Good morning. My name is Cynthia and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2025 Earnings Call and Business Update. Today's conference is being recorded. I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

Thanks, Cynthia and good morning, everyone. Welcome to Biogen's Second Quarter 2025 Earnings Call. During this call, we will make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results, as well as reconciliations between GAAP and non-GAAP results discussed on this call, can be found on the Investors section of biogen.com. We've also posted the slides to our website that we'll use during the call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; Alisha Alaimo, President of North America; and Robin Kramer, our Chief Financial Officer. We'll make some opening comments and then move to Q&A and to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question. I'll now turn the call over to Chris.

Thank you, Tim. Good morning, everybody. We're very pleased with the performance in the second quarter. In particular, we've seen growth from our new product launches offsetting our MS decline. MS has also proven to be a little bit more resilient this quarter. There was some gross to net adjustment. But I would like to call out the performance of VUMERITY. I think Alisha and her team in the U.S., in particular, have put a lot of emphasis on VUMERITY over the last two years and we've been seeing some nice growth. This is a product where we still have a lot of market exclusivity into the future. As we look at the growth products, I think we're also seeing continued consistent growth with LEQEMBI. We've got a number of enablers coming along that hopefully will remove some of the bottlenecks in the system. Those are things like the blood-based biomarkers. The first one has now been approved, but there are now multiple biomarker tests out there. We have a PDUFA date for our subcutaneous formulation for maintenance coming at the end of August. I think those are all things that are starting to generate some potential shift in momentum in LEQEMBI but Alisha will talk about that more. I'd say, we are feeling pretty encouraged by what we're seeing there. SKYCLARYS is now available in 29 markets. We probably have as many, if not more patients outside the U.S. as inside the U.S. It's rolling out extremely well. Not all patients are reimbursed yet. I think as we progress in each country, we've been able to get a lot of patients on early access programs. What we have seen is extremely strong take-up in those programs and then we work basically country by country to get reimbursement. ZURZUVAE had an extremely nice quarter. I think Alisha will be able to give some more color, but I think that's a bit of a sleeper in our portfolio. This is certainly outperforming our internal expectations. We also had good news in the quarter. We got approval in Europe, and we're looking forward to planning the launch there. As we turn to the pipeline, Priya is going to say more, but we've had some very good news there. All Phase III studies for felzartamab have been initiated. We potentially have another study being started in microvascular inflammation that could add to that portfolio. We saw some really interesting results for salanersen. This is our next-generation product for SMA and we're quite excited about that, and that will be another Phase III that starts this year. On business development, we continue to look across the spectrum of our development pipeline. We're very excited about the research agreement that we concluded in the past quarter with City Therapeutics. We expect to see several more of those research collaborations this year. We continue to look at later-stage, both M&A and collaborations. But we remain disciplined in terms of ensuring that anything we do would drive shareholder value. Looking at the quarter, we have growth top and bottom line. We've had very strong discipline on costs. I think the company is performing well. And with that, I'll turn it over to Priya, who can give us a lot more detail about the pipeline.

