Biogen Inc. (BIIB) Earnings Call Transcript & Summary

Good morning, and welcome to TD Cowen's 46th Annual Healthcare Conference. I'm Phil Nadeau, one of the Biotech analysts here at Cowen, and it's my pleasure to moderate a fireside chat with Chris Viehbacher, CEO of Biogen. Chris, could you give us your vision for Biogen over the next 5 years? How is it going to create shareholder value?

So good morning, everybody. And Phil, I just want to thank you and Cowen for always holding the conference here in Boston. Given the temps outside it's too bad, we don't actually have a real fire for this fireside chat. So it's an exciting year for Biogen. We have been on a journey to rebuild the company, expand its portfolio, its areas of focus. And just even in the last year, we've been adding meaningfully to our late-stage pipeline such that we now have 10 Phase III programs in the pipe. The first of which will start to read out this year. And then sequentially, every calendar year, we'll be turning over cards until now -- from now to the end of the decade. So that means inside, we're busy also preparing for launches, getting prelaunch activity, building up medical affairs. And One of the things I'm actually quite proud of is that we actually have dramatically expanded the pipeline and yet we still are spending 25% less on R&D than we did 3 years ago. So I think we've also seen a significant impact on productivity within the company. We still maintain a lot of the financial discipline. We've been able to draw resources from other parts of the company to invest in, for instance, all our prelaunch activities. And now some of the focus is really on reloading the early-stage pipeline because we're very happy with where we are in the late-stage pipeline, but now is the time to really be building up the preclinical and early clinical development pipeline. So I think we're in a good spot to start a whole new era of growth over the coming years.

And may be focusing on growth. You've guided to revenue decline by a mid-single-digit percentage in 2026. I think investors, therefore, are keenly focused on when revenue could return to growth. Can you talk about when that could happen? Do you think you currently have the right product portfolio and pipeline to drive growth? Do you need external assets or success internally?

Yes. So in some ways, Biogen is, there's two Biogens, right? There's a new Biogen that is already growing pretty sustainably. And that's with all our growth products, the 4 we launched in the last 3 years as LEQEMBI, QALSODY and ZURZUVAE and SKYCLARYS, plus we're also still heavily investing in SPINRAZA and VUMERITY. And those products actually outpaced the decline of our MS portfolio over the last couple of years. And that's the other Biogen. Obviously, we have a whole legacy portfolio that is facing ever-increasing competition. But I think we've been able to really manage the decline pretty substantially. So the new Biogen will continue to grow with all those products have runway into the next decade and what I think then starts to accentuate that growth are these new product launches coming along. So if we get positive results on lupus, Felzartamab coming along, we've got the successor to SPINRAZA with salanersen coming along. We've got Zorevunersen in Dravet syndrome coming out. So there's a lot of things coming along. And I think we also have a number of new catalysts in LEQEMBI. So I think we would look to see coming out of the end of this year and into next year, potentially some increased sales escalation of LEQEMBI.

We will discuss LEQEMBI but maybe before getting to that business development. So Biogen has been quite active over the last couple of years. Can you talk about Biogen's current thinking on business development? What's the appetite for doing deals? How big of a deal could you do and what therapeutic areas?

If you think about Biogen, there's if you want to replace $1 billion of after-tax profit, it's going to cost you about $15 billion to $20 billion. That's more than Biogen can do. So for us, we had to be quite careful about how we do M&A. I mean, I think the first thing you always want to do is get your own house in order. M&A should never be just the only plank in your strategy. And that's why we focused an awful lot on thinking about what therapeutic areas did we want to be in. We had been a purely neuroscience driven company. That was really the most risky area you could be in, in research and development, not to mention the most capital intensive. So thinking about expanding our research and development portfolio getting the pipeline full and part of that has been with some of the BD that we've been doing. And now I think if we're -- as we look at M&A, we're looking at what could actually accentuate that? What could we actually do that fits with the narrative of the company that perhaps gets us into certain therapeutic areas faster that could add to cash flow. But we don't really want to look at things that are going to launch in '28, '29 because I've got a lot of that stuff already. So I think what we're looking at is something that is early stage in its launch trajectory, something that's probably at least got Phase III results or extremely high conviction in Phase III and of course, you got to spend a lot of time and have a lot of patience for that because there's just not that many assets out there that you can acquire that still also drive shareholder value.

