Biogen Inc. (BIIB) Earnings Call Transcript & Summary

[Audio Gap] conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2026 Earnings Call and Business Update. [Operator Instructions] I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

Thanks, 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 Investors section of biogen.com. We've also posted slides to a website that will be used during the call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and Robin Kramer, our Chief Financial Officer; Alicia Alaimo, President of North America, will also be available for the Q&A section of the call. We'll make some opening comments, and we'll move to Q&A and to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question. And I'll now turn the call over to Chris.

[Audio Gap] with the goal of achieving sustainable revenue growth. So if I take the three elements that I think contribute to that is, first is our growth product portfolio. Now even before we include the products from Palace ], we've seen significant growth. And in fact, our growth portfolio now is greater than our legacy MS portfolio. And that's really been most recently enhanced by two important achievements. The first is SPINRAZA high dose, where we've seen across all markets. The first market to be approved was in Japan than Europe and now the U.S., and we're 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's an important development for us because this is an extremely competitive market where efficacy matters. And we've 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've got [ salinersen ] coming along behind that. So maintaining market share. And in fact, what we're seeing is some anecdotal switchbacks, particularly from the oral product to SPINRAZA, it's important not only for the quarter, but important for the franchise longer term. The second major achievement this quarter was really taken LEQEMBI IQLIK. It's the first of its kind, Alzheimer's treatment. So now offering [ one ] dosing for both initiation and maintenance. I think there's 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 don't think that the patient can get there on their own or there's not a caregiver who's 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. We think also that there could be a benefit in maintaining patients longer on therapy. And then finally, we think there's a competitive advantage because the benefit of the competitor has with once monthly dosing now seems to be much less when you've got a home subcutaneous option for them. The second element of the sustainable growth is our pipeline, and we'll come on and talk about that in a few minutes. But then the third element is really [ CYFOVRI and Pavel ] from the acquisition of appellate. You've seen strong double-digit growth for both the full quarter and year-to-date for the combined sales of those two products. Now we're only consolidating the revenue from the 14th of May when we closed the transaction. But those products are already contributing significantly to our own growth. And I'll take the opportunity here just to note that if I think about all of the integrations that I've certainly seen over my career, one of the most important metrics is really how revenue does through this period of turbulence really in an organization. There's an awful lot of uncertainty that comes from these major transactions. And the ability to maintain continuity of revenue is, I think, the #1 measure of the success of an integration. And I think so far that we have seen that, and that's really because this is mostly a U.S. transaction, this is really a credit to Alicia, Alicia's leadership and her team and really reaching out and making sure that the [ Appellate ] team feels great about joining Biogen. And certainly, when I talk to the former [ Apellis ] now Biogen employees, one sense is a sense of energy and passion and commitment. So we're 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've got a growing base, and now we've got 5 registrational Phase III clinical trial results coming along. Obviously, 2 in SLE for lupus, 1 in CLE for lupus, 1 for AMR and 1 which is really from our partner at Stoke in [ Dravet ] syndrome. So those are now within the next 4 quarters. So these are these are imminent and could really make a difference to the long-term growth outlook of Biogen. As we talked about before, we're also rebuilding our early-stage pipeline. We went 3 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've had 3 INDs already this year. We've got more to come. We've done a number of key collaborations like [ Bank and Dave ] last year, the acquisition of [ Bayer ] this year also substantially boosts our early-stage pipeline. These are -- this is really investing today for really what the products launching in the mid-2030s. But you've got to start today if you want to have those -- that growth tomorrow. And then if I look at this slide, this is a slide we first showed at JPMorgan earlier this year. At that time, you said, look, there are a number of near-term current growth drivers, and you see them with LEQEMBI IQLIK, VUMERITY, SPINRAZA, SKYCLARYS and [ Casady ]. And that is the group of products that now exceed our legacy MS portfolio and grew strongly in the quarter. Now when you add [ Ciporin and Pavel ], these products already and themselves are enough to help Biogen get back to a growth story. And then when you look at what's coming, we just talked about these these imminent data readouts, that's the second wave here, the registrational late-stage pipeline. These are all products with significant opportunity. Now this is also a major shift for Biogen. 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. in epileptologists and nephrology transplant. So there's been a significant growth in the breadth of our portfolio. That's 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's a lot going on inside the company to make sure that all of those launches are a success. But we're also keeping an eye on the longer term, and that's that third wave, the opportunities for longer-term growth. [ Dear Nursing ], and you've 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 removed 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 we have what we need to grow near term. I think we'll be less intentional about M&A and perhaps more opportunistic but we'll be certainly intentional about the earlier stage development. I mean ideally, we'd like to be bringing in assets between development candidate at IND stage. And so when you look at what is the opportunity, and these are not revenue forecast, but really an initial sense of what's the addressable market that come from the pipeline. And I would say we're still doing work. We've got lupus here as a potential $8 billion market. The MS market is over $20 billion. And I think we're not there yet in terms of being able to really say how we access that. It's probably a $2 billion to $3 billion market today, but there's no real reason why this market shouldn't be the size of MS. But even if you just say the $8 billion, that's a significant opportunity for us to go after. And obviously, not only with SLE, but we would hope to be the first product to be approved with for CLE. Then you got AMR, approximately 11,000 patients just in the U.S. alone. Phase III data coming in early 2027, that's at least a $2 billion addressable market. It depends on which pricing you're using. But when you see the pricing that is now occurring in IgAN, that is going to have a spillover effect on AMR. And then when you think about microvascular inflammation, which is another indication we're pursuing, that market could also grow. And, of course, then later on, we've got IgAN and PMM data coming for felzartamab. And then [ Dravet ] syndrome. As you know, we have the ex 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, that's at least a $2 billion opportunity. Again, we're busy working on that. We're still, in some ways, 18 to 24 months from launch on those things and continue to work. But this shows the potential. It also shows why we have to execute with excellence, and we're busy investing today to make sure those launches are a success. And so we go to the last slide. If you looked at Biogen pre the [ Appellate ] announcement, consensus of investors was that Biogen was going to be roughly flat through 2030. I think we're 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 appellate marketed products, and you add them to our own growth product portfolio. I think we're seeing a growing picture. And when you now then take the late-stage registration pipeline, now I can remember vividly, one investor in the meeting that we had just after we had announced [ Appellate ] saying, "I get it. The late-stage pipeline now comes on top of a growing basis instead of a stable basis." And I think this slide neatly encapsulates really the strategy to return to sustainable revenue growth. And with that, I turn it to Priya, who can talk a little bit more about that late-stage registration pipeline.

