Priya Singhal: Yes. Thanks, Geoff. Great question. So I’ll just step back and say, obviously, Alzheimer’s disease is a very complex disease with multiple biologies and complex pathophysiology. We do see ourselves as pioneers in this space and we have been successful with demonstrating the A-beta plaques as being central. And now we’ve kind of shifted gears to looking at tau. As you know, we had a lot of experience with extracellular tau and this was actually not successful because BIIB092 didn’t work which was gosuranemab. And we have really focused now on knocking down all post-translational isoforms of tau. So that’s what BIIB080 is aiming to do. As we’ve shared, I mean, obviously, these numbers are small in the Phase Ib study that went online in a publication yesterday in major medicine.
But very encouraging because we have seen close to 50% reduction of total tau and the sustained reduction post dosing. So this is very encouraging. As we kind of think about Alzheimer’s leadership and we think about multiple therapies, we have to first assess how tau knockdown kind of translates into clinical outcomes, how much is fired. Because when you look at the mouse models, transgenic mouse models for tau, you do see that about 50% actually can rescue neuronal cell loss and memory. So it’s encouraging, but we need to see more data from Phase III. That’s exactly how we’re approaching it. Eventually, I think we do believe strongly that this is going to be a multimodality space and patients will probably need more than one therapy. Now whether it will be combination or which way you have to determine whether it’s synergistic or whether it could be additive that remains to be seen.
And I think we’re going to let the data drive us on many of these questions. But we’re looking at all of this very, very carefully. Right now, we’re focusing on tau knockdown, all isoforms, as well as our Phase I asset, which has been 113 which is looking at preventing tau aggregation. So that’s how we’re focusing our efforts.
Christopher Viehbacher: If I could just follow up on that though, I think, Priya, I mean this is — Priya noted that we’ve been through the pipeline and we have deprioritized some programs. But that’s not just in an effort to reduce cost, it’s really to be able to focus resources on those assets that we think are most promising. I can tell you, following the announcement of these results in Sweden and then also publication of the article in Nature. There’s been a lot of attention on BIIB080 particularly from neurology community. And I think this is one of those assets that we really want to focus on. We’ve actually already allocated more resources to accelerate this program. And as Priya said, this is really one of the first manifestations of what it means to build a leadership position in Alzheimer’s as opposed to just launching one product in this space.
So most complex diseases do end up being combination therapies and there is some likelihood that will be the case in Alzheimer’s. And to your point, I think Biogen is pretty well placed in that regard. And we’re certainly getting even external interest in this program.
Operator: We will now take a question from Salveen Richter of Goldman Sachs. Please go ahead.
Salveen Richter: Good morning. Thanks for taking question. On LEQEMBI, could you discuss your strategy here with respect to infrastructure, particularly infusion centers and testing post a potential full approval and assuming broad coverage by CMS?
Christopher Viehbacher: Sure. Thanks for the question. One of the most interesting things is that the companies actually went through a launch planning process with ADUHELM and actually commissioned a study to actually have a look and understand what the learnings of that are. And there’s an awful lot of chicken and egg syndrome going on here. Until there’s been an approved therapy and reimbursement, there often isn’t enough investment in other areas. We see this with blood based diagnostic for example. They’ve been around, but there’s no market for a blood based diagnostic until you actually have an approved drug and a treatment. And the same is true really for the investment in infusion capacity and PET scans and lumbar punctures and even the neurology capacity.
So what we certainly are seeing is that there is a lot more interest. There are a lot of parties who are looking to invest in some of this infrastructure. But right now, the world is almost in a point of, well, the starting gate is really CMS approval. One of the things that we also learned was, you want to flex your commercial investment with the ability of the system to actually meet patients. I think one of the things that we would do differently and are doing differently is that, at the time Biogen ramped up a huge commercial machine in advance of reimbursement and in advance of some of that expansion. As we work with Eisai, we’re being a lot more prudent in looking at, okay, let’s make sure we’re out there, we’re educating physicians, we’re thinking about who’s the right patient for this and working with the different centers to make sure we know which centers are — have the ability to see patients and process the patients with this complex treatment paradigm.
So it will expand. And I think some of that expanded already at the time of ADUHELM. But I but do think that we’ll see — we’ll get a better sense of where that’s going once we have the confirmation of CMS’s reimbursement.
Operator: We will now take a question from Umer Raffat of Evercore.
Umer Raffat: Hi, guys. Good morning. Thanks for taking my question. I thought I would get some clarity on the minus $19 million in collaboration profit share on lecanemab. And specifically, is there any color we can get on what the end user revenues could look like from this minus $38 million for the franchise for 1Q, even if it’s a fraction of $1 million. It would just be very helpful. And also has Eisai indicated to you on where they are or what percentage of the commercial build out has already been baked into this 1Q number or not? Because you can imagine there’s a lot of investor concern around how much SG&A they could possibly build into this collaboration, especially in light of some of the concerns around the strained relationship from the past, et cetera. Thank you very much.
