Teva Pharmaceutical Industries Limited (TEVA) Earnings Call Transcript & Summary

Welcome to the Olanzapine LAI TEV-'749 Phase III SOLARIS Data Presentation Conference Call. My name is Elliot, and I'll be coordinating your call today. [Operator Instructions]. I would now like to hand over to Christopher Stevo. Please go ahead.

Thank you, Elliot. Good morning and good afternoon, everyone. Thank you for joining us for this call. In a moment, I'll introduce -- sorry, pass you on to my colleague, Eric Hughes, who will introduce the other speakers. But I just want to let you know we'll be making forward-looking statements during today's call, and we undertake no obligation to update those statements after today's call. And if you have any further questions on our forward-looking statements, please see the appropriate sections of our SEC filings under forms 10-Q and 10-K. And with that, my colleague, Dr. Eric Hughes, the floor is yours.

Thank you, Chris, and thank you for everyone joining today to talk about our SOLARIS Phase III data, safety and efficacy that we presented recently at the Psych Conference in San Diego. Moving forward, before we get talking about our program for schizophrenia, I did want to briefly highlight the strong neuroscience legacy we have at Teva, starting with COPAXONE and AZILECT in the past and now with AJOVY, AUSTEDO and UZEDY in our marketed products, and then looking forward to potential approvals for UZEDY in bipolar, and today our programs in Phase III for olanzapine LAI. And not to forget, we have emrusolmin developing in Phase II for multiple system atrophy. This legacy has given us great capabilities in our R&D organization from preclinical to clinical and approved products. It's been a great opportunity for us to build upon that legacy. And this is not just in the United States, but in the EU and the rest of the world. So moving on to what we're going to talk about today, and that's schizophrenia. Schizophrenia, as many of you know, is a devastating disease frequently for the patient as well as the family members of those patients. It's a complex disease. It has both positive and negative symptoms. It has cognitive implications, and it also affects the mood of patients suffering with this disease. All of these contribute to the functional deficits that really impact the quality of life of these patients who suffer with schizophrenia. So moving on to the -- why we're so excited about what we can do for the treatment of schizophrenia. It's important to remember that schizophrenia is a frequently progressive disease that is exacerbated by relapsing of the disease and then the progression of that disease. And remember, every time a patient relapse, it makes it more difficult for that patient to be treated and in progress of their disease. And it's also important to remember that 80% of patients, despite treatment, frequently relapse multiple times in the first 5 years of treatment. So what can we do about that? The things we can do about that is help with adherence because we know that adherence is important for the treatment of schizophrenia and preventing those relapses. And that's what brings us to olanzapine LAI, our new formulation that we studied in the SOLARIS Phase III study. This program and this formulation were designed specifically to show that we could make a subcutaneous injection of olanzapine that prevents the possibility of having PDSS. That's post-injection delirium/sedation syndrome. And why is that? Well, first of all, this is a subcutaneous injection that's easily given in a formulation that rapidly aggregates and is a very controlled release of this formulation so that you don't have any spikes in the exposure to olanzapine. And that's what we believe drives PDSS, the currently available injection. If people want to have more of a clear and more elegant video to watch about the way that this formulation works, we do provide a link on this page. And if you write to Teva, we can get you a password code, look at that link and see how the science behind an injection works. So moving more on to what is -- the results and what we're excited about at the conference this year in San Diego. Well, it goes from preclinical all the way to the clinical results. As I've talked about before, this formulation, when you're comparing it directly to the currently available LAI, you can see in this graph to the left that the currently available formulation rapidly dissolves. This is a study in vitro where we injected the formulations directly into serum. So in this worst-case scenario, you can see that in the green, there's a rapid dissolution of the currently available LAI. But with the new formulation that we have developed with Teva, there's a very slow and continued release even in this worst-case scenario. But going beyond this in vitro test now across the entire program for our olanzapine LAI formulation, we have over 4,000 or approximately 4,000 subcutaneous injections where we've seen no PDSS. It's important also to remember that the efficacy for all three doses were spot on and statistically and clinically meaningful. And that with this data, we're confident in the safety profile and the efficacy of this formulation. So I hope you can feel the excitement we have for this program and the potential of really opening up a whole new avenue of treatment for patients suffering with schizophrenia. And with that, I'm going to pass it off to my colleague, Chris Fox, to talk about the opportunity for Teva that this presents.

