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Amarin Corporation(AMRN) - 2025 Q1 - Quarterly Report
2025-05-07 11:05
[PART I – Financial Information](index=3&type=section&id=PART%20I%20%E2%80%93%20Financial%20Information) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited financial statements for Q1 2025 reflect decreased assets and revenue, a wider net loss, and continued cash usage in operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $655.7 million, driven by reductions in cash, investments, receivables, and inventory Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total current assets** | $573,061 | $595,399 | | **TOTAL ASSETS** | **$655,677** | **$685,349** | | **Total current liabilities** | $162,408 | $179,949 | | **Total liabilities** | $181,990 | $199,173 | | **Total stockholders' equity** | $473,687 | $486,176 | | **TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY** | **$655,677** | **$685,349** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net revenue for Q1 2025 declined to $42.0 million, resulting in an increased operating loss of $16.8 million and a net loss of $15.7 million Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | **Total revenue, net** | **$42,017** | **$56,519** | | Gross margin | $25,130 | $31,904 | | Total operating expenses | $41,885 | $45,487 | | **Operating loss** | **$(16,755)** | **$(13,583)** | | **Net loss** | **$(15,697)** | **$(9,953)** | | **Basic and Diluted Loss per share** | **$(0.04)** | **$(0.02)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $12.5 million, while the end-of-period cash balance decreased significantly year-over-year to $119.8 million Condensed Consolidated Statements of Cash Flows (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | **Net cash used in operating activities** | **$(12,459)** | **$(12,601)** | | **Net cash provided by investing activities** | **$12,064** | **$28,719** | | **Net cash used in financing activities** | **$(1,119)** | **$(1,426)** | | Net (decrease) increase in cash | $(1,514) | $14,692 | | **Cash, cash equivalents and restricted cash, end of period** | **$119,824** | **$214,469** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes disclose significant U.S. generic competition, high customer concentration, ongoing legal proceedings, and future purchase obligations - The company faces **significant competition in the U.S.** from multiple generic versions of icosapent ethyl following an adverse patent ruling in March 2020[21](index=21&type=chunk) - **Three major customers accounted for 91%** of gross product sales in Q1 2025, indicating significant customer concentration[46](index=46&type=chunk) - Amarin is involved in **multiple legal proceedings**, including antitrust class action lawsuits and a DOJ investigation into its promotional programs[71](index=71&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk) - The company has **$61.2 million in future contractual purchase obligations**, with an additional **$152.8 million contingent** on European regulatory and pricing approvals[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=41&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 26% revenue decline to U.S. generic competition, while highlighting European growth, improved gross margin, and sufficient liquidity [Overview](index=41&type=section&id=Overview) The company's strategy focuses on expanding European commercialization and international partnerships to offset significant generic competition in the U.S - Multiple generic versions of icosapent ethyl have entered the U.S. market following a **2020 court ruling that invalidated several key patents**[146](index=146&type=chunk)[147](index=147&type=chunk) - The company is expanding its global footprint through **partnerships with Edding in China, HLS in Canada, and CSL Seqirus in Australia/New Zealand**[160](index=160&type=chunk)[162](index=162&type=chunk) European Commercial Launch Status | Country | National Reimbursement | Product Availability | Launch Date | | :--- | :--- | :--- | :--- | | Sweden | March 2022 | March 2022 | March 2022 | | England/Wales | July 2022 | October 2022 | October 2022 | | Spain | July 2023 | September 2023 | September 2023 | | Netherlands | August 2023 | September 2023 | September 2023 | | Italy | December 2024 | December 2024 | January 2025 | [Results of Operations](index=51&type=section&id=Results%20of%20Operations) Q1 2025 revenue fell 26% to $42.0 million, driven by a sharp decline in U.S. sales that was partially offset by strong European growth - The decrease in U.S. revenue was driven by **lower net selling prices and reduced volume** due to generic competition and loss of exclusive PBM coverage[184](index=184&type=chunk)[185](index=185&type=chunk) - The company's share of the U.S. icosapent ethyl market **decreased from approximately 56% in Q1 2024 to 42% in