PART I – Financial Information [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements reflect a net loss, decreased assets, and the ongoing impact of generic competition, offset by a significant improvement in operating cash flow from restructuring efforts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $270,814 | $217,666 | +$53,148 | | Total current assets | $717,511 | $689,098 | +$28,413 | | Total Assets | $839,031 | $886,179 | -$47,148 | | **Liabilities & Equity** | | | | | Total current liabilities | $266,691 | $259,479 | +$7,212 | | Total liabilities | $285,883 | $290,846 | -$4,963 | | Total stockholders' equity | $553,148 | $595,333 | -$42,185 | - The company's total assets decreased by **$47.1 million** from year-end 2022, primarily driven by a reduction in long-term inventory and investments, although cash and cash equivalents increased[12](index=12&type=chunk) - Total stockholders' equity declined by **$42.2 million**, largely due to an increase in the accumulated deficit from net losses incurred during the period[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | 9 Months 2023 | 9 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $66,056 | $89,878 | $232,198 | $278,948 | | Gross margin | $29,822 | $62,859 | $120,417 | $178,880 | | Operating loss | $(21,451) | $(5,144) | $(62,751) | $(96,283) | | Net loss | $(19,311) | $(5,140) | $(53,331) | $(106,659) | | Diluted loss per share | $(0.05) | $(0.01) | $(0.13) | $(0.27) | - Total net revenue decreased by **26.5% in Q3 2023** and **16.8% in the first nine months of 2023** compared to the same periods in 2022, primarily due to lower product revenue[15](index=15&type=chunk) - The company incurred a significant cost of goods sold for restructuring inventory, amounting to **$12.7 million in Q3 2023** and **$39.2 million for the nine-month period**, impacting gross margin[15](index=15&type=chunk) - Despite lower revenues, the net loss for the nine months ended Sep 30, 2023, narrowed to **$53.3 million** from **$106.7 million** in the prior year, driven by lower operating expenses[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $7,525 | $(181,644) | | Net cash provided by investing activities | $45,477 | $203,107 | | Net cash provided by (used in) financing activities | $147 | $(417) | | **Net Increase in Cash** | **$53,149** | **$21,046** | - Cash flow from operations improved significantly, becoming a source of cash (**$7.5 million**) in the first nine months of 2023 compared to a large use of cash (**-$181.6 million**) in the same period of 2022[19](index=19&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company's lead product, VASCEPA, faces generic competition in the U.S. for its MARINE indication, with **six generic versions** having entered the market as of September 2023[22](index=22&type=chunk)[23](index=23&type=chunk) - In July 2023, the company implemented an Organizational Restructuring Plan (ORP), eliminating its entire U.S. sales force and reducing non-sales positions by 30%, resulting in restructuring charges of **$10.7 million** for the nine months ended Sep 30, 2023[44](index=44&type=chunk) - The company recognized a **$15.1 million positive adjustment to revenue** for the nine months ended Sep 30, 2023, due to a change in estimate for the Medicaid rebate provision[64](index=64&type=chunk) - Licensing revenue was significantly impacted by changes in estimates for performance periods with partners Edding and HLS, resulting in the recognition of an additional **$5.0 million** and **$5.3 million**, respectively, during the nine months ended Sep 30, 2023[68](index=68&type=chunk)[73](index=73&type=chunk)[77](index=77&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the impact of U.S. generic competition, the strategic shift to international expansion, and significant cost reductions from its organizational restructuring [Overview](index=26&type=section&id=Overview) - The company is focused on commercializing VASCEPA but faces significant U.S. generic competition, prompting a strategic pivot to international expansion in Europe, China, and other regions[90](index=90&type=chunk) - In July 2023, Amarin implemented an Organizational Restructuring Program (ORP) to reduce operating costs by approximately **$40.0 million annually** by eliminating its U.S. sales force and redesigning European operations[91](index=91&type=chunk) - As of September 2023, **six generic versions of VASCEPA** have launched in the U.S., increasing competitive pressure and shifting strategic priorities to maximizing U.S. cash flow and international expansion[91](index=91&type=chunk)[94](index=94&type=chunk) - The company has secured national reimbursement and launched commercially in several European countries, including England/Wales, Spain, and Sweden, and is pursuing market access in others[99](index=99&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Revenue Comparison (in millions) | Period | Q3 2023 | Q3 2022 | % Change | 9 Months 2023 | 9 Months 2022 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Product Revenue, Net** | $64.9 | $89.2 | -27% | $214.7 | $277.0 | -22% | | *U.S. Product Revenue* | $62.4 | $87.9 | -29% | $209.0 | $272.0 | -23% | | **Licensing & Royalty Revenue** | $1.2 | $0.7 | +76% | $17.5 | $1.9 | +798% | | **Total Revenue, Net** | **$66.1** | **$89.9** | **-27%** | **$232.2** | **$278.9** | **-17%** | - The decrease in U.S. product revenue was primarily due to a decline in net selling price from generic competition, with Amarin's market share decreasing from **~62% in Q3 2022 to ~58% in Q3 2023**[118](index=118&type=chunk) - Cost of goods sold increased, driven by restructuring inventory charges of **$12.7 million in Q3 2023** and **$39.2 million in the first nine months of 2023**[121](index=121&type=chunk)[134](index=134&type=chunk) Operating Expense Comparison (in millions) | Expense Category | Q3 2023 | Q3 2022 | % Change | 9 Months 2023 | 9 Months 2022 | % Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Selling, General & Admin | $45.5 | $58.7 | -23% | $156.0 | $236.3 | -34% | | Research & Development | $5.1 | $5.8 | -11% | $16.4 | $25.2 | -35% | - The significant decrease in SG&A expenses was primarily due to cost reductions from the ORP, including the elimination of the U.S. sales force and reduced promotional activities[124](index=124&type=chunk)[136](index=136&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company had total liquidity of **$321.1 million**, consisting of **$271.3 million in cash** and **$49.8 million in short-term investments**, with no outstanding debt[143](index=143&type=chunk) Cash Flow Summary (in millions) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Operating activities | $7.5 | $(181.6) | | Investing activities | $45.5 | $203.1 | | Financing activities | $0.1 | $(0.4) | - Management believes that its current cash, cash equivalents, and short-term investments are **sufficient to fund projected operations for at least one year** from the financial statement issuance date[145](index=145&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) There have been no material changes to the company's market risk disclosures as reported in its 2022 Annual Report on Form 10-K - There have been no material changes with respect to market risk disclosures from the company's 2022 Annual Report[147](index=147&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal controls during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective at a reasonable assurance level** as of September 30, 2023[148](index=148&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[149](index=149&type=chunk) PART II – Other Information [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings, with details provided in Note 5 of the financial statements - Information regarding legal proceedings is detailed in Note 5 of the financial statements, which discusses antitrust lawsuits from generic competitors, antitrust class actions, and a shareholder class action lawsuit[53](index=53&type=chunk)[54](index=54&type=chunk)[150](index=150&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from its dependence on VASCEPA, including U.S. generic competition, European reimbursement challenges, and restructuring execution - The company is **substantially dependent on its single product, VASCEPA**, and faces increasing competition from generic versions in the U.S., which could materially and adversely affect revenues[152](index=152&type=chunk)[153](index=153&type=chunk)[155](index=155&type=chunk) - Commercialization in Europe is contingent on securing favorable pricing and reimbursement on a country-by-country basis, a process which may not be successful[153](index=153&type=chunk)[158](index=158&type=chunk) - The July 2023 Organizational Restructuring Program (ORP), which eliminated the U.S. sales force, may not be successful in mitigating risks and could impact employee morale[153](index=153&type=chunk)[171](index=171&type=chunk) - The company relies on third-party manufacturers, is subject to minimum purchase commitments that may exceed supply needs, and faces related competitor litigation[153](index=153&type=chunk)[179](index=179&type=chunk)[202](index=202&type=chunk) - In October 2023, the company received a **deficiency letter from NASDAQ** because its ADS trading price fell below the $1.00 minimum bid price requirement, which could lead to delisting[231](index=231&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 235,344 shares during Q3 2023 to satisfy employee tax withholding obligations related to equity awards Issuer Purchases of Equity Securities (Q3 2023) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | July 2023 | 101,388 | $1.19 | | August 2023 | 123,047 | $1.18 | | September 2023 | 10,909 | $1.05 | | **Total** | **235,344** | **$1.18** | - The shares were withheld to satisfy tax withholding obligations related to employee equity awards and were not part of a publicly announced repurchase plan[253](index=253&type=chunk) [Other Information](index=74&type=section&id=Item%205.%20Other%20Information) An executive officer adopted a Rule 10b5-1 trading plan for the potential sale of up to 1,598,749 shares of common stock - Dr. Steven Ketchum, President of R&D and Chief Scientific Officer, adopted a Rule 10b5-1 trading plan for the potential sale of up to **1,598,749 shares** of common stock, ending December 31, 2025[254](index=254&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including a new CEO employment agreement and Sarbanes-Oxley certifications - Key exhibits filed include the employment agreement for new CEO Patrick Holt and certifications by the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[256](index=256&type=chunk)

Amarin Corporation plc (NASDAQ:AMRN) Cantor Fitzgerald Annual Global Healthcare Conference September 26, 2023 9:55 AM ET CompanyParticipants Patrick Holt - President and CEO Conference Call Participants Carvey Leung - Cantor Fitzgerald Carvey Leung My name is Carvey Leung, and I'm a research associate at Cantor here. Thank you for joining us today, Patrick. Question-and-Answer Session Q - Carvey Leung To start, can you tell us a little bit about yourself and your role at the company? Patrick Holt Yes, sure. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 000-21392 Amarin Corporation plc (Exact Name of Registrant as Specified in its Charter) England and Wales Not applicable (State or Other Jurisdicti ...