Focusing on LEQEMBI, maybe to set the table, where would you -- how would you characterize the launch today? Where is it in its various markets? And how could it evolve?

So I'll tell you, I've been in this business for 35 years. This is by far the most complex launch I've ever seen, largely because this has represented such a departure for the prescriber community in terms of how their work practice operates. This has been a major change in how they have to help patients. The neurologist isn't used to having to go and negotiate for infusion beds, thinking about the MRIs at a regular frequency, the website to get patients registered. So a lot of physicians, first and foremost, had to think about the care pathway, potentially hiring people in the office, where they going to get reimbursed? And I think one of the early things that was a win was actually reimbursement has almost never been a problem in this space. Whether it's the PET scans, the MRIs, the diagnostics. So that gave physicians already a lot of confidence. And the second thing they were worried about was the ARIA. There was this perception that, well, was there really that much efficacy and now we have ARIA to deal with. And I think one of the things that we've also seen is that physicians are still obviously appropriately concerned about ARIA, but they feel a lot more confident that they know how to deal with it. Remember that most ARIAs is asymptomatic. And once they realize they don't really have to do anything but monitor patients. That has really changed physician attitudes as well. I think one of the other things that we've seen is the perception of efficacy has changed. CDR Sum of Boxes is just not used in neurology practices. So what they are seeing are people who are having actually visible benefits from efficacy. We're talking about the priest who could suddenly -- who retired and was able to come back 6 months later and preach an Easter sermon. You're talking about people who can suddenly drive that we're able to infusion centers to the women who looked in the mirror and could remember her name for the first time in the year. So these sorts of things are what really matter to the physicians. Now in the meantime, what we've also been doing behind the scenes is how do we make that care pathway easier for physicians. And you've got the blood-based diagnostics. Now we have the first ones approved. And that has two major benefits. One is there are 13,000 neurologists roughly. And today, about half of them are actually prescribing in Alzheimer's because not all neurologists had Alzheimer's patients in their practice. But there are 500,000 patients newly diagnosed with Alzheimer's every year. So you can do the math pretty quickly to figure out it's going to be hard to get an appointment with a neurologist. And at the start 50% of those patients who are getting those appointments were too far advanced in their disease to be eligible for treatment. With the advent of the blood-based diagnostics, there is some triage that's now occurring, particularly primary care. Several hundred thousand tests were sold alone last year by the LabCorps and the Quest of this world. And so that yield is now up to 70%. The other benefit that we see is that physicians will, we think, will progressively stop doing the PET scans or lumbar punctures to validate the diagnosis. That was also a major step. I mean a PET scan, if you haven't ever done one is a hugely invasive and lengthy procedure and costs a lot of money. So then the next thing is the infusion beds. Well, one of the things that we could do was introduce a subcutaneous formulation. So we first got the maintenance therapy, which means people who are coming at the end of the 18-month amyloid removal process, want to stay on therapy. So we stepped them down to once monthly infusion. So that was already easier than every 2 weeks. Then last year, we got the approval for the subcutaneous form for infusion -- for maintenance. And this year, we've now had a priority review, and we expect to have on May 24, if all goes well, an approval for the subcutaneous in the induction. So at that point now, physicians have a choice between continuing with the infusions or having the at-home pens. And so all of these things are starting to make life easier for the physician. We have also started now the patient education through direct-to-consumer advertising because we've actually seen as we look at our prescriber details, we saw a number of physicians who are sort of treating one patient. And when we went and found them, we discovered that most of those were patients who had come in and asked for the treatment. And so now what we're trying to do is go deep with those prescribers and get more patients actually asking for it. And because it is a burden for the physician to actually go and do but as said, now that we're making it easier and we're getting more patients asking for it. All of that should really start to come together over the course of this year, and hopefully, we'll see the benefits of that going into next year.

To drill down on the subcu initiation regimen in its impact. You mentioned the May 24 PDUFA how quickly could we see an impact of subcu initiation on trends? What are the gating factors to the adoption of subcu initiation?

