Hi, everyone. I'm Andrew Fein. I'm one of the biotechnology analysts at H.C. Wainwright. Thank you very much for, for joining us this afternoon. Next company, speaking with us is Amarin. Long, storied history. And, and with us is the company's CEO, Patrick Holt. Very nice, very nice having you here. Thank you. So we have a very long history with Amarin, going back to when I was at Jefferies, and it was an Alzheimer's company. So it goes back quite a ways. So maybe the best place to start, given that we could all use a fresh take on things, is, you know, maybe we can start with setting the landscape for Amarin 4.0, whatever- Mm-hmm ... whatever version we're up to. Yeah. You know, what are the drivers? Forget about the history, you know, Amarin in its current state, and what, you know, drives re-engagement on investors' part from here? Yeah, great. Andrew, firstly, thanks so much for having us, and great to be with you all today. So, I've been with the company now, I think 10 months, and it's been wonderful to, to be working with the team and continue to advance, you know, what is a significant opportunity for us globally. So, you know, when we think about the company, I mean, most fundamentally, we have a fantastic product with Vascepa and Vazkepa that is founded on exceptional clinical data with the REDUCE-IT trial. That's the fundamental core to what is a significant global opportunity to impact patients and therefore create value for shareholders. So that's really at the core. As you, as you click into that, you know, we see Europe as a really important growth driver for us. We recently announced that our exclusivity in Europe is extended by another eight years, from 2031 to 2039. That gives us confidence and clarity in the investments we're making in Europe. So we're at early stages of our launches in Europe, most particularly Spain and the U.K., but I'd say headline, Europe is a very important growth driver for us. You know, secondly, you know, we've I think we've done a very good job with cash management and a good job with really being very thoughtful about our expenses. So we closed last quarter with, I think, $308 million of cash, no debt. And indeed, that represents seven quarters of cash flow, positive cash flow neutral. So the company's really stabilized and taken difficult decisions to right-size the expenses. I think flipping from Europe to then the US, the US is a really important region for us. Obviously, there's generic, as you alluded to, but the US still provides us with very important revenues, profits, and cash that can then fund our Europe, investments that we make. And that focus on extending the branded life cycle in the US is something that we're demonstrating success on. So, you know, we have now stable market share in the high 50s. That's stable for over a year. We have, you know, we participate in over 50% of the total IPE market with our exclusive strategy, which is really the core of what we're doing. And that's based on the investments we're making in managed care, trade, and also medical affairs. So that delivers us significant profits that we need for the rest of the business. We have the optionality of an authorized generic, should we need that. We continue to monitor it very closely. It's obviously a dynamic situation, but that's not a path that we see us needing in the immediate term. The third thing I'd mention is actually the rest of the world. So there's millions of patients out there globally. Cardiovascular disease is the number one killer globally. So when we think about, you know, different go-to-market strategies in different regions, when we think about markets like China or Canada or Australia, New Zealand or Asia, we see the value of working with partners. So as an example, in China, our partner, Eddingpharm, has recently launched a very high triglyceride indication. They had 100% growth in Q1 versus Q4. So our rest of world, you know, revenue is over $5 million for the quarter, as an example. That's very important for us because, one, we're working with, you know, key leaders in each of those key markets. It provides us with immediate profit, you know, with royalties and, milestone payments, et cetera, et cetera. So, so net-net, you know, our focus is to advance this, this significant opportunity with Vascepa, Vazkepa and Vascepa globally, to advance the business, which strengthens the business today, but also then enhances our strategic optionality in the future. To what extent is the challenge in the markets you described, you know, educating people about the uniqueness of the product, especially in the context of years now of data that the company's? Mm-hmm ... generated, relative to, you know, more logistical challenges from a reimbursement- Mm-hmm ... pricing perspective? You know, I guess which avenue do you think the more strong headwinds lie? Great question. So I think it, it differs region by region, but I think, possibly it makes most sense to click in a little bit on Europe in answering that question. So when we think about, you know, Europe, we think about the EU5 that represents, you know, two-thirds to three-quarters of the total market, and, and then other important markets in Europe. But in each of those markets, they really are unique. So there are different dynamics around reimbursement and pricing in each of those markets. And then secondly, there are different dynamics around how those healthcare systems work in terms of affording, physicians the ability to prescribe and how that works. So if you take the example of Spain, Spain is a fast uptake market, and it is a market that is fairly, on a European level, is fairly simple from a reimbursement perspective, subnationally, I mean. So that's why in Spain, we have seen a really rapid uptake of our product. So in Q1 relative to Q4, we grew 91% in Spain. We're absolutely on track of our launch plans, and we really, Spain is really demonstrating the value of Vascepa in Europe. The UK, we know, is a slower uptake market, so we have an excellent NICE recommendation, but beneath that, there's a huge amount of market access work