Q2 2024 Amarin Corp PLC Earnings Call

Welcome to Amarin Corporation's conference call to discuss its second quarter 2024 business update and financial results.

Mark Marmur: Second Quarter 2024 Business Update and Financials. I would now like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at ADR. Good morning, everyone.

2nd quarter, 2024, business, update, and financial results.

Mark Marmur: I would now like to turn the conference call over to Mark Marmur, Vice President Corporate Communications and Investor Relations at Amarin. Good morning, everyone, and thank you for joining us.

Mark Marmur: And thank you for joining us. Turning to our forward-looking statement. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change.

Mark Marmur: Turning to our four-looking statements, please be aware that this conference call will contain four-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our four-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change.

Speaker Change: Good morning everyone and thank you for joining us. Turning to our forward-looking statements.

Mark Marmur: Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the risk factors section of our annual report on Form 10-K for the year ended December 31st, 2023, and our quarterly report on Form 10-Q for the quarter ended June 30th, 2024, which has been filed with the SEC and is available through the investor relations section of our website at www.amarincorp.com.

Speaker Change: Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements.

Speaker Change: Actual results or events could differ materially, so you should not place undue reliance on these statements.

Speaker Change: We assume no obligation to update these statements as circumstances change.

Mark Marmur: Our four-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate.

Speaker Change: Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate.

Mark Marmur: For additional information concerning the risk factors that could cause actual results to differ materially, please see the risk factors section of our annual report on Form 10-K for the year-end of December 31st, 2023, and our quarterly report on Form 10-Q for the quarter-ended June 30th, 2024, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amerncorp.com. We encourage everyone to read these documents.

Speaker Change: For additional information concerning the risk factors that could cause actual results to differ materially,

Speaker Change: Please see the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2023, and our quarterly report on Form 10-Q for the quarter ended June 30, 2024.

Speaker Change: which has been filed with the SEC and is available through the investor relations section of our website at www.amarincorp.com. We encourage everyone to read these documents.

Mark Marmur: We encourage everyone to read these documents. An archive of this call will be posted on Amarin's website in the investor relations section. Turning to today's agenda, Aaron Berg, Amarin's President and Chief Executive Officer, will provide an overview of his perspectives on Amarin's value and second quarter business progress, and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our second quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions. I will now turn the call over to Aaron Burr, President and Chief Executive Officer of Amarin. Aaron.

Mark Marmur: In our call of this call, we posted an Amherndt website in the Investor Relations section.

Speaker Change: An archive of this call will be posted on Ameren's website in the Investor Relations section.

Mark Marmur: Turning to today's agenda, Aaron Berg, Amherndt's president and chief executive officer, will provide an overview of his perspectives on Amherndt's value and second-quarter business progress, and Tom Riley, Amherndt's chief financial officer, will provide a review of our second-quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions.

Speaker Change: Turning to today's agenda, Aaron Berg, Amarin's President and Chief Executive Officer, will provide an overview of his perspectives on Amarin's value and second quarter business progress, and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our second quarter 2024 financial results.

Aaron Berg: I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Amherndt. Aaron, thank you, Mark. Good morning, everyone, and thank you for joining us today. I'm thrilled to be back leading Amherndt in a very short time as interim CEO last year. I was able to spearhead several key global strategic and organizational adjustments. Now back in the CEO role for just a few short weeks, it's gratifying to see some of the impact of those changes. I've been with Amherndt for over a decade and remained as passionate and committed to the company as when I started for several very important reasons.

Speaker Change: At the end of the presentation, there will be the chance to ask questions.

Speaker Change: I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron?

Aaron Burr: Thank you, Mark. Good morning, everyone, and thank you for joining us today. I'm thrilled to be back leading Amarin for a very short time. As interim CEO last year, I was able to spearhead several key global, strategic, and organizational adjustments. Now back in the CEO role for just a few short weeks, it's gratifying to see some of the impact of those changes. I've been with Amarin for over a decade and remain as passionate and committed to the company as when I started for several very important reasons. First of all, Vasepa-Vaskepa is an incredible product.

Aaron Berg: Thank you, Mark. Good morning, everyone, and thank you for joining us today. I'm thrilled to be back leading Amarin in a very short time. As interim CEO last year, I was able to spearhead several key global strategic and organizational adjustments.

Aaron Berg: Now back in the CEO role for just a few short weeks, it's gratifying to see some of the impacts of those changes.

Aaron Berg: I've been with Ameren for over a decade and remain as passionate and committed to the company as when I started, for several very important reasons.

Aaron Berg: First of all, the SEPA Veskepa is an incredible product. Over the last 10 years, more than 300 scientific publications have been generated, confirming the unique attributes of the SEPA anchored by the landmark-produced trial, confirming that SEPA provides an important option for patients globally who need to reduce their risk of a cardiovascular event. I ran the U.S. commercial organization when the reduced trial read out and when we subsequently secured the cardiovascular risk reduction indication. The reception of this remarkable data by the scientific community and the potential to positively impact millions of patients with the SEPA generated incredible demand.

Speaker Change: First of all, the SEPA VSCEPA is an incredible product. Over the last 10 years, more than 300 scientific publications have been generated confirming the unique attributes of the SEPA, anchored by the landmark reduced to trial.

Aaron Burr: Over the last 10 years, more than 300 scientific publications have been generated confirming the unique attributes of Vasepa, anchored by the landmark REDUCE-IT trial, confirming that Vasepa provides an important option for patients globally who need to reduce their risk of a cardiovascular event. I ran the U.S. commercial organization when the REDUCE-IT trial read out and when we subsequently secured the cardiovascular risk reduction indication. The reception of this remarkable data by the scientific community and the potential to positively impact millions of patients with SEPA generated incredible demand.

Speaker Change: Confirming that the SEPA provides an important option for patients globally who need to reduce their risk of a cardiovascular event.

Speaker Change: I ran the U.S. commercial organization when the REDUCE-IT trial read out and when we subsequently secured the cardiovascular risk reduction indication.

Speaker Change: The reception of this remarkable data by the scientific community and the potential to positively impact millions of patients with the SEPA generated incredible demand. Prescriptions increased significantly and product revenue rose substantially.

Aaron Burr: Prescriptions increased significantly, and product revenue rose substantially. We witnessed a greater than 50% increase in the number of prescribers, resulting in more than 80% growth in new prescriptions in the first year post publication of the reduced prescribing rate. This evidence of uptake and market response provides evidence that with time to promote and educate, supported by outstanding execution, providers respond favorably to Visepa as a therapy that can benefit their patients. Our confidence remains steadfast that Veskepa represents an important option in the global arsenal against cardiovascular disease and therefore a true difference maker in patients' lives.

Aaron Berg: Prescriptions increased significantly, and product revenue rose Reilly. We witnessed a greater than 50 percent increase in the number of prescribers, resulting in more than 80 percent growth in new prescriptions in the first year post publication of reduces. This evidence of uptake and market response provides evidence that, with time to promote and educate, supported by outstanding execution, providers respond favorably to Masiba as a therapy that can benefit their patients. Second, even with many advancements and therapies and scientific data, cardiovascular disease remains the number one killer globally, causing a significant financial burden and negatively impacting patients and their families.

Speaker Change: We witnessed a greater than 50% increase in the number of prescribers, resulting in more than 80% growth in new prescriptions in the first year post-publication of REDUCE-IT.

Speaker Change: This evidence of uptake and market response provides evidence that with time to promote and educate, supported by outstanding execution, providers respond favorably to Visepa as a therapy that can benefit their patients.

Speaker Change: Second, even with many advancements in therapies and scientific data, cardiovascular disease remains the number one killer globally, causing a significant financial burden and negatively impacting patients and their families.

Aaron Berg: Additionally, millions of prescriptions are written globally each year for five rates and omega-3 mixture products for patients with cardiovascular risk, even though they're not beneficial in reducing cardiovascular risk. As a result, the reduction of cardiovascular events remains a top priority for healthcare providers, patients, caretakers, governments, and the investment community. Our confidence remains steadfast that Masiba Veskepa represents an important option in the global arsenal against cardiovascular disease and therefore a true difference maker in patients' lives. There are an unlike in the U.S., where we had time to commercialize Veskepa prior to the publication of the reduced data and the cardiovascular risk reduction indication. We're in the early phases of our global expansion effort targeting key markets around the world. To date, we've unlocked access and launched in some European markets.

Speaker Change: Additionally, millions of prescriptions are written globally each year for fibrates and omega-3 mixture products for patients with cardiovascular risk even though they're not beneficial in reducing cardiovascular risk.

Speaker Change: As a result, the reduction of cardiovascular events remains a top priority for health care providers, patients, caretakers, governments, and the investment community.

Speaker Change: Our confidence remains steadfast that Vaseepa Veskepa represents an important option in the global arsenal against cardiovascular disease, and therefore a true difference maker in patients' lives.

Aaron Burr: Third, unlike in the U.S., where we had time to commercialize SEPA prior to the publication of the reduced data and the cardiovascular risk reduction indication, Before we move on to operational performance in the second quarter, there are a few additional points I want to highlight about Amarin and how we'll operate moving forward under my leadership. As a significant shareholder with a substantial vested interest in the company's success, I'm determined to drive value for all of us and understand my responsibility to do just that.

Speaker Change: Third, unlike in the U.S. where we had time to commercialize the SEPA prior to the publication of the REDUCE-IT data and the cardiovascular risk reduction indication, we're in the early phases of our global expansion effort targeting key markets around the world.

Speaker Change: To date, we've unlocked access and launched in some European markets. However, there remains significant potential to advance access to VASCEPA for many at-risk patients in a number of additional critical markets.

Aaron Berg: However, there remains significant potential to advance access to Veskepa for many at-risk patients in a number of additional critical markets. And finally, Veskepa has a long runway to generate revenue based on a strong IP position, particularly in Europe, where we've recently received extended patent rights into 2039. The combination of the strength and extent of clinical data, its runway, and the opportunity for sustained growth and impact, together with the ability to save lives around the world, translate into a tremendous opportunity for us to maximize Masiba Veskepa's worldwide potential.

Speaker Change: And finally, Vizcapa has a long runway to generate revenue based on its strong IP position, particularly in Europe , where we have recently received extended patent rights into 2039.

Speaker Change: The combination of the strength and extent of clinical data, its runway, and the opportunity for sustained growth and impact, together with the ability to save lives around the world, translate into a tremendous opportunity for us to maximize Bicepa and Bicepa's worldwide potential.

Aaron Berg: Before we move on to operational performance in the second quarter, there are a few additional points I want to highlight about Amarin and how we'll operate moving forward under my leadership. We have a fantastic team, smart, committed, passionate, and I can assure you that no one here is satisfied with our commercial progress. We're always looking for ways that we can generate new ideas and improve execution, and we know we must find new ways to perform better and faster. As a significant shareholder with substantial vested interest in the company's success, I'm determined to drive value for all of us and understand my responsibility to do just that.

