Q4 2023 Amarin Corp PLC Earnings Call

Mark Mermin: Welcome to Amarin Corporation's conference call to discuss its fourth quarter and full year 2023 financial results in business. I would now like to turn the conference call over to Mark Mermin, Vice President of Corporate Communications at AMR. Good morning, everyone, and thank you for joining us.

Welcome to Amarin Corporation's conference call to discuss its fourth quarter and full year 2023 financial results and business updates I would now like to turn the conference call over to Mark Murmur, Vice President corporate communications at Amarin.

Mark Murmur: Good morning, everyone and thank you for joining us turning to our forward looking statements. 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 of our plan.

Unnamed Speaker: Turning to our forward-looking state. 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. The 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 Murmur: 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 our forward looking statements do not reflect the potential impact.

Unnamed Speaker: Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint vendors, 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 31, 2023, 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. An archive of this call will be posted on Amarin's website in the investor relations section. Turning to today's agenda, Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of 2023 highlights and 2024 priorities, and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our fourth quarter and full year 2023 financial results. Following prepared remarks, we will open the call to your questions. I will now turn the call over to Patrick Holt, President and Chief Executive Officer of Amarin. Thank you, Mark. Good morning, everyone, and thank you for joining us today.

Mark Murmur: A 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.

Mark Murmur: 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 31, 2023, which was which has been filed with the SEC and is available through the Investor Relations section of our website.

Mark Murmur: At Www Dot Ameren Corp.

We encourage everyone to read these documents an archive of this call will be posted on <unk> website in the Investor Relations section.

Mark Murmur: Turning to today's agenda, Patrick Cole Ameren as President and Chief Executive Officer will provide a brief overview of 2023 highlights in 2024 priorities and Tom Reilly average Chief Financial Officer will provide a review of our fourth quarter and full year 2023 financial results following prepared remarks.

Speaker Change: We will open the call to your questions I.

Patrick Holt: I will now turn the call over to Patrick <unk>, President and Chief Executive Officer, Robert half.

Patrick Holt: Thank you Mark good morning, everyone and thank you for joining us today.

Patrick Holt: Before we review our 2023 highlights and our 2024 priorities, I want to take a moment to reflect on our strategy. Every day, our team is focused on driving operational momentum to maximize patient uptake. To enhance the value of Amarin and deliver shareholder value, we must drive operational momentum across our three key regions. In Europe, where we have a potential IP runway out to 2039, we are focusing efforts and investment to accelerate prescription growth and revenue as well as secure pricing and reimbursement in those key markets. In the U.S., we're maintaining and extending our IP market leadership, and in the rest of the world, we're enabling our partners to get our product into the hands of as many patients as possible. We firmly believe this focus on operator momentum is the best path forward for Amarin and will more strongly position us for potential future operations. Turning to slide six.

Patrick Holt: Before I review, our 2023 highlights and our 2020 full priority I want to take a moment to reflect on our strategy to that route every day. Our team is focused on driving operational momentum to maximize patient uptake of the state.

Patrick Holt: Uh huh.

To enhance the value of amarin and deliver shareholder value, we must drive operational momentum across our three key regions in Europe, where we have potential IP runway out to 2039, we are focusing efforts and investments to accelerate prescription growth and revenue as well as secure pricing.

Patrick Holt: Reimbursement in those key markets in.

Patrick Holt: In the U S. We are maintaining and extending our market leadership and in the rest of world, We're enabling our partners to get our product into the hands of as many patients as possible.

Patrick Holt: We firmly believe this focus on operating momentum is the best path forward for Ameren, and we're more strongly position us for potential future options.

Patrick Holt: Turning to slide six.

Patrick Holt: While we believe this strategy is the best way to deliver shareholder value today, the only way to gain shareholder confidence is to deliver again. We have made meaningful progress in 2023, and we have clear priorities in place for 2021. For Europe in 2023, with new leadership and a more focused strategy in place, our teams made launch progress and have advanced pricing and reimbursement. In Spain, our team is focusing on healthcare practitioners who are early adopters of cardiovascular products.

Patrick Holt: While we believe this strategy is the best way to deliver shareholder value today, the only way to gain shareholder confidence it deliver against it.

Patrick Holt: We have made meaningful progress in 2023, and we have clear priorities in place for 2024.

For Europe in 2023, with new leadership and a more focused strategy in place our teams made launch progress and have advanced pricing and reimbursement goals.

Patrick Holt: In Spain, our team is focusing on health care practitioners, who are early adopters of cardiovascular products. We are continuing to deliver strong launch progress such that we now have approximately 2500 patients on therapy.

Patrick Holt: We are continuing to deliver strong launch progress such that we now have approximately 2,500 patients on therapy. In the United Kingdom, we have a more focused strategy in place, including driving uptake in key accounts. Currently, we have at least 1,500 patients.

Patrick Holt: In the United Kingdom, we have a more focused strategy in place, including driving uptake in key accounts currently.

Patrick Holt: We have at least 1500 patients on therapy.

Patrick Holt: Turning to pricing and reimbursement, we've secured pricing and reimbursement across nine countries in Europe. As I have shared previously, we have strengthened our focus to advance our opportunities in key EU five areas. I'm pleased to share that in Italy, we have now resubmitted our dossier and will advance this process with the authorities to potentially achieve market access for Basquefa by the end of 2021. In France and Germany, we are sharpening our scientific arguments and have strategies and plans in place to advance the missions for VEFGEPA in these markets. We do not expect these processes to conclude in 2020.

Patrick Holt: Turning to pricing and reimbursement, we've secured pricing and reimbursement across nine countries in Europe.

