Document Details

**Operator** (Operator):
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 Third Quarter 2025 Earnings Call and Business Update. Today's conference is being recorded. I'd like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

**Tim Power** (Head of Investor Relations):
Thanks, Cynthia, and good morning, everyone. Welcome to Biogen's Third Quarter 2025 Earnings Call. During this call, we will be making forward-looking statements that involve risks and uncertainties which could cause actual results to differ significantly from what we project. We have a detailed list of risk factors in our SEC filings, which I encourage you to review. You can find our earnings release and other documents related to our results, including reconciliations between GAAP and non-GAAP results discussed today, in the Investors section of biogen.com. We've ...

**Operator** (Operator):
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 Third Quarter 2025 Earnings Call and Business Update. Today's conference is being recorded. I'd like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

**Tim Power** (Head of Investor Relations):
Thanks, Cynthia, and good morning, everyone. Welcome to Biogen's Third Quarter 2025 Earnings Call. During this call, we will be making forward-looking statements that involve risks and uncertainties which could cause actual results to differ significantly from what we project. We have a detailed list of risk factors in our SEC filings, which I encourage you to review. You can find our earnings release and other documents related to our results, including reconciliations between GAAP and non-GAAP results discussed today, in the Investors section of biogen.com. We've also uploaded the slides for our webcast on our website. I'm joined on today's call by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; Alisha Alaimo, President and Head of North America; and Robin Kramer, our Chief Financial Officer. We will make some opening remarks and then proceed to the Q&A session. To allow us to address as many questions as possible, we kindly ask that you limit yourself to one question. Now, I'll turn the call over to Chris.

**Christopher Viehbacher** (CEO):
Good morning, everyone. Thank you, Tim. Can I have the first slide, please? I believe we've achieved a very strong third quarter. I am particularly pleased to report a 67% year-on-year growth in our launch products during this quarter. These launch products have more than compensated for the MS decline on a year-to-date basis. LEQEMBI continues to show robust global demand with sales of $121 million. As mentioned in the second quarter, we had increased inventory levels in China, which resulted in higher sales in Q2, though there was some offset in Q3. However, looking at this on a rolling 12-month basis, we are happy with LEQEMBI's progress. The IQLIK subcutaneous injection for maintenance has been approved in the U.S., and patients are already benefiting from it. SKYCLARYS is now available in 34 markets worldwide and has experienced a 30% year-over-year revenue growth. This growth is slightly lower than patient growth due to several early access programs in place as we negotiate pricing with governments. ZURZUVAE has shown an impressive 150% revenue growth year-over-year. It’s more than just a product; it's changing how postpartum depression is perceived, as highlighted by Jennifer Lawrence sharing her experiences. ZURZUVAE is also driving substantial revenue growth for us.  In terms of our pipeline, we are making solid progress. The Phase III studies for litifilimab are now fully enrolled and are expected to read out in the second half of 2026. The competitiveness in the lupus area has made patient recruitment in clinical trials a significant indicator of commercial success. We can accelerate our processes in such a competitive environment, which is a promising sign for litifilimab's potential. Additionally, we are advancing our early-stage pipeline and expect to introduce 3 to 4 new molecules over the next 18 months. On the business development side, we have agreed to acquire Alcyone Therapeutics, a strategic move as ASOs are vital for treating various diseases. This acquisition aligns with our goal of providing more convenient treatment options for patients, especially those requiring intrathecal injections. We have also added a C5aR1 antagonist through our licensing deal with Vanqua Bio, which allows us to create a diversified portfolio around immunological pathways, making it easier to explore multiple indications once safety is established. We aim to announce at least one or two additional research stage deals by the end of the year. If we can move to the next slide, please. I am excited about this slide as it showcases our strong pipeline, with 10 Phase III or Phase III-ready programs, which includes 5 new molecular entities. We've built a solid conviction around this pipeline and are close to seeing new data from our Phase II trials. Notably, these programs represent potential launches as well. For instance, felzartamab has 4 indications, including 2 for transplant and 2 in nephrology, along with three indications in lupus, and we are also targeting rare diseases with zorevunersen. We have an exciting next-generation SPINRAZA with salanersen and anticipate significant developments with BIIB080 in tau as well. To support these launches, we are focusing on building commercial teams and insights related to pricing and value propositions, indicating a lot of internal activity. Another important factor in predicting success is attracting top talent. I've been impressed with the high-quality individuals joining Biogen, which reflects their confidence in our new products. Market research is essential, but these indicators often hold more weight in forecasting commercial success. Over the past three years, we have aimed to grow our new product launches, achieving a remarkable 67% revenue growth from products like LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY, resulting in almost $1.2 billion in revenue over the last trailing 12 months. These products are not only first-in-class but also pioneering treatments in their respective areas. Creating markets is challenging, as experienced professionals understand, but our teams at Biogen have demonstrated impressive commercial strength. Additionally, we are focusing on the profitability of our legacy business. We have outperformed on the top line this quarter due to MS, not by coincidence. We are consistently surpassing most analogs of products nearing the end of their market exclusivity. This demonstrates our strong customer care and loyalty from patients, as we treat more MS patients than any other company. Furthermore, VUMERITY is performing exceptionally well, with nearly $0.5 billion in sales in the first nine months of this year, and it boasts market exclusivity well beyond the decade. We are committed to being efficient and delivering $1 billion in gross savings. From the outset, we acknowledged that some of these savings would be reinvested in new product launches and research and development. While our revenue has increased, our operating expenses have remained flat this year. We have successfully added products to our late-stage development and have been actively recruiting for commercial preparations as we approach Phase III launches. Notably, we've reduced development costs by nearly 25% and research costs by 40%, resulting in a stronger pipeline than ever before. Priya has played a crucial role in making strategic decisions in product development. Overall, we possess an exciting and high-conviction late-stage pipeline, and through early-stage deals, such as with Vanqua, we aim to expand our offerings. We are generating robust cash flow and remain disciplined about investing in growth opportunities. Everything we choose to invest in must contribute to our growth strategy. Now, let’s delve deeper into our pipeline as I pass it over to Priya.

