Teva Pharmaceutical Industries Limited (TEVA) Q1 2021 Earnings Report, Transcript and Summary

Good day, and thank you for standing by, and welcome to the Teva Pharmaceutical First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded.

Thank you, Annette, and thank you everyone for joining us today to discuss Teva's First Quarter 2021 Financial Results. We hope you've had an opportunity to review our press release, which was issued about an hour ago. A copy of the release as well as a copy of the slides being presented on this call can be found on our website at www.tevapharm.com. Please note that, the discussion on today's call includes certain non-GAAP measures as defined by the SEC. Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations to better understand its business. Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information and facilitates analysis by investors in evaluating the company's financial performance results of operations and trends. A reconciliation of GAAP to non-GAAP measures is available in our earnings release and in today's presentation. To begin today's call, Kåre Schultz, Teva's Chief Executive Officer will provide an overview of the first quarter recent events and priorities going forward. Our Chief Financial Officer, Eli Kalif will then review the results in more detail, including our 2021 financial outlook. Joining Kåre and Eli on the call today is Brendan O'Grady, Teva's Head of North America Commercial will be available during the question-and-answer session that will follow the presentation. Please note that, today's call will run approximately one hour. And with that, I'll now turn the call over to Kåre. Kåre, if you would please. Kåre Schultz: Good morning, good afternoon to all of you and thank you for dialing in. We are presenting today Q1 2021 financial highlights and we have a set of solid numbers to present to you. Our revenues came in at $4 billion, which we see as a good result given the continued COVID-19 pandemic and the effects it is having in the marketplace. We are seeing our adjusted EBITDA come in at $1.2 billion, meeting our expectations and in line with what we see as the continued improvement of our business. The GAAP diluted EPS came in at $0.07 and the non-GAAP diluted EPS came in at $0.63 again in line with our expectations. We continue to reduce our debt. We had one pay down on some convertible bonds in the period and net debt is now reduced to US$23.2 billion. And then last but not least, we reaffirm our 2021 outlook and Eli will show you some more details on that later in the presentation.

Thank you, Kare, and good morning, and afternoon to everyone. I hope you are all having a great start to 2021. I begin my review of the first quarter 2021 financial results on slide 15, starting with our GAAP performance. Revenue in the first quarter of 2021 were approximately $4 billion, a decrease of 9% compared to the first quarter of 2020. This decrease was mainly due to a lower revenue from generics, OTC, respiratory and COPAXONE in our Europe segment as well as lower revenue from our distribution business COPAXONE and BENDEKA/TREANDA in our North America segment. This was partially offset by higher revenue from generics in our North America segment as well as from AUSTEDO.

Thank you. And the first question comes from the line of Balaji Prasad from Barclays. Please ask your question. Your line is now open.

