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<p>Biogen ranks 28 on this year’s Fortune 100 Best Companies to Work For – Europe list.</p>

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<p>Biogen’s mission is to develop treatments for complicated neurological and immunological diseases, like Alzheimer’s and ALS (Lou Gehrig’s disease). These conditions are often life-altering, and affect billions around the world. It also focuses on rarer conditions that have been largely neglected by Big Pharma. Among Biogen’s recent approvals: the first oral drug to treat postpartum depression, and a treatment for a genetic mutation linked to ALS.</p>

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Industries included in the sector are insurance and managed care, medical products and facilities, pharmacy services, and pharmaceutical companies.

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The Fortune 500, in its 70th year in 2024, ranks the biggest U.S. companies by revenue.

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F500-2021-228-Biogen

Based in Cambridge, Mass., the biotech specializes in the development and delivery of treatments for neurological diseases. Biogen has developed medications for multiple sclerosis, plaque psoriasis, spinal muscular atrophy, and leukemia, and has research programs focused on neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, and neuropathic pain.

This year's Fortune 500 marks the 66th running of the list.

F500-2020-223-Biogen

The biotechnology company discovers and manufactures treatments for neurological and neurodegenerative diseases. It has recently garnered attention for its experimental Alzheimer’s drug, aducanumab.

This year's Fortune 500 marks the 65th running of the list.

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Biogen develops and manufactures pharmaceutical drugs that treat neurological and neurodegenerative diseases. The company, founded in 1978, has historically been among the leaders in therapies geared toward multiple sclerosis patients. The drugmaker also operates in other areas, such as the treatment of Alzheimer’s, where it has co-developed the FDA-approved drug Leqembi designed to slow the progression of the disease.

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Biogen (BIIB): Company Profile, Stock Price, News, Rankings

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Biogen

biogen

Good morning. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second 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 question remarks, Today's conference is being recorded. And

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, Cynthia, and good morning, everyone. Welcome to Biogen's second 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 on the Investors section of biogen.com.

We've also posted the slides to our website that we'll use during the call. On today's call, I'm joined by our President and Chief Executive Officer, Chris V. Packer Doctor. Priya Singal, Head of Development Alicia Alaimo, our President and Head of North America and Robin Craver, our Chief Financial Officer. We'll make some opening comments and then move to Q and A.

And to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question. I'll now turn the call over to Chris.

Thank you, Tim. Good morning, everybody. We're very pleased with the performance in the second quarter. In particular, we've seen growth the growth from our new product launches offsetting our MS decline. MS has also proven to be a little bit more resilient this quarter.

There was some gross to net adjustment, but I would like to call out the performance of VUMERITY. I think Alicia and her team in The US in particular have put a lot of emphasis on VUMERITY over the last two years, and we've been seeing some nice growth. And this is a product where we still got, a lot of market exclusivity, out into the future. As we look at the growth products, I think we're also seeing continued consistent growth, with Leukembi. You know, we've got a number of enablers coming along that hopefully will remove some of the bottlenecks, in the system.

Those are things like the blood based biomarkers. The first one has now been approved, but there are now multiple biomarker, tests out there. We have a PDUFA date for our subcutaneous formulation for maintenance coming at the August. And I think those are all things that are starting to generate some potential shift in momentum in lycanbi, but, you know, Alicia will talk about that more. But, I'd say I think we're feeling pretty encouraged by what we're seeing there.

SKYCLARIS, again, now is available in 29 markets. We have probably as many, if not more, patients outside The US as inside The US. It's rolling out extremely well. Not all patients are reimbursed yet, and I think as we progress each country, we've been able to get a lot of patients on early access programs. What we have seen is extremely strong take up in those programs, and then we work basically country by country to get reimbursement.

So XUME has had an extremely nice quarter. And again, I think Alicia will be able to give some more color commentary, but I think that's a bit of a sleeper in our portfolio. I think this is certainly outperforming our internal expectations. We also had good news in the quarter. We got approval in Europe and we're looking forward to planning the launch there.

As we turn to the pipeline, Priya is going to obviously be able to say more, but you know, we've had some very good news there. All phase three studies for, feldsartanib have been initiated. We potentially have another study being started microvascular inflammation, that could add to that portfolio. You know, we saw some really interesting results for salinersen. This is our next generation product for SMA, and we're quite excited about that.