**Priya Singhal** (Head of Development):
Thank you, Chris. This year, we've made important progress across the development pipeline and we are positioned to continue to deliver multiple expected milestones over the next 18 months. As Chris noted, we remain focused on execution against our strategic objectives. And there are a few achievements I'd like to highlight from this quarter. Importantly, as Chris mentioned, despite competitive recruitment for trials in the space, we have now fully enrolled both TOPAZ studies for litifilimab in SLE. This allows us to now pull forward both expected readouts from these studies into next year 2026. Next, we continue to advance two exciting new opportunities. First, with salanersen where the pivotal study design for presymptomatic infants and the broader clinical development plan has been aligned with the FDA. We are also engaging with ex-U.S. regulators and expect to initiate the registrational study in early 2026. We also continue to advance Felzartamab in Late MVI, where we expect to initiate a potential registrational trial in coming months. And today, we announced an update on high-dose SPINRAZA, where the FDA provided us with a path forward. We resubmitted promptly, and now we have a PDUFA in April 2026. Over the last few years, we have transformed both our late-stage and early-stage pipeline. We have followed the science and secured proof-of-concept to advance high-scientific-connection assets into potentially registrational stages. And as we prosecute the early-stage assets, we continue to follow the science by testing the most important scientific hypotheses. We now expect to deliver several readouts from our pre-POC pipeline next year. We're also focused on broadening the pre-POC pipeline, both with internal research assets that we advance to IND stage like BIIB142 IRAK4 degrader and by also remaining deeply engaged in targeting external innovation, including our announcement last week, as Chris mentioned, to collaborate with Vanqua Bio on a preclinical C5aR1 antagonist. Turning to our late-stage pipeline. I'm encouraged by the breadth of opportunities to further scientifically advance our assets including our ability to educate on the profile of our innovative medicines with our data. For example, this week at ACR we presented important differentiated data from our positive Phase III DAPI trial, showing a consistent clinically meaningful benefit across outcomes that are relevant for SLE patients and providers such as flare reduction, fatigue, morning stiffness, musculoskeletal pain, LLDAS as well as remission. And underscoring our comments that we made at our September lupus seminar on the potential importance of DAPI for patients with SLE, including women of childbearing age we presented data demonstrating limited placental transfer in a preclinical setting. Next, I would like to spend a few minutes on the continued LEQEMBI development to deliver optionality for Alzheimer's disease patients. As you can see on the left side of this slide, we have already been successful this year in delivering meaningful differentiated treatment options for LEQEMBI. Today, it is the only anti-amyloid therapy with a maintenance option as well as an at-home subcutaneous maintenance option. And we continue to advance our rolling submission to the FDA for LEQEMBI subcutaneous initiation. The option for maintenance and the availability of subcutaneous delivery are also potentially relevant to LEQEMBI in the presymptomatic AD population. The AHEAD 3–45 Study as you can see here, is an important study that aims to comprehensively evaluate LEQEMBI in 2 different stages of presymptomatic AD with the appropriate scientific questions and the relevant primary endpoints. Additionally, we have seen increasing momentum in the development, approval and utilization of blood-based biomarkers. We see this as a key enabler that potentially simplifies the diagnostic pathways. We remain excited and believe the potential for LEQEMBI in the presymptomatic AD population can be an important opportunity for Biogen. In closing, I'm encouraged that LEQEMBI AHEAD 3–45 Study is just one of several important registrational readouts we have over the next few years. As you can see on this slide, our high scientific conviction pipeline will play a critical role given the increasing momentum in our registrational data flow. This will begin with 2 litifilimab Phase III readouts in SLE next year, and 2027 onwards, we will see multiple registrational readouts across several assets in diverse and important therapeutic areas.

