Biogen Inc. (BIIB) Q2 2026 Earnings Report, Transcript and Summary

Please stand by. We are about to begin. Good morning. My name is Jess, and I will be your conference operator today. At this time, I would like to welcome everyone to Biogen's second quarter 2026 earnings call and business update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. To ask a question, please press star one on your telephone keypad. If you require any further follow-up, you may press one again to rejoin the queue. Today's conference is being recorded. Thank you. I would now like to turn the conference over to Tim Power. Tim, you may begin your conference.

Thanks, Jess, and good morning, everyone. Welcome to Biogen's second quarter 2026 Earnings Call. During this call, we will make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results as well as reconciliations between GAAP and non-GAAP results discussed on this call can be found in the Investor section of biogen.com. We have also posted slides to our website that will be used during the call. On today's call, I am joined by our President and Chief Executive Officer Christopher A. Viehbacher; Dr. Priya Singhal, Head of Development, and Robin Kramer, our Chief Financial Officer. Alisha Alaimo, President, North America will also be available for the Q&A section of the call. We will make some opening comments and we will move to Q&A. To allow us to get through as many questions as we can, we kindly ask that you limit yourself to just one question. And I will now turn the call over to Christopher. Christopher?.

Thank you, Tim. So if I take the three elements that I think contribute to that, first is our growth product portfolio. Now even before we include the products from Apellis, we have seen significant growth. And in fact, our growth portfolio now is greater than our legacy MS portfolio. And that has really been most recently enhanced by two important achievements. The first is SPINRAZA high-dose, where we have seen across all markets. The first market to be approved was in Japan. Then Europe, and now the U.S. And we are starting to see this roll out into more international markets. In all of those markets, this conversion has gone much faster than we expected. And that is an important development for us because this is an extremely competitive market, where efficacy matters. And we have seen considerable efficacy benefits come from the high-dose of SPINRAZA. And this is a franchise that we see for the longer term because we have got salinursen coming along behind that. So, maintaining market share, and in fact, what we are seeing is some anecdotal switchbacks particularly from the oral product to SPINRAZA. It is an important not only for the quarter, but important for the franchise long-term. The second major achievement this quarter, was really the LEQEMBI IQLIK. It is the first of its kind Alzheimer's treatment, so now offering home dosing for both initiation and maintenance. Think there is probably two opportunities in particular here, maybe even three. The first is obviously, with the biweekly infusion, a number of physicians are thinking carefully about which patients are actually going to be eligible for treatment. If they do not think that the patient can get there on their own or there is not a caregiver who is prepared to take the time to get that patient to the infusion centers, those patients are often not offered treatment. So this should perhaps make it easier for a broader section of patients to become eligible for treatment. Think also that there could be a benefit in maintaining patients longer on therapy. And then finally, we think there is a competitive advantage because the benefit that the competitor has with once monthly dosing now seems to be much less when you have got a home, option for them. The second element is our pipeline, and we will come on and talk about that in a few minutes. But then the third element is really SYFOVRE and Empaveli from the acquisition of Apellis. You know, you have seen strong double-digit growth for both the full quarter and year-to-date for the combined sales of those two products. Now we are only consolidating the revenue from May 14, when we closed the transaction. But those products are already contributing significantly to our own growth. And I will take the opportunity here, just to note that if I think about all of the integrations, that I have certainly seen over my career, one of the most important metrics is really how revenue does through this period of turbulence really in organization. There is an awful lot of uncertainty that comes from these major transactions. And the ability to maintain continuity of revenue, I think, is the number one measure of the success of an integration. And I think so far, that we have seen that. And that is really because this is mostly a U.S. transaction. This is really a credit to Alisha's leadership and her team. And, really, reaching out and making sure that the Apellis team feels great about joining Biogen. And, certainly, when I talk to the former Apellis, now Biogen employees, one senses energy and passion and commitment. So we are very much encouraged by the importance of this acquisition. So the next slide is really again and Priya is going to talk a lot more about this. But we have got a growing base. And now we have got five registrational Phase 3 clinical trial results coming along. Obviously, two in SLE for lupus, one in CLE for lupus, one for AMR, and one, which is really from our partner at Stoke in, Dravet syndrome. So those are now within the next four quarters. So these are imminent and could really make a difference to the long-term growth outlook of Biogen. As we talked about before, we are also rebuilding our early-stage pipe. We went three years really without filing an IND. We made some really pretty dramatic moves to, overhaul our research organization, how we do research. And the encouraging thing is that I think we are now in a much better place already in our early-stage pipeline. Some of that is coming early. We have had three INDs already this year. We have got more to come. You know, we have done a number of key collaborations like Vanqua and Dayra last year, the acquisition of Braceira this year, also substantially boosted our early-stage pipeline. This is really investing today for really what would be products that launch in the mid-2030s. But, you know, you have got to start today, if you want to have that growth, tomorrow. And then if I look at this slide, this is a slide we first showed that JPMorgan earlier this year. At that time, we said, look. There are a number of near-term current growth drivers. You see them with LEQEMBI and ZURZUVAE, VUMERITY, SPINRAZA, SKYCLARYS, and QALSODY. And that is the group of products that now, exceed our legacy MS portfolio and grew strongly in the quarter. Now when you add SYFOVRE and Empaveli, these products already in themselves are enough to help Biogen get back to a growth story. And then when you look at what is coming, we just talked about these imminent data readouts. Let's see. The second wave here, the registrational late-stage pipeline you know, these are all products with significant opportunity. Now this is also a major shift for Biogen. You know, 3.5 years ago when I came, we really only were visiting the neurologist. We had a few products that we could still promote in MS, and we had SPINRAZA. We are now looking at visiting rheumatologists, dermatologists, nephrologists, outside the U.S., epileptologists, and transplant nephrologists. So there has been a significant, growth in the breadth of our portfolio. That is exciting, but it also means that really, now we are shifting to, not just growing the substrate of growth, but now executing on that growth story. So there is a lot going on inside the company to make sure that all of those launches are a success. But, you know, we are also keeping an eye on the longer term, and that is that third wave, the opportunities for longer-term growth here. You have seen the data on that. Very promising new modality in Alzheimer's, not necessarily part of the equity story near-term, but longer term, this could significantly contribute to Biogen's growth. This is where this renewed early-stage pipeline that I just talked about is so important in the research portfolio. From a BD/M&A point of view, I think, you know, I think we have what we need to grow near-term. I think we will be less intentional about M&A and more opportunistic, but we will be certainly intentional about the early-stage development. I mean, ideally, we would like to be bringing in assets between development candidates and IND stage. And so when you look at, you know, what is the opportunity, and these are not revenue forecasts, but really, you know, an initial sense of what is the addressable market that comes from the pipeline and I would say we are still doing work. You know, we have got lupus here as a potential $8 billion market. You know, the MS market is over $20 billion. And, you know, I think we are not there yet. in terms of being able to really say how we access that. It is probably a $2 to $3 billion market today, but there is no real reason why this market should not be the size of MS. But even if you just say the $8 billion, that is a significant opportunity for us to go after. And obviously, not only with FLE, but we would hope to be the first product to be approved for CLE. Then you have AMR. Approximately 11,000 patients just in the U.S. alone. Phase 3 data coming in early 2027. Now, that is at least a $2 billion addressable market here. You know, it depends on which pricing you are using, but when you see the pricing, that is now, occurring in IgAN that is gonna have a spillover effect on AMR. And then when you think about microvascular inflammation, which is another indication where we are pursuing, that market could also grow. And, of course, then later on, we have got IgAN and PMN data coming for felzartamab. Then Dravet syndrome, as you know, we have the U.S. rights. But even in ex-U.S. markets, there are about 7,000 patients in Europe alone. And when you add up all of our key, Biogen territories, you know, that is at least a $2 billion opportunity. Again, you know, we are busy working on that. We are still, in some ways, 18 to 24 months from launch on those things and continuing to work. But this shows the potential. It also shows why we have to execute with excellence, and we are busy investing today to make sure those launches are a success. And so when I go to the last slide, you know, if you looked at Biogen pre-Apellis announcement, you know, consensus investor view was that Biogen was gonna be roughly flat through, 2030. I think we are already seeing that consensus start to shift because people start to appreciate, the Apellis transaction. But the way we certainly see it is when you take the Apellis marketed products and you add them to our own growth product portfolio, you know, I think we are seeing a growing picture. And when you now then take the late-stage registrational pipeline, now I can remember vividly one investor in a meeting that we had just after we had announced Apellis. Saying, you know, I get it. The late-stage pipeline now comes on top of a growing base instead of a stable basis. And I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth. And with that, Priya can talk a little bit more about that late-stage registrational pipeline.

