Amarin Corporation (AMRN) Conference Call Summary Company Overview - **Company**: Amarin Corporation - **Date**: June 24, 2025 - **Key Product**: VASCEPA (Veskepta in Europe) Core Industry Insights - **Industry**: Cardiovascular Pharmaceuticals - **Market Need**: Significant unmet need in cardiovascular disease treatment, particularly in Europe [5][9][31] Key Announcements - **Partnership with Recordati**: - Amarin has entered a long-term partnership with Recordati to commercialize VASCEPA in Europe [5][6] - Recordati is recognized for its extensive cardiovascular expertise and established infrastructure [5][6] - The partnership aims to enhance patient access to VASCEPA across Europe [5][9] Financial Highlights - **Upfront Payment**: Amarin will receive an upfront payment of $25 million [7] - **Milestone Payments**: Potential milestone payments up to $150 million based on Recordati's sales performance [7][25] - **Supply-Based Revenues**: Amarin will receive royalties and revenues from product supply, which are significant for the company [7][8] - **Cost Structure Improvement**: Expected cost savings of approximately $70 million over the next twelve months due to restructuring [13][14] Market Performance - **U.S. Sales**: Nearly 28 million prescriptions of VASCEPA have been written, with 2.4 million patients treated since launch [10] - **Global Strategy**: Focus on driving access and utilization in various international markets while maintaining a profitable U.S. business [10][15] Strategic Focus - **Restructuring**: Amarin plans to become a leaner organization to support global business and maximize shareholder value [8][19] - **Long-Term Vision**: The partnership with Recordati is seen as a critical step in executing Amarin's global strategy and strengthening its financial position [19][20] Competitive Landscape - **Complementary Positioning**: VASCEPA is positioned as a complementary therapy to existing LDL-lowering treatments, not a direct competitor [36][37] - **Market Dynamics**: The cardiovascular market is becoming increasingly crowded, but VASCEPA's unique clinical profile offers significant growth potential [36][38] Risk Factors - **Forward-Looking Statements**: The company cautions that actual results may differ from projections due to various risk factors, including market dynamics and operational challenges [2][3] Conclusion - **Future Outlook**: Amarin is optimistic about the partnership with Recordati and the potential for VASCEPA to address cardiovascular disease needs in Europe, while also maintaining a strong position in the U.S. market [19][20]

Core Points - Amarin Corporation has entered into a long-term licensing and supply agreement with Recordati S.p.A. to commercialize VAZKEPA in 59 countries, primarily in Europe, aiming to enhance the product's market reach and financial position [1][2] - The partnership is expected to generate approximately $70 million in cost savings over the next 12 months through streamlined global operations, particularly by reducing commercialization expenses in Europe [1][12] - Amarin's financial strength includes nearly $300 million in cash and no debt, positioning the company for accelerated positive cash flow [2][3] Company Strategy - The collaboration with Recordati is seen as a strategic move to leverage their expertise in the cardiovascular space, which aligns with Amarin's goal of maximizing long-term shareholder value [2][4] - Amarin will continue to focus on its U.S. operations, which are profitable and provide meaningful cash flows, while also exploring international partnerships to enhance revenue generation [12] Financial Terms of the Agreement - Amarin will receive an upfront payment of $25 million and potential milestone payments up to $150 million based on Recordati's commercial sales performance [5] - The agreement includes supply-based revenues and royalties from the commercialization of VAZKEPA [5] Market Context - Recordati is a well-established pharmaceutical company with a strong presence in the cardiovascular market, which constitutes about 25% of its Specialty and Primary Care business [3] - The partnership is expected to enhance the commercial opportunity for VAZKEPA in Europe, where Amarin holds patent protection until 2039 [2][4]

Core Viewpoint - Amarin Corporation PLC (AMRN) is showing potential for a bullish breakout as it has reached a key support level and formed a "golden cross" in its moving averages [1][2]. Technical Indicators - A "golden cross" occurs when a short-term moving average (50-day) crosses above a long-term moving average (200-day), indicating a potential bullish trend [2]. - The formation of a golden cross typically follows a downtrend, a crossover of moving averages, and culminates in an upward price movement [3]. Performance Metrics - AMRN has experienced a rally of 25.2% over the past four weeks, suggesting strong momentum [4]. - The company currently holds a 2 (Buy) rating on the Zacks Rank, indicating positive market sentiment [4]. Earnings Outlook - There have been no cuts to earnings estimates for the current quarter, with three revisions higher in the past 60 days, contributing to a positive earnings outlook [4]. - The Zacks Consensus Estimate for AMRN has also increased, further solidifying the bullish case for the stock [4]. Investment Consideration - Given the technical indicators and positive earnings revisions, investors are encouraged to consider adding AMRN to their watchlist [6].

