Welcome to Amarin Corporation Conference Call to discuss it's Third Quarter 2020 Financial Results and Operational Updates. This conference call is being recorded today, November 5, 2020. I would now like to turn the conference over to Elisabeth Schwartz, Senior Director of Investor Relations for Amarin. Please proceed.

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. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of VASCEPA prescriptions; VASCEPA product and licensing revenues, cost, gross margin and other commercial metrics; our current plans and expectations regarding spending, including expenditures for promotion of VASCEPA and for purchases of additional supply of VASCEPA; our current expectations regarding the adequacy of our financial resources; our current plans and expectations for product revenue growth, sales force productivity and product promotion in light of COVID-19 and the potential for added attention to cardiovascular risk reduction drugs, like VASCEPA, as a result of COVID-19; our current plans and expectations related to patent litigation and expectations related to the potential loss of generic versions of VASCEPA by generics companies and by ourselves; our current expectations for regulatory reviews outside the United States regarding VASCEPA approval; our goals regarding the timing, scope and success of international expansion, including expectations regarding our ability to launch VASCEPA in Europe and our expectations in China for clinical trial results and potential to bridge REDUCE-IT results in labeling and promotion of VASCEPA through our partner in China; our current plans and expectations regarding VASCEPA exclusivity outside of the United States, including Europe and China; our current plans for commercial expansion in United States with and without entry of potential generic competition; and our current plans and expectations regarding clinical study of VASCEPA related to COVID-19. These statements are based on information available to us today, November 5, 2020. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in…

Good morning, and thank you for joining us. As we announced in our press release earlier this morning, Amarin reported record revenue in the third quarter. Since our last investor conference call, we made progress across a number of areas key to our growth strategy, including advancing our plans for commercial launch of VASCEPA in Europe, increasing promotion of VASCEPA in the United States, and publication and presentation of several robust data sets in support of VASCEPA's demonstrated cardiovascular risk reduction in multifactorial mechanisms of action. Turning to our revenue. We achieved a year-over-year total net revenue increase of 39% in the third quarter and 56% for the first nine months of 2020. The 39% growth in the third quarter represents significant growth from the second quarter, but remains below the greater than 100% year-over-year growth reported in the first quarter of 2020 prior to the broad effects of COVID-19 that slowed patient visits to their doctors. These positive results reflect the effectiveness of VASCEPA in lowering cardiovascular risk in high-risk patients and further improved payer coverage. Moreover, this growth is a testament to the drive and dedication of our talented team of employees at Amarin, who continue to persevere despite the challenging headwinds we've all faced with the COVID-19 pandemic. Based upon TRx data from Symphony Health, VASCEPA growth during the third quarter and year to date continued to outpace the growth rate for more established drugs with positive cardiovascular outcomes data such as statins. Moreover, VASCEPA's growth in these periods also outpaced the growth of nearly all branded drugs for which positive cardiovascular outcome results were reported within the past four years. While VASCEPA does not compete against these other drugs, we are proud that in these challenging COVID-19 times and despite commercial spending to promote VASCEPA being…

Thank you, John. In support of the commercial launch preparations in Europe, we are building a team of experienced medical affairs professionals and building relationships with key opinion leaders and with medical experts who have extensive experience with the reimbursement agencies of key European markets. As John noted, VASCEPA was recently added to the recommendation of the EAS and ESC for the treatment of high-risk patients last year. Notably, in September 2020, the ESC expanded their guidelines to also include patients with acute coronary syndrome. Also, notable in late October, the Endocrine Society in the United States, which in the US is the largest professional society representing issues important to the field of endocrinology, added VASCEPA to their guideline, stating that VASCEPA should be considered for first-line therapy for people with elevated triglycerides in either atherosclerotic cardiovascular disease or type 2 diabetes, plus two additional risk factors. The Endocrine Society recommendation emphasized that this cardiovascular disease benefit seen with VASCEPA in a successful REDUCE-IT study does not apply to other omega-3 fatty acids, including those that are a mixture of EPA and DHA. These guidelines and recommendations of the ESC and the Endocrine Society increased to double-digit the number of medical societies worldwide which have publicly affirmed the importance and recommended use of icosapentethyl VASCEPA to provide meaningful clinical benefit. And in advance of our planned EU launch, global cardiovascular thought leaders have presented compelling data at the recent ESC and EAS Annual Scientific Sessions. A full VASCEPA story continues to unfold as we learn more about how eicosapentaenoic acid acts at the cellular level. In late August, at the ESC's Annual Scientific Sessions, results were presented from the EVAPORATE study, which showed VASCEPA demonstrated a significant 17% regression of low attenuation plaque volume as measured by multidetector computed tomography…

