Biogen Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 1, 2025

There are 9 speakers on the call.

Operator

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 twenty twenty five 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

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.

Operator

Power, you may begin your conference.

Speaker 1

Thanks, Melinda. Good morning, and welcome to Biogen's first quarter twenty twenty five earnings call. During this call, we'll 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.

Speaker 1

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 Vibacher doctor 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 and 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.

Speaker 2

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 we had a very good start to the year, strong quarter.

Speaker 2

You know, Biogen is really, a tale of two companies in in my view. There's one company which has been an MS company, and that portfolio, as you all know, has been gradually declining. But there's a new bird, emerging. And when I look at the rare disease business and I add Zuve and the Kembi and VUMERITY, we actually have a commercial portfolio that we're actively promoting that's now gotten to be about 45% of our product revenue. And those products mostly have a very long runway to continue to grow.

Speaker 2

And and so, you know, we've been talking about it for a few years, but I think now this is actually starting to become visible. We're rolling these products out worldwide. You know, we had the approval of Lekembi in in Europe, for example, which is very important approval, for us. But, you know, we've also seen the approval of Skyclaris in The UK and and and Brazil. Of course, the next, lever of growth is gonna be our pipeline.

Speaker 2

And there, we've, we're very happy to get the, FDA fast track designation for our ASO targeting BIB eighty. That's remarkable since that we we haven't actually even read out phase two yet, and and I think is a a sign of confidence in the importance of this, potential new medicine in treatment of of Alzheimer's. And, of course, we've initiated the phase three TRANSCEND study for fezartamab in in AMR. And, of course, we've always said we've got a very strong balance sheet. We're gonna continue to to patiently and and in a disciplined way, augment the pipeline through external innovation, and, we're very happy about the partnership that we built with on on, zoravirnusin in Dravet syndrome with Stokes.

Speaker 2

That's gonna be an important medicine. We have that for, the territories outside the The United States. Now if we turn to, where we are on these new product launches, so Lycanbi, I mean, look at that 96,000,000. That's almost a hundred million dollars now. We're into serious product territory.

Speaker 2

We have, as I said, obtained the marketing authorization in the EU, and it's not it's important not just because of the market potential in the EU, but now we can say that this is a drug that has been recognized for its, importance, its efficacy, its safety profile by all major regulators in the world. And and that's an important, sign of confidence. This is, again, the first disease modifying, agent that has ever been approved in Alzheimer's. This is a brand new territory, and and I think having that kind of a a regulatory endorsement is is extremely important. Now as we all know, this has been been a challenging product to launch, given the workload that this applies for, the treating physician.

Speaker 2

And we're looking very much forward to, a number of the innovations that are coming along that we think can actually reduce that workload. First, of course, is one we have in the bag in the first quarter, which was the approval for the IV maintenance, which will allow us to reduce the dosing for patients after eighteen months of treatment to once per month. Then we're gonna make that even easier for physicians with, hopefully, an approval in in August for the subcutaneous formulation, and that offers the potential of at home administration with an auto injector. And, of course, in the first half of next year, we're looking forward to, the approval, hopefully, again of the subcutaneous formulation for initiation, which will dramatically reduce the need for for infusion bed capacity. In addition, of course, this isn't, related to Eisai or or Biogen.

Speaker 2

These are independent companies, but there are companies who are pursuing approval for biomarker tests, blood based biomarker tests. And and, hopefully, at some point, we'll be able to see those blood based biomarkers supplant the the need for PET scans and or or lumbar punctures. So there's an awful lot of of of catalyst coming for Lykimbi, but we're very much encouraged now that we've got critical mass behind this. We've also, launched a a new approach on commercialization from April 1. We and our partners, Eisai, spent a lot of time going back through the data, thinking about the the lessons learned and have adapted, our commercial approach.

Speaker 2

And one of the things, for instance, that we will be doing this year is now starting direct patient engagement in in Alzheimer's. Now switching to XERZUV. This is a product that continues to do nicely. We had q one sales of 28,000,000. Since launch, we have now been able to treat ten thousand women with PPD, and the majority of those prescriptions are actually first line therapy, for postpartum depressions.

Speaker 2

A lesson that we learned along the way was actually the the physician who is the most important in in, treating postpartum depression is is actually not the psychiatrist, but the OBGYN. So 80% of our scripts in in q one, for instance, were from OBGYNs. One of the most important things here is you're talking about a a one and done treatment, essentially. And so, to make this commercially viable, you actually need to have writers, expand, and we we did see that. So we we're able to, expand the number of of of physicians writing this by 20% in q one.

