Welcome to Amarin Corporation's Conference Call to discuss its Fourth Quarter and Full Year 2023 Financial Results and Business Updates. I would now like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications at Amarin.

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 31st, 2023, which has been filed with the SEC, and is available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amarin's website in the Investor Relations section. Turning to today's agenda. Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of 2023 highlights and 2024 priorities; and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our fourth quarter and full year 2023 financial results. Following prepared remarks, we will open the call to your questions. I will now turn the call over to Patrick Holt, President and Chief Executive Officer of Amarin. Pat?

Thank you, Mark. Good morning, everyone, and thank you for joining us today. Before we review our 2023 highlights and our 2024 priorities, I want to take a moment to reflect on our strategy at Amarin. Every day, our team is focused on driving operational momentum to maximize the patient uptake of VASCEPA/VAZKEPA. To enhance the value of Amarin and deliver shareholder value, we must drive operational momentum across our three key regions. In Europe, where we have a potential IP runway out to 2039, we are focusing efforts and investment to accelerate prescription growth and revenue as well as secure pricing and reimbursement in those key markets. In the US, we're maintaining and extending our IP market leadership. And in the Rest of World, we're enabling our partners to get our product into the hands of as many patients as possible. We firmly believe this focus on operational momentum is the best path forward for Amarin and will more strongly position us or potential future options. Turning to Slide 6. While we believe this strategy is the best way to deliver shareholder value today, the only way to gain shareholder confidence is to deliver against it. We have made meaningful progress in 2023, and we have clear priorities in place for 2024. For Europe, in 2023, with new leadership and a more focused strategy in place, our teams made launch progress and have advanced pricing and reimbursement goals. In Spain, our team is focusing on health care practitioners who are early adopters of cardiovascular products. We are continuing to deliver strong launch progress such that we now have approximately 2,500 patients on therapy. In the United Kingdom, we have a more focused strategy in place, including driving uptake in key accounts. Currently, we have at least 1,500 patients on…

Thank you, Pat. Good morning, everyone. I'm pleased to report details on our financial performance for the fourth quarter of 2023. In the fourth quarter of 2023, Amarin reported total net revenue of $74.7 million, including net product revenue of $70.6 million versus $66.1 million in the third quarter of 2023 and $4.2 million in licensing and royalty revenue. US product revenue was $64.9 million, with stable performance in the US despite multiple competing generics on the market. The US business continues to provide profit supporting our expansion into Europe. The revenue results include European product revenue of $1.5 million, a 65% increase versus the third quarter of 2023, reflecting early revenues from European markets, including Spain and the United Kingdom. We recognized $8.4 million in the Rest of World revenue in the fourth quarter of 2023, including product revenue of $4.2 million related to commercial sales to our partners in Canada, China and the Middle East, and licensing and royalty revenue of $4.2 million, resulting primarily from the achievement of the Edding CVRR milestones. Cost of goods sold in the fourth quarter of 2023 were $29.6 million compared to $23.6 million, excluding restructuring in the third quarter in 2023. Amarin's overall gross margin on net product revenue in the fourth quarter was 58% compared with 64% in the third quarter of 2023. This was primarily due to an increase in one supply sales to our partner, Edding. Moving on to operating expenses. Operating expenses were $49.7 million in the fourth quarter, comprised of $43.9 million in selling and general and administrative expenses, and $5.8 million in research and development expenses. In the second half of 2023, Amarin reported operating expenses of $101.2 million. This represents a $21 million reduction in operating expenses versus the first half of 2023. We are on track to deliver the previously announced $40 million reduction in operating expenses by July 2024. Amarin reported a net loss of $5.8 million for the fourth quarter of 2023 or basic and diluted loss per share of $0.01. Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of December 31st, 2023, Amarin reported aggregate cash and investments of $321 million. Importantly, this is the sixth consecutive quarter of positive or neutral cash flow generation for Amarin, and our cash balance is now $10 million higher when compared to December 31st, 2022. In 2023, we made progress in controlling our costs and managing our cash position through our cost reduction programs and renegotiating supply agreements. In 2024, we will continue to focus on cash preservation, prudently invest in right opportunities, particularly in Europe, based on pricing reimbursement decisions and pending shareholder and UK High Court approvals will initiate our shareholder repurchase program. With that, I will now turn the call back over to Pat for closing remarks and to begin the Q&A portion of our call. Pat?

