BIOGEN INC. — Call Transcript 2025

Thank you guys for being here. Super excited to have Biogen management join us. Alisha, thank you for making time. I'll let you kick things off. Thank you. Thank you for all of you that just showed up today. Appreciate that you're here, even if you have other work to do. I love that you're at least in the room, so I don't feel alone up here with one of my favorite people, Umar. So first and foremost, I'm supposed to say the company line that I will be making forward-looking statements today. So if you have any questions, please go to the Biogen website and look at the disclosures. I think first, what I'd like to start with, and I don't know how close everyone is with the story of Biogen, I know that you are, but sitting in the seat today versus three years ago is a very different seat for this company since our new CEO took over, Chris Viehbacher. And I think one of the first things that we did as a company, which was calling it a new Biogen, he really started to overhaul what we were doing as an organization. Started with Fit for Growth, that was our cost-cutting measures. We really came into the organization and said, you know what, we need to restructure how we're allocating costs. And this is now the year that we have finalized that to achieve our $1 billion in gross savings and $800 million in net savings. And I think when you look across the board, he's done really, along with the executive team, a fantastic job of optimizing and maximizing where we're going as an organization, especially our pipeline. I think it becomes very important for pipeline because if you think of seven years ago with Biogen, we were just an MS company, and we now have four different franchises. The ones that I think that you probably talk about most often are LEQEMBI for Alzheimer's disease. But when you look at today, for Biogen, we have 10 phase III or phase III-ready programs in place. Next year is the first year that we start turning over some of those cards, which will be very important to us. When you look at that and you look at what's reading out next year, we have BIIB080 for tau. I think there's a lot of interest for that. We also have litifilimab for lupus. Two SLE readouts will happen along with Parkinson's phase, I believe phase I or II for a LRRK2 asset, which will also be interesting. But more importantly, we have several launches that are going to be coming along. Actually, when you look at where we were just a couple of years ago, someone earlier today asked me, you know, Alisha, but what's the one big product when you look at 2030? And I said, if you look at a pie chart, we're going to have several big products, which will be the first time that I think Biogen will be in that seat. So I think Chris has done an excellent job with capital allocation. And I think when you look at our launches, we've had some very good launches over the past couple of years. Outstanding. Outstanding. I guess I'll start with the topic everyone is obsessed with right now, which is preclinical Alzheimer's opportunity. I had a feeling you were going to go there. Let me just start by asking you, we hosted the R&D leadership team recently from Biogen. One of the takeaways was they expressed openness that in a scenario where Lilly shows a certain signal in their study, Biogen could find ways to accelerate the readout on their end as well. I guess my question to you is, there's a lot of numbers being thrown around from a commercial perspective and what the size of the market is. How have you thought about what that market size could look like in pre-Alzheimer's? So I think for pre-symptomatic, you know, what a wonderful day if we're able to actually go to individuals who are still in their prime in their life and say, if you would like to maybe prevent this from happening, you know, there's a possibility to doing it. When you look at the market size for that, you know, it's so tough to say because I think Alzheimer's in general right now, even when you look at MCI, mild or severe, you know, the numbers are quite large. So if you look at pre-Alzheimer's and if you think that Alzheimer's is getting worse and not better, then you're going to look at multiples of that for pre-symptomatic. And I think different numbers are thrown out there because there are no codes, there are no ways of diagnosing pre-symptomatic Alzheimer's. And because of that, even if you talk to someone in commercial or a different company or a payer or an HCP, no one will have any idea until we understand what these trials look like. I think the other interesting thing is if the trial from Lilly comes out as positive, that is great. I think also for Biogen and Eisai. But if it comes out as negative, it's not necessarily bad for Biogen or Eisai. And that is because the trials are truly completely different in the way in which we recruited the patients and what we're actually trying to answer. And so at the end of the day, I think there's a lot of runway. I mean, first of all, you see how long it's taking for the current patient population who have symptoms who go into a doctor's office and say, I have a memory problem, to try and get on product. Imagine it being, I mean, I always say everyone in the room obviously has no cognitive decline. That is what pre-symptomatic is. It's people like you who are living totally normal and then us saying, you know, you might want to go on to a drug. And so building an infrastructure for that and convincing patients to come into the office is a very different way of approaching the market. Makes sense. Would you agree that at its peak, the current indication is half or less versus the pre-Alzheimer's opportunity? Like the pre-Alzheimer's is 2x plus of the current indication theoretically? Theoretically, I think that is the number that has been thrown out most often and has also been the number that has been validated by external sources. But when I say sources, again, it's a very loose number. I do find it to be a large opportunity. I think, you know, going wild with the number is probably not useful. But I do think being a couple multiples is probably more of a reasonable. Got it. And Alisha, does your thought process change based on what the effect size looks like? So for example, there's an expectation Lilly trial should track 40%-50% effect size. Do you have to be in that ballpark to accomplish these numbers or not necessarily? You know, we had spoken about this earlier, but you know, even when our trials read out for LEQEMBI and even for Kisunla, doctors still say, but what does that mean? What do these numbers mean? What does that look like in like clinically for a patient? You know, a lot of, you know, these are just clinical trials. You know, doctors aren't close to it. So I think even like an effect size, it becomes you have to go to a doctor and say, this is the type of patient you're looking for. This is how you'll try and diagnose them, and then this is what we believe the benefits will be. Benefits, though, for physicians are very different depending on their experience. So even if you look at drugs today, it is not a doctor doesn't come back and say, wow, their CDR Sum of Boxes are really looking good, Alisha. You know, what they say to me is they remembered their husband's name for the first time. We had a priest who went back and finally went back to a Sunday service and could do a Sunday service again. That is the language in which they use. So until the trials read out and we understand the meaning of the outcomes and meeting the endpoints, that's when you know how to actually do it. So Alisha, have you heard of anecdotes like that? Because my perception, at least looking at the data, always was whatever you remember today, the further degradation will be slower. It's not like you will revert back to remembering more things. We have seen through a couple of our trials that some patients report improvements. There's also stabilization and there is also slower decline. I see. But you do get feedback where patients can remember things again. They feel differently. They also report back. I told you the priest, we had one gentleman who was this, he loved cooking. He lived in this house with this massive library. And his kids were so sad because he stopped cooking. That's how they knew something was wrong is he didn't cook anymore. And he had been on product for, I believe it was around the six- to eight-month time period. And the son had called one of our doctors and said, I knew something was working. He pulled out the most complicated recipe in his library and he made a meal for us that night. So that's the feedback, you know, that you hear from individuals that matter. Fascinating. I guess from your perspective and from the commercial organization perspective, is it a much heavier lift to convince people that, hey, I know you're 50 and healthy and no Alzheimer's, but you should really be on this because you might develop it. Like, wouldn't theoretically that be a far more difficult heavy lift? Or you're just going to show them their blood-based biomarker? Yeah. Well, you know, that's what I'd ask all of you. I mean, I know that for someone like me, if they told me I had to go on a statin, I'd be like, really? Are we sure about that? You know, and I'm in the industry, right? So I think that all of us have a natural thing of like, I don't know if I need that yet. You know, going to a 50-year-old or even, you know, in our trial, we have 55-year-olds and saying, hey, you need to go on this. It has to be pretty convincing. I think that we've all become much more difficult in being able to be convinced with everything that's out there. And I think we're all, especially all of you, you're so smart in this room. I think you can probably negotiate your way out of anything when it comes to medicine because you know much more than the average person, but you do have to be quite convincing, I think, to get people on. Okay, got it. Excellent. Fantastic. I guess maybe at that point, we should probably transition then into just understanding the commercial dynamics on LEQEMBI itself right now. I think there was an element of folks looked at this very, very