Biogen Inc. (BIIB) Earnings Call Transcript & Summary

Hello, everyone. Pleasure to have Biogen management join us right after Merck. And there's a lot to talk about, but let me turn it over to you, Mike, to kick things off.

Excellent. Thank you very much, Umer, and thank you for having us today, and thank you to everyone for joining us. Priya and I are very happy to be with you. Before we begin, I do want to just point out that we -- Priya and I will be making some forward-looking statements, and those are based on current expectations and believe actual results could differ, and I would encourage you to refer to our risk factors in our SEC filings. Here at Biogen, we're very focused on executing and delivering the best results that we can. We last reported in October. And at that time, we raised our guidance on both the top line and the bottom line for the second time this year. Our guidance back in October was on the top line, $10 billion to $10.15 billion, and our EPS -- adjusted EPS guidance was $16.50 to $17.15. We've had a number of important developments since that time. Most importantly, we've announced that Chris Viehbacher has joined Biogen as our new CEO. We are thrilled to have Chris. He's got extensive, just experience both in the industry and large -- running large international businesses at both GSK and Sanofi, and then a lot of experience working with entrepreneurial biotech companies as well. So Chris is now completing his third week at Biogen, and I know he looks forward to meeting many of you in the months to come. We also are very pleased to have announced some very positive top line results along with Eisai on the Clarity AD clinical trial for lecanemab. You may have seen that lecanemab -- its primary endpoint and all of the key secondary endpoints with highest statistical significance. And you may have also seen that Eisai presented additional data on lecanemab earlier this week at the CTEC conference. And the -- we have a filing that is going through a review with the FDA. Today, for accelerated approval, with a PDUFA date of January 6, we're also -- and we're, obviously, very excited to be working with Eisai on this very exciting project, where we share economics 50-50. We're also working very closely with Sage on a collaboration, which includes products zuranolone. And we are expecting to launch a single regulatory filing for both MDD and PPD sometime before the end of this year. So as we look ahead, we're very excited about both of those collaborations. Those are our 2 large near-term opportunities to bring ourselves back to growth, which is our #1 objective. We also have tofersen, which is an investigative drug for SOD1-ALS, with a PDUFA date in April. And we will remain very focused on execution as we always have. We continue to have a very strong balance sheet with over $5 billion of cash and a modest amount of debt. We've got 30 programs in the clinic, 12 of which are in Phase III or filed, which gives us a deep pipeline, and we believe good opportunities to, again, bring us back to growth, which is our #1 objective. So thank you again for having us. The last thing I want to say is encourage all of you that are interested on December 6, we will be hosting a joint presentation along with Sage, where we'll talk about zuranolone and some of the commercialization efforts that are underway in the event that, that drug is approved, and you can find information on how to join that on our website. So thank you for the opportunity to speak up front. Umer and Mike, and again, thank you for having Priya and I today.

Outstanding. So maybe -- and since lecanemab was -- fresh out of lecanemab data presentation, maybe let me just -- it will be fair to just spend a brief second on it. Any feedback that you guys heard out of the -- I mean I think the data state and we all know it, but any feedback in particular that stood out to you guys? And in some -- was it different or similar in anyways with the aducanumab data experience from a couple of years ago, to which was completely different, obviously?

I can get started on that. So I think overall, we're very pleased with the data set. I think it's a very robust data set, with the primary endpoint and all secondary endpoints having been met. A lot of sensitivity analysis have been done and were presented at CTAD, in addition to subgroup analyses, and we're really pleased across the board with all of this. So I think, overall, it's really a high-quality data set that can provide the strength of evidence. I believe that NCD laid out that they would be looking for. And in addition, I think that there is the potential for generalizability to the Medicare population because the Clarity AD did include patients with comorbidities, underserved populations about 25%. And we believe that this is really very encouraging, and we're optimistic about it.

Got it. So that's actually a nice segue into the question that really matters, which is on NCD side. I guess what is the strategy from your perspective right now? Do you want to let the existing entity update itself? Do you want to start a new lecanemab-specific NCD? How are you guys thinking about that?

