Q2 2024 Biogen Inc Earnings Call

August 1, 2024

Good morning. My name is Anna and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen second quarter 2024 earnings call and business update.

Operator: I'd like to welcome everyone to the Biogen second quarter 2024 earnings call and business update. All lines have been placed on mute to prevent any background noise.

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

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

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

Today's conference is being recorded. Thank you. I would now like to turn the conference over to Mr. Chuck Triano, Head of Investor Relations. Mr. Triano, you may begin your conference.

Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time please press star one on your telephone keypad. Please limit yourself to one question to allow other persons 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 call over to Chuck Triano, Head of Investor Relations. Mr. Triano, you may begin your conference.

Chuck Triano: Thank you. Good morning, good afternoon, and welcome to Biogen's second quarter 2024 earnings call.

Charles E. Triano: Good morning, good afternoon, and welcome to Biogen's second quarter 2024 earnings call. During this call, we'll make forward-looking statements that involve risks and uncertainties that may cause actual results to differ materially from those in our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review.

Speaker Change: During this call, we'll make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from those in our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings which I encourage you to review.

Chuck Triano: Our earnings release and other documents related to our results, as well as the reconciliation between GAAP and non-GAAP results discussed on the call, can be found in the Investors section at biogen.com. We have also posted the slides on our website that will be used during this call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; our Head of North America, Alisha Alaimo; Dr. Priya Singhal, Head of Development; Mike McDonnell, Chief Financial Officer; and we'll be introducing Dr. Travis Murdoch from HI-Bio during the call.

Our earnings release and other documents related to our results, as well as the reconciliation between GAAP and non-GAAP results discussed on the call, can be found in the Investors section at biogen.com. We have also posted the slides on our website that will be used during this call.

Speaker Change: Our earnings release and other documents related to our results, as well as the reconciliation between GAAP and non-GAAP results discussed on the call, can be found in the Investors section

Speaker Change: We have also posted the slides on our website that will be used during this call.

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; our Head of North America, Alisha Alaimo; Dr. Priya Singhal, Head of Development; Mike McDonnell, Chief Financial Officer; and we'll be introducing Dr. Travis Murdoch from HI-Bio during the call.

Speaker Change: On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher.

Speaker Change: Our Head and President of North America, Alisha Alaimo, Dr. Priya Singhal, Head of Development, Mike McDonnell, Chief Financial Officer, and we'll be introducing Dr. Travis Murdoch from High Bio on the call.

Chuck Triano: We'll make some opening comments, and then we'll move to the Q&A session, and 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.

Speaker Change: We'll make some opening comments, and then we'll move to the Q&A session. And to allow us to get through as many questions as possible, we ask that you limit yourself to one question.

Christopher A. Viehbacher: Thanks, Chuck. We have a lot to cover this morning, but first, in addition to our regular team of Priya, Alisha, and Mike, I'd like to welcome a new member to our team, Dr. Travis Murdoch. Travis is a physician who trained as a gastroenterologist and then studied immunology as a Rhodes Scholar at Oxford.

Speaker Change: With that, I'll now turn the call over to Chris.

Chris Viehbacher: Thanks Chuck. We've got a lot to cover this morning, but you know, first in addition to our regular team of Priya, Alisha, and Mike, I'd like to welcome a new member to our team, Dr. Travis Murdock.

Speaker Change: Travis is a physician who trained as a gastroenterologist and then studied immunology as a Rhodes Scholar at Oxford. Following a career at McKinsey, Third Rock and SoftBank, he became the founder and CEO of HiBio.

Chris Viehbacher: Following a career at McKinsey, Third Rock, and SoftBank, he became the founder and CEO of HI-Bio. I'm pleased to welcome Travis and the HI-Bio team to Biogen. We now have, again, a presence on the West Coast, and the HI-Bio team, working in collaboration with their Biogen colleagues on the East Coast, will drive forward the development of [inaudible]. So we're announcing really strong quarterly results this morning, but I would say this is really a quarter that has lasted 18 months.

Speaker Change: I'm pleased to welcome Travis and the HiBio team to Biogen. We now have, again, a presence on the West Coast, and the HiBio team, working in collaboration with their Biogen colleagues on the East Coast, will drive forward the development of Felzartumab.

Chris Viehbacher: I think the results we're presenting really reflect the hard work of Team Biogen to transform our company. 18 months ago, we were a company that had been declining for four years in revenue and profit. And we have been working pretty tirelessly for the last 18 months to really turn that around and create a new future for ourselves. At the Q4 earnings in February of 2023, we outlined five priorities. The first one was focused on new launches, second was to reduce our cost base and align resources with growth opportunities, third was to focus our investments on R&D and the most promising assets that improve the risk-reward profile, four was to optimize our existing portfolio, and five was external growth.

I think the results we're presenting really reflect the hard work of Team Biogen to transform our company. 18 months ago, we were a company that had been declining for four years in revenue and profit. And we have been working pretty tirelessly for the last 18 months to really turn that around and create a new future for ourselves.

Speaker Change: I think the results we're presenting really reflect the hard work of Team Biogen to transform our company. Eighteen months ago, we were a company that had been declining for four years in revenue and profit.

Speaker Change: And we have been working pretty tirelessly for the last 18 months to really turn that around and create a new future for ourselves.

At the Q4 earnings in February of 2023, we outlined five priorities. The first one was focused on new launches, second was to reduce our cost base and align resources with growth opportunities, third was to focus our investments on R&D and the most promising assets that improve the risk-reward profile, four was to optimize our existing portfolio, and five was external growth.

Speaker Change: The second was to reduce our cost base and align resources with growth opportunities. Third was to focus our investments in R&D on the most promising assets and improve the risk-reward profile. Four was to optimize our existing portfolio, and five was external growth.

Chris Viehbacher: We've had a few setbacks along the way but nonetheless, I think the results today really show that Biogen has done what is said it would do. And that to me has always been important in business. So if I take each one of those, I think that if we look at our new product launches, all of the launches are either in line or ahead of expectations. I'm particularly happy to see the very strong results for LEQEMBI, not only in the U.S, but there was a very successful launch in Japan. And the early data from China is also extremely promising and Alisha will talk more about that. Last year, we set out to reduce our cost base and we are more than on track on delivering those results. And you can see that, not only in the reduction of OPEX but the very strong improvements in margins, and Mike will talk about that. One of the things that you don't see in the P&L that I'm particularly proud of is although we really reduced our cost base and improved our margins, we have invested massively where we need to for growth opportunities, both in LEQEMBI and the other launches, but also on really trying to turbo charge some of the key assets in R&D and Priya will talk more about that but one of the beneficiaries of that [inaudible] and another one is [inaudible]. We also have, though, although we have seen a declining MS portfolio due to increased competition, particularly from biosimilars and from generics, we still had a number of products where we still had long patent protection and one was SPINRAZA. I think we've seen some very good performance. This is a very competitive space and SPINRAZA has been able to hold its own. I think when I first joined the company, most people were predicting the decline of that. Today, I would say the bumpiness tends to be in some countries where we only ship every now and then. I think in Russia for example, we do one shipment per year so that business has always been a little bit bumpy. But if we look at market share, I think SPINRAZA has done extremely well. And I'm very pleased to see VUMERITY growing at double digits again. Now in the U.S, this is the only patent protected [inaudible] in the oral segment for MS. We see an awful lot of movement in the injectable part but the oral segment has been pretty much constant. It's a great opportunity and I'm glad to see Alisha and her team really taking advantage of that. And then we always said we're going to be open to external growth. And I think the [inaudible] transaction we started last year is where we starting seeing dividends. We're seeing a very strong launch, not only in the U.S but now also in Europe. As you know, we tend to get patients on access programs and then reimbursement follows but we are expecting to be approved in 20 countries by the end of this year. And I think we're extremely happy with that. ZURZUVAE addressed a huge unmet need and that launch is also well in excess of expectations. So as I sit here today, I would say the results that you're seeing are not just the results of what we've done in the second quarter but really we're putting up scores on the scoreboard here that really now are starting to demonstrate all of those initiatives that we put in place last year and we're starting to deliver on them. Now, of course, we're not done yet and I think there's a real opportunity to continue to develop a sustainable growth platform and we'll do that in two ways. The first is really, now that we have prioritized R&D, I see the Alzheimer's portfolio as being a core franchise for us for the coming years. We're obviously continuing to invest heavily in LEQEMBI with the maintenance indication subcutaneous. But also I think the head study, if we can really get the evidence that we can really demonstrate the importance of early treatment, Priya will talk about it but the 36 months data that we showed at AAIC this week are extremely important for the future growth of LEQEMBI. We've always known though that the other modalities and I think [inaudible] is emerging as an important modality for the treatment of Alzheimer's and I think Biogen is a clear leader in that and again, Priya will say more about that. We're also seeing an emerging Lupus portfolio. We'll have a readout later this year with [inaudible] that we share with UCB but we're quite excited about [inaudible] both for SLE as well as cutaneous Lupus. And we add another element to the Lupus portfolio of [inaudible] because that is actually phase one for [inaudible]. And to me, and Travis will go into this more, the acquisition of HI-Bio is extremely important for our longer term growth outlook. This is an opportunity to present a set of opportunities that have a different risk benefit profile. We have very strong phase II results which gives us a whole lot more confidence in phase III results than some of the other assets we have in our portfolio. Neuroscience is an area of very important unmet need but it's also one of the riskiest and hardest areas. And so I think we get a little bit more balance in our portfolio by pursuing things in immunology and so I'm personally extremely excited about [inaudible] and what Travis and his team can do. The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

We've had a few setbacks along the way but nonetheless, I think the results today really show that Biogen has done what is said it would do. And that to me has always been important in business. So if I take each one of those, I think that if we look at our new product launches, all of the launches are either in line or ahead of expectations. I'm particularly happy to see the very strong results for LEQEMBI, not only in the U.S, but there was a very successful launch in Japan. And the early data from China is also extremely promising and Alisha will talk more about that.

Speaker Change: You know, we've had a few setbacks along the way, but nonetheless, I think the results today really show that Biogen has done what it said it would do, and that to me has been always important in business.

Last year, we set out to reduce our cost base and we are more than on track on delivering those results. And you can see that, not only in the reduction of OPEX but the very strong improvements in margins, and Mike will talk about that. One of the things that you don't see in the P&L that I'm particularly proud of is although we really reduced our cost base and improved our margins, we have invested massively where we need to for growth opportunities, both in LEQEMBI and the other launches, but also on really trying to turbo charge some of the key assets in R&D and Priya will talk more about that but one of the beneficiaries of that [inaudible] and another one is LITIFILIMAB. We also have, though, although we have seen a declining MS portfolio due to increased competition, particularly from biosimilars and from generics, we still had a number of products where we still had long patent protection and one was SPINRAZA. I think we've seen some very good performance. This is a very competitive space and SPINRAZA has been able to hold its own. I think when I first joined the company, most people were predicting the decline of that. Today, I would say the bumpiness tends to be in some countries where we only ship every now and then. I think in Russia for example, we do one shipment per year so that business has always been a little bit bumpy. But if we look at market share, I think SPINRAZA has done extremely well. And I'm very pleased to see VUMERITY growing at double digits again. Now in the U.S, this is the only patent protected [inaudible] in the oral segment for MS. We see an awful lot of movement in the injectable part but the oral segment has been pretty much constant. It's a great opportunity and I'm glad to see Alisha and her team really taking advantage of that. And then we always said we're going to be open to external growth. And I think the [inaudible] transaction we started last year is where we starting seeing dividends. We're seeing a very strong launch, not only in the U.S but now also in Europe. As you know, we tend to get patients on access programs and then reimbursement follows but we are expecting to be approved in 20 countries by the end of this year. And I think we're extremely happy with that. ZURZUVAE addressed a huge unmet need and that launch is also well in excess of expectations. So as I sit here today, I would say the results that you're seeing are not just the results of what we've done in the second quarter but really we're putting up scores on the scoreboard here that really now are starting to demonstrate all of those initiatives that we put in place last year and we're starting to deliver on them. Now, of course, we're not done yet and I think there's a real opportunity to continue to develop a sustainable growth platform and we'll do that in two ways. The first is really, now that we have prioritized R&D, I see the Alzheimer's portfolio as being a core franchise for us for the coming years. We're obviously continuing to invest heavily in LEQEMBI with the maintenance indication subcutaneous. But also I think the head study, if we can really get the evidence that we can really demonstrate the importance of early treatment, Priya will talk about it but the 36 months data that we showed at AAIC this week are extremely important for the future growth of LEQEMBI. We've always known though that the other modalities and I think [inaudible] is emerging as an important modality for the treatment of Alzheimer's and I think Biogen is a clear leader in that and again, Priya will say more about that. We're also seeing an emerging Lupus portfolio. We'll have a readout later this year with [inaudible] that we share with UCB but we're quite excited about [inaudible] both for SLE as well as cutaneous Lupus. And we add another element to the Lupus portfolio of [inaudible] because that is actually phase one for [inaudible]. And to me, and Travis will go into this more, the acquisition of HI-Bio is extremely important for our longer term growth outlook. This is an opportunity to present a set of opportunities that have a different risk benefit profile. We have very strong phase II results which gives us a whole lot more confidence in phase III results than some of the other assets we have in our portfolio. Neuroscience is an area of very important unmet need but it's also one of the riskiest and hardest areas. And so I think we get a little bit more balance in our portfolio by pursuing things in immunology and so I'm personally extremely excited about [inaudible] and what Travis and his team can do. The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: You know, one of the things that you don't see in the P&L that I'm particularly proud of is, although we've really reduced our cost base and improved our margins,

Speaker Change: We have invested massively where we need to for growth opportunities, both in Lakembi and the other launches, but also on really trying to turbocharge some of the key assets.

Speaker Change: in R&D and you know Priya will talk more about that but you know one of the beneficiaries of that is BABE 80 and another one is Lidofilamab.

We also have, though, although we have seen a declining MS portfolio due to increased competition, particularly from biosimilars and from generics, we still had a number of products where we still had long patent protection and one was SPINRAZA. I think we've seen some very good performance. This is a very competitive space and SPINRAZA has been able to hold its own. I think when I first joined the company, most people were predicting the decline of that. Today, I would say the bumpiness tends to be in some countries where we only ship every now and then. I think in Russia for example, we do one shipment per year so that business has always been a little bit bumpy. But if we look at market share, I think SPINRAZA has done extremely well.

And I'm very pleased to see VUMERITY growing at double digits again. Now in the U.S, this is the only patent protected [inaudible] in the oral segment for MS. We see an awful lot of movement in the injectable part but the oral segment has been pretty much constant. It's a great opportunity and I'm glad to see Alisha and her team really taking advantage of that. And then we always said we're going to be open to external growth. And I think the Reata transaction we started last year is where we starting seeing dividends. We're seeing a very strong launch, not only in the U.S but now also in Europe. As you know, we tend to get patients on access programs and then reimbursement follows but we are expecting to be approved in 20 countries by the end of this year. And I think we're extremely happy with that. ZURZUVAE addressed a huge unmet need and that launch is also well in excess of expectations. So as I sit here today, I would say the results that you're seeing are not just the results of what we've done in the second quarter but really we're putting up scores on the scoreboard here that really now are starting to demonstrate all of those initiatives that we put in place last year and we're starting to deliver on them. Now, of course, we're not done yet and I think there's a real opportunity to continue to develop a sustainable growth platform and we'll do that in two ways. The first is really, now that we have prioritized R&D, I see the Alzheimer's portfolio as being a core franchise for us for the coming years. We're obviously continuing to invest heavily in LEQEMBI with the maintenance indication subcutaneous. But also I think the head study, if we can really get the evidence that we can really demonstrate the importance of early treatment, Priya will talk about it but the 36 months data that we showed at AAIC this week are extremely important for the future growth of LEQEMBI. We've always known though that the other modalities and I think [inaudible] is emerging as an important modality for the treatment of Alzheimer's and I think Biogen is a clear leader in that and again, Priya will say more about that. We're also seeing an emerging Lupus portfolio. We'll have a readout later this year with [inaudible] that we share with UCB but we're quite excited about [inaudible] both for SLE as well as cutaneous Lupus. And we add another element to the Lupus portfolio of [inaudible] because that is actually phase one for [inaudible]. And to me, and Travis will go into this more, the acquisition of HI-Bio is extremely important for our longer term growth outlook. This is an opportunity to present a set of opportunities that have a different risk benefit profile. We have very strong phase II results which gives us a whole lot more confidence in phase III results than some of the other assets we have in our portfolio. Neuroscience is an area of very important unmet need but it's also one of the riskiest and hardest areas. And so I think we get a little bit more balance in our portfolio by pursuing things in immunology and so I'm personally extremely excited about [inaudible] and what Travis and his team can do. The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: If you look at market share, I think SpinRaz has done extremely well. And I'm very pleased to see Vimerity growing at double digits again now in the U.S. This is the only patent-protected product in the U.S.

