Teva Pharmaceutical Industries Limited (TEVA) Q1 2023 Earnings Report, Transcript and Summary

Hello, and welcome to the Q1 2023 Teva Pharmaceutical Industries Limited earnings conference call. My name is Alex. I'll be coordinating the call today. [Operator instructions]. I'll now hand over to your host, Ran Meir, SVP of Investor Relations. Please go ahead.

Thank you, Alex. Thank you, everyone, for joining us today. We hope you have had an opportunity to review our press release, which was issued earlier this morning. A copy of this press release, as well as a copy of the slides being presented on this call, can be found on our website at tevapharm.com. Please review our forward-looking statement on Slide No. 2. Additional information regarding these statements and our non-GAAP financial measures is available on our earning release and in our SEC Forms 10-K and 10-Q. To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's Q1 2023 results and business performance, recent events, and priorities going forward. Our CFO, Eli Kalif, will follow up by reviewing the financial results in more detail, including our 2023 financial outlook. Joining Richard and Eli on the call today are Sven Dethlefs, Teva's head of North America business; and Dr. Eric Hughes, our head of R&D and chief medical officer. They 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 will now turn the call over to Richard. Richard, if you would, please?

Thank you, Ran. And good morning and good afternoon, everyone. Thank you also for joining us today. Now before I start getting to the Q1 results, I thought I'd just take a bit of time to give you my thoughts and impressions of the last few months I've had at Teva. Now in short, impressed by many of the things I've seen and discovered while being around the world talking to many of our people, and it's because of this that I think we have real opportunity for the company, and maybe the company is underappreciated currently. Now let me go into sort of four areas I'd like to focus on here. Now I know most of you think of us as a generics company. And in truth, we are more than that. We have an emerging innovative business, primarily driven by AUSTEDO and AJOVY, but recently about to be supported by UZEDY, our long-acting schizophrenia product, and this is gonna fuel continued growth going forward. And already, this is 10% of our total revenue. We also have a biosimilar portfolio, which I'll talk a bit about later, which is an opportunity to benefit from $4 billion of brand value coming off patent in the next few years. Second, our pipeline. Now I definitely know this is not fully known and understood. But I can tell you, we have some exciting assets here. And as I sort of dug deeper, I've seen some unique capabilities in our R&D organization, particularly when it comes to antibody design and formulation expertise. And as we go through our pipeline, I think you'll see that we have a balanced risk profile on many of our assets. Now coming to our core business, our core generics business. This is a strong global business. And what I've discovered, this is more than the U.S. In fact, 60% of our business is outside the U.S., in Europe, and emerging markets. And this is a strong business and that it generates significant cash, which obviously we're currently using to pay down debt. Now then moving on to our people, which is probably what inspired me the most. We've got a great group of people here at Teva and a great culture, the real can-do attitude, and this is something we're gonna leverage as we move forward with Teva on our new strategy for growth. Now that said, we have some headwinds and some short-term challenges, which we'll discuss today, particularly around our cost of goods, but we have plans to deal with these going forward. And because of that, we are reaffirming our guidance for 2023. Now moving on to the next slide. I would just like to invite everybody to our investor day, which we're gonna hold in New York next week, where we're gonna introduce our new strategy for growth at Teva. Now this strategy will be built on some of the strong foundations that I described in the previous slide, and I've been working hard with the executive management team here at Teva, along with many others in the company, to really challenge ourselves to look at how we can, with the changing market, unlock and create real value for Teva going forward. I'm excited about the outcome. We have made some clear choices in this strategy, some clip prioritization. And we have a focused company going forward, where the capital allocation will follow this. So as I said, please join us next week where we unveil a new chapter to Teva. Now moving on to Q1 performance. Let's start with revenues. Our revenues for Q1 versus Q1 2022 were $3.7 billion, up 4%. AUSTEDO was up 10%; and AJOVY, up 5%, driving that innovative business that I mentioned earlier. And in European generics, in local currency, we're up 12%. In local currency and international markets were up 9%. So I think a solid performance for Q1 on the revenue. Now taking a look at it from a regional perspective. As you can see, all regions were up in local currency or growth, 2% for North America; 9%, Europe; and 8%, international markets. Now I would keep in mind that our revenues are still affected by the strengthening U.S. dollar, and we did have a negative impact of $128 million Quarter 1 versus 2022. Now moving on to the next slide to talk about AUSTEDO as part of this innovative portfolio that I talked about. Revenues were $170 million, up 10%. I was particularly pleased in its TRx, it was up 28% versus last year. Now I'm very excited about AUSTEDO and particularly because I see this as an untapped opportunity. We have 800,000 -- roughly 800,000 people suffering from this condition, and only 120,000 diagnosed, and then only 50,000 treated. So we have significant opportunity to grow this product and help patients suffering from this condition. On the next slide, you'll see this has been further improved, this patient offering, with the launch of AUSTEDO XR. This is the once-a-day formulation. Now I think this is the final piece of the puzzle for AUSTEDO because, obviously, as you appreciate, many of these patients are on multiple medications. And thus, having a once-a-day