Do you want to start, Priya?

Yes, I can start. So I think that the way the current NCD is written, there were a couple of important points. One was that there was a hard line drawn between accelerated approval and full approval. And in line with that, we are really going forward for the accelerated approval. As you know, our PDUFA date is January 6. And soon thereafter, we are in a position to file -- Eisai will file for full approval. So that's number one. I think the second point here is the strength of evidence, which I already spoke to in my earlier comment, which is going to be important. So while the NCD is for a class, NCD did point out that the data for every antibody will matter. And so that's really, I think, where we think we have a robust data set. And then the third piece was generalizability to the Medicare population. So I think all of these factors, we are very optimistic about. How the process will fold out with the CMS? I think that would be hard to speculate the way it's currently written. But there are 2 areas. One is if there is strength of evidence. It's possible that it could get reimbursed in a setting of prospective comparative studies. There are not too many details on that, but it would again depend it harks back to the strength of evidence, which we believe we have. And then the second is that there could be a reconsideration. And then the third piece here is that CMS did say that they would act with speed if the data were important and there was strength of evidence in rigor. So we believe that these are all very important factors. What I can say is that Eisai has already initiated dialogue, and they believe this dialogue is very constructive with the Clarity data in hand along with a peer-reviewed publication in the New England Journal of Medicine, I think it puts us in a very good position to have these dialogues. So beyond that, I think it's hard -- going to be hard to speculate, but we think we have everything we need.

Got it. And so that's very interesting. And your point around CMS saying they could act with speed, I mean, this is some of the buzz coming out of D.C. as well, but this may not necessarily be a full 9-plus month type of review. Do you guys think this could happen in much more rapid 3- to 4-month turnaround or just hard to say?

I think it's hard to say. Historically, it's been kind of a 9 to 12 months process, but CMS did indicate that if the evidence was strong that they would look to act more quickly. So we don't control that, hard to say. Obviously, we're hopeful to get to a good answer on reimbursement.

And Mike did you guys like -- or Eisai start that already or why not? Because theoretically, you could have been started a couple of months ago?

Yes. I mean Eisai serves as the lead of lecanemab development and regulatory submissions on a global basis. So I can't comment specifically on interactions that could be occurring between Eisai and CMS. But what I can say is that we have a high degree of confidence that they'll handle it in a way that's very well thought out. And obviously, there are -- there are lessons learned through the ADUHELM experience that we share very openly with each other and we can be informed by.

Makes sense, which actually is a good sort of segue into among the lessons learned from ADUHELM, one of the big ones that stands out to investors is on pricing side. And I feel like is there lessons from that, granted the data set was different? But the question that always comes up from investors is was ADUHELM just too high? And the granted entities not focused on pricing, but if we price lecanemab much lower might open up the market more? Like how are you guys thinking through pushes and pulls, granted that's not your decision to make?

Yes. So that's correct. lecanemab, Eisai will determine the pricing. I think as it relates to ADUHELM, it's hard to speculate exactly what CMS considered in all the different pieces. I personally believe at the end of the day, a lot of it was about the data and just the data set and a lot of the controversy around that. And there was the futility, and then there was the whole advisory committee situation and so forth. And so the data set that was in front of them and kind of the controversy around that, that they just couldn't get over. So my sense was that it was the biggest factor, but we're just not in a position to know for sure how much pricing played in. It's really hard.

Got it. Got it. Have you -- Mike, have you guys had discussions or given feedback to Eisai on pricing? Because one of the feedbacks that came out of their side was, initially, they had this health economics estimates of 10,000 to 38,000. And then since the data came out, they're saying it could be higher, while some investors were kind of encouraging them to go down more towards one-leg pricing, just to open it up. But I'm curious if any of those conversations have happened?

Yes, that's not really something that I can comment on, unfortunately, Umer. And as I said before, the pricing will be determined by -- ultimately be determined by Eisai.

Got it. Do you guys expect to be involved in marketing?