Thank you, Chris. This quarter, we made significant progress in continuing to build the breadth and depth across the pipeline in key areas. We obtained a positive CHMP opinion for zuranolone in Europe, initiated three Phase III studies, the pediatric Phase III study for SKYCLARYS as well as the felzartamab Phase III study for IgAN and PMN. We are working with Stoke Therapeutics towards an imminent first patient in for zorevunersen. We're also working to further expand felzartamab into a fourth indication called late microvascular inflammation or MVI, in patients who have had a kidney transplant. In support of our continued scientific leadership, we have also presented new data across our key franchises at medical congresses, including Cure SMA, EPNS, EULAR, and LUPUS 2025. Just yesterday at AAIC, new long-term data on LEQEMBI, showing treatment benefits over four years with the continued use and bioequivalence data for the initiation dose of subcutaneous lecanemab was presented. This quarter, we also announced exciting new interim Phase Ib data for salanersen in SMA, as Chris mentioned, demonstrating proof of concept. As the company that led transformation in SMA, we are excited about the potential to continue that journey and potentially address the residual unmet needs for patients. Salanersen leverages the same mechanism of action as SPINRAZA but was designed to be a more potent molecule, thus enabling the potential for high efficacy with once-yearly dosing, a profile we believe can further address the needs of the SMA community. The Phase Ib study included children who had previously been treated with gene therapy but had not achieved the expected motor milestones based on their age, such as sitting, standing, or walking despite the extended period of time since having received the gene therapy. We presented the interim results of this study at the Cure SMA meeting last month. While this is a small dataset, several features are compelling. First, salanersen was evaluated as a once-a-year administration. Second, we are seeing a significant reduction in neurofilament, which is a marker of neurodegeneration. Third, we observed meaningful improvements in motor function, including the achievement of significant motor milestones. On the slide, you can see two examples of participants who were previously treated with gene therapy several years prior to receiving salanersen. The first row represents a child who received gene therapy at around one year of age and could not sit when they enrolled in this trial at approximately five years of age. They received salanersen 80 milligrams, one dose, and by their 90-day visit, they were able to sit independently. Naturally, these results need to be confirmed in a registrational trial. These types of data support the potential of salanersen to transform the standard of care in SMA, and we're working with urgency as we engage with global regulators and finalize the Phase III study design. Turning to the lupus pipeline, together with UCB, we were excited to present new data from the positive Phase III dapi study in SLE. We know from patients that fatigue is a very common symptom in lupus. It affects up to 90% of patients and is often described as the most disabling symptom of the disease. What's important about this new analysis that we presented at EULAR is that dapi demonstrated consistent improvements across multiple domains of fatigue beyond what was achieved with just standard of care alone. These results further reinforce the potential for dapi to address the unmet need and become an important new treatment for SLE. Reflecting on our achievements this quarter, I believe that we're making steady progress towards our goal of transforming the pipeline and delivering the new Biogen. The next 12 to 18 months are marked by multiple key expected scientific milestones and regulatory outcomes, including LEQEMBI subcutaneous maintenance and high-dose SPINRAZA. Given the central role of the pipeline for our long-term growth strategy, we plan to build upon last quarter's felzartamab investor webcast by hosting a second thematic seminar this fall, now focused on our lupus pipeline. With that, I would like to now hand the call over to Alisha for an update on our commercial business. Thank you.

