I think we are ready to kick off the next session here. Good morning, everybody. I'm Chris Schott from J.P. Morgan, and I'm pleased to be introducing Biogen today. From the company, we have Chris Viehbacher, the company's President and CEO. Chris has been CEO for a little bit over two years now. Looking forward to the presentation here. We're going to do about a 20-minute presentation, and then we're going to go over to Q&A from there. So if I'm going to turn it over to Chris, we're going to have some folks on.
Yeah, I'll turn it over to you.
All right. Thank you, everybody.
All right. Good morning, everyone. So let's see. Where's this thing? Here we go. We covered that. So new year, new opportunities. What we're principally focused on, obviously, in the near term is really executing strongly on the four product launches that we did last year with LEQEMBI, with Skyclarys, with ZURZUVAE, and with QALSODY. What I'd like to talk about this morning is where's Biogen going longer term? And there's really three main areas of focus here. The first is nothing that we have seen so far with the launch of LEQEMBI dissuades us from the fact that there is still significant unmet need in Alzheimer's, and therefore there's also significant commercial opportunity, and we're doubling down on Alzheimer's. The second is, I think in 2024, we made significant progress on our pipeline.
In fact, I think we have really seen an awful lot of conviction and confidence in our pipeline, at least internally, from what we see. We all know all of the uncertainties around pipelines, but I think as we look at it with franchise and lupus and Alzheimer's and nephrology, that there is a real opportunity to have significant growth well into the next decade from the pipeline. The third is, I think we made an awful lot of change within Biogen, introducing accountability and a lot more rigor around how we allocate capital. Let's talk about Alzheimer's disease. Pretty much most investor meetings always focus on this. Let me start over on the right side of the chart. 120,000 deaths. I think a lot of people think about Alzheimer's. They think about a little bit of memory loss. Let's remind ourselves, Alzheimer's kills people.
120,000 every year. It's a fatal disease. And then there's a discussion around efficacy, and we often cite CDR sum of boxes. But if you go talk to any physician who's actually treating patients, they're not using CDR sum of boxes. So what really matters to patients is a worry about becoming a burden on their families. They do not want their spouse bathing them. They do not want their children feeding them. They do not want their friends having to drive them around. This loss of independence is extremely important. And as someone at the tail end of the baby boomer generation, I can tell you, we baby boomers don't want to stop living. We're living life to the fullest all the way. And this loss of independence from Alzheimer's is what really bothers people.
Now, usually when we talk about the market opportunity, we talk about 30 million people with Alzheimer's around the world. But really, that's not accurate in some ways because once your disease has progressed too far, we can't help you with LEQEMBI. What we do see is most of the patients who are getting treated are newly diagnosed. It's not the patients who've been in a neurology practice for a number of years, largely because the disease has advanced too much for that. And indeed, one of the things that is important when a patient first presents at a neurologist is that they have to have a cognitive assessment to see whether they are actually eligible. So really, the market opportunity is 500,000 new patients diagnosed in the U.S. alone. So what has been the experience?
Now, we always said that this was going to be a steady and a slower launch than what we might see for other products and that's simply because of the complexity of the treatment paradigm. If you're talking to physicians, the thing that will come across very rapidly is how much work this is for physicians when a new patient comes along. You've got to do that cognitive assessment. Where am I going to send them for either the PET scan or the lumbar puncture? I've got to think about scheduling these MRIs at exact time points. I've got to go and negotiate for use of the infusion beds. All of those things are things that neurologists haven't really had to do. Now, this is not unusual for an oncologist.
They've figured out how to go and do these collaborative approaches, but it is a real change in the practice of neurology. The good news is that they are actually doing that. And as you can see from that chart, every week we're finding new prescribers. Every week, more patients go on drugs. Every week and every quarter, and all through last year, we have been able to sell more. Now, it's not an accelerating path, and I think this is the path that we would expect to see, that steady quarter-on-quarter growth. Now, what can we do to accelerate that? Well, we have a number of catalysts, I think, that can help. The ones on the left really are meant to think about how do we make the burden on the physician easier. First one, hopefully, we'll see an FDA approval for IV maintenance.