closely, and I don't think they've looked at it as closely in a while. So maybe for the benefit of everyone, could you remind everyone, what's the price of LEQEMBI for induction? What's the price and maintenance? And then what's the price for subQ? Yes. So when you look at the WAC price for IV induction and you go to maintenance, that will be 50% off of the WAC of IV induction. Okay? IV maintenance is half of induction. Yes. IV maintenance, half of induction because you're only going in for one IV a month versus two. Now we just launched a new formulation, which is called IQLIK. And IQLIK is the subQ administration for LEQEMBI, which clearly offers flexibility and optionality for patients who don't want to go in to get their IV. If you go from IV induction to subQ maintenance, it's a 30% reduction in price or revenue. Got it. So I guess I'll tell you the direction I was going with this. When I think about your induction pricing, $23,000, maintenance, if it's once a month, it's half that, $13,000. But the subQ is more like around the $18,000 price point. Just sticking with that logic chain, when you get the induction approved on a subQ basis, theoretically, it sounds to me like there might be a bit of a price step up in the works implicitly, just the way the subQ could get priced. Is that an unreasonable way of thinking about it? I like the way that you think, Umar. I always have, and I will say that if you were to look at market research for sort of economics around this, I think that research would show that a higher price point could be sustainable because you're no longer having a patient come in for the cost around the infusion and the administration and the staff that take place, so I think we have not been public yet with our price. We're still working through that because Eisai is the final decision maker when it comes to price, but I think that it would not be unreasonable if we thought it could be higher because we believe that that is what market research shows. Got it. And for induction SubQ, will that be a single shot or two shots? Two shots. Two shots per week? Per week. Got it. Which then, and remind me, the blood-based biomarker, how often does that need to be done on an ongoing basis? So right now, the way in which blood-based biomarkers are being used is this year, which I think for anyone that's close to blood-based biomarkers in general, it usually takes, you know, over a decade for these things to take off. Just this year alone, 350,000 will probably be done, mostly by neurologists. 70% of those are being done by neurologists. 30% are being done by PCPs. The bigger question though is very few of them are using it for confirmation. That means that they are triaging. Triaging means if it's a negative, they knock the patient basically out as you don't have Alzheimer's. But if it's indeterminate or positive, they still go for a CSF or a PET scan. So blood-based biomarkers, I would call it right now, physicians play with them a little bit. I say they do their own testing and then they look at it with concordance versus their own PET or CSF. Now that guidelines are out and now that eight have launched that meet the specificity and sensitivity threshold, we believe they're going to move into confirmation, but that will be after a lot of education. So they're only really being used early on. They're not being used post while they're on product. Okay, great. Maybe just transitioning to some of the other programs as well. I remember last year when we were chatting right here, perhaps even on these seats, we talked about the ZURZUVAE program. You were fairly comfortable on how that launch was going and how perhaps it was under-invested at the time. So clearly the team has spent more time. How's that launch looking now? There was a little bit of choppiness in 3Q, I felt, but it kind of got back on trajectory. Yep. So first of all, ZURZUVAE or Zuranolone, which is for postpartum depression, is a 14-day oral medication. And for anyone who is a mom or who has suffered from postpartum depression, I think maybe you've heard recently Jennifer Lawrence came out. She was on Zuranolone. I have to say the day that she came out and spoke about basically the impact that it made on her life and as a mom, you know, the media would. I didn't know she was a mom actually. Yes. She is. She is. And so she had gone on zuranolone and she said it absolutely, you know, changed her for the good because she was really going through such a dark time in her life. I feel that we didn't actually invest a lot right up front, but I think looking back, it was probably just enough. If you remember during that time, we thought we'd have MDD as well as PPD. I built a team for MDD and it ended up not happening. We pivoted to PPD, which we didn't do a lot of research on. Thought we were going to psychiatrists because if you buy data, it looks like psychiatrists write the medications. It ends up they do not. They miscoded as PPD even though it's MDD. So then we had to pivot again and we ended up going to OB-GYNs and OB-GYNs have been excellent. The thing that we have figured out though over the last two years is it's called a mental minute. There is only a 60-second time period that a patient or a mom is in front of a doctor where they actually even talk about PPD and they don't even say PPD. They say, "How are you doing?" Typically, if a patient wells up and cries, they go, "ha, this might be a problem." If they say "I'm overwhelmed," they go, "oh, that's just being a mom." So we've had to work on what do you do in that 60-second mental minute to get them to react differently. The launch has gone very well. If you look at our numbers, our quarter-over-quarter growth has been excellent and it continues to go. We don't talk about Zuranolone or we're not asked a lot about Zuranolone. Everyone asks about LEQEMBI, but I would say keep your eye on the space because the product is doing very well. What is the peak opportunity like realistically on this? So we typically don't talk about peak opportunity, but I will tell you it's much larger than what you see today. Got it. Okay. I think the Felzartamab program is obviously. Oh, it might, but by the way, you know how you said you saw a little glitch in the summertime? Yeah. It's because IMS reinstated their methodology. That had nothing to do. It's just the data that. Yes, it was the data that. Oh, I see. We called them, we tried talking to them about their methodology, but you know, you're just going to have to rely on more revenue. There's multiple companies reporting this with IMS. Yeah. I don't know what they're doing and we tried to talk to them about it, but. Okay. Okay, got it. On Felzartamab, I think the first indication is perhaps where you don't have much competition at all. Could you speak to what the market opportunity could look like? We are very excited about Felzartamab. If anyone can recall, there was an acquisition that Chris had done with a company called HiBio, which now is part of Biogen. We kept them in the West Coast. They're called the West Coast Hub. And Felzartamab, we believe, is going to be a very, very good product for us in nephrology. Everyone asks us about IgAN. However, IgAN is the third launch that we have for this molecule. The first launch is the one I'm really excited about. It is an AMR. There's approximately 11,000 patients that suffer from this. We know which centers they're at. We know where these patients sit. And just so you know, AMR, if you have it, basically 75% of all patients with kidney transplants lose their kidney. And so this helps prevent that. There are 11,000 patients for that. We believe that this is going to be a very large product for us. The second indication is MVI, which is another 4,000-5,000 patients. Then the third indication is IgAN. As soon as we launch AMR, we do three launches in one year. We will go AMR, MVI, IgAN back to back. Then we have PMN a little bit after that. Felzartamab really is this comprehensive program that we have that we believe even AMR alone, we find to be a very nice sized indication. So, is it, I mean, this is very rough math, but every 20% penetration into that 11,000 patients could be $1 billion in sales. So AMR alone could be a multi-billion indication theoretically. I'm not saying necessarily that's where it happens, but is that inconsistent with how you've thought about it? So, right now we're looking at, because I'm just opening up a franchise as of January of next year. So I already have my franchise head that I have located and appointed. Now I just need to make the offer. And they will start building a team. I think one of the teams that will become very important is market access. And so what we need to do is look sequentially at these different indications and what price point will hold for each and then where the value is coming from. Depending on how you price it, you are reasonable depending on the number that you're using. But it also just, we do have to look at like what can the market hold, where is the value in this market, and then what happens when you have multiple indications one after the other. Excellent. The program we didn't talk about previously, but I wanted to touch up on for a brief second. Oral BTK, how important is that for future planning if you were to have a real clean liver profile oral BTK to put out there with all the MS infrastructure you have? I think that the key to your question is a clean liver profile. I think the market really wants BTKIs to work because of the high efficacy, so they're not doing the B-cell depletion through things like Ocrevus or Kesimpta, and so the glitch is going to be the side effect profile. I think that if it is clean, the MS market will be able to hold it even though there's a lot of competition out there. I do think an oral with high efficacy and good safety will be something that they'd be willing to pay for, but if you do have a safety problem, there will be a problem with probably reimbursement or step-throughs. Outstanding. I know that's all the time we have, so I want to be very respectful. Thank you. Thank you again. Thank you guys for everyone that was listening. Appreciate it. Thank you guys.