that needs to happen, before you can really then educate and convince physicians to prescribe. So we continue to work through that account by account. We're taking a much more focused approach in the UK, and then that is therefore delivering us a 28% growth in Q1 versus Q4. So in each of the markets, there are different dynamics from a commercial perspective, but I'd say it's a combination of, you know, the reimbursement pricing, then the account management, and then convincing physicians on the data. To bridge from that to reimbursement and pricing, so, you know, the next market in the EU5 that's really critical for us, that we are underway in, which is tracking solidly, is Italy, and we do expect Italy to read out sometime in 2024. If you think about an archetype, if you have Spain as a fast uptake market and UK, maybe the... It's kinda in the middle. And then if you think beyond that, we're working to advance our submissions in France, and we're thinking about potential options for Germany. You know, they are typically faster uptake markets. Maybe to just add a little bit more, what we have heard from our launches in Europe is our science is compelling. So, you know, Professor Gabriel Steg, who is one of the global leaders in this area, I mean, he shared with 150 Spanish key opinion leaders in the launch meeting, that the REDUCE-IT data is the most compelling scientific data he has seen. You have survival data from- Yeah, it's extraordinary. So, you know, as an example, at recent ACC, we had 6 abstracts. So the utility and the clinical value that we can bring with Vascepa and Vascepa is very significant, and the quality of our data, one of the abstracts was around the impact of Vascepa for lipoprotein(a) or Lp(a). And what we could see there is when you look, do a post-hoc analysis of the REDUCE-IT data, you know, and then that's an independent risk factor. So whether the patients had high Lp(a) or normal, the impact of Vascepa was still very significant. The other one, the other key abstract that we had from ACC, which was very interesting, was also looking at different LDL levels. Mm. What we could also see from that abstract was that irrespective of the LDL level, the cardiovascular impact from Vascepa was still there. So I'd say, you know, linking it to our activities, you know, we get really strong feedback on our clinical data, so it's just step by step. And the thing I'd say about Europe is, you know, each market is different. Mm. The learning we've had, I'd say, in the last period, is how do we ensure that we have country-specific capabilities to understand those needs at a payer level, to understand those needs at a physician level, at a medical association level, so that we can meet the customers and meet their needs? And that's why we're seeing, you know, an acceleration of our uptake in Europe. I think we've got new leadership that came into the region from mid-last year, and I think they're making an excellent impact with a much more targeted approach to the region. But it's still early days for us. We're two of the big five in the EU, and then we do expect about five of the other important markets to read out in 2024. As an example, I would say in the near future, we expect to have reimbursement and pricing information on Portugal and Greece. Given the number of years now that have passed- Mm. -since REDUCE-IT was initially, you know, shared at whatever the, there was ACC in Chicago that year, has the discernment among physicians of Vascepa's uniqueness- Mm. -relative to generalized fish oil broadly, has that sunk in? Like, in Europe, for instance, how challenging is the argument to physicians in the context of the vast amount of data that you've generated? Is it an easier pitch now than it was, you know, in the context of physician conversations years past? You know, certainly, you know, when all the generics news happened- Mm. There was a lot of noise. Mm. And it was easy for some people to, maybe from the get-go, to kind of lump you guys in, even though there was clear, you know, uniqueness to the asset. Are people better appreciative now, more appreciative now of the unique body of data that the company's generated over the years? I think they are, and look, you know, there's been a lot of work done by different scientific leaders, such as Preston Mason, to really demonstrate more, you know, what is the uniqueness of Vascepa and really understanding, you know, the fundamental nature of IPE and the high levels of EPA and the unique nature of IPE. And contrasting that to supplements that, you know, the FDA has concluded don't, you know, provide any scientific impact, and, you know, if you look at AHA guidelines, they do not support the use of supplements. And fundamentally, you know, some of the work, for instance, that Preston Mason has done, you can see the vast difference between a highly purified, FDA-approved, REDUCE-IT data of Vascepa relative to supplements. So, it doesn't come up, you know, certainly in the U.S., it doesn't come up in the way that it used to, or it doesn't. In Europe, each of the markets are different, but we don't see that as a significant hurdle in our launch activities, and really, the story about the sheer impact that the REDUCE-IT data creates and that the impact that Vascepa can create for patients, we're getting very good feedback on that. ... does, I guess, how do you balance the capital, the focus on, on, you know, cost control- Mm. In light of, you know, physician education? And also, at any level, is there, you know, I know over the years it's been, you know, thought about, but what's the current appetite for bringing in anything else, that you might be able to leverage with your sales force to try and, you know, further monetize? Yeah, great question. So again, we continue to challenge our strategy and discuss different options as a management team and also with the board, as you would expect. I think the context for your question is it's important to probably make a note that over the last year, there's been a huge amount of important work to rightsize the expense base of the