Teva Pharmaceutical Industries (TEVA) Q3 2024 Earnings Call Transcript

Teva Pharmaceutical Industries (TEVA -4.90%)
Q3 2024 Earnings Call
Nov 06, 2024, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Hello, and welcome to the Q3 2024 Teva Pharmaceuticals 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, senior vice president, head of investor relations. Please go ahead.

Ran Meir — Senior Vice President, Global Head of Investor Relations and Corporate Communications

Thank you, Alex, and thank you, everyone, for joining us today. We hope you have had a chance to review our Q3 results press release, which was issued earlier this morning. A copy of the press release, along with the slides presented during this call are available on our website. Please review our forward-looking statements on Slide No.

2. Additional information regarding these statements 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 second quarter business performance, recent events and 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 third quarter financial results and our updated financial outlook in more detail. 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?

Richard Francis — President and Chief Executive Officer

Thank you, Ran, and good morning, good afternoon, everybody. Thank you for joining Teva’s third quarter 2024 results. So I’m going to walk you through a presentation today, which — the backbone of it is in our Pivot to Growth strategy. And as you know, we launched this last year to get Teva back to growth, and it’s focused on four pillars: deliver on our growth engines, step up innovation, create a sustainable generics powerhouse and focus the business.

And through the presentation, myself, Eric and Eli will show the progress we’re making across this strategy. But just to give you some sort of areas to focus on, as you’ll see and deliver on our growth engines, we are driving strong performance with our innovative portfolio of AUSTEDO, AJOVY and UZEDY. In step up innovation, Eric will show you the great work his team have done at building a deep pipeline that’s coming to fruition, and we’ve got some exciting milestones and data points coming up in the near term. And then, on our sustainable generics powerhouse, you’ll see the performance we have across all of our regions, and I’ll give you a bit of context as to what’s driving that and what’s behind that.

And then, finally, focus the business. We’re very pleased to see that some of the credit ratings have looked at Teva and see the future is brighter. And also, we’ll give you an update on TAPI and the divestment process there. But now moving on to the next slide.

As you see, the consistency with which we are driving growth at Teva is impressive. From quarter 1, 2023 to now the 15% growth we see in quarter 3 2024 shows the consistency, and this all comes from the execution of our strategy and the diligent focus we have on operations. Now, let me go into a bit more detail as to what’s behind this number, 15%. Well, revenues of $4.3 billion, as I’ve said, up 15%.

Adjusted EBITDA of $1.3 billion, up 17% and our EPS is up 16%. Also, we have strong free cash at $922 million and it’s good to see that our net EBITDA is now touching three, shows our focus on our debt repayment. Now, because of these strong financial results, we’re going to be able to that give an increased outlook for the full year. And I’ll leave that pleasure to Eli Kalif, my CFO, to talk about a bit later in the presentation.

But now to go into a bit more detail as what’s behind this at 15% growth. As you can see from this slide, what I’m pleased about in this slide is the fact that our innovative business, our generics business and our TAPI business are all driving growth. As you see, AUSTEDO continues to perform impressively with 28% growth. AJOVY at 21% is our global driver.

And then, UZEDY, a strong launch and momentum there, and I’ll go into a bit more detail later about what’s behind that. Then we have a 17% growth in our global generics business, and you’ll see that that comes from all of the regions. And in TAPI, its third quarter of return to growth. We returned to growth in Q1.

We cemented that in Q2, and now we’re solidifying that in Q3. But let me double click on each one of these to give you a bit more detail. So starting with AUSTEDO, $435 million for Q3, impressive growth of 28% and strong TRx growth of 36%. So the team are doing an exceptional job here and I’d like to reaffirm the guidance of $1.6 billion for AUSTEDO for the full year.

Now, moving on to AJOVY, the oldest member of our innovative family, but it still continues to impress, a 21% growth versus the quarter 3, 2023. What I like about this, this is a highly competitive market, but it shows what Teva can do across all of its regions, all of its geographies and with this level of competition. And as you can see, regardless of which area you look at market share is impressive, whether it’s in Europe, whether it’s in international markets or whether it’s in the U.S., showing the full muscle that we have in our commercial teams. Now, moving on to UZEDY, which is the newest member of our family, our innovative family.

Good momentum with our launch. U.S. revenues of $35 million in Q3 ’24, and that gives us a year-to-date number of $75 million. Because of this strong performance, we’re increasing guidance for the full year, up from $80 million to $100 million.

And what’s behind this really is above from excellent execution by the team here in the U.S., it’s also driven by a great product profile that meets both physicians and patients’ needs. And Eric has talked about that on many occasions. But just to reiterate, this is a product which is a subcutaneous pre-filter and that doesn’t have to be refrigerated. And very importantly, for a physician, it allows the patient to get to therapeutic dose within eight to 24 hours, which is a very important criteria when treating these patients.

So great work with UZEDY, and I look forward to seeing continued momentum there. Now, staying with innovation, I’d like to move on to our pipeline but only briefly because I want to leave that to Eric to go in a bit more detail. But I think what I’d like to show is just the progress we’re making and the depth we’re creating in our innovative pipeline. But obviously, there are some exciting catalysts coming up.