**Alisha Alaimo** (President and Head of North America):
Thank you, Priya and good morning, everyone. Today, I'll review the commercial results we achieved in Q3, beginning with our multiple sclerosis portfolio. Our MS business continues to deliver significant revenue, which provides the resources to invest in our growth products, advance our pipeline and achieve our vision for the new Biogen. In the U.S., we saw strong performance, mainly driven by strategic actions to support VUMERITY's growth and some onetime events. When we look at competitive dynamics globally, we are seeing increased impact of TECFIDERA generics in Europe. And for TYSABRI, we believe we are well prepared for our biosimilars entrant in the U.S. Now turning to LEQEMBI, which delivered another strong quarter with global revenues growing 82% compared with Q3 2024, underscoring its increasing impact on the Alzheimer's community worldwide. In the U.S., our team is working collaboratively with Eisai driving strong execution and customer engagement, which we believe supported our prescriber base growing another 14% quarter-over-quarter. This quarter, we sustained consistent growth of new writers and new patients and LEQEMBI holds majority share as the #1 prescribed anti-amyloid treatment. Throughout 2025, we estimate LEQEMBI captured roughly half of all the new patients treated with anti-amyloid therapies. Now with the launch of IQLIK subcutaneous auto-injector for maintenance LEQEMBI is the first and only anti-amyloid treatment to offer an at-home injection, giving physicians, patients and care partners more options to continue to slow disease progression following the 18-month initial treatment period. Early feedback from customers and payers has been positive. And into next year, we will remain focused on securing Part D coverage and supporting patient access to LEQEMBI. Last quarter, we noted that for the first time we observed early signals indicating the anti-amyloid market grew with 2 players. We are encouraged that this quarter, our data shows the market continued to grow by approximately 15%. We also shared that blood-based biomarker testing was advancing at a significant pace. And here, our physicians have pointed to a meaningful impact. They report blood tests to help move from probable to definitive diagnosis more quickly, enabling HCPs, patients and their families to focus more on the treatment discussion. We anticipate up to 350,000 Alzheimer's blood tests this year and more than 60,000 PET scans to date, which is a 75% increase compared to this time last year. Our data show early indicators that PET, CSF positive tests are increasing, which we believe may be attributable to increasing use of Alzheimer's blood diagnostics as a triaging tool. As we previously noted, we are educating HCPs about the quality of blood-based biomarkers, including the performance of BBM that meet the requirements of the Alzheimer's Association's new practice guidelines for amyloid triage and confirmation. As we look to 2026, we expect LEQEMBI's momentum will continue to be driven by our focused strategies, which we believe are already having a positive impact on intent to prescribe perceptions of efficacy and safety and health care providers' understanding of the role of anti-amyloid therapies. Moving on to SKYCLARYS, where the launch continues to drive patient growth across all regions, including the U.S. and overseas. SKYCLARYS is now available in 34 countries, contributing to strong growth of 30% compared to the same time last year. In the U.S., as expected, patients continue to grow quarter-over-quarter with quarter 3 revenue being impacted by channel mix in the context of the IRA changes to Medicare. As we shared in the past, our strategy in the U.S. is to reach the remaining Friedreich's ataxia patients, their neurologists and PCPs, which our data indicate are primarily based in the community. Our efforts are focused on delivering on this goal as nearly 2/3 of new patients in Q3 were prescribed by first-time writers and roughly 1/4 of new scripts were written by PCPs. Outside the U.S., we remain focused on continued geographic expansion with multiple commercial launches planned in the first half of 2026. Last, turning to ZURZUVAE, which continues to perform above our expectations. As we shared earlier this year, our expanded field team has had a meaningful impact, delivering $55 million in the U.S., which is a 19% revenue growth compared to last quarter. We are also encouraged by the increasing breadth of writers, which grew 19% quarter-over-quarter. And in quarter 3, 80% of ZURZUVAE prescriptions were written as first line, demonstrating health care providers' belief in the value of therapy that provides rapid relief to mothers impacted by postpartum depression. Across our portfolio, I am proud of our teams for executing with discipline and delivering on our strategic priorities. Their hard work is helping us serve patient communities, build new markets and drive sustainable growth.

