Welcome to Amarin Corporation’s Conference Call to discuss its Second Quarter 2022 Financial Results and Operational Update. This conference call is being recorded today, August 3, 2022. I would like to turn the conference call over to Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs at Amarin.

Good morning, 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 by the Private Securities Litigation Reform Act. We may not achieve our goals, carryout 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, 2021 and our Form 10-Q for the quarter ended June 30, 2022, which have been filed with the SEC and are now available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of VASCEPA. An archive of this call will be posted on Amarin’s website in the Investor Relations section. Karim Mikhail, Amarin’s President and Chief Executive Officer, will lead our discussion; Dr. Steve Ketchum, President of R&D and Chief Scientific Officer, will provide an update on recent clinical data and publications; and Tom Reilly, Amarin’s new Chief Financial Officer, will provide a more detailed review of our second quarter 2022 financial results. After prepared remarks, we will open the call to your questions. I remind you that multiple audiences typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators and current and potential competitors. As always, in this call, we will attempt to provide constructive information without compromising our competitive and strategic positioning. I will now turn the call over to Karim Mikhail, President and Chief Executive Officer of Amarin.

Thank you, Lisa. Good morning and thank you all for joining us today. As we enter the second half of this pivotal year for Amarin, we continue to focus on our three dimensional growth strategy, breadth or geographic expansion; height, representing diversification; and depth or core operation evolution. Recently, I surpassed my one year anniversary as President and CEO of Amarin and have had the chance to reflect on the significant transformation of the Company over the past year. In the U.S. we face continued pressure from additional generic competition. We focused on maintaining profitability, and through our commercial efforts, we were able to retain a level of market share even to this day that is unprecedented in any generic market, and more importantly, continue to deliver significant positive contribution margin, allowing Amarin to self-fund the expansion to Europe and internationally. During this past year, we made the difficult decisions to implement two major restructurings. The first was fully focused on the U.S. commercial structure and the second impacted our company more broadly, in order to manage our costs throughout the period and to address the evolving and challenging U.S. market dynamics. We did this while undertaking a BOLD strategy for global expansion, which was highlighted by more than 10 market access filings in Europe and multiple regulatory filings in other geographies. With recent achievements, including three country reimbursement wins in Europe and a number of international product approvals for VASCEPA, we are beginning to see the BOLD strategy take shape. In addition, we completely reshaped our leadership team with over 70% of our executive team joining Amarin in the past year, many in the last six months. These accomplishments provide us an even greater confidence that our long-term objectives for Amarin are ambitious, but also achievable. Now to touch…

Thank you, Karim. Today, I would like to begin with some remarks in response to the recent media coverage and headlines regarding biomarker analyses of REDUCE-IT data as published in circulation. It is important that investors, medical professionals, patients, our employees and other stakeholders understand that we stand firmly behind the science of our product. Recently, there has been considerable discussion and debate around exploratory post hoc biomarker analyses published in circulation and what those exploratory data might mean in the overall story behind the science of the REDUCE-IT trial. Additional scientific facts are missing from this discussion and provide a more scientifically based perspective. First, it is important to note that these exploratory biomarker analyses published in circulation were not conducted to provide additional evidence demonstrating effectiveness in reducing cardiovascular risk, but instead to preliminarily explore a subset of potential pathways via which icosapent ethyl might exert some level of effect in this trial. Second, the circulation paper highlights relative percentage increases rather than the absolute increases across the set of biomarkers studied in this analysis. When analyzing these results from an absolute increase perspective, they are small and they do not correlate to any meaningful changes in outcomes seen in the REDUCE-IT trial. Importantly, all of these biomarkers are exploratory and none has been sufficiently validated or correlated with CBD risk and in across clinical trials to enable them to be relied upon to draw meaningful conclusions. In other words, any speculation on the potential impact of these biomarkers is purely theoretical, which has largely been ignored in the discussion to date. In addition, the authors submitted a number of additional analyses as part of the iterative manuscript review process, which provide a more balanced perspective on the exploratory biomarker data. However, the journal’s reviewers and editors elected…