I’d like to highlight the fact that we have achieved the Phase III target injections without any PDSS in our olanzapine study, so very excited about that. And obviously, when it comes to our TL1A there is a news to be announced toward the end of this year, but Eric will give you more detail on that. Now, moving on to biosimilars. Another area we’re excited about to drive our pivot to growth in the short, medium and long term.

We’re pleased with the fact that our Prolia biosimilar has been accepted for review by the U.S. FDA and the EU EMEA. And because of this, we anticipate a decision by both agencies in the second half of next year. Just to remind you, this product is a $3 billion brand.

And so, once again, we see good opportunity to drive growth for Teva in the short, medium and long term. Now, moving on to the biosimilar portfolio as a whole. As you can see, we are building a big portfolio. It’s up to 17 biosimilars now.

And as you see, this target is nearly $60 billion of brand value. What I’m pleased about here is we have a number of launches coming up in short term, but we are building a long-term portfolio to drive our growth, both medium and long term. And as you can see on this slide and an announcement we made in Q3. We do have — we have started a collaboration with mAbxience, where we bought two — we partnered on two oncology biosimilar assets.

So once again, building out the depth of our stable of biosimilars here. Now, moving from biosimilars to generics. Impressive growth of generics, 17% globally, and really pleased to see this growth continue across all regions. As you can see here, the U.S.

is up 30%, EU is up 8%, and our international market is up 13%, all in local currency. And what’s behind this is the work we’ve been doing for the last 20 months, focusing on product launches, focusing on supply chain and commercial execution. And I think it shows we’re getting traction across all regions of Teva with driving our generics business forward. Now, the final part of that growth that I talked about in the earlier slide was TAPI, and this is the third quarter of growth for TAPI, 4%.

So congratulations to the team and this shows that their strategy is working. The continued focus on our CDMO expansion is gaining traction and the 4% growth is a result of that. I would like to highlight that we are on track for our divestment in H1 of 2025. Now, with that, I would like to hand over to Eric Hughes, who will walk you through some of that exciting pipeline I was talking about.

Over to you, Eric.

Eric Hughes — Chief Medical Officer, Head of Research and Development

Thank you, Richard. Let me start off with our anti-TL1A program. I’m very proud of our Duvakitug team for accelerating this program, and we’re really excited to the top line results that’s on track for the fourth quarter of this year. Just as a reminder, it’s a study that includes both ulcerative colitis & Crohn’s disease.

It has 240 patients, 120 for each indication, and we have two doses against placebo. This is the induction phase of the study, and the primary endpoint is at week 14. And just to remind everyone, the primary endpoint for ulcerative colitis will be clinical remission using the Modified Mayo Score. And for Crohn’s disease, it will be the endoscopic readout.

So we’re very excited about that. The team has done a great job. Moving on to the olanzapine LAI program, which is right on track. We’ve now presented our period one of the study.

That’s the eight-week endpoint. And you can see here that our PAM score was right on target with all three doses that was presented last month externally. And we’re very excited about this program because this is a program with a formulation that’s specifically designed to prevent PDFF. We have not seen that to date.

And as Richard mentioned, we’ve exceeded the target that we have designed into the program as expected. We’ll be bringing our last patient in at the end of this year. and we will be presenting that data in the first half of 2025. So very excited to get the full data set presented externally.

Moving on to anti-IL-15 program. We have now presented our Phase I data last month. We already enrolled our POC study in Celiac disease. This is a high affinity anti-IL-15 antibody that really actually has great, robust, rapid and prolonged effects on free IL-15.

You can see in this graph that in fact, we have suppression at the higher dose here almost out to 80 days. So we’re very happy to see these initial Phase I results. We’re glad to be in Celiac disease already. But I’d also like to announce today that we’ve now initiated our second indication for our anti-IL-15 program, expanding the potential of this multi-indication product.

Vitiligo, if you don’t know, is an autoimmune disease that impacts patients’ quality of life by really depleting the melanocytes in the skin, causing a discoloration. And this can be highly impactful on us and it has a psychological burden on patients with impressing — a lot of depression and anxiety in their daily life. For many of the patients, over one third of these patients had more than 10% of their body affected. And we believe that IL-15 is a key cytokine in blocking these cytotoxic T cells from depleting monocytes in the skin.

And why is this important? Well, there are treatments with topical treatments, but since this is such an extensive disease for some patients, having a safe and effective and easily given systemic treatment is really needed. So we’re very excited about starting that study and enrolling our first patient. And finally, moving on to emrusolmin. We’re very pleased to announce that we’ve enrolled our first subject here, where we’re running a robust Phase II study with 200 participants against placebo for full 48 weeks.

And just to remind you, emrusolmin is a small molecule that penetrates the brain and reaches the site of where the alpha-synuclein is being produced in the brain cells. And these alpha-synuclein aggregates are the genesis of the problem that’s terribly degenerative and relentless disease that most people are on a wheelchair by five years after diagnosis. And frequently, many don’t survive past 10 to 12 years. So a high unmet medical need.

We’re making sure this is a very robust study, and we’ve enrolled our patient just last month. And finally, I just want to go over the slide that Richard had briefly mentioned. I hope you can see from this slide that we have a robust innovative pipeline in multiple indications with multiple novel molecules. Our olanzapine LAI is on track.