So just reminding everybody that LEQEMBI infusion is a Part B once you switch to the subcutaneous, that's a separate BLA and that will also be Part D. Part D reimbursement works differently. Remember, Part D is largely a privately delivered government-sponsored program. They come together every year in sort of the May, June time frame to decide what's on formulary. They announced it in the autumn, somewhere around October, November, then the patients sign up for these Part D plans, and it becomes effective on the first of January. So we would expect to be considered for the subcutaneous in the summertime. And if the plans do agree to reimburse that, that would be from a from 1st of January 2027. Now in the meantime, you can actually request formulary exemption and a number of patients, particularly what we're seeing on maintenance are doing that. And we're not aware of any patients who have requested that who have not received that formulary exemption. But there's clearly paperwork involved and effort on the physician.

Maybe looking further into the future, how confident is Biogen in the AHEAD 3-45 trial? And what could that do to utilization?

So Ahead 3-45 is really going to be a landmark study. Sometimes I read articles and things like that about efficacy. And you have this feeling that people think about Alzheimer's as people who are kind of like the absent minded professor type, they've forgotten where their car key is. They forget that this is a devastating neurodegenerative disease. Every day, when you have this, you are losing neurons. And what is incredible is that this is a disease that's a silent killer for many years. For 10 years or more, you could be accumulating these plaques in your brains and losing neurons. And so what we call mild cognitive impairment or what we think about as early Alzheimer's, when you get symptoms is nothing of the sort. You've already been suffering from this disease for quite a long time. So the logic is, the earlier you can treat, the more neurons, you should be able to retain and therefore, they also retain your cognitive ability. And what's also interesting is that actually, today, people believe that Alzheimer's is an amyloid driven tauopathy. So the severity of Alzheimer's really depends on how much tau you have. And it's really the amyloid that is driving the overproduction of tau. So we measure tau by a PET scan, and you can see the size of that and it's measured in centiloid. At about 40 centiloids of plaque, that's where it's believed that you start to produce tau. So AHEAD 3 is looking at these super early patients before they get to the 40 centiloids of amyloid. And there, the promise is, well, if we can prevent the amyloid from building up, do you ever get overproduction of tau and do you ever get Alzheimer. So that would be like the holy grail of Alzheimer's treatment. But of course, we also know that there are going to be people who don't yet have symptoms but have more than the 40 centiloids. So there, there's also going to be a question of risk benefit. So we take someone who's in their early 60s, has a scan because they've had a positive blood test. They're at 60 centiloids. Well, this is an otherwise healthy patient. Do I treat that patient today because there is still always a safety aspect to consider. And that's what AHEAD 45 we expect to answer is, first of all, what is the incidence of ARIA. I mean, I think most people would assume that it will be much less because the ARIA is believed to be as a result of removing the amyloid. So if you're starting with less amyloid to begin with, the hypothesis is that you won't have as much ARIA. But of course, we need data to prove that. But the second aspect is, well, if I also treat them, can I actually postpone Alzheimer's for an extended maybe an infinite time frame, so you're also into prevention. Or is it certainly going to be that the course of the disease would be much milder than you would otherwise expect. We started that study in 2020. That study is not going to read out until 2028. When Lilly was doing their study, remember, they had much different endpoints. By the way, we're always cheering for Lilly's positive result because this will have a positive impact on the overall disease state. But Lilly was looking at just time to event, and that really wouldn't answer that question. Is there a positive risk benefit for treating that 60-year-old with 60 centiloids and that's where I think we will have the definitive result. But the second question is, well, if they could do an interim, why couldn't we do an interim? The problem is we have no information. This is really groundbreaking science. We don't know how long it takes for someone with 60 centiloids of amyloid to actually progress to having symptoms. And so we have said, okay, we're going to give everybody at least 4 years of follow-up. You could do an interim but I think you risk getting the wrong result because nobody knows how long it takes to actually get. And I think that's why we're also seeing Lilly study, not reading out anytime soon because I think they also have kind of seen. Well, actually, we don't really know. Now again, this is an incredible study, this 8-year study that we've done because it really does provide, I think, so much information about how this disease originates and how you could alter the course of that disease. So we're excited about it because, clearly, if this is positive, now we can -- because we have these blood-based diagnostics, we can help people perhaps never get it or certainly get it much later in life. And the belief is that you're going to have much higher efficacy because you have a reserve of neurons now that you can protect.

Before we leave Alzheimer's, BIIB080 has data coming midyear. There's increasing enthusiasm for that program among investors. How does Biogen position? And what is your level of confidence we could see good data?