Thanks, Eric, and good morning, good afternoon, everyone. Eric, before I start, I just want to say thank you to you and your team. You guys continue to do amazing work in addressing unmet needs and kind of advancing medicine clearly with your know-how, but also with this technology, and we're really excited about it. So to frame it up, I would describe this opportunity as really unique for Teva at large to have a best-in-class LAI franchise. So not one medicine, but two. And underpinning that, it's with two very well-established molecules with a wide range of patients. All of you know and are familiar with UZEDY, and that really suits for patients that are on risperidone or paliperidone. They might be somewhat controlled but desired additional convenience or more sustainable control by being on an LAI. And many physicians characterize UZEDY and their use as the fastest and easiest way to get to a therapeutic optimal dose. On the right-hand side, we see olanzapine being an incredible complement to this. So patients that might be appropriate for olanzapine LAI will certainly be folks that are on orals or not suitably controlled on other orals and need more control. What we've seen in the research and from physicians is they particularly like this molecule for patients that present with agitation or aggression. So we see this combination being really powerful from a breadth perspective and offering new and innovative options for patients. When we think about the opportunity, I would like to start with characterizing it just on the overall approach and kind of the unmet need. And as Eric said, schizophrenia is a really severe mental illness that obviously is devastating for patients, their families and society as a whole. And you can see, just based on this bar graph, high unmet needs. Further, if you look at the graph, you can see that the market represents a significant number of patients with roughly similar numbers of treated patients across the U.S. and EU, and the propensity, most notably in the EU to favor the use of LAIs. If you ladder that down one run, you'll notice that oral olanzapine usage, both in the U.S. and EU, respectively, and then certainly the percentage of LAIs. So you can see some variation, but overall, really a significant opportunity, and we see this as really being a significant opportunity from the perspective of quicker utilization and broader adoption of LAIs. One of the things that makes this so complicated is when you look at kind of the patient journey across the board, how do we help and intervene with these patients. And the left-hand side is meant to take kind of a look at the patient journey. This is a very, very simplified perspective, and you'll see all the squiggly lines kind of representing inflection points that affect treatment and ultimately control for these patients. Most of these patients start seeing symptoms in their late adolescents or early teens, and they're often misdiagnosed or treated for depression or anxiety, and it can really take years. And in fact, what we see with schizophrenia is that in many of the treatment reports, it can take an average of 8.5 years between that first onset of symptoms and the assortment of treatment. And you can appreciate that, that's obviously a really, really difficult pathway to take. Why we spend so much time on this is we think we've taken the time to service these patients and the physicians treating them by understanding this. And we've used UZEDY as our foray into this market in this deep understanding of the patient journey, along with differentiated products, really lends itself to us being in a unique position from a go-to-market perspective when we're anticipating the launch of olanzapine. And I'll close just by saying that we're really, really excited about this opportunity. We think that this is a really unique position to be in on answering these unmet needs with a differentiated LAI franchise. We know that we can address a broad spectrum of patients. Most of the patients will either be able to benefit from UZEDY or olanzapine. And as I've said, we think we have a really excellent go-to-market capability and opportunity to really be a leader in the psych space and advance that as we go. And now it's my absolute privilege to introduce our keynote speaker today, Professor Correll, who is an incredible leader in the psychiatry space. He has multiple appointments including Professor of Psychiatry at Zucker School of Medicine in New York, Chair of Child & Adolescent Psychiatry at Charité in Berlin. He is a prolific researcher and has something to the effect of 900 peer-reviewed articles. And we're delighted today to have him be able to speak as the principal investigator leading the SOLARIS study. Welcome, Professor Correll.

