Amarin Corporation plc (AMRN) Earnings Call Transcript & Summary

Great. Good afternoon, everyone. My name is Jess Fye. I'm a senior biotech analyst for JPMorgan. And we're continuing the 2021 Healthcare Conference today with Amarin. I'm joined by the company's CEO, John Thero. Before I turn it over to him, I just want to let you know that instead of going across the hall to the breakout room this year, you can ask questions via the portal by clicking that blue Ask a Question button on the webcast, that will send me the questions. I can ask them to management once we move to Q&A after the presentation. So with that out of the way, let me turn it over to John.

Thanks, Jess, for the invitation and introduction. And thanks to everybody else for joining us here today. I'm excited to be talking about Amarin and what is an upcoming year that we're very encouraged by. Before I get into reasons for encouragement, I'll start on Slide 2, where I will be making forward-looking statements. There are risks involved with those statements. Anybody considering investing, I want to read our SEC filings. I'll also comment that I will be making some off-label comments today in this presentation. This is for investors and not intended for your drug promotion. On Slide 3, let me provide some comments on recent highlights as well as our priorities for 2021. Regarding highlights, last year, at this conference, we were talking about launching our lead product, VASCEPA as the first and only drug in the United States for addressing persistent cardiovascular risk at a very large unmet need. We went on to launch the drug in the first quarter of last year. And just shortly after training our expanded sales force, run in -- ran into the COVID headwinds. Despite that, we grew 42% last year approximately and had revenues of over $600 million. We look forward to building on that growth here in 2021. The growth that we saw occurred in part because of the expanded label, but in large part, due to increased awareness and to improve managed care coverage, reflecting that expanded label, that managed care coverage improved throughout 2020 and has improved further here as we began 2021. We also did an evaluation during 2020 of how to best create value in Europe. And there, we've decided that it's best for us to self-launch. It's a multibillion-dollar opportunity. We've put together a terrific team of people, which today numbers about 50. And we're in the late stages of label review, anticipating a CHMP opinion to come out either in their meeting -- from their meeting late this month or next month. In parallel, our partner in China has completed a Phase III study of VASCEPA, which is positive, which sets up advancing of the regulatory review and approval process in China, big market. We advanced multiple clinical trials in COVID-19, one of which has read out positively that I'll talk about here later. And we've paid off all of our debt and ended the year with over $550 million in cash. As priorities for the new year, we're looking to continue to grow in the United States, both in terms of revenues and in profits as we envision that these high-risk patients for cardiovascular disease who ironically many of them stop seeing their doctors for ordinary preventative care during 2020. As COVID recedes, we'll start coming back to their doctors and we look forward to continuing to launch of VASCEPA in the United States that was -- that ran into challenges due to these patients not coming to their doctors during 2020 and other access issues. So looking to really piggyback the COVID vaccines with preventative cardiovascular care, which VASCEPA is clearly a new and very good option for at-risk patients. We anticipate getting approval of VASCEPA in Europe. We are doing a lot of work here in advance relative to market access. We believe that based upon form of economics that the pricing for VASCEPA in Europe should be at least as good, if not better than the net pricing in the United States. We saw that happen in Canada, where again, in the United States, we launched for a niche indication of hypertriglyceridemia without outcomes data and a lot of generic competition. Whereas for cardiovascular risk reduction, we have outcomes data and endorsement from leading medical societies and no direct competition. So looking forward to that advancement of the regulatory access side of things and would anticipate that by the end of 2021, we would have launched at least in one country, probably Germany, if not more, in Europe and probably have grown our team in Europe to about 200 people. In the rest of the world, we're continuing -- we'll look to continue to advance that, particularly the support of our partner in China in that regulatory submission, but also our support of our commercial partners in Canada and our distributor in the Middle East. Some of the rest of the world will wait until after we get Europe, but there are big opportunities there to be pursued in time, and we'll continue to be opportunistic in looking at diversification opportunities, such as the trials that we have ongoing for COVID. Going to Slide 4, just as background for anybody who's new to this story. VASCEPA is a new preventative cardiovascular care treatment option, and this is a treatment option beyond LDL, bad cholesterol lowering. And the good news in this industry is that, I guess, I'd say, bad news and good news. Bad news is there are innovations fairly seldom. The good news is that, one something is innovated like VASCEPA, it should stay for a while based upon the history. On sort of pre-statin days, it was viewed that raise good cholesterol, you'd benefit. That's been the bunk lowering bad cholesterol was sort of the thesis that has been proven to be true with statins and other LDL-lowering drugs. But people for decades now have been trying to address that persistent cardiovascular risk that exists beyond the LDL lowering and beyond other traditional therapies, and we've done that with VASCEPA. And as shown on the next slide, Slide 5, it is very important to address risk beyond LDL. So we believe that it's important to manage your cholesterol, that's great. And lowering cholesterol, as shown on the pie chart on the left, can lower your cardiovascular risk by 25% to 35%. That should be encouraged. Of course, that still means that there's 65% to 75% risk remaining, and it's lowering that persistent cardiovascular risk that drugs have been trying for decades to address and where we have succeeded. If you're not being treated, what happens? The chart on the