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Conference · 2026-10-09
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Hello, and welcome to the Welltruza Approval Conference Call. My name is Alex, and I'll be coordinating today's call. If you'd like to ask a question during the presentation, please press star, followed by one on your telephone keypad. I'll now hand it over to Chris Stevo, SVP, Investor Relations. Please go ahead.
Thank you, Alex. Good morning and good afternoon, everyone. Thank you for joining us on short notice to discuss the US FDA approval of Welltruza, Lanzapine LAI. The materials are posted to the website this morning, and the press release is also on our website. And before I turn the call over to Richard Francis, I'd like to remind everyone that we'll be making forward-looking statements on the call. The company cautions investors that any forward-looking statement involves risks and uncertainties and is not a guarantee of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. These factors are described in our earnings press release in our most recent forms, 10-K and 10-Q, filed with the FCC. Any statements that we make are only valid as of today, and we undertake no obligation to update those statements subsequently. And with that, Richard, the floor is yours.
Thank you, Chris. Thank you, everybody, for joining the call. On the call today will be Eric Hughes, head of R&D Chief Medical Officer, and then for the Q&A, I will be joined by Chris Fox, EVP, our Executive Vice President of U.S. Commercial, and Eddie Khalif, Chief Financial Officer. So moving on to the next slide, and the next slide please. Once again, it's great to be having a call with you where we talk about the execution of our pivot to growth strategy. A strategy we started back in 2023. A strategy that was designed to move Tava from a pure play world-class generics company to a world-class biopharmaceutical company. And I think we made incredible progress. And if you remember, it was a three-phase strategy. The first was to return to growth. We've done that over the last three years. The second phase was to accelerate growth. And that acceleration was going to come through delivering on our growth engines, our innovative products that we have in the market that we often talk about. But it was also about really bringing and exciting pipeline to the market. And I'm really excited today that we're in a position where we can start to talk about that step up innovation and see our pipelines start to materialize. Now, if you go on to the next slide, 2026 has already been a year of acceleration, you could say. We've had a number of milestones already this year to do the key to maintenance data, the eco pipeline accepted by the FDA and given priority review, the NCR15, you saw some data in vitiligo and recently in celiac disease. But today is all about Welltrusa. And it's a special day for patients, for physicians, and for families that some of their members have schizophrenia. And as Teva, we're really proud to be able to bring Welltrusa to the market to help this patient population in coping with that condition. So, exciting for us at TEVA, exciting that it's a year where we keep bringing new data, new opportunities to drive this long-term acceleration of TEVA. But with that, I know everybody's excited to hear about the data, so I'll hand over to Eric.
Thank you, Richard. I really appreciate it. And if I could have the first slide. I have to start by saying we're just delighted by the approval of Welltrusa. by FDA. And I just want to start off by saying this begins with a patient. Patients with schizophrenia, it's a devastating disease for patients, and it can be a devastating disease for their families as well. But the most important thing is that we do have treatments for schizophrenia. And what Waltruza will bring, we hope, is that chance of decreasing relapses because we're going to take advantage of the long-acting injectable for them. So this relentless progression of negative positive cognitive symptoms over years, we want to prevent those relapses, which would cause the hospitalizations and cause the progression of their disease. So we've thought about the patient from day one, and we believe that we're really achieving a great thing for them today.
Come to the next slide.
You know, this patient population is not insignificant. There's 2.2 million people in the U.S., about 1.5 million of them get treated, And 20% of all those patients who get treated are on an oral olanzapine. Or, you know, olanzapine is a known treatment for schizophrenia. It has powerful efficacy and a known safety profile. And our telecommercial organization is set up to succeed here. You know, we have a deep understanding of the patient journey, which is very complex. You know, we have been doing and detailing these patients and caregivers with our UZETI program, and we're building upon that great expertise as i mentioned on to being as a demonstrated safety profile and we have go-to-market capabilities that are i think uh leading in the industry but let's get to well truza on the next slide you know well truza really epitomizes you know the r d strategy at teva you know we choose unmet medical needs that uh need to be addressed we innovate based on the the formulation we brought and built upon the known safety and efficacy of weltrusa we innovated with the formulation by design to differentiate it for the market we executed the studies with high velocity by accelerating the program six to nine months and that brought in an on-target submission which then led to an approval that was right first time So this is our plan. This is how we build upon known science and accelerate it to bring treatment for unmet need in patients. So we're very proud of this, and I think this is a winning paradigm for our company.
