Amarin Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 1, 2024

There are 8 speakers on the call.

Operator

Good day, and welcome to Amarin Corporation's Conference Call to discuss its First Quarter 2020 4 financial results and business update. I would now like to turn the conference over to Mark Murmur, Vice President, Corporate Communications and Investor Relations at Amarin. Please go ahead.

Speaker 1

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

Speaker 1

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 ventures or any material agreements that we may enter into, amend or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the Risk Factors section of our annual report on Form 10 ks for the year ended December 31, 2023, and our quarterly report on Form 10 Q for the quarter ended March 31, 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.

Speaker 1

Turning to today's agenda. Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of our Q1 2024 business update Jonathan Promos, Amarin's Chief Legal and Compliance Officer, will provide an intellectual property and legal update Steve Ketcham, Amarin's President of R and D and Chief Scientific Officer will provide an update on key data presented at ACC24 and Tom Reilly, Ameren's Chief Financial Officer, will provide a review of our Q1 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 Avamarone. Pat?

Speaker 2

Thank you, Mark. Good morning, everyone, and thank you for joining us today. 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 Vascepa and Vascepa. We firmly believe this focus is the best plan forward for Amarin and it will more strongly position us for the future.

Speaker 2

In Q1, our team continued to deliver considerable progress. So turning to our business highlights first. In the Q1, we were successful in both defending and extending our IP position in Europe. This effort delivered an extended IP runway in Europe until 2,039. This is really important as enhances the value of our business considerably.

Speaker 2

Jonathan will provide more details in this achievement later in the call. 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. Additionally, we remain on track to secure pricing reimbursement in 5 additional markets in 2024 in Europe.

Speaker 2

We expect to share pricing 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 Q1 with a cash position of $308,000,000 marking a stable cash position over 7 quarters. Importantly, we also secured shareholder approval for our share repurchase program of up to $50,000,000 Our next step is to secure U. K.

Speaker 2

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 Q1. Turning to Slide 6 and more specifically to Europe. Before we get into the results for the quarter, let me reiterate an important point that drives our confidence in the opportunity across Europe. Underpinning our progress in our path forward in Europe is our intellectual property position for Vasquez, which is now being extended into 2,039.

Speaker 2

This provides additional value for both patients and our company. So turning to the Q1'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 of the end of the Q1, the number of patients on VASCAPA therapy in Spain has increased 91% in quarter 1, 2024 versus quarter 4, 2023. The team continues to focus on HCPs who are early adopters of cardiovascular products.

Speaker 2

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.

Speaker 3

At the

Speaker 2

end of the Q1, the number of patients on VASCAPA therapy in the UK has increased 28% in Q1 2024 versus Q4 2023. Turning to pricing and reimbursement progress. We strengthened focus on advancing our opportunities in key EU5 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.

Speaker 2

We will continue to communicate progress on France and Germany as additional steps are achieved. In addition, we are pleased to share today that we're well on track to reach our goal of securing positive pricing reimbursement decisions in at least 5 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 Q1, the team maintained IPE market leadership.

Speaker 2

We have retained exclusive accounts representing more than 50% of the IPE market. Market share has remained stable in the U. S. For the 6th consecutive quarter. These results are a testament to the work our managed care, trade and medical best teams have done to extend Vascepa's lifecycle despite the elimination of our sales force and reduced marketing spend.

Speaker 2

While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic. Whilst our revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition, the U. S. Business remains highly profitable funding our efforts in Europe. Our U.

Speaker 2

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 will be bolstered by our strong supply position in order to retain IP market leadership. Moving to Slide 8, in the rest of world, Amarin and its partners continue to make regulatory market access and commercial launch progress across key markets. In China, the 2nd largest cardiovascular market globally by population, Amarin's partner, Edding continues to launch Vascepa for very high triglycerides with a focused strategy. In the Q1 of 2024, Edding delivered 100% increase in sales growth versus the Q4 of 2023.

Speaker 2

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 of National Reimbursement and Drug Listing or NRDA. 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 for Vascepa. And in Australia, Amarin's partner CSL Securus continue to advance the submission for Vascepa reimbursement with local health authorities and timelines for potential reimbursement remain on track.

Speaker 2

In summary, our teams and our partners have made significant progress in the Q1 across the business advancing momentum needed for Amlan. 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 Prevost to provide more detail on our IP extension for VASCEPRA in Europe. Jonathan?

