Amarin Corporation plc (AMRN) Earnings Call Transcript & Summary

Welcome to Amarin Corporation's Virtual Investor Day. I would like to turn today's event over to Mark Marmur, Vice President, Corporation (sic) [ Corporate Communications ] and Investor Relations at Amarin to walk us through today's agenda.

Thank you, Evelyn. Good morning, and good afternoon, everyone, and thank you for joining us for Amarin Corporation's Virtual Investor Day. Turning to Slide 2 on our forward-looking statements. Please be aware that this event 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 event, including both the webcast and related slide presentation will be made available on Amarin's website in the Investor Relations section. Turning to Slide 3 of today's agenda. We will begin today with Aaron Berg, Amarin's President and Chief Executive Officer, who will review the overall opportunity for VASCEPA and VAZKEPA globally; Steve Ketchum, Amarin's President of R&D and Chief Scientific Officer will discuss VASCEPA/VAZKEPA and its scientific foundation; David Keenan, Amarin's Executive Vice President of Technical Operations and President of Europe and Christos Papadopoulos, Senior Vice President and Head of Commercial for Europe will provide an overview of the European opportunity for VAZKEPA; and Eric Boothe, Amarin's Vice President of Business Development and Alliance Management will talk about the opportunity in the rest of world markets and U.S. market dynamics. Following the presentations, management will be addressing topics and questions submitted in advance of today's event in the Q&A portion of the event. With that, I will now turn it over to Aaron Berg, President and Chief Executive Officer of Amarin to get us started. Aaron?

Thanks, Mark. Welcome, everybody. First of all, thanks for the interest in Amarin. Thanks for taking the time to join us today. We've got quite a bit to cover. And the focus for today is there's a significant disconnect between the current share price and the unrealized value in VASCEPA/VAZKEPA globally. And we'll -- you'll hear -- for those of you who don't know, we use the brand name differently in different regions, and it will be used interchangeably here throughout the presentation. We recognize the urgent need to accelerate VASCEPA growth globally, and to increase shareholder value. There's a lot of potential -- untapped potential. We have a job to do, and we intend to do it. Today, we'll provide greater visibility into a number of changes and quite a bit of progress we've made from the ongoing initiatives and those changes to position VASCEPA for immediate and for long-term growth. So just to level set everybody, we are an Irish corporation traded on NASDAQ. We intend to maintain our NASDAQ listing. Last year, did just over $300 million in revenue. Market cap now is about $240 million with cash of $300 million and no debt and commercialized VASCEPA/VAZKEPA in a number of countries. So on the next slide, start off and talk about some of the strategic changes and the progress that have been made in the last 18 months. And I'll focus on the last 18 months because there have been significant changes. First and foremost, last year, we had a new Board and enhanced the leadership team, including changes broadly throughout the executive team, the CEO, obviously, Chief Legal Officer and European leadership. There's been a strategic shift in supporting the U.S. business to maximize cash generation. It's a movement that has gone from sales and marketing -- from a sales and marketing focus more to a managed care access and a rebate focus that's been successful. There have been significant changes in European pricing and reimbursement and overall brand strategy. We learned a lot from early stages. We've made adjustments, and you'll hear more about that today. And we've continued to execute regional partnerships. We have 6 new partnerships in the last 18 months. We know a number of regions. Partnerships are the best way to get VASCEPA in the hands of as many patients as possible. That's our goal, and we continue to execute that. And this year, year-to-date, we continue to execute the new commercial and pricing and reimbursement strategy for Europe, and you'll hear more about the progress throughout the presentation today. And then very importantly, earlier this year, we had new European IP granted, which extended the VAZKEPA exclusivity and opportunity in Europe until 2039. So you'll hear more about that. That's a significant opportunity for us, and that provides significant value. On the next slide, operational changes and progress that have been made over the last 18 months. So in 2023, in Europe, we secured pricing and reimbursement and launched VAZKEPA in 3 new markets: Spain, the U.K., most notably, Scotland as well and the Netherlands. In the U.S., we continue to retain VASCEPA IPE market share leadership. We've held on to our volume and that's been significantly beneficial. In rest of the World, we secured 5 regulatory approvals, including China for very high triglycerides, that's triglycerides over 500, advanced the cardiovascular risk reduction, regulatory process in China and entered into agreements in a number of key markets and regions, including Australia and New Zealand with CSL, and Asia Pac, including South Korea with Lotus. And significant R&D and medical progress. We're a science-based company. We -- our team has been very active, and there were 50 additional abstracts and publications supporting VASCEPA, 140 educational initiatives executed across Europe and a strong presence at 5 major congresses. 2024, we continued the progress. Spain, U.K. and Central and Eastern Europe continue to power the early growth that we're seeing in the countries where we've launched. So we've secured pricing and reimbursement in Portugal, Greece and Israel, and continued progress with pricing and reimbursement authorities in Italy, and you'll hear more about that today. In the U.S., we've continued to retain IPE market share leadership, and that's despite additional generic competition. As you know, we're in a generic market. We continue to battle. We've been successful so far. We'll continue to do that. Once we get to a certain point, we will be prepared to launch an authorized generic and generate continued revenue and cash moving forward. Rest of the world, Eddingpharm in particular, received regulatory approval for VASCEPA for cardiovascular risk reduction in China, and they're advancing efforts for the national reimbursement drug listing. And CSL Seqirus, our partner in Australia, they secured the pharmacy benefit listing -- price listing for VAZKEPA in Australia. And that will benefit them as they're launching now as well. So very good progress in a couple of key markets there. And R&D and medical continue to be very active, 25 additional abstracts and publications further supporting VASCEPA. Over 200 educational initiatives have been executed across Europe and a very strong presence at 4 major congresses. And then on the next slide, financial changes in progress. We have continued progress on renegotiating product supply agreements. We've limited significant at-risk spending in Europe prior to pricing and reimbursement agreements. We've learned a lot in Europe. Early on, we got a little ahead of ourselves with investments prior to pricing and reimbursement. You'll hear about some of the dynamics of those processes in various European countries and why we're trying to find the sweet spot of our investing to be very prudent and invest at the right time in the right countries, so we watch our cash. And we reduced operating expenses last year by $100 million compared to 2022. In 2024, we achieved $50 million in annual operating expense reduction as we committed in Q3 of '23. We secured approval for a $50 million share repurchase program, and we continued progress on renegotiating product supply agreements. So overall, there has been significant progress as a result of changes. And some of those changes, if you go to the next slide, please, are conducted by this team. This is our executive team, and we have a very deep bench for this team. You'll see that over the last year, certainly over the last 18 months, we've streamlined our executive team. The team has really stepped up. A lot of talent, a lot of experience, taking on additional roles and are driving the business in a manner that we think will be effective and successful moving forward. You'll hear from a number of these people today. Next slide, please. So the past progress and recent milestones set the stage for us for significant future potential for the brand. You know about the trials we conducted, 3 landmark trials, MARINE, ANCHOR and REDUCE-IT in particular. As a result of the data certainly led by REDUCE-IT, there's tremendous medical society support. Over 50 global medical societies have endorsed VASCEPA or VAZKEPA based on the data. 46 countries now have approved VASCEPA for cardiovascular risk reduction, and we're in the earliest stages in so many of those countries and just having gotten reimbursement or started in a number of those. So there's tremendous untapped potential. Now we know that this product responds to promotion. And so far, we have over $3 billion in sales globally from VASCEPA that we've generated primarily from the U.S., and I'll talk about that in just a moment because they're tremendous learnings. But with this extended runway to 2039, and a brand that has tremendous potential, that responds to promotion, supported by all these medical societies because of the strong data, we have a long runway to generate growth. Next slide, please. Now the U.S. is in a very different place from Europe, but there are learnings, many learnings from the U.S. experience that we had. And what you see in the graph on the left is the life cycle of VASCEPA since we launched in the U.S. in 2013 for very high triglycerides. Now what you see is we had time to promote and educate physicians ahead of the REDUCE-IT data, so there was awareness. Once the REDUCE-IT data hit, the acceleration was tremendous. The power of that data, I can't overstate it, greater than 50% increase in prescribers to over 200,000 prescribers in the first full year post publication and an 80% growth in new prescriptions in that first full year also. And the total IPE volume exceeded all PCSK9 inhibitors combined. And that continued, even though because of the generic introduction, we've reduced our promotion significantly. And that certainly made the difference in the ability to grow the total IPE market. But that is different than the experience we'll have in Europe. The experience in Europe, one, is we know, learning from the U.S., that if we take the time to promote and educate, providers respond favorably to VAZKEPA. We know they'll do that. We've seen that early. We're early in the stages. We've got a lot of work to do. We know we need to accelerate growth, and we'll do that. But a very important point is that in Europe, the IP runway is based on cardiovascular risk reduction. It's independent of the experience in the U.S. where we had the skinny label introduction of generics and lost that business. With the IP runway it's based on cardiovascular risk reduction. There is no very high triglyceride market for VASCEPA in Europe. So that's a tremendous benefit and adds strength and confidence in not only the ability to grow, but the long runway that we have for the next 15 years. Next slide, please. So bottom line is just to close by overall comments in this, there is a large global burden of cardiovascular disease. It's a tremendous unmet need, 60 million patients in Europe alone, and that is not going down anytime soon. We've got regulatory approvals, and we're very early in many of these countries, early with launch, early with introduction, early with pricing and reimbursement and we're just getting going. We've got a long runway of durable cash flows coming from rest of the world and the U.S. and certainly the opportunity to grow in Europe. That's on the foundation of this data, the REDUCE-IT data. And what you'll hear shortly is it's not just about the REDUCE-IT data, there's other data supporting IPE that provide support for the proven efficacy and safety, and that's why we have such strong broad global KOL and scientific guideline support. And an important point that affects commercialization is VASCEPA doesn't compete head on with other CVOT therapies. It's complementary to many of those. So there are a lot of products out there with CVOT data now, but VASCEPA is complementary, added on to standard of care. We don't have to displace other therapies, and that certainly makes a difference moving forward from a commercial perspective and should positively affect uptake. The next slide, please. So with that, I'm going to turn it over to Steve Ketchum. And what we're going to do is a lot of you are familiar with the REDUCE-IT data. And what we find in talking to investors is there's kind of a bell curve of understanding of the REDUCE-IT data. So what Steve will do is take you through the REDUCE-IT data, even though we know a lot of you know the data, but also show you how the data -- how we're looking at the data lends toward a new European strategy. So with that said, I'll turn it over to Steve.