Summary of Amarin Corporation Conference Call Company Overview - **Company**: Amarin Corporation plc (NASDAQ: AMRN) - **Event**: Goldman Sachs 44th Annual Global Healthcare Conference - **Date**: June 12, 2023 - **Participants**: Aaron Berg (Interim President and CEO), Tom Reilly (CFO), Paul Choi (Goldman Sachs) Key Points Company Performance and Strategy - The management team acknowledges that the company is not where it wants to be, particularly regarding share price and overall value creation [4] - Focus is on the U.S. business, which has maintained a 60% market share since the entry of generics, generating over $1 billion since the product went generic [4][21] - The company aims to drive profitability while managing cash carefully, having saved over $100 million in expenses, which is 30% of their cash base [9] Market Dynamics - The U.S. market has seen a return to pre-COVID patient visit levels, which is a positive sign for business recovery [11] - Physicians continue to prescribe the brand over generics, indicating strong brand loyalty despite the presence of generics [15] - The company has maintained managed care access, with significant improvements in copay structures, making their product more accessible compared to generics [23] International Expansion - The company is focusing on expanding its presence in Europe, particularly in the UK and Nordic countries, where they have launched their product [5][31] - Recent partnerships in Canada, the Middle East, Australia, New Zealand, and China are expected to drive revenue growth in these regions [6][32] - The company is actively negotiating pricing and reimbursement in several European countries, including Spain, Italy, and France [8] Clinical Insights and Product Development - VASCEPA is recognized for its unique mechanism of action, which goes beyond just lowering triglycerides to reducing cardiovascular events [38] - The company is exploring a potential VASCEPA-statin combination, with ongoing discussions with regulatory bodies [41] Future Outlook - The management emphasizes the need to build value by focusing on high-risk patient populations and efficient operational structures [48] - The company is open to business development opportunities that can enhance valuation while prioritizing current operational needs [46] Challenges and Considerations - The company faces challenges in pricing negotiations and market entry in Europe, which require careful management of cash flow and strategic planning [8][34] - There is a recognition of the need for continued learning and adaptation in both U.S. and European markets to improve performance [48] Additional Insights - The management team is committed to leveraging their learnings from past experiences to enhance their market position and drive future growth [48] - The unique characteristics of the generic market in the U.S. complicate pricing strategies, making it difficult to generalize across different countries [34] This summary encapsulates the key discussions and strategic directions outlined during the conference call, highlighting Amarin's focus on maintaining market share, expanding internationally, and navigating the complexities of the healthcare landscape.

Amarin Corporation plc (NASDAQ:AMRN) Jefferies 2023 Global Healthcare Conference June 7, 2023 8:00 AM ET Company Participants Aaron Berg - Interim CEO & President Tom Reilly - CFO Conference Call Participants Michael Yee - Jefferies Michael Yee All right. Good morning, everyone. Well, thank you for joining us on this morning session here to kick off the 2023 Jeffries Global Healthcare Conference. I'm Michael Yee, Managing Director and the Senior Biotech Analyst. Here with us to kick off a session is Amarin ...

Amarin Corporation plc (NASDAQ:AMRN) Q1 2023 Earnings Conference Call May 3, 2023 8:00 AM ET Company Participants Lisa DeFrancesco - Senior Vice President, Corporate Affairs and Investor Relations Aaron Berg - Interim President & Chief Executive Officer Tom Reilly - Chief Financial Officer Steve Ketchum - President R&D and Chief Scientific Officer Conference Call Participants Louise Chen - Cantor Roanna Ruiz - SVB Securities Operator Greetings and welcome to Amarin Corporation's Conference Call to Discuss i ...