Thank you, Tom, for the financial overview of our results. Our team is focused on operational momentum to maximize shareholder value across all three areas of our business. We believe we have the right plan, focus on operational momentum to drive shareholder value. We have a strong future because of our fundamentals, best-in-class science supporting VASCEPA/VAZKEPA, a large global opportunity to impact cardiovascular patients, a team that is dedicated to delivering results, and a strong balance sheet. Finally, thank you to our colleagues for their commitment and dedication. I look forward to driving shareholder value together. And with that, Mark, let's begin the Q&A portion of the call.

Thank you, Pat. As we announced last year, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin is partnering with Say Technologies to allow retail and institutional shareholders submit and upvote questions, a selection of which will be answered by Amarin Management during today's earnings call. Let's begin the Q&A. So Pat, we received a number of questions on the company's long-term strategy and ways that we plan to maximize shareholder value. What would you say to these investors?

Thanks for the question. I get this question a lot. It's a really an important question. And we believe, the best path forward for us to both increase our value and put us in the best possible place for future strategic options is today to focus on our current efforts around operational momentum, whether that be in Europe, in the US or in the Rest of World. As we shared earlier in the call, we really are making progress on all three fronts, which provides us greater optimism and optionality for the future.

Great. Thanks, Pat. Our second set of questions focuses on China and Asia Pacific. What can you tell us on progress around the commercial launch in China? And what is the status of the cardiovascular risk reduction regulatory following China? Also, more broadly in Asia Pacific, can you share any updates on efforts with our partners?

Well, there's a lot in that. And as for the, some of you know, I know this region pretty well. So let me break that down in some parts. Firstly, to the China launch. So Amarin's partner, Edding, is really making important progress in China, which I'll remind everybody, is the second-largest cardiovascular market globally. Edding have launched VASCEPA for very high triglycerides in Q4 2023. To give you a flavor, the Edding sales force is covering 200 hospitals, which includes around 500 key opinion leaders, the majority of which are cardiologists in the three largest cities of Beijing, Shanghai and Guangzhou. So in summary, the launch is progressing well, and the structure of the agreement provides immediate profitability to Amarin. So let's move from today and also think about the future in China as we reflect upon the cardiovascular risk reduction indication. The NMPA has accepted the regulatory filing for cardiovascular risk reduction, which opens up the potential for national reimbursement drug listing. The submission was accepted with a clinical trial waiver, meaning a separate clinical trial will not be required in order to be reviewed for approval. The teams are now focused on advancing that submission together with the authorities and we expect the regulatory review process to conclude in 2025. Asia Pacific is a large region, so let me just touch on some other areas within the region. As you know, last year, we entered into partnerships in Australia and New Zealand, with CSL Seqirus, and also 11 Asian markets, including South Korea with Lotus Pharmaceuticals. I'm pleased to share that CSL is advancing pricing and reimbursement processes in Australia with the authorities. And in other markets, our partner, Lotus, is advancing regulatory discussions and filings with the various authorities across the region.

Great. Thanks, Pat, for that information on China and Asia Pacific. Now turning to the US. Is there a path toward growth in the market? Could we potentially take market share from other products or classes?

Great question. And naturally, our US revenues and cash flows are incredibly important to our business. When we take a step back and we think about the US market and where it stands today, it's important to remember that the IP market in the US is highly genericized at this point. Our focus has been and continues to be to maintain IP market leadership. And as a result of that, not focused on growing the market. We really have achieved a highly atypical performance three years post LOA to end 2023 with a market-leading share of 57%. We've been able to secure market leadership and continue that success through our exclusive contracts, led by our capabilities in payor, managed care and medical areas. Again, as we mentioned, we've started 2024 in a strong position in terms of our exclusive contracts. But to remind everybody, it's a dynamic market, and we do watch it very closely and continue to assess our optionality for our branded product and beyond that should we consider other strategic alternatives. In terms of taking share from other products or classes, given those generic dynamics, we do not view this as an optimal strategy.