We know that after we remove all of the plaque, after 18 months, we have data that suggests that particularly the soluble form of plaque comes back, and indeed, we have data out three years that shows that people who continued on therapy do better. Now, we expect to get that indication, hopefully, in this month. Later in the year, and actually, we just put out a press release overnight. We now actually have a PDUFA date of 31st of August, where we'll expect to see the subcutaneous form. Now, that's big because although we make maintenance a little easier than treatment in that we move from biweekly infusion to once-monthly infusions, the subcutaneous will be definitely a lot easier for the physician. They don't have to utilize the infusion beds, for example, and then I think a major catalyst is going to be the subcutaneous form for initiation.
The final one on the bottom are blood-based diagnostics. There is an expectation that somewhere in the middle of this year, at least two blood-based diagnostics could have an FDA approval. And if that's the case, then we might be able to dispense with the PET scan or the lumbar puncture. So if you can dispense with the lumbar puncture and you can reduce the need for infusion beds, the burden on the physician will get lighter. So that's in the near term. Longer term, I think we have to think about efficacy. This CDR sum of boxes of 27% isn't really the measure of efficacy. Actually, these antibodies are highly efficacious. We can remove amyloid plaque to nearly undetectable levels. The question is really, for whom is that really the most benefit? And Alzheimer's is really a disease of progressive neuronal and synaptic injury and loss.
We showed data at CTAD in 2023 for low Tau patients. Those patients actually had much higher levels of efficacy. We had something like close to 70% stabilized after six months, and close to 60% actually demonstrated some form of actual improvement. It suggests that we need to really be thinking, who's the right patient for treatment, and can you go early enough? One of the things that our partner, AZI and Biogen are doing is we are funding a landmark study that we started in 2020, going and demonstrating the benefit of treatment in pre-symptomatic patients. Now, when I first saw this study, I said, how the heck do you find these people? There are potentially people in this room who have plaques growing in their brains right now, but don't know it. That's where these blood-based diagnostics have been important.
We have actually been able to now fully recruit that study. It'll take several years yet because there is a follow-up necessary to see what happens, but this will provide the answer as to whether or not we could actually have a preventive approach to Alzheimer's. And indeed, there are neurologists who will say, actually, we think that at some point in time, patients over the, well, anybody over the age of 50 will start to get a p-Tau test as part of the normal blood test, just like you get cholesterol or other measures in your blood. Because really, by the time you get diagnosed with Alzheimer's, a lot of damage has been done by this dreaded disease, so AHEAD, I think, could also be a major game changer to this. Now, we also know that Amyloid beta is probably not the only cause of Alzheimer's.
Tau is another. In fact, Biogen's view is that Alzheimer's is really an amyloid-driven tauopathy. Tau is related to the severity of the disease. So it makes sense to think about Tau. We have an ASO that targets Tau. A lot of people have tried this approach with antibodies. But the antibodies act extracellularly and have so far not been able to show that they work. The ASO acts intracellularly to reduce the production of Tau. Now, it turns out that you can't actually reduce it completely. We are targeting about a 50% reduction because it seems like some level of Tau is needed. We had presented some promising biomarker and clinical trends already in a phase 1b. We are currently in a phase 2 that we'll read out in 2026. We are testing dosing between quarterly dosing and semiannual dosing.
But we actually think that this could be an opportunity to have even greater efficacy for Alzheimer's patients. Lupus is another significant opportunity for Biogen. Our company was founded 45 years ago, and for much of that time, we have focused on multiple sclerosis. There's a lot of learning from multiple sclerosis that can be applied to lupus. And there are five million patients. They have a wide range of symptoms, different organ involvement, and there are limited treatment options. There have been, I think, two products so far that have been approved. The first one is dapirolizumab, which showed positive phase 3 results last fall. This actually acts on really reducing the production of T cells and B cells. So that's on the immunology pathway. What was important was not just the benefit on BICLA, which is the composite score that people use, 50% reduction in severe disease flares.