Great. Thank you, Aaron. Any medicinal product -- if we could just stay on the first cover slide, please. Any medicinal product that is truly successful within the pharmaceutical landscape is built on a strong scientific foundation. The science behind our product is what gives us confidence in the global opportunity for VASCEPA/VAZKEPA. Next slide, please. The backdrop is cardiovascular disease or CVD, which is depicted on this slide as the leading cause of death globally, with at far right, approximately 20 million CVD deaths reported globally in 2021. And this significant health problem is only increasing in prevalence and in terms of the economic burden, whether that be in the United States, as reflected in the middle of this slide, or at left in Europe where more than EUR 280 billion are spent annually on managing CVD disease. Cardiovascular disease remains the #1 killer globally, and innovative products and approaches guided by strong science are needed to address and impact the significant health challenge that CVD represents to society. Next slide, please. And it is important to acknowledge that there have been some therapeutic advances, including products such as statins that lower LDL-C, though residual risk remains a critical issue that we need to address in order to more positively impact cardiovascular disease. As depicted in the left panel on this slide, even statin-treated patients with well-controlled LDL-C levels are at risk for a cardiovascular event over the years of follow-up in the cited outcomes trials with that residual risk were reflected by the light blue, dark blue and red curves going up on the Y axis over time in the respective studies. In the right panel of this slide, the ability of VASCEPA/VAZKEPA to exert a cardiovascular benefit on top of statin therapy is shown, with a 25% relative risk reduction on the prespecified primary composite endpoint, looking at the time to first event for a 5-point composite of myocardial infarction, or MI, stroke, CV death, coronary revascularization or unstable angina. Next slide, please. So statins did represent a demonstrable leap forward compared to pre-statin therapies such as niacin, fibrates and bile acid sequestrants, which modestly lowered bad cholesterol or LDL-C, or increased good cholesterol also referred to as HDL-C. The era from 1987 forward was a period characterized by aggressive lowering of LDL-C, with the prevailing model being lower is better, which led to the successful development and introduction of a range of therapies, including statins, PCSK9 inhibitors, ezetimibe and bempedoic acid. But as previously mentioned, residual risk remains in spite of well-controlled LDL-C, and other innovative approaches are needed to address that residual risk. VASCEPA/VAZKEPA has been proven to reduce CVD risk on top of statin therapy and has been endorsed by leading cardiovascular medical societies, such as the American College of Cardiology, the American Heart Association, the European Atherosclerosis Society and the European Society of Cardiology. Next slide, please. And as Aaron mentioned and as summarized on this slide, there are a number of clinical studies conducted prior to the availability of the REDUCE-IT study results that independently demonstrated the consistent benefits of icosapent ethyl on either cardiovascular outcomes. See the top of the slide for the JELIS trial at left published in 2007 and the Nosaka et al. study at right published in 2017 or on plaque reduction as depicted in the bottom of the slide for the Nishio et al. and Watanabe et al. studies published in 2014 and 2017, respectively. And as reflected on the next slide, following the readout of our REDUCE-IT cardiovascular outcome study, an imaging trial with icosapent ethyl on top of statin therapy called EVAPORATE read out positively in 2020. And earlier this year, another Japanese outcome study research team published their study results showing a numerically lower risk of cardiovascular events in patients treated with icosapent ethyl statins. And as I will discuss later on, our own recently published subgroup analysis of high-risk patients with recent acute coronary syndrome shown at the bottom right of this slide, further reinforces and validates the clinical value of VASCEPA/VAZKEPA to address segments of unmet need in cardiovascular disease. Next slide, please. The clinical development program for VASCEPA/VAZKEPA is summarized on this slide. Across 2009 to 2011, 2 12-week lipid biomarker endpoint studies were conducted. The first of these was called MARINE and enrolled patients with severe hypertriglyceridemia characterized by baseline levels of triglycerides between 500 to 2,000 milligrams per deciliter. Primary endpoint in this study was change in triglycerides at week 12, and icosapent ethyl demonstrated a significant 33.1% reduction in that endpoint, which supported the very high triglycerides or VHTG indication in the United States. A second study called ANCHOR focused on statin-treated patients with well-controlled LDL-C, but who had high triglycerides in the range of 200 to 499 milligrams per deciliter. Icosapent ethyl in ANCHOR also met its prespecified endpoints of demonstrating significant reduction in triglycerides while not increasing LDL-C. But evolving scientific and regulatory standards, relegated the main role of this second study, ANCHOR to supporting the safety of VASCEPA/VAZKEPA in the VHTG label in the United States. Although TGs were reduced in the ANCHOR, 12-week lipid focused trial could not substitute our cardiovascular outcomes data to achieve a broader indication, which elevated the regulatory standard for it and then the importance of Amarin's landmark REDUCE-IT study. REDUCE-IT involves statin-treated patients with well-controlled LDL-C in multiple cardiovascular risk factors, including elevated triglycerides in the range of 135 to 499 milligrams per deciliter. 8,179 patients were enrolled, 70% of whom had established CVD also referred to as the secondary prevention cohort and 30% of whom had diabetes mellitus and other agent risk factors for CVD or the primary prevention. Patients were followed across time for a targeted 1,612 cardiovascular endpoint events and the key results are summarized across the next couple of slides. Next slide, please. The REDUCE-IT study demonstrated that icosapent ethyl significantly lowered the risk of ischemic events, including the primary endpoint of 5-point MACE displayed at left, which features prominently within the approved United States labeling and also met statistical significance for the key secondary endpoint of 3-point MACE, which features prominently within the Europe -- the approved European labeling and is displayed at right. And as shown on the next couple of slides, the consistency of the REDUCE-IT study data across key clinical endpoints and key patient subgroups has paved the foundation for Amarin's regulatory successes to date and obtaining approvals for the cardiovascular risk reduction indication. As shown in the green boxes at far left and far right of this slide, the study met the first 9 endpoints