Good day, and thank you for standing by, and welcome to the Teva Pharmaceutical Q1 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. To ask a question during the session, you will need to press star and one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star and zero. I would now like to hand the conference over to your speaker today, Kevin Mannix, Senior Vice President, Head of Investor Relations. Please go ahead, sir. Thank you, Annette. Thank you everyone for joining us today to discuss Teva's Q1 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 Q1, 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, who 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. With that, I'll now turn the call over to Kåre. Kåre, if you would please. Good morning, good afternoon to all of you, and thank you for dialing in. We are presenting today Q1 2021, the financial highlights. 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're 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. 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 of some convertible bonds in the period. Net debt is now reduced to $23.2 billion. Last but not least, we reaffirm our 2021 outlook, and Eli will show you some more details on that later in the presentation. Next slide, please. If we take a look at the quarterly revenue, I'd like you to remind you of a couple of things that's been happening when we look back and compare. We have a normal run rate of around $2 billion in North America and of around $1.2 billion in Europe. If you go back to the Q1 of last year, you see on the dark green that the European numbers, they were significantly higher than the normal, coming in at $1.4 billion. That was the $200 million patient-level hoarding of products related to the start of the COVID-19 pandemic. That reversed in Q2 last year, so you see Europe dropping down to $1 billion instead of the normal sort of $1.2 billion. That swing factor, of course, means that our comparator is more challenging in Q1 2020 than it is in Q2 2020. Apart from that, we have a couple of special cases that you can also see in the numbers, and that's really both in North America. That's Q1 2019. That was the very successful launch of TRUXIMA. The Q4 of 2020, that was the very successful launch of the generics to Truvada and ATRIPLA. Those things kept in mind, we see a good result for Q1 2021. We still see that the underlying volume is reduced in Europe, simply due to the fact that less people go to the doctor, less people go to the hospital due to the continued lockdowns in the Q1 of this year. We do expect the COVID-19 lockdowns to slowly ease here during the Q2, but really see the hopeful return to normal volumes in the third and the Q4 of this year in Europe. If we move to the next slide, please. On AUSTEDO, we saw U.S. sales of $146 million in the Q1. This is an increase of 20% versus last year. We always have a dip in the Q1. You can see that also happening in 2020 and in 2019. That's a consequence, really, of the insurance system in the U.S., where you have these resets of deductibles and other elements that typically lead to lower script volumes in the Q1, and then a resumption of growth once you get into the second, third, and Q4. We are expecting to see that also this year. We are seeing more than 35,000 prescriptions now in the Q1, and we continue to see future growth of this number. We're also focusing on expanding access and availability of AUSTEDO, especially to the tardive dyskinesia patient population. As you know, there's around 500,000 patients suffering from tardive dyskinesia in the U.S., and we are so far only delivering AUSTEDO to a fraction of this population. We will be starting DTC advertising in the coming months, and hopefully this will be a further driver behind the strong growth of AUSTEDO that we foresee for this year. Next slide, please. With regard to AJOVY, as you can see here, we continue to see a growth in our TRX count. Of course, some small variations, but underlying a strong development of the total number of TRX. We do see sales globally of $48 million in the Q1. $31 million in North America and $16 million in Europe. We've seen a uptick in our new-to-brand scripts rate in TRX, and it's right now around 25%. We want to try and drive this higher, and we'll be working hard to do so in the coming months. In January this year, we just launched a triple pack, which is a further sort of example of our quarterly dosing and the convenience that we offer to patients who are seeking preventive therapy for their migraine by taking AJOVY once a quarter. Next slide, please. We also now are at a stage where we have launched in the majority of European markets. We have now launched in 19 European markets. As you can see from this slide, the European market is now growing. You have it to the left, the total market has basically doubled within the last year, and we expect it to continue to grow. We're seeing nice growth in our share. We did not launch as the first company in this class in Europe, but we can see that when we launch, we start taking share, and it's been growing very steadily, and we expect it to continue to grow. We have especially strong positions in Germany, Nordic, U.K., and some of the other main markets. With regards to AJOVY, I'll just repeat what I said last time, that we are still bullish on our market share, and we do have an aim to have 1/3 of this market as a target over the coming years. Next slide, please. I showed you the nice effect we had on sales when we launched TRUXIMA, and we continue to see a very strong penetration of TRUXIMA. We are now up to more than 1/4 of the market. 