And one of the things that you see in a lot of these diseases is, can you reduce steroids? Because steroids are pretty damaging to people's health. And there we actually saw a significant number of patients successfully being able to taper. And we've got a pretty good safety profile here. So we have already started a second phase 3 study that is enrolling and expect to launch in a few years. We have a second molecule, homegrown litifilimab. And this is a first-in-class biologic, not only for SLE, but for also CLE. And there is no actual drug currently approved for CLE, which is the cutaneous form of lupus. And that has a different mechanism of action. That really is looking to reduce the production of interferon and so really is going on the inflammatory pathway. We have phase 3 studies ongoing in both SLE and CLE.
SLE is expected to read out in 2026, and CLE between 2026 and 2027. Finally, I think the acquisition of HI-Bio in 2024 was pretty transformational. First, this is a little different than what Biogen has been able to do in the past. We've been focused on neuroscience and a lot of neurodegenerative diseases. You can't really do phase 2 studies. Here, we can get proof of concept in studies. You look at the AMR indication, for example, we saw over 80% resolution in AMR. And we're starting to get these trials now up and running, and we expect to initiate all three studies in the course of 2025. And it's not only that we can give a lot more confidence. These are not five-year phase 3 studies. So we can do these studies shorter. We have a positive proof of concept. We can actually do pre-launch activities.
That's a change in the way we do things at Biogen. We're not looking to do left turns into oncology or cardiometabolic, but we need to be able to go into diseases where we understand the underlying disease biology. We're going to continue with ALS and Alzheimer's, and neuroscience has been who we are. We're trying to open the aperture and move more into both rare diseases and immunology and HI-Bio plants the flag in both of those. You can see we actually are getting momentum across our late-stage pipeline. Again, 2024 was really a watershed year, at least for me personally, because I'm starting to get increased confidence around the pipeline. The final areas, we've brought a lot of discipline to the company. First, we have clearly got this MS portfolio that is facing increased competition.
But what you can see is that actually last year with our new products, we were pretty much on the pharma side able to balance the decrease in our MS portfolio with the new products. Our decrease in revenue of $228 million really was a function of the decrease in contract manufacturing revenue, which was a contract that had been in place for a number of years. It was quite low margin and did not get renewed. And that's a little where we are going to be as Biogen for the next couple of years trying to balance, can the new products offset the decline in the MS portfolio. And finally, on the cost side, I just like to point out that on the gross margin side, you saw a significant improvement in margin, 400 basis points, and we have 800 basis points improvement in operating margin.
Tim Power joined us recently as the new head of IR from BMS, and I think, Tim, it'd be fair to say you're pretty impressed that a company can do 800 basis points of operating margin in one year. What is important in that is that we did not in any way scrimp on the investment in new products. We took $250 million essentially out of our legacy product portfolio and invested in new products and new product growth, and that actually, we shouldn't forget that actually cost savings generate cash, and you can see that the cash flow generation has gone from $1.3 billion to $2 billion. And that's important because we want to continue to invest in Biogen, and having the cash flow to be able to do that is what's important, so I'll just go back and say we continue to believe in the potential of Alzheimer's.
Nobody is really doing as much on as many modalities as Biogen in Alzheimer's. We believe we have a transformational multi-billion-dollar pipeline potential, and we're going to continue to be very disciplined about how we deploy our capital. With that, I'll turn it over to you, Chris.
Great. Thanks for those comments. Maybe to start the conversation, we'd love to kick off with LEQEMBI. It sounds like you're kind of laying out a ramp, this kind of steady ramp that we've been seeing continuing to 2025. When you think about the, I'd say, hurdles to adoption that have been on the market, how would you rank order at this point? What are the biggest hurdles for physicians who are still considering kind of prescribing the product and how to use it in their practice?