Thank you, Chris, 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 Chris 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 [ David Nelson], 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 [ tisotumab and ZorivoNursen ]. 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 II BTK inhibitor, [ BIB91 ], 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 6 new programs this year, including new Phase II proof-of-concept studies to broaden the potential of [indiscernible] and [indiscernible] in autoimmune disease as well as first-in-human studies from our internal pipeline and the lead asset from the pending [ Vatera ] 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 5 registrational studies across 4 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 III readouts for [ vazadimab ] in AMR and [ mitipiimab ] 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 II portion of the ongoing [ Ametis ] study at the EADV Annual Conference, which we believe will provide important insights into the durability of response for [ litefolumab ] in CLE. Taken together, these milestones are expected to generate important data over the next several months that has the potential to shape our next phase of growth. In summary, the strategic decisions and investments we have made over the past 3 to 4 years has 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'm 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 stand-alone growth products, excluding our [ appellate ] SYFOVRI and [ Apave ] revenue was $933 million, up 9% year-over-year and 10% quarter-over-quarter and as Chris noted, generating revenue in excess of our legacy MS portfolio again this quarter. Our growth portfolio has been further strengthened with the addition of SYFOVRI and [ EmpaVelli ] from the [ Appellate ] 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've 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 onetime 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 and prescriber communities for a higher efficacy option has been strong. We also believe this is encouraging for the opportunity for our registrational pipeline asset, [ Salanersen ], 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 with revenue of $168 million, representing 29% growth year-over-year and 11% on quarter-over-quarter. SKYCLARYS Claris 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're also pleased to announce that ZURZUVAE now launched in Germany. For the MS portfolio, I would like to highlight that [ TYSABRI ] continued to demonstrate resilience in 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've invested for a long time to establish [ Tysabri ] as an important option for MS patients. and we're pleased to see this reflected in the resilience of [ Tysabri ] thus far. Turning now to an update on the [ Appellate ] 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 and 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 2 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 million to $130 million of impact to our other income expense line in both 2026 and 2027 and associated with it 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 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 0.5 quarter of operating expenses and financing costs associated with the acquisition of [ Appellate ]. Non-GAAP cost of sales as a percentage of revenue was 22% in Q2 2026 versus 21% last year. The 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 SKYCLARYS from the [ Reata ] transaction and SYFOVRE and EMPAVELI from the [ Appellate ] transaction. Non-GAAP core OpEx or combined R&D and SG&A expense increased 20% year-over-year. This reflects approximately $95 million of [ Appellate ] 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 III clinical programs, including [ felzartamab ] indication in MDI and [indiscernible], which were advanced as registrational studies in the second half of 2025; and [ lidafilimab ], where we expect the Phase III SLE data later this year including a $25 million year-over-year decrease in R&D funding from the royalty pharma funding for [ lidafilimab ]. For sales and marketing, it reflects support of our U.S. 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 III trial for [ salinersen ] and SMA, and an upfront payment of $15 million to Ionis to opt into BIB147 in broad ALS. Now turning to cash flow and the balance sheet. We continue to generate strong cash flow with about $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 [ Appellate ] transaction in the second quarter, which was funded with $3.6 billion of cash from the balance sheet and $2 billion of term loans. During Q2, we repaid $200 million of the term loan and continue to expect to repay the remainder of the term loans by the end of 2027. Turning now to guidance. Based on the expected revenue performance of our base business, including our growth products and [ Tysabri ], our guidance update reflects a $0.60 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 into cabin 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 strategic investments in the early and late-stage pipeline as well as those associated with our near and midterm growth. It 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 1 ], our pivotal Phase III [ selinersen ] study in SMA; and the pending Vatera 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 $0.85 dilution associated with the [ Appellate ] 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 assumption. In closing, strong commercial execution in the Biogen based 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 midterm 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? .