offering, I think, really offers some advantage for them and strengthens the product offering for those patients and caregivers. So now, moving on to another part of our innovative pipeline or, say, portfolio is AJOVY. Now AJOVY is almost reaching $100 million a quarter, currently sitting at $95 million. Up 36% in North America, up 17% in Europe, and up 74% in international markets. So we've grown across all regions, which we're very pleased about. And what I've mentioned before and I'll reiterate, what I like about AJOVY is the fact that this was not a product we managed to bring to the market first in its category. In fact, in many areas, we were not, and we were last. But what we've shown with our commercial capability and muscle that despite this, we can achieve growing market share in a significant position in many of the markets often number two. So I still see growth going forward with AJOVY to a geographical expansion and expansion of market share. Now the new product to this innovative family is UZEDY, risperidone, which was board-approved about two weeks ago, and we're excited about this long-acting risperidone. I was recently on a field right in the U.S. with some of our sales representatives, and speaking to psychiatrists and clinical nurse practitioners actually about AUSTEDO, but many of them were asking when this long-acting risperidone would be available. And in discussing with them why they are so enthusiastic about it, we came back to our patient-friendly profile. The fact that we have rapid absorption within six to 24 hours of administration was important to them. There's a subcu small needle, lower volume. All of these made it an easy-to-use product for them in this patient population. Now keep in mind that the long-acting market is a $4 billion opportunity when it comes to schizophrenia. And so with UZEDY profile, we think we have a real opportunity to generate some revenue going forward. Now pivoting back to our generics business. As I mentioned before, we have a big business outside the U.S., over 60%, and we're seeing continued strong growth in both of those regions, 12% in local currency in Europe, 9% in international markets. And this is attributed to our core capabilities. We have a good pipeline. We can regularly launch products into our portfolio. We have a good supply chain, and we have a good commercial infrastructure. So I see no reason why we can't continue to leverage this capability going forward. Now to move on to our pipeline. And you'll notice for this call, I've separated the innovative pipeline from the biosimilar pipeline, and that's really to start to highlight the pipeline and some of the exciting assets we believe we have it. Now I'll just call out a few here, olanzapine, long-acting, another long-acting medication for patients, people suffering from schizophrenia, which we'll add to our franchise; ICS SABA, in asthma, which is in Phase 3; and anti-TL1A in Phase 2. I'll describe it in a bit more detail in a couple of slides. But obviously, looking forward to presenting more depth in our pipeline next week at our strategy today, where Dr. Hughes, our head of R&D, will be talking about this in far more detail. Now moving on to our biosimilar pipeline and franchise. I think what I've said in the past is you need to have a good pipeline and a good portfolio to succeed in biosimilars and to have a good commercial footprint. I think you can see we have both of those. Now to address a question, which I think is gonna come up today, is about biosimilar Stelara and where we are with that. So maybe I could take a few moments to talk about that. So as many of you know, the FDA issued a CRL to our partner Alvotech, based on certain inspection observations in their facility in Iceland. Now Alvotech is expecting communication from the FDA shortly, assessing their responses for their observations. Now once Alvotech receives communication from the FDA, we will have a better understanding of the timings of a potential launch of biosimilar Humira. Now going back to those promising late-stage assets from our innovative portfolio. Now I don't want to step on Eric Hughes' toes for next week when we launch the new strategy at the Investor Day, so I'll keep it brief, but maybe just give a slight headline on some of these programs. So olanzapine. We're excited by this because, obviously, I mentioned to you already with UZEDY, there's a significant opportunity to move the schizophrenia market to a long-acting therapy. Now this olanzapine product leverages our deeper technology with MedinCell, which is the company we work with on UZEDY. So I'd like to think this has been proven because of, obviously, the recent approval of UZEDY. Now moving on to ICS SABA. This clearly leverages our respiratory expertise and our ability to bring complex products to the market. It brings together two well-characterized and well-used products for a subset of the asthma market, which we believe is worth around $2.5 billion, and we will only have one competitor. Then lastly, moving on to the anti-TL1A, asset, which I'm sure you're all familiar with because it seems to be a very hot topic right now. We see this as a good opportunity because it's a validated target. And we see, because of the number of indications, that it could potentially go after a significant opportunity around $25 billion. And we believe we have a best-in-class profile, but more to come on those assets on the investment day. In closing, I want to talk about an important priority of ours, which is our commitment to ESG, and I just want to take a bit of time to give you an insight to the progress we've made. So let me just pick a few of these now. When it comes to greenhouse gas initiatives, we have a goal to reduce these to 25% by 2025. As you can see, we're closing on that already. Another area of focus has been on compliance and business integrity, and we have met our goal of 100% of all our employees trained in compliant policies. Finally, I can highlight the economic impact we've had, $44 billion in savings from Teva's generic medicines across 21 countries, and we've contributed $20 billion to GDP across 24 countries. So I think we've made very good progress with regard to our ESG commitments. And with that, I'll hand over to our CFO, Eli.