Speaker Change: We tend to get patients on access programs and then the reimbursement follows.

ZURZUVAE addressed a huge unmet need and that launch is also well in excess of expectations. So as I sit here today, I would say the results that you're seeing are not just the results of what we've done in the second quarter but really we're putting up scores on the scoreboard here that really now are starting to demonstrate all of those initiatives that we put in place last year and we're starting to deliver on them. Now, of course, we're not done yet and I think there's a real opportunity to continue to develop a sustainable growth platform and we'll do that in two ways. The first is really, now that we have prioritized R&D, I see the Alzheimer's portfolio as being a core franchise for us for the coming years. We're obviously continuing to invest heavily in LEQEMBI with the maintenance indication subcutaneous. But also I think the head study, if we can really get the evidence that we can really demonstrate the importance of early treatment, Priya will talk about it but the 36 months data that we showed at AAIC this week are extremely important for the future growth of LEQEMBI. We've always known though that the other modalities and I think [inaudible] is emerging as an important modality for the treatment of Alzheimer's and I think Biogen is a clear leader in that and again, Priya will say more about that. We're also seeing an emerging Lupus portfolio. We'll have a readout later this year with [inaudible] that we share with UCB but we're quite excited about [inaudible] both for SLE as well as cutaneous Lupus. And we add another element to the Lupus portfolio of [inaudible] because that is actually phase one for [inaudible]. And to me, and Travis will go into this more, the acquisition of HI-Bio is extremely important for our longer term growth outlook. This is an opportunity to present a set of opportunities that have a different risk benefit profile. We have very strong phase II results which gives us a whole lot more confidence in phase III results than some of the other assets we have in our portfolio. Neuroscience is an area of very important unmet need but it's also one of the riskiest and hardest areas. And so I think we get a little bit more balance in our portfolio by pursuing things in immunology and so I'm personally extremely excited about [inaudible] and what Travis and his team can do. The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: that really now are starting to demonstrate all of those initiatives that we put in place last year and we're starting to deliver on them.

Now, of course, we're not done yet and I think there's a real opportunity to continue to develop a sustainable growth platform and we'll do that in two ways. The first is really, now that we have prioritized R&D, I see the Alzheimer's portfolio as being a core franchise for us for the coming years. We're obviously continuing to invest heavily in LEQEMBI with the maintenance indication subcutaneous. But also I think the head study, if we can really get the evidence that we can really demonstrate the importance of early treatment, Priya will talk about it but the 36 months data that we showed at AAIC this week are extremely important for the future growth of LEQEMBI. We've always known though that the other modalities and I think [inaudible] is emerging as an important modality for the treatment of Alzheimer's and I think Biogen is a clear leader in that and again, Priya will say more about that. We're also seeing an emerging Lupus portfolio. We'll have a readout later this year with [inaudible] that we share with UCB but we're quite excited about [inaudible] both for SLE as well as cutaneous Lupus. And we add another element to the Lupus portfolio of [inaudible] because that is actually phase one for [inaudible]. And to me, and Travis will go into this more, the acquisition of HI-Bio is extremely important for our longer term growth outlook. This is an opportunity to present a set of opportunities that have a different risk benefit profile. We have very strong phase II results which gives us a whole lot more confidence in phase III results than some of the other assets we have in our portfolio. Neuroscience is an area of very important unmet need but it's also one of the riskiest and hardest areas. And so I think we get a little bit more balance in our portfolio by pursuing things in immunology and so I'm personally extremely excited about [inaudible] and what Travis and his team can do. The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: Now of course we're not done yet, and I think there's a real opportunity to continue to develop a sustainable growth platform, and we'll do that in two ways. The first is really, now that we have prioritized R&D,

Speaker Change: I see the Alzheimer's portfolio as being a core franchise for us for the coming years.

Speaker Change: We're obviously continuing to invest heavily in Lekembi with the maintenance indication, the subcutaneous, but also I think the AHEAD study, if we can really get the evidence that it will really demonstrate the importance of early treatment.

Speaker Change: Priya will talk about it but you know the the 36-month data that we showed at AAIC this this week are extremely important for the the future growth of Lekembi but you know we've always known there'll be other modalities and I think Tau is emerging as an extremely important modality for the treatment of Alzheimer's.

We're also seeing an emerging Lupus portfolio. We'll have a readout later this year with [inaudible] that we share with UCB but we're quite excited about LITIFILIMAB both for SLE as well as cutaneous Lupus. And we add another element to the Lupus portfolio of [inaudible] because that is actually phase one for [inaudible]. And to me, and Travis will go into this more, the acquisition of HI-Bio is extremely important for our longer term growth outlook. This is an opportunity to present a set of opportunities that have a different risk benefit profile. We have very strong phase II results which gives us a whole lot more confidence in phase III results than some of the other assets we have in our portfolio. Neuroscience is an area of very important unmet need but it's also one of the riskiest and hardest areas. And so I think we get a little bit more balance in our portfolio by pursuing things in immunology and so I'm personally extremely excited about [inaudible] and what Travis and his team can do. The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: We're also seeing an emerging lupus portfolio. We'll have a readout later this year with...

Speaker Change: DiPiriluzumab that we share with UCB but we're quite excited about Lidofilumab both for SLE as well as cutaneous lupus and you know we add another element to the lupus portfolio with with Felza because that is actually in phase one for lupus nephritis.

Speaker Change: opportunities that have a different risk

The other axis to this, we're going to continue to look at this as development. I think you have seen that we're pretty disciplined. I think both of the acquisitions that we've done so far with Reata and HI-Bio will drive an awful lot of shareholder value and that is certainly top of mind as we look at business development. So I think Biogen is in a much different place than we were 18 months ago. We still have a number of challenges like any other company but I think we're really positioned for longer term growth now as a company. And with that, I'd like to turn it over to Alisha to give us a little more color on the successful launches. Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: and what Travis and his team can do.

Speaker Change: The other axis to this is, you know, we're going to continue to look at business development. I think you have seen that we're pretty disciplined. I think that both of the acquisitions that we've done so far with Riata and HiBio,

Speaker Change: will drive an awful lot of shareholder value and that is certainly top of mind.

Alisha Alaimo: Thank you Chris and good morning everyone. Thank you for joining the call today. Today I'll provide our perspective on the progress of LEQEMBI, SKYCLARYS, and ZURZUVAE. So I will begin with the Alzheimer's market. We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Alisha Alaimo: We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients. And in Q2, we saw these promising trends continue. Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing LEQEMBI also grew by 50%. Depth of ordering at our priority 100 IDMs continue to accelerate and the total order volume more than doubled again in Q2 compared to Q1. It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: Thank you, Chris. And good morning, everyone. Thank you for joining the call today. Today, I'll provide our perspective on the progress with Lakembi, Skyclaris, and Zerzube. So I will begin with the Alzheimer's market.

Speaker Change: We believe we're continuing to build momentum with more health systems across the country now having the capability to treat a higher volume of Alzheimer's patients.

Speaker Change: And in Q2, we saw these promising trends continue.

Speaker Change: Notably, we sustained new patient growth. Nearly 40% of all commercial patients on therapy since launch started treatment during Q2. The number of physicians prescribing Lekembe also grew by 50%.

Alisha Alaimo: It's important to know that based on the data we've seen to date, these trends continued into the first week of July, demonstrating that we are sustaining launch progress. We also believe we're seeing positive signals that helps us in capacity may be increasing. For example, last quarter I described how some IDMs are expanding and extending their sites of care. Through Q2, nearly 70% of the activated priority 100 IDM expanded beyond their flagship sites to treat patients at their trial sites. And we have seen this dynamic play out beyond the priority IDMs as well. We believe this growing real world experience with LEQEMBI's efficacy and safety further strengthens its unique profile in a newly competitive market. Specifically, some HDC shared that because LEQEMBI was studied in the broadest and most diverse population of any anti amyloid drug today, it removed some of the complex considerations about which potential patients are appropriate for Alzheimer's treatment. Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: For example, last quarter I described how some IDNs are expanding and extending their sites of care.

Speaker Change: Through Q2, nearly 70% of the activated priority 100 IDNs expanded beyond their flagship sites to treat patients at their child sites. And we have seen this dynamic play out beyond the priority IDNs as well.

Alisha Alaimo: Alzheimer's is a chronic, degenerative, and fatal disease that does not stop even after plaque is removed. In fact, our long term data show that patients who stopped LEQEMBI treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning. Importantly, the rate of decline in most patients who stop therapy were verted to the rate of decline observed in patients who took placebo, which is why we believe patients deserve a therapy with a benefit risk profile that enables them to remain on treatment to stay ahead of disease progression even after removing plaque by preventing ongoing damage and plaque build up. Recent data that Priya will describe reinforces that in patients with three years of continuous treatment LEQEMBI showed continued benefits. And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: We believe this growing real-world experience with Lakembi's efficacy and safety further strengthens its unique profile in a newly competitive market.

Speaker Change: Specifically, some HCPs share that because Lekembe was studied in the broadest and most diverse population of any anti-amyloid drug to date, it removes some of the complex considerations about which potential patients are appropriate for Alzheimer's treatments.

Speaker Change: In fact, our long-term data show that patients who stopped Lakembi treatment experienced rapid reaccumulation of key plasma biomarkers that indicate Alzheimer's disease biology was returning.

Alisha Alaimo: And finally, though there are no head to head studies comparing the available therapies, the FDA has been clear that the incidents and timing of RAS vary among drugs in this class. Observed RAO rates in patients who receive LEQEMBI were the lowest reported among any phase III trial for a drug with traditional FDA approval in the class, with LEQEMBI rates nearly 50% lower. To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: which is why we believe patients deserve a therapy with a benefit-risk profile that enables them to remain on treatment to stay ahead of disease progression, even after removing plaques by preventing ongoing damage and plaque buildup.

Alisha Alaimo: To reinforce LEQEMBI's unique profile with our customers, Biogen deployed our expanded field force just last month. This team increases our focus and frequency, engaging with high value sites and expands our reach to 30% more HPCs. We've been receiving positive feedback since the launch of this team. Biogen's field force is working even more closely with our partner ASI and we believe this is deepening our customer insights and we will enable accelerated growth. We're encouraged by two strong quarters of growth and the sustained progress in July and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease. Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: And finally, though there are no head-to-head studies comparing the available therapies, the FDA has been clear that the incidence and timing of ARIA vary among drugs in this class.

Speaker Change: Observed ARIA rates in patients who receive Lekembe were the lowest reported among any Phase III trial for a drug with traditional FDA approval in the class, with Lekembe rates nearly 50% lower.

Alisha Alaimo: Now moving on to the SKYCLARYS update where we continue our strong launch momentum reaching more [inaudible] patients globally. In the second quarter, we delivered 100 million in revenue globally and remain ahead of our internal expectations. Europe launch is ahead of internal forecast and along with rest of world, builds on the success in the U.S. SKYCLARYS is now available in 12 markets outside the U.S including the E.U where we are initiating new patients in the catch-up population. These patients and their HCPs are highly engaged in their care and often awaiting SKYCLARYS approval as is typical for rare disease launches. In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: We've been receiving positive feedback since the launch of this team.

Speaker Change: Biogen's field force is working even more closely with our partner ASCI and we believe this is deepening our customer insights and we will enable accelerated growth.

Speaker Change: We're encouraged by two strong quarters of growth and the sustained progress in July , and we look forward to providing more support to the healthcare community and people living with Alzheimer's disease.

Alisha Alaimo: In the U.S, we have moved beyond the catch-up population as SKYCLARYS has been in the market for more than a year. The team continues to leverage our strong rare disease capabilities, and we are encouraged by the early results of engaging patients and physicians in this next phase. In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program which analyses hundreds of thousands of deintentified patient journeys. This includes a meaningful share from the community neurologists and CCPs. Globally, our outlook in FA is promising in both the short and long term. We anticipate driving strong growth by making SKYCLARYS available in additional geographies, potential expansion into pediatric populations and with our years of experience identifying patients, we believe we can help. Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: Europe launch is ahead of internal forecasts and along with the rest of the world, builds on the success in the U.S.

Speaker Change: SkyClaris is now available in 12 markets outside the U.S., including the EU, where we are initiating new patients in the catch-up population.

Speaker Change: These patients and their HCPs are highly engaged in their care and often awaiting Skyclaris approval as is typical for rare disease launches.

Alisha Alaimo: Turning to ZURZUVAE, we continue to outperform our expectations in the first six month of launch. We saw strong growth in the second quarter with U.S revenue growing 19% and patient demand nearly doubling versus the first quarter. OBGYNs continue to lead prescribing and patients are sharing positive early experiences with their physicians and on social media platforms. Based on our recent market research, we believe we have achieved higher than average aid of awareness of ZURZUVAE among providers, outperforming messaging recall analogs in the women's health and psychiatry markets. To achieve the next phase of growth and advance our vision to transform the care in post-partum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change. In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: In Q2, roughly one-third of new patient start forms came from new writers tied to our AI program, which analyzes hundreds of thousands of de-identified patient journeys.

Speaker Change: This includes a meaningful share from community neurologists and PCPs.

Speaker Change: Globally, our outlook in FA is promising in both the short and long term.

Speaker Change: We anticipate driving strong growth by making SkyClaris available in additional geographies, potential expansion into pediatric populations, and, with our years of experience identifying patients, we believe we can help.

Speaker Change: Turning to Zerzove, we continue to outperform our expectations in the first six months of launch.

Alisha Alaimo: In conclusion, while each launch is unique, we are pleased that we remain on track or ahead of our expectations across all three therapies. We know we have more work to do to help people living with Alzheimer's [inaudible] and post-partum depression and we are working with urgency to help these patient communities. I will now pass it to Priya. Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Priya Singhal: Thank you Alisha. Over the last year, we have focused heavily on reviewing our existing pipeline with an eye towards improving its risk profile. The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value. We also remain focused on investing to win in Alzheimer's disease where we believe we have a differentiated product in LEQEMBI as well as an industry-leading R&D pipeline of potential next generation therapies. Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: To achieve the next phase of growth and advance our vision to transform the care of postpartum depression, we are working to more deeply understand how to realize the patient opportunity in this market and drive real behavior change.

Priya Singhal: Beginning with LEQEMBI, LEQEMBI is the only approved anti amyloid antibody [inaudible]. First, a dual mechanism of action targeting both amyloid plus and highly toxic protofibers. Second, clinical data across the full early Alzheimer's disease population including individuals with low and no [inaudible] and third, extensive real world evidence. Importantly, as Alisha mentioned, Alzheimer's disease is a chronic progressive disease and we believe the dual action of LEQEMBI and the option for continue treatment is a unique advantage for patients looking to maintain or further clinical relevance.

Speaker Change: We know we have more work to do to help people living with Alzheimer's, Friedrich's ataxia, and postpartum depression, and we are working with urgency to help these patient communities. I will now pass to Priya.

Priya: The focus now is on building the pipeline through a combination of both internal and external opportunities with an eye towards risk diversification and creating value.

Chris Viehbacher: To this point, at AAIC earlier this week, ESAI presented three-year data from the Phase III Clarity Study and its open-label extension, which shows continued clinical benefit with longer-duration LEQEMBI treatment. Shown on the left, this includes data from the early start group or individuals who started LEQEMBI during the 18 month placebo controlled portion of the study, delayed start group, or patients from the placebo arm who switched over to LEQEMBI at the start of the open-label extension, as well as a baseline matched natural history cohort from ADNI. The early start group shows that three years of continuous LEQEMBI treatment reduced clinical decline by a negative 0.95 on CDR-Sumvox as compared to the natural history cohort, resulting in a clinically meaningful benefit for early AD patients. This represents an expansion of the benefit observed at 18 months. It is very important to keep in mind that a change from 0.5 to 1 on the CDR score domain of memory, community affairs, home and hobby is the difference between slight impairment and loss of independence. We believe these results are significant as the majority of individuals, approximately 70% had already successfully cleared plaque by the 18 month timepoint. Furthermore, data from the LECANEMAB phase two study shown on the right, which included a treatment gap of approximately two years on average shows that Alzheimer's disease continues to progress when treatment is stopped or interrupted, even after plaques are removed. Also at AAIC, ESAI presented data which showed that 51% of patients in the Clarity AD Study with either no or low [inaudible] representing an early stage of Alzheimer's showed improvement from baseline cognition and function over the three year period as assessed by [inaudible].

To this point, at AAIC earlier this week, ESAI presented three-year data from the Phase III Clarity Study and its open-label extension, which shows continued clinical benefit with longer-duration LEQEMBI treatment. Shown on the left, this includes data from the early start group or individuals who started LEQEMBI during the 18 month placebo controlled portion of the study, delayed start group, or patients from the placebo arm who switched over to LEQEMBI at the start of the open-label extension, as well as a baseline matched natural history cohort from ADNI. The early start group shows that three years of continuous LEQEMBI treatment reduced clinical decline by a negative 0.95 on CDR-Sumvox as compared to the natural history cohort, resulting in a clinically meaningful benefit for early AD patients. This represents an expansion of the benefit observed at 18 months.