Hi. Good morning, and thanks for the questions. This is Balaji from Barclays. So, firstly, on AJOVY, just wanted to understand a sense of what would be the key growth drivers in Europe considering that you have touched almost all the core markets there and what's going to drive market share from 22% to 33% goal and by what timeframe? And on generic side just one quick question on deflationary comments which have come through from the likes of Walgreens and Sandoz yesterday. And Teva doesn't seem to have been touched by it, especially this quarter. So can you, kind of, help us understand what were the offsetting factors here which helped you weather any generic deflationary trends recently? Thank you. Kåre Schultz: Thank you very much for those two questions. So if we start with the first one on Europe and AJOVY and how do we see the growth drivers, then the key growth driver is or that two key growth drivers. One is the underlying market growth as you saw the market grew more than 100% in volume over the last year. We expect this to continue. There's a nice uptick in almost all markets of this class. So that's one element. Then as you know in Europe, you have quite stable, quite good pricing. That doesn't really matter so much. It just means that there's no real change there expected. And then we really have a very, very good product offering. We have the fact that we have the longest acting product, which basically means that it's possible to take it once a month or once every three months. The experts they like that. We have the fact that we have a really nice Auto-Injector. It's a product we get from Switzerland. It's a really sleek device. And we have the fact that we have an unbeaten safety profile in our labeling. We don't have any issues in our labeling on the safety side. That's not the case for all of our competitors. So all these factors combined with the fact that we have a strong historic position with our sales force and with neurologists in Europe, basically means that we see that market shares continues to tick up. So when I say, we expect to reach 33%, it's really a continuation of that graph you're seeing in our deck. And I expected that with some smaller deviations, we'll see a continued uptick in market share over the coming years. And that means that it will not be very many years before we will hit those 33% in the European market. With regard to your second question, then I'll get back to the ice machine that I introduced before the previous call. So it's so that with all generics in the U.S. market, it is this ice machine where the new ice cubes in the machine drops down. And they're big and they contribute a lot to revenue and profitability because they're brand-new. And if you're lucky, you had a first to file, so you're alone for 180 days, otherwise you maybe one out of one, two, three companies that hit the market with a new generic once it goes off patent. And then gradually more competition comes in, the ice cube starts to melt and becomes less and less significant and there's price erosion as more competitors enter into the marketplace. Now we had some classical ice cubes, you could say in the fourth quarter last year with the generics of TRUVADA and ATRIPLA that we launched. And they made a good contribution in the fourth quarter. They also made a nice contribution in the first quarter. And then we have some, I would say, slower melting ice cubes and that's typically what you see within what I would call complex generics. When you talk complex generics, then you will sometimes see that the products will not get as much competition because it's simply complicated to make the product. And that's the case, for instance, for EpiPen. So we have a generic version of EpiPen and that is still having nice revenue, nice market share. We also have a generic version an authorized generic of ProAir. That's also a complicated product because it's an inhalator a respiratory product. So that also has a good position. So you can say that there’s a little difference in how fast the ice cube melts if it's a traditional solid oral dosage form generic then typically you get a lot of competition, which means relatively faster price erosion. If it's a complex generic, it goes a little slower. So it's really a combination of these factors that meant that we had a nice performance of our generic business in the first quarter. Thanks for the question.

Thanks, Kåre.

Thank you. And the next question comes from the line of Gary Nachman from BMO Capital Markets. Please ask your question. Your line is now open.

Hi, good morning. What have you been doing to help make the TRUXIMA launch successful? So talk about the dynamics behind the scenes. How you've been able to navigate with the payers and physicians, which gives you more confidence? Biosimilars can be big contributors for you going forward. And then a follow-up, just the much lower free cash flow in the first quarter, could you explain some more how the working capital impacted that and what you're doing to change that throughout the year to get to the target that you talked about in the guidance? Thank you. Kåre Schultz: Thanks, Gary, for those two questions. Brendan will answer the first one and then Eli will answer the second one. So over to you, Brendan.

So thank you. I don't want to give away too much of our commercial strategy really on TRUXIMA, but I will just comment in general to say when you think about TRUXIMA or you think about biosimilars in general, there's biosimilars that will go through kind of a medical channel and there will be biosimilars that go through more of a retail pharmacy channel. So the strategies are somewhat different as to how you navigate that. And if you think about Teva, Teva has a strong specialty business. And, of course, obviously, we have a very strong dominant position in generic. So I think it's the capabilities of both of those organizations the way we're structured bringing those together that have made us successful in the way that we've approached the biosimilar launches of recently with TRUXIMA. So I think I'd probably leave it there. I think that we are well-positioned to continue to do well with TRUXIMA. We'll grow TRUXIMA in 2021 over 2020. We'll probably flatten out in the out years and then a slow decline, which will replace as we launch new biosimilars. So I think that probably answers the question. Over to you, Eli. Kåre Schultz: Thanks, Brendan. Let's have Eli's comment on the cash flow.

Eli, are you on mute?

Yes. Sorry. Thanks for the question. I would say that if we will trend the working capital in average versus our revenue, I would say that we are up by 1% to 2% of our annual revenue. And this is mainly due to sequential increase a bit on the inventories due to demand behavior and also the mix in Q1 in terms of revenue and how this one resulted with actually payment terms inside revenue that actually contributed that one. Although, those one we consider it as a non-recurring event swings that we're actually working to stabilize it already with a lot of actions underway. Kåre Schultz: Thank you, Eli. Thanks for the questions.