Speaker Change: Before we move on to operational performance in the second quarter, there are a few additional points I want to highlight about Amarin and how it will operate moving forward under my leadership.

Speaker Change: We have a fantastic team. Smart, committed, passionate, and I can assure you that no one here is satisfied with our commercial progress. We're always looking for ways that we can generate new ideas and improve execution, and we know we must find new ways to perform better and faster.

Speaker Change: As a significant shareholder with substantial vested interest in the company's success, I'm determined to drive value for all of us and understand my responsibility to do just that. As I lead the company to build greater value, I think and act like a shareholder every day.

Aaron Berg: As I leave the company to build greater value, I think an act like a shareholder every day. My focus is clear to prioritize execution and performance while urgently evaluating opportunities to expand the impact of Veskepa to millions of patients worldwide. That's our commitment to provide value to patients, providers, payers, and, of course, shareholders.

Aaron Burr: As I lead the company to build greater value, I think and act like a shareholder every day. Part of the challenge we face in Europe is the reality that compelling data such as Reducit often clashes with budget realities in individual markets. In 2023, we implemented a strategy to accelerate progress, which focuses on a higher risk subset of reduced patients. In the second quarter, the team continued to deliver on the strategy and made advances.

Speaker Change: My focus is clear to prioritize execution and performance.

Speaker Change: while urgently evaluating opportunities to expand the impact of SEPA to millions of patients worldwide.

Speaker Change: That's our commitment, to provide value to patients, providers, payers, and of course, shareholders.

Aaron Berg: Let me now turn to some of the operational highlights from the quarter. Turning this slide six, in Europe, our teams are making progress and realizing incremental revenue growth, but we've much more work ahead of us. The focus on enhancing the value proposition for Veskepa in the markets that can deliver the greatest impact for patients. Part of the challenge we faced in Europe is the reality that compelling data, such as reducing, many times clashes with budget realities in individual markets. A broader label creates an enormous opportunity in Europe due to the strength of the reduced trial, which demonstrates that Veskepa can benefit millions of patients all within the label.

Speaker Change: Let me now turn to some of the operational highlights from the quarter.

Speaker Change: Turning to slide six. In Europe , our teams are making progress and realizing incremental revenue growth, but with much more work ahead of us.

Speaker Change: The seeds for recent growth were planted more than a year ago, when we put a new strategy in place centered around targeting a more focused patient population.

Speaker Change: Coupled with improved resource prioritization, all with a focus on enhancing the value proposition for Vizquepa in the market that can deliver the greatest impact for patients.

Speaker Change: Part of the challenge we faced in Europe is the reality that compelling data such as Reducit many times clashes with budget realities in individual markets.

Speaker Change: A broader label creates an enormous opportunity in New York due to the strength of the REDUCE-IT trial, which demonstrates that VASCEPA can benefit millions of patients, all within the label.

Aaron Berg: There are approximately seven million patients that meet the label criteria in Europe. While this is very powerful and the scale is an enormous opportunity for us, it's also a challenge for the reimbursement authorities from a budget perspective. We need to respect that and work with the authorities to find the middle ground of helping as many patients as possible, while doing so in a manner that's sensitive to the budget constraints. In 2023, we implemented the strategy to accelerate progress, which focuses on a higher risk subset of reducing patients. This is intended to help us obtain favorable access and reimbursement more quickly, while preserving long-term potential, as well as accelerate sales growth upon launch for the more focused, efficient commercial structure.

Speaker Change: There are approximately 7 million patients that meet the label criteria in Europe .

Speaker Change: While this is very powerful, and the scale is an enormous opportunity for us, it's also a challenge for the reimbursement authorities from a budget perspective.

Speaker Change: We need to respect that and work with the authorities to find the middle ground of helping as many patients as possible while doing so in a manner that's sensitive to the budget constraints.

Speaker Change: In 2023, we implemented a strategy to accelerate progress which focuses on a higher risk subset of reducing patients.

Speaker Change: This is intended to help us obtain favorable access and reimbursement more quickly while preserving long-term potential, as well as accelerate sales growth upon launch with a more focused, efficient commercial structure.

Aaron Berg: We're seeing this strategy resonate with authorities and hope that once we establish momentum in key country providers, they'll use the product to benefit more of their at-risk patients. In the second quarter, the team continues to deliver on the strategy and made advances. Specifically, Spain's delivering robust growth following our highly successful Veskepa launch in that country last fall. The early success in Spain further confirms what we learned from our promotional and educational efforts in the U.S. That when HCPs and payers learn about the science and benefits of Veskepa, this medication can sell in Europe. Our sales team there is targeting 2,500 key HCPs covering 80% of the total market, and augmenting our sales efforts with continued focus on a commercial and medical strategy centered on increased HCP interactions, regional conferences, and publication plans.

Speaker Change: We're seeing this strategy resonate with authorities and hope that once we establish momentum in key country providers, they'll use the product to benefit more of their at-risk patients.

Speaker Change: In the second quarter, the team continued to deliver on the strategy and made advances.

Speaker Change: Specifically...

Speaker Change: Spain's delivering robust growth following our highly successful Vescepa launch in that country last fall.

Aaron Burr: The early success in Spain further confirms what we learned from our promotional and educational efforts in the U.S., that when HCPs and payers learn about the science and benefits of VASCEPA, these efforts should help to solidify the case for Vizcapa in this important European market and should serve as a model for how we expect to execute our strategy in other European markets. We have key additional data available which will strengthen our clinical dossier. You can decide on seven in the rest of the world.

Speaker Change: The early success in Spain further confirms what we learned from our promotional and educational efforts in the U.S., that when HCPs and payers learn about the science and benefits of Veskepa, this medication can sell in Europe .

Speaker Change: Our sales team there is targeting 2,500 key HCPs, covering 80% of the total market.

Speaker Change: and augmenting our sales efforts with continued focus on a commercial and medical strategy centered on increased HCP interactions, regional congresses, and publication plans.

Aaron Berg: These efforts should help solidify the case for Veskepa in this important European market and to serve as a model for how we expect to execute our strategy and other European markets. In the UK, we implemented significant, impactful changes to accelerate growth. Our refined focus commercial strategy, coupled with organizational changes including a new general manager and a revamped sales force structure. The UKT is energized, focused, and accelerating growth. They are focused on the most critical accounts and optimizing access in these accounts. We expect this positive momentum to continue and contribute to sustained incremental revenue growth as we move forward.

Speaker Change: These efforts should help to solidify the case for VESCEPA in this important European market and should serve as a model for how we expect to execute our strategy in other European markets.

Speaker Change: In the UK, we implemented significant impactful changes to accelerate growth.

Speaker Change: A refined, focused commercial strategy, coupled with organizational changes, including a new general manager and a revamped salesforce structure.

Speaker Change: The UK team is energized, focused, and accelerating growth. They're focused on the most critical accounts and optimizing access in these accounts. We expect this positive momentum to continue and contribute to sustained incremental revenue growth as we move forward.

Speaker Change: Turning to pricing and reimbursement progress, we're focused on advancing opportunities in other key EU5 markets.

Speaker Change: In Italy, our dossier is now under review with local health authorities.

Aaron Berg: We are confident that our submission will again deliver a positive clinical assessment, and we remain committed to doing all we can with the authorities to lead to a successful price negotiation by the end of the year. In France, with the recent publication of the Respect EPA Cardiovascular Outcome Study of Icosipin Ethel, we have key additional data available which will strengthen our clinical dossiering. In other European markets, we recently secured national pricing and reimbursement in Greece and Portugal, and we look forward to realizing additional revenue contributions from these markets. As we look to the future, the European market represented an important, long-term source of growth from Esquepa.

Speaker Change: We're confident that our submission will again deliver a positive clinical assessment, and we remain committed to doing all we can with the authorities to lead to a successful price negotiation by the end of the year.

Speaker Change: In France, with the recent publication of the RESPECT-EPA cardiovascular outcome study of icosapenethyl, we have key additional data available which will strengthen our clinical dossier.

Speaker Change: In other European markets, we recently secured national pricing and reimbursement in Greece and Portugal, and we look forward to realizing additional revenue contributions from these markets.

Speaker Change: As we look to the future, the European market represents an important long-term source of growth for Vizcapa.

Aaron Berg: With IP protection in Europe out of 2039, we stand to realize tremendous value and impact millions of patients for years to come. We can decide seven in the rest of the world. Overall, the rest of the world represents a number of countries that together provide a sizable market expansion opportunity. Along with our partners, we continue to make regulatory market access and commercial launch progress across key markets, all of which further expands access for patients to Esquepa and Esquepa. Reinforced the impact, the product has already achieved and enhances cash generation for the future. Specifically looking at Asia, in China, our partner Edding Farm recently announced that they received regulatory approval from Esquepa for cardiovascular risk reduction from China's National Medical Products Administration or NMPA.

Speaker Change: With IP protection in Europe out to 2039, we stand to realize tremendous value and impact millions of patients for years to come.

Speaker Change: You can decide seven to the rest of the world.

Speaker Change: Overall, the rest of the world represents a number of countries that together provide a sizable market expansion opportunity.

Speaker Change: Along with our partners, we continue to make regulatory, market access, and commercial launch progress across key markets, all of which further expands access for patients to VASIPA and VASKEPA.

Speaker Change: reinforces the impact the product has already achieved and enhances cash generation for the future.

Aaron Burr: In China, our partner, Edding Farm, recently announced that they received regulatory approval from ACIPA for cardiovascular risk reduction from China's National Medical Products Administration, or NMPA. Following approval by NMPA, Edding is working to include Vaseepa on the National Reimbursement Drug List, or NRDL, and augment the ongoing commercial launch of Vaseepa in China to include the cardiovascular risk reduction indication. Products included in this listing can be readily prescribed from public hospitals in China.

Speaker Change: specifically looking at Asia

Speaker Change: In China, our partner Edding Farm recently announced that they received regulatory approval from ACIPA for cardiovascular risk reduction from China's National Medical Products Administration or NMPA.

Aaron Berg: Following approval by NMPA, Edding is working to include Esquepa on the National Reimbursement Drug List, or NRDL, and augment the ongoing commercial launch of Esquepa in China to include the Cardiovascular Risk Reduction indication. NRDL listing serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Products included in this listing can be readily prescribed from public hospitals in China. This is an important step in advancing access for Vaseepa to patients across China and to making it a key component in the treatment paradigm, addressing the growing CBD public health issue and the second most populated country in the world.

Speaker Change: Following approval by NMPA, Edding is working to include Vaseepa on the National Reimbursement Drug List, or NRDL, and augment the ongoing commercial launch of Vaseepa in China to include the cardiovascular risk reduction indication.

Speaker Change: NRDL listing serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population.

Speaker Change: Products included in this listing can be readily prescribed from public hospitals in China.

Speaker Change: This is an important step in advancing access for vesipa to patients across China and to making it a key component in the treatment paradigm addressing the growing CBD public health issue in the second most populated country in the world.