Speaker Change: We also remain focused on investing to win in Alzheimer's disease, where we believe we have a differentiated product in Lekembi, as well as an industry-leading R&D pipeline of potential next-generation therapies.

Speaker Change: Beginning with Lakembi.

Speaker Change: Second, clinical data across the full early Alzheimer's disease population, including individuals with no and low Tau.

It is very important to keep in mind that a change from 0.5 to 1 on the CDR score domain of memory, community affairs, home and hobby is the difference between slight impairment and loss of independence. We believe these results are significant as the majority of individuals, approximately 70% had already successfully cleared plaque by the 18 month timepoint. Furthermore, data from the LECANEMAB phase two study shown on the right, which included a treatment gap of approximately two years on average shows that Alzheimer's disease continues to progress when treatment is stopped or interrupted, even after plaques are removed. Also at AAIC, ESAI presented data which showed that 51% of patients in the Clarity AD Study with either no or low [inaudible] representing an early stage of Alzheimer's showed improvement from baseline cognition and function over the three year period as assessed by [inaudible].

Chris Viehbacher: To this point, at AAIC earlier this week, ESAI presented three-year data from the Phase III Clarity Study and its open-label extension, which shows continued clinical benefit with longer-duration Lekembe treatment, delayed start group, or patients from the placebo arm who switched over to Lekembe at the start of the open-label extension, as well as a baseline matched natural history cohort from ADNI. The early start group shows that three years of continuous Lekembe treatment reduced clinical decline by a negative 0.95 on CDR-Sumvox.

Furthermore, data from the LECANEMAB phase two study shown on the right, which included a treatment gap of approximately two years on average shows that Alzheimer's disease continues to progress when treatment is stopped or interrupted, even after plaques are removed. Also at AAIC, ESAI presented data which showed that 51% of patients in the Clarity AD Study with either no or low [inaudible] representing an early stage of Alzheimer's showed improvement from baseline cognition and function over the three year period as assessed by [inaudible].

Speaker Change: delayed start group or patients from the placebo arm who switched over to Lekembi at the start of the open label extension as well as a baseline matched natural history cohort from ADNI.

Speaker Change: As compared to the natural history cohort, resulting in a clinically meaningful benefit for early AD patients.

Chris Viehbacher: Taken together, these data suggest that earlier initiation of treatment with LECANEMAB may have a significant positive impact on disease progression and may provide continued benefits to patients with early Alzheimer's disease over the long term. We have continued to focus our efforts on LEQEMBI with a goal of characterizing dosing for its long term benefit, providing optionality with subcutaneous formulation, as well as evaluating its role in preclinical AD population as Chris mentioned. Lastly, while we were disappointed to learn that LECANEMAB received a negative opinion from the CHMP, we believe that the clinical data supports a clear, favorable benefit risk profile with a meaningful clinical benefit to patients. Furthermore, thousands of patients have now been treated with LECANEMAB globally providing further real world evidence on the efficacy and manageable safety profile. We are continuing to work with ESAI as they plan to request a reexamination of the EU filing as we work to enable access for people suffering from Alzheimer's globally. We continue to also invest in our broader Alzheimer's pipeline, including our investigational anti [inaudible]. Based on the encouraging data from the phase IB study, we have now implemented a protocol amendment for the ongoing phase II [inaudible] study with the aim of accelerating a potential proof of concept outcome. We're excited that this amendment combined with the robust enrollment trends observed to date may enable a readout in 2026. Beyond amyloid and [inaudible] and under [inaudible] guidance and research, we are advancing a pre-clinical AD pipeline that encompasses diverse targets and modalities including active transport approaches. As communicated today in our earnings release, we decided to exit the ATV [inaudible] collaboration with Denali. We continue to see merits in modalities that can actively transport therapeutic agents into the brain and we continue to prioritize these efforts as we work to build upon our existing leadership in AV. Looking back over the last few months, while we discontinued three mid-stage programs based on read outs, we continued to make progress across several other areas of the pipeline. The first patient has received a dose of SKYCLARYS in Biogen dose 1 signing studies for pediatric [inaudible]. This is the first step in potentially expanding SKYCLARYS access to the pediatric population and once a dose is identified we plan to conduct a phase III study to assess the benefit risk in pediatric patients. We also expect the Devote Study, evaluating high dose SPINRAZA to read out in this second half of the year. We have also made meaningful progress in immunology, where the first patient was dosed in the litifilumab phase III portion of the operationally seamless phase 2, 3 Amethyst Study in CLE following the completion of the phase II enrollment. As Chris mentioned, we continue to view immunology as a significant potential driver of Biogen's future growth and a recent acquisition of HI-Bio is an example of this importance. With that, I would like to hand over the call to Travis who will dive a bit deeper into [inaudible]. Thank you Priya. I'm very excited to be here speaking today as part of the Biogen team. I believe we have a unique opportunity to combine HI-Bio's expertise in immune mediated indications with Biogen's global development and commercial experience in specialized immunity and diseases. I believe the synergies will have significant benefits as we work to accelerate our lead asset [inaudible] into late-stage development. As [inaudible] CD-38 antibody, we believe [inaudible] is differentiated; a molecular design that specifically targets industry's plasma cells responsible for producing pathogenic antibodies. For [inaudible], the broader T cell lineage, this is different from other programs currently in development for antibody mediated diseases that more broadly impact T cells. Compared to other mechanisms, we believe the specificity [inaudible] we allow for it to be differentiated and a more desirable clinical profile characterized by more durable efficacies and improved safety profile. As Chris mentioned, one of Biogen's goal is to optimize the rich reward of the pipeline and I believe the acquisition of [inaudible] significantly advances that effort. Through it's cell depletion approach, [inaudible] has already demonstrated clinical proof of concept across multiple rare immunology indications. Antibody-Mediated Rejection, AMR, IgA nephropathy, IGAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease. And available treatment options lead to significant unmet need. So we see significant potential commercial opportunity here.

Taken together, these data suggest that earlier initiation of treatment with LECANEMAB may have a significant positive impact on disease progression and may provide continued benefits to patients with early Alzheimer's disease over the long term. We have continued to focus our efforts on LEQEMBI with a goal of characterizing dosing for its long term benefit, providing optionality with subcutaneous formulation, as well as evaluating its role in preclinical AD population as Chris mentioned.

Speaker Change: This represents an expansion of the benefit observed at 18 months.

Speaker Change: It is very important to keep in mind that a change from 0.5 to 1 on the CDR score domains of memory, community affairs, home and hobbies is the difference between slight impairment and loss of independence.

Speaker Change: Furthermore, data from the Leucanomab Phase 2 study, shown on the right, which included a treatment gap of approximately two years on average, shows that Alzheimer's disease continues to progress when treatment is stopped or interrupted, even after plaques are removed.

Lastly, while we were disappointed to learn that LECANEMAB received a negative opinion from the CHMP, we believe that the clinical data supports a clear, favorable benefit risk profile with a meaningful clinical benefit to patients. Furthermore, thousands of patients have now been treated with LECANEMAB globally providing further real world evidence on the efficacy and manageable safety profile. We are continuing to work with ESAI as they plan to request a reexamination of the EU filing as we work to enable access for people suffering from Alzheimer's globally. We continue to also invest in our broader Alzheimer's pipeline, including our investigational anti [inaudible]. Based on the encouraging data from the phase IB study, we have now implemented a protocol amendment for the ongoing phase II [inaudible] study with the aim of accelerating a potential proof of concept outcome. We're excited that this amendment combined with the robust enrollment trends observed to date may enable a readout in 2026. Beyond amyloid and [inaudible] and under [inaudible] guidance and research, we are advancing a pre-clinical AD pipeline that encompasses diverse targets and modalities including active transport approaches. As communicated today in our earnings release, we decided to exit the ATV [inaudible] collaboration with Denali. We continue to see merits in modalities that can actively transport therapeutic agents into the brain and we continue to prioritize these efforts as we work to build upon our existing leadership in AV. Looking back over the last few months, while we discontinued three mid-stage programs based on read outs, we continued to make progress across several other areas of the pipeline. The first patient has received a dose of SKYCLARYS in Biogen dose 1 signing studies for pediatric [inaudible]. This is the first step in potentially expanding SKYCLARYS access to the pediatric population and once a dose is identified we plan to conduct a phase III study to assess the benefit risk in pediatric patients. We also expect the Devote Study, evaluating high dose SPINRAZA to read out in this second half of the year. We have also made meaningful progress in immunology, where the first patient was dosed in the litifilumab phase III portion of the operationally seamless phase 2, 3 Amethyst Study in CLE following the completion of the phase II enrollment. As Chris mentioned, we continue to view immunology as a significant potential driver of Biogen's future growth and a recent acquisition of HI-Bio is an example of this importance. With that, I would like to hand over the call to Travis who will dive a bit deeper into [inaudible]. Thank you Priya. I'm very excited to be here speaking today as part of the Biogen team. I believe we have a unique opportunity to combine HI-Bio's expertise in immune mediated indications with Biogen's global development and commercial experience in specialized immunity and diseases. I believe the synergies will have significant benefits as we work to accelerate our lead asset [inaudible] into late-stage development. As [inaudible] CD-38 antibody, we believe [inaudible] is differentiated; a molecular design that specifically targets industry's plasma cells responsible for producing pathogenic antibodies. For [inaudible], the broader T cell lineage, this is different from other programs currently in development for antibody mediated diseases that more broadly impact T cells. Compared to other mechanisms, we believe the specificity [inaudible] we allow for it to be differentiated and a more desirable clinical profile characterized by more durable efficacies and improved safety profile. As Chris mentioned, one of Biogen's goal is to optimize the rich reward of the pipeline and I believe the acquisition of [inaudible] significantly advances that effort. Through it's cell depletion approach, [inaudible] has already demonstrated clinical proof of concept across multiple rare immunology indications. Antibody-Mediated Rejection, AMR, IgA nephropathy, IGAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease. And available treatment options lead to significant unmet need. So we see significant potential commercial opportunity here.

Speaker Change: Esai presented data which showed that 51% of patients

Speaker Change: In the CLARITY-AD study, with either no or low tau, representing an early stage of Alzheimer's, showed improvement from baseline in cognition and function over a three-year period as assessed by CDR sum of boxes.

Speaker Change: We continue to focus our efforts on Lekembe with a goal of characterizing dosing for its long-term benefit, providing optionality with subcutaneous formulation, as well as evaluating its role in preclinical AD population, as Chris mentioned.

Beyond amyloid and [inaudible] and under [inaudible] guidance and research, we are advancing a pre-clinical AD pipeline that encompasses diverse targets and modalities including active transport approaches. As communicated today in our earnings release, we decided to exit the ATV [inaudible] collaboration with Denali. We continue to see merits in modalities that can actively transport therapeutic agents into the brain and we continue to prioritize these efforts as we work to build upon our existing leadership in AV. Looking back over the last few months, while we discontinued three mid-stage programs based on read outs, we continued to make progress across several other areas of the pipeline. The first patient has received a dose of SKYCLARYS in Biogen dose 1 signing studies for pediatric [inaudible]. This is the first step in potentially expanding SKYCLARYS access to the pediatric population and once a dose is identified we plan to conduct a phase III study to assess the benefit risk in pediatric patients. We also expect the Devote Study, evaluating high dose SPINRAZA to read out in this second half of the year. We have also made meaningful progress in immunology, where the first patient was dosed in the litifilumab phase III portion of the operationally seamless phase 2, 3 Amethyst Study in CLE following the completion of the phase II enrollment. As Chris mentioned, we continue to view immunology as a significant potential driver of Biogen's future growth and a recent acquisition of HI-Bio is an example of this importance. With that, I would like to hand over the call to Travis who will dive a bit deeper into [inaudible]. Thank you Priya. I'm very excited to be here speaking today as part of the Biogen team. I believe we have a unique opportunity to combine HI-Bio's expertise in immune mediated indications with Biogen's global development and commercial experience in specialized immunity and diseases. I believe the synergies will have significant benefits as we work to accelerate our lead asset [inaudible] into late-stage development. As [inaudible] CD-38 antibody, we believe [inaudible] is differentiated; a molecular design that specifically targets industry's plasma cells responsible for producing pathogenic antibodies. For [inaudible], the broader T cell lineage, this is different from other programs currently in development for antibody mediated diseases that more broadly impact T cells. Compared to other mechanisms, we believe the specificity [inaudible] we allow for it to be differentiated and a more desirable clinical profile characterized by more durable efficacies and improved safety profile. As Chris mentioned, one of Biogen's goal is to optimize the rich reward of the pipeline and I believe the acquisition of [inaudible] significantly advances that effort. Through it's cell depletion approach, [inaudible] has already demonstrated clinical proof of concept across multiple rare immunology indications. Antibody-Mediated Rejection, AMR, IgA nephropathy, IGAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease. And available treatment options lead to significant unmet need. So we see significant potential commercial opportunity here.

Speaker Change: Furthermore, thousands of patients have now been treated with Leucanomab globally, providing further real-world evidence on the efficacy and manageable safety profile.

Speaker Change: We are continuing to work with ACI as they plan to request a re-examination of the EU filing as we work to enable access for people suffering from Alzheimer's globally.

Speaker Change: We continue to also invest in our broader Alzheimer's pipeline, including our investigational anti-tau ASO BIP-80.

Speaker Change: Based on the encouraging data from the Phase 1B study, we have now implemented a protocol amendment for the ongoing Phase 2 Celia study with the aim of accelerating a potential proof-of-concept outcome.

Looking back over the last few months, while we discontinued three mid-stage programs based on read outs, we continued to make progress across several other areas of the pipeline. The first patient has received a dose of SKYCLARYS in Biogen dose 1 signing studies for pediatric [inaudible]. This is the first step in potentially expanding SKYCLARYS access to the pediatric population and once a dose is identified we plan to conduct a phase III study to assess the benefit risk in pediatric patients. We also expect the Devote Study, evaluating high dose SPINRAZA to read out in this second half of the year. We have also made meaningful progress in immunology, where the first patient was dosed in the litifilumab phase III portion of the operationally seamless phase 2, 3 Amethyst Study in CLE following the completion of the phase II enrollment.

Jane: Beyond amyloid and tau, and under Jane's guidance and research, we are advancing a preclinical AD pipeline that encompasses diverse targets and modalities, including active transport approaches.

Speaker Change: As communicated today in our earnings release, we decided to exit the ATV-ABETA collaboration with Denali.

Speaker Change: Looking back over the last few months, while we discontinued three mid-stage programs based on readouts, we continued to make progress across several other areas of our pipeline.

Speaker Change: The first patient has received a dose of SkyClaris in Biogen's Phase I Dose Finding Study for Pediatric Friedreich's Ataxia.

Speaker Change: This is the first step in potentially expanding SkyClaris access to the pediatric population, and once a dose is identified, we plan to conduct a phase 3 study to assess the benefit risk in pediatric patients.

As Chris mentioned, we continue to view immunology as a significant potential driver of Biogen's future growth and a recent acquisition of HI-Bio is an example of this importance. With that, I would like to hand over the call to Travis who will dive a bit deeper into [inaudible]. Thank you Priya. I'm very excited to be here speaking today as part of the Biogen team. I believe we have a unique opportunity to combine HI-Bio's expertise in immune mediated indications with Biogen's global development and commercial experience in specialized immunity and diseases. I believe the synergies will have significant benefits as we work to accelerate our lead asset [inaudible] into late-stage development. As [inaudible] CD-38 antibody, we believe [inaudible] is differentiated; a molecular design that specifically targets industry's plasma cells responsible for producing pathogenic antibodies. For [inaudible], the broader T cell lineage, this is different from other programs currently in development for antibody mediated diseases that more broadly impact T cells. Compared to other mechanisms, we believe the specificity [inaudible] we allow for it to be differentiated and a more desirable clinical profile characterized by more durable efficacies and improved safety profile. As Chris mentioned, one of Biogen's goal is to optimize the rich reward of the pipeline and I believe the acquisition of [inaudible] significantly advances that effort. Through it's cell depletion approach, [inaudible] has already demonstrated clinical proof of concept across multiple rare immunology indications. Antibody-Mediated Rejection, AMR, IgA nephropathy, IGAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease. And available treatment options lead to significant unmet need. So we see significant potential commercial opportunity here.

Speaker Change: We also expect the DEVOTE study evaluating high-dose Spinraza to read out in this second half of the year.

Travis Murdoch: Thank you Priya. I'm very excited to be here speaking today as part of the Biogen team. I believe we have a unique opportunity to combine HI-Bio's expertise in immune mediated indications with Biogen's global development and commercial experience in specialized immunity and diseases. I believe the synergies will have significant benefits as we work to accelerate our lead asset [inaudible] into late-stage development. As [inaudible] CD-38 antibody, we believe [inaudible] is differentiated; a molecular design that specifically targets industry's plasma cells responsible for producing pathogenic antibodies.

