BIOGEN INC. — Call Transcript 2026

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 first quarter 2026 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 one 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 one 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. Thank you, and good morning, and welcome to Biogen's first quarter 2026 earnings call. During this call, we'll make forward-looking statements which involves 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 SEC filings, which we 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 on our website that will be used during the call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and Robin Kramer, our Chief Financial Officer. Alisha Alaimo, President of North America, will also be joining for the Q&A section of the call. We'll make some opening comments and move to the Q&A section. To allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question. I'll now hand the call over to Chris. Thank you, Tim. Good morning, everyone. We've had a very strong start to the year. You know, I was thinking about where we have been as a company. In 2023, we had just completed four years of declining revenue and profit. You know, since then, we've been able to pretty much stabilize the business, and that's really been a huge amount of work by all of our teams. You know, the interesting about this business is it's not enough to just trim some costs, and we did have to cut some excess costs. One of the things that we have really been doing is going through every single line of the P&L and thinking about, are we investing for growth? You do have to invest in this business. You cannot save your way to prosperity. There's been a lot of really careful thought about how do we, how do we invest for growth, be it in research and development or in commercial. You know, as Robin has talked about in the past, you know, we actually have shifted a lot of costs. 90% of our commercial costs were really behind the MS portfolio in 2023. By shifting that to our growth products, I think one of the things you see here on the first slide is that the growth products are now generating $850 million in the first quarter, and that's up 12%. The 12% is actually even a little bit of an understatement because SPINRAZA declined slightly. SPINRAZA declined mostly because of a timing of shipments, and there was a one-off event last year on VAT, I think, in Europe somewhere. Remember, timing of shipments is a big thing at Biogen. Out of the 15,000 patients on SPINRAZA that we treat every year, about 9,000 are ex-U.S. In a lot of countries, we only ship once or twice a year into those countries. It tends to be lumpy by nature. What is good news is the new High Dose SPINRAZA. As you've seen, this has now been approved in the U.S., and we already have patients on the new dosage regimen. It has already been approved in Japan, who's the first country to approve the high dose, and then Europe. We're getting a lot of positive feedback from those countries where it's been launched. Not only is this gonna be significant in terms of competitiveness in a highly competitive area, but we're also seeing some anecdotal reports of switch backs. You know, in this market, whenever you have one of these devastating diseases, efficacy is really paramount. I think the high dose really should help us have an edge on the efficacy front in this market. We're very happy to see the growth products growing like that. We look to our major opportunity with LEQEMBI. As you know, over the past few years since launch, a lot has been done to try to improve the care pathway, make it easier for both physicians and patients. The IQLIK is really fundamental to that. Last year, we had the approval for the maintenance indication. You'll see numbers where we have significant numbers of patients who are continuing on after the first 18 months regimen to remove the plaques and going on to maintenance. We have a PDUFA date of May 24th for the induction subcutaneous. Again, we see this as an opportunity to facilitate the care pathway, improve patient convenience, and improve our competitive profile versus Kisunla. That's the business. The Biogen business is doing well. Now on top of that, we have the proposed Apellis acquisition. We haven't yet closed, but we're limited in what we can say. Obviously, this expands our commercial growth portfolio. There are two marketed products. You know, I'll just remind everybody that this is one molecule. It has three indications, and it has two brands. You know, as I talk to a number of investors on SYFOVRE, there is this focus on ophthalmology. What I think a lot of people forget is that geographic atrophy is really an autoimmune disease. It is caused by the formation of lesions as a result of aberrant immune activity. What we're really trying to do with geographic atrophy is to prevent the growth of these lesions. When people start talking about visual acuity, that's probably gonna be very difficult because the eye tends to adjust around these lesions. What really is the goal of treatment is to prevent progression of the disease, which could potentially lead to blindness. I think there's a lot that we need to do in terms of thinking about how we really position this drug and where the benefit is. EMPAVELI, you know, is an enormous benefit to us. We have greater conviction every day on felzartamab, and we look forward to seeing the first data, and hopefully that those data will realize our aspirations for this product. You know, if you went back six, seven years ago, nobody was interested in nephrology. Now, you know, really with the advent of the FDA acceptance of proteinuria as a biomarker, a lot of companies have come into this space, and IgAN is obviously the biggest market in this. As we think about recruiting for felzartamab and our pre-launch activities, you're finding that, you know, you got a lot of companies out there that are recruiting in nephrology. I mean, Vertex is, Vera is, just to name a few, for example. With EMPAVELI and with the addition of the Apellis team, we have a whole team ready to go in nephrology. We'll be present in the nephrology offices, building those relationships, going to congresses now with a marketed product and not a future product. We believe both in the growth of EMPAVELI, but what that can do for a whole nephrology franchise at Biogen, and we're pretty excited about that, I have to say. I think, you know, all the conversations that we've been having with the Apellis team leading up to a potential integration, I think there's first of all, there's an incredible talent in the Apellis team. But I think it's also fair to say that within Biogen, I think we can probably bring more resources to really support those teams. You know, I don't see a big inflection in SYFOVRE, for example, but I do think there is an opportunity for a growing product there. I think, as I say, EMPAVELI within a broader nephrology franchise, that could be a game changer for Biogen in the future. You know, as we look at this, we do expect the acquisition to be accretive in 2027. When you look out over the next few years, this materially increases Biogen's EPS outlook. If I turn to the next chart here. Now, don't get your micrometers out here and try to measure these arrows here. This is meant to be illustrative of where we think this is going. If we just take what Wall Street thinks Biogen is going to do, I can't say that we would be happy with that, but that's what's out there in the public domain. It's roughly flat through 2030. When you look at what Apellis can do is, you know, this allows Biogen to start growing now, is our belief. You know, the pipeline starts to read out. We've got a lot of data readouts already starting this year and consecutively over the years. You know, as one investor told me, he said, "I get this. Before we had a pipeline coming on a flat business. I see a pipeline coming on a growing business. I think that's the fundamental difference in what the Apellis acquisition does for us. You know, we're still gonna continue to do business development. You know, in all of this, we just acquired the China rights for felzartamab. You know, that's an important market for IgAN, but China's a big, important market for us, and Biogen has been relatively small in China. China is the world's second-biggest pharmaceutical market. Felzartamab and acquiring these rights, not only just to acquire the worldwide rights for felza, but also really to build our business in China. Again, we continue to invest in growth, but I think a lot of the investments, a lot of the work that we have done over the last two, three years is now coming to fruition. At least this is the vision. Now we are very conscious of the fact that, you know, in business, 10% is strategy, 90% is execution. We need to now execute as a team to bring all of this, but at least this is the aspiration that we have for our company. With that, let's talk about that pipeline, and I'll pass it to Priya. Thank you, Chris. This was a very strong quarter for Biogen from a development standpoint, with meaningful progress across both our marketed products and our late-stage pipeline. Starting on the left-hand side of the slide, you can see the continued progress in supporting our marketed portfolio. First, the U.S. approval of High Dose SPINRAZA represents a meaningful advancement for people living with SMA and reinforces Biogen's leadership in the category. Additionally in Alzheimer's disease, new real world data for LEQEMBI shows strong treatment persistence with nearly 80% of patients remaining on therapy at 18 months and almost 70% at two years. We believe that these data underscore the importance that patients and HCPs attribute to ongoing treatment of this progressive disease, extending beyond just amyloid plaque reduction. Turning to the right-hand side, we presented important new data that reinforced the potential of our late-stage high conviction pipeline. New data from salanersen demonstrate durable benefit over one year in children previously treated with gene therapy, highlighting the potential for high efficacy with once-yearly dosing. Importantly, the first patient has now been dosed in the pivotal STELLAR-1 study evaluating salanersen in treatment-naive pre-symptomatic infants. At the same time, we continue to build confidence in litifilimab, where we presented positive phase II data from the ongoing phase II/III AMETHYST study in CLE. All of this progress reinforces our confidence in our late-stage pipeline. As you can see from this slide, we don't expect to wait long for that potential impact. This year marks the start of a multi-year registrational data flow that includes multiple programs and extends through the end of the decade. We believe these data, as you also heard from Chris, will continue to strengthen our growth outlook. Importantly, as previously reflected, we have several data-related inflection points in 2026. As you know, we have a PDUFA date coming up for our LEQEMBI IQLIK initiation next month. We also have readouts from our pre-proof of concept pipeline, where we continue to pioneer and address key scientific questions that could benefit patients. Our registrational readout cycle begins later this year, and over the next 18 months, we expect to see SLE and CLE data from all the phase III studies of litifilimab, as well as readouts from the first phase III study of felzartamab in AMR and the phase III study for zorevunersen in Dravet syndrome. I believe this is a very exciting time for the Biogen pipeline. I would now like to turn the call over to Robin for an update on our financial performance. Thank you, Priya. I'd like to start with key highlights from our strong first quarter 2026 results. Total revenue was $2.5 billion, up 2% year-over-year, with GAAP diluted EPS of $2.15, up 31% year-over-year, and non-GAAP diluted EPS of $3.57, up 18% year-over-year. We're pleased to see our growth products continue to perform well, generating $851 million of revenue, up 12% year-over-year. Our growth products, which includes VUMERITY, generated more revenue in first quarter of 2026 than our remaining MS products. We also maintained our cost discipline while supporting our late-stage pipeline development and product launches with approximately $1.1 billion of non-GAAP core operating expenses in the first quarter of 2026. As a result, we generated $594 million of free cash flow in the quarter, allowing us to further support the business and invest in future growth, including the expected Apellis transaction, which we believe represents a capital allocation opportunity that will further bolster both our top line and bottom line growth prospects and therapeutic areas aligned to our immunology and rare disease strategy. I'll speak more about the transaction in a few moment. I'll now turn to our revenue performance for the quarter, starting with our growth products. LEQEMBI end market revenue was $168 million for the first quarter of 2026, up 74% year-over-year. We saw a continuation of sequential market growth in key markets, including the U.S., Japan, and China. In China, we saw strong uptake with Q1 reflecting continued demand growth and sequential revenue benefited from completing the drawdown of inventory in Q4 2025. LEQEMBI remains the market leader by total patient share in the U.S., Japan, and China, and we look forward to next month's U.S. PDUFA date for IQLIK initiation. SKYCLARYS saw sequential global patient demand growth with first quarter 2026 global revenue of $151 million, representing 22% growth year-over-year. For SKYCLARYS, U.S. revenue was impacted by the inventory dynamics we discussed on the Q4 2025 call with moderate growth and demand. Outside the U.S., we continued to see demand growth as we continue our SKYCLARYS launch. SKYCLARYS is now available in 35 countries, and we continue to expect SKYCLARYS growth to come from ex-U.S. as we advance the launch. Turning to the highlights of our key P&L items for the quarter. Non-GAAP R&D expense in Q1 2026 was $480 million, with the increase year-over-year reflecting investments in our phase III clinical programs, including felzartamab and litifilimab, and due to phasing of spend within the year. Non-GAAP SG&A expense in Q1 2026 was $600 million, with the increase year-over-year reflecting planned pre-launch activities supporting lupus and nephrology, direct-to-consumer advertising for VUMERITY and ZURZUVAE, and due to phasing of spend within the year. First quarter 2026 GAAP and non-GAAP effective tax rates were 15.4% and 15.3% respectively. The year-over-year decrease was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards, partly offset by the increase in U.S. taxation on foreign earnings in 2026 under the One Big Beautiful Bill Act. As we previously announced, we recorded approximately $34 million of acquired IPR&D in the first quarter of 2026, related primarily to our Alcyone and Alloy transaction, resulting in an approximately $0.20 per share impact to GAAP and non-GAAP EPS. As a reminder, in the first quarter of 2025, we recorded $165 million of acquired IPR&D associated with the upfront payment to Stoke Therapeutics as part of our collaboration for zorevunersen for the treatment of Dravet syndrome in all the territories outside the U.S., Canada, and Mexico, resulting in approximately $0.95 per share impact to GAAP and non-GAAP EPS. This strong commercial execution, coupled with disciplined financial management, drove continued robust free cash flow performance. We generated $594 million of free cash flow in the first quarter of 2026 and exited the quarter with $4.7 billion of cash and marketable securities and $1.5 billion of net debt. With the Apellis transaction expected to close in the second quarter of 2026, we plan to fund the transaction with $3.6 billion of cash from the balance sheet and $2 billion from bank borrowing. Given our expected strong cash flow generation, we expect to repay the $2 billion in new borrowings by the end of 2027. Given the dynamic policy environment, we have updated the slide we first provided you this time last year. We continue to believe the structure of our U.S. manufacturing footprint, supply chain, and overall business model position us to be potentially more resilient to macroeconomic factors and policy uncertainty. Currently, based on potential tariffs as announced to date, we do not expect to see material impact to our business in 2026. This information does not reflect the impact of the pending acquisition of Apellis. Turning now to guidance. Our overall belief in the strength of the underlying business is as strong as when we guided in February. We also continue to believe it's important to make investments for growth. In addition to the roughly $0.20 EPS impact from the acquired IPR&D charges we incurred in Q1, we also expect to incur $145 million or an $0.80 EPS impact of acquired IPR&D charges in the second quarter. Specifically, the TJ Bio transaction for felzartamab rights in China, which further enhances our nephrology franchise and gives us worldwide rights to felzartamab, is expected to comprise $0.55 of this EPS impact. As Priya noted, we also achieved the first patient dosed in STELLAR-1, our pivotal phase III salanersen study, triggering a milestone in the second quarter, which results in approximately $0.25 of EPS impact. Turning to some key considerations for this updated guidance. You can see that our expected business outlook and underlying assumptions, including our revenue outlook, remain consistent with our prior guidance. As I mentioned earlier, we expect roughly $600 million of contract manufacturing revenue this year to be phased as roughly 2/3 coming in the first half of the year. We expect Q2 core operating expenses to be roughly consistent with Q1. It remains our objective to be disciplined on costs as we continue to invest, including supporting the programs that we've been bringing into our pipeline through business development. Please be sure to review this slide and our press release for other important full year 2026 guidance assumptions. Finally, a few points on the expected impacts from the Apellis transaction. The transaction is not yet closed, so we won't provide consolidated guidance today. That said, we do plan to provide 2026 guidance inclusive of Apellis when we report second quarter results following the transaction's close. We can say today that we believe we will be gaining two best-in-class commercialized medicines that enhance our growth portfolio. We believe SYFOVRE and EMPAVELI will contribute meaningfully to our top line growth in the near and long term. We expect approximately $120 million-$130 million of impact to our non-GAAP and other income expense line in 2026, driven largely by financing and foregone interest income. We expect that our strong combined cash flow generation will provide us with the opportunity to de-lever by the end of 2027, and that the transaction will be accretive to non-GAAP EPS in 2027. We believe this transaction represents an attractive use of capital that will further bolster both our top line and bottom line growth prospects in therapeutic areas aligned to our immunology and rare disease strategy. With that, I would like to pass the call back to Tim to open us up for questions. Thanks, Robin. Can we go to our first question, please? Thank you. If you would like to ask a question, please press star one on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow-up, you may press star one again to rejoin the queue. Your first question comes from the line of Brian Abrahams with RBC Capital Markets. Hey, guys. Good morning. Congrats on the quarter, and thanks for taking my question. As we look towards the upcoming BIIB080 data, I'm curious your latest views on, like, what kinds of signals you'd be looking for there to move forward, and how much would that be impacted by your expected potential to further improve the administration form there? Thanks. Priya? Thanks, Brian. Just stepping back, you know, BIIB080 is an antisense oligonucleotide. It addresses tau and aims to reduce tau. We've seen that in prior trials, an extracellular approach using an antibody has really not worked. That's where the ASO approach is differentiated. We believe it could target both intracellular and extracellular tau. We did see tau reduction in our phase Ib. It was a small trial, but it was very encouraging, which prompted us to get to a proof of concept study. That is what the CELIA readout will tell us. Because this is a pioneering effort, and what we're looking to see is whether reduction of tau leads to and translates into a clinical benefit, specifically on cognition. As we do that, we're exploring several dosing regimens, several treatment frequencies. We'll be looking at the totality of data. We're expecting the data sometime mid-year, and I think our goal would be to look at the data and then communicate it and present it, you know, at upcoming forums. That's the plan. On the dosing regimen? Yes. you know, on the dosing regimen, I'd like to say that really the trial enrolled very quickly from an intrathecal perspective. We recognize that if this actually, translates into a medicine, we would be considering other options. We are looking at other options of delivery. These are in preclinical and research. We recently acquired Alcyone, as you know, and that gives us another potential avenue to explore if, and as we continue with intrathecal delivery. Thanks, Priya. Let's go to the next question, please. Your next question comes from the line of Andrew Tsai with Jefferies. Hey, thanks. Good morning. As we think about your other catalysts for 2026, just wanted to ask on litifilimab, actually, and the filing strategy. Would you guys consider filing for SLE right away if both phase IIIs were positive later this year? Would you wait, opt to wait to file after the CLE data set right after? Do you file one or two NDAs? If just one SLE study hits that sig, but the other one was trending, would you still file in SLE? Thank you. Thank you, Andrew. We are excited about the potential for litifilimab. We have 2 phase III trials in SLE. We expect them to read out this year. We accelerated the second trial, and we are really doing well on our CLE trial. We expect that to read out early next year. Now, with regards to the filing strategy, we don't usually comment on it, but I'd like to say that we think that this would be a package as of now, and we'll communicate more as this the studies read out. Secondly, whether, you know, if we saw one positive trial and one negative trial, I think again, we'd be looking at the totality of data. You know, there is precedent for that with the other product in the field. We don't think that by itself, it would be a showstopper. We remain very encouraged, and we are very, you know, pleased with the breakthrough designation that litifilimab got for CLE earlier this year. We also just presented data from a second phase II that was positive in CLE. You know, we continue to be optimistic. Can we go to our next question, please? Your next question comes from the line of Geoff Meacham with Citi. Great. Hey, guys. Thanks for the question. Chris, you mentioned you're still looking at BD opportunities, you know, even post-Apellis. Maybe just help us with how maybe you rank external innovation versus investments and, you know, internal R&D and SG&A. Obviously, post-Apellis, you need to make investments to get that, to get the growth profile going. Thanks. Thanks, Geoff. We feel as we have said in the past, I think we're feeling very good about our late stage pipeline. You know, lupus, I think could be quite a significant franchise for us because in addition to litifilimab, we also have a partnership with UCB on dapirolizumab. We have, we'll be taking the marketing lead in the U.S. and Japan on that product. Of course, we have some other assets in early stage development coming along for lupus. The whole nephrology franchise, I think is gonna be quite significant for us as well. Obviously we have Apellis. As we look at BD, I would say really that most of what we're going to be focusing on is early stage development and research, because that part of the pipeline is quite thin. We have strengthened that with a few collaborations, particularly in immunology with Vanqua and Dara, for instance, last year, and the partnership with Citi, and there's some other ones in there. We're looking at really building the next generation of growth. I think, you know, if we execute well and, you know, we can bring everything and the pipeline does come through, this should be a company that can grow well into the 2030s. And what we need to really be thinking about is what comes after that. That's where, as I say, the early stage of research stage, pre-IND and perhaps phase I, is where the focus is gonna be. I think on M&A, we would probably be more opportunistic. I don't think there's any particular need at that point to do that, but, I guess we'll keep an eye out, but we're not gonna be doing the search. Over the last two, three years, we have had a very systematic search and felt that we wanted to do M&A. I would say with the Apellis transaction and with the pipeline, we don't see the same need to be as proactive on that front. Chris, can we go to the next question, please? Your next question comes from the line of Michael Yee with UBS. Hey, guys. Thanks. Good morning. Going back to BIIB080, you guys had downsized the study from 700 patients. I think you ultimately targeted or ultimately enrolled about 400 and wisely cut expenses to get a signal. Can you just remind us, given the context of wanting to be thoughtful about expenses, what type of trend would make sense for you to push forward? On the other hand, when you come out with the data, if you don't think there's a really strong trend, that you'd be pretty clear about that and would therefore signal to the street that we don't plan to invest there. Maybe just add some color to that, Chris or Priya. Help us understand in terms of the disclosure how we should be thoughtful about it. Thanks. Thanks, Mike. I think just stepping back, yes, we had designed the original CELIA trial with a larger N, and I think it was