We’ll have our full study safety readout in the first half of 2025. Our Duvakitug program is right on track with our top line results coming out in the Q4 of this year and also requires and Crohn’s disease. We’ve expanded anti-IL-15 from Celiac disease and into vitiligo, we working on initiating that study, which I mentioned, we have already started. Our anti-PD-1 IL-2 has enrolled its first — or screened its first patient, and we’re looking to fully enroll that study in the second half of 2026.

Our ICS SABA, our dual action rescue inhaler for asthma is rapidly enrolling in Phase III, and we’re working to accelerate that as fast as possible. And finally, as I mentioned, emrusolmin has enrolled its first patient and multiple system atrophy, a great unmet medical need that we’re proud to be in. And with that, I’ll pass it off to Eli Kalif.

Eli Kalif — Executive Vice President, Chief Financial Officer

Thank you, Eric, and good morning and good afternoon to everyone. I’ll begin a review of our Q3 2024 financial results with Slide 24, starting with our GAAP performance. Revenues in the third quarter of 2024 were $4.3 billion, an increase of 13% in U.S. dollars or 15% in local currency terms compared to the third quarter of 2023.

The increase in revenue was mainly driven by growth from generics products across all our segments globally, including continued strong contribution from generics Revlimid and from the recent launch of generic Victoza in the U.S. and a strong growth from our key innovative products, including AUSTEDO, AJOVY and UZEDY, as well as from the sale of certain product rights in our Europe and international market segments. Foreign exchange rate movements during the third quarter of 2024 and the year-to-date, including hedging effect, have negatively impacted our revenues and profitability compared to the same period last year. with a negative year-to-date impact of approximately $250 million on our revenue and $190 million on our gross profit mainly as a result of a stronger U.S.

dollar against the currencies of certain international markets in which we operate. In Q3 2024, we recorded a GAAP operating loss of $51 million compared to a GAAP operating income of $344 million in the same quarter last year. This reduction was mainly due to a goodwill impairment charges related to our API reporting unit and a higher legal settlement and loss contingencies recorded in the third quarter of 2024, partially offset by higher gross profit. GAAP net loss in Q3 2024 was $437 million and a GAAP loss per share was $0.39, compared to a net income of $69 million and an earnings per share of $0.06 in Q3 of last year.

The higher GAAP net loss in the third quarter of 2024 was mainly due to the operating loss that I just discussed. Turning to Slide 25. You can see that the total non-GAAP adjustment in the third quarter of 2024 were $1.2 billion, this include a $600 million goodwill impairment charge related to our API reporting unit, in line with our intention to divest this business. In addition, we recorded a legal settlement and loss contingencies of $450 million including a provision of $350 million in connection with the decision by the European Commission and its antitrust investigation into COPAXONE, which we intend to appeal.

Now, moving to Slide 26 for a review of our non-GAAP performance. As I mentioned earlier, our third quarter revenues were $4.3 billion, an increase of 13% in U.S. dollars or 15% in local currency terms compared to Q3 of last year. Our non-GAAP gross profit margin was 53.7% and compared to 53.5% in Q3 of last year and 52.9% in the second quarter of 2024.

This improvement in our non-GAAP gross profit margin was mainly driven by expected improvement in our portfolio mix, primarily AUSTEDO, partially offset by an adverse impact from foreign exchange immovements, including hedging effects that I just mentioned. We expect our gross margin to further improve in the fourth quarter with a further ramp in Q4 revenue and continuation of our cost optimization efforts. Non-GAAP operating margin was 28% in Q3 2024 compared to 26.5% in Q3 2023. The increase in the non-GAAP operating margin in the third quarter of 2024 was mainly due to lower operating expenses as a percentage of revenue, consistent with our expectation of the second half of the year and reflecting a higher revenue.

The lower spend on R&D in the third quarter was largely due to a benefit of reimbursement from our strategic partnership to support our key late-stage innovative programs. We continue to invest both in our existing innovative portfolio as well in our pipeline. As Eric highlighted earlier, we are looking forward to sharing Phase II top line results this quarter for our anti-TL1A program in partnership with Sanofi, as well as olanzapine LAI full Phase III external readout in the first half of 2025. Turning to EPS.

We ended the quarter with a non-GAAP earnings per share of $0.69 compared to $0.60 in Q3 2023, mainly driven by higher non-GAAP operating income I just discussed. Now, moving to Slide 27, which will highlight steady improvements in our margins and cash flow as we continue to invest in our business to drive short- and long-term growth. As you can see, our gross margin and gross profit has gradually improved throughout this year, driven by our portfolio mix and disciplined cost management. As part of our pivotal growth strategy, we are also constantly reviewing our generic product portfolio to rationalize where it makes sense, with a focus of the long-term profitability and sustainability.

And at the same time, we continue to make focus on investment to support our growing innovative portfolio through our marketing and other initiatives, as well as the progress on our key pipeline assets, leading to higher operating expenses. We expect these dynamics to continue in the fourth quarter with a further improvement in our margins, consistent with our full year guidance. We also remain focused on optimizing our working capital management. Over the past few years, we have strategically put the programs in place to ensure that our operational processes, commercial terms and financial solutions supporting growth sales with a reduced net working capital investment.