Speaker 2: Thank you guys for being here. Super excited to have Biogen management join us. Alisha, thank you for making time. I'll let you kick things off. Thank you guys for being here. thank you guys for being here Super excited to have Biogen management join us. super excited to have biogen management join us Alisha, thank you for making time. alisha thank you for making time I'll let you kick things off. i'll let you kick things off

Speaker 1: Thank you. Thank you for all of you that just showed up today. Appreciate that you're here, even if you have other work to do. I love that you're at least in the room, so I don't feel alone up here with one of my favorite people, Umar. So first and foremost, I'm supposed to say the company line that I will be making forward-looking statements today. So if you have any questions, please go to the Biogen website and look at the disclosures. I think first, what I'd like to start with, and I don't know how close everyone is with the story of Biogen, I know that you are, but sitting in the seat today versus three years ago is a very different seat for this company since our new CEO took over, Chris Viehbacher. Thank you. thank you Thank you for all of you that just showed up today. thank you for all of you that just showed up today Appreciate that you're here, even if you have other work to do. appreciate that you're here even if you have other work to do I love that you're at least in the room, so I don't feel alone up here with one of my favorite people, Umar. i love that you're at least in the room so i don't feel alone up here with one of my favorite people umar So first and foremost, I'm supposed to say the company line that I will be making forward-looking statements today. so first and foremost i'm supposed to say the company line that i will be making forward-looking statements today So if you have any questions, please go to the Biogen website and look at the disclosures. so if you have any questions please go to the biogen website and look at the disclosures I think first, what I'd like to start with, and I don't know how close everyone is with the story of Biogen, I know that you are, but sitting in the seat today versus three years ago is a very different seat for this company since our new CEO took over, Chris Viehbacher. i think first what i'd like to start with and i don't know how close everyone is with the story of biogen i know that you are but sitting in the seat today versus three years ago is a very different seat for this company since our new ceo took over chris viehbacher And I think one of the first things that we did as a company, which was calling it a new Biogen, he really started to overhaul what we were doing as an organization. Started with Fit for Growth, that was our cost-cutting measures. We really came into the organization and said, you know what, we need to restructure how we're allocating costs. And this is now the year that we have finalized that to achieve our $1 billion in gross savings and $800 million in net savings. And I think when you look across the board, he's done really, along with the executive team, a fantastic job of optimizing and maximizing where we're going as an organization, especially our pipeline. And I think one of the first things that we did as a company, which was calling it a new Biogen, he really started to overhaul what we were doing as an organization. and i think one of the first things that we did as a company which was calling it a new biogen he really started to overhaul what we were doing as an organization Started with Fit for Growth, that was our cost-cutting measures. started with fit for growth that was our cost-cutting measures We really came into the organization and said, you know what, we need to restructure how we're allocating costs. we really came into the organization and said you know what we need to restructure how we're allocating costs And this is now the year that we have finalized that to achieve our $1 billion in gross savings and $800 million in net savings. and this is now the year that we have finalized that to achieve our $1 billion in gross savings and $800 million in net savings And I think when you look across the board, he's done really, along with the executive team, a fantastic job of optimizing and maximizing where we're going as an organization, especially our pipeline. and i think when you look across the board he's done really along with the executive team a fantastic job of optimizing and maximizing where we're going as an organization especially our pipeline I think it becomes very important for pipeline because if you think of seven years ago with Biogen, we were just an MS company, and we now have four different franchises. The ones that I think that you probably talk about most often are LEQEMBI for Alzheimer's disease. But when you look at today, for Biogen, we have 10 phase III or phase III-ready programs in place. Next year is the first year that we start turning over some of those cards, which will be very important to us. When you look at that and you look at what's reading out next year, we have BIIB080 for tau. I think there's a lot of interest for that. We also have litifilimab for lupus. I think it becomes very important for pipeline because if you think of seven years ago with Biogen, we were just an MS company, and we now have four different franchises. i think it becomes very important for pipeline because if you think of seven years ago with biogen we were just an ms company and we now have four different franchises The ones that I think that you probably talk about most often are LEQEMBI for Alzheimer's disease. the ones that i think that you probably talk about most often are leqembi for alzheimer's disease But when you look at today, for Biogen, we have 10 phase III or phase III-ready programs in place. but when you look at today for biogen we have 10 phase iii or phase iii-ready programs in place Next year is the first year that we start turning over some of those cards, which will be very important to us. next year is the first year that we start turning over some of those cards which will be very important to us When you look at that and you look at what's reading out next year, we have BIIB080 for tau. when you look at that and you look at what's reading out next year we have biib080 for tau I think there's a lot of interest for that. i think there's a lot of interest for that We also have litifilimab for lupus. we also have litifilimab for lupus Two SLE readouts will happen along with Parkinson's phase, I believe phase I or II for a LRRK2 asset, which will also be interesting. But more importantly, we have several launches that are going to be coming along. Actually, when you look at where we were just a couple of years ago, someone earlier today asked me, you know, Alisha, but what's the one big product when you look at 2030? And I said, if you look at a pie chart, we're going to have several big products, which will be the first time that I think Biogen will be in that seat. So I think Chris has done an excellent job with capital allocation. And I think when you look at our launches, we've had some very good launches over the past couple of years. Two SLE readouts will happen along with Parkinson's phase, I believe phase I or II for a LRRK2 asset, which will also be interesting. two sle readouts will happen along with parkinson's phase i believe phase i or ii for a lrrk2 asset which will also be interesting But more importantly, we have several launches that are going to be coming along. but more importantly we have several launches that are going to be coming along Actually, when you look at where we were just a couple of years ago, someone earlier today asked me, you know, Alisha, but what's the one big product when you look at 2030? actually when you look at where we were just a couple of years ago someone earlier today asked me you know alisha but what's the one big product when you look at 2030 And I said, if you look at a pie chart, we're going to have several big products, which will be the first time that I think Biogen will be in that seat. and i said if you look at a pie chart we're going to have several big products which will be the first time that i think biogen will be in that seat So I think Chris has done an excellent job with capital allocation. so i think chris has done an excellent job with capital allocation And I think when you look at our launches, we've had some very good launches over the past couple of years. and i think when you look at our launches we've had some very good launches over the past couple of years

Speaker 2: Outstanding. Outstanding. I guess I'll start with the topic everyone is obsessed with right now, which is preclinical Alzheimer's opportunity. Outstanding. outstanding Outstanding. outstanding I guess I'll start with the topic everyone is obsessed with right now, which is preclinical Alzheimer's opportunity. i guess i'll start with the topic everyone is obsessed with right now which is preclinical alzheimer's opportunity

Speaker 1: I had a feeling you were going to go there. I had a feeling you were going to go there. i had a feeling you were going to go there

Speaker 2: Let me just start by asking you, we hosted the R&D leadership team recently from Biogen. One of the takeaways was they expressed openness that in a scenario where Lilly shows a certain signal in their study, Biogen could find ways to accelerate the readout on their end as well. I guess my question to you is, there's a lot of numbers being thrown around from a commercial perspective and what the size of the market is. How have you thought about what that market size could look like in pre-Alzheimer's? Let me just start by asking you, we hosted the R&D leadership team recently from Biogen. let me just start by asking you we hosted the r&d leadership team recently from biogen One of the takeaways was they expressed openness that in a scenario where Lilly shows a certain signal in their study, Biogen could find ways to accelerate the readout on their end as well. one of the takeaways was they expressed openness that in a scenario where lilly shows a certain signal in their study biogen could find ways to accelerate the readout on their end as well I guess my question to you is, there's a lot of numbers being thrown around from a commercial perspective and what the size of the market is. i guess my question to you is there's a lot of numbers being thrown around from a commercial perspective and what the size of the market is How have you thought about what that market size could look like in pre-Alzheimer's? how have you thought about what that market size could look like in pre-alzheimer's

