Biogen Inc. (NASDAQ:BIIB) Q4 2023 Earnings Call Transcript

Biogen Inc. (NASDAQ:BIIB) Q4 2023 Earnings Call Transcript February 13, 2024

Biogen Inc. beats earnings expectations. Reported EPS is $3.3, expectations were $3.16. Biogen Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good morning. My name is Katie and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Fourth Quarter and Full-Year 2023 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Today’s conference is being recorded. Thank you. I would now like to turn the conference over to Mr. Chuck Triano, Head of Investor Relations. Mr. Triano, you may begin your conference.

Chuck Triano: Thank you, Katie. Good morning and welcome to Biogen’s fourth quarter and full-year 2023 earnings call. Before we begin, I’ll remind you that the earnings release and related financial tables including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today are located in the Investors section of biogen.com. Our GAAP financials are provided in tables 1 and 2, and table 4 includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted the slides on our website that will be used during this call.

I would like to point out also that we will be making forward-looking statements, which are based on our expectations. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. On today’s call, I’m joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and our CFO, Mike McDonnell. Chris, Priya, and Mike will each make some opening comments and then we’ll move to the Q&A session. To allow us to get through as many questions as possible, we ask that you limit yourself to one question. With that, I’ll now turn the call over to Chris.

Chris Viehbacher: Thank you, Chuck. Good morning, everybody. A year ago, I had the — an opportunity of presenting Biogen’s quarterly results for the first time. At that time, we expressed the objective of returning Biogen to sustainable growth. And I think in the intervening year we’ve made substantial progress and today it is a great amount of pride and pleasure that we can announce earnings guidance, which Mike will go into in greater detail, which says that we will — we are expecting to see positive earnings per share growth. And as I have said on a number of occasions, once we can get Biogen growing, we really see it Biogen becoming a growth company for the foreseeable future. We have very little, if we have in fact no exposure to Inflation Reduction Act with our current portfolio.

We don’t have any new patent expiries really coming in anytime soon other than those that are already known. And I think we’ve undertaken a number of other measures that really reposition Biogen for growth. Now if I just review some of those things, the first is — was really to refocus the company on growth drivers, in particular our new product launches. Biogen had four new product launches from approvals from the FDA last year. That’s the second highest of anyone in our industry. And you know that required quite an awful lot of cultural change. The multiple sclerosis franchise has been the stalwart of our company for since its inception 45-years ago. Our people are passionate about the physicians to treat multiple sclerosis and the patients who have multiple sclerosis.

And we are still a market leader in this space. However, that is a franchise that is facing increasing competition and we have to embrace new therapeutic categories and new businesses. And so we have really had a major shift in resources and focus, particularly towards LEQEMBI, ZURZUVAE, SKYCLARYS, and QALSODY. We also though have still some products with patent protection, again, with substantial competition. And if I take a product like SPINRAZA, analyst forecasts had shown forecasts that this product would decline. Particularly proud of our teams in demonstrating that they could bring this product to — back to actually even modest growth. Obviously, the mode of administration of products can be a competitive advantage. So if you have a pill, you’re going to be a lot more preferred than if you have an infusion, for example.

But what we see in some of these really devastating diseases is that efficacy is still the most important factor. And that is why SPINRAZA continues to be a leader in its segment. And Biogen is extremely good at being able to develop the medical evidence to support the value proposition of its products. As many of you told me when I first came into the company, you know, you’ve got a mature product portfolio, but you’ve got one of the highest cost bases in our industry. And we took steps to address that. We — but it wasn’t just around reducing cost. We wanted to reengineer the business. We were shifting our focus, entering new therapeutic categories, and we needed to think about capabilities, we needed to think about the agility of the organization, the number of layers of management that we have.

And so we implemented a fit-for-growth reengineering project. We’ve already achieved $200 million of savings, and we’re on track to realize approximately half of the 800 million of net savings by the end of 2024. That’s, of course, a gross savings of $1 billion. And then we had to look at research and development. And Biogen is an extremely interesting company. All of the diseases that Biogen targets are really devastating diseases, and we target — and there is a lot of pride in the fact that we go and try to find solutions for diseases where nobody else is doing that. But of course, when you do that, you’re pioneering. You’re pioneering, because we don’t really understand often the underlying disease biology of these conditions, and so we end up taking a lot of risk, and these trials can be really quite expensive.

