Q1 2024 Amarin Corp plc Earnings Call

Operator: Good day, and welcome to Amarin Corporation's conference call to discuss its first quarter 2024 financial results and business updates. I would now like to turn the conference over to Mark Murmer, Vice President, Corporate Communications and Investor Relations at Amarin. Please go ahead.

Good day.

Welcome to you.

Marine Corporation's conference call to discuss its first quarter 2024 financial results and business update.

I would now like to turn the conference over to Mark Murmur.

Mark Murmur: Vice President corporate communications and Investor Relations.

Mark Murmur: Please go ahead.

Mark Murmer: 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 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.

Mark Murmur: Good morning, everyone and thank you for joining us.

Mark Murmer: We assume no obligation to update these statements as circumstances change. Our foreseeing statements do not reflect the potential impact of significant transactions we may enter into, such as acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate.

Mark Murmur: 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 Ari out our plans or intentions or meet the expectations disclosed in our forward looking statements actual.

Mark Murmer: 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 March 31st, 2024, 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 item.

Mark Murmur: 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 of significant transactions, we may enter into such as mergers acquisitions dispositions joint.

Mark Murmur: <unk> or any material agreements that we may enter into amend or terminate.

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, and our quarterly report on Form 10-Q for the quarter ended March 31 2024.

Mark Murmur: It has been filed with the SEC and is available through the Investor Relations section of our website at Www dot.

Mark Murmur: We encourage everyone to read these documents.

Mark Murmur: An archive of this call will be posted on <unk> website in the Investor Relations section.

Mark Murmer: Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of our first quarter 2024 business update. Jonathan Promos, Amarin's Chief Legal and Compliance Officer, will provide an intellectual property and legal update. Steve Ketchum, Amarin's President of R&D and Chief Scientific Officer, will provide an update on key data presented at ACC24, and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our first quarter 2024 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.

Mark Murmur: Turning to today's agenda.

Mark Murmur: Patrick Holt Ameren, President and Chief Executive Officer will provide a brief overview of our first quarter 2024 business update John.

Mark Murmur: Jonathan promos, our chief legal and compliance officer will provide an intellectual property and legal update Steve Ketchum Ameren President of R&D, and Chief Scientific Officer, who will provide an update on key data presented at ACC 'twenty, four and Tom Reilly <unk>, Chief Financial Officer to provide a review of our first quarter of 2024.

Thomas Charles Reilly: Our financial results.

Thomas Charles Reilly: Following prepared remarks, we will open the call to your questions.

Thomas Charles Reilly: I will now turn the call over to Patrick <unk>, President and Chief Executive Officer of <unk>.

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

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

Patrick Holt: Turning to slide 5, look, every day our team at Amarin is focused on making progress to enhance the value of our business and maximize the patient uptake of a C-score investigation. We firmly believe this focus is the best plan forward for Amarin, and it will more strongly position us for the future. In Q1, our team continued to deliver considerable progress. So, turning to our business highlights first.

Patrick Holt: Turning to slide five everyday our team at Amarin is focused on making progress to enhance the value of our business and maximize the patient uptake of the seat for invesco.

We firmly believe this focus is the best path forward.

Patrick Holt: And not more strongly position us for the future.

Patrick Holt: In Q1, our team continued to deliver considerable progress so turning to our business highlights.

Patrick Holt: In the first quarter, we were successful in both defending and extending our IP position in Europe. This effort delivered an extended IP runway in Europe until 2039. This is really important and enhances the value of our business.

In the first quarter, we were successful in both the spending and extending IP position in Europe.

Patrick Holt: Is that the deliberate and extended IP runway in Europe until 2039. This is really important and enhances the value of our business considerably Jonathan will provide more details image achievement later in the call.

Patrick Holt: Jonathan will provide more details on this achievement later in the presentation. From a commercial perspective, in Europe, our teams delivered approximately 65% in-market sales growth in Q1 2024 versus Q4 2023, led by Spain and the United Kingdom. On the pricing and reimbursement front in Europe, we resubmitted our dossier in Italy. In France, plans remain on track to submit our strengthened dossier in 2024. And in Germany, continued work is being done for a potential resubmission.

Patrick Holt: From a commercial perspective in Europe, our teams delivered approximately 65% in market sales growth in Q1.

Patrick Holt: 74 versus Q4, 2023 led by Spain, and the United Kingdom.

Patrick Holt: On the pricing and reimbursement front in Europe, we have resubmitted that dossier in Italy.

Patrick Holt: In France plans remain on track to submit our strengthened dossier in 2024 and in Germany continued work is being done for a potential resubmission.

Patrick Holt: Additionally, we remain on track to secure pricing reimbursement in five additional markets in 2024 in Europe. We expect to share pricing and reimbursement outcomes in Greece and Portugal in the near future. Our team continues to focus on prudent spending and our cash position. We ended the first quarter with a cash position of $308 million, marking a stable cash position over seven quarters.

Patrick Holt: Additionally, we remain on track to secure pricing and reimbursement in five additional markets in 2024 in Europe we.

Patrick Holt: We expect to share pricing and reimbursement outcomes in Greece, and Portugal in the near future.

Patrick Holt: Our team continues to focus on prudent spending and our cash position.

Patrick Holt: We ended the first quarter with a cash position of $308 million marketing is stable cash position of over seven quarters.

Patrick Holt: Importantly, we also secured shareholder approval for our share repurchase program of up to $50 million.

Patrick Holt: Our next step is to secure UK high court approval and the share repurchases are anticipated to begin in the second quarter.

Patrick Holt: Importantly, we also secured shareholder approval for our share repurchase program of up to $50 million. Our next step is to secure UK High Court approval, and the share repurchases are anticipated to begin in the second quarter. So let's now dive into each of our business areas and the performance in the first quarter. Turning to slide six, and more specifically to Europe.

Patrick Holt: So, let's now dive into each of our business areas and the performance in the first quarter.

Patrick Holt: Turning to slide six and more specifically to Europe.

Patrick Holt: Before we get into the results for the quarter, let me reiterate an important point that drives our confidence in the opportunities across Europe. Underpinning our progress and our path forward in Europe is our intellectual property position for Basquiat, which is now being extended into 2039. This provides additional value for both patients and our company. So, turning to the first quarter's commercial progress in Europe. In Spain, our team is delivering robust launch growth, and this market continues to prove the value of ESCEPA for the region and, frankly, globally and the new approach we have taken to the region following new leadership changes last year. As at the end of the first quarter, the number of patients on vascular therapy in Spain increased 91% in 4-1-2024 versus 4-4-2023.

Patrick Holt: Before we get into the results for the quarter, Let me reiterate an important point that drives our confidence in the opportunity across year underpinning our progress and our path forward in Europe is our intellectual property position for <unk>, which is now being extended into 2009. This provides additional.

Patrick Holt: For both patients and our company.

Patrick Holt: So turning to the first quarter's commercial progress in Europe.

Patrick Holt: In Spain, our team is delivering robust launch growth in this market continues to prove the value of escape.

Patrick Holt: For the region, and frankly globally and the new approach, we have taken to the region following new leadership changes last year.

Patrick Holt: As at the end of the first quarter the number of patients on <unk> therapy in Spain at increased 91% in quarter one.

