Biogen Inc.

Good morning. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter 2025 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1 on your telephone keypad. Please limit yourself to one question to allow other participants time for questions. If you require any further follow-up, you may press star 1 again to rejoin the queue. Today's conference is being recorded. Thank you. I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

Thanks, Cynthia, and good morning, everyone. Welcome to Biogen's third quarter 2025 earnings call. During this call, we make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our S&P filings, which I encourage you to review. Our earnings release and other documents related to our results, as well as reconciliations between GAAP and non-GAAP results discussed on this call, can be found in the Investors section of Biogen.com. We've also posted the slides for our webcast, or I beg your pardon, we've posted the slides on our website that will be used during this call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Biebacher. Dr. Priya Singhal, head of development, Alicia Alimo, our president and head of North America, and Robin Craver, our chief financial officer. We'll make some opening comments and then move to Q&A session. And to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question. And I'll now turn the call over to Chris.

Good morning, everyone. Thank you, Tim. Can I have the first slide, please? So I think we've delivered a very strong third quarter. I'm very happy to see our growth on launch products delivering year-on-year growth of 67% in the third quarter. The launch products, again, in this quarter, and if I look at this year-to-date as well, more than have offset the MS decline on a year-to-date basis. LeCambie continues to show good, strong, sustained, sequential global demand growth with sales globally of $121 million. You may recall that we disclosed in the second quarter that we had increased inventory levels in China, and so we had higher Q2 sales and with some offset now in Q3. But when you look at this on a rolling 12-month basis, we're very happy with the progress we're making on Lecambi. The approval of the iClick subcutaneous injection for maintenance is now approved in the US and has rolled out and patients are benefiting from that. Skyclarus is now available in 34 markets globally. We've got 30% year-over-year revenue growth. That is actually not as high as even the patient growth because we have a number of early access programs in countries making sure that patients benefit from the product while we negotiate with pricing and governments around the world. And Zerzivay, 150% revenue growth year over year. This is just an amazing product. One of the most interesting things is I think we are actually changing the perception of postpartum depression. Every day there are media stories about this terrible condition from others. Jennifer Lawrence is the most recent person to talk about her experience with postpartum depression. So Zerzuve is not just a product. I think we are really revolutionizing how people look at this, and that's important, but it's also driving a lot of revenue growth for us. If I look at the pipeline, again, very good, strong progress. We have litophilumab phase 3 studies now are fully enrolled. And both are now expected to read out in the second half of 2026. Now, I look at this as not just an acceleration. Lupus is an extremely competitive area. There are a lot of studies ongoing. And one of the things when you look commercially at a new product is can I recruit patients in clinical trials? That's kind of a harbinger of how things are going to work commercially. So if we can accelerate, and we can accelerate in a competitive environment, That tells me that already physicians are seeing something special about lidophilumab, and I'm certainly encouraged by that, not just from the fact that we're going to get the data earlier, but as I say, I think it's a good sign for the commercial success longer term of the product. We continue to build out our early stage pipeline. As we'll see in a minute, we've got, I think, an extremely robust late stage pipeline. Now's the time to turn to an earlier stage pipeline. We've started a phase one study for BIB142. It's an ARAC4 degrader for autoimmune disease. We actually expect to put another three to four molecules into our early stage pipeline over the coming 18 months. And then we continue to be active on the BD side. We announced the agreement to acquired Alcyon Therapeutics. This is a very strategic acquisition for us. You know, ASOs continue to be a mode of administration that is necessary to treat a number of diseases. We ourselves have other products such as Selenersen, Viv80, Zoravanersen. And so this is a mode of administration that will be much more convenient for patients. And we're seeing other companies obviously also developing ASOs. So this is This is really going to be a breakthrough, we believe, for patients who are taking intrathecal injections. And then we have just added a C5A-R1 antagonist through our licensing agreement with Anquibio. One of the nice things about immunology drugs is that they tend to offer you an opportunity to create a portfolio in a product. As you follow these immunological pathways, they can lead to a number of different indications. And the beauty of that is, of course, that once you've been able to demonstrate safety, you can then very efficiently go into other indications. And again, we expect to announce at least another