Speaker Change: With that, I would like to hand over the call to Travis, who will dive a bit deeper into Felzartomat.

Travis: Thank you Priya. I'm very excited to be here speaking today as part of the Biogen team.

Travis: I believe we have a unique opportunity to combine HighBio's expertise in immune-mediated indications with Biogen's global development and commercial experience in specialized immunology and reservoirs.

For [inaudible], the broader T cell lineage, this is different from other programs currently in development for antibody mediated diseases that more broadly impact T cells. Compared to other mechanisms, we believe the specificity [inaudible] we allow for it to be differentiated and a more desirable clinical profile characterized by more durable efficacies and improved safety profile.

Travis: I believe this synergy will have significant benefit as we work to accelerate our lead asset, Felpartamab, or Felba, into late-stage development.

Speaker Change: As an anti-CD38 antibody, we believe Selvartamib has a differentiated molecular design that specifically targets and depletes plasma cells responsible for producing pathogenic antibodies.

Speaker Change: While sparing the broader B-cell lineage, this is different from other programs currently in development for antibody-mediated diseases that more broadly impact B-cells.

As Chris mentioned, one of Biogen's goal is to optimize the rich reward of the pipeline and I believe the acquisition of [inaudible] significantly advances that effort. Through it's cell depletion approach, [inaudible] has already demonstrated clinical proof of concept across multiple rare immunology indications. Antibody-Mediated Rejection, AMR, IgA nephropathy, IGAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease. And available treatment options lead to significant unmet need. So we see significant potential commercial opportunity here.

Speaker Change: Compared to other mechanisms, we believe the specificity of Felder's MOA may allow for a differentiated and more desirable clinical profile characterized by more durable efficacy.

Speaker Change: and Improve Safety Profile.

Speaker Change: As Chris mentioned, one of Biogen's goals is to optimize the risk-reward of the pipeline, and I believe the acquisition of SELSA significantly advances that effort.

Chris Viehbacher: Through a cell depletion approach, SALSA has already demonstrated clinical proof of concept across multiple rare immunology indications.

Speaker Change: Antibody-Mediated Rejection, AMR.

Speaker Change: IJ nephropathy, IGAN, and primary membranous nephropathy, or PMN, are serious conditions that lead to severe consequences for patients, such as transplant failure or end-stage kidney disease, and available treatment options leave significant unmet need, and so we see significant potential commercial opportunity here.

Chris Viehbacher: Now I'd like to briefly review the [inaudible] data generated today across these indications to highlight the potential value for patients. AMR is the leading cause of kidney transplant loss in the U.S. With no approved treatments and prior investigational agents have not demonstrated [inaudible] biopsy, the consequences here can be dire ending with graft failure dialysis and a need for re-transplantation. In the phase II study, which we published in the New England Journal of Medicine, nine doses of [inaudible] IV administered over a 5 month period resulted in greater than 80% AMR resolution at age 24 versus 20% for the placebo group. Furthermore, two-thirds of responders maintained AMR resolution out [inaudible] disease. So we believe these results, if replicated in the registrational study, are potentially transformative for this disease. Next, I'd like to discuss IgA nephropathy or IGAN, which is the most prevalent chronic [inaudible] worldwide, which is another indication where we believe [inaudible] has a potential to deliver a treatment option for patients with important differentiation. [inaudible] directly depletes CD-38 positive plasma cells, the producers of both [inaudible] and its auto antibodies, which are believed to be the most upstream causes of IGAN. As shown here on the slide, [inaudible] resulted in durable reductions in IgA, up to 24 months which is more than 18 months after the last dose. Importantly, this pharmacodynamic effect was selected for IgA, with IgG and IgM levels rebounding to baseline after the completion of the five-month [inaudible] treatment. These results paired with the emerging clinical efficacy data suggest that [inaudible] could have a durable selective effect on IgA and thus impact IGAN disease biology while potentially allowing for the maintenance of general protective [inaudible] conferred by IgG and IgM antibodies over a prolonged period. Similar to the effect we saw on IgA, the interim results from the phase II [inaudible] study showed a durable reduction for [inaudible] as measured by PCR. Specifically, we saw that there was a dose dependent reduction in PCR durable out to the 24 month time point. In terms of potential differentiation, it's important to note that this improvement is after more than 18 months of being off therapy, supporting a potential for [inaudible] to be the first non-chronic treatment option in IGAN. Furthermore, in line with the selected targeting of plasma cells, administration of [inaudible] was generally well tolerated with a safety profile consistent with prior studies. We believe these interim results potentially provide for a wide therapeutic window and may ultimately lower the risk of chronic immuno suppression, which could be a significant benefit for IGAN patients. Moving to PMN, this is a severe antibody mediator for kidneys that's a leading cause of nephrotic syndrome, which is a severe syndrome resulting from excretion of too much protein in the urine and which causes symptoms such as swelling, fatigue, and increased risk of infection. Current standard of care, which includes immunosuppressive and chemotherapeutic agents has proven insufficient as up to 40% of patients do not achieve emission and many progress to end stage kidney disease. It's estimated that up to 80% of patients with PMN have autoantibodies against PLA2R, which is a kidney antigen and which provides us with a key biomarker, both for patient stratification as well as treatment response. In the phase II endpoint study which evaluated [inaudible] in the newly diagnosed and relapsed patients, as well as patients' refractory immunosuppressant therapy, a 24-week [inaudible] treatment resulted in rapid, deep and durable reduction in anti-PLA2R antibody in both patient cohorts at the one year timepoint. Many patients retained immunologic complete response more than six months after the last dose of [inaudible] which highlighted the durability of [inaudible] treatment effect. Importantly, the effect on anti-PLA2R was mirrored when examining reduction in [inaudible]. And in line with prior studies of [inaudible], PEAEs were generally mild or moderate in severity. Based on these results, we believe that [inaudible] has the potential to provide a meaningful new treatment for patients suffering with PMN. In summary, we believe the data generated to date highlight the potential for [inaudible] to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet need. Phase II data across AMR, IGANs, and PMN have provided proof of concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability and safety. I'm looking forward now to combining the strength of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our phase III plans. Now we expect to initiate phase III studies across AMR, IGAN, and PMN next year, beginning with AMR in the first half of the year. I'd now like to pass the call over to Mike for a financial update. Thank you Travis and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results and please note that all the comparisons that I will make are versus the second quarter of 2023. Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency. But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency. This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business.

Now I'd like to briefly review the [inaudible] data generated today across these indications to highlight the potential value for patients. AMR is the leading cause of kidney transplant loss in the U.S. With no approved treatments and prior investigational agents have not demonstrated [inaudible] biopsy, the consequences here can be dire ending with graft failure dialysis and a need for re-transplantation. In the phase II study, which we published in the New England Journal of Medicine, nine doses of [inaudible] IV administered over a 5 month period resulted in greater than 80% AMR resolution at age 24 versus 20% for the placebo group. Furthermore, two-thirds of responders maintained AMR resolution out [inaudible] disease. So we believe these results, if replicated in the registrational study, are potentially transformative for this disease.

Speaker Change: Now, I'd like to briefly review the FELTA data generated to date across these indications to highlight the potential value we see for patients.

Speaker Change: AMR is the leading cause of kidney transplant loss in the U.S. with no approved treatments and prior investigational agents have not demonstrated significant resolution of AMR in biopsy.

Speaker Change: The consequences here can be dire, ending with graft failure, dialysis, and a need for retransplantation in many cases.

Speaker Change: In the Phase II study, which we published in the New England Journal of Medicine.

Speaker Change: Nine doses of Delta IV administered over a five-month period resulted in greater than 80% AMR resolution at week 24 versus 20% for the placebo group.

Next, I'd like to discuss IgA nephropathy or IGAN, which is the most prevalent chronic [inaudible] worldwide, which is another indication where we believe [inaudible] has a potential to deliver a treatment option for patients with important differentiation. [inaudible] directly depletes CD-38 positive plasma cells, the producers of both [inaudible] and its auto antibodies, which are believed to be the most upstream causes of IGAN. As shown here on the slide, [inaudible] resulted in durable reductions in IgA, up to 24 months which is more than 18 months after the last dose. Importantly, this pharmacodynamic effect was selected for IgA, with IgG and IgM levels rebounding to baseline after the completion of the five-month [inaudible] treatment. These results paired with the emerging clinical efficacy data suggest that [inaudible] could have a durable selective effect on IgA and thus impact IGAN disease biology while potentially allowing for the maintenance of general protective [inaudible] conferred by IgG and IgM antibodies over a prolonged period. Similar to the effect we saw on IgA, the interim results from the phase II [inaudible] study showed a durable reduction for [inaudible] as measured by PCR. Specifically, we saw that there was a dose dependent reduction in PCR durable out to the 24 month time point. In terms of potential differentiation, it's important to note that this improvement is after more than 18 months of being off therapy, supporting a potential for [inaudible] to be the first non-chronic treatment option in IGAN. Furthermore, in line with the selected targeting of plasma cells, administration of [inaudible] was generally well tolerated with a safety profile consistent with prior studies. We believe these interim results potentially provide for a wide therapeutic window and may ultimately lower the risk of chronic immuno suppression, which could be a significant benefit for IGAN patients. Moving to PMN, this is a severe antibody mediator for kidneys that's a leading cause of nephrotic syndrome, which is a severe syndrome resulting from excretion of too much protein in the urine and which causes symptoms such as swelling, fatigue, and increased risk of infection. Current standard of care, which includes immunosuppressive and chemotherapeutic agents has proven insufficient as up to 40% of patients do not achieve emission and many progress to end stage kidney disease. It's estimated that up to 80% of patients with PMN have autoantibodies against PLA2R, which is a kidney antigen and which provides us with a key biomarker, both for patient stratification as well as treatment response. In the phase II endpoint study which evaluated [inaudible] in the newly diagnosed and relapsed patients, as well as patients' refractory immunosuppressant therapy, a 24-week [inaudible] treatment resulted in rapid, deep and durable reduction in anti-PLA2R antibody in both patient cohorts at the one year timepoint. Many patients retained immunologic complete response more than six months after the last dose of [inaudible] which highlighted the durability of [inaudible] treatment effect. Importantly, the effect on anti-PLA2R was mirrored when examining reduction in [inaudible]. And in line with prior studies of [inaudible], PEAEs were generally mild or moderate in severity. Based on these results, we believe that [inaudible] has the potential to provide a meaningful new treatment for patients suffering with PMN. In summary, we believe the data generated to date highlight the potential for [inaudible] to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet need. Phase II data across AMR, IGANs, and PMN have provided proof of concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability and safety. I'm looking forward now to combining the strength of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our phase III plans. Now we expect to initiate phase III studies across AMR, IGAN, and PMN next year, beginning with AMR in the first half of the year. I'd now like to pass the call over to Mike for a financial update. Thank you Travis and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results and please note that all the comparisons that I will make are versus the second quarter of 2023. Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency. But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency. This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business.

Speaker Change: So we believe these results, if replicated in a registrational study, are potentially transformative for this disease.

Speaker Change: Next, I'd like to discuss IgA nephropathy, or IgAN, which is the most prevalent chronic glomerular disease worldwide, and another indication where we believe Felsa has the potential to deliver a treatment option for patients with important differentiation.

Speaker Change: The producers of both Galactus-deficient IgA1 and its autoantibodies, which are believed to be the most upstream causes of IgAnts.

Speaker Change: Selva treatment resulted in durable reductions in IgA up to 24 months, which is more than 18 months after the last dose.

Similar to the effect we saw on IgA, the interim results from the phase II [inaudible] study showed a durable reduction for [inaudible] as measured by PCR. Specifically, we saw that there was a dose dependent reduction in PCR durable out to the 24 month time point. In terms of potential differentiation, it's important to note that this improvement is after more than 18 months of being off therapy, supporting a potential for [inaudible] to be the first non-chronic treatment option in IGAN. Furthermore, in line with the selected targeting of plasma cells, administration of [inaudible] was generally well tolerated with a safety profile consistent with prior studies. We believe these interim results potentially provide for a wide therapeutic window and may ultimately lower the risk of chronic immuno suppression, which could be a significant benefit for IGAN patients. Moving to PMN, this is a severe antibody mediator for kidneys that's a leading cause of nephrotic syndrome, which is a severe syndrome resulting from excretion of too much protein in the urine and which causes symptoms such as swelling, fatigue, and increased risk of infection. Current standard of care, which includes immunosuppressive and chemotherapeutic agents has proven insufficient as up to 40% of patients do not achieve emission and many progress to end stage kidney disease. It's estimated that up to 80% of patients with PMN have autoantibodies against PLA2R, which is a kidney antigen and which provides us with a key biomarker, both for patient stratification as well as treatment response. In the phase II endpoint study which evaluated [inaudible] in the newly diagnosed and relapsed patients, as well as patients' refractory immunosuppressant therapy, a 24-week [inaudible] treatment resulted in rapid, deep and durable reduction in anti-PLA2R antibody in both patient cohorts at the one year timepoint. Many patients retained immunologic complete response more than six months after the last dose of [inaudible] which highlighted the durability of [inaudible] treatment effect. Importantly, the effect on anti-PLA2R was mirrored when examining reduction in [inaudible]. And in line with prior studies of [inaudible], PEAEs were generally mild or moderate in severity. Based on these results, we believe that [inaudible] has the potential to provide a meaningful new treatment for patients suffering with PMN. In summary, we believe the data generated to date highlight the potential for [inaudible] to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet need. Phase II data across AMR, IGANs, and PMN have provided proof of concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability and safety. I'm looking forward now to combining the strength of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our phase III plans. Now we expect to initiate phase III studies across AMR, IGAN, and PMN next year, beginning with AMR in the first half of the year. I'd now like to pass the call over to Mike for a financial update. Thank you Travis and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results and please note that all the comparisons that I will make are versus the second quarter of 2023. Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency. But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency. This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business.

Speaker Change: While potentially allowing for the maintenance of general protective immunity conferred by IgG and IgM antibodies over a prolonged period of therapy.

Speaker Change: showed a durable reduction in protein area as measured by UPCR.

Speaker Change: Specifically, we saw there was a dose-dependent reduction in EPCR, durable out to the 24-month time point. Now, in terms of potential differentiation, it's important to note that this improvement

Speaker Change: is after more than 18 months of being off therapy, supporting the potential for FELTA to be the first non-chronic treatment option in IgAN.

Speaker Change: Furthermore, in line with the selective targeting of plasma cells, administration of cells was generally well-tolerated with the safety profile consistent with prior studies.

Moving to PMN, this is a severe antibody mediator for kidneys that's a leading cause of nephrotic syndrome, which is a severe syndrome resulting from excretion of too much protein in the urine and which causes symptoms such as swelling, fatigue, and increased risk of infection. Current standard of care, which includes immunosuppressive and chemotherapeutic agents has proven insufficient as up to 40% of patients do not achieve emission and many progress to end stage kidney disease. It's estimated that up to 80% of patients with PMN have autoantibodies against PLA2R, which is a kidney antigen and which provides us with a key biomarker, both for patient stratification as well as treatment response. In the phase II endpoint study which evaluated [inaudible] in the newly diagnosed and relapsed patients, as well as patients' refractory immunosuppressant therapy, a 24-week [inaudible] treatment resulted in rapid, deep and durable reduction in anti-PLA2R antibody in both patient cohorts at the one year timepoint. Many patients retained immunologic complete response more than six months after the last dose of [inaudible] which highlighted the durability of [inaudible] treatment effect. Importantly, the effect on anti-PLA2R was mirrored when examining reduction in [inaudible]. And in line with prior studies of [inaudible], PEAEs were generally mild or moderate in severity. Based on these results, we believe that [inaudible] has the potential to provide a meaningful new treatment for patients suffering with PMN. In summary, we believe the data generated to date highlight the potential for [inaudible] to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet need. Phase II data across AMR, IGANs, and PMN have provided proof of concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability and safety. I'm looking forward now to combining the strength of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our phase III plans. Now we expect to initiate phase III studies across AMR, IGAN, and PMN next year, beginning with AMR in the first half of the year. I'd now like to pass the call over to Mike for a financial update. Thank you Travis and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results and please note that all the comparisons that I will make are versus the second quarter of 2023. Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency. But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency. This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business.

Speaker Change: It's estimated that up to 80% of patients with TMN have autoantibodies against PLA2R, which is a kidney antigen, and which provides us with a key biomarker both for patient stratification as well as treatment response.

Speaker Change: As well as patients for refractory immunosuppressive therapy.

Speaker Change: A 24-week SELTA treatment resulted in rapid, deep, and durable reduction in anti-PLA2R antibodies in both patient cohorts at the one-year time point.

Speaker Change: Based on these results, we believe that SALSA has the potential to provide a meaningful new treatment for patients suffering with PMN.