On the next slide.
So what gets us so delighted and elated at tablets this morning? Well, you know, builds upon the known efficacy and safety, as Alonza and I said. This is a tried and true treatment for schizophrenia. And as I mentioned, that's 20% of the oral market right now for patients. But we innovated on it. We brought a once-monthly subcutaneous dose that is no loading dose, no oral supplementation, and no post-injection monitoring. These are the critical attributes of what we needed to achieve, and we delivered on that completely with this label that we have gotten approved by the FDA. So I'm very proud of the work that the R&D organization has done and the work that we're collaborating with our commercial colleagues to make sure that we get this treatment to patients as quickly as possible. So we're very excited by all the results that we've achieved today. And this really fills a longstanding gap in care. There are no other alternatives for long-acting injectables that are viable compared to Welltrusa. So we think that we really are addressing an unmet medical need with the innovations from our labs. Come to the next slide. And I want to bring it back to the patient on this last slide. I said that the most important thing is preventing relapse. That's what long-acting injectables continuously show, that when you get rid of the problem of adherence, adherence is the problem of breakthrough and relapse for these powerful drugs. By bringing an easily used subcutaneous injection that's once a month, we're chipping away at that adherence problem. And you can see in our follow-on study from Solaris and Period 2 out to about a one-year follow-on, only 4% of the patients relapsed. This is the critical element of what we want to help patients do, get a treatment that's easy to use, well-known, and efficacious, but take away that problem of adherence with a subcutaneous injection once a month. So we're very proud of this. We have great hope for patients in the future. And we're looking forward to getting this out as widely as possible. And with that, Richard, I'll hand it back to you.
Thank you, Eric. Thank you for walking through that. And we finish on this slide. I just want to give you a bit of context to this slide. This is the image that you will be seeing around with regard to Weltruza. We are doing a direct DTC campaign with Weltruza. And we're doing this because we believe that we have created a real opportunity for these patients, as Eric has mentioned, and the physicians that start treating their patients differently with this molecule. And to do that, we want to make sure people are aware of it. Physicians are aware of it. Patients are aware of it. Their loved ones are aware of it. So it gives them the chance to get back into that office and have a discussion with their physician. And the physicians are also aware of it. So be prepared to see this. And this builds on, for many of you who know us, this builds on the capability that we built with Esteda, where we had to remobilize a patient population with tardive dyskinesia and help physicians start to treat those patients differently for the first time in a long time. So good capabilities that Eric had mentioned we already have in schizophrenia, but good capabilities about how do we mobilize this patient population to help them understand there is a new treatment out there. And with that, I will now open it up for Q&A.
Well, as a reminder, sorry, thank you, Chris. Just as a reminder, if you'd like to ask a question, you may press the offload by one on your telephone keypad. And as a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question. Our first question for today comes from Joseph Tomey of TD Securities. Your line is now open. Please go ahead.
Hi there. Good morning. Congratulations on approval and thank you for taking my question. Maybe just as you think about the perfect patient for Wiltruza versus Uzzetti, I guess do these patients fit in sort of nice targeting boxes for you, or do you think there's going to be overlap? I guess, how do you think about that? And second, our physicians do indicate that they want to use LAIs more in practice, but sometimes there's some logistical hurdles at the site. Obviously, the differentiation of monitoring would be great, but can you talk a little bit more about what Teva's doing to make sure the physicians have a good first experience at the prescribing site for Maltreza. Thank you.
Thanks, Jay. Thanks very much for the call. Very much appreciate it. And I know Eric will be itching to answer that one because I think you'll hear that we very, very much thought about the value proposition, what physicians need from LAIs, what they expect that they may not have gotten. And also, will you talk about the co-positioning of these two product. So I'll hand over to you, Eric.