Speaker 1: So I think for pre-symptomatic, you know, what a wonderful day if we're able to actually go to individuals who are still in their prime in their life and say, if you would like to maybe prevent this from happening, you know, there's a possibility to doing it. When you look at the market size for that, you know, it's so tough to say because I think Alzheimer's in general right now, even when you look at MCI, mild or severe, you know, the numbers are quite large. So if you look at pre-Alzheimer's and if you think that Alzheimer's is getting worse and not better, then you're going to look at multiples of that for pre-symptomatic. And I think different numbers are thrown out there because there are no codes, there are no ways of diagnosing pre-symptomatic Alzheimer's. So I think for pre-symptomatic, you know, what a wonderful day if we're able to actually go to individuals who are still in their prime in their life and say, if you would like to maybe prevent this from happening, you know, there's a possibility to doing it. so i think for pre-symptomatic you know what a wonderful day if we're able to actually go to individuals who are still in their prime in their life and say if you would like to maybe prevent this from happening you know there's a possibility to doing it When you look at the market size for that, you know, it's so tough to say because I think Alzheimer's in general right now, even when you look at MCI, mild or severe, you know, the numbers are quite large. when you look at the market size for that you know it's so tough to say because i think alzheimer's in general right now even when you look at mci mild or severe you know the numbers are quite large So if you look at pre-Alzheimer's and if you think that Alzheimer's is getting worse and not better, then you're going to look at multiples of that for pre-symptomatic. so if you look at pre-alzheimer's and if you think that alzheimer's is getting worse and not better then you're going to look at multiples of that for pre-symptomatic And I think different numbers are thrown out there because there are no codes, there are no ways of diagnosing pre-symptomatic Alzheimer's. and i think different numbers are thrown out there because there are no codes there are no ways of diagnosing pre-symptomatic alzheimer's And because of that, even if you talk to someone in commercial or a different company or a payer or an HCP, no one will have any idea until we understand what these trials look like. I think the other interesting thing is if the trial from Lilly comes out as positive, that is great. I think also for Biogen and Eisai. But if it comes out as negative, it's not necessarily bad for Biogen or Eisai. And that is because the trials are truly completely different in the way in which we recruited the patients and what we're actually trying to answer. And so at the end of the day, I think there's a lot of runway. And because of that, even if you talk to someone in commercial or a different company or a payer or an HCP, no one will have any idea until we understand what these trials look like. and because of that even if you talk to someone in commercial or a different company or a payer or an hcp no one will have any idea until we understand what these trials look like I think the other interesting thing is if the trial from Lilly comes out as positive, that is great. i think the other interesting thing is if the trial from lilly comes out as positive that is great I think also for Biogen and Eisai. i think also for biogen and eisai But if it comes out as negative, it's not necessarily bad for Biogen or Eisai. but if it comes out as negative it's not necessarily bad for biogen or eisai And that is because the trials are truly completely different in the way in which we recruited the patients and what we're actually trying to answer. and that is because the trials are truly completely different in the way in which we recruited the patients and what we're actually trying to answer And so at the end of the day, I think there's a lot of runway. and so at the end of the day i think there's a lot of runway I mean, first of all, you see how long it's taking for the current patient population who have symptoms who go into a doctor's office and say, I have a memory problem, to try and get on product. Imagine it being, I mean, I always say everyone in the room obviously has no cognitive decline. That is what pre-symptomatic is. It's people like you who are living totally normal and then us saying, you know, you might want to go on to a drug. And so building an infrastructure for that and convincing patients to come into the office is a very different way of approaching the market. I mean, first of all, you see how long it's taking for the current patient population who have symptoms who go into a doctor's office and say, I have a memory problem, to try and get on product. i mean first of all you see how long it's taking for the current patient population who have symptoms who go into a doctor's office and say i have a memory problem to try and get on product Imagine it being, I mean, I always say everyone in the room obviously has no cognitive decline. imagine it being i mean i always say everyone in the room obviously has no cognitive decline That is what pre-symptomatic is. that is what pre-symptomatic is It's people like you who are living totally normal and then us saying, you know, you might want to go on to a drug. it's people like you who are living totally normal and then us saying you know you might want to go on to a drug And so building an infrastructure for that and convincing patients to come into the office is a very different way of approaching the market. and so building an infrastructure for that and convincing patients to come into the office is a very different way of approaching the market

Speaker 2: Makes sense. Would you agree that at its peak, the current indication is half or less versus the pre-Alzheimer's opportunity? Like the pre-Alzheimer's is 2x plus of the current indication theoretically? Makes sense. makes sense Would you agree that at its peak, the current indication is half or less versus the pre-Alzheimer's opportunity? would you agree that at its peak the current indication is half or less versus the pre-alzheimer's opportunity Like the pre-Alzheimer's is 2x plus of the current indication theoretically? like the pre-alzheimer's is 2x plus of the current indication theoretically

Speaker 1: Theoretically, I think that is the number that has been thrown out most often and has also been the number that has been validated by external sources. But when I say sources, again, it's a very loose number. I do find it to be a large opportunity. I think, you know, going wild with the number is probably not useful. But I do think being a couple multiples is probably more of a reasonable. Theoretically, I think that is the number that has been thrown out most often and has also been the number that has been validated by external sources. theoretically i think that is the number that has been thrown out most often and has also been the number that has been validated by external sources But when I say sources, again, it's a very loose number. but when i say sources again it's a very loose number I do find it to be a large opportunity. i do find it to be a large opportunity I think, you know, going wild with the number is probably not useful. i think you know going wild with the number is probably not useful But I do think being a couple multiples is probably more of a reasonable. but i do think being a couple multiples is probably more of a reasonable

Speaker 2: Got it. And Alisha, does your thought process change based on what the effect size looks like? So for example, there's an expectation Lilly trial should track 40%-50% effect size. Do you have to be in that ballpark to accomplish these numbers or not necessarily? Got it. got it And Alisha, does your thought process change based on what the effect size looks like? and alisha does your thought process change based on what the effect size looks like So for example, there's an expectation Lilly trial should track 40%-50% effect size. so for example there's an expectation lilly trial should track 40%-50% effect size Do you have to be in that ballpark to accomplish these numbers or not necessarily? do you have to be in that ballpark to accomplish these numbers or not necessarily