Thank you, Craig. In addition to advancing our plans for VASCEPA in Europe, we continue to make headway advancing our strategy to bring VASCEPA to a number of key geographies around the world. By year-end, we anticipate the topline clinical results from the triglyceride reduction study of VASCEPA conducted by Eddingpharm, our partner in China. Assuming positive results, we intend to support our partner in rapidly pursuing approval of VASCEPA in China. In Canada, our partner HLS Therapeutics launched VASCEPA in February. In July, they announced early success in achieving the Canadian Agency for Drugs and Technologies in Health recommendation for reimbursement of VASCEPA by participating public drug plans for statin-treated patients with established cardiovascular disease and elevated triglycerides. In addition, the introductory price submission by HLS did not trigger in excess of pricing investigation. Importantly, based upon these achievements, HLS highlighted their belief in the long-term sales potential of VASCEPA in Canada and reaffirmed their peak sales forecast of, and based in Canadian dollars, CAD200 million to CAD300 million, noting that there could be potential upside to those figures. We continue to work closely with HLS and are looking forward to continued progress with their ongoing launch in Canada. Hopefully, by building on the strong clinical efficacy demonstrated by VASCEPA, we will have similar market access success in Europe, China and other parts of the world. With that overview of the business, let me turn the call over to Mike Kalb, our CFO, for a more detailed discussion of our financials. Mike?

Thanks, John. For the first nine months of 2020, Amarin achieved significant growth in total net revenue despite the continued global impact created by the COVID-19 pandemic. We reached total revenue of $156.5 million and $446.8 million for the three and nine months ended September 30, 2020, respectively, representing 39% and 56% increases compared to corresponding periods in 2019. During the third quarter of 2020, we reported net product revenue of $155.2 million, a 38% increase compared with the third quarter of 2019, and we achieved $441.1 million in net product revenue for the first nine months of 2020, representing a 55% increase compared with the same period of 2019. These increases were largely driven by increased US VASCEPA sales, which include a modest increase in VASCEPA's US net selling price. For emphasis, the net selling price impact in the third quarter of 2020 over the same period of 2019 was small and due to annual donut hole issues with certain payer coverage and, as has been the pattern in prior years, the net price of VASCEPA in the third quarter of 2020 was modestly below its net price in the first two quarters of 2020. As a reminder, Amarin recognizes product revenue in the United States based on sales to wholesalers and specialty pharmacy providers in the US or collectively its distributors or its customers in accordance with Generally Accepted Accounting Principles and not based on prescription levels reported by Symphony Health or IQVIA. Amarin's gross margin on net product revenue was approximately 78% for the first nine months of the year. This slight increase compared to the same period in 2019 is driven by gross margin on US product sales of 79%, which was partially offset by the gross margin on product sales to Amarin's partners outside the…

As we look to the balance of 2020 and beyond, we continue to believe that even with generic entry in the United States market, there remains potential for us to build on our success in expanding branded VASCEPA in the United States for this important drug's new indication of cardiovascular risk reduction. And we continue to believe that there are significant opportunities to build the VASCEPA franchise in a number of key international markets, both on our own and through partners. 2020 has been a difficult year for everyone and while Amarin has had its share of challenges, I continue to be inspired by the hard work, dedication and unflappable enthusiasm of the Amarin team. I am proud to work with this team of accomplished professionals and to share a common goal of bringing VASCEPA to patients around the world in order to reduce cardiovascular risk. With that, operator, we are ready to open the call to questions.

Thank you. [Operator Instructions] Our first question comes from Ami Fadia with SVB Leerink. Please proceed with your question.

Hi. Good morning. This is Ethan on for Ami. Thanks for taking our questions. Maybe two, if I can. Yes. So first, I think, Hikma indicated today they're launching their generic, so I wanted to get your thoughts more broadly on cash management as – and sort of your thoughts on that as generics enter market, and maybe what degree of generic impact could result in a change in your promotional strategy? And maybe any sort of building up of this, we see that Hikma's generic came in at, I think, it's about 9% WAC discount. Obviously, we know that your net price is [indiscernible] than this. But just curious how you think about ability and willingness to maintain meaningful market share in the US. Should we think of this more as to limited generic supply or from Amarin's sort of willingness to compete with generics on price? Thank you.