The biggest hurdle is still clearly the need to implement the treatment paradigm.
I said there are 500,000 new patients diagnosed every year. There are only 13,000 neurologists. So there's already also a bottleneck in being able to get to see a neurologist. Now, that's where the blood-based diagnostics can help because I think a lot of the patients are in primary care. And I think over time, the primary care physicians can start to triage patients so that those who get in to see a neurologist are actually going to be able to be treated. The other is, I think, as we simplify this treatment paradigm, it's not necessarily the neurologist that has to do all this work. You can have nurse practitioners and other people in the office who can start to manage the patient. The neurologist is going to want to own the diagnosis, but things can happen.
Now, we had a big meeting in Tokyo before the holidays looking at first real full year of launch. And I think it's fair to say we had to spend an awful lot of time educating physicians, first about safety. Safety is clearly of primary importance, but also about this whole treatment pathway. Are PET scans reimbursed or not? And what about the diagnostics? And where do I go for the lumbar puncture?
We didn't have a lot of time to talk about treatment benefit. And I think we have an opportunity to refine our messages going into the second year where we really focus on that. Some of those patient preoccupations about independence. So I think there's also things that we can do on the commercial front.
But again, I think it is going to be this ability to create the care pathways and just funnel all these patients through. But as we simplify it, as we bring in primary care, I think over time, and particularly, I think after the subcutaneous for induction, we may see actually an acceleration at that point.
Great. Maybe just talk about the, I mentioned you mentioned the blood-based diagnostics coming in. How quickly would you anticipate that those get adopted once they're more broadly available?
Well, if you just let it take its natural course, it'll take quite a while because you can get a diagnostic onto the market and just have it clear lab. But you probably don't have reimbursement, and you might not have the validation. So the FDA approval is important for reimbursement. There has been a history of slow reimbursement for diagnostics, which seems crazy.
Perhaps if we do get an administration more interested in prevention, maybe we can get a little bit more emphasis on diagnostics and biomarkers. But I think my experience with abacavir at GSK, which had a hypersensitivity reaction, we developed a companion diagnostic at GSK for that. As GSK, we actually got actively involved in educating physicians about that, and take-up was pretty strong. So we'll have to see. Once these are approved, we may be able to work with the diagnostics company and educate physicians that they are available. And considering that it is a considerable cost to do a PET scan or even a lumbar puncture, one would think there's a cost-effectiveness argument that one could make with payers.
Yeah. Would you expect that with the blood-based diagnostic, that PET piece can kind of fall away in this?
That's the hope that that would be the case. I mean, as I see Priya here in the front row, as Priya would say, I think you're going to need something like 90% concordance between a PET scan and a diagnostic for that to happen. And it seems like some of them are going to be able to do that. But we'll see what happens.
On the subQ piece of it, I mean, the maintenance one first, how important is the maintenance subQ from your perspective?
Well, I think it's important from a couple of different reasons. We're probably just getting now to the point where the first patients have been on for 18 months. We've cleared the plaque. But what do you do then?
And what we saw when we started to withdraw Aduhelm was people don't want to come off the drug because they feel that they are doing better. And so they want that option. This will give that indication assuming it gets approved. And as subcutaneous, that then also makes that convenient. So we're expanding the market on one hand. The other is this is not an indication that the donanemab can go after. So it's a clear point of differentiation between the lecanemab and the donanemab. And I think that's going to be also quite important. Do you really want to go on one drug but then have to switch to another? And really on the ARIA front, you typically see ARIA early in the treatment. So you really are hopefully past most of the ARIA risk by the time you get to maintenance.
Yeah, makes sense.
And then in terms of, I guess I'm just making a subQ follow-up. When we think about kind of moving out to the earlier, like the patients starting this, what % of patients is just the infusion too much of a hurdle to get through? So we're getting a sense of as we have that next approval through, how big of a step up could that be?