Q1 2025**[186](index=186&type=chunk) - **Gross margin on product sales increased to 59%** in Q1 2025 from 55% in Q1 2024, primarily due to a change in customer mix[193](index=193&type=chunk) Revenue Comparison (in millions) | Revenue Type | Q1 2025 | Q1 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | U.S. Product Revenue | $35.7 | $48.1 | $(12.4) | -26% | | Europe Product Revenue | $5.4 | $1.9 | $3.5 | +184% | | RoW Product Revenue | ~$0.0 | $5.2 | $(5.2) | -100% | | Licensing & Royalty | $1.0 | $1.4 | $(0.4) | -28% | | **Total Revenue, net** | **$42.0** | **$56.5** | **$(14.5)** | **-26%** | [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains $282.1 million in total liquidity with no debt and believes its capital is sufficient to fund operations for at least one year - Management has concluded that its **cash and investments are adequate to support continued operations** for at least one year from the financial statement issuance date[208](index=208&type=chunk) - A **share repurchase program of up to $50.0 million** was approved in May 2024, but no repurchases have commenced to date[206](index=206&type=chunk) Key Liquidity Data (as of March 31, 2025) | Metric | Amount (in millions) | | :--- | :--- | | Cash, cash equivalents and restricted cash | $119.8 | | Short-term investments | $162.3 | | **Aggregate Liquidity** | **$282.1** | | Indebtedness | $0 | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=57&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 since its 2024 Annual Report - There have been **no material changes** with respect to market risk disclosures from the company's 2024 Annual Report[210](index=210&type=chunk) [Item 4. Controls and Procedures](index=57&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the quarter - The principal executive and financial officers concluded that as of March 31, 2025, the company's **disclosure controls and procedures were effective**[213](index=213&type=chunk) - **No material changes** occurred during the quarter that are reasonably likely to materially affect the company's internal control over financial reporting[214](index=214&type=chunk) [PART II – Other Information](index=58&type=section&id=PART%20II%20%E2%80%93%20Other%20Information) [Item 1. Legal Proceedings](index=58&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed discussion of legal matters found in Note 5 of the financial statements - Information regarding legal proceedings is detailed in **Note 5 – Commitments and Contingencies** and is incorporated by reference into this section[216](index=216&type=chunk) [Item 1A. Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) Key risks include potential Nasdaq delisting due to minimum bid price requirements and adverse effects from global trade sanctions - A key risk is the **potential delisting of the company's ADSs from Nasdaq** if the $1.00 minimum bid price is not maintained[219](index=219&type=chunk) - The company's business may be **adversely affected by tariffs, trade sanctions, or similar government actions**[221](index=221&type=chunk)[222](index=222&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=60&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company withheld 90,267 ADSs during the quarter to satisfy employee tax obligations related to equity awards Issuer Purchases of Equity Securities (Q1 2025) | Period | Total Number of ADSs Purchased | Average Price Paid per ADS | | :--- | :--- | :--- | | January 1 - 31, 2025 | 87,233 | $12.40 | | February 1 - 28, 2025 | 872 | $12.40 | | March 1 - 31, 2025 | 2,162 | $12.40 | | **Total** | **90,267** | **$12.40** | [Item 5. Other Information](index=60&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 trading arrangements during the first quarter of 2025 - **No officers or directors engaged in the adoption, modification, or termination** of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements in Q1 2025[224](index=224&type=chunk) [Item 6. Exhibits](index=61&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including Sarbanes-Oxley certifications and an amended Depositary Agreement - Exhibits filed with the report include **Sarbanes-Oxley Act certifications** (31.1, 31.2, 32.1) and an amendment to the Depositary Agreement (4.1)[227](index=227&type=chunk)
Amarin Corporation(AMRN) - 2025 Q1 - Quarterly Results
2025-05-07 11:05
Exhibit 99.1 Amarin Reports First Quarter 2025 Financial Results Europe • The Company generated revenue of $35.7 million from branded VASCEPA despite numerous generic versions of the product currently available. The U.S. business remains profitable and continues to generate cash. • The Company retained all major exclusive accounts through the first quarter, which forms the basis for a majority of U.S. product sales and margin. • The Company has prepared a plan for an authorized generic (AG) version of VASCE ...
