Good morning, everybody. I'm Chris Schott at JP Morgan, and it's my pleasure to be hosting a fireside chat today with Chris Viehbacher, who joined Biogen as CEO, I guess, a little bit over a year ago.
Yeah.
Chris, Happy New Year. Thanks for joining us.
Happy New Year to you, too, Chris.
Yeah. So, I think we were talking before, about a year ago, we were sitting in these same, same two seats. You had just come on as CEO. So would love to just start the conversation with just your reflections on how the last year's gone, anything that surprised you, either positive or negative, in the CEO seat, and we'll kick off from there.
Well, thanks, Chris. Yeah, it was a busy year in 2023. You know, a year ago, we were still as a company, kind of still under the cloud of Aduhelm. You know, we'd been declining already for 3 years. We've talked about our melting ice iceberg of the MS franchise. A lot of investors had said, "Well, you've got a fairly mature product portfolio. Why is your cost base so high?" So, I think last year, I said our objective is really return to growth. And obviously, that's important for investors, but it's also important inside the company.
Mm-hmm.
You know, a company that is declining year-on-year. It's how do you get motivated? And all your business metrics don't really work all that well because you're trying to do less bad. So we outlined five things that we thought were gonna be important. One was we had to shift the whole focus of the company from MS to new growth drivers, and that is actually not that easy. We've been doing MS for 45 years, and there are an awful lot of relationships with physicians and patients, and yet, unfortunately, we don't have a new medicine to launch, so we needed to move towards Leqembi, and at that time, zuranolone. Well, Leqembi, of course, has had not only an accelerated approval, we got full approval, then people were concerned around CMS. CMS came through.
The registry hasn't been difficult. We always knew it was going to be a slow ramp because this is such a pioneering activity. And on zuranolone, of course, we only got postpartum depression and not the MDD. But I think even postpartum depression, obviously, a huge unmet need, massive media interest, and I think we're off to a good start with the launch. Second thing was we said, you know, our R&D pipeline had an awful lot of things in there that didn't really make any sense. So with Priya's help, we went through and really weeded out a number of projects that were costing an awful lot of money but didn't have an awful lot of value.
The third one was to look at our cost base, and we didn't just do a cost reduction exercise, we decided to completely redesign the company. We said: What do we need to be successful in 2025 with the products we have, with the research and development we're doing? And let's build that company, and then basically manage out the other aspects that weren't going to contribute in the future. And so we announced $1 billion of gross cost savings, with about $800 million net. We also had a couple of products that people were not paying as much attention to, Vumerity and Spinraza. I mean, if you looked at analyst forecasts, they had, "Well, Spinraza is gonna decline. There's a gene therapy, there's an oral.
Oral always beats, an infusion." Well, the reality is that more serious a disease, the more efficacy matters, and I think that's what we're seeing, and we've put new energy behind both Vumerity and Spinraza, and we're seeing those products stabilize and even growing. And then, you know, we really also had to look at, what else could we do outside the company? We needed more for growth, and we started an exercise early in the new year and did the Reata acquisition in August. That's actually financially good because now that we have European approval, we can certainly say that the IRR is greater than WACC, which is not necessarily something you see every day in M&A in our business, but it's hugely important strategically for us.
So now I think we're actually well positioned to return to growth, and I think we're in a much different place than where we were a year ago.
Yeah, that's great. When I think about those kind of challenges and opportunities of the company, where do you think you've made the most progress, and where do you think there's still the most work to do?
Well, you know, in business, it's always easier to do restructuring, so we're certainly well ahead on the cost savings.
Mm-hmm.
We've done a great job, I think, of really getting our R&D focused. It's a lot harder to build -
Yeah
... and, and grow.
Mm-hmm.
