Q4 2023 Biogen Inc Earnings Call

February 13, 2024

Operator: Good morning, my name is Katie and I will be your conference operator today. At this time I'd like to welcome everyone to the Biogen fourth quarter and full year 2023 earnings call and business update. All lines have been placed on mute to prevent any background noise. 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 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. Chuck Triano, Head of Investor Relations. Mr. Triano, you may begin your conference.

Katie: All lines have been placed on mute to prevent any background noise. 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 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.

Katie: 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. Chuck Triano.

Chuck Triano: Head of Investor Relations. Mr. Triangle, you may begin your conference.

Chuck Triano: Thank you Katie. Good morning, and welcome to Biogen's fourth quarter and full year 2023 earnings call. Before we begin, I'll remind you that the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today are located in the investors section of Biogen dot com. Our GAAP financials are provided in tables, one and two, and table four includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business, and reflect how we manage the business internally. We have also posted the slides on our website that will be used during this call. I'd like to point out also that we will be making forward looking statements, which are based on our expectation. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail.

Chuck Triano: Good morning, and welcome to Biogen's fourth quarter and full year 2023 earnings call before we begin I'll remind you that the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today are located in the investors section of Biogen.

Chuck Triano: <unk> Dot com.

Chuck Triano: Our GAAP financials are provided in tables, one and two in table. Four includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally.

Chuck Triano: We have also posted slides on our website that will be used during this call I'd like to point out also that we will be making forward looking statements, which are based on our expectation. These statements are subject to certain risks and uncertainties and our actual results may differ materially I encourage you to consult the. Risk factors discussed in our SEC filings for additional detail.

Chuck Triano: Risk factors discussed in our SEC filings for additional detail.

Chuck Triano: On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher, Dr. Priya Singhal, Head of Development, and our CFO, Mike McDonnell. Chris, Priya, and Mike will each make some opening comments, and then we'll move to our Q&A session. To allow us to get through as many questions as possible, we ask that you limit yourself to one question. With that I'll now turn the call over to Chris.

Christopher A. Viehbacher: Dr. Priya Cingal head of development, and our CFO, Mike Mcdonnell, Chris and Mike will each make some opening comments and then we'll move to our Q&A session.

Christopher A. Viehbacher: Allow us to get through as many questions as possible. We ask that you limit yourself to one question with that I'll now turn the call over to Chris.

Christopher A. Viehbacher: Thank you, Chuck. Good morning, everybody. A year ago, I had the opportunity of presenting Biogen's quarterly results for the first time. At that time, we expressed the objective of returning Biogen to sustainable growth, and I think in the intervening year, we've made substantial progress. And today it isgreat, with a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into in greater detail, which says that we will, we are expecting to see positive earnings per share growth. And as I have said on a number of occasions, once we can get Biogen growing, we really see Biogen becoming a growth company for the foreseeable future. We have very little, in fact we have no exposure to Inflation Reduction Act. With our current portfolio. Don't have any new patent expiry is really coming in anytime soon other than those that are already known. And I think we've undertaken a number of other measures that. Lily. Reposition biogen for growth. I'll just review some of those things. The first is was really too.

Christopher A. Viehbacher: Thank you, Chuck. Good morning, everybody. A year ago, I had the opportunity of presenting Biogen's quarterly results for the first time. At that time, we expressed the objective of returning Biogen to sustainable growth, and I think in the intervening year, we've made substantial progress. And today it isgreat, with a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into in greater detail, which says that we will, we are expecting to see positive earnings per share growth. And as I have said on a number of occasions, once we can get Biogen growing, we really see Biogen becoming a growth company for the foreseeable future. We have very little, in fact we have no exposure to Inflation Reduction Act with our current portfolio. We don't have any new patent expiries, really, coming anytime soon other than those that are already known. And I think we've undertaken a number of other measures that really reposition Biogen for growth. I'll just review some of those things.

Christopher A. Viehbacher: Thank you, Chuck. Good morning, everybody. A year ago, I had the opportunity of presenting Biogen's quarterly results for the first time. At that time, we expressed the objective of returning Biogen to sustainable growth, and I think in the intervening year, we've made substantial progress. And today it isgreat, with a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into in greater detail, which says that we will, we are expecting to see positive earnings per share growth. And as I have said on a number of occasions, once we can get Biogen growing, we really see Biogen becoming a growth company for the foreseeable future. We have very little, in fact we have no exposure to Inflation Reduction Act with our current portfolio. We don't have any new patent expiries, really, coming anytime soon other than those that are already known. And I think we've undertaken a number of other measures that really reposition Biogen for growth.

Christopher A. Viehbacher: A year ago, I had the opportunity of presenting.

Christopher A. Viehbacher: <unk> quarterly results for the first time.

Christopher A. Viehbacher: At that time, we express the objective of returning biogen to sustainable growth. And I think in the intervening year, we've made substantial progress. And today it is a great. With a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into greater detail, which says that we will we are expecting to see positive earnings per share growth. And as I have said on a number of occasions. Once we can get biogen growing we really see a biogen, becoming a growth company for the foreseeable future we have very little effect. No. Exposure to inflation reduction Act.

And I think in the intervening year, we've made substantial progress. And today it is a great. With a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into greater detail, which says that we will we are expecting to see positive earnings per share growth. And as I have said on a number of occasions. Once we can get biogen growing we really see a biogen, becoming a growth company for the foreseeable future we have very little effect. No. Exposure to inflation reduction Act.

Christopher A. Viehbacher: And today it is a great. With a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into greater detail, which says that we will we are expecting to see positive earnings per share growth. And as I have said on a number of occasions. Once we can get biogen growing we really see a biogen, becoming a growth company for the foreseeable future we have very little effect. No. Exposure to inflation reduction Act.

Christopher A. Viehbacher: With a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into greater detail, which says that we will we are expecting to see positive earnings per share growth. And as I have said on a number of occasions. Once we can get biogen growing we really see a biogen, becoming a growth company for the foreseeable future we have very little effect. No. Exposure to inflation reduction Act.

Christopher A. Viehbacher: And as I have said on a number of occasions. Once we can get biogen growing we really see a biogen, becoming a growth company for the foreseeable future we have very little effect. No. Exposure to inflation reduction Act.

Christopher A. Viehbacher: No. Exposure to inflation reduction Act.

Christopher A. Viehbacher: Exposure to inflation reduction Act.

Christopher A. Viehbacher: With our current portfolio.

Christopher A. Viehbacher: Don't have any new patent expiry is really coming in anytime soon other than those that are already known.

Christopher A. Viehbacher: And I think we've undertaken a number of other measures that.

Christopher A. Viehbacher: Lily.

Christopher A. Viehbacher: Reposition biogen for growth.

Christopher A. Viehbacher: If I just review some of those things, the first was really to refocus the company on growth drivers, in particular, our new product launches. Biogen had four new product launches from approvals from the FDA last year; that's the second highest of anyone in our industry. And that required though quite an awful lot of cultural change. The multiple sclerosis franchise has been the stalwart of our company since its inception 45 years ago. Our people are passionate about the physicians who treat multiple sclerosis, and the patients who have multiple sclerosis. And we are still a market leader in this space. However, that is a franchise that is facing increasing competition, and we have to embrace new therapeutic categories and new businesses. And so we have really had a major shift in resources and focus, particularly towards Leqembi, Zurzuvae, Skyclarys, and Qalsody. We also though have still some products with patent protection, again with substantial competition. And if I take a product like Spinraza, analyst forecasts had shown forecast that this product would decline. Particularly proud of our teams in demonstrating that they could bring this product back to actually even modest growth. Obviously, the mode of administration of products can be a competitive advantage, so if you have a pill, you're going to be a lot more preferred than if you have an infusion, for example. But what we see in some of these really devastating diseases is that efficacy is still the most important factor, and that is why Spinraza continues to be a leader in its segment. And Biogen is extremely good at being able to develop the medical evidence to support the value proposition of its products.

Christopher A. Viehbacher: I'll just review some of those things. The first is was really too.

Christopher A. Viehbacher: The first is was really too.

Christopher A. Viehbacher: Refocus the company on growth drivers in particular, our new product launches Biogen had four new product launches from approvals from the FDA last year, that's the second highest of anyone in our industry.

And that required though quite an awful lot of cultural change.

Christopher A. Viehbacher: The multiple sclerosis franchise has been the <unk>. Word of our company for since its inception 45 years ago. Our people are passionate about physicians. To treat multiple sclerosis, and patients who have multiple sclerosis. And we are still a market leader in this space. However. That is a franchise that is facing increasing competition. And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Word of our company for since its inception 45 years ago. Our people are passionate about physicians. To treat multiple sclerosis, and patients who have multiple sclerosis. And we are still a market leader in this space. However. That is a franchise that is facing increasing competition. And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Our people are passionate about physicians. To treat multiple sclerosis, and patients who have multiple sclerosis. And we are still a market leader in this space. However. That is a franchise that is facing increasing competition. And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: To treat multiple sclerosis, and patients who have multiple sclerosis. And we are still a market leader in this space. However. That is a franchise that is facing increasing competition. And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: And we are still a market leader in this space. However. That is a franchise that is facing increasing competition. And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: That is a franchise that is facing increasing competition. And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

And we have to embrace new therapeutic categories and new businesses. And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: And so we have. Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Really had a major shift in resources and focus. Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Particularly towards the can be. <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: <unk> Sky Claris and <unk>. We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: We also though have still some products with patent protection again with substantial competition. And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: And if I take a product like spin Raza analyst forecasts had. Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Shown forecast that this product with decline, particularly proud of our teams and demonstrating that they can bring this product back to actually even modest growth. Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Obviously. The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: The motive administration of products it can be a competitive advantage. So if you have a pill youre going to be a lot. More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: More preferred than if you have an infusion for example, but what we see in some of these really devastating diseases is that efficacy is still the most important factor and that is why spin Raza continues to be a leader in its segment and Biogen is extremely good at being able to develop the medical evidence to support the value. Proposition of its products.

Christopher A. Viehbacher: Proposition of its products.

Christopher A. Viehbacher: As many of you told me when I first came into the company, you've got a mature product portfolio, but you've got one of the highest cost basis in our industry, and we took steps to address that. But it wasn't just around reducing cost, we wanted to reengineer the business; we were shifting our focus, entering new therapeutic categories, and we needed to think about capabilities, we needed to think about the agility of the organization, the number of layers of management that we have, and so we implemented a fit for growth reengineering project. We have already achieved $200 million of savings, and we're on track to realize approximately half of the $800 million of net savings by the end of 2024. That's of course a gross savings of $1 billion dollars. And then we have to look at research and development and Biogen is an extremely interesting company. All of the diseases that Biogen targets are really devastating diseases. And we target, and there is a lot of pride in the fact that we go and try to find solutions for diseases where nobody else is doing that. Of course [inaudible] that you're pioneering, you're pioneering because we don't really understand often the underlying disease biology of these conditions, and so we end up taking a lot of risk, and these trials can be really quite expensive. And yet we do need a company like Biogen in our world, and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio, we have to have Biogen as a sustainably growing company and one which is attractive to investors; we need the capital to go and invest in new projects. And so I think with Priya's help we've been able to take an extremely disciplined and objective view to the pipeline. We have four data readouts this year again on extremely important illnesses, and Priya will talk more about that. And as we go into next year, we're going to be looking at how do we reinforced that pipeline, how do we rethink our research efforts. A lot has changed in science, but we haven't necessarily done that kind of change at Biogen. So I think research and development is extremely important to Biogen, and I think continue to be a source of growth for the future. Now as we look at what does it drive growth clearly we have that can be.

Speaker Change: You've got a mature product portfolio, but you've got one of the highest cost basis in our industry and we took steps to address that.

Speaker Change: But it wasn't just around reducing cost we wanted to reengineer. The business, we were shifting our focus entering new therapeutic categories and we need to think about capabilities, we need to think about the agility of the organization. The number of layers of management that we have and so we implemented a fit for growth reengineering project.

<unk>. We have already achieved $200 million of. Savings and we're on track to realize approximately half of the $800 million of net savings by the end of 2024. That's of course, a gross savings of $1 billion. And then. We have to look at research and development and <unk>. <unk> is an extremely interesting company. All of the diseases that biogen targets, a really devastating disease. And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: We have already achieved $200 million of. Savings and we're on track to realize approximately half of the $800 million of net savings by the end of 2024. That's of course, a gross savings of $1 billion. And then. We have to look at research and development and <unk>. <unk> is an extremely interesting company. All of the diseases that biogen targets, a really devastating disease. And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: Savings and we're on track to realize approximately half of the $800 million of net savings by the end of 2024.

Speaker Change: That's of course, a gross savings of $1 billion.

Speaker Change: And then. We have to look at research and development and <unk>. <unk> is an extremely interesting company. All of the diseases that biogen targets, a really devastating disease. And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: We have to look at research and development and <unk>. <unk> is an extremely interesting company. All of the diseases that biogen targets, a really devastating disease. And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: <unk> is an extremely interesting company. All of the diseases that biogen targets, a really devastating disease. And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

All of the diseases that biogen targets, a really devastating disease. And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: And. We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: We target and there is a lot of pride in the fact that we go and try to find solutions for diseases, where nobody else is doing that. Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: Of course. That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: That youre pioneering youre pioneering because we don't really understand often the underlying disease biology of these conditions and so we ended up taking a lot of risk in these trials can be really quite expensive. And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Christopher A. Viehbacher: And yet we do need a company like Biogen in our world, and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio, we have to have Biogen as a sustainably growing company and one which is attractive to investors; we need the capital to go and invest in new projects. And so I think with Priya's help we've been able to take an extremely disciplined and objective view to the pipeline. We have four data readouts this year again on extremely important illnesses, and Priya will talk more about that. And as we go into next year, we're going to be looking at how do we reinforced that pipeline, how do we rethink our research efforts. A lot has changed in science, but we haven't necessarily done that kind of change at Biogen. So I think research and development is extremely important to Biogen, and I think continue to be a source of growth for the future.

Speaker Change: And yet we do need a company like Biogen in our in our world and so our objective has been to really focus our research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: And of course, we have to manage the risk in the portfolio that we have to have biogen as a. Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: Sustainably growing company and one which is attractive to investors, we need the capital to go and invest in new projects and so I think with previous help we've been able to take an extremely disciplined and objective view to the pipeline.

Speaker Change: We have four data readouts. This year again on an extremely important illnesses and Peter will talk more about that.

Speaker Change: And as we go into next year, we're going to be looking at how do we reinforced that pipeline how do we.

Rethink our research efforts a lot has changed in science, but we haven't necessarily done that kind of change at Biogen.

Peter: So I think our research and development is extremely important to Biogen and I think.

Peter: Continued to be a source of growth for the future now as we look at what does it drive growth clearly we have that can be.

