Q2 2026 Biogen Inc Earnings Call

July 29, 2026

Speaker #1: Operator today. At this time, I would like to welcome everyone to the Biogen's second quarter 2026 earnings call and business update. All lines have been placed on mute to prevent any background noise.

Operator: operator today. At this time, I would like to welcome everyone to the Biogen Q2 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.

Speaker #1: After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star 1 on your telephone keypad.

Speaker #1: Please limit yourself to 1 question to allow other participants time for questions. If you require any further follow-up, you may press star 1 again to rejoin the queue.

Speaker #1: 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.

Speaker #2: Thanks, Jess. And good morning, everyone. Welcome to Biogen's second quarter 2026 earnings call. During this call, we will make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements.

Tim Power: Thanks, Jess, and good morning, everyone. Welcome to Biogen's Q2 2026 earnings call. During this call, we will make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results, as well as reconciliations between GAAP and non-GAAP results discussed on this call, can be found in the investor section of biogen.com. We have also posted slides to our website that will be used during the call. On today's call, I am 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 available for the Q&A section of the call.

Speaker #2: We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results as well as reconciliations between GAAP and non-GAAP results discussed in this call can be found in the investor section of biogen.com.

Speaker #1: 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.

Speaker #2: Thanks, Jess. And

Speaker #2: We've also posted slides to our website that will be used during the call. On today's call, I'm joined by our president and chief executive officer, Chris Vebacker.

Tim Power: On today's call, I am 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 available for the Q&A section of the call. We will make some opening comments and we will move to Q&A. To allow us to get through as many questions as possible, we kindly ask that you limit yourselves to just one question. I will now turn the call over to Chris.

Speaker #2: Dr. Priya Singal, Head of Development, and Robin Kramer, our chief financial officer. Alicia, Elimo, president of North America, will also be available for the Q&A section of the call.

Speaker #2: We'll make some opening comments, and we'll move to Q&A. And to allow us to get through as many questions as possible, we kindly ask that you limit yourselves to just 1 question, and I'll now turn the call over to Chris.

Tim Power: We will make some opening comments and we will move to Q&A. To allow us to get through as many questions as possible, we kindly ask that you limit yourselves to just one question. I will now turn the call over to Chris.

Speaker #3: Will you? With the goal of achieving sustainable revenue growth.

Chris A. Viehbacher: portfolio with the goal of achieving sustainable revenue growth. If I take the three elements that I think contribute to that is first is our growth product portfolio. Now, even before we include the products from Apellis, we have seen significant growth, and in fact, our growth portfolio now is greater than our legacy MS portfolio. That has really been most recently enhanced by two important achievements. The first is SPINRAZA high dose, where we have seen across all markets. The first market to be approved was in Japan, then Europe, and now the US, and we are starting to see this roll out into more international markets. In all of those markets, this conversion has gone much faster than we expected, and that is an important development for us because this is an extremely competitive market, where efficacy matters, and we have seen considerable efficacy benefits come from the high dose of SPINRAZA.

Chris Viehbacher: portfolio with the goal of achieving sustainable revenue growth. If I take the three elements that I think contribute to that is first is our growth product portfolio. Now, even before we include the products from Apellis, we have seen significant growth, and in fact, our growth portfolio now is greater than our legacy MS portfolio. That has really been most recently enhanced by two important achievements. The first is SPINRAZA high dose, where we have seen across all markets.

Speaker #2: So if I take the 3 elements that I think contribute to that is, first is our growth product portfolio. Now, even before we include the products from Pellis, we've seen significant growth.

Speaker #2: And in fact, our growth portfolio now is greater than our legacy MS portfolio. And that's really been most recently enhanced by 2 important achievements.

Speaker #2: The first is Spinraza High Dose. Where we've seen across all markets, the first market to be approved was in Japan, then Europe, and now the US.

Chris Viehbacher: The first market to be approved was in Japan, then Europe, and now the US, and we are starting to see this roll out into more international markets. In all of those markets, this conversion has gone much faster than we expected, and that is an important development for us because this is an extremely competitive market, where efficacy matters, and we have seen considerable efficacy benefits come from the high dose of SPINRAZA.

Speaker #2: And we're starting to see this roll out into more international markets. In all of those markets, this conversion has gone much faster than we expected.

Speaker #2: And that's an important development for us because this is a extremely competitive market, where efficacy matters. And we've seen considerable efficacy benefits come from the high dose of Spinraza.

Speaker #2: And this is a franchise that we see for the longer term because we've got sala nursing coming along behind that. So maintaining market share and, in fact, what we're seeing is some anecdotal switchbacks particularly from the oral product to Spinraza, it's an important not only for the quarter but important for the franchise longer term.

Chris A. Viehbacher: This is a franchise that we see for the longer term because we've got salanersen coming along behind that. Maintaining market share and in fact, what we're seeing is some anecdotal switchbacks, particularly from the oral product to SPINRAZA. It's important not only for the quarter, but important for the franchise longer term. The second major achievement this quarter was really LEQEMBI IQLIK. It's the first of its kind Alzheimer's treatment, so now offering home dosing for both initiation and maintenance. I think there's probably two opportunities in particular here, maybe even three. The first is obviously with the biweekly infusion. A number of physicians are thinking carefully about which patients are actually going to be eligible for treatment.

Chris Viehbacher: This is a franchise that we see for the longer term because we've got salanersen coming along behind that. Maintaining market share and in fact, what we're seeing is some anecdotal switchbacks, particularly from the oral product to SPINRAZA. It's important not only for the quarter, but important for the franchise longer term. The second major achievement this quarter was really LEQEMBI IQLIK. It's the first of its kind Alzheimer's treatment, so now offering home dosing for both initiation and maintenance. I think there's probably two opportunities in particular here, maybe even three. The first is obviously with the biweekly infusion. A number of physicians are thinking carefully about which patients are actually going to be eligible for treatment.

Speaker #2: The second major achievement this quarter was really Leqembi I-Click. It's the first of its kind Alzheimer's treatment. So now offering home dosing for both initiation and maintenance.

Speaker #2: I think there's probably 2 opportunities in particular here. Maybe even 3. The first is, obviously, with the biweekly infusion a number of physicians are thinking carefully about which patients are actually going to be eligible for treatment.

Speaker #2: If they don't think that the patient can get there on their own, or there's not a caregiver who's prepared to take the time to get that patient to the infusion centers, those patients are often not offered treatment.

Chris A. Viehbacher: If they don't think that the patient can get there on their own, or there's not a caregiver who's prepared to take the time to get that patient to the infusion centers, those patients are often not offered treatment. This should perhaps make it easier for a broader section of patients to become eligible for treatment. We think also that there could be a benefit in maintaining patients longer on therapy. Finally, we think there's a competitive advantage because the benefit that the competitor has with once monthly dosing now seems to be much less when you've got a home subcutaneous option for them. The second element of the sustainable growth is our pipeline, and we'll come on and talk about that in a few minutes. The third element is really SYFOVRE and EMPAVELI from the acquisition of Apellis.

Chris Viehbacher: If they don't think that the patient can get there on their own, or there's not a caregiver who's prepared to take the time to get that patient to the infusion centers, those patients are often not offered treatment. This should perhaps make it easier for a broader section of patients to become eligible for treatment. We think also that there could be a benefit in maintaining patients longer on therapy. Finally, we think there's a competitive advantage because the benefit that the competitor has with once monthly dosing now seems to be much less when you've got a home subcutaneous option for them. The second element of the sustainable growth is our pipeline, and we'll come on and talk about that in a few minutes. The third element is really SYFOVRE and EMPAVELI from the acquisition of Apellis.

Speaker #2: So this should perhaps make it easier for a broader section of patients to become eligible for treatment. We think also that there could be a benefit in maintaining patients longer on therapy.

Speaker #2: And then finally, we think there's a competitive advantage because the benefit that the competitor has with monthly dosing now seems to be much less when you've got a home subcutaneous option for them.

Speaker #2: The second element of the sustainable growth is our pipeline, and we'll come on and talk about that in a few minutes. But then the third element is really Siphovery and Favelli from the acquisition of Apellis.

Speaker #2: You know, you've seen strong double-digit growth for both the full quarter and year-to-date for the combined sales of those 2 products. Now, we're only consolidating the revenue from the 14th of May when we closed the transaction.

Chris A. Viehbacher: You've seen strong double-digit growth for both the full quarter and year to date for the combined sales of those two products. Now we're only consolidating the revenue from 14 May when we closed the transaction. Those products are already contributing significantly to our own growth. I'll take the opportunity here, just to note that if I think about all of the integrations that I've certainly seen over my career, one of the most important metrics is really how revenue does through this period of turbulence really in organizations. There's an awful lot of uncertainty that comes from these major transactions. The ability to maintain continuity of revenue is, I think, the number one measure of the success of an integration. I think so far, that we have seen that and that's really because this is mostly a US transaction.

Chris Viehbacher: You've seen strong double-digit growth for both the full quarter and year to date for the combined sales of those two products. Now we're only consolidating the revenue from 14 May when we closed the transaction. Those products are already contributing significantly to our own growth. I'll take the opportunity here, just to note that if I think about all of the integrations that I've certainly seen over my career, one of the most important metrics is really how revenue does through this period of turbulence really in organizations. There's an awful lot of uncertainty that comes from these major transactions. The ability to maintain continuity of revenue is, I think, the number one measure of the success of an integration. I think so far, that we have seen that and that's really because this is mostly a US transaction.

Speaker #2: But those products are already contributing significantly to our own growth. And I'll take the opportunity here just to note that, you know, if I think about all of the integrations that I've certainly seen over my career, one of the most important metrics is really how revenue does through this period of, you know, turbulence really in organizations.

Speaker #2: There's an awful lot of uncertainty that comes from these major transactions. And, you know, the ability to maintain continuity of revenue is, I think, the number 1 measure of the success of an integration.

Speaker #2: And I think so far, that we have seen that. And that's really because this is mostly a US transaction, this is really a credit to Alicia's leadership and her team in really reaching out and making sure that the Apellis team feels great about joining Biogen.

Chris A. Viehbacher: This is really a credit to Alisha's leadership and her team in really reaching out and making sure that the Apellis team feels great about joining Biogen. Certainly when I talk to the former Apellis now Biogen employees, one senses a sense of energy and passion and commitment. We're very much encouraged by the importance of this acquisition. The next slide is really again, and Priya's going to talk a lot more about this, but we've got a growing base, and now we've got five registrational phase III clinical trial results coming along. Obviously, two in SLE for lupus, one in CLE for lupus, one for AMR and one which is really from our partner at Stoke in Dravet syndrome. Those are now within the next four quarters. These are imminent and could really make a difference to the long-term growth outlook of Biogen.

Chris Viehbacher: This is really a credit to Alisha's leadership and her team in really reaching out and making sure that the Apellis team feels great about joining Biogen. Certainly when I talk to the former Apellis now Biogen employees, one senses a sense of energy and passion and commitment. We're very much encouraged by the importance of this acquisition.

Speaker #2: And certainly, when I talk to the former Apellis, now Biogen employees, one senses a sense of energy and passion and commitment. So we're very much encouraged by the importance of this acquisition.

Chris Viehbacher: success and integration. I think so far, that we have seen that, and that's really because this is mostly a US transaction, this is really a credit to Alisha's leadership and her team in really reaching out and making sure that the Apellis team feels great about joining Biogen. Certainly when I talk to the former Apellis, now Biogen employees, one sense is a sense of energy and passion and commitment. We're very much encouraged by the importance of this acquisition. The next slide is really again, Priya's going to talk a lot more about this, but we've got a growing base, and now we've got five registrational phase III clinical trial results coming along. Obviously, two in SLE for lupus, one in CLE for lupus, one for AMR, and one, which is really from our partner at Stoke, in Dravet syndrome.

Chris Viehbacher: Success and integration. I think so far, that we have seen that, and that's really because this is mostly a US transaction, this is really a credit to Alisha's leadership and her team in really reaching out and making sure that the Apellis team feels great about joining Biogen. Certainly when I talk to the former Apellis, now Biogen employees, one sense is a sense of energy and passion and commitment. We're very much encouraged by the importance of this acquisition. The next slide is really again, Priya's going to talk a lot more about this, but we've got a growing base, and now we've got five registrational phase III clinical trial results coming along. Obviously, two in SLE for lupus, one in CLE for lupus, one for AMR, and one, which is really from our partner at Stoke, in Dravet syndrome.

Speaker #2: So the next slide is really, again, and Priya is going to talk a lot more about this. But, you know, we've got a growing base.

Chris Viehbacher: The next slide is really again, and Priya's going to talk a lot more about this, but we've got a growing base, and now we've got five registrational phase III clinical trial results coming along. Obviously, two in SLE for lupus, one in CLE for lupus, one for AMR and one which is really from our partner at Stoke in Dravet syndrome. Those are now within the next four quarters. These are imminent and could really make a difference to the long-term growth outlook of Biogen.

Speaker #2: And now we've got 5 registrational phase 3 clinical trial results coming along. Obviously, 2 in SLE for lupus, 1 in CLE for lupus, 1 for AMR, and 1 which is really from our partner at Stoke in Dravet syndrome.

Speaker #2: So those are now within the next 4 quarters. So these are imminent. And they could really make a difference to the long-term growth outlook of Biogen.

Speaker #2: As we've talked about before, we're also rebuilding our early-stage pipeline. We went 3 years really without filing an IND. We made some really pretty dramatic moves to overhaul our research organization, how we do research.

Chris A. Viehbacher: As we've talked about before, we're also rebuilding our early-stage pipeline. We went three years really without filing an IND. We made some really pretty dramatic moves to overhaul our research organization, how we do research. The encouraging thing is that I think we are now in a much better place already in our early-stage pipeline. Some of that is coming early. We've had three INDs already this year. We've got more to come. We've done a number of key collaborations like Vanqua and Dayra last year, the acquisition of RayThera this year also substantially boosts our early-stage pipeline. This is really investing today for really what would be products launching in the mid-2030s. You've got to start today if you want to have that growth tomorrow. If I look at this slide, this is a slide we first showed at J.P. Morgan earlier this year.

Chris Viehbacher: As we've talked about before, we're also rebuilding our early-stage pipeline. We went three years really without filing an IND. We made some really pretty dramatic moves to overhaul our research organization, how we do research. The encouraging thing is that I think we are now in a much better place already in our early-stage pipeline. Some of that is coming early. We've had three INDs already this year. We've got more to come.

Speaker #2: And the encouraging thing is that I think we are now on a much better place already in our early-stage pipeline. Some of that is coming early.

Chris Viehbacher: Those are now within the next 4 quarters. These are imminent and could really make a difference to the long-term growth outlook of Biogen. As we talked about before, we're also rebuilding our early-stage pipeline. We went 3 years really without filing an IND. We made some really pretty dramatic moves to overhaul our research organization, how we do research. The encouraging thing is that I think we are now in a much better place already in our early-stage pipeline. Some of that is coming early. We've had 3 INDs already this year. We've got more to come. We've done a number of key collaborations like Vanqua Bio and Dayra Therapeutics last year, the acquisition of HI-Bio this year, also substantially boosts our early-stage pipeline.

Speaker #2: We've had 3 INDs already this year. We've got more to come. You know, we've done a number of key collaborations like Vanquil and Deva last year.

Chris Viehbacher: We've done a number of key collaborations like Vanqua and Dayra last year, the acquisition of RayThera this year also substantially boosts our early-stage pipeline. This is really investing today for really what would be products launching in the mid-2030s. You've got to start today if you want to have that growth tomorrow. If I look at this slide, this is a slide we first showed at J.P. Morgan earlier this year.

Speaker #2: The acquisition of Bracera this year. Also substantially boosts our early-stage pipeline. These are this is really investing today for really what would be products launching in the mid-2030s.

Speaker #2: But, you know, you've got to start today if you want to have those that growth tomorrow. And then if I look at this slide, this is a slide we first showed at JP Morgan earlier this year.

Speaker #2: At that time, we said, look, there are a number of near-term current growth drivers, and you see them with Leqembi and Zerzervay, Vimerity, Spinraza, Skyclaris, and Kalsadi.

Chris A. Viehbacher: At that time, we said, "Look, there are a number of near-term current growth drivers," and you see them with LEQEMBI, ZURZUVAE, VUMERITY, SPINRAZA, SKYCLARYS, and QALSODY. That is the group of products that now exceed our legacy MS portfolio and grew strongly in the quarter. Now, when you add SYFOVRE and EMPAVELI, these products already in themselves are enough to help Biogen get back to a growth story. When you look at what's coming, we just talked about these imminent data readouts. That's the second wave here, the registrational late-stage pipeline. These are all products with significant opportunity. Now, this is also a major shift for Biogen. Three and a half years ago when I came, we really only were visiting the neurologist. We had a few products that we could still promote in MS, and we had SPINRAZA.

Chris Viehbacher: At that time, we said, "Look, there are a number of near-term current growth drivers," and you see them with LEQEMBI, ZURZUVAE, VUMERITY, SPINRAZA, SKYCLARYS, and QALSODY. That is the group of products that now exceed our legacy MS portfolio and grew strongly in the quarter. Now, when you add SYFOVRE and EMPAVELI, these products already in themselves are enough to help Biogen get back to a growth story. When you look at what's coming, we just talked about these imminent data readouts. That's the second wave here, the registrational late-stage pipeline. These are all products with significant opportunity. Now, this is also a major shift for Biogen. Three and a half years ago when I came, we really only were visiting the neurologist. We had a few products that we could still promote in MS, and we had SPINRAZA.

Chris Viehbacher: This is really investing today for really what would be products launching in the mid 2030s, but you've got to start today if you want to have that growth tomorrow. Then if I look at this slide, this is a slide we first showed at J.P. Morgan earlier this year. At that time, we said, "Look, there are a number of near-term current growth drivers," and you see them with LEQEMBI and ZURZUVAE, VUMERITY, SPINRAZA, SKYCLARYS, and QALSODY. That is the group of products that now exceed our legacy MS portfolio and grew strongly in the quarter. When you add SYFOVRE and EMPAVELI, these products already in themselves are enough to help Biogen get back to a growth story. Then when you look at what's coming, we just talked about these imminent data readouts. That's the second wave here, the registrational late-stage pipeline.

Speaker #2: And that is the group of products that now exceed our legacy MS portfolio. And grew strongly in the quarter. Now, when you add Siphovery and Favelli, these products already in themselves are enough to help Biogen get back to a growth story.

Speaker #2: And then when you look at what's coming, we just talked about these imminent data readouts. That's the second wave here, the registrational late-stage pipeline.

Speaker #2: You know, these are all products with significant opportunity. Now, this is also a major shift. For Biogen, you know, 3 and 1/2 years ago when I came, we really only were visiting the neurologist, we had a few products that we could still promote in MS, and we had Spinraza.

Speaker #1: And that is the group of products that now exceed our legacy MS portfolio and grew strongly in the quarter. Now, when you add Fionavir and Empaveli, these products already in themselves are enough to help Biogen get back to a growth story.

Speaker #1: And then, when you look at what's coming, we just talked about these imminent data readouts. That's the second wave here, the registrational late-stage pipeline.

Speaker #2: We are now looking at visiting rheumatologists, dermatologists, nephrologists, outside the US, and epileptologists. And nephrology transplants. So there's been a significant growth in the breadth of our portfolio.

Chris A. Viehbacher: We are now looking at visiting rheumatologists, dermatologists, nephrologists outside the US, and epileptologists and nephrology transplants. There's been a significant growth in the breadth of our portfolio. That's exciting, it also means that really now we are shifting to not just growing the substrate of growth, but now executing on that growth story. There's a lot going on inside the company to make sure that all of those launches are a success. We're also keeping an eye on the longer term, and that's that third wave, the opportunities for longer-term growth. diranersen, and you've seen the data on that. Very promising new modality in Alzheimer's, not necessarily part of the equity story near term, but longer term, this could significantly contribute to Biogen's growth. This is where this renewed early-stage pipeline that I just talked about is so important and the research portfolio.

Chris Viehbacher: We are now looking at visiting rheumatologists, dermatologists, nephrologists outside the US, and epileptologists and nephrology transplants. There's been a significant growth in the breadth of our portfolio. That's exciting, it also means that really now we are shifting to not just growing the substrate of growth, but now executing on that growth story. There's a lot going on inside the company to make sure that all of those launches are a success.

Speaker #1: You know, these are all products with significant opportunity. Now, this is also a major shift. For BIOGEN, you know, 3 and a half years ago when I came, we really only were visiting the neurologist, we had a few products that we could still promote in MS, and we had Spinraza.

Chris Viehbacher: These are all products with significant opportunity. This is also a major shift for Biogen. 3 and a half years ago when I came, we really only were visiting the neurologist. We had a few products that we could still promote in MS, and we had SPINRAZA. We are now looking at visiting rheumatologists, dermatologists, nephrologists outside the US, epileptologists, and nephrology transplants. There's been a significant growth in the breadth of our portfolio. That's exciting, but it also means that really, now we are shifting to not just growing the substrate of growth, but now executing on that growth story. There's a lot going on inside the company to make sure that all of those launches are a success. We're also keeping an eye on the longer term, and that's that third wave, the opportunities for longer-term growth.

Speaker #2: That's exciting. But it also means that really now we are shifting to not just growing the substrate of growth, but now executing on that growth story.

Speaker #2: So there's a lot going on inside the company to make sure that all of those launches are a success. But, you know, we're also keeping an eye on the longer term.

Speaker #1: We are now looking at visiting—we're pneumatologists, dermatologists, nephrologists, outside the U.S. in epileptologists, and nephrology transplants. So there's been a significant growth in the breadth of our portfolio.

Chris Viehbacher: We're also keeping an eye on the longer term, and that's that third wave, the opportunities for longer-term growth. diranersen, and you've seen the data on that. Very promising new modality in Alzheimer's, not necessarily part of the equity story near term, but longer term, this could significantly contribute to Biogen's growth. This is where this renewed early-stage pipeline that I just talked about is so important and the research portfolio.

Speaker #2: And that's that third wave, the opportunities for longer-term growth. Dear Nursen, and you've seen the data on that. Very promising new modality in Alzheimer's, not necessarily part of the equity story near-term, but longer-term.

Speaker #1: That's exciting. But it also means that, really, now we're shifting to not just growing the substrate of growth, but now executing on that growth story.

Speaker #2: This could significantly contribute to Biogen's growth. This is where this renewed early-stage pipeline that I just talked about is so important. And the research portfolio.

Speaker #1: So there's a lot going on inside the company to make sure that all of those launches are a success. But, you know, we're also keeping an eye on the longer term, and that's that third wave—the opportunities for longer-term growth: dear nursing, and you've seen the data on that.

Speaker #2: From a BD/M&A point of view, I think, you know, I think we have what we need to grow near-term. I think we'll be less intentional about M&A and perhaps more opportunistic.

Chris A. Viehbacher: From a BD M&A point of view, I think we have what we need to grow near term. I think we'll be less intentional about M&A and perhaps more opportunistic. We'll be certainly intentional about the earlier stage development. Ideally, we'd like to be bringing in assets between development candidate and IND stage. When you look at what is the opportunity, and these are not revenue forecasts, but really an initial sense of what's the addressable market that come from the pipeline, and I would say we're still doing work. We've got lupus here as a potential $8 billion market. The MS market is over $20 billion. I think we're not there yet in terms of being able to really say how we access that.

Chris Viehbacher: From a BD M&A point of view, I think we have what we need to grow near term. I think we'll be less intentional about M&A and perhaps more opportunistic. We'll be certainly intentional about the earlier stage development. Ideally, we'd like to be bringing in assets between development candidate and IND stage. When you look at what is the opportunity, and these are not revenue forecasts, but really an initial sense of what's the addressable market that come from the pipeline, and I would say we're still doing work. We've got lupus here as a potential $8 billion market. The MS market is over $20 billion. I think we're not there yet in terms of being able to really say how we access that.

Chris Viehbacher: diranersen, and we've seen the data on that. Very promising new modality in Alzheimer's, not necessarily part of the equity story near term, but longer term, this could significantly contribute to Biogen's growth. This is where this renewed early-stage pipeline that I just talked about is so important, and the research portfolio. From a BD M&A point of view, I think we have what we need to grow near term. I think we'll be less intentional about M&A and perhaps more opportunistic. We'll be certainly intentional about the earlier stage development. Ideally, we'd like to be bringing in the assets between development candidate and IND stage. When you look at what is the opportunity, and these are not revenue forecasts, but really an initial sense of what's the addressable market that come from the pipeline, I would say we're still doing work.

Chris Viehbacher: Diranersen, and we've seen the data on that. Very promising new modality in Alzheimer's, not necessarily part of the equity story near term, but longer term, this could significantly contribute to Biogen's growth. This is where this renewed early-stage pipeline that I just talked about is so important, and the research portfolio. From a BD M&A point of view, I think we have what we need to grow near term. I think we'll be less intentional about M&A and perhaps more opportunistic. We'll be certainly intentional about the earlier stage development. Ideally, we'd like to be bringing in the assets between development candidate and IND stage. When you look at what is the opportunity, and these are not revenue forecasts, but really an initial sense of what's the addressable market that come from the pipeline, I would say we're still doing work.

Speaker #1: Very promising new modality in Alzheimer's, not necessarily part of the equity story near-term, but longer-term, this could significantly contribute to BIOGEN's growth. This is where this renewed early-stage pipeline that I just talked about is so important, and the research portfolio.