Speaker 1: You know, we had spoken about this earlier, but you know, even when our trials read out for LEQEMBI and even for Kisunla, doctors still say, but what does that mean? What do these numbers mean? What does that look like in like clinically for a patient? You know, a lot of, you know, these are just clinical trials. You know, doctors aren't close to it. So I think even like an effect size, it becomes you have to go to a doctor and say, this is the type of patient you're looking for. This is how you'll try and diagnose them, and then this is what we believe the benefits will be. Benefits, though, for physicians are very different depending on their experience. You know, we had spoken about this earlier, but you know, even when our trials read out for LEQEMBI and even for Kisunla, doctors still say, but what does that mean? you know we had spoken about this earlier but you know even when our trials read out for leqembi and even for kisunla doctors still say but what does that mean What do these numbers mean? what do these numbers mean What does that look like in like clinically for a patient? what does that look like in like clinically for a patient You know, a lot of, you know, these are just clinical trials. you know a lot of you know these are just clinical trials You know, doctors aren't close to it. you know doctors aren't close to it So I think even like an effect size, it becomes you have to go to a doctor and say, this is the type of patient you're looking for. so i think even like an effect size it becomes you have to go to a doctor and say this is the type of patient you're looking for This is how you'll try and diagnose them, and then this is what we believe the benefits will be. this is how you'll try and diagnose them and then this is what we believe the benefits will be Benefits, though, for physicians are very different depending on their experience. benefits though for physicians are very different depending on their experience So even if you look at drugs today, it is not a doctor doesn't come back and say, wow, their CDR Sum of Boxes are really looking good, Alisha. You know, what they say to me is they remembered their husband's name for the first time. We had a priest who went back and finally went back to a Sunday service and could do a Sunday service again. That is the language in which they use. So until the trials read out and we understand the meaning of the outcomes and meeting the endpoints, that's when you know how to actually do it. So even if you look at drugs today, it is not a doctor doesn't come back and say, wow, their CDR Sum of Boxes are really looking good, Alisha. so even if you look at drugs today it is not a doctor doesn't come back and say wow their cdr sum of boxes are really looking good alisha You know, what they say to me is they remembered their husband's name for the first time. you know what they say to me is they remembered their husband's name for the first time We had a priest who went back and finally went back to a Sunday service and could do a Sunday service again. we had a priest who went back and finally went back to a sunday service and could do a sunday service again That is the language in which they use. that is the language in which they use So until the trials read out and we understand the meaning of the outcomes and meeting the endpoints, that's when you know how to actually do it. so until the trials read out and we understand the meaning of the outcomes and meeting the endpoints that's when you know how to actually do it

Speaker 2: So Alisha, have you heard of anecdotes like that? Because my perception, at least looking at the data, always was whatever you remember today, the further degradation will be slower. It's not like you will revert back to remembering more things. So Alisha, have you heard of anecdotes like that? so alisha have you heard of anecdotes like that Because my perception, at least looking at the data, always was whatever you remember today, the further degradation will be slower. because my perception at least looking at the data always was whatever you remember today the further degradation will be slower It's not like you will revert back to remembering more things. it's not like you will revert back to remembering more things

Speaker 1: We have seen through a couple of our trials that some patients report improvements. There's also stabilization and there is also slower decline. We have seen through a couple of our trials that some patients report improvements. we have seen through a couple of our trials that some patients report improvements There's also stabilization and there is also slower decline. there's also stabilization and there is also slower decline

Speaker 2: I see. I see. i see

Speaker 1: But you do get feedback where patients can remember things again. They feel differently. They also report back. I told you the priest, we had one gentleman who was this, he loved cooking. He lived in this house with this massive library. And his kids were so sad because he stopped cooking. That's how they knew something was wrong is he didn't cook anymore. And he had been on product for, I believe it was around the six- to eight-month time period. And the son had called one of our doctors and said, I knew something was working. He pulled out the most complicated recipe in his library and he made a meal for us that night. So that's the feedback, you know, that you hear from individuals that matter. But you do get feedback where patients can remember things again. but you do get feedback where patients can remember things again They feel differently. they feel differently They also report back. they also report back I told you the priest, we had one gentleman who was this, he loved cooking. i told you the priest we had one gentleman who was this he loved cooking He lived in this house with this massive library. he lived in this house with this massive library And his kids were so sad because he stopped cooking. and his kids were so sad because he stopped cooking That's how they knew something was wrong is he didn't cook anymore. that's how they knew something was wrong is he didn't cook anymore And he had been on product for, I believe it was around the six- to eight-month time period. and he had been on product for i believe it was around the six- to eight-month time period And the son had called one of our doctors and said, I knew something was working. and the son had called one of our doctors and said i knew something was working He pulled out the most complicated recipe in his library and he made a meal for us that night. he pulled out the most complicated recipe in his library and he made a meal for us that night So that's the feedback, you know, that you hear from individuals that matter. so that's the feedback you know that you hear from individuals that matter

Speaker 2: Fascinating. I guess from your perspective and from the commercial organization perspective, is it a much heavier lift to convince people that, hey, I know you're 50 and healthy and no Alzheimer's, but you should really be on this because you might develop it. Like, wouldn't theoretically that be a far more difficult heavy lift? Or you're just going to show them their blood-based biomarker? Fascinating. fascinating I guess from your perspective and from the commercial organization perspective, is it a much heavier lift to convince people that, hey, I know you're 50 and healthy and no Alzheimer's, but you should really be on this because you might develop it. i guess from your perspective and from the commercial organization perspective is it a much heavier lift to convince people that hey i know you're 50 and healthy and no alzheimer's but you should really be on this because you might develop it Like, wouldn't theoretically that be a far more difficult heavy lift? like wouldn't theoretically that be a far more difficult heavy lift Or you're just going to show them their blood-based biomarker? or you're just going to show them their blood-based biomarker

Speaker 1: Yeah. Well, you know, that's what I'd ask all of you. I mean, I know that for someone like me, if they told me I had to go on a statin, I'd be like, really? Are we sure about that? You know, and I'm in the industry, right? So I think that all of us have a natural thing of like, I don't know if I need that yet. You know, going to a 50-year-old or even, you know, in our trial, we have 55-year-olds and saying, hey, you need to go on this. It has to be pretty convincing. I think that we've all become much more difficult in being able to be convinced with everything that's out there. And I think we're all, especially all of you, you're so smart in this room. Yeah. yeah Well, you know, that's what I'd ask all of you. well you know that's what i'd ask all of you I mean, I know that for someone like me, if they told me I had to go on a statin, I'd be like, really? i mean i know that for someone like me if they told me i had to go on a statin i'd be like really Are we sure about that? are we sure about that You know, and I'm in the industry, right? you know and i'm in the industry right So I think that all of us have a natural thing of like, I don't know if I need that yet. so i think that all of us have a natural thing of like i don't know if i need that yet You know, going to a 50-year-old or even, you know, in our trial, we have 55-year-olds and saying, hey, you need to go on this. you know going to a 50-year-old or even you know in our trial we have 55-year-olds and saying hey you need to go on this It has to be pretty convincing. it has to be pretty convincing I think that we've all become much more difficult in being able to be convinced with everything that's out there. i think that we've all become much more difficult in being able to be convinced with everything that's out there And I think we're all, especially all of you, you're so smart in this room. and i think we're all especially all of you you're so smart in this room I think you can probably negotiate your way out of anything when it comes to medicine because you know much more than the average person, but you do have to be quite convincing, I think, to get people on. I think you can probably negotiate your way out of anything when it comes to medicine because you know much more than the average person, but you do have to be quite convincing, I think, to get people on. i think you can probably negotiate your way out of anything when it comes to medicine because you know much more than the average person but you do have to be quite convincing i think to get people on

Speaker 2: Okay, got it. Excellent. Fantastic. I guess maybe at that point, we should probably transition then into just understanding the commercial dynamics on LEQEMBI itself right now. I think there was an element of folks looked at this very, very closely, and I don't think they've looked at it as closely in a while. So maybe for the benefit of everyone, could you remind everyone, what's the price of LEQEMBI for induction? What's the price and maintenance? And then what's the price for subQ? Okay, got it. okay got it Excellent. excellent Fantastic. fantastic I guess maybe at that point, we should probably transition then into just understanding the commercial dynamics on LEQEMBI itself right now. i guess maybe at that point we should probably transition then into just understanding the commercial dynamics on leqembi itself right now I think there was an element of folks looked at this very, very closely, and I don't think they've looked at it as closely in a while. i think there was an element of folks looked at this very very closely and i don't think they've looked at it as closely in a while So maybe for the benefit of everyone, could you remind everyone, what's the price of LEQEMBI for induction? so maybe for the benefit of everyone could you remind everyone what's the price of leqembi for induction What's the price and maintenance? what's the price and maintenance And then what's the price for subQ? and then what's the price for subq