Christopher A. Viehbacher: Now as we look at what does it drive growth, clearly we have Leqembi. And I'll remind everybody that again, we are not just pioneering in science, but pioneering in commercial. One of the interesting things about this disease is that if we talk about the efficacy of the product, you know a lot of cases, we're looking at the characteristic of a product, but actually when you talk about efficacy, you're talking about, are you in the right patient? And in fact for decades our industry invested in drugs which failed to demonstrate a benefit in Alzheimer's disease, and there were two main problems with that. One was we couldn't get enough drug across the blood-brain barrier, and we weren't in the right patients. Clarity was the first study to really convincingly demonstrate the importance of reducing plaque and the impact on cognition. But we know that from data that we showed at CTAD that we believe that the earlier you can go, the more likely it is you're going to show even greater efficacy, because we're not, we're really in the business of trying to protect neurons, or create an environment where injured neurons can recover. And so we have a huge investment in our AHEAD study to look at pre-symptomatic patients, we're investing in what happens when you remove the plaque and looking at maintenance. We're trying to make this more convenient for patients by having a subcutaneous formulation. And so the pioneering continues, and the pioneering also is out there in the marketplace. Patients with Alzheimer's are not in the system today and are coming into the system. So we've got approximately 2,000 patients on therapy at the moment. Now we don't have, as companies, direct access to the patient registry, as you all know about theCMS registry, but there are a few other registries out there, like ALZ-NET for example. And we have seen some analysts have been able to access that data. There was one analyst report of 3,300 patients on the registry. Latest information that we have, and again this is not perfect information, but we have an indication that there are about 3,800 patients as of last week on the registry.

And I'll remind everybody that again, we are not just pioneering in science, but pioneering in commercial. One of the interesting things about this. This disease is that. If we talk about the efficacy of the product. A lot of cases, we're looking at the characteristic of a product, but actually when you talk about efficacy or you're talking about are you in the right patient and in fact for decades our industry. <unk> and drugs, which failed to demonstrate a benefit in Alzheimer's disease and there were two main problems with that one was we couldnt get enough drug across the blood brain barrier. And we Werent in the right patient clarity was the first study to really.

Peter: One of the interesting things about this. This disease is that. If we talk about the efficacy of the product. A lot of cases, we're looking at the characteristic of a product, but actually when you talk about efficacy or you're talking about are you in the right patient and in fact for decades our industry. <unk> and drugs, which failed to demonstrate a benefit in Alzheimer's disease and there were two main problems with that one was we couldnt get enough drug across the blood brain barrier. And we Werent in the right patient clarity was the first study to really.

Peter: This disease is that. If we talk about the efficacy of the product. A lot of cases, we're looking at the characteristic of a product, but actually when you talk about efficacy or you're talking about are you in the right patient and in fact for decades our industry. <unk> and drugs, which failed to demonstrate a benefit in Alzheimer's disease and there were two main problems with that one was we couldnt get enough drug across the blood brain barrier. And we Werent in the right patient clarity was the first study to really.

Peter: If we talk about the efficacy of the product. A lot of cases, we're looking at the characteristic of a product, but actually when you talk about efficacy or you're talking about are you in the right patient and in fact for decades our industry. <unk> and drugs, which failed to demonstrate a benefit in Alzheimer's disease and there were two main problems with that one was we couldnt get enough drug across the blood brain barrier. And we Werent in the right patient clarity was the first study to really.

Peter: A lot of cases, we're looking at the characteristic of a product, but actually when you talk about efficacy or you're talking about are you in the right patient and in fact for decades our industry. <unk> and drugs, which failed to demonstrate a benefit in Alzheimer's disease and there were two main problems with that one was we couldnt get enough drug across the blood brain barrier. And we Werent in the right patient clarity was the first study to really.

Peter: <unk> and drugs, which failed to demonstrate a benefit in Alzheimer's disease and there were two main problems with that one was we couldnt get enough drug across the blood brain barrier. And we Werent in the right patient clarity was the first study to really.

Peter: And we Werent in the right patient clarity was the first study to really.

Peter: Convincingly demonstrate the importance of reducing plaque and the impact on cognition, but we know that some data that we showed at <unk> that we believe that the earlier you can go.

Peter: More likely it is youre going to show, even greater efficacy because we're not we're.

Peter: We're really in the business of trying to protect neurons are creating an environment where injured neurons can recover.

Peter: And so we have a huge investment in our ahead study to look at pre symptomatic patients, we're investing and what happens when you remove the plaque and looking at maintenance.

Peter: Trying to make this more.

Peter: Convenient for patients by having a subcutaneous formulation and so.

Peter: The pioneering continues and the pioneering also is out there in the marketplace patients with Alzheimer's or not in the system today and are coming into the system. So we've got approximately 2000 patients on therapy at the moment now we don't have as companies direct access to the patient registry as you all know about.

CMS registry, but there are a few other <unk>.

Peter: Registries out there like ultimate for example.

Peter: And we have seen some analysts have been able to access that data.

Peter: There was one analyst report a 3300 patients on the registry latest information that we have and again. This is not perfect information, but we have an indication that there are about 3800 patients as of last week on the registry.

Christopher A. Viehbacher: When you look at that, that suggests we're getting about 260-265 patients per week in the month of January, and as far as we can tell that's about a 56% increase over what we were seeing in December. So we are clearly seeing that there is demand for the product. We are clearly seeing that IDNs are moving to put in place the care pathways and the treatment protocols to improve access. Seventy out of the top 100 IDNs have had positive P&T committee decisions; 80% of those have now actually ordered Leqembi, but if we talk to the people who are doing the PET scans, the MRIs, the people who sell the blood diagnostics, everybody is reporting increased activity and volume. And so, and as you saw with Eisai's results, their belief is that for all the patients on treatment, there are at least three- or four-fold of those who are actually in waiting rooms. So we do believe we are making very solid progress, and we believe that we have validated the go to market model, and now that we have enough IDNs with reimbursement and care pathways in place, we believe it's also time now to increase our level of promotion out there, and so as Eisai has announced, we will be expanding total US field force by about 30%. And as was already previously agreed last year, that once we had to go to market model really validated, that it's now time for Biogen colleagues to also go and visit physicians. And of course, we've seen the launch in Japan, I was there for the launch meeting, Biogen's very proud to be working alongside our colleagues from Eisai on the launch in Japan. And we've seen Leqembi approved in China and that launch will be for later this year. So everywhere, we look with Leqembi, we are making solid progress. This is as we have said before, a launch that really doesn't have an analog. We have always guided investors to the fact that this would be a progressive ramp, and that's what we're seeing, and we continue to believe in the long term importance of Leqembi, both the patients and to our financial results.

Peter: <unk> are moving to put in place the the care pathways and the treatment protocols to improve access.

Peter: 70 out of the top 100, <unk> have had positive PMT committee decisions.

Peter: 80% of those have now actually ordered Mccann b, but if we talk to the people who are doing the pet scans mris that people, who sell the blood diagnostics, everybody is reporting increased activity and volume and so.

Peter: And as you saw with <unk> results.

Peter: Their belief is that for all the patients on treatment or at least.

Peter: Three or four fold or those who are actually.

Peter: And waiting rooms so.

Peter: We do believe we are making very solid progress.

Peter: And we believe that we have validated the go to market model and now that we have enough <unk> with reimbursement and care pathways in place.

We believe it's also time now to increase. Hardware promotion out there and so as. ASI as announced we will be expanding total U S field force by about 30%. And as was already previously agreed last year that once we had to go to market model. Really validated that it's now time for Biogen colleagues to also. Go and visit physicians and of course, we've seen the launch in Japan I was I was there for the launch meeting in <unk>. <unk> is very proud to be working alongside our colleagues from ASI on the launch in Japan, and we've seen the can be approved in China and that launch will be for later this year. So everywhere, we look with <unk> we are. Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: Hardware promotion out there and so as.

Peter: ASI as announced we will be expanding total U S field force by about 30%.

Peter: And as was already previously agreed last year that once we had to go to market model. Really validated that it's now time for Biogen colleagues to also. Go and visit physicians and of course, we've seen the launch in Japan I was I was there for the launch meeting in <unk>. <unk> is very proud to be working alongside our colleagues from ASI on the launch in Japan, and we've seen the can be approved in China and that launch will be for later this year. So everywhere, we look with <unk> we are. Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: Really validated that it's now time for Biogen colleagues to also. Go and visit physicians and of course, we've seen the launch in Japan I was I was there for the launch meeting in <unk>. <unk> is very proud to be working alongside our colleagues from ASI on the launch in Japan, and we've seen the can be approved in China and that launch will be for later this year. So everywhere, we look with <unk> we are. Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: Go and visit physicians and of course, we've seen the launch in Japan I was I was there for the launch meeting in <unk>. <unk> is very proud to be working alongside our colleagues from ASI on the launch in Japan, and we've seen the can be approved in China and that launch will be for later this year. So everywhere, we look with <unk> we are. Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: <unk> is very proud to be working alongside our colleagues from ASI on the launch in Japan, and we've seen the can be approved in China and that launch will be for later this year. So everywhere, we look with <unk> we are. Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: So everywhere, we look with <unk> we are. Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: Making solid progress. This is as we have said before. Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Peter: Launched it really doesn't have an analog we have always guided investors to the fact that this would be a progressive ramp and that's what we're seeing and we continue to believe in the long term importance of law can be both the patients into our financial results moving on to Sky Claris.

Christopher A. Viehbacher: Moving on to Skyclarys. You've seen the launch numbers for the US; we have about 1,000 patients now on therapy, we don't have a pediatric indication yet, so the potential population is about 4,500, so we've got a little over 20% of the patients on therapy within about six months of launch. There is an awful lot of complexity to launching these rare diseases, and I think this is where Biogen has an awful lot of strength. There's a lot of logistics issues with specialty pharmacy and reimbursement, and so we've already been able to demonstrate that we can reduce the time from start form to shipment by 45%. We've got about two-thirds coverage out there in terms of reimbursement. And of course, patients and their physicians need an awful lot of support out there, and so we have patient services and family access managers who are assisting patients and physicians to navigate the care pathways. One of the things that we see with Spinraza is that we do about a third of our sales in the US and two thirds ex-US, and we expect that to be a model for Skyclarys. Last night, we announced the formal approval by the European Commission for Skyclarys. We have an expanded access program in a number of European countries, and we are in the process of setting those up in the countries, including those outside of the US. We have a global filing strategy that is underway to make sure that all patients with Friedreich's ataxia can benefit from Skyclarys, and of course, we are actively working on doing the [inaudible] we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: No.

Peter: You've seen the launch numbers for the for the U S.

Peter: We have about 1000 patients now on therapy, we do. Don't have a pediatric indication yet so the potential population is about 4500, so we've got a little over 20% of the patients on therapy. Within about six months of launch there is an awful lot of complexity to launching. Rare diseases, and I think just as where Biogen has an awful lot of strength. There's a lot of logistics issues with specialty pharmacy, and reimbursement and so we've already been able to demonstrate that we can reduce the time from start form to shipment by 45%. We've got about two thirds coverage out there. Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Don't have a pediatric indication yet so the potential population is about 4500, so we've got a little over 20% of the patients on therapy. Within about six months of launch there is an awful lot of complexity to launching. Rare diseases, and I think just as where Biogen has an awful lot of strength. There's a lot of logistics issues with specialty pharmacy, and reimbursement and so we've already been able to demonstrate that we can reduce the time from start form to shipment by 45%. We've got about two thirds coverage out there. Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Within about six months of launch there is an awful lot of complexity to launching. Rare diseases, and I think just as where Biogen has an awful lot of strength. There's a lot of logistics issues with specialty pharmacy, and reimbursement and so we've already been able to demonstrate that we can reduce the time from start form to shipment by 45%. We've got about two thirds coverage out there. Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: Rare diseases, and I think just as where Biogen has an awful lot of strength. There's a lot of logistics issues with specialty pharmacy, and reimbursement and so we've already been able to demonstrate that we can reduce the time from start form to shipment by 45%. We've got about two thirds coverage out there. Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: There's a lot of logistics issues with specialty pharmacy, and reimbursement and so we've already been able to demonstrate that we can reduce the time from start form to shipment by 45%. We've got about two thirds coverage out there. Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: We've got about two thirds coverage out there. Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: Terms of reimbursement. And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: And of course. Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: Patients and their physicians need an awful lot of them. Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: Part out there and so we have a patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: The things that we see with spin rather is that we do about a third of our sales in the U S and two thirds ex U S and we expect that to be. Our model for Sky Claris.

Peter: Our model for Sky Claris.

Peter: Last night, we announced the formal approval by the European Commission for Sky Claris.

Peter: We have <unk>. <unk> access program and a number of European countries and we are in the process of. Setting those up. The countries, including those outside of the U S. A global filing strategy that is underway to make sure that all patients with <unk>. Friedrichs ataxia can benefit from. From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: <unk> access program and a number of European countries and we are in the process of. Setting those up. The countries, including those outside of the U S. A global filing strategy that is underway to make sure that all patients with <unk>. Friedrichs ataxia can benefit from. From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Setting those up. The countries, including those outside of the U S. A global filing strategy that is underway to make sure that all patients with <unk>. Friedrichs ataxia can benefit from. From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: The countries, including those outside of the U S. A global filing strategy that is underway to make sure that all patients with <unk>. Friedrichs ataxia can benefit from. From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: A global filing strategy that is underway to make sure that all patients with <unk>. Friedrichs ataxia can benefit from. From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Friedrichs ataxia can benefit from. From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: From Sky Claris and of course, we are actively working on. The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: The second is that we needed to obtain an indication for children under age 16. Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Zubaie postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Christopher A. Viehbacher: Zurzuvae; postpartum depression, enormous unmet need. Tremendous media coverage. We're talking about maternal health, and we're also talking about mental health, and those are two key trends in our society today. It has been difficult often for mothers to seek treatment and get treatment. It's estimated about 80,000 women are diagnosed every year, but the incidence is believed to be way in excess of half a million, so there's an awful lot of work to do to really get outreach to women who are suffering from postpartum depression. I have to say the initial indications of launch are well above expectations and very promising, but you know it's six weeks of data, so I think we want to see more data to really come to any firm conclusions. But everything that we are seeing is is extremely positive. We were originally positioning this product for major depressive disorder, and we pivoted to postpartum depression; that meant we've had to go back and recontract with payers. I have to say I'm highly appreciative of payers, because they have actually been honoring prescriptions, even though we haven't got all of our contracting in place, and I think that is actually also helping with demand. So with that, I'll turn it over to Priya, because I think increasingly what we'd like to also start to talk about is not only what we're selling, but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you, Priya.

Christopher A. Viehbacher: postpartum depression enormous unmet need. Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Tremendous media coverage. We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: We're talking about. Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Maternal health and we're also talking about mental health. Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Those are two key trends in our society today. It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: It has been difficult to often. Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Others to seek treatment and get treatment. This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: This estimated about 80000. <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: <unk> are diagnosed every year, but the the incidences. Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Believed to be way in excess of a half a million dollars. So there's an awful lot of work to do to really get outreach to women. Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Peter: Women. We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

We're suffering from postpartum depression. I have to say the initial indications of launch or well above expectations and very promising.

Speaker Change: I have to say the initial indications of launch or well above expectations and very promising.