Thank you, Priya, and good morning, everyone. Today, I'll review the strong commercial execution we delivered in Q2 and how evolving market dynamics have created new opportunities that drove our most recent growth. As many of you may remember, more than 18 months ago, we reallocated capital as part of our Fit for Growth initiative to prepare for four new launches in the U.S. market. We took a hard look at our investments in MS to determine where they deliver the strongest return. Today, we believe we're seeing the results of those decisions. Before turning to the launch products, let me remind you that our MS business has remained resilient and an important contributor to our cash flow. Looking at Q2 performance, in addition to some one-time items benefiting the quarter, I am encouraged by the strength of VUMERITY as it continued to grow. We believe these results demonstrate the value of our team's deep institutional knowledge, strong access, and relationships in immunology. Moving on to SKYCLARYS. We are delivering on our commitment to bring the first Friedreich ataxia treatment to patients around the world. SKYCLARYS is now available in 29 markets globally, including key European countries and Brazil. Expanding into new markets is helping us realize the full potential of SKYCLARYS, and we grew revenue 5% globally compared to last quarter. Last year at this time, I shared the deliberate pivot made by our U.S. rare disease team to redirect investments to reach the remaining patients treated in the community as opposed to our initial patients, who were primarily at centers of excellence. We learned patients in the community had a different profile. They are generally older, averaging over 40 years old and often with slower progressing forms of FA. Community neurologists and primary care providers may only treat one or two FA patients in their careers, so they require more education. We have deployed advanced rare disease capabilities to identify patients in need and help HCPs understand the progressive nature of the disease and the potential urgency to start treatment with SKYCLARYS. I believe this shift in focus was a key factor behind the 13% quarter-over-quarter revenue growth in the U.S. In Q2, approximately 70% of new start forms were written by community neurologists and PCPs. This reinforces our belief in our ability to reach the remaining patient population in need. While we anticipate continued growth in the U.S., the pace may fluctuate from quarter to quarter due to the time it takes to identify and reach potential patients. We remain optimistic about the global opportunity and are encouraged that new clinical guidelines from the leading patient advocacy group and KOLs across the world are recommending intervention with SKYCLARYS. We believe this is helping to build momentum and prescriber awareness for the only DMT to slow the progression of FA. Next, turning to ZURZUVAE. We delivered a 68% quarter-over-quarter revenue growth in the U.S., supported by a 29% increase in new prescribers. Earlier this year, we expanded our field team and in just a few months, their impact reinforces our belief in ZURZUVAE's potential for sustained growth. Repeat prescribers now account for nearly 70% of prescriptions, indicating HCPs' growing trust and willingness to treat PPD with ZURZUVAE. Last quarter, 80% of ZURZUVAE prescriptions were written as first-line therapy. Most reimbursement policies do not require step edits or complex prior authorizations, helping to accelerate patient access. Looking ahead, we are hopeful to bring ZURZUVAE to patients outside the United States. Lastly, shifting to LEQEMBI. The U.S. Alzheimer's market is undergoing a significant evolution that began with LEQEMBI's FDA approval just two years ago. To accelerate this large-scale change, our efforts at launch were primarily focused on helping health systems establish capabilities to diagnose, treat, and safely monitor a high volume of Alzheimer's patients. We believe sites are making progress. For example, we estimate that since the beginning of LEQEMBI's launch, nearly one-third of customers have begun diagnosing MCI in mild AD patients for the very first time. On average, Medicare claims data has shown that prescribers have reduced the time from diagnosis to first infusion by six weeks since the beginning of last year. This year, we also see significant improvements in the time it takes sites to add patients beyond their first one and in their depth of prescribing. Monthly PET testing has increased approximately five-fold over the last 1.5 years. Blood-based biomarker testing has grown by 50% in the past six months from two major lab companies and has nearly tripled in the past year. We think this is an early promising indication that there is high awareness and willingness to adopt blood-based biomarkers. We will continue to work in partnership with the Alzheimer's community to educate about the quality of these tests and explore the opportunity for widespread use. This maturation of the market infrastructure gives us confidence earlier this year to launch new initiatives with Eisai, including sharper messaging, a targeted brand campaign, and a more precise focus on physicians with the highest potential to prescribe, which we believe are driving momentum. In Q2, U.S. revenue grew 20% quarter-over-quarter, and we increased new LEQEMBI prescribers by 34% year-to-date. It is particularly encouraging to see early signals that we believe the anti-amyloid market is now growing approximately 15% in Q2. These dynamics are prompting us to deploy the next phase of initiatives designed to further increase LEQEMBI prescribing. Today, awareness about Alzheimer's disease is high. Unfortunately, patient and caregiver awareness of new treatments is low. However, our research shows that when patients ask about LEQEMBI, an HCP will prescribe it most of the time. With health systems having advanced their capabilities to treat, we activated our direct-to-consumer campaign across TV and digital platforms to build patient demand and awareness. In our campaign testing, patients and caregivers felt empowered to pursue treatments and earlier intervention if LEQEMBI can help them still be like themselves longer. In parallel, we plan to pilot later this year an expanded field team to understand how to improve PCP referrals in key geographies. We are also preparing for the potential subcutaneous formulations of LEQEMBI, which we believe would add convenience and optionality for patients, caregivers, and HCPs. Looking ahead, we believe that our disciplined execution, efficient investments, and our ability to adapt to evolving market dynamics positions us to sustain this momentum and deliver continued growth. I will now turn it over to Robin for an update on our financial results.

