Earnings Call Transcript
TEVA PHARMACEUTICAL INDUSTRIES LTD (TEVA)
Earnings Call Transcript - TEVA Q4 2023
Operator, Operator
Hello and welcome to the fourth quarter and full year 2023 Teva Pharmaceutical Industries earnings conference call. My name is Alex and I’ll be coordinating the call today. If you’d like to ask a question at the end of the presentation, you can press star followed by one on your telephone keypad. If you’d like to remove your question, you may press star followed by two. I’ll now hand it over to your host, Ran Meir, Head of Investor Relations. Please go ahead.
Ran Meir, Head of Investor Relations
Thank you Alex. Thank you everyone for joining us today. We hope you’ve 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 this statement and our non-GAAP financial measures is available on our earnings 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 2023 full year results and business performance, recent events, and our focus and priorities going forward, then Dr. Eric Hughes, our Head of R&D and Chief Medical Officer will discuss progress on our innovative pipeline. Our CFO, Eli Kalif will follow up by reviewing the fourth quarter financial results in more detail before providing an overview of Teva’s 2024 financial outlook. Please note that today’s call will run approximately one hour. With that, I will turn the call over to Richard. Richard?
Richard Francis, CEO
Thank you, Ran, and welcome everyone. I appreciate you joining the call today. 2023 was a pivotal year for Teva. We implemented our Pivot to Growth strategy to drive Teva back to growth, and I’m happy to report that it accomplished that goal. I want to remind you that this strategy relies on four main pillars: delivering on our growth engines, enhancing innovation, becoming a generics powerhouse, and focusing our business. We are making progress on all these fronts, which I will outline in today's presentation. As you noted, we have decided to divest our TAPI business, and I'll provide more details later. Now, let’s review the numbers on this slide. I’m pleased to confirm that Teva has returned to growth. Additionally, I want to point out that the numbers reflect the Sanofi upfront payment linked to our collaboration on the development and commercialization of TL1A. Teva's growth was 7%, achieving sales revenue of $15.85 billion; when excluding Sanofi, the growth would be 3%. Adjusted EBITDA increased by 5%, non-GAAP EPS rose by 2%, and free cash flow was up by 6%. I’m also glad to report progress in our net debt to EBITDA ratio, which is now at 3.45. On the next slide, I will detail what has driven this performance. Our innovative business has performed admirably. In particular, Austedo saw significant growth of 28%, and Ajovy recorded an impressive 18% increase. In our generics sector, Europe grew by 3%, and international markets experienced a 14% increase, while our North American generics business shows signs of stabilization. Now, let's delve deeper into what’s driving these numbers, starting with Austedo. Austedo reached our $1.2 billion guidance, with U.S. sales up 27%, bolstered by strong TRx. This performance highlights the benefits of the additional resources we've allocated to the brand and the enhanced capabilities we've developed. Moving forward, I can reaffirm our 2027 guidance of $2.5 billion, with a near-term goal of $1.5 billion in revenue for 2024. It's important to note that many patients suffering from tardive dyskinesia remain undiagnosed, and we initiated a direct-to-consumer campaign in January to increase awareness and encourage these individuals to seek treatment. Now turning to our latest addition, Uzedy, we anticipate good growth with a 2024 guidance of $80 million, thanks to the groundwork laid in 2023 to enhance awareness and access. We've made strides with commercial payors, including Medicare and Medicaid, to ensure inclusion in hospital formularies. Feedback on the product has been positive, indicating a good fit for patient needs. The market for this drug is valued at $4 billion and is growing at 6%, so Uzedy is expected to contribute to our growth, both this year and in the future. Next, let’s discuss Ajovy. We are excited about the continued momentum, with growth of 18% across all regions. In various geographies, we are increasing our market share, showcasing Teva's competitiveness. Given this positive performance, we are setting a 2024 guidance of $500 million for Ajovy. Moving on to our biosimilar portfolio, I'll mention that we plan to launch five biosimilars in the next four years, which will significantly impact our growth. For biosimilar Humira, we are awaiting inspection results from the FDA regarding our partner Alvotech’s site in Ireland. A successful inspection will pave the way for this launch later this year. Transitioning to the second pillar of our Pivot to Growth strategy, my colleague Eric will provide a deeper dive into our pipeline. However, I want to emphasize that we are making meaningful progress. Olanzapine has completed recruitment for its Phase III study, with results anticipated in the second half of the year. The ICS/SABA product entered clinical trials in Q4 of last year, and we believe we have a competitive offering in an attractive market with only one other competitor. Our partnership with Sanofi regarding TL1A is also showing promising momentum. Now, regarding the third pillar of our strategy, we aim to solidify our position as a generics powerhouse. This is centered around three key areas: ensuring we have the right market portfolio executed by our commercial teams, focusing our pipeline on high-value products that can grow our bottom line in a timely manner, and optimizing our operational efficiency. I will discuss our pipeline shortly, but it's important to note that we closed three facilities in 2023 as part of our optimization efforts. We've also launched an operational excellence plan for 2024, targeting a reduction in costs of goods sold to drive gross margin expansion. Now, turning to our pipeline, we have made notable advancements. I believe we are well-positioned in the U.S. complex generics market, with multiple technologies available to launch complex generic products. We've introduced 10 products between 2022 and 2023, and I'm excited about the 13 products we plan to launch between 2024 and 2025. These opportunities will help us drive growth and counteract price erosion in the U.S. market. Finally, regarding capital strategy, we announced our intention to divest Teva API, which aligns with our Pivot strategy. This divestiture will allow TAPI to reach its full potential in the $85 billion global API market while enabling Teva to concentrate its capital on advancing our innovative and generics portfolios. As we look to 2024, we have a clear roadmap of milestones, continuing our strategy by pushing our innovative pipeline, targeting $1.5 billion for Austedo, progressing our pipeline to market swiftly, enhancing efficiency in our generics manufacturing, and executing the TAPI divestiture. To conclude, I want to present our Healthy Future plan, continuing our ESG journey. Teva focuses on three main areas: Healthy People, ensuring access to medicines globally and fostering a diverse culture; Healthy Planet, minimizing global warming impacts through various initiatives; and Healthy Business, maintaining compliance and the highest ethical standards. With that, I will pass the presentation to my colleague, Eric Hughes.