Phase II data across AMR, IGANs, and PMN have provided proof of concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability and safety. I'm looking forward now to combining the strength of the joint HI-Bio and Biogen team as we work to incorporate these learnings and further refine our phase III plans. Now we expect to initiate phase III studies across AMR, IGAN, and PMN next year, beginning with AMR in the first half of the year. I'd now like to pass the call over to Mike for a financial update.

Speaker Change: In summary,

Speaker Change: We believe the data generated to date highlights the potential for Felsa to be a best-in-class treatment option across multiple serious immunologic diseases with significant unmet need.

Speaker Change: Phase II data across AMR, IGAN, and PMN have provided proof of concept and highlighted a potentially differentiated clinical profile on the basis of efficacy, treatment durability, and safety.

Speaker Change: Now, we expect to initiate Phase III studies across AMR, IGAN, and PMN next year, beginning with AMR in the first half of the year.

Mike Mcdonnell: Thank you Travis and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results and please note that all the comparisons that I will make are versus the second quarter of 2023. Total revenue of $2.5 billion was up marginally versus the prior year at actual currency and grew 1% at constant currency. But importantly, we grew our core pharmaceutical revenue 5% at actual currency and 6% at constant currency. This was driven by the performance of our four recent launches, which more than offset the revenue decline in our MS business.

Speaker Change: I'd now like to pass the call over to Mike for a financial update.

Mike: Thank you, Travis, and good morning, good afternoon to everyone. I'd like to start by acknowledging the entire Biogen team for a strong second quarter. I'm pleased to provide some color on the results, and please note that all the comparisons that I will make are versus the second quarter of 2023.

Chuck Triano: Non-GAAP diluted EPS grew 31% to $5.28 and included a one-time benefit of $0.52 from the sale of one of our two priority review vouchers. Absence of PRV sales, non-GAAP EPS would have grown 18% to $4.76. We also reported a 43% improvement in non-GAAP operating income which was a 30% improvement excluding the PRV sales. We continue to benefit from our R&D prioritization and fit for growth initiatives. I'll provide more detail in a moment. We are pleased to be raising our full-year 2024 guidance range. In just a few moments, I will also provide some additional details on our guidance. Now a bit more color on our revenue for the second quarter. Our MS franchise revenue declined approximately 5% in the quarter and there are a few dynamics in this business that are worth highlighting. First, we continue to see erosion of our interferon business as the entire class is seeing a shift to higher efficacy or oral therapy. Regarding [inaudible] in the EU, we have now seen most generic exit the market, which helped drive ex-US growth of 11% at actual currency and 12% at constant currency to $208 million this quarter. We continue to believe that we are entitled to market protection in the EU until February of 2025. VUMERITY had its best quarter since launch as global revenue grew 13% at actual and constant currency to $166 million. VUMERITY remains the number one brand in the world in terms of share in the United States. U.S TYSABRI revenue of $249 million declined 4% and benefitted from the timing of shipment in the quarter which was offset by a decline through the competition within a high efficacy class. Next, our rare disease franchise produced revenue of $534 million and that represents a growth of 22% at actual currency and 25% at actual currency. SKYCLARYS global revenue was $100 million. Global SPINRAZA revenue of $429 declined 2% at actual currency and was flat at constant currency. U.S revenue was up 1% to $157 million and we remain encouraged by the resilience here. And on LEQEMBI we saw significant sequential growth with second quarter global in market sales booked by ESAI of approximately $40 million, which included $30 million of US in market sales. I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue which was driven by a more favorable product mix. Notably, growth in SKYCLARYS replacing lower margin in contract manufacturing revenue. We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023. As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitably. Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling cost per legacy product and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch cost for LEQEMBI and SKYCLARYS. Now a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we close the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully paid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions. Yes sir. If you would like to ask a question, please press star one on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow up, you may press star one again to rejoin the queue. Your first question comes from the line of Salveen Richter with Goldman Sachs.

Non-GAAP diluted EPS grew 31% to $5.28 and included a one-time benefit of $0.52 from the sale of one of our two priority review vouchers. Absence of PRV sales, non-GAAP EPS would have grown 18% to $4.76. We also reported a 43% improvement in non-GAAP operating income which was a 30% improvement excluding the PRV sales. We continue to benefit from our R&D prioritization and fit for growth initiatives. I'll provide more detail in a moment. We are pleased to be raising our full-year 2024 guidance range. In just a few moments, I will also provide some additional details on our guidance. Now a bit more color on our revenue for the second quarter. Our MS franchise revenue declined approximately 5% in the quarter and there are a few dynamics in this business that are worth highlighting. First, we continue to see erosion of our interferon business as the entire class is seeing a shift to higher efficacy or oral therapy. Regarding [inaudible] in the EU, we have now seen most generic exit the market, which helped drive ex-US growth of 11% at actual currency and 12% at constant currency to $208 million this quarter. We continue to believe that we are entitled to market protection in the EU until February of 2025. VUMERITY had its best quarter since launch as global revenue grew 13% at actual and constant currency to $166 million. VUMERITY remains the number one brand in the world in terms of share in the United States. U.S TYSABRI revenue of $249 million declined 4% and benefitted from the timing of shipment in the quarter which was offset by a decline through the competition within a high efficacy class. Next, our rare disease franchise produced revenue of $534 million and that represents a growth of 22% at actual currency and 25% at actual currency. SKYCLARYS global revenue was $100 million. Global SPINRAZA revenue of $429 declined 2% at actual currency and was flat at constant currency. U.S revenue was up 1% to $157 million and we remain encouraged by the resilience here. And on LEQEMBI we saw significant sequential growth with second quarter global in market sales booked by ESAI of approximately $40 million, which included $30 million of US in market sales. I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue which was driven by a more favorable product mix. Notably, growth in SKYCLARYS replacing lower margin in contract manufacturing revenue. We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023. As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitably. Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling cost per legacy product and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch cost for LEQEMBI and SKYCLARYS. Now a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we close the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully paid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: non-GAAP diluted EPS grew 31% to $5.28 and included a one-time benefit of $0.52 from the sale of one of our two priority review vouchers.

Speaker Change: Absent the PRV sale, non-GAAP EPS would have grown 18% to $4.76.

Speaker Change: We also reported a 43% improvement in non-GAAP operating income, which was a 30% improvement excluding the PRV sale.

Speaker Change: We continue to benefit from our R&D prioritization and Fit for Growth initiatives, where I'll provide more detail in a moment.

Now a bit more color on our revenue for the second quarter. Our MS franchise revenue declined approximately 5% in the quarter and there are a few dynamics in this business that are worth highlighting. First, we continue to see erosion of our interferon business as the entire class is seeing a shift to higher efficacy or oral therapy. Regarding [inaudible] in the EU, we have now seen most generic exit the market, which helped drive ex-US growth of 11% at actual currency and 12% at constant currency to $208 million this quarter. We continue to believe that we are entitled to market protection in the EU until February of 2025. VUMERITY had its best quarter since launch as global revenue grew 13% at actual and constant currency to $166 million. VUMERITY remains the number one brand in the world in terms of share in the United States. U.S TYSABRI revenue of $249 million declined 4% and benefitted from the timing of shipment in the quarter which was offset by a decline through the competition within a high efficacy class. Next, our rare disease franchise produced revenue of $534 million and that represents a growth of 22% at actual currency and 25% at actual currency. SKYCLARYS global revenue was $100 million. Global SPINRAZA revenue of $429 declined 2% at actual currency and was flat at constant currency. U.S revenue was up 1% to $157 million and we remain encouraged by the resilience here. And on LEQEMBI we saw significant sequential growth with second quarter global in market sales booked by ESAI of approximately $40 million, which included $30 million of US in market sales. I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue which was driven by a more favorable product mix. Notably, growth in SKYCLARYS replacing lower margin in contract manufacturing revenue. We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023. As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitably. Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling cost per legacy product and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch cost for LEQEMBI and SKYCLARYS. Now a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we close the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully paid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Regarding [inaudible] in the EU, we have now seen most generic exit the market, which helped drive ex-US growth of 11% at actual currency and 12% at constant currency to $208 million this quarter. We continue to believe that we are entitled to market protection in the EU until February of 2025. VUMERITY had its best quarter since launch as global revenue grew 13% at actual and constant currency to $166 million. VUMERITY remains the number one brand in the world in terms of share in the United States. U.S TYSABRI revenue of $249 million declined 4% and benefitted from the timing of shipment in the quarter which was offset by a decline through the competition within a high efficacy class. Next, our rare disease franchise produced revenue of $534 million and that represents a growth of 22% at actual currency and 25% at actual currency. SKYCLARYS global revenue was $100 million. Global SPINRAZA revenue of $429 declined 2% at actual currency and was flat at constant currency. U.S revenue was up 1% to $157 million and we remain encouraged by the resilience here. And on LEQEMBI we saw significant sequential growth with second quarter global in market sales booked by ESAI of approximately $40 million, which included $30 million of US in market sales. I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue which was driven by a more favorable product mix. Notably, growth in SKYCLARYS replacing lower margin in contract manufacturing revenue. We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023. As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitably. Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling cost per legacy product and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch cost for LEQEMBI and SKYCLARYS. Now a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we close the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully paid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: We continue to believe that we are entitled to market protection in the EU until February of 2025.

Speaker Change: Umerity remains the number one branded oral in terms of share in the United States.

Speaker Change: U.S. Tysabri revenue of $249 million declined 4% and benefited from the timing of shipments in the quarter which was offset by declines due to competition within the high-efficacy class.

Next, our rare disease franchise produced revenue of $534 million and that represents a growth of 22% at actual currency and 25% at actual currency. SKYCLARYS global revenue was $100 million. Global SPINRAZA revenue of $429 declined 2% at actual currency and was flat at constant currency. U.S revenue was up 1% to $157 million and we remain encouraged by the resilience here. And on LEQEMBI we saw significant sequential growth with second quarter global in market sales booked by ESAI of approximately $40 million, which included $30 million of US in market sales.

Speaker Change: Next, our rare disease franchise produced revenue of $534 million, and that represented growth of 22% at actual currency and 25% at constant currency.

Speaker Change: U.S. revenue was up 1% to $157 million, and we remain encouraged by the resilience here.

I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue which was driven by a more favorable product mix. Notably, growth in SKYCLARYS replacing lower margin in contract manufacturing revenue. We also had no idle capacity charges during the quarter versus $34 million in the second quarter of 2023. As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitably. Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling cost per legacy product and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch cost for LEQEMBI and SKYCLARYS. Now a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we close the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully paid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: I'll turn now to a few comments on expenses. We continue to see lower non-GAAP cost of sales as a percentage of revenue, which was driven by a more favorable product mix.

As mentioned previously, our R&D prioritization and fit for growth programs have begun to significantly improve our profitably. Second quarter non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million or 21% as we continue to focus our spend on programs with the highest probability of success. Non-GAAP SG&A expense increased 1% in the second quarter. We have significantly reduced selling cost per legacy product and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch cost for LEQEMBI and SKYCLARYS.

Speaker Change: Second quarter, non-GAAP R&D expense decreased from the second quarter of 2023 by $120 million, or 21%, as we continue to focus our spend on programs with the highest probability of success.

Now a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we close the HI-Bio acquisition. We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully paid the remaining balance of the $1 billion term loan that we put in place at the time of the Reata acquisition. And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024. We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities. Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: We have significantly reduced selling costs for legacy products.

Speaker Change: and also significantly reduced our general and administrative cost base, which has allowed us to absorb most of the approximately $100 million of Q2 2024 incremental launch costs for Lakembi and SkyClaris.

Speaker Change: Now, a brief update on our balance sheet. We ended the second quarter with $1.9 billion of cash and marketable securities. As a reminder, we utilized $1.15 billion of this balance in July when we closed the high bio acquisition.

Speaker Change: We ended the quarter with approximately $4.4 billion of net debt. During the quarter, we fully repaid the remaining balance of the $1 billion term loan that we put in place at the time of the RIATA acquisition.

Speaker Change: And we continued to generate strong cash flow in the second quarter with approximately $592 million of free cash flow, which brings us to approximately $1.1 billion of free cash flow in the first half of 2024.

Turning now to guidance, we're pleased that the operating performance of the business year-to-date supports raising our full-year 2024 non-GAAP diluted EPS guidance from a previous range of $15-$16 to a new range of between $15.75-$16.25. This new range reflects expected growth of approximately 9% at the mid-point of the range compared to the full year of 2023. I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: We continue to believe that our balance sheet has the capacity for us to invest in both internal and external growth opportunities.

Speaker Change: We're pleased that the operating performance of the business year-to-date supports raising our full year 2024 non-GAAP diluted EPS guidance.

I would like to highlight several important things to remember for the second half of 2024 as you update your models. In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full year total revenue to decline by a low single digit percentage when compared to 2023. We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress and provide an offset to some key potential dynamics in the second half of the year. These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entry in the U.S for TYSABRI. And we continue to monitor the timing of shipments for SPINRAZA in certain ex-US markets. Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: from a previous range of $15 to $16 to a new range of between $15.75 to $16.25.

Speaker Change: This new range reflects expected growth of approximately 9% at the midpoint of the range compared to the full year of 2023.

Speaker Change: In terms of revenue, with our key products all performing generally in line or slightly ahead of expectations, there is a slight increase to the previous expectations for the year. We now expect full-year total revenue to decline by a low single-digit percentage when compared to 2023.

Speaker Change: We also expect core pharmaceutical revenue to be roughly flat year over year as recent launches are expected to progress.

Next, the sale of one of our two priority review vouchers is a non-recurring item and since we expect to reinvest the proceeds of this sale and growth initiative later this year, we do not expect this benefit to impact our full year EPS. Also some key points to consider regarding our operating expenses, in the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the LEQEMBI field force which is coming online as well as additional spend for some targeted direct-to-consumer campaigns. In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year. I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: and provide an offset to some key potential dynamics in the second half of the year.

Speaker Change: These include expected continued pressure on our MS franchise, which incorporates the potential for a biosimilar entrant in the U.S. for Tysabri. And we continue to monitor the timing of shipments for Spinraza in certain ex-U.S. markets.

Speaker Change: Next.

Speaker Change: The sale of one of our two priority review vouchers is a non-recurring item, and since we expect to reinvest the proceeds of this sale in growth initiatives later this year, we do not expect this benefit to impact our full-year EPS.

Speaker Change: Also, some key points to consider regarding our operating expenses.

In addition, we expect incremental OPEX primarily on the R&D line of approximately $50 million in the back half of the year related to HI-Bio as we execute plans on three potential phase III starts. We continue to expect full year 2024 combined non-GAAP R&D SG&A expense of approximately $4.3 billion. We reported approximately $2 billion of spend in the first half of the year implying higher spend in the second half of the year due to reasons I just mentioned along with typical phasing of expenses throughout the year.

Speaker Change: In the second half of the year, we expect to continue to ramp launch spending on our new product launches. This will include the 30% increase in the Lakembi Field Force, which is coming online, as well as additional spend for some targeted direct-to-consumer campaigns.

Speaker Change: In addition, we expect incremental OPEX, primarily on the R&D line, of approximately $50 million in the back half of the year related to high bio as we execute plans on three potential Phase III starts.

Speaker Change: We continue to expect full year 2024 combined non-GAAP R&D and SG&A expense of approximately $4.3 billion.

I would also note that we now expect 2024 operating income to grow at a mid to high teens percentage versus the previous guide of a low double digit percent growth. This improvement factors in higher expense in the second half of the year versus the first half of the year partially offset by higher revenue due to our new product launches. I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: We reported approximately $2 billion of spend in the first half of the year, implying higher spend in the second half of the year, due to the reasons I just mentioned, along with some typical phasing of expenses throughout the year.

Speaker Change: I would also note that we now expect 2024 operating income to grow at a mid- to high-teen percentage versus the previous guide of a low double-digit percent growth.

I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024 and this is due to lower cash balances and associated lower interest income resulting from the HI-Bio acquisition. As always, our guidance does not consider the impact from any potential acquisitions or large business development transactions or pending and future litigations as these are often difficult to predict. I would refer you to our press release for other important guidance assumptions. And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: This improvement factors in higher expenses in the second half of the year versus the first half of the year, partially offset by higher revenue due to our new product launches.

Speaker Change: I would remind you that we expect a reduction in interest income of approximately $20 million for the remainder of 2024, and this is due to lower cash balances and associated lower interest income resulting from the high bio acquisition.

And just before we open it up for Q&A, I want to provide a brief update regarding the strategic review of our biosimilars business. After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability. And with that, we will open up the call for questions. Thanks Mike. Operator, please poll for questions.

Speaker Change: And just before we open it up for Q&A, I wanted to provide a brief update regarding the strategic review of our biosimilars business.

Speaker Change: After a comprehensive review of potential externalization options compared to retaining the business, we believe that the best value for shareholders going forward is to retain the business within our portfolio and to optimize the business with an aim to maximize profitability.

Charles E. Triano: Thanks Mike. Operator, please poll for questions.