Yeah, so thanks for the question. I heard two things there. You know, who do we envision, you know, starting on Welltrusa versus Yuzeti? Well, you know, the first and most obvious place is to start with those who are on an oral risperidone can take Yuzeti, and those who are on an oral Alonzapine can start Welltrusa. I think that's a natural selection that's already out there in the field. What we're delivering, though, to your second point is, you know, something that they haven't had before, an injection that is easy to give to a patient. It's subcutaneous. It doesn't require any loading doses. It doesn't require any other supplemental oral medication. So a lot of the hurdles of an intramuscular injection, a complicated way of starting it, we've removed that and given them something that really is a great treatment option for patients. That will also address the basic problem of relapse due to non-inherence. So we've removed a lot of those barriers, and the natural place that I think that patients will come from is those oral options that they're on already. Remember, 20% of the oral market is alanzapine, and we're providing the first best option that's really viable for a long-acting injectable.
Thanks, Eric. Is there anything you'd like to add to that, Chris Fox?
Sure, absolutely. Good morning, everyone. Yeah, this is a really exciting time for us, and I love the nature of your question of, you know, how do we instill a more better experience with LAIs? This is something that we've been partnering with Eric and his team on because we know that this was such an untapped need. And you can see that even as an example with Uzeti and how we're growing that market because there is starting to be, you know, more anticipation of how LEI specifically prevent relapse, as Eric showed in the data, and provide a much better experience, not just because of the no loading dose and no oral supplementation, but also it prevents, you know, irreversible function decline when these patients have, you know, breakthrough symptoms or are non-inherent on an oral. So we've been preparing for this launch, I got to say, for a long time. It's been well over a year. We had an extraordinary nationwide launch meeting last week and doing exactly that, you know, our go-to-market and really the education that we're going to use specifically on olanzapine, but also co-located with UZETI. I think we're in a unique leadership position to be able to cover most of the schizophrenic patients, about 80 percent across this continuum of oral loranzapine patients and oral paliperidone and risperidone patients with EZETI. So we're really excited. We've got lots of work to do, but we have the right tools and now, importantly, the right franchise in EZETI and Welltruso.
Thanks, Chris. Next question.
Our next question comes from Uma Raphat of Evercore ISI. The line's now open. Please go ahead. Hey, guys.
This is Mike DeFury in for Omer. Thanks so much for taking my question and congrats on the approval. Two questions for me. One, are you able to disclose the pricing at this juncture? And number two, just given that, if you look back at oral brand as Olanzapine, Zyprexa, I think it reached around $5 billion in worldwide peak sales. Would you be able to comment whether that potential could be reached with the lens of the LAI, or do you have any at least preliminary comments on what you expect for oral to LAI conversion?
Thanks for the question. So to answer the first question, the wholesale, the WAC price is $3,950, to give you that. And then to the second question, which was touching upon the opportunity here, which is a good question. And I think it's probably based on the product profile that Eric just walked through, as well as the label that we have. Look, we put down in our forecast 1.5 to 2 billion for Yoseti and Wiltruza. I think there's a lot of enthusiasm around Wiltruza because of the product profile that Eric just talked about. I think for us, it's about making sure we get out there and do what Chris Fox said, make sure people have an understanding where these products can be used, how effective they are, how they fit into their clinics, how patients can benefit from the compliance and the adherence. And if that plays out well, then obviously we're going to have an ability to hit those targets of 1.5 to 2 billion. But I think you probably know, Mike, from talking to us in the past, you know, we tend to think about this in a very thoughtful way. We want to see how this plays out. It is a very managed area, managed care. And so we've got to be thoughtful about that. And so let's get started. Let's get the excitement turned into prescriptions. Let's get patients on this drug. Let's get hospital formaries listing it. Let's get Medicaid to have on their formaries first. And then I think we can talk about what the ambition could be in the long run. But I'm glad you see it as a big step forward for the treatment of schizophrenia patients. So thank you for that.
Thank you. Our next question comes from Louise Chen of Scotiabank. The lines are open. Please go ahead.