Speaker 1: Yes. So when you look at the WAC price for IV induction and you go to maintenance, that will be 50% off of the WAC of IV induction. Okay? Yes. yes So when you look at the WAC price for IV induction and you go to maintenance, that will be 50% off of the WAC of IV induction. so when you look at the wac price for iv induction and you go to maintenance that will be 50% off of the wac of iv induction Okay? okay

Speaker 2: IV maintenance is half of induction. IV maintenance is half of induction. iv maintenance is half of induction

Speaker 1: Yes. IV maintenance, half of induction because you're only going in for one IV a month versus two. Now we just launched a new formulation, which is called IQLIK. And IQLIK is the subQ administration for LEQEMBI, which clearly offers flexibility and optionality for patients who don't want to go in to get their IV. If you go from IV induction to subQ maintenance, it's a 30% reduction in price or revenue. Yes. yes IV maintenance, half of induction because you're only going in for one IV a month versus two. iv maintenance half of induction because you're only going in for one iv a month versus two Now we just launched a new formulation, which is called IQLIK. now we just launched a new formulation which is called iqlik And IQLIK is the subQ administration for LEQEMBI, which clearly offers flexibility and optionality for patients who don't want to go in to get their IV. and iqlik is the subq administration for leqembi which clearly offers flexibility and optionality for patients who don't want to go in to get their iv If you go from IV induction to subQ maintenance, it's a 30% reduction in price or revenue. if you go from iv induction to subq maintenance it's a 30% reduction in price or revenue

Speaker 2: Got it. So I guess I'll tell you the direction I was going with this. When I think about your induction pricing, $23,000, maintenance, if it's once a month, it's half that, $13,000. But the subQ is more like around the $18,000 price point. Just sticking with that logic chain, when you get the induction approved on a subQ basis, theoretically, it sounds to me like there might be a bit of a price step up in the works implicitly, just the way the subQ could get priced. Is that an unreasonable way of thinking about it? Got it. got it So I guess I'll tell you the direction I was going with this. so i guess i'll tell you the direction i was going with this When I think about your induction pricing, $23,000, maintenance, if it's once a month, it's half that, $13,000. when i think about your induction pricing $23,000 maintenance if it's once a month it's half that $13,000 But the subQ is more like around the $18,000 price point. but the subq is more like around the $18,000 price point Just sticking with that logic chain, when you get the induction approved on a subQ basis, theoretically, it sounds to me like there might be a bit of a price step up in the works implicitly, just the way the subQ could get priced. just sticking with that logic chain when you get the induction approved on a subq basis theoretically it sounds to me like there might be a bit of a price step up in the works implicitly just the way the subq could get priced Is that an unreasonable way of thinking about it? is that an unreasonable way of thinking about it

Speaker 1: I like the way that you think, Umar. I always have, and I will say that if you were to look at market research for sort of economics around this, I think that research would show that a higher price point could be sustainable because you're no longer having a patient come in for the cost around the infusion and the administration and the staff that take place, so I think we have not been public yet with our price. We're still working through that because Eisai is the final decision maker when it comes to price, but I think that it would not be unreasonable if we thought it could be higher because we believe that that is what market research shows. I like the way that you think, Umar. i like the way that you think umar I always have, and I will say that if you were to look at market research for sort of economics around this, I think that research would show that a higher price point could be sustainable because you're no longer having a patient come in for the cost around the infusion and the administration and the staff that take place, so I think we have not been public yet with our price. i always have and i will say that if you were to look at market research for sort of economics around this i think that research would show that a higher price point could be sustainable because you're no longer having a patient come in for the cost around the infusion and the administration and the staff that take place so i think we have not been public yet with our price We're still working through that because Eisai is the final decision maker when it comes to price, but I think that it would not be unreasonable if we thought it could be higher because we believe that that is what market research shows. we're still working through that because eisai is the final decision maker when it comes to price but i think that it would not be unreasonable if we thought it could be higher because we believe that that is what market research shows

Speaker 2: Got it. And for induction SubQ, will that be a single shot or two shots? Got it. got it And for induction SubQ, will that be a single shot or two shots? and for induction subq will that be a single shot or two shots

Speaker 1: Two shots. Two shots. two shots

Speaker 2: Two shots per week? Two shots per week? two shots per week

Speaker 1: Per week. Per week. per week

Speaker 2: Got it. Which then, and remind me, the blood-based biomarker, how often does that need to be done on an ongoing basis? Got it. got it Which then, and remind me, the blood-based biomarker, how often does that need to be done on an ongoing basis? which then and remind me the blood-based biomarker how often does that need to be done on an ongoing basis

Speaker 1: So right now, the way in which blood-based biomarkers are being used is this year, which I think for anyone that's close to blood-based biomarkers in general, it usually takes, you know, over a decade for these things to take off. Just this year alone, 350,000 will probably be done, mostly by neurologists. 70% of those are being done by neurologists. 30% are being done by PCPs. The bigger question though is very few of them are using it for confirmation. That means that they are triaging. Triaging means if it's a negative, they knock the patient basically out as you don't have Alzheimer's. But if it's indeterminate or positive, they still go for a CSF or a PET scan. So blood-based biomarkers, I would call it right now, physicians play with them a little bit. So right now, the way in which blood-based biomarkers are being used is this year, which I think for anyone that's close to blood-based biomarkers in general, it usually takes, you know, over a decade for these things to take off. so right now the way in which blood-based biomarkers are being used is this year which i think for anyone that's close to blood-based biomarkers in general it usually takes you know over a decade for these things to take off Just this year alone, 350,000 will probably be done, mostly by neurologists. 70% of those are being done by neurologists. 30% are being done by PCPs. just this year alone 350,000 will probably be done mostly by neurologists 70% of those are being done by neurologists 30% are being done by pcps The bigger question though is very few of them are using it for confirmation. the bigger question though is very few of them are using it for confirmation That means that they are triaging. that means that they are triaging Triaging means if it's a negative, they knock the patient basically out as you don't have Alzheimer's. triaging means if it's a negative they knock the patient basically out as you don't have alzheimer's But if it's indeterminate or positive, they still go for a CSF or a PET scan. but if it's indeterminate or positive they still go for a csf or a pet scan So blood-based biomarkers, I would call it right now, physicians play with them a little bit. so blood-based biomarkers i would call it right now physicians play with them a little bit I say they do their own testing and then they look at it with concordance versus their own PET or CSF. Now that guidelines are out and now that eight have launched that meet the specificity and sensitivity threshold, we believe they're going to move into confirmation, but that will be after a lot of education. So they're only really being used early on. They're not being used post while they're on product. I say they do their own testing and then they look at it with concordance versus their own PET or CSF. i say they do their own testing and then they look at it with concordance versus their own pet or csf Now that guidelines are out and now that eight have launched that meet the specificity and sensitivity threshold, we believe they're going to move into confirmation, but that will be after a lot of education. now that guidelines are out and now that eight have launched that meet the specificity and sensitivity threshold we believe they're going to move into confirmation but that will be after a lot of education So they're only really being used early on. so they're only really being used early on They're not being used post while they're on product. they're not being used post while they're on product

