Welcome to Amarin Corporation's conference call to discuss its Second Quarter and Six Months 2021 Financial Results and Operational Updates. This conference call is being recorded today, August 5, 2021. I would like to turn the conference call over to Michael Kalb, Chief Financial Officer at Amarin.

Good morning, everyone, and thank you for joining us. Turning to Slide 2 of the presentation accompanying today's call, which can be found in the Investor Relations section of our website at www.AmarinCorp.com. Please be aware that this conference will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to - these statements are based on information available to us today, August 5, 2021. 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 factors that could cause actual results to differ materially, please see the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended June 30, 2021, and our Annual Report on Form 10-K for the year-ended December 31, 2020, which have been filed with the SEC and are available through the Investor Relations sections 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 outside its approved indications. An archive of this call will be posted on Amarin's website within the Investor Relations section. Karim Mikhail, Amarin's President and Chief Executive Officer will lead our discussion and I will provide a more detailed review of our 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 now turn the call over to Karim Mikhail for a review of the business.

Good morning and thank you all for joining us this morning. I'm particularly pleased to be addressing you for the first time as the President and CEO of Amarin. Following John Thero's planned retirement, which officially took place earlier this week. On behalf of the entire Amarin team, I'd like to thank John for his considerable contributions to the company and to patient care around the world. We wish him much success and happiness as he embarks on this retirement, following his distinguished career as the President and CEO of Amarin. I joined Amarin as Senior Vice President and Head of Commercial for Europe, approximately 1 year ago, because I was attracted by the magnitude of the evidence in the REDUCE-IT study and excited by the tremendous European opportunity we have that changed the treatment paradigm in preventative cardiovascular care. Turn to Slide 3 please. Developing and commercializing cardiometabolic acids is a daunting mission and many companies stepped away from this space due to 2 main challenges. First, for numerous indications you need cardiovascular outcomes data, which take years to generate and are a challenge to fund. And second, in order to ensure that as many patients can benefit from the new CV drug, you need to reach a broad prescribing audience. With the REDUCE-IT study, Amarin has already succeeded in developing the first and only approved medication for reducing cardiovascular risk beyond LDL lowering therapies in high-risk statin-treated patients. This foundational scientific trigger is the main driver for the consistent recognition of 19 global medical societies with the latest addition of the American College of Cardiology. In terms of broad prescriber reach, Amarin has established a go-to-market model in Europe that allows us to reach larger prescribing audiences through efficient omnichannel engagements that amplify our essential field-force efforts and…

Thanks, Karim. Turning now to Slide 8. During the second quarter of 2021, we reported net product revenue of $153.8 million, an increase of 15% compared with the second quarter of 2020 and we achieved $295.2 million for the first 6 months of 2021, an increase of 3% over the same period in 2020. As Karim noted, these increases were largely driven by increased U.S. VASCEPA sales and occurred despite the ongoing impact of the COVID-19 pandemic and the impact of generic products for VASCEPA's initial indication. We expect that net selling price may slightly decline in the second half of 2021 as we continue to be opportunistic in protecting and expanding our managed care access in light of generic availability. Signs of growth are encouraging and plans to selectively increase promotional spend in the second half of the year should drive increased revenue growth. Absent the reversal of certain non-cash charges, we were approximately breakeven in the second quarter of 2021. We are pleased that we were able to achieve this with our continued expense management and despite the limitations to our potential revenue growth, resulting from the continuing impact of the COVID-19 pandemic and the resulting reduction in patient visits to their physicians which impact new prescriptions. While a second generic launch in June, we remain confident in our ability to grow VASCEPA in the U.S. as this is an atypical generic market. We believe the growth in revenue in the second quarter of 2021 emphasizes the need for VASCEPA in the U.S. and the continued potential opportunity for Amarin in this market. This also further shows that we have the cash flow and profitability through our U.S. operations to support the expansion into Europe and other geographies around the world. However, due to variability of spend related to go-to-market initiatives in the U.S. and expansion into Europe, our overall profitability in the short-term may fluctuate. As of June 30, 2021, Amarin reported aggregate cash investments of $523.1 million consisting of cash and cash equivalents of $327 million and liquid short-term and long-term investments of $181.9 million and $14.2 million, respectively. We believe our current resources are sufficient to fund our projected operations, including a successful commercial launch in Europe. With that financial overview, I will now turn the call back to Karim for closing remarks. Karim?

Thanks, Mike, for that financial overview. Turning now to Slide 9, our vision is clear and our strategy is set. Our focus moving forward remains firmly on executing these plans, with the return to growth of VASCEPA in the U.S., the successful launch of VAZKEPA in Europe, and the global expansion as our top priorities. In closing, let me say that I'm honored and humbled to serve as Amarin's new CEO, and to work alongside the dedicated and talented Amarin team to advance our mission. I greatly appreciate the overwhelmingly positive welcome I have received from many of our loyal shareholders and analysts and will work diligently to earn your ongoing support, as together we work to create value, and lead a new paradigm in preventative cardiovascular care. With that, operator, we are ready to open the call for questions.