Speaker #2: But we'll be certainly intentional about the earlier-stage development. I mean, ideally, we'd like to be bringing in assets between development candidate and IND stage.

Speaker #2: And so when you look at, you know, what is the opportunity? And these are not revenue forecasts, but really you know, an initial sense of what's the addressable market that come from the pipeline.

Speaker #1: From a BD/M&A point of view, I think, you know, I think we have what we need to grow near-term. I think we'll be less intentional about M&A and perhaps more opportunistic.

Speaker #2: And I would say we're still doing work. You know, we've got lupus here as a potential $8 billion market. You know, the MS market is over $20 billion.

Speaker #1: But we'll be certainly intentional about the earlier-stage development. I mean, ideally, we'd like to be bringing in assets between development candidate and IND stage.

Speaker #2: And, you know, I think we're not there yet in terms of being able to really say how we access that. It's probably a 2 to 3 billion market today.

Chris A. Viehbacher: It's probably a $2 to 3 billion market today, but there's no real reason why this market shouldn't be the size of MS. Even if you just say the $8 billion, that's a significant opportunity for us to go after, and obviously not only with litifilimab, but we would hope to be the first product to be approved for CLE. You got AMR, approximately 11,000 patients just in the US alone. Phase III data coming in early 2027. That's at least a $2 billion addressable market here. It depends on which pricing you're using, but when you see the pricing that is now occurring in IGAN, that is going to have a spillover effect on AMR. When you think about microvascular inflammation, which is another indication we're pursuing, that market could also grow.

Chris Viehbacher: It's probably a $2 to 3 billion market today, but there's no real reason why this market shouldn't be the size of MS. Even if you just say the $8 billion, that's a significant opportunity for us to go after, and obviously not only with litifilimab, but we would hope to be the first product to be approved for CLE. You got AMR, approximately 11,000 patients just in the US alone. Phase III data coming in early 2027. That's at least a $2 billion addressable market here. It depends on which pricing you're using, but when you see the pricing that is now occurring in IGAN, that is going to have a spillover effect on AMR. When you think about microvascular inflammation, which is another indication we're pursuing, that market could also grow.

Speaker #1: And so when you look at, you know, what is the opportunity? And these are not revenue forecasts, but really—you know, an initial sense of what's the addressable market that come from the pipeline, and I would say we're still doing work.

Speaker #2: But there's no real reason why this market shouldn't be the size of MS. But even if you just say the $8 billion, that's a significant opportunity for us to go after.

Speaker #2: And obviously, not only with SLE, but we would hope to be the first product to be approved for CLE. Then you've got AMR. Approximately 11,000 patients just in the US alone.

Speaker #1: You know, we've got lupus here as a potential $8 billion market. You know, the MS market is over $20 billion. And, you know, I think we're not there yet in terms of being able to really say how we access that.

Chris Viehbacher: We've got lupus here as a potential $8 billion market. The MS market is over $20 billion. I think we're not there yet in terms of being able to really say how we access that. It's probably a $2 to 3 billion market today. There's no real reason why this market shouldn't be the size of MS. Even if you just say the $8 billion, that's a significant opportunity for us to go after. Obviously not only with SLE, but we would hope to be the first product to be approved for CLE. You got AMR. Approximately 11,000 patients just in the US alone. phase III data coming in early 2027. That's at least a $2 billion addressable market here.

Speaker #2: Phase 3 data coming in early 2027. You know, that's at least a $2 billion addressable market here. You know, it depends on which pricing you're using.

Speaker #1: It's probably a $2 to $3 billion market today, but there's no real reason why this market shouldn't be the size of MS. But even if you just say the $8 billion, that's a significant opportunity for us to go after.

Speaker #2: But when you see the pricing that is now occurring in IGAN, that is going to have a spillover effect on AMR. And then when you think about microvascular inflammation, which is another indication we're pursuing, that market could also grow, and of course, then later on, we've got IGAN and PMN data coming for palsartanab.

Speaker #1: And obviously, not only with SLE, but we would hope to be the first product to be approved for CLE. Then you've got AMR, approximately $11,000 patients just in the U.S.

Chris A. Viehbacher: Of course, later on, we've got IGAN and PMN data coming for felzartamab. Dravet syndrome, as you know, we have the ex-US rights, but even in ex-US markets, there are about 7,000 patients in Europe alone, and when you add up all of our key Biogen territories, that's at least a $2 billion opportunity. Again, we're busy working on that. We're still, in some ways, 18 to 24 months from launch on those things, and continuing to work. This shows the potential. It also shows why we have to execute with excellence, and we're busy investing today to make sure those launches are a success. If we go to the last slide. If you looked at Biogen pre the Apellis announcement, consensus of investors was that Biogen was going to be roughly flat through 2030.

Chris Viehbacher: Of course, later on, we've got IGAN and PMN data coming for felzartamab. Dravet syndrome, as you know, we have the ex-US rights, but even in ex-US markets, there are about 7,000 patients in Europe alone, and when you add up all of our key Biogen territories, that's at least a $2 billion opportunity. Again, we're busy working on that. We're still, in some ways, 18 to 24 months from launch on those things, and continuing to work. This shows the potential. It also shows why we have to execute with excellence, and we're busy investing today to make sure those launches are a success. If we go to the last slide. If you looked at Biogen pre the Apellis announcement, consensus of investors was that Biogen was going to be roughly flat through 2030.

Speaker #1: alone. Phase 3 data coming in early 2027. You know, that's at least a $2 billion addressable market here. You know, it depends on which pricing you're using, but when you see the pricing that is now occurring in IGAN, that is going to have a spillover effect on AMR.

Speaker #2: And then Dravet syndrome, as you know, we have the ex-US rights. But even in ex-US markets, there are about 7,000 patients in Europe alone.

Chris Viehbacher: It depends on which pricing you're using, but when you see the pricing that is now occurring in IgAN, that is going to have a spillover effect on AMR. When you think about microvascular inflammation, which is another indication we're pursuing, that market could also grow. Of course, later on, we've got IgAN and PMN data coming for felzartamab. Dravet syndrome, as you know, we have the ex-US rights. Even in ex-US markets, there are about 7,000 patients in Europe alone. When you add up all of our key Biogen territories, that's at least a $2 billion opportunity. Again, we're busy working on that. We're still, in some ways, 18 to 24 months from launch on those things, and continuing to work. This shows the potential.

Speaker #2: And when you add up all of our key Biogen territories, you know, that's at least a $2 billion opportunity. Again, you know, we're busy working on that.

Speaker #1: And then when you think about microvascular inflammation, which is another indication we're pursuing, that market could also grow, and of course, then later on we've got IGAN and PMN data coming for Felsartan.

Speaker #2: We're still in some ways 18 to 24 months from launch on those things. And continue to work. But this shows the potential. It also shows why we have to execute with excellence.

Speaker #1: And then Dravet syndrome, as you know, we have the ex-U.S. rights, but even in ex-U.S. markets, there are about 7,000 patients in Europe alone. And when you add up all of our key Biogen territories, you know, that's at least a $2 billion opportunity.

Speaker #2: And we're busy investing launches are a success. And so I go to the last slide. You know, if you looked at Biogen pre the epilepsy announcement, you know, consensus of investors was that Biogen was going to be roughly flat through 2030.

Speaker #1: Again, you know, we're busy working on that. We're still, in some ways, 18 to 24 months from launch on those things. And continue to work.

Speaker #2: I think we're already seeing that consensus start to shift because people start to appreciate the epilepsy transaction. But, you know, the way we certainly see it is when you take the epilepsy marketed products and you add them to our own growth product portfolio, you know, I think we're seeing a growing picture.

Chris A. Viehbacher: I think we're already seeing that consensus start to shift because people start to appreciate the Apellis transaction. The way we certainly see it is when you take the Apellis marketed products and you add them to our own growth product portfolio, I think we're seeing a growing picture. When you now take the late-stage registration pipeline, I can remember vividly one investor in the meeting that we had just after we had announced Apellis saying, I get it. The late-stage pipeline now comes on top of a growing basis instead of a stable basis. I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth. With that, turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Chris Viehbacher: I think we're already seeing that consensus start to shift because people start to appreciate the Apellis transaction. The way we certainly see it is when you take the Apellis marketed products and you add them to our own growth product portfolio, I think we're seeing a growing picture. When you now take the late-stage registration pipeline, I can remember vividly one investor in the meeting that we had just after we had announced Apellis saying, I get it. The late-stage pipeline now comes on top of a growing basis instead of a stable basis. I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth. With that, turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Speaker #1: But this shows the potential. It also shows why we have to execute with excellence, and we're busy investing today to make sure those launches are a success.

Chris Viehbacher: It also shows why we have to execute with excellence, and we're busy investing today to make sure those launches are a success. If I go to the last slide. If you looked at Biogen pre the Apellis announcement, consensus of investors was that Biogen was going to be roughly flat through 2030. I think we're already seeing that consensus start to shift because people start to appreciate the Apellis transaction. The way we certainly see it is when you take the Apellis marketed products and you add them to our own growth product portfolio, I think we're seeing a growing picture. When you now then take the late-stage registration pipeline. I can remember vividly one investor in a meeting that we had just after we had announced Apellis saying, I get it.

Speaker #1: And so, when I go to the last slide, you know, if you looked at Biogen pre the epilepsy announcement, consensus among investors was that Biogen was going to be roughly flat through 2030.

Speaker #2: And when you now then take the late-stage registration pipeline, you know, I can remember vividly one investor in a meeting that we had just after we had announced epilepsy, saying, you know, I get it.

Speaker #1: I think we're already seeing that consensus start to shift as people start to appreciate the epilepsy transaction. But, you know, the way we certainly see it is when you take the epilepsy marketed products and you add them to our own growth product portfolio, you know, I think we're seeing a growing picture.

Speaker #2: The late-stage pipeline now comes on top of a growing basis instead of a stable basis. And I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth.

Chris Viehbacher: The way we certainly see it is when you take the Apellis marketed products and you add them to our own growth product portfolio, I think we're seeing a growing picture. When you now then take the late-stage registration pipeline. I can remember vividly one investor in a meeting that we had just after we had announced Apellis saying, I get it. The late-stage pipeline now comes on top of a growing basis instead of a stable basis." I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth. With that, turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Speaker #2: And with that, I'll turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Speaker #1: And when you now then take the late-stage registration pipeline—you know, I can remember vividly one investor in a meeting that we had just after we had announced epilepsy, saying, 'You know, I get it.'

Speaker #1: Thank you, Chris. And good morning, everyone. As we deliver the new Biogen, a large part of our transformation and near-term opportunity for growth comes from our late-stage pipeline, as Chris mentioned, and I am excited about this future.

Priya Singhal: Thank you, Chris, and good morning, everyone. As we deliver the new Biogen, a large part of our transformation and near-term opportunity for growth comes from our late-stage pipeline, as Chris mentioned, and I am excited about this future. That is because today we have one of the strongest and most diversified late-stage pipelines in Biogen's history, with multiple near-term opportunities to create value in the upcoming years. We shared this slide with you at the beginning of the year, and today you can see that we are delivering on the opportunities we outlined, including the FDA approval of LEQEMBI IQLIK initiation, which is an important innovation for patients and caregivers. Beyond LEQEMBI IQLIK, Biogen and Eisai presented new data at AAIC earlier this month. This included real-world evidence supporting the long-term benefits of continuous LEQEMBI treatment.

Chris Viehbacher: The late-stage pipeline now comes on top of a growing basis instead of a stable basis." I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth. With that, turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Speaker #1: The late-stage pipeline now comes on top of a growing basis instead of a stable basis. And I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth.

Speaker #1: That is because today, we have one of the strongest and most diversified late-stage pipelines in Biogen's history, with opportunities to create value in the upcoming years.

Speaker #1: And with that, I'll turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Speaker #2: Thank you, Chris. And good morning, everyone. As we deliver the new BIOGEN, a large part of our transformation and near-term opportunity for growth comes from our late-stage pipeline, as Chris mentioned, and I am excited about this future.

Priya Singhal: Thank you, Chris. Good morning, everyone. As we deliver the new Biogen, a large part of our transformation and near-term opportunity for growth comes from our late-stage pipeline, as Chris mentioned. I am excited about this future. That is because today we have one of the strongest and most diversified late-stage pipelines in Biogen's history, with multiple near-term opportunities to create value in the upcoming years. We shared this slide with you at the beginning of the year, and today you can see that we are delivering on the opportunities we outlined, including the FDA approval of I click initiation, which is an important innovation for patients and caregivers. Beyond I click, Biogen and Eisai presented new data at AAIC earlier this month. This included real-world evidence supporting the long-term benefits of continuous LEQEMBI treatment.

Speaker #1: We shared this slide with you as the beginning of the year and today you can see that we are delivering on the opportunities we outlined.

Speaker #1: Including the FDA approval of ICLC initiation which is an important innovation for patients and caregivers. Beyond ICLC, Biogen and ASI presented new data at AAIC earlier this month.

Speaker #2: That is because today, we have one of the strongest and most diversified late-stage pipelines in BIOGEN's history, with multiple near-term opportunities to create value in the upcoming years.

Speaker #1: This included real-world evidence supporting the long-term benefits of continuous Leqembi treatment. We also shared new data for Dear Nursen, establishing proof of concept in Alzheimer's disease and we are now focused on developing the next steps for the program.

Priya Singhal: We also shared new data for diranersen establishing proof of concept in Alzheimer's disease, and we are now focused on developing the next steps for the program. More broadly, we continue to demonstrate medical leadership across our portfolio with important new data presentations for both felzartamab and vorivonersen. While these milestones reinforce the potential of our portfolio today, what makes this period particularly exciting is what lies ahead in the near term. We are now entering a multi-year registrational cycle, beginning with SLE data by the end of this year, and followed by multiple catalysts extending through the remainder of the decade. While we remain focused on advancing our high-conviction late-stage opportunities, in parallel, we continue to invest in the next wave of innovation. The progress we have made this quarter has meaningfully accelerated the transformation of our pre-proof of concept pipeline.

Speaker #2: We shared this slide with you at the beginning of the year and today you can see that we are delivering on the opportunities we outlined.

Speaker #2: Including the FDA approval of ICLC initiation which is an important innovation for patients and caregivers. Beyond ICLC, BIOGEN and ACI presented new data at AAIC earlier this month.

Speaker #1: And more broadly, we continue to demonstrate medical leadership across our portfolio with important new data presentations for both palsartanab and zoravanursen. While these milestones reinforce the potential of our portfolio today, what makes this period particularly exciting is what lies ahead in the near term.

Speaker #2: This included real-world evidence supporting the long-term benefits of continuous Leqembi treatment. We also shared new data for deer nursing establishing proof of concept in Alzheimer's disease and we are now focused on developing the next steps for the program.

Priya Singhal: We also shared new data for diranersen, establishing proof of concept in Alzheimer's disease. We are now focused on developing the next steps for the program. More broadly, we continue to demonstrate medical leadership across our portfolio with important new data presentations for both felzartamab and vorivornersen. While these milestones reinforce the potential of our portfolio today, what makes this period particularly exciting is what lies ahead in the near term. We are now entering a multi-year registrational cycle, beginning with SLE data by the end of this year, followed by multiple catalysts extending through the remainder of the decade. While we remain focused on advancing our high-conviction late-stage opportunities, in parallel, we continue to invest in the next wave of innovation. The progress we have made this quarter has meaningfully accelerated the transformation of our pre-proof of concept pipeline.

Speaker #1: We are now entering a multi-year registrational cycle beginning with SLE data by the end of this year, and followed by multiple catalysts extending through the remainder of the decade.

Priya Singhal: We are now entering a multi-year registrational cycle, beginning with SLE data by the end of this year, and followed by multiple catalysts extending through the remainder of the decade. While we remain focused on advancing our high-conviction late-stage opportunities, in parallel, we continue to invest in the next wave of innovation. The progress we have made this quarter has meaningfully accelerated the transformation of our pre-proof of concept pipeline.

Speaker #2: And more broadly, we continue to demonstrate medical leadership across our portfolio with important new data presentations for both Felsartanumab and Zoravir nursing. While these milestones reinforce the potential of our portfolio today, what makes this period particularly exciting is what lies ahead in the near term.

Speaker #1: And while we remain focused on advancing our high-conviction late-stage opportunities, in parallel, we continue to invest in the next wave of innovation. The progress we have made this quarter has meaningfully accelerated the transformation of our pre-proof of concept pipeline.

Speaker #2: We are now entering a multi-year registrational cycle, beginning with SLE data by the end of this year and followed by multiple catalysts extending through the remainder of the decade.

Speaker #1: At this point in the year, we are also now beyond our high-risk, high-reward readouts, as we mentioned at the outset. This includes our phase 2 BTK inhibitor, BIB91, where we achieved proof of concept in relapsing remitting MS. And in line with our disciplined approach, in how we advance assets we are evaluating next steps given the increasingly competitive nature of that market.

Priya Singhal: At this point in the year, we are also now beyond our high-risk, high-reward readouts, as we mentioned at the outset. This includes our phase II BTK inhibitor, BIIB091, where we achieved proof of concept in relapsing remitting MS. In line with our disciplined approach in how we advance assets, we are evaluating next steps given the increasingly competitive nature of that market. As we rebuild our early-stage pipeline, we expect to add six new programs this year, including new phase II proof of concept studies to broaden the potential of felzartamab and EMPAVELI in autoimmune disease, as well as first-in-human studies from our internal pipeline and the lead asset from the pending RayThera acquisition, which is now already in phase I. Overall, we believe these investments are building a durable innovation engine with the promise of delivering sustainable long-term growth and value creation.

Speaker #2: And while we remain focused on advancing our high-conviction late-stage opportunities, in parallel, we continue to invest in the next wave of innovation. The progress we have made this quarter has meaningfully accelerated the transformation of our pre-proof-of-concept pipeline.

Speaker #1: As we rebuild our early-stage pipeline, we expect to add six new programs this year. Including new phase 2 proof of concept studies, to broaden the potential of palsartanab and empoveline in autoimmune disease.

Speaker #2: At this point in the year, we are also now beyond our high-risk, high-reward readouts, as we mentioned at the outset. This includes our phase 2 BTK inhibitor, BIB91, where we achieved proof of concept in relapsing remitting MS. And in line with our disciplined approach, in how we advance assets we are evaluating next steps given the increasingly competitive nature of that market.

Speaker #1: As well as first-in-human studies from our internal pipeline and the lead asset from the pending Raythera acquisition, which is now already in phase 1.

Speaker #1: Overall, we believe these investments are building a durable innovation engine with the promise of delivering sustainable, long-term growth and value creation. So as we step back and look across the next several quarters, we expect readouts from five registrational studies across four important indications.

Priya Singhal: Overall, we believe these investments are building a durable innovation engine with the promise of delivering sustainable long-term growth and value creation.

Speaker #2: As we rebuild our early-stage pipeline, we expect to add six new programs this year. Including new phase 2 proof-of-concept studies, to broaden the potential of Felsartanumab and Empoveli in autoimmune disease.

Priya Singhal: As we step back and look across the next several quarters, we expect readouts from five registrational studies across four important indications, SLE, CLE, AMR, and Dravet syndrome. Reflecting the strong execution of our teams and enrollment momentum, we have also accelerated the expected phase III readouts for felzartamab in AMR and litifilimab in CLE, with data now expected in the first half of 2027. Later this fall, we also look forward to presenting new 52-week data from the phase II portion of the ongoing AMACUS study at the EADV Annual Conference, which we believe will provide important insights into the durability of response for litifilimab in CLE. Taken together, these milestones are expected to generate important data over the next several months that has the potential to shape our next phase of growth.

Speaker #2: As well as first-in-human studies from our internal pipeline and the lead asset from the pending Raythera acquisition, which is now already in phase 1.

Speaker #1: SLE, CLE, AMR, and Dravet syndrome. And reflecting the strong execution of our team's and enrollment momentum, we have also accelerated the expected phase 3 readouts for palsartanab in AMR and lidofenemab in CLE with data now expected in the first half of 2027.

Speaker #2: Overall, we believe these investments are building a durable innovation engine with the promise of delivering sustainable, long-term growth and value creation. So as we step back and look across the next several quarters, we expect readouts from five registrational studies across four important indications.

Priya Singhal: As we step back and look across the next several quarters, we expect readouts from 5 registrational studies across 4 important indications, SLE, CLE, AMR, and Dravet syndrome. Reflecting the strong execution of our teams and enrollment momentum, we have also accelerated the expected phase III readouts for felzartamab in AMR and litifilimab in CLE, with data now expected in H1 2027. Later this fall, we also look forward to presenting new 52-week data from the phase II portion of the ongoing AMETHYST study at the EADV Annual Conference, which we believe will provide important insights into the durability of response for litifilimab in CLE. Taken together, these milestones are expected to generate important data over the next several months that has the potential to shape our next phase of growth.

Speaker #1: Later this fall, we also look forward to presenting new 52-week data from the phase 2 portion of the ongoing Amethyst study at the EADV annual conference.

Speaker #2: SLE, CLE, AMR, and Dravet syndrome. And reflecting the strong execution of our team's and enrollment momentum, we have also accelerated the expected phase 3 readouts for Felsartanumab in AMR and Litofilumab in CLE with data now expected in the first half of 2027.

Speaker #1: Which we believe will provide important insights into the durability of response for lidofenemab in CLE. Taken together, these milestones are expected to generate important data over the next several months that has the potential to shape our next phase of growth.

Speaker #2: Later this fall, we also look forward to presenting new 52-week data from the Phase 2 portion of the ongoing Amethyst study at the EADV annual conference.

Speaker #1: In summary, the strategic decisions and investments we have made over the past three to four years have positioned us to deliver near-term readouts while advancing long-term innovation.

Priya Singhal: In summary, the strategic decisions and investments we have made over the past three to four years have positioned us to deliver near-term readouts while advancing long-term innovation. We look forward to continuing to share our progress with you. With that, I would now like to turn the call over to Robin, who will provide a financial update for the quarter. Thank you.

Speaker #2: Which we believe will provide important insights into the durability of response for Litofilumab in CLE. Taken together, these milestones are expected to generate important data over the next several months that has the potential to shape our next phase of growth.

Speaker #1: And we look forward to continuing to share our progress with you. With that, I would now like to turn the call over to Robin, who will provide a financial update for the quarter.

Priya Singhal: Taken together, these milestones are expected to generate important data over the next several months that has the potential to shape our next phase of growth. In summary, the strategic decisions and investments we have made over the past three to four years have positioned us to deliver near-term readouts while advancing long-term innovation. We look forward to continuing to share our progress with you. With that, I would now like to turn the call over to Robin, who will provide a financial update for the quarter. Thank you.

Speaker #1: Thank you.

Speaker #2: Thank you, Priya. Good morning, everyone. I'm pleased to be speaking with all of you today following a strong revenue performance in the second quarter.

Robin Kramer: Thank you, Priya. Good morning, everyone. I am pleased to be speaking with all of you today following a strong revenue performance in Q2. Total Q2 core pharmaceutical revenue was $1.8 billion, up 4% year-over-year and 12% quarter-over-quarter. This performance was driven by our growth portfolio, which generated over $1 billion of revenue in the quarter, up 24% year-over-year and 25% quarter-over-quarter. The Biogen standalone growth products, excluding our Apellis SYFOVRE and EMPAVELI revenue, was $933 million, up 9% year-over-year and 10% quarter-over-quarter. As Chris noted, generating revenue in excess of our legacy MS portfolio again this quarter. Our growth portfolio has been further strengthened with the addition of SYFOVRE and EMPAVELI from the Apellis transaction, which generated $128 million in combined revenue for the period post the 14 May acquisition date.

Speaker #2: In summary, the strategic decisions and investments we have made over the past three to four years have positioned us to deliver near-term readouts while advancing long-term innovation.

Speaker #2: Total second quarter core pharmaceutical revenue was $1.8 billion. Up 4% year over year, and 12% quarter over quarter. This performance was driven by our growth portfolio.

Speaker #2: And we look forward to continuing to share our progress with you. With that, I would now like to turn the call over to Robin who will provide a financial update for the quarter.

Speaker #2: Which generated over $1 billion of revenue in the quarter, up 24% year over year, and 25% quarter over quarter. The Biogen standalone growth products excluding our Apelis cyclovir and empoveline revenue was $933 million, up 9% year over year, and 10% quarter over quarter.

Speaker #2: Thank you.

Speaker #3: Thank you, Priya. Good morning, everyone. I'm pleased to be speaking with all of you today following a strong revenue performance in the second quarter.

Robin Kramer: Thank you, Priya. Good morning, everyone. I am pleased to be speaking with all of you today following a strong revenue performance in the Q2. Total Q2 core pharmaceutical revenue was $1.8 billion, up 4% year-over-year and 12% quarter-over-quarter. This performance was driven by our growth portfolio, which generated over $1 billion of revenue in the quarter, up 24% year-over-year and 25% quarter-over-quarter. The Biogen standalone growth products, excluding our Apellis SYFOVRE and EMPAVELI revenue, was $933 million, up 9% year-over-year and 10% quarter-over-quarter. As Chris noted, generating revenue in excess of our legacy MS portfolio again this quarter. Our growth portfolio has been further strengthened with the addition of SYFOVRE and EMPAVELI from the Apellis transaction, which generated $128 million in combined revenue for the period post the 14 May acquisition date.

Speaker #3: Total second quarter core pharmaceutical revenue was $1.8 billion. Up 4% year over year, and 12% quarter over quarter. This performance was driven by our growth portfolio.