Patrick Holt: I have said previously we have strengthened our purpose to advance our opportunities in key EU five market.

Patrick Holt: I'm pleased to share in Italy, we have now resubmitted dossier, and we will advance this process with the authorities.

Patrick Holt: Potentially achieved market access for <unk> by the end of 2024.

Patrick Holt: In France, and Germany, we are sharpening, our scientific arguments and have strategies and plans in place to advanced submissions for Vascepa in these markets. We do not expect these processes to conclude in 2024.

Patrick Holt: We will continue to communicate progress on France and Germany as additional steps are adopted. Importantly, we are also aiming to successfully conclude pricing reimbursement decisions in at least five additional markets. We remain confident in our path forward in Europe.

Patrick Holt: We will continue to communicate progress on France, and Germany as additional steps are achieved.

Patrick Holt: Importantly, we are also aiming to successfully conclude pricing and reimbursement decisions in at least five additional markets in 2024.

We remain confident in our path forward in Europe, we have patents and applications that have the potential to extend our IP up to 2039.

Patrick Holt: We have patents and applications that have the potential to extend our IP up to 2030. As a testament to this progress, we successfully defended our 2033 patent from opposition. We expect to share more on this topic in the coming months. Turning to the United States, in 2023, we continued to extend our IP market leadership, closing the year with a 57% mark.

Patrick Holt: As a testament of this progress we successfully defended it out 2033 patent from opposition.

Patrick Holt: We expect to share more on this topic in the coming months.

Patrick Holt: Turning to the United States in 2023, we continue to extend IP market latest ship closing the year with a 50, 57% market share.

Patrick Holt: We achieved this through focused investment in managed care, trade, and medical capabilities to extend the SEPA's lifecycle despite the elimination of our sales force and reduced marketing spend in July. As we turn to 2024, we have begun the year in a slightly improved position compared to last year. Based on what we currently know with our exclusive accounts, these represent at least 50% of the total I.P.

Patrick Holt: We achieved this through focused investment in managed care and trade and medical capabilities to extend the <unk> lifecycle. Despite the elimination of our salesforce and reduced marketing spend in July.

Patrick Holt: As we turn to 2024.

Patrick Holt: We have begun the year in a slightly improved position compared to last year based on what we currently know with our exclusive accounts. These represent at least 50% of the total IP market volume.

Patrick Holt: market share. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic, and we continue to monitor this closely. We do expect Q1 2024 results to be impacted by typical first quarter payor dynamics. We continue to stand ready to execute aggressive approaches, including the potential future launch of an authorized generic bolstered by our strong supply position to retain market leadership within the IP. In the rest of the world, in 2023, we made progress on regulatory, market access, and commercial fronts, as well as new partners. In China, the second largest cardiovascular market globally, Amarin's partner, Edding, launched FIPA in October for the very high triglyceride index.

Patrick Holt: While we are encouraged to start the year in a solid managed care position the market remains highly dynamic and we continue to monitor this closely.

Patrick Holt: We do expect Q1 2024 results to be impacted by typical first quarter payer dynamics.

Patrick Holt: We continue to stand ready to execute an aggressive approaches, including the potential future launch of an authorized generic bolstered by a strong supply position to retain market leadership.

Patrick Holt: Within the IP market.

Patrick Holt: In the rest of World in 2023, we made progress on regulatory market access and commercial fronts as well as new partnerships.

Patrick Holt: In China, the second largest cardiovascular market globally amarin its partner, adding launched Vascepa in October for the very high triglyceride indication.

Patrick Holt: Additionally, the NMPA has accepted the regulatory filing for the Cardiovascular Risk Reduction Indication, which opens up the potential for future national reimbursement and drug listing. In 2023, Amarin also entered into three new partnerships across 15 countries. In 2024, our focus for the rest of the world shifts toward enabling our partners to obtain market access and commercial uptake across key markets. Finally, in research and development and medical, our teams delivered important progress with data publications and medical education, supporting our brand globally to build confidence in our science. In 2024, we will continue to build on this momentum, including additional data on reduces and EPA. Indeed, we have seven abstracts for the upcoming American College of Cardiology meeting in April.

Patrick Holt: Additionally, the NPA has accepted the regulatory filings for the cardiovascular risk reduction indication, which opens up the potential for.

Patrick Holt: Our future national reimbursement drug list it.

In 2023, Ameren also entered into three new partnerships across 15 countries.

Patrick Holt: In 2024th our focus for rest of world shift towards enabling our partners to obtain market access and commercial uptake across key markets.

Patrick Holt: Finally in research and development and medical our teams delivered important progress with data publications and medical education supporting our brand globally to build confidence in our science.

Patrick Holt: In 2024, we will continue to build on this momentum, including additional data on reduce it and the EPA.

Patrick Holt: And Dave we have seven abstracts at the upcoming American College of Cardiology meeting in April, we'll be sharing more or less in coming weeks.

Patrick Holt: We'll be sharing more on this in coming... This important operational progress has supported our financial position, with $321 million in cash and no debt. As you are aware, due to our recent progress in our financial position, we announced plans for a share repurchase program of up to $50 million. I'm pleased to share that we are on track to complete the necessary shareholder and UK High Court approvals.

Patrick Holt: This important operational progress has supported our financial position.

With $321 million in cash and no debt.

Patrick Holt: As Youre aware <unk> recent progress and our financial position, we announced plans for a share repurchase program of up to $50 million.

Patrick Holt: I'm pleased to share that we are on track to complete the necessary shareholder and UK High Court approvals. We continue to anticipate completing the steps in the second quarter of 2024 and that share repurchases would commence shortly thereafter.