**Robin Kramer** (CFO):
Thank you, Alisha. I would like to provide some key highlights about our strong third quarter financial results. Unless otherwise noted, each of the comparisons I make during my remarks are versus the third quarter of 2024. We delivered 3% revenue growth this quarter, driven by continued strong commercial execution. Our 4 launch products generated $257 million in revenue in the quarter, representing a 67% growth. We continue to see resilient performance from our U.S. MS business which was favorably impacted by gross to net adjustments, timing of shipments and strong demand growth for VUMERITY. This was partially offset by continued generic erosion of TECFIDERA in Europe. Notably, the year-to-date cumulative revenue from our launch products has more than offset the year-to-date decline in our MS product revenue. This commercial execution, combined with our disciplined operating expense management resulted in non-GAAP diluted EPS growth of 18% for the quarter. We also delivered $1.2 billion of free cash flow in the quarter. Turning to our guidance. I'm encouraged by the strong business trends that we continue to observe in Q3. This is reflected in our improved revenue outlook. You'll note that our non-GAAP EPS outlook has been updated to reflect that stronger business outlook while adjusting for expected business development activities that are expected to close in the fourth quarter. I will provide more details on this in a moment. Let me cover some key components of our Q3 revenue performance. Starting with our MS franchise. In addition to the strong commercial execution that Alisha discussed, VUMERITY benefited from approximately $22 million of favorable inventory dynamics. And overall, U.S. MS benefited from favorable gross-to-net adjustments of $38 million in the quarter. Outside of the U.S., sales were primarily impacted by expected generic pressures for TECFIDERA. We continue to defend our IP. However, we observed an acceleration of erosion, particularly in Europe as generics continue to launch in new geographies, including Germany. This, combined with the channel dynamics, resulted in a sequential net decrease in TECFIDERA revenue of $28 million versus the prior quarter in Europe. On a positive note, year-over-year and quarter-over-quarter impact of the TYSABRI IV biosimilar in Europe was roughly offset by growing demand for our subcutaneous formulation, which has no biosimilar alternative and now accounts for more than 50% of all branded and biosimilar natalizumab patients in Europe. For SPINRAZA, we continue to be encouraged by the consistency and demand globally. And as expected, ex-U.S. SPINRAZA was impacted by the drawdown of the inventory build from the first quarter. We continue to expect full year global SPINRAZA revenue to be relatively similar in 2025 as compared to 2024. Turning to our launch products, starting with LEQEMBI. We continue to see steady sequential demand growth globally with third quarter end market sales booked by Eisai of approximately $121 million. As you will recall, we had a $35 million inventory build in China in the prior quarter, representing roughly 6 months in demand in the region. Approximately half of this build was drawn down in Q3. Therefore, as expected, there were negligible sales recognized for China in Q3 as demand was satisfied with the inventory in the channel. We continue to expect demand in China in Q4 to be satisfied with this remaining inventory with minimal revenue generated in the fourth quarter. SKYCLARYS saw continued growth globally with revenue increasing 30% from this time last year. In the U.S., continued sequential patient growth was offset by approximately $6 million adjustment related to channel mix in the context of the IRA redesign related to Medicare. We expect SKYCLARYS to continue to grow, and we are working to secure reimbursement in certain European markets as well as in Latin America. As Alisha noted, we are pleased to see continued strong growth for ZURZUVAE driven by increased demand. Now a few comments on the rest of the P&L. Before I get into the quarterly dynamics, I would like to highlight the variance shown here between GAAP and non-GAAP cost of sales. GAAP cost of sales was $674 million, up 6% year-over-year due to an approximately $100 million pretax charge accrued in Q3 that related to a judgment on Genentech's claim for past royalties and interest related to TYSABRI. Without this impact, it would have been approximately $570 million, representing an 11% decrease year-over-year. More broadly, cost of sales benefited from favorable product mix from lower contract manufacturing revenue in Q3 2025, which has a lower margin. This trend is expected to continue through the remainder of the year due to the planned campaign timing of contract manufacturing that we have previously discussed. Non-GAAP core operating expense or R&D plus SG&A expense is flat year-over-year. What's evident in our results is that we remain disciplined in our cost management as we continued to deliver on our R&D prioritization and Fit-for-growth initiative, while ensuring that we are supporting investments in our launch products and long-term growth potential. Now I'd like to provide a brief update on our balance sheet. This quarter, we generated approximately $1.2 billion of free cash flow due to business performance and continued cost management discipline. We exited the quarter with $4 billion in cash and marketable securities, and $2.3 billion of net debt. Our financial strength gives us the flexibility to reinvest in strategic growth initiatives, including advancing our pipeline, supporting product launches and exploring growth opportunities as we work to deliver the new Biogen. Turning now to guidance. We have updated our non-GAAP EPS guidance to reflect a stronger underlying business outlook and investment for growth from business development transactions expected to close in the fourth quarter. As you know, the SEC requires inclusion of acquired IP R&D charges associated with business development transactions and GAAP and non-GAAP financial results. Cleaning up onetime charges, our business outlook has continued to strengthen in the quarter, yielding a $0.25 per share improvement. Our updated full year guidance includes an approximately $1.25 per share impact for business development transactions that we expect to close during the fourth quarter including the license agreement with Vanqua Bio and the acquisition of Alcyone Therapeutics. The following are some key considerations underlying our financial guidance. We expect sales to be roughly flat to up 1% as compared to last year at constant currency, an improvement from our last guidance update in July. This reflects strong business performance, including the resilient performance of the U.S. MS business year-to-date. We also expect increased competitive pressures on the ex-U.S. MS business to accelerate, particularly for TECFIDERA in Europe, where we expect the sequential impact in Q4 to be roughly double the erosion we saw this quarter. In addition, as we discussed into July, we are investing to support exciting new pipeline expansion opportunities, including a new program for felzartamab and MVI and the salanersen Phase III study discussed by Priya earlier in the call. As discussed earlier in the call, we are also beginning to invest in prelaunch activities for our late-stage high-conviction pipeline and key initiatives such as direct-to-consumer advertising in support of our launch products. We believe these investments position us to drive future growth while delivering innovative solutions for patients. As we look ahead to the fourth quarter, we expect operating expenses will be approximately $1.1 billion. This reflects the typical seasonality of our Q4 spending, our ongoing investments to drive growth and our focus on cost efficiency. It also reflects the progress we've made in our pipeline with the opportunity to invest in 10 programs, either in Phase III or expected to start Phase III in the coming months. We are encouraged by our progress towards delivering the new Biogen, and we believe it's important to make these investments as we work toward our goal of sustainable growth and long-term value to shareholders. Importantly, we believe we remain on track to deliver the $1 billion of gross savings and $800 million of net savings projected under the Fit-for-Growth initiative by the end of 2025. And as I have mentioned previously, we expect contract manufacturing revenue in Q4 this year to be $10 million to $20 million due to planned timing of contract manufacturing batches versus Biogen innovator product manufacturing. Please be sure to review this slide and our press release for other important guidance assumptions.