Thank you.

Thank you. And the next question comes from Jason Gerberry from Bank of America. Please ask your question. Your line is now open.

Hi, guys. Thanks for taking my question. I guess, first question was just on the gross margins. Just kind of curious if you could talk about conceptually how you're thinking about quarterly phasing. It seems like TRUVADA was an offset against the seasonally soft AUSTEDO which has the 1Q pharma seasonality dynamics. So just curious how you're thinking about progression of gross margin as the TRUVADA exclusivity comes off? And then my second question is, just coming back to TRUXIMA from a biosimilar perspective. Can you give us a sense right now what proportion of the US oncology market where prescribers aren't operating to prescribe the drug with the highest average selling price given the markup dynamics effectively where providers participate in sort of capitated or value-based constructs where lower cost alternatives could potentially gain traction? Thanks. Kåre Schultz: Thanks, Jason, for those two questions. I'll address the gross margin and then we'll get back to Brendan on TRUXIMA again. So on the gross margin just to clarify TRUVADA is not a main element to the gross margin in the first quarter. And basically the reason is just to explain a little bit again about the ice cubes that TRUVADA launched in the fourth quarter with 180 days exclusivity. But technically how that works in the marketplace is that then you know after the 180 days you will get competition. And then in order to make sure you have a steady flow of products in the market, you sell the product and some of the sales you have, you don't record because at the moment that the generics number two, three, four, five launch then you will have to give a rebate to the wholesalers who bought your TRUVADA and Atripla for that matter. So that means that the TRUVADA sales they are -- there in the first quarter, but they are more significant in the fourth quarter. That's why I mentioned them in the beginning that you could see the bump up in US sales in the fourth quarter. And then of course there's something in the first quarter. But not really something that dramatically influences the gross margin. So I would rather say that the underlying performance is driven by the constant efforts to rationalize and optimize our manufacturing footprint, our manufacturing operation. And then you will see, like you said some small swings from quarter-to-quarter of course, based on if all of a sudden you have, some patient level hoarding you sell a couple of hundred million more then that can maybe affect it a little bit or you have a product launch that affects it a little bit. But the reason why we are committed to improving our operating margin is really because we know that the thousands of small sub projects we have in manufacturing is improving our gross margin. And the way we handle our total product portfolio is improving our gross margin. This is something that doesn't come easy. It doesn't come overnight. And I've said many times that you should expect that we can do this to the tune of 50 to 100 basis points per year. But you could also expect that once we get to 23% and we hit the 28% operating margin then of course, we don't really want to stop there. We want to keep on improving the way we operate and keep on improving our gross margin as we go further. So some quarterly fluctuations, nothing dramatic underlying steady improvements 50 to 100 basis points per year. With that over to you Brendan on TRUXIMA.

Sure. So when you look at biosimilars and you think about the commercialization of those products launch order matters. So if you launch first or second, you're going to get significant value. You launch third and fourth, you're going to get some value. You launch after fourth and the value declines rapidly. So TRUXIMA launched first, we were able to make significant inroads in the market. And then when the second product came out, they had some difficulty getting traction. But then of course, we got an ASP. They didn't have ASPs as you talked about. So they had an advantage grew share and it cost us more to keep the share that we had. So that's really the dynamic. It's very much like generic. Each time a new entrant comes into the market, there will be a period of time where they have an ASP advantage where they don't have one or the others do. That allows them to gain traction some share in the market. And it makes, it more expensive to keep your share, because it erodes your price and your discount so to speak. So that's really just a dynamic. It works very much like a generic market. I think when you look at TRUXIMA, again, we'll continue to grow share as we go through 2021. And as we get into 2022 and 2023, we'll see that flatten and then probably decline slowly over time.

Thank you.

Thanks for that question.

Thank you. And the next question comes from the line of Umer Raffat from Evercore. Please ask your question. Your line is now open.