And so, you know, I think this year is really about execution. We've got all of the elements that we need. Leqembi, I think, we're seeing some really good progress on that launch, but we're just launching PPD. Our team was just out in the field as of last week. Skyclarys is off to a very good launch. We had something like 25% of the entire population on drug by the end of last year. But I think we also have to think about the pipeline. I'm gonna spend an awful lot of time on our pipeline. We have a lot of very interesting, scientifically superb assets in there if they work, but it's still a fairly risky pipeline.
Right.
And I'd like to bring in some assets, and Priya's interested, and Adam's interested in doing this, too. Building that pipeline out for longer-term sustainable growth.
Okay. I think that's, that's great. Maybe pivoting over to Leqembi, just an update in terms of the launch and progress you've made, addressing some of the, the barriers to uptake.
Right. You know, one of the things that we have to remember with Leqembi is that we are dealing with pioneering a breakthrough almost every day. Remember, until about a year ago, there was still an awful lot of question about did it, did it add value to remove amyloid plaque? And the Clarity study clearly demonstrated that, not only in terms of CDR Sum of Boxes, but in terms of activities of daily life... But of course, up until now, there hasn't really been any disease-modifying treatments for Alzheimer's patients. And most of them are actually being seen by primary care physicians. So now there's kind of a rush. We gotta get appointments with the neurologists. Not everybody who has Alzheimer's is eligible for treatment.
They have to be cognitively assessed as to whether they have MCI or early dementia. You know, this is changing an awful lot of how neurologists practice medicine. There's a lot of teamwork that's needed. We need the PET scans, the MRI to monitor. One of the things that we're looking at, though, are reimbursement has not been an issue. CMS came out, not only on reimbursement of Leqembi, but also on the PET scans. You know, some of the things that are quite interesting, because of the lengthy sales cycle, it can be 2-3 months between the time someone says, "I want to go see a neurologist," before they actually get drug in arm. And so what we've tried to do is look upstream and see what kind of indicators we have for progress.
So, numbers of PET scans are going up, and we talk to people who are providing the PET scans. They're seeing lots of activity. People who are providing the blood-based biomarkers and diagnostics are seeing increased activity. We're seeing a significant increase in the numbers of new patient starts on the registry. And, you know, in terms of reimbursement, CMS said, "Okay, we're now changing and clarifying the reimbursement for PET scans," but that has to be pulled through by the dozen or so max that are out there. And they typically don't move that quickly, but they have moved faster than anybody has ever seen before. A lot of the IDNs were on formulary, and they have done out-of-cycle P&T committee meetings because they see it as an urgency.
We certainly have patients waiting for treatment. So the real job is just establishing the care pathways, getting the policies in place, and the blocking and tackling of being able to process the patients. So I think, you know, we're feeling pretty good. I'm looking forward to seeing how the January sales play out. A lot of positive data in December, but December is kind of a funny month with the holiday schedule. But I think we're certainly seeing an awful and tremendous progress on Leqembi.
So in terms of the ramp from here, is it really just kind of getting the neurologists, you know, kind of getting their treatment paradigms down? Is that, is that the... In education, is that the biggest gating factor at this point in your view?
There, there's gonna be a number of things that we have to to pioneer, again, because nobody has been treating patients essentially. So one of them is, I think that the primary care physicians will play a role at some point because, you know, patients coming in, if it's hard to find an appointment for a neurologist, one of the best things would be is, can we do a triage of those patients before they get to the neurologist?
Mm-hmm.
And this is where the blood-based diagnostics will play a big role. The next thing is a lot of physicians saying: Well, okay, there's—we can't obviously expand the number of neurologists quickly. But not everything has to be done by the neurologists, and so some of them are hiring nurse practitioners to do some of the work. We're not seeing any capacity constraints on PET scans, nor on MRIs, nor on infusion centers for the moment, so I think that will flex. So largely, it is really around the care pathways and just establishing those. And that increases every day when the number of centers ordering from when we did Q3 earnings to now was up 37%, for example.
