Welcome to Amarin Corporation's Conference Call to discuss its Third Quarter 2024 Business Update and Financial Results. I would like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin.

Good afternoon, everyone, and thank you for joining us. Turning to Slide 2 on 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 September 30, 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 Slide 3 in today's agenda, Aaron Berg, Amarin's President and Chief Executive Officer, will provide an update on the state of the Amarin business. Pete Fishman, Amarin's Vice President and Global Controller and currently overseeing all finance-related matters of the business will review our third quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions. I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron?

Thanks, Mark. Good afternoon, everyone, and thanks for joining us today. In my first full quarter as the President and CEO, I've spent time with our teams both in the U.S. and Europe, as well as valuable time with many of our partners and scientific experts from around the world. My aim has been straightforward to determine our path forward and execute the best strategies to drive access to and use of VASCEPA/VAZKEPA for the millions of at-risk patients across the globe. What I've known for years from the U.S. experience with VASCEPA was confirmed by those stakeholders I've heard from in Europe and around the world. VAZKEPA has the potential for significant growth, value, and impact globally that remains substantially untapped. These dynamics create a tremendous opportunity, one that directly addresses cardiovascular risk worldwide, and it's our obligation to patients, providers, and payers, as well as to shareholders to accelerate access to and use of this tremendous product. While our team has been working very hard and has made progress, this progress has not been enough. We are still in the early stages of launch in many regions around the world with a long runway, and there remains much more to do to maximize the value we know is inherent in the global VASCEPA and VAZKEPA franchise. This is based on the need, the science, and the impact this product can bring for patients. Let me start with the most critical component of all, the global unmet need to reduce cardiovascular disease. Despite more than four decades of progress in cardiovascular medicine, cardiovascular disease remains the number one killer globally. In 2021, roughly 20 million deaths were estimated for cardiovascular disease globally, which amounted to an increase of almost 22% of the prior decade. It's astonishing that with even…

Thank you, Aaron. Turning to Slide 8. Before I begin, I think it is important to introduce myself since I have assumed the role of Principal Financial and Accounting Officer of the company. I've served as the company's Global Controller since October, 2022, and held roles of increasing responsibility within Amarin's finance team since 2019. Overall, I come into this role with nearly 20 years experience in various roles in finance, including accounting, financial reporting, tax and audit. The transition has been seamless, and I look forward to continuing to work with our tremendous global finance team in my new role. Turning now to the numbers. In the third quarter of 2024, Amarin reported total net revenue of $42.3 million, including net product revenue of $41.9 million and $400,000 of licensing and royalty revenue compared to total net revenue of $66.1 million in the third quarter of 2023. U.S. product revenue was $30.6 million in the third quarter of 2024 compared to $62.4 million in the third quarter of 2023. This decline was driven by lower net selling price due to the generic competition in the market and a decrease in volume due to CVS moving from exclusive to not cover. Despite the revenue decline, the U.S. business continues to deliver significant cash. Product revenue this quarter also reflects European net product revenue of $4.3 million, a $3.5 million increase over the prior year period, and an 800,000 increase compared to last quarter, both driven primarily by revenue growth from Spain and the UK. Third quarter 2024 cost of goods sold was $26 million compared to $36.2 million in the prior year period. Gross margin was 38% compared to 64% in the prior year period excluding inventory restructuring charges in the third quarter of 2023. This decline is due to…

Thanks, Pete. Turning to Slide 11. As we've shared this evening, there is significant long-term value in VASCEPA and VAZKEPA. This is clear both from what Amarin has delivered as well as what the external world has expressed in terms of validation of the science, the impact, and the value that our product can provide to patients. As we move forward, our focus is simple and clear to harness the proven attributes of the product to expand access for patients. We will focus on the strengths of and opportunities for this product. Over 10 years of science and clinical data, including more than 300 publications on VASCEPA and the backing of 50 medical societies around the world, recognizing the value of the product, the significant experience and support this product has gained through its commercialization in the U.S, the extended IP position in Europe out to 2039. The unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer worldwide. The multiple untapped markets in Europe and the rest of the world where access can be further opened beyond what we've achieved so far and accelerating usage in key launch markets, all in the name of our commitment to maximize the value potential at a faster pace. We also remain fully committed to our public listing is very important for us as well as to our shareholders. In addition to continuing to drive the business, there are a number of mechanisms we are considering that would help us regain NASDAQ compliance. Overall, we are making progress on our core priorities, but there is much more work that needs to be done quickly. We understand the need to accelerate performance to realize the potential of VAZKEPA and VASCEPA and that's what I and the entire team at Amarin are committed to delivering. Before we turn to Q&A, I'd like to thank our Amarin colleagues and partners around the world for their continued commitment and dedication. Your efforts are sincerely appreciated and very important for patients around the world. Thanks for your efforts. And with that operator, let's begin the Q&A portion of the call.