Patrick Holt: <unk> 24 versus quarter four 2023, the team continues to focus on HCP to our early adopters cardiovascular products.

Patrick Holt: The team continues to focus on HCPs who are early adopters of cardiovascular products. In the United Kingdom, our team is executing against a more focused strategy and has new leadership in the form of a new country manager in place. At the end of the first quarter, the number of patients on vascular therapy in the UK increased 28% in Q1 2024 versus Q4 2023.

Patrick Holt: In the United Kingdom, our team is executing against the more focused strategy and his new leadership in the form of a new country manager in place.

Patrick Holt: At the end of the first quarter the number of patients on <unk> therapy in the U K has increased 28%.

Patrick Holt: Q1, 2024 versus Q4 of 2023.

Patrick Holt: Turning to pricing and reimbursement progress, we have strengthened our focus on advancing our opportunities in key EU 5 markets. In Italy, we resubmitted our dossier, and we're advancing this process with the authorities to potentially achieve market access for VASCEPA by the end of 2024. In France, plans remain on track to submit our strengthened dossier in 2024, and in Germany, continued work is being done on plans for a potential resubmission. We will continue to communicate progress on France and Germany as additional steps are achieved.

Patrick Holt: Turning to pricing and reimbursement progress we've strengthened focus on advancing our opportunity in key EU five market.

Patrick Holt: In Italy, we resubmitted dossier and we are advancing this process with the authority to potentially achieve market access for best effort by the end of 2024.

Patrick Holt: In France plans remain on track to submit our strengthened dossier in 2024 and in Germany continued work is being done on plans for a potential resubmission.

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

Patrick Holt: In addition, we're pleased to share today that we're well on track to reach our goal of securing positive pricing or investment DOTS decisions in at least five additional markets in 2024. We expect to share news on Pricing Reimbursement Outcomes in Greece and Portugal in the near future. Turning now to the United States, in the first quarter, the team maintained IPE market leadership. We have retained exclusive accounts representing more than 50% of the IPE market.

Patrick Holt: In addition, we are pleased to share today that we are well on track to reach our goal of securing positive pricing and reimbursement decisions in at least five additional markets in 2020, we expect to share news.

Patrick Holt: On pricing reimbursement outcomes in Greece, and Portugal in the near future.

Patrick Holt: Turning now to the United States in the first quarter the team maintained market.

Patrick Holt: Market leadership, we have retained exclusive accounts, representing more than 50% of the IP market market share has remained stable in the U S.

Patrick Holt: Market share has remained stable in the U.S. for the sixth consecutive year. These results are a testament to the work our managed care, trade, and medical affairs teams have done to extend the CSIS lifecycle despite the elimination of our sales force and reduced marketing spending. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic. Whilst revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition,

Patrick Holt: For the sixth consecutive quarter.

Patrick Holt: These results are a testament to the work and manage catch rate and medical affairs teams have done to extend the safest lifecycle. Despite the elimination of our sales force and reduced marketing spend.

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

Patrick Holt: <unk> revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition.

Patrick Holt: The U.S. business remains highly profitable, and funding happens in Europe. Our U.S. team is skilled at analyzing market dynamics, and we are prepared to change our approach to this business as the market continues to develop, including the potential future launch of an authorized generic, which would be bolstered by our strong supply position in order to retain I.P. market leaders. Moving to slide 8.

Patrick Holt: This business remains highly profitable funding our efforts in Europe.

Patrick Holt: Our U S team is skilled at analyzing market dynamics and we are prepared to change our approach to this business as the market continues to develop including the potential future launch of an authorized generic which should be bolstered by a strong supply position in order to retain market leadership.

Patrick Holt: In the rest of the world, Amarin and its partners continue to make regulatory market access and commercial launch progress across key markets. In China, the second largest cardiovascular market globally by population, Amarin's partner Edding continues to launch the SIPA for very high triglycerides with a focused strategy. In the first quarter of 2024, Edding delivered a 100% increase in sales growth versus the fourth quarter of 2023.

Patrick Holt: Moving to slide eight and the rest of World Amarin and its partners continue to make regulatory market access.

Patrick Holt: And commercial launch progress across key markets.

Patrick Holt: In China, the second largest cardiovascular market globally by population Ameren partner Eddie continues to launch the safer with very high triglycerides with a focused strategy in.

Patrick Holt: In the first quarter of 2024, adding delivered a 100% increase in itself.

Patrick Holt: Versus the fourth quarter of 2023.

Patrick Holt: The NMPA review of the Cardiovascular Risk Reduction Indication remains on track, and as a reminder, an approval for this indication would open up the potential for National Reimbursement and Drug Listing, or NRDR. In Canada, HLS continues to make important progress across the market. In British Columbia, HLS recently secured public access and listing with the leading private payer Pacific Blue Cross Orbis.

Patrick Holt: The MTA review of the cardiovascular risk reduction indication remains on track and as a reminder, an approval for this indication would open up the potential of <unk>.

Patrick Holt: National reimbursement drug list or <unk>.

Patrick Holt: In Canada HOS continues to make important progress across the market in.

Patrick Holt: In British Columbia, HOS recently secured club public access and listing with a leading private payer specific way across all the segments.

Patrick Holt: In Australia, Amarin's partner CSL Securis continues to advance the submission for VASCEPA reimbursement with local health authorities, and timelines for potential reimbursement remain on track. In summary, our teams and our partners have made significant progress in the first quarter across the business, advancing momentum needed by Amarin. Like all biopharmaceutical companies, intellectual property is a foundational element of our business and our ability to provide our product to patients. I would now like to turn the call over to Jonathan Provost to provide more detail on our IP extension for Vascapre in Europe. Jonathan

Patrick Holt: In Australia, <unk> partner CSL secures continued to advance a submission full basket, but reimbursement with local health authorities and timelines for potential reimbursement remained on track in summary, our teams and our partners have made significant progress in the first quarter across the business advil.

Patrick Holt: <unk> momentum needed for that.

Patrick Holt: Like all biopharmaceutical companies intellectual property is foundational elements of our business and our ability to provide a product to patients I would now like to turn the call over to Jonathan perverse to provide more detail on our ICA extensions for best Catherine Europe Jonathan.

Jonathan Promos: Thank you, Pat. Good morning, everyone, and thank you for the opportunity to give a brief update on our iCrew progress with us. Turning slide.

Jonathan Promos: Thank you Pat good morning, everyone and thank you for the opportunity to give a brief update on our <unk> progress what about capital.

Turning to slide 10.

Jonathan Promos: As we announced in April, we have been successful over the past few months, taking important steps to strengthen our intellectual property position for Vescapa in Europe. Before I go into the details, it's important to understand two key items. First, that Amarin's intellectual property for VASCEPA in this region is built upon a multi-layered collection of patents and regulatory protection, such that exclusivity for VASCEPA stems from a diverse portfolio of intellectual property

Jonathan Promos: As we announced in April we have been successful over the past few months, taking important steps to strengthen our intellectual property position or best capital in Europe.

Jonathan Promos: And second, the recent progress we have made extends commercial exclusivity for VASCAPA until 2039, eight years beyond the data exclusivity period of 2031. In our announcement in April, we shared that we were successful with two separate patent hours. First, we were recently successful in defending a European Vescepa patent from third-party opposition within the European Patent Office, or EPO. That patent expires in 2030. Following this decision, the company received a decision to grant from the EPO for a new patent covering VASCEPA that extends the product's exclusivity until April 2039.

