Amarin Corporation plc (AMRN) Earnings Call Transcript & Summary

Hey, good morning, everyone. My name is Jess Fye. I'm one of the senior biotech analysts at JPMorgan. We're continuing the 40th Healthcare Conference today with Amarin. I'm joined by the company's CEO, Karim Mikhail. He's going to give a presentation, and then we're going to do some Q&A afterwards. [Operator Instructions] So with that, let me pass it over to Karim.

Thank you, Jessica, and good morning, everyone. In today's presentation, I may make forward-looking statements for a complete of risk factors associated with investing in Amarin, please refer to our SEC filing. So at Amarin, we have a bold vision to stop heart disease from being a leading cause of test. And in today's world, and I'm today on Slide #4, it is very bold as a vision because people don't realize it, but cardiovascular disease is really maybe the most enormous and worsening public health problem we have today. And whether you're sitting in the U.S. or in Europe or anywhere internationally, the number of patients that are impacted by cardiovascular disease and the economic burden that the different countries carry today, especially at the time with COVID, where it is a significant burden, having to see all these additional cardiovascular challenges that are added to the -- because of COVID. So it's definitely a huge challenge everywhere in the world. And up to now on Slide #5, you'll see that definitely statins and LDL lowering in general has been the gold standard for a number of years. And if you look at the usage and the engagement that physicians, patients have today with LDL lowering, is very, very strong. But having said that, LDL lowering by itself does not completely abolish the risk, you still have more than 50% of the cardiovascular risk remaining no matter how far you go with LDL lowering, that's why there is a true need to go beyond the LDL lowering and to explore other strategies to reduce cardiovascular risk for those patients in need. And Amarin went and you, see on Slide 6, took a very challenging endeavor to engage in a multiyear cardiovascular outcome study that many large companies would shy away from committing to, simply because not only you're talking about close to $0.5 billion of investment, but also it's a number of years that you worked very, very hard, not knowing whether at the end of the day, this will succeed or not because many tried and failed, right? So you have to go and you have to test hoping and trusting that your molecule is going to demonstrate. And Amarin succeeded in this challenging environment in developing the first and only approved medication in reducing cardiovascular risk beyond LDL lowering and received the FDA approval in the U.S. with a very unique advisory committee positive vote of -- 16 positive votes. And when you look at the clinical evidence overall, especially for those who are very close to this field, they know that when you see a cardiovascular risk reduction above the 20%, you know that you're talking about some very significant real results that this is not just a single-digit type effect that it will be difficult to see clinically. This is really a quarter of the risk of the events that are prevented because of the use of VASCEPA in those patients. And when you translate this to number needed to treat means how much -- how many patients do you really need to reduce an event, you could see that the number needed to treat for VASCEPA compared to other products, other classes that reduce LDL, so the initial strategy of reducing cardiovascular risk is quite positive, which means you're not only bringing effectiveness, but you're bringing efficiency to the system because you're able to save money for the payers. And in the case of Europe, for example, for the governments who are really funding most of the budgets in the pharmaceutical market. So today, Amarin has this opportunity to establish VASCEPA as a new gold standard through gold standard in preventative care beyond the LDL lowering, and this is -- can become a true beginning of a new era for all of us. Now that's not only sort of Amarin and Amarin science talking for itself, but there has been wide recognition by many leading medical societies of the importance of icosapent ethyl and its place in the treatment paradigms. Many of these Many of these medical societies have actually recognized VASCEPA way before the product was even registered just based on the evidence of REDUCE-IT. And that, we believe, is unique recognition. So where do we stand today in terms of our presence and launch of VASCEPA overall? In the U.S., we have an approval. We have an approval for 2 indications, we have a VHTG, very high triglyceride indication, and we have a cardiovascular risk indication that we have achieved in 2019. The business in the U.S. unaudited this year is around $575 million, so above $0.5 billion despite the presence of 2 generics on the market, and we've had generics in 2021 for the 12 months. So this is a full year of generic presence in the U.S. In Europe, we have an approval, which we received early in the year, 10 years of regulatory exclusivity, we just launched in Germany, very -- just 2, 3 months ago. And we've submitted dossiers in 10 countries, including Germany, for reimbursement. Internationally, we have 3 partners. We have a partner in China, a partner in Canada, a partner in Middle East, Africa. We've launched in the Middle East in a number of countries. We've launched in Canada, by our partners, of course, but we still have coverage only in the private sector, not yet in the institutional sector, and we have communicated before that we are initiating regulatory process submission for multiple countries around approximately 20 countries beyond those, beyond Canada, China and the Middle East, where we're also going to be partnering on. So for us, the whole international business is really a partner business. We believe that, that's the right way to go. And you will see that even in Europe, we're only focusing on the major European markets to build our own infrastructure but in all of Central Eastern Europe, we're really going to partner most of these markets. It doesn't make business sense to be there. Now how can we drive the growth in the future? Now I'm on Slide #12. Well, there are 3 pathways to drive the growth. The first one is geographic expansion. The launch in Europe is very central to all of that, and we're going to talk about it a bit more in detail in just a few