Thank you, Christopher, and good morning, everyone. As we deliver the new Biogen, a large part of our transformation and near-term opportunity for growth comes from our late-stage pipeline, as Christopher mentioned, and I am excited about this future. That is because today, we have one of the strongest and most diversified late-stage pipelines in Biogen's history with multiple near-term opportunities to create value in the upcoming years. We shared this slide with you at the beginning of the year, and today you can see that we are delivering on the opportunities we outlined including the FDA approval of IQLIK initiation which is an important innovation for patients and caregivers. Beyond IQLIK, Biogen and Eisai presented new data at AAIC earlier this month. This included real-world evidence supporting the long-term benefits of continuous LEQEMBI treatment. We also shared new data for BIIB080/dirinersen establishing proof-of-concept in Alzheimer's disease and we are now focused on developing the next steps for the program. And more broadly, we continue to demonstrate medical leadership across our portfolio with important new data presentations for both felzartamab and zolevameran. While these milestones reinforce the potential of our portfolio today, what makes this period particularly exciting is what lies ahead in the near-term. We are now entering a multiyear registrational cycle beginning with SLE data by the end of this year and followed by multiple catalysts extending through the remainder of the decade. And while we remain focused on advancing our high-conviction late-stage opportunities, In parallel, we continue to invest in the next wave of innovation. The progress we have made this quarter has meaningfully accelerated the transformation of our pre-proof-of-concept pipeline. At this point in the year, we are also now beyond our high-risk, high-reward readouts as we mentioned at the outset. This includes our Phase 2 BTK inhibitor, BIIB091, where we achieved proof-of-concept in relapsing remitting MS. And in line with our disciplined approach in how we advance assets, we are evaluating next steps given the increasingly competitive nature of that market. As we rebuild our early-stage pipeline, we expect to add six new programs this year. Including new Phase 2 proof-of-concept studies, to broaden the potential of felzartamab and Empaveli in autoimmune disease as well as first-in-human studies from our internal pipeline and the lead asset from the pending Braceira acquisition, which is now already in Phase 1. Overall, we believe these investments are building a durable innovation engine with the promise of delivering sustainable, long-term growth and value creation. So as we step back and look across the next several quarters, we expect readouts from five registrational studies across four important indications. SLE, CLE, AMR, and Dravet syndrome. And reflecting the strong execution of our teams, and enrollment momentum, we have also accelerated the expected Phase 3 readouts for felzartamab in AMR and litifilimab in CLE with data now expected in the first half of 2027. Later this fall, we also look forward to presenting new 52-week data from the Phase 2 portion of the ongoing AMETHYST study at the EADV annual conference. Which we believe will provide important insights into the durability of response for litifilumab in CLE. Taken together, these milestones are expected to generate important data over the next several months that have the potential to shape our next phase of growth. In summary, the strategic decisions and investments we have made over the past three to four years have positioned us to deliver near-term readouts while advancing long-term innovation. And we look forward to continuing to share our progress with you. With that, I would now like to turn the call over to Robin who will provide a financial update for the quarter.