Well, thank you very much. I seem to have had trouble signing in with my Internet. I'm really sorry about that. And so I'm really privileged to talk about the SOLARIS study, which I believe is a milestone in the treatment of schizophrenia, which as we heard, is really troubled by a lot of relapses that have to do with mortality, poor functioning and also nonadherence. And while we've had multiple long-acting injectables available to us, first generation, but also second generation, those have been restrained to risperidone, paliperidone as one family, and the aripiprazole franchise. But the olanzapine, which has been used a lot for very chronically ill patients has not been really available to us as an LAI simply because we have problems with the PDSS or the post-injection delirium/somnolence syndrome, which can be potentially fatal when all of the olanzapine that's injected can enter the bloodstream. Now the subcutaneous formulation that Teva has been developing is really the solution to that. Because as you've seen, even when you inject it into the bloodstream itself, its formulation really flocks out and it can't enter the bloodstream. And what we've done in the SOLARIS study is that we have two different phases. The first one was the FDA [Technical Difficulty] us to show that the medication in that formulation works for schizophrenia. So basically, an 8-week acute study where you can see here that 20-point and more improvement in both and all of the three doses were achieved that were equivalent to 10, 15 and 20 milligrams, and that was the efficacy portion. But obviously, we know that olanzapine works, check. It works also when it's formulated as a subcutaneous formulation. But the question then obviously was what about the long-term safety. And here, we were able to show that over the next 48 weeks, there was very good tolerance of this medication, and there was over 3,400 injections and not a single PDSS. The patients who had been finishing the initial phase were then rerandomized and they were continued on the dose, but rerandomized when they came from placebo. When we look at the safety of the medication, we can see that it was also very well tolerated. This is olanzapine as we know it. There is weight gain that has to be monitored and managed and can also be, I think, monitored and managed as we know with olanzapine. Because you know that this medication, despite the cardiometabolic side effects, is still one of the most used medications orally, but not yet as an LAI because of the issues that we've had with the deep intramuscular injectables. You can also see that there are, obviously, as expected, also some injection site reactions. But when you put all of them together, they were mostly mild to moderate, and also less than 1% of patients discontinued treatment, either due to the weight gain and metabolic abnormalities, less than 1% due to injection site reactions, and also less than 1% due to sedation, which can be a side effect with olanzapine. So overall, this medication was very well tolerated, and this was also confirmed in the SOLARIS study. Now let me see which slide you're on now. I think I've gone through them. Is there anything else I need to cover?

Eric had the conclusion. Just a couple of slides before the Q&A. Eric, are you there still? I'll tell you what, I can do Eric slides. Okay. So thank you for that, Dr. Correll. We very much appreciate that. And we're also proud to say and proud that our colleagues hard work with olanzapine was honored and the hard work of the investigators and the patients who participate in the trials. And we just wanted to mention that here. So very well done on part of our colleagues. Next slide, please. Okay. And that's it. So now it's time for our Q&A. Elliot, now please feel free to go ahead and queue up the first question.

[Operator Instructions] First question comes from David Amsellem with Piper Sandler.

So just two for me. First, on the total number of injections, I think you cited 3,470 injections in the SOLARIS study experience or maybe it was the overall clinical experience. But I just wanted to clarify, I think you needed at least 3,600 injections per the FDA. So I just want to make sure that you have enough injections and exposures to pass muster with the FDA. Just give us a refresher on where that stands. I think you do, but just wanted to clarify there. That's number one. And then number two, regarding LAI olanzapine beyond schizophrenia. Can you talk about bipolar and also getting -- eventually getting that into the label? And just talk more generally about the mix between schizophrenia and bipolar usage among the oral olanzapine population, if you can.