Speaker 2

But more importantly, it's getting, physicians to to write repeat prescriptions. And one of the most encouraging things is that we are we're not only seeing the repeat prescriptions, but I think as physicians gain the experience with XERZUVEY, they're also gaining the confidence to actually go and be more proactive about diagnosing postpartum depression. And so I I think we're we're actually seeing a virtuous cycle here where this positive, response by patients is encouraging, you know, a greater attention to a disease that, unfortunately, I think has been sadly neglected, for for so many for so many women. So, very good progress on on Xerxuve. We've completed our own, field expansion at Biogen, and that's been in place since the middle of the, the quarter.

Speaker 2

Now if I turn to Skyclaris, we had worldwide sales of a hundred and $24,000,000. That's up 59% year over year and 21% quarter on quarter. We did have some effect from the IRA. You you all know about the the Medicare, tax that has been put in place, and that had an an effect. Actually, our gross sales, in The US rose faster than our our net sales in in in this quarter.

Speaker 2

You know, one of the things about this disease, of course, is that this is in European origin as a genetic disease. And and, essentially, where you find the patients is where all the European explorers went in in the world. And but logically, of course, and the the biggest number of patients is is in the in in Europe. And there, we have had an awful lot of success in finding patients. It's actually, I think, easier to find them in in Europe because they tend to be in centers, whereas they they tend to be all over the country in in The US.

Speaker 2

But even in The US, our our US team has been very creative in in thinking about new tools to to identify where patients are and and find them. I I can remember years ago, with the acquisition of Genzyme learning the the key marketing, component of rare disease, and that is finding needles in haystacks. And and that's what this is all about is is is looking through social media, following, family trees, and and looking for patients. And so how are we doing on that? If I could see the next slide, you can see that we've got a nice steady growth in in patient numbers.

Speaker 2

We've got about 2,400 patients on therapy globally. It's now available in in 26 markets. I would caution that not all of those patients yet are paying, patients. We have had an approach of having early access programs in countries to ensure that patients benefit from treatment as soon as possible, and we are following up then with negotiations on a country by country basis. But the the uptake is is very satisfying.

Speaker 2

When you think about, the penetration into this market, as we benchmark this, the penetration is actually much higher than than the average analog, rare disease launch and and actually in line, pretty much with the SPINRAZA launch. I wasn't here for that, but, as we've gone back and looked at it, the SPINRAZA launch was actually one of the best, if not the best, launch of of a rare disease product. So, we we're very happy with the the progress of of Skyclaris. Brazil approval is actually a very important market for us. There are a lot of patients in Brazil, again, going back to, where Europeans went in the world.

Speaker 2

And having been in Brazil last year and met with a number of physicians, I know that this, approval will be be, very welcome to to patients there. Moving on to the pipeline, you know, I think we made an awful lot of progress here I mean, you've heard me say, I think, time and time again that, you know, I think we had an extremely high risk pipeline when when I came here. First of all, it was highly concentrated in in neuroscience, and and and that's always an an issue when you only have one therapeutic area. The neuroscience was also a little complicated because we don't always understand the underlying disease biology.

Speaker 2

The slowly progressing nature of those diseases mean that you you often couldn't do a phase two study, and so you go immediately into a phase three study. So you end up doing incredibly expensive proof of concept studies as as phase three. Now neuroscience is who we are, and and we've not wanted to abandon that by any means. There's huge unmet need, but we did feel that we needed to add another pillar, to to our company's future growth. And the logical place to go was immunology.

Speaker 2

We've been in immunology since the the founding of our company, particularly through MS. And, you know, I I I quote my my good friend and former colleague, Elias Zahuni, you know, who who often said, we describe too many diseases by their symptoms and not by their cause. And when you get into immunology, actually, what's important is really the immune pathways, and that can lead you into a whole number of different indications. And and that is something that Biogen actually understands very well. And so you can see on the left chart, we've been able to balance this now.

Speaker 2

We've we we have got a nice balance between neurology, which has been, the pride and home of Biogen for many years, but also, I think, immunology where I think we have a very strong right to play. And then, of course, with that concomitantly, if you if you look at the right chart, in immunology, one of the things you can do is is do a a proof of concept. And, you know, fezardimab is probably the best example of that. That that is an ideal product where we've been able to get a very strong, proof of concept. There is never a guarantee in any clinical trial, as all of you know.

Speaker 2

But I think as as we look at the phase three clinical trials, for vals talcartamab that, you know, we we feel a whole lot more confident about that than than some of the other trials where, you know, again, we haven't had that. And so as you look at our pipeline, you know, I think, if I could go to the next chart, you know, first thing I would point out, we have five phase three studies that are initiating this year. And and that's important from a number of points of view. First is, obviously, there's a huge potential that is behind all of those products, and we're getting into late stage development. So it's a sign of maturation of our pipeline.

Speaker 2

But but the second thing is we're also increasing the number of shots on goal. We're not dependent on one or two projects, and and we're gonna continue to build that. And and I guess the third thing I would point out is, you know, we have a number of of data readouts that are coming. And so, as we move into phase three, we'll be able to also have some important readouts already in in in 2026. And I think that's a nice cadence that is is going to help underpin the the continued emergence of of that new Biogen.