Thanks Steve, for that detailed overview. As I mentioned earlier, in addition to revamping our BOLD strategy across our clinical and commercial organization, we continue to take steps to expand our team globally to better serve Amarin’s strategic focus and objectives. One important appointment was the addition of our new CFO, Tom Reilly. Tom brings significant financial leadership experience across large global pharma and biotechnology companies, as well as a proven track record, leading financial planning and analysis within international and commercial operations. He has already become an integral part of our leadership team and is a great asset, as we expand around the world. With that brief intro, let me turn the call over to Tom to discuss our second quarter 2022 financial performance in further detail. Tom?

Thank you, Karim for the introduction. Good morning, everyone. I’m pleased to be addressing you today for the first time as Amarin CFO and to report on our financial performance for the second quarter of 2022. Let me begin by discussing our results for the quarter. For the second quarter of 2022, we reported total net revenue of $94.4 million, including net product revenue of $93.8 million, a decrease of 39% compared to the second quarter of 2021. U.S. product revenue was $90.6 million, a decline of $2.9 million versus the first quarter of 2022. The results represent continued generic pressure in the U.S. including the first full quarter with three generics on the market. As a reminder, during the three months ended June 30, 2021, there was only one generic in the market. During the second quarter, we saw normalization in the trade channel. When compared to the prior quarter, we continued to experience pressure on both volume and price. We’ve continued our focus on retaining exclusive business and that business has remained stable. Moving forward, we are not investing to grow the molecule in the U.S. market, but we are investing in sustaining and supporting the VASCEPA brand and prescriber base we have today in the U.S. We expect volumes and price will continue to experience pressure throughout this year, and also anticipate the seasonality typically seen within the third quarter for the market. The results also included international product revenue of $3.1 million, including $2.3 million in commercial supply shipments to HLS in Canada, as they began receiving reimbursements in the individual provinces and $0.7 million in European product revenue. Cost of goods sold for the three months ended June 30, 2022 was $50.8 million, compared to $32.2 million in the corresponding period of 2021. During the…

Thank you, Tom, for that financial overview. We have made a great deal of progress, despite this year’s challenges for both, Amarin and for the industry. This progress provides us with a renewed sense of energy and focus on our bold vision to stop cardiovascular disease from being a leading cause of death worldwide. Our continued ability to adapt and evolve with changing dynamics over the last 12 months, as well as the recent important and significant reimbursement achievements in Europe provide me with even more confidence in our objective to build a multi-billion dollar global franchise and ensure patients globally can benefit from VASCEPA/VAZKEPA. And with that, operator, we are ready to take questions.

Thank you very much. [Operator Instructions] Your first question is coming from Michael Yee of Jefferies.

This is Joachin Wenn [ph] on the line for Michael Yee. Thanks for taking my questions. I guess a couple for me. First, can you comment on the U.S. sales trajectory going forward and how you expect EU sales to pick up? Appreciating that you are getting reimbursement decisions right now in that region for 2022, so, maybe a comment on how we should think about 2023. And secondly, I might have missed that part, but could you elaborate on the supplier agreement amendment and the unsellable inventory, and also do you expect this to happen again in the future? And maybe, lastly, appreciating your focus on the development of a fixed dose combination, but in the parallel could you comment on your BD efforts as well? Since I recall that you have plans to in-license some assets in the metabolic area. Thank you.