minutes, but also the expansion internationally. If you look at the number of patients on statin in Europe compared to U.S., that's a similar number. If you look internationally, that's even beyond that. And we've seen a number of cardio metabolic products that had similar businesses in the U.S. versus ex U.S. that would even others that had more ex U.S. than in the U.S. and some that just focused on the U.S. So there are possibilities to drive the growth beyond the U.S., and we're going to talk more about that. But there is also the pathway of portfolio diversification. Today, we have an established evidence with the REDUCE-IT study. It took the company 5, 6 years to have this evidence. And today, that's a big asset that you cannot just think about it and say, well, listen, let me move on to the second one without exploring every opportunity to maximize the business and the opportunity of helping more patients with VASCEPA, and we're going to talk about 1 of those life cycle opportunities today, which we're announcing it, which that we're initiating the development of a fixed-dose combination with statins. But we're also continuing to work on business development and exploring opportunities in that space, especially commercial assets in the U.S. where we believe we have a robust structure and we can handle 1 or 2 more products without adding significant investments. So if you look at the full year revenue, we have close to $580 million unaudited in the year 2021 compared to $614 million in 2020. So that's around a 5% decline with the introduction, obviously, of the generics full year of 2021. If you look at the quarterly results, our last quarter was a significant decline versus Q2, we had almost 8% decline. But what we've seen this quarter despite the fact that we've had a significant disruption in the U.S. business because of the restructure that we did despite Omicron, we've seen that we delivered around $140 million, which, considering the situation and how challenging the quarter was, we believe, is encouraging and we will continue to work, and I will move to talk to you more about the U.S. in just a second. Overall, versus generics, we still maintain in the last data points, which are the last 3 months, 80% of the business, close to $0.5 billion of cash and no debt. Now if you look at the U.S. and the U.S. business, we have announced beginning of October, that we are embarking on a significant go-to-market, a change and evolution of our go-to-market strategy. What we've seen is that the market is evolving and that having such a large field force today with the limited access that we have to physicians, it does not make a lot of sense to keep that structure. So we took the decision to go down from a structure of 700-something reps to 300 reps, and we implemented that in the last quarter of 2021. And we used part of these investments to reinvest in omnichannel. We can confirm that this quarter, we will be able to reach via omnichannel engagements around 150,000 physicians. That's definitely a very encouraging number that we were able already in very little time just to reach them. Now they are not full engagements, but at least in very little time, we were able to structure ourselves in a way that we can initiate this engagement with physicians in the U.S. As a reminder, even with a very, very significant field force, our total number audience, our target list was only 70,000 physicians back then. We also announced that managed care is and will continue to be an important priority for us. As of December 2021, we have 40% of total commercial and Medicare Part D lives having VASCEPA as the exclusive IPE product, and that's an area of focus, and we will continue to work on this. These are annual contracts, of course, that on an annual basis, we will have to renegotiate. So we stay very close to this priority, and we try to drive this because there is definitely a benefit for the payer in getting VASCEPA because the difference in price is not so big. Now if we look at the last priority, the last priority had to do with fulfillment. And we spoke about it many times that we were losing many, many patients who were cardiovascular risk patients. But unfortunately, at the pharmacy level, they were switched to a generic, which is not indicated for cardiovascular risk reduction. So what we did in this last quarter was partnered with an end-to-end digital first prescription fulfillment channel BlinkRx to support the fulfillment process from a physician down to the patient level, ensuring that we can facilitate the patient can start and remain on VASCEPA, especially the cardiovascular risk patients. Now on the next slide, Slide 15, you'll see that we're sharing encouraging early signals of the impact of the new go-to-market strategy. We're very early on. So definitely, this is just very first view of things, and we'll see if this trend continues. But we are back from a New to Brand prescription to the 8,000 prescription level, which we have not achieved in the last 15 months since the first generic was introduced. We're not yet at the pre-COVID level. At the pre-COVID level, we were at 12,000. So we're still a long way from getting to a pre-COVID level. But we have not reached this 8,000 NBRx before a New to Brand are really the engine of growth, right? If you don't grow a New to Brand, then you cannot really sustain the engine. So it's early signs. It's still very early on, but at least we're encouraged that it seems that what we're doing is being offered in the short term, and we'll see how this is going to evolve over time. If you look in Europe and what we have achieved as a company in 2021, we closed the year 2020 with no regulatory approval, no work done on reimbursement, obviously, because you need a label to start to -- have to submit anything. There's very limited infrastructure. It was just really the beginning. We are closing the year December 2021 with an approval by the EMEA and MHRA for a very broad label, I would say, especially compared to the label that we have in the U.S. We have 10 market dossiers submitted and ongoing constructive discussion with health authorities. We have established our infrastructure in Europe and a commercial hub in Zug, Switzerland. We now have a core team, especially from a medical affair and market access perspective, really working on medical education and getting ready for the launch. We have not hired any sales force in any country, except Germany, where we launched just because we're really