our phase Ib trial readout that gave us the confidence to redo the power for that study and redesign that trial. We feel quite confident that the trial is adequately set up to give us an answer on really testing this very important hypothesis. We already saw the tau reduction in phase Ib, and now we're looking for the translation of tau reduction to clinical efficacy. Just as a reminder, the primary endpoint of the trial is CDR Sum of Boxes, which as you know, is a validated endpoint. We are looking at a few different doses and two treatment paradigms, quarterly as well as six monthly. We'll be again looking at the totality of that to see if we can isolate a signal of clinical efficacy. I think we'll be very disciplined in how we look at that. The way we've really changed that over several years now is that we think about our go/no-go criteria well ahead of data readouts. This data readout is expected mid-year. You can expect that we'll be looking at that data very carefully, but with really being very disciplined about what the next step is, because that is what this proof of concept is designed for, if and how we get to phase III. I think, you know, one of the interesting here is that, again, there's just no precedent here, right? You know, in designing the study, I think, Priya, it'd be fair to say we basically looked at what we did with amyloid trials, right? We've got the 18-month follow-up. We're looking at a similar population because that's the only thing we knew. We're gonna be discovering an awful lot in this study. Certainly, you know, you wanna see the right reduction in tau and tau PET results will be important. Obviously, you know, can you see some movement on cognition? That would be important to be able to advance. Does that have to be statistically significant? Does that have to be a certain percentage? I think that's where the totality of information is gonna be. You know, while we feel relatively confident being able to reduce the tau, nobody knows how long you have to reduce the tau for to get a benefit on cognition. You know, when you think about the progression of plaque, that is a longer onset and, you know, tau is a shorter onset, so we don't really know exactly who the right patient population is going to be. That might be the same as amyloid. It might be different. That's why we've said from the outset, this is a, this is a pioneering study and we and the whole medical academic community are gonna learn from that. The bar doesn't necessarily have to be that high, but I think we do have to see some signs that, you know, give us obviously hope that this would have a clinical benefit. Let's go to the next question, please. Your next question comes from the line of Salveen Richter with Goldman Sachs. Good morning. Thanks for taking my question. On LEQEMBI, could you update us on the adoption and use of blood-based biomarkers and whether you're seeing patients who completed Kisunla switch to LEQEMBI maintenance? Sure. Maybe, Alisha, you'd like to take that one? Sure. Thank you. Blood-based biomarkers have been growing, you know, almost at the same clip as that we've been seeing in the past over 2025, which we know they've had really rapid adoption. Haven't typically been used for confirmation solely. What we are seeing, there is a PCP pilot that is going on right now, as you know, with Biogen and Eisai, and we do have early indicators that from that pilot, we're seeing a higher usage now of blood-based biomarkers in the PCP than what we do to the territories who do not have that pilot running. We're showing that once we educate, they are doing it more and more. Also, more importantly, recently CMS did add that blood-based biomarkers can be used as a confirmation when you go into their database. When you go and use the drug, you can actually get it reimbursed. I know last year that was a big question that physicians had, and now that has also been put into place. I believe moving forward, we are going to see that blood-based biomarkers will be used more and more for confirmation what they are today. The adoption will be a little bit slow, but awareness is extremely high. I do think the more that they use it, test and try it, the more they'll be used for confirmation. When you move towards something, the question that you asked about Kisunla, you know, in this first quarter of the year is when you'll expect to see the tranche of patients that started on Kisunla that are now hitting their 18-month mark. Quarter one is when you will see the patients now, typically stopping the product and for us to start getting the feedback. I can say that physicians are asking, what do we do? Some patients, and if you look at market research, patients in general who are on either of the products wanna stay on product. There is a fear of coming off and having a decline in their cognition. We do have several accounts that are looking at how do they switch them to LEQEMBI. As you know, we cannot provide data on that because we don't have data, but we do have physicians that are looking at can we switch them to maintenance or to subcute maintenance of LEQEMBI. Thanks, Alisha. Let's go to the next question, please. Your next question comes from the line of David Amsellem with Piper Sandler. Thanks. High-level question on SYFOVRE, if you can talk to it. I know the transaction hasn't closed, but can you comment at a high level on evolving competitive dynamics, particularly with other agents that are in development that are focused in terms of their primary outcome measures on visual acuity as opposed to lesion burden? Help us just understand, you know, how are you thinking about where SYFOVRE is going to fit in this evolving landscape, and ultimately what kind of data you can point to regarding the product regarding its impact on visual acuity. Thank you. Thanks, David. Just stepping back, I mean, I think SYFOVRE is indicated for geographic atrophy. This is, you know, a very highly prevalent, irreversible, and progressive disease that leads to blindness. I think the median time point is about six, 6.5 years. The gold standard for assessing efficacy has been lesion growth. I think that is where SYFOVRE has very compelling data, 42% statistically significant reduction in lesion growth. That's kind of at the time of launch. Subsequently, Apellis has also presented five-year long-term data that shows that you can actually slow down progression by 1.5 years. That's obviously really meaningful in that timeframe of six years. Totally agree that there is competitive dynamics here. I think with IZERVAY, that's on the other product that's on the market, it targets C5, which is upper, upstream of C3, which is the target for SYFOVRE. We haven't really seen that long-term data as of now from IZERVAY. Moving into what's on the horizon from a competitive landscape, I think we are seeing more targeting of C5 again. That's one. The other is that with Annexon, we haven't seen that the phase II data were very persuasive. Actually, it did not impact geographic atrophy lesion growth, which we believe is the standard, gold standard. Chris mentioned the lesion growth is really important to focus on. Eventually, the best-corrected visual acuity would be impacted. At the outset, that's not really the goal because the eye adjusts to peripheral vision. That's an important aspect to kinda keep in mind. When we saw the data from Annexon, this was obviously a very important aspect of our diligence. We saw that, actually the BCVA for placebo really went down, and therefore, you know, the drug arm looked good, but I think it remains to be seen. With regards to Regeneron, I know that's competition as well, also targets C5, and it's systemic, and it's a combination. We believe there also SYFOVRE, because it's targeted to the eye, it really enables that tissue delivery, which we believe is really important. Regeneron, the proof of concept still has to come, so we'll wait for that. We do know that SOLIRIS actually with a very similar mechanism of action failed in phase II in GA. I think a lot to watch out for, but we feel really that the SYFOVRE data are compelling, and it's going to be a very huge effort for us from an educational, medical, scientific leadership to make the case on why it's important to treat now. Yeah. I think just from a commercial point of view, the fact that SYFOVRE has five-year data creates sort of a data moat here. you know, this is a progressive, slowly progressive disease and you know, people wanna have confidence in the safety and how this also develops over time. I think it's gonna take a, quite a long time for any competitor actually to generate the same level of data that is gonna be necessary for the confidence of physician and patients. Let's go to the next question, please. Your next question comes from the line of Paul Matteis with Stifel. Great. Thanks so much and congrats on a great quarter. A couple other just quick hits on SYFOVRE, if I may. As it relates to just thinking about spending on that franchise over the next few years, how are you at least qualitatively right now thinking about, you know, synergies and leveraging existing capabilities with also the reality that GA may still be a pretty promotionally sensitive market that could require things like DTC? Then maybe just any quick thoughts on the pre-filled syringe, your level of optimism there, and how meaningful that could be? Thank you. Alisha, you've done a lot of work in this space. Yeah, I'll take that question. Thank you. You know, first I can say that, you know, we've met several of the leaders over at Apellis, and I wanna say that I'm very impressed with that team and with the leadership that they actually have. Many of those individuals have had the ophthalmology background for quite a long time and know the space very well. I will say they've done a very good job, and a tremendous job, especially with the vasculitis cases that came up early on handling that, and I think they're doing a very nice job today. When we look at this market and see the opportunities that it has, you know, it is a very large market. It's 1.5 million patients, as you know, and only 20% are treated. There is a really significant unmet need for this patient population. This launch has sustained growth in injections and in patient growth. We believe there is a very large number of patients who are untreated. There's around 500,000 that currently sit in these targeted physician offices that this team currently calls on for GA. In our experience, when you have a product that slows progression, activating the patients and creating urgency with these HCPs is critically important. Therefore, we know moving forward we will need thoughtful education, very strong messaging, and an explanation as to why there is a strong value to slowing this progression. With that being said, and knowing that we obviously do not, we have not closed the deal yet, we know that activating these patients will be critical in this space because when you go in and ask for something, you typically get it. We do know we will be spending money on DTC and TV ads. As you know, they did run TV ads for two quarters, and they did stop those TV ads. I think that would be something that we'd be looking at once we close the deal because educating these patients will be critically important. We'll also be looking at the messaging for how they're able to handle this in the office. We have no idea up until this space, you know, how much time have they had to spend on vasculitis versus actually being able to compete, hand in hand in these offices. Thirdly, I think that they are gonna benefit greatly from our patient services and also from this machine that we've had the luxury of building over the last seven years. If you really take a step back and look at Biogen, especially in North America, we've launched seven products over the last seven years in completely different spaces, which means we've created this dynamic engine that has been able to support the launches across all of the TAs that we now have. Therefore, we believe, going to your question, we will find synergies in a lot of the headquarters capabilities that we will bring to them that maybe they have not been able to invest in. We're also gonna look at where they currently spend money that maybe we could reallocate to some of these other areas that we believe will, you know, drive the growth. We're gonna be able to do a great analytics on understanding which tactics they're using now they think are working and which ones we might be able to tweak moving forward. I also have an understanding that they might have a wish list of things they'd like to do, maybe they haven't done so far for the launch. We're going to be looking at all of that with them and believe, you know, with Apellis and with Biogen, both of them together will be much stronger than either one of them alone. I know my teams are very excited about welcoming them into North America, and we're looking at giving especially SYFOVRE a lot of support, so they feel like they have everything they need to succeed in this space. Thanks, Alisha. Let's go to the next question, please. Your next question comes from the line of Mohit Bansal with Wells Fargo. Great. Thank you very much for taking my question, and congrats on all the progress. Would love to understand how High Dose SPINRAZA helps with switching and persistence as a new offering. Do you think it can stabilize the franchise or even grow at this point? Would love to understand how you're thinking about it. Thank you. You wanna take that from North America, Alisha? Is the question specifically about SPINRAZA or SPINRAZA High Dose? High dose. High dose. Okay. Well, first of all, I'll say that, I'm sitting in the same boardroom I was sitting in when we had a patient advocacy group, and I pitched to a couple executive committee members that we had feedback from patients that they wanted more. You fast-forward to today, we all of a sudden have SPINRAZA HD. First and foremost, I will say this is one area of the business which I have never seen in my career, where this patient community is smart, they are savvy, they know exactly what comes out, when it's coming out, and they will make those requests prior to any approval in the market. When you look at what has happened, the SPINRAZA HD has been out less than a month. I will tell you that 20% of my patient base have already have start forms in to go on SPINRAZA High Dose. We also have patients that are switching from competitors and patients that are adding on to ZOLGENSMA. For the U.S. organization specifically, I do believe that high dose, which we've had a pretty stable business so far with SPINRAZA. My team has done an excellent job with SPINRAZA 12 mg. We do believe high dose now has a new opportunity for us. We are seeing great interest in high dose from not just patients, but also physicians. We're off to a great start. Hundreds of start forms have been submitted. I think that this is gonna be very positive as we transition from SPINRAZA High Dose and hopefully one day to salanersen. Maybe Chris, I can cover ex-U.S. Yep. Similarly, we had the approval ex-U.S. in Europe. We're seeing similar traction, particularly in Germany, with roughly 20% of the patients converting over to high dose. Off to a really strong launch in Europe as well. Yeah, I think when you think about high dose, you think about Alcyone, the being able to potentially replace the intrathecal injection coming along. Then obviously salanersen, I think Priya can say we've had our first patient dosed in the phase III study here. You know, I think this is a franchise that is going to be durable and can grow over time as we introduce these things that make it easier. You know, I talk to physicians around the world when I go visit our affiliates. You know, every time they talk about someone who has switched off SPINRAZA, there's always a tone of regret in their voice. It generally is because of intrathecal fatigue. They, they have the regret because they know that in their view, that this is the most efficacious drug. I think the HD now gives them even more reason to defend the efficacy. I think, again, with the Alcyone device, we hopefully can eliminate some of the intrathecal fatigue. Certainly by the time we get salanersen, that's expected to be a once yearly intrathecal, and that should also help with the administration. You know, it's amazing that to hear the emotion of physicians. You know, these are children who are now going to school who would have died years before. This is just one of those amazing medicines that Biogen has come up with that has had such an impact on healthcare for particularly in the pediatric population. Let's go to the next question, please. Your next question comes from the line of Evan Seigerman with BMO Capital Markets. Hi, guys. Thank you so much for taking my question. Congrats on all the progress. I'd love to know, drill down a little more on the strength we saw with SKYCLARYS. You know, can you walk me through some of the drivers of this? I know it's been a lumpy product, you know, is this traction something we should really start to think through later in the year? Kind of what are some of the drivers there? Thank you so much. Let's start with you. Let you start with the U.S., and then we can talk about ex. Yeah. For SKYCLARYS, what you saw for the quarter, is with the $72 million year-over-year, it was a 4% growth. Quarter-over-quarter, it was down. It was down because the inventory was built at the end of Q4 last year. Fast-forward to Q1, if you look at the amount of buying weeks, Q1 has two fewer buying weeks than the prior quarter. If you look at patient demand, our patient demand was right on par. It's just we had a little bit of lumpiness with the inventory. Now, the second thing, though, just to remind everyone, is where the U.S. is at launch, is we are now at the launch phase where we are going out, we are using our patient finding our next best action in the field. Where, you know, our reps every week receive a list of all the different offices they can go visit because we believe a patient is there, and then they go on the hunt. With that being said, now, you know, the majority of our patients are coming from doctors who will only ever write one prescription, ever for Friedreich's ataxia. These patients tend to be slower progressers, and they're much older than what we had predicted when we first launched the product. It will take more time as we find them. The good news is that we are finding them, and they are going on product. It does take time from finding the patient to when they finally put in their script. In ex-U.S., actually our revenue in the quarter exceeded the U.S. for the first time from SKYCLARYS as we continue to execute on the launch there, both in Europe and starting in Latin America. We do see from a demand perspective, demand increasing ex-U.S. and expect that to continue as we continue the launches. As I mentioned earlier, it's already available in 35 countries. Yeah, in ex-U.S., we have a little different strategy. You know, as Alisha said, it's really finding the patient. As we found the patients, we have put them on drug, and they're on early access programs while we negotiate reimbursement. As we get reimbursement, you'll start to see the revenue suddenly flow through. It might be lumpy because we can switch potentially several hundred patients all at once from being a zero revenue patient to a full revenue patient. Right now we have not only more revenue, but we've had now for some time more patients outside the U.S. on drug than inside. Just as I say, they haven't been fully reimbursed. That is progressive. You know, we're now seeing really the rollout and potential reimbursement in Latin America, for example. Let's go to the next question, please. Your next question comes from the line of Alexandria Hammond with Wolfe Research. Thanks for taking the question. Another on BIIB080. What's the potential in other tauopathies? As a follow-up, what will be the most important biomarker from the upcoming phase II results in terms of informing next steps but beyond Alzheimer's? Thank you. Yes. Thank you. This is an area that we are discussing quite deeply. We know the high unmet need in primary tau, tauopathies. What we've seen in terms of tau reduction with BIIB080, at least in our phase Ib trial, was very encouraging. I think we would be looking for tau reduction, we would be looking for other details, I mean, regions of the brain, and such. That would inform our strategy on whether we would continue to think about doing more work in primary tauopathies. Yes, it remains high on our list of evaluations and potential possibilities. Thanks, Priya. Let's go to the next question, please. Your next question comes from the line of Terence Flynn with Morgan Stanley. Great. Thanks for taking the question. Just one on felza for me and AMR. Obviously, you called out the acquisition of the China rights for $100 million and then some pretty significant, back-end loaded milestones. Just thinking through what this means for the broader commercial opportunity, maybe both, not just in China, but also on the global basis and how you're thinking about that relative to consensus. Thank you. Yeah. You know, again, I think, as you look at kidney disease, a lot of this there have not been treatments for it. There's a whole alphabet soup of these things, right? You've got IC-MPGN, you've got AMR, you've got PMN, you've got C3G. I think it's hard actually even to come up with sometimes the epidemiology. I can tell you on the MPGN, for EMPAVELI, you know, it's actually not very clear exactly what the actual underlying epidemiology is. It's hard for, I think, investors to really assess some of these. What we do know, for instance, on AMR, is we just take that there are about probably 11,000 patients. If you actually look at the price of IgAN, and certainly even more if you, if you look at it with the latest Otsuka price in IgAN of about $350,000 a year, you know you're looking at a total addressable market of, you know, north of $2 billion, somewhere between $2 billion and $3 billion, in fact, right? There hasn't been any treatment there in the past. Certainly the phase II data, although small numbers, you know, showed remarkable 80% resolution of AMR. Then you've got MDI, which is sort of a cousin of AMR, that adds another 5,000 or 6,000 patients, and we've just initiated a trial in MDI. IgAN, you know, is obviously gonna be a significant market, particularly in Asia. You know, I think there's two things where we see competitiveness. When you start looking at any autoimmune disease, and Priya can speak more to this, but you really wanna think about where are you in the whole immune cascade. You know, in most cases, if you're treating an autoimmune disease, you're trying to suppress the immune system. You don't really wanna do that any more than you have to. Having something that is as close to the actual disease cause I think is gonna be relevant, and that's where we think CD38 has a huge advantage of really acting on the plasma cells and the NK cells. The other is really the durability of treatment. In IgAN, you know, we showed in a phase II that after nine infusions, that we still had durability of treatment after 18 months. You know, that says that, you know, maybe we're doing something here that looks more disease modifying than other agents. Priya, you should probably weigh in here, you, since you're much more expert than I am on this. I think you covered it well, Chris. We're really excited about the first readout for felzartamab. We expect this in 2027. Really it's stepping back. It's a seed. It's targeting the CD38 positive plasma cells, which we believe are a key source of the pathogenic autoantibodies. The readout is really a biopsy readout, which is also very objective. We're excited about this. Great. I think we've got time for one last question. Maybe go to the last one, please. Your next question comes from the line of Jay Olson with Oppenheimer. Oh, hey. Congrats on the quarter, and thanks for the update. Can you talk about the real-world treatment persistence of LEQEMBI that was presented at ADPD with regards to how you expect the subQ version to further impact treatment persistence? Thank you. Yes. Thanks, Jay. I think overall, you know, there's a question, there has been a question lingering out there whether after reduction and clearance of plaques, you continue to keep patients on an anti-amyloid therapy, specifically one like LEQEMBI, which has a dual target of the soluble toxic species as well as plaque reduction. We've shown extensive data in prior meetings on the benefits of keeping patients on therapy. This again is a progressive disease. Once neurons die, you cannot recover them. We've shown that fluid biomarkers actually come back within less than six months, and then, you know, although the plaque comes back much slower. That's one piece. I think the real-world evidence data is compelling because it shows that patients and neurologists actually want to continue to stay on therapy. That I think is the powerful reflection of that data, and this continues to be really, really important for us. Now, we are waiting. We already have subcutaneous maintenance, which again makes it simpler and offers patients optionality on staying on therapy. With subcutaneous initiation, where we'll get an outcome from the FDA next month, you know, we continue to remain very optimistic about how this could inflect in terms of the patient journey. Finally, I'll just add a point about our pre-symptomatic trial, AHEAD 3-45, which is still to read out in 2028. You know, we'll see about that readout. We think it's going to be an important landmark trial in the field. What becomes important with subcutaneous getting accepted is that there could be an interchangeability, which could be very relevant in the pre-symptomatic population. Again, we believe that this is gonna be a very important inflection point. Thanks, Priya. Thanks everybody for joining the call today. If you've got more questions, reach out to me or Daniel or Steve. Thank you. This concludes today's call. Thank you for your participation. You may now disconnect.