one, if not two, further research stage deals by the end of the year. So if we can move to the next slide, please. Now, I love this slide. When I look at this and I look at the lines that are extending all the way across the page, I mean, a company our size, 10 phase 3, or phase three ready programs. And that covers five phase three NMEs. And we've got a lot of conviction around this pipeline. We've seen a lot of good data in phase two. And we're getting close to now seeing a lot of the readouts out of that. Now, one of the things that you probably don't think about is that these are not just 10 phase three programs. This is also 10 launches. You know, if I take just, you know, felzartamab as an example, there are four indications of that. Two of those, AMR and MVI, are transplant. Two of those are in nephrology. And then, of course, we've got lupus coming along with three indications in lupus. And, of course, we're still in rare disease with zorvanursin. We have a next generation of Spinraza with felinursin. And we're quite excited about what's coming along with bid 80 in Tau. But all of those require now that we start building up commercial teams, building insights, thinking about pricing, thinking about value propositions. So a lot of activity going on inside the company. Another thing I like to look at in terms of trying to predict whether things are going to be a success or not is can we attract strong talent? Because people bet their careers when they come to a company, and especially if it's a new product. And I have to say, I've been super impressed with the talent that we've been bringing into Biogen. And that sort of says to me that people are willing to bet their careers on these exciting new products. And I have seen time and time again over my career that that often translates into commercial success. Market research is important, but I think some of these other other indicators are even more important. So let's go to the next slide. So what have we been trying to do over the last three years? You know, the first is obviously let's grow our new product launches. And, you know, again, 67% revenue growth says this is a very strong performance. We've got McKendree, SkyClarus, Zerjuve, even CalSati. And when I look over the last 12 months, that's almost $1.2 billion in revenue. So, and obviously these products all have long runways in terms of market exclusivity. And, you know, in each of these, these are first in, not only first in class, but first ever treatments in these areas. So we're actually doing an awful lot of market creation. For those of you who've got a lot of commercial experience, you know that creating markets is a lot tougher than just going into established markets and taking market share. And I think that speaks to a lot of the commercial strength of our teams at Biogen. Then, you know, let's look at the profitability of our legacy business. And yes, I think we beat on the top line this quarter because of MS, but that's not all by accident. And I think we are beating just about every analog when you're looking at products that have come to the end of their market exclusivity periods. I think that speaks to the strong customer care. I think it speaks to the strong loyalty of patients to Biogen's product. We are still the company that treats more patients with MS than any other company out there. And, you know, one of the things that we shouldn't forget is it's not all legacy. There's an amazing product out here called Bumerity that has been growing very strongly this year. It's almost a half a billion dollar sales in the first nine months of this year. And this is a product that has market exclusivity well beyond the end of the decade. And we're proud to see particularly our U.S. team investing more into this business, and that is responding well. And it is really the only patent-protected product still in the oral segment, which is an extremely important part of the MS market. And then we've been very conscious of being efficient. We are going to deliver this $1 billion of gross savings. We were clear right from the get-go that we would be investing some of that as part of the launch in our new products, but also in research and development. You've seen our revenue growing, but our OPEX growth was still flat over this year. Despite a lot of new investments we have, added products to our late stage development, and we are doing all of this recruitment for the commercial preparation of all these launches that are now in phase three. And then, you know, obviously, if I look at our pipeline, you know, we have cut development costs by almost 25% and research by 40%. And I would argue that we have a stronger pipeline than we did before. And that's really a lot of what Priya has done in terms of being very careful about which products we put into development, building conviction behind those. I think as I look at the pipeline, I'd say we've got a very exciting and a high conviction late stage pipeline. One of the reasons that we're doing these early stage deals is I think we now need to build an early stage pipeline and BankWiz is just one example of that. We continue to generate strong cash flow, and we continue to look at where are the opportunities across the entire spectrum about how we can grow our business. I think we are very disciplined about where we put that cash flow. Everything that we want to invest in has to be something that contributes to growth. And so with that, perhaps we can learn a little bit more about our pipeline, and I'll pass it over to Priya.

