Q4 2020 Earnings Call Transcript

Published: 25 Feb 2021

[Operator:]

Welcome to Amarin Corporation's Conference Call to discuss its Fourth Quarter and Full Year 2020 Financial Results and Operational Updates. This conference call is being recorded today, February 25, 2021. I would like to turn the conference call over to Alina Doubrovna, Associate Manager of Investor Relations at Amarin.

[Alina Doubrovna:]

Thank you, operator, and thank you to everyone for joining our fourth quarter and full year 2020 results. Before we begin, let me turn to our forward-looking statements. 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.

[John Thero:]

Hello and thank you all for joining us this morning. Because we provided substantial comments last month on our expected 2020 results, and our annual report has filed today reflects confirmation and formalization of what has already been reported, we intend today to be relatively brief in our prepared comments. 2020 was a year of considerable progress for Amarin with important achievements across multiple areas, including launch in the United States of VASCEPA for the treatment of high-risk patients with persistent cardiovascular risk or PCVR, creating the foundation of our European commercial organization, progress by our international partners and important scientific advancement including demonstration of plaque regression through administration of VASCEPA in patients evaluated in the EVAPORATE study. That said, 2020 was also a year we all face great challenges with the COVID-19 global pandemic. Amarin specifically faced both the difficulties posed by the pandemic and the loss of our patent litigation in the United States for VASCEPA's original triglyceride-lowering indication. I am proud to say that the Amarin team rose above these obstacles with great determination and advanced the company across all areas of the business, including commercial, clinical and corporate. Let me begin with our most visible achievement in 2020, our record level of revenue. We reported annual net total revenue of $614.1 million in 2020, an increase of 43% compared to 2019. Both our full year revenue and our fourth quarter 2020 net revenue, which was $167.3 million are record levels for Amarin. Our revenue growth was led by increased prescription levels of VASCEPA in the United States. As you know, we launched the new PCVR indication for VASCEPA in January 2020. And in March 2020, consistent with most companies throughout the industry, we had to pull our sales team from the field due to the COVID-19 pandemic.

[Michael Kalb:]

Thanks, John. We encourage investors to review our 2020 annual report on Form 10-K, now our corresponding press release as issued this morning. Both of these can be found on our website. They contain discussion of our fourth quarter and full year financial results including various details which go beyond the highlights I will cover in today's call. John noted our record levels of net revenue in both the full year and the fourth quarter of 2020. These increases were driven primarily by increased volume of VASCEPA sales to customers in the United States. The net price in VASCEPA, while it increased modestly in 2020 has essentially remained flat for many years. It is not possible to quantify the impact of COVID-19 on our 2020 net revenue, although we are certain that such impact was significant. Additionally, while it is also not possible to quantify the impact of the generic product launched in November 2020 on our net revenue, we do not believe such had a material impact. We do not breakout operating results by geography. However, the contribution to our business from commercial operations in the United States has been improving, while we have commenced making increased investment in Europe. As mentioned earlier this year, Amarin anticipates 2021 operating expenses of approximately $550 million to $600 million, which represents an increase of approximately 10% to 20%, compared with 2020 levels. Included in these anticipated expenses are increased costs associated with Amarin's commercial launch preparations, and initial launch in Europe, as well as continued U.S. promotional activities. Also included in these anticipated expenses is an assumed sales force in the U.S. of approximately 750 to 800 professionals consisting primarily of sales representatives and their managers. Due to the uncertainties regarding COVID-19 and potential generic supply, Amarin will continue to withhold 2021 revenue guidance for VASCEPA in the U.S., until there is greater clarity on the impact of these issues. As of December 31, 2020, Amarin reported aggregate cash and investments of $563.4 million, consisting of cash and cash equivalents of $187 million, and liquid short-term and long-term investments of $314 million and $62.5 million respectively. Furthermore, during the fourth quarter of 2020, we made our final royalty-like debt payment, which previously was 10% of net product revenue since VASCEPA was launched. We now have no debt. We reiterate that based on our current plans, we believe that our existing resources are sufficient to fund VAZKEPA's launch in Europe and to get us to cash flow positive on a consolidated basis. With that financial overview, I will now turn the call back to John for closing remarks. John?

[John Thero:]

Thanks, Mike. Like all of you, we entered 2021 with great hope that the vaccines developed by our industry colleagues will stem the tide of the global COVID-19 pandemic, yet aware that there will continue to be a need for effective therapeutics as well. Towards that end, we maintain our support of multiple investigator sponsored studies of icosapent ethyl to treat and prevent COVID-19. The first of these studies demonstrated encouraging results. After we see further study results, we will assess the potential role of VASCEPA related to COVID-19 and other infectious diseases where inflammation is an issue. Amarin has a very dynamic year ahead. 2021 is a year of execution for Amarin. And we are working hard to attain our goals including

[Operator:]

Thank you. And the first question is coming from Louise Chen. Louise, your line is live. Please announce your affiliation and pose your question.