Thank you, Richard, and good morning and good afternoon to everyone. I'll begin my review of our Q1 2023 financial results with Slide 18, starting with our GAAP performance. Revenue in the first quarter of 2023 were $3.7 billion. In dollar terms, they were flat compared to the first quarter of 2022. In local currency terms, revenue increased by 4%. To provide you some color on our revenue performance by region. North America, we had overall solid performance with 2% growth in Q1 2023 compared to the first quarter last year. This growth was mainly driven by higher revenue from certain innovative products, mainly AUSTEDO; and AJOVY; as well as Anda, our distribution business. This was partially offset by lower revenues from our generic business and BENDEKA and TREANDA. Our generic business in North America decreased in Q1 2023, mainly due to increasing competition to parts of our portfolio and timing of certain customer bids. The overall pricing environment in North America generics is stable and in line with historical trends. Revenues in our Europe segment grew strongly by 9% in local currency terms, mainly driven by higher revenue from our generic business, including new product launches. And revenue from our international market segment increased by 8% in local currency terms, mainly due to higher revenues in our generics business coming from price increases, largely as a result of raising costs due to inflationary pressures. Operating income was $2 million in the first quarter of 2023, compared to an operating loss of $730 million in the first quarter of 2022. We had a net loss of $205 million compared to a net loss of $955 million in Q1 2022, and a GAAP loss per share of $0.18 compared to GAAP loss per share of $0.86 in the same period a year ago. This improvement in our GAAP operating income, net loss, and net loss per share in the first quarter of 2023 were mainly due to the higher impact of legal settlement and loss contingencies that we had in the first quarter of 2022. Foreign exchange rate movements during the first quarter of 2023, including hedge effects, negatively impacted our revenue and GAAP operating income by $128 million and $32 million, respectively, compared to the first quarter of 2022. This was a result of the impact of stronger U.S. dollar against other currencies of main markets in which we operate, mainly the euro and other related currencies. As a reminder, approximately 50% of our revenues in Q1 2023 came from sales denominated in non-U.S. dollar currency. Turning to Slide 19. You can see the total non-GAAP adjustments in the first quarter of 2023 were $661 million compared to $1.564 billion in Q1 2022. A notable non-GAAP adjustment was legal expenses of $233 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. Other notable adjustments include amortization of purchased intangible assets of $165 million, the majority of which is included in cost of sales and impairments of long-lived assets totaling $188 million. I also want to provide you with an update on the progress with the nationwide opioid litigation settlement. During the previous quarter, we had confirmed a high level of state participation, 49 out of 50 states. Based on a strong state participation, we decided to move ahead to the next phase with the subdivision participation, which I'm happy to report is also going very well. To date, we have confirmed participation from over 99% of the litigating subdivision from those participating states. Overall, with the level of broad support we have seen by the states and subdivisions, we expect to move forward firmly in the process, and we anticipate making the first settlement payment in the second half of 2023. Now moving to Slide 20 for a review of our non-GAAP performance. I've already discussed our first quarter revenue, which totaled approximately $3.7 billion and represented a growth of 4% in local currency terms compared to the first quarter of 2022. Now let's move down the P&L and look at the margin. I would like first to drill down and analyze our gross profit performance this quarter. Our non-GAAP gross profit line was 49.1% in Q1 2023, compared to 54.2% in Q1 2022. The decrease in non-GAAP gross profit margin was driven by two main factors: our portfolio mix and the macroeconomic factors. Our first quarter came in with a different and unfavorable portfolio mix than we expected. While we continue our solid growth in our key focus area, including AUSTEDO, AJOVY, and our generic business in Europe and international markets, this is being offset by margin diluted growth of Anda business and lower contribution from our legacy brands. As we progress through the year, we anticipate a shift toward a more balanced and normalized portfolio mix in the coming quarter, mainly driven by growth in AUSTEDO and AJOVY. As for the impact of the macroeconomic factors, I already mentioned on our previous earnings call, we faced inflationary pressures in the second half of 2022, and much of that impact from last year was held in our inventory and sold this quarter. This resulted in a higher cost of goods sold in Q1 of this year. In addition, we also had some unfavorable impacts from hedging activities, which impacted our gross margin, with the majority of the impact in our European and international market segment. Going forward in 2023, we expected improvement on certain elements of the inflationary pressures, including on cost of energy and freight. In addition, we also expected a sequential improvement in our COGS driven by certain measures we