Thank you. Thank you, Priya. Good morning, everyone. I am pleased to be speaking with all of you today following a strong revenue performance in the second quarter. Total second-quarter core pharmaceutical revenue was $1.8 billion, up 4% year-over-year and 12% quarter-over-quarter. This performance was driven by our growth portfolio, which generated over $1 billion of revenue in the quarter, up 24% year-over-year and 25% quarter-over-quarter. The Biogen standalone growth products, excluding Apellis, SYFOVRE and Empaveli revenue, were $933 million, up 9% year-over-year and 10% quarter-over-quarter. And as Christopher noted, generating revenue in excess of our legacy MS portfolio again this quarter. Our growth portfolio has been further strengthened with the addition of SYFOVRE and Empaveli from the Apellis transaction, which generated $128 million in combined revenue for the period post the May 14 acquisition date. This quarter's results demonstrate strong commercial execution, and the significant progress we have made in our portfolio transition. Let me now take you through some key highlights from our core pharmaceutical product performance in the second quarter. First, for the growth portfolio. SPINRAZA revenue was $402 million, up 2% year-over-year and 7% quarter-over-quarter. This was driven by both demand and stocking for the high-dose regimen in the U.S., partially offset by shipment timing in certain ex-U.S. markets. High-dose SPINRAZA was approved in the U.S. in March, the EU in January, and Japan last year. During the period of patient transition to the high-dose regimen, we benefit from revenue associated with the one-time transition dose. SPINRAZA high-dose maintenance is priced at parity with SPINRAZA. We are pleased that the pace of conversion to high-dose has been going well, and enthusiasm from the patient community for a higher efficacy option has been strong. We also believe this is encouraging for the opportunity for our registrational pipeline asset salinursen, which has recently received breakthrough therapy designation. VUMERITY revenue of $197 million was down 7% year-over-year partly driven by inventory dynamics, and up 10% quarter-over-quarter. Revenue for the first half of 2026 was up 7% versus the comparable period in the prior year. LEQEMBI end-market revenue was $184 million, up 15% year-over-year, and 9% quarter-over-quarter. We saw a continuation of market growth in key markets, including the U.S., Japan and China. And as Priya mentioned, we are pleased to have received FDA approval for IQLIK initiation earlier this month. SKYCLARYS saw patient demand growth both in the U.S. and ex-U.S. In the second quarter, revenue of $168 million, representing 29% growth year-over-year and 11% quarter-over-quarter. SKYCLARYS is now available in 36 countries, and we continue to expect SKYCLARYS growth to come largely from ex-U.S. as we advance the launch. ZURZUVAE continued to show strong underlying demand growth with revenue of $71 million. And we are also pleased to announce that ZURZUVAE is now launched in Germany. For the MS portfolio, I would like to highlight that TYSABRI continued to demonstrate resilience and demand in the midst of a biosimilar launch in the U.S. and Europe. Second quarter revenue of $451 million, was down 1% year-over-year and up 2% quarter-over-quarter. We have invested for a long time to establish TYSABRI as an important option for MS patients, and we are pleased to see this reflected in the resilience of TYSABRI thus far. Turning now to an update on the Apellis acquisition, which closed mid-quarter on May 14. The integration is progressing well, and both SYFOVRE and Empaveli had strong performance in the quarter. SYFOVRE continued to demonstrate market leadership with total revenue in the quarter of $162 million, up 8% year-over-year and quarter-over-quarter. with total commercial injections up 13% year-over-year. Empaveli continues to launch in C3G, and primary IC-MPGN, with total revenue of $46 million, up 123% year-over-year and 12% quarter-over-quarter. The Apellis acquisition accelerates our return to growth. It adds two best-in-class commercialized medicines to our growth portfolio, which we expect to contribute materially to our top-line growth in the near and long term. We expect SYFOVRE and Empaveli on a combined basis to grow in the mid- to high-teens through at least 2028. In addition, we expect this transaction to materially increase our non-GAAP diluted EPS CAGR through the end of this decade. We expect approximately $120 to $130 million of impact to our other income and expense line in both 2026 and 2027 associated with interest expense and foregone interest income associated with financing the transaction. We expect to generate at least $250 million of run-rate synergies by the end of 2027, largely from optimization of general and administrative expenses and research and development. For 2026, we expect approximately $0.85 of non-GAAP EPS dilution primarily from financing costs associated with the transaction. We expect the transaction to be accretive to non-GAAP diluted EPS in 2027. We believe this transaction represents an attractive use of capital that will further bolster both our top-line and bottom-line growth prospects and in therapeutic areas aligned to our immunology and rare disease strategy. Moving on to the financial highlights. Total revenue for the quarter was $2.7 billion, up 3% year-over-year. Revenue from the anti-CD20 royalties and profit share included in other revenue was $514 million, up 10% year-over-year. This increase was driven by royalties from Ocrevus, which benefited from the recent subcutaneous launch, and resilience from Rituxan in the U.S. In addition to the revenue contribution in the quarter from SYFOVRE and Empaveli, as previously discussed, our results of operations for the second quarter of 2026 include a half quarter of operating expenses and financing costs associated with the acquisition of Apellis. Non GAAP cost of sales as a percentage of revenue was 22% in Q2 2026, versus 21% last year. Increase was primarily due to product mix. Largely from increased contract manufacturing revenue. GAAP cost of sales as a percentage of revenue was also impacted by higher amortization costs associated with the acquired inventory fair value step up adjustment for Skyclaris from the Reata transaction, and SYFOVRE and Empaveli from the Apellis transaction. Non GAAP core OpEx or combined R&D and SG&A expense increased 20% year-over-year. This reflects approximately $95 million of the Apellis operating expenses from the May 14 acquisition date through the end of the quarter. For R&D, it also reflects our investments in our Phase 3 clinical programs. Including felzartamab's indication in MVI, and salinursen, which were advanced as registrational studies in the second half of 25. And litifilimab where we expect the Phase 3 SLE data later this year, including a $25 million year-over-year decrease in R&D funding from the royalty pharma funding for litifilumab. For sales and marketing, it reflects support of our US and international product launches, and investments in prelaunch activities for our late-stage high-conviction pipeline. As we previously announced, we recorded $164 million of acquired IPR&D and milestone charges, associated with our investments in the development pipeline in the second quarter of 2026, including a $100 million upfront to TJ Bio associated with the acquisition of the felzartamab rights in China, giving us worldwide rights to felzartamab. A milestone payment of $45 million to Ionis in connection with the initiation of the Phase 3 trial for salinursen in SMA. And an upfront payment of $15 million to Ionis to opt in to BIIB147 in broad ALS. Now turning to cash flow and the balance sheet. We continue to generate strong cash flow. With $408 million of free cash flow generated in the second quarter. We exited the quarter with $1.3 billion of cash and $6.8 billion of net debt. We closed the Apellis transaction in the second quarter, which was funded with $3 billion of cash, from the balance sheet. And a billion term loan, During Q2, we repaid $200 million of the term loan and continue to expect to repay the remainder of the term loan by the end of 2027. Turning now to guidance. Based on the expected revenue performance of our base business, including our products and TYSABRI, our guidance update reflects a 60-point increase in the underlying business guidance as compared to our previous guidance. We are pleased to be increasing our total revenue guidance from a mid-single-digit percentage decrease to a mid-single-digit percentage increase. This reflects both the expected performance of our growth products and TYSABRI as well as the addition of SYFOVRE and Empaveli into our product portfolio. Our guidance also reflects updates to core operating expenses, other income and expense and our full year tax rate primarily to incorporate the impact of the acquisition of Apellis. We expect our core operating expenses in the second half of 2026 to be between $2.65 billion and $2.7 billion Our guidance also reflects updates associated with our investments in the early and late-stage pipeline. As well as those associated with our near and midterm growth and incorporates transactions that have been executed and our current expectations of those that will occur for the remainder of the year. It incorporates approximately a $3 non-GAAP diluted EPS impact of charges associated with IPR&D and milestones, including the Q2 TJ Bio transaction. The Ionis milestone associated with achieving the first patient dosed in STELLAR, our pivotal Phase 3 salinursen study in SMA, the pending Braceira transaction associated with the addition of a Phase 1 immunology asset into the early-stage pipeline which is expected to close in Q3. And the expected full-year 2026 -e.85 dilution associated with the Apellis transaction again, largely driven by the impact of financing costs. Our updated 2026 full year non-GAAP diluted EPS range is now between $12 and $13. Please be sure to review this slide as well as slide 25 in the appendix of this presentation and our press release for other important full-year 2026 guidance assumptions. In closing, strong commercial execution in the Biogen base business and the addition of SYFOVRE and Empaveli resulted in strong top-line performance in Q2, and the completion of the Apellis acquisition accelerates our near- and mid-term top-line and bottom-line growth potential. With that, I would like to pass the call back to Tim to open us up for questions.