Speaker 4

Thank you, Pat. Good morning, everyone, and thank you for the opportunity to give a brief update on our IP progress for Vascepa. Turning to Slide 10. As we announced in April, we have been successful over the past few months taking important steps to strengthen our intellectual property position for Vazkepa in Europe. Before I go into the details, it's important to understand 2 key items.

Speaker 4

First, that Amarin's intellectual property for VASCEPA in this region is built upon a multilayered collection of patents and regulatory protection, such that exclusivity for VASCAPA stems from a diverse portfolio of intellectual property assets. And second, the recent progress we have made extends commercial exclusivity toward Vaz Kappa until 2,039, 8 years beyond the data exclusivity period of 2,031. In our announcement in April, we shared that we were successful with 2 separate patent outcomes. First, we were recently successful in defending a European best capital patent from 3rd party opposition within the European Patent Office or EPO. That patent expires in 2,033.

Speaker 4

Following this decision, the company received a decision to grant from the EPO for a new patent covering Vascepa that extends the product exclusivity until April 2039. In addition to these patents, Amarin possesses additional European patents and pending patent applications that further our intellectual property protection for best kept up within the European market. Taken together, these patents collectively provide us with a high level of confidence that our intellectual property position for Vazkema in Europe is strong and dependent, providing us exclusivity protection in Europe into the 2,030 9 period. As was stated earlier, intellectual property is a foundational element of our business and our ability to provide our product to patients. As we've done in the past, Amarin will continue to vigorously defend our intellectual property to the fullest extent possible.

Speaker 4

As we know, the data and science behind VASCEPA and VASCEPA is 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 ACC24 conference. Steve?

Speaker 5

Thank you, Jonathan. Good morning, everyone, and thank you for the opportunity to summarize key data on Vascepa VASCEPA 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 levels.

Speaker 5

Data featured at ACC24 included key abstracts on REDUCE IT subpopulations as well as mechanistic activity data on EPA. The first abstract was a post hoc analysis of REDUCE IT that sought to measure Vascepa VASCEPA's effect on the relationship between lipoproteina, also known as Lp levels and reducing MACE. High Lp concentrations are associated with increased CV event risk even when low density lipoprotein cholesterol or LDL C levels are well managed.

Speaker 3

There

Speaker 5

are no treatments currently approved to reduce residual CD risk on top of contemporary medical therapy in patients with high Lp levels. In this analysis of REDUCE IT, Vascepa VASCEPA showed a clear clinical benefit for patients with both high and low baseline Lp levels. The molecule provided a relative risk reduction of 21% among patients with a high Lp level of greater than or equal to 15 milligrams per deciliter at baseline and a relative risk reduction of 25% among patients with a low Lp level of less than 50 milligrams per deciliter at baseline. These findings, which were published simultaneously in the Journal of the American College of Cardiology, reinforce Vascepa VASCEPA's clinical benefit in these at risk patient subpopulations. In a second abstract featured at ACC, investigators explored REDUCE IT data to determine if Vascepa veschepa reduces CD events among high risk CD patients irrespective of baseline LDL C.

Speaker 5

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. Findings from this analysis showed that among adults with increased CD risk and elevated triglycerides, icosapent ethyl clearly reduced the rate of CD outcomes irrespective of baseline LDL C, including in those with very well controlled LDL C of 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 in the mechanism of for Vascepa veschepa, including the effect of EPA in combination with high intensity statin on endothelial cell function during inflammation and EPA's effect on Lp levels. 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 Vascepa vaskepa 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.

Speaker 5

It is through their efforts that we are able to continue to better understand the science behind Vascepa veschepa. Now I would like to hand the call over to Tom Reilly to review our Q1 2024 financial performance. Tom?

Speaker 6

Thank you, Steve. Good morning, everyone. Today, I am reporting details on our financial performance for the Q1 of 2024. In the Q1 of 2024, Ameren reported total net revenue of $56,500,000 including net product revenue of $55,200,000 and $1,400,000 of licensing and royalty revenue versus $86,000,000 total revenue in the Q1 of 2023. U.

Speaker 6

S. Product revenue was $48,100,000 in the Q1 of 2024 versus $82,300,000 in the Q1 of 2023. This decline was driven largely by net selling price impact due to the generic competition in the market. Despite the revenue decline, the U. S.