are taking in our supply chain. Our non-GAAP operating margin in Q1 2023 was 21.4% versus 27.7% in Q1 2022. This decrease was mainly driven by the lower gross profit margin, as I just mentioned, as well as the higher other income in the first quarter of 2022, which mainly included one-time settlement proceeds in our international market segment. We ended the quarter with a non-GAAP earnings per share of $0.40 compared to $0.55 in Q1 2022, mainly due to the lower gross profit, which I referred to a moment ago. Now let's take a look at our spend base on Slide 21. As you can see, our quarterly spend base increased by $229 million or $324 million on a local currency basis. Most of this increase was due to a higher cost of goods sold related to the factors I described earlier as well as the higher other income in the first quarter of 2022, which mainly includes settlement proceeds in our international market segment. Our next slide, 22, shows how we have been transforming our global manufacturing and operating footprint over the last five years to consolidate our sites with more efficiency. And here, you can see, over the last five years, we have gone from 80 manufacturing sites down to around 52 sites, and we have plans to continue this progress. By the end of 2023, we expect to close or divest three additional sites, with plans already in place to close or divest four additional sites beyond 2023. So this evolution will continue as we drive ongoing optimization of our operations for efficiencies and improving margins. Turning to free cash flow on Slide 23. Our free cash flow in the first quarter of 2023 was $41 million. Teva's free cash flow tends to face headwinds at the start of the year due to the unusual timing of annual bonus payments paid out in the first quarter. In addition, our free cash flow for Q1 2023 was also impacted by lower profit and changes in working capital items, including an increase in accounts receivable, net of SR&A, partially offset by an increase in accounts payable. Today, we are reaffirming our 2023 free cash flow guidance, which we provided in February. Our 2023 free cash flow is expected to be in the range of $1.7 billion to $2.1 billion. We expect our free cash flow to pick up during the next three quarters as we see a ramp-up in our profitability and as we continue to drive working capital improvement. Turning to Slide 24. Our net debt at the end of Q1 2020 was $18.5 billion compared to $18.4 billion at the end of 2022. Our gross debt was $20.7 billion compared to $21.2 billion at the end of 2022. The decrease in our gross debt was mainly due to $646 million senior notes repaid at maturity, partially offset by exchange rate fluctuation of $176 million. Our net debt to EBITDA slightly increased coming at 4.25 turns for Q1 2023, mainly due to lower EBITDA. Looking at Slide 25. Debt reduction continue to be our focus. As you can see, we have made significant progress in the last six years to reduce the level of debt on our balance sheet, and we expect this progress to continue and our net debt further decline as we work toward our long-term financial target of being two times net debt to EBITDA by end of 2027. Turning to Slide 26, which represents our upcoming update maturities. During the first quarter of 2023, we successfully refinanced approximately $2.5 billion of our debt through sustainability-linked senior notes. This was done to mainly address the '23, '24, and '25 maturities and to align our near-term debt maturities with our free cash flow guidance for this year. These notes are linked to sustainability performance targets and reaffirm our continuing attention to establish a direct link between our corporate responsibility commitments and our funding strategy. If we combine this recent issuance with our previous SLB bond financing of $5 billion, Teva is now the second-largest corporate SLB issuer worldwide and the largest in the pharmaceutical industry. Given the interest rate environment, this will result in a higher financial expenses for the remainder of the year, which was already accounted for in our 2023 annual guidance that we provided in February. Now let's turn our attention to our 2023 non-GAAP outlook on Slide 27. As we guided in February, when we provided our full-year outlook, we had expected Q1 to be the lowest of the four quarters. both in terms of revenues and margin. For full year of 2023, we continue to expect our revenues to be between $14.8 billion to $15.4 billion. We are also reaffirming our 2023 non-GAAP outlook for operating income, EBITDA, earnings per share, and free cash flow as provided in February. We continue to expect a gradual pickup in margin in the second quarter with a further progress in the second half of the year. Our company is fully engaged in navigating and addressing the ongoing impact of the macroeconomic headwinds. Inflationary pressures that we saw in the second half of last year continue to have an impact in 2023. As indicated, we are working around certain measures to offset the collective increase in our cost of goods sold. In the coming quarter of '23, we expect a gradual increase in our gross margin with improvement in our portfolio mix, as I mentioned earlier, as well as easing of inflationary pressures, including the cost of energy and freight. In addition, we expect to continue our ongoing efforts to drive improvements in our operating expenses. With that, this concludes my review of Teva's results for the first quarter of 2023, and now I will hand it back to Richard for a summary.