Eric Hughes, Head of R&D and Chief Medical Officer
Thank you Richard. Moving onto the slide for Ajovy, we know physicians choose Ajovy because of its safety and efficacy, as well as its convenient auto-injector and monthly dosing options. But today, I’m excited to show you recent data that we’ve produced from two real-world evidence studies, PEARL and FINESSE, showing the durability of Ajovy. Migraine is a chronic disease and having durability of response is very important, and what we can see in this study is that the days that you’re free of migraines have been maintained for two years after starting Ajovy - this is significant, and this translates not only into a simple reduction in monthly migraines but it really is eight full days for some patients to achieve a day without migraines, so each month a patient gets back about a week of their life without migraines, so this is very important. Moving onto our slide for Uzedy, as Richard mentioned, we are very excited to get the approval last year and launch Uzedy, and we’re also happy to show more durability of Uzedy as well. Here, following up on subjects from our pivotal study, we show that the quality of life in patients not only is maintained up to 56 weeks but also slightly improved, so this is very important as well for patients with schizophrenia, because we had patients with long durations of disease and short durations of disease, but we can show here that with a long-acting injectable, we can actually not only maintain but improve their quality of life. This is important for a long-acting injectable because we believe this is important to maintain the exposure in the patient’s blood to the risperidone, so we think this is very important and we’re happy to see this durability of response. Moving on to Austedo, one of the things that’s important for Austedo, and as Richard mentioned, there is very much room to grow and access patients who have tardive dyskinesia, and one of the things we need to do is make sure it’s as easy and convenient to use Austedo as possible. We know in real world evidence that only about 50% of our patients without a titration pack can achieve the dose range that is necessary to get good outcomes, so we ran a study of the titration pack and were pleased to see that 78% of the subjects finished the titration pack and were 97% adherent. This is important because getting to the titration pack easily and simply for patients gets those patients up into the right dose range, that makes sure that we get our patients the right efficacy, and we hope this translates into durability and adherence for long-term treatment, so very important and we’re glad to see this works so well for our patients. Finally, I just want to review our milestones in the R&D organization. We are doing well in our enrollment for our Phase II study of TL1A, and it’s accelerating. We’re looking forward to that Phase II interim analysis in the second half of 2024. We are fully enrolled in our olanzapine LAI Phase III globally and will be having our full clinical package of efficacy and safety in the second half of 2024. Our anti-IL15 program is finishing up its Phase I SAD/MAD study in healthy volunteers, and we’ll present that data in the second half of this year, and we’ll also finish enrollment in our proof of concept study in celiac patients by the end of this year. We’re excited to look forward to the first-in-human dosing of our anti-PD1 IL2 program in the first half of this year, and finally we’re actively enrolling our Phase III study in ICS/SABA and looking forward to those results in the second half of 2026. With that, I’ll pass it off to Eli Kalif.