in the prespecified hierarchy, with statistical significance in favor of the icosapent ethyl treatment arm. As shown in the bottom row in the tenth position within the endpoint hierarchy, total mortality did not reach statistical significance below the 0.05p value level as reflected at far right, but the total mortality results did trend in favor of icosapent ethyl. In summary, this robustness and consistency and clinical endpoint data gives Amarin confidence in the global opportunity for VASCEPA/VAZKEPA. Next slide, please. On earlier slides, I summarized the various studies since 2007 that have consistently demonstrated positive results for icosapent ethyl products in cardiovascular outcomes and imaging trials. This consistent demonstration of cardiovascular benefit is also true across prespecified and post-hoc statistical analysis conducted on key patient subgroups from REDUCE-IT. Following the presentation and publication of the primary results for REDUCE-IT in late 2018 at the far left of this slide, which showed a 25% relative risk reduction in the full study population, Amarin and the study steering committee have continued across the past 6 years to perform further analyses of key patient subgroups and to present and publish time-to-first event and total or first in subsequent events data for these subgroups. At the far right of this slide, the subgroup of patients who have experienced a recent acute coronary syndrome or ACS, defined as myocardial infarction or unstable angina less than 12 months before randomization into the REDUCE-IT study. These data, which were presented at the American College of Cardiology Scientific Session in 2023 and published in the European Heart Journal earlier this year showed that icosapent ethyl substantially and significantly reduced the risk of first and total ischemic events by 37% and 36%, respectively, without increasing bleeding in these patients with recent ACS who are at very high risk of future CV events. In summary, this robustness and consistency of time-to-first event and total first and subsequent events data across key patient subgroups and REDUCE-IT gives Amarin confidence in the global opportunity for VASCEPA/VAZKEPA. Next slide, please. After the REDUCE-IT study results were first presented and published in late 2018, as Aaron mentioned, you can see at the far left of this slide, that leading medical societies in the United States at top and internationally at bottom began to issue statements in 2019, recognizing icosapent ethyl, the active pharmaceutical ingredient in VASCEPA/VAZKEPA as an important treatment for atherosclerotic cardiovascular disease. The fact that 50-plus leading medical societies across the globe have endorsed icosapent ethyl to date across the past 6 years is a testament to the robustness and consistency of the REDUCE-IT data across cardiovascular endpoints and across key patient sets. Next slide. As Aaron mentioned, across the span of the clinical development program, Amarin and the study investigators have remained committed to presenting and publishing on VASCEPA/VAZKEPA science, with a robust catalog of more than 500 abstracts, manuscripts, review articles and book chapters published from 2011 to the present day. This important scientific work continues, and we look forward to the presentation of a new REDUCE-IT sub-analysis in patients with and without coronary artery disease and to presentations and mechanistic data on eicosapentaenoic acid or EPA this coming weekend at the American Heart Association Scientific Sessions in Chicago, Illinois. Next slide, please. And that wealth of positive cardiovascular benefit data on VASCEPA/VAZKEPA and other icosapent ethyl products that I summarized on earlier slides stands in stark contrast to the 10 cardiovascular outcomes trials depicted on this slide, which have reported out across the past 20 years on various fibrates and darker fonts in EPA plus DHA mixtures in lighter font. Each of these 10 studies involving a total of more than 106,000 patients failed to demonstrate cardiovascular benefit. A key takeaway from this slide is that fibrates and EPA plus DHA mixtures provide no benefit to reducing cardiovascular risk. The millions of patients worldwide who are continuing to be treated with these therapies need other treatments that have proven to reduce CV event risk. Next slide, please. And this slide provides a high-level summary of select diabetes therapies, statin monotherapy, statin-intolerant therapy in various agents added on top of statin therapy, which have been proven across the past 20 years to reduce cardiovascular outcomes when added to current standard of care. The names of the specific therapies are listed above the names of their respective cardiovascular outcomes study, descriptors and names and the years that the primary study results were published. The percentage, relative risk reductions in major adverse cardiovascular events or MACE achieved by each therapy are listed in the arrows from each study's primary composite MACE endpoint. Below each arrow is cited the corresponding number needed to treat or NNT, which is the number of patients who need to be treated to prevent 1 additional bad outcome. Listed NNTs are based on the primary composite MACE endpoints of each trial. Although cross-trial comparisons are subject to differences in study populations, primary outcomes and other study design aspects, the data within the box element at the far right of this slide for VASCEPA/VAZKEPA gives us confidence in the global opportunity for the product. The robust 25% relative risk reduction reported for the primary composite 5-point MACE endpoint with an NNT of 21 for the whole study population demonstrates the ability of our product to reduce the residual risk that remains after controlling an LDL-C with stable statin therapy, and a 37% relative risk reduction in MACE with an NNT of 11 for the key subgroup of patients in REDUCE-IT with a recent acute coronary syndrome or ACS, highlights the ability of VASCEPA/VAZKEPA to substantially reduce the risk of another cardiovascular event in patients who are at very high risk of future cardiovascular events. As we have shown today, VASCEPA/VAZKEPA has a sound and compelling scientific foundation, clearly demonstrating our product's ability to reduce residual CV risk. Our products' relative risk reduction percentages and NNTs qualitatively stack up well relative to other therapies. And given the overlapping comorbidities of patients enrolled across these various trials and the differing mechanisms of action of their respective therapies, it is Amarin's view, as Aaron conveyed that the likely multifactorial mechanisms by which VASCEPA/VAZKEPA exerts its biological effects may very well be complementary to other therapies shown on this slide or to other investigational products under development for cardiovascular disease. I will now turn the call over to David Keenan and Christos Papadopoulos who will share more about the European market and how this compelling scientific story for VASCEPA/VAZKEPA is being leveraged for progress in the region.

