Amarin Corporation(AMRN)
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Amarin Corporation plc (AMRN) Presents at Goldman Sachs 44th Annual Global Healthcare Conference (Transcript)
2023-06-13 07:39
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 (AMRN) Presents at Jefferies 2023 Global Healthcare Conference (Transcript)
2023-06-07 15:51
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(AMRN) - 2023 Q1 - Earnings Call Transcript
2023-05-03 14:03
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 ...
Amarin Corporation(AMRN) - 2023 Q1 - Quarterly Report
2023-05-02 16:00
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)
Amarin Corporation plc (AMRN) Cowen 43rd Annual Healthcare Conference (Transcript)
2023-03-08 23:12
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.
Amarin Corporation(AMRN) - 2022 Q4 - Earnings Call Presentation
2023-03-07 15:26
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(AMRN) - 2022 Q4 - Earnings Call Transcript
2023-03-01 16:45
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 ...
Amarin Corporation(AMRN) - 2022 Q4 - Annual Report
2023-02-28 16:00
Commercialization and Market Presence - VASCEPA has been commercially available since 2013, with over 20 million estimated normalized total prescriptions reported by Symphony Health[444]. - The company has received marketing authorization for VAZKEPA in the EU, with national reimbursement secured in several countries, including Sweden, Finland, and the United Kingdom[452]. - In China, the regulatory review for VASCEPA commenced in February 2021, with expected approval by mid-2023 following delays due to COVID-19[455]. - The company has entered into agreements for VASCEPA commercialization in the MENA region, with launches in Lebanon, UAE, and Qatar[458]. - The company has filed thirteen dossiers for market access in European countries, with reimbursement negotiations being critical for commercial success[451]. - The company plans to resubmit a pricing and reimbursement dossier in Germany after previous negotiations concluded without agreement[454]. - The company is implementing a hybrid commercial model in Europe to balance digital and face-to-face approaches for market launches[452]. - The company launched commercial operations in five European countries in 2022 and received regulatory approval in seven countries outside of EMA[496]. - The company aims to secure partnerships for VASCEPA in international markets where it receives local regulatory approval[460]. Financial Performance - Total revenue, net decreased by $214.0 million, or 37%, to $369.2 million in 2022 from $583.2 million in 2021, primarily due to a $218.0 million decrease in U.S. product revenue[492]. - Product revenue, net fell by $213.8 million, or 37%, to $366.5 million in 2022, driven by a 38% decrease in VASCEPA sales in the U.S. due to generic competition[493]. - Licensing and royalty revenue decreased by $0.2 million, or 6%, to $2.7 million in 2022, reflecting the timing of milestone payments[497]. - Cost of goods sold increased by $5.4 million, or 4%, to $126.7 million in 2022, including a $18.1 million charge related to restructuring inventory[499]. - VASCEPA branded prescriptions decreased by 19% in 2022 compared to 2021, indicating a decline in demand[494]. - The overall icosapent ethyl market in the U.S. increased by 7% in 2022, but the company's market share decreased to approximately 60% from 85% in 2021[494]. - Gross margin on product sales decreased from 79% in 2021 to 65% in 2022, with a gross margin of 73% when excluding restructuring inventory[501]. - Selling, general and administrative expenses decreased by $103.9 million, or 25%, from $408.3 million in 2021 to $304.4 million in 2022[501]. - Net cash used in operating activities increased from $66.5 million in 2021 to $180.1 million in 2022, primarily due to decreased U.S. product revenue[510]. - The accumulated deficit as of December 31, 2022, was $1.5 billion, reflecting ongoing annual operating losses since inception[512]. Research and Development - Research and development expenses primarily include costs for clinical trials and independent monitoring, with a focus on VASCEPA[473]. - Total research and development expense, excluding non-cash expense, was $25.9 million in 2022 compared to $25.0 million in 2021[505]. - Research and development expenses increased by $1.1 million, or 4%, from $29.3 million in 2021 to $30.4 million in 2022[504]. - The company has updated 30 clinical treatment guidelines recommending the use of icosapent ethyl in at-risk patients based on REDUCE-IT results[462]. - The REDUCE-IT study demonstrated a 34% reduction in cardiovascular death and events in patients with a history of percutaneous coronary intervention[464]. - The company initiated development of a fixed-dose combination product containing both icosapent ethyl and a statin[465]. Inventory and Restructuring - As of December 31, 2022, the company had inventory valued at $392.4 million, with 90% approved for use in North America[467]. - In 2022, VASCEPA's cost of goods sold included $18.1 million related to restructuring inventory to align supply with market demand[470]. - Restructuring expenses remained relatively stable, with a slight decrease from $13.7 million in 2021 to $13.5 million in 2022[506]. - The company is focusing on engaging top prescribers and maintaining exclusive formulary coverage amid pressure from generic competitors[447]. Cash and Investments - Cash and cash equivalents as of December 31, 2022, were $217.7 million, with total liquidity sources of approximately $311.2 million[509]. - The company anticipates that quarterly net cash outflows will continue to be variable due to factors such as API purchases and generic competition in the U.S.[512]. - The company monitors investments with the objective of minimizing concentrations of credit risks[519]. - Short-term investments consist of held-to-maturity securities due in one year or less[519]. - Long-term investments consist of held-to-maturity securities due in more than one year[519]. - Cash is invested in accordance with an investment policy that limits amounts in any one type of investment[519]. - Investments must maintain minimum ratings from Nationally Recognized Statistical Rating Organizations to achieve liquidity and capital preservation[519]. - The investment policy mandates investment only in institutions that meet high credit quality and diversification standards[519]. - Established limits on the amount and time to maturity of investments are part of the investment policy[519].
SVB Securities Global Biopharma Conference
2023-02-14 18:50
SVB Securities Global Biopharma Conference Karim Mikhail President & CEO February 14, 2023 Forward Looking Statements & Disclaimer This presentation contains forward-looking statements which are made pursuant to U.S. federal securities law, including beliefs about Amarin's key achievements in 2022 and the potential impact and outlook for achievements in 2023 and beyond; Amarin's 2023 financial outlook and cash position; strategies to ensure profit maximization; Amarin's strategic direction and actions manag ...
Amarin JPM Presentation 2023
2023-01-11 04:39
41st Annual J.P. Morgan Healthcare Conference Karim Mikhail President & CEO January 23 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 development, and other statements that are forward-looking in na ...