[Operator Instructions] Your first question comes from the line of Chris Schott with JPMorgan..

Great. Sorry, on met again. Just a quick question for me on HD SPINRAZA. Just a little bit -- elaborate a little bit more on how the ramp is coming here compared to internal expectations. And just any metrics you can share on the conversion you're 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 HD to overall volumes? So the product as well? I'm just trying to get just a general sense of just how this is progressing and impacting the franchise.

Chris, this is Alisha. I'll take that question. So if you really think about SPINRAZA is almost a decade after introducing the first SMA treatment, what I think you're seeing is SPINRAZA still setting the bar on efficacy in the space. And also if you think about how to SPINRAZA HD even come about, this was from several years ago, we had many patients come forward. to Biogen saying 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've launched, we are seeing basically the demand in 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&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 spin 12 megs to high dose. However, we also have several patients who are either new to SPINRAZA and particularly babies, we hadn't dosed a baby in years. And so we are seeing babies now getting dosed. And also, we have had several switchbacks from [ RD ]. So we think for this year, what you're 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 switchback. One of the advantages that you have that we didn't realize was going to be such a positive in the market. is with the spin 12 mg, there are 4 loading doses with high dose, there's 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're seeing also some of the switchbacks and new patient starts.

Yes. And just the U.S. is actually 1 of the last countries to launch [ Axeon ] usually. So Japan, where we launched earlier as in Europe, that's where actually we're seeing, particularly in Germany, seeing a reversal of the trend of switching to oral therapy and some trending back now. I think it's still early days. And as Alisha said, it's 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'm visiting our affiliates, at the end of the day, it's really in these devastating diseases efficacy that really matters, and there is an enhanced opportunity here for that.

We'll go next to Umer Raffat with Evercore

I guess I want to touch up on expectations ahead of your lupus readouts this fall. And specifically, we've seen Benlysta track at sort of mid-teens separation on SRI. We've seen [ Safanella ] from AstraZeneca track at something in the 20s. I guess in your -- based on all the work you guys have done what separation versus placebo would constitute something that's considered very clinically meaningful and differentiated over what's 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'm just trying to think about the liver implications, but I would love to know what the dose is.

This is Priya. I'll take that. So I think just stepping back, we're really excited about our [ TOPAZ ] trial. This is [ TOPAS ] 1 and 2. We will have results from both of these in Q4 this year. These are our SLE trials. . So maybe just stepping back, I'll just comment on the fact that we've 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 you've seen in past trials. Our trials have had rules to limit standard-of-care utilization by that, I mean NSAs, corticosteroid [ tapers ], handling data for responders and nonresponders. But we've also stepped up to really think about the fact that this is a heterogeneous disease. So how do we control a 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 robust response. We'll see how we kind of perform in the trial, and we'll wait for the results. I won't speculate. Our primary endpoint is [ SRI4 ]. However, we have a key secondary endpoint in [indiscernible] and we have multiple patient-reported outcomes. So we'll really be looking at the totality of the data, including [Audio Gap] and we'll be presenting 52-week data at EADV this fall, so we remain confident in that data set as well. Now moving to your second question on the BTK inhibitor. We haven't actually disclosed doses, I won't be sharing much more information, and we're looking at what the next steps might be for this.

You want to add anything, Alicia, in the market research. Because I think -- this is 1 of those ones where it's no 1 thing that's going to be a marker of success. You've got steroid sparing. One of the things that we consistently hear from patients is fatigue and yet you can't 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's going to take commercially to succeed.