gauging when we invest in field force, and we plan to only do this when we are very, very close to reimbursement because it doesn't make sense to burn cash too early if we don't have a reimbursement decision. We advanced in signing wholesaler agreements in Germany, U.K., Italy and the Nordics, and now we have not just our go-to-market strategy in Europe, but our content engine, our digital capabilities and all the foundations that is needed. And our team now is around 250 associates at a European level. Slide 17 is 2022 is going to be a year of busy intense launches where we're going to continue negotiating following up on the 10 dossiers we submitted. We believe we're going to get the large majority of the reimbursement decisions this year 2022, and we plan to launch in more than half of the countries that we submitted, but we also plan to file the next wave of 5 additional countries in Europe to complete the 15 large and midsized countries at a European level. And then all the remaining Central Eastern Europe, which are above 10 countries, we are actually now in the process of executing several agreements with established companies that have an infrastructure already there because for us, this is not an area where we would like to build any infrastructure for the future. Now if you look at the launch we've had in Germany, and this is very, very early days. We've had a very successful launch event during COVID, where we've had 200 physicians and 200 leaders present in person right before Omicron hit, this was just -- we managed to do that. I mean we didn't know that there was going to be an additional surge obviously, in Q4, but we managed to do that in person, and we followed it by a number of speaker tours. If you look at the frequency and coverage we were able to have in Germany today because of COVID, you see that, that's still very limited. And we're showing here our average frequency on our A and B target lists, where you're talking about 2 to 3 calls only up to now. And as a reminder, that's not every A and B physicians we have, we still have even out of the 12,000, that's not every B potential physician we have. We have 7,000, 8,000 more that even up to now, we could not reach. So we're still working very hard on this, and we're exploring digital but other initiatives to maximize our reach to physicians in Germany. But despite that, we're encouraged that at least we're seeing our normalized uptake similar to other cardiometabolic products in Germany. It's also important to note that we received the second -- we were the finalist of the Pergamon for the most innovative product in primary care in Germany and #1 went to the COVID vaccine. So that expected maybe. So on Slide 19, you'll see an update on where we stand in terms of our partnerships in the world internationally. So Canada, Middle East, Africa and China. In China, we now are expecting the approval in the second half of 2022. We did receive in Q4 from the Chinese authority, a supplemental notice requesting additional technical data and information that we are now in the process of preparing with our partner adding and submitting, as was not really expected, but it's not uncommon, not in China and not even in EMEA to receive such requests, but they are really all focused on technical requirements not very much our scientific data that impact the usage nor the indication. So this is where we stand with those 3 partnerships. But we're seeking partnerships beyond that. On Slide 20, you'll see that the additional 20 countries where we're seeking now regulatory approval, which are going to come in 3 different waves. We're really solely focusing on partnerships in these markets. So we have no intention of doing this ourselves. We believe that there will be partners that can do this a lot better than us and a lot faster than us in many of these countries, and we are in the process of working on identifying the right partnerships. Finally, on Slide 21, you'll see that we are sharing the progress we're making in terms of life cycle management and that we are initiating the development of a fixed-dose combination between VASCEPA and statin. As you know, in cardiometabolic disease, fixed dose combinations are very, very important, simply because those patients are receiving multiple treatments. And if they have to take 5, 6, 7 different drugs that impacts your adherence, impacts the motivation, impacts the engagement of the patient but also the motivation of the physician. So we are progressing and initiating this development. We believe that it is going to be a very important opportunity for our cardiovascular risk patients. As a reminder, our cardiovascular risk indication is on top of a statin. So bringing those 2 products together in 1 product we believe, is going to be more convenient for our patients and may impact overall the engagement of physicians and patients overall. And to do that, you'll see on Slide 22, we're just summarizing where we stand in terms of strengthening our executive and leadership board. In August, we've had 2 senior executives joining us, Laurent Abaris as President of Europe; Jason Marks, our Chief Legal Officer; we're also happy to announce that in November, Alan Wills joined us as Head of our Corporate Business Development. And beginning February, Lisa DeFrancesco will join us heading our investor relationship at Amarin. We also have Per Wold-Olsen also joining us as a new Board member as of January 2022. So exciting opportunity to create value. A lot of it is really built on the launch in Europe, the successful launch in Europe. Expanding internationally with partners, not ourselves, but also growing and defending the U.S. for as long as we can, right? If the situation changes in the U.S., and we have a stronger generic penetration more than what we do because for the moment, in the U.S., we are contribution margin positive and we are using this contribution to actually invest in Europe and elsewhere. In Europe, so far, we have listed public prices in multiple countries, not just Germany, and they are all aligned around EUR 200, $240. So pretty aligned up to now. And we are having the negotiations in the price and hopefully successfully in 2022. Internationally, we continue to work with our partners in creating value in those 3 territories but offering VASCEPA for partnerships in multiple other territories, and we continue to drive these opportunities to create a future for Amarin and for our shareholders. Thank you. And Jessica, back to you.