And yet we do need a company like Biogen in our world, and so our objective has been to really focus research and development investments on those products that will have the greatest impact. And of course, we have to manage the risk in the portfolio. We have to have Biogen as a sustainably growing company and one which is attractive to investors. We need the capital to go and invest in new projects. And so I think with Priya’s help, we’ve been able to take an extremely disciplined and objective view to the pipeline. We have four data readouts this year, again, on extremely important illnesses, and Priya will talk more about that. And as we go into next year, we’re going to be looking at how do we reinforce that pipeline? How do we rethink our research efforts?

A lot has changed in science, but we haven’t necessarily done that kind of change at Biogen. So I think research and development is extremely important to Biogen and I think continued to be a source of growth for the future. Now, as we look at what does drive growth, clearly we have LEQEMBI. And I’ll remind everybody that, again, we are not just pioneering in science, but pioneering in commercial. One of the interesting things about this disease is that if we talk about the efficacy of the product, a lot of cases we’re looking at the characteristic of a product, but actually when you talk about efficacy, you’re talking about are you in the right patient? And in fact, for decades, our industry invested in drugs which failed to demonstrate a benefit in Alzheimer’s disease.

And there were two main problems with that. One was we couldn’t get enough drug across the blood-brain barrier, and we weren’t in the right patient. Clarity was the first study to really convincingly demonstrate the importance of reducing plaque and the impact on cognition. But we know that some data that we showed at CTAD that we believe that the earlier you can go, the more likely it is you’re going to show even a greater efficacy, because we’re not — we’re really in the business of trying to protect neurons or create an environment where injured neurons can recover. And so we have a huge investment in our AHEAD study to look at presymptomatic patients. We’re investing in what happens when you remove the plaque and looking at maintenance.

We’re trying to make this more convenient for patients by having a subcutaneous formulation. And so this — the pioneering continues. And the pioneering also is out there in the marketplace. Patients with Alzheimer’s are not in the system today and are coming into the system. So we’ve got approximately 2,000 patients on therapy at the moment. Now, we don’t have as companies direct access to the patient registries. You all know about the CMS registry, but there are a few other registries out there like ALZ-NET, for example. And we have seen some analysts have been able to access that data. There was one analyst report of 3,300 patients on the registry. Latest information that we have, and again, this is not perfect information, but we have an indication that there are about 3,800 patients as of last week on the registry.

When you look at that, that suggests we’re getting about 260, 265 patients per week in the month of January. And as far as we can tell, that’s about a 56% increase over what we were seeing in December. So we are clearly seeing that there is demand for the product. We’re clearly seeing that IDNs are moving to put in place the care pathways and the treatment protocols to improve access. 70 out of the top 100 IDNs have had positive P&T committee decisions. 80% of those have now actually ordered LEQEMBI. But if we talk to the people who are doing the PET scans, the MRIs, the people who sell the blood diagnostics, everybody is reporting increased activity and volume. And so — and as you saw with Eisai’s results, their belief is that for all the patients on treatment, there are at least three or four-fold of those who are actually in waiting rooms.

So we do believe we’re making very solid progress. And we believe that we have validated the go-to-market model. And now that we have enough IDNs with reimbursement and care pathways in place, we believe that it’s also time now to increase our level of promotion out there. And so as Eisai has announced, we will be expanding total U.S. field force by about 30%. And as was already previously agreed last year, that once we had the go-to-market model really validated, that it’s now time for Biogen colleagues to also go and visit physicians. And of course, we’ve seen the launch in Japan. I was there for the launch meeting, and Biogen’s very proud to be working alongside our colleagues from Eisai on the launch in Japan. And we’ve seen LEQEMBI approved in China, and that launch will be from later this year.

So everywhere we look with LEQEMBI, we are making solid progress. This is, as we have said before, a launch that really doesn’t have an analog. We have always guided investors to the fact that this would be a progressive ramp, and that’s what we’re seeing. And we continue to believe in the long-term importance of LEQEMBI, both to patients and to our financial results. Moving on to SKYCLARYS, you’ve seen the launch numbers for the U.S., we have about 1,000 patients now on therapy. We don’t have a pediatric indication yet. So the potential population’s about 4,500. So we’ve got a little over 20% of the patients on therapy within about six months of launch. There’s an awful lot of complexity to launching these rare diseases, and I think this is where Biogen has an awful lot of strength.