Speaker 12: 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 first quarter 2026 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 one 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 one 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. Good morning. good morning My name is Cynthia, and I will be your conference operator today. my name is cynthia and i will be your conference operator today At this time, I would like to welcome everyone to the Biogen first quarter 2026 earnings call and business update. at this time i would like to welcome everyone to the biogen first quarter 2026 earnings call and business update All lines have been placed on mute to prevent any background noise. 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. 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 one on your telephone keypad. if you would like to ask a question during this time simply press star one on your telephone keypad Please limit yourself to one question to allow other participants time for questions. please limit yourself to one question to allow other participants time for questions If you require any further follow-up, you may press star one again to rejoin the queue. if you require any further follow-up you may press star one again to rejoin the queue Today's conference is being recorded. today's conference is being recorded Thank you. thank you I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. i would now like to turn the conference over to mr tim power head of investor relations Mr. Power, you may begin your conference. mr power you may begin your conference

Speaker 18: Thank you, and good morning, and welcome to Biogen's first quarter 2026 earnings call. During this call, we'll make forward-looking statements which involves 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 SEC filings, which we 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 on our website that will be used during the call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and Robin Kramer, our Chief Financial Officer. Thank you, and good morning, and welcome to Biogen's first quarter 2026 earnings call. thank you and good morning and welcome to biogen's first quarter 2026 earnings call During this call, we'll make forward-looking statements which involves risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. during this call we'll make forward-looking statements which involves 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 SEC filings, which we encourage you to review. we provide a comprehensive list of risk factors in our sec filings which we 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. 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 on our website that will be used during the call. we've also posted the slides on our website that will be used during the call On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and Robin Kramer, our Chief Financial Officer. on today's call i'm joined by our president and chief executive officer chris viehbacher dr priya singhal head of development and robin kramer our chief financial officer Alisha Alaimo, President of North America, will also be joining for the Q&A section of the call. We'll make some opening comments and move to the Q&A section. To allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question. I'll now hand the call over to Chris. Alisha Alaimo, President of North America, will also be joining for the Q&A section of the call. alisha alaimo president of north america will also be joining for the q&a section of the call We'll make some opening comments and move to the Q&A section. we'll make some opening comments and move to the q&a section To allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question. to allow us to get through as many questions as possible we kindly ask that you limit yourself to one question I'll now hand the call over to Chris. i'll now hand the call over to chris

Speaker 5: Thank you, Tim. Good morning, everyone. We've had a very strong start to the year. You know, I was thinking about where we have been as a company. In 2023, we had just completed four years of declining revenue and profit. You know, since then, we've been able to pretty much stabilize the business, and that's really been a huge amount of work by all of our teams. You know, the interesting about this business is it's not enough to just trim some costs, and we did have to cut some excess costs. One of the things that we have really been doing is going through every single line of the P&L and thinking about, are we investing for growth? You do have to invest in this business. You cannot save your way to prosperity. Thank you, Tim. thank you tim Good morning, everyone. good morning everyone We've had a very strong start to the year. we've had a very strong start to the year You know, I was thinking about where we have been as a company. you know i was thinking about where we have been as a company In 2023, we had just completed four years of declining revenue and profit. in 2023 we had just completed four years of declining revenue and profit You know, since then, we've been able to pretty much stabilize the business, and that's really been a huge amount of work by all of our teams. you know since then we've been able to pretty much stabilize the business and that's really been a huge amount of work by all of our teams You know, the interesting about this business is it's not enough to just trim some costs, and we did have to cut some excess costs. you know the interesting about this business is it's not enough to just trim some costs and we did have to cut some excess costs One of the things that we have really been doing is going through every single line of the P&L and thinking about, are we investing for growth? one of the things that we have really been doing is going through every single line of the p&l and thinking about are we investing for growth You do have to invest in this business. you do have to invest in this business You cannot save your way to prosperity. you cannot save your way to prosperity There's been a lot of really careful thought about how do we, how do we invest for growth, be it in research and development or in commercial. You know, as Robin has talked about in the past, you know, we actually have shifted a lot of costs. 90% of our commercial costs were really behind the MS portfolio in 2023. By shifting that to our growth products, I think one of the things you see here on the first slide is that the growth products are now generating $850 million in the first quarter, and that's up 12%. The 12% is actually even a little bit of an understatement because SPINRAZA declined slightly. There's been a lot of really careful thought about how do we, how do we invest for growth, be it in research and development or in commercial. there's been a lot of really careful thought about how do we how do we invest for growth be it in research and development or in commercial You know, as Robin has talked about in the past, you know, we actually have shifted a lot of costs. 90% of our commercial costs were really behind the MS portfolio in 2023. you know as robin has talked about in the past you know we actually have shifted a lot of costs 90% of our commercial costs were really behind the ms portfolio in 2023 By shifting that to our growth products, I think one of the things you see here on the first slide is that the growth products are now generating $850 million in the first quarter, and that's up 12%. by shifting that to our growth products i think one of the things you see here on the first slide is that the growth products are now generating $850 million in the first quarter and that's up 12% The 12% is actually even a little bit of an understatement because SPINRAZA declined slightly. the 12% is actually even a little bit of an understatement because spinraza declined slightly SPINRAZA declined mostly because of a timing of shipments, and there was a one-off event last year on VAT, I think, in Europe somewhere. Remember, timing of shipments is a big thing at Biogen. Out of the 15,000 patients on SPINRAZA that we treat every year, about 9,000 are ex-U.S. In a lot of countries, we only ship once or twice a year into those countries. It tends to be lumpy by nature. What is good news is the new High Dose SPINRAZA. As you've seen, this has now been approved in the U.S., and we already have patients on the new dosage regimen. It has already been approved in Japan, who's the first country to approve the high dose, and then Europe. SPINRAZA declined mostly because of a timing of shipments, and there was a one-off event last year on VAT, I think, in Europe somewhere. spinraza declined mostly because of a timing of shipments and there was a one-off event last year on vat i think in europe somewhere Remember, timing of shipments is a big thing at Biogen. remember timing of shipments is a big thing at biogen Out of the 15,000 patients on SPINRAZA that we treat every year, about 9,000 are ex-U.S. out of the 15,000 patients on spinraza that we treat every year about 9,000 are ex-u.s In a lot of countries, we only ship once or twice a year into those countries. in a lot of countries we only ship once or twice a year into those countries It tends to be lumpy by nature. it tends to be lumpy by nature What is good news is the new High Dose SPINRAZA . what is good news is the new high dose spinraza As you've seen, this has now been approved in the U.S., and we already have patients on the new dosage regimen. as you've seen this has now been approved in the u.s and we already have patients on the new dosage regimen It has already been approved in Japan, who's the first country to approve the high dose, and then Europe. it has already been approved in japan who's the first country to approve the high dose and then europe We're getting a lot of positive feedback from those countries where it's been launched. Not only is this gonna be significant in terms of competitiveness in a highly competitive area, but we're also seeing some anecdotal reports of switch backs. You know, in this market, whenever you have one of these devastating diseases, efficacy is really paramount. I think the high dose really should help us have an edge on the efficacy front in this market. We're very happy to see the growth products growing like that. We look to our major opportunity with LEQEMBI. As you know, over the past few years since launch, a lot has been done to try to improve the care pathway, make it easier for both physicians and patients. We're getting a lot of positive feedback from those countries where it's been launched. we're getting a lot of positive feedback from those countries where it's been launched Not only is this gonna be significant in terms of competitiveness in a highly competitive area, but we're also seeing some anecdotal reports of switch backs. not only is this gonna be significant in terms of competitiveness in a highly competitive area but we're also seeing some anecdotal reports of switch backs You know, in this market, whenever you have one of these devastating diseases, efficacy is really paramount. you know in this market whenever you have one of these devastating diseases efficacy is really paramount I think the high dose really should help us have an edge on the efficacy front in this market. i think the high dose really should help us have an edge on the efficacy front in this market We're very happy to see the growth products growing like that. we're very happy to see the growth products growing like that We look to our major opportunity with LEQEMBI. we look to our major opportunity with leqembi As you know, over the past few years since launch, a lot has been done to try to improve the care pathway, make it easier for both physicians and patients. as you know over the past few years since launch a lot has been done to try to improve the care pathway make it easier for both physicians and patients The IQLIK is really fundamental to that. Last year, we had the approval for the maintenance indication. You'll see numbers where we have significant numbers of patients who are continuing on after the first 18 months regimen to remove the plaques and going on to maintenance. We have a PDUFA date of May 24th for the induction subcutaneous. Again, we see this as an opportunity to facilitate the care pathway, improve patient convenience, and improve our competitive profile versus Kisunla. That's the business. The Biogen business is doing well. Now on top of that, we have the proposed Apellis acquisition. We haven't yet closed, but we're limited in what we can say. The IQLIK is really fundamental to that. the iqlik is really fundamental to that Last year, we had the approval for the maintenance indication. last year we had the approval for the maintenance indication You'll see numbers where we have significant numbers of patients who are continuing on after the first 18 months regimen to remove the plaques and going on to maintenance. you'll see numbers where we have significant numbers of patients who are continuing on after the first 18 months regimen to remove the plaques and going on to maintenance We have a PDUFA date of May 24th for the induction subcutaneous. we have a pdufa date of may 24th for the induction subcutaneous Again, we see this as an opportunity to facilitate the care pathway, improve patient convenience, and improve our competitive profile versus Kisunla. again we see this as an opportunity to facilitate the care pathway improve patient convenience and improve our competitive profile versus kisunla That's the business. that's the business The Biogen business is doing well. the biogen business is doing well Now on top of that, we have the proposed Apellis acquisition. now on top of that we have the proposed apellis acquisition We haven't yet closed, but we're limited in what we can say. we haven't yet closed but we're limited in what we can say Obviously, this expands our commercial growth portfolio. There are two marketed products. You know, I'll just remind everybody that this is one molecule. It has three indications, and it has two brands. You know, as I talk to a number of investors on SYFOVRE, there is this focus on ophthalmology. What I think a lot of people forget is that geographic atrophy is really an autoimmune disease. It is caused by the formation of lesions as a result of aberrant immune activity. What we're really trying to do with geographic atrophy is to prevent the growth of these lesions. When people start talking about visual acuity, that's probably gonna be very difficult because the eye tends to adjust around these lesions. Obviously, this expands our commercial growth portfolio. obviously this expands our commercial growth portfolio There are two marketed products. there are two marketed products You know, I'll just remind everybody that this is one molecule. you know i'll just remind everybody that this is one molecule It has three indications, and it has two brands. it has three indications and it has two brands You know, as I talk to a number of investors on SYFOVRE, there is this focus on ophthalmology. you know as i talk to a number of investors on syfovre there is this focus on ophthalmology What I think a lot of people forget is that geographic atrophy is really an autoimmune disease. what i think a lot of people forget is that geographic atrophy is really an autoimmune disease It is caused by the formation of lesions as a result of aberrant immune activity. it is caused by the formation of lesions as a result of aberrant immune activity What we're really trying to do with geographic atrophy is to prevent the growth of these lesions. what we're really trying to do with geographic atrophy is to prevent the growth of these lesions When people start talking about visual acuity, that's probably gonna be very difficult because the eye tends to adjust around these lesions. when people start talking about visual acuity that's probably gonna be very difficult because the eye tends to adjust around these lesions What really is the goal of treatment is to prevent progression of the disease, which could potentially lead to blindness. I think there's a lot that we need to do in terms of thinking about how we really position this drug and where the benefit is. EMPAVELI, you know, is an enormous benefit to us. We have greater conviction every day on felzartamab, and we look forward to seeing the first data, and hopefully that those data will realize our aspirations for this product. You know, if you went back six, seven years ago, nobody was interested in nephrology. What really is the goal of treatment is to prevent progression of the disease, which could potentially lead to blindness. what really is the goal of treatment is to prevent progression of the disease which could potentially lead to blindness I think there's a lot that we need to do in terms of thinking about how we really position this drug and where the benefit is. i think there's a lot that we need to do in terms of thinking about how we really position this drug and where the benefit is EMPAVELI, you know, is an enormous benefit to us. empaveli you know is an enormous benefit to us We have greater conviction every day on felzartamab, and we look forward to seeing the first data, and hopefully that those data will realize our aspirations for this product. we have greater conviction every day on felzartamab and we look forward to seeing the first data and hopefully that those data will realize our aspirations for this product You know, if you went back six, seven years ago, nobody was interested in nephrology. you know if you went back six seven years ago nobody was interested in nephrology Now, you know, really with the advent of the FDA acceptance of proteinuria as a biomarker, a lot of companies have come into this space, and IgAN is obviously the biggest market in this. As we think about recruiting for felzartamab and our pre-launch activities, you're finding that, you know, you got a lot of companies out there that are recruiting in nephrology. I mean, Vertex is, Vera is, just to name a few, for example. With EMPAVELI and with the addition of the Apellis team, we have a whole team ready to go in nephrology. We'll be present in the nephrology offices, building those relationships, going to congresses now with a marketed product and not a future product. Now, you know, really with the advent of the FDA acceptance of proteinuria as a biomarker, a lot of companies have come into this space, and IgAN is obviously the biggest market in this. now you know really with the advent of the fda acceptance of proteinuria as a biomarker a lot of companies have come into this space and igan is obviously the biggest market in this As we think about recruiting for felzartamab and our pre-launch activities, you're finding that, you know, you got a lot of companies out there that are recruiting in nephrology. as we think about recruiting for felzartamab and our pre-launch activities you're finding that you know you got a lot of companies out there that are recruiting in nephrology I mean, Vertex is, Vera is, just to name a few, for example. i mean vertex is vera is just to name a few for example With EMPAVELI and with the addition of the Apellis team, we have a whole team ready to go in nephrology. with empaveli and with the addition of the apellis team we have a whole team ready to go in nephrology We'll be present in the nephrology offices, building those relationships, going to congresses now with a marketed product and not a future product. we'll be present in the nephrology offices building those relationships going to congresses now with a marketed product and not a future product We believe both in the growth of EMPAVELI, but what that can do for a whole nephrology franchise at Biogen, and we're pretty excited about that, I have to say. I think, you know, all the conversations that we've been having with the Apellis team leading up to a potential integration, I think there's first of all, there's an incredible talent in the Apellis team. But I think it's also fair to say that within Biogen, I think we can probably bring more resources to really support those teams. You know, I don't see a big inflection in SYFOVRE, for example, but I do think there is an opportunity for a growing product there. We believe both in the growth of EMPAVELI, but what that can do for a whole nephrology franchise at Biogen, and we're pretty excited about that, I have to say. we believe both in the growth of empaveli but what that can do for a whole nephrology franchise at biogen and we're pretty excited about that i have to say I think, you know, all the conversations that we've been having with the Apellis team leading up to a potential integration, I think there's first of all, there's an incredible talent in the Apellis team. i think you know all the conversations that we've been having with the apellis team leading up to a potential integration i think there's first of all there's an incredible talent in the apellis team But I think it's also fair to say that within Biogen, I think we can probably bring more resources to really support those teams. but i think it's also fair to say that within biogen i think we can probably bring more resources to really support those teams You know, I don't see a big inflection in SYFOVRE, for example, but I do think there is an opportunity for a growing product there. you know i don't see a big inflection in syfovre for example but i do think there is an opportunity for a growing product there I think, as I say, EMPAVELI within a broader nephrology franchise, that could be a game changer for Biogen in the future. You know, as we look at this, we do expect the acquisition to be accretive in 2027. When you look out over the next few years, this materially increases Biogen's EPS outlook. If I turn to the next chart here. Now, don't get your micrometers out here and try to measure these arrows here. This is meant to be illustrative of where we think this is going. I think, as I say, EMPAVELI within a broader nephrology franchise, that could be a game changer for Biogen in the future. i think as i say empaveli within a broader nephrology franchise that could be a game changer for biogen in the future You know, as we look at this, we do expect the acquisition to be accretive in 2027. you know as we look at this we do expect the acquisition to be accretive in 2027 When you look out over the next few years, this materially increases Biogen's EPS outlook. when you look out over the next few years this materially increases biogen's eps outlook If I turn to the next chart here. if i turn to the next chart here Now, don't get your micrometers out here and try to measure these arrows here. now don't get your micrometers out here and try to measure these arrows here This is meant to be illustrative of where we think this is going. this is meant to be illustrative of where we think this is going If we just take what Wall Street thinks Biogen is going to do, I can't say that we would be happy with that, but that's what's out there in the public domain. It's roughly flat through 2030. When you look at what Apellis can do is, you know, this allows Biogen to start growing now, is our belief. You know, the pipeline starts to read out. We've got a lot of data readouts already starting this year and consecutively over the years. You know, as one investor told me, he said, "I get this. Before we had a pipeline coming on a flat business. If we just take what Wall Street thinks Biogen is going to do, I can't say that we would be happy with that, but that's what's out there in the public domain. if we just take what wall street thinks biogen is going to do i can't say that we would be happy with that but that's what's out there in the public domain It's roughly flat through 2030. it's roughly flat through 2030 When you look at what Apellis can do is, you know, this allows Biogen to start growing now, is our belief. when you look at what apellis can do is you know this allows biogen to start growing now is our belief You know, the pipeline starts to read out. you know the pipeline starts to read out We've got a lot of data readouts already starting this year and consecutively over the years. we've got a lot of data readouts already starting this year and consecutively over the years You know, as one investor told me, he said, "I get this. you know as one investor told me he said "i get this Before we had a pipeline coming on a flat business. before we had a pipeline coming on a flat business I see a pipeline coming on a growing business. I think that's the fundamental difference in what the Apellis acquisition does for us. You know, we're still gonna continue to do business development. You know, in all of this, we just acquired the China rights for felzartamab. You know, that's an important market for IgAN, but China's a big, important market for us, and Biogen has been relatively small in China. China is the world's second-biggest pharmaceutical market. Felzartamab and acquiring these rights, not only just to acquire the worldwide rights for felza, but also really to build our business in China. I see a pipeline coming on a growing business. i see a pipeline coming on a growing business I think that's the fundamental difference in what the Apellis acquisition does for us. i think that's the fundamental difference in what the apellis acquisition does for us You know, we're still gonna continue to do business development. you know we're still gonna continue to do business development You know, in all of this, we just acquired the China rights for felzartamab. you know in all of this we just acquired the china rights for felzartamab You know, that's an important market for IgAN, but China's a big, important market for us, and Biogen has been relatively small in China. you know that's an important market for igan but china's a big important market for us and biogen has been relatively small in china China is the world's second-biggest pharmaceutical market. china is the world's second-biggest pharmaceutical market Felzartamab and acquiring these rights, not only just to acquire the worldwide rights for felza, but also really to build our business in China. felzartamab and acquiring these rights not only just to acquire the worldwide rights for felza but also really to build our business in china Again, we continue to invest in growth, but I think a lot of the investments, a lot of the work that we have done over the last two, three years is now coming to fruition. At least this is the vision. Now we are very conscious of the fact that, you know, in business, 10% is strategy, 90% is execution. We need to now execute as a team to bring all of this, but at least this is the aspiration that we have for our company. With that, let's talk about that pipeline, and I'll pass it to Priya. Again, we continue to invest in growth, but I think a lot of the investments, a lot of the work that we have done over the last two, three years is now coming to fruition. again we continue to invest in growth but i think a lot of the investments a lot of the work that we have done over the last two three years is now coming to fruition At least this is the vision. at least this is the vision Now we are very conscious of the fact that, you know, in business, 10% is strategy, 90% is execution. now we are very conscious of the fact that you know in business 10% is strategy 90% is execution We need to now execute as a team to bring all of this, but at least this is the aspiration that we have for our company. we need to now execute as a team to bring all of this but at least this is the aspiration that we have for our company With that, let's talk about that pipeline, and I'll pass it to Priya. with that let's talk about that pipeline and i'll pass it to priya