Thank you, Eli. Thanks a lot. So in summary, Today, we are reaffirming our 2023 non-GAAP guidance for the year. We believe the AUSTEDO, AJOVY are gonna continue to drive good growth. With the launch of AUSTEDO once daily, we believe that's gonna add to that. And obviously, as I mentioned, the upcoming commercial launch of AUSTEDO gives opportunity for more growth from our innovative portfolio with strong performance in Europe and international markets in Q1, and we continue to focus on cost discipline and working capital management. And as of next week, I look forward to introducing our new strategic framework and a few priorities to many of you in person. So with that, I'd like to open up to questions. Thank you.

[Operator Instructions]. Our first question for today comes from Jason Gerberry from Bank of America. Jason, your line is now open. Please go ahead.

This is Hassan Aftab for Jason. So first one on the anti-TL1A antibody, we saw the preclinical data that you published back in 2018. And from a head-to-head perspective, what do you think drives your confidence that this may compare favorably to maybe Prometheus' or Pfizer's anti-TL1A antibody? And then the second question on biosimilar Humira, we know that the revenue is risk-adjusted in your 2023 guidance. And last quarter, you mentioned that you have some other hedging elements that might allow you to maintain the guidance if the product was delayed. And so can you share what those elements are? Thank you.

I'll hand the first one on anti-TL1A to Eric. So Eric, can you give advice on anti-TL1A and why we're so excited about it?

Yes. Sure. Thank you, Richard. We're very excited about our TL1A program. The potential to bring a new class of biologics to people suffering from inflammatory bowel diseases, very exciting for us. We believe our anti-TL1A antibody is highly differentiated and has the potential to be best-in-class. This is really built on the potency of the antibody and our strategy in the way that we targeted the molecule. We've increased our resources and our efforts to bring this program forward as fast as possible. We understand the interest in this program, and I think we have the best one. So we'll hear more about this next week, as Richard alluded to our new strategy and our pipeline. So we'll talk about that more next week.

Thanks very much, Eric. And on to your second question on biosimilar Humira, you're right, we did risk-adjust it in our forecast because of the uncertainty that we knew existed. What I'd say is the reason why we're maintaining guidance is one that was just adjusted, so it's a relatively small amount. The other is we have our launches of UZEDY and our growing innovative pipeline. So because of that, we feel very clear that keeping guidance is the right thing to do. So hopefully that answers your questions.

Yes. And if I could just ask for a follow-up. Should we expect to see any updates to the long-term 2027 targets at the upcoming R&D Day?

So I suppose you know, there's one thing I could say is I cannot answer that question to make you come to the investor day. We are -- we haven't changed our guidance for 2027, so we're committing to the operating 30% net debt ratio and also the growth.

Thank you. Our next question comes from Umer Raffat of Evercore ISI. Your line is now open. Please go ahead.

Hi, guys. Thanks for taking my question. Maybe if I could spend a quick second on the Phase 3 olanzapine program. Could you speak to what level of alignment you have on FDA on -- what exactly is it that you need to show in your trial to not get the type of black box Lily got on their prior attempt at long-acting Zyprexa? And then secondly, on the risperidone program. I know you've shared commentary a few times, but the question I have is, J&J barely did about $300-ish million from a branded sales perspective on that program. So how much could a sort of follow-on to that risperidone long-acting molecule truly do? What's the true commercial potential look like? Thank you very much.

Thank you, Umer. Thank you for those questions, and I'll hand the first one to Eric again.

Yes. Thank you, Umer, for asking about our olanzapine program. We're very excited about this program. The prospect of bringing another treatment to patients with schizophrenia is really in our wheelhouse, so we're excited by it. The olanzapine long-acting injectable is building upon our formulation technology that we developed for UZEDY. It's really an ingenious formulation that provides a really advantage to both caregivers and patients. It's given subcutaneously. And given the characteristics of the formulation, we really hope to have a favorable safety profile compared to other injections that are available for olanzapine. I think you're referring specifically to the post-injection delirium and sedation that has a black box warning on the intramuscular injection of olanzapine. Now obviously, we've developed our Phase 3 program in conjunction with feedback from FDA. And we're confident in the way that we've designed the study the number of patients and the total number of injections that we'll have what we believe to be a very good safety profile to avoid these side effects. So the study is initiated. I'm very proud to say it's going well, and we're looking forward to the results.

Thanks, Eric. So maybe I'll start by answering your question. But I'll also ask Sven, our head of North America, to come in because, obviously, it's his team launching risperidone, long-acting UZEDY. So I think we think because of the favorable patient profile we have with the product and the feedback we've got from the physicians and then the clinical nurse practitioners already in the unmet medical need, we think we can make some inroads based on the product characteristics I just laid out. So we see the opportunity differently. We think this has an opportunity to catch between -- to grow between 10% to 20% of that $4 billion market, but I'll maybe give the call to Sven to add a bit more flavor to that.

Yes. Thank you, Richard. And thank you, Umer, for the question. So there are about 1.6 million treated schizophrenia patients in the U.S. 10 of them, as we know, receive long-acting injectable products. The category itself is growing at around about 4% to 5% per year. So it's always good to launch a new franchise into a growing category. We actually believe that we can compete with UZEDY across the LAI spectrum, which means that we do not see UZEDY being limited to the risperidone molecule alone. And the main reason that we believe that is that the product profile makes it ideal for the use in the hospital setting, where the majority of the new patients get initiated with LAIs. Among the many key attributes in patients' convenience, it's subcutaneous. It has several injection site options, short and narrow needle, small injection volume. We're actually most excited about the pharmacokinetic aspects of the product. And especially here, the therapeutic levels that can be reached within 24 hours, which is quite important for emergency treatment in hospitals. And we have, as compared to other drugs in the category, no oral supplementation or a loading dose. So you can discharge the patient right after first treatment in U.S. sales that you have here at therapeutic levels for one or two months. And for that reason, we believe we have a highly competitive product in the LAI category. And as I said, we believe we can compete here across all molecules and to set a new standard for LAI treatment.