Aaron Berg: To that point, according to the World Heart Federation, cardiovascular events such as the Schema Card Disease and stroke had been projected to increase by 50% among the population in China between 2010 and 2030. As a reminder, our agreement states that, as a result of achieving the cardiovascular risk reduction indication in China, Amarin earned a $15 million milestone payment from adding, in addition to future commercial milestone payments, as well as cured royalties on sales, a source of sustained cash in the years to come. In Australia, our partner CSL Securus has now advanced the pricing and reimbursement discussions with local authorities to the final stages.

Speaker Change: To that point, according to the World Heart Federation, cardiovascular events such as ischemic heart disease and stroke have been projected to increase by 50% among the population in China between 2010 and 2030.

Speaker Change: As a reminder, our agreement states that as a result of achieving the cardiovascular risk reduction indication in China.

Speaker Change: Amarin earned a $15 million milestone payment from Edding.

Speaker Change: In addition to future commercial milestone payments, as well as key royalties on sales, a source of sustained cash in the years to come.

Speaker Change: In Australia, our partner CSL Securus has now advanced the pricing and reimbursement discussions with local authorities to the final stages.

Aaron Berg: We're also supporting commercial launch readiness in the market through medical education and Salesforce readiness initiatives. In Canada, our partner HLS Therapeutics announced that it's entered into a product listing agreement with the province of Alberta for the listing and public reimbursement of Asipa. The PLA with Alberta Health has effective August 1, 2024.

Aaron Burr: We're also supporting commercial launch readiness in the market through medical education and the Salesforce readiness initiative. The PLA with Alberta Health is effective August 1st, 2024. In the second quarter, the U.S. team continued to maintain our IPE market leadership with exclusive accounts representing approximately 50% of the IPE market. Prescription market share remains stable in the U.S. for the seventh consecutive quarter.

Speaker Change: We're also supporting commercial launch readiness in the market through medical education and Salesforce readiness initiatives.

Speaker Change: In Canada, our partner HLS Therapeutics announced that it has entered into a product listing agreement with the province of Alberta for the listing and public reimbursement of ASIPA.

Speaker Change: The PLA with Alberta Health is effective August 1st, 2024.

Aaron Berg: In summary, our teams and partners are continuing to advance efforts to get Asipa and Veskepa into the hands of as many patients as possible globally. We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the Veskepa clinical data and what it means for patient care, our confidence continues to solidify on its long-term value.

Speaker Change: In summary, our teams and partners are continuing to advance efforts to get Vasepa and Vaskepa into the hands of as many patients as possible globally.

Speaker Change: We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the Visepa clinical data and what it means for patient care, our confidence continues to solidify on its long-term value.

Aaron Berg: Now turning to slide 8 in the U.S. In the second quarter of the U.S. team continued to maintain our IPE market leadership to exclusive accounts representing approximately 50% of the IPE market. Prescription market share remains stable in the U.S. for the seventh consecutive quarter. While revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition, the U.S. business continues to generate cash funding our efforts globally, particularly in Europe. Our market share strength is a direct result of what the U.S. team has done to work efficiently while maximizing Veskepa's value in the U.S.

Speaker Change: Now turning to slide 8 in the U.S.

Speaker Change: In the second quarter, the U.S. team continued to maintain our IPE market leadership through exclusive accounts representing approximately 50% of the IPE market.

Speaker Change: Prescription market share remains stable in the U.S. for the 7th consecutive quarter.

Thomas Charles Reilly: While revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition, the U.S. business continues to generate cash, funding our efforts globally, particularly in Europe. While we're encouraged that prescription volume has remained stable in the first half of 2024, as we've always said, the U.S. market is highly dynamic. We announced during the second quarter that in the second half of 2024, our business will be impacted by the loss of an important contract with a major exclusive commercial account, which brands SEPA to a blocked status on its formulary.

Speaker Change: While revenues of the quarter were impacted primarily by a decline in net selling price due to generic competition, the U.S. business continues to generate cash, funding our efforts globally, particularly in Europe .

Speaker Change: Our market share strength is a direct result of what the U.S. team has done to work efficiently while maximizing the CIPA's value in the U.S., despite last year's strategic decision to eliminate the sales force and significantly reduce marketing spend given increasing generic competition.

Aaron Berg: Despite last year's strategic decision to eliminate the sales force and significantly reduce marketing spend, given increasing generic competition. While we're encouraged that the prescription volume has remained stable in the first half of 2024, as we've always said, the U.S. Market is highly dynamic.

Speaker Change: While we're encouraged that the prescription volume has remained stable in the first half of 2024, as we've always said, the U.S. market is highly dynamic.

Aaron Berg: We announced during the second quarter that in the second half of 2024, our business will be impacted by the loss of an important contract with a major exclusive commercial account, which will brand Veskepa to a block status on its formulary. This account represents approximately 25% of our business and is expected to reduce our second half 2024 revenues. It is important to keep in mind that while the decision will undoubtedly have a significant impact on overall Veskepa volume, we believe that Brandon Veskepa will continue to be the market leader in the total IP market even after taking into account the full impact of the loss of this major exclusive plan is absorbed.

Speaker Change: We announced during the second quarter that in the second half of 2024, our business will be impacted by the loss of an important contract with a major exclusive commercial account, which moved branded Visepa to a blocked status on its formulary.

Speaker Change: This account represents approximately 25% of our business and is expected to reduce our second half 2024 revenues.

Speaker Change: It is important to keep in mind that, while the decision will undoubtedly have a significant impact on overall vestibular volume,

Speaker Change: We believe that Brandon Vecepa will continue to be the market leader in the total IPE market even after taking into account the full impact of the loss of this major exclusive plan is absorbed.

Aaron Berg: And importantly, despite the ongoing challenges presented by generic competition in the U.S., remember we've prepared for all scenarios and are ready to change our approach to this business as the market continues to evolve. This includes the launch of an authorized generic at the optimal time, which would be bolstered by our strong supply position. We believe this would help us retain our IP market leadership, as well as generate revenue for years to come.

Speaker Change: And importantly, despite the ongoing challenges presented by generic competition in the U.S., remember we've prepared for all scenarios and are ready to change our approach to this business as the market continues to evolve.

Thomas Charles Reilly: This includes the launch of an authorized generic at the optimal time, which will be bolstered by our strong supply position. Now, I'd like to hand the call over to Tom Reilly to review our second quarter 2024 financial performance.

Speaker Change: This includes the launch of an authorized generic at the optimal time, which will be bolstered by our strong supply position.

Speaker Change: We believe this would help us retain our IPE market leadership, as well as generate revenue for years to come.

Tom Reilly: Now, I'd like to hand the call over to Tom Reilly to review our second quarter 2024 financial performance. Tom. Thank you, Aaron. Good morning, everyone. Today, I'm reporting details regarding our financial performance in the second quarter of 2024. Turning to slide 10, in the second quarter of 2024, Amarin reported total net revenue of 67.5 million, which included net product revenue of 47.5 million and 20 million of licensing and royalty revenue. Versus 80.2 million total revenue in the second quarter of 2023. US product revenue was 43.8 million in the second quarter of 2024, versus 64.6 million in the second quarter of 2023.

Speaker Change: Thank you Aaron. Good morning everyone. Today I'm reporting details regarding our financial performance in the second quarter of 2024.

Thomas Charles Reilly: Turning to slide 10, to generic competition in the market. Despite the revenue decline, the U.S. business continues to deliver significant cash. This was driven by revenue growth from both Spain and the UK, as well as supply shipments to our partners in Greece and Israel. The current quarter amount also reflects the contribution of a $15 million milestone related to obtaining cardiovascular risk reduction approval in China and a $4 million non-cash payment related to changing the accounting estimate on a previously received partnership milestone, excluding inventory restructuring charges in the second quarter of 2020. This decline is due to a decline in the net selling price in the US.

Speaker Change: Turning to slide 10. In the second quarter of 2024, Amarin reported total net revenue of $67.5 million, which included net product revenue of $47.5 million and $20 million of licensing and royalty revenue.

Speaker Change: versus $80.2 million total revenue in the second quarter of 2023.

Speaker Change: U.S. product revenue was $43.8 million in the second quarter of 2024 versus $64.6 million in the second quarter of 2023.

Tom Reilly: This decline was driven largely by a lower net selling price due to the generic competition in the market. Despite the revenue decline, the US business continues to deliver significant cash. Product revenue also reflects European net product revenue of 3.5 million, a 2.9 million increase over the prior year, driven by revenue growth from both Spain and the UK, as well as supply shipments to our partners in Greece and Israel. Licensing and royalty revenue was 20 million in the second quarter of 2024, versus 15 million in the second quarter of 2023. The current quarter amount reflects the contribution of a 15 million milestone related to obtaining cardiovascular risk reduction approval in China, and a 4 million of non-cash payment related to change in accounting estimate on a previously received partnership milestone.

Speaker Change: This decline was driven largely by a lower net selling price due to the generic competition in the market.

Speaker Change: Despite the revenue decline, the U.S. business continues to deliver significant cash.

Speaker Change: Product revenue also reflects European net product revenue of $3.5 million, a $2.9 million increase over the prior year.

Speaker Change: driven by revenue growth from both Spain and the UK as well as supply shipments to our partners in Greece and Israel.

Speaker Change: Licensing and royalty revenue was $20 million in the second quarter of 2024 versus $15 million in the second quarter of 2023.

Speaker Change: The current quarter amount reflects the contribution of a 15 million milestone related to obtaining cardiovascular risk reduction approval in China.

Speaker Change: and a $4 million of non-cash payment related to a change in accounting estimate on a previously received partnership milestone.

Tom Reilly: Cost of goods sold in the second quarter of 2024 was 24.7 million, compared to 37.5 million in the second quarter of 2023. Growth margin in the second quarter of 2024 was 488%, and Q2-2023 was 64%, excluding inventory restructuring charges in the second quarter of 2023. This decline is due to a decline in the net selling price in the US.

Speaker Change: Cost of goods sold in the second quarter of 2024 was $24.7 million, compared to $37.5 million in the second quarter of 2023.

Speaker Change: Gross margin in the second quarter of 2024 was 48% and Q2 2023 was 64%.

Speaker Change: Excluding Inventory Restructuring Charges in the Second Order of 2023.

Speaker Change: This decline is due to a decline in the net selling price in the U.S.

Tom Reilly: Now moving on to operating expense of the PNL. July 2023, we announced we would reduce our cost basis by 40 million annually. Today, we are pleased to report that we have achieved 50 million in cost savings on an annualized basis. Overall, operating expenses were 43.3 million in the second quarter, compared to 38.5 million in selling, general, and administrative expenses. in 4.7 million in research and development expenses, which is approximately a 14 million reduction in operating expenses versus the second quarter of 2023, excluding the 2023 restructuring expenses. Turning to profitability, we reported a gap net income of 1.5 million for the second quarter of 2024.