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

Certainly. star one on your telephone keypad. Your first question comes from the line of Chris Schott with JPMorgan.

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

Hi, Chris. This is Alisha. I will take that question. So if you really think about SPINRAZA, it was almost a decade ago introducing the first SMA treatment. What I think you are seeing is SPINRAZA still setting the bar on efficacy in this space. And, also, if you think about how did SPINRAZA high-dose even come about, this was from several years ago. We had many patients come forward, to Biogen, you know, we just wish we had more. We wish we had more. We feel like we could take an even higher dose. And then, obviously, Biogen went in and developed this new formulation, and here we have high-dose today. So now that we have launched, we are seeing basically the demand and the urgency really being driven by this patient community. In fact, if you think about metrics, SPINRAZA high-dose is exceeding the original launch of SPINRAZA in both start forms and GRADs in the first 13 weeks of launch. And we are growing every single week. So when you look at the Q2 revenue, sites are ordering high-dose to prepare for each patient's next dose. And when you think about the dosing of the product, you do have to wait a quarter or 2 depending on when you had your last dose of SPINRAZA. The feedback from patients so far that have received the product has been quite positive. Also from the physicians quite positive. So the teams are really supporting the payer approvals and the account P and T reviews and patient transitions. Now in this initial bolus of launch demand, you are seeing that the majority of the patients are transitioning from SPINRAZA 12 mg to high-dose. however, we also have several patients who are either new to SPINRAZA and particularly babies. You know, we had not dosed the baby in years. And so we are seeing babies now getting dosed. And also, have had several switchbacks from Evrysdi. So we think for this year, what you are going to see is the bolus of the transitions along into the beginning of next year, but our big focus for 2027 is going to be on new starts and on switchbacks. one of the advantages that you have that we did not realize was going to be such a positive in the market is with the SPINRAZA 12 mg, there are 4 loading doses. With high-dose, there is only 2. And we do have patients who are more willing to do the 2 as the loading dose than the 4 and that is where you are seeing some of the switchbacks and patient starts. Yeah.