Thank you, Sven. Thank you, Umer. Thank you for the question. Next question.

Thank you. Our next question comes from Balaji Prasad from Barclays. Your line is now open. Please go ahead.

A couple for me. Firstly, on biosimilar Humira. I want to understand how much of a setback did Alvo's CRL posed you in your discussions with the PBMs. What is the total of the negotiations now? And is it fair to assume that 2023 is not the focus of your PBM discussions? One. Two, could you also clarify about the legal settlements that you are taking the provision for? What litigations are these related to? And lastly, if you could just maybe comment further on UZEDY and the market potential for this that you see currently? Thanks.

So as you know the PBM, Sven, I'll hand that one to you.

So of course, we had intense discussions with all major customers, PBMs, and all the downstream customers for Humira this year. And of course, changed the situation because our customers had to prepare for the market entry at -- happening end of June and July 1. So now, we received the CRL. That is, of course, transparent and known to all our customers. And we now have to wait for the outcome of the FDA discussions that Alvotech has concerning the approvability of the biosimilar BLA and also of the interchangeable BLA, and then we will see how we take it forward with the PBMs.

Thanks, Sven. And the legal settlement, Eli?

Thanks, Balaji, for the question. Yeah. So we had some few adjustments on -- mainly on two cases. One, we're actually progressing on the patient assistance program on COPAXONE with the DOJ. And currently, our estimation are around $100 million. This is what we're actually working on and trying to settle it. So this one -- this quarter, we actually at this launch. And the other element that we're actually looking now is kind of a tiny element related to the HIV and the reverse payment we're actually participating with Gilead. And this is $50 million, and the rest is kind of mostly about the timing and other elements relating to a very certain molecule, but that's the high level.

Thanks, Eli. And then on the UZEDY, allow me to clarify what Sven said and I said earlier, we think this is a great opportunity based on the product profile we have, the very patient-friendly profile. It's a $4 billion market. Based on what we understand about the needs of the patient and the physician feedback, we think we have a very good solution when it comes to our long-acting formulation. We see ourselves getting to between 10% and 20% of the market. We'll see how that plays out. I think one thing I would say when it comes to the schizophrenia market, and maybe Sven can add a bit of flavor of this is it will take a bit of time. This is a secondary care. This is in hospitals, as Sven alluded to, so there's a bit of time to get on by -- to get into those hospitals, to get into those departments and outpatient clinics to make sure it's ready and available for when these patients come in. So there is a bit of setting up the system to make sure that happens. But once that's in place, we see this product having a good trajectory. I don't know whether you want to add anything to that, Sven.

I think, Richard, you covered everything. As you said, we are prepared for launch. It will happen in the next days. We have a dedicated sales team, both in the field, but also for hospital coverage. We're working through the hospital listing, getting reimbursement in all places. And then we believe, of course, the molecule itself is well-known, the efficacy is well-established. That's clear. And I think we can communicate our product attributes also in a very clear and compelling way. We've done extensive market research to prepare for this launch. So I believe we will have a good uptake. Although you have to see that in schizophrenia in these indications, you typically have a slower development, like in other indications. But I think we are well-prepared here.

Thank you. Our next question comes from Ash Verma of UBS. Ash, your line is now open. Please go ahead.

So I have to -- one, just on biosimilar Stelara, are you planning to pursue interchangeability here as this can be an important feature in this self-administered market? And I think Amgen has already filed for interchangeability. And the resolution on the Iceland manufacturing side is still going on. And we understand, I think Stelara is also coming from that site. So can the Stelara launch timeline get impacted here? That's my first one. And then second, so for the free cash flow guidance that you provided, how confident are you on the reform outlook here? I mean, typically, gross margin improvements can be gradual, and this level of EBITDA deterioration in 1Q. Can you reach the free cash flow guide on gross margin improvement alone? Or do you think you need to cut some opex as you progress in the year? Thank you.

Thank you, Ash. Thanks for your question. I think on the Stelara one, Sven, if you'd like to give the answer. And then Eli, going on to the free cash flow.

Yes. On Stelara, of course, we are also preparing for this launch. Our launch is, of course, dependent on FDA approval, but also on clearance of all the patent aspects around it with J&J. Like for our biosimilar license applications, the site inspection will be part of the review process. So the Iceland from Alvotech will be inspected for approval of this drug. Concerning your question about interchangeability, we are still looking into that aspect of the drug. We will also see now, of course, with the market formation from Humira, how our customers look at interchangeability. But we believe we will have a competitive offering when we come to market with Stelara.