Speaker #2: And as Chris noted, generating revenue in excess of our legacy MS portfolio again this quarter. Our growth portfolio has been further strengthened with the addition of cyclovir and empoveline from the Apelis transaction, which generated $128 million in combined revenue for the period post the May 14th acquisition date.

Speaker #3: Which generated over a billion dollars of revenue in the quarter, up 24% year over year, and 25% quarter over quarter. The BIOGEN standalone growth products excluding our Apellis Ciphovri and Empoveli revenue was $933 million, up 9% year over year, and 10% quarter over quarter.

Speaker #2: This quarter's results demonstrate strong commercial execution and the significant progress we've made in our portfolio transition. Let me now take you through some key highlights from our core pharmaceutical product performance in the second quarter.

Robin Kramer: This quarter's results demonstrate strong commercial execution and the significant progress we have made in our portfolio transition. Let me now take you through some key highlights from our core pharmaceutical product performance in Q2. First, for the growth portfolio. SPINRAZA revenue was $402 million, up 2% year-over-year, and 7% quarter-over-quarter. This was driven by both demand and stocking for the high-dose regimen in the US, partially offset by shipment timing in certain ex-US markets. High-dose SPINRAZA was approved in the US in March, the EU in January, and Japan last year. During the period of patient transition to the high-dose regimen, we benefit from revenue associated with the one-time transition dose. SPINRAZA high-dose maintenance is priced at parity with SPINRAZA.

Speaker #3: And as Chris noted, generating revenue in excess of our legacy MS portfolio again this quarter. Our growth portfolio has been further strengthened with the addition of Ciphovri and Empoveli from the Apellis transaction, which generated $128 million in combined revenue to the period post the May 14th acquisition date.

Speaker #2: First, for the growth portfolio. Spinraza revenue was $402 million, up 2% year over year, and 7% quarter over quarter. This was driven by both demand and stocking for the high-dose regimen in the US, partially offset by shipment timing in certain ex-US markets.

Speaker #3: This quarter's results demonstrate strong commercial execution and the significant progress we've made in our portfolio transition. Let me now take you through some key highlights from our core pharmaceutical product performance in the second quarter.

Robin Kramer: This quarter's results demonstrate strong commercial execution and the significant progress we've made in our portfolio transition. Let me now take you through some key highlights from our core pharmaceutical product performance in the Q2. First, for the growth portfolio. SPINRAZA revenue was $402 million, up 2% year-over-year, and 7% quarter-over-quarter. This was driven by both demand and stocking for the high-dose regimen in the US, partially offset by shipment timing in certain ex-US markets. High-dose SPINRAZA was approved in the US in March, the EU in January, and Japan last year. During the period of patient transition to the high-dose regimen, we benefit from revenue associated with the one-time transition dose. SPINRAZA high-dose maintenance is priced at parity with SPINRAZA.

Speaker #2: High-dose Spinraza was approved in the US in March, the EU in January, and Japan last year. During the period of patient transition to the high-dose regimen, we benefit from revenue associated with the one-time transition dose.

Speaker #3: First, for the growth portfolio. Spinraza revenue was $402 million, up 2% year over year, and 7% quarter over quarter. This was driven by both demand and stocking for the high-dose regimen in the US, partially offset by shipment timing in certain ex-US markets.

Speaker #2: Spinraza high-dose maintenance is priced at parity with Spinraza. We are pleased that the pace of conversion to high dose has been going well, and enthusiasm from the patient and prescriber communities for a higher efficacy option has been strong.

Robin Kramer: We are pleased that the pace of conversion to high dose has been going well, and enthusiasm from the patient and prescriber communities for a higher efficacy option has been strong. We also believe this is encouraging for the opportunity for our registrational pipeline asset, salanersen, which has recently received breakthrough therapy designation. VUMERITY revenue of $197 million was down 7% year-over-year, partly driven by inventory dynamics, and up 10% quarter-over-quarter. Revenue for H1 2026 was up 7% versus the comparable period in the prior year. LEQEMBI in-market revenue was $184 million, up 15% year-over-year and 9% quarter-over-quarter. We saw a continuation of market growth in key markets including the US, Japan, and China. As Priya mentioned, we are pleased to have received FDA approval for LEQEMBI IQLIK initiation earlier this month.

Speaker #3: High-dose Spinraza was approved in the U.S. in March, the EU in January, and Japan last year. During the period of patient transition to the high-dose regimen, we benefit from revenue associated with the one-time transition dose.

Speaker #2: We also believe this is encouraging for the opportunity for our registrational pipeline asset, Salinersen, which has recently received breakthrough therapy designation. Vemerity revenue of $197 million was down 7% year over year, partly driven by inventory dynamics.

Speaker #3: Spinraza high-dose maintenance is priced at parity with Spinraza. We are pleased that the pace of conversion to high dose has been going well, and enthusiasm from the patient and prescriber communities for a higher efficacy option has been strong.

Speaker #2: And up 10% quarter over quarter. Revenue for the first half of 2026 was up 7% versus the comparable period in the prior year. Leqembi in-market revenue was $184 million, up 15% year over year, and 9% quarter over quarter.

Speaker #3: We also believe this is encouraging for the opportunity for our registrational pipeline asset, Salinurson, which has recently received Breakthrough Therapy designation. Famerity revenue of $197 million was down 7% year over year, partly driven by inventory dynamics.

Speaker #2: We saw a continuation of market growth in key markets, including the US, Japan, and China. And as Priya mentioned, we are pleased to have received FDA approval for iClic initiation earlier this month.

Speaker #3: And up 10% quarter over quarter. Revenue for the first half of 2026 was up 7% versus the comparable period in the prior year. Leqembi in-market revenue was $184 million, up 15% year over year and 9% quarter over quarter.

Speaker #2: SkyClara saw patient demand growth both in the US and ex-US in the second quarter, with revenue of $168 million representing 29% growth year over year, and 11% quarter over quarter.

Robin Kramer: SKYCLARYS saw patient demand growth both in the US and ex-US in Q2, with revenue of $168 million, representing 29% growth year-over-year and 11% quarter-over-quarter. SKYCLARYS is now available in 36 countries, and we continue to expect SKYCLARYS growth to come largely from ex-US as we advance the launch. ZURZUVAE continued to show strong underlying demand growth with revenue of $71 million. We are also pleased to announce that ZURZUVAE is now launched in Germany. For the MS portfolio, I would like to highlight that TYSABRI continued to demonstrate resilience and demand in the midst of a biosimilar launch in the US and Europe. Q2 revenue of $451 million was down 1% year-over-year and up 2% quarter-over-quarter.

Speaker #2: SkyClara is now available in 36 countries, and we continue to expect SkyClara's growth to come largely from ex-US as we advance the launch. Tazuve continued to show strong underlying demand growth with revenue of $71 million.

Speaker #3: We saw a continuation of market growth in key markets, including the US, Japan, and China. And as Priya mentioned, we are pleased to have received FDA approval for iQlik initiation earlier this month.

Robin Kramer: SKYCLARYS saw patient demand growth both in the US and ex-US in Q2, with revenue of $168 million, representing 29% growth year-over-year and 11% quarter-over-quarter. SKYCLARYS is now available in 36 countries, we continue to expect SKYCLARYS growth to come largely from ex-US as we advance the launch. ZURZUVAE continued to show strong underlying demand growth with revenue of $71 million. We are also pleased to announce that ZURZUVAE is now launched in Germany. For the MS portfolio, I would like to highlight that TYSABRI continued to demonstrate resilience and demand in the midst of a biosimilar launch in the US and Europe. Q2 revenue of $451 million was down 1% year-over-year and up 2% quarter-over-quarter.

Speaker #3: SkyClara saw patient demand growth both in the US and ex-US in the second quarter, with revenue of $168 million representing 29% growth year over year, and 11% quarter over quarter.

Speaker #2: And we're also pleased to announce that Tazuve is now launched in Germany. For the MS portfolio, I would like to highlight that Tazaveri continued to demonstrate resilience in demand in the midst of a biosimilar launch in the US and Europe.

Speaker #3: SkyClara is now available in 36 countries, and we continue to expect SkyClara's growth to come largely from ex-US as we advance the launch. Zarzuvay continued to show strong underlying demand growth with revenue of $71 million.

Speaker #2: Second quarter revenue of $451 million was down 1% year over year, and up 2% quarter over quarter. We've invested for a long time to establish Tazaveri as an important option for MS patients, and we're pleased to see this reflected in the resilience of Tazaveri thus far.

Robin Kramer: We've invested for a long time to establish TYSABRI as an important option for MS patients, and we're pleased to see this reflected in the resilience of TYSABRI thus far. Turning now to an update on the Apellis acquisition, which closed mid-quarter on 14 May. The integration is progressing well, and both SYFOVRE and EMPAVELI had strong performance in the quarter. SYFOVRE continued to demonstrate market leadership with total revenue in the quarter of $162 million, up 8% year-over-year and quarter-over-quarter, with total commercial injections up 13% year-over-year. EMPAVELI continues to launch in C3G and primary IC-MPGN with total revenue of $46 million, up 123% year-over-year and 12% quarter-over-quarter. The Apellis acquisition accelerates our return to growth.

Speaker #3: And we're also pleased to announce that Zarzuvay is now launched in Germany. For the MS portfolio, I would like to highlight that Tysabri continued to demonstrate resilience in demand in the midst of a biosimilar launch in the US and Europe.

Speaker #2: Turning now to an update on the Apelis acquisition, which closed mid-quarter on May 14th. The integration is progressing well, and both cyclovir and empoveline had strong performance in the quarter.

Speaker #3: Second quarter revenue of $451 million was down 1% year over year, and up 2% quarter over quarter. We've invested for a long time to establish patients, and we're pleased to see this reflected in the resilience of Tesabri thus far.

Speaker #2: Cyclovir continued to demonstrate market leadership with total revenue in the quarter of $162 million up 8% year over year, and quarter over quarter. With total commercial injections up 13% year over year.

Robin Kramer: We have invested for a long time to establish TYSABRI as an important option for MS patients, and we are pleased to see this reflected in the resilience of TYSABRI thus far. Turning now to an update on the Apellis acquisition, which closed mid-quarter on 14 May. The integration is progressing well, and both SYFOVRE and EMPAVELI had strong performance in the quarter. SYFOVRE continued to demonstrate market leadership with total revenue in the quarter of $162 million, up 8% year-over-year and quarter-over-quarter, with total commercial injections up 13% year-over-year. EMPAVELI continues to launch in C3G and primary IC-MPGN with total revenue of $46 million, up 123% year-over-year and 12% quarter-over-quarter. The Apellis acquisition accelerates our return to growth.

Speaker #2: Empoveline continues to launch in C3G, and primary ICMPGN with total revenue of $46 million up 123% year over year, and 12% quarter over quarter.

Speaker #3: Turning now to an update on the Apellis acquisition, which closed mid-quarter on May 14th. The integration is progressing well, and both Ciphovri and Empoveli had strong performance in the quarter.

Speaker #3: Ciphovri continued to demonstrate market leadership with total revenue in the quarter of $162 million up 8% year over year, and quarter over quarter. With total commercial injections up 13% year over year.

Speaker #2: The Apelis acquisition accelerates our return to growth. It adds two best-in-class commercialized medicines to our growth portfolio, which we expect to contribute materially to our top-line growth in the near and long term.

Robin Kramer: It adds two best-in-class commercialized medicines to our growth portfolio, which we expect to contribute materially to our top-line growth in the near and long term. We expect SYFOVRE and EMPAVELI on a combined basis to grow in the mid to high teens through at least 2028. In addition, we expect this transaction to materially increase our non-GAAP diluted EPS CAGR through the end of this decade. We expect approximately $120 to $130 million of impact to our other income expense line in both 2026 and 2027 associated with intrinsic expense and foregone interest income associated with financing the transaction. We expect to generate at least $250 million of run rate synergies by the end of 2027, largely from optimization of general and administrative expenses and research and development. For 2026, we expect approximately $0.85 of non-GAAP EPS dilution, primarily from financing costs associated with the transaction.

Speaker #2: We expect cyclovir and empoveline on a combined basis to grow in the mid to high teens through at least 2028. In addition, we expect this transaction to materially increase our non-GAP diluted EPS CAGR through the end of this decade.

Speaker #3: Empoveli continues to launch in C3G, and primary IC-MPGN with total revenue of $46 million up 123% year over year, and 12% quarter over quarter.

Speaker #2: We expect approximately $120 to $130 million of impact to our other income expense line, in both 2026 and 2027, associated with intrinsic expense and foregone interest income, associated with financing the transaction.

Speaker #3: The Apellis acquisition accelerates our return to growth. It adds two best-in-class commercialized medicines to our growth portfolio, which we expect to contribute materially to our top-line growth in the near and long term.

Robin Kramer: It adds two best-in-class commercialized medicines to our growth portfolio, which we expect to contribute materially to our top-line growth in the near and long term. We expect SYFOVRE and EMPAVELI on a combined basis to grow in the mid-to-high teens through at least 2028. In addition, we expect this transaction to materially increase our non-GAAP diluted EPS CAGR through the end of this decade. We expect approximately $120 to $130 million of impact to our other income expense line in both 2026 and 2027 associated with intrinsic expense and foregone interest income associated with financing the transaction. We expect to generate at least $250 million of run rate synergies by the end of 2027, largely from optimization of general and administrative expenses and research and development. For 2026, we expect approximately $0.85 of non-GAAP EPS dilution, primarily from financing costs associated with the transaction.

Speaker #3: We expect Ciphovri and Empoveli on a combined basis to grow in the mid to high teens through at least 2028. In addition, we expect this transaction to materially increase our non-gap diluted EPS CAGR through the end of this decade.

Speaker #2: We expect to generate at least $250 million of run-rate synergies by the end of 2027, largely from optimization of general and administrative expenses and research and development.

Robin Kramer: We expect to generate at least $250 million of run rate synergies by the end of 2027, largely from optimization of general and administrative expenses and research and development. For 2026, we expect approximately $0.85 of non-GAAP EPS dilution, primarily from financing costs associated with the transaction. We expect the transaction to be accretive to non-GAAP diluted 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. Moving on to the financial highlights.

Speaker #3: We expect approximately $120 to $130 million of impact to our other income expense line in both 2026 and 2027, associated with intrinsic expense and foregone interest income, associated with financing the transaction.

Speaker #2: For 2026, we expect approximately $85 cents of non-GAP EPS dilution primarily from financing costs associated with the transaction. We expect the transaction to be accretive to non-GAP diluted EPS in 2027.

Robin Kramer: We expect the transaction to be accretive to non-GAAP diluted 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. Moving on to the financial highlights. Total revenue for the quarter was $2.7 billion, up 3% year-over-year. Revenue from the anti-CD20 royalties and profit share included in other revenue was $514 million, up 10% year-over-year. This increase was driven by royalties from OCREVUS, which benefited from the recent subcutaneous launch and resilience from RITUXAN in the US. In addition to the revenue contribution in the quarter from SYFOVRE and EMPAVELI, as previously discussed, our results of operations for Q2 2026 include a half a quarter of operating expenses and financing costs associated with the acquisition of Apellis.

Speaker #2: We believe this transaction represents an attractive use of capital that will further bolster both our top-line and bottom-line growth prospects, and therapeutic areas aligned to our immunology and rare disease strategy.

Speaker #3: We expect to generate at least $250 million of run-rate synergies by the end of 2027, largely from optimization of general and administrative expenses and research and development.

Speaker #2: Moving on to the financial highlights. Total revenue for the quarter was $2.7 billion, up 3% year over year. Revenue from the anti-CD20 royalties and profit share, included in other revenue, was $514 million, up 10% year over year.

Speaker #3: For 2026, we expect approximately $85 cents of non-gap EPS dilution primarily from financing costs associated with the transaction. We expect the transaction to be accretive to non-gap diluted EPS in 2027.

Robin Kramer: Total revenue for the quarter was $2.7 billion, up 3% year-over-year. Revenue from the anti-CD20 royalties and profit share included in other revenue was $514 million, up 10% year-over-year. This increase was driven by royalties from OCREVUS, which benefited from the recent subcutaneous launch and resilience from RITUXAN in the US. In addition to the revenue contribution in the quarter from SYFOVRE and EMPAVELI, as previously discussed, our results of operations for Q2 2026 include a half a quarter of operating expenses and financing costs associated with the acquisition of Apellis.

Robin Kramer: We expect the transaction to be accretive to non-GAAP diluted 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. Moving on to the financial highlights. Total revenue for the quarter was $2.7 billion, up 3% year over year. Revenue from the anti-CD20 royalties and profit share included in other revenue was $514 million, up 10% year over year. This increase was driven by royalties from OCREVUS, which benefited from the recent subcutaneous launch and resilience from RITUXAN in the US. In addition to the revenue contribution in the quarter from SYFOVRE and EMPAVELI as previously discussed, our results of operations for Q2 2026 include a half a quarter of operating expenses and financing costs associated with the acquisition of Apellis.

Speaker #3: We believe this transaction represents an attractive use of capital that will further bolster both our top-line and bottom-line growth prospects, as well as therapeutic areas aligned with our immunology and rare disease strategy.

Speaker #2: This increase was driven by royalties from Ocrevus, which benefited from the recent subcutaneous launch, and resilience from Rituxan in the US. In addition to the revenue contribution in the quarter from cyclovir and empoveline as previously discussed, our results of operations for the second quarter of 2026 include a half a quarter of operating expenses and financing costs associated with the acquisition of Apelis.

Speaker #3: Moving on to the financial highlights. Total revenue for the quarter was $2.7 billion up 3% year over year. Revenue from the anti-CD20 royalties and profit share, included in other revenue, was $514 million, up 10% year over year.

Speaker #2: Non-GAP cost of sales as a percentage of revenue was 22% in Q2 2026 versus 21% last year. The increase was primarily due to product mix, largely from increased contract manufacturing revenue.

Robin Kramer: Non-GAAP cost of sales as a percentage of revenue was 22% in Q2 2026 versus 21% last year. The increase was primarily due to product mix, largely from increased contract manufacturing revenue. GAAP cost of sales as a percentage of revenue was also impacted by higher amortization costs associated with the acquired inventory, fair value step-up adjustment for SKYCLARYS from the Reata transaction, and SYFOVRE and EMPAVELI from the Apellis transaction. Non-GAAP core OPEX or combined R&D and SG&A expense increased 20% year-over-year. This reflects approximately $95 million of Apellis operating expenses from the 14 May acquisition date through the end of the quarter. For R&D, it also reflects our investments in our Phase III clinical programs, including felzartamab's indication in MVI and salanersen, which were advanced as registrational studies in H2 2025.

Speaker #3: This increase was driven by royalties from Ocrevus, which benefited from the recent subcutaneous launch, and resilience from Rituxan in the U.S. In addition to the revenue contribution in the quarter from Ciphovri and Empoveli, as previously discussed, our results of operations for the second quarter of 2026 include half a quarter of operating expenses and financing costs associated with the acquisition of Apellis.

Speaker #2: GAP cost of sales as a percentage of revenue was also impacted by higher amortization costs associated with the acquired inventory, fair value step-up adjustment for SkyClara from the Riyadah transaction, and cyclovir and empoveline from the Apelis transaction.

Speaker #3: Non-GAAP cost of sales as a percentage of revenue was 22% in Q2 2026, versus 21% last year. The increase was primarily due to product mix, largely from increased contract manufacturing revenue.

Robin Kramer: Non-GAAP cost of sales as a percentage of revenue was 22% in Q2 2026 versus 21% last year. The increase was primarily due to product mix, largely from increased contract manufacturing revenue. GAAP cost of sales as a percentage of revenue was also impacted by higher amortization costs associated with the acquired inventory, fair value step-up adjustment for SKYCLARYS from the Reata transaction and SYFOVRE and EMPAVELI from the Apellis transaction. Non-GAAP core OPEX or combined R&D and SG&A expense increased 20% year over year. This reflects approximately $95 million of Apellis operating expenses from the 14 May acquisition date through the end of the quarter. For R&D, it also reflects our investments in our phase III clinical programs, including felzartamab's indication in MVI and salanersen, which were advanced as registrational studies in H2 2025.

Speaker #2: Non-GAP core opex or combined R&D and SG&A expense increased 20% year over year. This reflects approximately 95 million dollars of Apelis operating expenses from the May 14th acquisition date through the end of the quarter.

Speaker #3: Gap cost of sales as a percentage of revenue was also impacted by higher amortization costs associated with the acquired inventory fair value step-up adjustment for SkyClara's from the Riyadah transaction, and Ciphovri and Empoveli from the Apellis transaction.

Speaker #2: For R&D, it also reflects our investments in our Phase III clinical programs. Including Valsartan-Mabz indication and MVI, and Salonarson, which were advanced as registrational studies in the second half of 2025.

Speaker #2: And Lutefilimab, where we expect the Phase III SLE data latest year, including a 25 million dollar year-over-year decrease in R&D funding from the royalty pharma funding for Lutefilimab.

Speaker #3: Non-gap core opex or combined R&D and SG&A expense increased 20% year over year. This reflects approximately $95 million of Apellis operating expenses from the May 14th acquisition date through the end of the quarter.

Robin Kramer: litifilimab, where we expect the phase III SLE data later this year, including a $25 million year-over-year decrease in R&D funding from the Royalty Pharma funding for litifilimab. For sales and marketing, it reflects support of our US and international product launches and investments in pre-launch activities for our late-stage high conviction pipeline. As we previously announced, we recorded $164 million of acquired IPR&D and milestone charges associated with our investments in the development pipeline in Q2 2026, including a $100 million upfront to TJ Bio associated with the acquisition of the felzartamab rights in China, giving us worldwide rights to felzartamab. A milestone payment of $45 million to Ionis in connection with the initiation of the phase III trial for salanersen in SMA, and an upfront payment of $15 million to Ionis to opt in to BIIB147 in broad ALS.

Speaker #2: For sales and marketing, it reflects support of our US and international product launches, and investments in pre-launch activities for our late-stage high-conviction pipeline. As we previously announced, we've recorded $164 million of acquired IPR&D and milestone charges, associated with our investments in the development pipeline in the second quarter of 2026, including a $100 million upfront to TJ Bio, associated with the acquisition of the Valsartan-Mabz rights in China, giving us worldwide rights to Valsartan-Mabz.

Speaker #3: For R&D, it also reflects our investments in our Phase III clinical programs, including Felsartamab's indication and MVI, and Salonarson, which were advanced as registrational studies in the second half of 2025.

Speaker #3: And Litafilumab, where we expect the Phase III SLE data later this year, including a $25 million year-over-year decrease in R&D funding from the royalty pharma funding for Litafilumab.

Robin Kramer: Litifilimab, where we expect the phase III SLE data later this year, including a $25 million year over year decrease in R&D funding from the Royalty Pharma funding for litifilimab. For sales and marketing, it reflects support of our US and international product launches and investments in pre-launch activities for our late stage high conviction pipeline. As we previously announced, we recorded $164 million of acquired IPR&D and milestone charges associated with our investments in the development pipeline in Q2 2026, including a $100 million upfront to TJ Bio associated with the acquisition of the felzartamab rights in China, giving us worldwide rights to felzartamab. A milestone payment of $45 million to Ionis in connection with the initiation of the phase III trial for salanersen in SMA, and an upfront payment of $15 million to Ionis to opt in to BIIB147 in broad ALS.

Speaker #3: For sales and marketing, it reflects support of our U.S. and international product launches, and investments in pre-launch activities for our late-stage, high-conviction pipeline.

Speaker #2: A milestone payment of $45 million to Ionis, and connection with the initiation of the Phase III trial for Salonarson and SMA. And an upfront payment of $15 million to Ionis to opt in to bid 147 in broad ALS.

Robin Kramer: A milestone payment of $45 million to Ionis in connection with the initiation of the phase III trial for salanersen in SMA, and an upfront payment of $15 million to Ionis to opt in to BIIB147 in broad ALS.

Speaker #3: As we previously announced, we've recorded $164 million of acquired IPR&D and milestone charges, associated with our investments in the development pipeline in the second quarter of 2026, including a $100 million upfront to TJ Bio, associated with the acquisition of the Felsartamab rights in China, giving us worldwide rights to Felsartamab.

Speaker #2: Now turning to cash flow and the balance sheet. We continue to generate strong cash flow with $408 million of free cash flow generated in the second quarter.

Robin Kramer: Turning to cash flow and the balance sheet. We continue to generate strong cash flow with $408 million of free cash flow generated in Q2. We exited the quarter with $1.3 billion of cash and $6.8 billion of net debt. We closed the Apellis transaction in Q2, which was funded with $3.6 billion of cash from the balance sheet and $2 billion of term loan. During Q2, we repaid $200 million of the term loan and continue to expect to repay the remainder of the term loan by the end of 2027. Turning to guidance. Based on the expected revenue performance of our base business, including our growth products and Tysabri, our guidance update reflects a $0.60 increase in the underlying business guidance as compared to our previous guidance.

Speaker #2: We exited the quarter with $1.3 billion of cash and $6.8 billion of net debt. We closed the Apelis transaction in the second quarter, which was funded with $3.6 billion of cash from the balance sheet, and $2 billion of term loan.

Speaker #3: A milestone payment of $45 million to Ionis and connection with the initiation of the Phase III trial for Salonarson and SMA. And an upfront payment of $15 million to Ionis to opt in to bid 147 in broad ALS.