Speaker 6

Business continues to deliver significant profit. Revenue results include European net product revenue of $1,900,000 a 35% increase versus the Q4 of 2023, reflecting growth in revenue primarily from Spain and the United Kingdom. We recognized $5,200,000 in rest of world revenue in the Q1 of 2024, including product revenue related to supply shipments to our partners in Canada, China and the Middle East. Cost of goods sold in the Q1 of 2024 was $24,600,000 compared to 38 $1,000,000 in the Q1 of 2023. Amarin's

Speaker 2

overall gross margin was $0.06 per share

Speaker 6

in the Q1 of 20 24 and 2023 was 55%. Excluding inventory restructuring charges in the first quarter 2023, gross margin was 70%. Moving on to operating expenses. Operating expenses were $45,500,000 in the 1st quarter comprised of $39,900,000 in selling, general and administrative expenses and $5,600,000 in research and development expenses, which is a $20,000,000 reduction versus Q1 2023. We are on track to deliver $40,000,000 reduction in operating expenses by July 2024, which we announced in Q3 2023.

Speaker 6

Ameren reported a net loss of $10,000,000 for the Q1 of 2024, basic and diluted loss per share of $0.02 Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of March 31, 2024, Amarin reported aggregate cash and investments of $308,000,000 While our cash balance has been impacted by revenue shortfall 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, certainly investing in right opportunities, particularly in Europe based on pricing and reimbursement decisions. 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 50,000,000 of Amarin Ordinary Shares.

Speaker 6

On April 18, Amarin announced we secured shareholder approval for the program. The next step in this process is to seek U. K. High Court approval and last week we filed our claim for approval with the court. Expected share repurchases would commence shortly after the court approval, which we expect in the Q2 of 2024.

Speaker 6

With that, I will now turn back to Pat for closing remarks and to begin the Q and A portion of our call.

Speaker 2

Pat? Thank you, Tom, for the overview of our financial results and update on our share repurchase program. Our team continues to remain focused on advancing goals across Ameren. In the Q1 of 2024, we delivered an enhanced European IP position, European growth led by the United Kingdom and Spain, stable cash position of 308,000,000 and advanced our share repurchase program. Our fundamentals continue to provide the foundation for our progress, best in class science supporting Vascepa and VASCEPA, a large global opportunity to impact cardiovascular patients, a team dedicated to driving results and a strong balance sheet.

Speaker 2

Before we turn to Q and 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. And with that, Mark, let's begin the Q and A portion of the call.

Speaker 1

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 upvote questions, a selection of which will be answered by Amarin management during today's earnings call. Let's begin the Q and A. Pat, we received a question from an investor regarding when can we expect revenue from China?

Speaker 2

Thanks very much for the question. First, it's important to remember that China is a really large market with substantial unmet needs. In fact, it's the 2nd largest cardiovascular market globally by population. And quite frankly, it's a market that I'm particularly bullish about. In China, our partner Eddy launched the CEPA for very high triglycerides in Q3 2023.

Speaker 2

And in this quarter, quarter 1 2024, they delivered 100% sales growth versus Q4 2023. In addition, cardiovascular risk reduction, which has been submitted 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. As a reminder of our deal, 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. The cardiovascular risk reduction filing remains on track.

Speaker 1

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 begin and when will it become completed?

Speaker 1

Finally, in addition, how much does the company plan to purchase?

Speaker 2

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 a 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 U.

Speaker 2

K. High Court for the program. Last week, we filed the claim for approval with the U. K. High Court.

Speaker 2

Importantly, commencement of share repurchases will follow UK High Court approval and will be conducted based on SEC and UK corporate 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 $308,000,000 in cash, stable over 7 quarters and no debt.

Speaker 1

Thanks, Pat. Turning to EU, UK sales, why is Ameren struggle with UK and EU product adoption? What are the main strategic issues and your confidence in addressing them?

Speaker 2

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.

Speaker 2

Firstly, targeted patient and customer segmentation at launch, 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 near term significant opportunities. And thirdly, enhancing and being flexible with our value proposition to address specific country payer needs. While we would all like to see faster update, we're encouraged by the progress we're making in Europe with 35% revenue growth and 65% in market sales growth in quarter 1 versus quarter 4 2023. At a country level, we can see that our new strategy is working, albeit at a different pace aligned to each market dynamic.