Thank you, Alisha. I'd like to provide some key highlights from our strong second quarter financial results. Unless otherwise noted, each of the comparisons I make during my remarks are versus the second quarter of 2024. We delivered 7% revenue growth in the quarter on strong commercial execution, particularly from our four launch products, which generated $252 million in revenue in the quarter, and our MS business in the U.S. This strong commercial execution, combined with our disciplined operating expense management, resulted in non-GAAP diluted EPS growth of 4% in the quarter. Absent the approximately $0.26 impact from the acquired IPR&D upfront and milestone expenses in the quarter, non-GAAP diluted EPS would have been $5.73, up 9%. Based on the strength of the business performance in the first half of the year, we are raising our full year 2025 financial guidance. I will provide details on guidance shortly. First, I will cover our Q2 performance. Starting with our MS franchise. In the U.S., as Alisha noted, we had a strong quarter with revenue of $657 million, driven in part by higher VUMERITY demand, approximately $32 million of favorable inventory dynamics from TYSABRI, and an approximately $48 million favorable gross to net change in estimate impact across the franchise, with $27 million of this gross to net dynamic favorably impacting VUMERITY. Outside the U.S., sales are primarily impacted by expected generic pressures for TECFIDERA and a biosimilar for TYSABRI in Europe. We continue to defend our IP. However, we expect accelerating competitive pressures on the ex-U.S. MS business in the second half of 2025, particularly for TECFIDERA in Europe. For SPINRAZA, we continue to be encouraged by the consistency in demand globally. As expected, ex-U.S. SPINRAZA was impacted by the drawdown of the inventory build from the first quarter, which we expect to continue into Q3. We continue to expect full-year global SPINRAZA revenue to be relatively similar in 2025 compared to 2024. Due to timing of shipments, we expect revenue in the second half of the year to be lower than the first half. Our four launch products each saw increases in demand in the second quarter and together delivered $252 million of revenue to Biogen, a 26% increase quarter-over-quarter and 91% year-over-year. Again this quarter, the year-over-year performance of these products together offset the decline in our MS portfolio. We continued to see steady sequential demand growth for LEQEMBI globally, with second-quarter global end-market sales booked by Eisai of approximately $160 million. This includes the favorable impact of the timing of shipments to China of approximately $35 million as the collaboration optimized global inventory positions in Q2. We expect this inventory build to work down in the second half of the year. What is encouraging is that excluding the China shipment timing impact, global sales grew 29% sequentially and 211% year-over-year. SKYCLARYS saw continued demand growth globally, and the U.S. demand growth more than offset the expected Medicare discount dynamics in the quarter. Internationally, SKYCLARYS was negatively impacted by the timing of shipments in certain markets. We expect SKYCLARYS to continue to grow globally and are working to secure reimbursement in certain European markets as well as in Brazil. We experienced strong demand growth for ZURZUVAE in the quarter, and as Alisha noted, Q2 revenue was $46 million, up 213% year-over-year and 68% quarter-over-quarter. Importantly, Biogen shares 50% of the profit or loss on ZURZUVAE, which is recognized in the collaboration profit-sharing line on our P&L. I would like to note we understand that earlier this month, IQVIA updated their methodology for reporting shipped prescriptions for ZURZUVAE and other products as part of their routine data review. This may mean the capture rate may be lower. We are encouraged by the opportunity for ZURZUVAE, including the potential in Europe with the recent positive CHMP opinion. Turning to contract manufacturing revenue, the increase in revenue was driven by the acceleration of timing for manufacturing batch releases, some of which were associated with LEQEMBI due to our Q4 planned plant maintenance activities. We continue to believe that contract manufacturing revenue will be roughly consistent when comparing full-year 2025 with full-year 2024, and we expect minimal revenue in Q4 2025 due to planned maintenance activity. Now a few comments on the rest of the P&L. Non-GAAP cost of sales was impacted by higher lower-margin contract manufacturing revenue in Q2 2025, a continuation of the trend we saw in the first quarter. Non-GAAP core operating expense or R&D plus SG&A expense decreased 2% year-over-year as we continued to deliver on our R&D prioritization and Fit for Growth initiatives. Non-GAAP operating