Mm-hmm. And just on that point, are you seeing, in terms of where the prescriptions are coming from, is this mostly still being driven by kind of top KOLs, or are you starting to see that broaden out a lot more into the community?
Actually, it's starting to broaden out.
Okay.
There's still... You know, we've probably got about a target of 10,000, and we're working our way through that.
Mm-hmm. And then in terms of your team's efforts, how much time are you spending on, I guess, the broader population versus kind of locking in those core prescribers?
We're still focused on some of the top centers, largely because we wanted to get the really go-to-market model down.
Okay.
You know, we have these, we call them neurology account specialist, NASs, and that's quite a heavy lift for a specialist because they've got to go in and explain the care pathway with the office. We have to do a lot of education around ARIA. We have to go through and explain not just the reimbursement for Leqembi, but the reimbursement for the physician's time, for the scans and everything else. And then, by the way, why Leqembi? You know, which is the selling proposition. So it's quite a heavy detail, if you like, and visit with physicians. And we really wanted to get that model. Then there's other people who are just looking after the patient journey. There's people who are looking at regional KOLs.
And so we wanted to get that down and get a certain critical mass. And as sites become ready, then you can start to ramp up your promotional effort further.
Okay. Just to tie this all together, just help me bridge a little bit from where we were with the 3Q results in terms of number of patients who are on, on drug versus the 10,000 patient target by, by April of 2024. I guess my question is just: How confident are you in that number? Is... And is that a number that makes sense to reset at some point?
... Well, remember, the 10,000 was really designed to try to give people some sort of milestone-
Yeah.
Because there are no real analogs for this launch. I haven't found a decent analog anywhere. So what, what I think we were trying to say is this isn't gonna be 100,000 patients, but it's not gonna be 1,000 either.
Yeah.
So that is a trajectory. And I think, you know, where we are right now, there's nothing that we're gonna do that's gonna change us on the trajectory. We'll get there. We don't get there. I think everything we're seeing, there's no reason to say that we can't get there. But again, the data were kind of choppy in December. So for me, I'm really looking for, for the January data.
Mm-hmm.
But where we are right now is, you know, the 10,000 isn't really what we're interested in anymore. It's how do we now get to the 100,000?
Yeah.
So that's where we're focused. But you can't get to 100,000 unless you've really got this go-to-market strategy really nailed down. I think, I think we're increasingly confident in that model.
Your focus is more on making sure you're getting the underlying pieces in place.
Yes.
And the number is the number, right?
Yes.
The other question I always is just duration of therapy. I know you've talked about the importance of continuous dosing. I think some of the feedback we get from physicians is a bit bifurcated, of some wanting to basically dose to plaque clearance, others, you know, looking at longer term. How are you thinking about how that plays out?
Well, remember, we're probably gonna be always well ahead of where physicians are because you know, right now, the physicians are interested in what's in the label and what do we have approved. And of course, that's all we can go out and tell. But as we think strategically about where this product is going, we're looking at other data. So right now, you're right. The Clarity study showed, okay, you remove the plaque, and you demonstrate a cognitive benefit. But the first question is, well, what happens when you stop?
Mm-hmm.
And we showed at CTAD last October that actually in a 24-month extension study that actually there is a benefit to continuing on therapy. So we will be... We intend to file for a maintenance indication by the end of the first quarter of this year. But the other was, you know, why did so many drugs fail before Leqembi? And there were really two reasons. One was, could you get enough drug across the blood-brain barrier? And the second one was, were you in the right patient?
Mm-hmm.
We all learned, okay, we needed to move earlier. And now we obviously, with Leqembi, are getting into the brain with the quantities we need. But have we still found the right patient?
Mm-hmm.
Some of the data we showed was a sub-study of Clarity, where we looked at really low Tau patients, so really early patients.
Mm-hmm.