As a result, we have achieved significant improvement in our net working capital as a percentage of revenue. Our free cash flow in the third quarter of 2024, and year-to-date reflects this progress we have made throughout this year. The year-to-date increase of 42% in our free cash flow compared to last year is driven by higher net profit, driven by revenue mix, as well as our ongoing efforts to improve our working capital management, partially offset by higher legal payments. As a reminder, during the third quarter of 2024, we made the second payment of the nationwide settlement in connection with the opioid litigation.

Our free cash flow year-to-date includes $390 million of opioid legal settlement payment, which was an increase of $210 million compared to the first nine months of 2023. Excluding these payments, our cash conversion year-to-date was 82%. Reflecting on these results, we are reaffirming our 2024 full year free cash flow guidance range of $1.7 billion to $2 billion, which we initially provided in January. Turning to Slide 28.

As you can see, we continue to reduce our net debt, which was $15.7 billion at the end of Q3 2024. Our gross debt was $19 billion compared to $19.8 billion at the end of 2023. This decrease in our gross debt was mainly due to a repayment of $956 million of 6% senior notes at maturity in April 2024, partially offset by $88 million from exchange rate fluctuations. Our net debt to EBITDA further improved during the third quarter coming at three times, reflecting the ongoing progress with our free cash flow generation, as well as higher EBITDA.

After the quarter closed on September 30 in mid of October, we also repaid the maturity of another $685 million of our senior notes. Currently, there are no additional maturities outstanding for 2024. As of September 30, and as of today, there is no amount outstanding under our $1.8 billion revolving credit facility. Moving to the next slide.

I want to share how the execution of our Pivot to Growth strategy, along with our disciplined capital allocation policy over the last several quarters has started to be recognized by the leading credit rating agencies. In June, S&P upgraded outlook to Teva credit from stable to positive, reflecting improved growth prospects and continued deleveraging of our balance sheet while maintaining our BB minus rating. In the last two months, both Fitch and Moody’s have also agreed to Teva credit outlook, with Fitch upgrading our rating to BB. The upgrade by Fitch marked the first time in over a decade that Teva’s credit ratings has been upgraded.

This upgrade reflects our focused and consistent execution of the strategy on multiple fronts, including return to and delivering sustainable growth, significant ongoing progress in reduction in our debt, improving operational efficiency and putting uncertainties related to legacy litigation behind us. We are pleased with these upgrades and remain committed to achieving an investment-grade rating. Now, let’s turn our attention to our 2024 non-GAAP outlook on Slide 30. As Richard highlighted earlier, our year to date results reflect solid progress across our business.

Our key innovative products continued to see strong growth driven by significant unmet needs in the markets we serve and supported by our focused investment to drive awareness and improve patient experience. With the year-to-date revenue progress with UZEDY, we are now expecting UZEDY revenue for the full year to be at $100 million compared to our prior expectation of $80 million, reflecting solid demand and growing adoption. We also expect COPAXONE revenue to be higher than our previous guidance, reflecting lower-than-expected erosion from competing therapies. In addition to the strong momentum in our innovative portfolio, our core generics business continued to perform well across all our key markets.

Therefore, to reflect our results in the first nine months and expected performance in the fourth quarter, we are raising our 2024 full year revenue guidance to $16.1 billion to $16.5 billion. This reflects an increase of $100 million from the previous guidance range we provided last quarter. We are also raising the lower end of 2024 non-GAAP outlook for operating income and EBITDA by $100 million and our earnings per share guidance range by $0.10 to be between $2.40 and $2.50. We continue to expect our non-GAAP gross margin to be between 53% to 54% for the full year with a further improvement in our fourth quarter and operating expenses to be in the 27% to 27.5% range for the full year as provided at the beginning of the year.

And as I mentioned earlier, free cash flow are expected to be between $1.7 billion to $2 billion for the full year. With this, I conclude my review of Teva’s results for the third quarter of 2024. And now I will hand it back to Richard for a summary.

Richard Francis — President and Chief Executive Officer

Thank you, Eli, and thank you, Eric. So moving on to our financial targets for 2027. We’re on track to meet these. And I think you can see from the robustness of our business across all segments.

You can see the confidence we have in meeting these targets, mid-single-digit growth operating income margin of 30%, net debt adjusted EBITDA of two times and cash to earnings of 80%. Now, moving on to my final slide. is to reiterate that we are executing with precision, our pivot to growth strategy. This is a strategy, I think we’ve shown really good traction over the last 20 months, but also I’d like to highlight that we see the potential going forward.

Some of the things we’ve highlighted in our pipeline around olanzapine, ICS SABA, the biosimilar portfolio. The generics business has now moved from stabilization to growth. We have many opportunities in this Pivot to Growth strategy to keep growing the company over the short, medium and long term. So with that, I’d like to conclude the presentation and open up the floor to questions.

Questions & Answers:

Operator

[Operator instructions] Our first question for today comes from Umer Raffat of Evercore ISI. Your line is now open. Please go ahead.

Umer Raffat — Analyst

Hi, guys. Thanks so much for taking my question and congrats on all the execution. I have three, if I may. First, I’m curious what your expectation is on placebo response in the TL1A Phase II trial coming up? Second, on UZEDY, the launch performance is clearly now tracking ahead.

And I wonder, what does that mean for you in terms of how you’re thinking about the peak sales for long-acting olanzapine? And then, finally, on long-acting olanzapine, I noticed you have a new trial of three extended-release formulations with different release rates. Why do that at this point?