Speaker 14: Thank you, Chris. This was a very strong quarter for Biogen from a development standpoint, with meaningful progress across both our marketed products and our late-stage pipeline. Starting on the left-hand side of the slide, you can see the continued progress in supporting our marketed portfolio. First, the U.S. approval of High Dose SPINRAZA represents a meaningful advancement for people living with SMA and reinforces Biogen's leadership in the category. Additionally in Alzheimer's disease, new real world data for LEQEMBI shows strong treatment persistence with nearly 80% of patients remaining on therapy at 18 months and almost 70% at two years. We believe that these data underscore the importance that patients and HCPs attribute to ongoing treatment of this progressive disease, extending beyond just amyloid plaque reduction. Turning to the right-hand side, we presented important new data that reinforced the potential of our late-stage high conviction pipeline. Thank you, Chris. thank you chris This was a very strong quarter for Biogen from a development standpoint, with meaningful progress across both our marketed products and our late-stage pipeline. this was a very strong quarter for biogen from a development standpoint with meaningful progress across both our marketed products and our late-stage pipeline Starting on the left-hand side of the slide, you can see the continued progress in supporting our marketed portfolio. starting on the left-hand side of the slide you can see the continued progress in supporting our marketed portfolio First, the U.S. approval of High Dose SPINRAZA represents a meaningful advancement for people living with SMA and reinforces Biogen's leadership in the category. first the u.s approval of high dose spinraza represents a meaningful advancement for people living with sma and reinforces biogen's leadership in the category Additionally in Alzheimer's disease, new real world data for LEQEMBI shows strong treatment persistence with nearly 80% of patients remaining on therapy at 18 months and almost 70% at two years. additionally in alzheimer's disease new real world data for leqembi shows strong treatment persistence with nearly 80% of patients remaining on therapy at 18 months and almost 70% at two years We believe that these data underscore the importance that patients and HCPs attribute to ongoing treatment of this progressive disease, extending beyond just amyloid plaque reduction. we believe that these data underscore the importance that patients and hcps attribute to ongoing treatment of this progressive disease extending beyond just amyloid plaque reduction Turning to the right-hand side, we presented important new data that reinforced the potential of our late-stage high conviction pipeline. turning to the right-hand side we presented important new data that reinforced the potential of our late-stage high conviction pipeline New data from salanersen demonstrate durable benefit over one year in children previously treated with gene therapy, highlighting the potential for high efficacy with once-yearly dosing. Importantly, the first patient has now been dosed in the pivotal STELLAR-1 study evaluating salanersen in treatment-naive pre-symptomatic infants. At the same time, we continue to build confidence in litifilimab, where we presented positive phase II data from the ongoing phase II/III AMETHYST study in CLE. All of this progress reinforces our confidence in our late-stage pipeline. As you can see from this slide, we don't expect to wait long for that potential impact. This year marks the start of a multi-year registrational data flow that includes multiple programs and extends through the end of the decade. We believe these data, as you also heard from Chris, will continue to strengthen our growth outlook. New data from salanersen demonstrate durable benefit over one year in children previously treated with gene therapy, highlighting the potential for high efficacy with once-yearly dosing. new data from salanersen demonstrate durable benefit over one year in children previously treated with gene therapy highlighting the potential for high efficacy with once-yearly dosing Importantly, the first patient has now been dosed in the pivotal STELLAR-1 study evaluating salanersen in treatment-naive pre-symptomatic infants. importantly the first patient has now been dosed in the pivotal stellar-1 study evaluating salanersen in treatment-naive pre-symptomatic infants At the same time, we continue to build confidence in litifilimab, where we presented positive phase II data from the ongoing phase II/III AMETHYST study in CLE. at the same time we continue to build confidence in litifilimab where we presented positive phase ii data from the ongoing phase ii/iii amethyst study in cle All of this progress reinforces our confidence in our late-stage pipeline. all of this progress reinforces our confidence in our late-stage pipeline As you can see from this slide, we don't expect to wait long for that potential impact. as you can see from this slide we don't expect to wait long for that potential impact This year marks the start of a multi-year registrational data flow that includes multiple programs and extends through the end of the decade. this year marks the start of a multi-year registrational data flow that includes multiple programs and extends through the end of the decade We believe these data, as you also heard from Chris, will continue to strengthen our growth outlook. we believe these data as you also heard from chris will continue to strengthen our growth outlook Importantly, as previously reflected, we have several data-related inflection points in 2026. As you know, we have a PDUFA date coming up for our LEQEMBI IQLIK initiation next month. We also have readouts from our pre-proof of concept pipeline, where we continue to pioneer and address key scientific questions that could benefit patients. Our registrational readout cycle begins later this year, and over the next 18 months, we expect to see SLE and CLE data from all the phase III studies of litifilimab, as well as readouts from the first phase III study of felzartamab in AMR and the phase III study for zorevunersen in Dravet syndrome. I believe this is a very exciting time for the Biogen pipeline. I would now like to turn the call over to Robin for an update on our financial performance. Importantly, as previously reflected, we have several data-related inflection points in 2026. importantly as previously reflected we have several data-related inflection points in 2026 As you know, we have a PDUFA date coming up for our LEQEMBI IQLIK initiation next month. as you know we have a pdufa date coming up for our leqembi iqlik initiation next month We also have readouts from our pre-proof of concept pipeline, where we continue to pioneer and address key scientific questions that could benefit patients. we also have readouts from our pre-proof of concept pipeline where we continue to pioneer and address key scientific questions that could benefit patients Our registrational readout cycle begins later this year, and over the next 18 months, we expect to see SLE and CLE data from all the phase III studies of litifilimab, as well as readouts from the first phase III study of felzartamab in AMR and the phase III study for zorevunersen in Dravet syndrome. our registrational readout cycle begins later this year and over the next 18 months we expect to see sle and cle data from all the phase iii studies of litifilimab as well as readouts from the first phase iii study of felzartamab in amr and the phase iii study for zorevunersen in dravet syndrome I believe this is a very exciting time for the Biogen pipeline. i believe this is a very exciting time for the biogen pipeline I would now like to turn the call over to Robin for an update on our financial performance. i would now like to turn the call over to robin for an update on our financial performance

Speaker 15: Thank you, Priya. I'd like to start with key highlights from our strong first quarter 2026 results. Total revenue was $2.5 billion, up 2% year-over-year, with GAAP diluted EPS of $2.15, up 31% year-over-year, and non-GAAP diluted EPS of $3.57, up 18% year-over-year. We're pleased to see our growth products continue to perform well, generating $851 million of revenue, up 12% year-over-year. Our growth products, which includes VUMERITY, generated more revenue in first quarter of 2026 than our remaining MS products. We also maintained our cost discipline while supporting our late-stage pipeline development and product launches with approximately $1.1 billion of non-GAAP core operating expenses in the first quarter of 2026. Thank you, Priya. thank you priya I'd like to start with key highlights from our strong first quarter 2026 results. i'd like to start with key highlights from our strong first quarter 2026 results Total revenue was $2.5 billion, up 2% year-over-year, with GAAP diluted EPS of $2.15, up 31% year-over-year, and non-GAAP diluted EPS of $3.57, up 18% year-over-year. total revenue was $2.5 billion up 2% year-over-year with gaap diluted eps of $2.15 up 31% year-over-year and non-gaap diluted eps of $3.57 up 18% year-over-year We're pleased to see our growth products continue to perform well, generating $851 million of revenue, up 12% year-over-year. we're pleased to see our growth products continue to perform well generating $851 million of revenue up 12% year-over-year Our growth products, which includes VUMERITY, generated more revenue in first quarter of 2026 than our remaining MS products. our growth products which includes vumerity generated more revenue in first quarter of 2026 than our remaining ms products We also maintained our cost discipline while supporting our late-stage pipeline development and product launches with approximately $1.1 billion of non-GAAP core operating expenses in the first quarter of 2026. we also maintained our cost discipline while supporting our late-stage pipeline development and product launches with approximately $1.1 billion of non-gaap core operating expenses in the first quarter of 2026 As a result, we generated $594 million of free cash flow in the quarter, allowing us to further support the business and invest in future growth, including the expected Apellis transaction, which we believe represents a capital allocation opportunity that will further bolster both our top line and bottom line growth prospects and therapeutic areas aligned to our immunology and rare disease strategy. I'll speak more about the transaction in a few moment. I'll now turn to our revenue performance for the quarter, starting with our growth products. LEQEMBI end market revenue was $168 million for the first quarter of 2026, up 74% year-over-year. We saw a continuation of sequential market growth in key markets, including the U.S., Japan, and China. As a result, we generated $594 million of free cash flow in the quarter, allowing us to further support the business and invest in future growth, including the expected Apellis transaction, which we believe represents a capital allocation opportunity that will further bolster both our top line and bottom line growth prospects and therapeutic areas aligned to our immunology and rare disease strategy. as a result we generated $594 million of free cash flow in the quarter allowing us to further support the business and invest in future growth including the expected apellis transaction which we believe represents a capital allocation opportunity that will further bolster both our top line and bottom line growth prospects and therapeutic areas aligned to our immunology and rare disease strategy I'll speak more about the transaction in a few moment. i'll speak more about the transaction in a few moment I'll now turn to our revenue performance for the quarter, starting with our growth products. i'll now turn to our revenue performance for the quarter starting with our growth products LEQEMBI end market revenue was $168 million for the first quarter of 2026, up 74% year-over-year. leqembi end market revenue was $168 million for the first quarter of 2026 up 74% year-over-year We saw a continuation of sequential market growth in key markets, including the U.S., Japan, and China. we saw a continuation of sequential market growth in key markets including the u.s japan and china In China, we saw strong uptake with Q1 reflecting continued demand growth and sequential revenue benefited from completing the drawdown of inventory in Q4 2025. LEQEMBI remains the market leader by total patient share in the U.S., Japan, and China, and we look forward to next month's U.S. PDUFA date for IQLIK initiation. SKYCLARYS saw sequential global patient demand growth with first quarter 2026 global revenue of $151 million, representing 22% growth year-over-year. For SKYCLARYS, U.S. revenue was impacted by the inventory dynamics we discussed on the Q4 2025 call with moderate growth and demand. Outside the U.S., we continued to see demand growth as we continue our SKYCLARYS launch. SKYCLARYS is now available in 35 countries, and we continue to expect SKYCLARYS growth to come from ex-U.S. as we advance the launch. In China, we saw strong uptake with Q1 reflecting continued demand growth and sequential revenue benefited from completing the drawdown of inventory in Q4 2025. in china we saw strong uptake with q1 reflecting continued demand growth and sequential revenue benefited from completing the drawdown of inventory in q4 2025 LEQEMBI remains the market leader by total patient share in the U.S., Japan, and China, and we look forward to next month's U.S. leqembi remains the market leader by total patient share in the u.s japan and china and we look forward to next month's u.s PDUFA date for IQLIK initiation. pdufa date for iqlik initiation SKYCLARYS saw sequential global patient demand growth with first quarter 2026 global revenue of $151 million, representing 22% growth year-over-year. skyclarys saw sequential global patient demand growth with first quarter 2026 global revenue of $151 million representing 22% growth year-over-year For SKYCLARYS, U.S. revenue was impacted by the inventory dynamics we discussed on the Q4 2025 call with moderate growth and demand. for skyclarys u.s revenue was impacted by the inventory dynamics we discussed on the q4 2025 call with moderate growth and demand Outside the U.S., we continued to see demand growth as we continue our SKYCLARYS launch. outside the u.s we continued to see demand growth as we continue our skyclarys launch SKYCLARYS is now available in 35 countries, and we continue to expect SKYCLARYS growth to come from ex-U.S. as we advance the launch. skyclarys is now available in 35 countries and we continue to expect skyclarys growth to come from ex-u.s as we advance the launch Turning to the highlights of our key P&L items for the quarter. Non-GAAP R&D expense in Q1 2026 was $480 million, with the increase year-over-year reflecting investments in our phase III clinical programs, including felzartamab and litifilimab, and due to phasing of spend within the year. Non-GAAP SG&A expense in Q1 2026 was $600 million, with the increase year-over-year reflecting planned pre-launch activities supporting lupus and nephrology, direct-to-consumer advertising for VUMERITY and ZURZUVAE, and due to phasing of spend within the year. First quarter 2026 GAAP and non-GAAP effective tax rates were 15.4% and 15.3% respectively. Turning to the highlights of our key P&L items for the quarter. turning to the highlights of our key p&l items for the quarter Non-GAAP R&D expense in Q1 2026 was $480 million, with the increase year-over-year reflecting investments in our phase III clinical programs, including felzartamab and litifilimab, and due to phasing of spend within the year. Non-GAAP SG&A expense in Q1 2026 was $600 million, with the increase year-over-year reflecting planned pre-launch activities supporting lupus and nephrology, direct-to-consumer advertising for VUMERITY and ZURZUVAE, and due to phasing of spend within the year. non-gaap r&d expense in q1 2026 was $480 million with the increase year-over-year reflecting investments in our phase iii clinical programs including felzartamab and litifilimab and due to phasing of spend within the year. non-gaap sg&a expense in q1 2026 was $600 million with the increase year-over-year reflecting planned pre-launch activities supporting lupus and nephrology direct-to-consumer advertising for vumerity and zurzuvae and due to phasing of spend within the year First quarter 2026 GAAP and non-GAAP effective tax rates were 15.4% and 15.3% respectively. first quarter 2026 gaap and non-gaap effective tax rates were 15.4% and 15.3% respectively The year-over-year decrease was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards, partly offset by the increase in U.S. taxation on foreign earnings in 2026 under the One Big Beautiful Bill Act. As we previously announced, we recorded approximately $34 million of acquired IPR&D in the first quarter of 2026, related primarily to our Alcyone and Alloy transaction, resulting in an approximately $0.20 per share impact to GAAP and non-GAAP EPS. As a reminder, in the first quarter of 2025, we recorded $165 million of acquired IPR&D associated with the upfront payment to Stoke Therapeutics as part of our collaboration for zorevunersen for the treatment of Dravet syndrome in all the territories outside the U.S., Canada, and Mexico, resulting in approximately $0.95 per share impact to GAAP and non-GAAP EPS. The year-over-year decrease was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards, partly offset by the increase in U.S. taxation on foreign earnings in 2026 under the One Big Beautiful Bill Act. the year-over-year decrease was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards partly offset by the increase in u.s taxation on foreign earnings in 2026 under the one big beautiful bill act As we previously announced, we recorded approximately $34 million of acquired IPR&D in the first quarter of 2026, related primarily to our Alcyone and Alloy transaction, resulting in an approximately $0.20 per share impact to GAAP and non-GAAP EPS. as we previously announced we recorded approximately $34 million of acquired ipr&d in the first quarter of 2026 related primarily to our alcyone and alloy transaction resulting in an approximately $0.20 per share impact to gaap and non-gaap eps As a reminder, in the first quarter of 2025, we recorded $165 million of acquired IPR&D associated with the upfront payment to Stoke Therapeutics as part of our collaboration for zorevunersen for the treatment of Dravet syndrome in all the territories outside the U.S., Canada, and Mexico, resulting in approximately $0.95 per share impact to GAAP and non-GAAP EPS. as a reminder in the first quarter of 2025 we recorded $165 million of acquired ipr&d associated with the upfront payment to stoke therapeutics as part of our collaboration for zorevunersen for the treatment of dravet syndrome in all the territories outside the u.s canada and mexico resulting in approximately $0.95 per share impact to gaap and non-gaap eps This strong commercial execution, coupled with disciplined financial management, drove continued robust free cash flow performance. We generated $594 million of free cash flow in the first quarter of 2026 and exited the quarter with $4.7 billion of cash and marketable securities and $1.5 billion of net debt. With the Apellis transaction expected to close in the second quarter of 2026, we plan to fund the transaction with $3.6 billion of cash from the balance sheet and $2 billion from bank borrowing. Given our expected strong cash flow generation, we expect to repay the $2 billion in new borrowings by the end of 2027. Given the dynamic policy environment, we have updated the slide we first provided you this time last year. This strong commercial execution, coupled with disciplined financial management, drove continued robust free cash flow performance. this strong commercial execution coupled with disciplined financial management drove continued robust free cash flow performance We generated $594 million of free cash flow in the first quarter of 2026 and exited the quarter with $4.7 billion of cash and marketable securities and $1.5 billion of net debt. we generated $594 million of free cash flow in the first quarter of 2026 and exited the quarter with $4.7 billion of cash and marketable securities and $1.5 billion of net debt With the Apellis transaction expected to close in the second quarter of 2026, we plan to fund the transaction with $3.6 billion of cash from the balance sheet and $2 billion from bank borrowing. with the apellis transaction expected to close in the second quarter of 2026 we plan to fund the transaction with $3.6 billion of cash from the balance sheet and $2 billion from bank borrowing Given our expected strong cash flow generation, we expect to repay the $2 billion in new borrowings by the end of 2027. given our expected strong cash flow generation we expect to repay the $2 billion in new borrowings by the end of 2027 Given the dynamic policy environment, we have updated the slide we first provided you this time last year. given the dynamic policy environment we have updated the slide we first provided you this time last year We continue to believe the structure of our U.S. manufacturing footprint, supply chain, and overall business model position us to be potentially more resilient to macroeconomic factors and policy uncertainty. Currently, based on potential tariffs as announced to date, we do not expect to see material impact to our business in 2026. This information does not reflect the impact of the pending acquisition of Apellis. Turning now to guidance. Our overall belief in the strength of the underlying business is as strong as when we guided in February. We also continue to believe it's important to make investments for growth. In addition to the roughly $0.20 EPS impact from the acquired IPR&D charges we incurred in Q1, we also expect to incur $145 million or an $0.80 EPS impact of acquired IPR&D charges in the second quarter. We continue to believe the structure of our U.S. manufacturing footprint, supply chain, and overall business model position us to be potentially more resilient to macroeconomic factors and policy uncertainty. we continue to believe the structure of our u.s manufacturing footprint supply chain and overall business model position us to be potentially more resilient to macroeconomic factors and policy uncertainty Currently, based on potential tariffs as announced to date, we do not expect to see material impact to our business in 2026. currently based on potential tariffs as announced to date we do not expect to see material impact to our business in 2026 This information does not reflect the impact of the pending acquisition of Apellis. this information does not reflect the impact of the pending acquisition of apellis Turning now to guidance. turning now to guidance Our overall belief in the strength of the underlying business is as strong as when we guided in February. our overall belief in the strength of the underlying business is as strong as when we guided in february We also continue to believe it's important to make investments for growth. we also continue to believe it's important to make investments for growth In addition to the roughly $0.20 EPS impact from the acquired IPR&D charges we incurred in Q1, we also expect to incur $145 million or an $0.80 EPS impact of acquired IPR&D charges in the second quarter. in addition to the roughly $0.20 eps impact from the acquired ipr&d charges we incurred in q1 we also expect to incur $145 million or an $0.80 eps impact of acquired ipr&d charges in the second quarter Specifically, the TJ Bio transaction for felzartamab rights in China, which further enhances our nephrology franchise and gives us worldwide rights to felzartamab, is expected to comprise $0.55 of this EPS impact. As Priya noted, we also achieved the first patient dosed in STELLAR-1, our pivotal phase III salanersen study, triggering a milestone in the second quarter, which results in approximately $0.25 of EPS impact. Turning to some key considerations for this updated guidance. You can see that our expected business outlook and underlying assumptions, including our revenue outlook, remain consistent with our prior guidance. As I mentioned earlier, we expect roughly $600 million of contract manufacturing revenue this year to be phased as roughly 2/3 coming in the first half of the year. We expect Q2 core operating expenses to be roughly consistent with Q1. Specifically, the TJ Bio transaction for felzartamab rights in China, which further enhances our nephrology franchise and gives us worldwide rights to felzartamab, is expected to comprise $0.55 of this EPS impact. specifically the tj bio transaction for felzartamab rights in china which further enhances our nephrology franchise and gives us worldwide rights to felzartamab is expected to comprise $0.55 of this eps impact As Priya noted, we also achieved the first patient dosed in STELLAR-1, our pivotal phase III salanersen study, triggering a milestone in the second quarter, which results in approximately $0.25 of EPS impact. as priya noted we also achieved the first patient dosed in stellar-1 our pivotal phase iii salanersen study triggering a milestone in the second quarter which results in approximately $0.25 of eps impact Turning to some key considerations for this updated guidance. turning to some key considerations for this updated guidance You can see that our expected business outlook and underlying assumptions, including our revenue outlook, remain consistent with our prior guidance. you can see that our expected business outlook and underlying assumptions including our revenue outlook remain consistent with our prior guidance As I mentioned earlier, we expect roughly $600 million of contract manufacturing revenue this year to be phased as roughly 2/3 coming in the first half of the year. as i mentioned earlier we expect roughly $600 million of contract manufacturing revenue this year to be phased as roughly 2/3 coming in the first half of the year We expect Q2 core operating expenses to be roughly consistent with Q1. we expect q2 core operating expenses to be roughly consistent with q1 It remains our objective to be disciplined on costs as we continue to invest, including supporting the programs that we've been bringing into our pipeline through business development. Please be sure to review this slide and our press release for other important full year 2026 guidance assumptions. Finally, a few points on the expected impacts from the Apellis transaction. The transaction is not yet closed, so we won't provide consolidated guidance today. That said, we do plan to provide 2026 guidance inclusive of Apellis when we report second quarter results following the transaction's close. We can say today that we believe we will be gaining two best-in-class commercialized medicines that enhance our growth portfolio. We believe SYFOVRE and EMPAVELI will contribute meaningfully to our top line growth in the near and long term. It remains our objective to be disciplined on costs as we continue to invest, including supporting the programs that we've been bringing into our pipeline through business development. it remains our objective to be disciplined on costs as we continue to invest including supporting the programs that we've been bringing into our pipeline through business development Please be sure to review this slide and our press release for other important full year 2026 guidance assumptions. please be sure to review this slide and our press release for other important full year 2026 guidance assumptions Finally, a few points on the expected impacts from the Apellis transaction. finally a few points on the expected impacts from the apellis transaction The transaction is not yet closed, so we won't provide consolidated guidance today. the transaction is not yet closed so we won't provide consolidated guidance today That said, we do plan to provide 2026 guidance inclusive of Apellis when we report second quarter results following the transaction's close. that said we do plan to provide 2026 guidance inclusive of apellis when we report second quarter results following the transaction's close We can say today that we believe we will be gaining two best-in-class commercialized medicines that enhance our growth portfolio. we can say today that we believe we will be gaining two best-in-class commercialized medicines that enhance our growth portfolio We believe SYFOVRE and EMPAVELI will contribute meaningfully to our top line growth in the near and long term. we believe syfovre and empaveli will contribute meaningfully to our top line growth in the near and long term We expect approximately $120 million-$130 million of impact to our non-GAAP and other income expense line in 2026, driven largely by financing and foregone interest income. We expect that our strong combined cash flow generation will provide us with the opportunity to de-lever by the end of 2027, and that the transaction will be accretive to non-GAAP EPS in 2027. We believe this transaction represents an attractive use of capital that will further bolster both our top line and bottom line growth prospects in therapeutic areas aligned to our immunology and rare disease strategy. With that, I would like to pass the call back to Tim to open us up for questions. We expect approximately $120 million-$130 million of impact to our non-GAAP and other income expense line in 2026, driven largely by financing and foregone interest income. we expect approximately $120 million-$130 million of impact to our non-gaap and other income expense line in 2026 driven largely by financing and foregone interest income We expect that our strong combined cash flow generation will provide us with the opportunity to de-lever by the end of 2027, and that the transaction will be accretive to non-GAAP EPS in 2027. we expect that our strong combined cash flow generation will provide us with the opportunity to de-lever by the end of 2027 and that the transaction will be accretive to non-gaap eps in 2027 We believe this transaction represents an attractive use of capital that will further bolster both our top line and bottom line growth prospects in therapeutic areas aligned to our immunology and rare disease strategy. we believe this transaction represents an attractive use of capital that will further bolster both our top line and bottom line growth prospects in therapeutic areas aligned to our immunology and rare disease strategy With that, I would like to pass the call back to Tim to open us up for questions. with that i would like to pass the call back to tim to open us up for questions