Well, thank you. We’ll try to take them one by one. Let’s just start with the U.S. trajectory. First of all, we’re pleased that this quarter we’ve seen our revenues to be in line with what we’ve had in Q1. If you really analyze this performance, you’ll see that from a volume perspective, we are declining in the 7%, 8% prescription versus the Q1 of 2022, which is what is expected. So, this is really in line with expectation. At the same time, we also continue to have price impact because we’re losing volume in the non-exclusive segment where we have lower rebates, but this is more or less getting to stabilization because now most of our business is really coming from the exclusive business. So, over time, yes, we anticipate obviously a Q3 decline because it’s seasonal and because we have a volume, but we see the price erosion over time, over the next two to three quarters stabilizing in a certain way. So, we’re pleased with this quarter, we continue to monitor the situation very closely and we’ll see how things are going to evolve. In terms of Europe, I’m going to try to address like two, three questions in one, further moment. 2022 is the year for reimbursement in Europe, that’s not our revenue generation here. The focus today is to get as many countries, but more importantly at the right price. And you’ve seen the team delivering very strongly on that promise with a final net price in the UK of around $176 is significantly higher than our net price in the U.S., even prior to any price erosion, right, totally in line with what we committed to at the beginning of our European journey. The UK is known to be a challenging market from a…

Yes, Karim, just to follow up. So, it’s multiple -- we have multiple arrangements, long lead time on the product. We see this as a good first step to stabilizing our working capital related to inventory. And we’ll continue to work with our suppliers moving forward, to make sure that we stabilize the supply purchases to reflect existing demand. And I think the second question was related to the inventory charge of approximately $10 million, which we had incurred this quarter. So just to give a little background, this charge was a result of inventory that was damaged by one of our third party suppliers and caused the inventory not to be our quality standards. So, we have worked diligent with this supplier to ensure that the proper procedures are in place to mitigate this in the future. So, that’s the situation.

Thank you, Tom. On the fixed dose combination, we continue, as you’ve seen, despite the fact that we streamlined investments in terms of development, to ensure that we keep the project active and ongoing, because we believe there is significant opportunity of having a fixed dose combination on the market. But we decided to focus only on one statin. We made progress. We are in the -- we’re in the phase of prototype manufacturing and getting ready for next steps. And our BD position remains as such we continue looking for assets that will provide U.S. revenue and U.S. asset for us and for the great team we have in the U.S. to focus on, on top of VASCEPA. But we are also open to other opportunities. So, we will see how that is going to evolve overtime. But thank you for the question.

Thank you so much. The next question is coming from Louise Chen of Cantor. Louise, please ask you a question.

Hi. Good morning. Congratulations on all the progress this quarter, and thanks for taking my questions. So, I wanted to ask you about your SG&A in the third and fourth quarter, given your cost reduction program. How should we think about it relative to second quarter, if you can’t give exact numbers? And then, secondly, just on the sales, the nuance in the third and fourth quarter, because just, I guess during the first half of year, we got a lot of questions on how to think about sales and if they are going to be up or down quarter-over-quarter. So, any color you could give or any thoughts and the cadence or nuances would be very helpful. And then, last question I had was just Tom, as the new CFO, what do you want to bring to Amarin and how will you do things differently at the organization going forward? Thank you.

Thank you, Louise. So, we can start with the SG&A and then basically from there, I can give it to Tom to continue. So, if you remember, we implemented our restructuring really in June. So, most of the benefits in terms of cost reductions are really going to start to be seen from Q3, Q4 and the first half of next year. And the split may be in the range of $50 million this year, $50 million next year. But that’s really at a high-level. Tom, you want to add to that?

Related to the savings? So, as we mentioned earlier in the call, now the results [Technical Difficulty] savings are reflected in the Q2 results. So, we expect overall that we’ll have over $100 million of savings related to these cost reductions over the next 12 months. And they’ll be spread over the next 12 months. Okay. And then Louise, I think you had a question related to me being the new CFO. Overall, very excited to be at Amarin, like every other CFO looking for to drive the function, to be best-in-class. So that’s number one focus or A focus. I think overall what we see is to stabilize U.S. continue contribution margin in the U.S. so that we can support overall the European investments and really grow the Company through a European and an international base. And that gets me very excited. I’m glad to join Amarin to deliver on that.