Those data are really striking because now you're seeing something like 75% to 76% of patients completely stable for six months, on the first six months of therapy. And intriguingly, which was really amazing, we actually saw an improvement. And then we say: How can that improve? I mean, neurons are dead, or they're not dead. Well, it turns out that maybe that's not the case. And I think those data are interesting because there is a promise. If we can actually show this, these results in our AHEAD clinical study that we have ongoing, it's gonna make sense that we go even before patients have symptoms. The earlier you go, before too many neurons have been damaged or killed, you're gonna get a benefit.
That's at least the promise that I think we are seeing out of that data. Now, we have to prove that with the clinical trial that's ongoing. So you could actually see people on drug for quite a long time. And, you know, is prevention even a possibility?
Yes.
That we have to think about for the longer term.
Mm-hmm.
But the other interesting aspect of those data were, why did you see an improvement? And nobody had seen that. And it seems like there are these protofibrils, which are in the soluble element of the amyloid plaque. And those protofibrils seem to have some impact, that's at least the view of some KOLs, on synaptic function. Now, Leqembi operates on those, has an efficacy against those protofibrils that other products don't have. And so, you know, again, if we can actually continue to do research and show that we can get into the right patients earlier, we could actually really have a dramatic impact on the course of this disease.
Mm-hmm. Now, those earlier-stage data sets are really, really exciting. So it'll be-
Yeah
to watch the preclinical studies
Yeah
- pretty closely. The other question I have just on a bigger picture with relationship with your partner here. Can you just talk about, you know, how the commercialization roles are setting up today, just the general status of the relationship?
So we started with the U.S.
Mm-hmm.
This is the first country, you know, this, as I described, this go-to-market model is pretty complicated. For those of us who've been in this industry a long time, and you, you're working in co-promoting or in co-marketing, these are not easy things to actually execute on. So we decided in the U.S., let's just have one of the companies go out there and in a phase one, if you like, really establish the go-to-market model. And at such time as we decide to increase, then let's talk about what role, for instance, Biogen will play.
Mm-hmm.
That was in the U.S. Now, outside the U.S., because I think we've gotten a lot of information around the go-to-market model, I'm actually flying to Japan tomorrow night for the launch of Leqembi in Japan, and Biogen is in the front lines of launching Leqembi in Japan. And that's our intention to do in Europe as well. So, you know, one of the things that we have tried to do is: How do you make this relationship not only work together collaboratively, but how do you make it efficacious and efficient?
Yeah.
'Cause there's an inherent inefficiency when you get two companies trying to do things. And, and what you find is every company wants to do half of everything, and that, that is hugely inefficient. So I think, I think we are both conscious of the fact that we have invested a lot of money in this, and how do we make this collaboration profitable as well as successful?
It sounds like ex-U.S., it's a more blended model. Does the U.S. model evolve, do you expect over time?
I do expect that, yes.
Okay. Is that something this year or that kind of further out?
We'll probably give you an update of that with Q4.
Okay. Okay, we'll watch closely there. Other question just on Leqembi's sub-Q. So just help us put some of the data we saw last year into context in terms of your confidence in that program.
Again, here we've got another breakthrough.
Yeah.
I mean, how do you get an antibody through the tissues and, you know, this is the first time that someone has demonstrated that we can do that on a bioequivalent basis. So that's a huge success, and that's gonna be extremely important because, as we talked about, we're gonna be on... Patients will likely go to be on drug longer over time as the clinical trials read out, and we get some of these other indications approved. And so obviously, the biweekly infusion is not gonna be very convenient, so the sub-Q will play a big role.
We're obviously in a lot of discussion with the FDA, and there is still an intent to file an approval for sub-Q at the end of the first quarter of this year.
Okay. So I guess in terms of the data we saw, do you think there'll need to be a dose adjustment, or do you feel comfortable with the dosing that you-
Well, first, we only saw 6-month data, so we now have to get the 12-month data.
Yep.
And so we'll look at that, and we'll have a discussion with the FDA, but I think there is still an awful lot of confidence that we can file a sub-Q at the end of the first quarter.