Great. So first of all, maybe I'll start with the -- we'll start with the FDA question that was just asked. Yes, so FDA has been in work conjunction developing the program with us for many years. Actually, I'm in Zagreb, Croatia right now with the -- in the very labs that the formulation was developed. And they reminded me that the first time we interacted with the FDA on that very question was back in 2016, and they said that there was the possibility of developing a formulation without a black box warning or monitoring. So that began the journey. You've seen the data that shows both preclinically and now clinically around 4,000 subcutaneous doses without PDSS. And this is checking all the boxes that we've discussed with FDA with regards to what the safety and efficacy should look like. So although everything is up for review with the FDA, we're confident in the data and the way that it's been developing over the years, and we're looking forward to their feedback. With your question about bipolar disease, that certainly is an opportunity that we could entertain as a life cycle management for olanzapine. Just to remind you, we actually have already submitted that very indication for UZEDY as well back in February of this year. So we're also looking for feedback on that program. So I think that we're really building a franchise, not only for schizophrenia, but potential other indications in the future. And when it comes to the use of this oral olanzapine LAI with regards to where patients would come from with regards to oral, perhaps I could ask Professor Correll to maybe highlight how he sees LAIs entering the market, maybe particularly for olanzapine and what the opportunity is there for patients.

Absolutely. And just to follow up on the other question, the 3,470 injections were just in the SOLARIS program. So overall, with all these studies, I believe there are almost 3,900 injections, if I'm not mistaken. In terms of where...

That's correct.

Okay, great. Thanks for confirming. Overall, where olanzapine LAI subcutaneous would now come from, I think there are multiple sources. I would certainly move over a number of my patients who are currently on oral olanzapine and most of my colleagues, I think, are waiting for that option, too. You may remember that olanzapine is used mostly for more severely ill patients that often have also more cognitive dysfunction, may not have as much supervision and family members who can guide them and help them to remember taking the medication. And they also have fragmented illness inside. So here, having an LAI can be very helpful. But we also have a number of patients who are currently on either aripiprazole LAIs or risperidone, paliperidone LAI and still have residual positive symptoms where we think they might be able to improve further, but we weren't able to move them to an olanzapine product because that wasn't available really as a manageable LAI. So in that sense, I also assume that some patients might move over from those patients. And then there are others that because of the lack of an LAI would not have been tried on oral olanzapine and therefore, might also come from that third group. So I believe that here, we have a treatment that will fulfill a gap and will also pretty quickly gain treatment users more than even with UZEDY, because UZEDY has had to fight actually against five or six other formulations that are available at risperidone or paliperidone and still has held its own very nicely with mucositis, also because of the subcutaneous formulation, patients might actually prefer that than intramuscular formulations, the ease of injection at the beginning, no dual injection needed, no oral sore treatment, no loading dose, no booster injection after 1 week. And the same assets are also present for olanzapine LAI, which I think makes it a very easy-to-use option now that many of us are waiting for.

We now turn to Jason Gerberry with Bank of America.

Maybe for Dr. Correll, I'm just curious with RELPREVV. How much of the issue was the box warning and the safety fear factor of PDSS versus the post-dose, I think, 3-hour monitoring requirement? My sense is that it's a monitoring requirement with a much bigger issue. And then just love to get your thoughts on the weight gain. Will that be a factor that you manage through patient selection? Or would you use weight mitigation strategies like metformin prescription for these patients or just pull patients off drug if there's the hint of metabolic parameters going in the wrong direction?