Speaker Change: But it is six weeks of data. So I think we want to see more data to really come to any firm conclusions but. Everything that we are seeing is is extremely positive. We were originally positioning this product for major depressive disorder, and we pivoted to postpartum depression that meant we've had to go back and re contract with payers. I have to say I'm highly appreciative of payers because they have actually been honoring prescriptions, even though we haven't got all of our contracting in place and I think that is actually also helping with demand. So with that. I'll turn it over to Preah, because I think. Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

Speaker Change: Everything that we are seeing is is extremely positive. We were originally positioning this product for major depressive disorder, and we pivoted to postpartum depression that meant we've had to go back and re contract with payers. I have to say I'm highly appreciative of payers because they have actually been honoring prescriptions, even though we haven't got all of our contracting in place and I think that is actually also helping with demand. So with that. I'll turn it over to Preah, because I think. Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

Speaker Change: We were originally positioning this product for major depressive disorder, and we pivoted to postpartum depression that meant we've had to go back and re contract with payers. I have to say I'm highly appreciative of payers because they have actually been honoring prescriptions, even though we haven't got all of our contracting in place and I think that is actually also helping with demand. So with that. I'll turn it over to Preah, because I think. Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

Speaker Change: I have to say I'm highly appreciative of payers because they have actually been honoring prescriptions, even though we haven't got all of our contracting in place and I think that is actually also helping with demand. So with that. I'll turn it over to Preah, because I think. Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

Speaker Change: So with that. I'll turn it over to Preah, because I think. Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

I'll turn it over to Preah, because I think. Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

Preah: Increasingly what we'd like to also start to talk about is not only what we're selling but the new hope for patients that's coming out of our pipeline. So I'll turn that over to you.

Priya Singhal: Thank you, Chris. As we've previously discussed, we have focused on reviewing and prioritizing our development pipeline with a keen eye towards maximizing probability of success and increasing potential return on investment, as Chris noted. The intention was always to focus our pipeline to better represent a risk reward balance, and one that we believe could help Biogen reach the goal of achieving sustainable growth. While this effort resulted in a number of program discontinuations last year, specifically in areas we perceived significant regulatory, development, or commercialization challenges, we also highlighted areas where we have deep expertise and promising pipeline programs and therefore warranted and invest to win approach.

Speaker Change: The intention was always to focus on our pipeline to better represent our risk reward balance.

Speaker Change: And one that we believe could help biogen reached the goal of achieving sustainable growth.

Speaker Change: While this effort resulted in a number of program discontinuation last year, specifically in areas be perceived significant regulatory development or commercialization challenges. We also highlighted areas, where we have deep expertise and promising pipeline programs and therefore.

Speaker Change: Warranted and invest to win Approx.

Priya Singhal: One such area is Alzheimer's disease, where we have an industry leading pipeline, and we do expect to continue investing in order to expand our leadership. This starts first with building upon our opportunity with Leqembi. Our first priority is to continue working with Eisai to help ensure that Leqembi is available globally to patients suffering from early Alzheimer's disease. With approval now obtained in the US, Japan, and China, and filings currently under review in 14 additional markets, we believe we are well on our way to achieving this goal.

Speaker Change: <unk> disease.

Speaker Change: We have an industry, leading pipeline and we do expect to continue investing in order to expand our leadership.

Speaker Change: This starts first.

Speaker Change: Building upon our opportunity can be.

Speaker Change: Our first priority is to continue working with ESI to help ensure that <unk> available globally to patients suffering from early Alzheimer's disease.

Speaker Change: With approval now obtained in the U S, Japan, and China and filings currently under review in 14 additional market. We believe we are well on our way to achieving this goal.

Priya Singhal: Second is creating additional treatment options for patients. The data presented at CTAD last year on Leqembi suggests that there is continued benefit associated with treatment out to 24 months, and that treatment earlier in the disease course had a greater effect on clinical outcomes. For this reason, we are working with Eisai to submit a filing for maintenance dosing with IV Leqembi, or every four week treatment, as well as evaluating Leqembi administration in preclinical AD, as Chris mentioned in the AHEAD 345 trial, which is before the onset of symptoms. Eisai also aims to submit a filing for subcutaneous version of Leqembi by the end of March.

Speaker Change: The data presented at <unk> last year on a can be suggests that that is continued benefit associated with treatment out to 24 months.

Speaker Change: And that treatment earlier in the disease course had a greater effect on clinical outcomes.

Speaker Change: But this season, we are working with ASI to submit a filing for maintenance dosing with IV that can be or every four week treatment as well as evaluating the can be administration in preclinical.

Speaker Change: As Chris mentioned in the ahead 345 trial, which is before the onset of symptoms.

Speaker Change: <unk> also aims to submit a filing for subcutaneous version of <unk> can be by the end of March.

Priya Singhal: Beyond Leqembi, Biogen is also advancing pipeline programs targeting Tau. We believe Tau represents the next frontier in Alzheimer's therapeutics, and we are working to support the development of diagnostic tests and pathways. Our ASO targeting Tau, BIIB080, represents a new mechanism for targeting Tau distinct from prior antibody attempts. In the Phase 1B study, we saw a convergence of target engagement, reduction in Tau pathology in the brain, and the improvement in acceleratory measures of clinical outcome. We are very encouraged by these results, and are currently evaluating BIIB080 in the Phase II CELIA study. We also have BIIB113, a Phase One small molecule aiming to reduce the aggregation of Tau. Importantly, Jane and the research organization is also focused on the future of Alzheimer's treatment, and is pursuing a multi-modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

We believe <unk> represents the next frontier in as I must add a few things and we are working to support the development of diagnostic tests and Barclays.

Speaker Change: Our ASO targeting Tau <unk> represents a new mechanism for targeting tau distinct from prior antibody attempt.

Speaker Change: In the phase one B study, we saw a convergent. Target engagement. <unk> and Tau pathology in the brain. And the improvement in <unk> III measures of clinical outcome. We are very encouraged by these results and are currently evaluating <unk> <unk> in the phase II <unk> study. We also have 113, a phase one small molecule aiming to reduce the aggregation of Dow. Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: Target engagement. <unk> and Tau pathology in the brain. And the improvement in <unk> III measures of clinical outcome. We are very encouraged by these results and are currently evaluating <unk> <unk> in the phase II <unk> study. We also have 113, a phase one small molecule aiming to reduce the aggregation of Dow. Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: <unk> and Tau pathology in the brain. And the improvement in <unk> III measures of clinical outcome. We are very encouraged by these results and are currently evaluating <unk> <unk> in the phase II <unk> study. We also have 113, a phase one small molecule aiming to reduce the aggregation of Dow. Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: And the improvement in <unk> III measures of clinical outcome. We are very encouraged by these results and are currently evaluating <unk> <unk> in the phase II <unk> study. We also have 113, a phase one small molecule aiming to reduce the aggregation of Dow. Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: We are very encouraged by these results and are currently evaluating <unk> <unk> in the phase II <unk> study. We also have 113, a phase one small molecule aiming to reduce the aggregation of Dow. Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: We also have 113, a phase one small molecule aiming to reduce the aggregation of Dow. Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: Importantly gain and the research organization is also focused on the future of Alzheimer's treatment. And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Speaker Change: And is pursuing a multi modality approach to evaluate a number of other potential targets implicated in Alzheimer's disease biology.

Looking beyond Alzheimer's disease, Biogen has an opportunity to expand our growing rare disease portfolio. We see rare disease expertise as a core competency at Biogen. I will now address BIIB121 in Angelman syndrome. Angelman syndrome is a rare genetic neurodevelopmental disorder that occurs in approximately one in 15,000 live births worldwide. It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays, speech impairment, problems with movement and balance, and may involve seizures. While there is no specific treatment approved, individuals with Angelman syndrome will generally have a near normal life expectancy. However, they will generally require continuous care and are unable to live independently. Normally, the paternal allele of the Ube3a gene is silenced in neurons, leading to expression of only the maternal allele. In Angelman syndrome, the maternal allele is either absent or inactivated through genetic mutation, leading to the loss of Ube3a gene expression and impairment of synaptic connections and brain network activity. This can be visualized by an increase in slow brainwaves, called delta waves. BIIB121 aims to remove the silencing of the paternal allele in order to restore expression of the Ube3a gene. While the Phase One HALOS study is designed as an open label, multiple ascending dose study across age groups and dose levels to assess safety and tolerability, importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective EEG assessments, as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The HALOS study has completed enrollment for the multiple ascending dose portion of the study, and last year Ionis presented some encouraging early interim results. Overall, safety and tolerability support continued dosing in the long term extension, with no concerning safety trends having been observed to date. The EEG data was suggestive of early trends towards reduction of slow delta wave activity as compared to baseline, and clinician-assessed clinical endpoints show a majority of participants demonstrating some level of improvement in overall functioning. Overall, we are encouraged by these early trends, and look forward to sharing a more comprehensive topline study readout expected mid year. Following a review of those results, Biogen will be in a position to make its decision whether to opt in to conduct a pivotal study.

Speaker Change: We see rare disease expertise as a core competency at Biogen. I will now address. 121 in Angelman syndrome. Angelman syndrome is a rare genetic neurodevelopmental disorder that occurs in approximately one in 115000 lives but worldwide. It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays speech impairment problems with movement in balance and may involve seizure. While there is no specific treatment approved. Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: I will now address. 121 in Angelman syndrome. Angelman syndrome is a rare genetic neurodevelopmental disorder that occurs in approximately one in 115000 lives but worldwide. It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays speech impairment problems with movement in balance and may involve seizure. While there is no specific treatment approved. Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: 121 in Angelman syndrome. Angelman syndrome is a rare genetic neurodevelopmental disorder that occurs in approximately one in 115000 lives but worldwide. It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays speech impairment problems with movement in balance and may involve seizure. While there is no specific treatment approved. Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: Angelman syndrome is a rare genetic neurodevelopmental disorder that occurs in approximately one in 115000 lives but worldwide. It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays speech impairment problems with movement in balance and may involve seizure. While there is no specific treatment approved. Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays speech impairment problems with movement in balance and may involve seizure. While there is no specific treatment approved. Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: While there is no specific treatment approved. Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: Individuals with Angelman syndrome <unk>. We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: We have a near normal life expectancy. However, they will generally require continuous scare and are unable to live independently. Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Normally the <unk>. <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: <unk> of the <unk> gene is silenced in Iran. Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: Leading to expression of only the Mcdonald. In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

In Angelman syndrome Mcdonald. Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: Either absent our inactivated through genetic mutation. Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: Leading to the loss of <unk> gene expression and impairment of cyanotic connections and bringing network activity. This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: This can be visualized by an increase in low slow brainwaves all called desktop. They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: They wanted when do you want to aim to remove the silencing of the paternal allele in order to restore expression of the <unk>. While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: While the phase one Halo study is designed as an open label multiple ascending dose study across age groups and it always elements to assess safety and Tolerability importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: This includes objective E AEG assessment as well as clinical assessments evaluating multiple domains of Angelman syndrome, like cognitive function and gross and fine motor skills. The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: The Halo study has completed enrollment for the multiple ascending dose portion of the study. And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: And last year I honest presented some encouraging early interim results. Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: Overall safety and Tolerability support continued dosing in the long term extension with no concerning safety trends, having been observed to date.

Speaker Change: The EEG beta was suggestive of tends towards reduction of slow delta wave activity as compared to baseline and. And clinician assesses clinical endpoint. A majority of participants demonstrating some level of improvement in overall functioning. Overall, we are encouraged by these early trends and look forward to sharing a more comprehensive topline study readout expected mid year.

Speaker Change: And clinician assesses clinical endpoint. A majority of participants demonstrating some level of improvement in overall functioning. Overall, we are encouraged by these early trends and look forward to sharing a more comprehensive topline study readout expected mid year.

Speaker Change: A majority of participants demonstrating some level of improvement in overall functioning. Overall, we are encouraged by these early trends and look forward to sharing a more comprehensive topline study readout expected mid year.

Speaker Change: Overall, we are encouraged by these early trends and look forward to sharing a more comprehensive topline study readout expected mid year.

Speaker Change: Following a review of those results Biogen will be in a position to make its decision whether to opt in to conduct a pivotal study.

Priya Singhal: Moving to Lupus, this is another area with significant unmet medical need. We currently have two Phase III assets in systemic Lupus erythematosus, or SLE. First is dapirolizumab pegol, being developed in collaboration with UCB, where we expect a top line readout of the Phase III study midyear this year. If positive, we expect to conduct a second Phase III study. The second is litifilimab, our anti-BDCA2 antibody, developed in house at Biogen. We currently have two Phase III studies of litifilimab in SLE ongoing. These studies are enrolling and utilize a 52-week primary endpoint. Litifimilab also has the potential to be a first in class biologic in cutaneous lupus erythematosus, or CLE, a skin-based autoimmune disease that can be associated with severe scarring and dyspigmentation, and can be distinct from SLE. As I've previously discussed, we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: We currently have two phase three assets in systemic lupus erythematosus RSV. <unk> all being developed in collaboration with UCB, maybe expected top line readout of the phase III study midyear this year. If positive we expect to conduct a second phase III study. The second is an independent lab, our anti <unk> two antibody developed in house at Biogen. We currently have two phase III studies of <unk> in SLE ongoing these. These studies are enrolling and utilize a 52 week primary endpoint. <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: <unk> all being developed in collaboration with UCB, maybe expected top line readout of the phase III study midyear this year. If positive we expect to conduct a second phase III study. The second is an independent lab, our anti <unk> two antibody developed in house at Biogen. We currently have two phase III studies of <unk> in SLE ongoing these. These studies are enrolling and utilize a 52 week primary endpoint. <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: If positive we expect to conduct a second phase III study. The second is an independent lab, our anti <unk> two antibody developed in house at Biogen. We currently have two phase III studies of <unk> in SLE ongoing these. These studies are enrolling and utilize a 52 week primary endpoint. <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: The second is an independent lab, our anti <unk> two antibody developed in house at Biogen. We currently have two phase III studies of <unk> in SLE ongoing these. These studies are enrolling and utilize a 52 week primary endpoint. <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: We currently have two phase III studies of <unk> in SLE ongoing these. These studies are enrolling and utilize a 52 week primary endpoint. <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: These studies are enrolling and utilize a 52 week primary endpoint. <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: <unk> also has the potential to be a first in class biologic in cutaneous lupus erythematosus or cle. Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: Skin based auto immune disease that can be associated with severe scarring and this pigmentation and can be distinct from SME. As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Priya Singhal: As I've previously discussed, we have focused on reviewing our pipeline to identify and prioritize the areas where we believe we have both sufficient expertise and confidence in the science to deliver meaningful new treatments for patients. While this initial review is complete, this process remains dynamic, and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk-reward balance. While we look forward to four important near term readouts this year, we continue to focus on identifying additional near term opportunities, as well as continued expansion beyond neuroscience. Through collaboration with Jane and research organization, as well as Adam Keeney, our Head of Corporate Development, we are taking a holistic look across the spectrum of opportunities with both a research and development focus to identify strategic assets that we believe can contribute to Biogen's growth story now and in the long term. With that, I would now like to pass the call over to Mike.

Speaker Change: As I've previously discussed we have focused on reviewing our pipeline to identify and prioritize the areas, where we believe we have sufficient expertise and confidence in the science to deliver deliver meaningful new treatments for patients. While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: While this initial review is complete this process remains dynamic and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk reward balance. While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: While we look forward to four important near term Readouts. This year and we continue to focus on identifying additional opportunities as well as continued expansion beyond neuroscience.

Speaker Change: Through collaboration with gene and research organization as well as Adam <unk>, our head of corporate development. We are taking a holistic look across the spectrum of opportunities with both a research and development focus to identify strategic assets that we believe can contribute to biogen's drugstore. <unk> now and in the long term with that I would now like to pass the call over to Mike.

Speaker Change: <unk> now and in the long term with that I would now like to pass the call over to Mike.