Thank you. Ladies and gentlemen, the floor is now open for questions. [Operator Instructions] The first question is coming from Ken Cacciatore from Cowen. Ken, your line is live.

Great. Thanks so much. Congratulations on all the progress and congratulations to John in all his contribution. Just wanted to follow up on the disclosure of the proposed list price, can you just talk us through mechanically when we know that we've secured it kind of in the various regions, so just timing around that, and maybe a little bit of the back-and-forth interaction that you have as you negotiate this? And then, in the U.S., just wondering, obviously, it's been a wonderful defense and generics have peaked out. Can you give us the balance? Is it the raw material issues that you've cited previously? Or is it the label defense that you're articulating, that is capping the generics? And then, maybe lastly, it does look like Teva has removed their NDA or there is language suggesting it's such on the FDA website. Can you just talk about future generics and expectations and timing? Thank you.

Thanks, Ken. So let me start by talking about the proposed price in Europe. Clearly, this is the list price that we are making public at this point in time. This was submitted currently to a number of countries as the initial step to start the negotiation. So you should think of this really as the first starting point of that journey. Now, we believe that we set this in a way to ensure that the different countries see the value in the price, and that they see that it's well justified within the patient population that we are targeting, and more importantly, the value that we are bringing. Now, the specific mechanics by country, in a country like Germany, this price is really going to be the price that we're going to be selling with minus 2 mandated single-digit rebates. But that's going to be the net price for the first year. After that first year, we're going to have an update of that price based on the negotiation. And in the other countries, that negotiation is already ongoing on the price. So when we will launch, we will launch with a fully negotiated final price. Now, I remind you that price structure and price negotiation in Europe is very different than in the U.S. rebates. And the markups are very, very different. So comparisons between list price in Europe and WAC in the U.S. may not be that useful at this stage. However, we stay true to what we disclosed earlier, which is our net price in Europe will be at the same level or higher than our net price in the U.S. Now, talking about the U.S. performance and how are we performing versus generics, I want to start by saying, I mean, clearly, this is a…

Thank you. And the next question is coming from Yasmeen Rahimi, from Piper Sandler. Yasmeen, your line is live.

Hi, Karim, thank you so much for your thoughtful prepared remarks. I wanted to understand a little bit more on the additional 4 dossiers that have been filed. I think, if you could just help us understand the timing of those to be put into place and the additional 6 in terms of filing. And then, also when we think about pricing outside of Germany, are certain geographies that are a little bit more, I guess, easier to negotiate versus other countries? So just kind of give us a little bit of color on timing, heterogeneity from the different 10 countries. That'd be very helpful. And thank you for taking my question.

Thank you, Yasmeen. So, we have submitted up to now 4 country dossiers, which is the UK, France, Italy and Denmark. And German dossier is ready for submission, has been ready for submission for a couple of months now. We're only basically keeping it until the right moment for a commercial launch, because if we submitted too early, it means we have to sell early. And because of the limitation of COVID and the limited access we have, we don't believe that it's the right moment. We believe that September is the right moment to launch in Germany after the summer vacation. Now, each one of these countries and the additional files that we will submit has a different negotiation timeline. There is a group of countries that has a pre-determined clock. So if you look at a country like the UK, which most of the discussions, negotiations, is actually public, so you can go on the NICE website and see what type of interactions we have with NICE, you will see that this is a process that will take from a HDA perspective, somewhere between 12 to 15 months, taking into account 2 or 3 back and forth committees to negotiate the price. Now, there are products that did that, who are delivered earlier than this timeline. It really depends on the evidence that you have, the appetite of the reimbursement body to say, yes, I need this. Specifically in the UK, we've seen that the market has been far more sensitive to the need for cardiovascular products in the UK recently. So we believe that that's a positive note. Having said that, it's a significant budget impact for the UK. So they will take all the time they need to negotiate the access and the price for that…

Thank you. Thanks. That's very helpful.

Thank you. The next question is coming from Louise Chen from Cantor. Louise, your line is live.

Hi, thanks for taking my questions here. So first question I had for you was, can you provide more color on where the $1 billion of incremental revenues are going to come from? Can you break it out maybe between EU and the rest of the world? And then how should we think about sales in the second half of this year in light of the EU launch in Germany, and then also competition from generics here in the U.S., and there's been an additional competitor? And the last question is, have you had any discussions with EU partners recently? And what type of partner are you looking for here? I think you had mentioned that you can keep all the options open. So just curious your most updated thoughts. Thank you.