income included approximately $47 million of acquired in-process R&D charges. This includes $16 million related to the City Therapeutics transaction and a $30 million milestone related to initiation of the second Phase III study for felzartamab. Excluding the impact from acquired IPR&D, non-GAAP operating income would have been approximately $1 billion, up 5% year-over-year. Now, I'd like to provide a brief update on our balance sheet. We generated $134 million of free cash flow in the second quarter. This reflects $745 million in cash tax payments in the quarter. Our cash tax payments for the year are heavily concentrated in Q2. In the second quarter, we used the proceeds of the $1.75 billion of newly issued debt to fully redeem our $1.75 billion of senior notes that were due in September. While this financial transaction resulted in no net change to our overall debt profile, we expect roughly $15 million to $20 million of incremental interest expense in the second half of 2025, which we have factored into our updated guidance for the year. We ended the second quarter with $2.8 billion of cash and approximately $3.5 billion of net debt and believe that our balance sheet remains strong, allowing us to continue to invest in both internal and external growth opportunities. We believe the structure of our business model positions us to be potentially more resilient to macroeconomic factors and policy uncertainty. A significant portion of our U.S. product revenue is derived from products largely manufactured in the United States. We recently announced a plan to continue to invest in our North Carolina manufacturing operations. This is a combination of capital and operating expense over several years that is intended to modernize and add manufacturing capabilities to fuel the continued advancement of Biogen's late-stage pipeline and support our next wave of potential products. It's also important to note that there are other aspects of our business model that we believe are important to our ability to be resilient in an uncertain environment. We generate a relatively high percentage of our revenue outside the U.S., we have a significant rare disease business, and our payer channel mix in the U.S. is diversified and skewed more towards commercial payers. These are important considerations as we navigate the current environment, and we will continue to monitor the evolving landscape. Turning now to guidance, we've raised our full-year 2025 non-GAAP diluted earnings per share to be in the range of between $15.50 and $16 from $14.50 to $15.50. We are raising our guidance to reflect a stronger expected business outlook for the full year, largely reflecting the strong first-half revenue performance, including the resilient performance of the U.S. business and MS, and the performance of our launch products, partially offset by the impact of the City Therapeutics transaction in the second quarter. Please note that the impact from the $30 million felzartamab milestone I mentioned earlier was already contemplated in our previous guidance. Some key considerations underlying the guidance raise include our expectation for total revenue for 2025 to be approximately flat compared to full-year 2024. This reflects the strong first-half revenue performance, including the resilient performance of the U.S. MS business. Excluding the $75 million of favorability from inventory and the one-time gross to net adjustments in the second quarter, we expect U.S. revenue trends for the second half of 2025 to be roughly in line with the first half. We also expect increased competitive pressures on the ex-U.S. MS business in the second half of 2025, particularly for TECFIDERA in Europe. I previously mentioned we expect minimal contract manufacturing revenue in Q4 this year due to planned maintenance activities. Importantly, we remain on track to deliver the $1 billion of gross savings and $800 million of net savings under our Fit for Growth initiative. In the second half of 2025, we plan to make additional investments in R&D to enable acceleration and expansion of clinical development activities, primarily in support of rare disease. On this call, we talked about our excitement around moving salanersen to registrational studies and plans for our fourth indication for felzartamab. As we continue to expand our increasingly exciting pipeline, we believe it's important to make these investments in support of our long-term growth objectives. We now expect combined non-GAAP R&D and SG&A expense for the full year 2025 to be approximately $4 billion. Please be sure to review this slide and our press release for other important guidance assumptions. Finally, we continue to focus on capital deployment that provides long-term value for our shareholders. With that, I will pass the call back to Tim to open the call for questions.

