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Good morning. My name is Melinda, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Biogen First Quarter 2025 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. [Operator Instructions] Today's conference is being recorded. Thank you. 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, Melinda. Good morning, and welcome to Biogen's first quarter 2025 earnings call. During this call, we will make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results as well as reconciliations between GAAP and non-GAAP results discussed on this call can be found in the Investors section of biogen.com. We've also posted the slides to our website that we'll be using during the call. On today's call, I'll be joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, our Head of Development; and Robin Kramer, our Chief Financial Officer. We'll make some opening comments and then we'll move to the Q&A session. And to allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question. I'll now turn the call over to Chris.

Thank you, Tim. Good morning, everybody. Maybe first a warm welcome to Robin. This is your first quarter as CFO of Biogen, Robin. So, we had a very good start to the year, strong quarter. Biogen is really a tale of two companies, in my view. There's one company which has been an MS company, and that portfolio, as you all know, it's been gradually declining. But there's a new Biogen emerging. And when I look at the rare disease business [in AD] (ph),

Thank you, Chris. This quarter, we made significant progress advancing and expanding our high-conviction late-stage pipeline. We believe our pipeline will play a critical role as we work to deliver sustainable long-term growth enabled by increased momentum in our data flow. This includes potential key approvals this year and expected registrational data starting next year. This quarter, we delivered key milestones across Alzheimer's, immunology and rare disease. First, as Chris mentioned, our tau targeting ASO BIIB080 received Fast Track designation from the FDA in Alzheimer's disease in April. Alzheimer's is a complex and fatal disease that we believe will require multiple therapeutic approaches to address its diverse pathologies. BIIB080 is a differentiated approach to targeting tau and the Fast Track designation was based on encouraging Phase 1b data, which showed dose-dependent CSF tau reductions, decreases in tau PET signal and favorable trends on exploratory cognitive and functional measures. In immunology, we initiated the TRANSCEND Phase 3 study of felzartamab in AMR. This is the first of three Phase 3 studies that we expect to initiate this year for felzartamab with additional studies in IgAN and PMN anticipated by midyear. And importantly, we expanded our late-stage rare disease pipeline where we acquired rights to zorevunersen in Dravet syndrome in all territories outside the United States, Canada and Mexico. Dravet syndrome is a developmental and epileptic encephalopathy, characterized by severe recurrent seizures and importantly significant cognitive and behavioral impairments. Importantly, more than 90% of patients continue to experience seizures despite treatment with the best available anti-seizure medicines, and there are currently no medications approved that meaningfully address the underlying cognitive and behavioral aspects of the disease.

Thank you, Priya. I'm pleased to be participating in my first earnings call since stepping into the CFO role. I'd like to begin by extending my gratitude to those in the investment community with whom I've had the pleasure of speaking with in my first few months as CFO, and I'm looking forward to spending time with many more of you in the near future. To start, I would like to provide a few highlights on our first quarter financial results. Please note, the comparisons I'm about to make are versus the first quarter of 2024, unless otherwise noted. Total revenue for the first quarter of $2.4 billion was up 6% year-over-year, aided in part by the timing of SPINRA

Thank you, Robin. Again, if I come back to where is Biogen going, you just have to look at our pipeline. We've got another four Phase 3 starts that's after the Phase 3 start already in AMR. We've got three clinical trial readouts coming. We've got three regulatory decisions coming. One of the other things I'll say is, in this first quarter, as we did a major restructuring of research, and I'm really quite excited about what we're doing there, as an industry, we rely way too much on late-stage business development. The most cost-effective place to do collaborations is actually pre-clinically and we have a goal of signing four to five new research collaborations this year. Just on research, Biogen has been known for breakthrough medicines. In fact, all four products that we launched in 2023 and '24 are first-in-class, first-ever disease-modifying agents. And we go after some of the hardest-to-treat diseases. But one of the problems about being breakthrough is that you're in diseases where a lot of the investment committee is not already doing an awful lot of research. If I take AMR, the antibody mediated rejection, for example, there's really no treatment there today. And so, one of the things that I think we feel that we would like to do is do a deeper dive into some of these diseases and pipeline assets, not with the intention of presenting new data, but to just say, okay, what's the competitive landscape? What's Biogen's right to win here? What's the patient journey? What is it going to really take to move the needle on one of these diseases? What's the reimbursement landscape going to be like? What's the epidemiology? If I look at AMR, for example, I think this is a huge opportunity for Biogen. And we saw 80% resolution of AMR in Phase 2 trials. So, we have a high level of confidence in that. But of course, a lot of people are interested in IgAN. What's it going to take to really be interested in IgAN? And I spent an entire day with our West Coast Hub, just on felzartamab. And there's a huge amount of things going on there. And even things like all CD38s are not created equally. So, what do they like? So, we would like to invite whoever is interested to come to some of these thematic seminars. The first one we're going to hold on June 11, and hopefully that'll be the first of the series. And it's just meant to be educational and a deeper dive and we'll have some of our top internal experts here on all of these subjects to answer any and all questions. So, with that, Tim, I'll turn it back to you for Q&A.