26% is the latest data point we have on our share of the market. As you know, we are the only rituximab biosimilar that also has an indication for RA. We are very optimistic that we'll continue to see a strong position for TRUXIMA in the market in the coming years. Next slide, please. Our portfolio, as we discussed earlier, I see it as nicely balanced between biosimilars, now biologics, and different improved versions of small molecules. I'm especially happy that we got such good results on risperidone LAI. This is a long-acting novel therapy where you can subcutaneously dose for a month or two with risperidone, and this will be very beneficial for people suffering from schizophrenia, who need better compliance, and a better therapy for these people. We are very much looking forward to filing this very soon and hopefully launching it next year. Apart from that, we have, as you know, a long list of biosimilars moving into the market over the coming years and some exciting lifecycle management, both for fremanezumab and for AUSTEDO. Next slide, please. One of our key targets, long-term financial targets that we've set for the end of 2023 is our operating margin. As I'm sure most of you know, the target is 28%, and we're also showing this here at the end of the line, so to speak, on this graph. The reason why the margin came down, as you probably also all know, was really the significant loss of revenue from COPAXONE going generic in U.S. and in Europe. That really drove our margin down from the level of around 28% down to 24.5% in 2019, where it bottomed out. We continue to see a nice improvement. We are still standing firm on the target for 2023. In this quarter, as an example, we had an actual margin of 27.1%. Talking about the long-term financial targets, not much new here. They are completely unchanged. The target for operating income margin is 28%, cash to earnings above 80%, and net debt to EBITDA below three times. Nothing new here. We are still committed to utilizing cash flow to pay down debt, and we do not plan to raise equity. Next slide, please. At Teva, ESG is everyone's business, and it actually always has been. We have always been very focused on both environmental, social, and governance issues, but we are getting better at reporting what we are actually doing. Our next report on this, our next ESG report, will come out soon, on May 4th. I can only encourage you to take a look at it. It will explain in much more detail how we are minimizing our impact on the environment, how we are taking a lot of steps to secure equity and good access to our medicines, how we're dedicating ourselves to quality ethics and transparency, and a lot of other good topics. You can see some of them here. It's a whole long report that will be coming out in a week's time that shows our strong progress and dedication to ESG. With that, I'll hand over to Eli, who will give us some more details on the numbers. Thank you, Kåre, and good morning and afternoon to everyone. I hope you are all having a great start to 2021. I begin my review of the Q1 2021 financial results on slide 15, starting with our GAAP performance. Revenue in the Q1 of 2021 were approximately $4 billion, a decrease of 9% compared to the Q1 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 high revenue from generics in our North America segment, as well as from AUSTEDO. Revenues were also affected by the impact of COVID-19 pandemic. I would like to remind you that when comparing the year-over-year performance, please note that the Q1 of 2020 benefited significantly from the high COVID-19-related revenues. Furthermore, please note that Q1 2020 included the generic product sales in Japan totaling $41 million and approximately $240 million for the full year 2020. As we communicated on our Q4 2020 earning call, as of February 1st, 2021, these products were divested, along with the manufacturing site in Japan. Exchange rate movement during the Q1 of 2021, net of hedging effects, positively impacted revenue by $74 million compared to the Q1 of 2020. In Q1 2021, we recorded a GAAP operating income of $434 million versus $191 million in Q1 2020. GAAP net income of $77 million versus $69 million in Q1 2020, and a GAAP earnings per share of $0.07 versus $0.06 in the same period a year ago. The year-over-year improvement in GAAP operating income, net income, and earnings per share was mainly due to a lower intangible asset impairment charges, partially offset by lower profit in Europe, along with a higher legal settlement and loss contingencies. Turning to Slide 16. You can see that the net GAAP adjustments in the Q1 of 2021 were $621 million versus $766 million in the Q1 of 2020. Non-GAAP net income of non-GAAP EPS for the Q1 of 2021 were adjusted to exclude these items, with the largest being amortization of purchased intangible assets totaling $242 million, the majority of which is included in cost of goods sold. This quarterly amount for amortization is slightly below the range of $250 