Thank you, Chris. This year, we've made important progress across the development pipeline, and we are positioned to continue to deliver multiple expected milestones over the next 18 months. As Chris noted, we remain focused on execution against our strategic objectives, and there are a few achievements I'd like to highlight from this quarter. Importantly, as Chris mentioned, despite competitive recruitment for trials in the space, we have now fully enrolled both topaz studies for litofilumab in SLE. This allows us to now pull forward both expected readouts from these studies into next year, 2026. Next, we continue to advance to exciting new opportunities. First, with salinursin, where the pivotal study design for pre-symptomatic infants and the broader clinical development plan has been aligned with the FDA. We are also engaging with ex-U.S. regulators and expect to initiate the registrational study in early 2026. We also continue to advance calzadamab in late MVI, where we expect to initiate a potential registrational trial in coming months. And today, we announced an update on high-dose finraza, where the FDA provided us with a path forward, we resubmitted promptly, and now we have a PDUFA in April, 2026. Over the last few years, we have transformed both our late stage and early stage pipeline. We have followed the science and secure proof of concept to advance high scientific conviction assets into potentially registrational stages. And as we prosecute the early stage assets, we continue to follow the science by testing the most important scientific hypotheses. We now expect to deliver several readouts from our pre-POC pipeline next year. We're also focused on broadening the pre-POC pipeline, both with internal research assets that we advance to IND stage, like WIG 142, our IRAC de-grader, and by also remaining deeply engaged in targeting external innovation including our announcement last week, as Chris mentioned, to collaborate with Banco Bio on a preclinical C5AR1 antagonist. Turning to our late-stage pipeline, I'm encouraged by the breadth of opportunities to further scientifically advance our assets, including our ability to educate on the profile of our innovative medicines with our data. For example, This week at ACR, we presented important differentiated data from our positive phase three DAPI trial, showing a consistent, clinically meaningful benefit across outcomes that are relevant for SLE patients and providers, such as flare reduction, fatigue, morning stiffness, musculoskeletal pain, LL-DAS, as well as remission. And underscoring our comments that we made at our September lupus seminar on the potential importance of DAPI for patients with SLE, including women of childbearing age, we presented data demonstrating limited placental transfer in a preclinical setting. Next, I would like to spend a few minutes on the continued Lekembe development to deliver optionality for Alzheimer's disease patients. As you can see on the left side of this slide, we have already been successful this year in delivering meaningful differentiated treatment options for Lekembe. Today, it is the only anti-amyloid therapy with a maintenance option as well as an at-home subcutaneous maintenance option. And we continue to advance our rolling submission to the FDA for Lekembe subcutaneous initiation. The option for maintenance and the availability of subcutaneous delivery are also potentially relevant to Lecambi in the pre-symptomatic AD population. The AHEAD 345 study, as you can see here, is an important study that aims to comprehensively evaluate Lecambi in two different stages of pre-symptomatic AD with the appropriate scientific questions and the relevant primary endpoint. Additionally, we have seen increasing momentum in the development, approval, and utilization of blood-based biomarkers. We see this as a key enabler that potentially simplifies the diagnostic pathways. We remain excited and believe the potential for Likendi in the pre-symptomatic AD population can be an important opportunity for Biogen. In closing, I'm encouraged that LeCambie AHEAD 345 is just one of several important registrational readouts we have over the next few years. As you can see on this slide, our high scientific conviction pipeline will play a critical role given the increasing momentum in our registrational data flow. This will begin with two litophilumab phase three readouts in SLE next year and 2027 onwards we will see multiple registration readouts across several assets in diverse and important therapeutic areas. With that, I would now like to hand the call over to Alicia for an update on our commercial business.