business so that, you know, for seven quarters, we've been cash flow positive or cash flow neutral, on track to deliver the $40 million annualized savings, and indeed, you know, year-over-year, over $100 million of SG&A has been taken out of the business. So that really strengthens the company, and it enables us still to make the focused investments we need to make in Europe. We've learned a lot in the U.S. over the years, and our U.S. capabilities focused on managed care, and trade, and medical affairs are really focused. So what we see is, I think, continuing to advance the business today and strengthening and proving our hypothesis in Europe, proving our rest of world hypothesis, and continuing to extend the life cycle in the U.S. is important. That strengthens the company for today, but definitely increases the optionality that we have for the future. I'd say it's step by step. So we need to focus on what we're doing today, and I think that then creates greater optionality for us in the future, such as, you know, how we think about portfolio, et cetera. Okay. You know, obviously, there's been a you know... one newfound paradigm in the context of the overall market has been the you know the launch of the obesity drugs and the vast popularity that they've gained. Is there a tie-in, in some way, of Vascepa's unique properties in the context of substantial weight loss, be it either the role 'cause they are anti-inflammatory- Mm-hmm. - properties. Mm-hmm. And we know that, you know, reduced inflammation, you know, should theoretically abet weight loss. I don't know, is there any way to, you know, tie in to the increased focus on metabolic disease? That probably didn't exist to the same extent when the drug got launched- Mm. - however many years ago. Well, look, I think fundamentally, you know, more solutions to help patients in this area is better. So, you know, the SELECT data that obviously has led to the expansion of indications for GLP-1 is obviously, you know, valuable data. What we really come back to is we look at our REDUCE-IT data, and we look at the strength of that data. As an example, you know, the main data is 25% relative risk reduction. Number needed to treat 21 or absolute risk reduction of, say, 4.7. If you look at a patient group, such as a recent ACS group, you know, you're talking about a 37% relative reduction. From a health economic perspective, particularly in Europe, you know, we feel we have a compelling value proposition. There certainly are, you know, potential synergies, and I think greater focus on the category, greater focus on treating urgently needed patients is helpful for all manufacturers and helpful for physicians and payors as well. So, we continue to monitor that very closely. We obviously, every day, you see information coming out on, in this area, but fundamentally, we think it actually continues to amplify the value proposition that we bring. And we welcome the more solutions that can assist with that. For investors taking a fresh look at the company, who see it as, you know, a growth at a reasonable price- Mm ... sort of stock, which might well be, how should they go about the work process? I guess what I'm asking is, you know, you've obviously spoken about some new geographies that represent- Mm ... you know, growth opportunities. What's the diligence process one can do to get comfortable with the Chinese market opportunity or the Italian market opportunity, or, you know, how big the asset could be in Spain? Are there precedents you'd point people towards? You know, what's the right way to kind of, you know, have investors begin to quantify- Mm ... those opportunities so the ultimate growth can be, you know, better calculated? It's a... Look, it's a great question. Yeah, and the reality is that the data that we have in Europe, let alone rest of world, is not the same level of data that we have in the U.S. So we, there's no avoiding acknowledging that, and so part of our job is how do we educate beyond that? So, you know, one of the things we've been trying to do is to bring more transparency and clarity to how our launches are work, how's our launch success. So, you know, in Europe, we talk about revenue growth quarter-over-quarter. We also talk at a regional level for Europe, what's the in-market sales? That is the sales to pharmacy. Mm. And then at a country level, to the best of our estimates, and they are estimates, we can also think about what's the patient growth. So we're also communicating every quarter what's the patient growth in those key markets that are launching. It is a global opportunity, and it is obviously very significant. If you think about, you know, where we're at in that process, we're still in very early stages. So to bring it back to your fundamental question, we're a company that has exceptional science. We have a global opportunity, somewhat nascent, frankly, outside the US, in Europe and then rest of world with partners, which provides immediate profitability. China is the second-largest market in the world. And then what we, what we've proven, despite the fact that we have generics in the U.S., we've proven our ability to navigate through that. Mm. We've proven our ability to manage our cash for, in a very, very effectively, so that we can still fund the investments we need to make in Europe. But at the same time, we're no longer burning cash. We're cash flow neutral or positive for seven quarters. So I think we're demonstrating credibility in what we're building in the company, but fundamentally, our science is really compelling. You know, the diligence I would ask folks to look at is just really look at what global, you know, global benchmarks are for cardiovascular products, and frankly, you know, our IP extending out to 2039 with eight more years just brings more, I think, more clarity and confidence to the growth opportunities we have outside the U.S. Great. I think we're almost out of time. So that was a very good, very good overview. Thank you. Thanks so much for your time. Our pleasure. Thank you. Thank you.
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