Welcome to Amarin Corporation's conferenc e call. I would like to turn the conference over to Jordan Zwick, Senior Vice President, Business Development and Investor Relations at Amarin. Good afternoon, everyone, and thank you for joining us. 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. 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, 2022, and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amarin's website in the Investor Relations section. Turning to today's agenda, here with us today, we have Aaron Berg, Amarin's Interim President and Chief Executive Officer, along with Tom Reilly, Amarin's Chief Financial Officer, and Patrick Holt, Amarin's newly announced President and Chief Executive Officer. Following brief prepared remarks, we will open the call to your questions. With that, I will now turn the call over to Aaron. Thank you, Jordan. Good afternoon. Thank you, everyone, for joining us today. This afternoon, we announced a number of strategic actions we're taking to position the company for the future, including an organizational restructuring program, as well as our new CEO, Pat Holt, who I'm pleased is joining us today. Over the last several months, our new board of directors and executive leadership team have been working closely together on a thoughtful review of the business, evaluating where we stand today against the execution of the current strategy and assessing what we see as the greatest opportunities to drive shareholder value, given the company's size, resources, and challenging operating environment. Vascepa and Vazkepa are supported by a wealth of clinical data and backed by strong science, addressing a significant unmet patient need. Amarin continues to generate revenue in the U.S. and maintain a strong cash position. We're also clear about the challenges we face given the current operating environment and market dynamics. This includes pricing and reimbursement hurdles in Europe and pricing pressure in the U.S., which are reflected in the preliminary financial results we announced earlier today. Let me begin there. Turning to the next slide. In connection with today's announcement, we released our preliminary unaudited financial results for the Q2 of 2023, including product revenue of approximately $65 million, which includes $600,000 of revenue in Europe, compared to $85 million in the Q1 of 2023. For the quarter, the company had positive cash flow of $9 million, which includes a $5 million milestone payment following the recent very high triglyceride regulatory approval in China. The Q2 end cash position was $313 million versus $304 million at the end of the Q1. While we've maintained our U.S. prescription volume for Vascepa and our overall cash position remains stable, we're experiencing increasing net pricing pressure in the U.S., driven largely by increased competition from generics as well as increased contract rebates within our current business. Adding to this pressure, we've also experienced slower-than-expected revenue growth and prolonged pricing and reimbursement negotiations in key markets in Europe. Given the reality of our business and the macro environment, it became clear to the board and leadership team that decisive and significant actions were needed to maximize our cash position and put Amarin on the right path to capture the value in the business. Turning to the next slide, the organizational restructuring program we announced earlier today is designed to rightsize and strengthen Amarin and is focused on three core areas: maximizing cash flow in the U.S. through a streamlined model, redesigning Europe, and expanding upon international partnerships. Let me now give an overview of each priority. In the U.S., Amarin plans to maintain Vascepa as a cost-effective option to generics while implementing a reduction in force of all U.S. salesforce positions and approximately 30% of non-sales roles. This will enable Amarin to execute on its U.S. strategy with payers to ensure access while maximizing its cash flow opportunity. To support these efforts, we'll retain our managed care and trade organization. In Europe, we are redesigning and improving the efficiency of our commercial infrastructure to better align with pricing and reimbursement status and commercial potential and progress to date, as well as streamlining certain cross-geographic functions and better leveraging learnings across countries. In addition, Amarin will continue to advance its pricing and reimbursement activities to drive access in remaining geographies, including those where progress has been delayed. As a result, we'll either reduce or eliminate our presence in certain countries which have lower sales potential and or limited current reimbursement. We intend to continue the pricing and reimbursement processes that are currently underway, and we'll maintain our existing commercial presence in key European countries where we're in the early stages of commercial launch. We will also continue exploring options for reimbursement in Germany. As we engage in these discussions, we will evaluate and pursue a thoughtful strategy for Vascepa to enhance its value and deliver its benefits to the greatest number of high-risk patients globally. In international markets, we will work on generating revenue from partnerships in key international markets, including Canada, MENA, China, and Australia, and New Zealand, and we'll continue exploring additional partnerships. In total, this program will bring with it a restructuring charge of $10 million and is expected to deliver annual cost savings of approximately $40 million. The restructuring includes a reduction in force of approximately 120 of 385 positions, or about one-third of our organization, most of which are in the U.S. The organizational restructuring program will support our strategic efforts to continue pricing and reimbursement processes underway in Europe, maintain our IP leadership position in the US, and maximize our cash flow opportunity. While decisions that affect good people are very difficult to make, they're the right ones for the business, the right ones for our