And that'll be another phase three that starts this year. On business development, know, we continue to look across the spectrum of our development pipeline. We're very excited about the research agreement that we concluded in the past quarter with Citi Therapeutics, and we would expect to see several more of those research collaborations this year. We continue to look at later stage, both M and A and collaborations. But again, we remain disciplined in terms of ensuring that anything we do would drive shareholder value.

So I think if I look at the quarter, we've got growth top and bottom line. We've had very strong discipline on costs. And so I think the company is performing well. And with that, I'll turn it over to Priya, who can give us a lot more detail about the pipeline.

Thank you, Chris. This quarter, we made significant progress in continuing to build the breadth and depth across the pipeline in key areas. We obtained a positive CHMP opinion for zuranolone in Europe, initiated three phase three studies, the pediatric phase three study for Skyclaris as well as talzartamab phase three studies for IgAN and PMN, and we are working with Stokes Therapeutics towards an imminent FBI for zorobunursen. We're also working to further expand telzartamab into a fourth indication called late microvascular inflammation or MBI in patients who have had a kidney transplant. In support of our continued scientific leadership, we have also presented new data across our key franchises at medical congresses, including Cure SMA, EPNS, EULAR, and lupus twenty twenty five.

And just yesterday at AAIC, new long term data on Leukembi showing treatment benefits over four years with the continued use and bioequivalence data for the initiation dose of subcutaneous lucanumab was presented. This quarter, we also announced exciting new interim Phase 1b data for salinersen in SMA, as Chris mentioned, demonstrating proof of concept. As the company that led transformation in SMA, we are excited about the potential to continue that journey and potentially address the residual unmet needs for patients. Talanersen leverages the same mechanism of action as SPINRAZA, but was designed to be a more potent molecule and hence enable the potential for high efficacy with once yearly dosing, a profile we believe that can further address the needs of the SMA community. The phase one b study included children who had previously been treated with gene therapy but had not achieved the expected motor milestones based on their age, such as sitting, standing, or walking, despite the extended period of time since having received the gene therapy.

We presented the interim results of this study at the CURE SMA meeting last month, and I would like to review the key features of that data with you next. While this is a small dataset, several features are compelling. First, salinersen was evaluated as a once a year administration. Second, we are seeing a significant reduction in neurofilament, which as you know, is a marker of neurodegeneration. And third, we observed meaningful improvements in motor function, including achievement of significant motor milestones.

And on the right hand side of the slide, you can see two examples of participants who were previously treated with gene therapy several years prior to receiving salinersen. The first row represents a child who received gene therapy at around one year of age and could not sit when they enrolled in the this trial at approximately five years of age. They received salinersen eighty milligrams, one dose, and by their ninety day visit, they were able to sit independently. Naturally, these results need to be confirmed in a registrational trial. But these types of data support the potential of salinersen to transform the standard of care in SMA, and we're working with agent urgency as we engage with global regulators and finalize the phase three study design.

Turning to the lupus pipeline, together with UCB, we were excited to present new data from the positive phase three DAPI study in SLE. We know from patients that fatigue is a very common symptom in lupus. It affects up to ninety percent of patients and is often described as the most disabling symptom of the disease. It can present as a profound, persistent, and debilitating tiredness and has proven to be a difficult to treat symptom of lupus. What's important about this new analysis that we presented at EULAR is that DAPI demonstrated consistent improvements across multiple domains of fatigue beyond what was achieved with just standard of care alone.

This includes the newly developed Fatigue PRO, which is a novel fatigue measure in patients with SLE. These results further reinforce the potential for DAPI to address the unmet need and become an important new treatment for SLE. Reflecting on our achievements this quarter, I believe that we're making steady progress towards our goal of transforming the pipeline and delivering the new Biogen. The next twelve to eighteen months are marked by multiple key expected scientific milestones and regulatory outcomes, including Lekambi subcutaneous maintenance and high dose SPINRAZA. And given the central role of the pipeline for our long term growth strategy, we plan to build upon last quarter's selzardomab investor webcast by hosting a second thematic seminar this fall now focused on our lupus pipeline.

With that, I would like to now hand the call over to Alicia for an update on our commercial business. Thank you. Thank you, Priya, and

good morning, everyone. Today, I'll review the strong commercial execution we delivered in Q2 and how evolving market dynamics have created new opportunities that drove our most recent growth. As many of you may remember, more than eighteen months ago, we reallocated capital as part of our Fit for Growth initiative to prepare for four new launches in The U. S. Market.