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

Your first question comes from the line of Phil Nadeau with TD Cowen.

Congrats on a strong quarter. Our question is actually on the AHEAD 3-45 trial with potential for an interim in the Kisunla TRAILBLAZER-ALZ 3 trial coming up. There's a lot of focus on early Alzheimer's. Could you remind us whether there's a similar interim in AHEAD 3-45 and maybe more broadly discuss the differences in design between AHEAD 3-45 and TRAILBLAZER-ALZ 3?

Thank you. Stepping back, we believe that the potential for amyloid therapies in the presymptomatic population is very significant. It's very important for patients. We would be interested in seeing what our competitor generates. If they have a successful trial, I think that would be helpful for patients and the amyloid class. But there are very important and significant differences between how we have attempted to address the questions that face prescribers when they think about anti-amyloid drugs for the presymptomatic population. The first and most important one is the scientific questions we are asking. In AHEAD 3-45, these are two trials: AHEAD 3, which attempts to ask the question of whether we can prevent further accumulation of amyloids, and AHEAD 45, which is asking the question of whether we can actually prevent cognitive decline in patients who have greater than 40 centiloids amyloid already in the brain. The second piece here is that we were quite specific in our recruitment and inclusion of patients. We used amyloid PET to screen patients before we brought them in and used a CDR global score of 0, which is no cognitive decline at all, whereas our competitor used mixed inclusion criteria that included telephone interviews but also the CDR global score of 0.5 and 1, which means mild and MCI dementia were included at baseline. This is an important aspect. Finally, I think it’s the endpoints. We are looking at a biomarker endpoint, which we believe will be very important. But for AHEAD 3-45, we're looking at a sensitive specific preclinical Alzheimer's disease composite endpoint. These will be very different trials and we are looking for a readout in 2028. Regarding the question of interim analysis, we reserve optionality, but at the moment, we are planning for 2028.

What a pleasure to follow Phil Nadeau on this call. I also have a question on LEQEMBI. Maybe this one for Alisha, more on the market side. We've seen some third-party data that suggests that LEQEMBI may be losing a little bit of share in the U.S. Wonder if you might comment on the competitive dynamic, especially considering donanemab has had a recent label update for safety.

Thank you for the question. As we anticipated and shared in the past, we did believe a second therapy would help expand the market by driving more physician, patient, and caregiver awareness. As I also mentioned, this is the first time we've seen this market grow approximately by 15% based on total new patient starts, which is a very encouraging development. However, as far as the competitive dynamics, we are seeing that Kisunla faces the same friction points that we did with health systems, which we have been actively addressing for the past two years. It’s notable that we believe the growth from our competitor is primarily among HCPs already prescribing LEQEMBI or physicians working alongside LEQEMBI prescribers at the same site. LEQEMBI still continues to hold the majority of the market share, which is nearly 70%. When looking at new patient starts, physicians are going to try new medications that enter the market. However, we are encouraged that we've had strong new writer growth year-to-date. Also, 70% of that new writer growth came from physicians at new sites of care. LEQEMBI is driving this expansion of new writers at new sites quarter-to-quarter. With our maintenance option and the potential subcutaneous options, this will provide great optionality that our competitor doesn't have. When considering the new label update, it's too early to say how that will influence a physician's choice, but our research indicates several doctors were already using this type of schedule and dosing regimen prior to the label update. Also, HCPs still need to conduct the same amount of MRIs, and that has not changed. ARIA numbers did not change that much in the dosing regimen. It's helpful that physicians gain more real-world experience with LEQEMBI, and we will keep a close eye on this as we move forward.