Michael McDonnell: Thank you, Priya. Good morning, everyone. I'm going to provide some highlights and color regarding our financial performance for the fourth quarter of 2023, and I'll follow that with some detail on our 2024 financial guidance assumptions. Please note that all of the financial comparisons that you will hear are versus the fourth quarter of 2022.

Michael R. McDonnell: Total revenue for the fourth quarter of 2023 was $2.4 billion dollars, that's a decrease of 6% at actual currency and 5% at constant currency. Non-GAAP diluted earnings per share in the fourth quarter was $2.95 and that includes a $.35 negative impact from the recently disclosed closeout costs related to Aduhelm. For the full year of 2023, total revenue of $9.8 billion dollars represents a decline of 3% at actual currency and 1% at constant currency, and that's consistent with our most recent guidance of a low single digit decline. Full year 2023 non-GAAP diluted EPS was $14.72, and that's also consistent with our most recent guidance range of $14.50 to $15. Total MS product revenue was $1.2 billion in the fourth quarter; that's a decrease of 8% at actual currency and 6% at constant currency, and that decline is broadly attributable to competition among the impacts from generic Tecfidera. I'd like to now provide just a couple of quick updates to the MS business during the fourth quarter. first protected there in Europe.

Michael McDonnell: Total revenue for the fourth quarter of 2023 was $2.4 billion dollars, that's a decrease of 6% at actual currency and 5% at constant currency. Non-GAAP diluted earnings per share in the fourth quarter was $2.95 and that includes a $.35 negative impact from the recently disclosed closeout costs related to Aduhelm. For the full year of 2023, total revenue of $9.8 billion dollars represents a decline of 3% at actual currency and 1% at constant currency, and that's consistent with our most recent guidance of a low single digit decline. Full year 2023 non-GAAP diluted EPS was $14.72, and that's also consistent with our most recent guidance range of $14.50 to $15. Total MS product revenue was $1.2 billion in the fourth quarter; that's a decrease of 8% at actual currency and 6% at constant currency, and that decline is broadly attributable to competition among the impacts from generic Tecfidera. I'd like to now provide just a couple of quick updates to the MS business during the fourth quarter. first protected there in Europe.

Michael R. McDonnell: non-GAAP diluted earnings per share in the fourth quarter was $2 95 and that includes a 35 <unk>.

Michael R. McDonnell: Negative impact from the recently disclosed closeout costs related to agile. For the full year of 2023 total revenue of $9 8 billion represented a decline of 3% at actual currency and 1% at constant currency and Thats consistent with our most recent guidance of a low single digit decline. Full year 2023, non-GAAP diluted EPS was $14 72. And that's also consistent with our most recent guidance range of $14 50. To $15. Total EMS product revenue was $1 2 billion in the fourth quarter Thats, a decrease of 8% at actual currency and 6% at constant currency.

Michael R. McDonnell: For the full year of 2023 total revenue of $9 8 billion represented a decline of 3% at actual currency and 1% at constant currency and Thats consistent with our most recent guidance of a low single digit decline. Full year 2023, non-GAAP diluted EPS was $14 72. And that's also consistent with our most recent guidance range of $14 50. To $15. Total EMS product revenue was $1 2 billion in the fourth quarter Thats, a decrease of 8% at actual currency and 6% at constant currency.

Michael R. McDonnell: Full year 2023, non-GAAP diluted EPS was $14 72. And that's also consistent with our most recent guidance range of $14 50. To $15. Total EMS product revenue was $1 2 billion in the fourth quarter Thats, a decrease of 8% at actual currency and 6% at constant currency.

And that's also consistent with our most recent guidance range of $14 50. To $15. Total EMS product revenue was $1 2 billion in the fourth quarter Thats, a decrease of 8% at actual currency and 6% at constant currency.

Michael R. McDonnell: To $15. Total EMS product revenue was $1 2 billion in the fourth quarter Thats, a decrease of 8% at actual currency and 6% at constant currency.

Michael R. McDonnell: Total EMS product revenue was $1 2 billion in the fourth quarter Thats, a decrease of 8% at actual currency and 6% at constant currency.

Michael R. McDonnell: And that decline is broadly attributable to competition among the impacts from generic tech Vadera I'd like to now provide just a couple of quick updates to the EMS business.

Michael R. McDonnell: During the fourth quarter first protected there in Europe.

quarter. first protected there in Europe.

Michael McDonnell: First, for Tecfidera in Europe. In December, the European Commission revoked the centralized marketing authorization for generic versions of Tecfidera, and in reaching this decision the European Commission affirmed that Biogen is entitled to marketing protection for Tecfidera until February of 2025, which makes Tecfidera the only dimethyl fumarate treatment for MS that may be lawfully placed on the market for sale in the EU until that date. Also a Tysabri biosimilar has now launched in a small number of countries in Europe. We expect that biosimilars will continue to launch in the first half of 2024 in other European geographies, as well as in the US. Biogen has patents related to Tysabri, and we will continue to seek to enforce our IP. And although Vumerity grew modestly in 2023, we are seeing continued effects from pricing pressure and an overall contraction of the oral segment of the market in the US, which we expect to continue to see in 2024.

Michael R. McDonnell: In December the European Commission revoked the centralized marketing authorization. For generic versions of <unk> and in reaching this decision of the European Commission affirmed that Biogen is entitled to marketing protection protect Vadera until February of 2025, which makes <unk>. The only dimethyl fumarate treatment for Ms that may be lawfully place on the market for sale in the EU until that date. Also at Tysabri Biosimilar is now launched in a small number of countries in Europe. We expect that. Biosimilars will continue to launch in the first half of 2024 and other European geographies as well as in the U S. <unk> has patents related. Tysabri and we will continue to seek to enforce our IP. And although primarily grew modestly in 2023, we are seeing continued effects from pricing pressure and an overall contraction of the oral segment of the market in the U S, which we expect to continue to see in 2024.

Michael R. McDonnell: For generic versions of <unk> and in reaching this decision of the European Commission affirmed that Biogen is entitled to marketing protection protect Vadera until February of 2025, which makes <unk>. The only dimethyl fumarate treatment for Ms that may be lawfully place on the market for sale in the EU until that date.

Michael R. McDonnell: Also at Tysabri Biosimilar is now launched in a small number of countries in Europe.

Michael R. McDonnell: We expect that.

Michael R. McDonnell: Biosimilars will continue to launch in the first half of 2024 and other European geographies as well as in the U S.

Michael R. McDonnell: <unk> has patents related.

Michael R. McDonnell: Tysabri and we will continue to seek to enforce our IP.

Michael R. McDonnell: And although primarily grew modestly in 2023, we are seeing continued effects from pricing pressure and an overall contraction of the oral segment of the market in the U S, which we expect to continue to see in 2024.

Michael McDonnell: Now an update on our rare disease portfolio, which includes Spinraza, Skyclarys, and Qalsody. In the fourth quarter, we reported revenue of $472 million dollars, which is an increase of 3% at actual currency and 6% at constant currency. On our third quarter call, we noted that's Spinraza outside the US benefited from the timing of shipments in certain markets. This prior period benefit negatively impacted fourth quarter performance, but we expect continued shipment timing impacts for Spinraza in 2024, we remain encouraged by its overall performance. Spinraza outside the US was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return Spinraza to growth over time. Skyclarys delivered $56 million of revenue in the first full quarter as a Biogen product, and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million dollars increased 8% at actual currency and 10% at constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti-CD20 revenue of $436 million dollars included a $12 million dollar operating loss related to our economics for Lunsumio. Contract manufacturing royalty and other revenue of $118 million dollars in the fourth quarter was notably lower year over year, mainly driven by the timing of batches, and I'll provide some additional detail on this dynamic shortly when I discuss our 2024 guidance.

Michael R. McDonnell: In the fourth quarter, we reported revenue of $472 million, which is an increase of 3% at actual currency and 6%. Constant currency. On our third quarter call. We noted that's been rozzer outside the U S benefited from the timing of shipments in certain markets. Prior period benefit negatively impacted fourth quarter performance. We expect continued shipment timing impacts for <unk> in 2024, we remain encouraged by its overall performance. It's been rozzer outside the U S was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return <unk> to growth over time. <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: Constant currency. On our third quarter call. We noted that's been rozzer outside the U S benefited from the timing of shipments in certain markets. Prior period benefit negatively impacted fourth quarter performance. We expect continued shipment timing impacts for <unk> in 2024, we remain encouraged by its overall performance. It's been rozzer outside the U S was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return <unk> to growth over time. <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: On our third quarter call. We noted that's been rozzer outside the U S benefited from the timing of shipments in certain markets. Prior period benefit negatively impacted fourth quarter performance. We expect continued shipment timing impacts for <unk> in 2024, we remain encouraged by its overall performance. It's been rozzer outside the U S was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return <unk> to growth over time. <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: Prior period benefit negatively impacted fourth quarter performance. We expect continued shipment timing impacts for <unk> in 2024, we remain encouraged by its overall performance. It's been rozzer outside the U S was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return <unk> to growth over time. <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: We expect continued shipment timing impacts for <unk> in 2024, we remain encouraged by its overall performance. It's been rozzer outside the U S was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return <unk> to growth over time. <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: As the market leader in SMA, we continue to believe that we can return <unk> to growth over time. <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: <unk> delivered $56 million of revenue in the first full quarter as a biogen product and we are encouraged by the continued patient growth that we've seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% in constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael McDonnell: Biosimilars fourth quarter revenue of $188 million dollars increased 8% at actual currency and 10% at constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders. Our anti-CD20 revenue of $436 million dollars included a $12 million dollar operating loss related to our economics for Lunsumio. Contract manufacturing royalty and other revenue of $118 million dollars in the fourth quarter was notably lower year over year, mainly driven by the timing of batches, and I'll provide some additional detail on this dynamic shortly when I discuss our 2024 guidance.

Michael R. McDonnell: Our anti CD 20 revenue of $436 million included a $12 million operating loss related to our economics for <unk>.

Michael R. McDonnell: Contract manufacturing royalty and other revenue of $118 million in the fourth quarter was notably lower year over year, mainly driven by the timing of batches and I'll provide some additional detail on this dynamic shortly when I discuss our 2020 for guidance.

Michael McDonnell: Now a few things to note regarding fourth quarter expenses. Fourth quarter non-GAAP cost of sales was 25% of total revenue, and that includes $52 million dollars of idle capacity charges. Fourth quarter non-GAAP R&D expense decreased $34 million dollars, and that's notwithstanding approximately $45 million dollars related to our portion of the Leqembi collaboration, and approximately $60 million dollars in closeout costs relating to Aduhelm. Non-GAAP SG&A expense decreased $44 million dollars in the fourth quarter, which was driven by approximately $110 million dollars in cost savings initiatives, and that was partially offset by an increase in commercialization expenses related to the launches of Skyclarys and Leqembi.

Michael R. McDonnell: Fourth quarter, non-GAAP, R&D expense decreased $34 million and that's notwithstanding approximately $45 million related to our portion of the law can be collaboration and approximately $60 million and closeout costs relating to agile.

Michael R. McDonnell: non-GAAP SG&A expense decreased $44 million in the fourth quarter, which was driven by approximately $110 million in cost savings initiatives and that was partially offset by an increase in commercialization expenses related to the launches of sky Claris and Mackenzie.

Michael McDonnell: Next, a brief update on our balance sheet. We ended the year with $1 billion dollars in cash and marketable securities, and $6.9 billion dollars in debt, which puts us in a net debt position of $5.9 billion dollars. In the fourth quarter, we utilized approximately $1.3 billion dollars of cash for final acquisition payment obligations related to the Reata transaction. We also paid down roughly $350 million dollars of the $1 billion dollar term loan that we put in place at the time of this acquisition. It's important to note that included in the $1.3 billion dollars I just mentioned, $393 million dollars was reflected in cash flow from operations for a onetime payment related to equity based compensation for the Reata transaction. So absent this, full year 2023 free cash flow of $1.3 billion dollars would have been approximately $1.7 billion dollars. We expect to continue to generate strong cash flow this year and expect to receive a payment of $437 million dollars from Samsung in early Q2 of this year.

Michael R. McDonnell: Okay.

Michael R. McDonnell: In the fourth quarter, we utilized approximately $1 3 billion of cash for final acquisition payment obligations related to the Rialto transaction, we also paid down.

Michael R. McDonnell: Roughly $350 million of the $1 billion term loan that we put in place at the time of this acquisition.

Michael R. McDonnell: It's important to note that included in the $1 $3 billion I, just mentioned $393 million was reflected in cash flow from operations for a onetime payment related to equity based compensation for the reata transaction. So absent. This full year 2023 free cash flow of $1 $3 billion would have been approximately one seven.

Michael R. McDonnell: Billion.

Michael R. McDonnell: We expect to continue to generate strong cash flow this year and expect to receive a payment of $437 million from Samsung in early Q2 of this year.

Michael R. McDonnell: Yeah.

Michael McDonnell: So now I'm going to discuss our full year 2024 guidance ranges and assumptions. We expect full year 2024, non-GAAP diluted earnings per share of between $15 and $16, and that reflects expected EPS growth of approximately 5% at the midpoint of the range compared to 2023. While total revenue is expected to decline by a low to mid single digit percentage, we expect our core pharmaceutical revenue, our product revenue plus Biogen's 50% share of Leqembi revenue (net of cost of sales and royalties) to be relatively flat for 2024 as compared to 2023. This assumption is driven by the expected increase in revenue from new product launches over the course of the year, roughly offsetting the declines in our MS product revenue. As has been the case in previous years, we expect Q1 to be a seasonally weaker quarter as compared to Q4 for our MS business in the US, and that is driven by higher discounts and allowances, and some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillerød, which is located in Denmark. We had manufacturing operations there, and these batch commitments contributed roughly $320 million dollars in 2023 which will not recur in 2024.

Michael R. McDonnell: And that reflects expected EPS growth of approximately 5% at the midpoint of the range compared to 2023. While total revenue is expected to decline by a low to mid single digit percentage, we expect our core pharmaceutical revenue. Our product revenue plus biogen's, 50% share of what can be revenue net of cost of sales and royalties to be relatively flat for 2024 as compared to 2023. This assumption is driven by the expected increase in revenue from new product launches over the course of the year roughly offsetting the declines in our EMS product revs. <unk>. As has been the case in previous years, we expect Q1 to be seasonally weaker quarter as compared to Q4 for our EMS business in the U S and that is driven by higher discounts and allowances in some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael R. McDonnell: While total revenue is expected to decline by a low to mid single digit percentage, we expect our core pharmaceutical revenue. Our product revenue plus biogen's, 50% share of what can be revenue net of cost of sales and royalties to be relatively flat for 2024 as compared to 2023. This assumption is driven by the expected increase in revenue from new product launches over the course of the year roughly offsetting the declines in our EMS product revs. <unk>. As has been the case in previous years, we expect Q1 to be seasonally weaker quarter as compared to Q4 for our EMS business in the U S and that is driven by higher discounts and allowances in some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael R. McDonnell: Our product revenue plus biogen's, 50% share of what can be revenue net of cost of sales and royalties to be relatively flat for 2024 as compared to 2023. This assumption is driven by the expected increase in revenue from new product launches over the course of the year roughly offsetting the declines in our EMS product revs. <unk>. As has been the case in previous years, we expect Q1 to be seasonally weaker quarter as compared to Q4 for our EMS business in the U S and that is driven by higher discounts and allowances in some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael R. McDonnell: <unk>. As has been the case in previous years, we expect Q1 to be seasonally weaker quarter as compared to Q4 for our EMS business in the U S and that is driven by higher discounts and allowances in some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael R. McDonnell: As has been the case in previous years, we expect Q1 to be seasonally weaker quarter as compared to Q4 for our EMS business in the U S and that is driven by higher discounts and allowances in some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael R. McDonnell: We also expect contract manufacturing revenue to be significantly lower throughout 2024 as compared to 2023. This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael R. McDonnell: This is in part due to completing certain vast commitments in 2023 as part of the 2020 sale of Hillary Rod. Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Which is located in Denmark, we have manufacturing operations, there and these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

Michael McDonnell: The increase in revenue from new product launches and decrease in contract manufacturing revenue, along with lower idle capacity charges, are expected to have a favorable impact on cost of sales as a percentage of revenue for 2024. We also believe we can grow our operating income at a low double digit percentage in operating margins by a mid single digit percentage as compared to 2023. We expect this to be driven by improved cost of sales as a percentage of revenue, as well as lower expected operating expenses, resulting from our fit for growth initiative. On fit for growth, we continue to expect to generate approximately $1 billion dollars in gross savings, and $800 million dollars in savings net of reinvestments by 2025.