shareholders, and the right ones to enable us to continue to bring Vascepa and Vazkepa to patients around the globe who could benefit from its proven science and ability to help reduce cardiovascular risk. I want to extend my deepest thanks to everyone in Amarin who's worked tirelessly, some for many years, to advance our mission in the US and globally. We're incredibly grateful for their efforts in serving our patients. We're now entering a new chapter of more efficient, focused action and value creation. Before I introduce our new president and CEO, I want to dive into a bit more detail on our European and international commercialization progress. We already have reimbursement in several European countries and are well into the negotiation process in key countries, including Spain, Italy, and the Netherlands. These negotiations have been challenging as a result of the market dynamics broadly impacting the prescription drug industry in many European countries. However, we're working to bring a number of these negotiations to conclusion. Within other international markets, we've recently received two additional approvals. A new indication and label expansion for Vascepa was approved in the Kingdom of Saudi Arabia in June, where we're working with our commercial partner, Biologics. Also in June, we received regulatory approval for Vascepa in mainland China. We've submitted regulatory dossiers for cardiovascular risk reduction in several other countries in Asia that could bring potential revenue as well, and we plan to commercialize with partners in these countries. We expect more updates on those submissions over the next several months. We know we have an outstanding product with a very strong data set. We're negotiating aggressively, and our goal is to obtain pricing and reimbursement access, maximize the value, get on the market, and drive revenue. Turning to our final slide, I'm excited to share that today we've announced the appointment of Pat Holt as Amarin's new President and Chief Executive Officer and as a member of the board, effective immediately. Pat brings more than 25 years of leadership in the life sciences industry and significant international operating experience. He most recently served as President of Cordis, Cardinal Health's global interventional cardiovascular business. In that role, he led a successful turnaround that included a return to revenue growth and a refocused R&D strategy, as well as sustained enhancements in operational effectiveness, delivering margin expansion. Following the turnaround, he led the transaction process, which resulted in the successful sale of Cordis for an enterprise value of more than $1 billion. Pat is supportive of the actions we're taking now to capitalize on the opportunity that remains for Vascepa and Vazkepa. As he takes on the CEO position, I'll continue to collaborate with the board and management team in a senior leadership role as we work together to chart Amarin's path for the future. Vascepa and Vazkepa is supported by a wealth of clinical data and has the opportunity to help millions of at-risk cardiovascular patients globally. Our mission remains to give millions of patients the opportunity to benefit from this tremendous product in a world where cardiovascular disease remains the number one killer globally. With our new organizational plan and focus, we're going to do that in a more efficient way that maximizes the opportunity ahead to drive value for all shareholders. With that, I'd like to turn the call over to Pat to provide our investors with a more detailed introduction. Pat? Thank you, Aaron, for that great introduction, and thank you all for joining us on the call today. Let me begin by saying that it is an honor to join Amarin and how excited I am to be here at this time. Amarin has a truly compelling asset, Vascepa, that is aligned with significant unmet need and with the ability to make a profound impact for patients, for physicians, and for payers. A product that can reduce cardiovascular events as significantly as Vascepa is a rarity in medicine and highly valuable for patient care. That is why I am here and why I have joined the company. I'm confident in the value we will create for all our stakeholders. With that said, decisive action is needed to achieve our full potential. Alongside the entire Amarin team, I'm committed to realizing the opportunities that lie ahead of us in order to maximize value for patients, physicians, payers, and shareholders. Over the next several weeks, I look forward to meeting with our leadership, colleagues, customers, shareholders, and other stakeholders as we evaluate and execute on all the opportunities to deliver value. Before I close, I would like to thank the Amarin Board of Directors for entrusting me with the leadership of the company as we work together to shape the future of Amarin. I would also like to thank Aaron for his outstanding work as our Interim President and CEO, and the executive leadership team, who bring a tremendous wealth of knowledge about the company and cardiovascular care. Finally, I would like to thank all our Amarin colleagues for their passion, commitment, and resilience. The organization has been through tremendous change, but through it all, the teams here at Amarin have remained focused and committed to the mission of helping patients. I look forward to speaking with and getting to know many of you in the coming days and weeks. Thank you. With that, operator, we are ready to take questions. Certainly. Everyone at this time will be conducting a question-and-answer session. If you have any questions or comments, please press star 1 on your phone at this time. We do ask that while posing your question, please pick up your handset if you're listening on speakerphone, to provide optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone. Please hold while we poll for questions. Your first question is coming from Michael Yee from Jefferies. Your line is live. Hi, this is Jiajun on the line for Michael Yee. Thanks for taking my questions. I have two questions. First one, it seems like there's some discordance between