Thank you, Steve. Hello, my name is David Keenan, and it's my pleasure, along with Christos, to talk to you about our progress to date in Europe and the significant opportunities we see in the years ahead. Before we get into the detail on the product itself, I think it's worthwhile maybe talking a bit about Europe and the pricing reimbursement process that takes place in the European countries. So first, if we look at the -- Europe is a significant market, but there are significant differences between it and the U.S. So we look, first of all, from pharmaceutical spending. In Europe, we spend approximately $200 billion annually on pharmaceutical products wherein the U.S. is in excess of $600 billion. When we look at the population, there are around 600 million people in Europe and around 335 million people in the U.S. And then when you look at the reimbursement environment, there's quite a difference. So you can't think of Europe as 1 block and everything is done the same. There's different pricing and reimbursement models in each country or each group of countries. And these can be a cost-effectiveness model, they can be a comparative clinical effectiveness model or they can be budget optimization market models. The system in Europe is publicly financed and the governments in each country focus on cost containment, affordability and predictability of health care budgets, and there is 100% accessibility for all citizens. When you look at the U.S. system, it's a mixed system. You've got the U.S. government financed Medicare and Medicaid and the coverage coexists with private insurance, and approximately 50% receive private insurance. When you look at the pricing environment in Europe, it's a list price international reference with confidential discounts, whereas in the U.S., it's a WAC price and its confidential discounts to payers. And then as Aaron mentioned earlier in the presentation, when it comes to generic competition in Europe, we have IP runway now to 2039. And really importantly, we don't have the VHTG skinny label competition where in the U.S., we're in the middle of a generic competition as we speak. And then we look at time lines. In the U.S., it's a quick access post-FDA approval; where in Europe, it's slow gradual access in each country post-EMA approval and each country is unique. And if we go to the next slide, I'll highlight this time consuming pricing and reimbursement and commercialization pathway and it's highly dependent in each government within Europe, its ability to pay and also its willingness to pay. So the process starts where the company submits the regulatory approval, market authorization either into the EMA or the U.K. MHRA. So we submit the market access and reimbursement dossier and the process starts. So the first part of that process, then there's scientific assessment and a recommendation, and then after that, it goes on to pricing and reimbursement negotiations and finally, onto country launch. But what's really important to note is that it's not just 1 step. So what can happen is there can be multiple iterative steps within the scientific assessment where it's back and forth between the scientific assessment community and the company. And then when it gets on to the pricing and reimbursement part, there can be multiple steps and back and forth between it and the companies as well. And when you look at the average time within Europe, it's just under 2 years, so 531 days average time to access at a country level after market authorization application. And what's also a point to note is that the average rate of availability in countries after market authorization is 43%, which means companies that have actually applied to submit their market access and reimbursement dossier, less than half of those companies are successful in getting reimbursement for their products. So then if we move to the next slide. So as Aaron mentioned, and Steve in his earlier presentation, there's a significant opportunity in Europe and it represents significant unmet need because we've got a broad approved VAZKEPA label. So we estimate there's 6.6 million VAZKEPA eligible patients on secondary prevention only in Western Europe. As we mentioned earlier, we're at the initial phase of this commercial opportunity. We have IP protection until 2039, with regulatory approval until 2031. So even though we're at the early phase, we've got a very long 15-year runway ahead of us. And then if we go to the next slide. So what's changed? So as Aaron mentioned earlier, about 18 months ago, we changed out the leadership team and changed about how we approach things. And just to highlight, before that, how we are approaching the market in Europe. So our past approach was based off VAZKEPA's strong data. We had an approved label and potential benefit for patients, and the team pursued large patient population focus and commercial effort, significant investment well before the pricing agreements were in place and the VAZKEPA budget impact was not aligned to the initial market access opportunity. So we could clearly see this wasn't working and a radical change was now required. We changed out the leadership team, but also we changed -- a different strategy was developed and adopted. And now with the way we operate, it's a new focused commercial strategy tailored to each country's needs. So this initial focused patient profiling and specialist customer targeting, the resource optimization and prioritization and finally, focused VAZKEPA value proposition emphasized and well understood. So this new team, new strategy, has led to recent successful P&R agreements, which Christos is going to go through in more detail, accelerated sales growth and reduction in operating expenses. And how are we doing this? If we go to the next slide, please. So we have a new operating model. So even though we maintain a critical regional support, it's significantly smaller now than it was in previous leadership teams. So the shift has focused now to ownership and country execution. We have a much leaner organization. We focus on speed to access, quick uptake and optimal use of resources. As I mentioned on previous slide, we've minimized investment at risk and ruthless prioritization on activities that generate revenue or access fast with a high probability of success. Fourthly, we have an entrepreneurial mindset and an agile shift of tactics when needed. So we have abort/quit fast. If something is not working, we stop doing it; if something is working, we're working it faster. We accelerate what works. And finally, a proximity between the teams. We have fast exchange of key learnings. So what's working in one country, we make sure that we apply that into another country as fast as possible. And if we go to the next slide. I'm going to hand you over now to Christos, who heads up the commercial organization. He's going to provide the details further on our success to date. Thank you, Christos.