Speaker 2

So, I think very good progress, and and Priya is gonna talk more about that. And then I guess the last topic I I would just cover is is one that I think is on everybody's mind, which is which is tariffs. It's a new topic for us all. In thirty five years in this industry, I've I've never had to spend as much time as as we as a team have on tariffs in the first quarter. This is a very complicated area, and I know for for investors, this is this is very complicated.

Speaker 2

And I I did wanna point out a number of features of Biogen, which I think differentiate Biogen from some of our colleague companies in in the industry. And a number of you have been using, for instance, the tax rate as a surrogate for what the tariff exposure might be. And I would submit to you that that that's actually not appropriate in the case of Biogen, and it's for a couple of of of important reasons. The first is that when you look at our product sales, 75 of our 2024 US product revenue was attributable to products that already have manufacturing operations in The US. And in fact, Biogen actually exports more than than we import.

Speaker 2

And and as a result, also, we we also pay an awful lot of tax, and and, Robin will will talk about that. But we pay taxes in The US at federal and state rates. But the other structural difference is that approximately 55% of our 2024 product revenue came from countries outside The US. Now that's pretty unusual in our business. In in in most of of this industry, what you see is 60 to 80% of product revenues come from The US.

Speaker 2

Biogen is a whole lot more diversified, and that's really a function of the the products that we have. So, as we look, out for 2025, you know, obviously, there is an exemption for the moment in place, and we know that the whole tariff situation is changing daily, and it's difficult to predict. But at least what we can say is even if we lost the exemption, and all of those tariffs that were announced by the US administration on April 22 were to actually not only come into being but also apply to pharmaceuticals, this would still not affect, our 2025 financial outlook. That's partly because of the long supply chains we have. It's partly because and I have to credit our our supply chain team.

Speaker 2

They've built in levels of inventory, not just of products, but also of of different ingredients and materials because, again, this is a highly complex area. But just structurally, you know, we are more of a US based company and and always have been, and and actually, we're quite proud of that. So with that, I'm gonna pass that on to to Priya to pick up the story on r and d.

Speaker 3

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.

Speaker 3

First, as Chris mentioned, our tau targeting ASO, BIIB 80, 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. Bebedi is a differentiated approach to targeting tau, and the fast track designation was based on encouraging phase one b 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 three study of fezardimab in AMR. This is the first of three phase three studies that we expect to initiate this year for fezardimab with additional studies in IGAN and PMN anticipated by midyear.

Speaker 3

And importantly, we expanded our late stage rare disease pipeline where we acquired rights to zorobinursen 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 ninety percent 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. Zoravunercin is an investigational ASO that is designed to potentially, for the first time, treat the underlying cause of Dravet syndrome by increasing the Nav 1.1 protein production in brain cells. What encourages us about this asset is the phase one two a data that we've seen, specifically in respect to cognition and behavior as well as seizure.

Speaker 3

And looking at the right hand slide side of the slide, you can see why. Scores on the Vineland three, a widely used standardized assessment of behavioral outcomes, show that zoravoneursen resulted in substantial improvements across multiple measures of cognition and behavior. This was initially observed within the phase one two way study with continued improvement in the open label extensions out to two years. We believe these results support the potential for zorobinursen to be the first disease modifying therapy in Dravet syndrome. We look forward to working with Stokes on advancing the phase three EMPEROR study, which we expect to initiate in the next few months.

Speaker 3

We continue to remain focused on advancing the standard of care in Alzheimer's, and I believe we've made significant progress. Starting with Lekembi, we are really excited about the recent approval in Europe. We're also continuing to advance the subcutaneous formulation for both treatment maintenance and initiation to further aid patient optionality and convenience. Furthermore, we believe that the strength of the LAKEMBY real world data continues to support the urgency to treat symptomatic early AD patients today, and we look forward to the potential of blood based diagnostics to help remove barriers in the health care system. I also believe it is important that we continue to execute on the opportunity in presymptomatic AD.

Speaker 3

Clarity AD established that removing plaque in a symptomatic early AD population leads to clinical benefit, and that symptomatic patients with low or no tau can potentially achieve an even greater benefit. And we believe a HET three four five is the right study design to evaluate the potential benefit of the can be in a true presymptomatic population. Beyond the can be, we continue to treat target Alzheimer's disease biology with the potential next wave of therapies, including VIBETI and novel delivery technologies. Overall, I'm encouraged by the progress we're making in Alzheimer's and believe we are well positioned to lead the evolution of the treatment landscape. Turning to the pre proof of concept pipeline, I'm excited again about the progress we've made in rebuilding this area of the pipeline.