Eli Kalif, CFO
Thank you Eric, and good morning and good afternoon to everyone. I’ll begin a review of our 2023 financial results with a main focus being on fourth quarter performance. This will be followed by our non-GAAP outlook for 2024 and some of the important assumptions behind it. Beginning on Slide 24, I would like to remind everyone that in October 2023, Teva entered into an exclusive collaboration with Sanofi to develop and commercialize Teva’s anti-TL1A asset. As per the terms of the collaboration agreement, Teva received an upfront payment of $500 million in the fourth quarter of 2023 which was recognized as license arrangement revenue. This upfront payment had a positive contribution of $500 million to both our revenue and free cash flow. After adjusting for certain transaction-related costs, this payment had a positive contribution of approximately $430 million. Now throughout the presentation, I will be discussing our results for the quarter and for the full year 2023 as reported. Also, I want to draw your attention to the disclosure we included in the press release this morning regarding a revision to certain GAAP financial metrics in 2022 and 2023 to correct errors related to contingent consideration liability. This revision did not impact our non-GAAP results for either year. Now starting with our Q4 GAAP performance, revenue in the fourth quarter of 2023 was $4.5 billion, an increase of 15% in U.S. dollars and 14% in local currency terms compared to the fourth quarter of 2022. The increase was mainly driven by the upfront payment that I just mentioned, the sale of certain product rights in Europe segment, continued strong growth in Austedo, and higher revenue from generics products in international markets. This was partially offset by lower revenue from generics products and our distribution business in North America and from Copaxone. In Q4 2023, we reported GAAP operating income of $765 million compared to an operating loss of $940 million in the same quarter last year. The increase in operating income was mainly due to goodwill impairment charges in the fourth quarter of 2022 and higher gross profit for this year, partially offset by higher impairment, restructuring and other items in the fourth quarter of 2023. We had net income of $461 million and a GAAP earnings per share of $0.41, which was higher than last year mainly driven by higher operating income, as I just explained. Turning to Slide 25, you can see the non-GAAP adjustments in the fourth quarter of 2023. A notable adjustment this quarter included a contingent consideration expense of $408 million mainly related to the change in the estimated future royalty payments in connection with generics revenue. Now moving to Slide 26 for a review of our non-GAAP performance, as I mentioned earlier, our fourth quarter revenues were approximately $4.5 billion, our annual revenue in 2023 were $15.8 billion, an increase of 6% in U.S. dollars or 7% in local currency terms compared to 2022. Excluding the contribution from the upfront payment regarding our anti-TL1A collaboration, our revenue growth in 2023 was 3%. Now let’s move down the P&L, starting with the gross profit margin. Our non-GAAP gross profit margin was 68.2% compared to 54.2% in Q4 2022. The increase in our gross margin was mainly due to the upfront payment, as I just mentioned, and a favorable portfolio mix as well as the sale of certain product rights in Europe as part of our portfolio rationalization. This was partially offset by higher costs related to inflationary and other macroeconomic pressures. Excluding the impact of the upfront payment, our non-GAAP gross profit margin would have been consistent with levels of Q3. This was slightly below our expectation mainly due to timing effects related to a certain element of our costs associated with inventory consumption, our portfolio mix, and better than expected performance of our low-margin distribution business, as well as an unfavorable impact from hedging activities. Overall, we saw sustainable improvement in our gross profit margin since the first quarter of 2023 with stabilization of the margins in the second half of 2023. Going forward in 2024, we expect our gross margin to continue to improve driven by continuous improvement in our portfolio mix, with strong growth in our innovative portfolio as well as continuation of the optimization program we have initiated. We expect that our non-GAAP gross profit margin to be between 53% to 54% in 2024 full year. Similar to 2023, we expect gross margin to gradually improve throughout this year. Moving to the non-GAAP operating margin in Q4 2023, which was 34.7% compared to 29.1% in Q4 2022, this increase was mainly driven by higher non-GAAP gross profit margin, as I just explained, as well as lower operating expenses as a percentage of revenue. On an absolute basis, our higher operating expenses this quarter were related to higher investment in R&D and sales and marketing in line with our Pivot to Growth strategy, partially offset by efficiencies in our operations. We ended the quarter with earnings per share of $1 compared to $0.71 in Q4 2022, mainly driven by higher operating income. Turning to free cash flow on Slide 27, our free cash flow in the fourth quarter of 2023 was $1.5 billion compared to $1.1 billion in Q4 2022. In addition to the factors driven by various items partially offset by sale of accounts receivable under our U.S. secured facility in the fourth quarter of 2022. During the fourth quarter of 2023, we also initiated the first payment of the nationwide settlement in connection with the opioid litigation that increased our total payment of legal settlements by approximately $244 million compared to Q4 2022. Overall, the full year of 2023 free cash flow was $2.4 billion compared to $2.2 billion in 2022. Turning to Slide 28, we continue to make strong progress in terms of reducing our debt. Our net debt at the end of Q4 2023 was $16.6 billion compared to $18.4 billion at the end of 2022. Our gross debt was $19.8 billion compared to $21.1 billion at the end of 2022. The decrease in our gross debt was mainly due to $1.6 billion senior notes repaid at maturity, partially offset by $202 million of exchange rate fluctuations. During Q4 2023, we repaid the full $500 million under our $1.8 billion revolving credit facility, and as of December 31 and as of today, there is no amount outstanding under the revolver. As a result, our net debt to EBITDA also improved, coming in at 3.45 times for Q4 2023. As part of our capital allocation strategy, we expect our net debt reduction to continue as we continue to progress towards our long-term target of two times net debt to EBITDA by the end of 2027. Now let’s turn our attention to 2024 non-GAAP outlook. As Richard mentioned, 2023 was a pivotal year for Teva, and through the year our colleagues around the world worked very hard to execute on our Pivot to Growth strategy. We made some deliberate choices and began investing in our growth drivers and our promising pipeline, while also navigating and addressing the impacts of the macroeconomic and geopolitical headwinds. As we move to 2024, we remain focused to continue to execute on our long-term strategy. With this in mind, we begin with 2024 total revenue which we expect to be between $15.7 billion and $16.3 billion. Compared to 2023, this represents a growth of 2% to 6% excluding the $500 million upfront payment received related to our TL1 asset. As Richard mentioned earlier, our revenue growth will be driven by continued strong momentum in our innovative portfolio and stabilized generics business. Coming to our non-GAAP operating profit, we expect our gross margin to gradually improve throughout 2024 as we continue to execute our Pivot to Growth strategy. We’ll also continue to make deliberate investments in our innovative portfolio and progress our key pipeline assets to drive both short and long-term growth for the company. With that in mind, we expect our operating expenses to be approximately 27% to 27.5% for the full year, including R&D expenses between 6% to 6.5% of revenue. As a result, our non-GAAP operating income is expected to be between $4 billion and $4.5 billion, and our non-GAAP adjusted EBITDA is expected to be between $4.5 billion to $5 billion, both growing over 2023 levels excluding the effects of the upfront payment. We expect finance expenses to be approximately $1 billion in 2024, in line with 2023 levels. Looking at our tax rate, we expect our non-GAAP tax rate to be slightly higher than the 2023 tax rate of 30%, which benefited partially due to intellectual property-related integration plans and carry-forward losses. This brings us to expected non-GAAP earnings per share in the range of $2.20 to $2.50. We expect our 2024 free cash flow to be in the range of $1.7 billion to $2 billion. While we do not provide quarterly guidance, I thought it would be helpful to share how we are thinking about the progression throughout the year. Overall, based on our expectations today, we expect revenue and earnings to progress gradually during the year with revenue in the second half of 2024 to be slightly higher than the first half. Our non-GAAP margins are also expected to improve throughout the year in line with the revenue trajectory, as well as improvements from the optimization program we have initiated. With that, this concludes my review of Teva’s results for the fourth quarter and fiscal year of 2023, and now I will hand it back to Richard for a summary.