Christopher Viehbacher: Thanks, Umer. Mike, do you want to take the first part of the question, and I’ll talk about the commercial infrastructure statement.
Michael McDonnell: Sure. No, happy to. So Umer, as you know, the line item that you’re referring to is the net of any revenue and commercial expense divided by two, basically, as you noted. And we are — we don’t have a number that we’re going to disclose on the revenue. What I can say is there was revenue during the quarter. It was minimal. The majority of patients on drug are cash pay. There’s not reimbursement yet, as you know. And I think the real game, so to speak, starts when we have reimbursement should we get approval and get to that point. So, yes, revenue was minimal. The majority of it was cost divided by two. And I’ll let Chris speak to the ramp from here.
Christopher Viehbacher: Yes. Thanks, Mike. Just in terms of relationship, I was in Japan last week and the CEO of Eisai and I had dinner. And I think our view is that the relationship and the partnership is actually working pretty effectively around the world. And as I said earlier, and I’ve said on a number of occasions, this is not a reach and frequency launch. So let’s not think about the fact that we’re just sending reps out and then that’s going to have some impact directly on sales. There’s an awful lot of certainly education that’s being done. We actually — Eisai has already reps out there in the field in the U.S. We, as Biogen, will likely — will add reps in the — at some point in the future, perhaps as early as next year, once reimbursement situation is known and the capacity increases.
As I say, one of the lessons that we have to learn is that you don’t want to get ahead of that. This is — the initial launch period is going to be really one that’s constrained by the capacity. And so there’s an awful lot of work working with the neurology community, educate how you diagnose the patient, the whole process in a practice of — when do you get the PET scan or the lumbar puncture, when are the — how do you schedule the MRIs, getting the reimbursement, understanding where the infusion centers are. So it’s a pretty high touch sell and customer relations at the start. I would say there’s an initial investment, there’ll be a second wave of investment once the CMS decision is known and then probably a third wave of investment as the capacity builds and the patient numbers increase.
Operator: Our next question comes from Tim Anderson of Wolfe Research.
Alice Nettleton: Hi. Thank you for taking our question. This is Alice Nettleton on for Tim Anderson. Just on Alzheimer’s, so we’re wondering what is Biogen’s working assumption on how the profile of Lilly’s Donanemab will look relative to LEQEMBI. Past data would suggest it would be less safe with efficacy about the same. Is that how Biogen views the most likely outcome? Thank you.
Christopher Viehbacher: Yes. Thanks for the question. I don’t think we really look at it that way. When — I think the world changed with the CLARITY study. If we went back two years ago, three years ago, a lot of still doubt amongst the neurology community, does the amyloid beta hypothesis really hold water. There’s been a huge debate within the community about whether that’s a valid target or not. CLARITY, I think, really starts to put that debate to rest. And but the studies were done over — in the case of CLARITY in an 18-month time frame. But actually, what we’re seeing is that the world has moved on. Those 18 months, yes, we would dramatically reduce plaque and we actually see that there is a benefit in terms of slower cognitive decline.
But that’s not where it’s going to end. In all likelihood, the way this is shaping up is that you’re going to have at some point a plaque clearing phase. Then what happens after you’ve cleared the plaque? If you don’t continue treating, the plaque is going to come back. So there’s going to be, in all likelihood, a maintenance phase, that’s where also the subcu formulation will be important. And then as we all know, MCI is not really early stage Alzheimer’s. By the time you have MCI, by the time you have symptoms, you probably already have a maximum load of plaque. There are probably people on this call who are accumulating plaque in their brains as we speak and they don’t know it. And by the time a certain amount of plaque has risen, then you’ve already had a certain amount of neuronal death.
And right now, we don’t know how to restore neurons. So there’s also going to be, with the advance of blood diagnostics, but also even Eisai Biogen study ahead and looking at earlier patients, as one neurologist said, we’re not looking at this any longer as a four to eight year disease, but we’re looking at this over the time frame of a 25-year period. So if I look at donanemab finite, in some ways, it will be good if their data are positive, that it further reinforces the amyloid — the beta amyloid hypothesis. And also there’s — we’ve always seen in new markets if there’s more players that those markets develop faster. But this donanemab thought process of I’m just treating to a certain amount of plaque reduction. Most neurologists I talked to don’t believe that fits anymore with the way we’re thinking about the treatment of Alzheimer’s.
So I think it will be there, but I think it’s going to be — it’s not really going to be adopted in the same way that people thought when that study was conceived. So let’s say, I think, it will be good if there’s other players in the market. But I don’t think we are too concerned about competing with donanemab.