Speaker 18: Thanks, Robin. Can we go to our first question, please? Thanks, Robin. thanks robin Can we go to our first question, please? can we go to our first question please

Speaker 12: Thank you. Thank you. thank you If you would like to ask a question, please press star one on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow-up, you may press star one again to rejoin the queue. Your first question comes from the line of Brian Abrahams with RBC Capital Markets. If you would like to ask a question, please press star one on your telephone keypad. if you would like to ask a question please press star one on your telephone keypad As a reminder, please limit yourself to one question. as a reminder please limit yourself to one question If you require any further follow-up, you may press star one again to rejoin the queue. if you require any further follow-up you may press star one again to rejoin the queue Your first question comes from the line of Brian Abrahams with RBC Capital Markets. your first question comes from the line of brian abrahams with rbc capital markets

Speaker 4: Hey, guys. Good morning. Congrats on the quarter, and thanks for taking my question. As we look towards the upcoming BIIB080 data, I'm curious your latest views on, like, what kinds of signals you'd be looking for there to move forward, and how much would that be impacted by your expected potential to further improve the administration form there? Thanks. Hey, guys. hey guys Good morning. good morning Congrats on the quarter, and thanks for taking my question. congrats on the quarter and thanks for taking my question As we look towards the upcoming BIIB080 data, I'm curious your latest views on, like, what kinds of signals you'd be looking for there to move forward, and how much would that be impacted by your expected potential to further improve the administration form there? as we look towards the upcoming biib080 data i'm curious your latest views on like what kinds of signals you'd be looking for there to move forward and how much would that be impacted by your expected potential to further improve the administration form there Thanks. thanks

Speaker 5: Priya? Priya? priya

Speaker 14: Thanks, Brian. Just stepping back, you know, BIIB080 is an antisense oligonucleotide. It addresses tau and aims to reduce tau. We've seen that in prior trials, an extracellular approach using an antibody has really not worked. That's where the ASO approach is differentiated. We believe it could target both intracellular and extracellular tau. We did see tau reduction in our phase Ib. It was a small trial, but it was very encouraging, which prompted us to get to a proof of concept study. That is what the CELIA readout will tell us. Because this is a pioneering effort, and what we're looking to see is whether reduction of tau leads to and translates into a clinical benefit, specifically on cognition. As we do that, we're exploring several dosing regimens, several treatment frequencies. Thanks, Brian. thanks brian Just stepping back, you know, BIIB080 is an antisense oligonucleotide. just stepping back you know biib080 is an antisense oligonucleotide It addresses tau and aims to reduce tau. it addresses tau and aims to reduce tau We've seen that in prior trials, an extracellular approach using an antibody has really not worked. we've seen that in prior trials an extracellular approach using an antibody has really not worked That's where the ASO approach is differentiated. that's where the aso approach is differentiated We believe it could target both intracellular and extracellular tau. we believe it could target both intracellular and extracellular tau We did see tau reduction in our phase Ib. we did see tau reduction in our phase ib It was a small trial, but it was very encouraging, which prompted us to get to a proof of concept study. it was a small trial but it was very encouraging which prompted us to get to a proof of concept study That is what the CELIA readout will tell us. that is what the celia readout will tell us Because this is a pioneering effort, and what we're looking to see is whether reduction of tau leads to and translates into a clinical benefit, specifically on cognition. because this is a pioneering effort and what we're looking to see is whether reduction of tau leads to and translates into a clinical benefit specifically on cognition As we do that, we're exploring several dosing regimens, several treatment frequencies. as we do that we're exploring several dosing regimens several treatment frequencies We'll be looking at the totality of data. We're expecting the data sometime mid-year, and I think our goal would be to look at the data and then communicate it and present it, you know, at upcoming forums. That's the plan. We'll be looking at the totality of data. we'll be looking at the totality of data We're expecting the data sometime mid-year, and I think our goal would be to look at the data and then communicate it and present it, you know, at upcoming forums. we're expecting the data sometime mid-year and i think our goal would be to look at the data and then communicate it and present it you know at upcoming forums That's the plan. that's the plan

Speaker 4: On the dosing regimen? On the dosing regimen? on the dosing regimen

Speaker 14: Yes. you know, on the dosing regimen, I'd like to say that really the trial enrolled very quickly from an intrathecal perspective. We recognize that if this actually, translates into a medicine, we would be considering other options. We are looking at other options of delivery. These are in preclinical and research. We recently acquired Alcyone, as you know, and that gives us another potential avenue to explore if, and as we continue with intrathecal delivery. Yes. you know, on the dosing regimen, I'd like to say that really the trial enrolled very quickly from an intrathecal perspective. yes you know on the dosing regimen i'd like to say that really the trial enrolled very quickly from an intrathecal perspective We recognize that if this actually, translates into a medicine, we would be considering other options. we recognize that if this actually translates into a medicine we would be considering other options We are looking at other options of delivery. we are looking at other options of delivery These are in preclinical and research. these are in preclinical and research We recently acquired Alcyone, as you know, and that gives us another potential avenue to explore if, and as we continue with intrathecal delivery. we recently acquired alcyone as you know and that gives us another potential avenue to explore if and as we continue with intrathecal delivery

Speaker 18: Thanks, Priya. Let's go to the next question, please. Thanks, Priya. thanks priya Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Andrew Tsai with Jefferies. Your next question comes from the line of Andrew Tsai with Jefferies. your next question comes from the line of andrew tsai with jefferies

Speaker 3: Hey, thanks. Good morning. As we think about your other catalysts for 2026, just wanted to ask on litifilimab, actually, and the filing strategy. Would you guys consider filing for SLE right away if both phase IIIs were positive later this year? Would you wait, opt to wait to file after the CLE data set right after? Do you file one or two NDAs? If just one SLE study hits that sig, but the other one was trending, would you still file in SLE? Thank you. Hey, thanks. hey thanks Good morning. good morning As we think about your other catalysts for 2026, just wanted to ask on litifilimab, actually, and the filing strategy. as we think about your other catalysts for 2026 just wanted to ask on litifilimab actually and the filing strategy Would you guys consider filing for SLE right away if both phase IIIs were positive later this year? would you guys consider filing for sle right away if both phase iiis were positive later this year Would you wait, opt to wait to file after the CLE data set right after? would you wait opt to wait to file after the cle data set right after Do you file one or two NDAs? do you file one or two ndas If just one SLE study hits that sig, but the other one was trending, would you still file in SLE? if just one sle study hits that sig but the other one was trending would you still file in sle Thank you. thank you

Speaker 14: Thank you, Andrew. We are excited about the potential for litifilimab. We have 2 phase III trials in SLE. We expect them to read out this year. We accelerated the second trial, and we are really doing well on our CLE trial. We expect that to read out early next year. Now, with regards to the filing strategy, we don't usually comment on it, but I'd like to say that we think that this would be a package as of now, and we'll communicate more as this the studies read out. Secondly, whether, you know, if we saw one positive trial and one negative trial, I think again, we'd be looking at the totality of data. You know, there is precedent for that with the other product in the field. Thank you, Andrew. thank you andrew We are excited about the potential for litifilimab. we are excited about the potential for litifilimab We have 2 phase III trials in SLE. we have 2 phase iii trials in sle We expect them to read out this year. we expect them to read out this year We accelerated the second trial, and we are really doing well on our CLE trial. we accelerated the second trial and we are really doing well on our cle trial We expect that to read out early next year. we expect that to read out early next year Now, with regards to the filing strategy, we don't usually comment on it, but I'd like to say that we think that this would be a package as of now, and we'll communicate more as this the studies read out. now with regards to the filing strategy we don't usually comment on it but i'd like to say that we think that this would be a package as of now and we'll communicate more as this the studies read out Secondly, whether, you know, if we saw one positive trial and one negative trial, I think again, we'd be looking at the totality of data. secondly whether you know if we saw one positive trial and one negative trial i think again we'd be looking at the totality of data You know, there is precedent for that with the other product in the field. you know there is precedent for that with the other product in the field We don't think that by itself, it would be a showstopper. We remain very encouraged, and we are very, you know, pleased with the breakthrough designation that litifilimab got for CLE earlier this year. We also just presented data from a second phase II that was positive in CLE. You know, we continue to be optimistic. We don't think that by itself, it would be a showstopper. we don't think that by itself it would be a showstopper We remain very encouraged, and we are very, you know, pleased with the breakthrough designation that litifilimab got for CLE earlier this year. we remain very encouraged and we are very you know pleased with the breakthrough designation that litifilimab got for cle earlier this year We also just presented data from a second phase II that was positive in CLE. we also just presented data from a second phase ii that was positive in cle You know, we continue to be optimistic. you know we continue to be optimistic

Speaker 18: Can we go to our next question, please? Can we go to our next question, please? can we go to our next question please

Speaker 12: Your next question comes from the line of Geoff Meacham with Citi. Your next question comes from the line of Geoff Meacham with Citi. your next question comes from the line of geoff meacham with citi

Speaker 8: Great. Hey, guys. Thanks for the question. Chris, you mentioned you're still looking at BD opportunities, you know, even post-Apellis. Maybe just help us with how maybe you rank external innovation versus investments and, you know, internal R&D and SG&A. Obviously, post-Apellis, you need to make investments to get that, to get the growth profile going. Thanks. Great. great Hey, guys. hey guys Thanks for the question. thanks for the question Chris, you mentioned you're still looking at BD opportunities, you know, even post-Apellis. chris you mentioned you're still looking at bd opportunities you know even post-apellis Maybe just help us with how maybe you rank external innovation versus investments and, you know, internal R&D and SG&A. maybe just help us with how maybe you rank external innovation versus investments and you know internal r&d and sg&a Obviously, post-Apellis, you need to make investments to get that, to get the growth profile going. obviously post-apellis you need to make investments to get that to get the growth profile going Thanks. thanks

Speaker 5: Thanks, Geoff. We feel as we have said in the past, I think we're feeling very good about our late stage pipeline. You know, lupus, I think could be quite a significant franchise for us because in addition to litifilimab, we also have a partnership with UCB on dapirolizumab. We have, we'll be taking the marketing lead in the U.S. and Japan on that product. Of course, we have some other assets in early stage development coming along for lupus. The whole nephrology franchise, I think is gonna be quite significant for us as well. Obviously we have Apellis. Thanks, Geoff. thanks geoff We feel as we have said in the past, I think we're feeling very good about our late stage pipeline. we feel as we have said in the past i think we're feeling very good about our late stage pipeline You know, lupus, I think could be quite a significant franchise for us because in addition to litifilimab, we also have a partnership with UCB on dapirolizumab. you know lupus i think could be quite a significant franchise for us because in addition to litifilimab we also have a partnership with ucb on dapirolizumab We have, we'll be taking the marketing lead in the U.S. and Japan on that product. we have we'll be taking the marketing lead in the u.s and japan on that product Of course, we have some other assets in early stage development coming along for lupus. of course we have some other assets in early stage development coming along for lupus The whole nephrology franchise, I think is gonna be quite significant for us as well. the whole nephrology franchise i think is gonna be quite significant for us as well Obviously we have Apellis. obviously we have apellis As we look at BD, I would say really that most of what we're going to be focusing on is early stage development and research, because that part of the pipeline is quite thin. We have strengthened that with a few collaborations, particularly in immunology with Vanqua and Dara, for instance, last year, and the partnership with Citi, and there's some other ones in there. We're looking at really building the next generation of growth. I think, you know, if we execute well and, you know, we can bring everything and the pipeline does come through, this should be a company that can grow well into the 2030s. And what we need to really be thinking about is what comes after that. As we look at BD, I would say really that most of what we're going to be focusing on is early stage development and research, because that part of the pipeline is quite thin. as we look at bd i would say really that most of what we're going to be focusing on is early stage development and research because that part of the pipeline is quite thin We have strengthened that with a few collaborations, particularly in immunology with Vanqua and Dara, for instance, last year, and the partnership with Citi, and there's some other ones in there. we have strengthened that with a few collaborations particularly in immunology with vanqua and dara for instance last year and the partnership with citi and there's some other ones in there We're looking at really building the next generation of growth. we're looking at really building the next generation of growth I think, you know, if we execute well and, you know, we can bring everything and the pipeline does come through, this should be a company that can grow well into the 2030s. i think you know if we execute well and you know we can bring everything and the pipeline does come through this should be a company that can grow well into the 2030s And what we need to really be thinking about is what comes after that. and what we need to really be thinking about is what comes after that That's where, as I say, the early stage of research stage, pre-IND and perhaps phase I, is where the focus is gonna be. I think on M&A, we would probably be more opportunistic. I don't think there's any particular need at that point to do that, but, I guess we'll keep an eye out, but we're not gonna be doing the search. Over the last two, three years, we have had a very systematic search and felt that we wanted to do M&A. I would say with the Apellis transaction and with the pipeline, we don't see the same need to be as proactive on that front. That's where, as I say, the early stage of research stage, pre-IND and perhaps phase I, is where the focus is gonna be. that's where as i say the early stage of research stage pre-ind and perhaps phase i is where the focus is gonna be I think on M&A, we would probably be more opportunistic. i think on m&a we would probably be more opportunistic I don't think there's any particular need at that point to do that, but, I guess we'll keep an eye out, but we're not gonna be doing the search. i don't think there's any particular need at that point to do that but i guess we'll keep an eye out but we're not gonna be doing the search Over the last two, three years, we have had a very systematic search and felt that we wanted to do M&A. over the last two three years we have had a very systematic search and felt that we wanted to do m&a I would say with the Apellis transaction and with the pipeline, we don't see the same need to be as proactive on that front. i would say with the apellis transaction and with the pipeline we don't see the same need to be as proactive on that front

Speaker 18: Chris, can we go to the next question, please? Chris, can we go to the next question, please? chris can we go to the next question please

Speaker 12: Your next question comes from the line of Michael Yee with UBS. Your next question comes from the line of Michael Yee with UBS. your next question comes from the line of michael yee with ubs