Thank you, Louise. So let me first clarify the $1 billion. So the $1 billion that we quoted in the discussion just a few minutes ago, was really an incremental $1 billion outside of the U.S. and outside of Europe, right? This is a new incremental revenue stream by pursuing additional 20 countries on top of the 30 where we are. So if you look at North American between U.S. and Canada, you add Europe, right, 27, you add China, that's around 30 markets out of the top 50. There are remaining 20 countries where we believe we can have access and generates revenue. If you look at these countries, I think the most important one would be countries like Australia and New Zealand. If you look at what other products have delivered within the cardiometabolic space in Australia and New Zealand, you'll see that these - this is a country that usually delivers a revenue size of a big 5 in Europe, so as a Germany or as a Spain or a France size. In these countries, we need to initiate the regulatory approval process. We are going to initiate that within the next month. And some of these countries have a rapid process, example, Australia, New Zealand, for example, where it's really 6 months, but some others, it takes far longer time. And to be specific on where those countries are, if you look at Latin America countries like Mexico, Brazil; if you look at Asia countries like Korea are very important countries from a lipid market perspective and a cardiovascular perspective. And in these countries, we believe we do not need to go ourselves to build an infrastructure. We can partner in a different evolved model that will allow us to sort of maintain our marketing authorization,…

Thank you.

Next question?

Thank you. The next question is coming from Michael Yee from Jefferies. Michael, your line is live.

Hi, good morning. This is Mike on for - sorry, this is Dennis on for Mike. Good morning. I just have 2 quick questions. Dr. Reddy's seems to be ramping up, and they said they aren't seeing any supply constraints. Do you feel like you have a good hold on your own supply chain? And can you comment on what you're seeing overall on the supply landscape? And then as a follow-up, how should we think about expenses in the U.S.? And can these be right size in the second half and 2022 as generics continue to ramp up? Thank you.

Thank you. So on DRL and the comments that they have no supply issues, well, if a generic company stays true to the size of the indication of VHTG of that 7% really of the total market. So that would not be an unexpected statement to make, if you are trying to communicate that you are not infringing on somebody else's patents and rights. Now to the reality of the supply, we definitely don't have information what we see is that supply from Hikma and from DRL is very sporadic and inconsistent, it's focused on where we are selling. And that's really the disruption that is creating today that's the fight we are having. The challenge is not very much in the through substitution we're having it, only 12% of the business is substituted. Our challenge is that this is creating a significant disruption in the market, because the patient goes to the pharmacy, he or she does not get his VASCEPA branded. They're told to wait a couple of days for a generic to be available in 2 days, so to wait another 2 days. And at the end of the day, we lose many of ongoing continuing patients. If you look at the new to brand business, we are driving the new to brand that are more new patients that are using VASCEPA. Our challenge is, is that we're losing from these refill of the continuing business. But we believe we have the supply needed, we made every effort over the many years to have enough supply for the U.S., for Europe. And today, as you can see, we have a plan beyond Europe, which by the way, if you look at prior disclosures is not new, we have always communicated that we will go international outside of…

Thank you. And the next question is coming from Jessica Fye from J.P. Morgan. Jessica, your line is live.

Hey, guys, good morning. Can you just elaborate a little on the comments that net selling price might decline in the back half as you aim to protect managed care access? Is that something we should also think about continuing into 2022 and beyond? I guess, what's the latest payor dynamic you're seeing that's driving this need to protect access? So kind of thought previously you had indicated that wouldn't really be necessary based on VASCEPA's already low net price in the U.S.

Thanks, Louise. So just commenting on the net price, if you look at our net price over the last many years, you'll see that the net price has been very much stable. And we made sure that over time we protected that. Today there is a slightly different dynamic. And you see we're going to be, we said opportunistic, because that's not going to be an overarching strategy. We're only going to do that when we believe it is business meaningful and will drive access to a meaningful business opportunity. I don't believe that that's going to be significant at this stage, simply because we are retaining and even improving our access despite having the 2 generics available. In fact, many players recognize the lower net cost benefit of VASCEPA. And for the moment, we have very good coverage at the market level. We don't see this as a continuing consistent trend. We say we may need to do this from an opportunistic perspective in a number of plans. But that's it, and we'll have to see how things evolve. We're also conscious to ensure that we keep prices similar between different parts of the world. As in Europe we have European reference pricing. So we will try to maintain our price is level, as close as possible to each other and not lose a lot of our value in terms of price.

Okay, great. And maybe just one more. I appreciate the kind of comments on how you're thinking about spend. Just to be clear, do you still expect OpEx to be in the guidance range that you provided earlier this year?

So, today, as you've seen from the first 2 quarters, numbers have changed over time, because we have to react to where the market is going and when is the right time to invest. The first half of the year, we felt we needed to hold a little bit on some of our investments, because we felt like it was not the right time. We believe that the second half seems to open up better. So we believe we're going to have more investments, both in the U.S., but outside of U.S. also. And again, we continue to monitor the market situation and evolve our investment choices quarter by quarter.

Great, thank you.

Thanks, Louise.

Thank you. And that's all the time we have for questions today. I would now like to turn the call back to Karim Mikhail for any closing remarks.

So I just want to thank you all for the warm welcome for the first quarter and the first earnings call. We look forward to continue to working together and answering your questions, whether it's quarterly calls or one-on-one. Thank you, [Cole] [ph], and thank you, all, and have a great day.

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.