million-$260 million per quarter that we guided to at the start of the year. Impairment of assets and accelerated depreciation totaled $134 million in the Q1 of 2021. This includes an expense of $79 million for identifiable intangible assets impairments compared to expenses of $60.49 million in the Q1 of 2020. I would also note that in the Q1 of 2021, we recorded an expense of $104 million in legal settlement and loss contingencies. The expense in the quarter was mainly related to a provision for a potential patent settlement. Moving to Slide 17. We'll review our non-GAAP performance. Kåre Schultz and I have already reviewed the Q1 revenues, which totaled approximately $4 billion. Let's move down to the P&L and look at the margins. Despite a 7% year-over-year decline in total non-GAAP gross profit, our gross profit margin improved to 53.8% compared to 53.1% in the Q1. The year-over-year increase in the non-GAAP gross profit margin was due to a favorable product mix, as well as our ongoing efforts to improve our cost of goods sold. A relatively flat operating expenses base helped to partially counter a $167 million decline in our non-GAAP operating profit versus Q1 2020 and resulted in a non-GAAP operating margin of 27.1%. We ended the quarter with a non-GAAP earnings per share of $0.63, a decrease of 17% versus Q1 2020, mostly due to the lower operating profit. While I will touch on the guidance later in my presentation, I would note that the Q1 came in as we had expected it to and as we guided in February. Now, let's take a brief look at our spend base on Slide 18. Year-over-year, our quarterly spend base declined by more than $200 million. The main driver for this exchange was a reduction in our cost of goods sold as operating expenses were flat. Decline in sales had their greatest impact on the reduced cost of goods sold, supported partially by our ongoing efforts to improve our gross margin through the transformation of our network. Based on the Q1, as well as an expected modest uptick in operating expenses in the H2 of the year, we believe our spend base will come in at approximately $12 billion for 2021. Now, turning to free cash flow on Slide 19. Teva's free cash flow in the Q1 was $59 million versus $551 million in Q1 2020. As you know, Teva's free cash flow tends to face headwinds at the start of the year due to usual timing of annual bonus payments paid out in the Q1. The headwind was especially large in the Q1, mainly due to timing of working capital items resulting from increase in net accounts receivable and inventories, as well as lower profit in our Europe segment. Please recall our 2021 free cash flow guidance, which we provided in February and are reaffirming today. 2021 free cash flow is expected to be in the range of $2 billion-$2.3 billion. We expect the free cash flow pick up during the next three quarters as we are driving inventory improvements as part of other working capital items. While our free cash flow was relatively lower for the Q1, we remain on our objective of 80% or greater free cash flow conversion as part of our long-term financial targets. Turning to our outstanding debts on slide 20. Net debt declined to $23.2 billion versus $23.7 billion at the end of 2020. Our net debt to EBITDA slightly increased to 4.9 times versus 4.83 times at the end of 2020. It's worth noting the sequential drop in EBITDA moving average total from $4.9 billion in Q4 2020 to $4.7 billion in Q1 2021. Recall that the first and Q4s of 2020 were particularly strong, benefiting from higher COVID-related sales in Q1 and the launch of generic Truvada in Q4. The Q2 of 2020 saw reversal of the COVID-related stocking, and the Q1 of 2021 saw lower sales of generic Truvada, resulting in the sequential decline in EBITDA moving annual total. Debt reduction continues to be our primary focus and main use of cash as we continue to push forward in our efforts to bring our net debt to EBITDA ratio under 3x by the end of 2023. Upcoming maturities include $1.5 billion in the Q3 and $1.2 billion in the Q4, both which will be covered by our liquidity and expected cash flow. Now turning to our financial outlook for 2021 on slide 21. Today, we are reaffirming all components of our annual guidance that was presented in February, including total revenues between $16.4 billion-$16.8 billion and earnings per share of $2.5-$2.7. Looking at the progression of both sales and earnings throughout the year, we are not changing the color that we provided in February. We still expect a gradual pickup in the Q2 following the Q1, which is expected to be the lowest of the four quarters for the sales earnings. Overall, we would expect that approximately 48% of our 2021 sales will be generated in the H1 of the year and approximately 52% in the H2. For annual earnings per share, approximately 45% will come in the H1 of 2021 and approximately 55% in the H2 of the year. This concludes our review of Teva's Q1 2021 results. We'll now open up the call for questions and answers. Operator, if you will please. Thank you. Thank you. As a reminder, to ask questions, you will need to press star and one on your telephone keypad. To withdraw a question, you will press star and the hash key. Please stand by while we compile the Q&A roster. In the interest of time, can we ask you to ask one question, followed by