Thomas Charles Reilly: Now moving on to operating expenses of the P&L. In July 2023, we announced we would reduce our cost basis by $40 million annually. Today we are pleased to report that we have achieved $50 million in cost savings on an annualized basis and $4.7 million in research and development expenses. Turning to profitability, we reported a gap net income of $1.5 million for the second quarter of 2024.

Speaker Change: Now moving on to operating expense of the P&L.

Speaker Change: July 2023, we announced we would reduce our cost basis by $40 million annually.

Speaker Change: Today, we are pleased to report that we have achieved $50 million in cost savings on an annualized basis.

Speaker Change: Overall operating expenses were $43.3 million in the second quarter, comprised of $38.5 million in selling, general, and administrative expenses.

Speaker Change: and $4.7 million in research and development expenses.

Speaker Change: which is approximately a $14 million reduction in operating expenses versus the second quarter 2023, excluding the 2023 restructuring expenses.

Speaker Change: Turning to profitability, we reported a gap net income of $1.5 million for the second quarter of 2024 versus a $17.6 million loss in the prior year period.

Tom Reilly: Versus a 17.6 million loss in the prior year period. On an adjusted basis, the company realized a profit of 5.9 million versus 8.6 million in 2023.

Thomas Charles Reilly: On an adjusted basis, the company realized a profit of $5.9 million versus $8.6 million in 2020. The sizable cash balance provides an important foundation for the company. Now, let me provide a brief update on our share repurchase program. As announced in January, Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald to purchase up to $50 million of its ordinary shares.

Speaker Change: On an adjusted basis, the company realized a profit of $5.9 million versus $8.6 million in 2023.

Tom Reilly: Now, let me turn to slide 11 and our efforts and results in control and costs and effectively managing our cash. As of June 30, 2024, Amarin reported cash and investments of 307 million. Where our cash balance has been impacted by revenue shortfall, we have successfully maintained a stable cash position over the last eight quarters. The sizable cash balance provides an important foundation from the company. We continue to focus on balancing preserving cash with managing costs and, at the same time, pursuing channels to expand product revenue.

Speaker Change: Now let me turn to slide 11 and our efforts and results in controlling costs and effectively managing our cash.

Speaker Change: As of June 30, 2024, Amarin reported aggregate cash and investments of $307 million.

Speaker Change: While our cash balance has been impacted by revenue shortfall, we have successfully maintained a stable cash position over the last eight quarters.

Speaker Change: The sizable cash balance provides an important foundation for the company. We continue to focus on balancing preserving cash with managing costs.

Speaker Change: and at the same time pursuing channels to expand product revenue.

Tom Reilly: Now, let me provide a brief update on our share repurchase program. As announced in January, Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald to purchase up to 50 million of Amarin's ordinary shares. The company announced this program given its confidence in the business and our cash position at that time, and the potential to return value to shareholders. In April, we secured shareholder approval, and in May, we successfully secured UK High Court approval for the share repurchase program. While we actively assess business and market conditions on an ongoing basis, including the performance of our business, our cash position, and other factors, at this time we have not initiated share repurchases given current conditions.

Speaker Change: Now let me provide a brief update on our share repurchase program.

Speaker Change: As announced in January , Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald to purchase up to $50 million of Amarin's ordinary shares.

Thomas Charles Reilly: The company announced this program given its confidence in the business and our cash position at that time and the potential to return value to shareholders. While we actively assess business and market conditions on an ongoing basis, including the performance of our business, our cash position, and other factors. At this time, we have not initiated share repurchases given current conditions.

Speaker Change: The company announced this program given its confidence in the business and our cash position at that time and the potential to return value to shareholders.

Speaker Change: In April , we secured shareholder approval, and in May, we successfully secured UK High Court approval for the Share Repurchase Program.

Speaker Change: While we actively assess business and market conditions on an ongoing basis, including the performance of our business, our cash position, and other factors, at this time we have not initiated share repurchases given current conditions.

Tom Reilly: We will continue to assess these conditions moving forward, and we would consider initiating share repurchases if and when the business and market conditions improve.

Aaron Burr: We will continue to assess these conditions moving forward, and we would consider initiating share repurchases if and when business and market conditions improve. With that, I will now turn back to Aaron for closing remarks and to begin the Q&A portion of our call. All right.

Speaker Change: We will continue to assess these conditions moving forward, and we would consider initiating share repurchases if and when the business and market conditions improve.

Aaron Berg: With that, I will now turn back to Aaron for closing remarks and to begin to accumulate portion of our call. Aaron, thanks for the overview of financial results and the update on the share repurchase programs. As we shared this morning, we believe there's significant long-term value in Vesipa Vesipa. Our goal is simple and clear: to harness the attributes of the product over 10 years of science and clinical data, including more than 300 publications on Vesipa and the backing of 30 medical societies around the world recognizing the value of the product. An extended IP position in Europe out to 2039, an unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer around the world.

Speaker Change: With that, I will now turn back to Aaron for closing remarks and to begin the Q&A portion of our call.

Aaron Burr: Thanks, Tom, for the overview of the financial results and the update on the share repurchase program. Our goal is simple and clear: harness the attributes of the product after 10 years of science and clinical data, including more than 300 publications on Visepa and the backing of 30 medical societies around the world recognizing the value of the product, an extended IP position in Europe out to 2039, an unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer around the world, and multiple key untapped markets in Europe and the rest of the world where access can be The progress we've made to date is not enough.

Aaron Berg: All right. Thanks, Tom, for the overview of financial results and the update on the share repurchase program.

Aaron Berg: As we shared this morning, we believe there's significant long-term value in Visepa Vescepa.

Aaron Berg: Our goal is simple and clear, to harness the attributes of the product over 10 years of science and clinical data.

Aaron Berg: including more than 300 publications on Visepa and the backing of 30 medical societies around the world recognizing the value of the product.

Aaron Berg: An extended IP position in Europe out to 2039 An unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer around the world And multiple key untapped markets in Europe and the rest of the world where access can be opened

Aaron Berg: And multiple key untapped markets in Europe and the rest of the world where access can be opened to maximize its value potential at a faster pace.

Aaron Berg: to maximize its value potential at a faster pace.

Aaron Berg: The progress we've made to date is not enough. We understand the need to accelerate performance, to realize the potential of the product across Europe and the rest of the world markets with our partners, and to continue to maximize profitability in the U.S. As we continue our operational execution to rapidly build value across global markets, we're also examining all possibilities and opportunities to unlock the value of this product for more patients.

Aaron Burr: We understand the need to accelerate performance, to realize the potential of the product across Europe and the rest of the world markets with our partners, and to continue to maximize profitability in the U.S. Before we turn to Q&A, I'd like to thank our Amarin colleagues for their continued commitment and dedication. And with that, Mark, let's begin the Q&A portion of the call. Let's begin the Q&A. It's important to keep in mind that while the loss of the commercial exclusive in the U.S. is certainly significant, we believe that branded Visepa will continue to be the market leader after the full impact of the loss of the major exclusive plans is absorbed.

Aaron Berg: The progress we've made to date is not enough. We understand the need to accelerate performance, to realize the potential of the product across Europe and the rest of the world markets with our partners, and to continue to maximize profitability in the U.S.

Aaron Berg: As we continue our operational execution to rapidly build value across global markets.

Aaron Berg: We're also examining all possibilities and opportunities to unlock the value of this product for more patients.

Aaron Berg: Before we turn to Q&A, I'd like to thank our Amarin colleagues for their continued commitment and dedication. Each of you come to work every day focused on bringing Mesipha and Veskepa to patients because you know it can make a difference. Thank you all for your efforts.

Speaker Change: Before we turn to Q&A, I'd like to thank our Amarin colleagues for their continued commitment and dedication. Each of you come to work every day focused on bringing VASIPA and VASKEPA to patients because you know it can make a difference.

Mark Marmur: And with that, Mark, let's begin the Q&A portion of the call.

Speaker Change: Thank you all for your efforts.

Speaker Change: And with that, Mark, let's begin the Q&A portion of the call.

Mark Marmur: Thank you, Aaron. As we previously shared, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin has partnered with State Technologies to allow retail and institutional shareholders submit and upflow questions, a selection of which will be answered by Amarin management during today's earnings call. Let's begin the Q&A.

Mark: Thank you, Aaron. As we previously shared, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin has partnered with SAIT Technologies to allow retail and institutional shareholders to submit and upvote questions, a selection of which will be answered by Amarin management during today's earnings call.

Aaron Berg: Aaron, this question is for you. In the U.S., what is our outlook for continued stabilization in Mesipha, U.S. revenues against additional generic competition, and what's the plan for renewing exclusive contracts for 2025? Thanks, Mark. And first of all, thanks again to all the investors who submitted these questions. We greatly appreciate it. It's important to keep in mind that while the loss of the commercial exclusive in the U.S. is certainly significant. We believe that branded Mesipha will continue to be the marked leader after the full impact of the loss of the major exclusive plans absorbed. This recent decision only impacts that single commercial plan under that account.

Speaker Change: Let's begin the Q&A.

Aaron Berg: Aaron, this question is for you. In the U.S., what is our outlook for continued stabilization in VISIPA U.S. revenues against additional generic competition and what's the plan for renewing exclusive contracts for 2025?

Aaron Berg: Yeah, thanks, Mark. And first of all, thanks again to all the investors who submitted these questions. We greatly appreciate it.

Speaker Change: It's important to keep in mind that while the loss of the commercial exclusive in the U.S. is certainly significant, we believe that Brandon Bacipa will continue to be the market leader after the full impact of the loss of the major exclusive plans absorbed.

Speaker Change: This recent decision only impacts that single commercial plan under that account. It does not impact Medicare Part D plans. The significant majority of our exclusive volume is in Medicare Part D plans.

Aaron Berg: It does not impact Medicare Part D plans. The significant majority of our exclusive volume is in Medicare Part D plans. We do have exclusive IPE status and other commercial plans, but those plans represent a small portion of our total volume. Based on the feedback we've received from the PBM for those plans, we expect that they will retain exclusive status for the remainder of 2024. So if we get 2025, we submitted what we believe to be competitive offers for 2025. And plans are now in the process of making their decisions regarding formulary coverage to start 2025.

Speaker Change: We do have exclusive IPE status at other commercial plans, but those plans represent a smaller portion of our total volume.

Aaron Burr: Based on the feedback we've received from the PBMs for those plans, we expect that they will retain exclusive status for the remainder of 2024. Looking at 2025, we submitted what we believe to be competitive offers for 2025, and plans are now in the process of making their decisions regarding formulary coverage for start in 2025. The feedback we've received to date regarding our office has been positive, but it's far too early to make any predictions regarding 2025 coverage status, even at the plans that have given us positive feedback to maintain our leadership position.

Speaker Change: Based on the feedback we've received from the PBM for those plans, we expect that they will retain exclusive status for the remainder of 2024.

Speaker Change: Looking at 2025, we submitted what we believe to be competitive offers for 2025, and plans are now in the process of making their decisions regarding formulary coverage to start 2025.