Hi, congratulations on the approval and thanks for taking my questions here. I just wanted to ask you on payer coverage. When do you expect that to ramp up and, you know, what are the different stages here? What is the out-of-pocket cost per patient? And then the other thing I wanted to ask you about is we think about modeling the sales. I know the progression will be later on in 2027, but how should we think about growth to net net progression and also margins for the product?
Yeah, so thanks, Louise. I'll probably start to frame a bit and then hand over to Chris Fox on this one. But from a payer point of view, as we've spoken about in the past, this is about firstly getting medicaid on board state by state and as you may well know these um do start at different times so day one we get some medicaid and then some take as much as 12 months even some beyond that and we think we'll have about 85 coverage at the end of the first year um medicare is is harder and that's about negotiation and uh as you've seen with your city we are all about making ensure that we get value and access. And we understand that we have a valuable product here because of the product profile, and we want to make sure that is appreciated. So I think that's how we think about it. And that's partly also why, to touch on your point of revenue, we don't see significant revenue in H1 next year, because this is about getting all the Medicaid states on board, getting into the hospital form raise, getting some good breadth of the use for physicians, and then actually some debt. And that's what you'll see in the second half of the year. So that's how we think about it. And that's how you should model it. That's how it comes from a payer access. It's mainly in Medicaid and Medicare. There is a small amount, which would be in commercial. And then maybe I'll hand over to Chris to talk a bit more about one thing about the out-of-pocket, but also the comprehensive services that we have to ensure that patients can get access to this. So over to you, Chris.
Thanks, Richard. Great question. You know, we are modeling this similarly, as Richard just said, you know, our approach is to really balance very wide access with preservation of value. And so it's really important to start with those Medicaid patients. And as Richard elegantly articulated about, you know, the process, it is state by state. And so that's something that we'll look to address much like we did UZETI. The out-of-pocket for patient is very different based on their coverage and if they're dual eligible, all of those things. And the team has built a really extraordinary kind of patient hub to be able to help that. And so it's a very bespoke service that allows for us to, you know, optimize their experience and give them access as early as possible. And I think the other big thing I'm excited about is very rarely do we get to launch another product so co-located with the current product, and that's Uzetti. So we have lots of synergies in this space, both in our experience with providing those patient services, you know, prescriber services as well, and as importantly, as Eric pointed out, this deep understanding of the patient journey. So, you know, how do they go from oral and get on an LAI? All of those things are such an important part of that. Access is a big part of it, but all of those other surround sound things contribute to that experience as well. So we're excited to apply the learnings and the knowledge that we have and, you know, help support patients. Thank you for the question.
Thanks, Chris. Thanks for the question, Louise. Next question.
Our next question comes from Les Saluski of Oppenheimer. Your line is now open. Please go ahead.
Good morning. Thank you for taking my questions, and congrats on the approval. I have two, one on distribution and one on the funnel of patients. So on the distribution side, given the refrigeration aspect, how are you setting up distribution and buy-and-build versus specialty pharmacy, and when do you expect the permanent J-code? And then second, on the funnel of patients, you sized the LAI suitable patients at 20% of the oral population. Can you perhaps just walk us through the first year patients come from? Is it breath practice switches, recent hospital discharges, or the stable oral patient group?
Hi, Les. All right. Thanks for joining the call. I'll hand those straight across to Chris Fox. So Chris, on the distribution, he had that, and then on the funnel of patients, which will be the first to come across to Valtruza.