a follow-up question? We will take questions in the order they have been received. The first question comes from the line of Balaji Prasad from Barclays. Hi. Good morning, and thanks for the question. This is Balaji from Barclays. Firstly, on AJOVY, just wanted to understand the sense of what will be the key growth drivers in Europe, considering that you have touched almost all the core markets there, and what's going to drive the market share from 22% to a 33% goal, and by what timeframe? On generic side, just one quick question on deflationary comments, which have come through from the likes of Walgreens and Sandoz yesterday. Teva doesn't seem to have been touched by it, especially this quarter. Can you kind of help us understand what are the offsetting factors here which help you weather any generic deflationary trends recently? Thank you. Thank you very much for those two questions. If we start with the first one on Europe and AJOVY and how do we see the growth drivers, then the key growth driver Of that two key growth driver, 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. That's one element. As you know, 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. We really have a 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. 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. 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. When I say we expect to reach 33%, it's really a continuation of that graph you're seeing in our deck. I expect that with some smaller deviations, we'll see a continued uptick in market share over the coming years. 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. It's so that with all generics in the U.S. market, there's 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. If you're lucky, you had a first to file, so you're alone for 180 days. Otherwise, you're maybe one out of one, two, three companies that hit the market with a new generic once it goes off patent. Gradually more competition comes in, the ice cube starts to melt and becomes less and less significant. There's price erosion as more competitors enter into the marketplace. We had some classical ice cubes, you could say, in the Q4 of last year with the generics of Truvada and ATRIPLA that we launched. They made a good contribution in the Q4. They also made a nice contribution in the Q1. We have some, I would say, slower melting ice cubes. 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. That's the case, for instance, for EPIPEN. 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. That also has a good position. You can say that there's a little difference in how fast the ice cube melts. If it's a traditional solid all dosage form generic, then typically you get a lot of competition, which means a relatively faster price erosion. If it's a complex generic, it goes a little slower. It's really a combination of these factors that meant that we had a nice performance of our generic business in the Q1. Thanks for the question. Thanks, Kåre. Thank you. The next question comes from the line of Gary Nachman from BMO Capital Markets. Hi, good morning. What have you been doing to help make the TRUXIMA launch successful? 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. Then a follow-up, just the much lower free cash flow in the Q1. 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. Thanks, Gary, for those two questions. Brendan will answer the first one, and then Eli will answer the second one. Over to you, Brendan. 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, you think about biosimilars in general. There's biosimilars that'll go through kind of a medical channel, and there will be biosimilars that go through more of a retail pharmacy channel. The strategies are somewhat different as to how you navigate that. If you think about Teva has a strong specialty business. Of course, obviously, we have a very strong, dominant position in generic. 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. 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. I think that probably answers the question. Over to you, Eli. Thanks, Brendan. Let's have Eli's comment on the cash flow. Eli, are you on mute? 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%-2% of our annual revenue. This is mainly due to sequential increase a bit on the inventory 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 contribute to that one. Although those one we consider it as a non-occurring event swing that we're actually working to stabilize it already with a lot of actions underway. Thank you, Eli. Thanks for the questions. Thank you. Thank you. Thank you. The next question comes from Jason Gerberry from the Bank of America. Please ask your question. Hi, guys. Thanks for taking my questions. I guess first question was just on 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 dynamic. Just curious how you're thinking about progression gross margins as the Truvada exclusivity comes off. My second question is just coming back to TRUXIMA from a biosimilar perspective. Could you give us a sense right now what proportion of the U.S. 