Tom Reilly: The feedback we've received to date regarding our offer has been positive, but it's far too early to make any predictions regarding 2025 coverage status, even at the plans that have given us positive feedback. We've also been preparing and have the ability to launch an authorized generic, if necessary, to maintain our leadership position.

Speaker Change: The feedback we've received to date regarding our office has been positive, but it's far too early to make any predictions regarding 2025 coverage status, even at the plans that have given us positive feedback.

Speaker Change: We also have been preparing and have the ability to launch an authorized generic, if necessary, to maintain our leadership position.

Tom Reilly: Thanks, Aaron.

Mark Marmur: Tom, during today's call, we provide an update regarding the share repurchase program. Can you share more on the market conditions impacting the decision not to commence share repurchases? Thank you for the question. While we receive both shareholder and UK High Court approvals in the second quarter, we did not commence any share repurchases in the second quarter due to business and market conditions. We are monitoring the cash generation in the U.S. business over the coming quarters, following the loss of a key commercial exclusive plan, as well as our progress in Europe. As these factors impact our cash position and the viability of the share repurchase program moving forward.

Aaron Burr: Tom, during today's call, we provided an update regarding the share repurchase program. Can you share more on the market conditions impacting the decision not to commence share repurchases? as well as our progress in Europe, as these factors impact our cash position and the viability of the share repurchase program moving forward? Okay, thanks, Mark.

Aaron Berg: Thanks, Aaron.

Aaron Berg: Tom, during today's call, we provided an update regarding the share repurchase program. Can you share more on the market conditions impacting the decision not to commence share repurchases?

Tom: Thank you for the question. While we received both shareholder and UK high court approvals in the second quarter, we did not commence any share repurchases in the second quarter due to business and market conditions.

Tom: We are monitoring the cash generation in the U.S. business over the coming quarters following the loss of a key commercial exclusive plan.

Tom: as well as our progress in Europe .

Tom: As these factors impact our cash position and the viability of the share repurchase program moving forward.

Tom Reilly: Thanks, Tom.

Aaron Berg: Investors would also like to know if we have an update on a potential delisting from NASDAQ and if we would consider a reverse split to increase the share price. Okay, thanks, Mark. First on the delisting, given that we traded under $1 for 30 consecutive trading days, we received official notice of a potential delisting from NASDAQ at the end of May. Keep in mind the full process could take up to 360 days if we continue to trade below $1. However, there are financial levers, strategic and operational opportunities to regain compliance. We believe the operational opportunities are to progress in Europe, advancing efforts with partners in the rest of the world, and delivering cash in the U.S., which all can help us to regain NASDAQ compliance.

Speaker Change: Thanks Tom. Investors would also like to know if we have an update on a potential delisting from NASDAQ and if we would consider a reverse split to increase the share price.

Mark: Okay, thanks, Mark.

Speaker Change: First, on the delisting, given that we traded under $1 for 30 consecutive trading days, we received official notice of a potential delisting from NASDAQ at the end of May.

Aaron Burr: Keep in mind the full process could take up to 360 days if we continue to trade below $1. However, there are financial levers, strategic, and operational opportunities to regain compliance. We believe the operational opportunities are to progress in Europe, advancing efforts with partners in the rest of the world, and delivering cash in the U.S., which can all help us to regain NASDAQ compliance. On a potential reverse stock split, we are always considering the pros and cons of all options to increase shareholder value.

Speaker Change: Keep in mind the full process could take up to 360 days if we continue to trade below $1.

Speaker Change: However, there are financial levers, strategic and operational opportunities to regain compliance.

Speaker Change: We believe the operational opportunities are to progress in Europe , advancing efforts with partners in the rest of the world, and delivering cash in the U.S., which all can help us to regain NASDAQ compliance.

Aaron Berg: On a potential reverse split, we are always considering the pros and cons of all options to increase shareholder value.

Speaker Change: On a potential reverse stock split, we are always considering the pros and cons of all options to increase shareholder value.

Jonathan Provoost: Jonathan, we've received a number of questions regarding the recent decision by the Federal Circuit to reverse a previous decision in the skinny label litigation. Can you comment on that? Sure Mark, to recap, in November 2020, we filed a patent infringement lawsuit against Tickla, alleging that Hickback activities associated with their marketing and sale of their generic COSA-PAM product induced infringement of patents covering the use of the SEBA to reduce specified CV risk. In January 2022, the District Court dismissed our complaint against Tickla for failure to state a claim. We repealed that decision to the Appellate Court, and the Appellate Court heard oral arguments in April of 2024.

Speaker Change: Jonathan, we've received a number of questions regarding the recent decision by the Federal Circuit to reverse a previous decision in the skinny label litigation. Can you comment on that?

Aaron Burr: To recap, in November 2020, we filed a patent infringement lawsuit against HICMA alleging that HICMA activities associated with their marketing and sale of their generic Ecosapam product induced infringement of patents covering the use of Visepa to reduce specified CV risk. However, in January 2022, the District Court dismissed our complaint against TICMA for failure to state a claim. We appealed that decision to the appellate court, and the appellate court heard oral arguments in April of 2024.

Jonathan: To recap, in November 2020, we filed a patent infringement lawsuit

Jonathan: Again, HICMA, alleging that HICMA activities associated with their marketing and sale of their generic Ecosapam product induced infringement of patents covering the use of Visepa to reduce specified TB risk.

Jonathan: In January 2022, the District Court dismissed our complaint against TICMA for failure to state a claim.

Jonathan: We appealed that decision to the Appellate Court, and the Appellate Court heard oral arguments in April of 2024. In late June , the Appellate Court reversed the District Court's decision, finding that our allegations against HICMA do indeed plause me state a claim for induced infringement.

Aaron Burr: In late June, the appellate court reversed the district court's decision, finding that our allegations against HICMA do indeed plausibly state a claim for induced infringement. Due to this finding, the case will return to the District Court. While we welcome the Federal Circuit's decision, this simply means that the case will now proceed within the District Court. No ruling has yet been made on the merits of the allegations we've made.

Jonathan Provoost: In late June, the Appellate Court reversed the District Court's decision, finding that our allegations against Tickla do indeed cause me state of claim for induced infringement. Due to this filing, the case will return to the district court. While we welcome the Federal Circuit's decision, this simply means that the case will now proceed within the District Court. No ruling has yet been made on the merits of the allegations we've made.

Jonathan: Due to this finding, the case will return to the District Court. While we welcome the Federal Circuit's decision, this simply means that the case will now proceed within the District Court. No ruling has yet been made on the merits of the allegations we've made.

Steven Ketchum: Thanks, Jonathan. Steve, we recently saw that the respective EPA study was published in Circulation. Can you remind our investors about the background of this study and why it is important? Thanks, Mark, for the question. The Respect EPA clinical trial is an independent study funded by the Japanese Heart Foundation.

Steve: Thanks, Jonathan. Steve, we recently saw that the Respect EPA study was published in Circulation. Can you remind our investors about the background of this study and why it is important? Thanks, Mark, for the question. The RESPECT EPA clinical trial is an independent study funded by the Japanese Heart Foundation. In 2005, the Japan EPA Lipid Intervention Study, or GELIS, first demonstrated a beneficial effect of highly purified eicosapentaenoic acid, or EPA, on cardiovascular outcomes in patients with or without coronary artery disease. Also referred to as CAD

Steve: Thanks Jonathan. Steve, we recently saw that the RESPECT EPA study was published in circulation. Can you remind our investors about the background of this study and why it is important?

Steve: Thanks Mark for the question. The RESPECT EPA clinical trial is an independent study funded by the Japanese Heart Foundation.

Steven Ketchum: In 2005, the Japan EPA Lipid Intervention Study, or Jellis, first demonstrated a beneficial effect of highly purified a COSA-Penta-Hinoic acid or EPA on cardiovascular outcomes in patients with or without coronary artery disease. Also referred to as C-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D-A-D In 2019, Amarin published a positive results of its double-blind placebo-controlled study reduces in patients with cardiovascular risk and elevated TG levels. And now, Respect EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD. The respect EPA study used 1.8 grams per day of purified EPA, which is consistent with the substantial body of evidence from the reducer and jealous trials.

Speaker Change: In 2005, the Japan EPA Lipid Intervention Study, or JELIS,

Speaker Change: first demonstrated a beneficial effect of highly purified eicosapentaenoic acid, or EPA, on cardiovascular outcomes in patients with or without coronary artery disease, also referred to as CAD.

Speaker Change: In 2019, Amarin published the positive results of its double-blind placebo-controlled study REDUCE-IT in patients with cardiovascular risk and elevated TG levels.

Speaker Change: And now, RESPECT-EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD.

Speaker Change: The RESPECT EPA study used 1.8 grams per day of purified EPA, which is consistent with the substantial body of evidence from the REDUCE-IT and JEALOUS trials.

Steven Ketchum: Showing that highly purified prescription EPA plus stat significantly reduces the risk of cardiovascular events in high and very high risk statin-treated patients. Importantly, the study achieved a borderline statistical significance with the 21.5 percent reduction in the primary composite endpoint measuring cardiovascular risk, with the p-value of 0.054, and achieved the statistically significant 26.6 percent reduction in the secondary composite endpoint of respect EPA, with the p-value of 0.03. EPA level also matters. A post-talk analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5 percent reduction in the primary endpoint, with a p-value of 0.02.

Speaker Change: showing that highly purified prescription EPA plus statin significantly reduces the risk of cardiovascular events in high and very high risk statin treated patients.

Speaker Change: Importantly, the study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk.

Speaker Change: EPA level also matters.

Speaker Change: A post-hoc analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5% reduction in the primary endpoint, with a p-value of 0.02.

Unknown Executive: Thank you all for those updates.

Unknown Executive: We will now open the Q&A up for additional questions. Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star 1 to ask a question. One moment, please, while we pull for questions.

Speaker Change: Thank you all for those updates. We will now open the Q&A up for additional questions.

Operator: In 2019, Amarin published the positive results of its double-blind placebo-controlled study REDUCE-IT in patients with cardiovascular risk and elevated TGE levels. The RESPECT EPA study used 1.8 grams per day of purified EPA, which is consistent with the substantial body of evidence from the REDUCE-IT and JELL-US trials showing that highly purified prescription EPA plus stat significantly reduces the risk of cardiovascular events in high and very high risk stat At this time, we will be conducting a question and answer session.

Speaker Change: Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad.

Operator: If you would like to ask a question, please press star 1 on your telephone keypad. You may press star 2 if you would like to remove your question from. Once again, that is star 1 to ask a question.

Speaker Change: A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star 1 to ask a question. One moment, please, while we poll for questions.

Operator: One moment, please, while we poll for questions. Second, from a growth perspective, which ex-US markets will be the strongest in driving commercial sales? Thank you. Thank you for the question. I appreciate it. So, first of all, regarding the obesity drugs, can you just clarify your question? It was a little bit muffled.

Unknown Executive: Your first question for today is from Louise Chen with Canter.