Speaker 3

We are applying a strong scientific rationale as we invest in these programs using a disciplined data driven decision making approach as we aim to build out a sustainable pipeline with a promising pre POC pipeline. During this quarter, we made significant progress in this area, including completing enrollment in the phase two study for our LAC two inhibitor for idiopathic Parkinson's disease with Denali. Applying our approach to follow the science, these phase two data, which are expected next year, will help provide us with clarity on the potential path forward to phase three. We will continue to maintain this approach as we work to grow the pipeline by introducing more assets into the early stage development, both from our organization as well as external innovation sources. With that, I would now like to hand the call over to Robin for a financial update.

Operator

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 twenty twenty four unless otherwise noted.

Operator

Total revenue for the first quarter of '2 point '4 billion dollars was up 6% year over year, aided in part by the timing of SPINRAZA and corporate partner revenue shipments. Our four launch products delivered approximately $200,000,000 of revenue in the first quarter, an increase of 22% quarter over quarter and more than doubling year over year. First quarter non GAAP diluted EPS was 3.02 which was down 18%. This includes the $165,000,000 upfront paid in connection with the Stoke transaction, which impacted EPS by approximately 95¢ in the quarter. Absent that charge, first quarter non GAAP diluted EPS would have been 3.97 up 8% year over year.

Operator

In the first quarter, we generated $222,000,000 of free cash flow, which includes the $165,000,000 upfront paid to Stoke. We ended the quarter with $2,600,000,000 of cash. Shortly, I will provide an update on our full year guidance. Now I'll turn to a few comments on revenue and commercial dynamics in the first quarter. Starting with our MS franchise, our global product revenue declined 11% year over year, driven primarily by competition.

Operator

This included impacts from a from a biosimilar for Tysabri in Europe and generic competition for TECFIDERA globally. We have started to see generics launch in certain countries in Europe, such as France and The Netherlands. While we will continue to vigorously defend our IP, we do expect to see further impacts from TECFIDERA generics in Europe this year. A bright spot for MS in q one was VUMERITY, where we saw an increase in demand, and VUMERITY remains the number one branded oral therapy. For SPINRAZA, we continue to be encouraged by the consistency in demand globally, which includes growth in The US of 4% year over year.

Operator

In the first quarter, ex US SPINRAZA revenue benefited from a onetime VAT refund and the timing of shipments in certain markets, which together was a benefit of approximately $26,000,000 versus Q1 of twenty twenty four. And as I mentioned earlier, our four launch products together delivered $200,000,000 of revenue to Biogen in the first quarter, an increase of 22% quarter over quarter and more than doubling year over year. We continue to see steady sequential growth of LOKEMBY with first quarter global end market sales booked by Eisai of approximately $96,000,000 up approximately 11% sequentially from the fourth quarter of twenty twenty four. Global Skyclaris revenue was $124,000,000, a sequential increase of 21% versus the fourth quarter of twenty twenty four, driven by continued geographic expansion outside The US. Revenue for Skyclaris in The US was $69,000,000 impacted by expected Medicare discount dynamics, partially offset by demand growth.

Operator

And both XERZUVEY and KALSATI continued to grow sequentially driven driven by increases in demand for each product. The increase in corporate partner revenue in the first quarter was driven by the timing of certain batch commitments related to our contract manufacturing business, some of which was associated with batches of Leukembi. We continue to believe that corporate partner revenue will be roughly consistent when comparing full year 2025 with full year 2024. Due to planned maintenance activities and the timing of batch releases, we expect minimal corporate partner revenue in Q4. I'll now turn to a few comments regarding expenses.

Operator

First quarter non GAAP cost of sales was impacted by increased lower margin contract manufacturing revenue. Non GAAP core operating expense, or R and D plus SG and A expense, decreased 1% year over year as benefits from our R and D prioritization and Fit for Growth initiatives allowed us to absorb incremental spend associated with our advancing and expanding development pipeline as well as our product launches. Non GAAP operating income included approximately $2.00 $1,000,000 of acquired in process R and D charges, including the $165,000,000 upfront payment made in connection with the Stoke transaction, which had an approximately 95¢ impact to EPS. Excluding the $165,000,000 upfront payment, non GAAP operating income would have been $748,000,000 up 7% year over year. As a reminder, we and our peers are required to present upfront and milestone charges in GAAP and non GAAP operating results.

Operator

Commencing this quarter, we will break out acquired and process R and D, including upfronts and milestones in a separate line item in our P and L, consistent with many of our peers. We believe this provides better transparency about our core R and D activities and business development activities. We plan to disclose a schedule of expected charges for each quarter ahead of our earnings calls to aid in modeling. Now I'd like to provide a brief update on our balance sheet. We generated $222,000,000 of free cash flow in the first quarter, which takes into account the aforementioned $165,000,000 upfront payment to Stoke.