Thank you, Priya, and good morning, everyone. Today, I'll review the commercial results we achieved in Q3, beginning with our multiple sclerosis portfolio. Our MS business continues to deliver significant revenue, which provides the resources to invest in our growth products, advance our pipeline, and achieve our vision for the new biogen. In the U.S., we saw strong performance, mainly driven by strategic actions to support Umerity's growth and some one-time events. When we look at competitive dynamics globally, we are seeing increased impact of Tecfidera generics in Europe, and for Tysabri, we believe we are well-prepared. for our biosimilar entrant in the U.S. Now, turning to Lekembe, which delivered another strong quarter with global revenues growing 82% compared with Q3 2024, underscoring its increasing impact on the Alzheimer's community worldwide. In the U.S., our team is working collaboratively with ACI, driving strong execution and customer engagement. which we believe supported our prescriber base growing another 14% quarter over quarter. This quarter, we sustained consistent growth of new writers and new patients, and Lekembe holds majority share as the number one prescribed anti-amyloid treatment. Throughout 2025, we estimate Lekembe captured roughly half of all the new patients treated with anti-amyloid therapies. Now, with the launch of iClick subcutaneous autoinjector for maintenance, Lekembe is the first and only anti-amyloid treatment to offer an at-home injection, giving physicians, patients, and care partners more options to continue to slow disease progression following the 18-month initial treatment period. Early feedback from customers and payers has been positive. And into next year, we will remain focused on securing Part D coverage and supporting patient access to Lecambi. Last quarter, we noted that for the first time, we observed early signals indicating the anti-amyloid market grew with two players. We are encouraged that this quarter, our data shows the market continued to grow by approximately 15%. We also shared that blood-based biomarker testing was advancing at a significant pace. And here, our physicians have pointed to a meaningful impact. They report blood tests help move from probable to definitive diagnosis more quickly, enabling HCPs, patients, and their families to focus more on the treatment discussion. We anticipate up to 350,000 Alzheimer's blood tests this year and more than 60,000 PET scans to date, which is a 75% increase compared to this time last year. Our data show early indicators that PET-CSF positive tests are increasing, which we believe may be attributable to increasing use of Alzheimer's blood diagnostics as a triaging tool. As we previously noted, we are educating HCPs about the quality of blood-based biomarkers including the performance of BBMs that meet the requirements of the Alzheimer's Association's new practice guidelines for amyloid triage and confirmation. As we look to 2026, we expect Lekembe's momentum will continue to be driven by our focus strategies, which we believe are already having a positive impact on intent to prescribe, perceptions of efficacy and safety, and healthcare providers' understanding of the role of anti-amyloid therapies. Moving on to SkyClaris, where the launch continues to drive patient growth across all regions, including the U.S. and overseas. SkyClaris is now available in 34 countries, contributing to strong growth of 30% compared to the same time last year. In the U.S., As expected, patients continue to grow quarter over quarter, with quarter three revenue being impacted by channel mix in the context of the IRA changes to Medicare. As we shared in the past, our strategy in the U.S. is to reach the remaining Friedreich ataxia patients, their neurologists, and PCPs, which our data indicate are primarily based in the community. Our efforts are focused on delivering on this goal as nearly two-thirds of new patients in Q3 were prescribed by first-time writers and roughly a quarter of new scripts were written by PCPs. Outside the U.S., we remain focused on continued geographic expansion with multiple commercial launches planned in the first half of 2026. Last, turning to Zerzivay, which continues to perform above our expectations. As we shared earlier this year, our expanded field team has had a meaningful impact, delivering 55 million in the U.S., which is 19% revenue growth compared to last quarter. We are also encouraged by the increasing breadth of riders, which grew 19% quarter over quarter. And in quarter three, 80% of Zirzavay prescriptions were written as first line, demonstrating healthcare providers' belief in the value of therapy that provides rapid relief to mothers impacted by postpartum depression. Across our portfolio, I am proud of our teams for executing with discipline and delivering on our strategic priorities. Their hard work is helping us serve patient communities, build new markets, and drive sustainable growth. I will now turn over to Robin for an update on our financial results.