[Louise Chen:]

Hi, Louise Chen with Cantor. Thanks for taking my questions here. So I had a few questions. First question I had was how should we think about this first quarter 2021 sales for VASCEPA, given the pandemic headwinds that we have this year when compared to last year? And then, second question I had was what gives you confidence that you can continue to grow faster than the market for generics, even if more generics can enter the market later this year? And then, last question I have is, how do you think about the peak end-market sales in China and what that means to you in revenue? Thank you.

[John Thero:]

Louise, good morning. It's John. Thanks for the questions. With respect to Q1 sales, we're in the middle of quarter and can't comment too much on the middle of the quarter activities. But as we commented during the prepared remarks, there are a couple of headwinds that we face in the first quarter. One, of course, is COVID. And that's been volatile. Certainly, there is some good news in the media recently about event rates going down. We've seen periods in the past, like we saw in sort of the September/October timeframe, whereas COVID pulled back the prescriptions in the United States of VASCEPA went up. I think it's early to be predicting that, but whether that's immediate or whether that's more of a Q2 phenomenon, we are hopeful and have confidence that that's going to happen. Two is the impact of the generic supply, which appears to be relatively fixed here, varying week to week, but it is taking a slice that I think you'd see the numbers. It's quantified. It bounces up and - bounces up and down. And then, of course, there are those headwinds that we get seasonally every Q1, and particularly, in the January and February timeframe has impact. And for those who aren't familiar with that, you can think about drug like VASCEPA, which somebody has insurance and copay card, they can get for $9 for a 30-day supply. But that copay card doesn't pick up every dollar from dollar one, if somebody doesn't have insurance. So if a patient has a $3,000 deductible on their insurance, and these patients tend to be on multiple therapies that they are used to paying $9 here and $25 there and $30 there, and then maybe a monthly bill of $100 for their portfolio of therapies. And they've got a $3,000 deductible, they go in, in January to get their prescriptions filled, instead of being an aggregate tab for the 5 of them for $100, they come back for the charge and, say, $3,000, those patients end up billing their pain meds, but they need - many of them just can't afford to fill all their medications. So they don't fill something as important as preventative cardiovascular care. Then historically, we've seen a sort of rebound in those scripts in March, and then particularly in April and May. So we're counting on that type of thing happening here again in the first quarter. The promotion that we have been doing, because of COVID, we did pull back a bit in the - during the fourth quarter and have continued to be somewhat constrained here in the first quarter relative to promotion. You've seen as much television advertisement, for example. We're preserving those resources with a view that as COVID pulls back further, we will ramp that up. So we're currently anticipating year-over-year growth in the first quarter versus last year, but we're not providing any quantified guidance on it at this point in time. With respect to why we believe that we can grow faster than generics, that's a complex topic. And I would begin with the fact that this really is very much an atypical generic market. Atypical in the sense that, for the generic that's launched, greater than 93% of the use is off-label. As I discussed VASCEPA is not a mature market. Most people don't know about it. Yet, this is a multibillion dollar opportunity that we think we're . We've just launched and just 13 months ago we just began the launch. We're focusing on patients' education. And this is not an expensive product, so it's not like the generics coming in, they'd be rushing after the generic, because it's less expensive. To the contrary, we've seen managed care coverage continue to expand. And then, the manufacturer of this product requires significant investment that Amarin has made and supported over multiple years to create efficiencies. But lead times here for product supply is long and then expensive. So probably contributes to why only one of the 3 approved generic have launched in this point in time. And the one that has launched has commented that their gross margins on that product is lower than what it is for other products, because of the relatively high cost for the production of this high-quality complex product to manufacture. I remind you that Epadel, which is based product in Japan has been generic for over a decade and is still greater than 60% branded. So we think it is the right thing for patient care for us to continue to focus in on increased promotion in United States. I know our sales team in the field is confident that we can grow. What we need to do is have patients go back to their doctors. And I think if patients were regularly going to the doctors for ordinary care, we will be growing at a rate that it would be convincing to many people that we should be in a world faster than generic. This is just a big, big market. And, of course, and a topic in generic is U.S. only. And in Europe, for example, is 10 years that we're respecting regulatory exclusivity, and then patents that could take us out potentially as long as 2039. What was your third question? Peak sales in China, right, right, right. So I think there we need to recognize it's a very large market in China. Unfortunately, cardiovascular disease is a global phenomenon. We're working with a very good partner, with Eddingpharm. They've got a lot of experience in taking products through the reimbursement process, which in China will be important as it is in Europe. And we put together a very good team in Europe to handle this. We first need to get the product approved in China and see what the label ends up being. And I don't want to step on the toes of Edding, they're responsible for the pricing there. We've got some say in it, but let's get these label first and then they will go province by province, aim towards the approval, but the rate of uptake of statin use has been high in China. And, certainly the cardiovascular need is high in China. I would remind folks that the terms of our agreement with Edding is that, there are various milestone based payments, but also, we will be manufacturing the product for them and doing that on a cost-plus basis. And then there are tiered royalties on top of that, that are starting in double digits and sort of escalating up through that. So it's a big, big potential opportunity for us. So let's get it approved first, see what the label is. And then, go through the provinces for reimbursement before we get in too much quantification there. So - and then, again, I don't want to step on Edding's toes. They're a perfect partner. Hopefully, those comments are helpful.