Yeah, sounds great. Yeah, so we assume that based on all the market research that we've done, that an oral olanzapine patient that is not compliant for a variety of reasons would be a perfect olanzapine LAI From what physicians tell us, they're very, very familiar with the molecule, and they really appreciate the efficacy and the control that it gives them. So in our discussions, you know, leading up to this and the market research that we've done. We see that opportunistically as the perfect place to start. And we'll see where that goes from there. I mean, some of the experiences that we've had on UZETI is that once patients and physicians get experienced, they then start to architect for themselves what that looks like and what the perfect patient profile is. And so that's something that we'll be interested in keeping you guys updated on. But we certainly think that that's going to be where we start and where we, you know, go from there and i think that this is going to be a very broad opportunity as as eric said given that oral lanthapine represents about 20 of the total patients um on the distribution question just general code so we don't have to wait for a j code um and we expect you know to launch as we did with use eddie so um we will have you know products available sample and hospital kits as well so physicians can have those experiences and then get the product in channel in the next couple of weeks and get patients on therapy thanks for the questions thanks chris that takes the question
let's next question our next question comes from david amson of piper sandler your lines are open please go ahead um hey thanks so if you take a step back and look at the lai antipsychotic space I think the share of all LAIs is somewhere in the team. So, I guess my question here is, as you think about this product, can you give us a sense of where you think its share of the market could be in terms of, you know, percentage of oral olanzapine switches? Do you think that share, you know, could ultimately be higher in terms of, you know, percent of LAI to oral? So that's number one. And then as you think about, you know, market expansion down the road, any comments on bipolar mania? I know oral olandipine also is used quite significantly in mania. So any thoughts on that program?
Thanks, David. Thanks for the question. And we've sort of, a lot of people ask this question. And when we think about it, you said, you know, the teams, it actually varies a bit. It's around about 13% to 14%, the LAI market. And slightly higher in Europe, by the way, worth noting. But that is obviously a non-olanzapine, because as Eric pointed out, There is not a used long ex-pene, olanzapine on the market right now. So an analogue could be, well, the same will happen in olanzapine. So 13% transfer to LAI. That's a very crude way of looking at it. But obviously that is something that's already happened, and that's fairly significant. Would that change with an olanzapine LAI? Would it be the same? Would it be lower? Would it be higher? We'll wait and see. What we do know, what I think Chris Fox highlighted is, to the market research we see, there is significant demand for this. And I think Eric mentioned it in his opening remarks. Compliance is key when you have severe schizophrenia. And they have been anticipating having an effective monthly treatment for some time, combined with the fact that obviously this has no loading, getting it to the therapeutic levels very quickly, et cetera. So I think that makes us feel optimistic. But if you're sort of trying to model it, David, I'd say, yeah, 13% is a good analog. Let's see how it plays out. In Europe, it's slightly higher. But this creates still a very significant opportunity for us. On the bipolar mania, I'll hand that to Eric, and maybe he can give some context of that.
Yeah, thank you, Richard, and thank you, Dave, for the question. We have been thinking about bipolar and other things that we can do in lifecycle management, so I think that with this launch, we'll continue to double down on what we can do in the future, but that's certainly one of the things we've been thinking about. As you know, we got the same indication for UZETI before, before, and that was on a modeling and simulating basis. I think we'll probably be running a study if we do it on Zipina LAI, but certainly a good opportunity.
Thanks, Jay. Thanks for the question, though. Next question.
Our next question comes from Jason Gerberi of Bank of America. Your line's now open. Please go ahead.
Hey, good morning, guys. Thanks for taking my questions. So, for me, I'm just curious, you know, how the sales force is going to be prioritizing the two LAIs now, and will Uzzetti still get a lot of attention, you know, now that there's this new shiny toy in the portfolio? So that's question one. And then my second question is just, what are you guys assuming for drop-off to patients who go on to olanzapine LAI due to elevated metabolic risks, which are just a risk associated with this API? How do you think about the drug and stay time? I don't know if there's learnings you can take from, like, oral therapy, olanzapine versus other atypicals, you know, as weight and other metabolic parameters go in the wrong direction. I just wonder, is there a kind of a higher discontinuation rate for patients who start olanzapine versus other atypicals?
Hi, Jason. Thanks for the questions. I'll hand those to Chris and Eric. And starting, Chris, on the Salesforce prioritization, how do they, the shiny toy, what happens there?
I love it. And it is a shiny toy for sure. But so is Uzetti, I got to say. You know, we love both of these products, and I think they serve different needs. But in total, you know, as I said before, I think we can cover about 80% of the schizophrenia patients offering them an LAI that they otherwise wouldn't have had that option. And we have been meeting with the sales force. They're super prepared. They can do both of these really, really well. 80% of the docs that we call on today already will be targets for Welltrusa. And so it's a really, really nice synergy. And as you probably can tell, I'm very excited about it, but our reps and management are too. They really have honed their craft and are doing an extraordinary job of understanding the patient flow and the office flow. they know all of these physicians, and I think that creates a really beautiful slipstream for us to step in and offer them a new alternative, all the while validating the patients that are appropriate for UZETI and supporting them with both of these tremendous assets. So we think we have a great advantage of having a lot of synergies in this space from a know-how and also from a physician certainty. Eric, I'll turn it over to you.