Thank you, Alicia. I would like to provide some key highlights about our strong third quarter financial results. Unless otherwise noted, each of the comparisons I make during my remarks are versus the third quarter of 2024. We delivered 3% revenue growth this quarter, driven by continued strong commercial execution. Our four launch products generated $257 million in revenue in the quarter, representing a 67% growth. We continued to see resilient performance from our USMS business, which was favorably impacted by gross donut adjustments, timing of shipments, and strong demand growth for Vumerity. This was partially offset by continued generic erosion of Tecfidera in Europe. Notably, the year-to-date cumulative revenue from our launch products has more than offset the year-to-date decline in our MS product revenue. This commercial execution combined with our disciplined operating expense management resulted in non-GAAP diluted EPS growth of 18% for the quarter. We also delivered $1.2 billion of free cash flow in the quarter. Turning to our guidance. I'm encouraged by the strong business trends that we continue to observe in Q3. This is reflected in our improved revenue outlook. You'll note that our non-GAAP EPS outlook has been updated to reflect that stronger business outlook while adjusting for expected business development activities that are expected to close in the fourth quarter. I will provide more details on this in a moment. Let me cover some key components of our Q3 revenue performance. starting with our MS franchise. In addition to the strong commercial execution that Alicia discussed, Vimerity benefited from approximately $22 million of favorable inventory dynamics, and overall, USMS benefited from favorable gross to net adjustments of $38 million in the quarter. Outside of the US, sales were primarily impacted by expected generic pressures for Tecfidera. We continue to defend our IP, However, we observed an acceleration of erosion, particularly in Europe, as generics continued to launch in new geographies, including Germany. This, combined with the channel dynamics, resulted in a sequential net decrease in Tecfidera revenue of $28 million versus the prior quarter in Europe. On a positive note, the year-over-year and quarter-over-quarter impact of the Tasabri IV biosimilar in Europe was roughly offset by growing demand for our subcutaneous formulation, which has no biosimilar alternative, and now accounts for more than 50% of all branded and biosimilar natalizumab patients in Europe. For Spinraza, we continue to be encouraged by the consistency in demand globally. And as expected, XUS Spinraza was impacted by the drawdown of the inventory bill from the first quarter. We continue to expect full-year global Spinraza revenue to be relatively similar in 2025 as compared to 2024. Turning to our launch products, starting with Lakembi, we continue to see steady sequential demand growth globally with third quarter and market sales booked by Azai of approximately $121 million. As you will recall, we had a $35 million inventory build in China in the prior quarter, representing roughly six months in demand in the region. Approximately half of this build was drawn down in Q3. Therefore, as expected, there were negligible sales recognized for China in Q3 as demand was satisfied with the inventory in the channel. We continue to expect demand in China in Q4 to be satisfied with this remaining inventory with minimal revenue generated in the fourth quarter. Guy Claris saw continued growth globally with revenue increasing 30% from this time last year. And the U.S. continued sequential patient growth was offset by approximately $6 million adjustment related to channel mix in the context of the IRA redesign related to Medicare. We expect SkyClarus to continue to grow, and we are working to secure reimbursement in certain European markets as well as in Latin America. As Alicia noted, we're pleased to see continued strong growth for Zerzuve, driven by increased demand. Now a few comments on the rest of the P&L. Before I get into the quarterly dynamics, I would like to highlight the variance shown here between GAAP and non-GAAP cost of sales. GAAP cost of sales was $674 million, up 6% year-over-year, due to an approximately $100 million pre-tax charge accrued in Q3 that related to a judgment on Genentech's claim for past royalties and interest related to Dysabri. Without this impact, it would have been approximately $570 million, representing an 11% decrease year over year. More broadly, cost of sales benefited from favorable product mix from lower contract manufacturing revenue in Q3 2025, which has a lower margin. This trend is expected to continue through the remainder of the year due to the planned campaign timing of contract manufacturing that we have previously discussed. Non-GAAP core operating expense, or R&D plus SG&A expense, is flat year over year. What's evident in our results is that we remain disciplined in our cost management as we continue to deliver on our R&D prioritization and fit for growth initiatives while ensuring that we are supporting investments in our launch products and long-term growth potential. Now I'd like to provide a brief update on our balance sheet. This quarter we generated approximately $1.2 billion of free cash flow due to business performance and continued cost management discipline. We exited the quarter with $4 billion in cash and marketable securities and $2.3 billion of net debt. Our financial strength gives us the flexibility to reinvest in strategic growth initiatives, including advancing our pipeline, supporting product launches, and exploring growth opportunities as we work to deliver the new Biogen. Turning now to guidance. We have updated our non-GAAP EPS guidance to reflect a stronger underlying business outlook and investment for growth from business development transactions expected to close in the fourth quarter. As you know, the SEC requires inclusion of acquired IPR&D charges associated with business development transactions in GAAP and non-GAAP financial results. As since these one-time charges, our business outlook has continued to strengthen in the quarter, yielding a 25 cent per share improvement. Our updated full-year guidance includes an approximately $1.25 per share impact for business development transactions that we expect to close during the fourth quarter. including the license agreement with Banco Bio and the acquisition of Alcyon Therapeutics. The following are some key considerations underlying our financial guidance. We expect sales to be roughly flat to up 1% as compared to last year at constant currency, an improvement from our last guidance update in July. This reflects strong business performance, including the resilient performance of the USMS business year-to-date. We also expect increased competitive pressures on the ex-US MS business to accelerate, particularly for Tecfidera in Europe, where we expect the sequential impact in Q4 to be roughly double the erosion we saw this quarter. In addition, as we discussed into July, we are investing to support exciting new pipeline expansion opportunities, including a new program for filzartamab and MBI, And it's our nurse in phase three study discussed by Priya earlier in the call. As discussed earlier in the call, we are also beginning to invest in pre-launch activities for our late stage high conviction pipeline and key initiatives such as direct to consumer advertising in support of our launch products. We believe these investments position us to drive future growth while delivering innovative solutions for patients. As we look ahead to the fourth quarter, we expect operating expenses will be approximately $1.1 billion. This reflects the typical seasonality of our Q4 spending, our ongoing investments to drive growth, and our focus on cost efficiency. It also reflects the progress we've made in our pipeline with the opportunity to invest in 10 programs either in phase three or expected to start phase three in the coming months. We are encouraged by our progress toward delivering the new Biogen and we believe it's important to make these investments as we work toward our goal of sustainable growth and long-term value to shareholders. Importantly, we believe we remain on track to deliver the $1 billion of growth savings and $800 million of net savings projected under the Fit for Growth initiative by the end of 2025. And as I had mentioned previously, we expect contract manufacturing revenue in Q4 this year to be $10 to $20 million due to planned timing of contract manufacturing batches versus Biogen Innovator product manufacturing. Please be sure to review this slide and our press release for other important guidance assumptions. And with that, I will pass the call back to Tim to open up questions.