Jonathan Promos: Alright go into the details it's important to understand two key items first that amarin is intellectual property or invest capital in this region is built upon a multi layered collection of patents and regulatory protection such that exclusivity for best Capa stems from a diverse portfolio of intellectual property.

Jonathan Promos: And second the recent progress we have made extend commercial exclusivity for best cap up until 2039 eight years beyond the data exclusivity period of 2031.

Jonathan Promos: In our announcement in April we shared that we were successful with two separate patent out further.

First we were recently successful in defending a European best kept a patent from third party obligations within the European patent office or Epo that patent expires in 2033.

Jonathan Promos: Following this decision the company received a decision to grant from the Epo or a new patent covering about that.

That extends our product exclusivity until April 2039.

Jonathan Promos: In addition to these patents, Amarin possesses additional European patents and pending patent applications that further our intellectual property protection, or VESCAPA, within the European market. Taken together, these patents collectively provide us with a high level of confidence that our intellectual property position for VASCAFA in Europe is strong and defensive, providing us exclusivity protection in Europe into the 2039 period. As stated earlier, intellectual property is a foundational element of our business and our ability to provide our product to patients.

Jonathan Promos: In addition to these patents amarin possesses additional European patents and pending patent applications.

Our intellectual property protection or best Capa within the European market, making.

Jonathan Promos: Taken together these patents collectively provide us with a high level of confidence that our intellectual property position <unk> catheter in Europe strong and defense, providing us exclusivity protection in Europe into the 2039 period.

Jonathan Promos: As was stated earlier intellectual property is a foundational element of our business and our ability to provide a product to patients as we've done in the past Amarin will continue to vigorously defend our intellectual property to the fullest extent possible as.

Jonathan Promos: As we've done in the past, Amarin will continue to vigorously defend our intellectual property to the fullest extent possible. As we know, the data and science behind VASIPA and VASKEPA are critical to its commercial success in markets around the world. I would now like to turn the call over to Steve Ketchum to provide an overview of key data presented at the ATC24 conference.

Jonathan Promos: As we know the data and science behind Vascepa Invesco.

Jonathan Promos: Critical to its commercial success in markets around the World I would now like to turn the call over to Steve Ketchum provide an overview T data presented at the ACC 'twenty for copper.

Steven B. Ketchum: Thank you Jonathan good morning, everyone and thank you for the opportunity to summarize key data.

Steven B. Ketchum: Jonathan. Good morning, everyone, and thank you for the opportunity to summarize key data and the CIPA Vizcaba and EPA recently presented at the American College of Cardiology's annual scientific session. Turning to slide 12. In early April, the American College of Cardiology held its annual scientific sessions in Atlanta, Georgia. The Congress brought together more than 17,000 attendees, surpassing pre-COVID attendance. Data featured at ACC24 included key abstracts on reduced subpopulations, as well as mechanistic activity data on EPA.

Steven B. Ketchum: Vascepa this gap.

Steven B. Ketchum: And the EPA recently presented at the American College of Cardiology annual scientific session.

Steven B. Ketchum: Turning to slide 12.

Steven B. Ketchum: In early April the American College of Cardiology held its annual scientific sessions in Atlanta, Georgia.

Steven B. Ketchum: <unk> brought together more than 17000 attendees, surpassing pre COVID-19 attendance swaps.

Steven B. Ketchum: Data featured at ACC 'twenty four included key abstracts on reduce it subpopulations as well as mechanistic activity data on EPA and the.

Steven B. Ketchum: The first abstract was a post hoc analysis of Reducit that sought to measure vascepa vascepa's effect on the relationship between lipoprotein A, also known as LP little a levels, and reducing mace. High LP little a concentrations are associated with increased CV event risk even when low density lipoprotein cholesterol or LDLC levels are well managed. There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high LP-a levels.

Steven B. Ketchum: The first abstract was a post hoc analysis of reduce it.

Steven B. Ketchum: Start to measure Vascepa, the skip has effect on the relationship between life of protein a.

Steven B. Ketchum: Also known as LP little a levels and reducing mace high LP little a concentrations are associated with increased CV event risks, even when low density lipoprotein cholesterol or LDL C levels are well managed.

Steven B. Ketchum: There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high LP Little a levels.

Steven B. Ketchum: In this analysis of REDUCE-IT, Vasitha Vaskepa showed a clear clinical benefit for patients with both high and low baseline LpA levels. The molecule provided a relative risk reduction of 21% among patients with a high LP little a level of greater than or equal to 50 milligrams per deciliter at baseline and a relative risk reduction of 25% among patients with a low LP little a level of less than 50 milligrams per deciliter at baseline.

Steven B. Ketchum: In this analysis of reduce it vascepa vascepa showed a clear clinical benefit for patients with both high and low baseline LP little a levels. The molecule provided a relative risk reduction of 21% among patients with high LP little a level of greater than or equal.

Steven B. Ketchum: <unk> 15 milligrams per deciliter at baseline and a relative risk reduction of 25% among patients with a low LP little a level of less than 50 milligrams per deciliter at baseline.

Steven B. Ketchum: These findings, which were published simultaneously in the Journal of the American College of Cardiology, reinforce Cepa Vescepa's clinical benefit in these at-risk patient subpopulations. In a second abstract, featured at ACC, investigators explore reduce-it data to determine if Cepa-Vaskepa reduces CV events among high-risk CV patients irrespective of baseline LDL-C. Elevated LDL-C is a well-established major CV risk factor supported by clinical evidence showing decreased atherosclerotic disease events when LDL-C is therapeutically lowered.

Steven B. Ketchum: These findings, which were published simultaneously in the journal of the American College of Cardiology rehab.

Steven B. Ketchum: And for specific of escape is clinical benefit in these at risk patient sub populations.

Steven B. Ketchum: And a second abstract featured at ACC investigators explored reduce it data to determine if the shipper skipper reduces CV events among high risk CV patients irrespective of baseline LDL C.

Steven B. Ketchum: Elevated ldlc is a well established major CV risk factor supported by clinical evidence showing decreased atherosclerotic disease events. When ldlc is therapeutically lowered find.

Steven B. Ketchum: Findings from this analysis showed that among adults with increased CV risk and elevated triglycerides, icosapent ethyl clearly reduced the rate of CV outcomes irrespective of baseline LDL-C, including in those with very well-controlled LDL-C of less than 55 mg per deciliter. And finally, a few comments on EPA mechanistic data that were presented at the Congress, which provide new insights into the mechanism of action for vascepa vascepa, including the effect of EPA in combination with high-intensity statin on endothelial cell function during inflammation and EPA's effect on LP little a level.

Steven B. Ketchum: Findings from this analysis showed that among adults with increased CV risk and elevated triglycerides iqos clearly reduce the rate of CV outcomes irrespective of baseline LDL C, including those with very well controlled ldlc up less than 55 milligrams per deciliter.

And finally, a few comments on EPA mechanistic data that were presented at the Congress, which provide new insights into the mechanism of action for Vascepa scupper, including the effect of EPA in combination with high intensity statin on endothelial cell function during inflammation and epa's effect on the LP.