We took a hard look at our investments in MS to determine where they deliver the strongest return. And today, we believe we're seeing the results of those decisions. Before turning to the launch products, let me remind you that our MS business has remained resilient and an important contributor to our cash flow. Looking at Q2 performance, in addition to some onetime items benefiting the quarter, I am encouraged by the strength of VUMERITY as it continued to grow. We believe these results demonstrate the value of our team's deep institutional knowledge, strong access and relationships in immunology.

Moving on to Skyclaris. We are delivering on our commitment to bring the first Friedreich ataxia treatment to patients around the world. Skyclaris is now available in 29 markets globally, including key European countries and Brazil. Expanding into new markets is helping us realize the full potential of Skyclaris, and we grew revenue 5% globally compared to last quarter. Last year at this time, I shared the deliberate pivot made by our US rare disease team to redirect investments to reach the remaining patients treated in the community, as opposed to our initial patients who were primarily at centers of excellence.

We learned patients in the community had a different profile. They are generally older, averaging older than 40 years old, and often with slower progressing forms of FA. Now keep in mind, community neurologists and primary care providers may only treat one or two FA patients in their career, so they can require more education. We have deployed advanced rare disease capabilities to identify patients in need and help HCPs understand the progressive nature of the disease and the potential urgency to start treatment on Skyclaris. I believe this shift in focus was a key factor behind the 13% quarter over quarter revenue growth in The US.

And in Q2, approximately 70% of new start forms were written by the community neurologists and PCPs. This reinforces our belief in our ability to reach the remaining patient population in need. As we have noted before, while we anticipate continued growth in The US, the pace may fluctuate from quarter to quarter due to the time it can take to identify and reach potential patients. We remain optimistic about the global opportunity, and we're encouraged that new clinical guidelines from the leading patient advocacy group and KMEs across the world are recommending intervention with Skyclaris. We believe this is helping to build momentum and prescriber awareness for the only DMT to slow the progression of FA.

Next, turning to Zurzave. We delivered 68% quarter over quarter revenue growth in The U. S, supported by a 29% increase in new prescribers. Earlier this year, we expanded our field team, and in just a few months, their impact is reinforcing our belief in zirzavage's potential for sustained growth. Repeat prescribers now account for nearly 70% of scripts, which we believe indicates HCP's growing trust and willingness to treat PPD with zirzavage.

And last quarter, eighty percent of Zurzave prescriptions were written as first line therapy. Today, most reimbursement policies do not require step edits or complex prior authorizations, helping to accelerate patient access. Looking ahead, we are hopeful to bring Zurzave to patients outside The United States. And lastly, shifting to Leukembi. The U.

S. Alzheimer's market is undergoing a significant evolution that began with Leukembi's FDA approval just two years ago. To accelerate this large scale change, our efforts at launch were primarily focused on helping health systems establish capabilities to diagnose, treat, and safely monitor a high volume of Alzheimer's patients. We believe sites are making progress. For example, we estimate that since the beginning of Leukembi's launch, nearly one third of customers have begun diagnosing MCI in mild AD patients for the very first time.

On average, Medicare claims data has shown that prescribers have reduced the time from diagnosis to first infusion by six weeks since the beginning of last year. This year, we also see significant improvements in the time it takes sites to add patients beyond their first one and in their depth of prescribing. Monthly PET testing has increased approximately fivefold over the last year and a half. Blood based biomarker testing has grown by 50% in the past six months from two of the major lab companies and has nearly tripled in the past year. We think this is an early promising indication that there is high awareness and willingness to adopt blood based biomarkers.

We will work in partnership with the Alzheimer's community to educate about the quality of these tests and explore the opportunity for widespread use. This maturing of the market infrastructure gave us confidence earlier this year to launch new initiatives with Eisai, including sharper messaging, a targeted brand campaign, and a more precise focus on physicians with the highest potential to prescribe. And we believe these are driving momentum. In Q2, US revenue grew 20% quarter over quarter, and we increased new Leukembi prescribers 34% year to date. It is particularly encouraging to see that we believe the anti amyloid market is now growing approximately 15% in Q2.

These dynamics are prompting us to deploy the next phase of initiatives designed to further increase Leukembi prescribing. Today, awareness about Alzheimer's disease is high. Unfortunately, patient and caregiver awareness of new treatments is low. However, our research shows that when patients ask about Lekambi, an HCP will prescribe it most of the time. With health systems having advanced their capabilities to treat, we activated our direct to consumer campaign across TV and digital platforms to build patient demand and awareness.