So we have a long-standing and ongoing collaboration, and we have co-commercialization and co-promotion rights. They are -- they have final decision-making authorities. So -- and we have things like joint steering committees that we develop strategies together. And as I said, we've been -- have a long-standing relationship, and we have deep respect for each other. So we'll work on those things together. But ultimately, they will have final decision-making rights similar to what we had on [indiscernible].

Would -- should we expect some sort of an update on that side by JPMorgan? Because I got to believe you, from a CFO perspective, you're trying to figure out resource allocations and all that appropriately depending on whether you will be or won't be marketing.

Yes. I mean, that's something that we're thinking about and it's all under development. I would say that another checkpoint, which would be -- after JPMorgan would be when we report the fourth quarter, it's likely that we would provide guidance for 2023 at that point in time. And as we provide guidance for 2023, certainly, as we think about our important potential product launches on things like zuranolone and lecanemab; if appropriate, we would try to provide some insights on how that was going to impact our estimates for 2023.

Got it. Okay. Got it. Makes sense. That makes a lot of sense. And maybe just my last one, Mike, please step in as well. Anything else you want to touch upon on Alzheimer's. But one more that I just want to touch up on is the status of the relationship. And I know this -- there's always been questions you guys have clarified on the last earnings call, I asked about it as well, but is it a functional relationship? Let's just ask it that way.

I think that -- look, I mean, we have worked together for many, many years. It's a long-standing and ongoing collaboration. I can tell you that we and Eisai share the same goal and vision, which is to serve people living with early AD and their families by bringing lecanemab to the market as soon as possible. I mean I think that's the best way that I can answer the question. We've got a very, very deep commitment to getting this right, and we've been working together for years and we have a deep mutual respect. I think that's probably the best way that I can -- hopefully, that answer...

I'll put a highlight on that deep mutual respect Okay. Excellent. So -- Go ahead.

I have a commercial question for Mike, and then a technical question for Priya. So Mike, a lot of this has been coming up from investors regarding the infusion capacity.

That's a good one.

Some rough math was done, whereby if we assume pricing parity to ADUHELM, and then we kind of just calculate a rough number of infusions required to get at a certain number. I mean -- but my question is, does the U.S. have enough infusion capacity to draw a meaningful sales from the drug?

Well, over time, our hope would be -- the answer would be absolutely yes, but there is some build-out that would have to happen from the infusion centers. And we saw that with ADUHELM. This is kind of a pioneering. There will be some positions that will have an infusion center that they can tap into and others that may not, and we'll need to find an affiliation or something new that has to be built out. So I think as you look at the aggregate infrastructure build-out that has to happen for lecanemab, infusion center, readiness and build-out is all part of that. Priya, I don't know if you want to comment further?

That's exactly right. I mean I think there was a RAN report a few years ago that commented on the fact that the availability of expect infusion centers, specialty centers and specialists could be bottlenecks. But this is something that we are working on very deliberately and thoughtfully. And I think systematically, we also have experience with aducanumab, as Mike mentioned, and we are sharing everything that we know with our -- with Eisai as they lead this effort. So I think that do they have it -- does the U.S. have it today? I think that would be maybe hard. But the other thing is that we would expect a ramp up of patients as well because they need to all get confirmed with amyloid and things like that. So I think there's more work to be done.

Can I just clarify Priya and Mike? Because I feel like there's a sliding scale here, and there might be a tendency among investors to confuse this broader topic. So when we say, "Over time, yes, there will be an infusion capacity." I think what you're referring is to be able to serve a big part of the market. And we know, for example, Namenda, Aricept is like 1.5 million or so folks on it, whereas some of the investor estimates, especially even for peak on lecanemab are 10 from that, so 150,000 patients or so. And near term, folks -- what folks are really just asking is when to the extent you launch 30,000 to 50,000 patients worth of infusion capacity, does that exist? So that would be, let's say, 50,000 times 12, 600,000 times twice a month, that's over 1 million infusion. Does that type of capacity already exist or not so much?