Michael R. McDonnell: We also believe we can grow our operating income at a low double digit percentage in operating margins.

Michael R. McDonnell: Mid single digit percentage as compared to 2023, we expect this to be driven by improved cost of sales as a percentage of revenue as well as lower expected operating expenses, resulting from our fit for growth initiatives.

Michael R. McDonnell: On fit for growth, we continue to expect to generate approximately $1 billion in gross savings and $800 million in savings net of Reinvestments by 2025.

Michael McDonnell: We have achieved approximately $200 million dollars of savings in 2023 and are on track to realize another $200 million dollars in 2024, which would put us at $400 million dollars, or half of the overall net savings by the end of this year, with the remainder in 2025. In 2024, we expect our 50% portion of SG&A spend for Leqembi, which as a reminder is not included in our fit for growth assumptions, and the reallocation of resources for Aduhelm, to roughly offset. With all of these considerations in mind, we expect our full year 2024 combined R&D and SG&A spend in total approximately $4.3 billion dollars. We expect our other income and expense line to continue to be a headwind this year given the reduction in interest income and increase in interest expense as a result of the Reata acquisition. And so in 2024, we expect an improving revenue profile, improved margins, and a return to non-GAAP EPS growth. Our number one goal remains to return to sustainable growth, and we remain committed to this goal and to creating long term value for our shareholders. And now back to Chris for some closing remarks.

Michael R. McDonnell: In 2024, we expect our 50% portion of SG&A spend for La <unk>, which as a reminder is not included in our fit for growth assumptions.

Michael R. McDonnell: And the reallocation of resources for age at home to roughly offset with.

Michael R. McDonnell: With all of these considerations in mind, we expect our full year 2020 for combined R&D and SG&A spend in total approximately $4 3 billion.

Michael R. McDonnell: We expect our other income and expense line to continue to be a headwind. This year given the reduction in interest income and increase in interest expense as a result of the reata acquisition.

And so in 2024, we expect an improving revenue profile.

Michael R. McDonnell: Improved margins and a return to non-GAAP EPS growth our number one goal remains to return to sustainable growth and we remain committed to this goal and to creating long term value for our shareholders. And now back to Chris for some closing.

Michael R. McDonnell: And now back to Chris for some closing.

Christopher A. Viehbacher: Thanks, Mike. So we have a number of milestones this year that we'll all be watching carefully. You've seen we have a scientific advisory group for Leqembi in the first quarter, and assuming a positive result for the CHMP, that should hopefully lead to approval by the European Commission in the first half, later in the first half of this year. Skyclarys in the European Union of course we've just achieved, as we announced last night. And the European approval for Qalsody, there is an expected decision by the CHMP and the European Commission in the first half. We have regulatory submissions coming up, as you know, with the subcutaneous formulation for Leqembi and IV maintenance dosing, also for Leqembi, and then as Priya's noted we have four data readouts expected sometime mid year for [inaudible] programs. As I said earlier, I think we're going to be spending an increasing amount of time focused on our pipeline and building out that pipeline, so Chuck I'll turn that back to you [inaudible] questions.

Christopher A. Viehbacher: We have a scientific advisory group for that can be in the first quarter and assuming a positive result for the <unk> that should hopefully lead to a approval and by the European Commission in the first half later in the first half of this year Sky Claris in the European Union of course, we've just achieved.

Christopher A. Viehbacher: As we announced last night.

Christopher A. Viehbacher: And the European approval for <unk>, Saudi.

There is an expected decision by the <unk> and the European Commission in the first half.

Christopher A. Viehbacher: We have. <unk> submissions coming up as you know with the subcutaneous formulation for the can be an IP maintenance dosing, but also for the can be and then as pre as noted we have four data readouts expected sometime mid tier four programs.

Christopher A. Viehbacher: <unk> submissions coming up as you know with the subcutaneous formulation for the can be an IP maintenance dosing, but also for the can be and then as pre as noted we have four data readouts expected sometime mid tier four programs.

Speaker Change: As I said earlier I think we're going to be spending an increasing amount of time focused on our pipeline.

Speaker Change: And building out that pipeline, so Chuck I'll turn it back.

Chuck Triano: Questions Alright, Thanks, Chris Katie could you. Please open polling for questions. Thank you.

Questions

Chuck Triano: Alright, thanks, Chris. Katie, could you please open polling for questions. Thank you.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow up, you may press star one again to rejoin the queue. Our first question comes from the line of Marc Goodman with Leerink Partners.

Marc Goodman - SVB Leerink LLC, Research Division: Yes, good morning. Can you walk us through just the sub-Q and the maintenance approvals. Obviously timelines I guess would be around the end of the year, but just talk about the impact into the market. Let's assume Lilly's on the market as well, they're going to get approved soon. So how do you expect this to change the dynamics, and the uptake, and just give us a sense of that, please, and then also maybe you could just talk about the uptake in Japan that you expect. Thanks.

Marc Harold Goodman: Obviously timelines I guess would be around the end of the year, but just talk about the impact into the market.

Marc Harold Goodman: Let's assume Lilly on the market as well, whether they're going to get approved soon so how do you expect this to change the dynamics and the uptake.

Marc Harold Goodman: Just give us a sense of that please and then also maybe you could just talk about the uptake in Japan would you expect thanks.

Speaker Change: Okay. Thanks, Mark prayer, you wanted to start with kind of the timelines and looking at the commercial sure.

Okay. Thanks, Mark prayer, you wanted to start with kind of the timelines and looking at the commercial sure.

Christopher A. Viehbacher: Okay. Thanks, Marc. Priya, you want to just start with kind of the timelines, and I'll hit the commercial.

commercial sure.

Priya Singhal: Sure. Thanks, Marc, for that question. So overall, we shared our six month data for the subcutaneous formulation at CTAD last year. We believe we've achieved bioequivalence with the IV formulation. Eisai has communicated very recently about the FDA meeting that is on the book to finalize our strategy for submission, and currently the aim is still to file by end of March 2024 for the subcutaneous formulation. In addition, there is data on the potential and need for IV maintenance, and that is also being aimed to filed by Q1 2024. So that's the plan currently, I'm going to turn it over to Chris for the dynamics and the commercial implications.

Speaker Change: Thanks, Mark for that question. So overall, we shared our six month data for the subcutaneous formulation Etsy Todd last year, we believe we've achieved bioequivalence with the IV formulation.

Speaker Change: <unk> has communicated very recently about the FDA meeting that is on the book to finalize our strategy for submission and currently the aim is still to file by end of March 2024 for the subcutaneous formulation. In addition that is data on.

Speaker Change: <unk> potential and need for IV maintenance and that is also being aimed to filed by Q1.

Speaker Change: 24, so that's the plan currently I'm going to turn it over to Chris for the dynamics and the commercial implications.

Christopher A. Viehbacher: Yeah so, Marc, the main benefit of subcutaneous is going to be convenience for patients. And as we talked about earlier, over time we're looking at the AHEAD study, where we could potentially when they get an indication for a much earlier stage patients, we're looking at maintenance, where patients should continue on if we get approved to prevent the recurrence of plaque. So the time on drug is expected to expand as we do these studies, and having a subcutaneous formulation at any stage of this disease could be quite beneficial. In terms of the actual competitiveness with Donanemab, I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety, and we have a significantly better safety profile with Leqembi than Donanemab. There is an interesting thing with Donanemab study, which, their study actually followed patients until there was a decrease in plaques, so where Clarity looked at an the endpoint for everybody at the same time point, after 18 months, there was a variable endpoint in terms of time on donanemab, and so the stopping criteria are not quite clear and I think we need to see what those are. If you need a PET scan for instance, that could be quite onerous. Now we don't know whether that's going to be the case or not, but I think we're going to have a number of variables with which we can compete with Donanemab, and subcutaneous at some point will be helpful. Obviously if the [inaudible] guidance looks like Donanemab is in this case is going to be on the market before the subcutaneous formulation is, so we're going to be focused on some of those non subcutaneous factors and competition, and then once we see the label for Lilly, once we see the label for the sub-Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: The main benefit of subcutaneous is going to be convenience for patients.

And as we talked about earlier overtime. We're looking at. The ahead study, where we could potentially when they get an indication for a much earlier stage patients we're looking at maintenance. Patients should continue on if we get approved. To prevent the. Recurrence of plaque so. The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: We're looking at. The ahead study, where we could potentially when they get an indication for a much earlier stage patients we're looking at maintenance. Patients should continue on if we get approved. To prevent the. Recurrence of plaque so. The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: The ahead study, where we could potentially when they get an indication for a much earlier stage patients we're looking at maintenance. Patients should continue on if we get approved. To prevent the. Recurrence of plaque so. The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Patients should continue on if we get approved. To prevent the. Recurrence of plaque so. The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: To prevent the. Recurrence of plaque so. The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Recurrence of plaque so. The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: The time on drug is expected to expand as we do these studies and having a subcutaneous formulation. At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: At any stage of this disease could could be quite beneficial in terms of the actual competitiveness with <unk> I think there's going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: We do know that physicians are highly sensitive to ARIA and safety. And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: And we have a significantly better safety profile with low can be than <unk>. There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: There is an interesting thing with 10 nanometer study, which. Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Their study actually. Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Followed patients until there was a decrease in plaques, so where clarity looked at and the endpoint for everybody at the same time point after 18 months. There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

There was a variable endpoint in terms of time on banana mab and so the stopping criteria not quite clear and I think we need to see what those are if you need a pet scan for instance. That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: That could be quite onerous now we don't know whether that's going to be the case or not but I think I think we're going to have a number of variables with which we can compete. Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Compete with with 10 nanometer and. Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Subcutaneous at some point will be helpful. Obviously. If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: If the. I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: I think to move these guidance looks like <unk> is in this case is going to be on the market before the subcutaneous formulation is so we're going to be focused on. Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Some of those non subcutaneous fat. Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Factors and competition and then. Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Christopher A. Viehbacher: Once we see the label for literally once we see the label for the sub Q, then we'll develop our commercial strategy accordingly.

Speaker Change: But do you want to comment on Japan, and Japan I think. We certainly have a <unk>. <unk> I is basically putting all of its field force not just the ones for but can be behind this. And <unk>. <unk> got a. The government managed health care system. So I think some of the complexity that we have in the United States with reimbursement in different. Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Chuck Triano: Did you want to comment on Japan?

Christopher A. Viehbacher: Oh and Japan, I think we certainly have a-- Eisai is basically putting all of its field force, not just the ones for Leqembi, behind this. And you've got a government managed health care system, so I think some of the complexity that we have in the United States with reimbursement and different actors could be simpler. We do expect that there will be some of the same constraints in terms of access to neurologists, the PET scans, they will probably use a lot more of the CSF markers than PET scans in Japan. I think we could potentially see a faster uptake in Japan than we saw even in the United States, just because of the current system. So we're just out there since January, and we'll give an update obviously again at first quarter, but certainly from what we're hearing from our own people in the field that there has been a very positive reception by physicians in Japan.

Speaker Change: We certainly have a <unk>. <unk> I is basically putting all of its field force not just the ones for but can be behind this. And <unk>. <unk> got a. The government managed health care system. So I think some of the complexity that we have in the United States with reimbursement in different. Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: <unk> I is basically putting all of its field force not just the ones for but can be behind this. And <unk>. <unk> got a. The government managed health care system. So I think some of the complexity that we have in the United States with reimbursement in different. Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: And <unk>. <unk> got a. The government managed health care system. So I think some of the complexity that we have in the United States with reimbursement in different. Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: <unk> got a. The government managed health care system. So I think some of the complexity that we have in the United States with reimbursement in different. Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: The government managed health care system. So I think some of the complexity that we have in the United States with reimbursement in different. Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: Actors could be simpler. We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: We do expect that there will be some. Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: Some of the same constraints in terms of access to neurologists. Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: Scans, they will probably use a lot more of the. The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: The CSF markers and pet scans in Japan. I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: I think. We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: We could potentially see a faster uptake in Japan than we saw even in the United States just because of the. The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: The current system. So we're just out there since January. We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: We'll give an update obviously again at first quarter, but. Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Certainly from what we're hearing from our own people on the field that. There has been a very positive reception by physicians in Japan.

Speaker Change: There has been a very positive reception by physicians in Japan.

Chuck Triano: Great. Thanks, Chris. Next question, please, Operator.

Operator: Thank you. We will go next to Salveen Richter with Goldman Sachs.

Salveen Richter - Goldman Sachs Group, Inc., Research Division: Good morning, thanks for taking my question. I have one with regard to the bottlenecks on the Leqembi launch. Could you speak to maybe two of those aspects: one is your expectations for Medicare Advantage to get to the same level of coverage is traditional Medicare, and over what timeframe. And then secondly, just an update on the patient access to neurologists. Thank you.

Solving Richter: One with regard to the bottlenecks on the law can be launch could you speak to maybe two of those aspects. One is your expectations for Medicare advantage to get to the same level of coverage is traditional Medicare.

And over what timeframe and then secondly, just an update on the patient access to neurologists. Thank you.

Christopher A. Viehbacher: Yeah so, I'll have to get back to you. I haven't heard anything that Medicare Advantage is any different than Medicare, so I haven't ever asked that question before, but I'll go check, but as far as I know, it's the same. You know the bottlenecks, you know are still, if you think about it, if the data from the patient registries are accurate, and again, we don't have direct access to that, but it suggests that we've got almost twice as many people on the registry as we do on treatment. And so that says that in addition to the bottleneck of getting into the neurologists, that there's [inaudible] you get to the registry, you've got a clear intent to prescribe, because on the registry, at least for CMS, you'll have to describe how you actually validated the diagnosis. So by then, you've triaged the patient, you've done either the PET scan or the CSF markers, and you're looking for reimbursement. And what we're hearing a little bit is that there is some challenge in just scheduling the first MRI, because when we initiate the infusion, you have to have the first MRI within the first two weeks. So people don't want to initiate the infusion until they've got that MRI scheduled, and the MRI-- there isn't an MRI capacity constraint per se, but you are looking for a specific date, and then you have to backup the infusion. So there's just I think, until people get the hang of this, getting all of that coordination, I think that that seems to be where one of the bottlenecks is.