In our campaign testing, patients and caregivers felt empowered to pursue treatments and earlier intervention if Leukembi can help them still be like themselves longer. In parallel, we plan to pilot later this year an expanded field team to understand how to improve PCP referrals in key geographies. We are also preparing for the potential subcutaneous formulations of Leukembi, which we believe would add convenience and optionality for patients, caregivers, and HCPs. Looking ahead, we believe that our disciplined execution, efficient investments, and our ability to adapt to evolving market dynamics positions us to sustain this momentum and deliver continued growth. I will now turn it over to Robin for an update on our financial results.

Thank you, Alicia. I'd like to provide some key highlights from our strong second quarter financial results. Unless otherwise noted, each of the comparisons I make during my remarks are versus the 2024. We delivered 7% revenue growth in the quarter on strong commercial execution, particularly from our four launch products, which generated two fifty two million dollars in revenue in the quarter and our MS business in The U. S.

This strong commercial execution, combined with our disciplined operating expense management, resulted in non GAAP diluted EPS growth of 4% in the quarter. Absent the approximately $0.26 impact from the acquired IPR and D upfront and milestone expense in the quarter, non GAAP diluted EPS would have been $5.73 up 9%. Based on the strength of the business performance in the first half of the year, we are raising our full year 2025 financial guidance. I will provide details on guidance shortly. First, I will cover our Q2 performance.

Starting with our MS franchise. In The U. S, as Alicia noted, we had a strong quarter with revenue of $657,000,000 This was driven in part by higher VUMERITY demand, approximately $32,000,000 of favorable inventory dynamics for Furon's and Tysabri, and an approximately $48,000,000 favorable gross to net change in estimate impact across the franchise, with $27,000,000 of this gross to net dynamic favorably impacting VUMERITY. Outside The US, sales are primarily impacted by expected generic pressures for TECFIDERA and a biosimilar for TESARBRI in Europe. We continue to defend our IP.

However, we expect accelerating competitive pressures on the ex US MS business in the 2025, particularly for TECFIDERA in Europe. For SPINRAZA, we continue to be encouraged by the consistency in demand globally. And as expected, ex U. S. SPINRAZA was impacted by the drawdown of the inventory build from the first quarter, which we expect to continue into Q3.

We continue to expect full year global SPINRAZA revenue to be relatively similar in 2025 as compared to 2024. Due to timing of shipments, we expect revenue in the second half of the year to be lower than the first half. Our four launch products each saw increases in demand in the second quarter and together delivered two fifty two million dollars of revenue to Biogen, which was an increase of 26% quarter over quarter and 91% year over year. Again, this quarter, the year over year performance of these products together offset the decline in our MS portfolio. We continued to see steady sequential demand growth for LAKEMBY globally, with second quarter global end market sales booked by Eisai of approximately $160,000,000 This includes the favorable impact of the timing of shipments to China of approximately $35,000,000 as the collaboration optimized global inventory positions in Q2.

We expect this inventory build to work down in the second half of the year. What is encouraging is that excluding the China shipment timing impact, global sales grew 29% sequentially and 211% year over year. Skyclaris saw continued demand growth globally. In The US, demand growth more than offset the expected Medicare discount dynamics in the quarter. Internationally, Skyclaris was negatively impacted by the timing of shipments in certain markets.

We expect Skyclaris to continue to grow globally, and we are working to secure reimbursement in certain European markets as well as in Brazil. We experienced strong demand growth for XERZUVEY in the quarter. And as Alicia noted, Q2 revenue was $46,000,000 up 213% year over year and 68% quarter over quarter. As a reminder, Biogen shares 50% of the profit or loss on XERZUVEY, which is recognized in the collaboration profit sharing line on our P and L. I would like to note we understand that earlier this month, IQVIA updated their methodology for reporting shipped prescriptions for ZERZUVEY and other products as part of their routine data review.

This may mean the capture rate may be lower. We are encouraged by the opportunity for ZERZUVE, including the potential in Europe with the recent positive CHMP opinion. Turning to contract manufacturing revenue. The increase in revenue was driven by the acceleration of timing for manufacturing batch releases, some of which were associated with Leukembi due to our Q4 planned plant maintenance activities. We continue to believe that contract manufacturing revenue will be roughly consistent when comparing full year 2025 with full year 2024, and we expect minimal revenue in Q4 twenty twenty five due to the planned maintenance activity.