Okay, great. I guess just maybe then putting them into broader context, how important is sub-Q for Leqembi in terms of the uptake?
Over time, I think it's gonna be hugely important. I... You know, there are some people that think, well, sub-Q is really important short term. I, I'm not as convinced about that because everything we've talked about is really prior to this, the initiation of treatment.
Mm-hmm.
You know, getting through the, the cognitive assessment, getting the, the PET scans and everything else, and the sub-Q versus infusion doesn't really have an impact on that. And for the initial period of, of plaque removal, but I think as we look to, to maintenance therapy, and if we're looking at going earlier and patients staying on drug, I think the sub-Q is extremely important for the long-term development of, of Leqembi, for sure.
Yeah. Absolutely. Maybe just one last one on this. As I think about, broader use of blood-based diagnostics, how important is that gonna be of maybe, you know, having less need for PET scans in terms of the uptake of these products?
I think it's gonna be a game changer. You know, most Alzheimer's patients are at primary care.
Mm-hmm.
Alzheimer's is not simple to diagnose. So, is this normal aging? Is this dementia? Is this Alzheimer's? And it can take quite a while, it can take years, before someone actually says, "Well, I think you really need to go see a neurologist." And this is where, you know, the first role of these blood-based diagnostics can play a role because you can get a much clearer read on, is this Alzheimer's or is this dementia, for example? It can play a role, I think, in triaging the patients so that those who really are eligible are the ones who go to see the neurologist.
Over time, what the companies who provide these diagnostics are doing are looking at validating these diagnostics such that you could get a confirmed diagnosis of Alzheimer's in place of a PET scan or a CSF. That'll probably take another 2-3 years, but, you know, it's quite interesting. Until you actually have a treatment, there is not the same investment in diagnosis, and we see this also in rare diseases. And I think that's what's happened. Now, there's a treatment, so now the diagnostics have been around, but nobody was really interested in using them if I didn't have a treatment. So now there's an awful lot of activity. I mean, Quest and LabCorp, C2N, these are all companies that are working a lot to bring these diagnostics to market.
Yeah, absolutely.
And they're actually out there and being used today.
Yeah. As we think about over time, those are-
Yes
Kind of a key piece of this. Excellent. So maybe just pivoting a little bit to Skyclarys.
Right.
So maybe just start with this, update on the U.S. launch and how that's progressing.
That, you know, there's a tremendous launch. I think, when we start comparing this to analogs, we are outperforming all the analogs.
Mm-hmm
... even our own Spinraza. You know, there are a couple of reasons for that. One is, remember, Skyclarys was originally approved, but then couldn't come to the market because there was a manufacturing issue, and so it didn't actually get to market until July. So there was no question that there was some warehousing of patients-
Yep
We saw that. But there's also an extremely active patient advocacy group that has been hugely helpful in really raising awareness of the disease and the availability of treatment. You know, we're seeing the same kind of interest actually outside the U.S.
Okay.
remember, one of the interesting things about rare diseases, we're not so U.S. market dependent. If you look at Spinraza, two-thirds of our sales are actually outside the U.S.-
Mm-hmm
... and we expect the same to be with Skyclarys. So we're in the process of setting up early access programs in a number of European countries. Actually, Latin America is expected to be a big market. There's no market in Asia just because of the genetic makeup of these patients. But it's off to a very strong start, and we're very pleased with the launch.
Great. Great. Maybe just getting a little bit more detail on that, the European market. Just elaborate a little bit more versus the U.S. in terms of, you know, patient identification, patient advocacy. Is it, you know, are there similarities and differences, I guess, to think about how that ramp could go?
Well, there's, I mean, there's two differences, I guess. On the one hand, patient advocacy groups are not quite as well developed, but the main group, FARA, for instance, is already establishing itself in Europe, but there are gonna be other groups that will be helpful. At the same time, you only have single-payer systems.