Eli, for the cash flow.

Hello, Ash, thanks for the question. It's Eli. Yes. So it's a fair question, and I will split it to two. First of all, what we see in the P&L. And I look earlier in the guidance for the year, I said that the consensus now is really close to $15 billion. We are well-seated in terms of revenue. And we are in the range, and very well set there, which means that we are growing in our innovative. And we'll see more growth also on our generics as well on outside of the U.S., European, and international markets. That's going to help us this year in terms of free cash flow. The gross margin will pick up gradually. But currently, we don't see now any departure from our view on the range on the free cash flow. The second part of it is the working capital element. We actually have a certain enhancement in place in the last year or so, and it's mostly about our optimizations on inventories and supplier base. So we will see from there also a certain level of benefit helping us to support our working capital and free cash flow. So the answer is that we are in the guidance.

Thank you. Our next question comes from Nathan Rich of Goldman Sachs. Nathan, your line is now open. Please go ahead.

Great. Thanks for the questions. Maybe just following up on the last one. Eli, how much of the gross margin pressure was mix-related versus inflation-related? And can you maybe just talk about the level of visibility you have into inflationary pressure, given there seems to be some lead time there, just in terms of confidence of that kind of easing as the year progresses? And then I'd be curious how AUSTEDO compared to your expectations for the quarter. I know there's some seasonality to sales, but revenue per script looked lower than we expected. So can you just expand on what drove that in the context of your full-year expectations? And how do you think the once-daily dosing improves your positioning with physicians going forward? Thanks for the questions.

Thank you, Nathan. So handing the first one to Eli.

Yes. So Nathan, thanks for the question. So percentage-wise, if you look year-over-year, this is a five-point decrease in gross margin. The first element related to inflationary pressures, this is around 2.5 points, like half of day back. And this is mostly related, as I mentioned in my prepared remarks, the inventory that we received on the second half of 2022 that embedded inflationary cost. And that actually went, and we consumed and sold the group a little this quarter. And that main impact really, it came with across, I would say, across the flavor and other elements related to direct material costs embedded in the cost and pricing, and as well energy and freight. Now, we see freight and energy rebounding. We had a successful hedging program last year on the energy that helped us to secure a certain rate, and we see the benefit this year. We're going to see a very nice benefit as well in freight in terms of the combinations and how we're managing long and short items in order to optimize more on the ocean versus the sea, as well as consolidation of shipments. That's for that element. The other element is around, I would say, the product mix is kind of between 1 to 1.5 points, and the rest is coming really from hedge and FX. So that's how you should frame and think about it, that difference. And as we look forward in terms of -- for your questions about inflationary pressures, some shortages on labor, and that happened in the industry in Q4. Getting more ease now. A lot of other elements starting to rebound. We see it in the pricing. We see it in the -- how we are sourcing. So we believe that this one will get kind of at least half effect throughout the rest of the year. As well, if you look on our product mix and the expected revenue mostly in our innovative portfolio, this one will rebound and give us more accretive margin going forward.

Thanks, Eli. And then to answer your AUSTEDO questions, it's -- Q1 AUSTEDO was in line with our expectations, what we had forecast. As I'm sure you're aware, there is a swing factor between Q4 and Q1, largely because of speculative buying and inventory build that happens. But if you look at the sort of fundamentals, the metrics, the leading indicators, TRx of 28%; and Rx, up 30%. So as I said in my opening remarks, very excited about AUSTEDO and its potential. Then your question about what does once a day do, I think if we had any one slight weakness with AUSTEDO and if there's any one, it was once a day. And now we have that. I think the product profile is very strong and is accepted by our physicians as a favorable product profile. So now, with the once a day, I think that strengthens that. And the other thing is we have -- we allocated resource and capital to AUSTEDO to match the expectations we place on it. We've allocated reasons to make sure that can happen. So I think we're well set for AUSTEDO for the rest of the year. And it's building a bit to Eli question and answer there on margins. I do see with the combination of UZEDY coming, the launch of that, the growth of AUSTEDO, the continued growth of AJOVY, that's gonna change our product mix into the high-margin innovative business. So strong expectations and confident about the AUSTEDO. Thank you for your question.

Thank you. Our next question comes from Chris Schott of JPMorgan. Chris, your line is now open. Please go ahead.

Just two questions for me. I'm just trying to get my hands around the gross margin update. So maybe you can just help us a little bit of what is a reasonable gross margin target for the year when we kind of balance maybe some of the dynamics in 1Q. It's what sounds like kind of gradual improvement for the rest of the year. So is something like 51% or 52% kind of the right ballpark? Or is it gonna bounce back more than that? Just help a little bit just so we don't make more surprises there. And the second question is a bigger picture one. I think you're highlighting kind of pipeline capabilities is one of the underappreciated pieces of the Teva story, and it seems like a number of pipeline assets that you're gonna be talking in more depth next week. How do you think about the overall level of investment that Teva is making in R&D? I know you have kind of a hybrid business between generics and brands. When I think about level of investment as a percent of sales, and it's not a perfect metric, but Teva is kind of at the low end of the industry on that front. And I'm just trying to kind of balance the resources you're allocating to R&D versus the desire to maybe push this pipeline and maximize pipeline value appropriately going forward. Thanks so much.

