Good day, and welcome to Amarin 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 Marmur. Vice President, Corporate Communications and Investor Relations at Amarin. Please go ahead.

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. 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-K 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 section of our website at www.amarincorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amarin's website in the Investor Relations section. Turning to today's agenda. Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of our first quarter 2024 business update. Jonathan Provoost, 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 ACC.24; and Tom Reilly, Amarin's Chief Financial Officer; 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. Pat?

Thank you, Mark. Good morning, everyone, and thank you for joining us today. Turning to Slide 5. Look, every day, our team in Amarin is focused on making progress to enhance the value of our business and maximize the patient uptake of VASCEPA/VAZKEPA. We firmly believe this focus is the best plan board for Amarin and more strongly position us for the future. In Q1, our team continued to deliver considerable progress. So turning to our business highlights first. 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 as it enhances the value of our business considerably. 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 break in Q1 2024 versus Q4 2023 led by Spain and United Kingdom. On the pricing and reimbursement front in Europe, we've 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. 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 7 quarters. Importantly, we also secured shareholder approval for our share repurchase program of up to $50 million. Our next step is to secure U.K. High Court approval and the share repurchases are anticipated to begin in the second quarter.…

Thank you, Pat. Good morning, everyone, and thank you for the opportunity to give a brief update on our IP progress for VAZKEPA. 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 is important to understand 2 key items. First, that Amarin's intellectual property for VAZKEPA in this region is built upon a multilayered collection patent and regulatory protection such that exclusivity for VAZKEPA stems from a diverse portfolio of intellectual property assets. And second, the recent progress we have made extend commercial exclusivity for VAZKEPA until 2039, 8 years beyond the data exclusivity period of 2031. 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 VAZKEPA patent from third-party opposition within the European patent office or EPO. That patent expires in 2032. Following this decision, the company received a decision to grant from the EPO for a new patent covering VAZKEPA 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 VAZKEPA within the European market. Taken together, these patents collectively provide us with a high level of confidence that our intellectual property position, for VAZKEPA in Europe is strong and dependent, providing us exclusivity protection in Europe into the 2039 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. As we know, the data and science behind VASCEPA and VAZKEPA 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 ACC.24 Conference. Steve?

Thank you, Jonathan. Good morning, everyone, and thank you for the opportunity to summarize key data on VASCEPA/VAZKEPA 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 roles. Data featured at ACC.24 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/VAZKEPA's effect on the relationship between lipoprotein A, also known as LP(a) levels and reducing MACE. High Lp(a) concentrations are associated with increased CV event risk even when low-density lipoprotein cholesterol, or LDL-C 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. In this analysis of REDUCE-IT, VASCEPA/VAZKEPA showed a clear clinical benefit for patients with both high and low baseline LP(a) levels. The molecule provided a relative risk reduction of 21% among patients with the high Lp(a) level of greater or equal to 15 milligrams per deciliter at baseline and a relative risk reduction of 25% among patients with a low Lp(a) 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/VAZKEPA'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/VAZKEPA 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. Findings from this analysis showed that among adults with increased CV 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 action for VASCEPA/VAZKEPA, including the effect of EPA in combination with high-intensity statin on endothelial cell function during inflammation and EPA's effect on Lp(a) 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/VAZKEPA 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 VASCEPA/VAZKEPA. Now I would like to hand the call over to Tom Reilly to review our first quarter 2024 financial performance. Tom?

Thank you, Steve. Good morning, everyone. 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 total revenue in the first quarter of 2023. The U.S. 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 net selling price impact due to the generic competition in the market. Despite the revenue decline, the U.S. business continues to deliver significant profit. Revenue results include European net product revenue of $1.9 million, a 35% increase versus the fourth quarter of 2023 reflecting growth in revenue primarily from Spain and the United Kingdom. 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. Cost of goods sold in the first quarter of 2024 was $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 2023, gross margin was 70%. 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 2023. We are on track to deliver $40 million reduction in operating expenses by July 2024, which we announced in Q3 2023. Amarin reported a net loss of $10 million for…

Thank you, Tom, for the overview of our financial results and update on our share repurchase programs. Our team continues to remain focused on advancing goals across Amarin. In the first quarter of 2024, we delivered an enhanced European IP position. European growth led by the United Kingdom and Spain, stable cash position of $308 million and advanced our share repurchase program. Our fundamentals continue to provide the foundation for our progress, best-in-class sign supporting VASCEPA/VAZKEPA, a large global opportunity to impact cardiovascular patients, a team is dedicated to driving results and a strong balance sheet. 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. And with that, Mark, let's begin the Q&A portion of the call.