Thomas Charles Reilly: We continue to anticipate completing these steps in the second quarter of 2024 and that share repurchases would commence shortly thereafter. In summary, 2023 was a meaningful year for Operation Momentum, and we are well positioned to continue to build on this in 2024. Now I'd like to hand over the call to Tom Reilly, who will review our fourth quarter and year-end 2023 financial performance. Thank you, Pat. Good morning, everyone.

Patrick Holt: In summary, 2023 was a meaningful year for operational momentum and we are well positioned to continue to build on this in 2024.

Patrick Holt: Now I'd like to hand over the call to Tom Reilly.

Thomas Charles Reilly: Our fourth quarter and year end 2023 financial performance Tom.

Thomas Charles Reilly: Thank you Pat.

Thomas Charles Reilly: Morning, everyone.

Thomas Charles Reilly: I'm pleased to report details on our financial performance for the fourth quarter of 2023. In the fourth quarter of 2023, Amarin reported total net revenue of $74.7 million, including net product revenue of $70.6 million, versus $66.1 million in the third quarter of 2023 and $4.2 million in licensing and royalty revenue. U.S. product revenue was $64.9 million, with stable performance in the U.S. despite multiple competing generics on the market. The U.S. business continues to provide profits, supporting our expansion into Europe. The revenue results include European product revenue of 1.5 million, a 65% increase versus the third quarter of 2023. Reflecting Early Revenues from European Markets, including Spain and the United Kingdom We recognized $8.4 million in revenue from the rest of the world in the fourth quarter of 2023, including product revenue of $4.2 million related to commercial sales to our partners in Canada, China, and the Middle East, and licensing and royalty revenue of $4.2 million, resulting primarily from the achievement of the Edding CVRR model. Cost of goods sold in the fourth quarter of 2023 were $29.6 million compared to $23.6 million, excluding restructuring in the third quarter of 2025.

Thomas Charles Reilly: I am pleased to report details on our financial performance for the fourth quarter 2023.

In the fourth quarter of 2023, Ameren reported total net revenue of $74 7 million, including net product revenue of $70 6 million.

Thomas Charles Reilly: First is $66 1 million in the third quarter of 2023, and $4 2 million in licensing and royalty revenue.

Thomas Charles Reilly: U S product revenue was $64 9 million with stable performance in the U S. Despite multiple competing generic on the market.

Thomas Charles Reilly: The U S business continues to provide profit supporting our expansion into Europe.

Thomas Charles Reilly: The revenue results include Europe PM product revenue of $1 5, million% to 65% increase versus the third quarter of 2023.

Thomas Charles Reilly: Reflecting earlier revenues from European markets.

Thomas Charles Reilly: <unk>, Spain, and the United Kingdom.

Thomas Charles Reilly: We recognized $8 4 million in the rest of the world revenue in the fourth quarter of 2023.

Thomas Charles Reilly: Including product revenue of $4 2 million related to commercial sales to.

To our partners in Canada, China, and the Middle East and licensing and royalty revenue of $4 2 million.

<unk>, primarily from the achievement of the adding CV are milestones cost of goods sold in the fourth quarter of 2023 were $29 6 million compared to $23 6 million.

Thomas Charles Reilly: Excluding restructuring in the third quarter in 2023.

Thomas Charles Reilly: Amarin's overall gross margin on net product revenue in the fourth quarter was 58%, compared with 64% in the third quarter of 2023. This was primarily due to an increase in one supply sales to our partner at. Moving on to operating expenses, operating expenses were $49.7 million in the fourth quarter, comprised of $43.9 million in selling, general and administrative expenses and $5.8 million in research and development expenses.

Thomas Charles Reilly: <unk> overall gross margin on net product revenue in the fourth quarter was 58% compared with 64% in the third quarter 2023.

This was primarily due to an increase in one supply sales to our partner adding.

Moving on to operating expenses.

Operating expenses were $49 7 million in the fourth quarter.

Thomas Charles Reilly: Comprised of $43 9 million.

Selling and general and administrative expenses and $5 8 million in research and development expenses.

Thomas Charles Reilly: In the second half of 2023, AMRI reported operating expenses of $101.2 million. This represents a $21 million reduction in operating expenses versus the first half of 2023. We are on track to deliver the previously announced $40 million Reduction in Operating Expenses by July 2021. AMRI reported a net loss of $5.8 million for the fourth quarter of 2023, or a basic and diluted loss per share of $1.6 million.

Thomas Charles Reilly: In the second half of 2023, Ameren reported operating expenses of $101 2 million.

Thomas Charles Reilly: This represents a $21 million reduction in operating expenses versus the first half of 2023.

Thomas Charles Reilly: We are on track to deliver the previously announced $40 million reduction in operating expenses by July 2024.

Thomas Charles Reilly: Amarin reported a net loss of $5 8 million for the fourth quarter of 2023 or basic and diluted loss per share.

Thomas Charles Reilly: <unk>.

Thomas Charles Reilly: Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of December 31st, 2023, Amarin reported aggregate cash and investments of $321 million. Importantly, this is the sixth consecutive quarter of positive or neutral cash flow generation for AMR, and our cash balance is now $10 million higher when compared to December 31st, 2022. In 2023, we made progress in controlling our costs and managing our cash position through our cost reduction programs and renegotiating supply agreements. In 2024, we will continue to focus on cash preservation.

Thomas Charles Reilly: Let me now turn to our efforts and results in controlling costs and effectively managing our cash.

Thomas Charles Reilly: As of December 31, 2023, Ameren reported aggregate cash and investments of $321 million.

Thomas Charles Reilly: Importantly, this is the sixth consecutive quarter of positive.