Carvey Leung: Hi, good morning, everyone. This is Carby on for Louise from Canter. Our first question is, with the rise of obesity drugs, has metabolic disease, education, and marketing been easier with physicians in getting a higher adoption rate for a placebo in your target markets.

Speaker Change: Hi, good morning, everyone. This is Carby Ahn for Louise from Canada. Our first question is, with the rise of obesity drugs, has metabolic disease education and marketing been easier with physicians in getting a higher adoption rate for Visepa in the target markets?

Carvey Leung: Second, from a growth perspective, which XUS markets will be the strongest in driving commercial sales. Thank you.

Speaker Change: Second, from a growth perspective, which ex-U.S. markets will be the strongest in driving commercial sales? Thank you.

Aaron Berg: Thank you for the question. I appreciate it.

Aaron Burr: Yeah, with obesity drugs, has the conversation with physicians about education and marketing a metabolic disease been easier? So, are you asking, is it making it easier for us to have conversations about vasepine cardiovascular risk reduction? Yes, the latter. The conversations with them.

Aaron Berg: So, first of all, regarding the obesity drugs, can you just clarify your question? It was a little bit muffled. Can you clarify that for us? Yeah, obesity drugs passed a conversation with physicians on education and marketing, and metabolic disease been easier. So, are you asking, is it making it easier for us to have conversations about the sheep and cardiovascular risk reduction? Yes, the latter: the conversations with them. I think that, so, first of all, that's a very good question because obviously the obesity drugs are, they are tremendous drugs, and what they've done for patients is tremendous.

Speaker Change: Can you clarify that for us?

Speaker Change: Yeah, with obesity drugs, has the conversation with physicians on education and marketing in metabolic disease been easier?

Speaker Change: So are you asking, is it making, is it making it easier, the GOP-1s, are you asking, is it making it easier for us to have conversations about vasepin cardiovascular risk reduction?

Aaron Burr: I think that, first of all, that's a very good question because obviously the obesity drugs are tremendous drugs, and what they've done for patients is tremendous. They've also heightened the awareness of the unmet need for cardiovascular risk reduction, which is exactly where our sweet spot is.

Speaker Change: I think that

Speaker Change: So first of all, that's a very good question because obviously the obesity drugs are, they are tremendous drugs and what they've done for patients is tremendous. They've also heightened the awareness of the unmet need in cardiovascular risk reduction.

Aaron Berg: They've also heightened the awareness of the unmet need and cardiovascular risk reduction. That's exactly where our sweet spot is. There's a lot of overlap with the patients, even with the obesity drugs. A lot of the patients continue to need cardiovascular risk reduction.

Aaron Burr: There's a lot of overlap with the patients, even with the obesity drugs. A lot of patients continue to need Cardiovascular Risk Reduction.

Speaker Change: That's exactly where our sweet spot is. There's a lot of overlap with the patients. Even with the obesity drugs, a lot of the patients continue to need

Aaron Berg: Part of the challenge with the noise around the GLP-1s is a share of voice issue for us, and that's that we're not a big company, like some of those companies that are marketing those drugs. So, we have to be very selective on who we speak with, make sure we identify the patients carefully and be very clear about today, the strength of the CEPA clinical data. But it does open the opportunity to make an increase the opportunity around cardiovascular risk reduction, and there's no question that when we get in front of the right customer, when we have the chance to educate, when we have the time to show them the wealth data around the CEPA, and the unmet need that the CEPA can, in fact, meet for a number of those patients.

Aaron Burr: Part of the challenge with the noise around the GLP-1s is a share of voice issue for us. And that's that we're not a big company like some of those companies that are marketing those drugs. So we have to be very selective about who we speak with, make sure we identify the patients carefully, and be very clear about conveying the strength of the SEPA clinical data.

Speaker Change: Cardiovascular Risk Reduction

Speaker Change: Part of the challenge with the noise around the GLP-1s is a share of voice issue for us.

Aaron Burr: But it does open up the opportunity and increase the opportunity around cardiovascular risk reduction. And there's no question that when we get in front of the right customer, when we have the chance to educate, we have the time to show them the wealth of data around this. Regarding the market, Spain launched more recently, and we are very encouraged with what we've seen in Spain. There's tremendous execution.

Speaker Change: But it does open the opportunity and increase the opportunity around cardiovascular risk reduction. And there's no question that when we get in front of the right customer, when we have the chance to educate, when we have the time to show them the wealth of data around MIS-HIPAA.

Aaron Berg: It benefits us.

Aaron Berg: Regarding the markets that are most important to us, as we spoke about, the U.K. is very important. We focused on the EU-5. Right now, we've launched the U.K. first as the EU-5, and the changes we've made last year, as commented on during the, during the earlier portion of the call. Those changes are taking hold, and we're seeing some acceleration; we're seeing an increase in demand; we're seeing an increase in the number of patients. We've got a long way to go, but we're pleased with the organization and the drive of the organization. We're seeing it in the performance, and we're really counting on the U.K.

Speaker Change: Regarding the markets,

Speaker Change: that are most important to us.

Speaker Change: As we spoke about, the UK is very important. We focus on the EU5. Right now we've launched the UK first out of the EU5 and the changes we've made last year as commented on during the earlier portion of the call.

Speaker Change: Those changes are taking hold, and we're seeing some acceleration. We're seeing an increase.

Speaker Change: In demand, we're seeing an increase in the number of patients. We've got a long way to go, but we're pleased with the organization and the drive of the organization. We're seeing it in the performance, and we're really counting on the UK to accelerate. There's a lot of potential there.

Aaron Berg: to accelerate. There's a lot of potential there.

Aaron Berg: Spain launched more recently, and we are very encouraged with what we've seen in Spain. There's tremendous execution; it's a very focused strategy, focused on the select group of patients that were referenced in the earlier portion of the call, particularly around a chief coronary syndrome. They're focused on 2,500 physicians, primarily specialists, and cover 80% of the market. Spain has also shown that there's promotion sensitivity, that when we have the time to promote Masipa, the SKEPA, as we did in the U.S., physicians respond. And we know, over time, if we continue to execute, that will continue to see that growth.

Speaker Change: Spain launched more recently.

Speaker Change: and

Speaker Change: We are very encouraged with what we've seen in Spain. There's tremendous execution. It's a very focused strategy, focused on the select group of patients that were referenced in the earlier portion of the call, particularly around acute coronary syndrome. They're focused on 2,500 physicians, primarily specialists, and covering 80% of the market.

Aaron Burr: It's a very focused strategy, focused on the select group of patients that were referenced in the earlier portion of the call, particularly around acute coronary syndrome. They're focused on 2,500 physicians, primarily specialists, and covering 80% of the market. Spain has also shown that there's promotion sensitivity, that when we have the time to promote VASEPA, VASCEPA, as we did in the U.S., physicians respond. And we know over time, if we continue to execute, that we'll continue to see that growth. And then China is another market we're very excited about. It's an enormous market.

Speaker Change: Spain has also shown that there's promotion sensitivity, that when we have the time to promote VACIPA, VASCEPA,

Speaker Change: As we did in the U.S., physicians respond. And we know over time, if we continue to execute, that we'll continue to see that growth.

Aaron Berg: And then China is another market. We're very excited about. Instead of the enormous market, we have a strong partner there. We just got the cardiovascular risk reduction indication. They are working to get, so in China, adding farm has launched with the very high time risk identification initially, similar to what we did in the U.S. They now have the cardiovascular risk reduction indication. And the next step is to get on the NRDL, which is the National Drug List. testing that will reimburse for a much broader population. So not only will we have the cardiovascular risk reduction indication, which is essentially, if it's like the US, 10 times the size of the market, a very high-track visorized, but it'll be reimbursed for so many of those patients nationally as well.

Speaker Change: And then China is another market we're very excited about.

Aaron Burr: We have a strong partner there. We just got the cardiovascular risk reduction indication. They are working to get, so in China, Edding Farm has been launched with a very high triglyceride indication initially, similar to what we did in the U.S.

Speaker Change: It's an enormous market. We have a strong partner there. We just got the cardiovascular risk reduction indication.

Speaker Change: They are working to get... So in China, Edding Farm has launched the very high triglyceride indication initially, similar to what we did in the U.S. They now have the cardiovascular risk reduction indication.

Aaron Burr: They now have the cardiovascular risk reduction, and the next step is to get on the NRDL, which is the National Drug List, that will reimburse for a much broader population. So not only will we have the cardiovascular risk reduction indication, which is essentially, if it's like the U.S., ten times the size of the market for very high triglycerides, but it'll be reimbursed for so many of those patients nationally as well. We look forward to that toward the end of the year.

Speaker Change: And the next step is to get on the NRDL, which is the National Drug Listing.

Speaker Change: that will reimburse for a much broader population. So not only will we have the cardiovascular risk reduction indication, which is essentially, if it's like the U.S., 10 times the size of the market of very high triglycerides, but it'll be reimbursed

Aaron Berg: We look forward to that toward the end of the year. Eddie is working hard to get that listing. And if successful, it'll be January 1st. And we're expecting a significant growth in China going into 2025.

Speaker Change: for so many of those patients nationally as well. We look forward to that toward the end of the year. Eddington is working hard to get that listing and if successful it'll be January 1st and we're expecting significant growth.

Aaron Burr: Eddie is working hard to get that listing, and if successful, it'll be January 1st, and we're expecting significant growth in China going into 2025. So we've got some markets, and then there are other markets where we're still seeking reimbursement, and we'll be ready to launch and execute in those markets as well. I hope I answered your question. Yes, thank you.

Aaron Berg: So we've got some markets, and then there are other markets where we're still seeking reimbursement, and we'll be ready to launch and execute in those markets as well. I hope I answer your questions.

Speaker Change: In China going into 2025. So we've got some markets and then there are other markets where we're still seeking reimbursement and We'll be ready to launch and execute in those markets as well

Unknown Executive: Yes, thank you.

Unknown Executive: I'm Graff on the auto progress. Thank you.

Speaker Change: I hope I answered your questions.

Speaker Change: Yes, thank you. Congrats on all the progress.

Jessica Fye: Your next question for today is from Jessica Fye with JP Morgan. Great. Good morning. Thanks for taking my question.

Aaron Burr: Congratulations on all the progress. Thank you. Your next question for today is from Jessica Fye with JPMorgan. Good morning.

Speaker Change: Thank you. Thank you.

Speaker Change: Your next question for today is from Jessica Fye with JP Morgan.

Jessica Macomber Fye: Thanks for taking my questions. Speak a little bit more about which country is contributing most to quarterly sequential growth. Yeah, sure, Jess.

Jessica Fye: With the several generics launching in the US over the past six months and the impact on net selling price, can you talk about how we should think about US net price in the back half relative to what we saw in the second quarter? And then for Europe, can you speak a little bit more to which country is contributing most to quarterly sequential growth? And also just tell us how much the supply shipments to the partners in Greece and Israel contributed in the quarter. Thank you.