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. Thanks, Jason, for those two questions. I'll address the gross margin and then we'll get back to Brendan on TRUXIMA again. On the gross margin, just to clarify, Truvada is not a main element to the gross margin in the Q1. Basically, the reason is, just to explain a little bit again about the ice cubes, that Truvada launched in the Q4 with 180 days exclusivity. Technically, how that works in the marketplace is that then you know after the 180 days, you will get competition. 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 you know that 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 Entyvio for that matter. That means that the Truvada sales, they are there in the Q1, but they're more significant in the Q4. That's why I mentioned them in the beginning, that you could see the bump up in U.S. sales in the Q4, then of course, there's something in the Q1, but not really something that dramatically influences the gross margin. I would rather say that the underlying performance is driven by the constant efforts to rationalize and optimize our manufacturing footprint, our manufacturing operation. 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 $200 million more, then that can maybe affect it a little bit, or you have a product launch that affects it a little bit. 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. I've said many times that you should expect that we can do this to the tune of 50- 100 basis points per year. You could also expect that once we get to 2023 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. Some quarterly fluctuations, nothing dramatic, underlying steady improvements, 50- 100 basis points per year. With that, over to you, Brendan, on TRUXIMA. Sure. When you look at biosimilars and you think about the commercialization of those products, launch order matters. If you launch first or second, you're going to get significant value. You launch third or fourth, you're going to get some value. You launch after fourth, then the value declines rapidly. TRUXIMA launched first. We were able to make significant inroads in the market. When the second product came out, they had some difficulty getting traction, but then of course, we got an ASP. They didn't have ASP as you talked about. They had an advantage root share, and it cost us more to keep the share that we had. 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 and the others do. That allows them to gain traction and 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. That's really just the 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. As we get into 2022 and 2023, we'll see that flatten and then probably decline slowly over time. Thanks. Thanks for the question. Thank you. The next question comes from the line of Umer Raffat from Evercore. Please ask your question. Hi. Thanks so much for taking my question. 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 counteroffer yet on the opioid side? I'm very curious about where things stand on that. Also on generics, just wanted to understand what you guys are baking in for full year for Europe. I ask because the commentary coming out of Sandoz appeared far more guarded than what I'm hearing on this call. Thank you so much. Yes, Umer, I'm sure your team is aware of we are in active litigation in California with four entities there. 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're still seeing that as the only good solution to this issue. That's really how much I can say. Sorry that I can't give you more details on that. With regards to generics in Europe, as I commented at the beginning of this call, we are seeing here in the Q1 a continued volume reduction in Europe OTC and generics, as we also saw in the third and Q4 of last year. We have not come out of lockdowns in the big markets. That's still the case here in the Q2. 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. We are basically sticking to the prediction which I gave last quarter, which is that the first and Q2, 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 Q4 this year will 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. The next question comes from the line of Gregg Gilbert from Truist. Please ask your question. 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 its sort of potential benefit? 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? 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. Thanks for the questions, Gregg. The first one goes to Brendan on NARCAN. Yes. 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. As to whether it could be part of a broader settlement or not, I'll leave that to Kåre to answer. Just real basically, continue to work on Narcan and when we're ready to introduce it to the market, I will certainly let you know. Yes. With regards to potential settlements and NARCAN, it's the same boring answer that really due to the fact that we're 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. 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. 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 3x EBITDA. 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. That really all lies in the period after 2023 when we're going to get below 3x net debt to EBITDA. 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. 