<unk> levels. This latest research reaffirms ameren commitment to advancing cardiovascular care and helps further advanced the medical communities understanding of the role the value and the potential mechanism of action of Vascepa to reduce cardiovascular events in at risk patients globally before I.

Steven B. Ketchum: This latest research reaffirms Amarin's commitment to advancing cardiovascular care and helps further advance the medical community's understanding of the role, the value, and the potential mechanism of action of the CIPA VASCEPA to reduce cardiovascular events in at-risk patients globally. Before I close, on behalf of the Amarin team, I would like to thank the investigators for their important work on the analyses featured at ACC. It is through their efforts that we are able to continue to better understand the science behind SIPA, the skeptic. Now, I would like to hand the call over to Tom Reilly to review our First Order 2024 financial performance. Tom?

Speaker Change: Close on behalf of the Amarin team I would like to thank the investigators for their important work on the analyses featured at ACC.

Speaker Change: Through their efforts that we are able to continue to better understand the science behind SIPA, but sketchup.

Speaker Change: Now I would like to hand, the call over to Tom Reilly to review, our first quarter 2024 financial performance Tom.

Thomas Charles Reilly: Thank you, Steve. Good morning, everyone.

Thomas Charles Reilly: Thank you Steve Good morning, everyone today, I am reporting details on our financial performance for the first quarter of 2024.

Thomas Charles Reilly: Today I am reporting details on our financial performance for the first quarter of 2024. In the first quarter of 2024, Amarin reported total net revenue of $56.5 million. Including net product revenue of $55.2 million and $1.4 million of licensing and royalty revenue, versus $86 million in total revenue in the first quarter of 2023. US product revenue was $48.1 million in the first quarter of 2024 versus $82.3 million in the first quarter of 2023. This decline was driven largely by the net selling price impact due to generic competition in the market.

Thomas Charles Reilly: In the first quarter of 2020 for Amarin reported total net revenue of $56 5 million.

Thomas Charles Reilly: Including net product revenue of $55 2 million.

Thomas Charles Reilly: $1 4 million of licensing and royalty revenue first.

Thomas Charles Reilly: First is $86 million total revenue in the first quarter of 2023.

Thomas Charles Reilly: U S product revenue was $48 1 million in the first quarter of 2024 versus $82 3 million in the first quarter of 2020 right.

Thomas Charles Reilly: This decline was driven largely by net selling price impact to the generic competition in the market.

Thomas Charles Reilly: Despite the revenue decline the U S business continues to deliver significant profit.

Thomas Charles Reilly: Despite the revenue decline, the U.S. business continues to deliver significant profits. Results include European net product revenue of $1.9 million, a 35% increase versus the fourth quarter of 2023, reflecting growth and revenue primarily from Spain and the United Kingdom.

Thomas Charles Reilly: Revenue results include European net product revenue of $1 9, million% to 35% increase versus the fourth quarter of 2023.

Thomas Charles Reilly: Reflecting growth renewed primarily from Spain, and the United Kingdom.

Thomas Charles Reilly: We recognize 5.2 million in rest of world revenue in the first quarter of 2024, including product revenue related to supply shipments to our partners in Canada, China, and the Middle East. Boston Goods sold in the first quarter of 2024 were $24.6 million, compared to $38 million in the first quarter of 2023. Amarin's overall gross margin on net product revenue in the first quarter of 2024 and 2023 was 55%. Excluding inventory restructuring charges in the first quarter of 2023, gross margin was 70%.

Thomas Charles Reilly: We recognized $5 2 million in rest of world revenue in the first quarter of 2024, including product revenue related to supply shipments to our partners in Canada, China and the Middle East.

Thomas Charles Reilly: Cost of goods sold in the first quarter of 2024 was $24 6 million.

Thomas Charles Reilly: <unk> to $38 million in the first quarter of 2023.

Thomas Charles Reilly: <unk> overall gross margin on net product revenue in the first quarter of 2024.

Thomas Charles Reilly: In 2023 was 55%.

Thomas Charles Reilly: Excluding inventory restructuring charges in the first quarter 2023 gross margin was 70%.

Thomas Charles Reilly: Moving on to operating expenses. Operating expenses were $45.5 million in the first quarter, comprised of $39.9 million in selling, general, and administrative expenses and $5.6 million in research and development expenses, which is a $20 million reduction versus Q1 2020. We are on track to deliver a $40 million reduction in operating expenses by July 2024, which we announced in Q3 2023. Amarin reported a net loss of $10 million for the first quarter of 2024. Base sinking diluted loss per share of two sets.

Thomas Charles Reilly: Moving on to operating expenses operating expenses were $45 5 million in the first quarter.

Thomas Charles Reilly: Price of $39 9 million and selling general and administrative expenses.

Thomas Charles Reilly: And $5 6 million in research and development expenses.

Thomas Charles Reilly: Which is a $20 million reduction versus Q1 2020 degree.

Thomas Charles Reilly: We're on track to deliver $40 million reduction in operating expenses by July 2024, which we announced in Q3 2023.

Thomas Charles Reilly: Amarin reported a net loss of $10 million for the first quarter 2024.

Thomas Charles Reilly: Basic and diluted loss per share of two sets.

Thomas Charles Reilly: Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of March 31st, 2024, Amarin reported aggregate cash and investments of $308 million. While our cash balance has been impacted by revenue shortfalls over the last several quarters, we remain focused on preserving cash and have maintained a stable cash position over the last seven quarters. The team continues to focus on cash preservation, brutally investing in the right opportunities, particularly in Europe, based on pricing and reimbursement decisions.

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

Thomas Charles Reilly: As of March 31, 2024.

Thomas Charles Reilly: <unk> reported aggregate cash and investments of $308 million.

Thomas Charles Reilly: While our cash balance has been impacted by revenue shortfall over the last several quarters.

Thomas Charles Reilly: We remain focused on preserving cash and have maintained a stable cash position over the last seven quarters.

Thomas Charles Reilly: The team continues to focus on cash preservation.

Investing in right opportunities, particularly in Europe based on pricing and reimbursement decisions.

Thomas Charles Reilly: Before I wrap up, I will 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 Ordinary Shares. On April 18th, Amarin announced it secured shareholder approval for the program. The next step in this process is to seek UK High Court approval. And last week, we filed our claim for approval with the court.

Thomas Charles Reilly: Before I wrap up I will provide a brief update on our share repurchase program.

Thomas Charles Reilly: As announced in January Ameren entered into conditional share repurchase agreement with Cantor Fitzgerald.

Thomas Charles Reilly: Purchase up to $15 million at the Amarin reported net shares.

Thomas Charles Reilly: On April 18th Ameren announced we secured shareholder approval for the program.

Thomas Charles Reilly: The next step in this process to seek UK high court approval.

Thomas Charles Reilly: And last week, we filed our claim for approval with the court.

Thomas Charles Reilly: Expected share repurchases would commence shortly after court approval, which we expect in the second quarter of 2024. With that, I will now turn back to Pat. [inaudible] and begin the Q&A portion of our call.

The expected share repurchases would commence shortly after the approval.

Thomas Charles Reilly: Which we expect in the second quarter of 2024.

Thomas Charles Reilly: With that I will now turn back to Pat.

Thomas Charles Reilly: Closing remarks and to begin the Q&A portion of our call Pat.