Yes. Thank you, Chris. 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've probably got more insights from them than the actual market research that you can get that through third parties. . And I have to say that we talk about things like SRI-4 and endpoints. But when you really look at a physician and a patient interactions they have, what we're finding in this market is there is a huge disconnect on what they expect from treatment. Doctors want to run a patient's experience just by what they see in labs and patients will come in and say, the 3 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's only less than 5% of CLE patients receiving advanced therapy. And I also -- because there is no approved therapy, I think the CLE patient members are undercalled. I know that we've reported out 75,000. I think that, that is a much lower number than is actually out there. Secondarily, you're seeing that patients are getting lost in the system being transferred from derm to room and room to derm where no one really knows how to treat them. And then with the treatments that are on market as of today, there is downfalls. One 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 a treatment that can work much more quickly and can work in both CLE and SLE. So I think that there's a very long runway for this therapeutic area. And because there is such a huge unmet need in these patients, are known. We can track them in the system because they are -- most of them are diagnosed. We know which physicians they've 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 good therapeutic area to enter.

We'll go next to Marc Godman with Leerink Partners.

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

Thank you for the question. There is a lot going on with SYFOVRI since we've been able to integrate them into the organization. First, I want to say I'm very much impressed and very grateful for the level of talent and expertise that joined from the Sipo routine. I think the first thing that we have noticed with both SYFOVRI and EMPAVELI is when they came onboard the company, both used very similar launch plans. . And I think the 1 thing that we've really learned over the last 7 years with our 7 launches is that we really tailor make our launch plans. We really build them from the ground up. We launched very much informed, and it's not templated. And so what we've been able to do is work with the SYFOVRI team across the board, understanding what's really driving sales, where can we maybe reallocate capital? And how do we get the Biogen machine to sort of help drive some of their momentum. And so I'm very encouraged by the strongest quarter since really launch for SIFOVRI. And in the month of June, the month of June was the best month in the brand's history. And so what we're really seeing is the quality of growth across a number of areas. I think, number one, you're seeing our free drug has been lowered by half. We did end up looking at free drug programs and looking at where we put some guardrails in place to make sure really only the patients that need access to free drug do get it. and that has dropped by half. That's been part of momentum. Secondly, if you look at where this brand started on sentiment across HCPs for slowing the progression of GA and where physicians are today, this SYFOVRI team has done a truly tremendous job on changing that sentiment. And because sentiment has improved so much, that is where you're seeing new writers coming on board. It's also where you're seeing many more patients coming onboard. They grew both in patient numbers and in physicians who are prescribing. And I think that 1 of the tailwinds on that was the long-term 5-year data that they've been presenting, which is really a lot of education around the progression of GA. And specifically, when you look ahead, the market is only 50% of the retina specialists are treating and only 20% of these patients are diagnosed. And so the team is really looking at a couple of things. One is the direct-to-consumer. We have decided to shut down a few programs we're reallocating to a new commercial. I think maybe the SYFOVRI 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, prefilled syringe. We do look forward to that launch as well. prefilled syringe is going to really support the workflow for physicians. We believe it will make it much faster for them, much more efficient, and they probably will be able to get more injections into the eyes with saving them approximately 15 minutes with these injections. So that's also great. But more importantly, on a previous call, I think I had mentioned to you when we were looking at SYFOVRI, one of the things we had seen in our diligence is that there really was a big discount, a lot of patients discount after a year. Well, now that the team is onboard and we really looked at the data, we've noticed that actually the discounts happen after the first injection. That's where the big bolus comes from, even though it really only shows up in the numbers after a year where you see the 50% drop off. And we now believe due to all of the brands that we've had, where we've had discount 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 discount 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 to the patients and activating them with DTC.

We'll go next to Salveen Richter with Goldman Sachs. .

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're thinking about the safety profile, given what's been seen?

Thank you, Salveen. This is Priya. So just stepping back, we took BIIB091, which is a peripheral BTK inhibitor, noncovalent, into a Phase II trial in RRMS a few years ago. And now we've 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're also looking at the external inflections that we've seen in the BTK landscape. So we will communicate more about how we see this asset progressing further. And we haven't actually made a decision to specifically advance it into an indication. So we're not there yet. We're still evaluating the data. Overall, we see that it could perform really well in RRMS, but I think it's 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're taking a pause. We're 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.

will go next to Michael Ye with UBS.

Thanks. Our question actually is going back to letefilimab in CLE. Do you believe that CLE is a higher probability given perhaps less heterogeneity of the patient population you've already sort of talked about some of the risks in SLE and 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's some additional data presentation coming up?