right here shows 3 separate outcome studies of high-risk patients, all who had been managed on statins for their LDL cholesterol. And you can see that whether it be FOURIER, IMPROVE-IT or REDUCE-IT, whether it be 3 years at roughly 15% of events or 5 years or 28% of events or 35% of events at 7 years, these are large numbers of events. I'm talking about events; I'm talking about strokes and heart attacks and deaths from cardiovascular disease. If you're at high risk, I think you want to be treated. And this is just first events. Someone who has had a heart attack, might have a second one, same for stroke. So LDL is important to manage. But even with managed LDL, your risk is really high for these patients. And if we go to Slide 6, I'll just emphasize that cardiovascular disease is an enormous and worsening public health burden. It's the #1 cause of death in the world. This is the most expensive area of care as strokes and heart attacks have huge treatment costs at the time and often very chronic costs thereafter. In the United States, there's one heart attack, stroke or cardiovascular deaths every 13 seconds. Numbers of patients on statins in Europe are even higher. Cardiovascular death rate in Europe is even higher. And if you look at the rest of the world, just pick up China, for example, a number of people who have cardiovascular disease and elevated triglycerides is over 50 million, roughly 2 to 3x that of the United States, for example. So a big market need. Slide 7 speaks to Amarin solution, which is VASCEPA, which has now demonstrated to provide significant cardiovascular risk reduction beyond cholesterol management. So primary endpoint of the study is shown in blue to the left was of 5-point MACE. And there, we showed a 25% relative risk reduction and a number needed to treat of 21. So that primary endpoint was based upon cardiovascular death, stroke, heart attack, revascularization or hospitalization for unstable angina. We looked just at hard MACE -- the key secondary endpoints that had a 26% relative risk reduction and that's for death, stroke and heart attack. And you can see in the green individually, those components, 31%, 28%, 20% relative risk reductions. Again, those are just the first occurrences of events. These patients often have multiple heart attacks or strokes. And there, all the way to the right, we had a 30% relative risk reduction. This is data that as you dig deeper into it, sub-data, it's very consistent, very robust. On top of this, we've had a lot of mechanistic studies that talk about how this drug works and how this drug uniquely works versus other therapies. Those are the therapies have failed clinically, but we can explain that through mechanism of action where improvement in endothelial cell function and impact on inflammation, impact on coronary plaque. For example, there was a study that read out this past year called the EVAPORATE study that showed that with -- in patients who had coronary plaque buildup, that VASCEPA lowered that plaque beginning at less than a year and by 18 months, had lowered that coronary plaque by 70%, which is obviously just marvelous. There are multifactorial effects of VASCEPA that have been broadly documented in the literature. And from a safety profile, VASCEPA has been shown to be safe. It's obviously approved both by Health Canada and by the U.S. FDA. In these high-risk patients, as studied in our cardiovascular outcome study, one can look at aspirin, for example, which is viewed to be generally safe. And aspirin in those patients look to have a higher risk profile from a safety perspective than does VASCEPA. Not suggesting that the 2 drugs are equivalent, VASCEPA has been shown to have this kind of results. We haven't seen these kind of efficacy results from aspirin. But just from a perspective on safety, very well tolerated for VASCEPA. If we go to Slide 8, just to put these results into context, again, there is no direct comparative drug to VASCEPA. We are the -- VASCEPA is the only drug approved for persistent cardiovascular risk. But starting with Lipitor on the left, that's just monotherapy, great drug; atorvastatin did about $13 billion before they're going generic, 22% relative risk reduction, number needed to treat of 45; Zetia, number needed to treat 50; Repatha, 67; VASCEPA, 21. Again, not competitive, just -- these aren't direct competitive drugs, just trying to put into context that the results with VASCEPA really are quite phenomenal. And that's the first occurrence of events. If you look at the recurrence of events, VASCEPA over a 5-year period on average lowered one major adverse cardiovascular event, that's death, heart attack or stroke, one fewer on average for every 6 patients treated, which is really quite remarkable. On Slide 9, you don't have to rely just on me. There's a dozen different medical societies around the world that have recommended the use of VASCEPA. Many of them have gone out of the way to emphasize that no other drug should be confused or thought to have similar results as does VASCEPA. There's been multiple cost-effective -- cost-effectiveness analyses, including ICER, which is usually fairly cynical on drug costs. ICER's report suggested that even as most stringent criteria that VASCEPA is cost effective, I think that's led to the strong managed care coverage that we've developed over the past year in the United States. And this has been broadly published results. It's now been used over 10 million times, and the data from real-world use suggests that it's also a well-tolerated and safe drug. And just slightly over a year ago that the FDA AdComm voted 16-0 in favor of approval of this drug. So we've been building off of that. And Slide 10 shows the label that we had in the United States. It's very similar to the label that we got just shortly after that through Health Canada. We're envisioning at the label that we will get for Europe is quite similar to this. We're in late stages of those negotiations at this point in time. That's for patients with established cardiovascular disease or patients who don't have established disease, but are diabetic and have 1 or 2 additional risk factors depending on geography. Most diabetic patients have at least 2 other risk factors. And we're not trying to replace that. Once again, this is on top of statin. So in the U.S., FDA went out of the way and say, maximally tolerated statins, which could mean 0, if you can't tolerate the statins. And then we do use triglycerides as an identifier risk. Lowering triglycerides doesn't necessarily reduce