Yeah.
Actually, you know, if you're in the business of vaccines, or if you're in the business of rare diseases, those single-payer systems are actually quite helpful. I mean, one of the things that Alisha deals with in launching in the U.S. is that you still have to go around all these payers, and then there's issues about getting the refills. You don't really have any of that in Europe. And generally, the pricing is actually quite acceptable in Europe. We certainly saw that with Spinraza, so we're using Spinraza as an analog. And I think that's why there was so much attention to the European approval. This, it's not usual that the European approval really matters to most drugs, but on this one, it does.
So, and we've had outreach from 26 countries around the world who are inquiring, "When is the drug going to be available?" So it's. There's nothing else out there for these patients. The next major thing that we have to do is launch a pediatric study.
Yeah.
Because a lot of patients are actually diagnosed under the age of sixteen, and we don't have that in our indication statement today.
Okay, great. Maybe post-Reata, can you just talk about financing capacity? And I think you mentioned before, kind of this maybe desire to de-risk the pipeline a little bit more. Kind of where's the BD focus right now? Is it pipeline, versus in market, or...?
Well, we could—we couldn't afford to do another Reata-
Okay
- at least this year. But, you know, we're generating quite a bit of cash flow every year.
Mm-hmm.
And we certainly have the capability of doing licensing deals. And I'm not sure we need to do another Reata. I mean, if we found one, I think we would, but I think we're really gonna be focused on earlier-stage licensing. You know, a lot of our pipeline are ASOs from Ionis, and they address huge unmet needs. And again, if they, if successful, each of them, whether it's in Angelman or sporadic ALS, we have another, our ASO for tau is-
Mm-hmm
... is a crown jewel in the pipeline. Plus, we have two molecules for lupus, one partnered with UCB, and we have our own litifilimab for SLE and CLE. But there's... You know, Biogen has always been out there on the risk curve on the development. And, you know, we'd like to complement the pipeline with more assets in rare diseases and in certain defined areas of immunology. And part of the reason for that is, you know, in most of what we do at Biogen, we can't do a proof of concept study. So we're doing these regulatory study, these approval studies, lengthy, expensive, and have no idea whether they're gonna work or not.
I think what we'd like to do is have parts of our R&D come through a classical drug development chain, where we can do a phase 2 and assess safety and efficacy before we spend money on the pivotal studies. Rare diseases, I think, really fits with our commercial capabilities as well as our scientific capabilities. Biogen has always been an immunology company. I mean, we've been in MS from the get-go.
Sure.
I think, you know, we can expand our pipeline range without having to acquire an awful lot of new capability.
Okay. Kind of, when you think about Maytalkin-
Yeah.
Kind of centered around those areas.
Research, you know, we've hired a new head of research-
Mm-hmm
... Dr. Jane Grogan. And there again, I think we can do so much more. As if you're Biogen, you know, we're in one of the most prolific R&D centers in the world, and we've done some collaborations, but I think we're gonna be looking to increase the amount of collaborations that we're doing in the Boston, Cambridge area. But I think, you know, Jane comes from the West Coast, and I'd like to make sure that Biogen is as present in the West Coast as it is on the East Coast.
Yeah. Great. Maybe just shifting to the kind of P&L and base business. Maybe just start with just thinking about 2024, kind of pushes and pulls we should keep in mind for the, the portfolio.
Well, I think a couple of things. One is, remember, we did a transaction for $7.5 billion. If we'd have done it two years ago or three years ago, money was-- didn't cost anything. You know, obviously, we had a lot of interest income on the money-
Yeah
we had in the bank that we're not gonna have this year.
Yeah.
So remember that, when you get below operating income, that there's not as much interest income as we did last year. But equally, there are a number of positives. First is that, we're shifting the revenue mix, so getting a lot more product revenue and less contract manufacturing revenue, which has a positive, accretive benefit on gross margin.