Thomas Charles Reilly: Our neutral cash flow generation for Ameren, and our cash balance is now $10 million higher when compared to December 31 2022.

Thomas Charles Reilly: In 2023, we made progress in controlling our costs and managing our cash position through our cost reduction programs and renegotiating supply agreements.

Thomas Charles Reilly: In 2024, we will continue to focus on cash preservation.

Thomas Charles Reilly: Prudently invest in the right opportunities, particularly in Europe, based on pricing reimbursement decisions. And pending shareholder and UK High Court approvals, we'll initiate our shareholder repurchase program. With that, I will now turn the call back over to Pat for closing remarks and to begin the Q&A portion of our call.

Thomas Charles Reilly: Prudently investing right opportunities, particularly in Europe based on pricing and reimbursement decisions.

Thomas Charles Reilly: Pending shareholder and UK High court approvals will initiate our shareholder repurchase program.

Thomas Charles Reilly: With that I will now turn the call back over to Pat for closing remarks and to begin the Q&A portion of our call.

Thomas Charles Reilly: Persons.

Patrick Holt: Thank you, Tom, for the financial overview of our results. Our team is focused on operating momentum to maximize shareholder value across all three areas. We believe we have the right plan, focus on operational momentum to drive shareholder value. We have a strong future because of our fundamentals. Best in Class Science Supporting the Seeper Festival, a large global opportunity to impact cardiovascular patients, a team that is dedicated to delivering results, and a strong balance.

Pat: Thank you Tom for the financial overview of our results.

Pat: Our team is focused and operating momentum to maximize shareholder value across all three areas of our business.

We believe we have the right plan focused on operational momentum to drive shareholder value, we have a strong future because of our fundamentals best.

Pat: Best in class signs supporting Vascepa best get book.

Pat: Large global opportunity to impact cardiovascular patients a team that is dedicated to delivering results and a strong balance sheet.

Patrick Holt: Finally, thank you to our colleagues for their commitment and dedication. I look forward to driving shareholder value. And with that, Mark, let's begin the Q&A portion of the call. Thank you, Pat.

Pat: Finally, thank you to our colleagues for their commitment and dedication I look forward to driving shareholder value together.

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

Mark Murmur: Thank you Pat as we announced last year to enhance engagement with the Companys shareholder base and facilitate connections with its investors Amarin is partnering with <unk> technologies to allow retail and institutional shareholders submit questions a selection of which will be answered by Ameren management during today's earnings call.

Unnamed Speaker: As we announced last year, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin is partnering 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. Let's begin the Q&A. So Pat, we've received a number of questions on the company's long-term strategy and the ways that we plan to maximize shareholder value. What would you say to these investors? Thanks for the question. I get this question a lot.

Mark Murmur: Let's begin the Q&A.

Mark Murmur: So Pat we've received a number of questions on the company's long term strategy in ways that we plan to maximize shareholder value.

Mark Murmur: Would you say to these investors thanks.

Pat: Thanks for the question I get this question a lot and it's really important question and we believe the best path forward for us to both increase our value and put us in the best possible place for future strategic options is today to focus on our current efforts around operational momentum whether that'd be in Europe in the U S or in.

Patrick Holt: It's a really important question, and we believe the best path forward for us to both increase our value and put us in the best possible place for future strategic options is today to focus on our current efforts around operations, whether that be in Europe, in the U.S., or in the rest of the world. As we shared earlier in the call, we really are making progress on all three fronts, which gives us greater. Optimism and Optionality Great, thanks.

Pat: The rest of world.

Pat: As we shared earlier in the call, we really are making progress on all three fronts, which provides us greater.

Pat: Optimism and Optionality for the future.

Speaker Change: Great. Thanks, Pat.

Unnamed Speaker: Our second set of questions focuses on China and Asia Pacific. What can you tell us about progress around the commercial launch in China, and what is the status of the cardiovascular risk reduction regulatory following China? Also, more broadly in Asia Pacific, can you share any updates on efforts with our partners? Well, there's a lot to that, and for some of you who know, I know this region pretty well. So let me break that down into some parts. Firstly, to China Long Island.

Speaker Change: Our second set of questions focuses on China, and Asia Pacific What can you tell us on progress around the commercial launch in China, and what is the status of the cardiovascular risk reduction in regulatory filing in China also more broadly in Asia Pacific can you share any updates on efforts with our partners.

Speaker Change: There's a lot in that and as for some of you know I know this region pretty well so let me break that down as some pops firstly to the China launch.

Patrick Holt: So Amarin's partner, Edding, is really making important progress in China, which I'll remind everybody is the second largest cardiovascular market. Edding launched the SIPA for very high triglycerides in Q4 2023. To give you a flavor, the Eding sales force is covering 200 hospitals, which includes around 500 key opinion leaders, the majority of which are cardiologists, in the three largest cities of Beijing, Shanghai, and Guangzhou.

Speaker Change: <unk> partners, adding its really making important progress in China, which I'll remind everybody is the second largest cardiovascular market globally.

Speaker Change: They have launched the safer for very high triglycerides in Q4 2023 to.

Speaker Change: To give you a flavor that adding sales forces covering 200 hospitals, which includes around 500 key opinion leaders. The majority of which are cardiologists in the three largest cities of Beijing, Shanghai and Guangzhou.

Patrick Holt: So in summary, the launch is progressing well, and the structure of the agreement provides immediate profitability. So let's move from today and also think about the future in China as we reflect upon cardiovascular risk reduction in China. The MMPA has accepted the regulatory filing for cardiovascular risk reduction, which opens up the potential for national reimbursement drug laws. The submission was accepted with a clinical trial waiver, meaning a separate clinical trial will not be required in order to be reviewed for approval.