There’s a lot of logistics issues with specialty pharmacy and reimbursement. And so we have already been able to demonstrate that we can reduce the time from the start form to shipment by 45%. We’ve got about two-thirds coverage out there in terms of reimbursement. And of course, patients and their physicians need an awful lot of support out there. And so we have patient services and family access managers, who are assisting patients and physicians to navigate the care pathways. One of the things that we see with SPINRAZA is that we do about a third of our sales in the U.S. and two-thirds ex-U.S., and we expect that to be a model for SKYCLARYS. Last night, we announced the formal approval by the European Commission for SKYCLARYS. We have expanded access program in a number of European countries, and we are in the process of setting those up in other countries, including those outside of the U.S. We have a global filing strategy that is underway to make sure that all patients with Friedreich’s Ataxia can benefit from SKYCLARYS.

And of course, we are actively working on doing the studies that would be needed to obtain the indication for children under age 16. ZURZUVAE, postpartum depression, enormous unmet need, tremendous media coverage. We’re talking about maternal health and we’re also talking about mental health. And those are two key trends in our societies today. It has been difficult often for mothers to seek treatment and get treatment. It is estimated about 80,000 women are diagnosed every year, but the incidence is believed to be way in excess of a half a million. So there’s an awful lot of work to do to really get outreach to women, who are suffering from postpartum depression. I have to say the initial indications of launch are well above expectations and very promising, but it’s six weeks of data.

So I think we want to see more data to really come to any firm conclusions, but everything that we are seeing is extremely positive. We were originally positioning this product for major depressive disorder and we pivoted to postpartum depression that meant we’ve had to go back and recontract with payers. I have to say I’m highly appreciative of payers, because they have actually been honoring prescriptions even though we haven’t got all of our contracting in place, and I think that is actually also helping with demand. So with that, I’ll turn it over to Priya because I think increasingly what we’d like to also start to talk about is not only what we’re selling, but the new hope for patients that’s coming out of our pipeline. So I’ll turn that over to you, Priya.

Priya Singhal: Thank you, Chris. As we previously discussed, we have focused on reviewing and prioritizing our development pipeline with a keen eye towards maximizing probability of success and increasing potential return on investment, as Chris noted. The intention was always to focus our pipeline to better represent a risk-reward balance, and one that we believe could help Biogen reach the goal of achieving sustainable growth. While this effort resulted in a number of program discontinuations last year, specifically in areas we perceived significant regulatory development or commercialization challenges. We also highlighted areas where we had deep expertise and promising pipeline programs and therefore warranted an invest-to-win approach.

One such area is Alzheimer’s disease where we have an industry-leading pipeline, and we do expect to continue investing in order to expand our leadership. This starts first with building upon our opportunity with LEQEMBI. Our first priority is to continue working with Eisai to help ensure that LEQEMBI is available globally to patients suffering from early Alzheimer’s disease. With approvals now obtained in the U.S., Japan and China, and filings currently under review in 14 additional markets, we believe we are well on our way to achieving this goal. Second is creating additional treatment options for patients. The data presented at CTAD last year on LEQEMBI suggests that there is continued benefit associated with treatment out to 24-months, and that treatment earlier in the disease course had a greater effect on clinical outcome.

For this reason, we are working with Eisai to submit a filing for maintenance dosing with IV LEQEMBI or every four-week treatment, as well as evaluating LEQEMBI administration in preclinical AD, as Chris mentioned, in the AHEAD 3-45 trial, which is before the onset of symptoms. Eisai also aims to submit a filing for subcutaneous version of LEQEMBI by the end of March. Beyond LEQEMBI, Biogen is also advancing pipeline programs targeting tau. We believe tau represents the next frontier in Alzheimer’s therapeutics, and we are working to support the development of diagnostic tests and pathways. Our ASO targeting tau, BIIB080, represents a new mechanism for targeting tau distinct from prior antibody attempt. In the Phase 1b study, we saw a convergence of target engagement, reduction in tau pathology in the brain, and improvement in exploratory measures of clinical outcome.

We are very encouraged by these results and are currently evaluating BIIB080 in the Phase 2 CELIA study. We also have BIIB113 of Phase 1 small molecule aiming to reduce the aggregation of tau. Importantly, Jane and the research organization is also focused on the future of Alzheimer’s treatments and is pursuing a multimodality approach to evaluate a number of other potential targets implicated in Alzheimer’s disease biology. Looking beyond Alzheimer’s disease, Biogen has an opportunity to expand our growing rare disease portfolio. We see rare disease expertise as a core competency at Biogen. I will now address BIIB121 in Angelman’s syndrome. Angelman’s syndrome is a rare genetic neurodevelopmental disorder that occurs in approximately one in 15,000 live births worldwide.