Operator: Yes sir. If you would like to ask a question, please press star one on your telephone keypad. As a reminder, please limit yourself to one question. If you require any further follow up, you may press star one again to rejoin the queue. Your first question comes from the line of Salveen Richter with Goldman Sachs.

Speaker Change: And with that, we will open up the call for questions. Thanks, Mike. Operator, can we please poll for questions?

Salveen Richter: Good morning. Congratulations on the quarter. At a high level, there's been significant focus on 2024 as a turning point for the company, both product-wise for the launches and operationally, given the cost savings programs and pipeline prioritization. Just given the raised guidance here of 9% year-over-year EPS growth for this year, can you just speak to your confidence around 2023 being the trough year for earnings and what needs to play out from here for clean growth through the end of the decade? Thank you. Yeah, thank you for the question Salveen. Our mission at Biogen remains to bring our self to sustainable growth on both the topline and the bottom line. And obviously, our original guidance which implies a growth of 5% on the bottom line at the midpoint and now 9% at the midpoint shows that we've now turned the corner on the bottom line and we're very focused on our cost savings program which is importantly not only improve our operating performance but also free up capital for growth initiatives so that's really important. Obviously, we don't guide beyond 2024 but I would say when you look at our guidance this year, we're pleased with the fact that we've been able to get our topline much more stabilized and we've got the bottom line growing again. And as we look to next year, we're pleased with the progress of the launches. Our ability to restore the topline is going to be somewhat dependent on how those launches continue to perform along with how the MS franchise continues to sustain and be durable. What I can say is that we're very focused on bringing the company back to growth and we're certainly hopeful that 2023 was the trough year and obviously we're doing a nice job growing the bottom line of 2024 and we'll more to say about the out years as we move to the latter part of this year and into early next. Thanks Mike. Can we take our next question, please operator? Yes, the next question will come from Mohit Bonsal with Wells Fargo. Hi, this is [inaudible] on for Mohit. Thanks for taking our question. I have a question on the EMA decision on LEQEMBI. Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this decision? And what's your confidence that this decision can be reversed? And what should we think about for the timeline for the EMA to reconsider? And would a [inaudible] need to be convened for this process? Thanks. Thank you. This is Priya Singhal. We are very disappointed along with ESAI at the outcome of the negative opinion for LEQEMBI. We continue to believe that a benefit risk is positive and favorable. As you know it's been approved in regions of the world like the US, China, Japan and recently we've also communicated approvals in Hong Kong, Israel, as well as South Korea. So yes, we have communicated perfectly and I can reaffirm that we will be applying for the re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed repertoire and co-repertoire for the process. So right now we would wait to receive the assessment report from the CHMP, the new repertoire and co-repertoire would be appointed and then we would work with them to understand what are the issues that are driving the decision and currently, based on the opinion that was rendered, we believe these are addressable with the data that we generated. Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application. Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Speaker Change: Good morning. Congratulations on the quarter.

Speaker Change: At a high level, there's been significant focus on 2024 as a turning point for the company, both product-wise for the launches and operationally.

Salveen Richter: Yeah, thank you for the question Salveen. Our mission at Biogen remains to bring our self to sustainable growth on both the topline and the bottom line. And obviously, our original guidance which implies a growth of 5% on the bottom line at the midpoint and now 9% at the midpoint shows that we've now turned the corner on the bottom line and we're very focused on our cost savings program which is importantly not only improve our operating performance but also free up capital for growth initiatives so that's really important. Obviously, we don't guide beyond 2024 but I would say when you look at our guidance this year, we're pleased with the fact that we've been able to get our topline much more stabilized and we've got the bottom line growing again. And as we look to next year, we're pleased with the progress of the launches. Our ability to restore the topline is going to be somewhat dependent on how those launches continue to perform along with how the MS franchise continues to sustain and be durable. What I can say is that we're very focused on bringing the company back to growth and we're certainly hopeful that 2023 was the trough year and obviously we're doing a nice job growing the bottom line of 2024 and we'll more to say about the out years as we move to the latter part of this year and into early next. Thanks Mike. Can we take our next question, please operator? Yes, the next question will come from Mohit Bonsal with Wells Fargo. Hi, this is [inaudible] on for Mohit. Thanks for taking our question. I have a question on the EMA decision on LEQEMBI. Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this decision? And what's your confidence that this decision can be reversed? And what should we think about for the timeline for the EMA to reconsider? And would a [inaudible] need to be convened for this process? Thanks. Thank you. This is Priya Singhal. We are very disappointed along with ESAI at the outcome of the negative opinion for LEQEMBI. We continue to believe that a benefit risk is positive and favorable. As you know it's been approved in regions of the world like the US, China, Japan and recently we've also communicated approvals in Hong Kong, Israel, as well as South Korea. So yes, we have communicated perfectly and I can reaffirm that we will be applying for the re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed repertoire and co-repertoire for the process. So right now we would wait to receive the assessment report from the CHMP, the new repertoire and co-repertoire would be appointed and then we would work with them to understand what are the issues that are driving the decision and currently, based on the opinion that was rendered, we believe these are addressable with the data that we generated. Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application. Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Mike Mcdonnell: Yeah, thank you for the question Salveen. Our mission at Biogen remains to bring our self to sustainable growth on both the topline and the bottom line. And obviously, our original guidance which implies a growth of 5% on the bottom line at the midpoint and now 9% at the midpoint shows that we've now turned the corner on the bottom line and we're very focused on our cost savings program which is importantly not only improve our operating performance but also free up capital for growth initiatives so that's really important. Obviously, we don't guide beyond 2024 but I would say when you look at our guidance this year, we're pleased with the fact that we've been able to get our topline much more stabilized and we've got the bottom line growing again. And as we look to next year, we're pleased with the progress of the launches. Our ability to restore the topline is going to be somewhat dependent on how those launches continue to perform along with how the MS franchise continues to sustain and be durable. What I can say is that we're very focused on bringing the company back to growth and we're certainly hopeful that 2023 was the trough year and obviously we're doing a nice job growing the bottom line of 2024 and we'll more to say about the out years as we move to the latter part of this year and into early next. Thanks Mike.

Speaker Change: sustainable growth on both the top line and the bottom line.

Speaker Change: four, but I would say that, you know, when you look at our guidance this year, we're pleased with the fact that we've been able to get our top line somewhat much more stabilized, and we've got the bottom line growing again as we look to next year.

Speaker Change: is going to be somewhat dependent on how those launches continue to perform along with

Salveen Richter: Can we take our next question, please operator? Yes, the next question will come from Mohit Bonsal with Wells Fargo. Hi, this is [inaudible] on for Mohit. Thanks for taking our question. I have a question on the EMA decision on LEQEMBI. Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this decision? And what's your confidence that this decision can be reversed? And what should we think about for the timeline for the EMA to reconsider? And would a [inaudible] need to be convened for this process? Thanks. Thank you. This is Priya Singhal. We are very disappointed along with ESAI at the outcome of the negative opinion for LEQEMBI. We continue to believe that a benefit risk is positive and favorable. As you know it's been approved in regions of the world like the US, China, Japan and recently we've also communicated approvals in Hong Kong, Israel, as well as South Korea. So yes, we have communicated perfectly and I can reaffirm that we will be applying for the re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed repertoire and co-repertoire for the process. So right now we would wait to receive the assessment report from the CHMP, the new repertoire and co-repertoire would be appointed and then we would work with them to understand what are the issues that are driving the decision and currently, based on the opinion that was rendered, we believe these are addressable with the data that we generated. Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application. Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Charles E. Triano: Can we take our next question, please operator?

Speaker Change: Thanks, Mike. Can we take our next question, please, operator?

Salveen Richter: Yes, the next question will come from Mohit Bonsal with Wells Fargo. Hi, this is [inaudible] on for Mohit. Thanks for taking our question. I have a question on the EMA decision on LEQEMBI. Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this decision? And what's your confidence that this decision can be reversed? And what should we think about for the timeline for the EMA to reconsider? And would a [inaudible] need to be convened for this process? Thanks. Thank you. This is Priya Singhal. We are very disappointed along with ESAI at the outcome of the negative opinion for LEQEMBI. We continue to believe that a benefit risk is positive and favorable. As you know it's been approved in regions of the world like the US, China, Japan and recently we've also communicated approvals in Hong Kong, Israel, as well as South Korea. So yes, we have communicated perfectly and I can reaffirm that we will be applying for the re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed repertoire and co-repertoire for the process. So right now we would wait to receive the assessment report from the CHMP, the new repertoire and co-repertoire would be appointed and then we would work with them to understand what are the issues that are driving the decision and currently, based on the opinion that was rendered, we believe these are addressable with the data that we generated. Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application. Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Operator: Yes, the next question will come from Mohit Bonsal with Wells Fargo.

Speaker Change: Yes, the next question will come from Mohit Bansal with Wells Fargo.

Salveen Richter: Hi, this is [inaudible] on for Mohit. Thanks for taking our question. I have a question on the EMA decision on LEQEMBI. Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this decision? And what's your confidence that this decision can be reversed? And what should we think about for the timeline for the EMA to reconsider? And would a [inaudible] need to be convened for this process? Thanks. Thank you. This is Priya Singhal. We are very disappointed along with ESAI at the outcome of the negative opinion for LEQEMBI. We continue to believe that a benefit risk is positive and favorable. As you know it's been approved in regions of the world like the US, China, Japan and recently we've also communicated approvals in Hong Kong, Israel, as well as South Korea. So yes, we have communicated perfectly and I can reaffirm that we will be applying for the re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed repertoire and co-repertoire for the process. So right now we would wait to receive the assessment report from the CHMP, the new repertoire and co-repertoire would be appointed and then we would work with them to understand what are the issues that are driving the decision and currently, based on the opinion that was rendered, we believe these are addressable with the data that we generated. Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application. Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Unknown: Hi, this is [inaudible] on for Mohit. Thanks for taking our question. I have a question on the EMA decision on LEQEMBI. Do you plan to submit additional evidence on efficacy or safety from trials or from real world evidence to reverse this decision? And what's your confidence that this decision can be reversed? And what should we think about for the timeline for the EMA to reconsider? And would a [inaudible] need to be convened for this process? Thanks.

Speaker Change: Do you plan to submit additional evidence on efficacy or safety from trials or from real-world evidence?

Speaker Change: to reverse this decision? And what's your confidence that the decision can be reversed? And what should we think about?

Speaker Change: for timeline for the EMA to reconsider, and would a SAG-N need to be convened for this process? Thanks.

Priya Singhal: Thank you. This is Priya Singhal. We are very disappointed along with ESAI at the outcome of the negative opinion for LEQEMBI. We continue to believe that a benefit risk is positive and favorable. As you know it's been approved in regions of the world like the US, China, Japan and recently we've also communicated approvals in Hong Kong, Israel, as well as South Korea. So yes, we have communicated perfectly and I can reaffirm that we will be applying for the re-examination process. The way the re-examination process works is that you can continue to work with a newly appointed repertoire and co-repertoire for the process. So right now we would wait to receive the assessment report from the CHMP, the new repertoire and co-repertoire would be appointed and then we would work with them to understand what are the issues that are driving the decision and currently, based on the opinion that was rendered, we believe these are addressable with the data that we generated. Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application. Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Speaker Change: Thank you. This is Priya Singhal.

Speaker Change: So right now, we would wait to receive the assessment report from the CHMP. The new rapporteur and co-rapporteur would be appointed. And then we would work with them to understand what are the issues that are driving the decision. And currently, based on the opinion that was rendered, we believe these are addressable with the data that we've generated.

Priya Singhal: Specifically, we have generated long term data as we shared at AAIC and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real world data that we have in the real world because thousands of patients now have been treated so we have long term continued benefit as we showed in the 3-month data, 3-year data at AAIC and also long term safety. So we're continuing to work very closely with ESAI on the re-examination process and strategy. It is possible that a new sag end will be appointed and this process would generally move faster than the original application.

Speaker Change: Specifically, we have generated long-term data, as we shared at AAIC, and we would look to be engaging with the EMA and CHMP to see how we can submit additional data and the extensive real-world data that we have in the real world, because thousands of patients now have been treated, so we have long-term continued benefit, as we showed in the three-year data at AAIC, and also long-term safety.

Priya Singhal: Thank you for the details Priya. Next question please. That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Charles E. Triano: Thank you for the details Priya. Next question please.

Priya Singhal: That'll be from [inaudible] with BMO Capital Markets. Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Operator: That'll be from [inaudible] with BMO Capital Markets.

Evan Seigerman: Hi, there. It's Evan Seigerman. A question for Priya, can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently and what aspects of the program do you now more closely scrutinize when you're thinking about what to do with a partner? Thank you. I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Speaker Change: Yes, that will be from Kevin Seigerman with BMO Capital Markets.

Evan Seigerman: Hi there, it's Evan Seigerman. Question for Priya. Can you walk me through some of the rationale on opting out of the Angelman Syndrome program with Ionis? How has your approach to evaluating partnerships evolved recently, and what aspects of a program do you now more closely scrutinize when you're thinking about what to do with a partner?

Evan Seigerman: I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III. If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S. Alright. Thank you both. Next question, please, operator. Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Priya Singhal: I think just stepping back, I want to point us to comments we've made externally before as well that we really looked at our readouts as important inflection points, which allow us to double down accelerating those programs if the data is objectively clear and compelling. And then the other option would be that we can pivot and pivot to other programs that we may be considering. So overall, our processes that we develop are [inaudible] go, no-go criteria and based on that we decide what the probability of technical and regulatory success is in a particular program. And that is exactly the approach that we applied with the Angelman Syndrome [inaudible] 121 data. That is going to be continuing the way that we look at all our readouts and we try to be very disciplined. I think things that we find very compelling are biomarkers, established regulatory pathways, clinical tractability as well as our confidence in regulatory end points or based on interactions with regulators. So we look at all of these and that's how we think about investments in phase III.

Priya: And that is exactly the approach that we applied.

Speaker Change: and we try to be very disciplined.

Speaker Change: I think things that we find very compelling are biomarkers.

Christopher A. Viehbacher: If I can just add, in addition to what Priya said, we're also looking at the ability to launch products globally and so we also are interested in the level of evidence and regulatory end points as they may be acceptable to payers and regulators around the world, not just in the U.S.

Speaker Change: If I could just add, I think in addition to what Priya said, we're also looking at the ability to launch products globally. And so we also are interested in the level of evidence and regulatory endpoints as they may be acceptable to payers and regulators around the world and not just in the U.S.

Charles E. Triano: Alright. Thank you both. Next question, please, operator.

Speaker Change: Thank you both. Next question please, operator.

Evan Seigerman: Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI. Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Operator: Yes sir. Our next question will come from Michael [inaudible] with Evercore ISI.

Speaker Change: Yes sir, that next question will come from Michael DiFiore with Evercore ISI.

Evan Seigerman: Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for. Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Unknown: Hi guys. Thanks so much for taking my question and congrats on the quarter. So I was wondering if there was any updates on the sub-q induction dose optimization work you're doing and whether this can lead to a more optimal risk benefit ratio that the EMA is looking for.

Michael DiFiore: Hi guys, thanks so much for taking my question and congrats on the quarter. I was wondering if there's any updates on the sub-q induction dose optimization work you're doing and whether this could lead to a more optimal risk-benefit ratio that the EMA is looking for.

Evan Seigerman: Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026. Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Priya Singhal: Yes, so overall, as ESAI and Biogen have communicated, we continue to--we've already filed for the IV maintenance and we have fast tracked and are rolling submission in place for the subcutaneous maintenance dosing. With the initiation of subcutaneous dosing, we are looking at optimizing the dose. We're continuing to work with the FDA on this effort and currently we are on track as we've communicated to have an outcome on this from the FDA in the U.S by Q1, in the calendar year Q1 by 2026.

Priya: Yes.

Speaker Change: So overall, as Esai and Biogen have communicated, we continue to, we've already filed for the IV maintenance and we have a fast track and a rolling submission in place.

Priya: for the subcutaneous maintenance dosing.

Evan Seigerman: with the initiation of subcutaneous dosing.

Evan Seigerman: Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation. Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Priya Singhal: Now with regards to your specific question about how this could impact the application in Europe, I just want to be really clear that the application in Europe that currently we're going to pursue re-examination is dependent on the original application which is rarely for intravenous LEQEMBI. We would hope that we can get a favorable outcome at the end of the re-examination process and if so, we would continue down the path of again providing options to patients as well as in Europe with the subcutaneous formulation.

Priya: which is really for intravenous Lekembe. We would hope that we can get that a favorable outcome at the end of the reexamination process and if so we would continue down the path of again providing options to patients as well as in Europe with subcutaneous formulation.

Evan Seigerman: Thank you Priya. Next question please. Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Charles E. Triano: Thank you Priya. Next question please.

Evan Seigerman: Yes, that'll be from Chris Raymond with Piper Sandler. Oh, thanks. This is Nicole Gabreski on for Chris.

Operator: Yes, that'll be from Chris Raymond with Piper Sandler.