risk, but triglycerides can be an identifier risk for patients. On Slide 11, I'm trying to go relatively quickly here to allow time for questions. Slide 11 gives a little bit of a context of where our focus has been and will be. Historically, it's been largely on the United States and on R&D. It's increasingly becoming on the United States R&D, Europe and rest of the world. In the United States, of course, we're approved. It's a multibillion-dollar opportunity. We have 2 indications. We have original indication of hypertriglyceridemia. And we have this new indication we just launched for last year in -- for persistent cardiovascular risk. $600 million in revenues was predominantly driven by our growth here in the United States. In Europe, an opportunity that could be as large or larger than in the United States. We're in late stages of review by the regulatory authorities in Europe for approval. We've done a lot of advanced work getting ready for market access and reimbursements in Europe. And upon approval, we'd be the only drug approved in Europe for this indication. And then, of course, in the rest of the world, we've partnered selectively in some markets, Canada, Middle East, China and held off other potentially large opportunities so after we're a bit further along in Europe, and we can focus more energies on those rest of the world opportunities. Slide 12 shows our quarterly revenue growth since the launch of VASCEPA. In 2018, you can see in the Q4, the green bar shoots up that just after we had cardiovascular outcomes -- results. Revenue has continued up through '19. And first quarter of 2020 had 112% growth over the same period of last year, and that's before we -- that's the quarter which we launched VASCEPA for cardiovascular risk reduction. And then, of course, unfortunately, we had some headwinds here from -- of patients, particularly in the areas of the country where we had the most sales experience, places like New York City and Southern Florida and Southern California, for example, somewhat going in -- largely going into lockdown mode. But through all of this, we still grew 42%, and we look forward to reaccelerating that growth here as COVID recedes. Slide 13, we don't have any direct comparators to VASCEPA, but it's often good to sort of see how we're doing compared to other therapies. We've got different plots against other cardiovascular drugs. These are all cardiovascular drugs that have positive cardiovascular outcome studies in recent years. Some household names here. And if you look at script growth during 2020, we do well. This is -- this particular plot is putting at week 0, the date of which there was cardiovascular outcomes trial positive data and viewing the growth from there. So the dark blue line in the chart is for VASCEPA. We can see very robust growth following the outcome study. And then it does drop a little bit, that's the onset of COVID. Again, these are different calendar time frames for the start of each of these drug launches, all calibrated. So week 0 is the time of their cardiovascular outcomes. I'm not trying to suggest that VASCEPA competes against these drugs. I'm just trying to put into perspective that our growth coming out of the outcome study has been pretty good, and this was with less resources than some of these other drugs have had. Slide 14, we remain early. A survey of physicians and at-risk patients done in September showed that unaided awareness of VASCEPA was less than 1/3 of health care professionals and less than 1% of patients. So we've got some work to do for VASCEPA. That really spells significant opportunity. We're growing where most people aren't yet aware of us, but probably not to be unexpected. We just launched the drug at the beginning of 2020 and then COVID slowed us down. In addition to lack of awareness, we're certainly aware that there are some myths to overcome or historical misconceptions. There is, I think, a sense out there amongst many patients that if you're managing your cholesterol, that's enough. I've shown you data. That suggests it's not, but there hasn't been an alternative for patients until recently. So it's not been an area of focus. It should be. There are older drugs out there, fenofibrates, Lovaza, niacin that still broadly used. They had outcome studies that failed. Those outcomes studies read out after they were generic. And I think in many cases, people don't realize those outcomes -- that those products have failed outcome studies. They're still broadly used. There's dietary supplements that some people resort to. And there's a place certainly in this world for dietary supplements. I just don't think it's for treating high-risk patients that want to be with a drug that's proven to work rather than a drug -- rather than products that for 30 years have been saying that they may work, but haven't yet been able to prove it. In fact, they've had multiple failed studies along the way. I think VASCEPA -- because it's launched as a triglyceride-lowering therapy, people still think of it as that and haven't seen a new data for cardiovascular risk reduction, which is a whole new indication and what our primary focus is today. And the managed care initially was limited. It's gotten a lot better and actually is quite good at this point in time. So we're taking steps to increase awareness and overcoming these misconceptions, and we're still very early in our launch in the United States. Slide 15 just provides some perspective to this. Most patients who have persistent cardiovascular risks aren't treated with anything. On the left, just gives statins. Statins are broadly used. We're not trying to replace statins, but approximately 1/4 of patients on statins ought to be -- have high risk and want to be treated with VASCEPA. VASCEPA is that little bar, the dark blue bar down there. To the right of it is the fenofibrates and Lovaza and the niacin drug that failed outcome studies that are used in this space. We'll just convert them with their failed studies to VASCEPA, a successful study. That's over $3 billion of potential. And then on the orange bar, again, we're not trying to replace dietary supplements. But if you're at risk and you have established cardiovascular disease, if you have diabetes and you've got high triglycerides, about 50% of those patients go to dietary supplements. And dietary supplements haven't been proven, VASCEPA has been. So all these is big opportunities for VASCEPA as we continue to increase education and awareness of our drug and look forward to piggybacking society coming out