Thank you, David. So both Aaron and David emphasized a few times now the different strategy we have been following in the last 18 months. So with this slide, I will try to make it in practical simple words, what are the 3 main pillars that create this new strategy. So one part is our very clear focus to very high-risk patients. And this practically means we are referring to the established CVD to the secondary prevention patients of our labels. These patients are practically patients that have had an event in their past. By focusing in this group of patients, it is clear that we are addressing first to both payers and clinicians, the patients first where we do have a subset with stronger results. But also, we are speaking about the patients that both payers and clinicians are more interested to treat now -- feel that they are more interested to treat. The implications are both for access and for marketing. So in terms of access, -- it means, first, that we are talking about patients that payers connect, that clearly, they have a critical unmet need. But at the same time, it means that we come with a more rational budget for the first years of access, which we can then open up. The second implication is directly linked to what Steve mentioned earlier about the recent publication about our recent ACS patients. So what is the recent ACS patient? The recent acute coronary syndrome patients are the patients that simply had an event over the last 1 year. So you do understand that when we start talking about this specific patient population, it's very evident, it's very clear that the doctors are much more willing to add a new therapy, new brake therapy in order to manage their residual cardiovascular risk simply because they know that these are the patients that do run the risk of having a subsequent event. I think as Dr. Sasha Koul mentions in the video that we will be playing a little bit later, you need to think about the way clinicians today treat hypertension, where they do prefer to use multiple brands that address multiple pathways in order to manage the hypertension issue, hypertension risk rather than exhaust the potency of just one therapy with one -- addressing just one pathway. This change in strategy in terms of patients does create subsequently a change in our go-to-market model at launch. So over the last 1.5 years, we have focused drastically on both specialty accounts, but also specialty prescribers. And why? Because first, this is where we are going to find these very high-risk patients that we would have had a recent event where doctors do need more tools to treat them with and for which patients are more open to receive more therapies. And this is providing us traction both in sales but also in creating advocacy and adoption of the brand faster for these very high-risk patients. The third pillar of our new strategy is a little bit, I would say, more opportunistic and linked to the constraints of Amarin, which is a more ruthless country prioritization and where we choose to place our resources over the last 1.5 years. So we did decide back 1.5 years ago to say, no, we are going to double down, we're going to maximize our effort and our resources in the countries that can deliver a positive reimbursement outcome sooner so that we can create the critical mass for us to start generating a sales uptake through our launches. So in the next slide, if we can go to the next slide, please, then we will see -- okay, that practically, with this new strategy that we did implement, we did have a series of P&R successes over the last 1.5 years. And you can see that we have Scotland, Spain, Netherlands, Israel and Greece until today. On this chart, you do see that we do estimate that we will have Italy within 2024. And the reason why we boldly state here that we will have Italy is because we do know that we have taken all the right steps from our side, but also all the right steps have been taken from AIFA side, from the payer side in order to be able to deliver a positive outcome within this year. I cannot share more today, but I'm very confident we will be able to share positive news in the coming weeks. These successes that we have over the last period and until the end of 2024, we have covered all Western European countries that accounts for 52% of the eCVD depopulation in Europe, up to the 6.6 million that David measured earlier. And this is a big enough critical mass. Now the key success factors that are driving -- that help us drive this access is, I have them in the bottom of the slide, but let us focus on 2 simple ones. The one is that, first, with benchmark, what we call the budget impact tolerance of the payer or better, the ability and willingness to pay. But we also couple this with the right patient population, the right patient profiles, which the payer can very easily recognize that, yes, these are the patients that need to be treated first. So this is how we accelerate our entrance in the market and leave open the opportunity to expand this population in future discussions with our payers. Now if we go to the next slide, it's also very clear that there is a big number of countries that we are in the process to reimburse in the coming years. And clearly, Germany and France have the biggest of those. But this still account for a little bit less than half of the countries that we have reimbursed today. And I want to make sure that we all understand that today versus a year ago, we did have open more than 50% of the population that will need to drive our seats. But these are all very recent launches and the countries that we have launched so far, clearly -- we've just had 3 launches in the past 1 month, clearly will be the ones that will source our growth in the coming years. But now if we go to the next slide, I would say the natural question that will come is, do we have a winning launch strategy? So do we have what we take -- what it takes in order to make sure that we can have an accelerated growth post launch? And I will answer with confidence today, yes. And I'm saying with confidence because we did manage over the last year 2 very significant markets, both Spain and the U.K. And both of these markets for 1 year has fed us back with very successful learnings. So if I would go a little bit faster on the titles of the 6 key success factors that constitute -- that create this winning plan post launch, one is yes, it's clear that we need to achieve strong medical advocacy, but it's also important to make sure that we provide the platforms to these KOLs that embrace the product years now to be able to speak about what they believe about the product. The second, we need to double down on explaining the medical need even before reimbursement, but still continue to do it after reimbursement. And the role of TGs on that, simply because there is an inertia out there with all the different therapies of the past year that we're managing a different pathway, and that's LDL. So this is an effort that we will keep maintaining at a very high intensity even post launch. The next 2 key success factors talk again about focus. So our choice is linked to what Aaron said earlier, that our product is promo sensitive, but our product also needs at least a certain number of visits, of deliveries of the right message to a certain -- to a physician in order for him or her to change their behavior. So our choice over the last year has been to reduce our targeting group and double down and increase in investment in order to achieve higher frequency in time. And we did that with a more targeted patient profile, which you understand by now with the recent ACS data that we do have, we have the ability to speak -- to use very impactful data and connect them to patients that need to be treated urgently with multiple pathways in order to address their risk. The last point, which is very important, and there has been a radical shift there is that we realized over the last year that we had to change our marketing mix and put much more effort into peer-to-peer education simply because the product has so strong data that is embraced by the scientific leaders and the key opinion leaders and the medical societies. So we need to create these forums where peers come together with the scientific leaders and do hear from them rather than just from our reps about the benefits of using VAZKEPA. And the last is much more technical. Yes, it does require discipline and a tight KPI monitoring in order to make sure that we will have a good launch. Next slide, please. With these success factors today, I do feel proud that we do manage to change the curve, to bend the curve and today, over the last 4 quarters, do run with a compound growth of 50% quarter-over-quarter. But I'm not ignoring the fact that this starts from a smaller base. And it's also important for all of you to know, although you know that we have reimbursed in 9 countries so far, this is mainly driven by the 2 big countries, Spain and the U.K. So Spain has had a strong launch right from the beginning, implementing one by one all the success factors that I mentioned before with a very tight execution plan. And the successful launch of Spain, allow me to say, that it did help us implement faster changes in U.K. And these changes combined both leadership, but also resetting the strategy and refocusing in the recent ACS patient strategy and in the ACS key accounts and this is -- these are the changes that today allow us to say that U.K. is delivering significantly increased growth. So concluding the European section, if we can go to the next slide. I would like just to highlight some key takeaways. I think it's very evident that we are addressing a very critical unmet need, yes, with a broad level, but focusing on very high-risk patients. We are the only clinically-proven cardiovascular risk reduction therapy today for the patients we studied. We do have a long run we simply because we have a strong IP protection until 2039. But most importantly, the last year, we have implemented significant strategic and operational changes that fundamentally alter the picture and are responsible for the progress we see today. The other point is that we do have a new laser-focused strategy that help us unlock advocacy, access and sales. And needless to say that we are sitting on a very robust supply chain ready to serve our future growth. I want to take the opportunity since you are all here to share with you a video, where actually we do have some significant scientific leaders from the countries we have already launched that do take this opportunity and share with us, first of all, the medical need they believe our product addresses, but most importantly, how we have adopted it already in their day-to-day clinical practice. Let's go through the video. [Presentation]