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. We are very disciplined in how we allocate the capital, and we will stay the course with that at least until we hit the end of 2023, where we will hit our long-term financial targets. Thanks for those questions, Gregg. Thanks. Thank you. The next question comes from the line of Ronny Gal from Bernstein. Please ask your question. Thank you very much, guys, and thanks for taking my question. Just a quick clarification and a couple of questions. The clarification is on QVAR. Have you stopped reporting that and why? The two questions I have is, what happened in the CGRP market? It looks like two of the three companies, the way we track the scripts, look like had a significant reduction in the price we see by dividing revenue by scripts in the Q1. I was wondering if this is just inventory or an agreement, a payer agreement that drove that down, if you can comment on that. More broadly, Kåre, some of your peers have adopted that strategy of licensing second-wave products in established markets from China, for example, that Coherus has adopted there with the PD-1. That seems to be a logical strategy if you have a salesforce in the oncology market. I was kind of wondering if you guys considered doing those kind of licensing deals for second-wave branded products as opposed to biosimilars, or is there a reason why that strategy does not make sense at all? 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 decided to just simply stop reporting that number. Okay, 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. 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. It's not something that I've been involved in discussing, just to let you know. Eli, do you have any comments to that, QVAR, why is it not specified? Yeah, Ronny, this is Kevin. 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. Okay, Ronny, nothing dramatic happened there. On the licensing, we're really not pursuing this, you could say, second wave of patent-protected specialty products. It's really not within our strategy. What we are pursuing is our own specialty products, 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. Then we are pursuing biosimilars and generics. It is a possible strategy you could have adopted, but that's really not what we're trying to aim at. Thanks for the question, Ronny. Thank you. The next question comes from the line of Elliot Wilbur from Raymond James. Good morning. First question for Kåre and perhaps Brendan, just thinking about full-year guidance for AJOVY, AUSTEDO in light of Q1 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 get to those numbers. Just help us think about your confidence in those numbers, given what we've seen year to date. I guess, what has to happen there? Is it just mainly script 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 H2? 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, TEV-48574 and TEV-53275. Anything you can say about where those fit in the current as-a-treatment paradigm and what may be some of the competitor products out there that those will be going up against? When might there be data or an update there? Is it late 2022 or potentially earlier? Thanks. 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, I'll hand it over to Brendan to give you some color on how we're seeing the U.S. 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. Of course, the bulk of the business for AJOVY will still be in the U.S., as is also the case, of course, with AUSTEDO. Over to you, Brendan. Yeah, sure. I'll take AJOVY first. If you think about AJOVY, we continue to grow the share nicely. We're up to basically since the launch of auto-injector, we've doubled the total prescription share as well as the new-to-brand share. New-to-brand share right now is hovering at around 25%. We think we can get that into the 28%-30% range. To do that, as we've grown share, we've 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. I think you can think of it that way. Of course, then we're still what I believe that the guidance that we put out is certainly achievable. If you think about 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 Q4 as people's benefits, they know they're going to change in the Q1. You see somewhat of a slow start, but we do think that the $950 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 and 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. We think that that'll be a significant catalyst to helping us get to that value that we put out. Thank you for the question. Thanks, Brendan. With regard to two products you mentioned in respiratory, these two products are biologics that are in phase II clinical development. The thinking behind them is really that what they offer is better efficacy and better convenience for patients. 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 doing 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 dates, but I think some of it in 2022 and some of it in 2023. Thanks for the questions, Elliot. Thank you. The next question comes from the line of David Amsellem from Piper Sandler. Please ask your question. Your line is now open. Thank you. 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 U.S. majors, including yourself, how do you think about the potential for divestitures? I'm asking that question broadly given how you're thinking about the evolution of the business. That's number one. 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? Is that a signal that even though penetration rates for VMATs 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 your thought process there. Thank you. Thanks, David. I'll answer the first one, and then I'll pass the AUSTEDO question on to Brendan. 