And just the U.S. is actually one of the last countries to launch actually unusually. So Japan where we launched earlier and as in Europe, that is where actually we are seeing particularly Germany, seeing a reversal of the trend of switching to oral therapy and some trending back. Now it is, you know, I think it is still early days, and as Alisha said, it is largely first. People moving from the lower dose to the high-dose. But again, as Alisha said, in all markets, and I go talk to physicians around the world when I am visiting our affiliates, You know, at the end of the day, it is really in these devastating diseases, efficacy that really matters, and there is an enhanced opportunity here for that.

Thank you. Let's go to the next question, please.

We will go next to Umer Raffat with Evercore.

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

Thanks. This is Priya. I will take that. So I think just stepping back, we are really excited about our TOPAZ trials. This is TOPAZ-1 and TOPAZ-2. We will have results from both of these in Q4, this year. These are our SLE trials. Maybe just stepping back, I will just comment on the fact that, you know, we have taken all the learnings from the prior trials to really ensure that we set these trials up appropriately. And by that, I mean, we focused on the high placebo responses that we have seen in past trials. Our trials have had rules to limit standard of care utilization. By that, I mean NSAIDs, corticosteroid tapers, you know, handling data for responders and nonresponders. But we have also stepped up to really think about the fact that this is a heterogeneous disease. So how do we control for patient and participant heterogeneity? And we have tried to model our inclusion-exclusion criteria to be really quite track very closely to Phase II LILAC proof-of-concept. Now with regards to what we expect, I think we remain confident in our trial design, site selection, patient selection, really to get a very robust response. We will see, how we kind of perform in the trial, and we will wait for the results. I will not speculate. Our primary endpoint is SRI-4, however, we have a key secondary endpoint in BICLA. And we have multiple patient reported outcomes. So we will really be looking at the totality of the data, including interferon signature and all of that. I will also remind us that from a MOA perspective, we think that litifilumab is truly differentiated. Yes. It affects the interferon pathway, but it also affects chemokines and cytokines. And we think this is what is going to provide, really the overall benefit. And then, of course, CLE, we expect data next year, and we will be presenting 52-week data at EADV this fall. So we remain confident in that dataset as well. Now moving to your second question on the BTK inhibitor, we have not actually disclosed doses, so I will not be sharing much more information. And we are looking at what the next steps might be for this. Alisha, do you want to add anything?

Alisha, in the market research, because I think this is one of those where it is no one thing that is going to be a marker of success. You have got steroid sparing. One of the things that we consistently hear from patients is fatigue. And yet you cannot really build fatigue into an endpoint in the clinical trials as easily. So real-world evidence will play a role, but maybe you can say a few words on what it is going to take commercially to succeed. Thank you, Christopher.

Hi, Umer. Nice to hear from you. First of all, we have now recruited several senior leaders with lupus experience, an entire medical team with lupus experience, and several marketers with lupus experience. And I have to say we have probably gotten more insights from them than the actual market research that you can get, you know, through third-party. And I have to say that, you know, we talk about things like SRI-4 and endpoints, but when you really look at a physician and patient interactions, what we are finding in this market is there is a huge disconnect on what they expect from treatment. Doctors wanna run a patient's experience just by what they see in labs. And patients will come in and say, the three things that are really bothering me are fatigue, brain fog, and joint pain. And I do believe in this market, when you look at CLE where there is only less than 5% of CLE patients receiving an advanced therapy. And I also, because there is no approved therapy, think the CLE patient numbers are undercalled. I know that we have reported out 75,000. I think that is a much lower number than is actually out there. Secondarily, you are seeing that patients are getting lost in the system being transferred from derm to rheum and rheum to derm where no one really knows how to treat them. And then with the treatments that are on market as of today, you know, there are drawbacks. One, you know, does not work very quickly or very well, and another has an infection safety issue. And so when you speak to these physicians, they are really looking for treatment that can work much more quickly and can work in both CLE and SLE. So I think that there is a very long runway for this therapeutic area. And because there is such a huge unmet need and these patients are known, we can track them in the system because most of them are diagnosed. We know which physicians they have been diagnosed by and who they see. I think that even though there is a lot of work to do, I find this to be a very, very good therapeutic area to enter.

Go to the next question, please, Jess.

We will go next to Mark Goodwin with Leerink Partners.

Yes. Can you give us a little more insight on SYFOVRE and just what is happening behind the scenes like new patient starts or I mean, just the durability of patients. And, you know, we understand that the injections were up 13%, but just trying to understand, like, what is going on there and what kind of growth we should be expecting from here. Thanks.

