Going to go a little past this, 20 minutes, just because there's a lot of topics of discussion, and for folks that are here, please let me know if you want to jump in with questions as well. You're absolutely welcome to jump in with questions. Richard, I'll let you kick it off, and we have a lot of topics to go through. Okay, well, I'll try and keep it brief. So, thanks, Umer, for having me. Appreciate people coming to listen. So I think, there's quite a bit to talk about Teva, which is quite nice. We launched the Pivot to Growth strategy two years ago, which laid out a clear, clear framework of how we're going to grow the company over multiple years. Four pillars. I will talk about those: how we're going to drive our innovative portfolio in the market, how, with the help of Eric, who to step up innovation and drive our pipeline through. Eric, we'll get you on mic over there. Get you on mic. Oh, yeah. And the third pillar was to create a generic powerhouse, and the fourth pillar was to make sure we focus the company, particularly the capital allocation. So, as I talk today with Umer and yourselves, I'll always refer back to those pillars, always refer back to the plan of what we're executing, and I'd like to think that the last two years we've shown that what we say we do, we do, and we execute really well. And, I think we've changed the trajectory of the company, but that will probably be the debate today. Great. Maybe just to kick it off, Richard, could you remind us, the pushes and pulls on EBITDA into next year? Yeah, I think, look, one of the things we've, I think we've been very clear about is we have a really exciting, we believe, pipeline and opportunities to grow the company long term, both on the top line and on the bottom line. What we've been very disciplined about is how we manage our OpEx, but at the same time, we have had to, we have spent more, we have invested more, particularly into the pipeline, particularly into our marketing products like Austedo or Uzedy, because that will give us EBITDA growth to 2027 and into the future beyond. So, as we think about moving to next year, we want to keep growing the top line. We want to have movement upwards on EBITDA as well, so we want to do that. What I would say is it's a measured approach because we're trying to invest in these things that are going to drive long-term value creation. So, we're always clear about that. Got it. Is Revlimid going to fade year-over-year? And is it over in 2026? Could you remind us? Yeah, it's going to be 2026 where it's over from the market we have now of Revlimid. So that's the headwind we'll hit in 2026. So the work we're doing as a team now is from our biosimilar portfolio and from our generics, particularly our complexes, how do we make sure we can launch those all on time and execute them well so we make sure that Revlimid revenue loss is minimized to keep us on the growth. Is next year flat or is it down year-over-year? Well, we have more, More volume. More volume. So it depends on what the pricing does in the market. So we don't really sort of comment on that because we have to wait and see. Got it. Okay, excellent. Now, an important catalyst coming up in February timeframe is the IRA list for 2027. Are you guys expecting Austedo to be on it? Yeah, so just to be clear, and I've spoke to many of you in this room, we forecast when we said in twenty, like two years ago that Austedo was going to hit $2.5 billion, which I remind a lot of people said, well, we think it's going to hit $1.4 billion peak. And this year we're going to do $1.6 billion. So we are going to do $2.5 billion in 2027. And when we did give that guidance, and I gave that guidance, I wanted to be very clear that what could happen with the IRA. So we made some assumptions that we are going to be in the IRA, we are going to be in 2027, and we are going to be hit. And we still believe we're going to do $2.5 billion. Now, what I would say, I've said this to you almost. I know we've got the number wrong, right? As in what will be that discount if we're in, but what I want you to understand is we haven't ignored it. We haven't, as we never do at Teva, seek the upside. We tend to be quite thoughtful and measured and maybe slightly conservative about what could happen, and that's what we've thought. So we think we're going to be included. We plan to be included, and we plan to have that hit us, but we still believe we're going to hit the $2.5 billion in 2027. And if you don't mind me, that's because there's so many tardive dyskinesia patients who are not on treatment. 80% are not on treatment. So we think we can see the momentum we have this year. If you look at the NBRX, you know, the team are doing an amazing job. We believe we have many levers to keep driving this. One of them is having more patients come in, but it's also about having the patients on the right milligram, have the patients more compliant, more adherent. There's many things we can do to keep driving Austedo, which makes me confident about the $2.5 billion. Do you think the market share changes versus Ingrezza when you're on IRA and they're not? So the negative becomes a positive. Yeah. Would you gain more volume or? Yeah, I mean, this is a crazy thing which shows how I think maybe poorly thought through was the IRA, but that could happen. I mean, look, that's not something which we're necessarily forecasting because there's a lot to work out with the IRA. For us, by the way, you mentioned Ingrezza. Not that I've ever commented on it, but you brought it up. You know, we are outperforming them month on month, right? Now, we don't think that's important because there's so many untreated patients. So it's not about taking market share, but I think it just highlights the ability for the team at Teva to execute and the value proposition that we have with Austedo that encourages physicians to use