**Tim Power** (Head of Investor Relations):
Thanks, Robin. Cindy, could we go to our first question, please?

**Operator** (Operator):
Your first question comes from Umer Raffat with Evercore.

**Umer Raffat** (Analyst):
I wanted to spend a quick second on EVOKE trial, if I may. And my question is, in a scenario where we do see a trend, how do you see that impacting the LEQEMBI franchise? And even more importantly, how does that change your thought process around the portfolio offering you have in the space? Would you need to have a GLP collaboration or an asset in-house in a scenario like that?

**Christopher Viehbacher** (CEO):
Regarding the study, we need to wait for the results and see how they will impact our approach. If the findings are positive, it is likely that the product will be used more in primary care settings at an earlier stage. We still need to see what the data shows, but it appears that it won't significantly affect the level of plaque. As a company, we are focused on having a comprehensive range of products to address Alzheimer's. We have the BIIB080 program, and we are also developing brain shuttle technology. We will assess this as new data becomes available, and there is plenty of GLP-1s in the market.

**Priya Singhal** (Head of Development):
I can just add that I think what's really important here is that they are hypothesizing that neuroinflammation will play an important role. And as Chris mentioned, I think that it doesn't really target the pathology. The important thing is that the EVOKE trials included patients on stable doses of Alzheimer's treatment, including the anti-amyloid antibodies. So we'll be interested in seeing that data. And what we also believe is that it will increase the awareness of the disease and the need for treating disease early.

**Evan Seigerman** (Analyst):
Can you step back, I'm really struck by your progress in immunology. Can you just talk to me about how this renewed focus can drive growth and pipeline expansion into the end of the decade? And what can you do with Biogen to accelerate some of these programs?

**Christopher Viehbacher** (CEO):
When I joined Biogen, I emphasized that we have always focused on immunology because many diseases, like MS, are treated by influencing the immune system. Our MS drugs don't cross the blood-brain barrier, which supports the idea that we are fundamentally an immunology company. The field of immunology has significantly evolved over the past decade, and I believe DUPIXENT showcased the potential for disease-modifying treatments. We have a solid understanding of this area, especially regarding rare immunology and overlaps with our existing expertise. For instance, lupus is a complicated disease with varied symptoms, and our experience with MS can inform our approach to lupus. I am confident we can tap into this market in ways that existing companies have not managed. Additionally, we aim to expand our portfolio to encompass a wide range of immunological products, showing the great opportunities ahead, even as we recognize there is still much to learn. In the short term, our focus will remain on rare immunology, but looking ahead to the next decade, we envision expanding into broader indications. Vanqua is a prime example of an asset with potential for multiple indications, and we plan to pursue more opportunities like that. Understanding the underlying scientific pathways is crucial, as many diseases share commonalities. For instance, insights from diseases involving Nrf2 and microglia might be applicable across different conditions. This scientific depth, combined with our knowledge from felzartamab, which is currently targeting four kidney indications while we explore additional unrelated indications, gives us a competitive edge in developing medicines that others might not pursue. Immunology is a key focus for us, but we are not neglecting neuroscience; we continue to invest heavily in Alzheimer's, ALS, and Parkinson's research. Overall, immunology presents a significant opportunity for Biogen.

**Salveen Richter** (Analyst):
You mentioned a focus on expanding your early-stage pipeline via BD, and this is partly driven by the late-stage pipeline here where you have about 10 Phase III trials ongoing. Could you just maybe speak to the confidence in the latter that's allowing you to kind of maybe just work on that earlier basket here.