Speaker 2

Specifically in Spain, this is really an excellent case study demonstrating the value of ASEQUA in Spain as well as across the region. And we're seeing a fast uptake, 91% increase in patients on therapy in quarter 1 2024 versus quarter 4 2023. In the U. K, we are also seeing our new strategy work, albeit in a slower uptake market. With the team focused on building momentum in key accounts, we see a 28% increase in patients on therapy in quarter 1 2024 versus quarter 4 2023.

Speaker 2

Again, taking a step back, underpinning all this, looking at our long term, we've successfully secured additional patent protection out into 2,039, which really gives us the confidence to invest and our belief around the future uptake, which enhances the value of our business.

Speaker 1

Thanks, Pat. Investors would like to know the long term future of the company. What can you tell us about this?

Speaker 2

Yes, great question. And naturally, it's a question that both management and the Board are really discussing often and remain incredibly focused on building value for shareholders. So firstly, in Europe, we continue to really focus and see growth in our key EU5 markets, especially the U. K. And Spain, and we're on track to deliver positive pricing reimbursement in at least 5 additional markets in 2024.

Speaker 2

That's underpinned by the confidence of our intellectual property, Borba's effort extending to 2,039, which adds value to the company and location. In the U. S, it's all about driving profitability. And then in rest of world, with our partners progressing, regulatory market access, commercial launches to advance our success. Additionally, we've taken critical steps to reduce operating expenses, which pays profitability and our cash position.

Speaker 2

All of this strengthens Amarin for today as well as for the future.

Speaker 1

Thanks, Pat. One final question. We saw that Amarin issued a press release regarding healthy women's citizens petition regarding fibrosis in

Speaker 5

the U. S. Can you tell us

Speaker 1

a bit more about that and why Amarin has weighed in on this issue?

Speaker 2

Yes, 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 to fibrates, fibrates 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 statin. Unfortunately, this clinical evidence has not translated to a significant change in prescribing for many patients.

Speaker 2

It is estimated that in the United States more than 1,000,000 patients are being prescribed fibroids and a statin together. Ultimately to reduce cardiovascular risk, this means that more than a 1000000 patients are being treated with a combination of products that has no benefit in reducing cardiovascular. 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 SAI Technologies platform.

Speaker 2

We are committed

Speaker 3

to continuing open and transparent dialogue with our shareholders and the

Speaker 2

SAI Technologies platform is one of platform. We look forward to continuing to hear from you and answering your questions on this platform and other opportunities as we move forward.

Speaker 1

Thank you for those updates, Pat. We'll now open the Q and A up for additional questions.

Operator

Thank you. At this time, we will be conducting our live Q and A session. Thank you. Our first question is coming from Roanna Ruiz with Leerink Partners. Your line is live.

Speaker 3

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.

Speaker 3

S?

Speaker 2

Hi, Wanna. Thanks so much for the question. So when we consider the U. S, 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.

Speaker 2

So we start the year and we continue to have significant progress with our exclusive accounts, which is yielding continuing to yield market leadership. And that is therefore delivering the profits that we expect that drives our investments in Europe and obviously protects our cash. With that said, it really is about the profitability that the U. S. Drives.

Speaker 2

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 shift to that strategy. But as it stands right now, our focus is on extending the branded life cycle of Vascepa in the U. S.

Speaker 2

Through the excellent capabilities that we have in managed care, trade and medical affairs that really are expert in navigating, particularly those contracting with our counterparties. Tom, would you like to add anything there?

Speaker 6

No. I mean, just other than related to, like you mentioned on the authorized generic, if and when we get to that point, we are prepared, and focus on the profitability that we're gathering today.

Speaker 3

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're launched and especially if you're seeing any important trends, particularly in the UK and countries like that?

Speaker 2

Yes. Thanks very much for the question. Look, Ryan, as you understand really well, the data we get from Europe is not the same that we get from the U. S. So it's important to always caveat that we don't have exactly the precise data that we come to expect in the United States.

Speaker 2

With that said, obviously, we're very much buoyed by our IP position extending out to 2,039. When we look at those different markets in Europe, each have different dynamics around market access and launch. So when we then click into the EU5, we're very pleased with our progress in Spain. So if you look at Spain, we launched in, I think October or September, it's completely on track. It's really demonstrating a percent increase in the number of patients on therapy that approximates about 3,800 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 2

In the U. K, it's important to note that with new leadership coming in last July, we really shifted and focused our strategy in the U. K. Much more as I previously disclosed. We're seeing early signs of that starting to take traction.