of COVID in the coming year. Slide 16 really focuses on that. So in the United States, awareness increasing, piggybacking patients coming out of COVID, using the data we have to grow. I will comment that there is -- has been a generic launch in the fourth quarter, a generic version of VASCEPA. This is not a typical generics market. This is not typical from the perspective of -- it's not mature. Most doctors and patients don't yet know about it. We just launched for the initial indication. It's not typical from the perspective of supply is limited. Amarin has spent huge amounts of time, effort and money building supply chain over a decade. It's not clear that the generic companies have made those investments yet or that they will, time will tell in that regard. And the launch generic is limited only for our initial indication, which is hypertriglyceridemia, which is about 7% of our current business, about $40 million in revenues. We had to give up $40 million in revenues, but our growth potentially is for our new indication and that's where our focus is today. As an analog, there's a drug that's similar to VASCEPA in Japan called Epadel. It's been generic there for over a decade and greater than 6% of that market is still the branded product. Slide 17 just puts us into a little bit further perspective of the original indication of treatment of patients with triglycerides greater than 500 is about 7% of our overall population. I will point out that in Europe, we have not gone for that original hypertriglyceridemia indication. We've only gone for the indication related to persistent cardiovascular risk. So the patents that were in question here for the United States on that original indication don't come into play in Europe. And in Europe, of course, there's 10 years of regulatory exclusivity plus that may go to 11 years. We had a second indication in patents that could -- patents on cardiovascular risk reduction, it could take out our exclusivity there to 2039. And Slide 18 really brings us to Europe, which is a large opportunity that I've described earlier. We've recruited a terrific team there. We've just expanded that to about 50 people -- a little over 50 people with some pre-market work going on, with particular emphasis on Germany because in Germany, you get a 1-year period where after approval and after launch, you can launch based upon proposed price and then continue negotiation on what the final price will be over that 1 year. Whereas in other countries, you have to have a negotiated price agreed generally before launch. The good thing is after it's agreed, doctors don't have to worry about whether the drug is reimbursed or not. They can just prescribe it. Germany becomes an attractive market, both because it's the largest market in Europe, but also because it allows us 1-year period to get into the market before pricing negotiations have been completed. We think we're well positioned for those pricing negotiations based upon pharmacoeconomic data, but we need to find a label before those negotiations can be formally commenced. We've started our interactions with the authorities in the various countries, but you can't convince it fully until you have data. China, good results, supports submission. Our partner there will take that through, hopefully, approval there in 2022, that was Slide 19. Slide 20 is switching topics a little bit. There's been a lot of data suggesting that the -- some of the mechanistic effects of VASCEPA could help for either preventing or treating COVID-19 patients. We've had various studies proposed and working via our clinical team and various investigators. One of those in Canada. The CardioLink-9 study has completed successfully. Studies in Argentina and studies at Kaiser in California are ongoing. We're looking forward to those additional results. Some of the docs involved with the Canadian study would, I think, argue that the results of what we've showed were strong enough to pursue use for the drug today. It argued too just better than remdesivir. But with -- it's not a vaccine. It's a therapeutic, just for clarity. But with additional data coming, we think it's better to wait for that additional data and then to better assess with that as to whether VASCEPA becomes an appropriate treatment for COVID patients for prevention, treatment, treatment of long COVID or potentially other infectious diseases. Slide 21 just shows that data from that trial at a very high level. This is a Canadian trial CardioLink study. It was 100 patients, all infected with COVID-19, half went to the VASCEPA arm, half went to an ordinary care arm. This is the upper left quadrant where I'm describing the trial. There was no placebo. Patients for the first 3 days received double a normal volume of VASCEPA. They received 8 grams per day. Results there seem to be safe. The -- then received 4 grams a day for the remaining 13 days of the -- 12 days of the study, rather -- 11 days of the study, 14 days until, sorry, good math. Primary endpoint is on the upper right, it was reduction in a marker of inflammation as hsCRP. In the middle there, you can see median percent change in baseline in the placebo arm is a 25% reduction in hsCRP. Patients who weren't treated had a little over 5% reduction. So significant reduction in hsCRP. And then at the bottom of the chart, you can see FLU-PRO score. FLU-PRO score is a validated means used in various other studies to measure the effects of lowering symptoms of things like flus from therapeutic treatment. And here, we're just looking on the left side -- lower left, patients all started. 100% of them had symptoms by the end of the 14-day period. That was down to 48% on the VASCEPA arm and 76% on the usual care arm. So a 28% reduction in the VASCEPA arm, largely driven by reductions in body of systemic and chest and respiratory type of symptoms. So looking forward to additional data from our other studies reading out, and then we'll decide what to do from there. Slide 22. Again, a strong balance sheet with over $550 million in cash. No debt. Some loss carryforwards, we look forward to working through. And in Slide 23, it pulls us together. VASCEPA is rapidly becoming a new pillar in preventative cardiovascular care. We have the drug, the signs, the people and the resources to, and we believe, being quite successful in the U.S., Europe and rest of the world. And with that, I'll conclude my prepared comments and take questions from Jess or questions that you may have submitted to Jess. Thank you. Jess, if you're speaking, I can't hear you.