PART I [Financial Statements](index=3&type=section&id=Financial%20Statements) Q1 2023 revenue declined to $86.0 million due to U.S. generic competition, but net loss improved to $16.5 million from reduced operating expenses, with $304.9 million in cash and investments [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased slightly to $860.2 million, driven by reduced cash, while liabilities and equity also saw minor reductions Balance Sheet Summary (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $191,412 | $217,666 | | Total current assets | $683,821 | $689,098 | | Total Assets | $860,188 | $886,179 | | **Liabilities & Equity** | | | | Total current liabilities | $244,242 | $259,479 | | Total Liabilities | $275,395 | $290,846 | | Total stockholders' equity | $584,793 | $595,333 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2023 total revenue decreased to $86.0 million, but net loss significantly improved to $16.5 million due to substantial operating expense reductions Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Total revenue, net | $85,975 | $94,630 | | Gross margin | $47,927 | $72,391 | | Total operating expenses | $65,268 | $100,698 | | Operating loss | $(17,341) | $(28,307) | | Net loss | $(16,460) | $(31,563) | | Diluted loss per share | $(0.04) | $(0.08) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved to $7.0 million in Q1 2023, with overall cash and equivalents decreasing by $26.3 million Cash Flow Summary (in thousands) | Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,008) | $(98,847) | | Net cash (used in) provided by investing activities | $(19,610) | $99,049 | | Net cash provided by (used in) financing activities | $364 | $(505) | | **Net Decrease in Cash** | **$(26,254)** | **$(303)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail VASCEPA's market challenges, U.S. generic impact, European expansion, and a $12.3 million restructuring charge related to supplier agreements - The company's lead product is VASCEPA® (icosapent ethyl), with generic versions entering the U.S. market following a patent litigation loss, impacting U.S. operations[17](index=17&type=chunk) - A Comprehensive Cost Reduction Plan initiated in June 2022 resulted in a **$12.3 million charge** in Q1 2023 within cost of goods sold, related to amending supplier agreements to align with market demand[41](index=41&type=chunk) - The company is a defendant in several antitrust class action lawsuits and complaints from generic manufacturers alleging anticompetitive practices related to VASCEPA's active pharmaceutical ingredient supply[52](index=52&type=chunk)[53](index=53&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Q1 2023 revenue declined 9% to $86.0 million due to U.S. generic competition, but net loss narrowed to $16.5 million from significant SG&A and R&D expense reductions, with $304.9 million in liquidity [Overview](index=24&type=section&id=Overview) Amarin focuses on VASCEPA commercialization, facing U.S. generic pressure, leading to a cost reduction plan and active international expansion in Europe and Asia - In June 2022, the company initiated a cost reduction plan, including reducing its U.S. field force from approximately **300 to 75 sales representatives** to address shifts from generic competition[90](index=90&type=chunk) - The company has launched VAZKEPA in several European countries, including Sweden, Finland, and the United Kingdom (Wales), and is pursuing reimbursement in other major European markets[94](index=94&type=chunk) - Partner Edding expects approval for VASCEPA in Mainland China by **mid-2023**, following delays due to COVID-19 resurgence in late 2022[95](index=95&type=chunk) [Comparison of Three Months Ended March 31, 2023 and March 31, 2022](index=31&type=section&id=Comparison%20of%20Three%20Months%20Ended%20March%2031%2C%202023%20and%20March%2031%2C%202022) Total net revenue decreased 9% to $86.0 million due to U.S. generic competition, while operating expenses significantly reduced through cost-saving initiatives Financial Performance Comparison (Q1 2023 vs Q1 2022, in millions) | Metric | Q1 2023 | Q1 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue, Net | $86.0 | $94.6 | -9% | | U.S. Product Revenue, Net | $82.3 | $93.5 | -12% | | Cost of Goods Sold | $38.0 | $22.2 | +71% | | SG&A Expense | $59.6 | $90.6 | -34% | | R&D Expense | $5.7 | $10.1 | -43% | - Cost of goods sold in Q1 2023 included a **$12.3 million charge** for restructuring inventory related to amending supplier agreements[116](index=116&type=chunk) - The decrease in SG&A expense was primarily due to reduced promotional activities and a smaller U.S. sales force as part of the cost reduction plan[118](index=118&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Amarin holds $304.9 million in total liquidity with no debt, deemed sufficient to fund operations for at least one year, with improved operating cash flow Liquidity Position as of March 31, 2023 (in millions) | Component | Amount | | :--- | :--- | | Cash, cash equivalents, and restricted cash | $191.9 | | Short-term investments | $113.0 | | Long-term investments | $0.5 | | **Total Liquidity** | **$305.4** | - Management concluded that the company's cash and investments are sufficient to fund operations for at least one year from the financial statement issuance date[125](index=125&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No material changes occurred in the company's market risk profile during the quarter - There were no material changes in the company's market risk profile during the quarter[127](index=127&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting - The interim principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[128](index=128&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) PART II [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings concerning intellectual property and commercial arrangements, with details in Note 5 - The company is involved in various legal proceedings related to intellectual property and commercial matters, with further details provided in Note 5 of the financial statements[130](index=130&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include substantial dependence on VASCEPA, increasing U.S. generic competition, European reimbursement challenges, and reliance on third-party manufacturers - The company is substantially dependent on its single product, VASCEPA, and faces increasing competition from generic versions in the U.S., which could continue to materially and adversely affect revenues[132](index=132&type=chunk)[133](index=133&type=chunk) - Commercialization in Europe is contingent on securing favorable pricing and reimbursement, which is not guaranteed and has already failed in Germany, leading to a discontinuation of business operations there[133](index=133&type=chunk)[138](index=138&type=chunk) - The company relies entirely on third-party manufacturers for its product supply, exposing it to risks of manufacturing problems, supply interruptions, and potentially burdensome minimum purchase commitments[133](index=133&type=chunk)[183](index=183&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=70&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 827,523 shares at an average of $1.82 per share in Q1 2023 to satisfy employee tax withholding obligations Issuer Purchases of Equity Securities (Q1 2023) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | January 2023 | 485,433 | $1.81 | | February 2023 | 218,374 | $1.82 | | March 2023 | 123,716 | $1.87 | | **Total** | **827,523** | **$1.82** | - The shares were withheld to satisfy tax withholding obligations related to employee equity awards[231](index=231&type=chunk) [Other Information](index=70&type=section&id=Item%205.%20Other%20Information) No other information was reported for this item - No other information was disclosed under this item[232](index=232&type=chunk) [Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including sublease agreements, SOX certifications, and XBRL taxonomy documents - Exhibits filed include sublease agreements, Sarbanes-Oxley certifications by the Interim CEO and CFO, and XBRL data files[233](index=233&type=chunk)

Summary of Amarin Corporation plc Conference Call Company Overview - **Company**: Amarin Corporation plc (NASDAQ:AMRN) - **Event**: Cowen 43rd Annual Healthcare Conference - **Date**: March 8, 2023 - **Participants**: Karim Mikhail (President and CEO), Georgi Yordanov (Cowen and Company) Key Points European Market Opportunity - The European market presents a significant opportunity with approximately **14 million statin-treated patients**, similar to the U.S. market [3] - An estimated **one-third** of these patients have elevated triglycerides, and **20%** have established cardiovascular disease (CVD), indicating millions of potential patients in Europe [3] Launch and Pricing Strategy - The launch process in Europe differs from the U.S., taking around **two years** for pricing and reimbursement negotiations [5] - Once pricing is established, there is open access to the patient population, which is critical for product value [6] - The company has completed pricing negotiations in **10 countries** by the end of 2022, with **5 countries** approved for launch, including the U.K., Sweden, Finland, Austria, and Denmark [13] Revenue Expectations - The U.K. is expected to contribute more than **50%** of the revenue in 2023, as it will have a full year of revenue compared to other markets [18] - The pricing in the five launched markets is around **€5 to €5.3 per day**, equating to nearly **$2,000** annually [13] Challenges in Germany - Germany poses a challenge due to budgetary constraints and a healthcare deficit, making it difficult to negotiate reimbursement [11] - The company plans to revisit the German market after establishing a presence in other European countries [40] Formularies and Prescribing - Amarin has achieved formulary access in **19 out of the top 20 accounts**, covering **50%** of the eligible patient population within three months of launch [24] - The U.K. has no restrictions on prescribers, allowing for broader access compared to countries like Italy, which restricts prescriptions to specialists initially [28] Future Growth and Partnerships - Amarin is exploring partnerships in Southeast Asia and Eastern Europe, with significant potential for revenue outside the U.S. and Europe [43] - The company is also pursuing fixed-dose combination strategies to enhance market penetration and lifecycle management [47] Overall Market Potential - The ex-U.S. revenue potential is significant, with the possibility of matching U.S. revenue levels over time [44] - The company is cautious about providing specific revenue guidance until major markets are negotiated [36] Conclusion - Amarin is focused on establishing a strong presence in Europe, navigating the complexities of pricing and reimbursement, and leveraging partnerships to maximize market potential. The company remains optimistic about its growth trajectory despite the challenges faced in specific markets like Germany.

Fourth Quarter & Full Year 2022 Financial Results and Business Update Conference Call Karim Mikhail President & CEO Tom Reilly CFO March 1, 2023 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 develo ...

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 ...