Now a few comments on the rest of the P and L. Non GAAP cost of sales was impacted by higher, lower margin contract manufacturing revenue in Q2 twenty twenty five, a continuation of the trend we saw in the first quarter as we accelerated batches ahead of the planned Q4 plant maintenance I just mentioned. Non GAAP core operating expense, or R and D plus SG and A expense, decreased 2% year over year as we continued to deliver on our R and D prioritization and Fit for Growth initiatives. Non GAAP operating income included approximately $47,000,000 of acquired in process R and D charges. This includes $16,000,000 related to Citi Therapeutics transaction and a $30,000,000 milestone related to initiation of the second phase three study for balzaratumab.

Excluding the impact from acquired IPR and D, non GAAP operating income would have been approximately 1,000,000,000 up 5% year over year. Now I'd like to provide a brief update on our balance sheet. We generated $134,000,000 of free cash flow in the second quarter. This reflects $745,000,000 in cash tax payments in the quarter. Our cash tax payments for the year are heavily concentrated in Q2.

Also in the second quarter, we used the proceeds of the $1,750,000,000 of newly issued debt to fully redeem our $1,750,000,000 of senior notes due that were due in September. And while this financial transaction resulted in no net change to our overall debt profile, we expect roughly 15,000,000 to $20,000,000 of incremental interest expense in the 2025, which we have factored into our updated guidance for the year. We ended the second quarter with $2,800,000,000 of cash and approximately $3,500,000,000 of net debt, and we believe that our balance sheet remains strong, allowing us to continue to invest in both internal and external growth opportunities. We believe the structure of our business model positions us to be potentially more resilient to macroeconomic factors and policy uncertainty. Today, a significant portion of our US product revenue is derived from products which are largely manufactured in The United States.

And we recently announced a plan to continue to invest in our North Carolina manufacturing operations. This is a combination of capital and operating expense over several years that is intended to modernize and add manufacturing capabilities to fuel the continued advancement of Biogen's late stage pipeline and support our next wave of potential products. It is also important to note that there are other aspects of our business model that we believe are important to our ability to be resilient in an uncertain environment. We generate a relatively high percentage of our revenue outside of The US. We also have a significant rare disease business, and our payer channel mix in The US is diversified and skewed more towards commercial payers.

We believe these are important considerations as we navigate the current environment, and we will continue to monitor the evolving landscape. Turning now to guidance, where we have raised our full year 2025 non GAAP diluted earnings per share to be in the range of between $15.5 and $16 from $14.5 to $15.5 We are raising our guidance to reflect a stronger expected business outlook for the full year, largely reflecting the strong first half revenue performance, including the resilient performance of The U. S. Business in MS and the performance of our launch products, partially offset by the impact of the Citi Therapeutics transaction in the second quarter. Please note that the impact from the $30,000,000 selzartamab milestone I mentioned earlier was already contemplated in our previous guidance.

The following are some key considerations underlying the guidance raise. We now expect total revenue for 2025 to be approximately flat compared to full year 2024. This reflects the strong first half revenue performance, including the resilient performance of the USMS business. Excluding the $75,000,000 of favorability from inventory and the onetime gross to net adjustments in the second quarter, we expect US revenue trends for the 2025 to be roughly in line with the first half. We also expect increased competitive pressures on the ex U.

S. MS business in the 2025, particularly for TECFIDERA in Europe. And as I mentioned previously, we expect minimal contract manufacturing revenue in Q4 this year due to planned plant maintenance activities. Importantly, we remain 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. In the 2025, we plan to make additional investments in R and D to enable acceleration and expansion of clinical development activities, primarily in support of rare disease.

On this call, we talked about our excitement around moving salinersen to registrational studies and plans for our fourth indication for belzartamab. As we continue to expand our increasingly exciting pipeline, we believe it's important to make these investments in support of our long term growth objectives. We now expect combined non GAAP R and D and SG and A expense for the full year 2025 to be approximately $4,000,000,000 Please be sure to review this slide and our press release for other important guidance assumptions. Finally, we continue to focus on capital deployment that provides long term value for our shareholders. And with that, I will pass the call back to Tim to open the call for questions.

Thanks, Robyn. Cynthia, could we go to the first question, please?

Thank Your first question comes from the line of Phil Nadeau with TD Cowen.