Richard Francis, CEO
Thank you Eli. I would like to just reiterate the financial targets to 2027. Revenue growth will be mid-single digit, operating margin of 30%, net debt and adjusted EBITDA two times, and cash to earnings ratio of 80%, so reconfirming these as we move forward, as we gain confidence on the Pivot to Growth strategy. Moving onto the final slide, just to reiterate what the Pivot to Growth strategy will do to provide growth. The main goal is to accelerate growth to return to growth in ’23 to ’24, to accelerate it in ’25 to ’27, and we believe this will be built on the momentum that Eric has in the pipeline and those products coming to the market, and also you’ll start to see the biosimilars gain traction as well, based on my earlier comments. To me, it’s clear to see that we’re gaining momentum with Pivot to Growth, and now it’s about executing as we did in ’23, in ’24. With that, I’ll hand it over to the Operator to take some questions. Thank you for your attention.
Operator, Operator
Thank you. Our first question for today comes from Glen Santangelo from Jefferies. Your line is now open, please go ahead.
Glen Santangelo, Analyst
Yes, thanks for taking my questions. Eli, I just wanted to follow up on the guidance, because there are a couple of things that are sticking out to me. It looks like you’re assuming at the midpoint that revenues are going to be up a little bit less than 1%, but you’re assuming EBITDA at the midpoint is down almost 2%. I think if I heard Richard correctly, you’re assuming gross margins are going to be up, perhaps due to product mix, and so it seems like you’re forecasting a much bigger ramp in operating expenses. I wonder if you could just sort of flesh that out a little bit, if it’s coming more in the sales and marketing side or greater R&D spend, and then I maybe have just a quick follow-up. Thanks.
Eli Kalif, CFO
Yes, thanks Glen for the question. First of all, we are looking at the midpoint, which is $16 billion, compared to the numbers we end up ’23 excluding the upfront payment, which means we are looking at 4.3% growth on the midpoint on the top line. As far as related to some dynamics to the operating margin, we see ourselves keeping operating expenses growing. I mentioned that we are looking at the range between 27% to 27.5%, and that means that R&D between 6% to 6.5%, stabilization around 6.2% in G&A, and sales and marketing around 14.5%, and that signifies that part of our growth will enable us to keep investing in the business. For your question, when we line up our guidance, we look at our 2023 excluding the upfront payment.
Glen Santangelo, Analyst
I want to follow up to ensure I understand the revenue guidance properly. You provided several details, which were helpful, but I want to clarify what you're indicating regarding the generics business in 2024. I see that you've significantly reduced the Copaxone assumption, but I'm trying to identify where the remaining offset is. I know you have several major launches in the generics area, such as Korlym and teriparatide/Forteo. Could you elaborate on your expectations for that generics business to ensure we fully understand your message?
Richard Francis, CEO
Hi Glen, it’s Richard here. Thanks for the question. Yes, so once again, just to reiterate, and I think your question is directed at the North American generics business, but just to highlight the fact that our European and international market business, we expect it to continue growing well, in line with what we did in '23. But to come back to your question about '24, yes, we do have a number of launches that are coming through. We’re pleased that we’ve made progress on those. I would like to highlight that some of those are coming in with competition as well, which you need to take into account when forecasting. And obviously when we launch products, part of the aim there is to offset some of the price degradation that we see every year in the U.S., and so net-net, we see a stabilization of our North American business going forward. As we continue to build and improve on our launches and our supply chain, that’s why we believe in the medium to long term, we can drive the business back to growth.
Glen Santangelo, Analyst
Okay, thank you.
Operator, Operator
Thank you. Our next question comes from Ash Verma of UBS. Your line is now open, please go ahead.