Mm-hmm.
Second thing is we have a huge facility in Switzerland, in Solothurn, for the manufacture of Leqembi, so we had an awful lot of idle capacity costs last year that we're not gonna have this year.
Mm-hmm.
Then you have Skyclarys, which is a small molecule and has a high gross margin. So, I would say we're gonna have a better gross margin this year, and you're gonna see some of the flow-through of Fit for Growth.
Mm-hmm
... flowing through on our OpEx line. So, you know, we're certainly. We've targeted 2025 to have OpEx to revenue ratios equal to our peers.
Okay. Okay, great. When I think about kind of Biogen's trough year in terms of whether it's revenue or EPS, when should we kind of think about that trough hitting and the company kind of heading to growth, do you think?
We'll give you an update on that Q4.
Okay. Stay tuned, it sounds like there.
... Well, we, I think we have all of the elements-
Yeah.
to grow now.
Yeah.
But, you know, I don't want to put out a press release today.
Okay, sounds good. Maybe just one last one. Just touching on the margins again. With the new accounting for Leqembi, I think you mentioned, you know, by 2025, has the margins normalizing. Just what's a reasonable margin to think about for your business looking out, you know, 4-6 years as we think about Skyclarys ramping, Leqembi becoming a big, bigger contributor? Like, where, what does that look like?
Well, I think you want SG&A roughly around 20%-22%. It all depends on where you are in launch cycles.
Okay.
Obviously, companies that are launching have a little bit lower ratios, some when mature. But I think if we're over time around the 20% and R&D around 20%, so you got kind of a total OpEx to revenue ratio of 40%.
Mm-hmm.
The one thing I would say in a company like Biogen, you know, in my days at Sanofi, we always were focused on this 15%. I think Biogen has a much higher scientific level than most companies. I wouldn't want to constrain our R&D budget if we actually find projects. I think we've established a lot of discipline-
Mm-hmm.
and that if we're going to invest, there's gonna. We think that we've got a real discipline to make sure that only things that make sense are going forward. So that could increase, but then we would have to demonstrate that there's value creation there. But I wouldn't want to cap us on that.
Mm-hmm.
Otherwise, I think, you know, if we can get to that, then we'll have a bottom line that is comparable to our peers.
Yeah, yeah. That's, that's helpful. A couple other quick ones. Biosimilar business, just update on that process of where you are and how that fits in the portfolio?
Yeah, we'll have another update on that in Q4. You know, that. It's a bit of a complicated business because we sold the equity-
Mm-hmm.
in the joint venture last year at a very good price.
Mm-hmm.
We have all the distribution rights for Samsung in Europe, and we have our own proprietary biosimilars that we're launching in the U.S. We're in discussion with a number of parties about that, but it is... It, it's kind of a complicated business to deal with.
Okay. Yeah.
But we don't... You know, I think, it's not necessarily core to Biogen.
Okay. So the goal is to, there's maybe a better owner for that business than Biogen. Another one just on Aduhelm. Just update in terms of Biogen's decision of where you go with that product.
Yeah, I'd like, I'd like to say that's kind of one of the hardest business problems I've almost ever confronted.
Mm-hmm.
You've got a product that clearly works.
Mm-hmm.
But the studies to finish the confirmatory studies is pretty significant.
Yeah.
The question is, and by the time you get there, what's the market gonna look like?
Mm-hmm.
And so we are actually in discussion with outside parties and outside financial interests, and we're coming to the conclusion of that, and we'll give you an update of that at the Q4 earnings, too.
Okay, great. A couple other ones. R&D pipeline, I think you've mentioned a couple before, but I guess, what do you see as the major opportunities in the pipeline, and, and what should we be paying the most attention to?
Well, one is, litifilimab-
Okay.