Good morning. Thanks for taking our question and congrats on a strong quarter. Our question is actually on the AHEAD-three 45 trial. With potential for an interim in the, CASINOLA TRAILblazer ELSE-three trial coming up, there's a lot of focus on early Alzheimer's. Could you remind us whether there's a similar interim in AHEAD-three 45 And maybe more broadly discuss the differences in design between a HED-three 45 and trailblazer ALS three? Thank you.

Thank you. So I think stepping back, you know, we believe that the potential for amyloid therapies in the presymptomatic population is very significant. It's very important for patients. You know, we would be interested in seeing what our competitor generates. But if they have a successful trial, I think that would be helpful for patients and the amyloid class.

But there are very important and significant differences between how we have attempted to address the questions that face prescribers when they think about drugs for anti amyloid drugs for the presymptomatic population. The first and most important one is the scientific questions we are asking. So in AHEAD three four five, these are two trials. AHEAD three, which attempts to ask the question of whether we can prevent further accumulation of amyloid. And AHEAD four five is asking the question of whether we can actually prevent cognitive decline in patients who have greater than 40 centelloids amyloid already in the brain.

The second piece here is that we were quite specific in our recruitment and inclusion of patients. We used amyloid PET to screen patients before we brought them in, and we used a CDR global score of zero, which is actually no no cognitive decline at all. Whereas our competitor has used a mixed inclusion criteria, which included telephone interviews for inclusion, but also the CDR global score of point five and one were included, which means mild and MCI dementia were included at the baseline. So that's an important aspect. Finally, I think that it's the endpoints.

So I think for us, for AHEAD three, we're looking at a biomarker endpoint, which we believe will be very important. But for AHEAD four five, we're looking at a at a sensitive, specific preclinical Alzheimer's disease composite endpoint. So I think overall, this is going to be very different trials, and we are looking for a readout in 2028. With a question of interim analysis, we reserve optionality, of course. But at the moment, we are planning for 2028. Thank you.

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

Your next question comes from the line of Eric Schmidt with Cantor.

Thank you, and what a pleasure to follow Phil Nadeau on this call. I also have a question on lukembi, maybe this one for Alicia, more market side. We've seen some third party data that suggests that, Lucanbi may be losing a little bit of share in The US. So wonder if you might comment on the competitive dynamic. Obviously, Danone Mab has had a recent label update for safety, which might enhance their competitive positioning.

Thank you for the question. As we anticipated and shared in the past and I mentioned on the call, we did believe a second therapy would help expand the market by driving more physician patient caregiver awareness. And as I also mentioned, this is the first time we've seen this market grow approximately by 15% based on total new patient starts. And this is what we believe to be a very encouraging development. However, as far as the competitive dynamics, we are seeing that Kasunla faces the same friction points that we did with health systems that we have been actively addressing for the past two years.

And it's notable that we believe the growth from our competitor is primarily among HCPs who are already prescribing LeKenbi or physicians who are working alongside LeKenbi prescribers at the same site. So LeKenbi still continues to hold the majority of the market share, which is almost 70%. I think when you look at new patient starts, physicians are going to try new medications that enter the market. But we're also encouraged that we've had very strong new rider growth year to date. And also 70% of that new rider growth came from physicians at new sites of care.

And so LeKenby is really driving this expansion of new riders at new sites quarter to quarter. And looking ahead, also with our maintenance option and our sub q options, this is going to provide really great optionality that obviously our competitor also doesn't have. Now when we think about the new label update, it's really too early to say how that will influence a physician's choice. But what I can share is if we base it off of market research that we've done, it does indicate that several doctors were already using this type of schedule and dosing regimen prior to the label update. And also keep in mind, HCP still need to conduct the same amount of MRIs.

And so that has also not changed. And, you know, RA has always been an important consideration. And the REH numbers obviously did not change that much in the dosing regimen. So it's helpful that physicians do gain more real world experience, especially with, lycanbi, and we're gonna keep a close eye on it as we move forward.

I can add also. Thank you, Alicia. I was just going to add that there was actually an independent presentation at AAIC by, Sabaag et al, and presented by Doctor. Burke. And this was an indirect treatment comparison talking about the lucanumab ARIA events and the donanemab ARIA events based on the modified titration.

And I think the conclusion from this group was that really the modified titration seems to be confined mainly to the homozygous, and that the number of patients that were in trailblazer six that assessed this modified titration was much smaller. And so there really wasn't a conclusion that it was very distinctly different. So I think that's an important consideration as well.