I don't think there's actually generally an infusion bed capacity issue. It can be at specific institutions. There's also what we have seen on occasion is even as capacity in a particular institution arises, there's a reluctance to let the patient go to an off-site infusion center because infusion beds are an important source of revenue for hospitals. But generally, there's not. Eisai has also had contractual arrangements to make more infusion beds available off-campus. But I don't think there's that.
It's more that you do have to have that at particular time points. You have to have someone who's scheduling that out in front, same as the infusion beds. It's not rocket science, but you need someone who does that. That's getting into that routine is really more of the barrier. The actual bed capacity does not seem to be, generally speaking, a problem.
This is a bit, a little bit more duration. How are you finding patients in terms of their willingness to stay on therapy? Is it generally once the patient's on, they're staying on for long periods of time?
That seems so. It's a little hard to track numbers of patients now because all we really can do is we have an algorithm that takes a number of vials that we're selling, and we try to back into actual patients.
But we haven't had a lot of reports of people dropping off therapy. There's a couple more on this. Competitor coming in the market. Just any early anecdotal comments of just how that has, on one hand, maybe a second player helping with the education helps. On the flip side, you've got a competitor. How's that balance working out? We're clearly mindful of the financial power of Lilly, and we certainly wouldn't want to underestimate a competitor. So far, but it's early days. We haven't really seen that much. It seems that from the data we have that they're getting about maybe 30% of new patients. It hasn't created market growth yet, but I think part of the problem is they can't just come into the, say, IDNs and use our protocols because they have a different treatment paradigm. They have an extra MRI.
It's not clear when you can stop treatment on that. So they're still probably working through some of that protocol. So I would think that they're not completely out there. But this isn't really going to be a share of voice game. This is really around growing a market, working with physicians, helping them to understand what's the most efficient pathway. Can we make that burden easier? Another point of differentiation is we have a subcutaneous formulation. Donanemab won't. And when you think about between now and the end of the decade, treatment is probably still going to be dominated by these two antibodies. And so I think we have enough points of differentiation that we'll be able to. We're not obviously as big and powerful as Lilly, but I think we'll be able to stand our ground on the competition.
And we have enough points of differentiation that we can be successful here.
Great. Maybe just shifting over to the AHEAD 3-45 trial. Just timing of that, when can we think about a readout?
We haven't actually disclosed that, but we've just had most recent patient in, and follow-up period is how long again? Four years. It's four years for everybody. So now we're not going to necessarily wait till the last patient has had four years. There may be an opportunity to do that sooner. But that is the commitment of Biogen and Eisai on Alzheimer's. Who else would do that study? I mean, that will be a truly landmark study. We will really define whether or not you can have a preventive care approach to Alzheimer's and who really can benefit the most.
And we think when you look at this early patient data on low Tau, the expectation is obviously we need the clinical trial data to validate that. But you can imagine if you could actually get to patients before they really have symptoms, we could really have an incredible impact on this terrible disease.
Y eah, absolutely. Yeah. It's an exciting study. So maybe just staying on Alzheimer's, talking about Tau. First of all, just how do you think about the opportunity with your Tau program relative to LEQEMBI?
Well, one of the things that we have seen, and one of the interesting things about Biogen is that pretty much all of our medicines are treating a pretty devastating disease. And I grew up in primary care medicines, and we think about once a day versus twice a day or pill versus IV.
When you have a truly devastating disease, it's all about efficacy, and I think that first and foremost is what Tau is going to offer. What we have seen in early data clearly has to be validated, but we're seeing multiple fold times efficacy that we saw with Aβ, so there's a real opportunity to see much greater efficacy. It's an intrathecal, which is not necessarily the most convenient way, but I think if we can get to quarterly, but certainly semi-annual dosing, that will be manageable for patients. One of the things that I always look at is what happened in clinical trial recruitment. We actually recruited that study even ahead of schedule, so it was clearly not an impediment to recruitment, and it comes back to, again, if this works and I have a terrible disease, I want the best efficacy I can get.