Great. Thanks for that presentation. [Operator Instructions] And actually, we've got a number of them in the portal, also I'm going to ask those ones first. Let's see here. Of the 10 European countries where you filed marketing dossiers, how do those break down in terms of patient volumes? I don't know if you're going to go through all 10, but maybe which countries do you expect to hear from first, second, kind of when within 2022, could kind of the next couple come online?

Sure. So first of all, the decision for those 10 markets was based on patient population, right? So we basically chose the 10 largest patient population markets, they have the big 5, which is Germany, U.K., France, Italy and Spain. Between those 5 markets, you're talking about 60% of the overall patient population in Europe. So that's a -- these are the most significant ones. And then everything after those big 5 really becomes a midsized market. Now in terms of the cadence, it's difficult to speculate at this point in time which one will come first, which one will come last. Simply because, especially with COVID, there is disruption of the cycle anyway, but it all depends on our negotiation and the price stakes. Certain countries actually have a clock. So if you follow our negotiation with NICE, there are just very clear, simple milestones. Today, we have a public hearing and it's public. So if somebody goes on the NICE website, they'll be able to see minutes and notes. But there are others that are just -- there is no clock that dictates what will happen when. So we're driving all of them. Some will come in the first half of 2022 and some will come towards the second half of 2022. But we believe 2022 is the year of negotiation, right? This is the year where we are in full-blown negotiation mode, and we hope to get as many of these completed during the year.

Turning to more coming in from investors. This one is, what is the German price now? And where will it likely settle out if we look out a couple of years? I guess maybe asking beyond the free pricing period.

Sure. So in the free pricing period, our price is EUR 240, okay? That's the list price. The rebates in Germany are mandated. So there's no guessing around them. You have 2 single-digit rebates that you have to pay. If you add them up, they are maybe close to 10%, and that's the net you make during this year. After a year, it really depends on how the negotiation goes especially in terms of patient population. So there is this balance that exists, and this is not specific only to Germany. What price are you going to get for which patient population? The larger of the patient population usually the lower price because at the end of the day, the government is calculating the impact on their overall budget. So this is what the negotiation is about. The negotiation is usually you get a government that says, well, listen, if you're willing to discount X percent, I'll give you full access. And if you say, yes, you'll probably have very fast access but listen, no matter what, you're never going to reach all of this population, even if you try very hard, right? So where is the balance? Which is the most important patient population? Where you know physicians see the need, where patients are going to stay on therapy and what price is really reasonable. That's what the negotiation is really about.