**Christopher Viehbacher** (CEO):
I believe there are two aspects to this question. Regarding our confidence in the late-stage pipeline, particularly with felzartamab, we have observed some very promising data in the Phase II trials. Naturally, there is risk when moving into Phase III. However, when we look at AMR, we achieved an 80% resolution in patients. For IgAN, we found that two years after treatment, patients continued to experience benefits. This leads us to believe that we have a disease-modifying effect in IgAN. Concerning felzartamab and BIIB080, we are conducting groundbreaking work, as no one has managed to reduce tau to the levels we anticipate. The outcomes of these trials will be enlightening. For lupus, we also had strong Phase II results, especially in CLE, where no drugs are currently approved. We are confident that dapirolizumab has already demonstrated its potential in one Phase III trial, and conducting a second Phase III seems likely to succeed. Similarly, with SLE and litifilimab, our company has been dedicated to this area for quite some time. While there are no guarantees in research and development, we have transformed our pipeline from many speculative projects to a more strategic approach that reduces risk. Looking at the peak sales potential of our late-stage pipeline relative to our current business gives us further optimism.

**Tim Power** (Head of Investor Relations):
Great. Thanks. Sorry, we got disconnected there. Chris, do you want to just respond to the last question, and if you don't mind?

**Christopher Viehbacher** (CEO):
Yes, I'm not sure where we left off. It's interesting that despite the massive investments in data centers and AI, we still rely on traditional communication methods like telephone calls. We have strong confidence in both the late-stage and early-stage developments, and we are currently enhancing our commercial capabilities in preparation for the upcoming late-stage launch. We are significantly expanding our knowledge and skills in immunology, which allows us to build upon our early-stage initiatives. Many companies concentrate so much on late-stage launches that they may overlook research, but now is the perfect time to invest in the next generation of products. I believe there has never been a better time to focus on immunology, and Biogen is perfectly positioned for it.

**Brian Abrahams** (Analyst):
Maybe a question for Alisha. Can you give us a sense on the early experience with LEQEMBI subcu maintenance uptake and access with regards to non-formulary exceptions what the potential timelines might look like to get on formularies, both for maintenance and induction? And maybe whether we should be thinking about net price here, ultimately landing at parity between the IV and the subcu forms?

**Alisha Alaimo** (President and Head of North America):
All right. Thank you for the questions. I think so far, the feedback has been very positive from not only payers, but HCPs and patients. We also anticipate that subcu maintenance is going to enable patients to also stay on therapy longer. So we see it as a big upside. It will take some time for providers and patients to adjust to this new outpatient treatment modality even in a maintenance capacity. But we do see this as a great bridge as we move into the potential of subcu initiation. So we do expect a gradual uptake, but over time, it will become a meaningful driver for long-term therapy and for our treatment outcomes. Now and into next year, what the teams are doing is first are educating sites on what you referenced, which is this non-formulary exemption process. However, payers have told us that this should not pose challenges to HCPs who are interested in transitioning their patients from IV and we are already aware of the first patients successfully navigating this process with their physicians, and we do know that we have several patients that are already on subcu. We also have a companion that has rolled out to the entire market that also helped patients with how to do the auto-injection, making sure they get their shipments and also making sure that physicians feel comfortable. Also through the non-formulary exemption process, if you look at analogs in the market outside of Alzheimer's disease grade rates are typically quite high. So again, we don't think that will pose a challenge. And then second is working through this Medicare Part D formulary for the goal of gaining access for patients across the nation. So we are now going through that process for Medicare, and we believe that we will have access, full access by 2027. In the meantime, though, they do go through the non-formulary exemption process. But at the end of the day, we are hearing that IQLIK is really just an amazing option for patients and physicians. In fact, just the other day, I was speaking to a physician who had done his 10,000 infusion of LEQEMBI. And he said some of his patients are very excited they can go on vacation. They can take this with them, and it's now giving them freedom to be able to travel even more than what they do today. So far, so good. Moving into 2026, and we believe the initiation is going to even be a great accelerator for us as well.

**Paul Matteis** (Analyst):
There has been growing interest in the prevention studies being conducted by Lilly and Eisai. I would like to ask a broader question about the commercial implications if these studies yield positive results. These outcomes could significantly alter the perception of Abeta drugs. However, our team is facing challenges in treating the diagnosed population due to various capacity issues. There are complications with MRIs and the supply chain overall. It seems that diagnosing asymptomatic patients and encouraging providers to treat them could exacerbate existing capacity problems and difficulties in the entire process of using and monitoring these drugs. What are your thoughts on this? How can you prepare for a successful outcome that generates significant returns on investment?

**Alisha Alaimo** (President and Head of North America):
Thank you for the question. I’ll address that. We’ve been considering this quite extensively, particularly with the possibility of favorable trial results, whether from Eli Lilly or Eisai/Biogen. One aspect we are focusing on is how primary care physicians can enhance the quality of their referrals. Blood-based biomarkers are advancing rapidly, and recently Roche received approval for a blood-based biomarker called Elecsys, which is designed to rule out asymptomatic or very early stage Alzheimer’s disease in primary care settings. We believe that through ongoing educational efforts—not just from us but also from several supporting organizations—physicians are becoming aware that many of these biomarkers can confirm diagnoses. During our current pilot study, which we will assess after the next quarter, we aim to determine if we can improve the prescribing, diagnosing, and quality of referrals. Notably, we have observed significant increases in the positivity rates for PET CSF tests; previously, these tests showed a 50-50 positive to negative rate, and now we have seen that number rise. This improvement is likely due to better triaging facilitated by blood-based biomarkers. Additionally, some patients may not qualify for Medicare based on age, prompting us to engage with commercial plans, as they will ultimately need to cover the product. We have begun those discussions, especially with younger patients who are interested in the product. By the time the trial results are available, we expect our capacity to be much improved.

