Amarin Corporation(US:AMRN)2023-02-28 16:00Commercialization 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].