Yes, thanks. Yeah, and the question was about, you know, the AE profile of, you know, oral alanzapine and the rate at which, you know, people drop off or manage that. Well, although that sounds like a bad thing, the great thing about Welltrusa is we're building upon a known foundation, alanzapine. People know, physicians know how to use it. They know what to expect. They know how to monitor their patients. Our side effect profile is identical to the oral. So we're adding an innovation and a benefit on top of what they already know. So that isn't going to be the biggest barrier. The positive is that we're bringing them something that actually makes it more convenient to give the drug in a more efficient way so that we remove the problem of an adherence. So I'm particularly excited by that 4% relapse. That's 96% of the people who are stable are staying on the drug because it's working.
So that's how I think most physicians will approach it. thank you Eric and thanks for the question Jason next question our next question comes from Ash Verma of UBS your line is now open please go ahead hey good morning this is Dee on behalf of Ash and just congrats on the news I have a couple on the launch trajectory can you give us some like a product analog that we can look for for the like a launch trajectory and then the second thing is you mentioned the overall conversion to IOAI could be like 13%. I just wonder, like, do you have a split between, like, patient split between, like, a conversion from overall versus from other IOAI agents? And my last question is just on the gating fact, like, what are some of the gating factors for the launch, given that I guess the meaningful contribution will come into, like, second half next year? Thank you.
Yeah, thanks for the question. So I think, you know, when it comes to the launch trajectory, I think the way we'll think about it is it's about getting a few things in place. First, it's about getting the coverage. And so that's Medicaid, making sure you get the Medicaid states on board. And as I mentioned earlier, you know, that's a slight rate limiting step because some will do it in day one and some will do it in six months and some in 12 and some even in 18. and that's just the procedure they have you need medicaid uh for physicians to to start to use it in any volume so we'll do that we're good at doing that we know how to do that we did that with you study uh the other one is to get hospital formally because obviously you know many of these patients will end up in the hospital so once again we've done that with you study we know who the people are in the hospital formally uh committees so we know where we need to go uh the other is is the physicians and as chris eloquently pointed out uh you said he uh salesforce commercial teams call on these 80 of these efficient physicians all the time so i think that gives us a good opportunity for a good trajectory trajectory should be thought about use of our samples scripts hospital formaries how many physicians use it what's the breadth of positions and then what is the depth of physicians so that's the reason why we talk about more trajectory in those ways uh versus uh revenue is because of as i've highlighted that that really limiting step of of payer access which means that it's really the second half of next year that we'll see meaningful revenue come through but you'll see all those leading indicators of volume of shift you know trx and and the factors and the use of the sampling the factors which will be able to articulate why we believe this will be a very good launch but obviously that that's something which we will be mentioning on all our quarterly earnings calls. The second, where do these come from? Is it orals? Is it LAIs? I think predominantly it'll come from orals because people on all olanzapine will want to, who compliance is key for them or in their physician's eyes or the patient's eyes, will want to move across to Walthusia. So what we've seen on all others is that the patients who are on the molecule already, because the physician has chosen olanzapine for a reason, and I think Eric's highlighted it most of the time, and they'll pick it because of his efficacy. And so we see the majority of patients coming from oral olanzapine onto the LAI. Will some come from other LAIs? That's possible, because maybe they were put on that because of compliance reasons. But think of it in that way. And then I think you said gating factors, and I think probably go back to the gating factors are coverage, Medicaid, and hospital formaries. But those we've planned out, and I hope you felt from Chris Fox's answer, the thoroughness of the preparation of this launch is excellent, but the thoroughness of this preparation through a team who are already in this market, I think, just makes it even more impactful. So I hope those answer questions.
