, we basically have 75% of new board members. So, you see on the list here all the new board members who were added to the list wh ...

Amarin Corporation plc (NASDAQ:AMRN) 13th Annual Jefferies London Healthcare Conference 2022 November 16, 2022 9:40 AM ET Company Participants Karim Mikhail - President and Chief Executive Officer Tom Reilly - Chief Financial Officer Conference Call Participants Michael Yee - Jefferies Michael Yee Well, we'll get stared. Hey, it's Michael Yee here, senior biotechnology analyst at Jefferies. Very happy to have the team from Amarin. Up here with us to give a brief presentation, we have the CEO, Karim Mikhail ...

Amarin Corporation plc (NASDAQ:AMRN) Q3 2022 Results Earnings Conference Call October 27, 2022 8:00 AM ET Company Participants Lisa DeFrancesco - Senior Vice President, Corporate Affairs and Investor Relations Karim Mikhail - President and Chief Executive Officer Tom Reilly - Chief Financial Officer Conference Call Participants Michael Yee - Jefferies Georgi Yordanov - Cowen and Company Roanna Ruiz - SVB Leerink Carvey Leung - Cantor Fitzgerald Daniel Wolle - J.P. Morgan Paul Choi - Goldman Sachs Operator W ...

Amarin Corporation Plc (NASDAQ:AMRN) H.C. Wainwright Global Investment Conference September 12, 2022 9:00 AM ET Company Participants Karim Mikhail - President, CEO & Director Thomas Reilly - CFO & SVP Conference Call Participants Andrew Fein - H.C. Wainwright & Co. Andrew Fein Hello, everyone. I'm Andrew Fein, one of the biotechnology analysts at H.C. Wainwright. Thank you for coming. Glad to be back in person. So the next company presenting will be Amarin, and presenting for the company will be its Presid ...