Yes. Thanks for the two questions. I believe that it's really a combination. The fear of PDSS, even though it's just 1 in the 1,100 to 1,200 injections, but that can be potentially fatal is something that has made it very difficult to prescribe this medication. And to then mitigate that the 3 hours observation in the hospital, it's just so hard to do operationally. And what if the patient just walks out and says, thank you very much and then we're responsible for them. I think it's really this combination of the risk and the risk mitigation strategy that has made it unmanageable in most settings. And therefore, not having either of the two is really freeing up olanzapine LAI as a new option for us. In terms of the weight gain, this has been something that we know is a problem with olanzapine as well as with clozapine. So the two most effective drugs at the moment of the, at least, postsynaptic dopamine modulators have not deterred clinicians from using this medication. And actually, when we look at long-term studies with oral olanzapine, olanzapine is adhered to longer -- generally even than other medications. So the weight gain is an issue, but it's monitorable and manageable. And many patients recognize, especially when they're more into the illness that, yes, weight gain is something that has been happening with other agents, too. And now I need to get my feet on the ground and be back into life. And what we've also shown is that despite the weight gain, actually, the mortality is reduced with medications, including the high metabolic risk agents because as patients improve functionally, they are going more to doctors to have secondary prevention of weight gain and blood pressure problems and glucose problems, and they also have less psychosis-related stress, so that's hormonal changes and also basically have better lifestyle behaviors. So in that sense, what we would do is improve the healthy lifestyle by giving lifestyle instructions. And when patients are less psychotic, they can follow them more. And on the other hand, you're right, metformin is something that we're now proposing very much at the beginning even of olanzapine treatment because prevention of weight gain is easier than intervention. And at the same time, GLP-1 agonist might also be an option to actually mitigate the weight gain.

We now turn to Les Sulewski with Truist.

A couple for Dr. Correll. How do you ensure or how did you ensure representation across schizophrenia subtypes among the 675 participants? And what strategies were used to minimize the dropout rates in the OLE study? And then just to go back to the metabolic and weight effects, the 5.6 kilogram weight gain over the 48 weeks stabilized after week 32. Can you elaborate on the dosing impact between the 318 and the 531 mg? And how does that compare to oral within your experience? And then I have a follow-up for Eric.

Yes. Thank you for the three questions. So first of all, we used sites that have patients who come in and are exacerbated and need to be treated for their relapse. This is a patient population that actually agrees to be in the study. So in that sense, I think it's very representative of patients in RCTs. Is it fully representative of all patients with schizophrenia? Most likely not. I mean we didn't enroll patients who had suicidal ideas, who are so aggressive that they couldn't understand the study procedures and adhere to them. But I think overall, the population is very much on par with other medications that we've seen. And we know that olanzapine actually, the efficacy really translates from RCT data into the real world because it has such robust efficacy. In terms of keeping the people in the trial in the long-term study, I mean, these are patients who are called. They are in the study. They have agreed to it. But we have seen in other studies, too, that olanzapine is actually a drug that despite the weight gain, patients seem to somehow feel well enough and maybe sometimes even better than other medications that they do stay in, and we've seen that in this study, too. And then the third question, remind me, was...

Yes, so the stabilization of weight gain after week 32 and then in comparison between the dosing and oral.

Yes. Okay. So there has been in the literature a small dose-dependent effect on weight, but we really, I don't think, have looked at that in depth. And if anything, the delta is not very large between the doses because all of them are efficacious. But when you look at the 5.6 kilograms overall, this is very consistent with both oral treatments of olanzapine for a year or above as well as with the RELPREVV data, the olanzapine deep intramuscular long-acting injectables. So there are no surprises, it's the same molecule.

Very helpful. Perhaps just last one for me, if I may, for Eric. How might the '749 impact hospitalization rates given the separate UZEDY data that showed cost savings?

If Eric can't answer, maybe I jump in again until he comes in. So I mean, I think we can really learn from the UZEDY data. We know that olanzapine is highly efficacious, and we know that LAIs really beat all antipsychotics. We've done multiple meta-analysis on that and particularly on relapse prevention and hospitalization. And since hospitalizations are the most costly aspects of care, not only in the United States, but overall, this will lead to cost reductions. And I think pharmacoepi studies will follow and will also show that.

We now turn to Umer Raffat with Evercore ISI.

This is Mike DiFiore in for Umer. Congrats on the data. Two for me. This is more of a commercial question. How should we think about the peak penetration into the oral olanzapine segment? And as a follow-up to that, I mean, you had a slide saying that your total franchise peak revenue was between $1.5 billion and $2 billion. That seems kind of conservative. I just wanted to get your thoughts on that, especially in light of the fact that back in the days, our production peak sales were over $5 billion.

Thanks for the question, Mike. Chris, do you want to take those?