Speaker Change: So in summary, the launch is progressing well and the structure of the agreement provides immediate profitability to amarin.

Speaker Change: So let's move from today and also think about the future in China as we reflect upon the cardiovascular risk reduction indication.

Speaker Change: And then he has accepted the regulatory filings for cardiovascular risk reduction, which opens up the potential for national reimbursement drug listing.

Speaker Change: The submission was accepted with a clinical trial waiver, meaning a separate clinical trials will not be required in order to be reviewed for approval.

Patrick Holt: The teams are now focused on advancing that submission together with the authorities, and we expect the regulatory review process to conclude in 2021. Asia-Pacific is a large region, so let me just touch on some other areas within the region. As you know, last year we entered into partnerships in Australia and New Zealand with CSL Securis, and also 11 Asian markets, including South Korea, with Lotus Pharmaceuticals. I'm pleased to share that CSL is advancing pricing and reimbursement processes in Australia with the authorities, and in other markets, our partner Lotus is advancing regulatory discussions and filings with the various authorities across the region. Great

Speaker Change: The teams and are focused on advancing that submission together with the authorities and we expect the regulatory review process to conclude in 2025.

Speaker Change: Asia Pacific the large regions, but let me just touch on some other areas within the region.

Speaker Change: As you know last year, we entered into partnerships in Australia, and New Zealand with CSL superiors.

Speaker Change: And also 11 Asian markets, including South Korea with Lotus Pharmaceuticals.

I'm pleased to share that CSL is advancing pricing and reimbursement processes in Australia with the authorities and in other markets our partner Lotus is advancing.

Speaker Change: Regulatory discussions and filings with the various authorities across the region.

Patrick Holt: Thanks, Pat, for that information on China and Asia-Pacific. Now, turning to the U.S., is there a path toward growth in the market? Could we potentially take market share from other products or classes?

Speaker Change: Great. Thanks, Pat for that information I'm trying to in Asia Pacific now turning to the U S is there a path toward growth in the market could we essentially taking market share from other products or classes.

Patrick Holt: Great question, and naturally, our US revenues and cash flows are incredibly important to us. But when we take a step back and we think about the US market and where it stands today, it's important to remember that the I.P. market in the US is highly generous.

Pat: Great question, and that's really our U S revenues and cash flows are incredibly important to our business.

Pat: When we take a step back and we think about the U S market and where it stands today, it's important to remember that the IP market in the U S is highly generic sized at this point.

Patrick Holt: Our focus has been and continues to be to maintain IP market leadership and, as a result of that, not focus on growth. We really have achieved a highly atypical performance three years post-LOE to end 2023 with a market-leading share of 57%. We've been able to secure market leadership and continue that success through our exclusive contracts, led by our capabilities in payer, managed care, and Medicare.

Pat: Our focus has been and continues to be to maintain market leadership and as a result of that not focus on growing the market.

Pat: We really haven't shaved a highly atypical performance three years post LOI to end 2023, with a market leading share of 57%.

Pat: We've been able to secure market leadership and continue that success through our exclusive contracts led by our capabilities in pay or managed care and medical areas.

Patrick Holt: Again, as we mentioned, we started 2024 in a strong position in terms of our exclusive contracts. But to remind everybody, it's a dynamic market and we do watch it very closely and continue to assess our optionality. For our branded product and beyond that, should we consider other strategies? In terms of taking share from other products or classes, given those generic dynamics, we do not view this as an optimal strategy.

Pat: Again, as we mentioned we started 2024 in a strong position in terms of our exclusive contracts.

Pat: But to remind everybody, it's a dynamic market and we do watch it very closely and continue to assess our optionality.

Pat: <unk> branded product and beyond that should we consider other strategic alternatives.

Pat: In terms of taking share from other products or classes given those generic dynamics, we do not view this as an optimal strategy.

Patrick Holt: Turning to supply, if we see demand increase from Europe or our rest of the world partners, are you confident that we can meet those supply demands? It's a very important question, and we do have strong relationships with our key supply partners. Over the last several years, we've made really important progress renegotiating our supply agreements to ensure that we can both meet our demands as well as reduce key supply commitments. We feel really confident that we can meet those supply demands. Now, one last question on the R&D side from the State Technologies questions: is Amarin working on advancing any additional indications for Visepa, or Vizcapa?

Thank you turning to supply we see demand increase from Europe or rest of World partners are you confident that we can meet those supply demands. It's a very important question and we do have strong relationships with our key supplier partners.

Pat: Over the last several years, we've made really important progress renegotiating our supply agreements to ensure that we can both may add demands as well as reduce key supply commitments, we feel really confident that we can meet our supply demand moving forward.

Now one last question on the R&D side from the CA technologies questions is I have been working on advancing any additional indications for Vascepa Vascepa I was really played this question came up at such an important question. When you think about the core strengths that Ameren has in terms of our R&D team and IP capabilities and latest ship yes.

Patrick Holt: I was really pleased this question came up, and it's such an important question when you think about the core strengths that Amarin has in terms of our R&D team and our IP capabilities. This is the team that has developed and advanced the molecule from day one and delivered the reduced data that has really had a global impact that we see. With our team in place, we do continue to look at opportunities for new indications, and we will update investors based on potential future progress of that work. So before we take additional questions, I'd like to thank those shareholders who submitted questions via the Say Technologies platform. We are committed to continuing an open and transparent dialogue with all of our shareholders.

Pat: This is the team that has developed and advanced the molecule from day, one and delivered the reduce it data is really has a global impact that we see today.

Pat: Without taking place we do continue to look at opportunities for new indications and we will update investors based on potential future progress of that work.