Hi. Thanks so much for taking my questions. Kåre a couple for you and a quick one – a couple for you really. One have the cities and counties lawyers come back with a counter offer yet on the opioid side. I'm very curious about, where things stand on that. And also, on generics just wanted to understand what you guys are baking in for full year for Europe. And I ask because the commentary coming out of Sandoz appeared far more guarded than what I'm hearing on this call? So thank you so much. Kåre Schultz: Yes, Umer, I'm sure you're keenly aware of we are in active litigation in San Francisco – in California, with four entities there. So I can't really make any specific comments due to the fact that we are in active litigation. I can tell you that, we have all the time since we sort of went into the framework agreement in supporting a settlement to the benefit of people suffering from substance abuse in the United States. And we are still seeing that, as the only good solution to this issue. So that's really how much I can say. Sorry that, I can't give you more details on that. With regard to generics in Europe then as I commented in the beginning of this call, we are seeing here in the first quarter, a continued volume reduction in Europe OTC and generics, as we also saw in the third and fourth quarter of last year. So we have not come out of lockdowns in the big markets. That's still the case here in the second quarter. So we are still seeing for instance France, Italy, Germany, having some level of lockdowns. However, we are also seeing vaccination rates come up very fast now eventually in Europe. So we are basically sticking to the prediction, which I gave last quarter which is that the first and second quarter, Europe will be sort of affected by reduced volumes on OTC and generics and that we are expecting the lockdowns to basically ease such that third and fourth quarter of this year, we'll see more normal patterns of doctor visits hospital visits and so on And a more normal volume of OTC and generics in Europe? Thanks for the questions.

Thank you.

Thank you. And the next question comes from the line of Greg Gilbert from Truist. Please ask your question. Your line is now open.

Thank you. My first one is perhaps for Brendan on generic NARCAN. Can you update us on the opportunity and what happens next there and whether that could become part of a broader settlement framework discussion given it's sort of potential benefit? And then Kåre a bigger picture question with the turnaround phase of the company well underway and the margin progression and the good progress we've seen, I'm curious, how much time and energy you and the Board are spending on thinking about positioning Teva for growth later in the decade beyond the assets you've already identified as worthy of your investment. Are you considering licensing bolt-ons et cetera things that you can bring to the party beyond, what you already have? And as part of that, I'm curious as to whether your answer would be different, if you had a settlement in hand with a set amount of cash outflows over x number of years? Is it sort of a – we can make a list now, but we can't execute on it, because of that uncertainty? Just curious, if your answer would be different, if you had the bird in hand in terms of knowledge of liability size and pacing? Thank you. Kåre Schultz: Thanks for the questions, Greg. So the first one goes to Brendan on NARCAN.

Yes. So I really don't have much of an update on NARCAN. We continue to work on it. I think, we still have some legal issues that we're working through with it. But as to whether it could be part of a broader settlement or not, I'll leave that to Kare to answer. But just real basically, we continue to work on NARCAN. And when we're ready to introduce into the market, I will certainly let you know. Kåre Schultz: Yes. And with regard to potential settlements on NARCAN, it's the same boring answer that really due to the fact that we are in active litigation, I can't comment on it. I can comment on your second question about, how do we see the strategy going forward. And as you probably know, it's really our vision for the company to continue to be leaders in generics and strive for leadership in biopharmaceuticals including biosimilars. And that's really our focus now. That of course, might include as you suggested in licensing M&A and so on. However, our financial position and that is really not related to whether, we have a settlement on opioids or not, our financial position is such that, we are totally committed to reducing net debt below three times EBITDA. And once we get past that point, then you'll probably see that we will continue to be very capital disciplined, very cash disciplined and probably want the debt to continue further down, before we consider things such as M&A or dividends or share buybacks, but that really all lies in the period after '23, when we're going to get below three times net debt-to-EBITDA. And if we then think about the strategy we have, which is linked to our vision and mission then to the extent, it's possible within those targets. We do of course do in-licensing. We have been in-licensing early-stage assets. We have been in-licensing different biosimilars. So, it's not that we don't do it. But we just don't do any M&A. We don't go out and buy Phase III products or already launched products. So we are very disciplined in how we allocate the capital. And we will stay in the course of that, at least until we hit the end of '23, where we will hit our long-term financial targets. Thanks for those questions Greg.

Thanks.

Thank you. And the next question comes from the line of Ronny Gal from Bernstein. Please ask your question. Your line is now open.