Operator

We ended the quarter with $2,600,000,000 of cash and approximately $3,700,000,000 of net debt and believe that our balance sheet remains strong, allowing us to continue to invest in both internal and external growth opportunities. Turning now to guidance, where we are pleased that our expected underlying business outlook for the year has not materially changed. We are updating our full year EPS guidance to reflect the approximately $0.95 impact from the Stoke transaction along with $0.20 of an earnings tailwind from foreign exchange impacts from a weaker US dollar. We now expect our full year 2025 non GAAP diluted earnings per share to be between $14.50 and $15.50. We continue to expect total revenue for 2025 to decline by a mid single digit percentage, driven primarily by an increased decline in our MS business.

Operator

We expect that our launch products will generate sequential revenue growth, but we expect the absolute MS revenue decline to be steeper than this growth in 2025. As a reminder, we expect a potential biosimilar entry for Tysabri in The U. S, which we believe could occur sometime in the fourth quarter of this year. And as I mentioned a few minutes ago, we have started to see generics for TECFIDERA enter in Europe. And while we will continue to vigorously defend our IP, we do expect to see further impacts from generics in Europe this year.

Operator

As I noted earlier, we believe that corporate partner revenue will be roughly consistent when comparing full year 2025 with full year 2024. Due to planned maintenance activities and the timing of batch releases, we expect minimal corporate partner revenue in Q4. We believe we are on track to deliver the $1,000,000,000 of gross savings and $800,000,000 of net savings under our Fit for Growth initiative. As you can see on the slide, many of our guidance considerations have remained the same as when we guided for the year back in February. I will also refer you to our press release for other important guidance assumptions.

Operator

And finally, a topic of great interest to many investors is the impact to our business from tariffs. Biogen currently does not expect a material impact in 2025 from potential tariffs as announced by the administration US administration on 04/02/2025, even if the exemption for pharmaceuticals were to be removed. This is based on both a significant portion of US revenue being derived from products which have manufacturing operations in The United States as well as our current global inventory position. Our guidance range also considers potential retaliatory tariffs from China as announced. However, The US and international tariff landscape remains uncertain, and our guidance does not contemplate any new tariffs that may be announced in the future.

Operator

I will also note that when excluding onetime tax impacts, our tax rate is broadly a function of our business mix and, therefore, does not serve as a good proxy for estimating potential tariff impacts. Biogen's effective tax rate is a reflection of our US market revenues being almost entirely taxable in The US at the full federal plus state tax rates. We also generate a relatively high percentage of our revenue outside The US, which is taxable in those markets and in The US under the GILTI regime. We will continue to monitor and analyze the current and future U. S.

Operator

And reciprocal tariff landscape as it evolves. I'll now pass the call over to Chris for some closing comments.

Speaker 2

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 three starts. That's, after the, phase restart already in AMR. We've got three clinical trial readouts coming.

Speaker 2

We've got three regulatory decisions, coming. One of the other things I'll say is in this first quarter is we did a a major restructuring of research, and I'm really quite excited about what we're doing there. You know, as an industry, we rely way too much on late stage business development. The most cost effective place to do collaborations is actually preclinically, and and we have a goal of of signing four to five new research collaborations this year. Just on research, Biogen has been known, for breakthrough, medicines.

Speaker 2

In fact, all four products that we launched in 2023 and '24 are first in class, first ever disease modifying agents, and 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 and so one of the things that I think we feel that we would like to do is is do a deeper dive into some of these diseases and and pipeline assets, not with the intention of presenting new data, but to just say, okay. What's the competitive landscape?

Speaker 2

What's Biogen's right to win here? What's the patient journey? What is it gonna really take to to move the needle on on one of these diseases? What's the reimbursement, landscape gonna be like? What's the epidemiology?

Speaker 2

If I look at AMR, for example, I I think this is a huge opportunity, for for Biogen. And, you know, we saw 80% resolution of AMR in phase two 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 gonna take to really to be interested in IgAN?

Speaker 2

And I I spend an entire day with our West Coast hub, just on selzartamab, and there's a huge amount of of things going on there. And, you know, even things like all c d 30 eights are not created equally. So what are they like? So we would like to invite whoever's interested, to come to some of these thematic seminars. The first one we're gonna hold on June 11, and, hopefully, that'll be the first of the series.

Speaker 2

And it's just meant to be educational and and a deeper dive, and we'll have some of our 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 for q and a.

Speaker 1

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

Operator

And your first question comes from Brian Abrahams with RBC Capital Markets.

Speaker 4

Congrats on the recent Leukembi 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.

Speaker 2

Yeah. Thanks, Brian. Well, that that is, is certainly going to take some time. You know, the fact that the approval took while tells you that, you know, there's enough a lot of thought going into that. You know, 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 in a budget.