Speaker 10: Hey, guys. Thanks. Good morning. Going back to BIIB080, you guys had downsized the study from 700 patients. I think you ultimately targeted or ultimately enrolled about 400 and wisely cut expenses to get a signal. Can you just remind us, given the context of wanting to be thoughtful about expenses, what type of trend would make sense for you to push forward? On the other hand, when you come out with the data, if you don't think there's a really strong trend, that you'd be pretty clear about that and would therefore signal to the street that we don't plan to invest there. Maybe just add some color to that, Chris or Priya. Help us understand in terms of the disclosure how we should be thoughtful about it. Thanks. Hey, guys. hey guys Thanks. thanks Good morning. good morning Going back to BIIB080, you guys had downsized the study from 700 patients. going back to biib080 you guys had downsized the study from 700 patients I think you ultimately targeted or ultimately enrolled about 400 and wisely cut expenses to get a signal. i think you ultimately targeted or ultimately enrolled about 400 and wisely cut expenses to get a signal Can you just remind us, given the context of wanting to be thoughtful about expenses, what type of trend would make sense for you to push forward? can you just remind us given the context of wanting to be thoughtful about expenses what type of trend would make sense for you to push forward On the other hand, when you come out with the data, if you don't think there's a really strong trend, that you'd be pretty clear about that and would therefore signal to the street that we don't plan to invest there. on the other hand when you come out with the data if you don't think there's a really strong trend that you'd be pretty clear about that and would therefore signal to the street that we don't plan to invest there Maybe just add some color to that, Chris or Priya. maybe just add some color to that chris or priya Help us understand in terms of the disclosure how we should be thoughtful about it. help us understand in terms of the disclosure how we should be thoughtful about it Thanks. thanks

Speaker 14: Thanks, Mike. I think just stepping back, yes, we had designed the original CELIA trial with a larger N, and I think it was our phase Ib trial readout that gave us the confidence to redo the power for that study and redesign that trial. We feel quite confident that the trial is adequately set up to give us an answer on really testing this very important hypothesis. We already saw the tau reduction in phase Ib, and now we're looking for the translation of tau reduction to clinical efficacy. Just as a reminder, the primary endpoint of the trial is CDR Sum of Boxes, which as you know, is a validated endpoint. We are looking at a few different doses and two treatment paradigms, quarterly as well as six monthly. Thanks, Mike. thanks mike I think just stepping back, yes, we had designed the original CELIA trial with a larger N, and I think it was our phase Ib trial readout that gave us the confidence to redo the power for that study and redesign that trial. i think just stepping back yes we had designed the original celia trial with a larger n and i think it was our phase ib trial readout that gave us the confidence to redo the power for that study and redesign that trial We feel quite confident that the trial is adequately set up to give us an answer on really testing this very important hypothesis. we feel quite confident that the trial is adequately set up to give us an answer on really testing this very important hypothesis We already saw the tau reduction in phase Ib, and now we're looking for the translation of tau reduction to clinical efficacy. we already saw the tau reduction in phase ib and now we're looking for the translation of tau reduction to clinical efficacy Just as a reminder, the primary endpoint of the trial is CDR Sum of Boxes, which as you know, is a validated endpoint. just as a reminder the primary endpoint of the trial is cdr sum of boxes which as you know is a validated endpoint We are looking at a few different doses and two treatment paradigms, quarterly as well as six monthly. we are looking at a few different doses and two treatment paradigms quarterly as well as six monthly We'll be again looking at the totality of that to see if we can isolate a signal of clinical efficacy. I think we'll be very disciplined in how we look at that. The way we've really changed that over several years now is that we think about our go/no-go criteria well ahead of data readouts. This data readout is expected mid-year. You can expect that we'll be looking at that data very carefully, but with really being very disciplined about what the next step is, because that is what this proof of concept is designed for, if and how we get to phase III. We'll be again looking at the totality of that to see if we can isolate a signal of clinical efficacy. we'll be again looking at the totality of that to see if we can isolate a signal of clinical efficacy I think we'll be very disciplined in how we look at that. i think we'll be very disciplined in how we look at that The way we've really changed that over several years now is that we think about our go/no-go criteria well ahead of data readouts. the way we've really changed that over several years now is that we think about our go/no-go criteria well ahead of data readouts This data readout is expected mid-year. this data readout is expected mid-year You can expect that we'll be looking at that data very carefully, but with really being very disciplined about what the next step is, because that is what this proof of concept is designed for, if and how we get to phase III. you can expect that we'll be looking at that data very carefully but with really being very disciplined about what the next step is because that is what this proof of concept is designed for if and how we get to phase iii

Speaker 5: I think, you know, one of the interesting here is that, again, there's just no precedent here, right? You know, in designing the study, I think, Priya, it'd be fair to say we basically looked at what we did with amyloid trials, right? We've got the 18-month follow-up. We're looking at a similar population because that's the only thing we knew. We're gonna be discovering an awful lot in this study. Certainly, you know, you wanna see the right reduction in tau and tau PET results will be important. Obviously, you know, can you see some movement on cognition? That would be important to be able to advance. Does that have to be statistically significant? Does that have to be a certain percentage? I think that's where the totality of information is gonna be. I think, you know, one of the interesting here is that, again, there's just no precedent here, right? i think you know one of the interesting here is that again there's just no precedent here right You know, in designing the study, I think, Priya, it'd be fair to say we basically looked at what we did with amyloid trials, right? you know in designing the study i think priya it'd be fair to say we basically looked at what we did with amyloid trials right We've got the 18-month follow-up. we've got the 18-month follow-up We're looking at a similar population because that's the only thing we knew. we're looking at a similar population because that's the only thing we knew We're gonna be discovering an awful lot in this study. we're gonna be discovering an awful lot in this study Certainly, you know, you wanna see the right reduction in tau and tau PET results will be important. certainly you know you wanna see the right reduction in tau and tau pet results will be important Obviously, you know, can you see some movement on cognition? obviously you know can you see some movement on cognition That would be important to be able to advance. that would be important to be able to advance Does that have to be statistically significant? does that have to be statistically significant Does that have to be a certain percentage? does that have to be a certain percentage I think that's where the totality of information is gonna be. i think that's where the totality of information is gonna be You know, while we feel relatively confident being able to reduce the tau, nobody knows how long you have to reduce the tau for to get a benefit on cognition. You know, when you think about the progression of plaque, that is a longer onset and, you know, tau is a shorter onset, so we don't really know exactly who the right patient population is going to be. That might be the same as amyloid. It might be different. That's why we've said from the outset, this is a, this is a pioneering study and we and the whole medical academic community are gonna learn from that. You know, while we feel relatively confident being able to reduce the tau, nobody knows how long you have to reduce the tau for to get a benefit on cognition. you know while we feel relatively confident being able to reduce the tau nobody knows how long you have to reduce the tau for to get a benefit on cognition You know, when you think about the progression of plaque, that is a longer onset and, you know, tau is a shorter onset, so we don't really know exactly who the right patient population is going to be. you know when you think about the progression of plaque that is a longer onset and you know tau is a shorter onset so we don't really know exactly who the right patient population is going to be That might be the same as amyloid. that might be the same as amyloid It might be different. it might be different That's why we've said from the outset, this is a, this is a pioneering study and we and the whole medical academic community are gonna learn from that. that's why we've said from the outset this is a this is a pioneering study and we and the whole medical academic community are gonna learn from that The bar doesn't necessarily have to be that high, but I think we do have to see some signs that, you know, give us obviously hope that this would have a clinical benefit. The bar doesn't necessarily have to be that high, but I think we do have to see some signs that, you know, give us obviously hope that this would have a clinical benefit. the bar doesn't necessarily have to be that high but i think we do have to see some signs that you know give us obviously hope that this would have a clinical benefit

Speaker 18: Let's go to the next question, please. Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Salveen Richter with Goldman Sachs. Your next question comes from the line of Salveen Richter with Goldman Sachs. your next question comes from the line of salveen richter with goldman sachs

Speaker 16: Good morning. Thanks for taking my question. On LEQEMBI, could you update us on the adoption and use of blood-based biomarkers and whether you're seeing patients who completed Kisunla switch to LEQEMBI maintenance? Good morning. good morning Thanks for taking my question. thanks for taking my question On LEQEMBI, could you update us on the adoption and use of blood-based biomarkers and whether you're seeing patients who completed Kisunla switch to LEQEMBI maintenance? on leqembi could you update us on the adoption and use of blood-based biomarkers and whether you're seeing patients who completed kisunla switch to leqembi maintenance

Speaker 5: Sure. Maybe, Alisha, you'd like to take that one? Sure. sure Maybe, Alisha, you'd like to take that one? maybe alisha you'd like to take that one

Speaker 2: Sure. Thank you. Blood-based biomarkers have been growing, you know, almost at the same clip as that we've been seeing in the past over 2025, which we know they've had really rapid adoption. Haven't typically been used for confirmation solely. What we are seeing, there is a PCP pilot that is going on right now, as you know, with Biogen and Eisai, and we do have early indicators that from that pilot, we're seeing a higher usage now of blood-based biomarkers in the PCP than what we do to the territories who do not have that pilot running. We're showing that once we educate, they are doing it more and more. Also, more importantly, recently CMS did add that blood-based biomarkers can be used as a confirmation when you go into their database. Sure. sure Thank you. thank you Blood-based biomarkers have been growing, you know, almost at the same clip as that we've been seeing in the past over 2025, which we know they've had really rapid adoption. blood-based biomarkers have been growing you know almost at the same clip as that we've been seeing in the past over 2025 which we know they've had really rapid adoption Haven't typically been used for confirmation solely. haven't typically been used for confirmation solely What we are seeing, there is a PCP pilot that is going on right now, as you know, with Biogen and Eisai, and we do have early indicators that from that pilot, we're seeing a higher usage now of blood-based biomarkers in the PCP than what we do to the territories who do not have that pilot running. what we are seeing there is a pcp pilot that is going on right now as you know with biogen and eisai and we do have early indicators that from that pilot we're seeing a higher usage now of blood-based biomarkers in the pcp than what we do to the territories who do not have that pilot running We're showing that once we educate, they are doing it more and more. Also, more importantly, recently CMS did add that blood-based biomarkers can be used as a confirmation when you go into their database. we're showing that once we educate they are doing it more and more. also more importantly recently cms did add that blood-based biomarkers can be used as a confirmation when you go into their database When you go and use the drug, you can actually get it reimbursed. I know last year that was a big question that physicians had, and now that has also been put into place. I believe moving forward, we are going to see that blood-based biomarkers will be used more and more for confirmation what they are today. The adoption will be a little bit slow, but awareness is extremely high. I do think the more that they use it, test and try it, the more they'll be used for confirmation. When you move towards something, the question that you asked about Kisunla, you know, in this first quarter of the year is when you'll expect to see the tranche of patients that started on Kisunla that are now hitting their 18-month mark. When you go and use the drug, you can actually get it reimbursed. when you go and use the drug you can actually get it reimbursed I know last year that was a big question that physicians had, and now that has also been put into place. i know last year that was a big question that physicians had and now that has also been put into place I believe moving forward, we are going to see that blood-based biomarkers will be used more and more for confirmation what they are today. i believe moving forward we are going to see that blood-based biomarkers will be used more and more for confirmation what they are today The adoption will be a little bit slow, but awareness is extremely high. the adoption will be a little bit slow but awareness is extremely high I do think the more that they use it, test and try it, the more they'll be used for confirmation. i do think the more that they use it test and try it the more they'll be used for confirmation When you move towards something, the question that you asked about Kisunla, you know, in this first quarter of the year is when you'll expect to see the tranche of patients that started on Kisunla that are now hitting their 18-month mark. when you move towards something the question that you asked about kisunla you know in this first quarter of the year is when you'll expect to see the tranche of patients that started on kisunla that are now hitting their 18-month mark Quarter one is when you will see the patients now, typically stopping the product and for us to start getting the feedback. I can say that physicians are asking, what do we do? Some patients, and if you look at market research, patients in general who are on either of the products wanna stay on product. There is a fear of coming off and having a decline in their cognition. We do have several accounts that are looking at how do they switch them to LEQEMBI. As you know, we cannot provide data on that because we don't have data, but we do have physicians that are looking at can we switch them to maintenance or to subcute maintenance of LEQEMBI. Quarter one is when you will see the patients now, typically stopping the product and for us to start getting the feedback. quarter one is when you will see the patients now typically stopping the product and for us to start getting the feedback I can say that physicians are asking, what do we do? i can say that physicians are asking what do we do Some patients, and if you look at market research, patients in general who are on either of the products wanna stay on product. some patients and if you look at market research patients in general who are on either of the products wanna stay on product There is a fear of coming off and having a decline in their cognition. there is a fear of coming off and having a decline in their cognition We do have several accounts that are looking at how do they switch them to LEQEMBI. we do have several accounts that are looking at how do they switch them to leqembi As you know, we cannot provide data on that because we don't have data, but we do have physicians that are looking at can we switch them to maintenance or to subcute maintenance of LEQEMBI. as you know we cannot provide data on that because we don't have data but we do have physicians that are looking at can we switch them to maintenance or to subcute maintenance of leqembi

Speaker 18: Thanks, Alisha. Let's go to the next question, please. Thanks, Alisha. thanks alisha Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of David Amsellem with Piper Sandler. Your next question comes from the line of David Amsellem with Piper Sandler. your next question comes from the line of david amsellem with piper sandler

Speaker 6: Thanks. High-level question on SYFOVRE, if you can talk to it. I know the transaction hasn't closed, but can you comment at a high level on evolving competitive dynamics, particularly with other agents that are in development that are focused in terms of their primary outcome measures on visual acuity as opposed to lesion burden? Help us just understand, you know, how are you thinking about where SYFOVRE is going to fit in this evolving landscape, and ultimately what kind of data you can point to regarding the product regarding its impact on visual acuity. Thank you. Thanks. thanks High-level question on SYFOVRE, if you can talk to it. high-level question on syfovre if you can talk to it I know the transaction hasn't closed, but can you comment at a high level on evolving competitive dynamics, particularly with other agents that are in development that are focused in terms of their primary outcome measures on visual acuity as opposed to lesion burden? i know the transaction hasn't closed but can you comment at a high level on evolving competitive dynamics particularly with other agents that are in development that are focused in terms of their primary outcome measures on visual acuity as opposed to lesion burden Help us just understand, you know, how are you thinking about where SYFOVRE is going to fit in this evolving landscape, and ultimately what kind of data you can point to regarding the product regarding its impact on visual acuity. help us just understand you know how are you thinking about where syfovre is going to fit in this evolving landscape and ultimately what kind of data you can point to regarding the product regarding its impact on visual acuity Thank you. thank you

Speaker 14: Thanks, David. Just stepping back, I mean, I think SYFOVRE is indicated for geographic atrophy. This is, you know, a very highly prevalent, irreversible, and progressive disease that leads to blindness. I think the median time point is about six, 6.5 years. The gold standard for assessing efficacy has been lesion growth. I think that is where SYFOVRE has very compelling data, 42% statistically significant reduction in lesion growth. That's kind of at the time of launch. Subsequently, Apellis has also presented five-year long-term data that shows that you can actually slow down progression by 1.5 years. That's obviously really meaningful in that timeframe of six years. Totally agree that there is competitive dynamics here. Thanks, David. thanks david Just stepping back, I mean, I think SYFOVRE is indicated for geographic atrophy. just stepping back i mean i think syfovre is indicated for geographic atrophy This is, you know, a very highly prevalent, irreversible, and progressive disease that leads to blindness. this is you know a very highly prevalent irreversible and progressive disease that leads to blindness I think the median time point is about six, 6.5 years. i think the median time point is about six, 6.5 years The gold standard for assessing efficacy has been lesion growth. the gold standard for assessing efficacy has been lesion growth I think that is where SYFOVRE has very compelling data, 42% statistically significant reduction in lesion growth. i think that is where syfovre has very compelling data 42% statistically significant reduction in lesion growth That's kind of at the time of launch. that's kind of at the time of launch Subsequently, Apellis has also presented five-year long-term data that shows that you can actually slow down progression by 1.5 years. subsequently apellis has also presented five-year long-term data that shows that you can actually slow down progression by 1.5 years That's obviously really meaningful in that timeframe of six years. that's obviously really meaningful in that timeframe of six years Totally agree that there is competitive dynamics here. totally agree that there is competitive dynamics here I think with IZERVAY, that's on the other product that's on the market, it targets C5, which is upper, upstream of C3, which is the target for SYFOVRE. We haven't really seen that long-term data as of now from IZERVAY. Moving into what's on the horizon from a competitive landscape, I think we are seeing more targeting of C5 again. That's one. The other is that with Annexon, we haven't seen that the phase II data were very persuasive. Actually, it did not impact geographic atrophy lesion growth, which we believe is the standard, gold standard. Chris mentioned the lesion growth is really important to focus on. Eventually, the best-corrected visual acuity would be impacted. At the outset, that's not really the goal because the eye adjusts to peripheral vision. I think with IZERVAY, that's on the other product that's on the market, it targets C5, which is upper, upstream of C3, which is the target for SYFOVRE. i think with izervay that's on the other product that's on the market it targets c5 which is upper upstream of c3 which is the target for syfovre We haven't really seen that long-term data as of now from IZERVAY. we haven't really seen that long-term data as of now from izervay Moving into what's on the horizon from a competitive landscape, I think we are seeing more targeting of C5 again. moving into what's on the horizon from a competitive landscape i think we are seeing more targeting of c5 again That's one. that's one The other is that with Annexon, we haven't seen that the phase II data were very persuasive. the other is that with annexon we haven't seen that the phase ii data were very persuasive Actually, it did not impact geographic atrophy lesion growth, which we believe is the standard, gold standard. actually it did not impact geographic atrophy lesion growth which we believe is the standard gold standard Chris mentioned the lesion growth is really important to focus on. chris mentioned the lesion growth is really important to focus on Eventually, the best-corrected visual acuity would be impacted. eventually the best-corrected visual acuity would be impacted At the outset, that's not really the goal because the eye adjusts to peripheral vision. at the outset that's not really the goal because the eye adjusts to peripheral vision That's an important aspect to kinda keep in mind. When we saw the data from Annexon, this was obviously a very important aspect of our diligence. We saw that, actually the BCVA for placebo really went down, and therefore, you know, the drug arm looked good, but I think it remains to be seen. With regards to Regeneron, I know that's competition as well, also targets C5, and it's systemic, and it's a combination. We believe there also SYFOVRE, because it's targeted to the eye, it really enables that tissue delivery, which we believe is really important. Regeneron, the proof of concept still has to come, so we'll wait for that. We do know that SOLIRIS actually with a very similar mechanism of action failed in phase II in GA. That's an important aspect to kinda keep in mind. that's an important aspect to kinda keep in mind When we saw the data from Annexon, this was obviously a very important aspect of our diligence. when we saw the data from annexon this was obviously a very important aspect of our diligence We saw that, actually the BCVA for placebo really went down, and therefore, you know, the drug arm looked good, but I think it remains to be seen. we saw that actually the bcva for placebo really went down and therefore you know the drug arm looked good but i think it remains to be seen With regards to Regeneron, I know that's competition as well, also targets C5, and it's systemic, and it's a combination. with regards to regeneron i know that's competition as well also targets c5 and it's systemic and it's a combination We believe there also SYFOVRE, because it's targeted to the eye, it really enables that tissue delivery, which we believe is really important. we believe there also syfovre because it's targeted to the eye it really enables that tissue delivery which we believe is really important Regeneron, the proof of concept still has to come, so we'll wait for that. regeneron the proof of concept still has to come so we'll wait for that We do know that SOLIRIS actually with a very similar mechanism of action failed in phase II in GA. we do know that soliris actually with a very similar mechanism of action failed in phase ii in ga I think a lot to watch out for, but we feel really that the SYFOVRE data are compelling, and it's going to be a very huge effort for us from an educational, medical, scientific leadership to make the case on why it's important to treat now. I think a lot to watch out for, but we feel really that the SYFOVRE data are compelling, and it's going to be a very huge effort for us from an educational, medical, scientific leadership to make the case on why it's important to treat now. i think a lot to watch out for but we feel really that the syfovre data are compelling and it's going to be a very huge effort for us from an educational medical scientific leadership to make the case on why it's important to treat now