Richard Francis — President and Chief Executive Officer

Umer, thanks for the questions. I will hand over the first one TL1A to the Q2 to Eric, and then I’ll take the UZEDY one and then hand you back to olanzapine one.

Eric Hughes — Chief Medical Officer, Head of Research and Development

Thanks, Richard, and thanks Umer for the question. So placebo responses in ulcerative colitis & Crohn’s disease are variable. You can see in the study that have been recently completed, there are differences. Sometimes those differentiation are related to how they calculate certain aspects of the modified Mayo score.

But it’s hard to predict, and I’ll just leave it at that with regard to the study.

Richard Francis — President and Chief Executive Officer

Actually, why don’t you take the olanzapine one as well?

Eric Hughes — Chief Medical Officer, Head of Research and Development

Oh, yes. And olanzapine LAI studies that have just come online. So that’s part of our European submission package that we’re running for a PK analysis of the olanzapine LAI.

Richard Francis — President and Chief Executive Officer

Thanks, Eric. And then, on UZEDY, yes, we’re obviously very pleased with the work the team have done and showing the capability of driving growth in that market. I think what I’d say with regard to olanzapine, yes, we believe we have a real asset in olanzapine, a real unmet need because there hasn’t been a long-acting olanzapine in the market. I think we’ve shown in a congested market where UZEDY if we have a differentiated product, and a quality team behind in what we can do.

That gives us a lot of optimism for olanzapine because of the unmet medical need and the fact that we will be coming to this market, maybe not a standing start. If I remind everybody, with UZEDY, that came along. And we really didn’t do the level of prelaunch that we would like to do normally. And so, I think the team have done a good job in picking up the ball and getting running quickly.

That won’t be the case with olanzapine. We know the positions. We know the payers, we know the hospitals. We know the forming committees we have to.

We’ve got good relationships with them because we have a good asset in UZEDY. And so, for us, the ability to prepare ourselves and to make sure the market is prepared for olanzapine. I think we put ourselves in a very good position. What that looks like is a potential.

I think as we start to really get into the detail of the data and understanding the landscape with regard to key opinion leaders and payers and patients. We will clarify that. But we’re very optimistic and very enthusiastic about it. Thanks for the questions, Umer.

Operator

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

Balaji Prasad — Barclays — Analyst

Thank you. Congratulations on the results and great to see the all around growth and pipeline progress. But firstly, I wanted to start off with a bigger thematic question, Richard. So making America had received significant push under the previous Trump presidency, especially as a supply chain situation post-COVID exposed the U.S.

generic vulnerabilities and will likely to be a priority again, I think. In such an event, is there a structural tailwind? Or how can Teva leverage such a possible push in the generics in biosimilars as well? And what does it do for margins in the longer run? That’s one. Two, on the pipeline front, we recently hosted a CNS call on olanzapine LAI. We discussed in-depth around the no monitoring requirement and said that’s needed for it to be a big drug, a $1 billion drug.

So with the safety data available till now, can you comment on your expectations or confidence with such a label?

Richard Francis — President and Chief Executive Officer

Thanks, Balaji. Thanks for the question. I’ll take the first one, which is a tricky one because obviously, we’re dealing in something that’s happened real-time. I think first and foremost, I’d like to point out that Teva as any company, I’m sure that’s a global company, works with any administration productively.

So I think we’ll do that here. And with regards to, is there any policy changes which impact the generic market? And then, obviously, as a major player — the major player in the U.S. generic market, I think that’s something that if it benefits a company like Teva then obviously, that is helpful. But I think for us, we’ll have to wait and see how that plays out.

I think what you’re talking about is something that may happen, but I think it still hasn’t crystallized. So over the next in a few months, actually, until into next year when the administration is actually in place as soon as we see what that looks like, then we can probably comment more on that in other earnings. But maybe to hand the other question on olanzapine over to Eric.

Eric Hughes — Chief Medical Officer, Head of Research and Development

Yes. So to review for the olanzapine LAI program and what we’ve designed the program in conjunction with the FDA, as we mentioned before, we’ve exceeded, as expected, the targeted number of injections that we need for the submission package. We have not seen any PDSS in real time at this point. We’ll have our last patient coming toward the end of the year.

But we’re excited because the scientific story is very strong, I believe, when it comes to our formulation. It’s designed to control spikes in the PK. It’s a subcutaneous shot, so it’s very unlikely to hit a large vessel like our competitors have a problem with. And we have a clinical data set and Phase I data that shows in very intensive PK that we don’t have this problem.

I think at the end of the day, though, it also — there’s an important unmet medical need for patients. They need an option for olanzapine in a long-acting injectable. So I think with all those things, the fact that we’ve design this in conjunction with the FDA. I think that our chances here are good.

That’s always going to be a review question for the FDA, but I think that we’ve checked all the boxes.

Richard Francis — President and Chief Executive Officer

Thanks, Eric. Thanks for the questions, Balaji.

Operator

Thank you. Our next question comes from David Amsellem of Piper Sandler. Your line is now open. Please go ahead.

David Amsellem — Analyst

Thanks. So just to ask a couple of quick ones. First, can you comment on how you’re thinking about U.S. generics for 2025, particularly interested in products that can offset pressure on lenalidomide given the competitive dynamics there.