Speaker 2

So these types of products are incremental adds to the total health care budget of countries. And and so that's sometimes where it's easier to launch a product that's that's kind of a me too that comes in and and and can simply cannibalize the budget of another product. So this is this is obviously a significant market in in Europe. The the Europe is is an aging continent even more so than, than The United States, so there are an awful lot of eligible patients. But we'll be taking that with our partners, ASI, market by market.

Speaker 2

I do think that also, Lykimbi 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 of of 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 and fully evaluated. But, you know, I think it'll be it'll it'll still take some time, and and, you know, we'll go to some of the some of the countries we'll launch clearly faster as is the the case generally in in Europe.

Speaker 1

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

Operator

We go next to Evan Seigerman with BMO Capital Markets.

Speaker 4

Hi all. Thank you so much for taking my question. I want to touch again on Lekembi, but this time with the subcutaneous formulation. You know, maybe remind us how that potential for at home administration can help accelerate sales in The United States? You know, 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.

Speaker 4

Thank you.

Speaker 2

Right. So the the first is is subcutaneous for maintenance. And, you know, these are patients who have been going undergoing biweekly infusions now for eighteen months. And so there I think there are there are two aspects for the commercial. First is, you know, we are busy focusing on making sure that physicians and patients understand the need to continue on therapy.

Speaker 2

And and there we have long term extension data, and we've demonstrated that that in thirty six months after treatment, patients are still doing, better on on treatment than than if they stop treatment. So there's the the whole establishment of the, maintenance market. But if you know, these are also older patients, and and, it's not always easy to get to in infusion centers. Obviously, we make it easier with once monthly dosing, but, our view is is that, this is gonna be more effective as a long term chronic therapy if you have a patient friendly, administration like subcutaneous. So I I think, as a first step, the subcutaneous really helps establish and and, extends the treatment, life of of a patient, in in maintenance.

Speaker 2

And then, of course, in the in the in in the initiation phase, that that'll be interesting to see. I think in in major urban centers, I think we'll we we may see that some physicians may wanna continue at least in the first few months of therapy on infusion, because they're 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 is not as easy for patients that the subcutaneous might even be right from from the get go. So I think it'll depend a little bit on on where you are as a patient, but there's no question that, you know, this is again a simplification of the physician's workload. You know, it's it's a heavy load to to think about the 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.

Speaker 2

And, you you know, just from a caregiver point of view of bringing the patient to the infusion center, I I think this will be welcomed by them as well that that they they can do this at home. So I I think this is, you know, an an enabler for the patient but also for

Speaker 1

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

Operator

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 LAKEMBY uptake and growth on the FORWARD, not only with subcutaneous maintenance dosing in the second half, but also with Fujair's Bio's in vitro diagnostic, which should enter the market as well?

Speaker 2

Yeah. We don't have that much information about the the diagnostic. You know, the the process to get a diagnostic approved is different, obviously, than than than a drug. And then the reimbursement situation is is also different. I do think the, recent report by the Alzheimer's Association highlighted the the need for early diagnosis.

Speaker 2

You know, one of the issues that has has I think, been in 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 and so two or three years can go by, and and sometimes even longer before the Alzheimer's diagnostic is 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, you know, the earlier you can get, to a patient before there has been too much neuronal damage or death, the better. And and so I think I think there's a real effort to be done to really get those diagnostics established.

Speaker 2

And so the benefit really is, I think, twofold. One is, hopefully, we can get patients on treatment at a much earlier stage of their disease, and and we believe and there's obviously studies ongoing, to actually gain the evidence of that. But even, you know, even the data that we presented at CTAD in 2023 of low tau patients, which surrogate for early stage patients, demonstrated that, you know, sixty percent of patients were stable after six months. And and, actually, seventy percent, sorry, seventy percent were stable after six months, and sixty percent actually showed some level of improvement. So, I I think the the the blood based diagnostics are gonna be extremely important.

Speaker 2

But, you know, again, we have to wait and see where where, those companies are in in the regulatory, process.

Speaker 1

Can we go to the next question, please?

Operator

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

Speaker 5

Thank you. On the Kimby, how are you seeing the market parse out between your product and Lilly's Kusuma? 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. Chris, you answered an earlier question starting off talking about getting docs to keep patients on therapy.

Speaker 5

So the product, your pricing on the market now for coming up on two and a half years, 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?

Speaker 2

Yeah. I mean, I think, first, I I would say, you know, we would really consider the launch of this product to have been September of twenty three because, know, that's when we had full approval. We had reimbursement from CMS. In actual fact, we we didn't even really get the question on the reimbursement for PET scans clarified till about November of that year. So I I think we're still much earlier in in in that launch phase.

Speaker 2

To your question on on this versus dananemab, you know, it depends on the physician. And and I think we're gonna see those who who like this idea of, potentially saying, well, there's there's a finite point to this. Equally, know, what we have seen even at the recent ADPD, once you have a maintenance indication and you start to see the data, you you'd start to realize that, well, actually, once you've released the removed the plaque, you're not done, because there is some return of of the plaque and and potential damage. So there will be, you know, obviously, a lot of education to be done to to demonstrate the importance of of, continuing on that. But I think at the end of the day, it's it's largely gonna be up to the physician and and the patient.