[Louise Chen:]

Yeah, thank you.

[Operator:]

Thank you. And the next question is coming from Ken Cacciatore. Ken, your line is live. Please announce your affiliation and pose your question.

[Ken Cacciatore:]

Hi, it's Ken with Cowen. Thanks, John, for all the details. I appreciate them. Just wondering if you could give us a sense of what would be the best analog that you would like to point us to in Europe, in terms of pricing? Any recent cardiovascular product that you think would be best comparison, maybe a sense of where the kind of average branded statin pricing was? And any nuance around that would be wonderful. And then, just thinking about the U.S. spending as you embark on the European opportunity, sounds like you're going to try to nuance a little bit, obviously, be as aggressive as you can in the U.S., but be thoughtful about how that balances against the investment in Europe. Just wanting a little bit more detail on how you're going to try to strike that relative balance. Thanks so much.

[John Thero:]

Hey, Ken. Good morning. Thanks for the questions and giving free advertisement. We're looking forward to being at your conference next week, where I'm sure you'll have many other questions for me. With regard to an analog in Europe, I think one of the things that I would emphasize and I think that's the positive is that really there is no good in analog. And, the way that reimbursement works for market access perspective, being a unique product in that perspective is probably a good thing. So I think what we can point to is that from a pharmacoeconomic perspective, that the cost of things like heart attacks and strokes are very expensive. And not only as a time of occurrence, but at something like a stroke you go on for - a could go on for years. So, those kinds of pharmacoeconomic arguments have been effective in the United States, there also were effective in Canada. Canada is also, of course, a single payer government to the system, are largely served. And we and our partner there were pleased that reimbursement came along faster than what we expected. And I think follow of the pharmacoeconomic arguments to provide a reasonable price number. So as we go into Europe, they're really is no direct analog, but there is a very substantial market of patients with persistent cardiovascular risk for which there is no therapy today, a product in VAZKEPA, that has proven outcomes data, usually products aren't launching with outcomes data, which also sort of takes away in analogs for other products, and it's first market, and it already has recommendations from the 2 leading medical societies, the European Society of Cardiology, and the European Atherosclerosis Society. So we're looking forward to a launch in Europe, that's considerably different than the launch we had in the United States, when we launched the United States, it was a step launch based off of initial biomarker change indication does lowering very high triglycerides, we didn't have outcomes data. There's lots of generic competition, and it was a niche market in Europe, we're going in with outcomes data, and no direct competition. And, I think, we should in Europe like we've done in the United States, you'll focus on how can we get this reimbursed in a way that we can help as many people as we can in terms of at-risk patients in Europe market access, of course, is a country-by-country proposition in Europe, and we've talked about in the past that we'll be looking to prioritize that. With regard to spending, the Amarin is increasingly becoming a multinational company. For years, we limited resources sort of start, but we're doing in the United States commercially, as we focus it on investments in R&D particularly for the REDUCE-IT study. And then, after the positive results of the REDUCE-IT study in late 2018, we began building our U.S. commercial infrastructure and expanded that further in late 2019. And, of course, doubled and coming into 2020, started the launch and then got slowed down here by COVID. Throughout this past, really 2 years, the overall business on a cash flow basis has had generally operated pretty close to cash flow neutrality, we've had some quarters are slightly positive, some quarters are slightly negative. Our view is that will be variables from quarter to quarter, that we should be growing revenues in the United States. And, the spending may be somewhat variable, but we're looking forward to both increased revenues and increased positive contribution coming from our U.S. activities. The European investment, we think it is important, it's the eighth of that investment as sort of the irony of the - faster the countries get market access, the fast that we would be potentially spending in Europe, of course, then translates into revenues coming in faster as well. So, in Europe right now, we've got a core team. And, of course, our corporate team in Dublin, the core sort of marketing team set up in Switzerland. And then a field team that we've started to put together for Germany on a non-branded basis working on market awareness. Once we get approval, which we're anticipating in the April timeframe, we'll be able to ramp up that sort of pre-launch promotion. And then assumedly launch in Germany and potentially other countries subject to market access. So we've talked about the size of the sales - size of the team in Europe, increasing during this calendar year to approximately 200 people that assumes a certain level of market access, if the market access is faster than that we would increase our spending faster than that. If we're promoting, and say, Germany, and that's against the speed and get revenues, that begins to pay for itself, and then that is less of a burden, as we're going into other countries that were getting market access faster in other countries, maybe we're launching a little more simultaneous, the amount of spend will differ based upon that. And in any of those cases, we believe that our current capital resources are sufficient to make the investment necessary to be successful in Europe. But first, we need to get the regulatory approval then we need to get started on a market access, we need to do some pre-launch education, and then we'll get out into launching each country. And as we do so we'll certainly have much more feedback relative to spending. The European market focus for us should be a bit more concentrated than it is in the United States probably not need there for television advertisement, much more, maybe a digital focus. And, there's a bit more concentration of at-risk patients with cardiologists in Europe, which we think will help as well. So I know I haven't provided much quantification there, but at least that some background information that may be useful to you.