At this time, we will be conducting a question-and-answer session. [Operator Instructions] Okay. And our first question comes from Roanna Ruiz with RBS. Please proceed.

Hi. This is [Maisie Ali Mohammed] at Leerink Partners on for Roanna Ruiz. Just two from us. So the first, given the increasing rebating in 2024 for VASCEPA, what are your expectations for net pricing pressure kind of going forward in the short-term? And then secondly, are there any additional trials or data points that you believe could enable greater reimbursement coverage for VAZKEPA in the EU and/or China? Thank you.

First of all, thank you for your questions. We appreciate it. Thanks for taking the time to listen this evening. Regarding rebates and rebate pressure in the U.S. As you know, we've been in an increasingly generic market with the brand in the U.S. since November of 2020. The fact that we've maintained a 50% share of our volume speaks to the great work done by the team and the uniqueness of the product. In that, of course, the pressures have been increasing. There are now eight generic companies that are marketed in the U.S. So we do expect rebates to continue to need to go up, but that being said, we've maintained our exclusives. That's helped us maintain our volume. We still believe we can compete profitably in the U.S. and we'll continue to do that for the foreseeable future. Of course, it's a generic market. So it's something that as time goes on those pressures would increase. But each year, every time we get to this point in time, we say the same thing, and we've managed to maintain that 50 share. And hopefully that'll continue going forward. In terms of trials or markers to help increase reimbursement in Europe, I'm joined here by Dr. Steve Ketchum. He's our Executive Vice President, President of R&D and Chief Scientific Officer. Steve, do you want to touch on that?

Yes, certainly. So as we continue to support the brand globally including in Europe, we continue to conduct various subgroup analyses in this high risk patient populations, which not only interesting to the clinical community in terms of peer-reviewed publications and congress presentations, but also sometimes in pricing and reimbursement context to – provide that context in patients who are difficult to treat and clearly at high cardiovascular risk. There are obviously over time. There are other data points from other research groups that we feel continue to support that highly purified EPA is efficacious. And we continue to keep an eye on those and to fold them into our story as well.

And I'll just build on that because it's a good question. It would be – certainly if there was some silver bullet marker or some additional data that would add to what we already have and accelerate the process, we'd certainly be looking at that. The good news for us is we're well armed. We have tremendous clinical data now. And part of what we're experiencing in Europe with reimbursement is not really unique to Amarin. It's a challenging market dynamic for reimbursement for even some of the biggest companies with the biggest brands in Europe. So we feel very well armed with what we have managing the process as best we can. We're always looking for ways to improve. We've certainly done it in the last year or so. We've focused in on acute coronary syndrome patients. So there are higher risk patient population, more costly, more easily identified, more likely to get to have additional events, more likely to get combination therapy. And that seems to be helping accelerate things not only from a reimbursement perspective, but from a launch uptake perspective. So we're confident in what we have, where we realize that it's never fast enough. But I think the team is executing well and we look forward to more progress. As I mentioned in the prepared comments, hopefully, we have more to say about Italy fairly soon. We look forward to that.

Great. Thank you.

Okay. The next question comes from Jessica Fye with JPMorgan. Please proceed.

Hi, can you hear me?

Yes.

Hi. So we noticed that there is some momentum in the rest of the world in terms of revenue. Can you please give us some color on what is driving that? And then as far as EU, can you talk about the growth dynamic there? And then for the net price for VASCEPA in U.S., how do we think about the net price going forward? Do you think this is stabilized? Or like do you think it's going to continue to erode? Thank you.