Speaker Change: I'll have to get back to you.

Speaker Change: Haven't heard anything that Medicare advantage is any different in Medicare so.

I havent ever asked that question before but I'll go check, but as far as I know, it's the same.

Speaker Change: Bottlenecks.

Yes.

Speaker Change: If you think about it if the data from the patient registry is are accurate and again, we don't have direct access to that but it suggests that we've got almost twice as many people on the registry as we do on treatment and so that says that.

Speaker Change: In addition to the bottleneck of getting into the neurologists that theirs.

Speaker Change: You get to the registry you have got a clear intent to prescribe.

Speaker Change: On the registry at least for CMS Youll have to describe how you actually validated the diagnosis. So by then you've triage patients you've done either the pet scan or the CSS markers.

Speaker Change: And youre looking for reimbursement.

Speaker Change: And what we're hearing a little bit is that.

Speaker Change: There is some.

Speaker Change: Challenge in Gist.

Speaker Change: Julien the first MRI, because when we initiate the infusion you'll have to have the first MRI within the first two weeks. So people don't want to initiate the infusion until they've got that MRI scheduled.

Speaker Change: The MRI there isn't an MRI capacity constraint per se, but you are looking for a specific date and then you have to backup the infusion. So there's just I think.

Speaker Change: Until people get the hang of this getting all of that coordination I think that that seems to be where.

Speaker Change: We're one of the bottlenecks is.

Chuck Triano: Great. Thank you, Chris. Let's move to the next question, please.

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

Speaker Change: With Evercore ISI.

Umer Raffat: Hi, guys. Thanks for taking my question. I thought I'd ask for something a little different today. Your CD40 Phase III in lupus, and my question is two things: one, the trial size has shrunk from 450 down to 320. Could you speak to the recruiting challenges and whether they bode well or not well on efficacy. And then secondly, the primary endpoint. This one has three components, but the FDA guidance appears to want one clear index, like a BILAG or SLEDAI, et cetera. Is there alignment with the regulator on that? Thank you.

Speaker Change: Two things one the trial size has shrunk from $4 50 down to 320 could you speak to the recruiting challenges and whether they bode well or not well on efficacy and then secondly.

Speaker Change: The primary endpoint. This one has three components.

Speaker Change: But the FDA guidance appears to want one clear index like a biologic or selling off late I et cetera is their alignment with the regulator on that thank you.

Priya Singhal: Thank you, Umer, I'll take that. So just starting off, I think we expect our results from the first Phase III mid 2024. We expect that we will need a second Phase III if this is positive to generate the safety and efficacy to support a reg filing. We did make a protocol amendment and this was really working very closely with Biogen and UCB, looking at the study design, balancing our commitment to execute a well designed, informative study with a desire to potentially expedite the delivery of [inaudible] if positive to patients in need. So we do think it's appropriately powered, and we continue with our regulatory engagements and facilitate a discussion on the next step. So we think yes, it is positioned to give us a clear readout on the therapeutic potential as of now, yes.

Speaker Change: Very close closely with Biogen and UCB looking at the study design balancing our commitment to execute a well designed informative study with a desire to potentially expedite the delivery of data if positive to patients in need. So we do think it's appropriately powered and we continue with our regulatory engaged.

Speaker Change: Women's and facilitate a discussion on the next step. So we think yes, we it is positioned to give us a clear readout.

Speaker Change: On the therapeutic potential as of now yes.

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

Speaker Change: Let's go to our next question please.

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

Evan Seigerman: Hi, all thank you so much for taking my question. Chris, can you walk me through some of the rationale for adding on more Biogen resources to the Leqembi launch, and maybe kind of what's changed or evolved with your partnership with Eisai where you think you need to add more Biogen resources in the United States. Thank you.

Christopher A. Viehbacher: Yeah, thanks, Evan. I mean to be clear, we're adding both more Biogen as well as more Eisai. You know, a year ago, the CEO and I talked about the launch of Leqemby and for the US just discussed the complexity of the launch. We've been through all that, and I won't necessarily bore everybody again with that complexity, but we just felt that we wanted to really make sure we understood the go to market model. In addition to these neurology account specialists, you've got MSLs, you've got some patient care navigators, you've got some people looking after [inaudible] in the region. There's probably, for every Nav, there's probably another two or three people who are actually out there in the field. And there is an awful lot of coordination that is needed, and even the role of the Nav is quite complex because you've got to go in there, you've got to work with the office around, helping them to understand the safety. You have to help them understand what the care pathway is, you have to help them to understand the reimbursement, not just for Leqemby, but there is the reimbursement for the PET scans, the MRIs, and for the care. And then finally there's what people in the field have as a principal objective: why Leqemby. So we wanted to make sure we understood all of that, and to be honest, whenever you do these co-promotions, they require an awful lot of coordination between the companies, and we just felt that it would be simpler if one company went out at the start. We were sure that we knew exactly how the role of the Nav was going to work in relation to the other accompanying roles that are out there in the field. And we also needed to get a certain number of core IDNs ready and signed up, because there's not a lot of point in increasing the number of people out in the field unless you've got enough sites that are activated and ready. So now we are more than six months into the launch I think we feel very comfortable about the role of the Nos works. We understand how long it takes between going to visit. Neurologist or an IBM and how long, it's going to take for them to be activated. Say this. You can put an awful lot of resource out there, but if you're not able to pull the drug through its not a very efficient process. So that's that's just where we are we're confident in that model obviously. It is. We need to now reach out to more sites. So we're looking at this from both a geographic expansion, but also I think. Even within certain geographies. Reducing the territory side because. When these <unk> go in they spent quite a long time with the specialists. So it was always the agreement between. Between the two Ceos that when we scale up that Biogen would come in. But we both our objective is to make the joint venture as efficient as possible and so we just felt that the efficiency at the start would be maximized. If we had one company in the field now, we've obviously learned from that and and Thats. What also gives us the confidence to put two companies out into the field immediately in Japan for example, because. While there are differences in the market. Number of the dynamics that would be the same pretty much in most markets. So it is an increase. ASI is increasing their resource and so and biogen will be out there as well. And then that could still evolve overtime. We're going to be in this business together for many years to come.

Christopher A. Viehbacher: Yeah. Yeah. Year ago. <unk> talked about. Launch of <unk> and <unk>. And for the U S. Just. Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Yeah. Year ago. <unk> talked about. Launch of <unk> and <unk>. And for the U S. Just. Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Year ago. <unk> talked about. Launch of <unk> and <unk>. And for the U S. Just. Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: <unk> talked about. Launch of <unk> and <unk>. And for the U S. Just. Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Launch of <unk> and <unk>. And for the U S. Just. Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

And for the U S. Just. Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Just discussed. The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: The complexity of the launch. We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: We've been through all that and they won't necessarily where everybody again with that complexity, but we just felt that we. We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

We wanted to really make sure we understood the go to market model. In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

In addition to these neurology account specialists. <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: <unk> got <unk> got some. Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Patient care navigators, you've got some people looking after. <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: <unk> in the region and. Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Theres probably for every now theres another two or three people who are actually out there in the field and there is an awful lot of coordination that is needed and even the role of the NAV is quite. It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

It's quite complex because <unk> got to go in there and you've got to work with the office around helping. Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Helping them to understand the safety. Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Have to help them understand what the care pathway is you have to help them to understand the reimbursement not just from Mckinsey, but there is the reimbursement for the pet scans mris and for the care and then finally in others. What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

What people don't feel there has been a principal objective while it can be so so we wanted to make sure we understood all of that. And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: And to be honest whenever you do these co promotions. They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: They require an awful lot of coordination between the companies and we just felt that it would be simpler if one company went out at the start we were sure that we knew. <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: <unk>. How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: How the role of the <unk> was going to work in relation to the other accompanying rules that are out there in the field and we also needed to get a certain number of of of core <unk>.

Christopher A. Viehbacher: Ready and signed up because theres not a lot of point in in increasing the number of people out in the field unless you've got enough sites that are activated and ready. So now we are more than six months into the launch I think we feel very comfortable about the role of the Nos works.

Christopher A. Viehbacher: So now we are more than six months into the launch, I think we feel very comfortable about the role of the NAS works. We understand how long it takes between going to visit a neurologist or an IDN, and how long it's going to take for them to be activated. Say there's, you can put an awful lot of resource out there, but if you're not able to pull the drug through, it's not a very efficient process. So that's just where we are, we're confident in that model. Obviously, it is, we need to now reach out to more sites. So we're looking at this from both a geographic expansion, but also I think even within certain geographies, perhaps reducing the territory size, because when these NASs go in they spent quite a long time with the specialists. So it was always the agreement between the two CEOs that when we scale up that Biogen would come in. But we both, our objective is to make the joint venture as efficient as possible, and so we just felt that the efficiency at the start would be maximized if we had one company in the field. Now, we've obviously learned from that, and that's also what gives us the confidence to put two companies out into the field immediately in Japan for example, because while there are differences in the market, a number of the dynamics would be the same pretty much in most markets. So it is an increase. Eisai is increasing their resource, and Biogen will be out there as well. And that could still evolve over time. We're going to be in this business together for many years to come.

Christopher A. Viehbacher: We understand how long it takes between going to visit.

Christopher A. Viehbacher: Neurologist or an IBM and how long, it's going to take for them to be activated.

Christopher A. Viehbacher: Say this.

Christopher A. Viehbacher: You can put an awful lot of resource out there, but if you're not able to pull the drug through its not a very efficient process. So that's that's just where we are we're confident in that model obviously.

Christopher A. Viehbacher: It is.

Christopher A. Viehbacher: We need to now reach out to more sites. So we're looking at this from both a geographic expansion, but also I think.

Christopher A. Viehbacher: Even within certain geographies.

Christopher A. Viehbacher: Reducing the territory side because.

Christopher A. Viehbacher: When these <unk> go in they spent quite a long time with the specialists. So it was always the agreement between.

Christopher A. Viehbacher: Between the two Ceos that when we scale up that Biogen would come in.

Christopher A. Viehbacher: But we both our objective is to make the joint venture as efficient as possible and so we just felt that the efficiency at the start would be maximized.

Christopher A. Viehbacher: If we had one company in the field now, we've obviously learned from that and and Thats. What also gives us the confidence to put two companies out into the field immediately in Japan for example, because.

Christopher A. Viehbacher: While there are differences in the market.

Christopher A. Viehbacher: Number of the dynamics that would be the same pretty much in most markets. So it is an increase.

Christopher A. Viehbacher: ASI is increasing their resource and so and biogen will be out there as well.

Christopher A. Viehbacher: And then that could still evolve overtime.

Christopher A. Viehbacher: We're going to be in this business together for many years to come.

Chuck Triano: Alright, thanks, Chris. Let's move to our next question, please.

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

Paul Matteis: Hi, this is James on for Paul, thanks for taking our question. Just one more on the Lecanemab sub-Q, and specifically in treatment naive patients, just wondering if you're confident that you have enough data from a regulatory perspective here, if you've aligned with regulators, you and Eisai aligned with regulators, and specifically if you have enough safety data in that treatment naive patient population. Any color there would be great. Thanks.

James: Just one more on <unk>.

Speaker Change: I can't imagine sub Q and specifically in treatment naive patients just wondering.

Speaker Change: Youre confident that you have enough data from <unk>.

James: Regulatory perspective here, if you've aligned with regulators and <unk> line with regulators and specifically if you have enough safety data in that treatment naive patient population any color there would be great. Thanks.

Priya Singhal: So yes, overall this has been a topic that we've discussed, Eisai and Biogen have discussed, with the FDA, and just to step back, the design was to add a sub-study, a subcutaneous sub study, in the Phase III Clarity study open label extension. And the cohort that was treatment naive from Lecanemab was about 72 patients. And then there was a whole cohort of 322 additional patients that provided safety and tolerability. So this was, the 72 patients is the premise for the PKPD and bioequivalents, but there's a larger subset of data that speaks to the safety data. So yes, discussions are ongoing but overall these have been discussed with regulators prior to starting them. Thank you.

Speaker Change: And cohort that was treatment naive from Mccann and Mab was about 72 patients.

Speaker Change: And then there was a whole cohort of 322 additional patients that provided safety and Tolerability. So this was the 72 patients is the premise for the PK PD and bio equivalents, but theres a larger subset of data that speaks to the safety data. So yes discussions are ongoing but overall these have been to.

Speaker Change: Cost with regulators prior to starting them. Thank.

Chuck Triano: Thanks, Priya. Next question, please.

Operator: We'll go next to Phil Nadeau with TD Cowen.

Phil Nadeau: Good morning, a question on Skyclarys following last night's approval in the EU. Chris highlighted the importance of the ex-US markets. Could you discuss the expected cadence and trajectory of Skyclarys' launch outside the US, in Europe in particular, When will it be available in the major territories, and would you expect the uptake in those major territories to be as fast as it has been here in the United States. Thanks.

Phil Nadeau: Could you discuss the expected cadence and trajectory of Sky Congresses launch outside the U S and Europe in particular, when it will be available on the major territories and would you expect the uptake in those major territories to be as fast as it has been here in the United States.

Christopher A. Viehbacher: So there is two aspects, I guess, to the launch. One is the early access programs, and the other is the formal launch. So for example, we'll be able to launch now in Germany with this approval. So we will, this will be a formal launch, we still have an early access program and maybe patients on that will now convert to commercial patients, remembering that actually the patients in early access programs in Europe are expected to be revenue generating for the most part. We have another program that's up and running in France, and we are negotiating the establishment of early access programs in two other European countries, and there are some early access programs under discussion in countries outside of the EU. And the early access program is important because as we all know in Europe, getting pricing and reimbursement can take some time. So it's a little hard to predict, just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the US. That said, there is some suggestion that there are some patients the warehousing effect could well be in Europe, but as I say, as a general matter, just because of the time to get reimbursement and the fact that we are not going to be able to have early access programs in all countries, that that will be a slower uptake than in the US. That said, there is also probably more patients actually per capita. Remember this is a disease that is related to European descent, and so the incidence of Friedreichs ataxia is slightly higher in Europe [inaudible]. The next big market opportunity would be Latin America, and we are submitting in Brazil and perhaps Priya you can give us an update on the regulatory timelines there. yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: For example. You'll be able to launch now in Germany with this approval. So we will this will be a formal launch we. Still have an early access program and maybe patients on that will now convert to commercial patients remembering that. Actually the patients in early access programs in Europe are expected to be revenue generating for the most part we have another program, that's up and running in France. And we are negotiating. The establishment of early access programs in two other European countries and there is some. Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: You'll be able to launch now in Germany with this approval. So we will this will be a formal launch we. Still have an early access program and maybe patients on that will now convert to commercial patients remembering that. Actually the patients in early access programs in Europe are expected to be revenue generating for the most part we have another program, that's up and running in France. And we are negotiating. The establishment of early access programs in two other European countries and there is some. Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: Still have an early access program and maybe patients on that will now convert to commercial patients remembering that. Actually the patients in early access programs in Europe are expected to be revenue generating for the most part we have another program, that's up and running in France. And we are negotiating. The establishment of early access programs in two other European countries and there is some. Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: Actually the patients in early access programs in Europe are expected to be revenue generating for the most part we have another program, that's up and running in France. And we are negotiating. The establishment of early access programs in two other European countries and there is some. Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: And we are negotiating. The establishment of early access programs in two other European countries and there is some. Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: The establishment of early access programs in two other European countries and there is some. Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: Early access programs under discussion in countries outside of the EU and the early access program is important because as we all know in Europe getting pricing and reimbursement can take some time. So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: So. It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: It's a little hard to predict. Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: Just because we have to understand the cadence of these early access programs. So I would expect that it's not going to be quite as fast as it was in the U S. That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: That said. There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: There is some. Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: Suggestion that there are some patients the warehousing effect could well be in Europe, but as a sale and as a general matter just because of the time to get. First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: First men and the fact that we are not going to be able to have early access programs in all countries. That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: That will be a slower uptake than in the U S. That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

That said there is also probably more patients actually per capita and remember this is a disease that is related to European descent, and so the incidence of friedrichs ataxia is slightly higher in Europe and Fitbit. The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: The next big. The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Phil Nadeau: The market opportunity in Latin America. And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Speaker Change: And we are submitting in Brazil, and perhaps you can give us an update on the regulatory timelines there, yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timeline, but our teams are working very expeditiously meeting with. <unk>, so really define the pathways that could provide earliest access to patient.