Ash Verma, Analyst
Yes, thanks for taking my questions. Just to clarify on 2024 guidance, you’re including the partnership accounting here from Sanofi upfront. For 2024, is there any specific amount that you’re expecting to receive? I believe the next set of milestones is on Phase III initiation, which I believe it won’t happen this year. That’s the first one. Then second, just curious on the North American generics, what you print seems like a step down from where the franchise has been run rating at. Is that because there wasn’t any kind of a benefit from generic revlimid, or are we starting to see any change to the price stabilization narrative? Thanks.
Richard Francis, CEO
Hi Ash, thanks for those questions. I’ll tackle them. With regard to Sanofi, correct - we will not receive any payments in ’24 and ’25. Based on, as Eric highlighted, a successful interim analysis this year of our Phase II data of TL1A, we’ll move into Phase III in ’25 and that will trigger some milestones from Sanofi, but in ’24, there won’t be anything. To go to your North American generics question, a couple of things to note. Part of what you saw was that we don’t really have any significant revenue of revlimid in quarter four, so that’s worth noting. Then, if you think about the business, we do have Truxima, which is our biosimilar business, which as you know has performed well and generated good revenue over a number of years, but obviously is declining steadily now. If you factor those elements in, then I think my comment about stabilization of the North American generics business going forward stands true. Based on the number of launches we have coming out, I think we have the ability to offset a significant amount of the price erosion that we see yearly in the U.S., and so I think the way to think about it is stabilization, but on that quarterly change, it’s primarily driven by a bit of the portfolio and a bit in relation to our biosimilar single product, Truxima. Hopefully that helps, Ash.
Ash Verma, Analyst
Thanks.
Operator, Operator
Thank you. Our next question comes from Jason Gerberry with Bank of America. Jason, your line is now open. Please go ahead.
Jason Gerberry, Analyst
Hey guys, thanks for taking my question. My question is on the biosimilars. I’m wondering if you think you could potentially make hay with this biosimilar Humira if you get the interchangeability designation with the February approval. Can you leverage that to get a big, chunky contract as a preferred biosimilar supplier? I know that the other non-interchangeable high concentrates have struggled to gain share. Then, how that maybe carries over into 2025, right? I mean, there’s a question about Stelara and is the PBM biosimilar space sort of broken, you know, with innovators playing the rebating game, or could you leverage a portfolio play with interchangeable Humira and then layering on top of that Stelara? So just kind of wondering your overall perspective on what you’ve observed with the PBM biosimilars and whether you think there’s an opportunity there. Thanks.
Richard Francis, CEO
Thank you, Jason, for the question. Regarding the biosimilar Humira, our ability to launch really depends on the FDA successfully inspecting our partner Alvotech’s facility in Iceland. If that happens, we should know relatively soon and can move forward. However, there are still many factors at play, as 2023 has been slow for biosimilar penetration. We're waiting for FDA approval of the site, the timing of the launch, and how we can effectively penetrate with the PBM. That being said, we’re having positive discussions, with significant interest in when our product will hit the market, largely because of its profile—not just interchangeability but also the auto-injector feature—which I see as an opportunity. Overall, I view it as an opportunity that will unfold over the short, medium, and long term. I believe Humira could contribute to our revenue this year and will definitely do so in 2025, 2026, and 2027. The trajectory for biosimilars will become clearer, and Humira's performance in 2023 won't dictate future outcomes. As for Stelara, my experience in biosimilars has taught me that one product doesn’t determine the success of the next. Stelara differs in several key aspects: it faces fewer competitors and we have a clear timeline for its approval or launch in February 2025, which makes us optimistic. We view it as a significant asset that can generate considerable revenue. However, we will need to see how quickly it gains traction. Importantly, Teva is not solely reliant on these products for immediate revenue since we have a portfolio in play. We aim to launch 13 assets, with five expected by 2027, all of which should yield good returns and enhance our revenue. However, I prefer not to specify which ones will generate revenue at what times due to the unpredictability we've encountered recently. I hope this adequately addresses your question, Jason.
Jason Gerberry, Analyst
Got it, thank you.
Operator, Operator
Thank you. Our next question comes from Umer Raffat of Evercore. Your line is now open, please go ahead.
Umer Raffat, Analyst
Hi guys, thanks for taking my question. A couple here, if I may. First, maybe just on the design of your UC Crohn’s study at baseline, are you expecting mild to moderate or moderate to severe patients, and what percentage may be biologics experienced in your expectations? Secondly, I noticed for your Crohn’s study, the endpoint you’re using, which is endoscopic response, is actually different than what FDA wants for their co-primary. There are a couple of your secondary endpoints on CDI less than 150, or endoscopic remission, which is what FDA is very focused on for co-primary, so should we really be focused on those secondary endpoints as the primary basis of determining how the Crohn’s trial looked? Then finally, if you could just give a quick update on your recent generic launch of Korlym, given all the interest, and how the launch is going to date? Thank you.