Thanks, Chris. Melinda, can we go to our first question, please?

Certainly. [Operator Instructions] And your first question comes from Brian Abrahams with RBC Capital Markets. Please go ahead.

Hey, good morning, and thanks for taking my question. Congrats on the recent LEQEMBI approval in Europe. Can you talk about what the rollout strategy could look like there and your sense of what the reimbursement process and amenability could be? Thanks.

Yeah. Thanks, Brian. Well, that is certainly going to take some time. The fact that the approval took a while tells you that there's an awful lot of thought going into that. One of the things about when you first -- when you launch a first-in-class disease-modifying agent is that you're not displacing anything in a budget. So, these types of products are incremental adds to the total healthcare budget of countries. And so, that's sometimes where it's easier to launch a product that's kind of a me-too that comes in and can simply cannibalize the budget of another product. So, this is obviously a significant market in Europe. The Europe is an aging continent, even more so than the United States. So, there are an awful lot of eligible patients. But we'll be taking that with our partners Eisai market by market. I do think that also LEQEMBI has run the gauntlet. I mean, there has been a full examination of the efficacy, the safety, but also the economic benefit. As you know, the EMA does take into account some aspects of the economic impact. So, I think that in some ways, this deep interrogation by all of the countries of the European Union, by the way, I think should actually, if anything help us as we go into reimbursement, because this has been fully examined and fully evaluated, but I think it'll be -- it'll still take some time and we'll go to -- some of the countries will launch clearly faster as is the case generally in Europe.

Thanks, Chris. Let's go to the next question, please.

We go next to Evan Seigerman with BMO Capital Markets.

Hi, all. Thank you so much for taking my question. I want to touch again on LEQEMBI, but this time with the subcutaneous formulation. Maybe remind us how that potential for at-home administration can help accelerate sales in the United States? I mean, we're seeing some good uptake, but I think that that could really help get things going further. And maybe some of the hurdles that you have to overcome to really get full penetration there? Thank you.

All right. So, the first is subcutaneous for maintenance. And these are patients who have been going -- undergoing bi-weekly infusions now for 18 months. And so, there -- I think there are two aspects for the commercial. First is, we are busy focusing on making sure that physicians and patients understand the need to continue on therapy. And there, we have long-term extension data and we've demonstrated that in 36 months after treatment, patients are still doing better on treatment than if they stop treatment. So, there's the whole establishment of the maintenance market. But if -- these are also older patients and it's not always easy to get to infusion centers. Obviously, we make it easier with once monthly dosing, but our view is that this is going to be more effective as a long-term chronic therapy if you have a patient-friendly administration like subcutaneous. So, I think as a first step, the subcutaneous really helps establish and extends the treatment life of a patient in maintenance. And then, of course, in the initiation phase, that will be interesting to see. I think in major urban centers, I think we may see that some physicians may want to continue at least in the first few months of therapy on infusion, because they're timed with the MRIs to monitor ARIA, and then move to subcutaneous. I can imagine in more rural settings where getting to infusion centers is not as easy for patients that the subcutaneous might even be right from the get go. So, I think it will depend a little bit on where you are as a patient, but there's no question that this is again a simplification of the physician's workload. It's a heavy load to think about the PET scans or the lumbar punctures, going to negotiate for use of the infusion beds, which are often considered to be the domain of the oncologist. And just from a caregiver point of view of bringing the patient to the infusion center, I think this will be welcomed by them as well that they can do this at-home. So, I think this is an enabler for the patient, but also for the physician.

Melinda, can we go to the next question, please?

We go to Salveen Richter with Goldman Sachs.