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

Your next question comes from the line of Michael Yee with Jefferies.

Hey, guys. Thanks. Congrats on continued great progress. We had a question on the SMA market dynamics. I appreciate your developments with selenursen.

There are also myostatin products that are could be coming, in a month or two, and your competitor Roche is also very bullish on their myostatin program to drive SMA share. Maybe just comment about how you think myostatin would change the dynamics, whether you think that is additive to, SMN correctors, and how would that impact you if competitors have combination products? Thank you.

I'll go ahead and I'll start the answer for that one. You know, we've been looking at the myostatin dynamic for quite some time, and we do believe that will be a good additive benefit for patients. We don't see it as a main competitor for SPINRAZA or for the SMA therapies that are currently being used. So we don't think that that's going to be an issue for us.

Great. Let's go to the next question, please, Cynthia.

Your next question comes from the line of David Amsellem with Piper Sandler.

Thanks. Wanted to ask a question about the lupus pipeline. First, on daprolizumab, maybe give us a sense of when the earliest when is the earliest we can see data from that second phase III. And just more broadly, you're taking a multi mechanistic approach to lupus drug development, but I wanted to pick your brain on the competitive landscape. And we do have oral agents, like, tick to, for instance, that are are in late stage development here.

Obviously, we have to see what the data looks like. But how are you thinking about daprolizumab and lutefilumab in the context of a more crowded landscape that potentially could include, oral agents? Thank you.

Thank you, David. So I think overall, you know, I think the first comment I'd like to make is the fact that the way we've tackled lupus is really looking at the unmet need. And when you look at the unmet need, I think it quickly becomes apparent that despite a very competitive investigational landscape, DAPI was actually only the third agent ever to have a positive phase three trial. And that tells you quite a bit about the heterogeneity, the variability in the patient population, and the need, the unmet need that is still outstanding. The second piece here is we have attempted to tackle this from, like, a very broad holistic perspective, and that I mean by mechanism of action.

So with litifilumab, we are really trying to tackle the type one interferon signature. We are looking at the the b d c a two, and we have proof of concept in phase two with our Part a and Part b, both in cutaneous and systemic lupus. And with DAPI, we are looking at a much broader perspective of the c d 40 ligand, c d 40 pathway, which affects both T and B cells. And the the data that we generated from our first phase three gives us confidence that really we are being able to target the disease in an effective manner because we showed the impact on Bicla. But importantly, not just Bicla, we also showed the importance of DAPI on severe moderate to severe patient population and in decreasing flares, so decreasing fifty fifty percent of the severe flares, and then also steroid sparing.

And then I just presented today, of course, the fatigue data that we also presented earlier this year at EULAR. So we think that this is a very important high unmet need area, and we're tackling it from a scientific perspective by looking at different phenotypes. And we think these will be complementary. I'll also say that we are falzartamab, which is an anti CD thirty eight, and it's in phase one. But but we remain excited about the mechanism of action for lupus nephritis.

So we are continuing to look at different aspects. And to the question about when we might see data, I think we expect it in the twenty seven-twenty eight timeframe for the second phase three. But we expect litifilumab SLE data as early as late next year.

Yeah. And Michael, we have, as you may have seen in the press release, planned a seminar on to do a deep dive on loop as much as we just did with selzartamab in the past quarter. I think this notion of heterogeneity is extremely important. We had a panel of four patients talk to our senior executives, and one of the things I remember very distinctly from that is one patient saying to another, your lupus is not my lupus. And I think that is what's made it very difficult to develop drugs here.

I think one of the things that benefits Biogen is our experience in MS. You know, yes, there'll be oral therapies, but I think if you look at the MS market Alicia, what was the total share of the, orals in the total MS market? It was a third. It was about a third. So, I wouldn't just go and automatically say an oral is gonna beat an injectable in in this market.

Efficacy, I think, is gonna matter. But there are also, different symptoms. Some have expressed fatigue, and then there's the flares, and there's the joint pain. There's the skin issues. So it's it's a complex disease, and and as I say, I think we'll have an opportunity to do a deeper dive September, and we welcome everybody to that seminar.

next question comes from the line of Yimir Raffat with Evercore.