I've been in this business a long time with GSK and Sanofi, but I've never seen so much groundbreaking sciences when I came to Biogen, I have to say. These studies whether it's for LRRK2 or BIIB080, these are studies that are being watched by the entire medical community. Tau is, by far, the most exciting target, if you ask neurologists because, again, as I said earlier, the severity of Alzheimer's is really related to the level of tou you have. So the belief is, actually, it's really the tou that is the most toxic part of this. And if you can affect tou, you could have an even bigger effect than affecting amyloid. That's what the belief is. So we're going to test that. Now you've seen antibodies that don't work. And that's because we believe you have to affect the intracellular tau and the antibodies are really affecting the extracellular. So you're not really getting enough impact on tau. We did a study, in Phase Ib, where we actually demonstrated that we can significantly reduce the levels of tau. You have to be a little careful because unlike amyloid, you don't want to eliminate tou entirely. So you have to get to the right level of tau reduction. And now we'll have to see, okay, you can reduce tau. How long do you have to reduce the tau to get an impact on cognition. And I think one of the things we saw with the GLP-1 studies is it ain't easy to move that needle on cognition. So this all again will be a groundbreaking study, we have no idea until we actually see the results, but we will see that by midyear. And as I say, the entire Alzheimer's community is waiting anxiously for those results as am I.

I think we all are. Moving on to some of the other commercial products. SPINRAZA could have your next milestone with an April 3 PDUFA for high dose SPINRAZA. How do you think that, that could change the competitive dynamics in the SMA field.

So one of the things about -- if I were to go ask the audience here, what do you think is the best way to deliver drugs? Do you want to pill? Do you want an injection or do you want a spinal tap, everybody would say, pill, right? Well, it turns out that that's true until you get into really life-threatening devastating diseases. And at that point, what you really want to do is have the best possible efficacy. And when you think about Biogen competing against a gene therapy that offers or their advertising is one and done And a pill. How do we even compete? Well, we compete because it is believed that we have the highest level of efficacy. And when you have children who would otherwise not survive, children who need to walk and sit and you're a parent, you want the best possible efficacy. So -- but what we have seen is that at some point, there is a fatigue of the intrathecal injections and people will wander over to the oral treatment. So what we have done is now said, let's offer a higher dose. So we get you to a higher therapeutic level faster. We're going from 12 milligrams to the 50 milligrams. And that changes, again, the equation on efficacy. We just launched in Japan, and it's early days, but we're actually already seeing the switchbacks from some of the Evrysdi patients. And we're also seeing a number of new patients coming on from other therapies, potentially gene therapy. We did a study, for example, that demonstrated the benefit of adding SPINRAZA even after gene therapy. So those dynamics about the drug administration will still stay. But I think we are shifting the debate a little bit and shifting the debate on efficacy in favor of SPINRAZA.

How is Biogen thinking about pricing HD?

I think we're looking more at market share as a lever for growth and for pricing.

Can you talk about how salanersen butcould contribute to the SMA franchise over the long haul?

Salanersen we first developed was to really deal with the intrathecal fatigue. And we had offered what we're really looking for is a once-yearly injection. And that in itself would have been a value-enhancing product. But what we're actually seeing is that not only, only once a year, but we've actually seen indicators of development in children that nobody has actually seen before in our Phase II study. We had children who had received gene therapy in infancy. But at age 4 could still not sit or at age 5 could still not walk. And and again, these are all small numbers, and they have to be validated by our Phase III program. But after 3 months of treatment on salanersen, these children were sitting and these children were walking. So there is a promise of even higher efficacy in addition to the improved administration. And quite frankly, I think once yearly intrathecal could really compete in terms of mode of administration against any other form.

On SKYCLARYS one of the key growth drivers that you mentioned before, how do you see that launch progressing in the U.S. and Europe?