Patrick Holt: Thank you, Tom, for the overview of our financial results and the update on our share repurchase program. Our team continues to remain focused on advancing goals across AMRIN. In the first quarter of 2024, we delivered an enhanced European IP position, with European growth led by the United Kingdom and Spain.

Pat: Thank you Tom for the overview of our financial results and update on our share repurchase program.

Pat: Our team continues to remain focused on advancing goals across AMR in the first quarter of 2024, we delivered an honest European IP position.

Pat: Japan's growth led by the United Kingdom, and Spain stable cash position of $308 million and advanced our share repurchase program.

Patrick Holt: Stable cash position of $308 million and an Advanced Star Share Repurchase Program. Our fundamentals continue to provide the foundation for our progress. Best in class science support for Invasiva and Vaskepa. A large global opportunity to impact cardiovascular patients.

Pat: Our fundamentals continue to provide the foundation for our progress best in class Science supporting the secret by schedule, a large global opportunity to impact cardiovascular patients attain.

Patrick Holt: A team dedicated to driving results and achieving a strong balance. Before we turn to Q&A, I'd like to thank our colleagues for their ongoing commitment and dedication. I look forward to continuing to advancing our priorities in order to deliver shareholder value together.

Pat: <unk> dedicated to driving results and a strong balance sheet.

Speaker Change: Before we turn to Q&A I'd like to thank our colleagues for their ongoing commitment and dedication I look forward to continuing to advancing our priority in order to deliver shareholder value together.

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

Mark Murmer: Thank you, Pat. As we previously shared, 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 upload questions, a selection of which will be answered by Amarin Management during today's earnings call. Let's begin the Q&A. Pat, we received a question from an investor regarding when can we expect to see revenue from China?

Mark Murmur: Thank you Pat as we previously shared to enhance engagement with the company's 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, let's begin the Q&A.

Mark Murmur: We received a question from an investor regarding when can we expect to see revenue from China.

Patrick Holt: Thanks very much for the question. Firstly, it's important to remember that China is a really large market with substantial unmet needs. In fact, it's the second largest cardiovascular market globally by population. And quite frankly, it's a market that I'm particularly bullish about. In China, our partner Edding launched the SIPA for very high triglycerides in Q3 2023, and in this quarter, quarter one of 2024, they delivered 100% sales growth versus Q4 2020. In addition, Cardiovascular Risk Reduction, which has been submitted to and has been accepted by the NMPA, would open the potential for the National Drug and Reimbursement Listing, or NRDL, which would, therefore, increase royalties to Amarin over time.

Speaker Change: Thanks very much for the question.

Speaker Change: Firstly, it's important to remember that China is a really large market with substantial unmet needs. In fact is the second largest cardiovascular market slightly by population.

Speaker Change: Frankly, it's a market that I'm, particularly bullish about.

Speaker Change: In China, our partners, adding launched Vascepa with very high triglycerides in Q3 2023.

Speaker Change: And in this quarter quarter, one 2024, they delivered 100% sales growth versus Q4 2023.

Speaker Change: In addition.

Speaker Change: Cardiovascular risk reduction, which has been submitted and has been accepted by the NFPA would open the potential for the national drug reimbursement listing or NHL.

Speaker Change: Which would therefore increase royalties to ameren overtime.

Patrick Holt: As a reminder of our deal, the structure of our agreement provides us with immediate profitability, tiered double-digit royalty payments on net sales, as well as development, regulatory, and revenue-based milestone payments. The Cardiovascular Risk Reduction filing remains on track.

Speaker Change: As a reminder, about the structure of our agreement provides us immediate profitability tiered double digit royalty payments on net sales as well as development regulatory and revenue based milestone payments.

Speaker Change: Your vascular risk reduction filing remains on track.

Patrick Holt: Thanks, Pat. Our second set of questions focuses on the share buyback program. What can you tell us about progress? When can we expect the UK High Court to approve it? When will the purchase begin, and when will it become completed? Finally, in addition, how much does the company plan to purchase?

Speaker Change: Thanks, Pat our second set of questions focuses on the share buyback program. What can you tell us on progress when can we expect the UK high court will approve it when will the purchase began and when will it become completed finally in addition, how much does the company plan to purchase.

Patrick Holt: This is progressing well, and it's really aligned to our view of the business and the needs the business has. So firstly, we've achieved a very critical step, which is shareholder approval. At our recent AGM, shareholders approved the share repurchase program overwhelmingly with 91% approval. We sincerely appreciate the support and engagement from our shareholders on this. The next step is to secure approval from the UK High Court for the program. Last week, we filed a claim for approval with the UK High Court.

Pat: This is progressing well, it's really aligned to our view of the business and as the business has.

Pat: So firstly, we have achieved a very critical step which is shareholder approval at our recent AGM shareholders approved a share repurchase program overwhelmingly with 91% approval. We sincerely appreciate the support and engagement from our shareholders on this.

Pat: The next step is to secure approval from the UK High Court, Florida program last week, we filed the claim for approval with the UK High Court.

Patrick Holt: Importantly, commencement of share repurchases will follow UK High Court approval and will be conducted in accordance with the SEC and UK Corporation. Broadly, we continue to believe this is a prudent use of capital to deliver value back to shareholders, given our cash position. We continue to show a strong balance sheet with $308 million in cash, stable over seven quarters and no debt.

Pat: Importantly, commencement of share repurchases will follow UK high court approval and will be conducted based on SEC and U K corporate law.

Pat: Broadly we continue to believe this is a prudent use of capital to deliver value back to shareholders. Given our cash position. We continue to show a strong balance sheet with $308 million in cash stable over seven quarters and no debt.

Patrick Holt: Thanks Pat. Turning to EU-UK sales, why has Amarin struggled with UK and EU product adoption? What are the main strategic issues and your confidence in addressing them?

Speaker Change: Thanks, Pat turning to EU UK sales why is amarin struggle with UK and EU product adoption, what are the main strategic issues and your confidence in addressing thanks.

Patrick Holt: Thanks very much for the question. Well, firstly, I am confident about our progress in Europe, and as we've noted previously, in Europe, the process for reimbursement, pricing, and launch is both complicated, and it varies country by country. It's important to remember that last year we installed new leadership across the region with a new strategy for Europe that had some really key focus areas. Firstly, targeted patient and customer segmentation at launch, focusing on the highest risk patients where the urgency to treat is the highest.

Pat: Thanks very much for the question.

Pat: Well, firstly I am confident about our progress in Europe and as we have noted previously in Europe to process full reimbursement pricing and launch is both complicated and it varies country by country.

Speaker Change: It is important to remember that last year, we installed new leadership across the region with a new strategy for Europe.

Speaker Change: That has some really key focus areas, firstly targeted patient and customer segmentation at launch.

Speaker Change: Focusing on the highest risk patients where the urgency to treat is the highest secondly, really prioritizing and optimizing our resource aggressively focused on where we see that.

Patrick Holt: Secondly, really prioritizing and optimizing our resources, aggressively focused on where we see the near-term significant opportunities. And thirdly, enhancing and being flexible with our value proposition to address specific country pay and needs. While we would all like to see a faster update, we're encouraged by the progress we're making in Europe with 35% revenue growth and 65% in-market sales growth in Q1 versus Q4 2023. At a country level, we can see that our new strategy is working, albeit at a different pace aligned to each market dynamics, specifically in Spain.