I don't think I missed anything. um apologies if i did but next question our next question comes from umur rafat of evercore isi your lines now open please go ahead hi guys thanks for taking my question and congrats on the approval i have uh three quick ones if i may perhaps first um for eric eric is there a post marketing requirement and if you could also speak to the underlying tech because the label does get into the pdss cases but it always is constantly keeps saying it was on an another extended release of lands means could you just speak to your technology in the med and sale platform as well um and then for you chris and and perhaps richard as well i noticed the pricing philosophy teva used on uzeti was a it was not flat pricing and b the range across doses was anywhere from two thousand to seven thousand dollars on this one it's flat pricing first of all but also the prices kind of like in between at 3750 um and i understand relprev is not a comp because that pricing is from 2010 but how should we think about that and why is it flat pricing and i mean because you said you can ramp up to almost to 7 000 so i'm just trying to think out loud about uh this price point okay thanks thanks for the question i'll uh start with uh with eric uh we can talk about the post-marketing question and the medicinal technology, which I think you'll love to talk
about. And then I'll hand over to Chris Fox, who can talk about the pricing that you've mentioned, Umar.
Yeah. Yeah. Thank you, Umar. Thanks for the question. And with regards to the post-marketing commitment, you know, there's no particular post-marketing commitment other than, you know, monitoring for any suspected PDSS in the future, which is something we'd be doing anyways through of pharmacovigilance. So that's probably the only thing we'll be doing in the background, doing expedited events reporting if that's coming up, but nothing particularly unusual about that. The second thing about the technology, I think that in our discussions with FDA, they saw the value of what we're bringing to the table with this technology. Remember, it's a subcutaneous injection that rapidly aggregates under the skin. It was specifically designed to make sure that the safety profile was good. And in fact, some of that data, if you look deep into the label, is mentioned there. There is a mention of the fact that this other product, this injectable version of Alonzapine, has a dissolution rate in 24 hours of 91%, while I believe the number for well, Trues is 7% over 12 hours in an in vitro assay. So that was actually fantastic data to have in the label. Surely point out what the value of the formulation is that, you know, theoretically brings to the patient. So no significant post-marketing commitments, and the technology, you know, is highlighted in the label compared to another product out in the market. And with that, I'll pass it over to Chris.
Thanks. Thanks, Uma, for the question. Very astute observations, and I would say that, you know, we really thought about this differently than UZETI, and mainly because UZETI can come in one or two months. So, in thinking about WALTRUZA, we still use the same principle of striking that right balance by having as broad of access as we can while value preservation. And we didn't want to unknowingly disincent someone from using the dose that they need because of pricing, And so this was the best way to go. We do, as you can appreciate, massive market research on this to try to get this right. And we feel like, you know, this reflects the innovation and also will ensure that we get the best adoption and access across the board. Thank you for the question.
Thanks, Eric. Thanks, Chris. Thanks, Suva. Thanks for the question.
At this time, we currently have no further questions, so I'll hand it back to Richard Francis for any further remarks.
So thank you. So thank you, everybody, for joining the call. i do appreciate you giving us your time um just like to reiterate we are very excited here at teva as we continue to execute on our pivot to growth strategy uh particularly on our uh drive to create a world-class biopharma company by launching innovative products on a regular basis as you saw we had five submissions in five years and so we really have some momentum here and what Chris and her team have done in commercializing these products, I think, should give people a lot of optimism as to what we can do with Wiltruza. And just to remind, many of the questions today have been around the huge unmet medical need there is in schizophrenia, particularly for a long-acting olanzapine molecule, and particularly one with the product characteristics that Eric has clearly highlighted. So, you know, for me, somebody's been in this industry a long time, I know I speak on behalf of my colleagues, you know, it's a real privilege to bring something to the market that allows patients suffering from this very difficult condition to have an improved quality of life that they so desperately want and for physicians to help them treat those patients. So very proud. And I look forward to giving you an update of how we do with the launch at our various quarterly earnings. But for me, very excited. Thank you for your time and wish you all a good weekend.
This concludes today's conference call. Thank you all for joining. You may now disconnect your lines.
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