Speaker Change: So before we take additional questions I'd like to thank those shareholders, who submitted questions via the state technologies platform.

Speaker Change: We are committed to continuing open and transparent dialogue with all of our shareholders and assay technologies platform is one way that we are trying to increase engagement and two way dialogue with you. We look forward to continuing to hear from you in answering your questions on this platform as well as other opportunities.

Patrick Holt: The SANE Technologies platform is one way that we are trying to increase engagement and two-way dialogue with you. We look forward to continuing to hear from you and answering your questions on this platform as well as other opportunities moving forward. Thank you for those updates, Pat. We'll 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. A confirmation tone will indicate your line is busy. You may press star 2 if you would like to remove your question from... For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.

Speaker Change: Forward.

Speaker Change: Thank you for those updates that we'll now open the Q&A up for additional questions.

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 one on your telephone keypad.

Confirmation tone will indicate your line is in the question queue. You May press star two if he 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.

Unnamed Speaker: One moment, please, while we poll for questions. Your first question for today is from Roanna Ruiz with Larrington. Hi, morning everyone.

Speaker Change: One moment, please while we poll for questions.

Speaker Change: Your first question for today is from Rowenta Ruiz with Leerink partners.

Roanna Clarissa H. Ruiz: Hi, good morning, everyone.

Roanna Clarissa H. Ruiz: So, could you talk a bit more about the ongoing generic competition in the U.S.? Like, what trends are you seeing in the field, and what do you expect in terms of possible pressure on Visipa's net price in the next couple years? Hi Roanna

Roanna Clarissa H. Ruiz: So could you talk a bit more about the ongoing generic competition in the U S. Like what trends are you seeing in the field and what do you expect in terms of possible pressure on Vascepa net price in the next couple of years.

Roanna Clarissa H. Ruiz: Hi, everyone. Good morning. Thanks, so much for the question great to hear from you.

Patrick Holt: Good morning. Thanks so much for the question. Great to hear from you. You know, as you probably have followed, there are more generics that have got regulatory approval. There are more generics that have also got prices.

Speaker Change: As you probably have followed you there are more generics that have got regulatory approval. There are more generics that have also got prices and.

Patrick Holt: And with that said, you know, what we see in terms of the market dynamics in the market so far, they remain fairly stable. So, as we mentioned, we closed the year and we started the year with a strong position with our exclusive contracts that represent greater than 50% of the IPE volume. So as we end the year and start the year, you know, we are feeling really good about that position.

Speaker Change: With that said here is what we see in terms of the market dynamics in the market. So far they remain fairly stable. So as we mentioned we closed the year and we started the year with a strong position with our exclusive contracts that represents greater than 50% of the IP volume. So as we end the year and start the year.

Speaker Change: I feel really good about that position, but as I'm sure. You've noted there is more dynamics and there are more entrants in the market. So we continue to monitor it very closely but I would say so far and we haven't seen any dynamic changes.

Patrick Holt: But, as I'm sure you've noted, there is more dynamics, and there are more entrants in the market. So we continue to monitor it very closely. But I would say so far that we haven't seen any dynamic changes from what we have seen historically. But obviously, we track it closely. And as you know, we have options in the short term as well as in the long term to maximize the economics for us in the US. Yep, makes sense. And a quick follow up on the rest of the world. I noticed it's gaining some traction. So could you talk about what regions you expect might contribute the most momentum to future growth in revenues in 2024 and beyond? Yeah, it's a great question.

Speaker Change: From what we have seen historically, obviously, we track it closely and as you know we have optionality in the short term as well as the long term to maximize the economics for us in the U S.

Speaker Change: Yes makes sense then a quick follow up on the rest of world I noticed that's gaining some traction. So could you talk about what regions do you expect might contribute the most momentum to future growth in revenues in 2024 and beyond.

Speaker Change: Yes, it's a great question as I mentioned, where we're really it's pleasing to see the progress in 2023 as you think.

Patrick Holt: As I mentioned, we're really pleased to see the progress in 2023. As you think we always do, we signed up some new countries in 2023. If you take a step back in 2023, the main revenue sources until China came on board were really coming from Canada and then parts of the Middle East and North Africa. So what we'll see in 2024 is certainly continued value coming from those existing partnerships such as what I've just mentioned. So I do expect that China will make more progress in 2024.

Speaker Change: We signed up some new new countries in 2000 registered but if you take a step back in 2023 of the main revenue sources until China came on board was really coming from Canada, and then parts of Middle East North Africa. So what we'll see in 2024 is certainly continued value coming from those existing partnerships such as <unk>.

Speaker Change: What I've just mentioned.

I do expect the charge and then we will have more and more progress in 2024, and then there is the opportunity.

Patrick Holt: And then there is the opportunity, I think, as some of these partnerships start to go from signing regulatory processes such as Lotus, market access, reimbursement, and pricing, such as CSL Securus in Australia and New Zealand. So you're starting to see a shift from entering partnerships to really driving through those pre-commercial and commercial outputs. So we're pleased that we're progressing through that life cycle of partnership and alliance management, and we see that shift in the business toward more revenue, market access, and revenue generation. And internally, that means we're beefing up our capabilities and leadership to support that growth.

Speaker Change: As some of these partnership start to go from signing through regulatory prices, such as Lotus market access reimbursement and pricing such as sea of social security in Australia, and as you'll see we're starting to see a shift from.

Speaker Change: Entering partnerships to really more driving through those pre commercial and commercial output.

Speaker Change: So we're pleased that we're progressing through that lifecycle of partnership and Alliance management, I would say and we say that shift in the business toward more.