the actual sales numbers and what we estimated from the scripts. Maybe if you can provide us with some color on, like, on how much of the sales was impacted by the price cut, and how much was due to rebates, et cetera. Eventually, what should we expect for the price down the road for the rest of this year? Second one, I think from a cost perspective, how should we think about the cadence of the $40 million SG&A cuts to happen? Is it more like a linear process or, you know, or is it more like a step function? I'm still seeing about, like, $230 million SG&A for the rest of the full year. Is there any room for more cost-cutting in the SG&A? It would be helpful if you comment on that as well. Thank you. Thank you for the questions. I'm gonna have Tom Reilly, our Chief Financial Officer, address those questions. Tom? Sure. Thanks for the questions. You asked 3 questions. Let me go through all of them. When you asked about price related to managed care, maintaining our managed care access and the pricing impact. When compared to Q1, we saw a high teens price decline versus Q1 of 2023 on the price. We did have some impact related to trade as well, the wholesaler channel in the quarter. Even though our script volume was up, as you indicated, in the mid single digit, it was impacted by the price decline and the wholesaler or inventory trade decline. On the second question, you asked about the $40 million operating expense savings that we priced as part of this restructuring. You can expect that to be linear when you're thinking about it from a modeling approach. You should expect approximately $10 million or so per quarter over the next 12... excuse me, over the next four quarters on a linear approach. The third component you asked, related to operating expense, and I think what you're asking for is more guidance. We do see operating expense in the range between $240 million to $250 million for the remainder of the year. That does not include the $10 million of the restructuring charge that we will incur. I hope I answered all your questions. Thanks. That's very helpful. Thank you. You're welcome. Thank you. Your next question is coming from Louise Chen from Cantor. Your line is live. Hi, good afternoon, everyone. This is Carvey on for Louise from Cantor. Thank you for taking our questions. Our question goes to Patrick. Congratulations on the new role. Out of three strategic priorities announced today, what are your most immediate action as the CEO, and what is the potential quick wins for the company? Thank you so much. Thank you very much for your call. Obviously, I'm delighted to be here at the company. Today is day one, so naturally I'll be taking time to listen to colleagues, listen to stakeholders across the whole business, to then really plot our pathways forward. Firstly, I'd like to reinforce that really we have a fantastic asset in Vascepa and Vazkepa, also long-term data. Really our opportunity is to firstly ensure that we're maximizing our opportunities to bring value to patients and therefore maximize the value we're bringing to shareholders and that's the path that I'll be taking. Got it. Sounds good. Congratulations again. I'll just build off and poor Pat's thrown into the fire here on day one. You know, we'll continue to focus on core priorities that I mentioned in the prepared remarks. One is we'll continue to drive revenue in the U.S. We still have significant revenue to generate. We'll do it more profitably and efficiently as we go forward here. Regarding Europe, as mentioned, we have a number of pricing and reimbursement negotiations ongoing. We need to bring those to conclusion, and we need to get on the market and drive revenue. Where we're on the market, we need to be able to drive revenue at a more accelerated rate, in particular, places like the U.K. It's a major market, and we need to get that going quicker. Of course, rest of the world, we've got partnerships in place, we've got approvals, it now comes down to an increased focus on driving revenue in those other countries as well, and where we can get approved or secure additional partnerships, we'll do that. Makes sense. Thank you again. Thank you. Your next question is coming from Paul Choi from Goldman Sachs. Your line is live. Hi, this is Roderick Kong for Paul, and thanks for taking our questions. We have two. For the first one, what kind of metrics that we will provide or focus so that we can actually to measure the progress here? The second question is, in the EU market, are you willing to reapproach maybe pricing in key markets to gain better access or perhaps maybe certain minimum, like, purchase agreements? Thanks. I'm sorry. I apologize. I heard one question. Can you just repeat? The first question was regarding metrics, and then was the second question regarding the pricing reimbursement approach and strategy in Europe? Did I get that right? Yeah. For the second question, it's that, are you willing to reapproach maybe some the pricing, terms in the key markets to gain better access or maybe just to have some certain minimum purchase agreements in the EU market? Yes. Okay, I'll address that question. Let me know if there was another question. The approach to each country has been very dynamic. We've been learning from across Europe and learning from within each country in Europe. For each of those countries, we're being as creative and aggressive as we possibly can, but also being responsive to what the particular country's budget needs are. We are open to those creative approaches over there. Each of those countries has a different history in terms of precedents around different structures for the access. If they do minimums, they do direct purchase, if they do other things, we're open to that. There's not a lot of that going on in Europe, but what we have to do is find a way to meet these reimbursement bodies and extract the value in a way that's profitable for us, but also is sensitive to the challenges, these macroeconomic challenges, that so many of these countries have across budgets. Again, as we've said before in prior calls, this is not just a Vazkepa issue. This