I don't know, Mike, if you want to comment on that?

Yes. I mean it's a hard question to answer because it depends in part on where are the patients geographically. You have some areas that are concentrated or not. So the short answer, yes, depending on if there's a concentration of patients in the right areas and potentially some gaps if they're not. So a lot of it depends on kind of the geographic footprint and how it...

Got it. Got it. Got it. That makes sense. Mike, you had another follow-up on those numbers?

Just -- yes, one more question for Priya. Regarding the plaque lowering data, you guys showed good data and you used -- in terms of the lower limit of detection, you used a level of below 30 centiloids to kind of establish that. And one thing I noticed and maybe a lot of other investors noticed that when take donanemab as plaque lowering data, they established a lower limit of detection as about 24.1 centiloids, I think. So why did they use 24.1 versus why did you guys use less than 30?

And by the way, does it even matter? That's the other thing.

Yes. I was going to say that this is why it's going to be a difficult question to answer. We believe that the limits are quite fair in terms of amyloid positivity that Eisai used. And I think that the most important thing is that with a baseline of about 79, there was a big reduction, and that's what's important. The other thing I think that's going to be important here is what is the implication of maintaining that. So I think that's the other unanswered question that Eisai is also evaluating in the Phase II open-label extension, where they're assessing what's the frequency of dosing that's needed both with the 4 weekly or the 12 weekly dosing. So I think, overall, I don't know that that's going to be that relevant. I think it's going to be a matter of amyloid reduction and demonstration of clinical benefit.

Got it. Okay. Makes sense. Maybe sort of transitioning a little beyond. I want to spend a couple of minutes on a bigger picture P&L, if I may. Mike, if that's okay? First is sort of with Chris on board, how are you guys thinking about the P&L as it stands today and P&L as you think about it going out? And I realize there's some pushes and pulls, whether you need to market or not, whether Alzheimer's is a big number -- midsize number, et cetera. But how are you thinking about that?

It's something we're thinking about a lot, and it's a really good question. I would say a few things. When you look at our cost base, we've done a lot to take cost out. We had an OpEx base of $5.2 billion in 2021, which included a pretty fully built out ADUHELM infrastructure in the U.S., and now that's been removed. And we will deliver on the $1 billion of run rate cost reductions that we committed to. We will reinvest some of those savings, and that's something that's under review, but primarily the -- any investments that we would make would be to support product launches. And at the end of the day, as I mentioned in my opening commentary, our #1 objective is to return the company to growth on both the top line and the bottom line. So there are a couple of scenarios, one of which is if lecanemab and ADUHELM -- excuse me, if lecanemab and zuranolone are successful, and we're able to get both of those drugs approved and have successful launches. We'll, obviously, have to put money behind that to support. And in some cases, you'll have to see spend in front of revenue. And so that will potentially pressure the P&L a bit in front of longer-term growth, and that's something that we will evaluate very carefully. And then in the hopefully unlikely event that either or both of those drugs are unsuccessful, then I think you would have to probably put a little more pressure on some of your business development efforts, and we've got a lot of cash on hand and a modest amount of debt and more borrowing capacity that we could utilize there as well as looking at your cost base, and having to do some further work there to kind of rightsize it to a new normal. So at this point in time, I would say that we've done a lot with the cost base to rationalize it to some extent, but we're really, really focused right now and hopefully getting to the finish line in the near term, along with Sage on lecanemab and zuranolone, and spending the funds necessary for commercial launches to make sure that we can get successfully off the ground unfold if we were able to get to approval.

Got it. Okay. Makes sense. And is there any consideration on some sort of EPS number you have to be at, regardless of where some of these opportunities go in outer years? And I realized I'm not necessarily looking for some sort of guidance.

Sure. No, I would say that -- I'll go back to what I said before, which is we do understand that our #1 objective is to grow on both the top line and the bottom line. And so that would mean growing EPS. I would say that that path back to growth is probably faster if we're able to achieve success, along with Eisai and Sage. And if not, then we'll have to find a different path to achieve that objective, and maybe it takes a little bit longer. And maybe there's -- it's a little more of a mix of incremental revenue and cost reductions versus just more revenue, but we will -- our job is to find a path back. So I can't give you a target number, but what I can say is it's a return...