Jessica Macomber Fye: With the several generics launching in the U.S. over the past six months and the impact on net selling price, can you talk about how we should think about U.S. net price in the back half relative to what we saw in the second quarter?

Speaker Change: And then for Europe , can you speak a little bit more to which country is contributing most to quarterly sequential growth? And also just tell us how much the supply shipments to the partners in Greece and Israel contributed in the quarter. Thank you.

Tom Reilly: Sure. Thank you for the questions. Nice to hear from you.

Speaker Change: You're.

Tom Reilly: I'll comment on the market dynamics of the US. And Tom, we want to comment on the impact on net selling price. There were three additional generics that entered the market in Q2. What we haven't seen is consistent. We monitor very carefully the pricing, the net cost, the discount that the generics are giving, and we haven't seen consistent behaviors across the genera category. Nevertheless, of course, we are getting more pressure because we've said for years now that it's a very dynamic market, increasing the genera size market, and it's requiring us to, as we compete on price, to dig deeper on the rebate side.

Speaker Change: Thank you for the questions and nice to hear from you.

Speaker Change: I'll comment on the market dynamics in the U.S. and Tom may want to comment on the impact on net selling price.

Speaker Change: There were three additional generics that entered the market in Q2.

Tom: What we haven't seen is a consistent

Tom: We monitor very carefully the pricing, the net cost.

Tom: The discount that the generics are giving and we haven't seen consistent behaviors across the generic category.

Tom: as the capito price to to dig deeper on the rebate side.

Tom Reilly: Right now, we've been able to maintain our leadership position, other than the CVS commercial plan that we lost starting in Q3. So that puts pressure on us. And of course, going into 2025, we expect the rebates to go up as well and give additional pressure. Downward pressure on the state.

Tom: Right now, we've been able to maintain our leadership position other than the CBS commercial.

Tom: [inaudible]

Tom Reilly: Tom, I don't know if you want to add any additional color specifics. Let's see. Yeah, sure, Jess. Related to the second half of the year, we expect to see continued price decline in the second half of the year related to pricing. And specifically related to MIX, as we lost the commercial plan, our volume would be heavier in Medicare Part D. We expect to see high single digit price decline versus what we saw in the first half. So continuous price decline.

Thomas Charles Reilly: Related to the second half of the year. We expect to see continued price declines in the second half of the year related to pricing, and specifically related to mix as we lose the key commercial plan. Our volume would be heavier in Medicare Part D. We expect to see high single-digit price declines versus what we saw in the first half, so continuous price decline. And then, Jess, I think your second question was related to the supply shipments related to Greece and Israel. We don't give revenue by country.

Speaker Change: Transcribed by https://otter.ai

Speaker Change: Yes, sure, Jess. Related to the second half of the year...

Speaker Change: We expect to see continued price declines in the second half of the year related to pricing.

Tom Reilly: And then, Jess, I think your second question was related to the supply shipments related to Greece and the Greece and Israel. We don't give country-by-country revenue, but I can say about 15 to 20 percent of our total revenue in Europe was related to the supply shipments, to those particular countries, which we're very excited about, the partners in place and ready to expand in the market in Greece and Israel. On the EU5, the two countries that we've launched out of the EU5, UK and Spain, we're seeing more growth; we have a long way to go. We've just started in Spain, but are very encouraged.

Speaker Change: The Greece and Israel.

Thomas Charles Reilly: What I can say is that about 15 to 20% of our total revenue in Europe was related to the supply ship, to those particular countries, which we're very excited about. We have partners in place and ready to expand in the market in Greece and Israel. Just to the question you raised about the countries, as Tom said, we don't give specific numbers for each of the countries, but what we could say, as we've said, is that the UK and Spain are seeing more growth. We have a long way to go. We've just started in Spain, but we are very encouraged.

Speaker Change: We don't give country-by-country revenue.

Speaker Change: What I can say about 15-20% of our total revenue in Europe was related to the supply shipments.

Speaker Change: to those particular countries which we're very excited about. We have partners in place and ready to expand in the market in Greece and Israel.

Speaker Change: Just to the question you raised about the countries, as Tom said, we don't give specific numbers for each of the countries, but what we could say, as we've said, is UK, the focus is on the EU5, the two countries

Speaker Change: that we've launched out of the EU5, UK and Spain.

Aaron Burr: We announced Portugal, which will complement what we're seeing in Iberia. And then UK; the changes we've made, the way the team is executing, we expect growth as well. We know both markets have significant potential. And are there other countries we should anticipate seeing reimbursement come online in 2020? Well, our hope is that we're working closely with the authorities in Italy, and we're hopeful that we can find that win-win with the reimbursement authorities. And if so, then our hope would be that by the end of the year, we'd see that in Italy.

Speaker Change: We have a long way to go. We've just started in Spain, but are very encouraged. We announced Portugal, which will complement what we're seeing in Iberia. And then UK, the changes we've made, the way the team is executing, we expect growth as well. We know both markets have significant potential.

Tom Reilly: We announced Portugal, which will complement; we're seeing in Iberia, and then UK. The changes we've made, the way the team is executing, we expect growth as well. We know both markets have significant potential.

Tom Reilly: Great, and are there other countries we should anticipate seeing reimbursement come online in 2024?

Speaker Change: Great, and are there other countries we should anticipate seeing reimbursement come online in 2024?

Tom Reilly: Well, our hope is we're working closely with the authorities in Italy, and we're hopeful that we can find that win and win with the reimbursement authorities, and our hope would be by the end of the year. We see that in Italy.

Speaker Change: Well, our hope is we're.

Speaker Change: We're working closely with the authorities in Italy.

Speaker Change: And we're hopeful that we can find that win-win with the reimbursement authorities. And if so, then our hope would be by the end of the year, we'd see that in Italy.

Aaron Burr: France, we have, we're at the stage where Respect EPA should be very helpful in bolstering our clinical dossier, and that'll allow us to ramp up the reimbursement discussions there as well. But we don't expect that in twenty, twenty four.

Tom Reilly: France, we have, we're at the stage where respect EPA should be very helpful, and bolstering our critical dossier, and that will allow us to ramp up the reimbursement discussions there as well, but we don't expect that in 2024.

Speaker Change: France, we have, we're at the stage where Respect EPA should be very helpful in bolstering our clinical dossier and that'll allow us to ramp up the reimbursement discussions there as well, but we don't expect that in 2024.

Jessica Macomber Fye: Thank you. Thank you. The next question for today is from Paul Choi with Goldman Sachs. Hi. Good morning, Aaron. Good morning, Tom.

Speaker Change: Thank you.

Paul Choi: The next question for today is from Paul Choi with Goldman Sachs. Hi. Good morning, Aaron. Good morning, Tom. Thank you for taking our questions. My first question relates to China, and can you maybe comment on when your partner there expects potential inclusion in our DL? Would it be permissible for 2025, or should we anticipate 2026?

Speaker Change: The next question for today is from Paul Choi with Goldman Sachs.

Paul Choi: Thank you for taking our questions. My first question relates to China. Can you maybe comment on when your partner there expects potential inclusion in the NRDL? Would it be permissible for 2025, or should we anticipate 2026? My second question is, this quarter you benefited from the one-time milestone for the CV risk reduction, which allowed you guys to be operating break-even, but without that, I think you would have been at a loss. So, my question there is...

Paul Choi: Hi, good morning, Aaron. Good morning, Tom. Thank you for taking our questions. My first question relates to China. Can you maybe comment on when your partner there expects potential inclusion into NRDL? Would it be permissible for 2025 or should we anticipate 2026?

Paul Choi: My second question is this quarter, you benefited from the one-time milestone for the CV risk reduction, which let you guys be operating break even, but without that, I think you would have been at a loss. So, my question there is given that one-time milestone as well as the formulary loss with regard to CVS Anthem. Can you maybe just comment on what is the up-ex flexibility there, and is the aim to remain break even from an enterprise perspective, or will we continue to spend in the back half of the year supporting the XUS launch?

Speaker Change: My second question is, this quarter you benefited from the one-time milestone for the CV risk reduction, which let you guys be operating break-even, but without that, I think you would have been at a loss. So, my question there is,

Paul Choi: Given that one-time milestone, as well as the formulary loss with regard to CVS Anthem, can you maybe just comment on what the OPEX flexibility there is, and is the aim to remain break-even from an enterprise perspective, or will you continue to spend in the back half of the year supporting the XUS launch? Thank you.

Speaker Change: Given that one-time milestone.

Speaker Change: as well as the formulary loss with regard to CVS Anthem. Can you maybe just comment on what is the OPEX flexibility there, and is the aim to remain break-even from an enterprise perspective, or will you continue to spend in the back half of the year supporting the XUS launch? Thank you.

Paul Choi: Thank you.

Paul Choi: Thanks, Paul.

Aaron Berg: So, regarding NRDL, because of when the Quality Vest of Risk Reduction Dedication was granted, which was before the end of June, it's very possible that that SEPA is only NRDL for January 1st, 2025. There are a number of steps that we need to go through, adding needs to go through, but that would be hopeful, and of course that would be us. Significant.

Aaron Burr: So regarding NRDL. Because of when the cardiovascular risk reduction dedication was granted, which was before the end of June, it's very possible that SEPA is on the NRDL for January 1st, 2025. There are a number of steps that we need to go through, Eddie needs to go through, but that would be hopeful. And, of course, that would be a SEPA.

Speaker Change: Thanks, Paul.

Speaker Change: So, regarding NRDL,

Speaker Change: Because of when the cardiovascular risk reduction education was granted, which was before the end of June , it's very possible that SEPA is on the NRDL for January 1st, 2025. There are a number of steps that we need to go through, that Edding needs to go through.

Tom Reilly: Tom, do you want to comment on the milestone and op-x? Sure, extra question, Paul, could they hear from you and correct your correct? We benefited from a 15 million milestone received from adding the cardiovascular risk reduction, and with that, we also had a change in accounting estimate related to $4 million of deferred revenue that we recognize in the quarter as well from revenue recognition.

Thomas Charles Reilly: Tom, do you want to comment on the milestone in OPEX? Sure. Thanks for the question, Paul. Good to hear from you. And you're correct, we benefited from a $15 million milestone received from adding the cardiovascular risk reduction. And with that, we also had a change in accounting estimate related to $4 million of deferred revenue that we recognized in the quarter as well as revenue recognition. So, your math is correct.

Speaker Change: But that would, that would be hopeful and of course that would be significant.

Speaker Change: Tom, do you want to comment on the milestone in OPEX?

Tom: Sure. Thanks for your question, Paul. Good to hear from you.

Tom: And you're correct, we benefited from a $15 million

Tom: milestone received from adding the cardiovascular risk reduction and with that we also had a change in accounting estimate related to four million dollars of deferred revenue that we recognized in the quarter as well from revenue recognition so

Tom Reilly: So, your math is correct. Related to our plans, our plans are to continue to invest in expanding into Europe with the levels, and depending on pricing and reimbursement decisions that are upcoming, we do expect a slight decline in cash for the next couple of quarters, given the fact that we continue to invest into Europe at this point in time. You probably saw from our announcement, we have been very prudent on cash; we maintain cash over the last eight quarters. We have looked at our operating expense base; we reduced 50 million annually on an annualized basis.