Thank you for the question. There is a lot going on with SYFOVRE since we have been able to integrate them into the organization. First, I wanna say I am you know, very much impressed, and very grateful for the level of talent expertise that joined from the SYFOVRE team. I think the first thing that we have noticed with both SYFOVRE and Empaveli is when they came on board, the company, used very similar launch plans. And I think the one thing that we have really learned over the last seven years with our seven launches is that we really tailor-make, our launch plans. We really build them from the ground up. We launch very much informed, and it is not templated. So what we have been able to do is work with the SYFOVRE team on across the board understanding what is really, you know, driving sales, where can we maybe reallocate capital, and how do we get the Biogen machine, sort of, help drive, some of their momentum? And so I am very encouraged by the strongest quarter since really launch for SYFOVRE. And in the month of June, which was the best month in the brand's history. And so what we are really seeing is a quality of growth across a number of areas. I think number one, you are seeing our free drug has been lowered by half. We did end up looking at the free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need free drug do get it, and that has dropped by half. That has been part of the momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of geographic atrophy and where physicians are today, this SYFOVRE team has done a truly tremendous job on changing that sentiment. And because sentiment has improved so much that is where you are seeing new writers coming on board. It is also where you are seeing many more patients coming on board. So they grew both in patient numbers and in physicians who are prescribing. And I think that one of the tailwinds on that was the long-term five-year data that they have been presenting, and there is really a lot of education around progression of geographic atrophy. And specifically, when you look ahead, the market's only 50% of the retina specialists are treating and only 20% of these patients are diagnosed. So the team is really looking at a couple of things. One is direct-to-consumer. We have decided to shut down a few programs. We are reallocating to a new commercial. I think maybe the SYFOVRE team and leadership thought their DTC came out a little too soon now that we think that the market is ready. We do plan on launching a DTC campaign that we believe will be very effective. Secondly, a prefilled syringe. We do look forward to that launch as well. Prefilled syringe is going to really support the workflow physicians. We believe it will make it much faster for them, much more efficient. And they probably will be able to get, you know, more injections into the eyes with saving them approximately 15 minutes with these injections, so that is also great. But more importantly, on a previous call, I had mentioned to you when we were looking at SYFOVRE, One of the things we had seen in our diligence is that there was a disconnect. A lot of patients discontinue after one year. Well, now that the team is on board and we have really looked at the data, we have noticed that actually the discontinuations happen after the first injection. That is where the big bolus comes from. Even though it really only shows up in the numbers after one year where you see the 50% drop-off. And we now believe due to all of the brands that we have had where we have had disconnect issues after either the first injection or first IV infusion, we know exactly what to do for that. So we are also rallying the team around how we support educating those patients and physicians on why they do not need to disconnect after the first injection, what kind of education needs to happen in the doctor's office. So right now we believe the HCP growth is trending in the right direction. We believe we will keep up that momentum. And then our focus is going to turn to educating the patients and activating them with DTC. Thank you.

Let's go to the next question, please.

We will go next to Salveen Richter with Goldman Sachs.

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

Thank you, Salveen. This is Priya. So just stepping back, you know, we took BIIB091, which is a peripheral BTK inhibitor, noncovalent, into a Phase 2 trial in RRMS a few years ago. And now we have concluded the trial, and what we see is that it could have compelling efficacy in RRMS. But, actually, as I mentioned in my remarks, we are looking at what is the appropriate next step. Because we see RRMS as a very crowded competitive market, but we are also looking at the external inflections that we have seen in the BTK landscape. So we will communicate more about how we see this asset progressing further. And we have not actually made a decision to specifically advance it into an indication. So we are not there yet. We are still evaluating the data. Overall, we see that it could perform really well in RRMS, but I think it is another very important example of how we prioritize assets in our portfolio where we look at the scientific data, but we marry it up with the value and the opportunity in terms of totality and really capital allocation. So this is an example of where we are taking a pause. We are looking at the data, and we will assess how and when and if we would advance it beyond where it is today. I hope that helps.

Thank you. Let's go to the next question, please, Jess.

We will go next to Michael Yee with UBS.

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

Thank you. I think stepping back, I actually do not see a difference in terms of probability of success between SLE and CLE. I remain confident in really the data that we saw from our LILAC Phase 2 trial, which we believe was a compelling proof-of-concept trial. And it was important because we tested the SLE population. However, it was enriched for where we believe litifilimab will have the strongest actions based on its mechanism of action. So we have focused our SLE trial to be quite specific to patients who have skin and joint involvement. And that is why I think I remain confident in, you know, how we have set this trial up and probability of success. Similarly, with CLE, I also remain confident because of the, you know, focus on the skin and the data that we have generated so far. It just happens to be the situation that for SLE, given the broad indication, and it is a very, unfortunately prevalent disease, we have 2 Phase 3 trials. And then with CLE, we have a Phase 2/3 trial, and that was a seamless trial, the AMETHYST trial. So you may remember that we actually have the opportunity to share Phase 2 data. It is not because we are more or less confident that we are sharing it. We have the opportunity to look at the Phase 2 data by itself without disrupting the Phase 3 portion. And we are just simply taking that data forward and bringing it to EADV. We have already shared the Phase 2 randomized controlled part of AMETHYST earlier this year. So now we are sharing the 52-week data which hopefully will say more about durability of response. But, no, I think we remain confident in all three trials. And then as was mentioned, we think this is really highly undertreated. You know, very few biologics have made it. And they have not really penetrated the market. And we think that is actually related to their treatment response. We think, you know, with the right mechanism of action, we really have we could meet a very high unmet need in this area.