Hey, there. Can you hear me?

Yes. Thank you.

Great. So we have a couple of questions coming in from the portal. The first one is, at what point will you reevaluate the U.S. infrastructure, if generics take more share in the U.S. in 2021?

We evaluate our business almost daily. Right now, it's very early, and there's an awful lot of variables going on. I think had we not had COVID this year and had grown at the rate that we thought we were going to grow at, I think we would have done $800 million, $900 million this year. I don't think anybody would be questioning whether we could grow faster than generic could supply the market. If COVID ends up pulling back and we can begin to reaccelerate our growth, I think that's a factor that we need to look at. Right now, we believe that's going to happen at some point that we can reaccelerate our growth. The -- we're also, of course, regularly reviewing what supply might be available to generics and how willing generics are to go beyond their labels, and we'll see where all that leads. It's clearly not a typical generic market. And based upon the information available to us today, we believe that there is considerably more value to continuing to promote this drug and expand this market. Also more patients get helped that way. But if we're wrong, we certainly could change directions and relatively quickly. But based upon information available to us today, we don't think we're wrong.

Got it. And the pre-announcement you've provided on revenue for 2020 last week, you came in a little bit lower than we were expecting. I'm curious if you noticed any inventory drawdown in the channel that might have come as a result of the generics in the market?