Thank you, Tom. Just to go back, because I think there was also a question on the cadence on the U.S. revenue and what to expect over the next quarter. So, as we said, we have seen within the exclusive segment, which is now the large majority of our business stabilization in volume if not a sort of a single digit growth in volume. So, we feel fairly confident that we are keeping track on that one. We continue to see price erosion, and then on exclusive, we continue to lose volume, obviously there, but this impact is slowing over time, obviously Q3, there is a seasonality. So, overall, we continue to focus on contribution margin. This is the number one driver of our efforts in the U.S. The U.S. is delivering a very significant contribution margin that is supporting the organization drive European business and our investments in the regulatory approvals globally. So, for the moment, from a contribution margin, we continue to deliver on target and will keep the effort.

Your next question is coming from Roanna Ruiz of SVB Securities.

So, maybe focusing on the Europe front, two questions for me. I noticed you mentioned suspending the primary care field force in Germany, and I’m curious, how might that impact or benefit your overall spend and how long do you plan to keep the suspension in place? And also, what’s focusing on Sweden in the UK as newer countries coming on line. I was curious, when additional investments do you plan there and how do you see the outlook and spend for those countries as well?

Sure. So, in Germany, we chose very early on, because we came very, very early to the German market, to basically have a contractual agreement with the third party to have our primary care field force hired through them, by them, because labor laws in Europe are complex. And if you have to change course or make any changes can be very, very difficult from a process, but also with cost implications. So, based on that agreement, that field force contract would end now. So, we just decided since we’re still in negotiation, not to extend and not to continue, but to suspend at this point in time, because it will get us to save a good six months of investments in that field force, looking at the German situation. Now, we’ll have to see how the negotiations are going to evolve. Are we going to be successful, and come back to the primary care field force? And that allows us to do whatever we want, right? With flexibility or the situation would remain very, very difficult, and then we would consider everything from exiting to the market or having minimal presence, depending on what agreements we reach with the Germans. So, we took advantage of the moment. As a reminder, at the same time, we hired every -- our full team in the UK, I would say a bit ahead of time. So, in a way that balances our investments. So, we knew we could save in Germany and we knew that we could invest earlier in the UK. By taking those two actions together, we are in a way normalizing this so that it doesn’t have the additional UK investments don’t hit us that hard since we’re saving in Germany. Having said that, investing more in Europe is…

Your next question is coming from Daniel Wolle of JP Morgan.

Couple of questions here. First, in the U.S., can you quantify for us the benefit for this quarter that potentially derived from the normalization and trade destocking scene in 1Q? And I can follow-up with the rest.

So, we cannot really articulate it in the second quarter as a benefit. In reality, there was a destocking in Q1 and a hit, which was normalized this quarter, right? So, this is really how it is analyzed. It’s not like there is an artificial benefit this quarter. In fact, this is the first quarter where we see prescriptions and bottles really align. So, we feel confident that we’re balanced where we are today and the hit that we’ve seen in the Q1 has been basically normalized where we stand. Moving forward, we hope that we’re not going to see any of these disturbances in the trade. You can never speculate. I think, the market overreacted to a third generic and we’re not surprised, right? Usually in a generic market, you have all the generics coming in together on the first month. So, you rarely see situations where you have six months with one generic, then another six months with the second generic, then a third generic coming in literally after a year and three months. So, yes, the wholesalers reacted. We understand that. But, I think now they see that the erosion or the volume progression of the generics in general is linear, no matter how many they are on the market, and we continue, as a reminder, to retain 60% of the market despite a year and a half of generic presence, which I believe the U.S. team is very proud of.

And then, focusing on the Europe side, on Germany, can you provide us with a bit more color on the ongoing discussion with the health authorities there? What the process entails and what exactly are the possible outcomes that are expected when the process comes to completion in November? And then, switching to UK, while there might be a slow uptake in 2022, as you might, as you have discussed due to budgeting not being allocated, how should we expect the launch to look like in 2023? And what are some of the dynamics at play that would shape the launch trajectory?