Priya Singhal: Yes, I can comment on the fact that really we are trying to expedite our regulatory filings in Latin America, Brazil, Argentina, we haven't yet communicated the timelines, but our teams are working very expeditiously, meeting with to really define the pathways that could provide earliest access to patients.

Speaker Change: <unk>, so really define the pathways that could provide earliest access to patient.

Christopher A. Viehbacher: We estimate, it's hard to get the numbers precisely, but we do estimate there is around 2,000 to 4,000 patients in Latin America. So, and when we look at the experience of Spinraza, we are expecting particularly Latin America to contribute substantially to our revenue outlook as well. As you know, there are very few patients in Asia, just because of the genetics, so we don't intend to be filing and launching in Asia.

Speaker Change: Hard to get the numbers precisely, but we do estimate there is. Around 2% to 4000 patients in Latin America. So. And when we look at the experience that's been Rosa. We are expecting. Particularly in Latin America to contribute substantially to our revenue. <unk> as well as you know there are very few patients in Asia. Just because of the genetic so we don't intend to be filing and launching in Asia.

Speaker Change: Around 2% to 4000 patients in Latin America. So. And when we look at the experience that's been Rosa. We are expecting. Particularly in Latin America to contribute substantially to our revenue. <unk> as well as you know there are very few patients in Asia. Just because of the genetic so we don't intend to be filing and launching in Asia.

Speaker Change: And when we look at the experience that's been Rosa. We are expecting. Particularly in Latin America to contribute substantially to our revenue. <unk> as well as you know there are very few patients in Asia. Just because of the genetic so we don't intend to be filing and launching in Asia.

Speaker Change: We are expecting. Particularly in Latin America to contribute substantially to our revenue. <unk> as well as you know there are very few patients in Asia. Just because of the genetic so we don't intend to be filing and launching in Asia.

Speaker Change: Particularly in Latin America to contribute substantially to our revenue. <unk> as well as you know there are very few patients in Asia. Just because of the genetic so we don't intend to be filing and launching in Asia.

Speaker Change: <unk> as well as you know there are very few patients in Asia. Just because of the genetic so we don't intend to be filing and launching in Asia.

Speaker Change: Just because of the genetic so we don't intend to be filing and launching in Asia.

Chuck Triano: Great, thank you. Next question, please.

Operator: We'll go next to Michael Yee with Jefferies.

Michael J. Yee: Thanks. We had a question on Skyclarys; can you maybe shed some more light on the dynamics of 800 patients to 1000, and then the trajectory as we go forward into 2024, I know you mentioned there is about 4,000 patients, but how many of those are actually identified, do you expect growth to moderate just from an expectation standpoint. Talk a little bit about the complexities in 2024 that you commented about. Thank you.

Michael J. Yee: Scott can you maybe shed some more light on the dynamics of 800 patients to 1000, and then the trajectory as we go forward into 2024 I know you mentioned there is about 4000 patients, but how many of those are actually identified do you expect growth to moderate just from an expectation standpoint talk a little bit about the complexities.

Michael J. Yee: <unk> 2024 that you commented about thank you.

Christopher A. Viehbacher: Yeah, thanks, Michael. Certainly the growth is going to moderate. Remember this is a, when this product was in the hands of Reata, they had approval I think it was back in the first quarter, I think it was February if I remember accurately. And, but they were not able to commercially launch because of the manufacturing specification issue, and that did not get cleared until July. So in other words, the market and physicians knew the product would be coming to the market, that it was approved, and they were just waiting for product availability. So I think the warehousing effect was even greater than what you would normally see for any rare disease drug. Now we're back into the process of finding the patients. I have to say the Friedreich's ataxia research alliance, otherwise known as FARA, is an extraordinarily effective patient association, and we're working with them to help identify patients. There is a requirement, really, to diagnose a patient, to accurately genetic test, but this genetic test is not so readily available, and so we're having to look and make sure that the supplier of that test can make the tests readily available. And then we're also doing the contracting, really to make sure that as patients have start forms that they can quickly get on drug. So we'll be back to I think a regular growth cadence on Skyclarys in the US. I don't think we're necessarily going to get another 20% this year, but we're growing every month, and certainly Skyclarys is contributing significantly to our return to growth in 2024.

Scott: Certainly the growth is going to moderate. No. Remember this is a. When this product was in the hands of reorder. They had approval I think it was back in the first quarter I think it was February if I remember accurately. And but they were not able to commercially launch because of the manufacturing specification issue, so and that did not get cleared until July so in other words, the market and physicians knew the product would be coming to the market that it was approved and. And they were just waiting for product availability. So I think the warehousing effect was even greater than what you would normally see for any rare disease drug now we're back into the process of finding the patients. Have to say the friedrichs ataxia research alliance or otherwise known as Farah. It's an extraordinarily effective patient association. And we're working with them to help identify patients. There is a requirement. To diagnose a patient accurately a genetic test, but this genetic test is not so. Readily available and so we're having to to look and make sure that the supplier of that test can make the tests readily available. And then we're also doing the contracting. Really to make sure that as patients have start forms that they can they can quickly get on drug. So we'll be we'll be back to I think a regular growth cadence on sky Claris in the U S. I don't think we're necessarily going to get another 20% this year, but we're growing every every month. Certainly sky Clarus is contributing significantly to our return to growth in 2024.

Scott: No.

Speaker Change: Remember this is a.

Speaker Change: When this product was in the hands of reorder. They had approval I think it was back in the first quarter I think it was February if I remember accurately.

Speaker Change: And but they were not able to commercially launch because of the manufacturing specification issue, so and that did not get cleared until July so in other words, the market and physicians knew the product would be coming to the market that it was approved and.

Speaker Change: And they were just waiting for product availability. So I think the warehousing effect was even greater than what you would normally see for any rare disease drug now we're back into the process of finding the patients.

Speaker Change: Have to say the friedrichs ataxia research alliance or otherwise known as Farah.

Speaker Change: It's an extraordinarily effective patient association.

Speaker Change: And we're working with them to help identify patients.

Speaker Change: There is a requirement.

Speaker Change: To diagnose a patient accurately a genetic test, but this genetic test is not so.

Speaker Change: Readily available and so we're having to to look and make sure that the supplier of that test can make the tests readily available.

Speaker Change: And then we're also doing the contracting.

Speaker Change: Really to make sure that as patients have start forms that they can they can quickly get on drug. So we'll be we'll be back to I think a regular growth cadence on sky Claris in the U S.

Speaker Change: I don't think we're necessarily going to get another 20% this year, but we're growing every every month.

Speaker Change: Certainly sky Clarus is contributing significantly to our return to growth in 2024.

Chuck Triano: Great. Thank you, Chris. Let's move to our next question, please.

Operator: We'll go next to Colin Bristow with UBS.

Colin Bristow: Hi, good morning, and thanks for taking the questions. I just wanted to clarify something. In your slides it says that [inaudible] first half of '24, but in your commentary it sounds like it's still 1Q '24. So if you could just clarify that. And just talk to specifically what FDA is waiting to see, I think it was the 12-month data last time we spoke. What is it within that. And then maybe just as a follow on, the AHEAD 3-45 study. What are the timing of thresholds for any interim analyses there. Thank you.

Colin Bristow: I just wanted to clarify something in your slides it says that the.

Colin Bristow: Sometimes it can be thought of as now first half of 'twenty four but in your commentary it sounds like it's still <unk> 24.

Colin Bristow: So if you could just clarify that.

Colin Bristow: And just talk too specifically. FDA is waiting to see I think it was the 12 month data last time, we say what is it within the. And then maybe just. As a follow on you had 345 study. What are the timing of thresholds for any interim analysis that thank you.

Colin Bristow: FDA is waiting to see I think it was the 12 month data last time, we say what is it within the. And then maybe just. As a follow on you had 345 study. What are the timing of thresholds for any interim analysis that thank you.

Colin Bristow: And then maybe just. As a follow on you had 345 study. What are the timing of thresholds for any interim analysis that thank you.

Colin Bristow: As a follow on you had 345 study. What are the timing of thresholds for any interim analysis that thank you.

Colin Bristow: What are the timing of thresholds for any interim analysis that thank you.

Priya Singhal: I can get started. So overall I think with the subcutaneous, just to be very clear: Eisai has communicated as recently as their earnings a few days ago that we aim to file by Q1 2024, which is end of the first quarter this year. And just shifting gears to AHEAD 3-45, this is really a platform, set of platform trials, with different amyloid levels for defining preclinical Alzheimer's disease. So at a very high level A-45 is preclinical Alzheimer's disease with an enrollment target of 1,000 patients, and patients need to have an amyloid level of 40 centiloids or more. There's three phases of dosing with different doses, which is titration, induction, and maintenance, and in this particular trial, the outcome is a PACC 5, which is a preclinical composite for Alzheimer's disease where it's sensitive to patients who are still in the preclinical phase. The A-3 trial has a target enrollment of about 400, and the preclinical amyloid cutoff is between 20 and 40 centiloids, and then again, it's got a different dosing schedule of titration and then maintenance. Now the primary endpoint for the A-3 trial is really a biomarker endpoint. We haven't really communicated exact timelines; these are very large trials, I think Eisai and Biogen are very pleased with how they are being enrolled, and I think we will communicate more. There is an opportunity to do an interim analysis, and Eisai has spoken to this, but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Eisai has communicated as recently as their earnings a few days ago that we aim to file by Q1 2020 full which is end of the first quarter. This year.

Speaker Change: And.

Speaker Change: Just shifting gears to have 345 this is really.

Speaker Change: Platform set of platform trials with different amyloid levels defining preclinical Alzheimer's disease, so at a very high level.

Speaker Change: <unk> five is critical preclinical Alzheimer's disease with an enrollment target of 2000 patients.

Speaker Change: And Ah patients need to have an amyloid level of 40 Center Lloyd's Omar. There's three phases of dosing with different doses. Which is titration induction and maintenance and. And in this particular trial the outcome is a back five reaches a preclinical composite. Okay got it. Sensitive to patients who are still in the preclinical phase. A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: There's three phases of dosing with different doses. Which is titration induction and maintenance and. And in this particular trial the outcome is a back five reaches a preclinical composite. Okay got it. Sensitive to patients who are still in the preclinical phase. A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Which is titration induction and maintenance and. And in this particular trial the outcome is a back five reaches a preclinical composite. Okay got it. Sensitive to patients who are still in the preclinical phase. A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: And in this particular trial the outcome is a back five reaches a preclinical composite. Okay got it. Sensitive to patients who are still in the preclinical phase. A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Okay got it. Sensitive to patients who are still in the preclinical phase. A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Sensitive to patients who are still in the preclinical phase. A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: A pre trial is has a target enrollment of about 400 and the preclinical. Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Amyloid cutoff is between 20 and 40% of Lloyds and then again, it's Scott again. Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Julie of titration, and then maintenance now the primary endpoint for the <unk> III trial, Israeli a biomarker endpoint, we havent really communicated. Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Exact timelines. These are very large trials I think he signed Biogen are very pleased with how they are being enrolled and I think we will communicate more there is an opportunity to do an interim analysis. And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Christopher A. Viehbacher: And Colin, just a quick note on slide 28, right, the dots, that does show Q1. We have our wordings as expected mid year, if there's something sort of in the middle of the year. So I get the confusion, because it says half one, half two, but the dots are kind of at the end of the quarter there. So if you were looking at to see if there was a disconnect, there's not, it is they have said, the end of March is what we're looking at here. So Priya, thanks. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: And <unk> has spoken to this but we haven't communicated a timeline yet. And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: And Collyn just just a quick note on slide 28 right. Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: Dots that does show. Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Collyn: Q1, right, we have our wordings as. As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Collyn: As expected mid year, if there is something sort of in the middle of the year. So I guess I get the confusion because it does half one half two but the dots are in effect at the end of the end of the quarter. There. So if you were looking at to see if there was a disconnect. There is not it is that I've said. End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Collyn: End of March is what we're looking at here. So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Priya Singhal: I think there was a latter part of the question, I'll just wrap it up that with regards to FDA, I think I mentioned previously there've been a lot of discussions, Eisai recently mentioned the scheduling of more meeting, another meeting, and so that strategy will be finalized. Looking at the six month data, we are very encouraged with what we saw, we believe that the highest threshold, really the biggest hurdle, was to meet bioequivalence, which we believe we've met. So we will continue to wait for more data, but we're very encouraged with what we've seen so far.

Collyn: So. I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: I think there wasn't a latter part of the question I'll just wrap it up that way.

Speaker Change: With regards to <unk> I think I mentioned previously there's been a lot of discussions <unk> recently mentioned the scheduling of more meeting another meeting and so that strategy will be finalized looking at the six month data. We are very encouraged with what we saw we believe that the highest threshold really the biggest hurdle was to meet bioequivalence, which we believe is. But we will continue to wait for more data, but we're very encouraged with what we've seen so far alright. Thank you.

Speaker Change: But we will continue to wait for more data, but we're very encouraged with what we've seen so far alright. Thank you.

Chuck Triano: Great, thank you, Priya. Let's go to our next questioner.

Operator: We'll go next to Chris Raymond with Piper Sandler.

Chris Raymond: Hey, thanks, I wanted to maybe circle back on the Angelman program, and I wanted to understand a little bit better Priya's commentary around the program. Can you maybe clarify the calculus that goes into deciding to participate in future development. Obviously there's the competitive approach, with Ultragenyx's program. Curious how you're thinking about approvable endpoints. That's obviously been a big question mark, and how you think this product if successful would sort of compare, and any sort of commentary there in terms of the competitive set. Thanks.

Christopher J. Raymond: Clarify that calculus that goes into deciding to participate in future development.

Christopher J. Raymond: And then you know obviously, there's a competitive approach with ultra <unk> program.

Christopher J. Raymond: Curious, how you're thinking about approvable endpoints.

Christopher J. Raymond: That's obviously been a big question Mark and how you think this product if successful would sort of compare and.

Christopher J. Raymond: Any sort of commentary there in terms of the competitive set.