Hey, Ethan. Hi. This is John. Thanks for the question. Yes. So, as you have cited, Hikma has published their WAC price for their generic product, which is about 8.9% lower than our WAC price which would be a price that is going to be more expensive for many payers than what VASCEPA is available to them on a net basis. But, as you know, the decisions often for what drug is dispensed is made at the retail pharmacy, not at the payer, although based upon that pricing, I wouldn't anticipate that the generics would get preferential treatment by the payers. It is our understanding, and this includes based upon public comments made from the generics companies that they have limited supply. It's also our view that the market opportunity for VASCEPA in the United States is very large. The -- as cited during our prepared comments, most patients, most physicians don't yet know about VASCEPA. This is very early in the life of VASCEPA for a generic to be introduced to the market. It is our view that because of that substantial upside and because of the tremendous cost and time associated with building supply capacity, something that we've been working earnestly on for over a decade, that we can in the United States grow our revenues faster than the generics can supply the market, and it's our intention to do so. And, certainly, if we're wrong in that, we don't think we are, but if we are wrong in that, we could compete with our own generic and move to that very quickly. But right now, our view is firmly that there is much more value under the curve by growing revenues and taking a substantial piece of that growth than there is by going and trying to compete on price or trying to compete as an authorized generic. So, our strategy that we articulated in the call today was in anticipation of generic launch. There may be others. Those launches are for the -- in the US only and those launches are for the initial indication of VASCEPA for triglyceride lowering in patients with very high triglycerides, and we will continue to pursue aggressively the growth of the market, while also considering whatever legal options remain. Hopefully, those comments are helpful.

Great. Thank you.

Our next question comes from Louise Chen with Cantor Fitzgerald. Please proceed.

Hi. Thanks for taking my questions. So, first question I had was, how should we think about, broadly topline basis, 2021 sales growth and OpEx in light of several moving parts, the pandemic, potential generic competition, EU expansion, and expansion into other geographies? And the second question I had for you is that, is there any update you can give on the China opportunity market size? Where your economics are there? How should we think about that versus US and EU opportunities? Thank you.

Louise, good morning. With regard to 2021, that's a difficult one. It's very difficult to predict where COVID is going to go to, or is there a vaccine? Is it effective? Isn't it effective? We saw a significant improvement in physicians opening their offices to our sales reps during the third quarter versus the second quarter. But still roughly half of them -- half of the doctors don't allow face-to-face direct sales calls yet, but again much better than it was in the second quarter continuing to see many fewer patients going to doctors for preventative care than they did sort of pre-COVID, but again that was better in the third quarter than in the second quarter. How much of a -- how much does COVID have a second wave here? When does it get eradicated, if ever? What the effectiveness of vaccines are? It's our view, right or wrong, that by the middle of the coming year, the world relative to patient access to physicians and our sales force access with physicians will be somewhat back to normal, probably never quite exactly the same but somewhat back to normal. Whether that hypothesis turns out to be true, I think it is unchartered territory. But we think things will continue to improve, albeit with some volatility. And as we're betting on that, we are continuing forward with our promotion both through our direct sales force and through various forms of electronic and TV-based promotion to educate physicians and patients about VASCEPA. As cited during the call, the knowledge out there, particularly on aided awareness of VASCEPA for cardiovascular risk reduction is very low, which is a huge opportunity, but can't at this point in time quantify what our revenues will be going forward. I also can't quantify specifically that the…

Thank you.

Our next question comes from Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Hi, team. Congrats on the continued progress that you're making given these challenging times. So, two quick questions for you. The first one is, can you comment on just generally -- we get this question constantly from investors, how many high-quality suppliers are there in the world? What percentage of them have you secured? And how long is sort of your supply chain secured for? And then the second question is, the COVID studies that you have ongoing, they are quite large prepared as 1,500 patients mitigated, 16,500 patients. Can you comment on what you hope to see on those -- in those studies and to move forward what the next steps be in the utility of that data? And thank you again for taking my questions.