Speaker 5: Yeah. I think just from a commercial point of view, the fact that SYFOVRE has five-year data creates sort of a data moat here. you know, this is a progressive, slowly progressive disease and you know, people wanna have confidence in the safety and how this also develops over time. I think it's gonna take a, quite a long time for any competitor actually to generate the same level of data that is gonna be necessary for the confidence of physician and patients. Yeah. yeah I think just from a commercial point of view, the fact that SYFOVRE has five-year data creates sort of a data moat here. you know, this is a progressive, slowly progressive disease and you know, people wanna have confidence in the safety and how this also develops over time. i think just from a commercial point of view the fact that syfovre has five-year data creates sort of a data moat here you know this is a progressive slowly progressive disease and you know people wanna have confidence in the safety and how this also develops over time I think it's gonna take a, quite a long time for any competitor actually to generate the same level of data that is gonna be necessary for the confidence of physician and patients. i think it's gonna take a quite a long time for any competitor actually to generate the same level of data that is gonna be necessary for the confidence of physician and patients

Speaker 18: Let's go to the next question, please. Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Paul Matteis with Stifel. Your next question comes from the line of Paul Matteis with Stifel. your next question comes from the line of paul matteis with stifel

Speaker 13: Great. Thanks so much and congrats on a great quarter. A couple other just quick hits on SYFOVRE, if I may. As it relates to just thinking about spending on that franchise over the next few years, how are you at least qualitatively right now thinking about, you know, synergies and leveraging existing capabilities with also the reality that GA may still be a pretty promotionally sensitive market that could require things like DTC? Then maybe just any quick thoughts on the pre-filled syringe, your level of optimism there, and how meaningful that could be? Thank you. Great. great Thanks so much and congrats on a great quarter. thanks so much and congrats on a great quarter A couple other just quick hits on SYFOVRE, if I may. a couple other just quick hits on syfovre if i may As it relates to just thinking about spending on that franchise over the next few years, how are you at least qualitatively right now thinking about, you know, synergies and leveraging existing capabilities with also the reality that GA may still be a pretty promotionally sensitive market that could require things like DTC? as it relates to just thinking about spending on that franchise over the next few years how are you at least qualitatively right now thinking about you know synergies and leveraging existing capabilities with also the reality that ga may still be a pretty promotionally sensitive market that could require things like dtc Then maybe just any quick thoughts on the pre-filled syringe, your level of optimism there, and how meaningful that could be? then maybe just any quick thoughts on the pre-filled syringe your level of optimism there and how meaningful that could be Thank you. thank you

Speaker 5: Alisha, you've done a lot of work in this space. Alisha, you've done a lot of work in this space. alisha you've done a lot of work in this space

Speaker 2: Yeah, I'll take that question. Thank you. You know, first I can say that, you know, we've met several of the leaders over at Apellis, and I wanna say that I'm very impressed with that team and with the leadership that they actually have. Many of those individuals have had the ophthalmology background for quite a long time and know the space very well. I will say they've done a very good job, and a tremendous job, especially with the vasculitis cases that came up early on handling that, and I think they're doing a very nice job today. When we look at this market and see the opportunities that it has, you know, it is a very large market. It's 1.5 million patients, as you know, and only 20% are treated. Yeah, I'll take that question. yeah i'll take that question Thank you. thank you You know, first I can say that, you know, we've met several of the leaders over at Apellis, and I wanna say that I'm very impressed with that team and with the leadership that they actually have. you know first i can say that you know we've met several of the leaders over at apellis and i wanna say that i'm very impressed with that team and with the leadership that they actually have Many of those individuals have had the ophthalmology background for quite a long time and know the space very well. many of those individuals have had the ophthalmology background for quite a long time and know the space very well I will say they've done a very good job, and a tremendous job, especially with the vasculitis cases that came up early on handling that, and I think they're doing a very nice job today. i will say they've done a very good job and a tremendous job especially with the vasculitis cases that came up early on handling that and i think they're doing a very nice job today When we look at this market and see the opportunities that it has, you know, it is a very large market. when we look at this market and see the opportunities that it has you know it is a very large market It's 1.5 million patients, as you know, and only 20% are treated. it's 1.5 million patients as you know and only 20% are treated There is a really significant unmet need for this patient population. This launch has sustained growth in injections and in patient growth. We believe there is a very large number of patients who are untreated. There's around 500,000 that currently sit in these targeted physician offices that this team currently calls on for GA. In our experience, when you have a product that slows progression, activating the patients and creating urgency with these HCPs is critically important. Therefore, we know moving forward we will need thoughtful education, very strong messaging, and an explanation as to why there is a strong value to slowing this progression. There is a really significant unmet need for this patient population. there is a really significant unmet need for this patient population This launch has sustained growth in injections and in patient growth. this launch has sustained growth in injections and in patient growth We believe there is a very large number of patients who are untreated. we believe there is a very large number of patients who are untreated There's around 500,000 that currently sit in these targeted physician offices that this team currently calls on for GA. there's around 500,000 that currently sit in these targeted physician offices that this team currently calls on for ga In our experience, when you have a product that slows progression, activating the patients and creating urgency with these HCPs is critically important. in our experience when you have a product that slows progression activating the patients and creating urgency with these hcps is critically important Therefore, we know moving forward we will need thoughtful education, very strong messaging, and an explanation as to why there is a strong value to slowing this progression. therefore we know moving forward we will need thoughtful education very strong messaging and an explanation as to why there is a strong value to slowing this progression With that being said, and knowing that we obviously do not, we have not closed the deal yet, we know that activating these patients will be critical in this space because when you go in and ask for something, you typically get it. We do know we will be spending money on DTC and TV ads. As you know, they did run TV ads for two quarters, and they did stop those TV ads. I think that would be something that we'd be looking at once we close the deal because educating these patients will be critically important. We'll also be looking at the messaging for how they're able to handle this in the office. With that being said, and knowing that we obviously do not, we have not closed the deal yet, we know that activating these patients will be critical in this space because when you go in and ask for something, you typically get it. with that being said and knowing that we obviously do not we have not closed the deal yet we know that activating these patients will be critical in this space because when you go in and ask for something you typically get it We do know we will be spending money on DTC and TV ads. we do know we will be spending money on dtc and tv ads As you know, they did run TV ads for two quarters, and they did stop those TV ads. as you know they did run tv ads for two quarters and they did stop those tv ads I think that would be something that we'd be looking at once we close the deal because educating these patients will be critically important. i think that would be something that we'd be looking at once we close the deal because educating these patients will be critically important We'll also be looking at the messaging for how they're able to handle this in the office. we'll also be looking at the messaging for how they're able to handle this in the office We have no idea up until this space, you know, how much time have they had to spend on vasculitis versus actually being able to compete, hand in hand in these offices. Thirdly, I think that they are gonna benefit greatly from our patient services and also from this machine that we've had the luxury of building over the last seven years. If you really take a step back and look at Biogen, especially in North America, we've launched seven products over the last seven years in completely different spaces, which means we've created this dynamic engine that has been able to support the launches across all of the TAs that we now have. We have no idea up until this space, you know, how much time have they had to spend on vasculitis versus actually being able to compete, hand in hand in these offices. we have no idea up until this space you know how much time have they had to spend on vasculitis versus actually being able to compete hand in hand in these offices Thirdly, I think that they are gonna benefit greatly from our patient services and also from this machine that we've had the luxury of building over the last seven years. thirdly i think that they are gonna benefit greatly from our patient services and also from this machine that we've had the luxury of building over the last seven years If you really take a step back and look at Biogen, especially in North America, we've launched seven products over the last seven years in completely different spaces, which means we've created this dynamic engine that has been able to support the launches across all of the TAs that we now have. if you really take a step back and look at biogen especially in north america we've launched seven products over the last seven years in completely different spaces which means we've created this dynamic engine that has been able to support the launches across all of the tas that we now have Therefore, we believe, going to your question, we will find synergies in a lot of the headquarters capabilities that we will bring to them that maybe they have not been able to invest in. We're also gonna look at where they currently spend money that maybe we could reallocate to some of these other areas that we believe will, you know, drive the growth. We're gonna be able to do a great analytics on understanding which tactics they're using now they think are working and which ones we might be able to tweak moving forward. I also have an understanding that they might have a wish list of things they'd like to do, maybe they haven't done so far for the launch. Therefore, we believe, going to your question, we will find synergies in a lot of the headquarters capabilities that we will bring to them that maybe they have not been able to invest in. therefore we believe going to your question we will find synergies in a lot of the headquarters capabilities that we will bring to them that maybe they have not been able to invest in We're also gonna look at where they currently spend money that maybe we could reallocate to some of these other areas that we believe will, you know, drive the growth. we're also gonna look at where they currently spend money that maybe we could reallocate to some of these other areas that we believe will you know drive the growth We're gonna be able to do a great analytics on understanding which tactics they're using now they think are working and which ones we might be able to tweak moving forward. we're gonna be able to do a great analytics on understanding which tactics they're using now they think are working and which ones we might be able to tweak moving forward I also have an understanding that they might have a wish list of things they'd like to do, maybe they haven't done so far for the launch. i also have an understanding that they might have a wish list of things they'd like to do maybe they haven't done so far for the launch We're going to be looking at all of that with them and believe, you know, with Apellis and with Biogen, both of them together will be much stronger than either one of them alone. I know my teams are very excited about welcoming them into North America, and we're looking at giving especially SYFOVRE a lot of support, so they feel like they have everything they need to succeed in this space. We're going to be looking at all of that with them and believe, you know, with Apellis and with Biogen, both of them together will be much stronger than either one of them alone. we're going to be looking at all of that with them and believe you know with apellis and with biogen both of them together will be much stronger than either one of them alone I know my teams are very excited about welcoming them into North America, and we're looking at giving especially SYFOVRE a lot of support, so they feel like they have everything they need to succeed in this space. i know my teams are very excited about welcoming them into north america and we're looking at giving especially syfovre a lot of support so they feel like they have everything they need to succeed in this space

Speaker 5: Thanks, Alisha. Let's go to the next question, please. Thanks, Alisha. thanks alisha Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Mohit Bansal with Wells Fargo. Your next question comes from the line of Mohit Bansal with Wells Fargo. your next question comes from the line of mohit bansal with wells fargo

Speaker 11: Great. Thank you very much for taking my question, and congrats on all the progress. Would love to understand how High Dose SPINRAZA helps with switching and persistence as a new offering. Do you think it can stabilize the franchise or even grow at this point? Would love to understand how you're thinking about it. Thank you. Great. great Thank you very much for taking my question, and congrats on all the progress. thank you very much for taking my question and congrats on all the progress Would love to understand how High Dose SPINRAZA helps with switching and persistence as a new offering. would love to understand how high dose spinraza helps with switching and persistence as a new offering Do you think it can stabilize the franchise or even grow at this point? do you think it can stabilize the franchise or even grow at this point Would love to understand how you're thinking about it. would love to understand how you're thinking about it Thank you. thank you

Speaker 5: You wanna take that from North America, Alisha? You wanna take that from North America, Alisha? you wanna take that from north america alisha

Speaker 2: Is the question specifically about SPINRAZA or SPINRAZA High Dose? Is the question specifically about SPINRAZA or SPINRAZA High Dose? is the question specifically about spinraza or spinraza high dose

Speaker 5: High dose. High dose. high dose

Speaker 2: High dose. Okay. Well, first of all, I'll say that, I'm sitting in the same boardroom I was sitting in when we had a patient advocacy group, and I pitched to a couple executive committee members that we had feedback from patients that they wanted more. You fast-forward to today, we all of a sudden have SPINRAZA HD. First and foremost, I will say this is one area of the business which I have never seen in my career, where this patient community is smart, they are savvy, they know exactly what comes out, when it's coming out, and they will make those requests prior to any approval in the market. When you look at what has happened, the SPINRAZA HD has been out less than a month. High dose. high dose Okay. okay Well, first of all, I'll say that, I'm sitting in the same boardroom I was sitting in when we had a patient advocacy group, and I pitched to a couple executive committee members that we had feedback from patients that they wanted more. well first of all i'll say that i'm sitting in the same boardroom i was sitting in when we had a patient advocacy group and i pitched to a couple executive committee members that we had feedback from patients that they wanted more You fast-forward to today, we all of a sudden have SPINRAZA HD. you fast-forward to today we all of a sudden have spinraza hd First and foremost, I will say this is one area of the business which I have never seen in my career, where this patient community is smart, they are savvy, they know exactly what comes out, when it's coming out, and they will make those requests prior to any approval in the market. first and foremost i will say this is one area of the business which i have never seen in my career where this patient community is smart they are savvy they know exactly what comes out when it's coming out and they will make those requests prior to any approval in the market When you look at what has happened, the SPINRAZA HD has been out less than a month. when you look at what has happened the spinraza hd has been out less than a month I will tell you that 20% of my patient base have already have start forms in to go on SPINRAZA High Dose. We also have patients that are switching from competitors and patients that are adding on to ZOLGENSMA. For the U.S. organization specifically, I do believe that high dose, which we've had a pretty stable business so far with SPINRAZA. My team has done an excellent job with SPINRAZA 12 mg. We do believe high dose now has a new opportunity for us. We are seeing great interest in high dose from not just patients, but also physicians. We're off to a great start. Hundreds of start forms have been submitted. I think that this is gonna be very positive as we transition from SPINRAZA High Dose and hopefully one day to salanersen. I will tell you that 20% of my patient base have already have start forms in to go on SPINRAZA High Dose. i will tell you that 20% of my patient base have already have start forms in to go on spinraza high dose We also have patients that are switching from competitors and patients that are adding on to ZOLGENSMA. we also have patients that are switching from competitors and patients that are adding on to zolgensma For the U.S. organization specifically, I do believe that high dose, which we've had a pretty stable business so far with SPINRAZA. for the u.s organization specifically i do believe that high dose which we've had a pretty stable business so far with spinraza My team has done an excellent job with SPINRAZA 12 mg. my team has done an excellent job with spinraza 12 mg We do believe high dose now has a new opportunity for us. we do believe high dose now has a new opportunity for us We are seeing great interest in high dose from not just patients, but also physicians. we are seeing great interest in high dose from not just patients but also physicians We're off to a great start. we're off to a great start Hundreds of start forms have been submitted. hundreds of start forms have been submitted I think that this is gonna be very positive as we transition from SPINRAZA High Dose and hopefully one day to salanersen. i think that this is gonna be very positive as we transition from spinraza high dose and hopefully one day to salanersen

Speaker 15: Maybe Chris, I can cover ex-U.S. Maybe Chris, I can cover ex-U.S. maybe chris i can cover ex-u.s

Speaker 5: Yep. Yep. yep

Speaker 15: Similarly, we had the approval ex-U.S. in Europe. We're seeing similar traction, particularly in Germany, with roughly 20% of the patients converting over to high dose. Off to a really strong launch in Europe as well. Similarly, we had the approval ex-U.S. in Europe. similarly we had the approval ex-u.s in europe We're seeing similar traction, particularly in Germany, with roughly 20% of the patients converting over to high dose. we're seeing similar traction particularly in germany with roughly 20% of the patients converting over to high dose Off to a really strong launch in Europe as well. off to a really strong launch in europe as well

Speaker 5: Yeah, I think when you think about high dose, you think about Alcyone, the being able to potentially replace the intrathecal injection coming along. Then obviously salanersen, I think Priya can say we've had our first patient dosed in the phase III study here. You know, I think this is a franchise that is going to be durable and can grow over time as we introduce these things that make it easier. You know, I talk to physicians around the world when I go visit our affiliates. You know, every time they talk about someone who has switched off SPINRAZA, there's always a tone of regret in their voice. It generally is because of intrathecal fatigue. Yeah, I think when you think about high dose, you think about Alcyone, the being able to potentially replace the intrathecal injection coming along. yeah i think when you think about high dose you think about alcyone the being able to potentially replace the intrathecal injection coming along Then obviously salanersen, I think Priya can say we've had our first patient dosed in the phase III study here. then obviously salanersen i think priya can say we've had our first patient dosed in the phase iii study here You know, I think this is a franchise that is going to be durable and can grow over time as we introduce these things that make it easier. you know i think this is a franchise that is going to be durable and can grow over time as we introduce these things that make it easier You know, I talk to physicians around the world when I go visit our affiliates. you know i talk to physicians around the world when i go visit our affiliates You know, every time they talk about someone who has switched off SPINRAZA, there's always a tone of regret in their voice. you know every time they talk about someone who has switched off spinraza there's always a tone of regret in their voice It generally is because of intrathecal fatigue. it generally is because of intrathecal fatigue They, they have the regret because they know that in their view, that this is the most efficacious drug. I think the HD now gives them even more reason to defend the efficacy. I think, again, with the Alcyone device, we hopefully can eliminate some of the intrathecal fatigue. Certainly by the time we get salanersen, that's expected to be a once yearly intrathecal, and that should also help with the administration. You know, it's amazing that to hear the emotion of physicians. You know, these are children who are now going to school who would have died years before. They, they have the regret because they know that in their view, that this is the most efficacious drug. they they have the regret because they know that in their view that this is the most efficacious drug I think the HD now gives them even more reason to defend the efficacy. i think the hd now gives them even more reason to defend the efficacy I think, again, with the Alcyone device, we hopefully can eliminate some of the intrathecal fatigue. i think again with the alcyone device we hopefully can eliminate some of the intrathecal fatigue Certainly by the time we get salanersen, that's expected to be a once yearly intrathecal, and that should also help with the administration. certainly by the time we get salanersen that's expected to be a once yearly intrathecal and that should also help with the administration You know, it's amazing that to hear the emotion of physicians. you know it's amazing that to hear the emotion of physicians You know, these are children who are now going to school who would have died years before. you know these are children who are now going to school who would have died years before This is just one of those amazing medicines that Biogen has come up with that has had such an impact on healthcare for particularly in the pediatric population. This is just one of those amazing medicines that Biogen has come up with that has had such an impact on healthcare for particularly in the pediatric population. this is just one of those amazing medicines that biogen has come up with that has had such an impact on healthcare for particularly in the pediatric population

Speaker 18: Let's go to the next question, please. Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Evan Seigerman with BMO Capital Markets. Your next question comes from the line of Evan Seigerman with BMO Capital Markets. your next question comes from the line of evan seigerman with bmo capital markets

Speaker 7: Hi, guys. Thank you so much for taking my question. Congrats on all the progress. I'd love to know, drill down a little more on the strength we saw with SKYCLARYS. You know, can you walk me through some of the drivers of this? I know it's been a lumpy product, you know, is this traction something we should really start to think through later in the year? Kind of what are some of the drivers there? Thank you so much. Hi, guys. hi guys Thank you so much for taking my question. thank you so much for taking my question Congrats on all the progress. congrats on all the progress I'd love to know, drill down a little more on the strength we saw with SKYCLARYS. i'd love to know drill down a little more on the strength we saw with skyclarys You know, can you walk me through some of the drivers of this? you know can you walk me through some of the drivers of this I know it's been a lumpy product, you know, is this traction something we should really start to think through later in the year? i know it's been a lumpy product you know is this traction something we should really start to think through later in the year Kind of what are some of the drivers there? kind of what are some of the drivers there Thank you so much. thank you so much

Speaker 5: Let's start with you. Let's start with you. let's start with you Let you start with the U.S., and then we can talk about ex. Let you start with the U.S., and then we can talk about ex. let you start with the u.s and then we can talk about ex