So I hope you enjoyed the video. And now let me pass it to Eric Boothe to speak about the rest of the world opportunity as well as the U.S. market insights. Eric?

Thank you, Christos. And yes, I'm going to just take a brief moment and update on rest of world as well as U.S. First, when we talk about the rest of the world, those regions outside of Amarin's core footprint, as you've heard, our goal is to get VASCEPA/VAZKEPA into as many patients' hands as possible. You hear the clinical benefits that Steve walked through from those KOLs, and we really want to get that to as many patients as possible. To do that and to expand in geographic reach, we do that through partnerships. And importantly, that allows to access those patients faster, more efficiently using that local expertise of those companies. They have the relationships, the know-how and the infrastructure in place. This allows us to not only share the cost, but also mitigate the risk. And again, like I said, to get VASCEPA/VAZKEPA into hands of patients as efficiently and rapidly as possible. On the next slide, you'll see our 9 current partnerships. And these are across the world, folks like HLS in Canada, CSL in Australia, Edding in China. Each partner is somewhat in a different stage within the process. You've heard outside the U.S., the various processes for pricing and reimbursement beyond approval, from David and Christos, that plays similarly in many of these regions. Lotus in South Korea and Asia, Southeast Asia, for example, is in a very early regulatory process, as well as Central Eastern Europe, our partners, Vianex, Neopharm, MagnaPharm and Salus are also in various processes of regulatory price reimbursement as well as commercialization. So you can see we've selected partners who have that local expertise, really driving that efficiency to get VASCEPA/VAZKEPA across the globe and into patients' hands. On the next slide, I want to highlight 3 markets and 3 partners that we're working with. As you've heard, with cardiovascular risk reduction, really, VASCEPA is just getting started, not only in Europe but also globally. Eddingpharm in China, very large market. It's been shown, 330 million patients with cardiovascular disease. And Eddingpharm was -- we've had great success. The team has worked very hard, not only that approval in 2023 for VHTG, but this year in July, received that label expansion for cardiovascular risk reduction and is initiating that commercial launch as we speak against that market. Biologic similarly is expanding into cardiovascular risk reduction, in particular in Saudi Arabia. And in that market, they're working with the authorities on pricing and reimbursement and progressing that commercial launch as well. Additionally, most recently, CSL Seqirus in Australia, they received the approval in November of '22. Pricing and reimbursement process there was just achieved in October and very excited as that commercial team gets going and brings VAZKEPA to that market and those patients. The next slide will touch on the U.S. And as we look at the U.S., as Aaron said, significant growth post REDUCE-IT. And this slide is to highlight the durability and show the market share that the brand has been able to maintain and that market leadership that we continue to drive with the brand. Through that time, we've generated $2 billion worth of revenue for the brand here in the U.S. Additionally, to maximize profitability, we've reduced our operating expenses which this graph also depicts for you as we've gone across time and to today, as our strategy continues to be to maximize profitability of the brand and reduce OpEx where possible. To continue that cash flow and the durability ongoing, the next slide kind of shows the levers we have to work with. I'll start with the managed care exclusive contracts. Those really drive that brand leadership in the market, and we will work to continue to keep those in place. We also have additional potential operating expense reductions as we go forward that we can leverage. And then as Aaron mentioned, we continue to monitor the market and the dynamics of pricing and profitability of the brand and have the ability to launch an authorized generic when necessary. So with that, I'll turn it back to Mark for the Q&A session.

Thanks, Eric. So we're going to start the Q&A now. In the lead up to the event and the registration process for the event, we asked participants to submit their questions in advance. We did receive around 60 questions for participants who registered for today. What we've done is we've kind of bucketed those into core topics and themes and we're going to start to address those in the Q&A session now. So to begin, there is a lot of focus on the stock price and specifically the NASDAQ delisting. Aaron, you mentioned it earlier in the presentation that we're committed to that listing. Can you tell our investors a little bit more about our plans and how we plan to mitigate that and address that?