our product. But as I said, that's not relevant to the $2.5 billion. The $2.5 billion is based on 80% of patients are still not on therapy. Got it. Maybe transitioning to TL1A, very important readout coming up. Eric, could you remind us first, has there ever been an interim? Has there been any visibility to the drug? No, the study remains blinded. We're very excited that we, you know, accelerated the program. Everything's right on track. We're going to read out by the end of this year. Got it. So it'll still by the end of the year? Yeah, absolutely. Is it reasonable to assume this is not a Christmas readout and it's a little? We've got 26 days, but it's not Christmas. Okay. Okay, got it. And, as it relates to how you guys intend to communicate, it'll both be UC and Crohn's, both will be reported? Yeah, yeah. So just to remind everyone, so this study is a combined program. It has both ulcerative colitis and Crohn's disease in it. Equally, they're equally divided within the study. You know, we plan to have a press release that has, you know, three numbers for each, the placebo and the two doses for the primary endpoint. Got it. And as it, you will have the efficacy numbers in there? Yeah, that's what we plan to do. Okay, got it, and will we get some visibility on the immunogenicity as well, the IRRs? So remember, this is a top line report. You know, there's other work that we do for the, you know, the deep things like the pharmacokinetics, the, you know, the other measures that we put in the study. So that'll come later. Okay. And we have to say some things for the presentations at the congresses. So if all's on track, is this a registration program that goes up almost immediately in first half 2026, or do you guys wait a while for that? I'm sorry, first half 2025, or are you guys, is it going to take longer? To present the data or? Oh, no, phase III, timing to phase III. Just given the timelines versus compared to. So yeah, we've been working very closely with Sanofi, our partner, on this, planning all year long. You know, it all depends on the data. So we'll be using that to launch as quickly as possible in the phase III in 2025. Got it. I'm sure you guys remember I was trying to raise some questions on whether placebo response could be high or not based on the number of Eastern European sites. I'm just curious. What was your reaction to that thought process? Well, for one thing, it's still blinded, so I have no idea what our placebo rate is. You know, I mean, I think it's good to remember that, you know, our study is very reflective of the studies that have done recently. So the, the proportion of people in Europe, the proportion on corticosteroids, the number of people who are, prior treatment experience. So it's a part and parcel for ulcerative colitis and Crohn's disease. You know, I think I would focus on more of the fundamentals. You know, we have a compound that's probably more, well, is more important than in vitro that we, we see. We have a compound that's more selective. We have a compound that has PK that's estimated to be over the EC50. And we have biomarkers of target engagement that shows that we suppress the free TL1A for quite a while. So all those things being equal, I, you know, think it's a, you know, it's a good competitive molecule. Got it. Got it. And then as it relates to the, I mean, I know there was a 1% placebo response in the Prometheus study, and I think it was 11% in the Pfizer trial. Remind us, I think you guys shared data on what your assumption is. Yeah, yeah. So, you know, there, there has been variability in these studies with regards to the placebo and ulcerative colitis. Crohn's disease is a little bit more stable, but it's ranged over the last couple of years in all the different MOAs, from 1.5%-15%. For the purposes of designing our protocol for ulcerative colitis, we chose 8%, which is supported by the literature, and we chose 12% for the Crohn's study, which is a little bit more stable. Got it. As a base case, do you guys expect Crohn's to be active? I know it's the first randomized trials in Crohn's for any TL1A. Yeah, I mean, there's evidence out there, you know, in single-arm studies that this MOA works for Crohn's. You know, we're excited to be the first to show that, you know, in a controlled randomized fashion, what that true delta is. I think the exciting part about it is that we'll have, you know, robust data to be able to go into phase III with a good estimate of what our study can do, what our compound can do. Got it. Excellent. And sorry, maybe one last, and I think I might have spaced out. You had, have you mentioned 8% of the placebo response assumption in the trial? Our assumption is 8% for ulcerative colitis and 12% for Crohn's disease. Eight and 12, and then the Prometheus single-arm was 26% on the MOA that took a single-arm. That's right. That's a single-arm. That was their top-end dose. They used a historical control for their study, what I read. And remind me also, Eric, as it relates to what measures did you guys put into place in the trial which would drive the placebo up or down? So maybe the prior treatment status? Yeah, I mean, the placebo will always be dependent on your patient mix, you know, geography, but geography is usually a reflection of the amount of corticosteroids in the study and the amount of treatment experienced patients you get in it. So that's really the thing that's going to drive any difference in the placebo. But at the end of the day, it's going to be the importance is the delta between the placebo and the active. Got it. Do you have visibility on discontinuations in this trial so far? You know, I can't quote you chapter and verse. I haven't heard of any significant amount of discontinuation in the study. Got it. And maybe my one last one on TL1A, will the data be processed at Teva or at Sanofi? For a phase two study, remember