-which is actually a homegrown asset. You know, lupus is a huge opportunity, but it's been a very complex target. I was at GSK when we developed Benlysta, so I know this disease pretty well. What is interesting, what I particularly like, it has a cutaneous lupus. And part of the problem with lupus is you've got numerous organs involved, and I think on the skin side, that we might have a little bit more success. Certainly, we are getting inbound interest on that product.
Mm-hmm.
So that tells me that we're not just believing in our own optimism here.
Mm-hmm.
I think the ASO for tau is extremely important. You know, what really started the whole Aduhelm-Leqembi progression was a study that Biogen did 10 years ago called PRIME. It was in that phase 1 study where we actually were able to demonstrate for the first time a benefit on cognition. I think if anything, we've seen even more promising data.
Mm-hmm.
It's all very early, and we're in a phase 2 that is ongoing. But you know, if you look at Tau, Tau determines the severity of Alzheimer's. And we've been able to demonstrate that we can knock down Tau. Antibodies have not, because it seems like you have to act intracellularly-
Mm-hmm.
So the ASO is very good for that.
Mm-hmm.
And I think that could be another major market in Alzheimer's. The complementarity between reducing amyloid plaque and reducing tau makes an awful lot of sense over time. So I think that one is one to watch. But we'll have data in the first half on our ASO for Angelman's.
Yep.
We'll have some data on the sporadic ALS for ASO as well. We've got a number of things that. We have also completed another study in lupus. We have a product in collaboration with UCB.
Mm-hmm.
phase III has completed enrollment, and we'll have data on that phase III in about midyear.
On the Tau program, what's the next update we should kind of think about for that one?
Probably looking at an interim analysis, but it's probably another year or two away.
Okay.
About two years away, Priya?
Yes, two years.
Two years.
Okay. Excellent. Maybe just last topic here, just on-
It's always good to put your head of R&D under a little pressure in these meetings.
Get the yes/no on it. On Zurzuvae, can you just talk a little bit about just, I think you had mentioned before, how the launch is going and, and just expectations for the first year for that one?
Yeah, the interesting is expectations are quite low.
Yeah.
But when you look at it, the unmet need is phenomenal. You know, only a fraction of women are being treated for this, and it's devastating. And what was amazing is when Zurzuvae, Zurzuvae got approved. We had this unprecedented media wave. I mean, it's been in Time Magazine, on CBS, something like 5 billion media impressions. And I think what I'm hearing from our U.S. team is essentially, we're at the crossroads of two major societal trends on women's health and mental health. And so, actually, there's a huge amount of resonance that we need to help women with this condition, help to displace some of the taboos around this, and actually provide a treatment that can act quickly.
You know, this onset within three days could be quite important for women who are trying to cope with new children and feeling guilty about this. So, we've come up with a commercial plan, which I think recognizes that, you know, we have to build this market.
Yep.
We can do this profitably. But I actually think, I would actually think that Zurzuvae is probably an underestimated opportunity. I think there's upside here.
You think a PPD-only indication is, can be a profitable business for Biogen?
I think it can be, yep.
Okay, excellent. Maybe just to wrap up here in the last minute or two, just as I think, as you walk through some of the pipeline, but if we look at catalysts for 2024, what are, what are you most focused on or kind of updates that we should be watching most closely?
Well, you know, clearly Leqembi.
Yep.
Although Leqembi obviously is not profitable this year, but it is a major growth opportunity.
Mm-hmm.
Skyclarys will really be driving an awful lot of operating revenue, as well as top-line revenue. Obviously, the cost savings on Fit for Growth.
Mm-hmm.
I think people could be surprised, potentially, by the gross margin. I think we're gonna do better. So, we'll be giving update on guidance for the year at Q4. But, you know, like I say, I think we're in a much better place than we were a year ago.
Yeah.
But, you know, we equally recognize we now have to pull this through and execute.
Yeah. Well, thanks again for the discussion today. You made a lot of progress in the first year.
Yeah. Thanks, Chris.
Yeah. Thanks again for joining us.