Company Performance - Amarin (AMRN) has returned 36.6% year-to-date, significantly outperforming the average loss of 2.3% in the Medical sector [4] - The Zacks Consensus Estimate for AMRN's full-year earnings has increased by 57% over the past three months, indicating improved analyst sentiment and a positive earnings outlook [3] Industry Context - Amarin is part of the Medical - Biomedical and Genetics industry, which consists of 502 individual stocks and currently ranks 78 in the Zacks Industry Rank [5] - The average performance of the Medical - Biomedical and Genetics industry has seen a loss of 0.6% year-to-date, further highlighting Amarin's strong performance relative to its peers [5] Sector Ranking - The Medical group, which includes Amarin, is currently ranked 6 within the Zacks Sector Rank, which evaluates 16 different sector groups [2] - Amarin holds a Zacks Rank of 2 (Buy), suggesting a favorable investment outlook [3][4]

Core Viewpoint - Amarin (AMRN) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Amarin's Earnings Outlook - For the fiscal year ending December 2025, Amarin is expected to earn -$2.50 per share, unchanged from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Amarin has increased by 57%, reflecting a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions [9][10].

Core Insights - Three stocks are highlighted with strong momentum characteristics and a buy rank, including Amarin Corporation, Comfort Systems USA, and UiPath Inc. [1][2][3] Company Summaries - **Amarin Corporation plc (AMRN)**: - Zacks Rank 1 - Current year earnings estimate increased by 50% over the last 60 days - Shares gained 31.1% over the last three months, outperforming the S&P 500's 7.7% increase - Momentum Score of A [1] - **Comfort Systems USA, Inc. (FIX)**: - Zacks Rank 1 - Current year earnings estimate increased by 5.9% over the last 60 days - Shares gained 54.4% over the last three months, significantly outperforming the S&P 500's 7.7% increase - Momentum Score of B [2] - **UiPath Inc. (PATH)**: - Zacks Rank 1 - Current year earnings estimate increased by 3.8% over the last 60 days - Shares gained 11.7% over the past three months, also outperforming the S&P 500's 7.7% increase - Momentum Score of A [3]

Core Insights - Amarin Corporation reported a narrower loss of 4 cents per share for Q1 2025, significantly better than the Zacks Consensus Estimate of a loss of $1.12 [1] - Total revenues for Q1 2025 were $42 million, exceeding the Zacks Consensus Estimate of $40 million, but representing a decline of approximately 26% year-over-year due to lower product revenues [2] - The company's stock has increased by 5% year-to-date, contrasting with an 8% decline in the industry [3] Financial Performance - Net product revenues from Vascepa, Amarin's sole marketed drug, were $41 million in Q1 2025, down 25.7% year-over-year [4] - U.S. product revenues from Vascepa were $35.7 million, a decline of nearly 25.8% from the previous year, although it surpassed the model estimate of $22.1 million [4] - European product revenues from Vazkepa totaled $5.4 million, up from $1.9 million in the year-ago quarter, while revenues from the rest of the world fell to $0.1 million from $5.2 million [5] Expenses and Cash Position - Selling, general and administrative expenses were $36.6 million, down almost 8.3% year-over-year due to cost optimization efforts [6] - Research and development expenses totaled $5.3 million, a decrease of around 5.4% year-over-year [6] - Amarin ended Q1 2025 with cash and investments of $281.8 million, down from $294.2 million at the end of December 2024 [8] Corporate Actions - Amarin initiated a ratio change for its American Depositary Shares (ADS) effective April 11, 2025, changing from one ADS representing one ordinary share to one ADS representing 20 ordinary shares, regaining compliance with Nasdaq listing standards [9]

Financial Data and Key Metrics Changes - In Q1 2025, total net revenue was $42 million, down from $56.5 million in Q1 2024, with U.S. product revenue declining to $35.7 million from $48.1 million due to lower net selling prices and decreased volume [23][24] - European product revenue increased to $5.4 million, a $3.5 million increase year-over-year, driven by growth in Spain, the UK, and Central Eastern Europe [25] - Gross margin on product revenue improved to 59% from 55% in the prior year, attributed to changes in customer mix [27] Business Line Data and Key Metrics Changes - Vascepa revenues in Europe showed 16% sequential growth, reaching $5.4 million, with significant progress in pricing and reimbursement efforts in Italy and Austria [12][13] - The U.S. business continues to generate cash despite the introduction of generics, retaining major exclusive accounts from Q4 2024 into Q1 2025 [14] - Rest of the world revenues were minimal in Q1 2025, but there is optimism for growth as many markets are in early commercialization stages [26][38] Market Data and Key Metrics Changes - The company expanded its presence from 7 to 21 countries where Vascepa is reimbursed and launched since Q1 2023, indicating a broader patient impact [8] - In China, efforts are focused on promoting Vascepa for at-risk patients, with a significant market opportunity due to high cardiovascular disease rates [17] - In Australia, Vascepa was included in new clinical guidelines, reinforcing its value in managing cardiovascular risk [18] Company Strategy and Development Direction - The company is focusing on managed care access in the U.S. and targeting high-risk patient groups in Europe to maximize branded revenue [5][6] - Strategic partnerships in Southeast Asia, MENA, and Australia are being pursued to enhance global presence and revenue diversification [6][19] - The company aims to reduce operating costs while investing in growth opportunities to maximize shareholder value [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Vascepa, emphasizing the need to address cardiovascular disease, the leading global killer [33] - The company is committed to generating new data to differentiate Vascepa from generics and emerging therapies in the lipid management landscape [44][46] - Management acknowledged the challenges posed by the generic market but remains focused on leveraging the unique benefits of Vascepa [27][46] Other Important Information - The company completed a one-for-20 ADS ratio change to preserve its NASDAQ listing, regaining full compliance [20] - As of March 31, 2025, the company reported cash and investments of $282 million with no debt, maintaining a solid financial base [28][29] Q&A Session Summary Question: What drove the decline in rest of world revenues and should we expect a bounce back? - Management acknowledged the limited revenues but expressed optimism about growth, noting that the early stages of commercialization can lead to variable quarterly revenues [38][40] Question: What additional real-world evidence or clinical development plans do you have to strengthen differentiation against generics? - Management highlighted ongoing efforts to generate new data to differentiate Vascepa, emphasizing its unique benefits and the importance of addressing residual cardiovascular risk [44][46]