Amarin Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-07 11:00
Core Insights - Amarin Corporation reported a 26% decrease in total net revenue for Q1 2025, amounting to $42.0 million compared to $56.5 million in Q1 2024, primarily due to lower net selling prices and reduced volume amid U.S. generic competition [6][8][19] - The company continues to focus on maximizing the global value of its products VASCEPA and VAZKEPA, with strategic initiatives aimed at enhancing revenue streams and managing operating expenses [2][3] - Amarin regained compliance with Nasdaq listing standards following a 1-for-20 ADS ratio change, which was completed on April 11, 2025 [13][14] Financial Performance - Total net revenue for Q1 2025 was $42.0 million, a decrease of 26% from $56.5 million in Q1 2024 [6] - Net product revenue for Q1 2025 was $41.0 million, down from $55.2 million in the same period of 2024 [6][19] - Operating expenses decreased by 8% to $41.9 million in Q1 2025 from $45.5 million in Q1 2024 [6][10] - The company reported a net loss of $15.7 million for Q1 2025, compared to a net loss of $10.0 million in Q1 2024 [11][32] Market Performance - In the U.S., the company generated $35.7 million from branded VASCEPA, despite competition from generics [7][19] - In Europe, VAZKEPA's in-market demand grew 16% sequentially quarter over quarter, with significant contributions from Spain, the UK, and Central Eastern European markets [7] - In Italy, patient access was secured in 14 of 21 regions, representing over 85% of the eligible population [7] - In China, the partner Edding is advancing commercialization efforts, targeting top private hospitals and planning for National Reimbursement Drug Listing submission in 2026 [7] Strategic Initiatives - The company is focused on capitalizing on opportunities in Europe and efficiently generating revenue in the U.S. and Rest of World markets while managing operating expenses [2][3] - Amarin is preparing to introduce an authorized generic version of VASCEPA when advantageous [7] - The company continues to evaluate opportunities to expand the impact of VASCEPA/VAZKEPA in addressing cardiovascular risk globally [2][3]
Amarin Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-04-29 20:15
Core Points - Amarin Corporation has regained compliance with Nasdaq's continued listing standards for minimum share price, confirming an average closing share price of at least $1.00 over the last 10 consecutive business days as of April 28, 2025 [2][3] - The company is now fully compliant with all Nasdaq listing requirements and will continue to be listed and traded on the Nasdaq Capital Market [3] - Amarin's focus remains on maximizing the global value of its products VASCEPA and VAZKEPA for patients [3] Company Overview - Amarin is an innovative pharmaceutical company specializing in cardiovascular disease management, with offices in Bridgewater, New Jersey, Dublin, Ireland, and Zug, Switzerland, among other locations [3] - The company is committed to enhancing the scientific understanding of cardiovascular risk that persists beyond traditional therapies and advancing treatment options [3]
Amarin to Report First Quarter 2025 Financial Results and Host Conference Call on May 7, 2025
Globenewswire· 2025-04-28 20:15
Group 1 - Amarin Corporation plc will host a conference call on May 7, 2025, at 8:00 a.m. ET to discuss its first quarter 2025 results [1] - The financial results will be released in the pre-market hours on the same day [1] - The call will include a Q&A session with the management team, including President & CEO Aaron Berg [1] Group 2 - Amarin is an innovative pharmaceutical company focused on cardiovascular disease management, with offices in multiple countries including the United States, Ireland, and Switzerland [3] - The company aims to enhance the scientific understanding of cardiovascular risks that persist beyond traditional therapies [3] - Amarin maintains communication with investors through its website and investor relations section, providing access to various materials and updates [4]
Amarin Confirms Effective Date for 1-For-20 ADS Ratio Change
Newsfilter· 2025-04-09 11:30
DUBLIN and BRIDGEWATER, N.J., April 09, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today confirmed that April 11, 2025 will be the effective date for the Company's previously announced Ratio Change on its American Depositary Shares ("ADS") -- an action in which the Company will effect a ratio change from one (1) ADS representing one (1) ordinary share to a new ratio of one (1) ADS representing twenty (20) ordinary shares (the "Ratio Change"). The objective of this action is to increase t ...