**Christopher Viehbacher** (CEO):
We can also add to what Alisha mentioned about the subcutaneous form, which we expect to get approved for maintenance initiation. If blood-based diagnostics begin to replace PET scans and lumbar punctures, it will significantly lessen the workload on neurologists. As we've discussed before, our aim has been to streamline the care pathway for physicians to enhance throughput. Currently, about half of the patients who secure appointments with their neurologists are not truly eligible. By improving the efficiency of referrals, as Alisha noted, we will effectively boost capacity. It's important to mention that many neurologists have yet to start treating Alzheimer's patients. As we move forward, we anticipate that capacity will adapt accordingly.

**Marc Goodman** (Analyst):
My question is about SKYCLARYS. Can you just give us a little more color on what's happening behind the scenes? I mean, you mentioned the $6 million impact in U.S. sales, and you talked about OUS reimbursement issues a little bit. What's going on with volume growth maybe in the U.S. and then just overseas? Or are we seeing patient growth? Are we seeing good persistence like are there discontinuations? Just give us a sense of just what's happening with SKYCLARYS a little bit more?

**Alisha Alaimo** (President and Head of North America):
Thank you. I'll go ahead and take that question. I think first, 4, I'll start with ex-U.S. Building on the successful launch in the U.S., we continue unlocking new geographies for SKYCLARYS, which is now available, as we said earlier, in 34 countries. And we are pleased to see the steady and continuous growth once the access is granted overseas. And with that is a country-by-country basis, and they do continue to add patients on a weekly basis, which we see updates about. When you look at the U.S., the U.S. is in a different situation because we did launch earlier. And with that, we have basically had very high penetration in our centers of excellence, and we believe 90% of our remaining opportunity sits in the community. And so we do have patient growth, and we do have volume growth. When it comes to discontinuations, when we first launched, we did notice that in the beginning, our discons, though in line with MOXIe, we're happening quite early on, and we put a lot of tactics into place over this last year to address that with not only the field force, but the medical team. And I will say, fast forward to today, our discons rates have actually declined. So we've improved our discontinuation with education with physicians about some of the side effects they see and also what patients can expect. I think the second part of this, which I think will probably impact the entire world with this launch is how patients after they've been on it for a year or 1.5 years, because it slows the progression, it's very hard to be able to see like what is slowing progression look like. And we have had a couple of instances where patients have discon after about a year's time period, they've declined actually quite quickly, and they've now come back on to products. So we do know that at that time point, we will put more tactics into place on educating the actual patients and activating the patients.

**Andrew Tsai** (Analyst):
So going back to Alzheimer's, you guys have a Phase II tau data set coming up mid-2026. So I'm curious what you would want to see on CDR-SB and the degree of talent reduction as well? And if that study is positive, what would be your guys' base case and upside case expectation on the regulatory pathway?

**Priya Singhal** (Head of Development):
Sure. So I think overall, we believe that tau is really important pathological target and accumulation of tau is relevant and central to Alzheimer's disease. With BIIB080, the approach we've taken is really to address whether knocking down tau, all 6 isoforms of tau can result in target engagement. So we would need to see impact on biomarkers, fluid biomarkers, imaging biomarkers and then see at least a trend on the clinical benefit. That would be important for us to kind of think about the hypothesis. We know that early-stage research in AD is always highly uncertain. But I think if this hypothesis is proven, there's a huge opportunity. Now I think the other question you had was how would we think about it in the portfolio perspective. I think once we have that, it would be a stepwise approach to thinking of if it is positive, is there value to combination, parallel, sequential dosing and these are areas that we're thinking about really deeply as we think about what would be the optimal approach and outcome for patients with early Alzheimer's.

**Terence Flynn** (Analyst):
Maybe just a follow-up for me on tau. I know J&J is progressing an anti-tau antibody in Phase II and could have some data early next year. You guys obviously explored this approach as well. I think there are some differences maybe in terms of binding here. But when we see that J&J data, assuming it comes before BIIB080, how should we think about read through to your ASO program?

**Priya Singhal** (Head of Development):
I think overall, based on what I understand from the J&J program, this is posdinemab. And it's a tau monoclonal antibody it targets the mid-domain of tau. So it is different. And in our experience, we've had an experience and the field has had an experience of targeting tau with monoclonal antibodies thus far, that has not been promising. And we believe that the main reason here is the extracellular tau that it targets. And actually, that is the hypothesis posdinemab is testing. So we'll wait to see they are in Phase II. And I think what we saw from the Phase I data was an impact in some of the fluid biomarkers. However, we didn't actually see any data on tau PET, which we believe is very important. So we'll look for that data. And in terms of read-through I think, as I said, it's early days for research in Alzheimer's disease with an anti-tau agent. So we'll have to see what we see and then really try to analyze it, but I think if it works, it could be helpful, right? Because it would then address the point that is knocking down tau actually has an impact. So I think it would be overall positive, but we wait to see the data first.