Yes, sure. So obviously, this is a question first and foremost, in so many minds and ours as well. And just to reiterate, as I've said, as Mark just said, we're committed to maintaining that listing. And we have several paths that we can do -- that we can execute to maintain that listing. We've talked about the share buyback. Of course, many are aware of a reverse split. We're going to be very thoughtful and very judicious about which way we go. And there are other paths that are available to us as well. One thing that we've done just recently is we've been working with NASDAQ, and we filed an application with the exchange for a deadline extension. And this is a commonly used path in situations like this. NASDAQ doesn't want to delist anyone. Once approved, if approved, and we do expect it to be approved, then that would extend the time for our compliance out to May of 2025. So overall, we're going to do what's best for the company. We recognize the importance of maintaining that listing, and we will find a path and choose the optimal one that benefits shareholders.

Great. Thanks, Aaron. There's a lot of focus on our plan. There were questions around, do we really feel like we have a realistic plan? Does management and Board feel like our plan is sound and realistic?

I mean, that's a good question. I hope today that was enlightening, that we showed we have a plan. And we continue to learn. We continue to evolve the plan. And we do it urgently. We make changes, as you heard from Christos and others that -- and David that we take those learnings, and if we need to shift course, we do that, and we do that quickly. We understand the urgency to drive our business, and we need to move that forward. So we'll continue to execute the plan that we have presented today, the activities today, but we are open to exploring every opportunity to get this product to as many patients as possible globally. Nothing is off the table.

Thanks, Aaron. Going beyond the plan that was laid out today, investors want to know about the life cycle management and are there opportunities that go beyond the current opportunity with this product?

Yes. I think I'll have Steve touch on that. Steve runs R&D. We explore so many opportunities. We're presented with so many opportunities from a lot of experts out there because this molecule is so unique and has so many systemic effects. There are a lot of places that we could invest. We have to be judicious. But Steve, do you want to comment on that?

Yes. Thanks, Aaron. And you're right, in terms of life cycle management, there certainly are other potential opportunities for this molecule beyond its value in addressing residual CV risk. And we've seen that through, as you mentioned, inbound requests, but also independent investigator-initiated studies in other disease areas. We also have a multifaceted collaboration with our partner, Mochida to explore development of potential drug products and indications based on the active ingredient in VASCEPA/VAZKEPA. But those potential future opportunities that are contemplated under that collaboration agreement are currently in early stages of development. And the reason for that is really based on the fact that we need to stay disciplined and focused on the near-term opportunity for our existing commercialized product. And that takes, again, a strong scientific foundation, a lot of blocking and tackling in these various markets. And so we need to focus for the moment on VASCEPA/VAZKEPA, maximizing that opportunity. But with the extended IP runway, it certainly makes some of these other life cycle management opportunities possible in the longer term.

I mean we'll explore, but it will not detract from what our mission is, as Steve said, that is we need to get VASCEPA/VAZKEPA going at a faster rate. And we're encouraged by our progress. We have confidence in our plan, confidence in the team, and we're determined to do that.

Thanks, Aaron. Thanks, Steve. We shared a lot of information about the plan and the business today. One question that our investors had around today's session is, is it positioned for -- positioning the company for a sale or a partnership?

We get that question all the time, right? We have a product that has tremendous potential. I mean the cardiovascular burden globally is actually increasing. We've got a product that can certainly make a difference there. We are making commercial progress. We're making regulatory progress with more approvals, pricing and reimbursement progress and that -- we're encouraged by that. We are in the early stages in a lot of countries. It may not feel that way because there's a long history, especially people that have been focused on the U.S. In the U.S., we've been at it since 2013, that's quite a long time. But really, outside the U.S., we're still in the early stages. And some countries, we haven't even gotten started yet but are encouraged by the potential in those countries. Now that being said, we need to find a way, and we're open to explore any opportunity to get VASCEPA in the hands of as many patients as possible. We know based on the data, what this drug can do and benefit in so many countries, and there are millions of patients that could benefit from it. And we'll be open to any opportunity that's presented, and we'll continue to explore. But in the meantime, we will execute the plan.

Great. Thanks, Aaron. Turning attention to Europe. There is a lot of focus on making sure launches are successful. As we think about in advance of pricing and reimbursement processes, what steps do we take to prime the market to prepare faster access and uptake for those launches?

Why don't we have Christos and David. They've been so hard at work in Europe and really made a difference. So maybe you guys want to address that.

Maybe before Christos jumps in, maybe just at a high level, and I touched this earlier on in the presentation about the change that's taking place. So historically in Europe, we invested heavily in building up teams within country before we had the pricing reimbursement decision. And as I outlined in the presentation, it can take 2 years to get a decision. So that was a significant cost for the business. So in July of 2023, we made a decision that we would only invest significantly in a country once we had pricing reimbursement, but we would invest judicially. And what we were investing in was in medical. So when we look at countries from price reimbursement, we're negotiating with the countries. But at the same time, we're building up medical efficacy in that country using our medical employees. And I think that's where we've learned significantly from other countries what works well. And I think Christos can go into the details of how we pick the patient groups, how we do that, but that's the big shift. We're saying, look, we spend our money on the medical advocacy within that country identifying who are the right doctors, consultants in those countries that we need to engage in, how many times we need to engage in. And then once we've got the pricing and reimbursement, then we look to invest and hire the commercial organization. So maybe Christos can go into detail of how we pick those key people that we need to talk to and who will be kind of key opinion leaders for those countries going forward.

Exactly. And always under the umbrella -- under the understanding that even every country is different. There is a common ground on how we need to prime the country, first of all, for access, but also for subsequent faster uptake. So going back even to the success factors I was mentioning earlier, there are 2 areas that anyway, these are the most critical ones in order for us to prime the market to get access but also to be in a position for a fast uptake. One is what, David said, strong medical advocacy, but this is not only identifying the right patients. And of course, with our experienced medical colleagues, we have -- we are able to identify the right key opinion leaders. But it's also making sure that they can -- they are in a position to advocate so strongly for the product that they can be -- they can speak on our behalf, both to payers or future early adopters. That's the first one. And I would say that the second item, we always need to remember that we are introducing a breakthrough therapy, a new paradigm, which on top of all these LDL therapies that were launched recently, which means that despite on top of just prepping through the KOL community, we really need early enough to start educating the broader community about the need -- the medical need that exists there, residual risk, and making sure they understand what is the TG role about. Now -- and that's after -- and these 2 can be very much supported by our medical teams, and this is where we invest, even prelaunch for the countries that we are pursuing reimbursement. Now there is a difference, I would say, in the countries where I did speak openly earlier where there is a high probability to get reimbursement simply because we know their process. We see the level of advocacy. There, we can open up our investment without necessarily bringing an army of reps early enough where we can start speaking about the very specific, very high-risk patient profile even to a broader prescribing base through the different congresses and through the different peer-to-peer events that are happening. And the second part is this is a period where we do take advantage in order to identify this focus target group that we will need to start creating frequency and promoting right after reimbursement. Now if we do feel that we have a more -- a longer runway to educate even KOLs or if we do understand that it's going to take longer to get access, then we -- this is where we are really prudent on how we are investing our resources. But medical, I would say the #1 resource and the #1 focus of this priming phase.