Speaker Change: Revenue at market access and revenue generation and internally that means we're basing up our capabilities in latest shipped to support that growth.

Patrick Holt: Thanks. And that's your to add that it's really a key part of our goals and our strategy as compared to the rest of world business, and it provides immediate profitability. Administration. Administration.

Speaker Change: Got it thanks.

Speaker Change: And that's just add that it's really you know it is a key part of our goals and our strategy that rest of world business and it provides immediate profitability for us.

Speaker Change: Okay.

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

Jessica Macomber Fye: Your next question for today is from Jessica Fye with JPMorgan. Hi guys, good morning. This is Nassan on behalf of Jessica Fye.

Speaker Change: Hi, guys. Good morning. This is <unk> on for Jessica Fye I'm I have a question on your progress in.

Unnamed Speaker: I have a question on your progress in the launch of the SIPA there. Can you just talk a little bit about, you know, how to accelerate the growth in the UK? And then for Germany, you know, have you come up with a plan to re-enter the market there? And then for Italy as well?

Jessica Macomber Fye: Launching vascepa there.

Jessica Macomber Fye: Can you just talk a little bit about.

Speaker Change: About you know how to accelerate the growth in U K.

Speaker Change: And then for Germany, you know have you come up with a plan to reenter the market there.

Speaker Change: And then for Italy as Paul Thank you.

Patrick Holt: Thank you. Thanks Nasser, great to hear from you. Look, Europe is obviously critical for us.

Speaker Change: Thanks, Great.

Speaker Change: Great to hear from you.

Speaker Change: Look Europe is obviously critical for us it's a key focus of our investments in the key focus of the whole organization as we move forward. So as we break that down we think about those key launch markets and as we've previously mentioned.

Patrick Holt: It's a key focus of our investments and a key focus of the whole organization as we move forward. So as we break that down, we think about those key launch markets. And as we've previously mentioned, the UK is quite an individual market, and the uptake in the UK is typically solar.

Speaker Change: The U K.

Speaker Change: Is it is quite an individual market and the uptake in the U K is typically so we are making progress with our more focused strategy on those key accounts and as I signaled earlier, we now believe.

Patrick Holt: We are making progress with a more focused strategy on those key accounts, and as I signaled earlier, we now believe, we estimate we have at least 1,500 patients on therapy. Building on that, we did say from that moment of launch last September that we expected Spain to be a faster uptake market, and that is proving true. So we're pleased with the progress in the uptake. We're seeing Spain in Spain on a national basis.

Speaker Change: We estimate we have at least 1500 patients on therapy.

Speaker Change: Building on that we did say from from that moment of launch last September that we did expect Spain to be a fast uptake market and that is proving true. So we're pleased with the progress and the uptake we're seeing Spain in Spain on a national basis and today, we say we estimate we have around 22600 patients on therapy, which is.

Patrick Holt: And today, we estimate we have around 22,600 patients on therapy, which is important progress for us. So there are two key launch markets for us as we move into some of the reimbursement markets. We've resubmitted in Italy, building on our previous strong scientific assessment, and we do expect Italy pricing reimbursement to conclude in 2024. And then if we think about Germany, to your next question, you know, our history in Germany.

Speaker Change: As important progress for.

There are two key launch market for us as we moved into some of the reimbursement markets here, we've resubmitted <unk> building on our previous strong scientific assessment, and we do expect Italy pricing reimbursement to conclude in 2024.

Speaker Change: If we think about Jeremy to your to your next question.

Speaker Change: You know our history in Germany, So that's a topic, where we've taken a step back and we are re developing potential new strategy to enter the market. We're working with the authority to assess different ways to consider patient populations that can be relevant for Jim the German market and we're working with you authorities on those.

Patrick Holt: So that's that's a topic where we've taken a step back, and we are redeveloping a potential new strategy to enter the market. We are working with the authority to assess different ways to consider patient populations that could be relevant for the German market. And we're working with the authorities on those plans, and we will continue to advance them through 2024. But, as I mentioned, I don't expect that those processes will conclude in 2024. Thanks very much for the questions. Your next question for today is from Louise Chen with Cancer Fitzgerald. Hi team.

Speaker Change: And we continue to advance that through 2024, but as I mentioned I don't expect that those processes will conclude in 2024.

Speaker Change: Thanks very much for the question.

Speaker Change: Your next question for today is from Louise Chen with Cantor Fitzgerald.

Louise Alesandra Chen: Hi, this is Wayne on behalf of Louise, and thanks for taking our questions. So first, you have reiterated that you're on track to deliver the $40 million annual savings. And so how should we think about the operating expense for 2024? Because compared to the second quarter, you save about $7 million in the third quarter and $8 million this quarter.

Louise Alesandra Chen: Hi team this is way off or Luisa thanks for taking our questions. So first you have to reiterate that you're on track to deliver the 40 million annual savings and if so how should we think about the operating expense for 2024, because compared to the second quarter, you save about 7 million third quarter and 8 million this call.

Unnamed Speaker: So should we expect a similar number going forward? And then the gross margin has dropped to 58%. So how should we think about this going forward? Thank you. Go to Beadaholique.com for all of your beading supply needs!

Louise Alesandra Chen: So shall we expect a similar number going forward and then the.

Louise Alesandra Chen: The gross margin has dropped to 58%. So how should we think about this going forward. Thank you.

Louise Alesandra Chen: Yeah, great. Thanks. This is Tom thanks for the question.

Thomas Charles Reilly: Yeah, great. Thank you. This is Tom.

Thomas Charles Reilly: Related to the operating expense in the $40 million.