**David Amsellem** (Analyst):
I have a ZURZUVAE question. So just wanted to get your thoughts on the fit of the product in the commercial portfolio, given that it's primarily a women's health product that doesn't really synergize with your other business units. I guess, how are you thinking about keeping the asset now that more well-resourced, well-capitalized partner now controls the other 50%?

**Christopher Viehbacher** (CEO):
I'm not certain about how well capitalized we are. However, we are very pleased with our partnership with Supernus, which is progressing extremely well. They have adopted a different strategy compared to Sage, but I believe there is still a significant opportunity for Biogen in this product, especially given the substantial unmet need. Shaping the market is crucial, and this is an area where Biogen excels commercially. From a resource perspective, I'm unsure if this aligns easily with Supernus, since their typical prescriber is a psychiatrist, while the primary prescriber here is actually an OB/GYN. Despite this, I believe there is still a viable opportunity given the sales and profit potential of the product. I'm not sure that we’re interested in expanding into other neuropsychiatry areas, but Alisha and her team are doing an excellent job in creating a market. This is a challenging scenario since this treatment is a one-time solution, making it important to build a base of prescribers who will prescribe it repeatedly. The opportunity is substantial, as only about 80,000 women are treated currently, while around 500,000 mothers in the U.S. are believed to suffer from postpartum depression. This aligns closely with Biogen's ethos. Alisha, do you want to add anything?

**Alisha Alaimo** (President and Head of North America):
Yes. Just to add to what Chris said. I mean, first of all, we have really gotten off to a great start with Supernus, and they've done a really nice job of trying to minimize the business impact anytime you have a handover. And so we really are off to a very good start with them. On the surface, it looks like there are synergies when it comes to the rest of the portfolio, but that's only when you look at really the field force. If you look behind the scenes and you look at really our infrastructure of Biogen, which we're in a very fortunate situation. And you look at things like our bio group, which is really our commercial operations group, we have a lot of synergy when it comes to data and analytics, insights generation. And especially, we have a very strong omnichannel presence. And so what's been great about even putting ZURZUVAE into our portfolio is that we've been able to utilize a lot of the back-office support to support this launch. And we believe that's also part of the reason why the launch has been successful is because of all of the experience that we've had with our other products. And also with our AI generation, we're doing some really interesting things for the ZURZUVAE launch as well. So stay tuned also on some more direct-to-consumer that we're planning for next year, which I think is really going to be a great accelerator for ZURZUVAE.

**Priya Singhal** (Head of Development):
Maybe I can just add that we also have approvals in the EU and U.K., and it is a very important moment for mothers with PPD because it wasn't really recognized as an entity, and this speaks to the quality of the data and the efforts and the high unmet way.

**Unknown Analyst** (Analyst):
It's Ross on for Jeff. Our question is how the company is approaching capital allocation, particularly in balancing business development and new launches, especially given the increased focus on developing an earlier-stage pipeline.

**Christopher Viehbacher** (CEO):
Yes. Thanks, Jeff. I mean, first, everything we're doing, as I said earlier, is to invest in long-term sustainable growth. We have been able to, I think, do a great job through previous judgment of building a very strong late-stage development pipeline. I mean a lot of companies when you're putting a lot of things into Phase III development start having to increase the R&D spend and yet we are still actually spending less than what we did 3 years ago. So I think we've demonstrated capital efficiency on that. We're being very thoughtful, but also the indications. So we're not going into indications where we have to go up against typically an AbbVie or a Sanofi or people like that. So the actual commercial investment is relatively modest compared to the opportunity. And that's, again, a space where Biogen plays well. We are recruiting people to bring in new capabilities in nephrology and in transplant and in lupus, but that's actually a relatively small number of people. And I think one of the best times to bring in assets is actually pre-IND you can do that on a cost-effective basis. You can take advantage of the fact that a lot of companies have venture capital backed financing, that is designed to take that risk, and you can actually build a portfolio easier of early-stage assets, either by collaboration or licensing and then you bring them in at the right point where Biogen can actually start to use, its more commercially oriented skills and development skills to shape those products. So I think from a capital allocation point of view, I think we can manage all of this. And I think we still have room, and we're not abandoning looking at later-stage assets, but the later this stage, obviously, the more expensive and you have to be extremely disciplined on ensuring that whatever you buy is going to generate a return on investment. So I think we are in a good spot today. And I think we've got the capital we need to do the business. But of course, we're continually monitoring that and making sure that everything we do is driving shareholder value.

**Tim Power** (Head of Investor Relations):
Thanks, Chris. That's it for today. I know it's a very busy morning for everybody. When you've got more questions, the IR team is here to answer those for you. Thank you.

**Operator** (Operator):
This concludes today's call. Thank you for your participation. You may now disconnect.