Are you looking for a path back?

Correct.

And when you say path back, you do have some of the -- okay, Got it. Makes sense. Okay. And if I may also, BD-wise, is there a certain number in mind?

So the way I would answer that is we've got over $5 billion of cash and a modest amount of leverage, call it, like 2 turns on a gross basis. On a net basis, we're basically close to a net zero in terms of net debt relative to EBITDA. So if you were to hypothetically have gross debt at, say, 3x, which is probably still within investment grade, along with the cash on hand, you've got $8 billion, $8.5 billion of capacity. I don't necessarily see us utilizing all that in one transaction, but there are a number of things that we could do with the balance sheet, and we've got quite a bit of capacity to bring in incremental programs in addition to the [ 30 ] that we already have underway.

Would you guys ever use equity, Mike?

Well, you never want to rule out anything for the right transaction, but it would be one where you'd be making a transformational bet, and you'd have to make sure that we're comfortable with it.

Makes sense. Mike, just before we move on to some R&D topics, there's a couple of investor questions that came in live. So one of the questions is, someone pushing back saying Eisai has out to the contract. Is that true or not?

We share economics 50-50 under a binding contract.

Okay. So that was one. And then the other one was, give me 1 second -- sorry, I just -- I think I just misplaced it. You know what -- oh, here we go. You know what, I'll find it. If I find it, we'll come back to it. Okay. let's keep moving. Let's turn to some R&D topics. The BTK inhibitor, can you perhaps speak to that on what would be realistic from Biogen perspective in terms of commercial potential knowing that it's slightly versus some of the other competitors, although they've had a little bit of stumbles too? And how important is it from a more derisked pipeline perspective?

I can speak to sort of what we're looking for from a scientific perspective. And I will say that obviously, BTK inhibition is thought to be really important from a mechanistic perspective. And the fact that we have access to both central and peripheral BTK inhibitors is important for us, as we consider how we make progress in MS, which is obviously a very important area, a very important disease that we've been focusing on. So from that perspective, BIIB135, which is in our collaboration with InnoCare that we announced about a year ago, it remains in Phase II in RRMS and will read out in Phase II, and that will then decide how we take it forward. But from a molecule perspective, it has high selectivity. It has good CNS penetration, and we believe that eventually the data, both from an efficacy and safety perspective will be important for us, as we think about it in the context of BTK inhibitors and also in context of our own pipeline. So I think that, that's going to be really the key point. How does it read out in Phase 2? And we also have access, I don't know if you know, but we have BIIB091, which is a peripheral BTK inhibitor. So we continue to advance that, and that will potentially enter Phase II at some point next year.

Got it. Priya, do you think this Phase IIb that's coming out could count as the first pivotal?

I think that it's going to be hard to really speculate on that, and it depends on what kind of indication we are going for. So if you have a bigger plan in terms of progressive MS or just RRMS, I think all those factors will be important on what constitutes the pivotal program, if that makes sense.

And what's the timing again Priya on this readout, the Phase II.

I don't believe we've commented on when it will readout. I don't believe we've commented on that publicly.

Okay. Got it. Okay. Makes sense. And then perhaps the BDCA2 in lupus, I know that's a high-profile Phase III readout that's coming up. Could you remind us any lessons from the AstraZeneca program that could be incorporated here?