Speaker Change: Near term significant opportunities and thirdly, enhancing and being flexible with that value proposition to address specific country names.

Speaker Change: While we would all like to see faster uptake. We're encouraged by the progress we are making in Europe, with 35% revenue growth and 65% in market sales growth in quarter, one versus quarter four 2023.

Speaker Change: At a country level, we can say that our new strategy is working albeit at a different pace aligned to each market dynamic.

Speaker Change: Specifically in Spain.

Patrick Holt: This is really an excellent case study demonstrating the value of Askepa in Spain as well as across the region, and we're seeing a fast uptake, a 91% increase in patients on therapy in 4-1-2024 versus 4-4-2023. In the UK, we are also seeing our new strategy work, albeit in a slower-uptake market. With a team focused on building momentum in care counts, we see a 28% increase in patients on therapy in Q1 2024 compared to Q4 2022.

Speaker Change: This is really an excellent case study demonstrating the value of escape.

Speaker Change: In Spain, as well as across the region and we're seeing a fast uptake 91% increase in patients on therapy in quarter, one 2020 versus quarter four 2023.

Speaker Change: In the UK. We are also seeing a new strategy work, albeit in a slower uptake market.

Speaker Change: With the team focused on building momentum in key accounts, we see at 28% increase in patients on therapy in quarter, one 2024 versus quarter four 2023.

Patrick Holt: Again, taking a step back, underpinning all of this, looking at the long term, we've successfully secured additional patent protection out into 2039, which really gives us the confidence to invest and our belief around future uptake, which enhances the value of our business.

Speaker Change: Again, taking a step back underpinning all of US looking at our long term, we have successfully secured additional patent protection into 2039, which really gives us the confidence to invest.

Speaker Change: And our beliefs around the future uptake, which enhances the value of our business.

Patrick Holt: Thanks, Pat. Investors would like to know the long-term future of the company. What can you tell us about that?

Speaker Change: Thanks, Pat investors would like to know the long term future of the company. What can you tell us about this yeah, great question and actually it's a question that both management and the board are really discussing often and remain incredibly focused on building value for shareholders.

Patrick Holt: www.adr.gov.au So firstly, in Europe, we continue to really focus on and see growth in our key EU5 markets, especially the UK and Spain, and we're on track to deliver positive pricing reimbursement in at least five additional markets in 2022. That's underpinned by the confidence of our intellectual property, Orbitz Gephardt, extending to 2039, which adds value to the company and for patients. In the U.S., it's all about driving profitability. And then, in the rest of the world, with our partners, we're seeing regulatory, market access, and commercial launches to advance our business. Additionally, we've taken critical steps to reduce operating expenses, which aids profitability and our cash flow. All of this strengthens Amarin for today as well as for the future.

Speaker Change: So firstly in Europe, we continue to really focus and see growth in our key markets, especially the U K and Spain, and we're on track to deliver positive pricing reimbursement and at least five additional markets in 2020, it's Paul.

Speaker Change: That's underpinned by the confidence of our intellectual property for about extending to 2039, which adds value to the company and for patients in the U S. It's all about driving profitability.

Speaker Change: And then in rest of World without partners racing regulatory market access commercial launches to advanced optics.

Speaker Change: Additionally, we've taken critical steps to reduce operating expenses, which aid profitability and our cash position all of this strengthens amarin for today as well as for the future.

Speaker Change: Thanks Pat.

Patrick Holt: One final question. We saw that Amarin issued a press release regarding the Healthy Women's Citizens petition.

One final question, we sold in Amarin issued a press release regarding healthy women citizen's petition regarding fiber in the U S. Can you tell us a bit more about that and why amarin has weighed in on this issue.

Patrick Holt: Yeah, thanks very much. That's a great question. Look, fundamentally, this is all about patient care and ensuring that patients are being prescribed proven effective therapies that will reduce their cardiovascular risk, specifically fibroids. Fibroids are an old class of drugs studied over many years, and through a number of clinical studies, most recently the prominent trial, they do not reduce cardiovascular risk when prescribed in combination with statins. Unfortunately, this clinical evidence has not translated to a significant change in prescribing for many patients. It is estimated that in the United States, more than one million patients are being prescribed Vibrate and a statin together.

Speaker Change: Yes, thanks very much that's a great question look fundamentally this is all about patient care and ensuring that patients have been prescribed proven effective therapies that will reduce their cardiovascular risk.

Speaker Change: Specifically to five rigs.

Speaker Change: <unk> an old class of drug studied over many years and through a number of clinical studies. Most recently the prominent trial, they do not reduce cardiovascular risk when prescribed in combination with statin.

Speaker Change: Unfortunately, this clinical evidence has not translated.

Speaker Change: To a significant change in prescribing for many patients.

Speaker Change: It is estimated that in the United States more than 1 million patients have been prescribed <unk> and Staten together.

Patrick Holt: Sponsored ADR, And that is why we have continued to come out strongly in support of this issue. We will be filing additional comments to the docket on the citizen's petition during the current open comment period. 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 open and transparent dialogue with our shareholders, and the Say Technologies platform is one of the ways that we're trying to increase shareholder engagement and a two-way dialogue with you all. We look forward to continuing to hear from you and answering your questions on this platform and other opportunities as we move forward. Thank you

Speaker Change: Dumped to reduce cardiovascular risk. This means that more than 1 million patients are being treated with a combination of product that has no benefit in reducing cardiovascular risk and that is why we have continued to come out strongly in support of this issue.

Speaker Change: We will be filing additional comments to the docket.

Speaker Change: On the citizens petition during the current open comment period.

Speaker Change: Well, we take additional questions I'd like to thank those shareholders, who submitted questions via the same technology platform. We are committed to continuing open and transparent dialogue with our shareholders and assay technologies platform is one of the ways that we're trying to increase shareholder engagement and a two way dialogue with you all.

Speaker Change: We look forward to continuing to hear from you in answering your questions on this platform and other opportunities as we move forward.

Mark Murmer: Thank you for those updates, Pat. We'll now open the Q&A up for additional questions.

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

Operator: Thank you. At this time, we will be conducting our live Q&A 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 key, and you may press star 2 if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we pull for questions. Thank you. Our first question is coming from Roanna Ruiz of Lering Park. Your line is live.

Speaker Change: Thank you at this time, we will be conducting our live Q&A session.

Speaker Change: If you would like to ask a question. Please press star one on your telephone keypad.

Speaker Change: A confirmation tone will indicate your line. This is the question Keith.

Speaker Change: You May press Star two if you would like to remove your question from.

Speaker Change: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

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

Speaker Change: Thank you.

Speaker Change: Our first question is coming from Roanna Ruiz with Leerink partners. Your line is life.

Roanna Clarissa H. Ruiz: Hi, good morning, everyone. A couple for me. First one, in the U.S., I was curious, are there any new strategies that you're implementing to help preserve the exclusive business? And do you have any updates on your outlook on possibly launching an authorized generic in the U.S.?

Roanna Clarissa H. Ruiz: Hi, Good morning, everyone. A couple for me first one in the U S. I was curious are there any new strategies that you're implementing to help preserve the exclusive business and do you have any updates on your outlook on possibly launching an authorized generic in the U S.