Thank you, David. Thank you, Christos. Looking forward, would we be open to acquiring another company or assets to build out portfolio or the pipeline?

Yes. So first of all, of course, I will say it again, we're focused on executing the plan for VASCEPA. And it's certainly a thought given the strength of our balance sheet that we've got, $300 million in cash and no debt. But there are limitations to what a company our size can do. And right now, until we get further traction with VASCEPA/VAZKEPA, our focus is on that, is driving growth. We think in the future, there'll be that opportunity. But for right now, we're certainly focused. We get presented with a lot of options, but -- and we're always listening, but listening more for the future.

Great. Thanks, Aaron. Turning to the U.S., what else could we do to grow that market and for VASCEPA in that market?

I mean, it's a generic market. And it's important to remember, one, is how well we've done, even though we've seen declining revenue. It's 4 years since the first generic was introduced, and we still have brand, and we still have half the volume. Obviously, the -- it's cost us more to do that, but we've done what a lot of other companies simply could not do. And that's really what we focused on. So we've been very opportunistic in a generic market. What happened in the U.S., unfortunately, was the indication for cardiovascular risk reduction was granted in November of -- I'm sorry, December of 2019. And it was a rocket ship in terms of growth, but then COVID and generic introduction occurred, and we scaled back our promotion. And that made all the difference, because this is a promotion responsive brand and being able to grow the market really requires significant investment. And as I commented on earlier, we changed our strategy in the U.S. to focus less on sales and marketing, because to stay profitable, we focused more on maintaining volume by making sure we secured managed care access. And we've done a very good job doing it. It's the best way we've had to run the business, and the team has done an outstanding job executing that. Now we'll continue to be opportunistic. We -- there are smaller accounts where we can get into and win that business, and the team does a very good job identifying that to maintain the volume. And then, of course, lastly, we'll be prepared to launch an AG when we think the time is right to launch an AG. And the thing to remember with an AG is it's a great opportunity, but it becomes another generic. So the strategy we have right now is still a better strategy than putting the AG on the market.

Great. Thanks, Aaron. So looking at the rest of the world and specifically the opportunity in China, what does that look like moving forward?

Eric manages that partnership in that market. And Eric, do you want to comment on that?

Yes, sure. Thanks, Aaron. As I noted, the scale of that opportunity is large. You saw 330 million patients with cardiovascular disease in that country. So the need is great. And we're pleased that VASCEPA/VAZKEPA is available in that country. And the teams have progressed very well. A lot of work, leveraging the REDUCE-IT trial and getting that cardiovascular risk reduction from the authorities in China. But we're excited. As Edding launches, they're putting over 100 salespeople on the product targeting over 300 of the key hospitals that are seeing cardiovascular patients, interventions, all the things you heard Christos talk about as well is our targeting around the clinical benefits of the step up VASCEPA/VAZKEPA. So we're excited for how that effort is progressing here just in the first couple of months of their launch. Additionally, Edding sees the benefit too of getting this into as many hands as possible and to try and work towards that future expansion of access in their country, are working with the authorities for both potential future listing on NRDL. So all these things really drive good future for China.

I'll just comment that -- just to build on your perspective, one, is we recognize the opportunity, but Edding has been a very good partner. They're committed to this. They're passionate. They see the opportunity that we see and we look forward to them making a significant impact.

Great. Thanks, Eric. Thanks, Aaron. One final question. As we think about the future and the opportunity for VASCEPA/VAZKEPA, how do you characterize that potential globally? And what does growth look like in the next 3 to 5 years?

Yes, I think we have to break it up. First and foremost, it's tangible traction with the current plan. And what I mean by that is we need to see the countries where we've launched significant growth, and hopefully, the growth accelerates. We're at the earliest stages in those -- in many of those countries and we just need to keep that going. And hopefully, ultimately, we're able to expand beyond the ACS population, but we could build quite a business off of just the recent ACS population, that is not a small market. So that's what we need to see where we're commercialized. And that's true with the rest of the world. We need to see that growth. The countries where we're not launched or don't have pricing and reimbursement, we obviously need pricing and reimbursement. And we're planning to see more progress. And this strategy, the change in strategy last year from the broad strategy where we went after the label, it's the good and the bad of the label in Europe. It's a very broad label. It's broader than the REDUCE-IT criteria, which is already broad. The downside is it affects the budget. So we have to be balanced in how we approach those reimbursement authorities. But the changes that Christos and David characterized are, in fact, making a difference. So we need to get more countries online and launch rapidly. One thing that will help in some of those countries is there's more time to build a scientific foundation and awareness. So hopefully, once they launch, as we saw in the U.S. as I characterized about the U.S., if you have more time to build awareness once you launch, then hopefully, there's faster uptake, and that's what we'll see. So we do need to see that overall. We need to maintain our cash and manage that carefully. That's something else that we have to do for the company overall. But we're focused on, I think, what we need to focus on -- the team is -- we've got a really good team. We're executing very, very well right now. We know we need more. No one is satisfied. We need a lot more growth all the way around, and we're determined to get it.

Thanks, Aaron. So that concludes the Q&A portion of today's event. I'll hand it over to you, Aaron, for closing remarks.

If you could go to the next slide, please. So I'll end where we started. And first of all, I want to thank everybody for joining us and taking the time. And we hope this was informative. We hope this gives you the visibility into what we're doing and gives you greater clarity and greater confidence. There is a significant disconnect between the current share price and unrealized value. And hopefully, seeing some of this information and how we're approaching it makes a difference. We recognize the need to accelerate the growth, plain and simple. And we need to generate more shareholder value and drive the share price. The share price where it is today is just -- it's hard to understand, but that's on us and me in particular, and we've got work to do, and hopefully, we're on the path to address that. So with that said, thanks again. We hope you'll tune in again as we go forward. We'll continue to communicate as we have tangible milestones. And with that said, have a good day.