And how you’re thinking about new contributors to the U.S. generic/biosimilar portfolio in ’25 beyond, say, Stelara? So that’s No. 1. And then, No.

2 is, as you looking at the UZEDY ramp, I was wondering where you’re getting patients from? Are these switches from oral risperidone? Are you getting switches from other oral atypical antipsychotics? I’m just interested in the patient mix? And then, the third one, if I may, is just how you’re thinking long term about any impact on LAI antipsychotics from the availability of muscarinic agonists in schizophrenia?

Richard Francis — President and Chief Executive Officer

Thanks for the questions, David. I think I’ll give my view on those and then maybe ask Eric to chime in. So on the U.S. generics business for 2025, obviously, we’ll give guidance on that at the start of the year.

But let me sort of help answer your question at least a bit and how we’re thinking about it. Yes, obviously, the team have done a great job with Revlimid. But I’d also like to add that we have launched other complex generics in the U.S. this year with Victoza, octreotide, and Forteo and others.

And so, that’s part of, obviously, we get the benefit of those when we move into ’25. But we also have some good launches planned for ’25 with Symbicort, Saxenda, etc. So I think we’ve already shown as we focus on launching our generics and our complex generics, we have the ability to do that better than we’ve done in the past. We then add into that, as you’ve highlighted, our biosimilars, biosimilar Humira, biosimilar Stelara, that obviously, you put that together collectively.

I think that gives — puts us in a very good position to manage the change that we’re going to have with Revlimid in 2026. So that’s how we think about it. With regard to UZEDY, I’ll sort of start a bit and I’ll like Eric to give a sort of physician’s point of view, as well as the new entrants. So you UZEDY, there’s a couple of things, I think, that we benefited from.

One is a great product profile. So it’s a really good product profile. And because of that, physicians see the benefit of using it over other long-actings. That ability to get to therapeutic dose within eight to 24 hours is really critical when you have a patient who’s having an episode.

Then we have some more practical ones about subcutaneous prefilled syringes out of the refrigerator or important when dealing — when working in these institutions. And the second is we have a great commercial team here in the U.S. that’s really focused on executing, understanding the dynamics of the market, understanding the dynamics when it comes to physicians, payers, patient journey. And so, real capability we have at Teva, which maybe people didn’t appreciate.

So those are the things that have driven it, and we’re taking it from both orals and we’re taking it from other long-actings. What is interesting, we are getting a lot from orals. So showing that when people reach for a long-acting, they’re reaching for UZEDY more and more. But then actually, when it comes to question the long-acting they’re on, then they also reach for UZEDY more and more.

So I think that just goes to show that product profile. Now, before I hand over to Eric, I would say new entrants to the market, actually, we think, is a good thing because, one, optionality for patients is good, but it stimulates the market even more. And so, for us, with good products like used and olanzapine, we think we can benefit from that. But maybe I’ll hand over to Eric.

Eric Hughes — Chief Medical Officer, Head of Research and Development

Yes. When it comes to UZEDY and its product profile — and I’ve been very encouraged by the uptake of UZEDY because when we developed it, we are always proud of the product profile. I mean, it’s a prefilled syringe. It’s subcutaneous.

The PK — the drug levels get up to active levels in 24 hours. There’s no PO supplementation. We’re already presenting data showing how people can switch onto this very convenient product. When you’re a bit in the psychiatrist office it’s very busy.

You want to be able to have something ready and easily administered to your patients. So that’s what I’ve been proud of. And as far as muscarinic — there’s new muscarinic treatments for schizophrenia. We keep a close eye on that.

We’re very happy to see new MOAs come into this field. It is a BID oral medication, though. And there will be also step-throughs when it comes to reimbursement and the use of other generic treatments. So though if it’s a BID oral treatment adherence has been and always will be a problem with this population, and that’s why it’s a different value proposition when it comes to our long-acting injectables.

Richard Francis — President and Chief Executive Officer

Thanks for the questions, David.

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

Hey, good morning, guys. Thanks for taking my questions. Just on TL1A for the fourth quarter update, just wanted to confirm that we’ll get placebo-adjusted UC mayo remission scores at week 14, just so we have some relative sense of benchmarking against competitors? And is the Crohn’s subgroup power to show stats? And then, just on TAPI, can you just maybe give us an update where you’re at in the process that underpins confidence for a first half ’25 close of that, and you’ve made really good progress on the net debt deleveraging. So really just trying to get a handle on some of these legal matters like the recent European fine? Like is that something that you take a cash hit on more in the near term? Or given the multiyear appeals process, something that maybe there’s not a cash hit for a while?

Richard Francis — President and Chief Executive Officer

Thanks, Jason. Thanks for the question. I think I’ll hand the first one to Eric.

Eric Hughes — Chief Medical Officer, Head of Research and Development

Yes. Thank you. I appreciate the question. So yes, both ulcerative colitis and Crohn’s disease is placebo-controlled in the study and we will provide the placebo-adjusted numbers.

That’s critical in thinking about Umer’s question early on, the placebo is key. And I would remind you, too, that this is the first placebo-controlled randomized study for Crohn’s disease with this MOA. So we’re proud to be the first one to do that, and that’s what we’re targeting to give you.