Speaker 2

We've also strengthened the U. K. Organization with a new country leader who has just started. So that more focused strategy in the U. K.

Speaker 2

We're seeing is 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 a 28% increase in Q1 versus Q4 in the number of patients on therapy, which approximates about 1750 patients.

Speaker 2

I would say Spain is top of the league table. U. K. Is improving and we're incredibly focused on those 2 EU5 markets. And certainly my time and the management team's time is uber focused on driving our success there.

Speaker 3

Got it. Thanks.

Operator

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

Speaker 7

Hi, thank you. Good morning and thanks for taking our questions. Maybe just to follow-up on the question regarding a potential generic here in the U. S. Can you maybe just comment on what other mechanics would be required with regard to the FDA before you could launch that?

Speaker 7

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 regard to the cash position, excluding the pending U. K. Court decision on that, your 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?

Speaker 7

Thank you.

Speaker 2

Thanks very much for the question. So to your first part of your question in regards to the authorized generic, we have a well established plan in place. 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 life cycle of Vascepa in the U. S.

Speaker 2

Given there is 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 that. Obviously, that's bolstered by the very strong supply position we have that underpins that strategy.

Speaker 2

To your second question, as a management team with the Board, we continue to assess opportunities in the marketplace when it comes to business development. We have a strong balance sheet with $308,000,000 and no debt, and we continue to demonstrate our cash position stable over the last 7 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 2,039, our key launches in EU5, continuing to drive really important significant profits in the U. S. And advancing our business in the rest of world by our partners.

Speaker 2

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.

Operator

Thank you. Our next question is coming from Jessica Fye with JPMorgan. Your line is live.

Speaker 3

Hey, this is Nick on for Jessica. Thanks for taking Maybe just one from us. Spain is contributing pretty robust uptake, maybe more focused approach in the UK. Can you maybe compare, contrast those dynamics there a bit more? And maybe how should we think about Portugal and Greece in terms of the launch uptake?

Speaker 2

Hi, Nick. Thanks very much for your question. So firstly, 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 Vascepa and we're really encouraged.

Speaker 2

It's a great CATIES 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 the complexity of the national health system in the UK. 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 attraction as I've noted in my previous comments. In regard to Portugal and Greece, time will tell.

Speaker 2

Greece is via a partner, Portugal obviously is our Spanish team. But we do broadly expect, if you think about that scale between say 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 markets moving forward. So that's a great question, Nick. Thanks very much. There is complexity as we think through all these various markets as you understand well.

Speaker 3

All right. Understood. Thanks.

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 2

Well, thank you all for your support this morning and appreciate your time. As you can hear from our results this morning, we're encouraged by our results, particularly we're pleased that the runway we have out to 2,039 in Europe. We're pleased with the growth that we're demonstrating albeit from still early stages in Europe with 35% revenue growth, 65% in market sales growth. To be very clear, the U. S.

Speaker 2

Is declining. 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.

Speaker 2

Continues to drive significant profits for us, which is enabling our investments in Europe and supporting our cash position. And we closed the quarter with $300,000,000 in cash $308,000,000 in cash, no debt. As we've noted, we're really pleased that we secured shareholder approval for our share repurchase up to $50,000,000 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 continue to update you as the business progresses.

Speaker 2

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.

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Key Takeaways

  • Amarin successfully extended Vascepa’s European IP exclusivity to April 2039 through two new patent decisions, reinforcing its multi-layered protection and underpinning long-term value.
  • The European business grew strongly with Q1 market sales up ~65% vs. Q4 2023, driven by a 91% patient increase in Spain and 28% in the UK, while submissions for Italy, France and Germany continue.
  • In the U.S., Vascepa maintained exclusive accounts covering >50% of the IPE market and stable market share for six consecutive quarters, despite a revenue decline to $48.1 M from generic competition, with high profitability funding Europe.
  • Data presented at ACC24 reinforced Vascepa’s cardiovascular benefits across patient subpopulations—showing 21–25% MACE risk reduction by lipoprotein(a) levels and efficacy irrespective of baseline LDL-C.
  • Amarin closed Q1 with $308 M cash (stable over seven quarters), cut operating expenses by $20 M YoY, and won shareholder approval for a $50 M share buyback program pending U.K. High Court clearance.
AI Generated. May Contain Errors.
Earnings Conference Call
Amarin Q1 2024
00:00 / 00:00