Thank you. Good morning. Just following up on Evan's question here, could you just speak to your thoughts on LEQEMBI uptake and growth on the [forward] (ph), not only with subcutaneous maintenance dosing in the second half, but also with Fujirebio's in vitro diagnostic, which should enter the market as well? Thank you.

Yeah, we don't have that much information about the diagnostic. The process to get a diagnostic approved is different obviously than a drug. And then, the reimbursement situation is also different. I do think the recent report by the Alzheimer's Association highlighted the need for early diagnosis. One of the issues that has, as I think, been in Alzheimer's is that patients -- most patients are actually seeing their primary care physician, and it can take quite a long time for the physician to distinguish, is this just part of the normal aging process, is this some other form of dementia, or is this Alzheimer's? And so, two or three years can go by, and sometimes even longer before the Alzheimer's diagnostic is done through a referral to a neurologist. Now, one of the things that that Alzheimer's report also pointed out is that there's a real interest in getting treatment earlier. And that the earlier you can get to a patient before there has been too much neuronal damage or death, the better. And so, I think there is a real effort to be done to really get those diagnostics established. And so, the benefit really is I think two-fold. One is, hopefully, we can get patients on treatment at a much earlier stage of their disease and we believe and there's obviously studies ongoing to actually gain the evidence of that. But even the data that we presented at CTAD in 2023 of low tau patients, which is surrogate for early-stage patients, demonstrated that 60% of patients were stable after six months and actually 70% -- sorry, 70% were stable after six months and 60% actually showed some level of improvement. So, I think the blood-based diagnostics are going to be extremely important, but again, we have to wait and see where those companies are in the regulatory process.

Can we go to the next question, please?

Your next question comes from Tim Anderson with Bank of America.

Thank you. On LEQEMBI, how are you seeing the market parse out between your product and Lilly's Kisunla? Because obviously there's a very big difference in terms of commercial positioning around finite dosing. And I'm wondering who's going to kind of win that battle. And Chris, you answered an earlier question starting off talking about getting docs to keep patients on therapy. So, the product -- your product still in the market now for coming up on two-and-a-half year. Are you actually seeing some prescribers take patients off therapy after a period under the idea that once plaque is gone, you no longer need to give drug?

Yeah. I mean, I think first, I would say, we would really consider the launch of this product to have been September of '23, because that's when we had full approval. We had reimbursement from CMS. In actual fact, we didn't even really get the question on the reimbursement for PET scans clarified till about November of that year. So, I think we're still much earlier in that launch phase. To your question on this versus donanemab, it depends on the physician. And I think we're going to see those who like this idea of potentially saying, well, there's a finite point to this, equally, what we have seen even at the recent AD/PD, once you have a maintenance indication and you start to see the data, you'd start to realize that, well, actually once you've removed the plaque, you're not done, because there is some return of the plaque and potential damage. So, there will be obviously a lot of education to be done to demonstrate the importance of continuing on that. But I think at the end of the day, it's largely going to be up to the physician and the patient. There will be patients where donanemab may be the right answer for them, depends on their fragility, their age, whether they're in a rural setting or an urban setting. And I think the market ultimately just gets split between us and donanemab. The most important thing for both Lilly, I think, and Biogen and Eisai is that we start to really expand this market. We've got maybe, I don't know, 12,000 to 13,000 patients somewhere in there on treatment, less for donanemab, but they will get there. But when you consider the number of patients who desperately need treatment, we're still only treating a small fraction. And I think that's really got to be the focus of all the companies in this space is to really ensure that more patients benefit from these disease-modifying treatments.

Can we go to the next question, please, Melinda?

Next up is Chris Schott with JPMorgan.

Great. Thanks so much for the question. I just would love a bit more elaboration on latest thoughts on business development in terms of the size and scopes of deals you're considering. It's obviously been a pretty volatile market out there. And I'm just wondering if that's changing your views at all or the range of opportunities that might be available to Biogen. Thank you.

