Biogen Inc. (NASDAQ:BIIB) 5th Annual Evercore ISI HealthCONx Conference Call December 1, 2022 10:30 AM ET
Company Participants
Mike McDonnell – Chief Financial Officer
Priya Singhal – Head of Global Safety and Regulatory Sciences and Interim Head of R&D
Conference Call Participants
Umer Raffat – Evercore ISI
Umer Raffat
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.
Mike McDonnell
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 beliefs. 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 experienced both in the industry and large, you know, 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 lecanumab. You may have seen that lecanumab met its primary endpoint and all of the key secondary endpoints with high statistical significance. And you may have also seen that Eisai presented additional data on lecanumab earlier this week at the CTEC Conference, and we have a filing that is going through review with the FDA.
Today, for accelerated approval with the PDUFA 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 two large near-term opportunities to bring ourselves back to growth, which is our number one 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 three were filed, which gives us a deep pipeline and we believe good opportunities to again bring us back to growth, which is our number one 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 named [at that] [ph] drug is approved, and you can find information on how to join that on our website.
So, thank you for the opportunity to speak upfront. Umer and Mike. And again, thank you for having Priya and I today.
Umer Raffat
Outstanding. So, maybe and since lecanumab was fresh out of lecanumab data presentation, maybe let me just – it’ll be fair to just spend a brief second on it. Any feedback that you guys heard out of the [indiscernible]. I mean, I think the [data’s data] [ph], and we all know it, but any feedback in particular that stood out to you guys in some – how – was it different or similar in any ways with the aducanumab data experienced from a couple of years ago to which was completely different obviously?
Priya Singhal
I can get started on that. So, I think overall, you know, 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 analysis 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, you know underserved populations, about 25% and we believe that this is really very encouraging and we’re optimistic about it.
Umer Raffat
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 NCD update itself? Do you want to start a new lecanumab specific NCD? How are you guys thinking about that?
Mike McDonnell
You want to start, Priya?
Priya Singhal
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 for 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 that the data for every antibody will matter. And so, that’s really I think where we think we have a robust dataset. 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 two 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 hops 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, you know, CMS did say that they would act with speed if the data, you know, were important then there was strength of evidence and 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 these 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 dialogs. So, beyond that, I think it’s going to be hard to speculate, but we think we have everything we need.
Umer Raffat
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 DC as well that this may not necessarily be a full nine plus one type of review, do you guys think this could happen in a much more rapid three or four month turnaround or just hard to say?
Mike McDonnell
I think it’s hard to say. Historically, it’s been, kind of a 9 to 12 months process, but, you know, 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, you know, we’re hopeful to get to a good answer on reimbursement.
Umer Raffat
And Mike, did you guys, like, or Eisai start that already or why not? Because theoretically, it could have been started a couple months ago.
Mike McDonnell
Yeah. I mean Eisai serves as the lead of lecanumab 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, you know, we have a high degree of confidence that they’ll, you know, handle it in a way that’s, you know, very well throughout. And obviously, there are, you know, there are lessons learned through the ADUHELM experience that we share very openly with each other we can be informed by.
Umer Raffat
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 dataset was different, but the question that always comes up from investors is, was ADUHELM just too high? And the granted entity is not focused on pricing, but if we price lecanumab 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?
Mike McDonnell
Yeah. So, that’s correct. Lecanumab Eisai will determine the pricing. I think as it relates to ADUHELM, you know, 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, you know, the data set and a lot of the controversy around that and there was, you know, the [utility] [ph] and then there was, you know, the whole advisory committee situation and so forth. And so the dataset 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 was the biggest factor, but, you know, we’re just not in a position to know for sure how much pricing played in is really hard.
Umer Raffat
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 [indiscernible] pricing just to open it up, but I’m curious if any of those conversations have happened?
Mike McDonnell
Yeah. That’s not really something that I can comment on, unfortunately, Umer. And as I said before, the pricing will be determined by, you know, ultimately be determined by Eisai.
Umer Raffat
Got it. Do you guys expect to be involved in marketing? So, we have a, you know, a long standing and ongoing collaboration, and we have co-commercialization and co-promotion rights. They have final decision-making authority. So, and we have things like joint steering committees that we develop, you know, strategies together. And as I said, you know, 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 ADUHELM.
Umer Raffat
Should we expect some sort of an update on that side by JPMorgan because I got to believe even 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?
Mike McDonnell
Yeah. I mean, that’s something that we’re thinking about, and, you know, is all under development. I would say that, you know, 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 and on things like Zuranolone, and lecanumab, if appropriate, we would try to provide some insights on how that was going to impact our estimates for 2023.
Umer Raffat
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 on any anything else you want to touch upon on Alzheimer’s, but one more that I just want to touch upon is, the status of the relationship, and I know there’s always been questions you guys have clarified on last earnings call. So I think I asked about it as well, but is it a functional relationship? Let’s just ask that way.