Morning, guys. I wanted to touch up briefly on your, long term commitment to Alzheimer's and the status of ESI relationship. I'm asking in part because, it seems like there's been an arbitration initiated by Biogen on commercialization allocations in Europe and whether it's equitable or not. So I'm just curious how the Eisai relationship is going and where the disagreements may be.

So I'll start with, first, we are very committed to Alzheimer's, and have been for years.

Actually, the partnership with AISI, I think, goes back at least ten years. And, you know, obviously, our investment in Bib80 is is extremely important to the future of the company, and we continue to actually do research in in other modalities. You know, Biogen has a history of multiple, partnerships and collaborations. It's not always easy for companies to to work together, and it's normal, because a lot of things are just never black and white in terms of how we approach them. I would say the relationship with Eisai is better than it has ever been.

And, you know, when I look at the amount of executive time at Biogen that we spend actually in different committees with our colleagues at Eisai, You know, I think the relationship that Alicia and her team have with her counterparts is extremely strong. Manufacturing, our head of manufacturing just recently had a one on one meeting with the CEO of Eisai in Japan, that was, you know, since the arbitration was filed. We have this on the development side. I think there's a very close working relationship. But, you know, there are times where, you know, there is gonna be a disagreement, and, I think we have that in terms of how we launch in in Europe.

And, we're just following the process in our contract. And and, so I think, that'll that'll go to arbitration. I don't think there's anything particular about it. It happens, in in relationships, but it hasn't affected the overall working relationship with Aesim.

Your next question comes from the line of Brian Abrahams with RBC Capital Markets.

Hey, good morning. Thanks for taking my question and congrats on the quarter. It seems like the use of the blood based biomarkers is expanding pretty considerably. I was wondering if you could talk a little bit more about how you educate further around proper patient triads leveraging these new diagnostics and what your sense is just from being in the field on what it's going to take to convince neurologists that these can be used in place of PET or CSF. Is this something that could potentially happen soon, and what sort of inflection might we see in beta amyloid adoption Thanks.

Yeah. Alicia, I think you can say that you're seeing an awful lot of activity in this in the market. Can you perhaps give a little more color commentary there?

Yep. Thank you for the question. So the Alzheimer's blood tests are evolving at an incredible pace right now. In fact, it's way more than what we thought it was gonna be at this time point. And so we do believe this is a pivotal moment, especially when it comes to diagnosing patients.

As I mentioned in my opening remarks, testing nearly tripled in the past year. And just this week, the Alzheimer's Association issued their first practice guidelines for blood based biomarkers. So these tests, as you're probably well aware, are more convenient, faster, and cheaper compared to what's out there now with CSF or PET. So the market dynamics are fluid. But I can share with you what we understand as of today, which I am sure is going to even change when we get to the next earnings call.

So first and foremost, our market research shows that neurologists have an extremely high awareness And many are already using these tests. Now if you're already prescribing an anti amyloid therapy, you also have a higher propensity for writing these tests as well and performing them on patients. But according to claims data, PCPs are also adopting them. However, we believe these early adopters are only using them for a fraction of their patients. So they're not being used all the time in the offices, but they are being used for a fraction.

So while the utilization is growing significantly, physicians are primarily using them for triage. So this means the physician, if the test is negative, will rule out Alzheimer's. However, even when the test is positive or even indeterminate, we believe most physicians are still confirming with CSF and PET scans today. The majority opportunity and the major opportunity ahead of us is to establish these tests as the standard for amyloid confirmation. In order to make the shift, we are actively positioning ourselves to drive the awareness, the education, and we need real world evidence for physicians.

So specifically, we believe education is needed about the new guidelines. Those just came out. And so we are definitely going to need to be able to disseminate that. And there are multiple tests that hit the 90% sensitivity and specificity threshold that are in the guidelines. So we also believe physicians need clarity whether these tests are sufficient for therapy reimbursement.

And when I say therapy reimbursement, that will be specifically around CSS. And that is since PET or sorry, with CMS. And that is because only PET and CSF are mainly used today. So physicians won't know until they try to put that into their CMS database. But because not many are doing it right now instead of CSF or PET, we don't know whether they're gonna get reimbursement.

So we're gonna work through clarity with the payers and with the physicians to make sure that they have that. So it is rapidly evolving, but there is significant potential to accelerate the diagnosis for patients. And so we are very much encouraged by what we're seeing in the market today. And we do see that the amount of tests are really accelerating, even our predictions until year end.

Biogen (BIIB) Q2 2025 Earnings Call Transcript

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