Thank you very much, guys, and thanks for taking my question. Just a quick clarification and then a couple of questions. The clarification is around QVAR. Have you stopped reporting that and why? Then the two questions I have is what happened with the CGRP market? It looks like two of the three companies the way we track the scripts looks like had a significant reduction in the price we see by dividing revenue by scripts in the first quarter. I was wondering, if this is just inventory or for an agreement or payer agreements that drove that down if you can comment on that. And then more broadly Kåre, some of your peers have adopted that strategy of licensing second wave products in established markets from China for example the Coherus has adopted there with the PD-1. And that seems to be a logical strategy, if you have a sales force in oncology market. And I was kind of wondering, if you guys considered doing those kind of licensing deals or second wave branded product as opposed to biosimilars, or is there a reason why that strategy does not match Teva? Kåre Schultz: Thanks for those questions, Ronny. Could you just clarify once more exactly your first question? I didn't completely get it.

No QVAR. QVAR is not anywhere in your reporting and I was wondering, if you guys just simply stopped reporting that number? Kåre Schultz: Okay. So I don't have a firm answer to that. I guess it's something to do with the thresholds of revenue and so on. That's my guess. But I'll just refer to Eli and he can maybe fill us in on what the thresholds are and why it really isn't there. But it's not something that I've been involved in discussing just to let you know. So Eli, do you have any comments to that QVAR? Why is it not specified?

Ronny, this is Kevin. Just -- it is really just a threshold and we are still supporting the product, but the sales have dropped to a level we just did not include it.

Okay got it. Kåre Schultz: Okay. So Ronny, so nothing dramatically happening there. Then on the licensing, we're really not pursuing this you could say a second wave of patent-protected specialty products, it's really not within our strategy. So what we are pursuing is our own specialty products and of course, given the size of our portfolio, that is a limited number of launches that you'll be seeing once a year, once every second year, we'll have probably a product that we can launch. And then we are pursuing biosimilars and generics. So it is a possible strategy. You could have adopted but that's really not what we are – what we're trying to aim at. Thanks for the questions Ronny.

Thank you. And the next question comes from the line of Elliot Wilbur from Raymond James. Please ask your question. Your line is now open.

Good morning. First question for Kåre and perhaps Brendan. Just thinking about full year guidance for AJOVY, AUSTEDO in light of 1Q performance and recent prescription trends, particularly with AUSTEDO, seems like obviously there has to be a significant acceleration in the back half of the year to kind of get to those numbers. Just help us think about your confidence in those numbers given what we've seen sort of year-to-date? And I guess what has to happen there? Is it just mainly scrip volume, or is there something that I might not be thinking about in terms of net pricing that may swing in your favor fairly substantially in the second half? And then for Kåre, just maybe thinking about potential hidden pockets of value in the company's proprietary pipeline. You have a couple of novel biologics programs in the respiratory area 48574 and 53275. Anything you can say about where those fit kind of in the current asthma treatment paradigm and what maybe some of the competitor products out there that those will be going up against? And when might there be data or an update there? Is it late 2022 or potentially earlier? Thanks. Kåre Schultz: Elliot, thanks for those two questions. The first one I'll just say I'm very confident in our guidance for both AJOVY and AUSTEDO, but I'll hand it over to Brendan to give you some color on how we're seeing the US piece of it. I'll just add that on AJOVY, we see a steady growth in Europe, which we are very positive about. And we also expect to see our partner Otsuka get the approval and do the launch of AJOVY in Japan at the end of this year. But of course the bulk of the business for AJOVY will still be in the US This is also the case of course with AUSTEDO. But over to you Brendan.