I can also add, thank you, Alisha. There was an independent presentation at AAIC by Sabbagh presented by Dr. Burke. This was an indirect treatment comparison of lecanemab ARIA events and donanemab ARIA events based on the modified titration. The conclusion from this group was that the modified titration seems to be confined mainly to the homozygotes. The number of patients in TRAILBLAZER-6 that assessed this modified titration was much smaller. No distinct conclusion was derived here. This is an important consideration as well.

Congrats on continued great progress. We had a question on the SMA market dynamics. I appreciate your development with salanersen. There are also myostatin products that could be coming in a month or two; competitor Roche is very bullish on their myostatin program to drive SMA share. Can you comment on how you think myostatin would change the dynamics, whether you think that is additive to SMN correctors, and how would that impact you if competitors have combination products?

I'll go ahead and start the answer. We've been looking at the myostatin dynamic for quite some time, and we believe that this will be a good additive benefit for patients. We don't see this as a main competitor for SPINRAZA or for the SMA therapies that are currently being used. So we don't believe that this will be an issue for us.

I wanted to ask a question about the lupus pipeline. First on dapirolizumab, maybe give us a sense of when is the earliest we can see data from that second Phase III? More broadly, you're taking a multi-mechanistic approach to lupus drug development. But I wanted to get your thoughts on the competitive landscape. We have oral agents like SOTYKTU, for instance, that are in late-stage development here. How are you thinking about dapirolizumab and litifilimab in the context of a more crowded landscape that could also include oral agents?

Thank you, David. Overall, the first comment I'd like to make is about how we've tackled lupus, really looking at the unmet need. When you look at the unmet need, it quickly becomes apparent that dapi was only the third agent ever to have a positive Phase III trial. The heterogeneity, the variability in the patient population signifies the unmet need that is still outstanding. We've tackled this from a broad perspective, looking at different mechanisms of action. With litifilimab, we are focused on tackling the type 1 interferon signature. We are looking at BDCA2, and we have proof-of-concept in Phase II with our Part A and Part B, both in cutaneous and systemic lupus. With dapi, we are looking at the much broader perspective of the CD40 ligand and CD40 pathway, affecting both T and B cells. The data from our first Phase III gives us confidence that we are able to target the disease effectively. Importantly, we showed the impact on severe moderate to severe patient population, plus decreasing flares and steroid sparing. We also presented the fatigue data earlier this year at EULAR. We believe this is a high unmet need area, and we are tackling it scientifically by looking at different phenotypes, which we believe will be complementary. I think we expect data from the second Phase III in '27 or '28, and expect litifilimab SLE data to be as early as late next year.

Yes. Michael, we have, as you may have seen in the press release, planned a seminar to do a deep dive on lupus, as we recently did with felzartamab. This notion of heterogeneity is extremely important. We had a panel of four patients talk to our senior executives, and one patient said to another, 'Your lupus is not my lupus.' This has made it very challenging to develop drugs here. One thing benefiting Biogen is our experience in MS. Yes, there will be oral therapies. But if you look at the MS market, around one-third is the share of orals within the total MS market. It wouldn't be correct to assume that an oral will always beat an injectable in this market. Efficacy matters, but there are also different symptoms. Some have expressed fatigue while there are flares and joint pain. It's a complex disease. And we will have an opportunity to do a deeper dive in September and welcome everyone to that seminar.

I wanted to touch up briefly on your long-term commitment to Alzheimer's and the status of the Eisai relationship. It seems like there's been arbitration initiated by Biogen on commercialization allocations in Europe. How is the Eisai relationship going?