Amarin Appoints JEC Capital Partners' Michael Torok to Board of Directors
GlobeNewswire News Room· 2025-04-07 11:30
DUBLIN, Ireland and BRIDGEWATER, N.J., April 07, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the appointment of Michael Torok, Co-Founder and Managing Director of investment firm JEC Capital Partners, as a member of the Board of Directors, effective immediately. “On behalf of the board, I welcome Michael. His financial expertise, experience on other boards and, as a fellow shareholder, his shared priority to continue focusing on strategies to maximize shareholder value, mak ...
Amarin Highlights Recent Data Presented at ACC.25 Evaluating Mechanistic Effects of Eicosapentaenoic Acid (EPA) in Lp(a)-Enriched Plasma and in Combination with GLP-1 Agonist
Globenewswire· 2025-03-31 12:00
– Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of Action and Utility as A Complementary Therapy for Residual Risk Reduction in Combination with Statins in Important Patient Sub-Categories – DUBLIN and BRIDGEWATER, N.J., March 31, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted key data presentations at ACC.25 showcasing the mechanistic activity of eicosapentaenoic acid (EPA) on lipoprotein(a) [Lp(a)]-enriched plasma and the effects of a glucagon ...
Amarin Corporation(AMRN) - 2024 Q4 - Earnings Call Transcript
2025-03-12 14:30
Financial Data and Key Metrics Changes - In Q4 2024, Amarin reported total net revenue of $62.3 million, a decrease from $74.7 million in Q4 2023, with U.S. product revenue dropping to $44.2 million from $64.9 million due to lower net selling prices and decreased volume [33][34] - The company ended 2024 with a strong cash position of $294 million and no debt, reflecting prudent cash management and a focus on strengthening the financial foundation [28][39] Business Line Data and Key Metrics Changes - U.S. product revenue decline was attributed to the loss of CVS commercial exclusivity, leading to a shift in business mix and higher rebates [34][74] - European product revenue increased to $4 million, driven by growth in Spain and the UK, while partnership revenue from the rest of the world rose to $11.9 million, a $7.7 million increase year-over-year [34][35] Market Data and Key Metrics Changes - VASCEPA revenues in Europe gradually increased throughout 2024, with significant contributions from Spain, the UK, and Central Eastern Europe [19] - The company secured pricing and reimbursement in 10 European markets, with ongoing efforts to expand access in various regions [19][20] Company Strategy and Development Direction - The company aims to maintain its NASDAQ listing through an ADS ratio change, which is intended to increase the per-share market price to comply with NASDAQ's minimum bid price requirement [14][43] - Amarin is focused on driving momentum in Europe and the rest of the world, leveraging patent protection until 2039 and exploring opportunities for additional products in the cardiovascular and cardiometabolic areas [63][80] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in generating further momentum in 2025, emphasizing the importance of addressing cardiovascular disease, which remains a leading global health challenge [66][68] - The company acknowledged the challenges posed by the generic market but highlighted the resilience of the U.S. business and the significant untapped potential for VASCEPA globally [30][34] Other Important Information - The company successfully extended its intellectual property position in Europe, enhancing exclusivity for VASCEPA through 2039 [15] - Amarin has supported over 500 publications to advance the understanding of icosapent ethyl's clinical benefits, which has driven regulatory progress globally [11][48] Q&A Session Summary Question: Factors influencing U.S. net price in Q4 - Management noted that the U.S. market is increasingly generic, with a mix of business changing over time, impacting net prices [72] - The shift in business mix due to CVS commercial moving from exclusive to not covered was a significant driver of the revenue changes [74] Question: Outlook on building the pipeline - Management indicated a focus on executing with VASCEPA while remaining opportunistic regarding business development, particularly in cardiovascular and cardiometabolic areas [78][80] Question: Driving rest of the world revenue growth - Management highlighted that they are early in most regions, with ongoing efforts to establish medical advocacy and access, particularly in China and Australia [84][90]