Mike McDonnell
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 that we and Eisai share the same goal and vision, which is to serve people living with early AD and their families by bringing lecanumab 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 get] [ph]. Hopefully that…
Umer Raffat
I’ll put a highlight on that deep mutual respect. Okay. Excellent. So, sorry [Mike] [ph]. Go ahead
Unidentified Analyst
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. So, 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, my question is, does the U.S. have enough infusion capacity to [indiscernible] a meaningful sales from the drug?
Mike McDonnell
Well, over time, you know, our hope would be – the answer would be absolutely yes, but, you know, there is some build out that would have to happen for infusion centers. And we saw that with ADUHELM. This is, you know, this is kind of a pioneering. There would be some, because [indiscernible] that will have an infusion center that they can tap into and others that 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 lecanumab, you know, infusion center, readiness and build-out is all part of that. Priya, I don’t know if you want to comment further.
Priya Singhal
That’s exactly right. I mean, I think there was a RAN Report a few years that commented on the fact that, you know, the availability effect, infusion centers, specialty centers, and specialists could be bottlenecks. But this is something that we’re 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.
Umer Raffat
Can I 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, 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 [indiscernible] on lecanumab are 10% of 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 a million infusions. Does that type of capacity already exist or not so much?
Priya Singhal
I don’t know. Mike, if you want to comment on that?
Mike McDonnell
Yeah, I mean, it’s a hard question to answer because it depends in part on where the patients geographically. You have some areas that are concentrated or not. So, the short answer, yes, depending on, you know, if there’s 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 [indiscernible].
Umer Raffat
Got it. Got it. Got it. That makes sense. Mike, you had another follow-up on Alzheimer’s?
Unidentified Analyst
Yeah. One more question for Priya. Regarding the [plaque lowering data] [ph], you guys showed good data and you used – in terms of the lower limit of detection, you used a level of below [30 centiloids] [ph] to kind of establish that. And one thing I noticed, I mean, you know, a lot of other investors noticed that when, you know, take the [indiscernible] [plaque lowering data] [ph], they established a lower limit of detection as low 24.1 centiloids, I think. So. why did they use 24.1 versus why did you guys use less than 30?
Umer Raffat
And by the way, does it even matter? That’s the other thing. Yeah.
Priya Singhal
Yeah. 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 2 open label extension where they’re assessing what’s the frequency of dosing that’s needed both with the four-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 demonstration of clinical benefit.
Umer Raffat
Got it. Okay. Makes sense. Maybe sort of transitioning a little beyond, I want to spend a couple of minutes on the 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 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 or mid-sized number, etcetera. But how are you thinking about that?
Mike McDonnell
It’s something we’re thinking about a lot, and it’s a really good question. I would say, you know, 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 billion dollars 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 investment 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 number one, objective is to return the company to growth on both the top line and the bottom line.
So, there are a couple of scenarios, you know, one of which is if lecanumab and ADUHELM, excuse me, if lecanumab and Zuranolone are successful and we’re able to get both of those drugs approved and have successful launches, you know, we’ll obviously have to put money behind that to support. And in some cases, you know, you’ll have to see spend in front of revenue.
And so that will, you know, potentially pressure the P&L a bit in front of longer-term growth, and that’s something that we will evaluate very, 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, you know, 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, you know, do some further work there to, kind of, you know, right size 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 a science age on lecanumab and Zuranolone, and spending the funds necessary for commercial launches to make sure that we could get successfully off the ground on both if we were able to get to approval.
Umer Raffat
Got it. Okay. Makes sense. And is there any consideration on some sort of an EPS number you have to be at, regardless of where some of these opportunities go in outer years and I realize I’m not necessarily looking for some, sort of guidance?
Mike McDonnell
Sure. No. I would say that, you know, I’ll go back to what I said before, which is, we do understand that our number one 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, you know, 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, you know, 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 to [Multiple Speakers] Correct.
Umer Raffat
And when you say pass 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?
Mike McDonnell
So, the way I would answer that is, you know, we’ve got over $5 billion of cash and, you know, a modest amount of leverage, call it like two 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, you know, have gross debt at say 3x, which is probably still within investment grade. Along with the cash on hand, you’ve got, you know, $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.
Umer Raffat
Would you guys ever use equity, Mike?
Mike McDonnell
Well, you know, you never want to rule out anything for the right transaction, but I don’t know, it would be one where, you know, you’d be making a transformational bet and you’d have to make sure that we’re comfortable with it.
Umer Raffat
Makes sense. Mike, just before we move on to some R&D topics, there’s a couple 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?
Mike McDonnell
We share economics 50/50 under our binding contract.
Umer Raffat
Okay. So, that was one. And then the other one was, give me one second. Sorry. I’m just – I think I’ve 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 behind versus some of the other competitors, although they’ve had a little bit stumbles to? And how important is it from a more de-risk pipeline perspective?
Priya Singhal
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, very important disease that we’ve been focusing on.
So, from that perspective, BIB135, which is in our collaboration with Enercare that we announced about a year ago, it remains in Phase 2 in our RMS, and we’ll readout in Phase 2 , 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, you know, both from an efficacy and safety perspective will be important for us as we think about it in the context of PDK 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?