Go to the next question, please.

We will go next to David Amsellem with Piper Sandler.

So on Empaveli, I noticed you are initiating a Phase 2 in FSGS. Wondering broadly how wide of a development that you are going to cast regarding the molecule just given its complement C3 inhibition and how you are thinking about, you know, other indications potentially beyond FSGS? And then secondly, if you can comment on your anti-CD40 ligand that is Phase 1 ready. Maybe comment on how it is different mechanistically than the CD40 ligand antagonist dapirolizumab that is running a Phase 3 program in Sjogren's. Thank you.

Thank you. Maybe I will start with Empaveli there. So I think we remain excited about the fact that we have brought in Empaveli and, of course, its nephrology indications as well as the paroxysmal nocturnal hemoglobinuria remain very important commercial indications. But as we have been you know, we brought this in our legacy Apellis team was already working up a lot of indications, and we looked at these, and there were 2 important nephrology trials that they were considering. 1 was delayed graft function, which we have paused, and, we would not be continuing that. But for FSGS, we believe, remains a really important indication. And the reason for this is that we believe it is a high unmet need. It does have clarity on the primary endpoint and a regulatory path as well as the ability of Empaveli to really address the C3, C3b cleavage pathway and thereby impact the autoantibodies. And we have real-world data, but also murine models where we have seen elevated levels of C3. So we believe this really is a science-forward approach and we are being very prudent. We are taking this forward as a Phase 2 proof-of-concept, and we could have data really in short order once we initiate the trial. We also already have sought, I think, our Empaveli legacy team has already sought FDA feedback. So this really comes with a really nice package which we believe is worth prosecuting. So that is where we are. We will be looking across really where does complement specifically C3 have a large role in disease. But the other part, as I mentioned in the other example, just a short while ago, is really the value proposition. So we are always looking at the addressable market. For example, with this FSGS, we know there are about 27,000 patients in the U.S. We know there are four types. We will be running a very clear and decision-enabling, you know, trial to really give us next steps. Now with regards shifting to your second question about the anti-CD40, we remain excited about the pathway. We think it is differentiated, and it could be something that we bring forward also in autoimmune disease. We have not shared that yet, but we will be communicating more when the time is right. Thank you.

Jess, could we go to the next question, please?

We will go next to Alex Hammond with Wolfe Research.

Hey, guys. Thanks for taking the question. So it is been a few weeks since you posted or presented the full CELIA-AD data at AAIC. I guess given it is been some time for you to digest the reaction from the medical and regulatory community, what feedback have you been getting? Has there been any feedback that is kind of shifted your thinking at all in the Phase 3 trial design, particularly the potential for early combination with anti-beta antibodies? Thank you.

Yeah, I will take that one. And as I said in my remarks, BIIB080/dirinersen is really part of the longer term story of Biogen. And, you know, the Phase 2 was really an exploratory study. And the main objective was really to see if you reduce tau, could you move cognition? Because up until now, tau has been a theory, a favorite theory, but it is still a theory. And this is the first time anybody's shown any data on this. Now the business decision really to go forward with that is Priya had already, when we got the data, arranged for an independent biostatistician to review the data. We had an outside expert to review the data before we announced it. Then multiple advisory groups. We had the presentation at AAIC. One of the very strong pieces of feedback is the signal is real. This is not due to chance. You know, a lot of people got there doing a lot of over-analysis of the dosing question. There are a lot of different hypotheses. One is that it is very clear that tau is important to neurotransmission. And so while too much is not good, maybe too little is also not good. We just do not know. This is the issue of being in breakthrough science. It is very exciting, but It is also one of the reasons we decided not to build the company on this type of product. This is one of these high-risk, high-reward program. We are doing a lot of investigation and discussion with the neurology community. And, obviously, we will be consulting with the FDA. We also have long-term extension data that are coming along, and we will make those available. But, you know, this is a long-term investment. We are confident in the signal. And, you know, it could be an exciting option, but, you know, still gonna have to go through Phase 3, and it is not something that is gonna affect Biogen's growth, over the rest of this decade. So that is all we really want to say about BIIB080/dirinersen at this stage.

Thank you. Let's go to the next question, please.

We will go next to Brian Abrahams with RBC Capital Markets.

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

Hi. Thank you. I will take that question. As you know, earlier this month, we received approval for LEQEMBI IQLIK for induction. And it will be available by the end of August in the market. So what we have done is our field teams are trained. We are educating the HCPs and letting them know availability is expected next month. So we have already had some demand. Of course, it is not getting filled yet, but they are put into a queue. So we know as of yesterday, several physicians have already written scripts, and so we are not really counting that yet in our expectations until the product is actually readily available for the market. So we are keeping a close eye on that. Now as you also know, Eisai is trying to make access very easy for this and as simple as possible. They are the ones working with the payers on Part D access. And so we will find out again in several months what kind of access we will receive at the beginning of next year. however, even if some of the Part D plans do not contract for LEQEMBI, the other route, which they have been going through with IQLIK maintenance has been medical exceptions. Now when we pull the data to look at the medical exception rate for the product, it is quite high. Higher than most other therapeutic areas. And so even when a physician does put that through, the grant approval rate is high, meaning that they are getting the product for the patient. And so it remains to be seen what happens as of 1/1 next year for the coverage, which, by the way, even if you get a Part D plan coverage, a prior authorization must be filled out. So a doctor's either filling out a prior authorization or filling out a medical exception form for the product. So we also believe that based on the market research, that we have done recently, IQLIK will evolve this market and will be another contributor to growth once it gets off the ground. Now keep in mind, a lot of the protocols for LEQEMBI are written for IV, and so a lot of the IDNs and hospitals and systems are starting to rewrite those to incorporate IQLIK, obviously, also into their workflow. And we also see that Christopher had mentioned earlier, when you look at drop-off rates, where, you know, there are drop-offs at many points in a patient journey, but one particularly is when they finally get to a physician who believes in anti-amyloid therapies, and goes to prescribe the product, one of the largest drop-offs is patients not wanting to take IV in general. That is agnostic of LEQEMBI or donanemab. We also believe in our market research it shows that those patients would opt in to doing subcutaneous. And so there is a big portion of patients who drop off exactly for that reason, and so we believe that will also help accelerate the market.