Thanks, Robin. Cynthia, could we go to our first question, please?

Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow-up, you may press star 1 again to rejoin the queue. Your first question comes from Umar Rafat with Evercore.

Good morning, guys. Thank you for taking my question. I wanted to spend a quick second on Evoke Trial, if I may. And my question is, in a scenario where we do see a trend, how do you see that impacting the Lakembi franchise? And even more importantly, How does that change your thought process around the portfolio offering you have in the space? Would you need to have a GLIP collaboration or an asset in-house in a scenario like that? Thank you very much.

Well, I think on the study, let's see what the results are and where that's going to affect. We've looked at that. I think if it is positive... We do think it's probably going to be more used in the primary care setting at an earlier stage. You know, we'll have to see again what the results are, but it doesn't seem like this would actually affect the amount of plaque. I do think as a company, though, we are interested in having a full portfolio of products to achieve Alzheimer's. You know, we have the BID-80 program and, you know, obviously working on brain shuttle technology So, you know, I think we would probably evaluate that as and when the data are available. There's certainly no lack of GLP-1s out there.

I can just add that I think what's really important here is that they are hypothesizing that neuroinflammation will play an important role. And as Chris mentioned, I think that it doesn't really target the pathology. The important thing is that the evoke trials included patients on stable doses of Alzheimer's treatment, including the anti-amyloid antibodies. So we'll be interested in seeing that data. And what we also believe is that it'll increase the awareness of the disease and the need for treating disease early.

Thanks, Priya. Let's go to our next question, please.

Your next question comes from the line of Evan Segerman with BMO Capital Markets.

Hi, guys. Thank you so much for taking my question. You know, taking a step back, I'm really struck by your progress in immunology. Can you just talk to me about how this rude focus can drive growth and pipeline expansion to the end of the decade? And what can you do with Biden to accelerate some of these programs?