Speaker 2: Okay, great. Maybe just transitioning to some of the other programs as well. I remember last year when we were chatting right here, perhaps even on these seats, we talked about the ZURZUVAE program. You were fairly comfortable on how that launch was going and how perhaps it was under-invested at the time. So clearly the team has spent more time. How's that launch looking now? There was a little bit of choppiness in 3Q, I felt, but it kind of got back on trajectory. Okay, great. okay great Maybe just transitioning to some of the other programs as well. maybe just transitioning to some of the other programs as well I remember last year when we were chatting right here, perhaps even on these seats, we talked about the ZURZUVAE program. i remember last year when we were chatting right here perhaps even on these seats we talked about the zurzuvae program You were fairly comfortable on how that launch was going and how perhaps it was under-invested at the time. you were fairly comfortable on how that launch was going and how perhaps it was under-invested at the time So clearly the team has spent more time. so clearly the team has spent more time How's that launch looking now? how's that launch looking now There was a little bit of choppiness in 3Q, I felt, but it kind of got back on trajectory. there was a little bit of choppiness in 3q i felt but it kind of got back on trajectory

Speaker 1: Yep. So first of all, ZURZUVAE or Zuranolone, which is for postpartum depression, is a 14-day oral medication. And for anyone who is a mom or who has suffered from postpartum depression, I think maybe you've heard recently Jennifer Lawrence came out. She was on Zuranolone. I have to say the day that she came out and spoke about basically the impact that it made on her life and as a mom, you know, the media would. Yep. yep So first of all, ZURZUVAE or Zuranolone, which is for postpartum depression, is a 14-day oral medication. so first of all zurzuvae or zuranolone which is for postpartum depression is a 14-day oral medication And for anyone who is a mom or who has suffered from postpartum depression, I think maybe you've heard recently Jennifer Lawrence came out. and for anyone who is a mom or who has suffered from postpartum depression i think maybe you've heard recently jennifer lawrence came out She was on Zuranolone. she was on zuranolone I have to say the day that she came out and spoke about basically the impact that it made on her life and as a mom, you know, the media would. i have to say the day that she came out and spoke about basically the impact that it made on her life and as a mom you know the media would

Speaker 2: I didn't know she was a mom actually. I didn't know she was a mom actually. i didn't know she was a mom actually

Speaker 1: Yes. She is. She is. And so she had gone on zuranolone and she said it absolutely, you know, changed her for the good because she was really going through such a dark time in her life. I feel that we didn't actually invest a lot right up front, but I think looking back, it was probably just enough. If you remember during that time, we thought we'd have MDD as well as PPD. I built a team for MDD and it ended up not happening. We pivoted to PPD, which we didn't do a lot of research on. Thought we were going to psychiatrists because if you buy data, it looks like psychiatrists write the medications. It ends up they do not. They miscoded as PPD even though it's MDD. So then we had to pivot again and we ended up going to OB-GYNs and OB-GYNs have been excellent. Yes. yes She is. she is She is. she is And so she had gone on zuranolone and she said it absolutely, you know, changed her for the good because she was really going through such a dark time in her life. and so she had gone on zuranolone and she said it absolutely you know changed her for the good because she was really going through such a dark time in her life I feel that we didn't actually invest a lot right up front, but I think looking back, it was probably just enough. i feel that we didn't actually invest a lot right up front but i think looking back it was probably just enough If you remember during that time, we thought we'd have MDD as well as PPD. if you remember during that time we thought we'd have mdd as well as ppd I built a team for MDD and it ended up not happening. i built a team for mdd and it ended up not happening We pivoted to PPD, which we didn't do a lot of research on. we pivoted to ppd which we didn't do a lot of research on Thought we were going to psychiatrists because if you buy data, it looks like psychiatrists write the medications. thought we were going to psychiatrists because if you buy data it looks like psychiatrists write the medications It ends up they do not. it ends up they do not They miscoded as PPD even though it's MDD. they miscoded as ppd even though it's mdd So then we had to pivot again and we ended up going to OB-GYNs and OB-GYNs have been excellent. so then we had to pivot again and we ended up going to ob-gyns and ob-gyns have been excellent The thing that we have figured out though over the last two years is it's called a mental minute. There is only a 60-second time period that a patient or a mom is in front of a doctor where they actually even talk about PPD and they don't even say PPD. They say, "How are you doing?" Typically, if a patient wells up and cries, they go, "ha, this might be a problem." If they say "I'm overwhelmed," they go, "oh, that's just being a mom." So we've had to work on what do you do in that 60-second mental minute to get them to react differently. The launch has gone very well. If you look at our numbers, our quarter-over-quarter growth has been excellent and it continues to go. We don't talk about Zuranolone or we're not asked a lot about Zuranolone. The thing that we have figured out though over the last two years is it's called a mental minute. the thing that we have figured out though over the last two years is it's called a mental minute There is only a 60-second time period that a patient or a mom is in front of a doctor where they actually even talk about PPD and they don't even say PPD. there is only a 60-second time period that a patient or a mom is in front of a doctor where they actually even talk about ppd and they don't even say ppd They say, "How are you doing?" Typically, if a patient wells up and cries, they go, "ha, this might be a problem." If they say "I'm overwhelmed," they go, "oh, that's just being a mom." So we've had to work on what do you do in that 60-second mental minute to get them to react differently. they say "how are you doing?" typically if a patient wells up and cries they go "ha this might be a problem." if they say "i'm overwhelmed," they go "oh that's just being a mom." so we've had to work on what do you do in that 60-second mental minute to get them to react differently The launch has gone very well. the launch has gone very well If you look at our numbers, our quarter-over-quarter growth has been excellent and it continues to go. if you look at our numbers our quarter-over-quarter growth has been excellent and it continues to go We don't talk about Zuranolone or we're not asked a lot about Zuranolone. we don't talk about zuranolone or we're not asked a lot about zuranolone Everyone asks about LEQEMBI, but I would say keep your eye on the space because the product is doing very well. Everyone asks about LEQEMBI, but I would say keep your eye on the space because the product is doing very well. everyone asks about leqembi but i would say keep your eye on the space because the product is doing very well

Speaker 2: What is the peak opportunity like realistically on this? What is the peak opportunity like realistically on this? what is the peak opportunity like realistically on this

Speaker 1: So we typically don't talk about peak opportunity, but I will tell you it's much larger than what you see today. So we typically don't talk about peak opportunity, but I will tell you it's much larger than what you see today. so we typically don't talk about peak opportunity but i will tell you it's much larger than what you see today

Speaker 2: Got it. Okay. I think the Felzartamab program is obviously. Got it. got it Okay. okay I think the Felzartamab program is obviously. i think the felzartamab program is obviously

Speaker 1: Oh, it might, but by the way, you know how you said you saw a little glitch in the summertime? Oh, it might, but by the way, you know how you said you saw a little glitch in the summertime? oh it might but by the way you know how you said you saw a little glitch in the summertime

Speaker 2: Yeah. Yeah. yeah

Speaker 1: It's because IMS reinstated their methodology. That had nothing to do. It's just the data that. Yes, it was the data that. It's because IMS reinstated their methodology. it's because ims reinstated their methodology That had nothing to do. that had nothing to do It's just the data that. it's just the data that Yes, it was the data that. yes it was the data that

Speaker 2: Oh, I see. Oh, I see. oh i see

Speaker 1: We called them, we tried talking to them about their methodology, but you know, you're just going to have to rely on more revenue. We called them, we tried talking to them about their methodology, but you know, you're just going to have to rely on more revenue. we called them we tried talking to them about their methodology but you know you're just going to have to rely on more revenue

Speaker 2: There's multiple companies reporting this with IMS. There's multiple companies reporting this with IMS. there's multiple companies reporting this with ims

Speaker 1: Yeah. I don't know what they're doing and we tried to talk to them about it, but. Yeah. yeah I don't know what they're doing and we tried to talk to them about it, but. i don't know what they're doing and we tried to talk to them about it but

Speaker 2: Okay. Okay, got it. On Felzartamab, I think the first indication is perhaps where you don't have much competition at all. Could you speak to what the market opportunity could look like? Okay. okay Okay, got it. okay got it On Felzartamab, I think the first indication is perhaps where you don't have much competition at all. on felzartamab i think the first indication is perhaps where you don't have much competition at all Could you speak to what the market opportunity could look like? could you speak to what the market opportunity could look like