Nicole Gabreski: Oh, thanks. This is Nicole Gabreski on for Chris. Maybe just one on LEQEMBI, so some of the survey work we've done recently with neurologists and Alzheimer's specialists has kind of indicated a less favorable view of the risk-benefit and cost-benefit ratios for LEQEMBI in recent quarters. And I guess we're starting to see some feedback from docs also questioning the amyloid hypothesis as a whole. I guess maybe just given this, could you speak to the interactions and or feedback that reps are having in the field? I guess you are starting to maybe experience any pushback as you move from HBPs who are sort of ready and waiting to prescribe LEQEMBI soon after approval to those who are in the next [inaudible]?

Evan Seigerman: Yes, that'll be from Chris Raymond with Piper Sandler.

Chris Viehbacher: Maybe just one on LEQEMBI, so some of the survey work we've done recently with neurologists and Alzheimer's specialists has kind of indicated a less favorable view of the risk-benefit and cost-benefit ratios for LEQEMBI in recent quarters. And I guess we're starting to see some feedback from docs also questioning the amyloid hypothesis as a whole. I guess maybe just given this, could you speak to the interactions and or feedback that reps are having in the field?

Nicole Dobreski: Oh, thanks. This is Nicole Dobreski on for Chris. Maybe just one on Lakembi. So some of our survey work we've done recently with neurologists and Alzheimer's specialists has kind of indicated maybe a less favorable view of the risk-benefit and cost-benefit ratios for Lakembi in recent quarters.

Chris Viehbacher: I guess you are starting to maybe experience any pushback as you move from HBPs who are sort of ready and waiting to prescribe LEQEMBI soon after approval to those who are in the next [inaudible]? Thank you for the question. This is Alisha. Whenever we look at market research I think it's important to understand who you're asking in the market research. And so when we look at what's happening in the field at least on the ground, when you're asking the physicians if you were to parse out market research and ask the physicians who are currently obviously prescribing and the ones who aren't, the ones who are prescribing are the ones that we've been working really hard on over this past year. They are the ones that understand the data. They've been visited by MSLs, they've been visited by representatives and then it takes them time to obviously get up and running with their facilities. You also then see across the board that other physicians see this happening and some in like a nearer location will also start obviously picking up the product. And so on the ground and with our representatives, they go from office to office. We're obviously expanding now with the additional field force. And what we've seen is the ones that you call on are the ones that actually start writing. And there's a lot of dynamics at play here. I think understanding that data is important, I think understanding all the mechanics in order to get a patient diagnostic is important and having them set up their capacity is important. And so we don't really hear any push back about cost benefit. I can say that. And I think more importantly, what we're hearing now is because we are a year out, we're starting to really get the real world experience feedback from physicians on the impact this is having on patients and the caregivers and the families. And I think that alone has really also accelerated some of these physicians to try and treat patients even more quickly. And so for now, we're not really hearing that push back. And if I could just add to that, after decades of this, I tend to pay more attention to what physicians do versus what they say. And this is a very heavy lift for physicians to introduce this treatment into their practices and institutions. And when you look at the increase of 50% of physicians writing this

I guess you are starting to maybe experience any pushback as you move from HBPs who are sort of ready and waiting to prescribe LEQEMBI soon after approval to those who are in the next [inaudible]?

Alisha Alaimo: Thank you for the question. This is Alisha. Whenever we look at market research I think it's important to understand who you're asking in the market research. And so when we look at what's happening in the field at least on the ground, when you're asking the physicians if you were to parse out market research and ask the physicians who are currently obviously prescribing and the ones who aren't, the ones who are prescribing are the ones that we've been working really hard on over this past year. They are the ones that understand the data. They've been visited by MSLs, they've been visited by representatives and then it takes them time to obviously get up and running with their facilities. You also then see across the board that other physicians see this happening and some in like a nearer location will also start obviously picking up the product. And so on the ground and with our representatives, they go from office to office. We're obviously expanding now with the additional field force. And what we've seen is the ones that you call on are the ones that actually start writing. And there's a lot of dynamics at play here. I think understanding that data is important, I think understanding all the mechanics in order to get a patient diagnostic is important and having them set up their capacity is important. And so we don't really hear any push back about cost benefit. I can say that. And I think more importantly, what we're hearing now is because we are a year out, we're starting to really get the real world experience feedback from physicians on the impact this is having on patients and the caregivers and the families. And I think that alone has really also accelerated some of these physicians to try and treat patients even more quickly. And so for now, we're not really hearing that push back. And if I could just add to that, after decades of this, I tend to pay more attention to what physicians do versus what they say. And this is a very heavy lift for physicians to introduce this treatment into their practices and institutions. And when you look at the increase of 50% of physicians writing this and the depth of ordering from the IDNs, we're seeing a lot of physicians investing huge amounts of time and energy to actually get through all of the processes, schedule the PET scans or lumbar punctures, and MRIs. And to me, you don't do that if you don't have a strong conviction about the importance of this treatment for patients.

Evan Seigerman: Starting to maybe experience any pushback as we move from HBPs who are sort of ready and waiting to prescribe what can be soon after approval to those who are in the next wave of uptake.

Priya: Thank you for the question. This is Alisha. You know, whenever we look at market research, I think it's important to understand the who you're asking.

Alisha Alaimo: You also then see across the board that other physicians see this happening and some in like a nearer location will also start obviously picking up the product. And so on the ground and with our representatives, they go from office to office. We're obviously expanding now with the additional field force. And what we've seen is the ones that you call on are the ones that actually start writing. And there's a lot of dynamics at play here. I think understanding that data is important, I think understanding all the mechanics in order to get a patient diagnostic is important and having them set up their capacity is important. And so we don't really hear any push back about cost benefit. I can say that. And I think more importantly, what we're hearing now is because we are a year out, we're starting to really get the real world experience feedback from physicians on the impact this is having on patients and the caregivers and the families. And I think that alone has really also accelerated some of these physicians to try and treat patients even more quickly. And so for now, we're not really hearing that push back. And if I could just add to that, after decades of this, I tend to pay more attention to what physicians do versus what they say. And this is a very heavy lift for physicians to introduce this treatment into their practices and institutions. And when you look at the increase of 50% of physicians writing this and the depth of ordering from the IDNs, we're seeing a lot of physicians investing huge amounts of time and energy to actually get through all of the processes, schedule the PET scans or lumbar punctures, and MRIs. And to me, you don't do that if you don't have a strong conviction about the importance of this treatment for patients.

Priya: And so on the ground and with our representatives.

Speaker Change: And what we've seen is the ones that you call on are the ones that actually start writing. And there's a lot of dynamics at play here. I think that understanding this data is important. I think understanding all the mechanics in order to get a patient diagnosed is important and having them set up their capacity is important.

Alisha Alaimo: And I think more importantly, what we're hearing now is because we are a year out, we're starting to really get the real world experience feedback from physicians on the impact this is having on patients and the caregivers and the families. And I think that alone has really also accelerated some of these physicians to try and treat patients even more quickly. And so for now, we're not really hearing that push back. And if I could just add to that, after decades of this, I tend to pay more attention to what physicians do versus what they say. And this is a very heavy lift for physicians to introduce this treatment into their practices and institutions. And when you look at the increase of 50% of physicians writing this and the depth of ordering from the IDNs, we're seeing a lot of physicians investing huge amounts of time and energy to actually get through all of the processes, schedule the PET scans or lumbar punctures, and MRIs. And to me, you don't do that if you don't have a strong conviction about the importance of this treatment for patients.

Chris Viehbacher: and the depth of ordering from the IDNs, we're seeing a lot of physicians investing huge amounts of time and energy to actually get through all of the processes, schedule the PET scans or lumbar punctures, and MRIs. And to me, you don't do that if you don't have a strong conviction about the importance of this treatment for patients.

Evan Seigerman: You know, we're seeing a lot of physicians investing huge amounts of time and energy

Priya: And to me, you don't do that if you don't have a strong conviction in the importance of this treatment to patients.

Chris Viehbacher: So personally, as I look at this, I'm extremely encouraged by where we are. I think now, for the first time since the launch, that we can look forward to the growth of this market, not just because of the prescriptions, but I look at the evidence base that we are building with our partners at ESAI on LEQEMBI. It's very clear now from the three-year data that it probably is not going to be enough to just remove the plaque; that the plaque, we'll need to continue to treat patients.

Speaker Change: But I look at the evidence base that we are building with our partners at ASI on the KEMBE. You know, it's very clear now from the three-year data.

Priya: That it probably is not going to be enough to just remove the plaque that the plaque, you know, we need will need to continue to treat patients. And again, as I was saying earlier,

Chris Viehbacher: And again, as I was saying earlier, with the AHEAD study, we hope to show that there is a benefit to treating early. So, this market is going to grow, and the evidence base is going to grow. It is market building that we're doing, and that certainly takes time and patience. But I've said in the past that it's difficult to predict where we're going to go. With this quarter, I think we're seeing we're on a very solid track, and I think the entry of Lilly will only accelerate the development of this market.

Chris Viehbacher: With this quarter, I think we're seeing we're on a very solid track, and I think the entry of Lilly will only accelerate the development of this market.

Chris Viehbacher: Thank you. Let's take our next question, please. Yes, our next question will come from Brian Abraham with RBC Capital Markets. Hi everyone. This is [inaudible] on for Brian here. Congratulations on a good quarter and thank you in advance for taking the questions. I just wanted to ask a little bit more about the SKYCLARYS dynamics that we're seeing, specifically what you're seeing on patient resistance or [inaudible] rates there, some of the educational efforts that you're taking for patients to remain on therapy and that they're not seeing the efficacy of the therapy right away. And maybe if you can speak a little bit more to some of the perception that patients and doctors may have on cardiac [inaudible] and benefits there as well. Thanks. Alright, thank you for the question. This is Alisha. First, we are very pleased with what we're seeing right now, especially globally and in the U.S with SKYCLARYS. And as I mentioned before, we're past the catch-up population. And we're now really into the patient identification phase. We look at every metric from discon, compliance, adherence, start times. And when it comes to discons, we do not see anything outside of what you see in the clinical trials. So the discontinuation rate is not anything more than obviously what we saw in trials. I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients and what to expect from SKYCLARYS. The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product. So you do see that patients tend to stay on product. And physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good. I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week to week and month to month. And we are adding patients every single week. We're also adding them every single month and we acquire new data on a regular basis. And what we're seeing recently and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainly across the board. And I think it's been very promising as we find new patients that come on. Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create. Thanks, Chris. Next question, please. Yes, that'll be from Michael Yee with Jefferies. Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc? Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Charles E. Triano: Thank you. Let's take our next question, please.

Yes, our next question will come from Brian Abraham with RBC Capital Markets. Hi everyone. This is [inaudible] on for Brian here. Congratulations on a good quarter and thank you in advance for taking the questions. I just wanted to ask a little bit more about the SKYCLARYS dynamics that we're seeing, specifically what you're seeing on patient resistance or [inaudible] rates there, some of the educational efforts that you're taking for patients to remain on therapy and that they're not seeing the efficacy of the therapy right away. And maybe if you can speak a little bit more to some of the perception that patients and doctors may have on cardiac [inaudible] and benefits there as well. Thanks. Alright, thank you for the question. This is Alisha. First, we are very pleased with what we're seeing right now, especially globally and in the U.S with SKYCLARYS. And as I mentioned before, we're past the catch-up population. And we're now really into the patient identification phase. We look at every metric from discon, compliance, adherence, start times. And when it comes to discons, we do not see anything outside of what you see in the clinical trials. So the discontinuation rate is not anything more than obviously what we saw in trials. I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients and what to expect from SKYCLARYS. The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product. So you do see that patients tend to stay on product. And physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good. I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week to week and month to month. And we are adding patients every single week. We're also adding them every single month and we acquire new data on a regular basis. And what we're seeing recently and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainly across the board. And I think it's been very promising as we find new patients that come on. Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create. Thanks, Chris. Next question, please. Yes, that'll be from Michael Yee with Jefferies. Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc? Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Operator: Yes, our next question will come from Brian Abraham with RBC Capital Markets.

Hi everyone. This is [inaudible] on for Brian here. Congratulations on a good quarter and thank you in advance for taking the questions. I just wanted to ask a little bit more about the SKYCLARYS dynamics that we're seeing, specifically what you're seeing on patient resistance or [inaudible] rates there, some of the educational efforts that you're taking for patients to remain on therapy and that they're not seeing the efficacy of the therapy right away. And maybe if you can speak a little bit more to some of the perception that patients and doctors may have on cardiac [inaudible] and benefits there as well. Thanks. Alright, thank you for the question. This is Alisha. First, we are very pleased with what we're seeing right now, especially globally and in the U.S with SKYCLARYS. And as I mentioned before, we're past the catch-up population. And we're now really into the patient identification phase. We look at every metric from discon, compliance, adherence, start times. And when it comes to discons, we do not see anything outside of what you see in the clinical trials. So the discontinuation rate is not anything more than obviously what we saw in trials. I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients and what to expect from SKYCLARYS. The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product. So you do see that patients tend to stay on product. And physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good. I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week to week and month to month. And we are adding patients every single week. We're also adding them every single month and we acquire new data on a regular basis. And what we're seeing recently and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainly across the board. And I think it's been very promising as we find new patients that come on. Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create. Thanks, Chris. Next question, please. Yes, that'll be from Michael Yee with Jefferies. Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc? Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Unknown: Hi everyone. This is [inaudible] on for Brian here. Congratulations on a good quarter and thank you in advance for taking the questions. I just wanted to ask a little bit more about the SKYCLARYS dynamics that we're seeing, specifically what you're seeing on patient resistance or [inaudible] rates there, some of the educational efforts that you're taking for patients to remain on therapy and that they're not seeing the efficacy of the therapy right away. And maybe if you can speak a little bit more to some of the perception that patients and doctors may have on cardiac [inaudible] and benefits there as well. Thanks. Alright, thank you for the question. This is Alisha. First, we are very pleased with what we're seeing right now, especially globally and in the U.S with SKYCLARYS. And as I mentioned before, we're past the catch-up population. And we're now really into the patient identification phase. We look at every metric from discon, compliance, adherence, start times. And when it comes to discons, we do not see anything outside of what you see in the clinical trials. So the discontinuation rate is not anything more than obviously what we saw in trials. I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients and what to expect from SKYCLARYS. The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product. So you do see that patients tend to stay on product. And physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good. I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week to week and month to month. And we are adding patients every single week. We're also adding them every single month and we acquire new data on a regular basis. And what we're seeing recently and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainly across the board. And I think it's been very promising as we find new patients that come on. Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Speaker Change: Yes, our next question will come from Brian Abrahams with RBC Capital Markets.

Speaker Change: Hi everyone, this is Nevin for Brian here, congrats on a good quarter and thank you in advance for taking our questions.

Alisha Alaimo: Alright, thank you for the question. This is Alisha. First, we are very pleased with what we're seeing right now, especially globally and in the U.S with SKYCLARYS. And as I mentioned before, we're past the catch-up population. And we're now really into the patient identification phase. We look at every metric from discon, compliance, adherence, start times. And when it comes to discons, we do not see anything outside of what you see in the clinical trials. So the discontinuation rate is not anything more than obviously what we saw in trials. I think when it comes to efficacy of the patients, physicians have been really good on setting expectations with patients and what to expect from SKYCLARYS. The field teams do a really good job of also educating both physicians and educational materials with patients on what to expect when you start this product. So you do see that patients tend to stay on product. And physicians are very good also about saying to patients, at least stay on it for a year and let's talk about how you're feeling and where we're going and what we're seeing as adherence has been actually very good. I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week to week and month to month. And we are adding patients every single week. We're also adding them every single month and we acquire new data on a regular basis. And what we're seeing recently and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainly across the board. And I think it's been very promising as we find new patients that come on. Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Speaker Change: All right, thank you for the question. This is Alisha. First, you know, we are very pleased with what we're seeing right now, especially globally and in the U.S. with SkyClaris, and as I've mentioned before, we're past the catch-up population, and we're now really into the patient identification phase.

Speaker Change: You know, we look at every metric from discon, compliance, adherence, start times.

Priya: And when it comes to discons, you know, we do not see anything outside of what you see in the clinical trials. And so the discontinuation rate is not anything more than obviously what we also saw in trials.

And so, you do see that patients tend to stay on product, and physicians are very good also about saying to patients, you know, at least stay on it for a year and let's talk about, you know, how you're feeling and where we're going and what we're seeing is that adherence has been actually very good.

Alisha Alaimo: I think the other dynamic that's playing out that you could be referring to is because we're now in the patient identification phase, you are going to see a little bit of difference from week to week and month to month. And we are adding patients every single week. We're also adding them every single month and we acquire new data on a regular basis. And what we're seeing recently and I was sharing this with Chris the other day, we have this new AI engine that we've been deploying and we have identified a significant number of coded FA patients that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainly across the board. And I think it's been very promising as we find new patients that come on. Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Priya: I think the other dynamic that's playing out that you could be referring to...

Priya: is because we're now in the patient identification phase, you are gonna see a little bit of difference from week to week and month to month.