Patrick Holt: Hi Roanna, thanks so much for the question. So when we consider the US, obviously, we see a decline in revenues this quarter. With that said, we see that our exclusive strategy continues to yield the expected results that we understand. So we start the year, and we continue to have significant progress with our exclusive accounts, which is delivering, and will continue to deliver market leadership. That is, therefore, delivering the profits that we expect and driving our investments in Europe and, obviously, protecting our cash.

Speaker Change: Alright, well thanks, so much for the question. So when we consider the U S and obviously, we see a decline in revenues.

This quarter with that said, we say that our exclusive strategy continues to yield the expected results that we understand and we start the year and we continue to have significant progress with our exclusive accounts, which yielding continuing to yield market leadership and that is therefore, delivering the profits that we expect that drives our.

Speaker Change: Investments in Europe, and obviously protects our cash.

Patrick Holt: With that said, it really is about the profitability that the U.S. drives, so we continue to monitor that dynamic market very closely. We have the optionality of an authorized generic strategy, particularly given our supply position, and we continue to monitor as to whether that time would eventuate when we would shift to that strategy. But as it stands right now, our focus is on extending the branded lifecycle of the SIPA in the U.S. through the excellent capabilities that we have in managed care, trade, and medical affairs that really are experts in navigating, particularly those contracting with our counterparts. Tom, would you like to add any more?

Speaker Change: With that said it really is about the profitability of the U S drive. So we continue to monitor that dynamic market very closely we have the optionality of an authorized generic strategy, particularly given our supply position and we continue to monitor as to whether that time would eventuate that we would ship.

Thomas Charles Reilly: I know.

Speaker Change: To that strategy, but as it stands right now.

Speaker Change: This is on extending the brand lifecycle of Vascepa in the U S through the excellent capabilities that we have in managed care trade and medical affairs, but really are experts in navigating.

Speaker Change: Particularly those contract with our Counterparties, Tom would you like to add anything there.

Patrick Holt: No, I mean, just other than related to the convention down the authorized generic. If and when we get to that point, we will be prepared and focus on profitability. We're gathering today.

Thomas Charles Reilly: No I mean other than related to that you mentioned on the authorized generic.

Thomas Charles Reilly: If and when we get to that point, we are prepared.

Thomas Charles Reilly: And focus on the profitability.

Thomas Charles Reilly: We're gathering today.

Tom Reilly: Yeah.

Patrick Holt: Yep, understood. And one on Europe, too.

Speaker Change: Yes, understood and one on Europe too could you talk a bit about the rate of new prescriber growth that you're seeing across some of the different European countries, where you launched in especially if youre seeing any important trends, particularly in the U K and countries like that.

unknown: Could you talk a bit?

Speaker Change: Yes, thanks very much for the question look.

Patrick Holt: Yeah, thanks very much for the question. Look, as you understand really well, the data we get from Europe is not the same that we get from the US. So it's important to always caveat that we don't have exactly the precise data that we have come to expect in the United States.

Speaker Change: Brian as you understand really well the date the data we get from Europe is not the same that we get from the U S. That's important so always caveat that we don't have exactly the precise data that we've come to expect in the United States with that said, obviously we are.

Patrick Holt: With that said, obviously, we're very much buoyed by our IP position extending out to 2039. When we look at those different markets in Europe, each has different dynamics for our market access and launch. So when we then click into the EU5, we're very pleased with our progress. So if you look at Spain, which we launched in, I think, October or September, it's completely on track. It's really demonstrating an excellent case study of the launch of ASCEPI in the region.

Speaker Change: We're very much buoyed by our IP position extending out to 2039.

Speaker Change: When we look at those different markets.

Speaker Change: Europe, each have different dynamics around market access and launch so when we then click into the EU five.

Speaker Change: We're very pleased with our progress in Spain.

So if you look at Spain, we launched in I think October or September. It is completely on track, it's really demonstrating an excellent case study all the launch of Vascepa in the region to the best of our data we see that in quarter. One we see about a 91% increase in the number of patients on therapy that approximates about three.

Patrick Holt: To the best of our data, we see that in quarter one, we saw about a 91% increase in the number of patients on therapy that approximates about 3,800 patients, which really is demonstrating breadth of prescribing across the various parts of the country. And we're really pleased with those dynamic results. In the UK, it's important to note that with new leadership coming in last July, we really shifted and focused our strategy in the UK much more, as I've previously disclosed.

Speaker Change: 800 patients, which really is demonstrating a breadth of prescribing across the various parts of the country and we're really pleased with those dynamics.

Speaker Change: In the UK it is important to note.

Speaker Change: With new leadership coming in last July, we really shifted and focused our strategy in the UK much more as I previously disclosed we're seeing early signs of that starting to take traction. We've also strengthened the UK organization within new country. Later, who has just started so that more focused strategy in the U K, we're seeing it.

Patrick Holt: We're seeing early signs of that starting to take traction. We've also strengthened the UK organization with a new country leader who has just started. So that more focused strategy in the UK we're seeing is starting to show early signs of progress. We also have excellent market access in the UK, so our focus is on really driving depth of prescribing in key accounts. As a result of that, we see, to the best of our estimates, about a 28% increase in Q1 versus Q4 in the number of patients on therapy, which approximates about 1,750 patients.

Starting to make early signs of progress we have excellent market access in the U K. So our focus is on really driving depth of prescribing in key accounts as a result of that you see to the best of our estimates about 28% increase in Q1 versus Q4, and the number of patients on therapy, which approx.

Speaker Change: <unk> makes about 1750 patients I would say, Spain top of the league table UK is improving and we're incredibly focused on those two EU five markets and certainly my time and the management teams time is focused on driving our success there.

Patrick Holt: I would say, you know, Spain's top of the league table, the UK is improving, and we're incredibly focused on those two EU five markets, and certainly my time and the management team's time is uber focused on driving us.

Speaker Change: Got it thanks.

Speaker Change: Banking.

Paul Choi: Thank you. Our next question is coming from Paul Choi with Goldman Sachs. Your line is:

Speaker Change: Our next question is coming from Paul Choi with Goldman Sachs. Your line of sight.

Paul Choi: Hi, thank you. Good morning.

Paul Choi: Hi, Thank you good morning, and thanks for taking our questions maybe.

Paul Choi: Maybe just to follow up on the question regarding <unk>.

Paul Choi: Potential generic here in the U S. Can you maybe just comment on what other mechanics would be required.

Paul Choi: With regard to the FTAA before before you can launch that and just how roughly how quickly that process could be completed should you decide to go forward with that and my second question is with regards to the cash position.

Paul Choi: Excluding the pending U K court decision on that cash position has been relatively stable and consistent for the past few quarters. So I'm just curious as you survey the landscape just where you see the best potential opportunities for business development. Thank you.

Patrick Holt: And thanks for taking our questions. Maybe just to follow up on the question regarding stable and consistent growth for the past few quarters. So I'm just curious, as you survey the landscape, just where you see the best potential opportunities for business development. Thank you. Thank you very much for the questions.

Patrick Holt: Thanks very much for the question. So the first part of your question concerns the authorized generic. We have a well-established planning plan, and that plan has been developed in detail over a period of time. So our number one goal continues to be to extend the profitable branded lifecycle of the SEPA in the US, given the really world-class capabilities we have. With that said, we are genuinely ready to pivot to an authorized generic strategy and plan should we need to. And that's really simply a matter of us doing that with the partner that we have selected. So that's ready to go should we need it.