Okay. Got it. Just a question about, I guess, the recent COVID surge. How things in Germany and how were they in the fourth quarter with COVID?

I mean, this was definitely completely unexpected. I think not for us, but for everybody, we had our launch event that I attended and many of us flew to Berlin to attend them, be with our German team. But basically, Germany was hit very, very hard with Omicron. I remember I had another investor presentation and between the time I recorded it and the time it went live, there were almost 700,000 cases in Germany. So there has been very significant disruption in the German market, literally from November 10 until now. So it has impacted, we cannot deny that. We have to see how things are going to progress in Q1. But for the moment, yes, it's limiting our access to physicians, and we are exploring all sorts of other avenues of how can we still reach and engage physicians. Germany tends to be a traditional market. So digital is not very entrenched unlike the Nordics, unlike some Spain where digital is very entrenched. So yes, it is impacting us. We'll have to wait and see. That's why we were very cautious in showing early results for Germany because it's -- the situation may change in different directions.

Thanks for all these questions coming in, everybody. Which statin are you planning for the statin combo? And can you talk a little bit about the degree of difficulty in creating a fixed-dose combination of a product like VASCEPA with a statin?

Sure. So first of all, we have not shared nor disclosed up to now, which statin we're going to go with. I think when you embark on this journey, you have to first demonstrate that you can do 1 statin, right? You're not going to go do 2, 3, 4, 5 at the same time because it's a challenging process and it involves money. So you want to do this right, especially that technologically. So second half of the question, how easy or difficult? Doesn't require a big manufacturing guru to imagine that putting us solid with a liquid together is not an easy thing, right? So technologically, there is definitely a barrier just for layman thinking. You don't need an expert to realize that, that's not an easy one. Having said that, the good news is that the 2 products already have clinical evidence, already have data demonstrated. So the work that has to be done is technological, so manufacturing, stability and bioequivalents mainly and to follow the usual regulatory pathway in the U.S. But it's definitely, I believe, a very big opportunity. If you look overall, in the large cardiometabolic portfolios that were built on top of a statin or on a base molecule, they usually have more than 50% of their business in the combo form at loss of its exclusivity. So this can be an important strategy to manage our life cycle over time.

Okay. Got it. I guess this is kind of a manufacturing question. I think applies to your business as opposed to [indiscernible]. But as you grow volume of VASCEPA, is there enough drug substance available?

Yes. This question, I think, was asked to Amarin back when the REDUCE-IT study was positive and everybody was wondering do we have enough supply because everybody knows that the supply chain is a challenging one. And we had to make sure that we have plans to have enough supply. Today, the reality is we have enough supply. The business is impacted by all what's happening in COVID, even from a shipping perspective, it is impacted. So we are doing our best to manage this balance of having enough inventory but not too much, but not too little, knowing that you don't know what's going to happen over the next few months. So we feel confident of the level that we have, but we continue to monitor it very, very closely. And as a reminder for everyone, I mean this is a supply chain that took Amarin years of investment and years of planning to arrive at where we are today. And obviously, with our plan for a fixed-dose combination, we take that into account because that's still a lot of supply of the mono, right, of the mono just to make sure that we can produce the combo from that. So we stay very closely monitoring that picture of the inventory.

And I guess while we're on this topic of supply, what's your latest diligence telling you about what the supply picture is looking like for the generics?

Yes. So what we've seen over the last 15 months since generic introduction was a steady, slow supply of the generic in the market in the U.S. So if you look at the volumes there is 1 trend that has not accelerated nor decelerated, right? And it was more or less in line with our expectations. And the expectation is, if you want a lot of supply of this product, you need to invest money and it takes time, even if you have the money, right? Just because you need to build the capacity, you cannot go from 1 to 10 in one go. It's just you have to build it over time. So for the moment, there are 2 generics and the 2 generics have supply. We've seen that in the last month, Apotex was listed on Medi-Span but we have not seen supply on the market, and we have not seen ever listed or bringing any product. We continue to monitor the situation. Our assumptions for the U.S. are built on that curve, meaning that, that curve stays the same in terms of the supply of generics. So if the supply goes down, then we have definitely an added opportunity. And if the supply goes up, then we have to revisit our plans and see what makes sense. For the moment, where contribution margin positive in the U.S., we were before, by the way, the go-to-market strategy, before we go down to 300 reps. Now that we went down to 300 reps, we are still contribution margin positive. But we have to continue to monitor this because there could be unexpected events. And if they happen, we'll address them immediately and take the actions that are needed. We are ready to go authorize generic if need be. But for the moment, we have $0.5 billion business and it's contribution margin positive. So we're not going to let go of this unless we really see that this is non-sustainable, and we're not at this point.