Speaker 1: We are very excited about Felzartamab. If anyone can recall, there was an acquisition that Chris had done with a company called HiBio, which now is part of Biogen. We kept them in the West Coast. They're called the West Coast Hub. And Felzartamab, we believe, is going to be a very, very good product for us in nephrology. Everyone asks us about IgAN. However, IgAN is the third launch that we have for this molecule. The first launch is the one I'm really excited about. It is an AMR. There's approximately 11,000 patients that suffer from this. We know which centers they're at. We know where these patients sit. And just so you know, AMR, if you have it, basically 75% of all patients with kidney transplants lose their kidney. And so this helps prevent that. There are 11,000 patients for that. We are very excited about Felzartamab. we are very excited about felzartamab If anyone can recall, there was an acquisition that Chris had done with a company called HiBio, which now is part of Biogen. if anyone can recall there was an acquisition that chris had done with a company called hibio which now is part of biogen We kept them in the West Coast. we kept them in the west coast They're called the West Coast Hub. they're called the west coast hub And Felzartamab, we believe, is going to be a very, very good product for us in nephrology. and felzartamab we believe is going to be a very very good product for us in nephrology Everyone asks us about IgAN. everyone asks us about igan However, IgAN is the third launch that we have for this molecule. however igan is the third launch that we have for this molecule The first launch is the one I'm really excited about. the first launch is the one i'm really excited about It is an AMR. it is an amr There's approximately 11,000 patients that suffer from this. there's approximately 11,000 patients that suffer from this We know which centers they're at. we know which centers they're at We know where these patients sit. we know where these patients sit And just so you know, AMR, if you have it, basically 75% of all patients with kidney transplants lose their kidney. and just so you know amr if you have it basically 75% of all patients with kidney transplants lose their kidney And so this helps prevent that. and so this helps prevent that There are 11,000 patients for that. there are 11,000 patients for that We believe that this is going to be a very large product for us. The second indication is MVI, which is another 4,000-5,000 patients. Then the third indication is IgAN. As soon as we launch AMR, we do three launches in one year. We will go AMR, MVI, IgAN back to back. Then we have PMN a little bit after that. Felzartamab really is this comprehensive program that we have that we believe even AMR alone, we find to be a very nice sized indication. We believe that this is going to be a very large product for us. we believe that this is going to be a very large product for us The second indication is MVI, which is another 4,000-5,000 patients. the second indication is mvi which is another 4,000-5,000 patients Then the third indication is IgAN. then the third indication is igan As soon as we launch AMR, we do three launches in one year. as soon as we launch amr we do three launches in one year We will go AMR, MVI, IgAN back to back. we will go amr mvi igan back to back Then we have PMN a little bit after that. then we have pmn a little bit after that Felzartamab really is this comprehensive program that we have that we believe even AMR alone, we find to be a very nice sized indication. felzartamab really is this comprehensive program that we have that we believe even amr alone we find to be a very nice sized indication

Speaker 2: So, is it, I mean, this is very rough math, but every 20% penetration into that 11,000 patients could be $1 billion in sales. So AMR alone could be a multi-billion indication theoretically. I'm not saying necessarily that's where it happens, but is that inconsistent with how you've thought about it? So, is it, I mean, this is very rough math, but every 20% penetration into that 11,000 patients could be $1 billion in sales. so is it i mean this is very rough math but every 20% penetration into that 11,000 patients could be $1 billion in sales So AMR alone could be a multi-billion indication theoretically. so amr alone could be a multi-billion indication theoretically I'm not saying necessarily that's where it happens, but is that inconsistent with how you've thought about it? i'm not saying necessarily that's where it happens but is that inconsistent with how you've thought about it

Speaker 1: So, right now we're looking at, because I'm just opening up a franchise as of January of next year. So I already have my franchise head that I have located and appointed. Now I just need to make the offer. And they will start building a team. I think one of the teams that will become very important is market access. And so what we need to do is look sequentially at these different indications and what price point will hold for each and then where the value is coming from. Depending on how you price it, you are reasonable depending on the number that you're using. But it also just, we do have to look at like what can the market hold, where is the value in this market, and then what happens when you have multiple indications one after the other. So, right now we're looking at, because I'm just opening up a franchise as of January of next year. so right now we're looking at because i'm just opening up a franchise as of january of next year So I already have my franchise head that I have located and appointed. so i already have my franchise head that i have located and appointed Now I just need to make the offer. now i just need to make the offer And they will start building a team. and they will start building a team I think one of the teams that will become very important is market access. i think one of the teams that will become very important is market access And so what we need to do is look sequentially at these different indications and what price point will hold for each and then where the value is coming from. and so what we need to do is look sequentially at these different indications and what price point will hold for each and then where the value is coming from Depending on how you price it, you are reasonable depending on the number that you're using. depending on how you price it you are reasonable depending on the number that you're using But it also just, we do have to look at like what can the market hold, where is the value in this market, and then what happens when you have multiple indications one after the other. but it also just we do have to look at like what can the market hold where is the value in this market and then what happens when you have multiple indications one after the other

Speaker 2: Excellent. The program we didn't talk about previously, but I wanted to touch up on for a brief second. Oral BTK, how important is that for future planning if you were to have a real clean liver profile oral BTK to put out there with all the MS infrastructure you have? Excellent. excellent The program we didn't talk about previously, but I wanted to touch up on for a brief second. the program we didn't talk about previously but i wanted to touch up on for a brief second Oral BTK, how important is that for future planning if you were to have a real clean liver profile oral BTK to put out there with all the MS infrastructure you have? oral btk how important is that for future planning if you were to have a real clean liver profile oral btk to put out there with all the ms infrastructure you have

Speaker 1: I think that the key to your question is a clean liver profile. I think the market really wants BTKIs to work because of the high efficacy, so they're not doing the B-cell depletion through things like Ocrevus or Kesimpta, and so the glitch is going to be the side effect profile. I think that if it is clean, the MS market will be able to hold it even though there's a lot of competition out there. I do think an oral with high efficacy and good safety will be something that they'd be willing to pay for, but if you do have a safety problem, there will be a problem with probably reimbursement or step-throughs. I think that the key to your question is a clean liver profile. i think that the key to your question is a clean liver profile I think the market really wants BTKIs to work because of the high efficacy, so they're not doing the B-cell depletion through things like Ocrevus or Kesimpta, and so the glitch is going to be the side effect profile. i think the market really wants btkis to work because of the high efficacy so they're not doing the b-cell depletion through things like ocrevus or kesimpta and so the glitch is going to be the side effect profile I think that if it is clean, the MS market will be able to hold it even though there's a lot of competition out there. i think that if it is clean the ms market will be able to hold it even though there's a lot of competition out there I do think an oral with high efficacy and good safety will be something that they'd be willing to pay for, but if you do have a safety problem, there will be a problem with probably reimbursement or step-throughs. i do think an oral with high efficacy and good safety will be something that they'd be willing to pay for but if you do have a safety problem there will be a problem with probably reimbursement or step-throughs

Speaker 2: Outstanding. I know that's all the time we have, so I want to be very respectful. Outstanding. outstanding I know that's all the time we have, so I want to be very respectful. i know that's all the time we have so i want to be very respectful

Speaker 1: Thank you. Thank you. thank you

Speaker 2: Thank you again. Thank you again. thank you again

Speaker 1: Thank you guys for everyone that was listening. Appreciate it. Thank you guys for everyone that was listening. thank you guys for everyone that was listening Appreciate it. appreciate it

Speaker 2: Thank you guys. Thank you guys. thank you guys