Amarin Corporation(AMRN) - 2024 Q4 - Earnings Call Transcript
2025-03-12 13:02
Financial Data and Key Metrics Changes - In 2024, the company reported total revenues of $228.6 million, with a cash position of $294 million and no debt, indicating a strong financial foundation [7][20] - The fourth quarter of 2024 saw total net revenue of $62.3 million, a decrease from $74.7 million in the same quarter of 2023, primarily due to lower net selling prices and decreased volume [22][23] - The GAAP net loss for Q4 2024 was $48.6 million, compared to a loss of $5.8 million in the prior year, largely due to the impact of generic competition [26] Business Line Data and Key Metrics Changes - U.S. product revenue in Q4 2024 was $44.2 million, down from $64.9 million in Q4 2023, affected by lower selling prices and volume declines [23][24] - European product revenue increased to $4 million, driven by growth in Spain and the UK, marking a $2.5 million increase year-over-year [24] - Revenue from partnerships in the rest of the world reached $11.9 million, a $7.7 million increase compared to the previous year, reflecting ongoing market launches [25] Market Data and Key Metrics Changes - The company has secured approvals for Vascepa in 49 markets globally, with ongoing efforts to establish pricing and reimbursement agreements [8][9] - In Europe, the commercialization strategy has led to increased revenues, particularly in Spain, the UK, and Central Eastern Europe [12][13] - The U.S. market continues to show resilience, with 74% of the Vascepa branded business coming from exclusives, covering approximately 43 million lives [14] Company Strategy and Development Direction - The company aims to maintain its NASDAQ listing through an ADS ratio change, reflecting its commitment to realizing the full value potential of Amarin [10][30] - Strategic focus includes expanding Vascepa's market presence in Europe and other regions, leveraging patent protection until 2039 [42] - Continued investment in research to enhance understanding of Vascepa's therapeutic value and its role in reducing cardiovascular risk is a priority [43] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges posed by the generic market but remains optimistic about the untapped potential of Vascepa globally [21][41] - The company is focused on driving momentum in Europe and maximizing profitability in the U.S. while maintaining financial discipline [42][44] - There is a strong belief in the product's value as a complementary therapy to existing lipid-lowering treatments, addressing residual cardiovascular risk [36][39] Other Important Information - The company has successfully reduced operating expenses by 26% year-over-year, reflecting ongoing cost optimization initiatives [20][26] - The ADS ratio change is intended to comply with NASDAQ's minimum bid price requirement, ensuring continued access to public equity capital markets [30][31] Q&A Session Summary Question: Factors influencing U.S. net price in Q4 - Management noted that the U.S. market is increasingly generic, with a mix of business that fluctuates, impacting net prices [49][50] - The shift in business mix due to CVS moving from exclusive to not covered has led to higher rebates and volume impacts [52] Question: Outlook on building the pipeline - The company remains focused on executing with Vascepa while being opportunistic about potential business development opportunities in cardiovascular and cognitive metabolic areas [56][57] Question: Driving revenue growth in the rest of the world - Management highlighted that they are early in the launch phase in many regions, with ongoing efforts to establish medical advocacy and access [61][63]