Speaker 2: Yeah. For SKYCLARYS, what you saw for the quarter, is with the $72 million year-over-year, it was a 4% growth. Quarter-over-quarter, it was down. It was down because the inventory was built at the end of Q4 last year. Fast-forward to Q1, if you look at the amount of buying weeks, Q1 has two fewer buying weeks than the prior quarter. If you look at patient demand, our patient demand was right on par. It's just we had a little bit of lumpiness with the inventory. Now, the second thing, though, just to remind everyone, is where the U.S. is at launch, is we are now at the launch phase where we are going out, we are using our patient finding our next best action in the field. Yeah. yeah For SKYCLARYS, what you saw for the quarter, is with the $72 million year-over-year, it was a 4% growth. for skyclarys what you saw for the quarter is with the $72 million year-over-year it was a 4% growth Quarter-over-quarter, it was down. quarter-over-quarter it was down It was down because the inventory was built at the end of Q4 last year. it was down because the inventory was built at the end of q4 last year Fast-forward to Q1, if you look at the amount of buying weeks, Q1 has two fewer buying weeks than the prior quarter. fast-forward to q1 if you look at the amount of buying weeks q1 has two fewer buying weeks than the prior quarter If you look at patient demand, our patient demand was right on par. if you look at patient demand our patient demand was right on par It's just we had a little bit of lumpiness with the inventory. it's just we had a little bit of lumpiness with the inventory Now, the second thing, though, just to remind everyone, is where the U.S. is at launch, is we are now at the launch phase where we are going out, we are using our patient finding our next best action in the field. now the second thing though just to remind everyone is where the u.s is at launch is we are now at the launch phase where we are going out we are using our patient finding our next best action in the field Where, you know, our reps every week receive a list of all the different offices they can go visit because we believe a patient is there, and then they go on the hunt. With that being said, now, you know, the majority of our patients are coming from doctors who will only ever write one prescription, ever for Friedreich's ataxia. These patients tend to be slower progressers, and they're much older than what we had predicted when we first launched the product. It will take more time as we find them. The good news is that we are finding them, and they are going on product. It does take time from finding the patient to when they finally put in their script. Where, you know, our reps every week receive a list of all the different offices they can go visit because we believe a patient is there, and then they go on the hunt. where you know our reps every week receive a list of all the different offices they can go visit because we believe a patient is there and then they go on the hunt With that being said, now, you know, the majority of our patients are coming from doctors who will only ever write one prescription, ever for Friedreich's ataxia. with that being said now you know the majority of our patients are coming from doctors who will only ever write one prescription ever for friedreich's ataxia These patients tend to be slower progressers, and they're much older than what we had predicted when we first launched the product. these patients tend to be slower progressers and they're much older than what we had predicted when we first launched the product It will take more time as we find them. it will take more time as we find them The good news is that we are finding them, and they are going on product. the good news is that we are finding them and they are going on product It does take time from finding the patient to when they finally put in their script. it does take time from finding the patient to when they finally put in their script

Speaker 15: In ex-U.S., actually our revenue in the quarter exceeded the U.S. for the first time from SKYCLARYS as we continue to execute on the launch there, both in Europe and starting in Latin America. We do see from a demand perspective, demand increasing ex-U.S. and expect that to continue as we continue the launches. As I mentioned earlier, it's already available in 35 countries. In ex-U.S., actually our revenue in the quarter exceeded the U.S. for the first time from SKYCLARYS as we continue to execute on the launch there, both in Europe and starting in Latin America. in ex-u.s actually our revenue in the quarter exceeded the u.s for the first time from skyclarys as we continue to execute on the launch there both in europe and starting in latin america We do see from a demand perspective, demand increasing ex-U.S. and expect that to continue as we continue the launches. we do see from a demand perspective demand increasing ex-u.s and expect that to continue as we continue the launches As I mentioned earlier, it's already available in 35 countries. as i mentioned earlier it's already available in 35 countries

Speaker 5: Yeah, in ex-U.S., we have a little different strategy. You know, as Alisha said, it's really finding the patient. As we found the patients, we have put them on drug, and they're on early access programs while we negotiate reimbursement. As we get reimbursement, you'll start to see the revenue suddenly flow through. It might be lumpy because we can switch potentially several hundred patients all at once from being a zero revenue patient to a full revenue patient. Right now we have not only more revenue, but we've had now for some time more patients outside the U.S. on drug than inside. Just as I say, they haven't been fully reimbursed. That is progressive. Yeah, in ex-U.S., we have a little different strategy. yeah in ex-u.s we have a little different strategy You know, as Alisha said, it's really finding the patient. you know as alisha said it's really finding the patient As we found the patients, we have put them on drug, and they're on early access programs while we negotiate reimbursement. as we found the patients we have put them on drug and they're on early access programs while we negotiate reimbursement As we get reimbursement, you'll start to see the revenue suddenly flow through. as we get reimbursement you'll start to see the revenue suddenly flow through It might be lumpy because we can switch potentially several hundred patients all at once from being a zero revenue patient to a full revenue patient. it might be lumpy because we can switch potentially several hundred patients all at once from being a zero revenue patient to a full revenue patient Right now we have not only more revenue, but we've had now for some time more patients outside the U.S. on drug than inside. right now we have not only more revenue but we've had now for some time more patients outside the u.s on drug than inside Just as I say, they haven't been fully reimbursed. just as i say they haven't been fully reimbursed That is progressive. that is progressive You know, we're now seeing really the rollout and potential reimbursement in Latin America, for example. You know, we're now seeing really the rollout and potential reimbursement in Latin America, for example. you know we're now seeing really the rollout and potential reimbursement in latin america for example

Speaker 18: Let's go to the next question, please. Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Alexandria Hammond with Wolfe Research. Your next question comes from the line of Alexandria Hammond with Wolfe Research. your next question comes from the line of alexandria hammond with wolfe research

Speaker 1: Thanks for taking the question. Another on BIIB080. What's the potential in other tauopathies? As a follow-up, what will be the most important biomarker from the upcoming phase II results in terms of informing next steps but beyond Alzheimer's? Thank you. Thanks for taking the question. thanks for taking the question Another on BIIB080. another on biib080 What's the potential in other tauopathies? what's the potential in other tauopathies As a follow-up, what will be the most important biomarker from the upcoming phase II results in terms of informing next steps but beyond Alzheimer's? as a follow-up what will be the most important biomarker from the upcoming phase ii results in terms of informing next steps but beyond alzheimer's Thank you. thank you

Speaker 14: Yes. Thank you. This is an area that we are discussing quite deeply. We know the high unmet need in primary tau, tauopathies. What we've seen in terms of tau reduction with BIIB080, at least in our phase Ib trial, was very encouraging. I think we would be looking for tau reduction, we would be looking for other details, I mean, regions of the brain, and such. That would inform our strategy on whether we would continue to think about doing more work in primary tauopathies. Yes, it remains high on our list of evaluations and potential possibilities. Yes. yes Thank you. thank you This is an area that we are discussing quite deeply. this is an area that we are discussing quite deeply We know the high unmet need in primary tau, tauopathies. we know the high unmet need in primary tau tauopathies What we've seen in terms of tau reduction with BIIB080, at least in our phase Ib trial, was very encouraging. what we've seen in terms of tau reduction with biib080 at least in our phase ib trial was very encouraging I think we would be looking for tau reduction, we would be looking for other details, I mean, regions of the brain, and such. i think we would be looking for tau reduction we would be looking for other details i mean regions of the brain and such That would inform our strategy on whether we would continue to think about doing more work in primary tauopathies. that would inform our strategy on whether we would continue to think about doing more work in primary tauopathies Yes, it remains high on our list of evaluations and potential possibilities. yes it remains high on our list of evaluations and potential possibilities

Speaker 5: Thanks, Priya. Let's go to the next question, please. Thanks, Priya. thanks priya Let's go to the next question, please. let's go to the next question please

Speaker 12: Your next question comes from the line of Terence Flynn with Morgan Stanley. Your next question comes from the line of Terence Flynn with Morgan Stanley. your next question comes from the line of terence flynn with morgan stanley

Speaker 17: Great. Thanks for taking the question. Just one on felza for me and AMR. Obviously, you called out the acquisition of the China rights for $100 million and then some pretty significant, back-end loaded milestones. Just thinking through what this means for the broader commercial opportunity, maybe both, not just in China, but also on the global basis and how you're thinking about that relative to consensus. Thank you. Great. great Thanks for taking the question. thanks for taking the question Just one on felza for me and AMR. just one on felza for me and amr Obviously, you called out the acquisition of the China rights for $ 100 million and then some pretty significant, back-end loaded milestones. obviously you called out the acquisition of the china rights for $ 100 million and then some pretty significant back-end loaded milestones Just thinking through what this means for the broader commercial opportunity, maybe both, not just in China, but also on the global basis and how you're thinking about that relative to consensus. just thinking through what this means for the broader commercial opportunity maybe both not just in china but also on the global basis and how you're thinking about that relative to consensus Thank you. thank you

Speaker 5: Yeah. You know, again, I think, as you look at kidney disease, a lot of this there have not been treatments for it. There's a whole alphabet soup of these things, right? You've got IC-MPGN, you've got AMR, you've got PMN, you've got C3G. I think it's hard actually even to come up with sometimes the epidemiology. I can tell you on the MPGN, for EMPAVELI, you know, it's actually not very clear exactly what the actual underlying epidemiology is. It's hard for, I think, investors to really assess some of these. What we do know, for instance, on AMR, is we just take that there are about probably 11,000 patients. Yeah. yeah You know, again, I think, as you look at kidney disease, a lot of this there have not been treatments for it. you know again i think as you look at kidney disease a lot of this there have not been treatments for it There's a whole alphabet soup of these things, right? there's a whole alphabet soup of these things right You've got IC-MPGN, you've got AMR, you've got PMN, you've got C3G. you've got ic-mpgn you've got amr you've got pmn you've got c3g I think it's hard actually even to come up with sometimes the epidemiology. i think it's hard actually even to come up with sometimes the epidemiology I can tell you on the MPGN, for EMPAVELI, you know, it's actually not very clear exactly what the actual underlying epidemiology is. i can tell you on the mpgn for empaveli you know it's actually not very clear exactly what the actual underlying epidemiology is It's hard for, I think, investors to really assess some of these. it's hard for i think investors to really assess some of these What we do know, for instance, on AMR, is we just take that there are about probably 11,000 patients. what we do know for instance on amr is we just take that there are about probably 11,000 patients If you actually look at the price of IgAN, and certainly even more if you, if you look at it with the latest Otsuka price in IgAN of about $350,000 a year, you know you're looking at a total addressable market of, you know, north of $2 billion, somewhere between $2 billion and $3 billion, in fact, right? There hasn't been any treatment there in the past. Certainly the phase II data, although small numbers, you know, showed remarkable 80% resolution of AMR. Then you've got MDI, which is sort of a cousin of AMR, that adds another 5,000 or 6,000 patients, and we've just initiated a trial in MDI. If you actually look at the price of IgAN, and certainly even more if you, if you look at it with the latest Otsuka price in IgAN of about $350,000 a year, you know you're looking at a total addressable market of, you know, north of $2 billion, somewhere between $2 billion and $3 billion, in fact, right? if you actually look at the price of igan and certainly even more if you if you look at it with the latest otsuka price in igan of about $350,000 a year you know you're looking at a total addressable market of you know north of $2 billion somewhere between $2 billion and $3 billion in fact right There hasn't been any treatment there in the past. there hasn't been any treatment there in the past Certainly the phase II data, although small numbers, you know, showed remarkable 80% resolution of AMR. certainly the phase ii data although small numbers you know showed remarkable 80% resolution of amr Then you've got MDI, which is sort of a cousin of AMR, that adds another 5,000 or 6,000 patients, and we've just initiated a trial in MDI. then you've got mdi which is sort of a cousin of amr that adds another 5,000 or 6,000 patients and we've just initiated a trial in mdi IgAN, you know, is obviously gonna be a significant market, particularly in Asia. You know, I think there's two things where we see competitiveness. When you start looking at any autoimmune disease, and Priya can speak more to this, but you really wanna think about where are you in the whole immune cascade. You know, in most cases, if you're treating an autoimmune disease, you're trying to suppress the immune system. You don't really wanna do that any more than you have to. Having something that is as close to the actual disease cause I think is gonna be relevant, and that's where we think CD38 has a huge advantage of really acting on the plasma cells and the NK cells. The other is really the durability of treatment. IgA N, you know, is obviously gonna be a significant market, particularly in Asia. iga n you know is obviously gonna be a significant market particularly in asia You know, I think there's two things where we see competitiveness. you know i think there's two things where we see competitiveness When you start looking at any autoimmune disease, and Priya can speak more to this, but you really wanna think about where are you in the whole immune cascade. when you start looking at any autoimmune disease and priya can speak more to this but you really wanna think about where are you in the whole immune cascade You know, in most cases, if you're treating an autoimmune disease, you're trying to suppress the immune system. you know in most cases if you're treating an autoimmune disease you're trying to suppress the immune system You don't really wanna do that any more than you have to. you don't really wanna do that any more than you have to Having something that is as close to the actual disease cause I think is gonna be relevant, and that's where we think CD38 has a huge advantage of really acting on the plasma cells and the NK cells. having something that is as close to the actual disease cause i think is gonna be relevant and that's where we think cd38 has a huge advantage of really acting on the plasma cells and the nk cells The other is really the durability of treatment. the other is really the durability of treatment In IgAN, you know, we showed in a phase II that after nine infusions, that we still had durability of treatment after 18 months. You know, that says that, you know, maybe we're doing something here that looks more disease modifying than other agents. Priya, you should probably weigh in here, you, since you're much more expert than I am on this. In IgAN, you know, we showed in a phase II that after nine infusions, that we still had durability of treatment after 18 months. in igan you know we showed in a phase ii that after nine infusions that we still had durability of treatment after 18 months You know, that says that, you know, maybe we're doing something here that looks more disease modifying than other agents. you know that says that you know maybe we're doing something here that looks more disease modifying than other agents Priya, you should probably weigh in here, you, since you're much more expert than I am on this. priya you should probably weigh in here you since you're much more expert than i am on this

Speaker 14: I think you covered it well, Chris. We're really excited about the first readout for felzartamab. We expect this in 2027. Really it's stepping back. It's a seed. It's targeting the CD38 positive plasma cells, which we believe are a key source of the pathogenic autoantibodies. The readout is really a biopsy readout, which is also very objective. We're excited about this. I think you covered it well, Chris. i think you covered it well chris We're really excited about the first readout for felzartamab. we're really excited about the first readout for felzartamab We expect this in 2027. we expect this in 2027 Really it's stepping back. really it's stepping back It's a seed. it's a seed It's targeting the CD38 positive plasma cells, which we believe are a key source of the pathogenic autoantibodies. it's targeting the cd38 positive plasma cells which we believe are a key source of the pathogenic autoantibodies The readout is really a biopsy readout, which is also very objective. the readout is really a biopsy readout which is also very objective We're excited about this. we're excited about this

Speaker 18: Great. I think we've got time for one last question. Maybe go to the last one, please. Great. great I think we've got time for one last question. i think we've got time for one last question Maybe go to the last one, please. maybe go to the last one please

Speaker 12: Your next question comes from the line of Jay Olson with Oppenheimer. Your next question comes from the line of Jay Olson with Oppenheimer. your next question comes from the line of jay olson with oppenheimer

Speaker 9: Oh, hey. Congrats on the quarter, and thanks for the update. Can you talk about the real-world treatment persistence of LEQEMBI that was presented at ADPD with regards to how you expect the subQ version to further impact treatment persistence? Thank you. Oh, hey. oh hey Congrats on the quarter, and thanks for the update. congrats on the quarter and thanks for the update Can you talk about the real-world treatment persistence of LEQEMBI that was presented at ADPD with regards to how you expect the subQ version to further impact treatment persistence? can you talk about the real-world treatment persistence of leqembi that was presented at adpd with regards to how you expect the subq version to further impact treatment persistence Thank you. thank you

Speaker 14: Yes. Thanks, Jay. I think overall, you know, there's a question, there has been a question lingering out there whether after reduction and clearance of plaques, you continue to keep patients on an anti-amyloid therapy, specifically one like LEQEMBI, which has a dual target of the soluble toxic species as well as plaque reduction. We've shown extensive data in prior meetings on the benefits of keeping patients on therapy. This again is a progressive disease. Once neurons die, you cannot recover them. We've shown that fluid biomarkers actually come back within less than six months, and then, you know, although the plaque comes back much slower. That's one piece. I think the real-world evidence data is compelling because it shows that patients and neurologists actually want to continue to stay on therapy. Yes. yes Thanks, Jay. thanks jay I think overall, you know, there's a question, there has been a question lingering out there whether after reduction and clearance of plaques, you continue to keep patients on an anti-amyloid therapy, specifically one like LEQEMBI, which has a dual target of the soluble toxic species as well as plaque reduction. i think overall you know there's a question there has been a question lingering out there whether after reduction and clearance of plaques you continue to keep patients on an anti-amyloid therapy specifically one like leqembi which has a dual target of the soluble toxic species as well as plaque reduction We've shown extensive data in prior meetings on the benefits of keeping patients on therapy. we've shown extensive data in prior meetings on the benefits of keeping patients on therapy This again is a progressive disease. this again is a progressive disease Once neurons die, you cannot recover them. once neurons die you cannot recover them We've shown that fluid biomarkers actually come back within less than six months, and then, you know, although the plaque comes back much slower. we've shown that fluid biomarkers actually come back within less than six months and then you know although the plaque comes back much slower That's one piece. that's one piece I think the real-world evidence data is compelling because it shows that patients and neurologists actually want to continue to stay on therapy. i think the real-world evidence data is compelling because it shows that patients and neurologists actually want to continue to stay on therapy That I think is the powerful reflection of that data, and this continues to be really, really important for us. Now, we are waiting. We already have subcutaneous maintenance, which again makes it simpler and offers patients optionality on staying on therapy. With subcutaneous initiation, where we'll get an outcome from the FDA next month, you know, we continue to remain very optimistic about how this could inflect in terms of the patient journey. Finally, I'll just add a point about our pre-symptomatic trial, AHEAD 3-45, which is still to read out in 2028. You know, we'll see about that readout. We think it's going to be an important landmark trial in the field. That I think is the powerful reflection of that data, and this continues to be really, really important for us. that i think is the powerful reflection of that data and this continues to be really really important for us Now, we are waiting. now we are waiting We already have subcutaneous maintenance, which again makes it simpler and offers patients optionality on staying on therapy. we already have subcutaneous maintenance which again makes it simpler and offers patients optionality on staying on therapy With subcutaneous initiation, where we'll get an outcome from the FDA next month, you know, we continue to remain very optimistic about how this could inflect in terms of the patient journey. with subcutaneous initiation where we'll get an outcome from the fda next month you know we continue to remain very optimistic about how this could inflect in terms of the patient journey Finally, I'll just add a point about our pre-symptomatic trial, AHEAD 3-45, which is still to read out in 2028. finally i'll just add a point about our pre-symptomatic trial ahead 3-45 which is still to read out in 2028 You know, we'll see about that readout. you know we'll see about that readout We think it's going to be an important landmark trial in the field. we think it's going to be an important landmark trial in the field What becomes important with subcutaneous getting accepted is that there could be an interchangeability, which could be very relevant in the pre-symptomatic population. Again, we believe that this is gonna be a very important inflection point. What becomes important with subcutaneous getting accepted is that there could be an interchangeability, which could be very relevant in the pre-symptomatic population. what becomes important with subcutaneous getting accepted is that there could be an interchangeability which could be very relevant in the pre-symptomatic population Again, we believe that this is gonna be a very important inflection point. again we believe that this is gonna be a very important inflection point

Speaker 18: Thanks, Priya. Thanks everybody for joining the call today. If you've got more questions, reach out to me or Daniel or Steve. Thank you. Thanks, Priya. thanks priya Thanks everybody for joining the call today. thanks everybody for joining the call today If you've got more questions, reach out to me or Daniel or Steve. if you've got more questions reach out to me or daniel or steve Thank you. thank you

Speaker 12: This concludes today's call. Thank you for your participation. You may now disconnect. This concludes today's call. this concludes today's call Thank you for your participation. thank you for your participation You may now disconnect. you may now disconnect