Speaker #2: During Q2, we repaid $200 million of the term loan and continue to expect to repay the remainder of the term loan by the end of 2027.

Speaker #3: Now turning to cash flow and the balance sheet. We continue to generate strong cash flow with $408 million of free cash flow generated in the second quarter.

Robin Kramer: Now turning to cash flow and the balance sheet. We continue to generate strong cash flow with $408 million of free cash flow generated in Q2. We exited the quarter with $1.3 billion of cash and $6.8 billion of net debt. We closed the Apellis transaction in Q2, which was funded with $3.6 billion of cash from the balance sheet and $2 billion of term loan. During Q2, we repaid $200 million of the term loan and continue to expect to repay the remainder of the term loan by the end of 2027. Turning now to guidance. Based on the expected revenue performance of our base business, including our growth products and TYSABRI, our guidance update reflects a $0.60 increase in the underlying business guidance as compared to our previous guidance.

Speaker #2: Turning now to guidance. Based on the expected revenue performance of our base business, including our products and to Sabri, our guidance update reflects a 60-cent increase in the underlying business guidance as compared to our previous guidance.

Speaker #3: We exited the quarter with $1.3 billion of cash and $6.8 billion of net debt. We closed the Apellis transaction in the second quarter, which was funded with $3.6 billion of cash from the balance sheet, and $2 billion of term loan.

Speaker #2: We are pleased to be increasing our total revenue guidance from a mid-single-digit percentage decrease to a mid-single-digit percentage increase. This reflects both the expected performance of our growth products and to Sabri, as well as the addition of cyclovir and empoveline into our product portfolio.

Robin Kramer: We are pleased to be increasing our total revenue guidance from a mid-single-digit percentage decrease to a mid-single-digit percentage increase. This reflects both the expected performance of our growth products in Tysabri, as well as the addition of SYFOVRE and EMPAVELI into our product portfolio. Our guidance also reflects updates to core operating expenses, other income and expense, and our full-year tax rate, primarily to incorporate the impact of the acquisition of Apellis. We expect our core operating expenses in H2 2026 to be between $2.65 billion and $2.7 billion. Our guidance also reflects updates associated with our strategic investments in the early and late-stage pipeline, as well as those associated with our near and midterm growth. It incorporates transactions that have been executed and our current expectations of those that will occur for the remainder of the year.

Speaker #3: During Q2, we repaid $200 million of the term loans and continue to expect to repay the remainder of the term loans by the end of 2027.

Speaker #3: Turning now to guidance. Based on the expected revenue performance of our base business, including our products and to Sabri, our guidance update reflects a 60 cent increase in the underlying business guidance as compared to our previous guidance.

Speaker #2: Our guidance also reflects updates to core operating expenses, other income and expense, and our full-year tax rate, primarily to incorporate the impact of the acquisition of Apelis.

Speaker #2: We expect our core operating expenses in the second half of 2026 to be between $2.65 billion and $2.7 billion. Our guidance also reflects updates associated with our strategic investments in the early and late-stage pipeline, as well as those associated with our near and mid-term growth.

Speaker #3: We are pleased to be increasing our total revenue guidance from a mid-single-digit percentage decrease to a mid-single-digit percentage increase. This reflects both the expected performance of our growth products and to Sabri, as well as the addition of Ciphovri and Empoveli into our product portfolio.

Robin Kramer: We are pleased to be increasing our total revenue guidance from a mid-single-digit percentage decrease to a mid-single-digit percentage increase. This reflects both the expected performance of our growth products in TYSABRI, as well as the addition of SYFOVRE and EMPAVELI into our product portfolio. Our guidance also reflects updates to core operating expenses, other income and expense, and our full-year tax rate, primarily to incorporate the impact of the acquisition of Apellis. We expect our core operating expenses in the H2 2026 to be between $2.65 billion and $2.7 billion. Our guidance also reflects updates associated with our strategic investments in the early and late-stage pipeline, as well as those associated with our near and mid-term growth. It incorporates transactions that have been executed and our current expectations of those that will occur for the remainder of the year.

Speaker #3: Our guidance also reflects updates to core operating expenses, other income and expense, and our full-year tax rates, primarily to incorporate the impact of the acquisition of Apellis.

Speaker #2: It incorporates transactions that have been executed and our current expectations of those that will occur for the remainder of the year. It incorporates approximately a $3 non-GAP diluted EPS impact of charges associated with IPR&D and milestones, including the Q2 TJ Bio transaction, the Ionis milestone, associated with achieving the first patient dosed in Stellar One, our pivotal Phase III Salonarson study in SMA, and the pending Raythera transaction associated with the addition of a Phase I immunology asset into the early-stage pipeline, which is expected to close in Q3.

Robin Kramer: It incorporates approximately a $3 non-GAAP diluted EPS impact of charges associated with IPR&D and milestones, including the Q2 TJ Bio transaction. The Ionis milestone associated with achieving the first patient dosed in STELLAR-1, our pivotal phase III salanersen study in SMA, and the pending Rayhera transaction associated with the addition of a phase I immunology asset into the early-stage pipeline, which is expected to close in Q3. The expected full-year 2026 $0.85 dilution associated with the Apellis transaction, again, largely driven by the impact of financing costs. Our updated 2026 full-year non-GAAP diluted EPS range is now between $12 and $13. Please be sure to review this slide, as well as slide 25 in the appendix of this presentation and our press release for other important full-year 2026 guidance assumptions.

Speaker #3: We expect our core operating expenses in the second half of 2026 to be between $2.65 billion and $2.7 billion. Our guidance also reflects updates associated with our strategic investments in the early and late-stage pipeline, as well as those associated with our near and mid-term growth.

Speaker #3: It incorporates transactions that have been executed and our current expectations for those that will occur for the remainder of the year. It incorporates approximately a $3 non-GAAP diluted EPS impact of charges associated with IPR&D and milestones, including the Q2 TJ Bio transaction, the Ionis milestone associated with achieving the first patient dosed in STELLAR-1, our pivotal Phase 3 SALSARAN study in SMA, and the pending Raythera transaction associated with the addition of a Phase 1 immunology asset into the early-stage pipeline, which is expected to close in Q3.

Robin Kramer: It incorporates approximately a $3 non-GAAP diluted EPS impact of charges associated with IPR&D and milestones, including the Q2 TJ Bio transaction, the Ionis milestone associated with achieving the first patient dosed in STELLAR-1, our pivotal Phase III salanersen study in SMA, and the pending RayThera Inc. transaction associated with the addition of a Phase I immunology asset into the early-stage pipeline, which is expected to close in Q3. The expected full-year 2026 $0.85 dilution associated with the Apellis transaction, again, largely driven by the impact of financing costs. Our updated 2026 full-year non-GAAP diluted EPS range is now between $12 and $13. Please be sure to review this slide, as well as slide 25 in the appendix of this presentation and our press release for other important full-year 2026 guidance assumptions.

Speaker #2: And the expected full-year 2026 $85-cent dilution associated with the Apelis transaction again largely driven by the impact of financing costs. Our updated 2026 full-year non-GAP diluted EPS range is now between $12 and $13.

Speaker #2: Please be sure to review this slide, as well as slide 25 in the appendix of this presentation, and our press release for other important full-year 2026 guidance assumptions.

Speaker #2: In closing, strong commercial execution in the Biogen base business and the addition of cyclovir and empoveline resulted in strong top-line performance in Q2, and the completion of the Apelis acquisition accelerates our near and mid-term top-line and bottom-line growth potential.

Robin Kramer: In closing, strong commercial execution in the Biogen-based business and the addition of SYFOVRE and EMPAVELI resulted in strong top-line performance in Q2. The completion of the Apellis acquisition accelerates our near and mid-term top-line and bottom-line growth potential. With that, I would like to pass the call back to Tim to open us up for questions.

Speaker #3: And the expected full-year 2026 $85 cent dilution associated with the Apellis transaction again largely driven by the impact of financing costs. Our updated 2026 full-year non-gap diluted EPS range is now between $12 and $13.

Speaker #2: With that, I would like to pass the call back to Tim to open us up for questions.

Speaker #3: Please be sure to review this slide, as well as slide 25 in the appendix of this presentation, and our press release for other important full-year 2026 guidance assumptions.

Robin Kramer: Please be sure to review this slide, as well as slide 25 in the appendix of this presentation and our press release for other important full-year 2026 guidance assumptions. In closing, strong commercial execution in the Biogen-based business and the addition of SYFOVRE and EMPAVELI resulted in strong top-line performance in Q2. The completion of the Apellis acquisition accelerates our near and mid-term top-line and bottom-line growth potential. With that, I would like to pass the call back to Tim to open us up for questions.

Speaker #1: Thanks, Robin. Jess, could we go to our first question, please?

Tim Power: Thanks, Robin. Jess, could we go to our first question, please?

Speaker #3: Certainly. If you would like to ask a question, please press star 1 on your telephone keypad. As a reminder, please limit yourself to one question.

Operator: Certainly. 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 Chris Schott with J.P. Morgan.

Speaker #3: In closing, strong commercial execution in the Biogen base business and the addition of Ciphovri and Empaveli resulted in strong top-line performance in Q2, and the completion of the Apellis acquisition accelerates our near- and mid-term top-line and bottom-line growth potential.

Speaker #3: If you require any further follow-up, you may press star 1 again to rejoin the queue. Your first question comes from the line of Chris Schott with JPMorgan.

Speaker #3: With that, I would like to pass the call back to Tim to open us up for questions.

Speaker #1: Great. Sorry. On mute again. Just a quick question for me on HD Spinraza. Just a little bit elaborate a little bit more on how the ramp is coming here compared to internal expectations.

Chris Schott: Great. Sorry, on mute again. Just a quick question from me on HD SPINRAZA. Just elaborate a little bit more on how the ramp is coming here compared to internal expectations, and just any metrics you can share on the conversion you're seeing in some of the markets where the product has been launched for longer. Maybe also as part of that answer, can you just talk about how meaningful is the impact from patients switching back to HD to overall volume for the product as well? I'm just trying to get just a general sense of just how this is progressing and impacting the franchise. Thank you.

Speaker #1: Thanks, Robin. Jess, could we go to our first question, please?

Chris Viehbacher: Thanks, Robin. Jess, could we go to our first question, please?

Speaker #2: Certainly. If you would like to ask a question, please press star 1 on your telephone keypad. As a reminder, please limit yourself to one question.

Speaker #1: And just any metrics you can share on the conversion you're seeing in some of the markets with the products been has been launched for longer.

Speaker #2: If you require any further follow-up, you may press star 1 again to rejoin the queue. Your first question comes from the line of Chris Schott with JPMorgan.

Speaker #1: Maybe also as part of that answer, can you just talk about how meaningful is the impact from patients switching back to HD to overall volume so the product as well?

Speaker #1: I'm just trying to get just a general sense of just how this is progressing and impacting the franchise. Thank you.

Chris Schott: Great. Sorry, on mute again. Just a quick question for me on HD SPINRAZA. Just elaborate a little bit more on how the ramp is coming here compared to internal expectations, and just any metrics you can share on the conversion you're seeing in some of the markets where the product has been launched for longer. Maybe also as part of that answer, can you just talk about how meaningful is the impact from patients switching back to HD to overall volumes for the product as well? I'm just trying to get just a general sense of just how this is progressing and impacting the franchise. Thank you.

Speaker #4: Hi, Chris. This is Alicia. I'll take that question. So if you really think about Spinraza, it's almost a decade after introducing the first SMA treatment.

Alisha Alaimo: Hi, Chris. This is Alisha. I'll take that question. If you really think about SPINRAZA, it's almost a decade after introducing the first SMA treatment. What I think you're seeing is SPINRAZA still setting the bar on efficacy in the space. If you think about how did SPINRAZA HD even come about, this was from several years ago. We had many patients come forward to Biogen saying, we just wish we had more. We wish we had more. We feel like we could take an even higher dose. Obviously, Biogen went in and developed this new formulation, and here we have high dose today. Now that we've launched, we are seeing basically the demand and the urgency really being driven by this patient community.

Speaker #1: And just any metrics you can share on the conversion you're seeing in some of the markets with the products been has been launched for longer.

Speaker #4: What I think you're seeing is Spinraza still setting the bar on efficacy in the space. And also, if you think about how did Spinraza HD even come about?

Speaker #1: Maybe also as part of that answer, can you just talk about how meaningful is the impact from patients switching back to HD to overall volume so the product as well?

Speaker #4: This was from several years ago. We had many patients come forward to Biogen saying, "You know, we just wish we had more. We wish we had more.

Speaker #1: I'm just trying to get just a general sense of just how this is progressing and impacting the franchise. Thank you.

Speaker #4: We feel like we could take an even higher dose." And then obviously, Biogen went in and developed this new formulation and here we have high dose today.

Speaker #4: Hi, Chris. This is Alisha. I'll take that question. So if you're really thinking about Spinraza, it's almost a decade after introducing the first SMA treatment.

Alisha A. Alaimo: Hi, Chris. This is Alisha. I'll take that question. If you really think about SPINRAZA, it's almost a decade after introducing the first SMA treatment. What I think you're seeing is SPINRAZA still setting the bar on efficacy in the space. If you think about how did SPINRAZA HD even come about, this was from several years ago. We had many patients come forward to Biogen saying, "We just wish we had more. We wish we had more. We feel like we could take an even higher dose." Obviously, Biogen went in and developed this new formulation, and here we have high dose today. Now that we've launched, we are seeing basically the demand and the urgency really being driven by this patient community.

Alisha Alaimo: Hi, Chris. This is Alisha. I'll take that question. If you really think about SPINRAZA, it's almost a decade after introducing the first SMA treatment. What I think you're seeing is SPINRAZA still setting the bar on efficacy in the space. If you think about how did SPINRAZA HD even come about, this was from several years ago. We had many patients come forward to Biogen saying, "We just wish we had more. We wish we had more. We feel like we could take an even higher dose." Obviously, Biogen went in and developed this new formulation, and here we have high dose today. Now that we've launched, we are seeing basically the demand and the urgency really being driven by this patient community.

Speaker #4: So now that we've launched, we are seeing basically the demand and the urgency really being driven by this patient community. In fact, if you think about metrics, Spinraza high dose is exceeding the original launch of Spinraza in both start forms and grads in the first 13 weeks of launch.

Speaker #4: What I think you're seeing is Spinraza still setting the bar on efficacy in the space. And also, if you think about how did Spinraza HD even come about?

Alisha Alaimo: In fact, if you think about metrics, SPINRAZA high dose is exceeding the original launch of SPINRAZA in both start forms and grads in the first 13 weeks of launch, and we are growing every single week. When you look at the Q2 revenue, sites are ordering high dose to prepare for each patient's next dose. When you think about the dosing of the product, you do have to wait a quarter or two, depending on when you had your last dose of SPINRAZA. The feedback from patients so far that have received the product has been quite positive, also from the physicians, quite positive. The teams are really supporting the payer approvals and the account P&T reviews and patient transitions. Now, in this initial bolus of launch demand, you are seeing that the majority of the patients are transitioning from SPINRAZA 12 mg to high dose.

Speaker #4: This was from several years ago. We had many patients come forward to BIOGEN saying, you know, we just wish we had more. We wish we had more.

Speaker #4: We feel like we could take an even higher dose. And then, obviously, Biogen went in and developed this new formulation, and here we have high dose today.

Speaker #4: And we are growing every single week. So when you look at the Q2 revenue, sites are ordering high dose to prepare for each patient's next dose.

Speaker #4: And when you think about the dosing of the product, you do have to wait a quarter or two depending on when you had your last dose of Spinraza.

Speaker #4: The feedback from patients so far that have received the product has been quite positive. Also from the physicians, quite positive. So the teams are really supporting the payer approvals and the account P&T reviews and patient transitions.

Alisha A. Alaimo: In fact, if you think about metrics, SPINRAZA high dose is exceeding the original launch of SPINRAZA in both start forms and grads in the first 13 weeks of launch, and we are growing every single week. When you look at the Q2 revenue, sites are ordering high dose to prepare for each patient's next dose. When you think about the dosing of the product, you do have to wait a quarter or two, depending on when you had your last dose of SPINRAZA. The feedback from patients so far that have received the product has been quite positive, also from the physicians, quite positive. The teams are really supporting the payer approvals and the account P&T reviews and patient transitions. Now, in this initial bolus of launch demand, you are seeing that the majority of the patients are transitioning from SPINRAZA 12 mg to high dose.

Alisha Alaimo: The teams are really supporting the payer approvals and the account P&T reviews and patient transitions. Now, in this initial bolus of launch demand, you are seeing that the majority of the patients are transitioning from SPINRAZA 12 mg to high dose.

Speaker #4: And we are growing every single week. So when you look at the Q2 revenue, sites are ordering high dose to prepare for each patient's next dose.

Speaker #4: Now, in this initial bolus of launch demand, you are seeing that the majority of the patients are transitioning from Spin 12 meds to high dose.

Speaker #4: And when you think about the dosing of the product, you do have to wait a quarter or two depending on when you had your last dose of Spinraza.

Speaker #4: However, we also have several patients who are either new to Spinraza and particularly babies. You know, we hadn't dosed the baby in years. And so we are seeing babies now getting dosed.

Alisha Alaimo: However, we also have several patients who are either new to SPINRAZA, and particularly babies. We hadn't dosed a baby in years, we are seeing babies now getting dosed. We have had several switchbacks from risdiplam. We think for this year, what you're going to see is the bolus of the transitions along into the beginning of next year. Our big focus for 2027 is going to be on new starts and on switchbacks. One of the advantages that you have that we didn't realize was going to be such a positive in the market is with the SPINRAZA 12 mg, there are four loading doses.

Speaker #4: And also, we have had several switchbacks from Evresde. So we think for this year, what you're going to see is the bolus of the transitions along into the beginning of next year.

Speaker #4: Now, in this initial bolus of launch demand, you are seeing that the majority of the patients are transitioning from Spin 12 meds to high dose.

Speaker #4: But our big focus for 2027 is going to be on new starts and on switchbacks. One of the advantages that you have that we didn't realize was going to be such a positive in the market is with the Spin 12 meds, there are four loading doses with high dose.

Speaker #4: However, we also have several patients who are either new to Spinraza, and particularly babies—you know, we hadn't dosed a baby in years. And so we are seeing babies now getting dosed.

Alisha A. Alaimo: However, we also have several patients who are either new to SPINRAZA, particularly babies. We hadn't dosed a baby in years, so we are seeing babies now getting dosed. Also, we have had several switchbacks from AGWIZBI. We think for this year, what you're going to see is the bolus of the transitions into the beginning of next year. Our big focus for 2027 is going to be on new starts and on switchbacks. One of the advantages that you have that we didn't realize was going to be such a positive in the market is with the SPIN 12 mg, there are four loading doses.

Alisha Alaimo: However, we also have several patients who are either new to SPINRAZA, particularly babies. We hadn't dosed a baby in years, so we are seeing babies now getting dosed. Also, we have had several switchbacks from AGWIZBI. We think for this year, what you're going to see is the bolus of the transitions into the beginning of next year. Our big focus for 2027 is going to be on new starts and on switchbacks. One of the advantages that you have that we didn't realize was going to be such a positive in the market is with the SPIN 12 mg, there are four loading doses. With high dose, there's only two, and we do have patients who are more willing to do the two as a loading dose than the four, and that is where you're seeing also some of the switchbacks and new patient starts.

Alisha Alaimo: With high dose, there's only two. We do have patients who are more willing to do the two as a loading dose than the four. That is where you're seeing also some of the switchbacks and new patient starts.

Speaker #4: There's only two. And we do have patients who are more willing to do the two as the loading dose than the four. And that is where you're seeing also some of the switchbacks and new patient starts.

Speaker #4: And also, we have had several switchbacks from Evresde. So we think for this year, what you're going to see is the bolus of the transitions along into the beginning of next year.

Speaker #1: Yeah. And just the US is actually one of the last countries to launch actually unusually. So Japan, where we launched earlier as in Europe, that's where actually we're seeing particularly in Germany, seeing a reversal of the trend of switching to oral therapy and some trending back.

Chris A. Viehbacher: Yeah, just the US is actually one of the last countries to launch, actually unusually so. Japan, where we launched earlier, as in Europe, that's where actually we're seeing, particularly in Germany, seeing a reversal of a trend of switching to oral therapy and some trending back. Now, I think it's still early days, and as Alisha said, it's largely first people moving from the lower dose to the high dose. Again, as Alisha said, in all markets, and I go talk to physicians around the world when I'm visiting our affiliates. At the end of the day, it's really in these devastating diseases efficacy that really matters, and there is an enhanced opportunity here for that.

Chris Viehbacher: Yeah, just the US is actually one of the last countries to launch, actually unusually so. Japan, where we launched earlier, as in Europe, that's where actually we're seeing, particularly in Germany, seeing a reversal of a trend of switching to oral therapy and some trending back. Now, I think it's still early days, and as Alisha said, it's largely first people moving from the lower dose to the high dose. Again, as Alisha said, in all markets, and I go talk to physicians around the world when I'm visiting our affiliates. At the end of the day, it's really in these devastating diseases efficacy that really matters, and there is an enhanced opportunity here for that.

Alisha A. Alaimo: With high dose, there's only two, and we do have patients who are more willing to do the two as a loading dose than the four, and that is where you're seeing also some of the switchbacks and new patient starts.

Speaker #1: Now, it's you know, I think it's still early days and as Alicia said, it's largely first. People moving from the lower dose to the high dose.

Speaker #1: But again, as Alicia said, in all markets, and I go talk to physicians around the world when I'm visiting our affiliates, you know, at the end of the day, it's really in these devastating diseases, efficacy that really matters.

Speaker #1: Yeah. And just, the US is actually one of the last countries to launch, actually unusually. So, Japan, where we launched earlier, as in Europe, that's where actually we're seeing—particularly in Germany—seeing a reversal of the trend of switching to oral therapy and some trending back.

Chris Viehbacher: Yeah, just the US is actually one of the last countries to launch, actually unusually. Japan, where we launched earlier, as in Europe, that's where actually we're seeing, particularly in Germany, seeing a reversal of a trend of switching to oral therapy and some trending back. I think it's still early days, and as Alisha said, it's largely first people moving from the lower dose to the high dose. Again, as Alisha said, in all markets, and I go talk to physicians around the world when I'm visiting our affiliates. At the end of the day, it's really in these devastating diseases efficacy that really matters, and there is an enhanced opportunity here for that.

Speaker #1: And there is an enhanced opportunity here for that. Okay. Thanks, Chris. Let's go to the next question, please.

Tim Power: Thanks, Chris. Let's go to the next question, please.

Speaker #3: We'll go next to Uma Ruffett with Evercore.

Speaker #1: Now, it's you know, I think it's still early days and as Alisha said, it's largely first. People moving from the lower dose to the high dose.

Operator: We'll go next to Umer Raffat with Evercore.

Speaker #5: Hi, guys. Thanks for taking my question. I guess I want to touch up on expectations ahead of your lupus readouts this fall, and specifically we've seen Benlysta track at sort of mid-teens separation on SRI.

Umer Raffat: Hi, guys. Thanks for taking my question. I guess I want to touch up on expectations ahead of your lupus readouts this fall. Specifically, we've seen BENLYSTA track at sort of mid-teens separation on SRI. We've seen SAPHNELO from AstraZeneca track at something in the 20s. I guess based on all the work you guys have done, what separation versus placebo would constitute something that's considered very clinically meaningful and differentiated over what's out there in the marketplace right now? Priya, could you also just remind us what dose of your BTK inhibitor is going forward? I'm just trying to think about the liver implications, but I would love to know what the dose is. Thank you.

Speaker #1: But again, as Alisha said, in all markets, and I go talk to physicians around the world when I'm visiting our affiliates, you know, at the end of the day, it's really in these devastating diseases, efficacy that really matters.

Speaker #5: We've seen cefenil from AstraZeneca track at something in the 20s. I guess in your based on all the work you guys have done, what separation versus placebo would constitute something that's considered very clinically meaningful and differentiated over what's out there in the marketplace right now?

Speaker #1: And there is an enhanced opportunity here for that.

Speaker #3: Thanks, Chris. Let's go to the next question, please.

Chris Viehbacher: Thanks, Chris. Let's go to the next question, please.

Tim Power: Thanks, Chris. Let's go to the next question, please.

Speaker #2: We'll go next to Uma Ruffett with Evercore.

Operator: We'll go next to Umer Raffat with Evercore.

Speaker #5: And Priya, could you also just remind us what dose of your BTK inhibitor is going forward? I'm just trying to think about the liver implications, but I would love to know what the dose is.

Umer Raffat: Hi, guys. Thanks for taking my question. I want to touch up on expectations ahead of your lupus readouts this fall. Specifically, we've seen BENLYSTA track at mid-teens separation on SRI. We've seen SAPHNELO from AstraZeneca track at something in the 20s. Based on all the work you guys have done, what separation versus placebo would constitute something that's considered very clinically meaningful and differentiated over what's out there in the marketplace right now? Priya, could you also just remind us what dose of your BTK inhibitor is going forward? I'm just trying to think about the liver implications, but I would love to know what the dose is. Thank you.

Speaker #5: Thank you.

Speaker #4: Thanks. This is Priya. I'll take that. So I think just stepping back, we're really excited about our Topaz trials. This is Topaz 1 and 2.