Yasmeen, thanks for the comments and I appreciate that. Relative to supply, when we started in this area, there were -- which again, this goes back more than a decade, there were, at that point in time, dozens of companies that thought that they could produce VASCEPA API to the quality standards that we wanted. And we began working with some of them and have developed those capacities over the years. Some of them started off as manufacturers of product for dietary supplements and we needed to help them become qualified manufacturers of API for pharmaceutical grade, somewhere manufacturers of other APIs. But in all cases, it required handholding by Amarin from a technical perspective and/or investments from Amarin, and we have been continuing to grow that supply chain. At this point in time, we are using suppliers and we are buying, because we needed all of the products that those suppliers can produce. And as we get ready for Europe and China, it's our view that we're going to need more supply than what we're currently getting from those suppliers and talking to those suppliers about potential growth beyond that and we're certainly hopeful that they appreciate the upside opportunity that we present. We are assuming that the generic companies are looking out there and saying that there are dozens of companies that produce API or produce omega-3 products, and they are probably going through some of the same decision-making that we were making over the last decade of how much do you invest in companies? Do you invest in companies that have done products for dietary supplements and try to make them qualified for API under -- for pharmaceutical grade product? Or do you try to take a product companies that are used to doing pharmaceutical grade products…

Thank you, John.

Thanks, Yasmeen.

Our next question comes from Michael Yee with Jefferies. Please proceed with your question.

Hey, John. Thanks. Good morning and appreciate all the work during these times. Two-part question for you. First was, as you can see there is a lot of questions around the dynamics of the generic, but it -- for investors, it's pretty hard to figure out what the next year even looks like or next two years. So, maybe you could just put all these pieces together, do you think that you could actually grow in 2021 over 2020, or maintain a substantial amount? Yes. The answer is yes?

Yes.

And, John, year-over-year [ph]. Okay.

And beyond. That's what we're betting on. There is, obviously, risk to that. But based upon our view of the market opportunity, which is substantial, and based upon our -- both our experience with supply and knowledge and public comments from some of the generic companies, we believe that we can grow the market in the United States faster than what they can do in terms of supply in the market, probably good for everybody.

Wow. Okay. And then, secondly for, I guess, those who are not confident [ph].

There may be some variability in there, right, Michael?

Yes.

So, the -- I don't know how much supply has been built up by Hikma, for example. I don't think it's huge, but anytime you're putting product into the pipeline, the wholesalers will probably buy initially whatever that product exists and that may take a little bit of bump on our sales to wholesalers. But ultimately a steady state will be reached and it's against that steady state that we think we can grow the market faster. Now COVID is a wildcard in that mix. But you saw we did in the first quarter before COVID and that was even before our full sales force was put into place, before advertising was put into place. So, we think if we can get beyond COVID, there are so many patients out there who could potentially benefit. We now have broad medical support, reimbursement has improved really tremendously as we've moved here through 2020 and we anticipate as we go into 2021. So, all of those factors we think leads us to a view that we can grow prescriptions faster than what can be supplied by generics. If we're wrong, we can adjust. But right now, that's our view.

Okay. And then just to close that out, even if you go out farther than 2021 or 2022, Lovaza, Renagel, some of these other drugs, are those good examples for where you think you would sustain a substantial amount of your existing US revenues, even in the face of having some generics in the market? Do you think that is the case, 50%, something like that?

In Japan, Mochida, which sells Epadel, which is an EPA-based product. Their product has been generic now for over a decade. I believe the branded product still represents over 60% of the market share. The Lovaza, I don't know that's such a great example, because GSK in the United States, when generics were launched, essentially, stopped all promotion and all focusing on that product. Whereas -- and that was a much more mature product when generics were launching. We just got approval launching in the first quarter of this year for cardiovascular risk reduction. It is somewhat unusual for a generic to be being introduced when the product is still not well-known by the medical community or the patient community. So, not sure that Lovaza is [indiscernible]. Also, the manufacturing of VASCEPA is more difficult than that of Lovaza. Time will tell, but I think if you're trying to pick out an example, Mochida example might be a better one.

Okay. Perfect. Thank you. I appreciate it.

Thank you. At this time, there are no further questions in queue. And we would like to thank you for joining the conference today. You may disconnect your lines at this time and thank you for your participation.

Thanks, everyone.

Thank you. All right. I'm going to hang up the phone.