Sure. So regarding the momentum in the rest of the world, as we mentioned we're early in a number of countries with launch, with reimbursement, with a number of partners and a number of regions that we're just getting going. So fortunately this is a product we know from the U.S. experience that when you educate, when you have the chance to promote that physicians respond well. It doesn't always happen fast in every market, but it happens. And the good news is we have a number of partners. We now have nine partnerships in rest of the world. In some of those regions, they are starting to kick in. So we're starting to see some of that momentum. Hopefully, we will see some of our partners make greater progress. Australia just got started for one. China just got started with the cardiovascular risk indication, and hopefully, that will accelerate being the big market that it is, and hopefully that will continue. The Europe growth dynamics, we've been encouraged by both UK and Spain, and maybe for slightly different reasons, UK we launched, close to two years ago. We changed our strategy, made a number of changes in the organization within the last year. And we're seeing that those changes have made a difference. And we're seeing a greater acceleration in growth. Spain was, from our perspective from launch on and now we have Portugal as well for reimbursement. Very good execution. The market is receiving it very well. We're seeing early signs of impact of education and promotion and growth, and we're excited to see what Spain can do going forward. Hopefully, we have good news on Italy going forward and as well as continued good news in some of these, again, back to the rest of the world, some of the rest of the world partnerships. So the foundation we think is getting stronger and hopefully we see more countries come along in the near-term. In terms of the net price, I'm going to turn it over to Pete to address that in the U.S.

Sure. Thanks, Aaron. I think just building off of what you said in the last question in terms of net price. Being in a generic environment, we are seeing price pressure, working with our partners and also the mix in terms of our business moving more towards Medicare Part D from commercial as a result of the CVS going from exclusive to not covered. Medicare is at a higher discounted rate. So we are seeing some pricing pressure there and just given the environment, we expect to see that pressure continue moving forward.

Thanks, Pete. Hopefully that – does that answer your questions?

Yes. Thank you.

Okay. Thank you.

[Operator Instructions] The next question comes from Paul Choi with Goldman Sachs. Please proceed. Paul, your line is live.

Hi. Good afternoon. Thank you for taking our questions. I wanted to ask about prioritization of capital. Your cash position has held relatively steady for several quarters now. But I think you've also discussed a share repurchase program. I just wanted to ask on the status of that. And secondly, as you think about business development opportunities and looking for potential pipeline assets, can you maybe just comment on how you're seeing the landscape and your capacity there? Thank you.

Sure. Thanks, Paul. Thanks for joining us. So prioritization of capital and on the repurchase, Pete, do you want to address both of those?

Sure. So in terms of the repurchase, as you know, we did get approval to initiate a repurchase program. We have that ability to initiate it for 10 years. And similar to what we said last quarter, we're continuing to monitor the business and market dynamics to determine whether we will commence that program. At this point, we have not purchased – repurchased any shares. In terms of just general kind of cash prioritization, we're always continuing to be mindful of our cash balance. We have been neutral to cash positive for nine straight quarters. During this quarter, we did receive the $15 million EDDING CVRR milestone payment. While we don't expect to have one – another material one-time milestone in the next quarter, we still are mindful of the cash and monitoring it and making sure that when our investments are prudent and that we are always looking for ways to find cost optimization.

And then the third question on business development and any consideration of looking at additional assets. Right now, our focus is on executing with VAZKEPA and VASCEPA. I think that we are very optimistic about our ability to grow that. We're starting to see that momentum that has been hard fought. We know that we need to – we'd like to get on firmer footing. When it comes to that growth, the cash we have as you can see and you followed us the last few years, we've been very judicious about managing our cash and our operating expenses. We've had several restructurings, including one last year with a singular focus to grow VAZKEPA in Europe because that market is enormous. We have till 2039 for a runway now. Thanks to a significantly expanded IP protection and those markets, we barely scratched the surface. And in some of those key markets, we haven't even gotten on the market yet. Again, not unusual for Europe and for a lot of companies, not that unique to Amarin, but we have a product that has significant upside. And we determine – we're determined to find a way to get it in more patients hands any way that we can. So that's our focus right now. In the future, we'll consider putting another product in the bag if we get to that point. But right now, we're pretty laser focused.

Okay. Great. Thank you.

This concludes the Q&A portion of the call. I would now like to turn the floor back to management for any closing remarks.

Yes. Thank you, John. First of all, thanks, everybody for joining us this evening. We appreciate it. Just as a reminder, on November 14th, we'll be hosting a virtual analyst and investor event. And what we'll do is we'll focus on the VASCEPA and VAZKEPA franchise, focusing in on the dynamics for some of the key geographies that represent the future of that franchise, our growth, and in particular a focus on Europe. And you can register for that through Amarin's corporate website. And beyond that, thanks again for joining us. Have a good evening. Bye now.

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