Sure. Happy to, and thank you for that. I appreciate your optimism. I guess I'll start in reverse order. I think we're trying to be thoughtful about the opportunity, and we realize that for olanzapine specifically, right, the opportunity is going to be bigger, at least at the onset in Europe, given that they have higher olanzapine and higher LAI. I think the bigger thing in the U.S. is kind of the behavior shift to using LAIs and using them sooner in the treatment algorithm to gain that control. And I think to your point about peak penetration, we certainly expect, as Professor Correll said, that the early usage will come from patients that are on oral olanzapine, but you could see the opportunity and just based on the data that if patients are not controlled, there could be other oral to olanzapine LAI use as well as LAI to LAI. I think we'll have to see how that nets out. But we certainly think at start, people are very comfortable with olanzapine as a molecule, and that's where we will get kind of the initial uptake.

I appreciate that. Just really quick. You said that the U.S. will kind of require like a behavioral change amongst physicians and HCPs in prescribing olanzapine LAI. I mean is this going to be kind of a Herculean effort? I mean, how long do you think it will take for physicians to kind of realize the value proposition of this medication and really start prescribing it regularly?

I don't know that we can set a watch to that necessarily. I didn't mean specifically behavioral change to LAI, olanzapine, just LAIs in general. I think adoption rates, we have less penetration of LAIs. I think that, that's just maybe because they haven't had good options. Certainly, we've seen great uptake with UZEDY. So if that flows through, I think it could be something similar in that kind of traction with this bigger opportunity. As Dr. Correll said, there's a big comfort. People know olanzapine is a molecule. And so we haven't been prolific around stating the curve because we don't know that yet, that will depend on access and reimbursement and all the other things that flow through once you launch. But we're very optimistic about this. And as importantly, I think we underscore not only our responsibility in leading this proposition, but also in what it can do for patients from a lifestyle change as we described how important and significant it can be in a schizophrenic's life.

Professor Correll, do you have anything to add to that?

Yes. I think I fully agree with that, that in the sense of olanzapine LAI, there will be a very short runway because we know the medication, we know what an LAI is. And if we see that patients on olanzapine or other LAIs now have this future option that that's an easy sell. What's more problematic, as Chris was saying, is getting overall the LAI use increased over 16%. And I think this has happened over time more and more. But having now a new option in terms of a molecule, I think, will add to the overall sales of LAIs. And here, olanzapine LAI will really keep quite a bit of that percentage, and we'll see a steeper increase in the [ feed ] value. That's my depiction.

We now turn to Matt Dellatorre with Goldman Sachs.

Congrats on the results. Maybe just following up on the peak sales side, especially the LAI franchise. Could you also share any more details on what that breaks down between UZEDY and olanzapine? It looks like UZEDY peak consensus sales are around $650 million. And then how are you thinking about the time to peak sales as well as the durability of this franchise? And then maybe just drilling a little more specifically into UZEDY, just given the strength of the profile to date, how confident are you in its ability to expand into other molecule classes such as Invega Sustenna, just given you highlighted that as a key aspect of forward growth.

Chris, I don't know, were you able to hear me ask questions? I can repeat them for you, if you like.

Yes. I think I got most of them. Maybe you can help me out if I don't touch them all. So I'll start with UZEDY first and just say, listen, we're really pleased with our results, and we think we've done an excellent job. A big part of that comes from the deep understanding and have penetrated the part of the market in which we directly play, having a majority of that share. So I think we're hovering at -- pretty much maxed out on that. So you're exactly right. We will expand into other utilization from other molecules and switches from other orals, and that's going to be a big important part. And I think as physicians get more and more experience with UZEDY, they tend to be more and more comfortable with that. And so I think composition-wise, overall, for the franchise, olanzapine LAI will contribute more, particularly because Europe is going to play such a big important role, having about 30% base oral olanzapine usage to date and a much higher LAI usage as well. So I think that behavioral change that I was talking about before, a lot of that already exists. And physicians and government bodies, payers have recognized how important it is to the system to get patients controlled and have embraced that. So I think we have two really great products, and that combination allows us to hit most of the potential patients. So that's a wide swath, 70%, 80% of patients could be eligible for either one of these compounds. Time to peak, I don't think we're commenting on yet. That will all flush out when we see uptake and once we know access both within U.S. and ex U.S. Chris, did I miss anything?