What do we think about for the bar to move this forward as we think about the phase two data in 2026? What are you hoping for to see in the profile?
I think really phase two will certainly inform us about the dosing. That's important. We're looking to see validation of some of the data we saw in phase one. I think there's quite a high degree of optimism that we will see that data. And then one of the most interesting things is if we are able to validate that with the phase two, obviously we're thinking about phase three to go into with the Tau program. But you could also go into other tauopathies. And there are a number of those. So there's an opportunity to really have multiple shots on go here.
Priya and her team did an amazing job of redesigning the phase two study and been able to lop four years off the program. And I think what we are going to be doing are things in parallel. So by the time we get the phase two data, we want to go as fast as possible into the phase three. And we'll be doing some of that development of phase three and preparation at risk to make sure we can go as fast as possible.
Bigger picture question on R&D. I know when you started, part of the goal was to maybe rebalance the portfolio a little bit. How far along in the process are we with your pipeline today?
So I think we still have what we have inherited. I mean, lupus is clearly also has been a challenging target.
I mean, we're very proud of the fact that this is only the third medicine to actually get a phase 3 trial. But it also shows that this is a pretty tough area in which to do R&D. But I do think we will succeed. I think we're feeling pretty good about the Tau. But I think that's why HI-Bio was important for us. This is really trying to move us into an adjacent space. Biogen has an awful lot of capability. We understand the immune system because we've been in it with the MS for many years. We're not necessarily going to go into the big indications like AD or RA. But I think we can find rare disease spaces, specialty immunology where we can play. We've been specialized at low volume, high value products. We have an incredible ability to help patients navigate the system.
I think one of the reasons that Biogen was so successful in MS is we have been able to actually help patients navigate the very complex reimbursement programs. We know how to provide genetic testing. We have an awful lot of really high-level scientific education that physicians. And that's what I think we really want to leverage when we go into these other areas.
Yeah, makes sense. Just on the lupus programs, how do you kind of position the two programs against each other? How do you think about them?
Well, they're going to be in the different mechanisms of action. And this is a complex disease that affects different organs at a time. So I think it's going to be a little like MS. You're really going to decide which product is best at which point in time for every patient.
And so I don't think this is one product for the whole disease. CLE is clearly something that's of interest because no one has actually been approved in that space. And so Litifilimab certainly can play there where Dapi is probably not going to play. But I think that'll be some of the things that come out of now the phase 3 studies is to figure out exactly where you would position that for which patients. Again, we did the same thing in MS. Great. Maybe just pivoting over to Skyclarys. We'd love just to update in terms of how that ramp has been progressing, both U.S. and ex-U.S. Yeah. So the interesting thing about Friedreich's ataxia is that there is a group of patients out there who have been diagnosed, and you can get at those quite early. We did that in the U.S., first 1,000 patients, fine.
Seeing the same thing in Europe. We're expecting to see now Skyclarys approved outside of U.S. and Europe sometime this year, particularly in South America. There's a high prevalence there. But the reality is that a lot of physicians, particularly primary care, have never heard of Friedreich's ataxia. And so it can take quite a long time for patients to actually get diagnosed. So one of the things that occurs in most rare diseases is once you offer a therapy, there's a whole lot more interest in diagnosing patients. So that's where we are now in really educating physicians about if you see these symptoms, you should ask, could this be Friedreich's ataxia? If you think that, you may want to consider a genetic test. So it's hunting patients. That's what rare disease is all about.
You start to see a slower growth because they're not there in physician waiting rooms. But we have been able to validate from an analysis of medical records that there are, in fact, we thought there were about 4,400 patients in the U.S. Actually, we think there's about 4,800. There's more in Europe. And there's actually quite an awful lot in Brazil, in Colombia, in Argentina. And so we see steady growth. It's a little lumpy because it depends on how many patients you found last week. But that's just the nature of rare diseases.