we're operationalizing phase two on the Teva side. We share everything and on an ongoing basis with Sanofi because we need them to be prepared because they're going to take over the phase III program. We're operationalizing, we're sharing everything, and then they take over on phase III. Excellent. Any questions on TL1A just before we move on? Maybe switching gears to the long-acting olanzapine. Yeah. Could you remind us, so we saw the efficacy readout, we've seen some color on safety, but the trial hasn't fully completed. Could you just remind us on the timelines on that? Yeah, so the last patient's last visits dependent on that, how they schedule the patient, but it's the end of this year. We'll have the full data set complete. You know, today, you know, we have about 675 patients that enrolled in the study. So that gave us, you know, over our targeted number of injections that we, you know, wanted to get to, to the FDA. You know, we're at about 105% of what our target was. So we exceeded the number that we wanted to get. To date, we haven't seen any PDSS. And so we'll lock that database in the early, you know, first quarter of, of next year and be presenting that data, the full safety database or set in the second quarter of next year. Got it. There's a trial last fall. I think there was like three different formulations of this long-acting olanzapine. Could you just give us some color on that? Yeah, so that's, you know, when you make a compound, you need to be able to, you know, develop it and use different production facilities. You have to do studies where you kind of change the formulation a little bit so you can define the specs around the production of the compound. That's what that phase one study does. Those specs of the product. Yeah. Got it. And I guess, thought process as you start to re-engage with FDA again, what they've said to you guys previously and how that informs any remote possibility of black box from a class perspective anyways? Yeah. So, I mean, one thing that, you know, I haven't talked about before, we had a Type C meeting in August and, you know, we talked about what the safety database, what are you going to provide is and the structure we're going to provide is, and they thought it was reasonable at this point. So, you know, we're moving forward with the plan that we have. Does FDA think of this as being differentiated right now in terms of the profile? I mean, I think the FDA appreciates what the program is. I mean, I would remind people, you know, we talk to KOLs and people who treat patients with psychiatry. This is a new product that they can really use. I mean, our Uzedy program, which, you know, I've always liked the profile of the compound, even in that competitive space, the fact that it's a very easy formulation, that's subcutaneous, no oral supplementation, and something you can get up the therapeutic levels rapidly. Same thing applies with olanzapine, but olanzapine really has no other options at this point. So the KOLs and the people who treat patients think this is valuable. Got it. Okay. Makes sense. And, got it. So presumably this could be a filing by no later than next summer. Is that a reasonable way to think about it? Yeah, I think, you know, that we're going to present the data in Q2 of next year, shortly thereafter we'll do the work on the submission and, you know, we're looking for a 2026 launch. Got it. Richard, I guess how are you thinking about the sales potential? Because for now, investors are just going with, oh, it could be, I don't know, maybe a billion, maybe not, but I guess as you guys are doing it in a more sort of structured way, bottom-up work on commercial potential, how are you guys thinking about what the realistic scenarios are? I mean, in theory, why can't this be as big as an Invega Sustenna, presumably, given the olanzapine volumes out there? Yeah, look, we're really excited about it because of a lot of what Eric said and also because of how well Uzedy 's done, which is the same technology. I think if we sort of model it crudely and we're going to be more sophisticated into next year because we're doing more market research, which will help us model. If we follow what's happened with the non-LAI market now, which is about 13% of the orals, we think there's an opportunity for 13% of olanzapine patients to move across if you just take it as a crude benchmark. So we sort of have that as, then it's a question of whether it could be more and what would drive more. There is, you know, an understanding if you use olanzapine, you're using it on the most severe patients. And the most severe patients, compliance and adherence is absolutely critical. And so a long-acting would be even more valuable if you have severe schizophrenia. So I think that's one thing. I would also remind people that we're having a great launch with Uzedy, yet we didn't prepare ourselves well for Uzedy. You know, we just arrived, we just got together as a team focused on innovation, and that launch was not something that I think we would ever repeat, right? But if you think about olanzapine, it launches in 2026. We have our Uzedy team who are out there speaking to the same physicians, speaking to the same KOLs, the same payers, the same hospital formulary people with Uzedy. We've been working with them for two years. This is not a standing start launch. This is one where we've been well prepared. We'll understand the segmentation, understand the needs, understand the key decision makers, and we anticipate this will be a very good launch based on that. I think the way I think about it is how do we model to peak sales, but then it's how quickly do we get to peak sales? Because for me, area under the curve is sometimes even more important than actually what the peak is and how quickly you get to that. I think there's lots of reasons to be optimistic. Uzedy is doing really