Core Insights - Amarin's shares surged by 32.9% following the announcement of strong preliminary fiscal fourth-quarter results, a new share-repurchase authorization, and positive guidance for 2024 [1] Financial Performance - For the fourth quarter of 2023, Amarin expects revenue between $72 million and $74 million, significantly exceeding analysts' consensus estimates of approximately $62 million [2] - Full-year 2023 revenue is projected to be between $304 million and $306 million, compared to estimates of $294 million [2] - The company ended the year with approximately $321 million in cash and investments, achieving a positive cash flow of $10 million for the year, marking the sixth consecutive quarter of cash-positive or cash-neutral operations [2] Future Plans - Amarin announced a new conditional share repurchase agreement with Cantor Fitzgerald for up to $50 million in shares, pending shareholder and U.K. High Court approvals, with expected completion around mid-2024 [3] - The company aims to reduce operating expenses further in 2024, targeting $40 million in annual savings from a restructuring plan initiated in July 2023, in response to increasing competition for its cholesterol drug Vascepa [3] - Amarin plans to focus on preserving cash to invest in value-adding opportunities, particularly in the European market, where further efforts are needed [3]

Amarin Corporation plc (NASDAQ:AMRN) 42nd Annual J.P. Morgan Healthcare Conference January 10, 2024 4:30 PM ET Company Participants Pat Holt - President & CEO Conference Call Participants Jess Fye - JPMorgan Jess Fye Great. Good afternoon, everyone. Welcome. My name is Jess Fye. I'm a Senior Biotech Analyst at JPMorgan, and we're continuing the 42nd Annual Healthcare Conference today with Amarin. I'm joined up here by the company's President and CEO, Pat Holt. He's going to give a presentation on the busine ...

Amarin Corporation plc (NASDAQ:AMRN) 42nd Annual J.P. Morgan Healthcare Conference January 10, 2024 4:30 PM ET Company Participants Pat Holt - President & CEO Conference Call Participants Jess Fye - JPMorgan Jess Fye Great. Good afternoon, everyone. Welcome. My name is Jess Fye. I'm a Senior Biotech Analyst at JPMorgan, and we're continuing the 42nd Annual Healthcare Conference today with Amarin. I'm joined up here by the company's President and CEO, Pat Holt. He's going to give a presentation on the busine ...

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Core Insights - Amarin Corporation reported preliminary unaudited total revenues for Q4 2023 between $72 million and $74 million, with full-year revenues estimated between $304 million and $306 million [2][3] - The company ended 2023 with a cash position of approximately $321 million and achieved a positive cash flow of around $10 million for the year [2][3] - Key priorities for 2024 include accelerating revenue in key European markets, maintaining IPE market leadership in the U.S., and maximizing patient uptake in the Rest of World (RoW) through partnerships [1][3] Financial Performance - Q4 2023 revenue breakdown: Europe approximately $1.5 million, U.S. $64 million to $65 million, and RoW $7 million to $8 million [2] - The company has reported six consecutive quarters of cash positive or neutral operations [2] Strategic Initiatives - Amarin plans to initiate a share repurchase program of up to $50 million, pending shareholder and UK High Court approval [1][7] - The company aims to focus on opportunities to accelerate revenue in Europe, particularly in Spain and the UK, and to advance pricing and reimbursement processes in Italy, France, and Germany [4] Market Position - In the U.S., Amarin retained IPE market share leadership at 57% despite increased generic competition [5] - The company secured five regulatory approvals in RoW, including China, and entered into marketing agreements in key regions [6] Future Outlook - Amarin is on track to deliver $40 million in annual savings from a reduction in force announced in July 2023 [9] - The company anticipates that its current cash and investments are adequate to support ongoing operations, including the share repurchase program [9]

Amarin Corporation plc (NASDAQ:AMRN) Q3 2023 Earnings Call Transcript November 1, 2023 8:00 AM ET Company Participants Jordan Zwick - SVP, Business Development & IR Patrick Holt - President & CEO Tom Reilly - CFO Conference Call Participants Louise Chen - Cantor Roanna Ruiz - Leerink Paul Choi - Goldman Sachs Operator Welcome to Amarin Corporation's conference call to discuss its third quarter 2023 financial results and business updates. I would now like to turn the conference call over to Jordan Zwick, Sen ...

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.