No, I think those are all the key points, Chris. Thanks for the question, Matt.

We now turn to Ash Verma with UBS.

This is Dee here on Ash's behalf. We have two questions. So the first one is that as you are getting ready for the regulatory filing here, just wanted to see if there's any consideration similar to the UZEDY regulatory review process, where I think the FDA flagged the instances of like patients receiving higher than assigned dose or duly truthfully enrolled patients. Are you -- I guess, are you confident that olanzapine LAI data is clean from that standpoint? And then my second question is, can you talk about which division of the FDA would like applicable to go through? And as you think about agency adoption -- like agency adopting a class label or not, what makes you believe that FDA would be discerning enough in the case of olanzapine LAI to give you a label that's differentiated?

Thanks for the question, Dee. Eric, are you able to answer?

Yes, I'm here. Yes, thank you for the question. And I'd start off by saying we learned a lot from the UZEDY filing when we had that CRL and we had the review and identified the problems you frequently see in schizophrenia trials of dual enrollment. We incorporated that all in our process of executing the olanzapine study. So we had extra monitoring. We had 100% unblinded monitors during the study to make sure that we were giving out the drug appropriately and positively to only a single patient. So that's the challenge that you sometimes have in these studies. So that, in addition to extra monitoring and oversight of the study as well as an additional pre-submission inspection we did on our own to make sure that all the problems we had seen before were not recapitulated in the study. So we're really confident in making sure this is a picture perfect submission. So I'm confident we've addressed all the issues with UZEDY. With regards to the favorability or the willingness of FDA to address this label issue with regards to PDSS. As I mentioned before, we have been in these discussions positively interacting with the idea that if we can generate a database of safety and efficacy that checks a number of the boxes that FDA worked with us on throughout this development program, that is a possibility for what our label will look like. So that is still the open -- that's still open possibility. And I think that the data that we've generated and talked about today supports a very favorable label for this treatment that would give people or patients a new opportunity for treatment. It is the same division that we've worked with on UZEDY. So we're very familiar with them.

And again, that includes the totality of the preclinical work as well, demonstrating the, as Eric would say, the impossibility of PDSS, not just the clinical.

Yes. It's the totality of the data. As I keep going over, the in vitro data is very supportive of the fact that the formulations are completely different. One dissolves rapidly. It's an intramuscular injection. Ours is a subcutaneous shot that rapidly aggregates in the aqueous environment of the subcutaneous tissue. Our Phase I data has shown no spikes in the PK. The totality of subcutaneous injections is almost 4,000 injections. So this has fulfilled all the data points that we've discussed with FDA. They understand what the submission will look like, and we've had productive discussions on formulating what the submission structure would be, and we're moving forward with that.

We have no further questions. So I'll hand back for any closing remarks.

Eric, any closing remarks you'd like to make?

Well, I'd like to first thank Professor Correll for participating in the call today and being the lead investigator for our Phase III SOLARIS data and study. We're pleased with the results. I'm proud of the team at Teva for executing a well one Phase III and an entire program, including the great formulation and preclinical work. I think the totality of the data is really exciting. And I think that this will be a great moment to build our franchise in the LAI market for patients with schizophrenia, and there'll be more to come. Chris, I don't know if you had anything else you want to add today.

No. Just thank you all for calling, and thank you for your interest. We really appreciate it. You can tell that we're excited and expect really great things. So thank you for your time.

Great. Thanks, everyone.

Thank you to my colleagues. Thank you, Dr. Correll. And if you -- as Eric mentioned earlier, if you'd like the password for that video, please reach out to Investor Relations, and we can provide that to you. Thank you, everyone. Bye-bye.

Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.