Well, maybe I'll start. You know, when I came to Biden, I argued that we've always been in immunology. because basically a lot of diseases like MS, we are treating by really trying to have an impact on the immune system. As I pointed out, our MS drugs don't even cross the blood-brain barrier, so I would argue we've always been an immunology company. And immunology is really an area that has really flourished over the last 10 years, and I think Dupixent was really one of the first drugs to really demonstrate the disease-modifying capability when you follow those pathways. And of course, they can lead into a wide range of activities. So that's an area we understand. In the short run, I think we're more focused on rare immunology and immunology that overlaps with areas that we already have some experience in. I would argue, for example, with lupus, Lupus is an extremely complex disease with a lot of different symptoms and things that affect patients. And I think the experience that Biogen has had in MS will be directly applicable to lupus. And I think we'll be able to develop that market in a way that the existing companies with their products haven't been able to do. And I think over time... you know, we can actually build out a portfolio of products that fraudly affect the immunology. There's a lot of opportunity here. There's a lot that we still don't understand. And as we look at kind of the first, the next five years, you know, they're more in this rare immunology. But if I look at a 10-year timeframe, then I think we can go into broader indications. And You know, Vanqua is just one example of bringing in an asset that could actually have multiple indications. And I think you'll see us do more of those. And again, you know, these are areas where you really have to have a deep scientific understanding of how these pathways work. They can be, there are a lot of things that cross over. You know, one of the things that, you know, we just see even in diseases is NRF2, microglia, and things like that that actually cross over diseases. And that crossover, I think, is something that we can bring to the immunology part as we go into different indications, even with salzartumab, for example. Although we're in four kidney indications, we're looking at another three indications that have nothing to do with kidney. And again, because we understand things like neurofilament and other things, we think that we have perhaps some insight that will allow us to develop medicines that other companies don't. So for us, it's a core area. We're not abandoning neuroscience by any means, and we still have a very strong investment in Alzheimer's and ALS. We still have a big one going on in Parkinson's as well. But I do think immunology is a great space for Biogen to be.

Thanks, Colonel.

Priya, did you want to add something?

We'll go to the next one. Thanks, Chris.

Your next question comes from the line of Salveen Richter with Goldman Sachs.

Good morning. Thanks for taking my question. You mentioned a focus on expanding your early stage pipeline via BD, and this is partly driven by the late stage pipeline here where you have about 10 Phase III trials ongoing. Could you just maybe speak to the confidence in the latter that's allowing you to kind of you know, maybe just work on that earlier basket here?

Well, I guess there's two parts to the question. The confidence in the late-stage pipeline, certainly if I look at Fells-Ottoman, I think we feel that we've seen some pretty compelling data in the phase two. Obviously, there's always a risk as you go into phase three, but, you know, we've got – we've seen – If you just take AMR, I mean, we had an 80% resolution of AMR in patients. On IGAN, we saw that actually even two years after the last treatment of a patient that they were still seeing a benefit. So it makes us believe that we have a disease-modifying effect in IGAN. So all of those things on felzotamab, on IVF, On BID-80, obviously, we're doing pioneering work. Nobody has really ever reduced tau to the levels that we expect to be able to do so, and we'll see what the results of that trial is. As I look at lupus, again, we had very strong Phase II results. I think particularly in CLE, where there is no drug yet approved, I think we have a very strong belief The piralizumab has already proven itself in one phase three, and so doing a second phase three would seem to have a reasonably high probability of success. And I think, again, even on SLE and lidophilumab, it's an area that the company has been working on for quite a long time. So I think there's never a guarantee in research and development, but I think we have morphed the pipeline from you know, a lot of moonshots, if you like, to something where we've actually had a thoughtful progression and de-risking of our pipeline. And, you know, if I look at the peak sales potential of that late stage pipeline in relation to our existing business,

Ladies and gentlemen, this is the conference operator. We are experiencing an interruption in today's call. Please stand by. I'm going to place music back on the conference. Do not disconnect your line.

Thank you.

. . . . . .

And you are now reconnected with the audience. You may proceed.

Great. Thanks, Cynthia. Sorry, we got disconnected there.

Chris, do you want to just respond to the last question, Ken, if you don't mind?

Yeah, I'm not sure where we dropped off. You know, it's interesting.