Umer Raffat
Got it. Okay. Makes sense.
Priya Singhal
And we also have access, I don’t know if you know, but we have BIB91, which is a peripheral BTK inhibitor. So, we continue to advance that and that will potentially enter Phase 2 at some point next year.
Umer Raffat
Got it. Priya, do you think this Phase 2b that’s coming out could count as a first pivotal?
Priya Singhal
I think that it’s going to be hard to really speculate on that, and it depends on what kind of indication we’re 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.
Umer Raffat
Got it. And what’s the timing again, Priya, on this readout? The phase 2 that’s [indiscernible].
Priya Singhal
I don’t believe we’ve commented on when it will readout. I don’t believe we’ve commented on that publicly.
Umer Raffat
Okay. Got it. Okay. Makes sense. And then perhaps the BDCA2 in lupus, I know that’s a high profile Phase 3 readout set that’s coming up, could you remind us any lessons from the AstraZeneca program that could be incorporated here?
Priya Singhal
Yeah, sure. So, I think that we are very excited about BIB059. It’s an anti-BDCA tool. We believe that it can be really important not only in SLE, but also in cutaneous [lupocidizumatosis] [ph], which remains a high unmet need. We think that the package that we have currently is really the two [topaz studies] [ph] in SLE and one-stop Phase 2b study [indiscernible] in CLE. So, we believe that this is going to be really important.
In terms of lessons learned, you know, the topaz studies have SRI, the responder index as the primary endpoint. This is the endpoint that we saw activity from the LILAC Phase 2 study that we published recently this past summer two 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, you know, 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 is SRI-4.
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.
Umer Raffat
Makes sense, makes sense. Maybe the SOD1, there’s 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?
Priya Singhal
So, maybe I can talk about the data. So, tofersen, which is the SOD1 ASO, you know, as you know, SOD1 is a genetic type of ALS, about 2% of the population. And I think what’s really, really important here is, we ran the [ballast study] [ph], which was a Phase 3 study, but it completed at six 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 two 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 their ALSFRS-R slope, 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 receive. We saw this with the 12-month data that we presented earlier this year in the summer [ENCALS] [ph] 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 confirmatory 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 a 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 tofersen 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, you know, 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 scientific perspective. We are very excited about this.
Mike McDonnell
Yeah. No, I think you’ve I think you’ve covered it very, very well. So, are you looking for some commentary on the commercial opportunity for ALS there?
Umer Raffat
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 I get so much of a focus on lecanumab that even the BTK or the BDCA is not much of a focus. So, 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?
Priya Singhal
Yes. Thank you. That’s a great question and a great time for me to comment on that. So, obviously, lecanumab 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 3.
We just talked about our SLE program. In addition, we’ve got bid 122, which is very exciting, you know. And before I leave, SLE, we have our [indiscernible] program, as well as BIB059 addressing different pathways, and then I’ll move to BIB122, 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, you know, inability to, kind of be great proteins and accumulation of proteins, including proteins like alpha synuclein, 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 two programs, BIB131, which is acute ischemic stroke, and we also have BIB093 in Phase 3 for large [indiscernible]. So, we think we are addressing a very high overarching population of stroke, which again remains a high unmet need and not much innovation beyond TPA, which was, you know, almost two 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, you know, we’ve been focusing on it for more than 15 years. It wasn’t just about lecanumab 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 BIB080, which is our antisense oligonucleotide about to enter Phase 2, 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 BIB080, we’re very excited about BIB080 in the Phase 1b.
So, 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 beta amyloid reducing therapies, and it could be potentially combinations and more. So, behind that, we also have BIB113, which is an O-GlcNAcase inhibitor in Phase 1. We’ve already dosed our patient in Phase 1. 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 and 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, you know, many exciting programs, I might I might be able to talk for another hour, but I don’t want to take up all your [time on it] [ph].
Umer Raffat
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 an investor question. If you are not allowed to co-commercialize by Eisai, the economics do not change, but at that point, you take a harder look at the cost structure and cut more SG&A to maximize profitability of the royalty stream?
Mike McDonnell
So, the economics on lecanumab are shared 50-50. So, it doesn’t matter whether it’s a dollar spent by Biogen or a dollar spent by Eisai, it shared equally. So that would that would have no impact. and it’s a 50-50 on everything.
Umer Raffat
Got it. Okay. Mike, anything outstanding on your end
Unidentified Analyst
Yes, just kind of want to drill down on the [indiscernible] assets. I know, I’m feeling that these stroke is something that’s largely underappreciated. I guess number one, how big could this opportunity be? And for the IV glibenclamide, the 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 wave] [ph] in terms of…?
Priya Singhal
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, you know, how can we listen to sites, you know, 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.] [ph].
Umer Raffat
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.
Mike McDonnell
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.
Umer Raffat
Thank you, guys. Take care. Good luck.
Priya Singhal
Thank you very much. Bye-bye.
Question-and-Answer Session
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