The inventory at wholesalers was pretty much flat at the -- end of the quarter to the beginning of the quarter or maybe moved slightly, but not too much. I think the wholesalers saw that there were stock-outs by the generic at the wholesale level during December and also that were continuing to promote, I think, that to the extent that there may have been shortfalls versus what you're expecting. It may have come from a couple of things. One is, I don't know, to the extent to which you had built the generics into the market, but they did take some share. I think also, we lost some prescriptions where patients just didn't get the drug because they went to the pharmacy expecting that they would get VASCEPA branded, were told by the pharmacist that they're going to get the -- going to wait and try to get the generic and then weren't able to get the generic or do get the generic and found that the pricing was higher and ended up not filling that prescription. So I think there's some balancing going on there. And I think also, unfortunately, COVID, which was pulling back a bit in September and October, got a bit worse in November and December. And we saw some of the patient flows begin to slow down, particularly the high-risk patient's slowdown in November and December and some of the access to offices start to recede a little bit. And that I think hurt us. We still grew, but I think we did have some COVID in back. And along with that, we made some moves to pull back on some of our DTC, for example, that just doesn't make sense to be doing a lot of consumer promotion if the consumers aren't going to their doctors and began to do a little bit less DTC in December, for example, and that will carry over here into the early part of the coming year until we see that the -- that COVID has receded enough and patients are going back that makes sense to build back up on that promotion again.

Great. And when we think about the growth in operating expenses, you've pointed to year-over-year in '21 relative to 2020. How much of that increase is continued investment in the U.S. relative to building out the team to support the launch in Europe?

Before answering, I will comment that we did fully pay off our debt this past year. And I think you know this, but others may not, Jess, that we have spent 10% of our revenues, but that did not go through operating expenses. Cost of that went down below the line, but that's -- that cash outflow is disappearing, which is not in those numbers you just cited. The growth that we've talked about in operating expenses reflects both our anticipation of increased revenues in the United States for which there is some cost and getting back to the launch that we started and was pulled back on during 2020. But it also assumes that we're launching at least in Germany and potentially in some other countries, the smaller countries in Europe in 2020, and there's cost related to getting there. We're increasingly managing our U.S. business to focus in on increased positive contributions. The business has been running -- the consolidated business has been running at roughly cash flow neutral for the last couple of years with fairly heavy R&D investment and preparations in Europe. But as we start breaking that out. We're looking forward to the U.S. piece contributing more, but there will be expenditures here for preparations for Europe as well as some of the work that we're doing, exploring other indications like the COVID studies and for considering other geographies.

Okay. Here's another one from the portal. I'm not sure if you can answer it, specifically. But I think conceptually, it's an interesting question, which is what penetration do you expect for generics in the U.S. by the end of 2022?

We have so many scenarios for that as being possibilities. It's really very hard to say and trying to predict whether generic companies that have skinny labels will disregard that label and take their chances and litigation, I just can't predict that. Building supply, I'm just not sure whether they're willing to put tens or potentially hundreds of millions of dollars into building supply. So it's -- we do have scenarios for it, but there are so many different scenarios for it that it's hard to predict. I would say that they're doing is trying to build new facilities for supply that you can't build a new facility and bring it online that quickly. So that time frame means trying to retrofit existing facilities, which almost by definition, is somewhat limiting relative to supply.

Great. Maybe lastly, in light of the most recent lawsuit against the generics on off-label promotion, how do you assess whether off-label promotion is taking place when the volume data itself doesn't necessarily speak to their promotional approach? What else do you look to verify that?

So that is ongoing litigation. We do have our complaints. I think our complaint speaks to some of the things that we've looked at and to the extent that people are building capacity for more than what is labeled for, to the extent that people are getting out there and otherwise making statements about going beyond their label, I would consider those to be forms of promotion. I would also say that to the extent that somebody is not putting up warnings to others that they'll be trampling on their property, if you will. I mean that there is some responsibility for company that has a product to inform others of their limited label and that facilitating somebody else to infringe upon our rights, if there's an obligation of those companies to do what's right there. But I would refer people to our complaint for some of those examples.

Okay. Got it. Looks like we are out of time here. So John, I want to thank you very much for the presentation. And thanks, everyone, for tuning in.

Thank you, Jess. Thanks, everybody, for tuning in as well. Have a great and happy, healthy and prosperous 2021.

Thanks.