Yes, sure. So I think that we are very excited about BIIB059, anti-BDCA2. We believe that it can be really important not only in SLE, but also in cutaneous lupus erythematosus, which remains a high unmet need. We think that the package that we have currently is really the 2 TOPAZ studies in SLE and 1 Phase IIb study AMETHYST in CLE. So we believe that this is going to be really important. In terms of lessons launched, the TOPAZ studies have SRI, the responder index as the primary endpoint. This is the endpoint that we saw activity from the LILAC Phase II study that we published recently this past summer, 2 publications in the New England Journal of Medicine, both on part A, which was SLE and part B, which was CLE. So we think that several lessons learned in terms of baseline characteristics of the patients as well as other medications that they might be on and the primary endpoint, which Eisai for. So we think that all of those have definitely enhanced our understanding and our development of -- the clinical development program and also of the TOPAZ studies themselves. So we look forward to kind of continue to enroll. It's a global study. And we remain very excited about the mechanism of action.

Makes sense. Makes sense. Maybe the SOD1, there's a buzz that FDA has a lot of inclination towards a biomarker-based approval there. But if a scenario like that plays out, is there real commercial appetite, if it's just biomarker supporting the approval?

So maybe I can talk about the data. So tofersen, which is the SOD1 ASO. As you know, SOD1 is a genetically -- generic type of about 2% of the population. And I think what's really, really important here is we ran the VALOR study, which was a Phase III study, but it completed at 6 months and it did not meet the primary endpoint, which was ALSFRS-R. But what's really important is we saw a huge movement on neurofilament. And I think 2 criteria that we utilized, one was, of course, the duration of the study. But the second was how we distributed sort of thought about the patient population. We divided it up based on the mutations as well as on the ALSFRS-R slow decline prior to randomization. And now we believe that both these factors are actually not that important because there's a lot of inter mutation variability. And what's really important is the duration of the person that the patients received. We saw this with the 12-month data that we presented earlier this year in the summer at [indiscernible], and then has been also published in the New England Journal of Medicine. And I think what we see is that it's actually not just a biomarker impact, and that biomarker, by the way, is really important, based on all the literature that we've seen on neurofilament and the importance of neurofilament reduction for ALS, specifically SOD1-ALS. So I think that's very critical. But we also saw hints of movement on clinical benefit, respiratory function, muscle strength, pulmonary function. And at the 12-month time point, we really see significant impact. And if you step back and think of the biological pathway here and the biology in totality, it makes sense that by the time you see the neurofilament reduction, it takes some time for that to translate into a clinical benefit. So we've been accepted by the FDA on an accelerated approval pathway. It's a very small population. We remain in discussion with FDA about what a consummatory data package could look like. And I'll just remind us that we have an open-label extension that's ongoing. We also have almost more than 120 patients in the expanded access program that's global. And in addition, we have the ATLAS study that aims to kind of assess the impact of the person in a 12-month period based on a baseline of NFL and conversion to a clinical phenotype. So we've got a lot of access to ongoing data readouts and data generation, which we believe will continue to be important. Turning to the -- and from everything we've seen and talking to the key opinion leaders, we believe that this is very important data. We believe that the neurofilament is really important and that physicians are really excited about what tofersen could do for their patients with SOD1-ALS. So turning to the commercial opportunity, I'm going to turn to Mike, but that's -- from a scientific perspective, we are very excited about this.

Yes. No, I think you covered it very, very well. So are you looking for some commentary on the commercial opportunity for ALS?

No, no. I think Priya covered it pretty well. And then I guess, maybe just beyond in the pipeline Priya, what are -- some of the things that you feel like there should be more questions on, but you just don't get very many. I feel like it's so much of a focus on lecanemab that even the BTK or the BDC is not much of a focus. What are the things that you're always excited to talk about and what's high on your mind and where you're spending your time?