Priya Singhal: Thanks. This is Priya. I think just stepping back, we're really excited about our TOPAZ trials. This is TOPAZ 1 and 2. We will have results from both of these in Q4 this year. These are our SLE trials. Maybe just stepping back, I'll just comment on the fact that we've taken all the learnings from the prior trials to really ensure that we set these trials up appropriately. By that I mean we've focused on the high placebo responses that we've seen in past trials. Our trials have had rules to limit standard of care utilization, by that I mean NSAIDs, corticosteroid tapers, handling data for responders and non-responders. We've also stepped up to really think about the fact that this is a heterogeneous disease. How do we control for patient and participant heterogeneity?

Speaker #5: We've seen Sefnelo from AstraZeneca track at something in the 20s. I guess in your based on all the work you guys have done, what separation versus placebo would constitute something that's considered very clinically meaningful and differentiated over what's out there in the marketplace right now?

Speaker #4: We will have results from both of these in Q4 this year. These are our SLE trials. So maybe just stepping back, I'll just comment on the fact that, you know, we've taken all the learnings from the prior trials, to really ensure that we set these trials up appropriately.

Speaker #4: And by that, I mean we focused on the high placebo responses that you've seen in past trials. Our trials have had rules to limit standard of care utilization.

Speaker #5: Thank you.

Speaker #4: Thanks. This is Priya. I'll take that. So, I think just stepping back, we're really excited about our TOFAZ trials. This is TOFAZ 1 and 2.

Priya Singhal: Thanks. This is Priya. I'll take that. I think just stepping back, we're really excited about our TOPAZ trials. This is TOPAZ one and two. We will have results from both of these in Q4 this year. These are our SLE trials. Maybe just stepping back, I'll just comment on the fact that we've taken all the learnings from the prior trials to really ensure that we set these trials up appropriately. By that I mean we've focused on the high placebo responses that we've seen in past trials. Our trials have had rules to limit standard of care utilization. By that I mean NSAIDs, corticosteroid tapers, handling data for responders and non-responders. We've also stepped up to really think about the fact that this is a heterogeneous disease. How do we control for patient and participant heterogeneity?

Speaker #4: By that, I mean NSAIDs, corticosteroid tapers, you know, handling data for responders and non-responders. But we've also stepped up to really think about the fact that this is a heterogeneous disease.

Speaker #4: So how do we control for patient and participant heterogeneity? And we have tried to model our inclusion-exclusion criteria to be really quite tracked very closely to phase 2 LYLAC proof of concept.

Priya Singhal: We have tried to model our inclusion/exclusion criteria to be really quite, track very closely to phase II LILAC proof of concept. Now, with regards to what we expect, I think we remain confident in our trial design, site selection, patient selection, really to get a very robust response. We'll see how we kind of perform in the trial, and we'll wait for the results, so I won't speculate. Our primary endpoint is SRI-4. However, we have a key secondary endpoint in BICLA, and we have multiple patient-reported outcomes. We'll really be looking at the totality of the data, including interferon signature and all of that. I'll also remind us that from an MOA perspective, we think that litifilimab is truly differentiated. Yes, it affects the interferon pathway, but it also affects chemokines and cytokines, and we think this is what's going to provide really the overall benefit.

Speaker #4: And by that, I mean we've focused on the high placebo responses that you've seen in past trials. Our trials have had rules to limit standard of care utilization.

Speaker #4: Now, with regards to what we expect, I think we remain confident in our trial design, site selection, patient selection, really to get a very robust response.

Speaker #4: We'll see how we kind of perform in the trial. And we'll wait for the results. So I won't speculate. Our primary endpoint is SRI 4.

Speaker #4: However, we have a key secondary endpoint in BICLA. And we have multiple patient-reported outcomes. So we'll really be looking at the totality of the data, including interferon signature and all of that.

Priya Singhal: We have tried to model our inclusion/exclusion criteria to track very closely to phase II LILAC proof of concept. Now, with regards to what we expect, I think we remain confident in our trial design, site selection, patient selection, really to get a very robust response. We'll see how we perform in the trial, and we'll wait for the results. I won't speculate. Our primary endpoint is SRI-4. However, we have a key secondary endpoint in BICLA, and we have multiple patient-reported outcomes. We'll really be looking at the totality of the data, including interferon signature and all of that. I'll also remind us that from a MOA perspective, we think that litifilimab is truly differentiated. Yes, it affects the interferon pathway, but it also affects chemokines and cytokines, and we think this is what's going to provide really the overall benefit.

Priya Singhal: We'll really be looking at the totality of the data, including interferon signature and all of that. I'll also remind us that from an MOA perspective, we think that litifilimab is truly differentiated. Yes, it affects the interferon pathway, but it also affects chemokines and cytokines, and we think this is what's going to provide really the overall benefit.

Speaker #4: Now, with regard to what we expect, I think we remain confident in our trial design, site selection, and patient selection—really, to get a very robust response.

Speaker #4: I'll also remind us that from an MOA perspective, we think that lutefilimab is truly differentiated. Yes, it affects the interferon pathway, but it also affects chemokines and cytokines.

Speaker #4: We'll see how we kind of perform in the trial. And we'll wait for the results. So I won't speculate. Our primary endpoint is SRI 4.

Speaker #4: And we think this is what's going to provide really the overall benefit. And then, of course, CLE, we expect data next year. And we'll be presenting 52-week data at EADV this fall.

Priya Singhal: Then, of course, CLE, we expect data next year, and we'll be presenting 52-week data at EADV this fall. We remain confident in that data set as well. Now moving to your second question on the BTK inhibitor. We haven't actually disclosed doses, so I won't be sharing much more information, and we're looking at what the next steps might be for this.

Speaker #4: So we remain confident in that data set as well. Now, moving to your second question on the BTK inhibitor, we haven't actually disclosed doses.

Speaker #4: I'll also remind us that from an MOA perspective, we think that litophilumab is truly differentiated. Yes, it affects the interferon pathway, but it also affects chemokines and cytokines.

Speaker #4: So I won't be sharing much more information. And we're looking at what the next steps might be for this.

Priya Singhal: Yes, it affects the interferon pathway, but it also affects chemokines and cytokines, and we think this is what's going to provide really the overall benefit. CLE, we expect data next year, and we'll be presenting 52-week data at EADV this fall. We remain confident in that data set as well. Now, moving to your second question on the BTK inhibitor, we haven't actually disclosed doses, so I won't be sharing much more information, and we're looking at what the next steps might be for this.

Speaker #1: Nobody want to add anything. Alicia, in the market research. Because I think this is one of those ones where it's no one thing that's going to be a marker of success.

Chris A. Viehbacher: I don't know if you want to add anything, Alisha, in the market research, because I think this is one of those ones where it's no one thing that's going to be a marker of success. You've got steroid sparing. One of the things that we consistently hear from patients is fatigue, and yet you can't really build fatigue into an endpoint in clinical trials as easily. Real-world evidence will play a role, but maybe you can say a few words on what it's going to take commercially to succeed.

Chris Viehbacher: I don't know if you want to add anything, Alisha, in the market research, because I think this is one of those ones where it's no one thing that's going to be a marker of success. You've got steroid sparing. One of the things that we consistently hear from patients is fatigue, and yet you can't really build fatigue into an endpoint in clinical trials as easily. Real-world evidence will play a role, but maybe you can say a few words on what it's going to take commercially to succeed.

Speaker #4: And we think this is what's going to provide really the overall benefit. And then, of course, CLE, we expect data next year. And we'll be presenting 52-week data at EADV this fall.

Priya Singhal: CLE, we expect data next year, and we'll be presenting 52-week data at EADV this fall. We remain confident in that data set as well. Now, moving to your second question on the BTK inhibitor, we haven't actually disclosed doses, so I won't be sharing much more information, and we're looking at what the next steps might be for this.

Speaker #1: You've got steroid sparing. One of the things that we consistently hear from patients is fatigue. And yet, you can't really build fatigue into an endpoint in the clinical trials as easily.

Speaker #4: So we remain confident in that data set as well. Now, moving to your second question on the BTK inhibitor, we haven't actually disclosed doses.

Speaker #1: So real-world evidence will play a role. But maybe you can say a few words on what it's going to take commercially to succeed.

Speaker #4: So I won't be sharing much more information. And we're looking at what the next steps might be for this.

Speaker #4: Yeah. Thank you, Chris. Hi, Umar. Nice to hear from you. First of all, we have now recruited several senior leaders with lupus experience and entire medical team with lupus experience.

Alisha Alaimo: Yeah. Thank you, Chris. Hi, Umer, nice to hear from you. First of all, we have now recruited several senior leaders with lupus experience, an entire medical team with lupus experience, and several marketers with lupus experience. I have to say, we've probably gotten more insights from them than the actual market research that you can get through third parties. I have to say that we talk about things like SRI-4 and endpoints, when you really look at a physician and a patient and interactions they have, what we're finding in this market is there is a huge disconnect on what they expect from treatment.

Speaker #1: Nobody wants to add anything. Alisha, in the market research—because I think this is one of those ones where it's not any one thing that's going to be a marker of success.

Chris Viehbacher: I don't know if you want to add anything, Alisha, in the market research, because I think this is one of those ones where it's no one thing that's going to be a marker of success. You've got steroid sparing. One of the things that we consistently hear from patients is fatigue, and yet you can't really build fatigue into an endpoint in the clinical trials as easily. Real-world evidence will play a role, but maybe you can say a few words on what it's going to take commercially to succeed.

Speaker #4: And several marketers with lupus experience. And I have to say, we've probably gotten more insights from them than the actual market research that you can get that, you know, through third parties.

Speaker #1: You've got steroid sparing. One of the things that we consistently hear from patients is fatigue. And yet you can't really build fatigue into an endpoint in the clinical trials.

Speaker #4: And I have to say that, you know, we talk about things like SRI 4 and endpoints. But when you really look at a physician and a patient interactions they have, what we're finding in this market is there is a huge disconnect on what they expect from treatment.

Speaker #1: As easily. So real-world evidence will play a role. But maybe you can say a few words on what it's going to take commercially to succeed.

Speaker #4: Yeah. Thank you, Chris. Hi, Umar. Nice to hear from you. First of all, we have now recruited several senior leaders with lupus experience and an entire medical team with lupus experience.

Alisha A. Alaimo: Yeah. Thank you, Chris. Hi, Umer, nice to hear from you. First of all, we have now recruited several senior leaders with lupus experience, an entire medical team with lupus experience, and several marketers with lupus experience. I have to say, we've probably gotten more insights from them than the actual market research that you can get through third parties. I have to say that we talk about things like SRI-4 and endpoints, but when you really look at a physician and a patient and interactions they have, what we're finding in this market is there is a huge disconnect on what they expect from treatment.

Alisha Alaimo: Yeah. Thank you, Chris. Hi, Umer, nice to hear from you. First of all, we have now recruited several senior leaders with lupus experience, an entire medical team with lupus experience, and several marketers with lupus experience. I have to say, we've probably gotten more insights from them than the actual market research that you can get through third parties. I have to say that we talk about things like SRI-4 and endpoints, but when you really look at a physician and a patient and interactions they have, what we're finding in this market is there is a huge disconnect on what they expect from treatment.

Speaker #4: Doctors want to run a patient's experience just by what they see in labs. And patients will come in and say, the three things that are really bothering me are fatigue, brain fog, and joint pain.

Alisha Alaimo: Doctors want to run a patient's experience just by what they see in labs, patients will come in and say, "The three things that are really bothering me are fatigue, brain fog, and joint pain." I do believe in this market, when you look at CLE, where there's only less than 5% of CLE patients receiving advanced therapy. I also, because there is no approved therapy, think that CLE patient numbers are under-called. I know that we've reported out 75,000. I think that that is a much lower number than is actually out there. Secondarily, you're seeing that patients are getting lost in the system, being transferred from derm to rheum and rheum to derm, where no one really knows how to treat them. With the treatments that are on market as of today, there is downfalls.

Speaker #4: And several marketers with lupus experience. And I have to say, we probably gotten more insights from them than the actual market research that you can get that, you know, through third parties.

Speaker #4: And I do believe in this market, when you look at CLE, where there's only less than 5% of CLE patients receiving an advanced therapy, and I also because there is no approved therapy, think the CLE patient numbers are undercalled.

Speaker #4: And I have to say that, you know, we talk about things like SRI-4 and endpoints, but when you really look at the interaction between a physician and a patient, what we're finding in this market is there is a huge disconnect on what they expect from treatment.

Speaker #4: I know that we've reported out 75,000. I think that that is a much lower number than is actually out there. Secondarily, you're seeing that patients are getting lost in the system, being transferred from derm to room and room to derm, where no one really knows how to treat them.

Speaker #4: Doctors want to assess a patient's experience just by what they see in labs, and patients will come in and say, "The three things that are really bothering me are fatigue, brain fog, and joint pain."

Alisha A. Alaimo: Doctors want to run a patient's experience just by what they see in labs, patients will come in and say, The three things that are really bothering me are fatigue, brain fog, and joint pain. I do believe in this market, when you look at CLE, where there's only less than 5% of CLE patients receiving an advanced therapy, I also, because there is no approved therapy, think that CLE patient numbers are under-called. I know that we've reported out 75,000. I think that that is a much lower number than is actually out there. Secondarily, you're seeing that patients are getting lost in the system, being transferred from derm to rheum and rheum to derm, where no one really knows how to treat them. With the treatments that are on market as of today, there is downfalls.

Alisha Alaimo: Doctors want to run a patient's experience just by what they see in labs, patients will come in and say, The three things that are really bothering me are fatigue, brain fog, and joint pain. I do believe in this market, when you look at CLE, where there's only less than 5% of CLE patients receiving an advanced therapy, I also, because there is no approved therapy, think that CLE patient numbers are under-called. I know that we've reported out 75,000. I think that that is a much lower number than is actually out there. Secondarily, you're seeing that patients are getting lost in the system, being transferred from derm to rheum and rheum to derm, where no one really knows how to treat them. With the treatments that are on market as of today, there is downfalls.

Speaker #4: And then with the treatments that are on market as of today, you know, there is downfalls. One, you know, does not work very quickly or very well.

Alisha Alaimo: One does not work very quickly or very well, another has an infection safety issue. When you speak to these physicians, they are really looking for a treatment that can work much more quickly and can work in both CLE and SLE. I think that there's a very long runway for this therapeutic area. Because there is such a huge unmet need and these patients are known, we can track them in the system because most of them are diagnosed. We know which physicians they've been diagnosed by and who they see. I think that even though there is a lot of work to do, I find this to be a very good therapeutic area to enter.

Speaker #4: And another has an infection safety issue. And so when you speak to these physicians, they are really looking for treatment that can work much more quickly and can work in both CLE and SLE.

Speaker #4: I know that we've reported out 75,000. I think that is a much lower number than is actually out there. Secondarily, you're seeing that patients are getting lost in the system, being transferred from derm to rheum and rheum to derm, where no one really knows how to treat them.

Speaker #4: So I think that there's a very long runway for this therapeutic area. And because there is such a huge unmet need and these patients are known, we can track them in the system because they are most of them are diagnosed.

Speaker #4: And then with the treatments that are on market as of today, you know, there is downfalls. One, you know, does not work very quickly or very well.

Speaker #4: We know which physicians they've been diagnosed by and who they see. I think that even though there is a lot of work to do, I find this to be a very good therapeutic area to enter.

Alisha A. Alaimo: One does not work very quickly or very well, another has an infection safety issue. When you speak to these physicians, they are really looking for a treatment that can work much more quickly and can work in both CLE and SLE. I think that there's a very long runway for this therapeutic area. Because there is such a huge unmet need and these patients are known, we can track them in the system because most of them are diagnosed. We know which physicians they've been diagnosed by and who they see. I think that even though there is a lot of work to do, I find this to be a very good therapeutic area to enter.

Speaker #4: And another has an infection safety issue. And so, when you speak to these physicians, they are really looking for treatment that can work much more quickly and can work in both CLE and SLE.

Speaker #1: Let's go to the next question, please, Jess.

Chris A. Viehbacher: Let's go to the next question please, Jess.

Tim Power: Let's go to the next question please, Jess.

Speaker #2: We'll go next to Mark Goodwin with Learning Partners.

Operator: We'll go next to Marc Goodman with Leerink Partners.

Speaker #1: Yeah. Can you give us a little more insight on ciphlovir and just what is happening behind the scenes? Like, you know, new patient starts or, I mean, just the durability of patients and, you know, we understand that the injections were up 13%.

Marc Goodman: Yeah, can you give us a little more insight on SYFOVRE and just what is happening behind the scenes? Like, new patient starts or just the durability of patients and we understand that the injections were up 13%, but just trying to understand what's going on there and what kind of growth we should be expecting from here. Thanks.

Speaker #4: We know which physicians they've been diagnosed by and who they see. I think that even though there is a lot of work to do, I find this to be a very good therapeutic area to enter.

Speaker #1: But just trying to understand, like, what's going on there and what kind of growth we should be expecting from here. Thanks.

Speaker #4: Thank you for the question. There is a lot going on with ciphlovir since we've been able to integrate them into the organization. First, I want to say I'm very much impressed and very grateful for the level of talent and expertise that joined from the ciphlovir team.

Alisha Alaimo: Thank you for the question. There is a lot going on with SYFOVRE since we've been able to integrate them into the organization. First, I want to say I'm very much impressed and very grateful for the level of talent and expertise that joined from the SYFOVRE team. I think the first thing that we have noticed with both SYFOVRE and EMPAVELI is when they came on board the company, both used very similar launch plans. I think the one thing that we've really learned over the last 7 years with our 7 launches is that we really tailor-make our launch plans. We really build them from the ground up. We launch very much informed, and it's not templated.

Speaker #1: Let's go to the next question, please, Jess.

Chris Viehbacher: Let's go to the next question, please, Jess.

Tim Power: Let's go to the next question, please, Jess.

Speaker #5: We'll go next to Mark Goodwin with Learning Partners.

Operator: We'll go next to Mark Goodman with Leerink Partners.

Speaker #1: Yeah. Can you give us a little more insight on Syfovri and just what is happening behind the scenes? Like, you know, new patient starts or just the durability of patients and, you know, we understand that the injections are up 13%.

Mark Goodman: Yeah. Can you give us a little more insight on SYFOVRE and just what is happening behind the scenes? Like new patient starts or just the durability of patients, and we understand that the injections were up 13%, but just trying to understand what's going on there and what kind of growth we should be expecting from here. Thanks.

Marc Goodman: Yeah. Can you give us a little more insight on SYFOVRE and just what is happening behind the scenes? Like new patient starts or just the durability of patients, and we understand that the injections were up 13%, but just trying to understand what's going on there and what kind of growth we should be expecting from here. Thanks.

Speaker #4: I think the first thing that we have noticed with both ciphlovir and Epivaly is when they came on board with the company, both used very similar launch plans.

Speaker #4: And I think the one thing that we've really learned over the last seven years with our seven launches is that we really tailor-make our launch plans.

Speaker #1: I'm just trying to understand what's going on there and what kind of growth we should be expecting from here. Thanks.

Speaker #4: Thank you for the question. There is a lot going on with Syfovri since we've been able to integrate them into the organization. First, I want to say I'm very much impressed and very grateful for the level of talent and expertise that joined from the Syfovri team.

Speaker #4: We really build them from the ground up. We launch very much informed. And it's not templated. And so what we've been able to do is work with the ciphlovir team on across the board understanding what's really, you know, driving sales, where can we maybe reallocate capital, and how do we get the Biogen machine, you know, to sort of help drive some of their momentum.

Alisha A. Alaimo: Thank you for the question. There is a lot going on with SYFOVRE since we've been able to integrate them into the organization. First, I want to say I'm very much impressed and very grateful for the level of talent and expertise that joined from the SYFOVRE team. I think the first thing that we have noticed with both SYFOVRE and EMPAVELI is when they came on board, the company both used very similar launch plans. I think the one thing that we've really learned over the last seven years with our seven launches is that we really tailor-make our launch plans. We really build them from the ground up. We launch very much informed, and it's not templated.

Alisha Alaimo: Thank you for the question. There is a lot going on with SYFOVRE since we've been able to integrate them into the organization. First, I want to say I'm very much impressed and very grateful for the level of talent and expertise that joined from the SYFOVRE team. I think the first thing that we have noticed with both SYFOVRE and EMPAVELI is when they came on board, the company both used very similar launch plans. I think the one thing that we've really learned over the last seven years with our seven launches is that we really tailor-make our launch plans. We really build them from the ground up. We launch very much informed, and it's not templated.

Alisha Alaimo: What we've been able to do is work with the SYFOVRE team on across the board, understanding what's really driving sales, where can we maybe reallocate capital, and how do we get the Biogen machine to sort of help drive some of their momentum. I'm very encouraged by the strongest quarter since really launch for SYFOVRE. In the month of June, the month of June was the best month in the brand's history. What we're really seeing is the quality of growth across a number of areas. I think number 1, you're seeing our free drug has been lowered by half. We did end up looking at free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need access to free drug do get it. That has dropped by half.

Speaker #4: I think the first thing that we have noticed with both Syfovri and Epivaly is, when they came on board with the company, both used very similar launch plans.

Speaker #4: And so I'm very encouraged by the strongest quarter since really launch for ciphlovir. And in the month of June, the month of June was the best month in the brand's history.

Speaker #4: And I think the one thing that we've really learned over the last seven years with our seven launches is that we really tailor-make our launch plans.

Speaker #4: We really build them from the ground up. We launch very much informed. And it's not templated. And so what we've been able to do is work with the Syfovri team on across the board understanding what's really, you know, driving sales, where can we maybe reallocate capital, and how do we get the Biogen machine, you know, to sort of help drive some of their momentum.

Speaker #4: And so what we're really seeing is the quality of growth across a number of areas. I think number one, you're seeing our free drug has been lowered by half.

Alisha A. Alaimo: What we've been able to do is work with the SYFOVRE team on across the board, understanding what's really driving sales, where can we maybe reallocate capital, and how do we get the Biogen machine to sort of help drive some of their momentum. I'm very encouraged by the strongest quarter since really launch for SYFOVRE. In the month of June, the month of June was the best month in the brand's history. What we're really seeing is the quality of growth across a number of areas. I think number 1, you're seeing our free drug has been lowered by half. We did end up looking at free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need access to free drug do get it. That has dropped by half.

Alisha Alaimo: I think number 1, you're seeing our free drug has been lowered by half. We did end up looking at free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need access to free drug do get it. That has dropped by half. That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, the SYFOVRE team has done a truly tremendous job on changing that sentiment. Because sentiment has improved so much, that is where you're seeing new writers coming on board. It's also where you're seeing many more patients coming on board.

Speaker #4: We did end up looking at free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need access to free drug do get it.

Speaker #4: And that has dropped by half. That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, this ciphlovir team has been a truly tremendous job on changing that sentiment.

Speaker #4: And so I'm very encouraged by the strongest quarter since really launch for Syfovri. And in the month of June, the month of June was the best month in the brand's history.

Alisha Alaimo: That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, the SYFOVRE team has done a truly tremendous job on changing that sentiment. Because sentiment has improved so much, that is where you're seeing new writers coming on board. It's also where you're seeing many more patients coming on board. They grew both in patient numbers and in physicians who are prescribing. I think that one of the tailwinds on that was the long-term five-year data that they've been presenting, which is really a lot of education around slowing the progression of GA. Specifically, when you look ahead, the market's only 50% of the retina specialists are treating, and only 20% of these patients are diagnosed. The team is really looking at a couple things.

Speaker #4: And so, what we're really seeing is the quality of growth across a number of areas. I think, number one, you're seeing our free drug has been lowered by half.

Speaker #4: And because sentiment has improved so much that is where you're seeing new writers coming on board. It's also where you're seeing many more patients coming on board.

Speaker #4: We did end up looking at free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need access to free drug do get it.

Speaker #4: So they grew both in patient numbers and in physicians who are prescribing. And I think that one of the tailwinds on that was the long-term five-year data.

Alisha Alaimo: They grew both in patient numbers and in physicians who are prescribing. I think that one of the tailwinds on that was the long-term five-year data that they've been presenting, which is really a lot of education around slowing the progression of GA. Specifically, when you look ahead, the market's only 50% of the retina specialists are treating, and only 20% of these patients are diagnosed. The team is really looking at a couple things.

Speaker #4: And that has dropped by half. That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, the Syfovri team has been a truly tremendous job on changing that sentiment.

Alisha A. Alaimo: That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, the SYFOVRE team has done a truly tremendous job on changing that sentiment. Because sentiment has improved so much, that is where you're seeing new riders coming on board. It's also where you're seeing many more patients coming on board. They grew both in patient numbers and in physicians who are prescribing. I think that one of the tailwinds on that was the long-term five-year data that they've been presenting, which is really a lot of education around the slowing the progression of GA. Specifically, when you look ahead, the market's only 50% of the retina specialists are treating, and only 20% of these patients are diagnosed.

Alisha Alaimo: That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, the SYFOVRE team has done a truly tremendous job on changing that sentiment. Because sentiment has improved so much, that is where you're seeing new riders coming on board. It's also where you're seeing many more patients coming on board. They grew both in patient numbers and in physicians who are prescribing. I think that one of the tailwinds on that was the long-term five-year data that they've been presenting, which is really a lot of education around the slowing the progression of GA. Specifically, when you look ahead, the market's only 50% of the retina specialists are treating, and only 20% of these patients are diagnosed.

Speaker #4: That they've been presenting, which is really a lot of education around the slowing the progression of GA. And specifically, when you look ahead, the market's only 50% of the retina specialists are treating.