Eric Hughes, Head of R&D and Chief Medical Officer
Thank you, Umer. Richard, I'll respond to this question. Regarding the inclusion criteria for our study, we are concentrating on mild to moderate patients participating in the study at this time. This is in line with what has been typical for recent studies. We are pleased to see that our inclusion criteria has effectively enrolled participants; in fact, our criteria and study execution have progressed rapidly for both ulcerative colitis and Crohn’s patients, which is very encouraging, as this is one of the first well-controlled placebo-controlled studies for Crohn’s using this new mechanism of action. The criteria specifically target patients currently entering the study. As for the endpoints, we have included FDA-approved endpoints that we've discussed with the agency. These are generally consistent across various studies. A key aspect to consider is how some clinical endpoints are counted, as this may affect the comparison between the placebo response and the active response. We are confident in our study's design, which was developed in collaboration with the FDA. Regarding your final question about Korlym, Richard, do you want to take that?
Richard Francis, CEO
Yes, I’ll take that. Thanks for the question, Umer. We have launched Korlym; we launched that, I think, a week ago, so that is launched in the market, so I think that answers your question.
Umer Raffat, Analyst
Thank you very much.
Richard Francis, CEO
Thanks Umer.
Operator, Operator
Thank you. Our next question comes from David Amsellem of Piper Sandler. Your line is now open, please go ahead.
David Amsellem, Analyst
Hey, thanks. One question on Austedo and one on Uzedy. On Austedo, I wanted to get a sense of the level of sales and marketing investment and DTC investment that you’re thinking about the product longer term. Certainly, your competitor has spent pretty heavily promoting and supporting Ingrezza. So how do you think about that and how does that tie into your long-term thinking regarding the trajectory of operating margins? That’s number one. Then number two on Uzedy, I think you mentioned the $80 million for ’24. Just wanted to drill down on where these patients are coming from, whether these patients are switching from other LAIs or if they are naïve to LAIs. Are you getting switches from, say, Invega, one of the Invega products? Just wanted to get a sense of where your business on Uzedy is coming from in these early days. Thank you.
Richard Francis, CEO
Thanks David. Thanks for the question. On Austedo, you're right - we have invested significantly in Austedo. We have that capability, so it’s not just about self-source; it’s about bringing in pharmaceutical expertise, so we’ve done that, and that, I think, has been a significant contributor to the acceleration of the product’s continued performance. We aim to make sure that we are competitive and maximizing the revenue of Austedo, but also knowing that, to the last part of your question, we want to be driving improvement in our operating margin, and we see the ability to do that definitively with Austedo and the sales and marketing we’ve put into it. As we talk about the $2.5 billion in 2027, this will be a major contributor to us driving our top line, but particularly our operating profit. With regard to Uzedy, what we’re seeing right now, and to highlight, this is relatively small data, but we’re seeing a considerable number of patients coming from oral risperidone, so a lot of patients are going straight from the oral to our long-acting Uzedy. But when it comes to choosing a long-acting risperidone, a significant proportion of those are going onto Uzedy as well, so I think that just highlights what Eric pointed out, how much the physicians like this product profile, primarily the fact that you can get onto therapeutic levels within six to 24 hours, which when you’re having a schizophrenic episode is really critical, so I think that’s why we’re seeing that enthusiasm. '24 is about taking that enthusiasm and the access and converting it into scripts, so that’s what we’re doing. Hopefully that answers your question, David.
David Amsellem, Analyst
Yes, that’s helpful. Thank you.
Richard Francis, CEO
Thank you.
Operator, Operator
Thank you. Our next question comes from Chris Schott of JP Morgan. Chris, your line is now open. Please go ahead.
Chris Schott, Analyst
Great, thanks so much. Just two questions for me. Just following up on that opex comment, you’ve obviously stepped up opex, you’re seeing really nice core growth in these core drivers, you’ve got a pipeline that’s progressing. I’m just trying to get my hands around opex beyond 2024, so I guess, is this kind of 27% to 27.5% range that we’re seeing this year a good level for the next few years, or are you now actually reaching an absolute spend level where we can somehow think about some opex leverage looking beyond ’24? My second question was just a little bit more color on the international generics growth drivers. It seemed like that business was particularly strong in ’23. I think from your comments, you’re assuming similar growth this year, and would just love a little bit more color on the dynamics you’re seeing in those markets. Thank you.
Richard Francis, CEO
Okay, thanks for the questions, Chris. On the first one, I’ll tag team a bit with Eli. I think just to give you a high level on the opex, one of the things we’ve realized here at Teva, we have a significant opportunity in front of us here and now with our innovative portfolio on the market - Uzedy, Austedo, and Ajovy, and a great pipeline that Eric just talked about. It’s really important we invest in those to optimize them and bring them to market as soon as possible, so that’s what we’re doing. Now, we absolutely commit and believe we’re going to hit our 30% margin in 2027, and investing now allows us to change the trajectory of those products, the speed at which we bring them to the market - Olanzapine potentially end of ’25, early ’26, and that obviously changes once again not only our portfolio mix but the gross margin that they deliver, which obviously flows down to our operating profit. We’ve thought this through very carefully about that and how we invest, and then when we actually start to see some significant pick-up on our bottom line. But I’ll give the specifics to Eli as well.