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 Safe technologies to allow retail and institutional shareholders 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?

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 VASCEPA for very high triglycerides in Q3 2023. 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 NNPA 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.

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 U.K. High Court will approve it. When will the purchase begin and when will become completed. Finally, in addition, how much does the company plan to purchase?

This is progressing well, and it's really aligned to our view of the business and the needs that 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.K. High Court for the program. Last week, we filed a claim for approval with the U.K. High Court. Importantly, commencement of share repurchases will follow U.K. high court approval and will be conducted based on SEC and U.K. corporate law. 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 strong balance sheet with $308 million in cash stable over 7 quarters and no debt.

Thanks, Pat. Turning to EU/U.K. sales, why is Amarin struggled with U.K. and EU product adoption? What are the main strategic issues and your confidence in addressing.

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. Secondly, really prioritizing and optimizing our resource, 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 payer needs. While we would all like to see faster update, we're encouraged by the progress in 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. Specifically in Spain, this is really an excellent case study demonstrating the value of VAZKEPA in Spain as well as across the region, and we're seeing a fast uptake. 91% 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. Again, taking a step back, underpinning all of this, looking at our long term, we've successfully secured additional patent protection out in 2039, which really gives us the confidence to invest and our belief around the future uptake, which enhances the value of our business.

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

Yes. 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. 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. That's underpinned by the confidence of our intellectual property for VAZKEPA 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 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 aids profitability and our cash position. All of this strengthens Amarin for today as well as for the future.

One final question. We saw that Amarin issued a press release regarding healthy women's citizens petition regarding fibrates in the U.S. Can you tell us a bit more about that and why Amarin has weighed in on this issue?

Yes. Thanks very much. That's a great question. Look, fundamentally, this is 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 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 1 million patients are being prescribed by fibrates and a statin together to reduce cardiovascular risk. This means that more than 1 million patients are being treated with a combination of products that has no benefit in reducing cardiovascular disease 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 citizens 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 2-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 for those updates, Pat. We'll now open the Q&A up for additional questions.

[Operator Instructions] Our first question is coming from Roanna Ruiz with Leerink Partners.

A couple for me. First one in the U.S. So 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, 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. So we start the year and we continue to have a 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. 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. 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 counterparties. Tom, would you like to add anything there?

No. I mean just other than related to -- I think 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.

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 for your launch, especially if you're seeing any important trends, particularly in the U.K. and countries like that.

Thanks very much for the question. Look, Roanna, 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. 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 have different dynamics around market access and launch. So 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 an excellent case study of a launch of VAZKEPA in the region. To the best of our data, we see that in quarter 1, we see about a 91% 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. 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. 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. 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, 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. I would say Spain's 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 over focused on driving our success there.

Our next question is coming from Paul Choi with Goldman Sachs.

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? 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 opportunity for business development.

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 #1 goal continues to be to extend the profitable branded life cycle of VASCEPA in the U.S. given there's 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. 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. 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 million 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 in the immediate term, advancing our opportunities in Europe given our runway out to 2039, 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 via 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's options in the future.

Our next question is coming from Jessica -- with JPMorgan.

This is Nick on for Jessica. Maybe just 1 from us. Spain is contributing a pretty robust uptake, 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 increase in terms of the launch uptake.

Thanks 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 VAZKEPA, and we really encouraged, it's a great case study for our success in Europe. Contrasting that, the U.K. 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 we're making greater traction, as I noted in my previous comments. In regard to Portugal and Greece, time will tell. Greece is via a partner, Portugal obviously is our Spanish team. But we do broadly expect, if you think about that scale, between, say, U.K. 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.

Thank you. 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 you may have.

Well, thank you all for your support this morning. I appreciate your time. As 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 from a still early stages in Europe with 35% revenue growth, 65% in-market sales growth. To be very clear the U.S. is declining. It's not unexpected given our continued market leadership in IP 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 in supporting our cash position. And we closed the quarter with $300 million in cash -- $308 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 U.K. High Court approval which is the next step towards then triggering our share repurchases in Q2, subject to U.K. and SEC laws. 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.

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