Yes. Thank you. That's a great question and a great time for me to comment on that. So obviously, lecanemab and zuranolone, they're very important. Our teams are very much focused collaborating with both our partners, in this case, for filings and more. And that's important. Beyond that, we have 30 clinical development programs, 12 of them are in Phase III. We just talked about our SLE program. In addition, we've got BIIB122, which is very exciting. And before I leave SLE, we have [indiscernible] program as well as BIIB059 addressing different pathways. And then I'll move to BIIB122, which is important because this is addressing LRRK2 mutations as well as idiopathic Parkinson's. Obviously, this is a very high unmet need, and we believe this is a very important target, genetically validated in the LRRK2 mutation population for sure, but also in idiopathic Parkinson's, we have data from autopsies and such, which lead us to believe that lysosomal dysfunction, specifically the LRRK2 mutations can really result in a very high kinase activity, which then results in inability to kind of degrade proteins and accumulation of proteins, including proteins like alpha-syn, which we all know are hallmarks for PD. So this remains very important. We have already enrolled our patients in the LIGHTHOUSE and LUMA study. And I think it's a very innovative clinical development program with our collaborators, Denali. So that's important. I'll go then to stroke with -- we have 2 programs, BIIB131, which is acute ischemic stroke, and we also have BIIB093 in Phase III for large hemispheric infarct. So we think we're addressing a very high overarching population of stroke, which again remains a high unmet need and not much innovation beyond TPA, which was almost 2 decades ago here. So that's important. And then moving beyond that, Alzheimer's remains a very important area of focus. And I want to say I'm very proud of the fact that we've been focusing on it for more than 15 years. It wasn't just about lecanemab or aducanumab, we've got a lot of depth in our scientific expertise here and also in our programs. And for today, I would love to comment on BIIB080, which is our antisense oligonucleotide, about to enter Phase II. And this is a very exciting program. It's an anti-tau, ASO. Obviously, through our collaboration with Ionis, we believe our partnerships have been very instrumental in sort of us breaking the science together with our partners. And BIIB080, we are very excited about BIIB080 in the Phase Ib, show time and dose-dependent reduction in tau, and we think this is going to be really, really important. Because we do believe that the future of Alzheimer's would go beyond addressing it with the amyloid reducing therapies, and it could be potentially combinations and more. So behind that, we also have BIIB113, which is an O-GlcNACase inhibitor in Phase I. We've already dosed our patient in Phase I. And then we are looking at a lot of targets, and we have a lot of collaborations. The -- I think the privilege here at Biogen, in terms of leadership of the pipeline is that we have access to many modalities. And we are looking across the board at significant diseases of high unmet need, but we're really going with the science first. So I think that many exciting programs, I might be able to talk for another hour, but I don't want to take up all your time.

No, no, that's great. That's very helpful. Maybe just last minute. And Mike, please jump into, if anything outstanding on your end. An investor question that came through, which I was looking for earlier. And here's the investor question. If you aren't allowed to co-commercialize by Eisai, the economics do not change. But at that point, do you take a harder look at the cost structure and cut more SG&A to maximize profitability of the royalty stream?

So the economics on lecanemab are shared 50-50. So it doesn't matter whether it's $1 spent by Biogen or $1 spent by Eisai, it's shared equally. So that would have no impact. And that's -- it's a 50-50 share on everything.

Got it. Okay. Mike, anything outstanding on your end?

Yes. Just I kind of want to drill down on the stroke. I know -- I'm feeling that these stroke is something that's largely underappreciated. Number one, how big could this opportunity be? And for the IV glibenclamide CHARM study, I feel like that study has been kind of ongoing for a while. I think it kind of stalled due to COVID. Is that study very prone to bouts of COVID waves in terms of...

Yes. Thank you, Mike. So it's a great question. I do believe that, that part of the pipeline is kind of underappreciated. And -- but you're right that the CHARM study has had some setbacks due to COVID. What I can tell you is that the teams are very focused on it. It's been a very important area of attention for me and the teams broadly, and we have brought everything to bear in terms of how can we listen to sites, manage the protocol, address the COVID impact and look at operational aspects of execution. So this continues to be an important area. I think we are on the right track, and I'm optimistic that we will be able to close the study and complete it.

Well, I know we're out of time. So I just want to be very respectful as well. Thank you, guys, again. Mike, unless we miss anything on your end, we're going to go ahead and wrap it up here.

That's great. Thank you very much, Umer and Mike, for having us. It was our pleasure. And thanks to everyone for sitting in with us today. Thank you.

Thank you, guys. Take care. Good luck.

Thank you very much. Bye-bye.