So we're rolling that out worldwide. This is a disease that affects principally descendants of European populations. So actually, you go where all of the explorers went. So we were actually just doing a business review on Friday. Most of these patients really are in Europe, North America, Latin America, but we're actually now starting to find them in the Middle East. You won't find them necessarily in China, but we're saying, well, actually, there was quite a significant European population at various times in places like Shanghai. Or you could go to India. And we were talking about Goa actually, which is the former Portuguese Colony. So the big thing is finding the patients. We're talking about fewer than like 10,000 in the world. And we just got approval in Brazil. So now we're seeking reimbursement in Brazil. We think that's going to be a significant market. We already have more patients outside the U.S. than inside the U.S. Inside the U.S., I think the thing that we hadn't known at the start because, again, there was no therapy before, so nobody really knew anything about these patients. But there's actually a lot more older patients and it turns out that the pediatric are a lot more severe and you have a milder form when people are older. And so the real effort right now is twofold. One is to really convince the older patients who've lived with this condition that there is still a benefit to going on therapy. And the other is now to complete the study for the pediatric indication because right now, we're limited to 16 and above, and there'll be a significant market for patients who are less than 16. So it's finding those patients. It's going and getting the reimbursement country by country. We tend to get them on drug through the early access programs early and then negotiate pricing. Given an MFN world, rare diseases is you don't really have the same variations in price simply because you can't afford to because there is no volume effect. But nonetheless, we've probably taken longer to negotiate pricing just to make sure that we don't get caught up in any MFN difficulties. So it's going out and rolling out very successfully.

Can you remind us what is Biogen's guidance for when that pediatric trial could complete?

We think that will be done by 2028.

Moving to multiple sclerosis. Biogen's guided to a mid-teens decline in the MS franchise, excluding VUMERITY this year. Is there anything that can be done to slow that decline? Or is it just the function of a maturing aging product portfolio?

Well, I think -- so you've got a number of products in there. One is you have the AVONEX, the interferons, AVONEX and PLEGRIDY actually declined at about a 8% to 10% rate actually. So we're still selling close to $1 billion of those products around the world. And one of the things about multiple sclerosis is that patients who are doing well are tend to be patients you don't want to touch their treatment because they're not having relapses. They're not progressing. And so most physicians tend to be quite sticky in their prescribing habits. And we certainly see that with the AVONEX as well. Then you have TYSABRI is probably considered by most neurologists to be their favorite drug actually. If you actually just looked at pure efficacy and the benefits of it, but of course, you have the whole risk of PML through the JC virus and you have to do the assay. So what we tend to have right now is a group of really dedicated physicians who just are highly loyal to their patients who are on TYSABRI. We've seen the introduction of a biosimilar, but they don't have the same assay as we do. And given that you have to administer the assay on a regular basis, I think it's going to take a while for the biosimilar to really gain the confidence of physicians that their assay is as reliable as ours. Because on the one hand, you've got amazing efficacy but you always have that risk on the side. You don't want to just take any chances with that. Now the small molecule business, the TECFIDERA, that has gone down to almost nothing. We were able to get a reprieve on market exclusivity in Europe. So we gained an extra year, but now we're seeing the erosion on a classic small molecule basis in Europe. So we had 6 months of that in 2025. We'll have a full year effect in 2026. I would say, though, coming out of that, I think you're going to see some of that decline in the MS portfolio start to level off a little. It will still decline, but maybe not at such a high rate because it's really being driven by the rapid erosion of TECFIDERA in Europe. But TYSABRI in Europe, we have actually a subcutaneous version of that, and the biosimilar does not. So we've actually been able to retain the 50% of the business that is subcutaneous. And that seems to be pretty sticky as well. So I think it declines on a gradual basis. We don't promote. I mean, when I got to Biogen, we were putting 80% to 90% of our promotional effort behind that business. And we have basically cannibalize those resources to invest in new products, there's nothing new, I mean that you can say about that. The one thing that Biogen has is an extraordinary patient services organization. Most companies have outsourced that. We have not. And if you know anybody who has any kind of serious disease today, one of the things you're going to hear is how about -- how much you have to fight with insurance companies. Something like 70% of branded prescriptions now face some sort of delay because of prior auths or some other paperwork problems we help patients negotiate on that. We help patients find the co-pay assistance. We help patients just understand the care pathway. We happen to be in San Francisco at the JPMorgan conference going to see an investor, a young women associate takes us into the meeting room. And as we're getting seated in the portfolio managers are walking in, she just stops to thank Biogen because she's been on TYSABRI for so many years, and she said, no other company offers this kind of level of patient support. And this is really something that's particularly important in rare diseases. And I think it's going to be important for us as we launch in lupus, for example. Most companies are mass marketers and you can't get down to thinking about each and every patient. This is actually something I saw years ago at Genzyme too from Sanofi. If you really can develop that capability, but it's not easy to do and you do have to have patience and invest in that.

Great. With that, I think we're out of time. Thanks so much.