Thomas Charles Reilly: Related to our plans, our plans are to continue to invest in expanding into Europe, right at the current levels and depending on pricing and reimbursement decisions that are upcoming. Then we do expect a slight decline or a declining cash for the next couple quarters, right, given the fact that we'll continue to invest in Europe at this point in time. We've reduced $50 million annually on an annualized basis. So we're going to continue to monitor our operating expenses and to invest prudently, but we do expect somewhat of a decline for the remainder of the year. Roanna, if you're on mute, please unmute it.

Speaker Change: Your math is correct. Related to our plans, our plans are to continue to invest in expanding into Europe , right, with the current, with the levels and depending on pricing and reimbursement decisions that are upcoming.

Speaker Change: We do expect a slight decline in cash for the next couple of quarters, given the fact that we continue to invest into Europe at this point in time.

Speaker Change: You probably saw from our announcement, we have been very prudent on cash. We've maintained cash over the last eight quarters.

Speaker Change: We have looked at our operating expense base. We've reduced $50 million annually on an annualized basis. So we're going to continue to monitor our operating expenses and to invest prudently. But we do expect somewhat of a decline in the remainder of the year.

Tom Reilly: So, we're going to continue to monitor our operating expenses and to invest brilliantly, but we do expect somewhat of a decline in the year.

Paul Choi: Okay, got it. Thank you very much.

Speaker Change: Okay, got it. Thank you very much.

Roanna Ruiz: Your next question is from Rwana Ruiz with Lering. Rwana, your line is live. Rwana, if you're on mute, please unmute it. We're unable to hear you.

Speaker Change: Your next question is from Roanna Ruiz with LARINC.

Speaker Change: Roanna, your line is live.

Speaker Change: Roanna, if you're on mute, please unmute it.

Roanna Ruiz: Hi, Aaron. Sorry, this is Mayzion for Rwana Ruiz. Thanks for taking the question. Given the recent approval of the cardiovascular risk reduction indication for Perseppo by the NMPA in China, could you please elaborate on what you think that market opportunity looks like in China, and kind of just what are the exact next steps that adding would need to take to launch commercially? So, well, they've already launched. First of all, the opportunity for cardiovascular risk reduction is around 300 million for the total market, in terms of the SEPA numbers. In terms of which, what the size of the population that meets the label criteria, I'm not sure of hand, but certainly, of course, a subset of that deals to say it's a very large market.

Aaron Burr: Hi Aaron. Sorry, this is Maisy on behalf of Roanna Ruiz. Thanks for taking the question. Given the recent approval of the cardiovascular risk reduction indication for Vercepa by the NMPA in China, could you please elaborate on what you think that market opportunity looks like in China and kind of just what are the exact next steps that Edding would need to take to launch commercially? So, uh, well, they've already launched. First of all, the opportunity for cardiovascular risk reduction is, uh, around $300 million for the total market.

Speaker Change: We're unable to hear you.

Maisy: Hi Aaron, sorry this is Maisy on for Roanna Ruiz. Thanks for taking the question.

Speaker Change: Given the recent approval of the Cardiovascular Risk Reduction Indication for Vercepa by the NMPA in China, could you please elaborate on what you think that market opportunity looks like in China and kind of just what are the exact next steps that Edding would need to take to launch commercially?

Speaker Change: So, well, they've already launched, first of all, the opportunity for cardiovascular risk reduction is

Aaron Burr: In terms of the SIPA numbers, in terms of the size of the population that meets the label criteria, I'm not sure offhand, but certainly, of course, a subset of that is to say it's a very large market.

Speaker Change: Around $300 million for the total market in terms of the SIPA numbers.

Speaker Change: In terms of what the size of the population that meets the label criteria, I'm not sure offhand, but certainly, of course, a subset of that is to say it's a very large market.

Aaron Berg: Adding has already launched with the very high triglyceride indication, but what they'll be able to do is, so they have about 100 reps, they'll focus on about 300 hospitals, and then once it's on NRGL, then they'll see how the progress is and make decisions, proven decisions, as to how they can expand. Again, hopefully, NRGL is January 1st, and even between now and January 1st, because of the cardiovascular risk reduction indication, perhaps they'll see the trajectory ramp up as we did in the US, and they'll be able to make decisions on expansion even prior to NRGL, but I'll leave it to them.

Aaron Burr: Edding has already launched with a very high triglyceride indication, but what they'll be able to do is, so they have about 100 reps, they'll focus on about 300 hospitals. And then once it's on NRDL, then they'll see how the progress is and make decisions, prudent decisions as to how they can expand. And, you know, again, hopefully, NRDL will be January 1st, and even between now and January 1st, because of the Cardiovascular Risk Reduction Indication, perhaps they'll see the trajectory ramp up as we did in the U.S., and they'll be able to make decisions on expansion even prior to NRDL, but I'll leave it to them. They're closer to the market. Tom, do you wanna? I know you're close to it as well.

Speaker Change: Edding has already launched with a very high travisor ride indication.

Speaker Change: But what they'll be able to do is, so they have about a hundred reps, they'll focus on about 300 hospitals. And then once it's on NRDL, then they'll see how the progress is and make decisions, prudent decisions, as to how they can expand.

Speaker Change: And, you know, again, hopefully NRDL is January 1st.

Tom Reilly: They're closer to the market, Tom. If you want to find that you're close to them as well. I just like that to the RN, so as you mentioned, the population of 300 million eligible. patients under the label. In addition, just keep in mind the economics in China with our partner, tiered royalty structure, no cost infrastructure that we have, and then subject to Dale's milestones. We're very excited about the overall opportunity, economics in favor, and, as Aaron mentioned earlier, with our partner, and we have a very good partner in China to support us. And just for all of our partners, now that we have a number of partners, we work very closely with them to help them succeed.

Thomas Charles Reilly: Yeah, no, I'd just like to add to that, Aaron. So, as you mentioned, a population of 300 million eligible patients. Under the label.

Thomas Charles Reilly: In addition, just keep in mind the economics of our partnership with China with our partner, the tiered royalty structure, the no cost infrastructure that we have, and then subject to sales milestones. We're very excited about the overall opportunity, the economics are in favor. And as Aaron mentioned earlier, with our partner, we have a very good partner in China to support. And just for all of our partners, now that we have a number of partners, we work very closely with them to help them succeed.

Thomas Charles Reilly: We have a wealth of experience over a decade commercializing it, not to mention all the other regulatory and clinical and medical affairs sides, everything that we can share with them, we work closely to help them succeed. And we look forward to a number of them. But, of course, given the size of China, that's significant.

Aaron Berg: We have a wealth of experience over a decade commercializing it, and not to mention all the other regulatory and clinical and medical affairs side. Everything that we can share with them, we work closely to help them succeed, and we look forward to a number of them. But of course, given the size of China, that's significant, and we are more excited about that. Great, great. Thanks.

Aaron Burr: We're excited about that. So, we've been very judicious about first it comes down to the reimbursement side and the patient criteria, and then the analytics around who we target. So we're starting, as I mentioned in the earlier portion, with a pair of comments. We're focused on, there's a big focus on ACS patients. That's a patient population that is readily identifiable. They clearly have unmet needs. They see their physicians more often. They're more inclined to get combination therapy, more inclined to need combination therapy beyond just standard of care.

Speaker Change: Great Great I think just one follow up then is how can we also think about the sales force increase in like regional personnel as you guys start to ramp up more in the European markets.

Aaron Berg: There's one follow-up then: how should we also think about the sales force increase, and like regional personnel as you guys start to ramp up more in the European market? So we've been very judicious about first that comes down to the reimbursement side in the patient criteria, and then the analytics around who we target. So we're starting, as I mentioned in the earlier portion of the prayer comments, we're focused on, there's a big focus on the ACS patients. That's a patient population that are readily identifiable; they clearly have unmet need, they see the physicians more often, they're more inclined to get combination therapy, more inclined to need combination therapy beyond just standard of care.

Speaker Change: So.

Speaker Change: We've been very judicious about.

Speaker Change: First it comes down to the reimbursement side and the patient criteria and then the analytics around Hulu.

Speaker Change: Who we target so we're starting as I mentioned in the in the earlier portion of the prepared comments.

Speaker Change: We're focused on there is a big focus on the ACS patients. That's a patient population that are readily identifiable they clearly have unmet need they see the physicians more often.

Speaker Change: More inclined to get combination therapy.

Speaker Change: More inclined to need combination therapy beyond just standard of care.

Aaron Berg: So it's a real opportunity, and it also allows us to focus on cardiologists or specialists, depending on the market. So, based on when we launch each of the markets, it depends on how we get started and then expand from there. So there are a lot of variables; every country is different, but we'll get started with a more specialty approach. We're doing that, for example, in Spain, in the UK. We're very efficient in our focus. Once we get a foothold, those patients tend to go back to the GP audiences, and then that'll be time for us to expand.

Aaron Burr: So it's a real opportunity, and it also allows us to focus on cardiologists or specialists, depending on the market. So, based on when we launch in each of the markets, it depends on how we get started and then expand from there. So there are a lot of variables. Every country is different, but we'll get started with a more specialized approach. We're doing that, for example, in Spain and the UK.

Speaker Change: So it's a real opportunity and it also allows us to focus on cardiologists or specialists, depending on the market.

Speaker Change: So.

Aaron Burr: We're very efficient in our focus. Once we get a foothold, those patients tend to go back to their GPs, and then that'll be time for us to expand. So that's how we think about it. As a smaller company, we try to be very prudent about our investment and get traction first. But it's a balance with getting the opportunity and accelerated lift as soon as we have the opportunity to launch.

Aaron Berg: So that's how we think about it as a smaller company. We try to be very prudent about our investment and get traction first, but it's a balance with getting the opportunity and accelerating lift as soon as we have the opportunity to launch. So I hope that makes sense. Yeah, now that's that clearly answered the question.

Aaron Burr: I hope that makes sense. Yeah, no, that that clearly answers the question. Thank you for your time. Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone. We have reached the end of the question and answer session, and I will now turn the call over to Aaron for closing. Thank you, Holly. I appreciate it. And thanks to everybody for your continued interest in Amarin. We greatly appreciate it. Thank you for your questions. Thanks for taking the time today. We hope it was helpful, and I hope everyone has a good day. Thank you. This concludes today's program.

Unknown Executive: Thank you for your time.

Unknown Executive: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad.

Unknown Executive: We have reached the end of the question-and-answer session, and I will now turn the call over to Aaron for close. Thank you, Holly. Appreciate it. And thanks to everybody for your continued interest in Amarin. We greatly appreciate it. Thank you for your questions. Thanks for taking the time today. We hope it was helpful, and everyone has a good day. Thank you.

Speaker Change: This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.