Speaker Change: Thanks very much for the question.

Speaker Change: To your first part of your question in regards to the authorized generic.

Speaker Change: We have a well established plan in place.

Speaker Change: And that plan has been developed in detail over a period of time. So our number one goal continues to be to extend the profitable branded lifecycle of vascepa in the U S. Given there is theres really world class capabilities. We have with that said, we are genuinely ready to pivot to an authorized generic strategy and plans should we need to.

Speaker Change: And Thats really simply a matter of us doing that with the partners that we have selected so that's ready to go should we need that obviously, that's bolstered by a very strong supply position, we had to underpin set strategy.

Patrick Holt: Obviously, that's bolstered by the very strong supply position we have that underpins that strategy. To your second question, you know, as a management team with the board, we continue to. Success opportunities in the marketplace when it comes to business development. We have a strong balance sheet with $308 million and no debt, and we continue to demonstrate our cash position stable over the last seven quarters. With that said, we continue to feel very strongly that, in the immediate term, advancing our opportunities in Europe, given our runway out to 2039, our key launch in EU5, continuing to drive really important, significant profits in the US, and advancing our business in the rest of the world via our partners, is the most important thing for Amarin to do, which strengthens the company for today and also enhances the company's options in the future. Thank you.

Speaker Change: To your second question.

Speaker Change: As a management team with the board we continue to.

Speaker Change: Assess opportunities in the marketplace. When it comes to business development, we have a strong balance sheet with $308 million.

Speaker Change: And no debt and we continue to demonstrate our cash position stable over the last seven quarters with that said, we continue to feel very strongly that in the immediate term advancing our opportunities in Europe, given our runway out to 2039 Ah Kee launched in EU five continuing to drive really important significant profits in the U S.

Speaker Change: And advancing our business in the rest of world.

Speaker Change: Our partners, we continue to believe that in the immediate term that is the most important thing for amarin to do which strengthens the company for today and also enhances the company the company's options in the future.

Speaker Change: Thank you.

Jessica Macomber Fye: Our next question is coming from Jessica Fye with JP Morgan. Your line is live. Hey.

Our next question is coming from Jessica Fye with Jpmorgan. Your line is life.

Speaker Change: Hey, this is Nick on for Jessica Thanks for taking my questions, maybe just one from us that spans contributing pretty robust uptake.

Speaker Change: Maybe more focused approach in the U K can you maybe compare and contrast, those dynamics there a bit more and maybe how should we think about Portugal and Greece in terms of the launch uptake.

Patrick Holt: Hi Nick, thanks very much for your questions. Um, firstly, each of the European markets has different dynamics, so as we previously signalled, we did expect Spain to be a fast uptake market, which is typically the case. And the good news is that we're proving that for Basquiat, and we really encourage it as a great case study for our success, in Europe. Contrasting that, the UK is typically a slower uptake market for a variety of reasons, not least of which is the complexity of the national health system in the UK.

Speaker Change: Thanks very much for your question Sir.

Speaker Change: Yeah Firstly.

Speaker Change: Each of the European markets have different dynamics. So as we previously signaled we did expect Spain to be a fast uptake market, which is typically the case and the good news is that we're proving that for best Catherine we really encourage it as a great case study for our success.

Speaker Change: In Europe and.

Speaker Change: Contracting that the UK is typically a slower uptake market for a variety of reasons, not least of which the complexity of the national health system in the U K and our uptake is not dissimilar to that with that said given the focus we have right. Now we are seeing that with we are making great attraction as I've noted in my previous comments.

Patrick Holt: And our uptake is not dissimilar to that. With that said, given the focus we have right now, we are seeing that we're making great attractions, as I've noted in my previous comments. In regard to Portugal and Greece, time will tell. Greece is our partner; Portugal, obviously, is our Spanish team. But we do, you know, broadly expect, if you think about that scale, between say the UK and Spain, I think we would broadly expect Portugal and Greece to be more toward faster uptake rather than slower uptake as we think about those. Moving forward. So that's a great question, Nick. Thanks very much. There is

Speaker Change: In regard to Portugal, and Greece.

Speaker Change: Time will tell Grace's via our partner, Portugal, obviously is our Spanish team.

Speaker Change: But we do broadly expect if you're thinking about that scale.

Speaker Change: Wayne say, UK and Spain, I think we would broadly expect Portugal and grades to be more toward faster uptake rather than slower uptake as we think about those market.

Speaker Change: And moving forward. So that's a great question Nick Thanks, very much there is complexity as we think through all these various markets is as you understand well.

Speaker Change: Totally understood. Thanks.

Speaker Change: Thank you.

Operator: We have reached the end of our question and answer session, so I will now turn the call back over to Mr. Holt for any closing remarks he may have.

Speaker Change: We have reached the end of our question and answer session. So I will now turn the call back over to Mr Hall for any closing remarks, he may have.

Patrick Holt: Well, thank you all for your support this morning. I appreciate your time.

Mr Hall: Well. Thank you all for your support this morning I appreciate your time.

Mr Hall: You can hear from our results. This morning, we are encouraged by our results, particularly we're pleased that the runway we have out to 2039 in Europe. We're pleased with the growth that we're demonstrating albeit still early stages in Europe with 35% revenue growth, 65% in market sales growth.

Patrick Holt: As you can hear from our results this morning, we're encouraged by our results. Particularly, we're pleased with the runway we have out to 2039 in Europe. We're pleased with the growth that we're demonstrating, albeit from still early stages in Europe with 35% revenue growth, and 65% market sales growth. To be very clear, the U.S. is declining.

Mr Hall: To be very clear the U S is declining it's not unexpected and given our continued.

Patrick Holt: It's not unexpected, given our continued market leadership in IPE, as well as the expense management steps that we have taken. The U.S. continues to drive significant profits for us, which is enabling our investments in Europe and supporting our cash flow, and we closed the quarter with $300 million in cash, $308 million in cash, and no debt. As we've noted, we're really pleased that we secured shareholder approval for our share repurchase of up to $50 million.

Mr Hall: Market latest ship in IPA as well as the expense management steps that we have taken the U S continues to derive significant profits for us, which is enabling our investments in Europe and supporting our cash position.

Closed the quarter with $300 million in cash stood at $8 million in cash no debt. As we've noted we are really pleased that we secured shareholder approval for our share repurchase up to $50 million and we're on track to our UK High Court approval.

Patrick Holt: We're on track to a UK High Court approval, which is the next step toward then triggering our share repurchases in Q2, subject to UK and SEC laws. So, thank you so much for your support. We look forward to continuing to update you as the business progresses. Thank you for your time.

Mr Hall: Which is the next step towards triggering our share repurchases in Q2 subject to U K and SEC laws.

Speaker Change: So thank you so much for your support we look forward to continue to update you as the business progresses. Thank you for your time.

Operator: Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

Speaker Change: Keith this.

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

Speaker Change: We thank you for your participation.

Q1 2024 Amarin Corp plc Earnings Call

Demo

Amarin

Earnings

Q1 2024 Amarin Corp plc Earnings Call

AMRN

Wednesday, May 1st, 2024 at 12:00 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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