Speaker Change: We have this new AI engine that we've been deploying and we have identified significant number of additional coded FA patients.

Priya: that we didn't even have at the beginning of launch because we're starting to see that patients are engaging even more with their physicians. And so now we're able to reach them with more efficiency and with more certainty across the board. And I think it's been very promising as we find new patients to come on.

Priya: Yes, that'll be from Paul Matteis with Stiefel.

Alisha Alaimo: Thanks Alisha. Next question please. Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Charles E. Triano: Thanks Alisha. Next question please.

Alisha Alaimo: Yes, that'll be from Paul [inaudible] with Stifel. Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I thin we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Alisha Alaimo: Yes, that'll be from Paul [inaudible] with Stifel.

Paul Matteis: Great, thanks so much for taking my question. I think over the past year, Biogen's commentary on business development capacity has evolved a couple times. And more recently, I think you said around $10 billion, maybe minus the high bio deal. I guess just kind of going forward in 2024, or the near to midterm, what's Biogen's appetite for bigger transactions or a RIATA-like transaction? And what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you.

Unknown: Great, thanks so much for taking my question. I think over the past year Biogen's commentary on business development capacity has evolved a couple of times and more recently I think you said around 10 billion maybe minus the HI-Bio deal. I guess just kind of going forward in 2024 or near the mid term, what's Biogen's appetite for bigger transactions or Reata like transactions and what's the updated thinking on specific therapeutic areas or types of assets of interest? Thank you. Yeah, I'll take that one. I think first in terms of where we're looking, I think we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Yeah, I'll take that one. You know, I think...

Unknown: Yeah, I'll take that one. I think first in terms of where we're looking, I think we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Christopher A. Viehbacher: Yeah, I'll take that one. I think first in terms of where we're looking, I think we're already long neuroscience so we're probably looking outside of that space--immunology, rare diseases. As I look at Biogen, I would say we have an extremely high scientific and medical capability within the company. We have been historically a company that is in the low volume, high value area. We really understand the necessity to assist patients and physicians for some expensive products to get through reimbursement, provide and sponsor genetic testing for example, thinking about studies and real world evidence becomes extremely important in this. So I think there is a capability of Biogen in rare diseases.

Speaker Change: You know, as I look at Biogen...

Speaker Change: You know, we have been historically a company that is in the low volume, high value area. We really understand

Paul Matteis: The necessity to assist patients and physicians for some expensive products to get through reimbursement.

Paul Matteis: provide and sponsor genetic testing, for example.

Unknown: Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky. I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Christopher A. Viehbacher: Immunology is really an area we've been in since we started with multiple sclerosis. So I think we have the capabilities to go into those areas. I think where we are now is we're on a growth pattern. If we could find another Reata type acquisition I think we would look for that but those come along pretty rarely. It's rare that you can find a company that is that close to the market. In fact, it already launched by the time we actually had acquired that but acquire that for a price that still creates shareholder value. And we will continue to look but they don't come along every day. And we're not in a position where I think we are desperate to do a deal so I think if you look at what we've done with HI-Bio for example, as an alternative to that, being able to launch more products in the sort of 2027-2030 timeframe is a priority for us and that's why we're really also focused on the mid to late stage development process. But we can be picky.

Paul Matteis: Thinking about studies and real-world evidence becomes extremely important in this. So I think there's a capability of Biogen in rare diseases. Immunology is really an area we've been in since we started with multiple sclerosis.

So, I think we have the capabilities to go into those areas.

and we will continue to look, but they don't come along every day.

So the 2027 to 2030 time frame is a priority for us.

Unknown: I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

Christopher A. Viehbacher: I think also where we look is also not necessarily where everybody else is looking. You really don't create value if you're into these auction processes. And so I think by being able to stick to those areas where we think this is a space where Biogen can be a strong payer will avoid over paying. I think the other thing I would say is, Biogen is a nice size. A billion dollars moves the needle hugely in our company. There are a lot of bigger companies where a billion dollars doesn't move the needle. And so I think we can look at assets where we have the capital that might be too small for some of the bigger players but be too expensive for some smaller players.

And that's why we're really also focused on the mid to late stage development process. But, you know, we can be picky. I think also where we look is not necessarily where everybody else is looking. You know, you really don't create value if you enter into these auction processes.

Be a strong player Will avoid overpaying. I think the other thing I would say is The Biogen's a nice size. A billion dollars moves the needle hugely in our company

And so I think we can look at assets where we have the capital.

Christopher A. Viehbacher: So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where again you risk overpaying. But we're looking; we take a systematic view. We're not going to take any sudden left turns strategically just because they're not sure that that's really where the sweet spot is for Biogen, but I do think there are a number of opportunities out there. We also are doing a lot more research on collaborations and I think one of the things I'd like to see us do is really bring a lot more assets in from an earlier stage because the earlier you can acquire these assets the more shareholder value you can create.

but be too expensive for some smaller players. So I think in some ways we're in a position where we can look for assets and not necessarily be in such competitive places where, again, you risk overpaying. But, you know, we're looking. We take a systematic view. You know, we're not going to take any sudden left turns strategically just because I'm not sure that that's really where the sweet spot is for Biogen.

But I do think there's a number of opportunities out there.

We also are doing a lot more in research on collaborations, and I think one of the things I'd like to see us do is really bring a lot more assets in from an early stage, because the earlier you can acquire these assets, the more shareholder value you can create.

Thanks, Chris. Next question, please. Yes, that'll be from Michael Yee with Jefferies. Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc? Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Charles E. Triano: Thanks, Chris. Next question, please.

Yes, that'll be from Michael Yee with Jefferies. Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc? Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Operator: Yes, that'll be from Michael Yee with Jefferies.

Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc? Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Michael J. Yee: Hey guys, thank you. Earlier in the call you commented about an emergent Lupus portfolio and I know that you do have some upcoming Lupus data. We've looked at the prior data, there are reasons to believe that longer treatment and a bigger study could hep here. Can you just speak to your expectations, what you're looking for, what you need to happen to move forward etc, etc, etc?

Priya Singhal: Thank you. Yes, thank you. This is Priya Singhal. So overall, we're excited about the readout for [inaudible]. It is upcoming in the next several weeks. This is a partnered program [inaudible] and the collaboration is in a very good place. We're expecting a headline or topline result of the first global phase III trial. And specifically, I want to be clear that this study is investigating in a very high unmet disease area. The safety and efficacy of [inaudible] as an add on to standard SLE therapy versus placebo as an add on to standard SLE therapy. We are conducting the study in patients who have persistent, active or frequent flaring despite stable standard of care and very similar to the phase one and phase two, we will be looking at efficacy assessed by bilag base composite Lupus assessment of [inaudible] but different than the phase two study. It will take place over the 48 weeks to demonstrate the long term effects. We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this. In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now. Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Priya Singhal: Yes, thank you. This is Priya Singhal. So, overall, we're excited about the readout for DAPI. It is upcoming in the next several weeks. This is a partnered program with UTD. The collaboration is in a very good place.

We are expecting a headline or top-line results of the first global phase 3 trial.

Paul Matteis: We are conducting the study in patients who have persistent active or frequent flaring despite stable standard of care.

Paul Matteis: And very similar to the Phase I and Phase II, we will be looking at efficacy assessed by bilag-based composite lupus assessment, or BCLR. But different than the Phase II study, it will take place over the 48 weeks to demonstrate the long-term effect.

Priya Singhal: We also increased the sample size to provide a substantial data set on safety and efficacy. Eventually and ultimately, we will be looking for a meaningful change on the primary endpoint and key secondary such as severe [inaudible] prevention, patients achieving low dose activity. And we really think that [inaudible] a sensitive clinically meaningful composite for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activities without the need for escalation of steroids and other background medications as well as without worsening. So we're looking forward to this.

Paul Matteis: We also increased the sample size to provide a substantial data set on safety and efficacy.

Paul Matteis: Eventually, and ultimately, we'll be looking for a meaningful change on the primary endpoint and key secondaries, such as severe flare prevention, patients achieving low-dose activity.

Paul Matteis: And we really think that Bickler is a sensitive, clinically meaningful composite.

Paul Matteis: for SLE disease activity that requires disease improvement across all body symptoms with moderate or severe baseline activity without the need for escalation in steroids or other background medications as well as without worsening.

Priya Singhal: In addition to an acceptable safety and tolerability profile, we think this could be really painful for patients suffering from SLE. So if the results warrant continuing development, at this point we expect to have the need to run another phase three but we are planning some of the [inaudible] right now.

Paul Matteis: So we're looking forward to this, you know, in addition to an acceptable safety and tolerability profile, you know, we think this could be really meaningful for patients suffering from SLE.

Priya Singhal: Thanks Priya. Next question, please. Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Charles E. Triano: Thanks Priya. Next question, please.

Operator: Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Paul Matteis: Yes, we'll now move to Eric Schmidt with Cantor Fitzgerald.

Chris Viehbacher: Thanks for taking my question. Maybe for Chris, this call today seems to be like a relative high watermark in your tenure as CEO given some of the initiatives that are now well in place and all that you've accomplished. And you certainly called that out in your prepared remarks. You also called out that you got some challenges and you're not done so what in particular is top of mind there? Thank you. Well thanks for the question. I would hope that's not the high water mark because we're aiming much higher here I can tell you. I think clearly we've still got an MS franchise. We're not done yet in terms of seeing the competitive threats and there's potentially a biosimilar for TYSABRI. We have an important patent litigation that we'll see in the fall for TECFIDERA in Europe and there is a market exclusivity that expires in February. So shorter term, there's always a chop in the water but I think where we have an opportunity is we have an amazing talent base inside of Biogen. As you all know, I've been in this business a long time, seen a lot of companies, and I continue just to be impressed by the scientific and medical capability that we have in the company. And we've got capital, and so I think we can do smart things with that capital. We've been busy transforming essentially passive capital into active capital. We had two priority review vouchers sitting on the shelf.

Eric Thomas Schmidt: Thanks for taking my question. Maybe for Chris, this call today seems to be like a relative high watermark in your tenure as CEO given some of the initiatives that are now well in place and all that you've accomplished. And you certainly called that out in your prepared remarks. You also called out that you got some challenges and you're not done so what in particular is top of mind there? Thank you.

Eric Schmidt: Thanks for taking my question. Maybe for Chris, you know, this call today seems to be like a relative high-water mark in your tenure as CEO , given some of the initiatives that are now well in place and all that you've accomplished.

Speaker Change: And you certainly called that out in your prepared remarks. You also called out that you've got some challenges and you're not done. So, you know, one in particular is top of mind there. Thank you.

Christopher A. Viehbacher: Well thanks for the question. I would hope that's not the high water mark because we're aiming much higher here I can tell you. I think clearly we've still got an MS franchise. We're not done yet in terms of seeing the competitive threats and there's potentially a biosimilar for TYSABRI. We have an important patent litigation that we'll see in the fall for TECFIDERA in Europe and there is a market exclusivity that expires in February. So shorter term, there's always a chop in the water but I think where we have an opportunity is we have an amazing talent base inside of Biogen. As you all know, I've been in this business a long time, seen a lot of companies, and I continue just to be impressed by the scientific and medical capability that we have in the company. And we've got capital, and so I think we can do smart things with that capital. We've been busy transforming essentially passive capital into active capital. We had two priority review vouchers sitting on the shelf.

Chris: Well, thanks for the question. I would hope it's not the high-water mark because we're aiming much higher here, I can tell you. Yeah, you know, I think...

Paul Matteis: You know clearly we've got a still an MS franchise that you know is

Paul Matteis: A biosimilar for Tysabri.

Paul Matteis: We have an important patent litigation that we'll see in the fall for Tecfidera in Europe .

Paul Matteis: and there is the market exclusivity that expires in February . So, you know, shorter term, there's always chop in the water. But, you know, I think where we have an opportunity is...

Chris Viehbacher: And we've got capital, and so I think we can do smart things with that capital. We've been busy transforming, you know, essentially passive capital into active capital. You know, we had two priority review vouchers sitting on the shelf.

Paul Matteis: We have an amazing talent base inside of Biogen, you know, as you all know, I've been in this business a long time, seen a lot of companies. I continue just to be impressed by the scientific and medical capability that we have in the company, and we've got capital.

Paul Matteis: And so I think we can do smart things with that capital. We've been busy.

Paul Matteis: transforming you know essentially passive capital into active capital.

Chris Viehbacher: You know, the innovative nature of Biogen's products is such that, you know, we don't really need those vouchers because of the innovative products we're bringing to market anyway. So we had this one priority review voucher sitting on the shelf for six years that we've now converted, hopefully, into an active asset. We sold it.

The innovative nature of Biogen's products is such that we don't really need those vouchers because of the innovative products we're bringing to market anyway. So we had this one priority review voucher sitting on the shelf for six years that we've now converted, hopefully, into an active asset. We sold it but the objective is to spend that on milestones and business development in the second half. If I look at HI-Bio, we took a year and a half of fit for growth savings out of operating expenses and transformed that into a growth opportunity with the acquisition of HI-Bio. So where I see us is that I think we've been able to change the trajectory of the company. We've been able to release resources from the business and reinvest them intelligently and we've got great people that I think can do that with tremendous results. So I think, as we look toward the future, it's really building out now the R&D portfolio, both internally and externally. I'd like to make sure we are still an innovation company going forward, that we're not just acquiring our future but really investing in that. So I think I'm now focused on the 2025 to 2030 timeframe.

Paul Matteis: You know, we had two priority review vouchers sitting on the shelf.

You know, the innovative nature of Biogen's products is such that, you know, we don't really need those vouchers because of the innovative products we're bringing to market anyway.

Paul Matteis: So we had this one priority review voucher sitting on the shelf for six years that we've now converted hopefully into an active asset. We sold it, but the objective is to spend that.

So we had this one priority review voucher sitting on the shelf for six years that we've now converted, hopefully, into an active asset. We sold it.

Paul Matteis: on milestones in business development in the second half.

Paul Matteis: If I look at HighBio...

Chris Viehbacher: But, you know, the objective is to spend that on milestones and business development in the second half. If I look at Hyde Bio, we took a year and a half of fit for growth savings on out-of-operating expenses and transformed that into a growth opportunity with the acquisition of Hyde Bio. So, you know, where I see us is that I think we've been able to change the trajectory of the company. We've been able to release resources from the business and reinvest them intelligently.

Paul Matteis: We took a year and a half of fit-for-growth savings out of operating expense.

and transform that into a growth opportunity with the acquisition of iBio.

So, you know, where I see us is...

We've been able to release resources from the business and reinvest them intelligently and we've got great people that I think can do that with tremendous results.

Chris Viehbacher: and we've got great people that I think can do that with tremendous results. So I think, as we look toward the future, it's really building out now the R&D portfolio, both internally and externally. I'd like to make sure we are still an innovation company going forward, that we're not just acquiring our future but really investing in that. So I think I'm now focused on the 2025 to 2030 timeframe.

So I think as we look towards the future, it's really building out now the R&D portfolio both internally and externally.

So I think, as we look toward the future, it's really building out now the R&D portfolio, both internally and externally. I'd like to make sure we are still an innovation company going forward, that we're not just acquiring our future but really investing in that. So I think I'm now focused on the 2025 to 2030 timeframe.

Paul Matteis: I'd like to make sure we are still an innovation company going forward, that we're not just acquiring our future.

But really investing in that.

Paul Matteis: So I think I'm now focused on the 2025 to 2030 time frame.

Paul Matteis: I think we're in good shape to grow through that period, but I think we can do more to really take advantage of the capability in R&D. And I think you'll see us continue to deploy capital with a lot of discipline, but I think be able to turn passive capital into active capital and then into active growth.

Chris Viehbacher: I think we're in good shape to grow through that period, but I think we can do more to really take advantage of the capabilities and R&D. And I think you'll see us continue to deploy capital with a lot of discipline, but I think we will be able to turn passive capital into active capital and then into active growth. Alright, thank you Chris. Thank you everybody for joining us today. The IR team will remain available for any additional questions. Thank you. Once again [inaudible] conference. We thank you all for your participation. You may now disconnect.

I think we're in good shape to grow through that period, but I think we can do more to really take advantage of the capabilities and R&D. And I think you'll see us continue to deploy capital with a lot of discipline, but I think we will be able to turn passive capital into active capital and then into active growth.

Alright, thank you Chris. Thank you everybody for joining us today. The IR team will remain available for any additional questions. Thank you. Once again [inaudible] conference. We thank you all for your participation. You may now disconnect.

Charles E. Triano: Alright, thank you Chris. Thank you everybody for joining us today. The IR team will remain available for any additional questions.

Operator: Thank you. Once again [inaudible] conference. We thank you all for your participation. You may now disconnect.

Paul Matteis: Thank you Chris and thank you everybody for joining us today. Our team will remain available for any additional questions. Thank you.

And once again that does conclude today's conference. We thank you all for your participation. You may now disconnect.

Q2 2024 Biogen Inc Earnings Call

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