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. There's nothing major left, so don't expect us to announce all of a sudden that we're selling a big chunk of the business. We are committed both to the complex generics and biosimilars, but we are also committed to solid oral dosage forms, classical generics. We have to remember that biologics will be an increasing part of what goes off patent over the coming years as it has been the last five years. Thank you. 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? 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 U.S. as the FDA gets back to more normalized inspection activity. I wanted to ask a follow-up on gross margin. Eli, do you think that you guys can continue to build off of this level that you set in the U.S.? You've made nice progress on gross margins over the past several quarters. I think you also called out some mixed dynamics that were favorable in the Q1 here. I just wanted to get a sense of what the key moving pieces are on the gross margin line over the balance of the year. Thank you. Operator, can you hear us? Yes, we can. Please mute the backup line. Annette, can you hear us from the backup? Yes, we can hear you. Okay. Can we continue? Nathan? Yes. You might need to ask your question again. Please continue. Yes. Sure. No. 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 U.S. David, you'll get your answer now on AUSTEDO DTC in the U.S. I'll introduce by saying we're not doing this due to any weakness in AUSTEDO, but simply to reach more people with tardive dyskinesia. Brendan, please fill us in on the DTC for AUSTEDO in the U.S. Yeah. I think that's exactly right. The reason for the DTC in AUSTEDO, we've been looking at DTC for a period of time. The real reason is we see strength in this market. We see a lot of opportunity in this market. There are 500,000 patients estimated with tardive dyskinesia in the U.S. We've got about 30,000 patients currently treated, about 6%. The upswing and the potential is huge. It has been shown to be sensitive to DTC advertising. It's really just a matter of resource allocation. We think that the trends that we've seen with AUSTEDO are strong. We think it makes a significant impact on patients' lives. 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 a tremendous value. 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. Thank you, Brendan. We'll move to the next two questions that were asked. The first one is about the erosion on generics. I'll answer this one and just reiterate that in our two key markets it's of course different. 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. That price level is relatively stable, no dramatic changes there. In the U.S., of course, we do see price erosion. I won't repeat the whole ice machine analogy, just say that some ice cubes melt a little faster than others. It's basically like we've been discussing, the complex generics often get less competition, they keep 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. We also see good launch prices for new launches of generics. All in all, no big changes there. We have a question on the gross margin, and I'll refer that question to Eli. Yes. On the gross margin, as we did in 2020, when we took 1% on gross margin, that actually contributed additional one point to our operating margin. This is what we see now in our planning for a year. We expect it to be at least a 1% versus 2020. Call it like 53.5%, and that will actually contribute to the level of 27% plus in OP. It's still on track. Thank you, Eli. I think we have time for one more question. Thank you. 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? Yes. Okay. 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? Second, just on generic price fixing litigation, could you remind us what the next steps are here and when's the earliest date we could see a potential trial, whether that be on the civil side or the DOJ side? Thank you. Thank you for those two questions. 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. It's definitely a negative for the product class. Right now, with fasinumab, we are having, you could say, all non-essential 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. It remains to be seen, but of course, we're 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 U.S. has slowed down proceedings 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. It will be a, I would say, significant period of time before that happens. I think on the civil side, it's pretty much the same. No real updates on the timing. We'll just have to wait and see how things progress with the legal system in the U.S. getting back in gear now as the pandemic is reducing its impact in the U.S. 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. Thank you, ladies and gentlemen. That does conclude our conference for today. This conference will be available for replay within the next couple of hours after today's call. You may access the remote replay system at any time by dialing 0044 333 300 9785 and entering the access code 8347148. Those numbers again. The dialing number is 044 333 300 9785 and the access code is 8347148. Thank you for today.