Speaker #4: And because sentiment has improved so much, that is where you're seeing new writers coming on board. It's also where you're seeing many more patients coming on board.

Speaker #4: And only 20% of these patients are diagnosed. And so the team is really looking at a couple of things. One is the direct-to-consumer. We have decided to shut down a few programs where we reallocating to a new commercial.

Speaker #4: So they grew both in patient numbers and in physicians who are prescribing. And I think that one of the tailwinds on that was the long-term five-year data that they've been presenting, which is really a lot of education around the slowing the progression of GA.

Alisha Alaimo: One is the direct-to-consumer. We have decided to shut down a few programs. We're reallocating to a new commercial. I think maybe the SYFOVRE team and leadership thought their DTC came out a little too soon. Now that we think that the market is ready, we do plan on launching a DTC campaign that we believe will be very effective. Secondly, prefilled syringe. We do look forward to that launch as well. Prefilled syringe is going to really support the workflow for physicians. We believe it will make it much faster for them, much more efficient, and they probably will be able to get more injections into the eyes with saving them approximately 15 minutes with these injections, that's also great.

Speaker #4: I think maybe the ciphlovir team and leadership thought their DTC came out a little too soon. Now that we think that the market is ready, we do plan on launching a DTC campaign that we believe will be very effective.

Speaker #4: And specifically, when you look ahead, the market is only 50% of the retina specialists are treating, and only 20% of these patients are diagnosed. So, the team is really looking at a couple of things.

Speaker #4: Secondly, prefilled syringe. We do look forward to that launch as well. Prefilled syringe is going to really support the workflow for physicians. We believe it will make it much faster.

Alisha A. Alaimo: The team is really looking at a couple of things. 1 is the direct-to-consumer. We have decided to shut down a few programs. We're reallocating to a new commercial. I think maybe the SYFOVRE team and leadership thought their DTC came out a little too soon. Now that we think that the market is ready, we do plan on launching a DTC campaign that we believe will be very effective. Secondly, prefilled syringe. We do look forward to that launch as well. Prefilled syringe is going to really support the workflow for physicians. We believe it will make it much faster for them, much more efficient, and they probably will be able to get more injections into the eyes with saving them approximately 15 minutes with these injections, so that's also great.

Alisha Alaimo: The team is really looking at a couple of things. 1 is the direct-to-consumer. We have decided to shut down a few programs. We're reallocating to a new commercial. I think maybe the SYFOVRE team and leadership thought their DTC came out a little too soon. Now that we think that the market is ready, we do plan on launching a DTC campaign that we believe will be very effective. Secondly, prefilled syringe. We do look forward to that launch as well. Prefilled syringe is going to really support the workflow for physicians. We believe it will make it much faster for them, much more efficient, and they probably will be able to get more injections into the eyes with saving them approximately 15 minutes with these injections, so that's also great.

Speaker #4: One is the direct-to-consumer. We have decided to shut down a few programs where we reallocating to a new commercial. I think maybe the Syfovri team and leadership thought their DTC came out a little too soon now that we think that the market is ready.

Speaker #4: For them, much more efficient. And they probably will be able to get, you know, more injections into the eyes with saving them approximately 15 minutes with these injections.

Speaker #4: So that's also great. But more importantly, on a previous call, I think I had mentioned to you when we were looking at ciphlovir, one of the things we had seen in our diligence is that there really was a big discon.

Alisha Alaimo: More importantly, on a previous call, I think I'd mentioned to you when we were looking at SYFOVRE, one of the things we had seen in our diligence is that there really was a big discon. A lot of patients discon after a year. Well, now that the team is on board and we've really looked at the data, we've noticed that actually the discons happen after the first injection. That's where the big bolus comes from, even though it really only shows up in the numbers, after a year where you see the 50% drop-off. We now believe due to all of the brands that we've had where we've had discon issues after either the first injection or first IV infusion, we know exactly what to do for that.

Speaker #4: We do plan on launching a DTC campaign that we believe will be very effective. Secondly, prefilled syringe. We do look forward to that launch as well.

Speaker #4: A lot of patients discon after a year. Well, now that the team is on board and we really looked at the data, we've noticed that actually the discon has happened after the first injection.

Speaker #4: Prefilled syringe is going to really support the workflow for physicians. We believe it will make it much faster. For them, much more efficient. And they probably will be able to get, you know, more injections into the eyes with saving them approximately 15 minutes with these injections.

Speaker #4: That's where the big bullish comes from. Even though it really only shows up in the numbers, you know, after a year where you see the 50% drop-off.

Speaker #4: And we now believe due to all of the brands that we've had, where we've had discon issues after either the first injection or first IV infusion, we know exactly what to do for that.

Speaker #4: So that's also great. But more importantly, on a previous call, I think I had mentioned to you, when we were looking at Syfovri, one of the things we had seen in our diligence is that there really was a big discon.

Alisha A. Alaimo: More importantly, on a previous call, I think I'd mentioned to you when we were looking at SYFOVRE, one of the things we had seen in our diligence is that there really was a big discon. A lot of patients discon after a year. Well, now that the team is on board and we've really looked at the data, we've noticed that actually the discons happen after the first injection. That's where the big bolus comes from. Even though it really only shows up in the numbers after a year, where you see the 50% drop-off. We now believe, due to all of the brands that we've had where we've had discon issues after either the first injection or first IV infusion, we know exactly what to do for that.

Alisha Alaimo: More importantly, on a previous call, I think I'd mentioned to you when we were looking at SYFOVRE, one of the things we had seen in our diligence is that there really was a big discon. A lot of patients discon after a year. Well, now that the team is on board and we've really looked at the data, we've noticed that actually the discons happen after the first injection. That's where the big bolus comes from. Even though it really only shows up in the numbers after a year, where you see the 50% drop-off. We now believe, due to all of the brands that we've had where we've had discon issues after either the first injection or first IV infusion, we know exactly what to do for that.

Speaker #4: So we are also rallying the team around how we support educating those patients and physicians on why they do not need to discon after the first injection, what kind of education needs to happen in the doctor's office.

Alisha Alaimo: We are also rallying the team around how we support educating those patients and physicians on why they do not need to discon after the first injection, what kind of education needs to happen in the doctor's office. Right now, we believe the HCP growth is trending in the right direction. We believe we will keep up that momentum. Our focus is going to turn to educating the patients and activating them with DTC.

Speaker #4: A lot of patients discontinue after a year. Well, now that the team is on board and we've really looked at the data, we've noticed that actually the discontinuations happened after the first injection.

Speaker #4: That's where the big bullishness comes from. Even though it really only shows up in the numbers, you know, after a year—where you see the 50% drop-off.

Speaker #4: So right now, we believe the HCP growth is trending in the right direction. We believe we will keep up that momentum. And then our focus is going to turn to educating the patients and activating them with DTC.

Speaker #4: And we now believe due to all of the brands that we've had, where we've had discon issues after either the first injection or first IV infusion, we know exactly what to do for that.

Speaker #1: Thanks, Alicia. Let's go to the next question, please.

Tim Power: Thanks, Alisha. Let's go to the next question, please.

Speaker #4: So, we are also rallying the team around how we support educating those patients and physicians on why they do not need to discontinue after the first injection, and what kind of education needs to happen in the doctor's office.

Speaker #2: We'll go next to Salveen Richter with Goldman Sachs.

Alisha A. Alaimo: We are also rallying the team around how we support educating those patients and physicians on why they do not need to discon after the first injection, what kind of education needs to happen in the doctor's office. Right now, we believe the HCP growth is trending in the right direction. We believe we will keep up that momentum, our focus is going to turn to educating the patients and activating them with DTC.

Alisha Alaimo: We are also rallying the team around how we support educating those patients and physicians on why they do not need to discon after the first injection, what kind of education needs to happen in the doctor's office. Right now, we believe the HCP growth is trending in the right direction. We believe we will keep up that momentum, our focus is going to turn to educating the patients and activating them with DTC.

Operator: We'll go next to Salveen Richter with Goldman Sachs.

Speaker #5: Thank you. Good morning. Just circling back on your BTK inhibitor, BIB-091. Could you just speak to how you expect. Asset to be differentiated versus the later stage assets under development and how you're thinking about the safety profile given what's been seen?

Salveen Richter: Thank you. Good morning. Just circling back on your BTK inhibitor, BIIB091. Could you just speak to how you expect this asset to be differentiated versus the later-stage assets under development and how you're thinking about the safety profile given what's been seen? Thank you.

Speaker #5: Thank you.

Speaker #4: Thank you, Salveen. This is Priya. So I'd just stepping back, you know, we took BIB-91, which is a peripheral BTK inhibitor, non-covalent. Into a phase two trial in RRMS a few years ago.

Priya Singhal: Thank you, Salveen. This is Priya. Just stepping back, we took BIIB091, which is a peripheral BTK inhibitor, non-covalent, into a phase II trial in RRMS a few years ago. Now we've concluded the trial, and what we see is that it could have compelling efficacy in RRMS. Actually, as I mentioned in my remarks, we are looking at what is the appropriate next step, because we see RRMS as a very crowded, competitive market. We're also looking at the external inflections that we've seen in the BTK landscape. We will communicate more about how we see this asset progressing further. We haven't actually made a decision to specifically advance it into an indication. We're not there yet. We're still evaluating the data.

Speaker #1: Thanks, Alisha. Let's go to the next question, please.

Chris Viehbacher: Thanks, Alisha. Let's go to the next question, please.

Tim Power: Thanks, Alisha. Let's go to the next question, please.

Speaker #5: We'll go next to Salveen Richter with Goldman Sachs.

Operator: We'll go next to Salveen Richter with Goldman Sachs.

Speaker #6: Thank you. Good morning. Just circling back on your BTK inhibitor, BIB 091. Could you just speak to how you expect this asset to be differentiated versus the later stage assets under development and how you're thinking about the safety profile given what's been seen?

Speaker #4: And now we've concluded the trial and what we see is that it could have compelling efficacy in RRMS. But actually, as I mentioned in my remarks, we are looking at what is the appropriate next step.

Speaker #6: Thank you.

Speaker #4: Because we see RRMS as a very crowded competitive market. But we're also looking at the external inflections that we've seen in the BTK landscape.

Speaker #4: Thank you, Salveen. This is Priya. So I'd just stepping back, you know, we took BIB 91, which is a peripheral BTK inhibitor, non-covalent. Into a phase two trial in RRMS a few years ago.

Speaker #4: So we will communicate more about how we see this asset progressing further. And we haven't actually made a decision to specifically advance it into an indication.

Speaker #4: And now we've concluded the trial, and what we see is that it could have compelling efficacy in RRMS. But actually, as I mentioned in my remarks, we are looking at what is the appropriate next step.

Speaker #4: So we're not there yet. We're still evaluating the data. Overall, we see that it could perform really well in RRMS. But I think it's another very important example of how we prioritize assets in our portfolio where we look at the scientific data, but we marry it up with the value and the opportunity in terms of totality and really capital allocation.

Priya Singhal: Overall, we see that it could perform really well in RRMS, I think it's another very important example of how we prioritize assets in our portfolio, where we look at the scientific data, but we marry it up with the value and the opportunity in terms of totality and really capital allocation. This is an example of where we're taking a pause, we're looking at the data, and we will assess how and when and if we would advance it beyond where it is today. I hope that helps.

Speaker #4: Because we see RRMS as a very crowded competitive market. But we're also looking at the external inflections that we've seen in the BTK landscape.

Speaker #4: So, we will communicate more about how we see this asset progressing further, and we haven't actually made a decision to specifically advance it into an indication.

Speaker #4: So this is an example of where we're taking a pause. We're looking at the data. And we will assess how and when and if we would advance it beyond where it is today.

Speaker #4: I hope that helps.

Alisha A. Alaimo: Overall, we see that it could perform really well in RRMS, I think it's another very important example of how we prioritize assets in our portfolio, where we look at the scientific data, we marry it up with the value and the opportunity in terms of totality and really capital allocation. This is an example of where we're taking a pause, we're looking at the data, and we will assess how and when and if we would advance it beyond where it is today. I hope that helps.

Priya Singhal: Overall, we see that it could perform really well in RRMS, I think it's another very important example of how we prioritize assets in our portfolio, where we look at the scientific data, we marry it up with the value and the opportunity in terms of totality and really capital allocation. This is an example of where we're taking a pause, we're looking at the data, and we will assess how and when and if we would advance it beyond where it is today. I hope that helps.

Speaker #1: Thanks, Priya. Let's go to the next question, please, Jeff.

Tim Power: Thanks, Priya. Let's go to the next question please, Jess.

Speaker #2: We will go next to Michael Yee with UBS.

Operator: We will go next to Michael Yee with UBS.

Speaker #6: Thanks. Our question actually is going back to metafilimab in CLE. Do you believe that CLE is a higher probability given perhaps less heterogeneity of the patient population?

Michael Yee: Thanks. Our question actually is going back to litifilimab in CLE. Do you believe that CLE is a higher probability given perhaps less heterogeneity of the patient population? You've already sort of talked about some of the risks in SLE and heterogeneity and placebo rates. Could you just comment about your view of CLE versus SLE and perhaps some of the data you might be getting at EADV that could help drive more confidence in that? I think there's some additional data presentation coming up.

Speaker #4: So this is an example of where we're taking a pause. We're looking at the data, and we will assess how, when, and if we would advance it.

Speaker #6: You've already sort of talked about some of the risks in SLE. And heterogeneity in placebo rates. So could you just comment about your view of CLE versus SLE?

Speaker #4: Beyond where it is today. I hope that helps.

Speaker #1: Thanks, Priya. Let's go to the next question, please, Jess.

Chris Viehbacher: Thanks, Priya. Let's go to the next question, please, Jess.

Tim Power: Thanks, Priya. Let's go to the next question, please, Jess.

Speaker #6: And perhaps some of the data you might be getting at EADV that could help drive more confidence in that. Because I think there's some additional data presentation coming up.

Speaker #5: We will go next to Michael Yee with UBS.

Operator: We will go next to Michael Yee with UBS.

Speaker #7: Thanks. Our question actually is going back to metafilimab in CLE. Do you believe that CLE is a higher probability given perhaps less heterogeneity of the patient population?

Speaker #6: Thanks.

Speaker #4: Thank you. I think stepping back, I actually don't see a difference in terms of probability of success between SLE and CLE. I remain confident in really the data that we saw from our LYLAC phase two trial, which we believe was a compelling proof of concept trial.

Priya Singhal: Thank you. I think stepping back, I actually don't see a difference in terms of probability of success between SLE and CLE. I remain confident in really the data that we saw from our LILAC phase II trial, which we believe was a compelling proof of concept trial. It was important because we tested the SLE population. However, it was enriched for where we believe litifilimab will have the strongest actions based on its mechanism of action. We have focused our SLE trial to be quite specific to patients who have skin and joint involvement. That is why I think I remain confident in how we've set this trial up and probability of success. Similarly, with CLE, I also remain confident because of the focus on the skin and the data that we've generated so far.

Speaker #7: You've already sort of talked about some of the risks in SLE, and heterogeneity in placebo rates. So, could you just comment about your view of CLE versus SLE?

Speaker #4: And it was important because we tested the SLE population however it was enriched for where we believe lidofilimab will have the strongest actions based on its mechanism of action.

Speaker #7: And perhaps some of the data you might be getting at EADV that could help drive more confidence in that, because I think there's some additional data presentation coming up.

Speaker #7: Thanks.

Speaker #4: Thank you. I think stepping back, I actually don't see a difference in terms of probability of success between SLE and CLE. I remain confident in really the data that we saw from our LILAC phase two trial, which we believe was a compelling proof of concept trial.

Speaker #4: So we have focused our SLE trial to be quite specific to patients who have skin and joint involvement. And that is why I think I remain confident in, you know, how we've set this trial up and probability of success.

Speaker #4: Similarly, with CLE, I also remain confident because of the, you know, focus on the skin and the data that we've generated so far. It just happens to be the situation that for SLE, given the broad indication and it's a very unfortunately prevalent disease, we have two phase three trials.

Speaker #4: And it was important because we tested the SLE population however it was enriched for where we believe litafilimab will have the strongest actions based on its mechanism of action.

Priya Singhal: It just happens to be the situation that for SLE, given the broad indication, and it's a very unfortunately prevalent disease, we have two phase III trials. With CLE, we have a phase II, phase III trial, and that was a seamless trial, the AMETHYST trial. You may remember that we actually have the opportunity to share phase II data. It is not because we are more or less confident that we're sharing it. We have the opportunity to look at the phase II data by itself without disrupting the phase III portion. We are just simply taking that data forward and bringing it to EADV. We've already shared the phase II randomized control part of AMETHYST earlier this year. Now we're sharing the 52-week data, which hopefully will say more about durability of response.

Speaker #4: And then with CLE, we have a phase two phase three trial. And that was a seamless trial. The Amethyst trial. So you may remember that we actually have the opportunity to share phase two data.

Speaker #4: It is not because we are more or less confident that we're sharing it. We have the opportunity to look at the phase two data.

Speaker #4: By itself, without disrupting the phase three portion. And we're just simply taking that data forward and bringing it to EADV. We've already shared the phase two randomized control part of Amethyst earlier.

Priya Singhal: It just happens to be the situation that for SLE, given the broad indication, and it's a very unfortunately prevalent disease, we have two phase III trials. Then with CLE, we have a phase II, phase III trial, and that was a seamless trial, the AMETHYST trial. You may remember that we actually have the opportunity to share phase II data. It is not because we are more or less confident that we're sharing it. We have the opportunity to look at the phase II data by itself without disrupting the phase III portion, and we are just simply taking that data forward and bringing it to EADV. We've already shared the phase II randomized control part of AMETHYST earlier this year. Now we're sharing the 52-week data, which hopefully will say more about durability of response.

Speaker #4: This year. So now we're sharing the 52-week data, which hopefully will say more about the audibility of response. But no, I think we remain confident in all three trials.

Speaker #4: It is not because we are more or less confident that we're sharing it. We have the opportunity to look at the phase 2 data.

Priya Singhal: No, I think we remain confident in all three trials. As was mentioned, we think this is really highly under-treated. Very few biologics have made it, and they haven't really penetrated the market. We think that is actually related to their treatment response. We think with the right mechanism of action, we could meet a very high unmet need in this area.

Speaker #4: And then as was mentioned, we think this is really highly under-treated. You know, very few biologics have made it. And they haven't really penetrated the market.

Speaker #4: By itself, without disrupting the Phase 3 portion. And we're just simply taking that data, EADV. We've already shared the Phase 2 randomized control part of Amethyst earlier.

Speaker #4: And we think that is actually related to their treatment response. And we think, you know, with the right mechanism of action, we really have a very we would be we could meet a very high unmet need in this area.

Speaker #4: This year. So now we're sharing the 52-week data, which hopefully will say more about durability of response. But no, I think we remain confident in all three trials.

Priya Singhal: Now we're sharing the 52-week data, which hopefully will say more about durability of response. No, I think we remain confident in all three trials. As was mentioned, we think this is really highly undertreated. Very few biologics have made it, and they haven't really penetrated the market. We think that is actually related to their treatment response. We think, with the right mechanism of action, we could meet a very high unmet need in this area.

Speaker #1: Go to the next question, please.

Tim Power: Go to the next question, please.

Priya Singhal: no, I think we remain confident in all three trials. As was mentioned, we think this is really highly undertreated. Very few biologics have made it, and they haven't really penetrated the market. We think that is actually related to their treatment response. We think, with the right mechanism of action, we could meet a very high unmet need in this area.

Speaker #2: We'll go next to David Anselm with Piper Sandler.

Operator: We'll go next to David Ansdell with Piper Sandler.

Speaker #4: And then, as was mentioned, we think this is really highly undertreated. You know, very few—very few—biologics have made it, and they haven't really penetrated the market.

Speaker #1: Hey, thanks. So on empathily, noticed you are initiating a phase two in FSGS. Wondering broadly how wide of a development net you're going to cast regarding the molecule.

David Ansdell: Hey, thanks. On empagliflozin, noticed you are initiating a phase II in FSGS. Wondering broadly how wide of a development net you're going to cast regarding the molecule, just given its complement C3 inhibition and how you're thinking about other indications potentially beyond FSGS. Secondly, if you can comment on your anti-CD40 that's phase I ready. Maybe comment on how it's different mechanistically than the CD40 ligand antagonist, dazodalibep, that Amgen is running a phase III program in Sjögren's. Thank you.

David Amsellem: Hey, thanks. On empagliflozin, noticed you are initiating a phase II in FSGS. Wondering broadly how wide of a development net you're going to cast regarding the molecule, just given its complement C3 inhibition and how you're thinking about other indications potentially beyond FSGS. Secondly, if you can comment on your anti-CD40 that's phase I ready. Maybe comment on how it's different mechanistically than the CD40 ligand antagonist, dazodalibep, that Amgen is running a phase III program in Sjögren's. Thank you.

Speaker #1: Just given its complement C3 inhibition and how you're thinking about, you know, other indications potentially beyond FSGS. And then secondly, if you can comment on your anti-CD40 that's phase one ready.

Speaker #1: Go to the next question, please.

Chris Viehbacher: Go to the next question, please.

Tim Power: Go to the next question, please.

Speaker #5: We'll go next to David Anselm with Piper Sandler.

Operator: We'll go next to David Ansdell with Piper Sandler.

Speaker #1: Maybe comment on how it's different mechanistically than the CD40 ligand antagonist data Dalibet that Amgen is running phase three program in Sjögren's. Thank you.

Speaker #1: Hey, thanks. So on empatholy, noticed you are initiating a phase two in FSGS. Wondering broadly how wide of a development net you're going to cast regarding the molecule.

David Ansdell: Hey, thanks. On EMPAVELI, noticed you are initiating a phase II in FSGS. Wondering broadly how wide of a development net you're going to cast regarding the molecule, just given its complement C3 inhibition and how you're thinking about other indications potentially beyond FSGS. Secondly, if you can comment on your anti-CD40 that's phase I ready. Maybe comment on how it's different mechanistically than the CD40 ligand antagonist, dazodalibep, that Amgen is running a phase III program in scleroderma. Thank you.

David Amsellem: Hey, thanks. On EMPAVELI, noticed you are initiating a phase II in FSGS. Wondering broadly how wide of a development net you're going to cast regarding the molecule, just given its complement C3 inhibition and how you're thinking about other indications potentially beyond FSGS. Secondly, if you can comment on your anti-CD40 that's phase I ready. Maybe comment on how it's different mechanistically than the CD40 ligand antagonist, dazodalibep, that Amgen is running a phase III program in scleroderma. Thank you.

Speaker #4: Thank you. Maybe I'll start with empathily there. So I think we remain excited about the fact that we've brought an empathily and of course its nephrology indications as well as the paroxysmal nocturnal hemoglobinuria remain very important commercial indications.

Priya Singhal: Thank you. Maybe I'll start with empagliflozin there. I think we remain excited about the fact that we've brought in empagliflozin and of course, its nephrology indications as well as the paroxysmal nocturnal hemoglobinuria remain very important commercial indications. As we brought this in, our legacy Apellis team was already working up a lot of indications, and we looked at these and there were two important nephrology trials that they were considering. One was delayed graft function, which we have paused and we would not be continuing that. The FSGS, we believe remains a really important indication. The reason for this is that we believe it's a high unmet need. It does have clarity on primary endpoint and a regulatory pathway, as well as the ability of empagliflozin to really address the C3, C3b cleavage pathway and thereby impact the autoantibodies.

Speaker #4: But as we've been, you know, we brought this in our legacy of Pellis team was already working up a lot of indications. And we looked at these and there were two important nephrology trials that they were considering.

Speaker #1: Maybe comment on how it's different mechanistically than the CD40 ligand antagonist data DALABEP that Amgen is running phase three program in Sjogren's. Thank you.

Speaker #4: One was delayed graft function. Which we have paused and we would not be continuing that. But the FSGS we believe remains a really important indication.

Speaker #4: Thank you. Maybe I'll start with empatholy there. So I think we remain excited about the fact that we've brought an empatholy and of course its nephrology indications as well as the paroxysmal nocturnal hemoglobinuria remain very important commercial indications.

Priya Singhal: Thank you. Maybe I'll start with EMPAVELI there. I think we remain excited about the fact that we've brought in EMPAVELI and of course, its nephrology indications as well as the paroxysmal nocturnal hemoglobinuria remain very important commercial indications. We brought this in, our legacy Apellis team was already working up a lot of indications, and we looked at these, and there were two important nephrology trials that they were considering. One was delayed graft function, which we have paused, and we would not be continuing that. The FSGS, we believe remains a really important indication. The reason for this is that we believe it's a high unmet need. It does have clarity on primary endpoint and a regulatory pathway, as well as the ability of EMPAVELI to really address the C3/C3d cleavage pathway and thereby impact the autoantibodies.

Priya Singhal: The FSGS, we believe remains a really important indication. The reason for this is that we believe it's a high unmet need. It does have clarity on primary endpoint and a regulatory pathway, as well as the ability of empagliflozin to really address the C3, C3b cleavage pathway and thereby impact the autoantibodies.

Speaker #4: And the reason for this is that we believe it's a high unmet need. It does have clarity on primary endpoint and a regulatory pathway.

Speaker #4: But as we've been, you know, we brought this in our legacy of PELIS team was already working up a lot of indications and we looked at these and there were two important nephrology trials that they were considering.