Yeah. Thanks for that question. I mean, I think there is -- there has been a shift even perhaps in the last, I would say, four to six weeks in a couple of ways. I mean, valuation is one thing, but you're still really focused on getting the right thing. And what I think has changed is, you have a lot of healthcare investors who are facing a lot of pressure from LPs and I think they are looking for liquidity. And I think we've had a lot of companies who not really wanted to do much because valuations are low, but we're also finding that there's a lot of companies who are struggling to get financing. So, I think if you're looking to acquire, I think there might be a little bit more of an ease in actually getting at least into a discussion. But I think even from a collaboration point of view, I think one of the things we're going to see and I think this is also where we're doing this in the early research collaborations, I think companies will be able to provide some of the funding as some of the venture capital and some of the other sources of funding dry up for other companies. And so, there are opportunities in there. It still requires an awful lot of patience and discipline to work your way through and find companies that work together. I do think Biogen is actually well-positioned. One of the things I'm particularly proud of is, we have this West Coast Hub, which is essentially the HI-Bio team and we have been able to retain virtually everybody in that HI-Bio team. Jane has hired our Head of Immunology, came from BMS, who's out there on the West Coast and we're building out that team. And so, I think Biogen, just because of our own biotech roots, is a company that knows how to do collaborations and I think can be a trusted partner in this. So, I do think this is an opportunity, but again -- and we look at a lot of things, but even in this environment, you still have to stay disciplined.

Thanks, Chris. Could we go to the next question, please?

We'll go to Michael Yee with Jefferies.

Thanks. Good morning. I wanted to ask Priya about the early AHEAD 3-45 study. I know that you've guided to a 2028 readout. Your competitor is also guiding to a readout, although I think there's an assumption that they may come earlier. Can you just talk about maybe one or two points about your positioning versus that study and particularly what would get you extremely confident that that's going to work and/or readout? Because I know that you have an interim, but I'm just going to assume you're not going to take that interim. Thank you.

Yes. Thanks, Mike. So, overall, I would say, I'd like to start by saying that with Clarity AD, we established that LEQEMBI clears plaque and that translates to clinical benefit. Now, with regards to the presymptomatic Alzheimer's disease area, it's a big spectrum. And we believe that AHEAD 3-45 is truly positioned to provide a comprehensive understanding and evaluation of how LEQEMBI can preserve cognition across the full spectrum of presymptomatic AD. And the reason for that is that we are testing it in two parallel trials. The first one is AHEAD 3, which is about 400 subjects and really by the inclusion criteria are 20 to 40 centiloids of amyloid. And then, the other trial is greater than 40 centiloids, which is the AHEAD 45 amyloid levels. And there we're looking at whether it can prevent cognitive decline. So AHEAD 3 is looking at can we stop the accumulation of amyloid, has amyloid PET as the primary endpoint and then AHEAD 45 is looking at preventing cognitive decline and we have a very sensitive clinical by endpoint called the PAC-5 along with amyloid and tau PET. I think, in contrast, TRAILBLA

And I think if I could just from a commercial point of view, I do think the AHEAD study will actually answer much more of the question that physicians will be looking to ask. I mean, if you're in presymptomatic patients, these are otherwise healthy people, right? And the risk benefit equation becomes different at that point. And there is ARIA that is associated with both products. So, you're going to have to answer the question about the risk benefit of treating earlier and at what level of amyloid burden. And I think that's going to be useful because the blood-based diagnostics will tell you that if there is a presence of amyloid, they will not tell you about how much. So, at some point -- you're sort of, say, 55, you had a positive blood test, someone's going to send you for a PET scan to see how much amyloid you have. And let's say you're at 50, well, are you in a watch-and-wait mode or do you actually treat? And unless you've actually done the study of looking at the full spectrum of amyloid burden, I'm not sure that physicians are going to feel comfortable about treating. So, I do think actually AHEAD 3 and 45 are going to be really landmark studies in Alzheimer's.

Can we go to the next question, please, Melinda?

We'll go next to Umer Raffat with Evercore ISI.

Hi, this is Mike DiFiore on for Umer. Thanks so much for taking our question. Again, one on LEQEMBI. Lilly's drug did about $20 million -- $21 million of sales in Q1, which is its second full quarter of launch. And this tracks slightly ahead of LEQEMBI sales at the same time point. So, my question is, has Biogen and Eisai perhaps paved the way for Lilly in terms of opening up healthcare infrastructure? And maybe perhaps could you speak to any competitive dynamics at play now that you're roughly 18 months into launch? Thank you.