Speaker 2

There will be patients where dananemab 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 and I think the market ultimately just gets split between us and and and inanemab. The the most important thing for both Lilly, I think, and Biogen and Eisai is that we start to to, to really expand this market. There you know, we've we've got maybe, I don't know, 12,000, 13 thousand patients somewhere in there on on on treatment, less for for Dananemab, but they they will get there.

Speaker 2

But, you know, when you consider the number of patients who desperately need treatment, we're still only, treating a small fraction. And and I think that's really gotta be the the focus of all the companies in this space is to really ensure that that that more patients benefit from these disease modifying treatments. Can we go to

Speaker 1

the next question, please, Melinda?

Operator

Next up is Chris Schott with JPMorgan.

Speaker 6

Oh, 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.

Speaker 6

Thank you.

Speaker 2

Yeah. Thanks for that, Quinn. I I mean, I think there is a there has been a a shift even perhaps in the last, I would say, four to six weeks, you know, in a couple of ways. I mean, valuation is one thing, but, you know, you're still really focused on getting the right thing. And what I think has changed is, you know, you have a lot of health care investors who are facing a lot of pressure from LPs, and I think they are are looking for liquidity.

Speaker 2

And and I think we've had a lot of companies who've, you know, not really wanted to to to do much, because valuations are low. And 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, you know, I I think one of the things we're gonna see, and I think this is also where we're doing this in the early restate search 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.

Speaker 2

It still requires an awful lot of patience and discipline to to work your way through and and find companies, that work together. I do think Biogen is actually well positioned. I'm I'm one of the things I'm particularly proud of is we have this West Coast hub, which is essentially the high bio team, and we have been able to retain virtually everybody in that high 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.

Speaker 2

So I I do think this is an opportunity, but, you know, again and and we look at a lot of things. But, you know, it's even in this environment, you still have to stay disciplined.

Speaker 1

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

Operator

We'll go to Michael Yee with Jefferies.

Speaker 5

Thanks. Good morning. I

Speaker 7

wanted to ask Priya about the, early AHEAD-three 45 study. I know that you've guided to a twenty twenty eight 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 gonna work and or will read out because I know that you have an interim, but I'm just gonna assume you're not

Operator

gonna take that interim. Thank you.

Speaker 3

Yes. Thanks, Mike. So overall, I would say I'd like to start by saying that, you know, with Clarity AD, we established that Lycanbi 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 three four five is truly positioned to provide a comprehensive understanding and evaluation of how the can be can preserve cognition across the full spectrum of presymptomatic AD.

Speaker 3

And the reason for that is that we are testing it in two parallel trials. The first one is a head three, which is about 400 subjects, and really by the inclusion criteria are 20 to 40 centelloids, of amyloid. And then the other trial is greater than 40 centelloids, which is the head four five amyloid levels. And there, we're looking at whether it can prevent cognitive decline. So AHEAD three is looking at can we stop the accumulation of amyloid, has amyloid PET as the primary endpoint, and then AHEAD four five is looking at preventing cognitive decline.

Speaker 3

And we have a very sensitive clinical by endpoint called the PAC five with along with amyloid and tau PET. I think in contrast, Trailblazer ALVS three is really evaluating whether donanemab can slow clinical progression in a mixed population. And this is by based on their baseline CDR global scores. So a pre true presymptomatic is about fifty five percent, and they have included forty five percent of symptomatic patients. So these studies are actually quite different, and we are looking at the entire range of presymptomatic patients with varying degrees of amyloid.

Speaker 3

We will we do expect we fully enroll. We do expect to read out in 2028. We always reserve the, optionality of looking at data earlier or such, but we're not commenting on that right now. We are looking at a readout in 2028.

Speaker 2

Yeah. And I think if I could just from a commercial point of view, I 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 and the risk benefit equation becomes different at that point.

Speaker 2

And and there is ARIA that is associated with both products. So you're gonna have to answer the question about the risk benefit of treating earlier and and at what level of of amyloid burden. And I I think that's gonna be useful because the the blood based diagnostics will tell you that if there is a presence of amyloid. They won't tell you about how much. So at some point, you know, you're you're sort of, say, 55.

Speaker 2

You had a positive blood test. Someone's gonna send you for a PET scan to see how much amyloid you have. And let's say you're at at 50. Well, you know, 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, and I'm not sure that physicians are gonna, feel comfortable about treating.

Speaker 2

So I I do think I do think actually ahead, three and and four, five are gonna be really landmark studies in in Alzheimer's.

Speaker 1

We go to to go to the next question, please, Melinda.

Operator

We go next to Umer Raffat with Evercore ISI.