Speaker #4: As well as the ability of empathily to really address the C3, C3b cleavage pathway and thereby impact the autoantibodies and we have real-world data but also murine models where we've seen elevated levels of C3.

Speaker #4: One was delayed graft function. Which we have paused and we would not be continuing that. But the FSGS we believe remains a really important indication.

Priya Singhal: We have real world data, but also murine models where we've seen elevated levels of C3. We believe this really is a science forward approach and we are being very prudent. We're taking this forward as a phase II proof of concept, and we could have data really in short order once we initiate the trial. We also already have sought, I think our empagliflozin legacy team has already sought FDA feedback. This really comes with a really nice package, which we believe is worth prosecuting. That's where we are. We will be looking across really where does complement, specifically C3, have a large role in disease. The other part, as I mentioned in the other example just a short while ago, is really the value proposition. We are always looking at the addressable market.

Speaker #4: So we believe this really is a science forward approach. And we're being very prudent. We're taking this forward as a phase two proof of concept and we could have data really in short order once we initiate the trial.

Speaker #4: And the reason for this is that we believe it's a high unmet need. It does have clarity on primary endpoint and a regulatory pathway as well as the ability of empatholy to really address the C3, C3B cleavage pathway and thereby impact the autoantibodies and we have real-world data but also murine models where we've seen elevated levels of C3.

Speaker #4: We also already have sought, I think our empathily legacy team has already sought FDA feedback. So this really comes with a really nice package which we believe is worth prosecuting.

Priya Singhal: We have real world data, but also murine models where we've seen elevated levels of C3. We believe this really is a science forward approach, and we're being very prudent. We're taking this forward as a phase II proof of concept, and we could have data really in short order once we initiate the trial. We also already have sought, I think our EMPAVELI legacy team has already sought MPA feedback. This really comes with a really nice package, which we believe is worth prosecuting. That's where we are. We will be looking across really where does complement, specifically C3, have a large role in disease. The other part, as I mentioned in the other example, just a short while ago, is really the value proposition. We are always looking at the addressable market.

Speaker #4: So that's where we are. We will be looking across really where does complement specifically C3 have a large role in disease. But the other part, as I mentioned in the other example, just shortly short while ago, is really the value proposition.

Speaker #4: So we believe this really is a science forward approach and we're being very prudent. We're taking this forward as a phase two proof of concept and we could have data really in short order once we initiate the trial.

Speaker #4: So we are always looking at the addressable market. For example, with this FSGS we know there's about 27,000 patients in the US. We know there's four types.

Speaker #4: We also already have sought, I think our empatholy legacy team has already sought FDA feedback. So this really comes with a really nice package which we believe is worth prosecuting.

Priya Singhal: For example, with this FSGS, we know there's about 27,000 patients in the US. We know there's 4 types. We will be running a very clear and decision enabling trial to really give us next steps. With regard shifting to your second question about the anti-CD40. We remain excited about the pathway. We think it's differentiated and it could be something that we bring forward also in autoimmune disease. We haven't shared that yet, but we will be communicating more when the time is right.

Priya Singhal: This really comes with a really nice package, which we believe is worth prosecuting. That's where we are. We will be looking across really where does complement, specifically C3, have a large role in disease. The other part, as I mentioned in the other example, just a short while ago, is really the value proposition. We are always looking at the addressable market. For example, with this FSGS, we know there's about 27,000 patients in the US. We know there's 4 types. We will be running a very clear and decision enabling trial to really give us next step. Now, with regard shifting to your second question about the anti-CD40, we remain excited about the pathway. We think it's differentiated and it could be something that we bring forward also in autoimmune disease. We haven't shared that yet, but we will be communicating more when the time is right.

Speaker #4: We will be running a very clear and decision enabling, you know, trial to really give us next steps. Now with regard shifting to your second question about the anti-CD40, we remain excited about the pathway.

Speaker #4: So that's where we are. We will be looking across, really, where does complement—specifically C3—have a large role in disease? But the other part, as I mentioned in the other example just a short while ago, is really the value proposition.

Speaker #4: We think it's differentiated. And, you know, it could be something that we bring forward also in autoimmune disease. We haven't shared that yet. But we will be communicating more when the time is right.

Speaker #4: So, we are always looking at the addressable market. For example, with this FSGS, we know there's about 27,000 patients in the U.S. We know there are four types.

Speaker #1: Thanks, Priya. Jess, could we go to the next question, please?

Speaker #4: We will be running a very clear and decision enabling, you know, trial to really give us next steps. Now with regards shifting to your second question about the anti-CD40, we remain excited about the pathway.

Tim Power: Thanks, Priya. Jess, could we go to the next question, please?

Speaker #2: We'll go next to Alex Hammond with Wolf Research.

Operator: We'll go next to Alex Hammond with Wolfe Research.

Speaker #5: Hey guys, thanks for taking the question. So it's been a few weeks since you posted or presented the full Celia data at AAIC. I guess giving given it's been some time for you to digest the reactions on the medical and regulatory community, what feedback have you been getting?

Priya Singhal: Now, with regard shifting to your second question about the anti-CD40, we remain excited about the pathway. We think it's differentiated and it could be something that we bring forward also in autoimmune disease. We haven't shared that yet, but we will be communicating more when the time is right.

Speaker #4: We think it's differentiated and, you know, it could be something that we bring forward also in autoimmune disease. We haven't shared that yet. But we will be communicating more when the time is right.

Speaker #5: Has there been any feedback that's kind of shifted your thinking at all in the phase three trial design, particularly the potential for early combination with A beta antibodies?

Paul Matteis: Has there been any feedback that's kind of shifted your thinking at all in the Phase III trial design, particularly the potential for early combination with Aβ antibodies? Thank you.

Alex Hammond: Has there been any feedback that's kind of shifted your thinking at all in the Phase III trial design, particularly the potential for early combination with Aβ antibodies? Thank you.

Speaker #5: Thank you.

Speaker #1: Thanks, Priya. Jess, could we go to the next question, please?

Chris Viehbacher: Thanks, Priya. Jess, could we go to the next question, please?

Tim Power: Thanks, Priya. Jess, could we go to the next question, please?

Speaker #1: Yeah, I'll take that one. And, you know, as I said in my remarks, you're a nurse and it's really part of the longer-term story of Biogen.

Chris A. Viehbacher: Yeah, I'll take that one. As I said in my remarks, diranersen is really part of the longer-term story of Biogen. The Phase II was really an exploratory study. The main objective was really to see, if you reduce tau, could you move cognition? Because up until now, tau has been a theory, been a favorite theory, but it's still a theory, and this is the first time anybody's shown any data on this. Now, the business decision really to go forward with that is Priya had already, when we got the data, arranged for an independent biostatistician to review the data. We had an outside KOL review the data before we announced it. Multiple advisory groups, we had the AAIC. One of the very strong feedbacks is the signal is real. This is not due to chance.

Chris Viehbacher: Yeah, I'll take that one. As I said in my remarks, diranersen is really part of the longer-term story of Biogen. The Phase II was really an exploratory study. The main objective was really to see, if you reduce tau, could you move cognition? Because up until now, tau has been a theory, been a favorite theory, but it's still a theory, and this is the first time anybody's shown any data on this. Now, the business decision really to go forward with that is Priya had already, when we got the data, arranged for an independent biostatistician to review the data. We had an outside KOL review the data before we announced it. Multiple advisory groups, we had the AAIC. One of the very strong feedbacks is the signal is real. This is not due to chance.

Speaker #5: We'll go next to Alex Hammond with Wolfe Research.

Operator: We'll go next to Alex Hammond with Wolfe Research.

Speaker #6: Hey guys, thanks for taking the question. So it's been a few weeks since you posted or presented the full Celia data at AAIC. I guess giving given it's been some time for you to digest the reactions on the medical and regulatory community, what feedback have you been getting?

Alex Hammond: Hey, guys. Thanks for taking the question. It's been a few weeks since you posted or presented the full CELIA data at AAIC. I guess given it's been some time for you to digest the reaction from the medical and regulatory community, what feedback have you been getting? Has there been any feedback that's kind of shifted your thinking at all in the phase III trial design, particularly the potential for early combination with Aβ antibodies? Thank you.

Speaker #1: And, you know, the phase two was really an exploratory study. And the main objective was really to see if you reduce tau, could you remove could you move cognition?

Speaker #6: Has there been any feedback that's kind of shifted your thinking at all in the Phase 3 trial design, particularly the potential for early combination with A-beta antibodies?

Speaker #1: Because up until now, tau has been a theory. It's been a favorite theory. But it's still a theory. And this is the first time anybody's shown any data on this.

Speaker #6: Thank you.

Speaker #1: Yeah, I'll take that one. And, you know, as I said in my remarks, dear nursing is really part of the longer-term story of Biogen.

Speaker #1: Now, the business decision really to go forward with that is Priya had already when we got the data range for an independent biostatistician to review the data.

Chris Viehbacher: Yeah. I'll take that one, as I said in my remarks, diranersen is really part of the longer-term story of Biogen. The phase II was really an exploratory study. The main objective was really to see if you reduce tau, could you move cognition? Because up until now, tau has been a theory, been a favorite theory, but it's still a theory, and this is the first time anybody's shown any data on this. Now, the business decision really to go forward with that is Priya had already, when we got the data, arranged for an independent biostatistician to review the data. We had an outside ex KOL review the data before we announced it. Multiple advisory groups. We had the AAIC. One of the very strong feedbacks is the signal is real. This is not due to chance.

Speaker #1: And, you know, the Phase 2 was really an exploratory study. And the main objective was really to see if, if you reduce tau, could you move cognition.

Speaker #1: We had an outside KME review the data before we announced it. Done multiple advisory groups. We had the AAIC one of the very strong feedbacks is the signal is real.

Speaker #1: Because up until now, tau has been a theory. It's been a favorite theory. But it's still a theory. And this is the first time anybody's shown any data on this.

Speaker #1: This is not due to chance. You know, a lot of people got their doing a lot of over-analysis of the dosing question. There's a lot of different hypotheses.

Chris A. Viehbacher: A lot of people got there doing a lot of over-analysis of the dosing question. There's a lot of different hypotheses. There's one, it's very clear that tau is important to neurotransmission. While too much is not good, maybe too little is also not good. We just don't know. This is the issue of being in breakthrough. It's very exciting, it's also one of the reasons we decided not to build the company on this type of product. This is one of these high risk, high reward. We're doing a lot of investigation and discussion with the neurology community. Obviously we'll be consulting with the FDA. We also have long-term extension data that are coming along and we'll make those available. This is a long-term investment. We're confident in the signal.

Chris Viehbacher: A lot of people got there doing a lot of over-analysis of the dosing question. There's a lot of different hypotheses. There's one, it's very clear that tau is important to neurotransmission. While too much is not good, maybe too little is also not good. We just don't know. This is the issue of being in breakthrough. It's very exciting, it's also one of the reasons we decided not to build the company on this type of product. This is one of these high risk, high reward. We're doing a lot of investigation and discussion with the neurology community. Obviously we'll be consulting with the FDA. We also have long-term extension data that are coming along and we'll make those available. This is a long-term investment. We're confident in the signal.

Speaker #1: Now, the business decision really to go forward with that is Priya had already, when we got the data, arranged for an independent biostatistician to review the data.

Speaker #1: There's one it's very clear that tau is important to neurotransmission. And so while too much is not good, maybe too little is also not good.

Speaker #1: We had an outside KME review the data before we announced it. Done multiple advisory groups. We had the AAIC one of the very strong feedbacks is the signal is real.

Speaker #1: We just don't know. This is the issue of being in breakthrough. It's very exciting, but it's also one of the reasons we decided not to build the company on this type of product.

Speaker #1: This is one of these high-risk, high-reward. We're doing a lot of investigation and discussion with the neurology community. And obviously we'll be consulting with the FDA.

Speaker #1: This is not due to chance. You know, a lot of people have gotten there doing a lot of over-analysis of the dosing question. There's a lot of different hypotheses.

Chris Viehbacher: A lot of people got there doing a lot of over-analysis of the dosing question. There's a lot of different hypotheses. There's one, it's very clear that tau is important to neurotransmission, so while too much is not good, maybe too little is also not good. We just don't know. This is the issue of being in breakthrough. It's very exciting, but it's also one of the reasons we decided not to build a company on this type of product. This is one of these high-risk, high-reward. We're doing a lot of investigation and discussion with the neurology community. Obviously, we'll be consulting with the FDA. We also have long-term extension data that are coming along, and we'll make those available. This is a long-term investment. We're confident in the signal.

Speaker #1: There's one it's very clear that tau is important to neurotransmission. And so while too much is not good, maybe too little is also not good.

Speaker #1: We also have long-term extension data that are coming along and we'll make those available. But, you know, this is a long-term investment. It'll be we're confident in the signal.

Speaker #1: We just don't know of being in breakthrough. It's very exciting, but it's also one of the reasons we decided not to build the company on this type of product.

Speaker #1: And, you know, it could be an exciting option. But, you know, it's still going to have to go through phase three and it's not something that's going to affect Biogen's growth over the rest of this decade.

Chris A. Viehbacher: It could be an exciting option, but still going to have to go through Phase III, it's not something that's going to affect Biogen's growth over the rest of this decade. That's all we really want to say about diranersen at this stage.

Chris Viehbacher: It could be an exciting option, but still going to have to go through Phase III, it's not something that's going to affect Biogen's growth over the rest of this decade. That's all we really want to say about diranersen at this stage.

Speaker #1: This is one of these high-risk, high-reward. We're doing a lot of investigation and discussion with the neurology community. And obviously we'll be consulting with the FDA.

Chris Viehbacher: This is one of these high-risk, high-reward. We're doing a lot of investigation and discussion with the neurology community. Obviously, we'll be consulting with the FDA. We also have long-term extension data that are coming along, and we'll make those available. This is a long-term investment. We're confident in the signal. It could be an exciting option, still going to have to go through phase III, it's not something that's going to affect Biogen's growth over the rest of this decade. That's all we really want to say about diranersen at this stage.

Speaker #1: So that's all we really want to say about dear nursing at this stage. Thanks, Chris. Let's go to the next question, please.

Tim Power: Thanks, Chris. Let's go to the next question, please.

Speaker #1: We also have long-term extension data that are coming along and we'll make those available. But, you know, this is a long-term investment. It'll signal.

Speaker #2: We'll go next to Brian Abrahams with RBC Capital Market.

Operator: We'll go next to Brian Abrahams with RBC Capital Markets.

Speaker #6: Hey, good morning. Congrats on the solid quarter. Thanks for taking my question. On subcutal can be induction. Just curious what the initial demand or interest has looked like on the ground here versus your expectations.

Brian Abrahams: Hey, good morning. Congrats on the solid quarter. Thanks for taking my question. On subcu LEQEMBI induction, just curious what the initial demand or interest has looked like on the ground for you versus your expectations, and then your latest views on the access dynamics and potential timelines there. Thanks.

Speaker #1: And, you know, it could be an exciting option, but, you know, it's still going to have to go through Phase 3, and it's not something that's going to affect Biogen's growth over the rest of this decade.

Chris Viehbacher: It could be an exciting option, still going to have to go through phase III, it's not something that's going to affect Biogen's growth over the rest of this decade. That's all we really want to say about diranersen at this stage. Thanks, Chris. Let's go to the next question, please.

Speaker #6: And then your latest views on the access dynamics and potential timelines there. Thanks.

Speaker #1: So that's all we really want to say about dear nursing at this stage. Thanks, Chris. Let's go to the next question, please.

Speaker #4: Hi, thank you. I'll take that question. As you know earlier this month, we received approval for Leqembi iQlik for induction. And it will be available by the end of August in market.

Alisha Alaimo: Hi, thank you. I'll take that question. As you know, earlier this month, we received approval for LEQEMBI LEQEMBI IQLIK for induction, and it will be available by the end of August in market. What we've done is our field teams are trained. We are educating the HCPs, and letting them know availability is expected next month. We've already had some demand. Of course, it's not getting filled yet, but they are put into a queue. We've had, we know as of yesterday, several physicians have already written scripts, and so we're not really counting that yet in our expectations until the product is actually readily available for the market. We're keeping a close eye on that.

Tim Power: Thanks, Chris. Let's go to the next question, please.

Speaker #5: We'll go next to Brian Abrahams with RBC Capital Markets.

Operator: We'll go next to Brian Abrahams with RBC Capital Markets.

Speaker #7: Hey, good morning. Congrats on the solid quarter. Thanks for taking my question. On subcu Leqembi induction, just curious what the initial demand or interest has looked like on the ground here versus your expectations.

Speaker #4: So what we've done is our field teams are trained. We are educating the HCPs and letting them know availability is expected next month. So we've already had some demand.

Brian Abrahams: Hey, good morning. Congrats on the solid quarter. Thanks for taking my question. On subcu LEQEMBI induction, just curious what the initial demand or interest has looked like on the ground here versus your expectations, your latest views on the access dynamics, and potential timelines there. Thanks.

Speaker #4: Of course, it's not getting filled yet, but they are put into a queue. And so we've had we know as of yesterday several physicians have already written scripts.

Speaker #7: And then your latest views on the access dynamics and potential timelines there. Thanks.

Speaker #4: Hi, thank you. I'll take that question. As you know, earlier this month we received approval for Leqembi iQlik for induction, and it will be available by the end of August in market.

Speaker #4: And so we're not really counting that yet in our expectations until the product is actually readily available for the market. So we're keeping a close eye on that.

Alisha A. Alaimo: Hi. Thank you. I will take that question. As you know, earlier this month, we received approval for LEQEMBI Cube Click for induction, and it will be available by the end of August in market. What we have done is our field teams are trained. We are educating the HCPs and letting them know availability is expected next month. We have already had some demand. Of course, it is not getting filled yet, but they are put into a queue. We have had, we know as of yesterday, several physicians have already written scripts. We are not really counting that yet in our expectations until the product is actually readily available for the market. We are keeping a close eye on that.

Alisha Alaimo: Hi. Thank you. I will take that question. As you know, earlier this month, we received approval for LEQEMBI Cube Click for induction, and it will be available by the end of August in market. What we have done is our field teams are trained. We are educating the HCPs and letting them know availability is expected next month. We have already had some demand. Of course, it is not getting filled yet, but they are put into a queue. We have had, we know as of yesterday, several physicians have already written scripts. We are not really counting that yet in our expectations until the product is actually readily available for the market. We are keeping a close eye on that.

Speaker #4: Now, as you also know, ACI is trying to make access very easy for this and as simple as possible. And they are the ones working with the payers on part D access.

Alisha Alaimo: As you also know, Eisai is trying to make access very easy for this and as simple as possible, they are the ones working with the payers on Part D access. We will find out again in several months what kind of access we will receive at the beginning of next year. However, even if some of the Part D plans don't contract for LEQEMBI, the other route which they have been going through with LEQEMBI IQLIK maintenance has been medical exceptions. When we pull the data to look at the medical exception rate for the product, it is quite high. Higher than most other therapeutic areas, even when a physician does put that through, the grant approval rate is high, meaning that they are getting the product for the patient.

Speaker #4: So what we've done is our field teams are trained. We are educating the HCPs and letting them know availability is expected next month. So we've already had some demand.

Speaker #4: And so we will find out again in several months what kind of access we'll receive at the beginning of next year. However, even if some of the part D plans don't contract for Leqembi, the other route, which they've been going through with iQlik maintenance, has been medical exceptions.

Speaker #4: Of course, it's not getting filled yet, but they are put into a queue. And so we've had we know as of yesterday several physicians have already written scripts.

Speaker #4: And so we're not really counting that yet and our expectations until the product is actually readily available for the market. So we're keeping a close eye on that.

Speaker #4: Now, when we pull the data to look at the medical exception rate for the product, it is quite high. Higher than most other therapeutic areas.

Speaker #4: Now, as you also know, ASI is trying to make access very easy for this and as simple as possible. And they are the ones working with the payers on part D access.

Alisha A. Alaimo: As you also know, Eisai is trying to make access very easy for this and as simple as possible. They are the ones working with the payers on Part D access. We will find out again in several months what kind of access we will receive at the beginning of next year. However, even if some of the Part D plans do not contract for LEQEMBI, the other route, which they have been going through with Cube Click maintenance, has been medical exceptions. When we pull the data to look at the medical exception rate for the product, it is quite high. Higher than most other therapeutic areas. Even when a physician does put that through, the grant approval rate is high, meaning that they are getting the product for the patient.

Alisha Alaimo: As you also know, Eisai is trying to make access very easy for this and as simple as possible. They are the ones working with the payers on Part D access. We will find out again in several months what kind of access we will receive at the beginning of next year. However, even if some of the Part D plans do not contract for LEQEMBI, the other route, which they have been going through with Cube Click maintenance, has been medical exceptions. When we pull the data to look at the medical exception rate for the product, it is quite high. Higher than most other therapeutic areas. Even when a physician does put that through, the grant approval rate is high, meaning that they are getting the product for the patient.

Speaker #4: And so even when a physician does put that through the grant approval rate is high, meaning that they are getting the product for the patient.

Speaker #4: And so it remains to be seen what happens as of 1/1 next year for the coverage, which by the way, even if you get a part D plan coverage, a prior auth must be filled out.

Alisha Alaimo: It remains to be seen what happens as of 1 January next year for the coverage, which by the way, even if you get a Part D plan coverage, a prior auth must be filled out. A doctor is either filling out a prior auth or filling out a medical exception form for the product. We also believe that based on the market research that we have done recently, LEQEMBI IQLIK will evolve this market and will be another contributor to growth once it gets off the ground. Keep in mind, a lot of the protocols for LEQEMBI are written for IV, a lot of the IDNs and hospitals and systems are starting to rewrite those to incorporate LEQEMBI IQLIK obviously also into their workflow.

Speaker #4: So a doctor is either filling out a prior auth or filling out a medical exception form for the product. So we also believe that based on the market research, that we have done recently, iQlik will evolve this market and will be another contributor to growth once it gets off the ground.

Speaker #4: Now, when we pull the data to look at the medical exception rate for the product, it is quite high. Higher than most other therapeutic areas.

Speaker #4: And so even when a physician does put that through the grant approval rate is high, meaning that they are getting the product for the patient.

Speaker #4: Now, keep in mind a lot of the protocols for Leqembi are written for IV. And so a lot of the IDNs and hospitals and systems are starting to rewrite those to incorporate iQlik, obviously also into their workflow.

Speaker #4: And so it remains to be seen what happens as of January 1st next year for the coverage, which, by the way, even if you get a Part D plan coverage, a prior auth must be filled out.

Alisha A. Alaimo: It remains to be seen what happens as of 1 January next year for the coverage, which by the way, even if you get a Part D plan coverage, a prior auth must be filled out. A doctor is either filling out a prior auth or filling out a medical exception form for the product. We also believe that based on the market research that we have done recently, Cube Click will evolve this market and will be another contributor to growth once it gets off the ground. Now keep in mind, a lot of the protocols for LEQEMBI are written for IV. A lot of the IDNs and hospitals and systems are starting to rewrite those to incorporate Cube Click obviously also into their workflow.

Alisha Alaimo: It remains to be seen what happens as of 1 January next year for the coverage, which by the way, even if you get a Part D plan coverage, a prior auth must be filled out. A doctor is either filling out a prior auth or filling out a medical exception form for the product. We also believe that based on the market research that we have done recently, Cube Click will evolve this market and will be another contributor to growth once it gets off the ground. Now keep in mind, a lot of the protocols for LEQEMBI are written for IV. A lot of the IDNs and hospitals and systems are starting to rewrite those to incorporate Cube Click obviously also into their workflow.

Speaker #4: So, a doctor is either filling out a prior auth or filling out a medical exception form for the product. We also believe that, based on the market research we have done recently, iQlik will evolve this market and will be another contributor to growth once it gets off the ground.

Speaker #4: And we also see that, and Chris had mentioned earlier, when you look at drop-off rates, which, you know, there's drop-offs at many points in a patient journey.

Alisha Alaimo: We also see that, Chris had mentioned earlier, when you look at drop-off rates, which there is drop-offs at many points in a patient journey. But one particularly is when they finally get to a physician who believes in AATs and goes to prescribe the product. One of the largest drop-offs are patients not wanting to take IV in general. That is agnostic of LEQEMBI or of Kisunla. We also believe in our market research, it shows that those patients would opt on to doing subcu. There is a big portion of patients that drop off exactly for that reason. We believe that that will also help accelerate the market.

Speaker #4: But one particularly is when they finally get to a physician who believes in AATs and goes to prescribe the product, one of the largest drop-offs are patients not wanting to take IV in general.

Speaker #4: Now, keep in mind a lot of the protocols for Leqembi are written for IV. And so a lot of the IDNs and hospitals and systems are starting to rewrite those to incorporate iQlik.

Speaker #4: That is agnostic of Leqembi or of Casunla. We also believe in our market research. It shows that those patients would opt on to doing subcue.

Speaker #4: Obviously also into their workflow. And we also see that and Chris had mentioned earlier, when you look at drop-off rates, which, you know, there's drop-offs at many points in a patient journey.

Alisha A. Alaimo: We also see that, and Chris had mentioned earlier, when you look at drop-off rates, which there is drop-offs at many points in a patient journey, but one particularly is when they finally get to a physician who believes in AAT and goes to prescribe the product. One of the largest drop-offs are patients not wanting to take IV in general. That is agnostic of LEQEMBI or of Kisunla. We also believe in our market research, it shows that those patients would opt on to doing subcu. There is a big portion of patients that drop off exactly for that reason. We believe that that will also help accelerate the market.