Thank you. Turning to supply. If we see demand increase from Europe or Rest of World partners, are you confident that we can meet those supply demands?

It's a very important question. And we do have strong relationships with our key supply partners. Over the last several years, we've made really important progress, renegotiating our supply agreements to ensure that we can both meet our demands as well as reduce key supply commitments. We feel really confident that we can meet those supply demands moving forward.

Now, one last question on the R&D side from the Say Technologies questions. Is Amarin working on advancing any additional indications for VASCEPA/VAZKEPA?

I was really pleased this question came up. And it's such an important question when you think about the core strength that Amarin has in terms of our R&D team and our IP capabilities and leadership. This is the team that has developed and advance the molecule from day one, and deliver the REDUCE-IT data that really has a global impact that we see today. With our team in place, we do continue to look at opportunities for new indications and we will update investors based on potential future progress of that work. So before we take additional questions, I'd like to thank those shareholders who submitted questions via the Say Technologies platform. We are committed to continuing open and transparent dialogue with all of our shareholders, and the Say Technologies platform is one way that we are trying to increase engagement and two-way dialogue with you. We look forward to continuing to hear from you and answering your questions on this platform as well as other opportunities moving forward.

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

Certainly. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Your first question for today is from Roanna Ruiz with Leerink Partners.

Hi. Good morning, everyone. So could you talk a bit more about the ongoing generic competition in the US? Like what trends are you seeing in the field? And what do you expect in terms of possible pressure on VASCEPA net price in the next couple of years?

Hi, Roanna. Good morning. Thanks so much for the question. Great to hear from you. As you probably have followed, there are more generics that have got regulatory approval, there are more generics that have also got prices. And with that said, what we see in terms of the market dynamics in the market so far, they remained fairly stable. So as we mentioned, we closed the year and we started the year with a strong position with our exclusive contracts that represents greater than 50% of the IP volume. So as we end the year and start the year, we are feeling really good about that position. But as I'm sure you've noted, there is more dynamics and there are more entrants in the market. So we continue to monitor it very closely. But I would say so far, and we haven't seen any dynamic changes from what we have seen historically. But obviously, we track it closely. And as you know, we have optionality in the short term as well as the long term to maximize the economics for us in the US.

Yes, makes sense. And a quick follow-up on the Rest of World. I noticed it's gaining some traction. So could you talk about what regions you expect might contribute the most momentum to future growth in revenues in 2024 and beyond?

Yes. It's a great question. As I mentioned, we're really -- it's pleasing to see the progress in 2023. As you think, we always -- we signed up some new countries in 2023. If you take a step back in 2023, the main revenue sources, until China came on board, was really coming from Canada and then parts of Middle East, North Africa. So what we'll see in 2024 is certainly continued value coming from those existing partnerships such as what I've just mentioned. So I do expect that China will have more progress in 2024. And then there is the opportunity, I think as some of these partnerships start to go from signing through regulatory process such as Lotus, market access, reimbursement and pricing, such as CSL Seqirus in Australia, New Zealand, you're starting to see a shift from entering partnerships to really more driving through those pre-commercial and commercial outputs. So we're pleased that we're progressing through that life cycle of partnership and lines management, I would say, and we see that shift in the business towards more revenue, market access and revenue generation. And internally that means we're beefing up our capabilities and leadership to support that group.

Got it. Thanks.

And that's -- to add that. It's really -- it is a key part of our goals and our strategy, that Rest of World business, and it provides immediate profitability for us.

Your next question for today is from Jessica Fye with JPMorgan.

Hi, guys. Good morning. This is Na Sun on for Jessica Fye. I have a question on your progress in launching VASCEPA there. Can you just talk a little bit about how to accelerate the growth in UK. And then for Germany, have you come up with a plan to reenter the market there? And then for Italy as well? Thank you.