Yes sure. Taking AJOVY first so, if you think about AJOVY, we continue to grow share nicely. I mean we're up to – we basically since the launch of auto-injector we've doubled the total prescription share as well as the new-to-brand share. And new-to-brand share right now is hovering at around 25%. And we think we can get that into the 28% to 30% range. But to do that as we've grown share, we made significant investments in access and in patient assistance to facilitate that share growth. As we move to the back half of 2021 and into 2022, as we improve our access then we'll have a more balanced approach in regards to share growth as well as revenue generation. So I think you can think of it that way. And as Kare said we're still believe that the guidance that we put out is certainly achievable. If you think about AUSTEDO, AUSTEDO also had a 20% share growth quarter-over-quarter. It started out maybe a little bit slow in January, February, which is not unusual. Typically you see increased demand in the fourth quarter as people's benefits. They know they're going to change in the first quarter. So you see somewhat of a slow start. But we do think that the $950 million is an achievable target and something that is built into that number which you're not aware of and I'll make you aware of it here is that we're starting a DTC campaign a direct-to-consumer campaign around tardive dyskinesia in AUSTEDO, that will kick off with mental health awareness month here in the month of May just starting here in the next couple of weeks. So we think that that will be a significant catalyst to helping us get to that guidance that we put out. Thank you for the question. Kåre Schultz: Thanks Brendan. With regard to two products you mentioned in respiratory, these two products are biologics that are in Phase II clinical development. And the thinking behind them is really that what they offer is better efficacy and better convenience for patients. So what we're hoping to do with them and it's too early to give any details on it. But what we're hoping to do is really to be able to position them in a way where they're both superior in efficacy and convenience but also by being so, we are able to expand the share of the population that really gets biologics. Because right now, as I'm sure you know, there's a certain part of the asthma and COPD population that is not on biologics and we think that these products might be a way to expand the share to the benefit of patients. We will not have Phase II data publicized this year on these, but we hope to see some of it. I can't remember the exact date, but I think some of it in 2022 and some of it in 2023. Thanks for the questions, Elliot.

Thank you. And the next question comes from the line of David Amsellem from Piper Sandler. Please ask your question. Your line is now open.

Thank you. So high-level question as a starting point. As the business evolves into more of a focus on biosimilars and complex generics and we hear those terms thrown around a lot by the US majors including yourself. How do you think about the potential for divestitures and I'm asking that question broadly -- given how you're thinking about the evolution of the business? So that's number one. And then number two on AUSTEDO, I just wanted to drill down on the direct-to-consumer campaign. To be clear is that a function of any, sort of, worry about maturation and volume trends? And is that a signal that even though penetration rates for VMAT2s are low perhaps there needs to be more heavy lifting in terms of winning over hearts and minds in the psychiatry community. Just help me understand the thought process there? Thank you. Kåre Schultz : Thanks, David. I'll answer the first one and then I'll pass the AUSTEDO question on to Brendan. So when we talk about divestitures then it's important to explain the process we've been through in connection with our restructuring. We really looked at all our businesses. And we have basically sold everything that we thought was not strategic. There might be some small bits and pieces left and we've just sold a few bits and pieces. The old generics we had in Japan we've sold those. We've sold a few OTC products in Scandinavia. But there's nothing major left. So don't expect us to announce all of a sudden that we are selling a big chunk of the business. We are committed both to the complex generics and biosimilars, but we're also committed to solid oral dosage forms classical generics. And we have to remember that biologics will be a increasing part of our dose off-patent over the coming years as it has been in the last five years.

Thank you. And we will now take our next question from the line of Nathan Rich from Goldman Sachs. Please ask your question. Your line is now open.

Thank you and good morning. Kåre, could you remind us your expectations for generic price erosion in the U.S. that's assumed in guidance this year? And do you expect this to be fairly stable over the course of this year? Just wondering if you think there'll be any change in the competitive dynamics in the US as the FDA gets back to kind of more normalized inspection activity? And then I wanted to ask a follow-up on gross margin. Eli, do you think that you guys can kind of continue to build off of this level that you said in the US? You've made nice progress on gross margins over the past several quarters. I think you also called out some mix dynamics that were favorable in the first quarter here. And so I just wanted to get a sense of, kind of, what the key moving pieces are on the gross margin line over the balance of the year? Thank you. Kåre Schultz: Please, operator. We need to answer the questions from David. We answered about the divestitures and then we got cut off by you introducing the next question before we answered the question about AUSTEDO and the DTC in the US. So David you'll get your answer now on AUSTEDO of DTC in the US. I'll introduce by saying, we are not doing this due to any weakness in AUSTEDO, but simply to reach more people with tardive dyskinesia. But Brendan please fill us in on the DTC for AUSTEDO in the U.S.