Richard Francis — President and Chief Executive Officer

And I’ll maybe tag team this with Eli a bit. So just starting on the TAPI, we’re well on track with that, and we should be in a position to complete that divestment in H1 of 2025, as we’ve already previously announced. With regard to debt, before I hand that to Eli, just on the European announcement. I’d just like to point out that, as you saw in our press release, we don’t agree with that decision, and we are going to appeal that.

And that will take many, many years, unfortunately, but we are going to appeal it because we don’t agree with it. And so, there’s no cash impact in the short term because of that. And we think we have a good case. With that, I’ll hand it over to Eli to maybe comment if there’s any questions relating to debt or —

Eli Kalif — Executive Vice President, Chief Financial Officer

Yes. So thank you, Jason. So first of all, about the — you asked also about what does it mean in terms of the EU commission fine in terms of cash. So for the coming several years, we don’t see this one as a cash event.

We were able to structure with certain levels of facilities in order to accommodate any pledge that we required to do as part of the appeal process until the final judgment. As far as related to the net debt and deleveraging, as I mentioned in my prepared remarks, in October, we made another payment of maturities. So for ’24, we don’t have any of these. But we do have in the first quarter of ’25, around $1.4 billion, one in January, one in March, in total, $1.4 billion.

So next year, it’s kind of more front-loaded in terms of debt payment. But that will actually — we will be able to manage it versus our organic free cash flow generation and our ongoing prediction. Other than that, we’re still constantly looking on the market to decide if and when we will need to require to make any refinancing plan heading to the ’26 and ’27 towers.

Richard Francis — President and Chief Executive Officer

Thanks, Eli, and thanks for your question, Jason.

Operator

Thank you. Our next question comes from Chris Schott of J.P. Morgan. Your line is now open.

Please go ahead.

Chris Schott — Analyst

Great. Thanks so much. Just a couple of quick ones for me. Maybe just on the pipeline first on emrusolmin.

Can you just talk about, is there a filing pathway for this one based on the Phase I? Or we have to think about a Phase III kind of program coming from there? My second question was on TL1A and to the extent the Phase II data reads out successfully. Just curious how quickly you can move that forward into Phase III just given the competitive landscape that’s out there? And then, finally, just a bigger picture one. Can you just talk about overall level of investment going on at Teva right now? You’ve obviously accelerated the pipeline. You’ve made some really good investments on that front.

But to the extent we continue to see kind of this momentum in the core business, how should we think about that upside flowing through the P&L versus going into incremental investments and further accelerating some of these growth drivers? I’m trying a sense of like do we reach a point where there is more of it flowing down to the bottom line? Or should we think about kind of a balanced approach as you invest in the business?

Richard Francis — President and Chief Executive Officer

Thanks, Chris. Thanks for the questions. First two, I’ll give to you Eric. And then, the next one investment, I’ll start and maybe ask Eli to also contribute.

So over to you, Eric.

Eric Hughes — Chief Medical Officer, Head of Research and Development

Yes. So I’ll take the second one first on TL1A, our Duvakitug program. We’re running this in partnership with Sanofi. And one of the great things about the partnership is we’ve already started a year ago.

We’ve started this relationship, and we’re working very closely with them. So as soon as we get the data, we’re preparing to as rapidly as possible to start Phase III with them targeted in 2025, and we’ll have further announcements in that — about that next year. The emrusolmin, I did mention that we’re trying to make that Phase II study as robust as possible. It’s 200 patients placebo-controlled with one active arm.

This is a great unmet medical need. These patients need treatment. So if we see responses in there, I’ll be the first one to push for an approval and an accelerated pathway, but it’s all going to be dependent on the data, but that’s certainly our hope for these patients.

Richard Francis — President and Chief Executive Officer

And then, on the final question around investments. I think I’ll probably start with reiterating how we think about capital allocation at Teva. And the first part of that, when we announced the Pivot to Growth was obviously to pay down debt. Then it was to invest in our growth drivers and then to do BD.

Now, as we’ve — as you’ve highlighted, Chris, we made really great progress on driving our innovative portfolio in the market, but also accelerating our pipeline. So for us, this is always about creating long-term sustainable value. And to do that, we’ve had the opportunity and the need to invest in these potential growth drivers. As we’ve done, I think that very thoughtfully, to make sure we manage our opex level.

And as you hear from Eli, on a regular basis, the percentage of opex versus revenue is something we focused on and we’re keeping constant. So we think about that balance very carefully. What do we need to invest to create a sustainable long-term growing business, but also what do we do to make sure we can increase value for shareholders. And that’s something which we do think about.

I don’t think we ever think that that’s — there’s one extreme or the other, I think we need to try and deliver both over the medium and long term. And that’s why we’re committed to that 30% operating margin in 2027. But we need to do that thoughtfully to make sure that we’re not missing out on opportunities to drive long-term growth in the short term. So maybe that’s my opening statement.

Eli, do you have anything to add to that?

Eli Kalif — Executive Vice President, Chief Financial Officer

I will just add, Chris, if you go back in the last three quarters year-to-date, we generate in total-wise, $600 million incremental gross profit versus year-to-date year ago. We really kind of allocate around 45% from that one into — back to opex to invest in the business and the rest really flow through and enable us to expand our margin, be it the EBITDA expansion. I think that pattern we will try to manage as we move forward with how Richard mentioned and how we’re going to position our capital allocation.