Eli Kalif, CFO
Thanks Richard, and thanks Chris for the question. Just to continue Richard’s answer, in terms of absolute numbers, we don’t see that one too much expand dollar-wise more than what we have in '24 to '25 onwards, and as we grow with revenue, of course the percentage will go down. But currently, for this year, that’s the range. We also would like to remind that there are certain elements in our R&D and our sales and marketing that are still considered variable elements, that we have some level of control in terms of prioritization and timing on that level, so this is still a controllable item from our perspective.
Richard Francis, CEO
Then on the second question you asked, Chris, around international, I’m pleased to see you’re seeing the good growth there in 2023 and the continued ambitions for 2024. That’s primarily driven by prioritization, continued market expansion, but really making sure we focus on the markets that can deliver. Our team there has done a tremendous job in doing that, and so we’re making sure the prioritization of our resources goes to the markets that drive top line and bottom line, which is a sub-component of our Pivot to Growth strategy. Hopefully that answers both of your questions, Chris, and thank you for them.
Operator, Operator
Thank you. Our next question comes from Balaji Prasad of Barclays. Your line is now open, please go ahead.
Balaji Prasad, Analyst
Hi, good morning everyone, and thank you for the questions. A couple, just firstly on both your Q4 performance and the 2024 outlook, which is very strong, midpoint higher than the highest Bloomberg estimate I see. It looks like this has been drowned in the aftermath of the restatement, going by the stock reaction, so can you please provide more color on how this happened and the implications for this one-time restatement? Secondly on your partnership with Alvo, considering that Teva is having greater involvement in the biosimilars facility inspection, looking at the FDA letter that Alvotech has received, the 483 is related to FDA observing frequent sanitation of operators, so help us understand how easy or difficult it is to address this issue and in general, what is a normal resolution which the FDA can accept for such observation? Thank you.
Richard Francis, CEO
Thanks Balaji, I appreciate the question. I’ll start with the second question and then I’ll hand the first question over to Eli. With regard to the Alvotech partnership, correct, we have been heavily involved in helping them. I think I’ve said in the past, I think we have around about 30 FDA inspections a year across our 54 sites, so we’re very proficient at dealing with this and we’ve given that guidance and help to Alvotech. I think with regard to the observations that you’ve seen, the one observation, I think for us, is considered a relatively small observation. What I’d caution is with the FDA; it’s entirely up to them to give their view on whether that allows us or allows Alvotech to have that site cleared, but we think that is a good inspection which shows the huge amount of work that’s being done at that site to be approvable by the FDA. But I must caution, the FDA has to approve the site first, so what I’d say, I think Alvotech has put themselves in a very good position, but we’ll have to see how that plays out. Then to answer the first question, I’ll hand it back to Eli.
Eli Kalif, CFO
Thanks Balaji for the question. Yes, so as part of our preparation for the consolidation statement for ’23, we determined that there were errors in a single contingent consideration liability and related expenses, which connected to the estimated future royalty payments, and those errors resulted from exclusions of some payments related to royalties, and in that way the fair value and the revision, we need to recalculate. We assessed the materiality of those errors and determined that those errors were not material to each one of those periods, ’22 and ’23. About the revisions of the numbers, which is not a restatement, we actually implemented them in those financials. I would like to mention that those errors did not impact at all our non-GAAP results, as well as not impacting at all our total cash flow from operating activities from financing activities, investing activities. As we speak, we are in progress and process to implement a remediation plan to address this internal control.
Balaji Prasad, Analyst
Thank you.
Richard Francis, CEO
Thank you Balaji.
Operator, Operator
Thank you. Our next question comes from Nathan Rich of Goldman Sachs. Your line is now open, please go ahead.
Nathan Rich, Analyst
Great, good morning, and thanks for the questions. I wanted to follow up on the North America generics business. I think Richard, in response to an earlier question, you had talked about stabilization in the North American generics business in ’24. I guess, does that mean we should be annualizing the Q4 revenue run rate, or is that more of a flat year-over-year relative to 2023 comment? Then maybe a longer-term question on pricing. Some of the PBMs have talked about moving to cost-plus drug reimbursement. Just curious if you would expect that to have any longer-term impact on generic pricing for the industry.
Richard Francis, CEO
Hi Nathan, thank you for your question. I think when it comes to North America, what we talk about is, and I think we talked about this early on in the Pivot to Growth, we want to stabilize the U.S. generic business in particular and then get it back to growth. I think what you see here is with the number of launches we’ve had, that we have an opportunity to do that. Now, whether that tips into growth or whether it tips back into flat stabilization, we’ll have to see how it plays out. The reason for the hesitation in being absolutely definitive is because of what you talked about around pricing and what the erosion will be next year, and also with the number of launches we have, how many competitors come in and how they play out, so there are a lot of variables within that. I think for us, it’s about stability and building on that and getting it back to growth, and to be thoughtful about how we communicate that. That’s the way to think about it. With regard to pricing and what you said about the PBMs, look - I welcome anybody that starts to look at generics pricing to make it sustainable. I think right now, it’s a very challenging environment, continues to be, where the value that generics bring to the healthcare industry, to the hospitals, to society is not reflected in the price that we can sell them at, and I think that creates a very challenging environment. I think probably that has led to the PBMs and the payors thinking about actually supply challenges and how do we mitigate those, and I think is what has raised this discussion. Would this be a solution? I think there are many others I could also suggest. I think ultimately you have to have a price that creates sustainability, that allows us to invest in not only launches but in capital in our manufacturing sites, and I think that requires people just to step back and understand a bit more about what it takes to achieve that. So it’s good that it’s having a conversation now, but I don’t think that is the silver bullet necessarily to improve the market. Thanks for the question, Nathan.