Should we think about the growth of this product coming more ex-U.S., or do you think that we can start to see an acceleration in the U.S.?
Yeah, I think Spinraza is a good model for that.
I mean, we have, I think, remember, we have a, I think it's about 50% or 60% of our revenue for Spinraza ex-US. Actually, on rare diseases, we tend to get actually quite good pricing outside the US. So I think you'll see a significant part of the revenue coming from ex-US. And by the way, I didn't mention it, but the same is true of LEQEMBI.
Okay. Yeah. Looks like that's a fair mess ramp there. Just maybe pivoting to business development. Just talk about appetite right now for BD and how are you thinking about priorities?
Y eah. So to me, as an industry, we have been sourcing innovation from outside our companies for quite a long time. And there is a sense that, well, you do M&A when you've got your back up against the wall.
But actually, what you want to really be doing is looking outside constantly. Actually, today we have Priya as head of development. We have Jane Grogan, head of research, and we have Adam Keeney in business development. All three of those see as their day job the need to actually look outside the company and where can we find innovation to bring in. How do we grow the substrate for future growth of the company? And that might be an early stage asset like we did with Neomorph. That might be a mid-stage asset like HI-Bio, or it might be an acquisition like Reata. But we're not necessarily saying, "Hey, wow, we're seeing the decline of the MS business and the pipeline is over here. We need to go do a deal." That's not where we are. I see some proposals that we should be prepared to overpay.
We're never going to do that, not knowingly anyway. So I think that's where the discipline of capital is. But I think R&D is what it is. I've learned over 35 years, you can never actually have enough pipeline, no matter who you are, and you should be constantly looking for things.
Is there any bias right now just in terms of the opportunities you're seeing, looking more at the earlier stage versus mid versus Reata, something in this later stage?
Bias is actually for early to mid just because of cost, right? I mean, trying to find something that's late stage that's affordable is difficult. I was at a seminar and a banker was doing a presentation on M&A in our industry. Average premium in our industry is 70%. And there is no other industry where that's the case.
You think about the IRA, you think about the pressure our industry is under. Our industry is kind of out of favor versus tech, for example. I think the pricing of later stage assets can be inhibitory to doing a deal. Now, that said, if we could find another Reata, that would be a nice thing to do. But those things are really hard to find.
Great. Maybe just last few minutes here. Just as we go into 2025, pushes and pulls, would you just directionally think about for numbers this year?
Well, you are probably going to hear from a number of companies. Obviously, there is the Medicare tax to fund the $2,000 deductible. There is a currency effect. The euro is down. And for all of us who have international business, there is going to be some headwinds there. Our MS business, we are not sure when a Tysabri biosimilar comes in.
We were able to defend a patent in Europe for Tecfidera. Exactly how that holds is also a bit of a question. But we continue to really drive focus on LEQEMBI, on Skyclarys. ZURZUVAE has been doing well. And Qalsody, although a smaller product, has a really important patient impact. So we're focused on execution of new product launches and really getting this pipeline to market as soon as we can .
I think as you mentioned in the presentation, that kind of balance you saw affects the contract manufacturing. Is that a reasonable way to think about the next few years?
Yeah, I think we're going to be. Does MS decline in one year a little more than the new products? I mean, that is where we're going to be.
Absent a deal, I think we're not going to have enormous growth until we really get LEQEMBI growing on a different trajectory. But you can't really run this business on a one-year perspective. Our job is to build a strong Biogen for the future. We see some of these new products coming in in 2028, and then the company can grow in the 2030s and beyond. And you don't want to really have a lot of distraction for that. That's just we've seen that movie play out many times. This is not a new situation in our industry where the heritage products are under competitive threat and the pipeline hasn't yet arrived. And you just have to be resilient and stay the course and build the company.