Go to our next question, please, Jess.

We will go next to Paul Matteis with Stifel.

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

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

Yeah. I mean, longer term, you know, Alzheimer's is certainly gonna be a core part of the portfolio of Biogen. Particularly now that, you know, there is a very good chance that BIIB080/dirinersen ultimately makes it to market. Clearly, we have to go through the Phase 3 program. Again, you know, I think what really is important for this market and you talk to physicians to actually treat patients, it is really moving cognition. So that is what has caused us to go forward with BIIB080/dirinersen. Now, it probably makes sense to have a portfolio of products. And, you know, we are already even talking internally and have not made any decisions yet, but are you gonna combine an A-beta with an anti-tau, for example? There is a question of, well, maybe you do not even need to take after you do three or four injections of anti-tau. Maybe you need just an anti-beta, or anti-A-beta to keep the tau from coming back. But all of those things are kind of what we are war-gaming. This would be something that certainly would affect the business in the next decade. But I think if we are gonna be in all Alzheimer's, we are certainly looking to have a portfolio and, clearly, brain shuttles would be the next generation of products to pursue. And as Priya said, we have been working on that for several years now. Thank you.

We might be trying to squeeze two last ones in. Could we go to the next one, please, Jess?

Certainly. We will go next to Evan Seigerman with BMO Capital Markets.

I think, Christopher, you had mentioned felzartamab in AMR could be a $2 billion opportunity. My question: What do you think we, as investors, need to see to be convinced of that? And what could you be showing us when we get that data come next year? Thank you so much.

Thanks, Evan. You know, One of the things that we saw when we were doing diligence on Apellis was that there really had not been much value associated with Empaveli. And you know, I think there is a tendency to really focus on kind of lead products in companies. And for some of these programs where there is no treatment, there are also no analogs. And so I think what we see is and what we have heard from a number of, analysts and experts is that there tends to be a placeholder value put in there. And people then wanna wait and see the data. But, you know, 11,000 patients, and if you took even the Otsuka price in IgAN of $350,000 you know, you are getting somewhere between the $3 billion and $4 billion market. And when you consider that the Phase 2 data showed an 80% resolution of AMR in an open-label in a small study and obviously something we have to repeat in a Phase 3. But there is no product approved for AMR today. So, you know, the option for patients is either, treatment with felzartamab or perhaps a second kidney transplant. I mean, I was in Brazil recently and visited the hospital where they do more kidney transplants than anywhere else in the world. I estimate that somewhere between 10 and 20% of people on the kidney transplant list are people who have already had a kidney transplant. So there is a huge unmet need. This is a product that really seems to work. So we have very high hopes for this product. Thank you.

Let's go to our last question, please, Jess.

We will go to Terence Flynn with Morgan Stanley.

Maybe a follow-up on that last point. This is probably for Christopher or Priya. Just in terms of the TRANSCEND trial, can you remind us of the powering on the primary endpoint and what is required from the FDA to support approval in the late AMR indication? And then, how should we think about lateral implications from TRANSCEND for microvascular inflammation? Thanks.

Yep. I can start. I mean, we have not commented publicly on the powering. We believe we have a very robust trial design and power to really give us confidence in the outcome. So I think we remain confident in our trial design. As you know, the trial, the TRANSCEND trial is a 6-month placebo-controlled. This is biopsy-driven as an endpoint, which is really important. And then, you know, patients move on to maintenance for the next 6 months. And I think durability, but the 6-month time point are both important. We have been able to-- I think that is another really good sign, but we have been able to accelerate the trial. So now we expect data in the first half of 2027. And I think overall, we remain really excited. Now the MVI is obviously a more recent, you know, diagnostic criteria through the Banff criteria. And this is important because these are donor-specific antibody-negative patients, but it is a very important population. And what we decided to do along with our, you know,, HI-Bio team, they are experts in the area, is to actually initiate the MVI trial, which is not a TRANSCEND trial, as soon as possible. So that trial is already underway. And so we will also have, you know, data emerging from that trial. And we think that, yes, the felzartamab mechanism of addressing plasma cells and the anti-CD38 will have an impact in both MVI as well as in AMR. MVI itself in the U.S. is a sizable population of about 6,000 patients. So this remains an important auxiliary but very important aspect of the unmet need. So we think this is really a very, very important opportunity, and we remain confident that felzartamab really has a very good high probability here of giving us the data that we are looking for. Thank you.

Thanks, everybody, for joining us today. If you have got follow-up, you know where to find us. Take care.

Thank you. Ladies and gentlemen, that will conclude today's call. We thank you for your participation. You may disconnect at this time.