Yes, Kåre, I think that's exactly right. The reason for the DTC in AUSTEDO. We've been looking at DTC for a period of time. And the real reason is as we see strength in this market and we see a lot of opportunity in this market. There are 500,000 patients estimated with tardive dyskinesia in the US. We've got about 30,000 patients currently treated about 6%. So the upswing and the potential is huge. So it has been shown to be sensitive to DTC advertising and it's really just a matter of resource allocation. So we think that the trends that we've seen with AUSTEDO are strong. We think it is a -- makes a significant impact on patients' lives and to be able to put some direct-to-consumer advertising out there to educate patients who may not even be aware necessarily that they have it, that there's something available for this treatment could be of tremendous value. So that's really the rationale behind the DTC and we look forward to seeing those results which will probably start to show up in Q3 and Q4 this year. Kåre Schultz: Thank you, Brendan. Now we'll move to the next two questions that were asked. And the first one is about the erosion on generics and I'll answer this one. And just reiterate that in our two key markets is of course different. So in Europe, we don't see much price erosion. It's really a question of when things go off patent, they shift to another price level and then that price level is relatively stable. So no dramatic changes there. In the US, of course we do see price erosion and I won't repeat the whole ice machine analogy, but just say that some ice cubes melt a little faster than others. And it's basically like we've been discussing so that the complex generics often get less competition. So they keep a attractive pricing for a longer period of time, where more simple products in a few years they get two, three, four, five competitors and the price goes down significantly. There's no dramatic change from the way we analyze the business this year compared to last year. We see of course the normal level of erosion of pricing on generic products as they get older. But we also see good launch prices for new launches of generics. So all in all, no big changes there. Then we have a question on the gross margin and I'll refer that question to Eli.

Yes. So on the gross margin as we did in 2020 when we talk 1% on gross margin that actually contributed additional one point to our operating margin. This is what we see now in our planning for the year. So we expect it to be at least by 1% versus 2020, so call it like 53.5% and that will actually contribute to the level of 27 plus in OP. So it's still on track. Kåre Schultz: Thank you, Eli. I think we have time for one more question.

Thank you. And the last question is from Daniel Busby from RBC Capital Markets. Please ask your question. Your line is now open.

Sorry about that. Can you hear me? Kåre Schultz: Yes.

Yes. Connection issue. Thanks for squeezing me in. First question on fasinumab. Just curious, if your plans or outlook for that product have changed following last month's advisory committee meeting for tanezumab. And we're still waiting on long-term safety data there. When should we expect that data? And second just on generic price fixing litigation, could you remind us what the next steps are here? And when is the earliest date we could see a potential trial whether that be on the civil side or the DOJ side? Thank you. Kåre Schultz: Thank you for those two questions. So of course, we were watching the tanezumab AdCom and the vote that came out there was of course disappointing was a vote on the REMS, whether it was sufficient for tanezumab. There hasn't been any sort of complete clarification on FDA's point of view on the product itself so to speak with the different REMS, but it's definitely a negative for the product class. And right now with fasinumab, we're having you could say all nonessential costs are on hold and we are looking forward to discussing the product together with Regeneron. We are looking forward to discussing the product with FDA. So remains to be seen. But of course, we are disappointed about the results of the AdCom for tanezumab as an indirect indicator that it is a difficult path forward for fasinumab. On the generic price fixing litigation, I think it's fair to say that the COVID-19 pandemic in the US has slowed down proceedings on the legal -- in the legal system. And it basically means that on the criminal side, we don't have any clear time schedule for when this will move to trial, but it will be a I would say a significant period of time before that happens. And I think on the civil side, it's pretty much the same. So no real updates on the timing. We'll just have to wait and see how things progress with the legal system in the US getting back in gear now as the pandemic is reducing its impact in the US. So thanks for those two questions Daniel.

Thank you everybody for joining us. As always, we'll be available to take questions throughout the day, rest of the week and we look forward to connecting with you all soon. Take care.