Thanks for the question, Chris. So Eli, you start on the gross margin then.

Yes. Thanks, Chris, for the question. So yes, as I mentioned, in the second half of '22, most of the impact was actually coming from what we call sustained cost related to inflationary pressures. And now it really depends on the mix that's coming in the quarter, on element that you consume for your inventory. What we see for the rest of the year, I will say that we are at the low of the 53 currently. Considering on rebounding, I would say, at least half of the impact on the inflationary pressures from the reasons that starting from mid of Q2 start to actually to source, as well new inventories that actually embedded a different pricing now as more of the stuff are starting to increase. So I would say you should actually look from low 53.

Thank you, Eli. Now moving on to pipeline assets. So if I understand your question correctly, Chris, is do we -- have we allocated enough capital and resources to execute on what we highlight is a good pipeline. It's a great question, and we'll give you a bit more flavor to that next week in New York. But yes, in short, we are. We're making sure we prioritize and allocate capital to where the opportunity is to drive growth and profitable growth. And as Eli alluded to, we have some really exciting assets that we think, to a certain degree, are derisked or validated. So to allocate capital to that seems a very sensible thing to do. So when it comes to that, we are making sure those assets are funded well to go through. And then on our capital markets day, we'll probably give you a better idea of how we're thinking about capital allocation across the two different types of business, you talked about there from our generics pipeline to an innovative pipeline and how we're managing that. So we'll go into more detail next week. So I hope we answer your question, Chris, and thank you for it.

Thank you. Our final question for today comes from David Amsellem of Piper Sandler. David, your line is now open. Please go ahead.

Maybe just expanding upon the last question. In the past, you've talked about 505(b)(2) opportunities, and I guess I wanted to ask about the balance between 505(b)(2) products, brand products, versus new molecular entities and how you're thinking about it. Or maybe asking differently, how far along the innovation spectrum are you looking to go? And then secondly, on AUSTEDO, can you just talk about the mix between tardive and Huntington's chorea and how you're thinking about the potential impact of Ingrezza to the extent that it gets its label expansion for Huntington's?

Thank you, David. Thank you for your question. So if I understood your question correctly is sort of how do we balance that focus for effort resource on pure innovation to 505(b)(2)s., and I think we balance that based on the opportunities that we see that we have already and then going forward, where we apply resource and capital. So I think the 505(b)(2)s, we see as complex generics, they're difficult to make, and so that falls in our wheelhouse nicely. And from an innovative point of view, we're leveraging our capability in neuroscience and immunology with particular focus on this antibody engineering capability we have. So we don't think we have to sacrifice one for the other. I think what it comes down to is how do we reallocate capital from the other aspects, whether 505(b)2 is innovative to mention or we can find the opportunities we have. Right now, we're doing that well. And as you'll see from the strategy next week, we have a clear strategic and operational plan as to how that's gonna be done over the longer term, and so I think that's how we're approaching it now. And then with regard to Huntington's disease, and tardive dyskinesia, and the mix of the Ingrezza with potentially an upcoming label expansion, I'll hand that back to Sven in the U.S.

Yes. Thank you, Richard. So Huntington's disease is around about 50% of our sales. So 85% is the tardive dyskinesia. If you look at the size of the patient population, tardive dyskinesia is, of course, the larger market, which is still significantly underpenetrated and underserved. So that's clearly our strategic focus. For Huntington's disease, of course, we are here well-established because that was the first indication that we launched. We know that the prescribers that treat Huntington's disease are highly scientific. They value the dose options that we provide, the titration ability, and they also value the long-term efficacy data combined with the safety profile that we have. For that reason, we believe that we are highly competitive in this category despite the anticipated label expansion from Neurocrine. On the other hand, also, we now have with AUSTEDO XR, exactly the drug formulation with the once-daily as Richard explained, was missing. We did extensive market research here about the prescriber segments that value these convenience factors. And I think we will have a very competitive product going forward being it now in tardive dyskinesia or in Huntington's disease. So for that reason, we are quite optimistic for the year 2023 and our growth in both categories going forward.

Thank you, Sven. And thank you again, David, for your question. I think that concludes all the questions we have time for today, so I want to thank everybody again for dialing in and listening in, and the ones who asked the questions for doing so. I'd just like to remind you all of the investor day we have on May 18 in New York next week, starting at 12 p.m. Eastern time, and look forward to seeing some of you in person now and look forward to hearing and seeing you online if you can't make it in person. Thank you again for your time and attention today and look forward to catching up next week.

Thank you for joining today's call. You may now disconnect your lines.