Thanks, Na Sun. Great to hear from you. Look, Europe is obviously critical for us. It's a key focus of our investments and a key focus of the whole organization as we move forward. So as we break that down, we think about those key launch markets. And as we've previously mentioned, the UK is quite an individual market, and the uptake in the UK is typically solar. We are making progress with a more focused strategy on those key accounts. And as I signaled earlier, we now believe, we estimate we have at least 1,500 patients on therapy. Building on that, we did say from that moment of launch last September that we did expect Spain to be a faster uptake market, and that is proving true. So we're pleased with the progress and the uptake we're seeing in Spain on a national basis. And today, we see -- we estimate we have around 22,600 patients on therapy, which is important progress for us. So they're two key launch markets for us. As we move into some of the reimbursement markets, we've resubmited in Italy, building on our previous strong scientific assessment and we do expect Italy pricing reimbursement to conclude in 2024. And then if we think about Germany, to your next question, you know our history in Germany. So that's a topic where we've taken a step back and we are redeveloping a potential new strategy to enter the market. We're working with the authority to assess different ways to consider patient populations that can be relevant for the German market, and we're working with the authorities on those plans, and we continue to advance that through 2024. But as I mentioned, I don't expect that those processes will conclude in 2024. Thanks very much for the question.

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

Hi, team. This is Wayne on for Louise and thanks for taking our questions. So first, you have reiterated that you're on track to deliver the $40 million annual savings. And so how should we think about the operating expense for 2024 because compared to the second quarter, you save about $7 million in the third quarter and $8 million this quarter? So should we expect a similar number going forward? And then the gross margin has dropped to 58%. So how should we think about this going forward? Thank you.

Yes. Great. This is Tom. Thanks for the question. Related to the operating expense and the $40 million, which we're on track to deliver and our expectations for expenses. As mentioned before, we reduced expenses from the second half to the first half of '23 by $21 million. Our cost basis is approximately $50 million per quarter. Our expectation is to stay within that range, depending on pricing reimbursement decisions. We will invest in those opportunities, but we'll find other ways to reduce costs. So our overall expectation is to stay within that $50 million operating expense basis. Related to your question on gross margin, very good question. Thanks for picking it up. What you've seen versus Q3 is a deterioration of gross margin, but that's primarily due to launch supply that we provided for our partners, in particular in China. So as the China market is moving forward, we're providing products for revenue there. It's about a 2.5 to 3-point reduction in margin impact this quarter versus the previous quarter. And then the question on how do you expect for margins moving forward. I think it all depends on the uptake in China and how much product side we'll be providing. But we'll give updates on the progress of the China market.

Thank you very much.

Your next question is from Paul Choi with Goldman Sachs.

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

Khalil, thanks very much for the question. Look, obviously, we track those contracts very carefully. We do see, I would say, on an annual basis, to renegotiate our exclusive contract, we do see annual impact to those pricings in the sort of low double-digit range typically. And that's been something that we are seeing consistently. We don't see necessarily significant changes to that, but that's the sort of range that we see. What's really pleasing is we have had a strong end to the year and a strong start to the year in terms of how we're landing our negotiations. So the net-net of that means that we are participating in greater than 50% of the IP market volume. That has enabled us with our great managed care and trade and medical capabilities to pull through as we close 2023, a 57% market share in retained market leadership. To your second part of your question, of course, we track the economics and the overall profitability incredibly closely. We have specific scenarios in our mind as to when we think those are attractive and when they start to become more marginal, and we have plans in place to react based on how those dynamics change, should they change. But as it stands right now, our focus is to extend our branded life cycle as long as we can. Our organization, our US team, from my perspective, has delivered a highly atypical performance for over three years since LOA, which provides incredibly important profits for the business, particularly for our growth in Europe. So we couldn't be happier in terms of how we finished the year and how we started the year. But as you well know, it's highly dynamic. We monitor it very closely.

Got it. Thank you so much.

We have reached the end of the question-and-answer session. And I will now turn the call over to Patrick for closing remarks.

Well, thank you all for your attention, and thanks for all the Q&A. We really appreciate the interest and we look forward to having additional conversations on these important results in the coming days ahead. So thank you again for your time and wish you a great day ahead. Thank you.

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