well. I think it's very differentiated, but to Eric's point, there's no differentiation needed for olanzapine. There is no long-acting olanzapine that's used. Right. Makes sense. Makes a lot of sense. And, in terms of the oral to injectable dose equivalents, do you think the current doses that in the trial, they're sufficient for as much conversion as you're hoping for, or should there be more oral to injectable, doses that should be, investigated further? Yeah, so we targeted the 10, 15, and 20 milligrams per day dose of the oral olanzapine. That's the indication for schizophrenia. It actually is also the indication for bipolar. So we cover all that. The other ones are smaller indications. The lower dose is used for like pediatrics, or adolescents and another indication. So the doses we targeted were on purpose for schizophrenia and covers the majority of the market. Got it. I mean, would it make sense to have those as well just because you have the tech? Yeah, we can do that. I mean, if that's something we want to do in the future, I'm sure we can do it. Okay, great. Any questions in the audience on? Okay, maybe let's just keep going. I know there's a trial coming up in celiac. It's small. Anything we should be holding our breath for on that trial? I mean, the first study in celiac is a small study. Its primary endpoint safety. We're testing a couple of biomarkers that we're looking at with regards to, you know, serum markers. It's too early. It's too early for that. The important thing is that we're actually starting in the first quarter of next year an endoscopy-based study, which is actually important. It's going to be 40 patients, one-to-one randomization, and that will be a nice objective view of how we're affecting the actual villi in the gut. So I'm excited about that, and we've started a vitiligo study for IL-15 as well. Could that read out next year, vitiligo study? I think we have to see how the enrollment goes. I'm not going to promise anything, but I am excited about vitiligo. I think that's a, for effective systemic treatment, vitiligo would be a good indication too. Okay. Last one. ICS/ SABA. I feel like the street has done very limited work on this opportunity. Could you just lay out for us in broad strokes what it is and what this could look like? Do you want me to start? You start what it is, and I'll start what it is. Yeah. So I get very excited about it because this fits the wheelhouse of Teva very well. We have a very good device group, especially for inhaled devices. We have many on the market. But this one is, you know, a really good device where it's a combination. It's a dual-action rescue inhaler with fluticasone and albuterol in it and a dry powder inhaler. So this is a really easy device. You just click it and you inhale. You don't have to coordinate any inhalations. But the disease area is particularly important. You know, there's 11 million people with asthma. There's 10 million exacerbations every year. And people should be using these combinations. The guidelines tell you it. So, you know, we're excited about the differentiation from our competitors in this. And we're happy to come in with a differentiated product with pediatrics in the future. You said timing is what again for this? We readout in the second half of 2026. phase III. Yeah. And so, yeah, this is one I really want to spend a tiny bit of time on because I do think to your point, Umer, this hasn't really been focused. And I this is maybe super sexy, but I think this is a really exciting opportunity, because the unmet need is massive. There should be 10 million patients who move into this part of the market. We only sort of model 3 million moving across, but we've seen the success of the one that's been launched recently. And that seems to be taking off. And as we've seen, because we're very experienced in respiratory at Teva, when people start to move across and start to follow guidelines and start to actually treat based on those, then there's generally a bigger part of that market should move across. And we are differentiated. We will come to the market later than the competitor, but they will help create the market. And we'll come in and our differentiation is pretty simple. We'll have the pediatric differentiate. We also have a simpler device. But even if we take a more conservative approach, then that's a big market that we will have right to have the adolescent and then the pediatric. So I think this is one that I would encourage people to look at a bit more. We get very excited about it. We talk about how we can work on speeding up the trial, which is difficult because it's pediatric, but we spend a lot of time on it because we see this as another growth driver for the top and bottom line. Excellent. Any last minute questions? Please. Can you share your current thoughts on using a Teva biomarker? And will there be any information in the phase II that will change that? Yeah, this is a hot topic all the time. I think one of the most important biomarkers that we're using is our free TL1A assay. That really is a good guide of target engagement and, you know, driving your dose selection. I would caution people that using like proteomics, genomics, fecal biomarkers and serum biomarkers are a little challenging at this stage of TL1A development. In my experience in inflammatory disease programs, you need a lot of patients before you have a really predictive baseline marker. I don't think we've got the science to where we need it to be to use a baseline, you know, population choice biomarker. On treatment response with free TL1A, I think is very important. I wanted to touch up on your biosimilars, and I know we ran out of time, but the good news is I have Alvotech coming up, so I'll go through the Stelara and the Humira in as much detail as we need. There you go. Eliyahu. Thank you guys. Thanks, Teva. Thanks, everybody.