Financial Data and Key Metrics Changes - In Q1 2025, total net revenue was $42 million, down from $56.5 million in Q1 2024, with net product revenue of $41 million compared to $35.7 million in the prior year [23][24] - The net loss for Q1 2025 was $15.7 million, compared to a net loss of $10 million in the same period last year, primarily due to the U.S. generic market impact [27][28] - Gross margin on product revenue improved to 59% from 55% in the prior year, driven by changes in customer mix [26] Business Line Data and Key Metrics Changes - European product revenue reached $5.4 million in Q1 2025, representing a $3.5 million increase year-over-year, driven by growth in Spain, the UK, and Central Eastern Europe [25][12] - U.S. product revenue declined to $35.7 million from $48.1 million in Q1 2024, attributed to lower net selling prices and decreased volume due to generic competition [24][14] - Minimal net product revenue was recorded from partnerships in the rest of the world, down from $5.2 million in Q1 2024, but there is sequential growth in market demand [26] Market Data and Key Metrics Changes - The number of countries where Vascepa is reimbursed increased from 7 in 2023 to 21 in Q1 2025, indicating broader market access [7] - In Italy, access has been secured in 14 of 21 local regions, covering over 85% of the eligible market [12] - In China, efforts are focused on the self-pay market, with plans for inclusion in the National Retail Drug Listing for 2026, highlighting the significant market opportunity [16] Company Strategy and Development Direction - The company is focusing on managed care access in the U.S. and targeting high-risk patient groups in Europe to maximize branded revenue [5] - Strategic partnerships in Southeast Asia, MENA, and Australia are being pursued to expand the global presence of Vascepa [6] - The company aims to reduce operating costs while improving cash management and supply position to strengthen its foundation for future growth [10][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in Europe and the rest of the world, despite early-stage commercialization challenges [9][40] - The company is committed to advancing patient treatment and reducing cardiovascular risk globally while delivering value to shareholders [10][22] - Management acknowledged the need for continued efforts to unlock the full potential of Vascepa in various markets [22] Other Important Information - The company completed a one-for-20 ADS ratio change to preserve its NASDAQ listing, regaining full compliance [20] - As of March 31, 2025, the company had cash and investments totaling $282 million with no debt, maintaining a solid financial base [28][29] Q&A Session Summary Question: What drove the decline in rest of world revenues and should we expect a bounce back? - Management noted that revenues were limited due to the early stages of commercialization and that growth is expected as market demand increases [37][40] Question: What additional real-world evidence or clinical development plans are in place to strengthen differentiation against generics? - Management highlighted ongoing efforts to generate new data to differentiate Vascepa, emphasizing its unique benefits in cardiovascular risk reduction [42][46]

Financial Performance - Total revenue for Q1 2025 was $42.0 million[14, 21] - U S revenue was $35.7 million, a ~26% year-over-year reduction[21] - Europe revenue was $5.4 million, a ~284% year-over-year increase[14, 21] - Operating expenses for Q1 2025 were $41.9 million, an 8% reduction year-over-year[14, 19] - The company maintained a strong cash position with $281.8 million and no debt[14, 24] Business Updates - Achieved sequential growth in in-market demand across all European markets where VAZKEPA was launched, particularly in Spain, the UK, and CEE[13] - Secured pricing and reimbursement in Austria and continued progress in other EU markets[13] - CSL's efforts led to VAZKEPA's inclusion in the National Heart Foundation/Cardiac Society Acute Coronary Syndrome guidelines in Australia[13] - Edding continued CVRR launch in the private pay market in China, working towards National Reimbursement Drug List (NRDL) review for 2026[13] Strategic Priorities - Drive growth in access and revenue in Europe and Rest of World markets[30] - Drive efficient VASCEPA U S revenue generation[30] - Support research that reinforces VASCEPA science and therapeutic value[30] - Maintain fiscal and operational discipline while pursuing all avenues to maximize shareholder value[30]