[Ken Cacciatore:]

Okay. Thanks. Looking forward to the conversation next week. Thanks so much.

[John Thero:]

Thanks, Ken.

[Operator:]

Thank you. And the next question is coming from Michael Yee. Michael, your line is live. Please enter affiliation and pose your question.

[Unidentified Analyst:]

Hi, this is on for Michael Yee at Jefferies. Congratulations on the progress. I just have 2 questions, one on the U.S. and one for Europe. So in the U.S., generics have launched for about a quarter now? How often do you guys encounter generics on the ground? And what are physician prescribing patterns in areas, where you having to compete with them? Or this decision happened at the pharmacy? And how has that changed from Q4 to Q1? And then my second question on Europe. Have you been engaging in conversations with potential partners and has there been a lot of interest, in what's their biggest area of pushback? Thanks so much.

[John Thero:]

Thanks for the question. So, regarding generics in the United States, there's one launch generic at this point in time, it came out of the beginning of November. We're seeing it in various respects. We're seeing it from patients sometimes calling us to complain that the cost of that generic is higher than what they were paying for the branded product. We're seeing it from various managed care companies that have been interacting with us, recognizing that the generic is causing them more on a net basis. And that's driven in some cases to improve the managed care coverage. Most physicians are not highly aware of the generic that's out there. And, as you see through our litigation, we have seen activity that we think is inappropriate by the generic company and at least by certain payers that we think create situation where they're trying to go beyond, they approved label for that product. Right now, they are self-described as being limited by supply. There have been outages various pharmacies were also closed, some complaints by patients where the patients are going to get their script billed, the pharmacists look other uses of generic here, tries to get it, can't get it, sends the patient away, I'll try to get it and then still can't get it, and that's frustrating to patients. So, there's learning going on, and we're always trying to make sure that all parties involved, whether it be payers, physicians, patients, pharmacists are aware of, there's skinny label of the generic, in fact that the pricing of the random product is often less than a net basis than the generic product, and the risk of outages relative to the branded product, all while trying to introduce this event to the market as the awareness of the product is still pretty low just launched 13 months ago, and much of that launch was during a - it's been during the pandemic. So we see there's significant educational need and opportunity out there. With regard to European partners, the - I guess, I'll approach your question in 2 ways, but I'm not sure when you're referring to partners, whether you mean, sort of the - what we've gone through in the past, or what we might be going through in the future. In terms of going through in the past, we did before deciding to go for a self-launch in Europe review partnering opportunities with larger companies in Europe, and we found interest from that. But we also convinced ourselves as the enormity of the opportunity in Europe, justifies an investment on our own to create the required infrastructure in Europe, and that we know the product best And, we have a lot of experience with the product in the United States and Canada, for example. On reimbursement in that approaching with ourselves was - will provide greater upside value to our shareholders then partnering it off to some larger company. So we went through that previously, and describe that process previously. So perhaps you're referring to the fact that we've talked about Europe as being sort of 3 levels of countries, right. So there's large countries, there's mid-sized countries, and then there's smaller countries. In smaller countries, it is true that it probably does not make as much sense for Amarin to create infrastructure there, where there are local companies that can do that potentially better than we can. We have been doing some planning and thinking in that areas, but the biggest markets are the EU-5 starting with Germany, and some most of our attention has been on getting ready for approval and preparing for market access reimbursement negotiations in the Big Five and in some of the sort of the medium size countries. So, we'll have more to say relative to partnering in the smaller countries, and after we get approval and get on a little bit further, but first and foremost, we need to be successful in the larger country. So hopefully, those comments are helpful.