Speaker 8

Hi. This is Mike Difeore on for Umer. Thanks so much for taking our question. Again, one on Lekembi. Lilly's Drug did about 20,000,000 $21,000,000 of sales in q one, which is its second full quarter of launch.

Speaker 8

And this tracks slightly ahead of Leukembi sales at the same time point. So my question is, has has Biogen and Eisai perhaps paved the way for Lilly in terms of opening up health care infrastructure? And and maybe perhaps could you just speak to any competitive dynamics at play now that you're you're roughly eighteen months into Thank you.

Speaker 2

Well, I think that the the answer is probably yes. You you know, clearly, you know, there's been a lot of hard work and particularly the IDNs to to work through the all the treatment pathways and protocols and treatment regimens that are that are needed. And and so, you know, then now we're into a question of, you know, lecanumab versus dananemab in those questions. And as I said earlier, I think I think there will be cases where physicians, are looking at at at both products. You know, I think it'll be a question of who gets initiated.

Speaker 2

I don't think we're seeing any switching going on here. So, you know, it's really a question of which one are you gonna start on and then stay on. I think the bigger question is, can we actually collectively grow the market? And and that's really what's most important. And and I don't think we particularly wanna get into just trying to duke it out over market share in a in a in a relatively still small market.

Speaker 2

There is a there are a lot of patients out there, and we are not yet doing a full service to to patients who are suffering. And so the more that we can get, more centers up and running and and better education, the better it will be for patients and actually for both companies.

Speaker 1

Chris, let's go to the next one, please.

Operator

Next up is Terence Flynn with Morgan Stanley.

Speaker 7

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, you know, your Dravet program moving into a Phase III. 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 is going to be advancing very rapidly and and be more favorable to the industry in terms of thinking about maybe surrogate endpoints?

Speaker 7

Thank you.

Speaker 3

Yes. Thank you. Overall, I I'd I'd 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, you know, obviously, the data that we saw during diligence and, you know, which I spoke to as well today, for us, that has been very compelling.

Speaker 3

That has been you know, it has several aspects to it. First of all, this population, although it was

Speaker 5

a

Speaker 3

small, you know, open label trial, I think what was important about it was that these patients were on standard of care. And, unfortunately, the, you know, the burden of disease is high in Dravet, and they have a number of seizures, sometimes, you know, seven to 10 a week. And and they are on multiple medications, antiseizure medications. And in fact, we saw the impact of zorvonorcin on top of standard of care. So the impact that we saw was, you know, eighty seven percent seizure reduction on top of background standard of care, full standard of care.

Speaker 3

And then that was durable out to about seventy six percent when you look out six months. So that the data was important. But the other aspect of 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 three EMPORER trial.

Speaker 3

So we remain fairly confident that this is the right trial to conduct. And so, you know, 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.

Speaker 2

But I I think to your broader question, I think, certainly, the right now at Biogen, we have not really seen any delays in in in our interactions with the FDA. And, you know, I personally am encouraged by some of the more recent comments by the new commissioner about particular ultra rare and and thinking about, you know, surrogate markers and making sure patients get drugs earlier. And, you know, 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, you know, there's certainly a lot of change going on at the FDA, and we're watching, very carefully.

Speaker 2

And, you know, obviously, there's been, some key leaders who have left and some reduction in staff. But they say so far, at least from a Biogen point of view, we haven't seen any adverse, effect to that. And and perhaps some of the new perspectives of the the new commissioner, Macarie, could actually be helpful to us.

Speaker 1

Thanks, Chris. I know it's a busy morning, so maybe we can squeeze one last question in here. Our last question, please.

Operator

We go next to Jeff Meacham with Citibank.

Speaker 6

Great. Morning, everyone. Thanks for the question. For Chris or Robin, on manufacturing, you know, Biden has historically had a lot of capacity in The US going back to, you know, the original expectations in Alzheimer's. I guess the question is as we see more companies in biopharma announced plans to, you know, onshore capacity, do you guys view your own capacity or resources differently?

Speaker 6

I wonder, you know, if there's a short term opportunity to partner that's that's not in the model. Obviously, all, of course, depends on on what you have in in excess. Thank you.

Speaker 2

Yeah. We we've actually, recently, our our main facility in in Solothurn, for example, we've recently, there. We're actually doing CDMO business to absorb capacity. Obviously, that doesn't help, for for someone looking in in The US. In in RTP, we we actually do quite a lot of manufacturing already for third party companies.

Speaker 2

And I think, you know, even before I joined Biogen, I knew of reputation of our RTP facility. It's a very high quality, very efficient site. So, yes, I think, we certainly will be, open and and looking for opportunities on on that front.

Operator

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

Speaker 1

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.

Operator

This concludes today's conference. We thank you for your participation. You may disconnect at this time.

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Earnings Conference Call
Biogen Q1 2025
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