Priya Singhal: Sure. So overall, just to step back, this is a program that Ionis, our partner, is operationalizing, and the way the contractual agreements are written, we have the option of opting in to take the data that we see mid year and decide whether we would like to do a pivotal program--a pivotal study. So that's how it's set up. And then to a step back, I described it briefly in my opening remarks that this is a Phase 1B trial, so this is a Phase I trial that's being conducted in patients. It has a multiple ascending dose component for three months, followed by a long term extension. So we will get data, this is across different age groups and different doses. So we will get a composite of data, and importantly, we'll be looking for trends on EEG, which we know these patients suffer from the delta waves as I spoke to, the slowing, so we'll be looking at that as well as clinical end points, and very specifically there are quite a few clinical endpoints. There's the Bayley score, there is the CGI, and there's the Vineland. We'll be looking at all of them.

Speaker Change: Our partner is Operationalize, Inc, and the way the contractual agreements are written we have the option of opting in to take the data that we see mid deal and decide whether we would like to do pivotal program. A pivotal study. So that's how it's setup and then just a step back I described it briefly.

Speaker Change: In my opening remarks that this is a phase one b trial. So this is a phase one trial, that's being conducted in patients. It has a multiple ascending dose component for three months followed by a long term extension. So we will get data this is across different age groups and different doses.

Speaker Change: So we will get a composite of data and importantly, we will be looking for trends on EG Mitch.

Speaker Change: These patients suffer from the Delta waves as I spoke to the slowing so we'd be looking at that as well as clinical end points and maybe specifically there are quite a few clinical endpoints. There's the bayley score there is the CGI and Theres. The vineland, we'll be looking at all of them.

Stepping out into what do we feel about the competitive landscape, we feel that this, as designed, the program is well positioned just from an ASO perspective, the backbone of the BIIB121 ASO we believe is different. That's one, from the Ultragenyx ASO. Second, we believe that the dosing may be needed at a quarterly level to really see the PKPD impact that we need to make an impact in this disease, and we do have a three-monthly dosing in the LT. So the MAD is two doses have been given one month apart, and then the third dose two months later, and then patients go into a three month dosing. So we feel that we will have a dataset that we can look at and really assess whether we see an adequate signal to really take it into Phase III. And with regards to Roche discontinuing their program, we believe again that this is a different product, and we believe we may have a competitive advantage. Ultimately, of course, we need to see the data.

Speaker Change: As designed the program is well positioned just from an ASO perspective, the backbone of the Big 121, ASO, We believe is different. One from the allergenic. ASO. We believe that the dosing may be needed at a quarterly level to really see the PK PD impact that we need to have and make an impact in this disease and we do have three monthly dosing in the <unk>. So the Mad is two doors has been given one month apart and then Todd dose two months later and then patients. Going to a three month dosing. So we feel that we will have a dataset that we can look at and really assess whether we see an adequate signal to really take it into phase III and with regards to Roche discontinuing their program. We believe again that this is a different. Product and we believe we may have a competitive advantage ultimately of course, we need to we need to see the data.

Speaker Change: One from the allergenic. ASO. We believe that the dosing may be needed at a quarterly level to really see the PK PD impact that we need to have and make an impact in this disease and we do have three monthly dosing in the <unk>. So the Mad is two doors has been given one month apart and then Todd dose two months later and then patients. Going to a three month dosing. So we feel that we will have a dataset that we can look at and really assess whether we see an adequate signal to really take it into phase III and with regards to Roche discontinuing their program. We believe again that this is a different. Product and we believe we may have a competitive advantage ultimately of course, we need to we need to see the data.

Speaker Change: ASO. We believe that the dosing may be needed at a quarterly level to really see the PK PD impact that we need to have and make an impact in this disease and we do have three monthly dosing in the <unk>. So the Mad is two doors has been given one month apart and then Todd dose two months later and then patients. Going to a three month dosing. So we feel that we will have a dataset that we can look at and really assess whether we see an adequate signal to really take it into phase III and with regards to Roche discontinuing their program. We believe again that this is a different. Product and we believe we may have a competitive advantage ultimately of course, we need to we need to see the data.

Speaker Change: We believe that the dosing may be needed at a quarterly level to really see the PK PD impact that we need to have and make an impact in this disease and we do have three monthly dosing in the <unk>. So the Mad is two doors has been given one month apart and then Todd dose two months later and then patients. Going to a three month dosing. So we feel that we will have a dataset that we can look at and really assess whether we see an adequate signal to really take it into phase III and with regards to Roche discontinuing their program. We believe again that this is a different. Product and we believe we may have a competitive advantage ultimately of course, we need to we need to see the data.

Speaker Change: Going to a three month dosing. So we feel that we will have a dataset that we can look at and really assess whether we see an adequate signal to really take it into phase III and with regards to Roche discontinuing their program. We believe again that this is a different. Product and we believe we may have a competitive advantage ultimately of course, we need to we need to see the data.

Speaker Change: Product and we believe we may have a competitive advantage ultimately of course, we need to we need to see the data.

Chuck Triano: Thank you, Priya. Let's move to the next question, please.

Speaker Change: Move to the next question please.

Operator: We will go next to Mohit Bansal with Wells Fargo.

Mohit Bansal: Thank you very much for taking my question. Maybe I can, if you can comment a little bit on the previous comments you made regarding Spinraza return to growth. What is happening in the market right now, and how do you plan to get back to growth on this product.

Mohit Bansal: Maybe I can if you can comment a little bit on the previous comments you made regarding.

Mohit Bansal: It's been rather return to growth.

Mohit Bansal: Happening in the market right now and how do you plan to.

Mohit Bansal: Getting back to growth on this product.

Christopher A. Viehbacher: Sure, so as you know we have an oral therapy out there, we have a gene therapy, and we have Spinraza with the intrathecal. So short term, I think one of the data points that was very important was demonstrating the efficacy of Spinraza following Zolgensma, because there has been some feeling that Zolgensma wanes over time, so we're getting what we call switchbacks. And the other on the oral therapy is that there has sometimes appeared to be that the efficacy is limited to certain body weights. So we can actually go after more adult populations. We believe that only about 30% of patients with SMA are actually treated. Clearly the pediatric patients are screened for and readily identified, but there are a number of adult pop patients where the disease is manifest but it is sometimes difficult to diagnose, and so we're back to the rare disease job of hunting for patients. But we think actually we will be the most appropriate patient--most appropriate treatment for that patient population. So that's one source of growth, and then longer term, as you know we have a high dose Spinraza program in development, which could, if it's successful, lead to just one intrathecal injection per year, and that would make an enormous difference to patients in terms of patient convenience and makes Spinraza even more competitive compared to the others. Now thats still going to take a number of years, but we do expect that still to come to market before the patent on the Spinraza occurs. yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: As you know we have an oral therapy out there we have a gene therapy, and we have spin raza with the intra vehicle.

Speaker Change: So short term.

Speaker Change: I think one of the. Data points. It was very important was demonstrating the efficacy of spin Raza. Following so Jane Smith, because there has been some feeling that so jensen wanes over time, so we're getting what we call switchbacks. And the other on the oral therapy is that there has sometimes appeared to be that the efficacy is limited to certain body weights. So we can actually go after. More adult populations. We believe that only about 30% of patients with SMA are actually treated clearly the pediatric patients are screened for and readily identified but there are a number of adult pop. Patients where the disease is as is manifest but it is sometimes difficult to diagnose and so we're back to the rare disease job of. Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Data points. It was very important was demonstrating the efficacy of spin Raza. Following so Jane Smith, because there has been some feeling that so jensen wanes over time, so we're getting what we call switchbacks. And the other on the oral therapy is that there has sometimes appeared to be that the efficacy is limited to certain body weights. So we can actually go after. More adult populations. We believe that only about 30% of patients with SMA are actually treated clearly the pediatric patients are screened for and readily identified but there are a number of adult pop. Patients where the disease is as is manifest but it is sometimes difficult to diagnose and so we're back to the rare disease job of. Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

And the other on the oral therapy is that there has sometimes appeared to be that the efficacy is limited to certain body weights. So we can actually go after. More adult populations. We believe that only about 30% of patients with SMA are actually treated clearly the pediatric patients are screened for and readily identified but there are a number of adult pop. Patients where the disease is as is manifest but it is sometimes difficult to diagnose and so we're back to the rare disease job of. Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: More adult populations. We believe that only about 30% of patients with SMA are actually treated clearly the pediatric patients are screened for and readily identified but there are a number of adult pop. Patients where the disease is as is manifest but it is sometimes difficult to diagnose and so we're back to the rare disease job of. Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: We believe that only about 30% of patients with SMA are actually treated clearly the pediatric patients are screened for and readily identified but there are a number of adult pop. Patients where the disease is as is manifest but it is sometimes difficult to diagnose and so we're back to the rare disease job of. Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Patients where the disease is as is manifest but it is sometimes difficult to diagnose and so we're back to the rare disease job of. Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Hunting for patients. But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

But we think actually we will be the most appropriate patient. Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Most appropriate treatment for that patient population. So that's one source of growth and then longer term. As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: As you know we have a high dose spin rise a program in development. Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Which could if it's successful. Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Lead to just 1% with FICO injection procure and that would make. An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: An enormous difference to patients in terms of patient convenience and makes us even more competitive. Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Compared to the others now thats still going to take a number of years, but we do expect that still to come to market before the patent on the spin rise occurs yeah, and I'll just quickly add to that that in the. As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Michael McDonnell: Yeah, and I'll just quickly add to that, Mohit, that in the, as we mentioned in our prepared remarks, there tends to be some lumpiness quarter over quarter, particularly outside of the US with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the US, modest decline OUS, and overall moving back toward the modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: As we mentioned in our prepared remarks, there tends to be some. Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Some lumpiness quarter over quarter, particularly outside of the U S with shipments, but overall when you look at the full year of 2023, we actually saw modest growth in the U S modest decline. And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: And overall moving back toward. Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: Towards. The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: The modest growth trajectory that we're hoping for and we are pleased with how that franchise has stabilized over time, yes. There is a dynamic is sort of the oral comes into a market at one point or the gene therapy comes into a market. 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Christopher A. Viehbacher: Yeah, there's a dynamic as sort of as the oral comes into a market at one point, or the gene therapy comes into a market. You know, if you have 100% market share and a competitor comes in, mathematically you're going to lose market share, but what we see is that there is some churn for a year or two, and then the markets settle out, and that's when people start focusing on efficacy and patient populations. And as I say, so far we have been able to maintain leadership in SMA despite the competition, and I think that's where there'll be, there'll be different products for different patients, but there's still enough of a patient population, and even with the switchbacks that we can find reservoirs of growth.

Speaker Change: 100% market share in a competitor comes in mathematically youre going to lose market share, but but what we see is is that. There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: There is some churn for a year or two and then the market settle out and that's when people start focusing on efficacy and patient populations. As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: As I say, so far we have been able to maintain leadership in SMA. Despite the competition and I think thats, where there'll be there'll be different products for different patients, but there's still enough of a patient population. And even with the switchback that we can find the reservoirs of growth.

Speaker Change: And even with the switchback that we can find the reservoirs of growth.

Chuck Triano: Great, thanks, and Operator can we move to our last question, please.

Operator: We will go next to Jay Olson with Oppenheimer.

Jay Olson: Hey, guys. This is Matt on for Jay, thanks ao much for taking our questions and Jay sends his regards. So we were wondering, I guess it's still early of course, but the PPD launch so far, just in terms of any metrics or signals that you see that support your confidence in the launch so far, and of course over the next few months to quarters, what kind of metrics do you believe will become meaningful and that you might plan to share. And maybe just your overall, longer term goals for that PPD launch in your general interest in the psychiatry space would be interesting to hear as well. I really appreciate the question.

Speaker Change: So we were wondering I guess, it's still early of course, but the <unk> launch so far just in terms of any metrics or signals that you see.

Matt: That support your confidence in the launch so far and of course over the next few months or quarters, what kind of metrics do you believe will become meaningful in that you might plan for sure and maybe just your overall longer term goals for that PPD launch in your general interest in the psychiatry space.

Speaker Change: Interesting to hear as well I really appreciate the question.

Christopher A. Viehbacher: Sure, thanks, stunt double. We, so there are a number of things that I think are quite encouraging. One is, our initial target has been high prescribing psychiatrists in this space, as well as OB-GYNs, and one of the things that we were wondering about is, are the OB-GYNs really going to be willing to prescribe, and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them, I think Medicaid, for example, where 40% of births occur, have moved very quickly on that in a number of states. And some of the large, at least one of the large commercial insurers is moving much quicker than we expected as well. So I think the reimbursement is a key statistic. Now personally, I'm interested in knowing how many patients are treatment naive versus people who have been on treatment. What is interesting is, is there a warehousing effect here as well; there's been an awful lot of media coverage. The product was approved in July, we were not able to launch because of the DEA inspection until the very end of 2023. So what we don't know is are we seeing a bolus of patients come in because these are patients physicians have been following for some time who have been identified as being particularly important for to have Zurzuvae. So I think we'll need to see a little bit more data about who are the patients, and where they are coming from, but as I say, so far we're running, for the first month I mean, we're certainly doing much better than what we had anticipated. And we'll give you another update at Q1, we will sit with Sage sometime in March to look at the data and say, what do we see as some of the trends, but so far so good.

Speaker Change: We. Yes. So. There are a number of things that I think are quite encouraging one is. Our initial target has been high prescribing psychiatrists in this space as well as will be <unk> and <unk>. And one of the things that. We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Yes. So. There are a number of things that I think are quite encouraging one is. Our initial target has been high prescribing psychiatrists in this space as well as will be <unk> and <unk>. And one of the things that. We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: So. There are a number of things that I think are quite encouraging one is. Our initial target has been high prescribing psychiatrists in this space as well as will be <unk> and <unk>. And one of the things that. We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: There are a number of things that I think are quite encouraging one is. Our initial target has been high prescribing psychiatrists in this space as well as will be <unk> and <unk>. And one of the things that. We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Our initial target has been high prescribing psychiatrists in this space as well as will be <unk> and <unk>. And one of the things that. We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: And one of the things that. We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: We were wondering about is. It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: It'll be guidance really going to be. Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Willing to prescribe and so one of the encouraging signs is that they in fact are doing so. So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: So we're seeing quite a high percentage of the prescriptions coming from them. Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Another has been I think as I mentioned earlier that payers have really wanted to ensure access to patients. I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: I'm quite thankful to them I think. Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Medicaid for example, where 40% of births occur have moved very quickly on that in a number of states. And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: And some of the large at least one of the large. Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Commercial insurers. <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: <unk> much quicker than we expected as well so I think. The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: The reimbursement is a key statistics now personally I'm interested in knowing how many patients are treatment nave versus people who have been on treatment. No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: No. What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: What is interesting is is there a warehousing effect here as well there's been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: We were not able to launch because of the DEA inspection until the very end of 2023. So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: So while we don't know is are we seeing a bolus of patients come in because. These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: These are patients physicians have been following for some time have been identified as being. Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Particularly. <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: <unk> four to have their survey. So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: So I think we'll need to see a little bit more data about who are the patients and where they are coming from but as I say, so far where we're running. For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: For the first month I mean, we're certainly doing much better than what we had anticipated. We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: We will give you another update at Q1, we will sit with sage. Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: Sometime in March to look at the data and say. What do we see as some of the trends, but so far so good.

Speaker Change: What do we see as some of the trends, but so far so good.

Chuck Triano: Great. Thanks, Chris, and that will conclude our call. I appreciate you all joining us today.

Operator: That concludes today's call. We appreciate your participation. You may now disconnect.

Q4 2023 Biogen Inc Earnings Call

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