Okay. And that kind of steady slow trend you described of generic uptake. Is that mainly influenced by their access to supply? How much of it is influenced by your working to kind of get compendias updated to make sure that scripts written for the cardiovascular outcomes indication are not filled with generic product?

Sure. I mean, the sale of any product, not just the generic, is impacted, obviously, by supply and market dynamics. So we cannot say, well, if it's mostly supply where it is mostly market dynamic. The reality is if they have more supply, probably they would have pushed it into the market, and it would make an impact, right? Now we are doing everything to protect our business and the indication where we have right and exclusivity. And that's -- we believe it is the right thing to do. So we are educating every stakeholder in the chain from the physician to the payer, to the pharmacist on the fact that generics do not have an indication. And today, we are attractive to payers because of our price that we can offer to them today. And we are making sure that we are attractive to the patient because with Blink, for example, all our patients can benefit from the co-pay of course, who are eligible for using the co-pay card, can use it, while in the real world, maybe half of the patients don't get to get that benefit, right? So we're trying to make sure that we maximize the benefit of the patient or the payer while working in the most professional way within the limit of our indication.

Okay. You cited some of the new-to-brand data in your presentation. It looks like it's starting to tick higher in the U.S. even through -- was a pretty challenging kind of end of the year period even without COVID, just going through the holidays. So can you, I guess, elaborate a little bit more on how much you're reading into this kind of initial trend?

No, it is 1 quarter, right? So to me, although there are multiple weeks on this curve, it's still 1 quarter. So I take it as 1 data point, right? But it's 1 data point in the right direction and the fact that we reached 8,000 NBRx which we did not achieve for the last 15 months. At least internally, we look at it with our team as an important milestone that the U.S. team is delivering, right? It's bringing back the NBRx, the New to Brand level that is needed because without that, we're not tenable. We have to see how we're going to maintain this over time. But we also have to see what's going to happen from a generic perspective, right? Will there be more supply or not, there are a number of unknowns. So it's still early. But again, we received many questions about whether we believe in the go-to-market strategy that we have implemented. And we were just trying to say we see encouraging signs. We will continue to fight this. And if the situation changes, we will take other decisions and we will act accordingly.

Can you talk about gross margin for VASCEPA outside the U.S. What does it look like in Europe today? And what do you think it will look like if we look out several years?

Sure. So the difference between gross to net in Europe and the U.S. is very, very different. The structure from which you go from gross to net is different, simply because you're -- at the end, your gross, your list in Europe is very important because as to really what the government pays more or less, unless you do a confidential discount. So we have communicated earlier that we believe that our net price in Europe is going to be the same or higher than our net in the U.S. And today, we believe that, that's going to be the case based on the discussions and the negotiations we're having with the different governments, okay? Now how does the price evolve over time? In Europe, the price can only go lower, unfortunately, over time. So you don't have the chance, unlike the U.S. to raise your price at any point in time. That's why it is so critical to start at the most logical premium level because it can only go down. However, it does not go down without prediction, right? So it's very predictable. So in a country like I'm going to give the example of France. France will have a price revision 3 years after launch. So for the first 3 years, whatever you agreed upon, you continue to sell within those 3 years without any price impact, right? The rebates you pay are the rebates you pay, nothing changes during that period of time. In 3 years, there is a renegotiation that depends very much on the change in realities. Do you have a new competitor that has better evidence and cheaper than you, then you have to lower your price. But if nobody has better evidence than you, then your price is still reasonable. So you may get a 2%, 3% maximum reduction, not more. Now if you cannot defend the price 3 years later because somebody brought a better innovation with a lower price, then it's a tougher fight. But where we stand today, we feel confident that the initial communication that we've had about our price in Europe being higher or the same of our U.S. net at still stands to.

Okay. Great. So we are out of time now. So I'm going to say thank you so much, and thanks, everyone, for listening.

Thank you.