Richard Francis — President and Chief Executive Officer

Thanks Eli. Thanks for your questions, Chris. Appreciate it.

Operator

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

Ash Verma — Analyst

Hi. Thanks for taking my question. So I just wanted to clarify on the API business. You’ve kind of accumulated a $1 billion impairment charge in the last two quarters.

What’s sort of driving that? Is there some material change in the business conditions? And then, how does that impact the divestment discussions that you’re having? And then, on the TL1A, I wanted to understand the rationale for the endpoint selection here. So for CD, you’re looking at endoscopic response as the primary end point. Some of the KOL feedback suggests that it’s a harder endpoint to show meaningful benefit in a short-term study like this versus you see, you sort of have a more realistic clinical remission end point, if you can comment on that?

Richard Francis — President and Chief Executive Officer

Ash, thanks for your questions. I’ll have the TAPI one to Eli and then Eric, if you can take the TL1A.

Eli Kalif — Executive Vice President, Chief Financial Officer

Thank you, Ash. So related to TAPI, internally, as you know, Tape is a stand-alone unit, and it includes both commercial and operational functions. Now, with the ongoing progress of the potential carve-out, we are reviewing constantly our allocated net assets, including the goodwill, which is kind of the legacy assets in that perspective and adjusting it for the potential expected deal structure. The impairment has no connection to the great performance that we have with TAPI as long as with the business plan that we are projecting.

Richard Francis — President and Chief Executive Officer

Thanks, Eli. And then, the next question, Eric?

Eric Hughes — Chief Medical Officer, Head of Research and Development

Yes. Ash, thanks for the question. For Crohn’s disease, yes, our primary endpoint is endoscopic endpoint. You’re right, that is more challenging on the short end of the study to show a difference.

Our key secondary endpoint is the clinical remission. So those two should be a good judge of the activity of the compound.

Richard Francis — President and Chief Executive Officer

Thanks, Eric. Thanks, Eli. Thanks for your questions, Ash.

Operator

Thank you. Our next question comes from Yifeng Liu of HSBC. Your line is now open. Please go ahead.

Yifeng Liu — HSBC — Analyst

Hi. Good morning. Thanks for taking my questions. I’ve got two questions.

One, could you talk about how you’re seeing the pricing environment of generic medicine this year and how you see it evolve maybe into 2025? And the second question is also on TL1A. Could you maybe tell — share a bit more color on the baseline split between UC and the Crohn’s disease across your three groups, if that’s possible?

Richard Francis — President and Chief Executive Officer

Thank you for the questions. So let me start on the generic one on pricing. So there’s nothing that’s changed in the pricing environment in the U.S. Obviously, the general pressure is downward because of the nature of the business.

And so, the way we tackle that is by launching new products, and improving our product supply and our cost of goods. And that’s something which we’ve been focused on significantly for the last 20 months. And so, for us, when we look about pricing pressures for 2025, we expect the market to be the same. Our general point of view on this is prices will be pushed down.

And so, how we offset that is by launching more products, as we’ve talked about in the U.S., and we do this regularly in the EU and international markets and then improving our supply chain. And I think we’ve shown, we have improved in this area, and we’re doing that better, and that’s hence the reason you’ll see the performance of our business being robust and strong across all regions. And then, maybe hand over TL1A question to you, Eric.

Eric Hughes — Chief Medical Officer, Head of Research and Development

And I hope I’ll interpret your baseline split question correctly. But in the study, it’s designed that it’s fixed, half of the study is ulcerative colitis, and half of the study is containing Crohn’s disease patients. When it comes to the baseline characteristics of the patients, they’re both going to be moderate to severe patients, a good proportion will probably be biologically experienced patients up taking to have up to three different biologics and/or some advanced oral therapies. And we’ll probably have about half of them have experienced a steroid use as well.

Richard Francis — President and Chief Executive Officer

Thanks, Eric. Thanks, Yifeng.

Yifeng Liu — HSBC — Analyst

That’s super helpful. Thank you.

Richard Francis — President and Chief Executive Officer

Thank you. Thanks for the question. Next question please.

Operator

Thank you. I’ll now hand back to Richard Francis for any closing remarks.

Richard Francis — President and Chief Executive Officer

OK. Well, thank you once again for your interest in Teva Pharmaceuticals. I appreciate the questions and your time. Hopefully, you see once again in quarter three our execution of our Pivot to Growth strategy continues to gain momentum.

We continue to execute on the things we said we’re going to execute on, and they have continued to deliver performance and value. We look forward to giving you an update for quarter 4 at the start of next year and to give you guidance for next year. Thanks very much. Have a good day.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Ran Meir — Senior Vice President, Global Head of Investor Relations and Corporate Communications

Richard Francis — President and Chief Executive Officer

Eric Hughes — Chief Medical Officer, Head of Research and Development

Eli Kalif — Executive Vice President, Chief Financial Officer

Umer Raffat — Analyst

Balaji Prasad — Barclays — Analyst

David Amsellem — Analyst

Jason Gerberry — Analyst

Chris Schott — Analyst

Ash Verma — Analyst

Yifeng Liu — HSBC — Analyst

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