Speaker #4: And so there is a big portion of patients that drop off exactly for that reason. And so we believe that that will also help accelerate the market.

Alisha Alaimo: We also see that, and Chris had mentioned earlier, when you look at drop-off rates, which there is drop-offs at many points in a patient journey, but one particularly is when they finally get to a physician who believes in AAT and goes to prescribe the product. One of the largest drop-offs are patients not wanting to take IV in general. That is agnostic of LEQEMBI or of Kisunla. We also believe in our market research, it shows that those patients would opt on to doing subcu. There is a big portion of patients that drop off exactly for that reason. We believe that that will also help accelerate the market.

Speaker #1: Go to our next question, please, Jess.

Tim Power: Go to our next question please, Jess.

Speaker #2: We'll go next to Paul Matias with Stifel.

Operator: We'll go next to Paul Matteis with Stifel.

Speaker #5: Great. Good morning. Thanks for taking my question. How are you guys thinking about the brain shuttle space right now? And as you think about yourselves investing so much in building this Alzheimer's market, do you feel like Biogen needs to have a brain shuttle to capture what the peak sales potential of A beta is going to look like?

Paul Matteis: Great, good morning. Thanks for taking my question. How are you guys thinking about the brain shuttle space right now? As you think about yourselves investing so much in building this Alzheimer's market, do you feel like Biogen needs to have a brain shuttle to capture what the peak sales potential of Aβ is going to look like? If so, what's the best way to get there? Thank you.

Speaker #4: That is agnostic of Leqembi or of Casunla. We also believe in our market research, which shows that those patients would opt to do subcu.

Speaker #4: And so, there is a big portion of patients that drop off exactly for that reason. We believe that will also help accelerate the market.

Speaker #5: And if so, what's the best way to get there? Thank you.

Speaker #1: Go to our next question, please, Jess.

Speaker #4: Thanks. It's a very important area for us and has been for a while. Precedes any data readouts that we've had recently. So that's what I can tell you.

Chris Viehbacher: Go to our next question please, Jess.

Tim Power: Go to our next question please, Jess.

Priya Singhal: Thanks. It's a very important area for us and has been for a while, precedes any data readouts that we've had recently. That's what I can tell you. We are working internally. We're also looking externally, and we've been doing the work on shuttle delivery really deeply here. We remain very interested in getting to tissue delivery modalities, and I think we would think about that across several targets. That's what I can share, but it's a high priority for us.

Speaker #5: We'll go next to Paul Matias with Stifel.

Operator: We'll go next to Paul Matteis with Stifel.

Speaker #6: Great. Good morning. Thanks for taking my question. How are you guys thinking about the brain shuttle space right now? And as you think about yourselves investing so much in building this Alzheimer's market, do you feel like Biogen needs to have a brain shuttle to capture what the peak sales potential of A beta is going to look like?

Paul Matteis: All right, great. Good morning. Thanks for taking my question. How are you guys thinking about the brain shuttle space right now? As you think about yourselves investing so much in building this Alzheimer's market, do you feel like Biogen needs to have a brain shuttle to capture what the peak sales potential of Aβ is going to look like? If so, what's the best way to get there? Thank you.

Speaker #4: We are working internally. We're also looking externally. And we've been doing the work on shuttle delivery. Really deeply here. So we remain very interested in getting to tissue delivery modalities and I think we would think about that across several targets.

Speaker #6: And if so, what's the best way to get there? Thank you.

Speaker #4: That's what I can share. But it's a high priority for us.

Speaker #4: Thanks. It's a very important area for us and has been for a while. Precedes any data readouts that we've had recently. So that's what I can tell you.

Priya Singhal: Thanks. It's a very important area for us and has been for a while. It precedes any data readouts that we've had recently. That's what I can tell you. We are working internally. We're also looking externally, and we've been doing the work on shuttle delivery really deeply here. We remain very interested in getting to tissue delivery modalities, and I think we would think about that across several targets. That's what I can share, but it's a high priority for us.

Speaker #5: Yeah. I mean, longer term, you know, Alzheimer's is certainly going to be a core part of the portfolio of Biogen. Particularly now that, you know, there's a very good chance that dear nursing ultimately makes it to market.

Chris A. Viehbacher: Yeah. Longer term, Alzheimer's is certainly going to be a core part of the portfolio of Biogen. Particularly now that there's a very good chance that lecanemab ultimately makes it to market. Clearly, we have to go through the phase III program. Again, I think what really is important for this market, and you talk to physicians who actually treat patients, it's really moving cognition. That's what has caused us to go forward with lecanemab. Now, it probably makes sense to have a portfolio of products. We're already even talking internally, and we haven't made any decisions yet, but are you going to combine an Aβ with an anti-tau, for example?

Chris Viehbacher: Yeah. Longer term, Alzheimer's is certainly going to be a core part of the portfolio of Biogen. Particularly now that there's a very good chance that lecanemab ultimately makes it to market. Clearly, we have to go through the phase III program. Again, I think what really is important for this market, and you talk to physicians who actually treat patients, it's really moving cognition. That's what has caused us to go forward with lecanemab. Now, it probably makes sense to have a portfolio of products. We're already even talking internally, and we haven't made any decisions yet, but are you going to combine an Aβ with an anti-tau, for example?

Speaker #5: Clearly, we have to go through the phase three program. But again, you know, I think when you what really is important for this market and you've talked to physicians actually treat patients, it's really moving cognition.

Speaker #4: And I think we would think about that across several targets. That's what I can share. But it's a high priority for us.

Speaker #1: Yeah. I mean, longer term, you know, Alzheimer's is certainly going to be a core part of the portfolio of Biogen. Particularly now that, you know, there's a very good chance that dear nursing ultimately makes it to market.

Speaker #5: So that's what has caused us to go forward with the dear nursing. Now, then it probably makes sense to have a portfolio of products.

Chris Viehbacher: Longer term, Alzheimer's is certainly going to be a core part of the portfolio of Biogen, particularly now that there's a very good chance that lecanemab ultimately makes it to market. We have to go through the phase III program. Again, I think what really is important for this market, and you talk to physicians who actually treat patients, it's really moving cognition. That's what has caused us to go forward with lecanemab. It probably makes sense to have a portfolio of products. We're already even talking internally, and we haven't made any decisions yet, but are you going to combine an A-beta with an anti-tau, for example? There's a question of, well, maybe you don't even need to take, after you do, say, three, four injections of anti-tau, maybe you need just an anti-A-beta to actually keep the tau from coming back.

Speaker #5: And, you know, we're already even talking internally and we haven't made any decisions yet, but are you going to combine an A beta with an anti-TAU, for example?

Speaker #1: Clearly, we have to go through the phase three program. But again, you know, I think when you what really is important for this market and you've talked to physicians actually treat patients, it's really moving cognition.

Speaker #5: There's a question of, well, maybe you don't even need to take after you do, say, three, four injections of anti-TAU. Maybe you need that just an anti-beta anti-A beta to actually keep the TAU from coming back.

Chris A. Viehbacher: There's a question of, well, maybe you don't even need to take, after you do, say, three, four injections of anti-tau, maybe you need just an anti-Aβ to actually keep the tau from coming back. All of those things are kind of what we're war gaming. This would be something that certainly would affect the business in the next decade. I think if we're going to be in Alzheimer's, we are certainly looking to have a portfolio, and clearly brain shuttles would be the next generation of products to pursue, and as Priya said, we've been working on that for several years now.

Chris Viehbacher: There's a question of, well, maybe you don't even need to take, after you do, say, three, four injections of anti-tau, maybe you need just an anti-Aβ to actually keep the tau from coming back. All of those things are kind of what we're war gaming. This would be something that certainly would affect the business in the next decade. I think if we're going to be in Alzheimer's, we are certainly looking to have a portfolio, and clearly brain shuttles would be the next generation of products to pursue, and as Priya said, we've been working on that for several years now.

Speaker #1: So that's what has caused us to go forward with the dear nursing. Now, then it probably makes sense to have a portfolio of products. And, you know, we're already even talking internally and we haven't made any decisions yet.

Speaker #5: But all of those things are kind of what we're wargaming. This would be something that certainly would affect the business in the next decade.

Speaker #5: But I think if we're going to be in Alzheimer's, we are certainly looking to have a portfolio. And clearly, brain shuttles would be the next generation of products to pursue.

Speaker #1: But are you going to combine an A beta with an anti-TAU, for example? There's a question of, well, maybe you don't even need to take after you do, say, three, four injections of anti-TAU.

Speaker #5: And as Priya said, we've been working on that for several years now.

Speaker #1: Thanks, Chris. We'll maybe try and squeeze two last ones. Can we go to the next one, please, Jess?

Tim Power: Thanks, Chris. We'll maybe try and squeeze two last ones in. Could we go to the next one, please, Jess?

Speaker #1: Maybe you need that just an anti-beta anti-A beta to actually keep the TAU from coming back. But all of those things are kind of what we're wargaming.

Speaker #2: Certainly. We'll go next to Evan Seagerman with BMO Capital Market.

Operator: Certainly. We'll go next to Evan Seigerman with BMO Capital Markets.

Speaker #5: Hi guys. Thank you so much for taking my question. I think, Chris, you had mentioned Feldartramab and AMR could be a $2 billion opportunity.

Evan Seigerman: Hi, guys. Thank you so much for taking my question. I think, Chris, you had mentioned felzartamab and AMR could be a $2 billion opportunity, but that's really not reflected in Biogen's current valuation. What do you think we, as investors, need to see to be convinced of that? What could you be showing us when we get that data come next year? Thank you so much.

Evan Seigerman (BMO Cap: Hi, guys. Thank you so much for taking my question. I think, Chris, you had mentioned felzartamab and AMR could be a $2 billion opportunity, but that's really not reflected in Biogen's current valuation. What do you think we, as investors, need to see to be convinced of that? What could you be showing us when we get that data come next year? Thank you so much.

Chris Viehbacher: All of those things are kind of what we're war gaming. This would be something that certainly would affect the business in the next decade. I think if we're going to be in Alzheimer's, we are certainly looking to have a portfolio, and clearly brain shuttles would be the next generation of products to pursue. As Priya said, we've been working on that for several years now. Thanks, Chris. We'll maybe try and squeeze two last ones in. Can we go to the next one, please, Jess?

Speaker #1: This would be something that certainly would affect the business in the next decade. But I think if we're going to be in Alzheimer's, we are certainly looking to have a portfolio.

Speaker #5: But that's really not reflected in Biogen's current valuation. What do you think we as investors need to see to be convinced of that? And what could you be showing us when we get that data come next year?

Speaker #1: And clearly, brain shuttles would be the next generation of products to pursue. And as Priya said, we've been working on that for several years now.

Speaker #5: Thank you so much.

Speaker #3: Thanks, Evan. You know, one of the things that we saw when we were doing diligence on the PELAs was that there really hadn't been much value associated with Empoveli.

Speaker #1: Thanks, Chris. Maybe try and squeeze two last ones. Can we go to the next one, please, Jess?

Chris A. Viehbacher: Thanks, Evan. One of the things that we saw when we were doing diligence on Apellis was that there really hadn't been much value associated with EMPAVELI. I think there is a tendency to really focus on kind of lead products in companies. For some of these programs where there is no treatment, there are also no analogs. I think what we see is, what we've heard from a number of analysts and experts, is that there tends to be a placeholder value put in there. People then want to wait and see the data. 11,000 patients, if you took even the Otsuka price for IGAN of $350,000, you're getting somewhere between a $3 and $4 billion market.

Chris Viehbacher: Thanks, Evan. One of the things that we saw when we were doing diligence on Apellis was that there really hadn't been much value associated with EMPAVELI. I think there is a tendency to really focus on kind of lead products in companies. For some of these programs where there is no treatment, there are also no analogs. I think what we see is, what we've heard from a number of analysts and experts, is that there tends to be a placeholder value put in there. People then want to wait and see the data. 11,000 patients, if you took even the Otsuka price for IGAN of $350,000, you're getting somewhere between a $3 and $4 billion market.

Speaker #5: Certainly. We'll go next to Evan Seegerman with BMO Capital Market.

Operator: Certainly. We'll go next to Evan Seigerman with BMO Capital Markets.

Speaker #6: Hi guys. Thank you so much for taking my question. I think, Chris, you had mentioned Feldartramab and AMR could be a $2 billion opportunity.

Speaker #3: And, you know, I think there is a tendency to really focus on kind of lead products in companies. And for some of these programs where there is no treatment, there are also no analogs.

Evan Seigerman: Hi, guys. Thank you so much for taking my question. I think, Chris, you had mentioned felzartamab and AMR could be a $2 billion opportunity, that's really not reflected in Biogen's current valuation. What do you think we, as investors, need to see to be convinced of that? What could you be showing us when we get that data come next year? Thank you so much.

Speaker #6: But that's really not reflected in Biogen's current valuation. What do you think we as investors need to see to be convinced of that? And what could you be showing us when we get that data come next year?

Speaker #3: And so I think what we see is and what we've heard from a number of analysts and experts is that there tends to be a placeholder value put in there.

Speaker #6: Thank you so much.

Speaker #1: Thanks, Evan. You know, one of the things that we saw when we were doing diligence on the PELAs was that there really hadn't been much value associated with Empaveli.

Chris Viehbacher: Thanks, Evan. One of the things that we saw when we were doing diligence on Apellis was that there really hadn't been much value associated with EMPAVELI. I think there is a tendency to really focus on kind of lead products in companies. For some of these programs where there is no treatment, there are also no analogs. I think what we see is, and what we've heard from a number of analysts and experts, is that there tends to be a placeholder value put in there. People then want to wait and see the data. 11,000 patients, and if you took even the Otsuka price for IgAN of $350,000, you're getting somewhere between a $3 and $4 billion market.

Speaker #3: And people then want to wait and see the data. But, you know, 11,000 patients and if you took even the Otsuka price for Igen, a $350,000, you know, you're getting somewhere between a $3 and $4 billion market.

Speaker #1: And, you know, I think there is a tendency to really focus on kind of lead products in companies. And for some of these programs, where there is no treatment, there are also no analogs.

Speaker #3: And when you consider that the phase two data showed an 80% resolution of AMR, in an open label in a small study and obviously something we have to repeat in a phase three.

Chris A. Viehbacher: When you consider that the phase II data showed an 80% resolution of AMR in an open label in a small study, obviously something we have to repeat in a phase III. There is no product approved for AMR today. The option for patients is either treatment with felzartamab or perhaps a second kidney transplant. I was in Brazil recently and visited the hospital where they do more kidney transplants than anywhere else in the world. They estimate that somewhere between 10% and 20% of people on the kidney transplant list are people who've already had a kidney transplant. There is a huge unmet need. This is a product that really seems to work. We have very high hopes for this product.

Chris Viehbacher: When you consider that the phase II data showed an 80% resolution of AMR in an open label in a small study, obviously something we have to repeat in a phase III. There is no product approved for AMR today. The option for patients is either treatment with felzartamab or perhaps a second kidney transplant. I was in Brazil recently and visited the hospital where they do more kidney transplants than anywhere else in the world. They estimate that somewhere between 10% and 20% of people on the kidney transplant list are people who've already had a kidney transplant. There is a huge unmet need. This is a product that really seems to work. We have very high hopes for this product.

Speaker #1: And so I think what we see is and what we've heard from a number of analysts and experts is that there tends to be a placeholder value put in there.

Speaker #3: But there is no product approved for AMR today. So and, you know, the option for patients is either treatment with Feldartramab or perhaps a second kidney transplant.

Speaker #1: And people then want to wait and see the data. But, you know, 11,000 patients and if you took even the Otsuka price for Igen, a $350,000, you know, you're getting somewhere between a $3 and $4 billion market.

Speaker #3: I mean, I was in Brazil recently and visited the hospital where they do more kidney transplants than anywhere else in the world. They estimate that somewhere between 10 and 20% of people on the kidney transplant list are people who have already had a kidney transplant.

Speaker #1: And when you consider that the phase two data showed an 80% resolution of AMR, in an open label in a small study, and obviously something we have to repeat in a phase three, but there is no product approved for AMR today.

Chris Viehbacher: When you consider that the phase II data showed an 80% resolution of AMR in an open label in a small study, and obviously something we have to repeat in a phase III. There is no product approved for AMR today. The option for patients is either treatment with felzartamab or perhaps a second kidney transplant. I was in Brazil recently and visited the hospital where they do more kidney transplants than anywhere else in the world. They estimate that somewhere between 10% and 20% of people on the kidney transplant list are people who've already had a kidney transplant. There is a huge unmet need. This is a product that really seems to work. We have very high hopes for this product. Thanks, Chris. Let's go to our last question, please, Jess.

Speaker #3: So there is a huge unmet need. This is a product that really seems to work. So you know, we have very high hopes for this product.

Speaker #1: So and, you know, the option for patients is either treatment with Feldartramab or perhaps a second kidney transplant. I mean, I was in Brazil recently and visited the hospital where they do more kidney transplants than anywhere else in the world.

Speaker #1: Thanks, Chris. Let's go to our last question, please, Jess.

Tim Power: Thanks, Chris. Let's go to our last question, please, Jess.

Speaker #2: We'll go to Terrence Flynn with Morgan Stanley.

Operator: We'll go to Terence Flynn with Morgan Stanley.

Speaker #5: Hi. Thanks for taking the question. Maybe just a follow-up on that last point. This is probably for Chris or Priya. Just in terms of the Transcend trial, can you remind us of the powering on the primary endpoint and what's required from the FDA to support approval in the late AMR indication?

Terence Flynn: Hi. Thanks for taking the question. Maybe just a follow-up on that last point. This is probably for Chris or Priya. Just in terms of the TRANSCEND trial, can you remind us of the powering on the primary endpoint and what's required from the FDA to support approval in the late AMR indication? How should we think about lateral implications from TRANSCEND for microvascular inflammation? Thanks.

Speaker #1: They estimate that somewhere between 10 and 20% of people on the kidney transplant list are people who have already had a kidney transplant. So there is a huge unmet need.

Speaker #1: This is a product that really seems to work. So, you know, we have very high hopes for this product. Thanks, Chris. Let's go to our last question, please, Jess.

Speaker #5: And then how should we think about lateral implications from Transcend for microvascular inflammation? Thanks.

Speaker #4: Yeah. I can start. I mean, we haven't commented publicly on the powering. We believe we have a very robust trial design and power to really give us confidence in the outcome.

Tim Power: Thanks, Chris. Let's go to our last question, please, Jess.

Priya Singhal: Yeah. I can start. We haven't commented publicly on the powering. We believe we have a very robust trial design and power to really give us confidence in the outcome. I think we remain confident in our trial design. As you know, the trial, the TRANSCEND trial, is a six-month placebo control. This is biopsy-driven as an endpoint, which is really important. Patients move on to maintenance for the next 6 months. I think durability, but the six-month time point are both important. I think that's another really good sign, but we've been able to accelerate the trial, so now we expect data in H1 2027. I think overall, we remain very excited. Now, the MVI is obviously a more recent diagnostic criteria through the Banff criteria.

Speaker #5: We'll go to Terrence Flynn with Morgan Stanley.

Operator: We'll go to Terence Flynn with Morgan Stanley.

Speaker #6: Hi. Thanks for taking the question. Maybe just a follow-up on that last point. This is probably for Chris or Priya. Just in terms of the Transcend trial, can you remind us of the powering on the primary endpoint and what's required from the FDA to support approval in the late AMR indication?

Speaker #4: So I think we remain confident in our trial design. As you know, the trial, the Transcend trial is a six-month placebo-controlled. This is biopsy-driven as an endpoint, which is really important.

Speaker #6: And then how should we think about lateral implications from Transcend for microvascular inflammation? Thanks.

Speaker #4: And then, you know, patients move on to maintenance for the next six months. And I think durability, but the six-month time point are both important.

Speaker #4: Yeah, I can start. I mean, we haven't commented publicly on the powering. We believe we have a very robust trial design and power to really give us confidence in the outcomes.

Priya Singhal: Yeah. I can start. We haven't commented publicly on the powering. We believe we have a very robust trial design and power to really give us confidence in the outcome. I think we remain confident in our trial design. As you know, the trial, the TRANSCEND trial, is a six-month placebo control. This is biopsy driven as an endpoint, which is really important. Patients move on to maintenance for the next six months. I think durability, but the six-month time point are both important. I think that's another really good sign, we've been able to accelerate the trial, so now we expect data in the first half of 2027. I think overall, we remain very excited. The MVI is obviously a more recent diagnostic criteria through the Banff criteria.

Speaker #4: We have been able to I think that's another really good sign. But we've been able to accelerate the trial. So now we expect data in the first half of 2027.

Speaker #4: And I think overall we remain really excited. Now, the MVI is obviously a more recent, you know, diagnostic criteria through the BAMS criteria. And this is important because these are donor-specific antibody negative patients.

Priya Singhal: This is important because these are donor-specific antibody-negative patients, but it's a very important population. What we decided to do, along with our HI-Bio team, they are absolute experts in the area, is to actually initiate the MVI trial, which is a TRANSPIRE trial, as soon as possible. That trial is already underway, and so we will also have data emerging from that trial. We think that, yes, the felzartamab mechanism of action of addressing plasma cells and the anti-CD38 will have an impact in both MVI as well as in AMR. MVI itself in the US is a sizable population of about 6,000 patients. This remains an important auxiliary but very important aspect of the unmet need.

Speaker #4: And then, you know, patients move on to maintenance for the next six months. And I think durability at the six-month time point are both important.

Speaker #4: But it's a very important population and what we decided to do along with our high bio team they are absolute experts in the area is to actually initiate the MVI trial, which is a transpire trial as soon as possible.

Speaker #4: We have been able to I think that's another really good sign. But we've been able to accelerate the trial. So now we expect data in the first half of 2027.

Speaker #4: And I think overall, we remain really excited. Now, the MVI is obviously a more recent, you know, diagnostic criteria through the BAMS criteria. And this is important because these are donor-specific antibody-negative patients.

Speaker #4: So that trial is already underway. And so we will also have data emerging from that trial. And we think that, yes, the Feldartramab mechanism of action of addressing plasma cells and the anti-CD38 will have an impact in both MVI as well as in AMR.

Priya Singhal: This is important because these are donor-specific antibody-negative patients, but it's a very important population. What we decided to do, along with our HI-Bio team, they are absolute experts in the area, is to actually initiate the MVI trial, which is a TRANSPIRE trial, as soon as possible. That trial is already underway. We will also have data emerging from that trial. We think that, yes, the felzartamab mechanism of action of addressing plasma cells and the anti-CD38 will have an impact in both MVI as well as in AMR. MVI itself in the US is a sizable population of about 6,000 patients. This remains an important auxiliary, but very important aspect of the unmet need.

Priya Singhal: This is important because these are donor-specific antibody-negative patients, but it's a very important population. What we decided to do, along with our HI-Bio team, they are absolute experts in the area, is to actually initiate the MVI trial, which is a TRANSPIRE trial, as soon as possible. That trial is already underway. We will also have data emerging from that trial. We think that, yes, the felzartamab mechanism of action of addressing plasma cells and the anti-CD38 will have an impact in both MVI as well as in AMR. MVI itself in the US is a sizable population of about 6,000 patients. This remains an important auxiliary, but very important aspect of the unmet need. We think this is really a very important opportunity, and we remain confident that felzartamab really has a very good high probability here of giving us the data that we're looking for.

Speaker #4: But it's a very important population, and what we decided to do, along with our high-bio team—they are absolute experts in the area—is to actually initiate the MVI trial, which is the Transpire trial, as soon as possible.

Speaker #4: MVI itself in the US is a sizable population of about 6,000 patients. So this remains an important auxiliary, but very important aspect of the unmet need.

Speaker #4: So that trial is already underway. And so we will also have data emerging from that trial. And we think that, yes, the Feldartramab mechanism of action of addressing plasma cells anti-CD38 will have an impact in both MVI as well as in AMR.

Speaker #4: So we think this is really a very, very important opportunity. And we remain confident that Feldartramab really has a very good high probability here of giving us the data that we're looking for.

Priya Singhal: We think this is really a very important opportunity, and we remain confident that felzartamab really has a very good high probability here of giving us the data that we're looking for.

Speaker #1: Thanks. Thanks, Priya. And thanks, everybody, for joining today. If you've got follow-up questions, you know where to find us. Take care.

Tim Power: Great. Thanks, Priya, and thanks, everybody, for joining today. If you've got follow-up questions, you know where to find us. Take care.

Speaker #4: MVI itself in the US is a sizable population of about 6,000 patients. So, this remains an important auxiliary, but very important aspect of the unmet need.

Operator: Thank you, ladies and gentlemen. That will conclude today's call. We thank you for your participation. You may disconnect at this time.

Speaker #4: So we think this is really a very, very important opportunity, and we remain confident that felzartamab really has a very good, high probability here of giving us the data that we're looking for.

Speaker #1: Great. Thanks, Priya. And thanks, everybody, for joining today. If you've got follow-up questions, you know where to find us. Take care.

Chris Viehbacher: Great. Thanks, Priya. Thanks, everybody, for joining today. If you've got follow-up questions, you know where to find us. Take care.

Tim Power: Great. Thanks, Priya. Thanks, everybody, for joining today. If you've got follow-up questions, you know where to find us. Take care.

Operator: Thank you. Ladies and gentlemen, that will conclude today's call. We thank you for your participation. You may disconnect at this time.

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