Sure. So, on Germany, we are now in, I would say, the final stages of the negotiation with GKV with the payer. If those negotiations come -- we come to an agreement, then that would end maybe in a month or so. And if that doesn’t, then there is an additional opportunity for an arbitration that would take you until end of November. That’s why we decided since things are still ongoing and we clearly see based on the market dynamics, the situation in Germany, not for us, but for everybody is incredibly challenging in terms of healthcare. I mean, there are unprecedented decisions on controlling healthcare budgets and so on. So, we thought that the wisest thing is to just save money, right, save money. This is conserve cash, make sure we save this money waiting for a final decision. Now, if by November or by end of this month, we see a positive decision, then we will very easily rebuild because we have the contacts of our teams and we can reinitiate that. But if not, then we would have in a way restructured and saved the money with very, very minimal cost/labor law impact. So, all the scenarios on the table. We can’t speculate at this point in time. I have disclosed before that in the UK, which was a very successful negotiation at the end, we went through a third round of negotiation, which is very, very uncommon in the UK, and it has given a positive result. We can speculate or say that that’s going to be the same in Germany, but the message is, we continue fighting and we continue negotiating until the last minute we have in the process. For the UK, if you remember, we decided not to invest in any country ahead of reimbursement to ensure we don’t burn cash too prematurely. Now in the UK, we have a final decision. We have a full team onboard. Those -- this team is on the field where we are today and working very hard for us to have a strong launch. 2023 is going to be a full year for them. We have huge efforts in scientific engagement to build the awareness and the adoption. We believe the UK launch will be a good proxy of what we can deliver, at a European level, because there is significant adoption. We have actually seen tweets by NHS, by the Ministry of Health, by others saying, they are excited to reimburse the product for their patients in the UK, which is unheard of. So, we feel encouraged and we are doing everything possible to drive that moving forward.

Thank you. Our final question is coming from Kade Cruz [ph] of Goldman Sachs.

Hi. Thank you for taking our questions. This is Kade on for Paul. We have two. We wanted to know how you were thinking about planning for potentially recessionary environment, both in the U.S. and the EU in addition to the restructuring, if there is any steps you’re going to take. And then, number two was, how do you think about the margins for the U.S. business going forward post restructuring? Thank you so much.

Thank you. So, I think, the environment is very challenging. Now overall, it was tough for us as a company for the last year in any case. And again, as a reminder, we did implement two restructurings already. So, we had one in October of 2021, then we had the second one in June of 2022. So we’ve been very proactive so far to be on top of our cost structure. And I can tell you, we are going quarter by quarter looking at our contribution margin, because that’s for us the most important KPI we look at. The key actions we’ve taken, we are proactive to ensure we will be able to deliver future contribution margin that is needed for us to self fund. At the same time, we keep our finger on the pause. If we see that the market conditions, you’ve seen us sticking action in Germany, right, we are ready to take further actions if need be. For the moment, we don’t see that happening because I believe we’ve done a pretty significant effort in the last restructuring with almost 40% of headcount impacted in the company, right, ahead of all those headwinds. But you never know how the market is going to shape, so we continue to be vigilant and we will react, if need be. The last question was on margins. In the U.S., I mean, look, we’ve had a 1 time impact on our margins this quarter. We don’t see this being repeated. We’ll have to see how things evolve, but if there are any additional 1 time effects, it is possible, but we don’t see that as a trend. Tom, do you want to add anything?

Yes. I would just say, with that, we are contribution margin positive again in the quarter, and we continue to do so in order to invest into the European and the rest of the world market.

Okay. We don’t have any further questions in the queue. I’ll now hand back over to Karim, if he has any final comments.

Well, I just wanted to thank everyone for the call today. We believe we’ve had a strong quarter with significant success in the UK, in Sweden. Our U.S. performance is on track and is delivering the contribution margin that we expect. So, we continue to move forward, and we look forward to share more progress and update with you in the next quarter. Thank you all for being on the call. Thank you.

Thank you. Ladies and gentlemen, this does conclude today’s conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.