I'll start by noting we are very committed to Alzheimer's and have been for years. The partnership with Eisai goes back at least 10 years. Our investment in BIIB080 is extremely important to the future of the company. We also continue to conduct research in other modalities. Biogen has a history of multiple partnerships and collaborations. It's not always easy for companies to work together, as a lot of things aren't black and white in terms of how we approach them. I would say the relationship with Eisai is better than it has ever been. The amount of executive time at Biogen spent in different committees with colleagues at Eisai is significant. Our Head of Manufacturing recently had a one-on-one meeting with Eisai's CEO in Japan, and that was after arbitration was filed. We have a very close working relationship on the development side. However, disagreements can arise, particularly in launching in Europe. We are simply following the process in our contract, and that will go to arbitration. That said, it hasn't affected our overall relationship with Eisai.

Congrats on the quarter. It seems like blood-based biomarkers are expanding considerably. How do you further educate around proper patient triage leveraging these new diagnostics?

Alisha, could you provide more color on the activity in the market?

Yes, thank you for the question. The Alzheimer's blood tests are evolving at an incredible pace right now. In fact, it’s progressing faster than we anticipated at this time point. We believe this is a pivotal moment, especially regarding diagnosing patients. As I mentioned earlier, testing nearly tripled over the past year, and this week, the Alzheimer's Association issued their first practice guidelines for blood-based biomarkers. These tests are convenient, faster, and cheaper compared to CSF or PET. Our market research shows that neurologists have high awareness and many are already using these tests. If they're already prescribing an anti-amyloid therapy, they also have a higher propensity for writing these tests. PCPs are adopting them too, but early adopters use them for a fraction of their patients. They primarily use them for triage. This means if the test is negative, they rule out Alzheimer's. However, even when positive or indeterminate, most physicians confirm with CSF and PET scans today. The main opportunity ahead is to establish these tests as the standard for amyloid confirmation. We actively plan to drive awareness, education, and real-world evidence for physicians. We need clarity whether these tests are sufficient for therapy reimbursement, specifically around CSF, as CMS mainly uses PET and CSF. Clarity with payers and physicians is essential. While utilization is growing significantly, there is potential to accelerate diagnosis for patients, and we are encouraged by the current market trends.

Congrats on the quarter. Our question is about subcutaneous LEQEMBI. You presented important data updates on LEQEMBI at AAIC. Subcutaneous seems a key differentiator from donanemab. Can you share any feedback received from physicians at AAIC and how large the incremental patient population you can address with subcut? Is there a direct-to-consumer education opportunity about subcutaneous LEQEMBI?

We are excited because, as mentioned, we believe blood-based biomarkers will be an important catalyst. We think that approval for the subcutaneous option will significantly improve convenience and streamline the infrastructure. The goal with subcutaneous auto-injector maintenance is to give patients the option to transition to weekly at-home injections after completing the intravenous initiation period. We are also preparing to file for subcutaneous initiation therapy. The data on bioequivalence was presented at AAIC. It has safety advantages as we see fewer infusion reactions with subcutaneous compared to intravenous. This is a clear benefit. Now I'll turn it over to Alisha.

Thank you, Priya. With subcutaneous, we believe this will be an excellent opportunity for patients, physicians, and especially for high-writing physicians, as it allows them to allocate chairs for patients who might need them. Depending on caregiver situations and physicians' preferences, initial administration may occur in centers of excellence before being transitioned to at-home self-administration. The flexibility will be tailored to each patient's needs. Many patients in rural areas are more likely to want to go on subcutaneous, while others may prefer IV. The decision will ultimately depend on the patient and their individual circumstances, but it allows for more choices for patients.

This is Julian for Paul. Just specifically, again following up on subcutaneous lecanemab, people are trying to better understand the logistics of how subcutaneous initiation will work when it eventually comes online. Do you foresee this being primarily administered in centers initially, then patients transitioning to home administration? How do you see this playing out? What value does this bring given concerns over ARIA for this class of agents?

Thanks, Robin. That's all the time we have for today. Thanks for your participation. If you've got questions and want to follow up, just reach out to the IR team. Thank you.

This concludes today's call. Thank you for your participation. You may now disconnect.