is an issue affecting the pharmaceutical industry over there. A lot of companies with a lot of very good drugs, like a Vazkepa, maybe not as good, but certainly good drugs are facing these increasing challenges due to these macroeconomic issues. That being said, cardiovascular disease is a major killer over there. It's a high-cost driver. What we're trying to do is show that Vascepa is a cost-effective alternative. We are willing to negotiate and be creative. I hope I answered that question. Did you have another one? Thank you. Just, what kind of metrics that we will actually provide so we can measure the progress there? The first metric is going to be getting pricing reimbursement agreements in place. Of course, once those agreements are in place, the next metric is going to be what will sales be, and as we drive that. As you know, as you may know, in Europe, it's a little different in terms of prescription-level data over there and sales level data. As soon as we have data in terms of the progress, once commercialized, we'll certainly report that as appropriate. The first step is getting on the market. Got it. Thank you. You got it. Thank you. Once again, everyone, if you have any questions or comments, please press Star, then one on your phone. Your next question is coming from Nik Gasic from Leerink Partners. Your line is live. Hi, everybody. This is Nik Gasic on for Roanna Ruiz. Thanks for taking our questions. Maybe just a quick one from us. Could you give a little more color around your plans to redesign the commercial infrastructure in Europe? Maybe could you discuss which geographies you're planning to focus on, in particular, and whether you see an opportunity to revisit Germany as a potential market in the future? Sure. In terms of restructuring the plans, and what we've done through this process now, overall the strategy will be, we'll focus efficiently on, 1, where do we have access now? Where are we selling the product, and are we doing it efficiently and getting a return? It's still the early stages in places like the U.K., countries like Sweden, to a smaller scale, but we'll focus on generating the revenue, but are we doing it in a way that's getting the return, and are we investing accordingly there? From a pricing and reimbursement perspective, and then subsequently commercialization and commercial scale, it'll be based on the potential in those countries, as well as the pricing and reimbursement agreements we reach with those countries. In those agreements, of course, comes down to price and patient population. Once we have those agreements, well, we will structure accordingly to be able to launch and maximize the potential that we have with Vazkepa in each individual country. We're going to do it by focusing first on where we can drive revenue as rapidly as possible and not get ahead of ourselves. For example, we may not go out immediately with a GP sales force or broad promotion until we get in some countries, you need the specialists on board. We're gonna focus more on that small, more specialized company, more guerrilla approach to, efficient approach to how we should commercialize the product. Obviously, there are some countries that are bigger than others, and we need to bring those to closure, as we said, from a pricing reimbursement perspective. Italy and Spain in motion, and then, as you mentioned, Germany. We have had an effort to find out what the path forward in Germany will be. As you know, Germany has been a real challenge for many companies with many drugs. We certainly had our challenges hitting a wall there previously, and we've been evaluating how to approach it, and I know that will be one of Pat's first priorities, is to determine what is the right approach, and we hope to have further clarity on that in the near term. Very helpful. Thank you. Maybe just a quick follow-up. What's your outlook on potentially launching an authorized generic in the U.S., and how might this impact competitive dynamics, and sort of when do you expect to provide more clarity on timing? Sure. We still have a viable brand business in the U.S. Right now, as we've announced in our restructuring, we're going to continue to maintain our exclusives. We still have not lost any exclusive coverage. We still have good access, and that is doing a good job protecting the brand that we have. Once the market dynamics erode more, in other words, if it becomes. We have almost 60% of the volume right now, and if we can maintain that in a profitable way with the structure we have, we'll continue to do that before we launch an authorized generic. We are, however, prepared to launch an authorized generic, and we'll do that when we see more of the brand start to erode, the branded business erode. We'll launch that authorized generic and do so very aggressively. We intend to be a leader in the IP category. We certainly have plenty of product. What'll happen there as we launch the AG is we'll see how some of the generic companies do respond. That would, of course, lead it into a fully genericized market as we go forward, and we expect the net cost all the way around to erode. We'll make it up on a volume perspective. Right now, the timing is not right to launch an authorized generic because we still have a viable branded business. Once we do go with the AG, of course, that would erode the brands more, so we'd be eroding our own business. We'll monitor that carefully, and we'll be prepared to act. Very helpful. Thanks for the color. Thank you. That concludes our Q&A session. I'll now hand the conference back to our host for closing remarks. Please go ahead. Again, thanks, everyone, for the time today. Thank you for joining us on such short notice. We're committed to driving value. We welcome Pat, who is hitting the ground running, and we'll look forward to updating you as appropriate moving forward. Thanks again. Thank you for your time. Please reach out with questions or to schedule one-on-ones. Have a nice evening. Thank you, everyone. This concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.
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