I think the answer is probably yes. Clearly, there's been a lot of hard work, particularly the IDNs to work through all the treatment pathways and protocols and treatment regimens that are needed. And so, then -- now we're into a question of lecanemab versus donanemab in those questions. And as I said earlier, I think there will be cases where physicians are looking at both products. I think it'll be a question of who gets initiated. I don't think we're seeing any switching going on here. So, it's really a question of which one are you going to start on and then stay on. I think the bigger question is, can we actually collectively grow the market? And that's really what's most important. And I don't think we particularly want to get into just trying to duke it out over market share in a relatively still small market. There are a lot of patients out there and we are not yet doing a full service to patients who are suffering. And so, the more that we can get more centers up and running and better education, the better it will be for patients and actually for both companies.

Thanks, Chris. Let's go to the next one, please.

Next up is Terence Flynn with Morgan Stanley.

Great. Thanks so much for taking the questions. Obviously, there's been a lot of focus on the FDA under the new administration. And I know you made some comments about your Dravet program moving into a Phase 3. So, just wondering, if you could comment high level, number one, on your interactions with FDA, and if there have been any changes to the review teams, things like that. But then, also, in some of these rare diseases, do you think this FDA is going to be advancing very rapidly and be more favorable to the industry in terms of thinking about maybe surrogate endpoints? Thank you.

Yes. Thank you. Overall I'll just make a high-level statement, that based on our interactions on review meetings and requests, we're not really seeing any changes at a high level. Currently, we remain on track with our engagements. And with regards to Dravet syndrome, I think that -- obviously the data that we saw during diligence and which I spoke to as well today, for us that has been very compelling. That has been it has several aspects to it. First of all, this population, although it was a small open-label trial, I think what was important about it was that these patients were on standard of care. And unfortunately, the burden of disease is high in Dravet's and they have a number of seizures sometimes seven to 10 a week and they are on multiple medications, anti-seizure medications. And in fact, we saw the impact of zorevunersen on top of standard of care. So, the impact that we saw was 87% seizure reduction on top of background standard of care -- full standard of care. And then that was durable out to about 76% when you look out six months. So that -- the data was important. But the other aspect to the question that you asked is that, Stoke had already engaged with FDA, Europe and Japan. So, we have regulator input, which we have evaluated carefully. We have agreement on the approach and design to the Phase 3 EMPEROR's trial. So, we remain fairly confident that this is the right trial to conduct. And so, we remain encouraged about where we are in our engagement, not only with the FDA, but global regulators and that the design is appropriate to really give us that answer on what we hope will be a disease-modifying therapy impact on -- in this population.

But I think to your broader question, I think certainly right now at Biogen, we have not really seen any delays in our interactions with the FDA. And I personally am encouraged by some of the more recent comments by the new commissioner about particular ultra rare and thinking about surrogate markers and making sure patients get drugs earlier. And I think he seems to be more interested in innovating some of the process. I think about his statements on reducing the use of animals in studies, for example, and use of AI. So, there's certainly a lot of change going on at the FDA and we're watching very carefully. And obviously, it's been some key leaders who have left and some reduction of staff. But let's say so far, at least from a Biogen point of view, we haven't seen any adverse effect to that. And perhaps some of the new perspectives of the new Commissioner Makary could actually be helpful to us.

I know it's a busy morning, so maybe we can squeeze one last question in here. Melinda, our last question, please?

We go next to Geoff Meacham with Citibank.

Great. Good morning, everyone. Thanks for the question. For Chris or Robin, on manufacturing, Biogen has historically had a lot of capacity in the U.S. going back to the original expectations in Alzheimer's. I guess, the question is, as we see more companies in biopharma announced plans to onshore capacity, do you guys view your own capacity or resources differently? I wonder if there's a short-term opportunity to partner that's not in the model, obviously, all of course depends on what you have in excess. Thank you.

Yeah. We've actually recently -- our main facility in Solothurn, for example, we've recently, -- there, we're actually doing CDMO business to absorb capacity. Obviously, that doesn't help for someone looking in the U.S. In RTP, we actually do quite a lot of manufacturing already for third-party companies. And I think even before I joined Biogen, I knew of the reputation of our RTP facility. It's a very high-quality, very efficient site. So, yes, I think we certainly will be open and looking for opportunities on that front.

Yeah, we have a good mix in both facilities between our own product manufacturing as well as those for partners.

Well, thanks for your time everybody. Really appreciate it. And if you've got more questions later today, just reach out to the IR team. Thank you.