[Unidentified Analyst:]

Yeah. Thank you very much.

[Operator:]

Thank you. And the next question is coming from Jessica Fye. Jessica, your line is live. Please announce your affiliation and pose your question.

[Jessica Fye:]

Hey, there, good morning. It's Jess Fye from JPMorgan. I was curious what you think of some good price analogs for China?

[John Thero:]

Hi, good morning, Jess. I think, first, we see what the label is going to be in China. We are certainly pleased with the recommendation coming out of the medical society in China recommending the use of icosapent ethyl for addressing cardiovascular risk reduction. But let's see what China FDA has to do relative to the label first. And then, China is a complex market, the reimbursement that can be really different from province to province. And then there's cash sales and reimburse sales, it really is the domain for our partner adding in one of the reasons why we picked anything is that they're really good at this type of thing. So it's just I think early for us to be setting a price. And I don't want to step on the toes of Edding. This is their domain. This is why we selected them as a partner. So it's a bit premature for us to provide an analog at this point.

[Jessica Fye:]

Okay, thank you.

[Operator:]

Thank you. And the next question is coming from Joel Beatty. Joel, your line is live. Please announce your affiliation and pose your question.

[Joel Beatty:]

Hi, this is Joel Beatty from Citi. Congrats on the progress. First question is, are there any examples of analogs in Europe in terms of trajectory of the launch? And how to think about drugs launching into large market indications there? And then the second question is, for the U.S., could you characterize the current level of awareness of VASCEPA, and how changes in awareness can impact sales? Thanks.

[John Thero:]

Joel, good morning. Relative to analogs for Europe, that's one that we have studied and studied and studied. And really there - I can't, we have not found any product that has launched with outcomes that have no direct competition for a patient population of this size. There just isn't a good analog. We have seen products with lesser results do quite well in Europe, but I think we need to first get approval then get into the market - the market access side of things. And there, I think we're probably going to try to be thoughtful, not , with the aim to try to help as many people as possible. But I think it's premature for us to really predict an analog at this point. So the - with regard to the United States and awareness, we've done some market survey work there. And, Aaron Berg, who runs that side of things is with us. And, Aaron, maybe you can cite some of our recent awareness survey and your sense of where the market is relative to - from an awareness perspective.

[Aaron Berg:]

Sure. Overall, un-aimed awareness of VASCEPA is very low. We just launched the indication right before the pandemic. We had just expanded the sales force. We significantly expanded our target audience of HCPs, and then essentially shut down as most of the industry, so we never got that off the ground and - to have the ability to build that awareness. And, of course, without awareness, you're not going to get understanding and prescriptions. And that's where it starts. We started to see recovery through the summer. As we're getting toward physician and sales force back out there, and starting to build more. But then again - and then, as you headed into Q4, there was a significant resurgence and it dampened the promotional efforts, as well. So our awareness overall from an HCP perspective is low and even more so with consumers. In fact, even though we ran the campaign, the awareness stayed in the teams through the second half of 2020. So we've got a lot of opportunities, still very small brand. Overall, we hope as we head into the recovery here, as we're all optimistic about our promotional efforts, will take hold of patients, will return to physicians, and the cycle will begin. And, yeah, we'll see that growth as a result of them, but it does start with awareness.

[John Thero:]

And just on the Europe piece, just one other comment. I remind people, because there's been some media articles recently that have maybe taken us out of context. We are not in Europe going after every single patient that has elevated triglycerides. Who we're going after are patients who despite cholesterol management, particularly statins, continue to have cardiovascular risks? So we're not trying to replace statins and it is a substantial market, but it's not the 80 million patient market as shown up recently in some media articles. And we do provide some market statistics in our 10-K filing today that are consistent with what we've talked about in the past. But I just wanted to - in light of some recent media pieces, emphasize that it's not every patient with elevated triglycerides that we're going after in Europe. So I appreciate the interest in questions. We've taken an hour here. I know everybody's got to get on to other things. So we're presenting tomorrow at the Leerink Conference, Cowen next week. I'm sure there'll be additional questions there. I thank you all for your support and interest, and look forward to providing updates here as we continue to progress. Thanks everybody. Have a great day.

[Operator:]

Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time. Have a wonderful day. Thank you for your participation.