Thomas Charles Reilly: Thanks for the question. Related to the operating expense of $40 million, which we're on track to deliver and our expectation for expenses. As mentioned before, we reduced expenses from the second half to the first half of 23 by $21 million.

Thomas Charles Reilly: We are on track to deliver and we are.

Thomas Charles Reilly: Our expected expectations for expenses.

Thomas Charles Reilly: As mentioned before we reduced expenses from the second half to the first half of 2020 by $21 million, our cost basis is approximately $50 million per quarter our expectations.

Thomas Charles Reilly: Our cost basis is approximately $50 million per quarter. Our expectation is to stay within that range. Depending on pricing reimbursement decisions, we'll invest in those opportunities, but we'll find other ways to reduce costs. So our overall expectation is to stay within that $50 million operating expense base. Related to your question on gross margin, very good question. Thanks for picking it up.

Is to stay within that range, depending on pricing reimbursement decisions.

Thomas Charles Reilly: We'll invest in those opportunities we will find other ways to reduce cost. So our overall expectations is to stay within that 50 million operating expense basis.

Speaker Change: Relating to your question on gross margin very good question, thanks for picking it up.

Thomas Charles Reilly: What you've seen versus Q3 is a deterioration of gross margin, but that's primarily due to launch supply that we provided for our partners, in particular in China. So as the Chinese market is moving forward, we're providing product for revenue there. It's about a two and a half to three point reduction in margin impact this quarter versus the previous quarter.

Speaker Change: What you're seeing versus Q3 is a deterioration of.

Speaker Change: Gross margin for that is primarily due to launch supply that we've provided for our partners and particularly in China. So as the China market is moving forward, we're providing product for revenue there is about a two five to three.

Thomas Charles Reilly: And then, you know, the question on how to expect margins moving forward, I think it all depends on the uptake in China and how much product supply we'll be providing. But we'll give updates on the progress of the Chinese market. Thank you very much. Your next question is from Paul Choi with Goldman. Hi, everyone. Good morning. This is Khalil calling in for Paul.

Paul Choi: Thank you so much for taking our question. I guess our question is about the exclusive contracts that you've mentioned in the past. As those are renegotiated, have you seen any additional pushback as more generics enter the market? And have you or will you set a threshold for those for deterioration and those at which point the company would pivot to your own generic?

Patrick Holt: Thank you. Khalil, thanks very much for the question. Look, obviously, we track those contracts very carefully. We do see, you know, I would say on an annual basis to renegotiate our exclusive contracts. We do see an annual impact on those prices, you know, in the sort of low double-digit range typically. And that's something that we are seeing consistently. We don't necessarily see necessarily significant changes to that, but that's the sort of range that we see.

Speaker Change: Thanks very much for the question.

Speaker Change: But obviously, we track those contracts very carefully we do say.

Speaker Change: You know I would say on an annual basis to renegotiate our exclusive contracts here, we do see annual impact too to those pricings or in the sort of low double digit range typically.

Speaker Change: That's been something that we're asking consistently we don't see necessarily significant changes to that but that's the sort of range that we say uhm. What's really pleasing is is here. We have had a strong entered a year and a strong stop there in terms of how we landing on negotiation surf. The net net of that means that we are participating in <unk>.

Patrick Holt: What's really pleasing is, you know, we have had a strong end to the year and a strong start to the year in terms of how we're landing our negotiations. So the net of that means that we are participating in greater than 50% of the IPE market volume. That has enabled us, with our great managed care and trade, and medical capabilities, to pull through as we close 2023 at 57% market share and retain market leadership. To the second part of your question, of course, we track the economics and the overall profitability incredibly closely. We have specific scenarios in our minds as to when we think those are attractive and when they start to become more marginal, and we have plans in place to react based on how those dynamics change, should they change.

Speaker Change: Later than 50 per cent of the I P market volume that has enabled us without great managed care and trade in an medical capabilities to pull through as we closed 2023 of 57% market share and retain market leadership Uhm to your second part of your question of course, we tracked economics and the overall profitability and <unk>.

Speaker Change: Credibly closely we have specific scenarios in our mind as to when we think those are attractive, but when they start to become more modular when we have plans in place to react based on how how those dynamics change should they change, but as it stands right now focuses to extend our branded lifecycle as long as we can.

Patrick Holt: But as it stands right now, our focus is to extend our branded life cycle as long as we can. Our organization, our US team, From my perspective, it has delivered a highly atypical performance for over three years since LOE, which provides incredibly important profits for the business, particularly for our growth in Europe. So we couldn't be happier in terms of how we finish the year and how we start the year. But, as you well know, it's highly dynamic. We monitor it very closely.

Speaker Change: Our organization our U S came up for.

Speaker Change: From my perspective, as as delivered a highly I typical performance for over three years since <unk>, which provides incredibly important promise pulled the business, particularly frog growth in Europe, Sir Uhm, we couldn't be happier in terms of how we finished the year and how we stopped there, but as you well know it's highly dynamic we monitor very closely.

Patrick Holt: Got it. Thank you so much. We have reached the end of the question and answer session, and I will now turn the call over to Patrick for closing. Well, thank you all for your attention, and thanks for all the Q&A. We really appreciate the interest, and we look forward to having additional conversations on these important results in the coming days. So, thank you again for your time and wish you a great day ahead. Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Speaker Change: Got it thank you so much.

Speaker Change: We have reached the end of a question and answer session.

Patrick: Patrick for closing remarks.

Patrick: Well. Thank you all for your attention and thanks for all the Q&A, we really appreciate the interest and we look forward.

Patrick: To having additional conversations on these important results are in the coming days ahead, Sir. Thank you again for your time and wish you a great day ahead. Thank you.

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

Speaker Change: You for your participation.