Nathan Rich, Analyst
Thank you.
Operator, Operator
Thank you. Our next question comes from Jason Gerberry of Bank of America. Your line is now open, please go ahead.
Jason Gerberry, Analyst
Thanks for taking my follow-up. Just curious, can you comment on the margins now that the planned divestiture, I think it was $700 million external, $300 million internal revenues, but just wondering how to think about how profitable that business is when we try to think about potential valuations. Then with the Olanzapine LAI program, will you guys give any updates regarding the number of injections without PDSS signal, or will the next update just be the second half of 2024 pivotal top-line update? Thanks.
Richard Francis, CEO
Thank you Jason. Thanks for your questions coming back. I think with regard to TAPI, I think the idea was what it’s going to do for margins, and I’ll hand that to Eli, but on the whole I think it’s pretty neutral with regard to what it does to margins, so don’t think of it impacting our margins in a positive or negative way - that’s probably the simplest way to think of that one. Anything to add to that, Eli?
Eli Kalif, CFO
No, I don’t have anything to add.
Richard Francis, CEO
Okay, and then going onto Olanzapine, I’ll hand that one to Eric and maybe get more specifics about the fact that we’ve fully recruited the study, and maybe how many injections we’ve had.
Eric Hughes, Head of R&D and Chief Medical Officer
Yes, so I can give you up to the minute data on that right now. There are 675 patients in the study - that’s fully enrolled globally at this point. To date, we’ve had 2,030 injections completed, no PDSS at this point - that’s 62% of our total target that we want for the clinical package for the submission, so we’re well on our way and we’ll monitor this very closely.
Richard Francis, CEO
Thanks Eric. Thank you for the question, Nathan.
Nathan Rich, Analyst
Thank you.
Operator, Operator
Thank you. Our next question comes from Oleksy Soroka of ING. Your line is now open, please go ahead.
Oleksy Soroka, Analyst
Yes, hi. Thank you for taking my questions. With regards to your debt, what are your plans for refinancing the upcoming maturities, including the bonds?
Richard Francis, CEO
Thank you, Oleksy, for the question. Eli, could you take that one?
Eli Kalif, CFO
Yes, thanks for the question. Yes, so if we’re looking at the coming year, we’ll have a maturity of around $950 million due in April and another approximately $700 million due in October on the euro maturity, and we are pretty positioned very well to manage the maturities of ’24 and ’25 from our organic free cash flow. We will have a tower of around $3.4 billion around October ’26, which is allowing us enough time to consider when we will need to make the next refinancing. We are constantly looking at the market in terms of capacity and trends, and we are calculating our strategy along this; but currently, we don’t have any specific need to go early.
Oleksy Soroka, Analyst
But would you expect to deal with the ramp with this peak that you mentioned in October 2026 this year, to start pre-funding it?
Eli Kalif, CFO
Yes, so it really depends on the dynamics and the weighted average of our maturities that we need to tear down, which is at the level of 3%-plus. That maturity in ’26 and the market is now doing 6% to 7%, so it really depends on how this one evolves because that will require some capital allocation regarding interest expenses and timing. But as I mentioned, we are constantly looking at that one, and usually we would like to go between 12 to 16 months ahead in order to address those maturities, but we think there is enough time, but still we are reviewing all those strategies around it.
Oleksy Soroka, Analyst
Okay, all right. Thank you.
Richard Francis, CEO
Thanks Oleksy, thanks for the question.
Operator, Operator
Thank you. Our next question comes from Madison Aron from JP Morgan. Your line is now open, please go ahead.
Madison Aron, Analyst
Hi, thanks for taking my question. On your Page 14 on the generic pipeline, you include Nexplanon as one of your technology targets. Can you just walk us through as to what you’re planning there? Is that an ANDA filing that you’re planning? Just if you could give us some detail, thank you.
Richard Francis, CEO
Hi Madison, thanks for the question. I’m glad you noticed Slide 14 and the numerous complex generics we’re bringing to the market. With regard to some of these, obviously it’s quite a competitive environment, so we don’t like to go into too much of the specifics because of the nature of that. I think highlighting them gives a good insight into what we have and what’s coming, and I think that’s what we wanted to show here and the fact that we have a very broad portfolio across a number of technologies, so that’s our aim here. But for competitive reasons, we really don’t want to get into the strategy and the details around that, and hopefully you can understand that.
Madison Aron, Analyst
Thank you.
Operator, Operator
Thank you. At this time, we currently have no further questions, so I’ll hand back to Richard Francis for any further remarks.
Richard Francis, CEO
Thank you, and thank you everybody for dialing in. I appreciate your interest in Teva and I appreciate the questions, and I look forward to catching up with many of you in the next couple of days and obviously look forward to speaking to you at quarter one earnings later in the year. Thank you very much.
Operator, Operator
Thank you for joining today’s call. You may now disconnect your lines.