It is diagnosed in early childhood and is characterized by symptoms such as severe developmental delays, speech impairment, problems with movement and balance, and may involve seizures. While there is no specific treatment approved, individuals with Angelman’s syndrome will generally have a near-normal life expectancy. However, they will generally require continuous care and are unable to live independently. Normally, the paternal allele of the UBE3A gene is silenced in neurons, leading to expression of only the maternal allele. In Angelman’s syndrome, the maternal allele is either absent or inactivated through genetic mutation, leading to loss of UBE3A gene expression and impairment of synaptic connections and brain network activity. This can be visualized by an increase in low — slow brainwaves or called delta waves.

BIIB121 aims to remove the silencing of the paternal allele in order to restore expression of the UBE3A gene. While the HALOS 1 study is designed as an open-label, multiple ascending dose study across age groups and dose levels to assess safety and tolerability, importantly, the study also utilizes clinical measures that we can use to assess therapeutic potential. This includes objective EEG assessment, as well as clinical assessments evaluating multiple domains of Angelman’s syndrome, like cognitive function and gross and fine motor skills. The HALOS Study has completed enrollment for the multiple ascending dose portion of the study, and last year, Ionis presented some encouraging early interim results. Overall, safety and tolerability support continued dosing in the long-term extension with no concerning safety trends having been observed to-date.

The EEG data was suggestive of early trends to a reduction of slow delta wave activity as compared to baseline. And clinician-assessed clinical endpoints show a majority of participants demonstrating some level of improvement in overall functioning. Overall, we are encouraged by these early trends and look forward to sharing a more comprehensive topline study readout expected midyear. Following our review of those results, Biogen will be in a position to make its decision whether to opt in to conduct a pivotal study. Moving to lupus, this is another area with significant unmet medical need. We currently have two Phase 3 assets in Systemic Lupus Erythematosus or SLE. First is dapirolizumab pegol, being developed in collaboration with UCB, where we expect a topline readout of the Phase 3 study midyear this year.

If positive, we expect to conduct a second Phase 3 study. The second is litifilimab, our anti-BDCA2 antibody developed in-house at Biogen. We currently have two Phase 3 studies of litifilimab in SLE ongoing. These studies are enrolling and utilize a 52-week primary endpoint. Litifilimab also has the potential to be a first-in-class biologic in Cutaneous Lupus Erythematosus or CLE, a skin-based autoimmune disease that can be associated with severe scarring and dyspigmentation and can be distinct from SLE. As I’ve previously discussed, we have focused on reviewing our pipeline to identify and prioritize the areas where we believe we have both sufficient expertise and confidence in the science to deliver meaningful new treatments for patients.

While this initial review is complete, this process remains dynamic, and we are committed to holding ourselves accountable to efficiently seeking out scientific insights and continuing to build the pipeline with what we believe is the right risk-reward balance. While we look forward to four important near-term readouts this year, we continue to focus on identifying additional near-term opportunities, as well as continued expansion beyond neuroscience. Through collaboration with Jane and research organization, as well as Adam Keeney, our Head of Corporate Development, we are taking a holistic look across a spectrum of opportunities with both a research and development focus to identify strategic assets that we believe can contribute to Biogen’s growth story now and in the long-term.

With that, I would now like to pass the call over to Mike.

Mike McDonnell: Thank you, Priya. Good morning, everyone. I’m going to provide some highlights and color regarding our financial performance for the fourth quarter of 2023, and I’ll follow that with some detail on our 2024 financial guidance assumptions. Please note that all the financial comparisons that you will hear are versus the fourth quarter of 2022. Total revenue for the fourth quarter of 2023 was $2.4 billion. That’s a decrease of 6% at actual currency and 5% at constant currency. Non-GAAP diluted earnings per share in the fourth quarter was $2.95, and that includes a $0.35 negative impact from the recently disclosed closeout costs related to ADUHELM. For the full-year of 2023, total revenue of $9.8 billion represents a decline of 3% at actual currency and 1% at constant currency, and that’s consistent with our most recent guidance of a low single-digit decline.

Full-year 2023 non-GAAP diluted EPS was $14.72, and that’s also consistent with our most recent guidance range of $14.50 to $15. Total MS product revenue was $1.2 billion in the fourth quarter. That’s a decrease of 8% at actual currency and 6% at constant currency, and that decline is broadly attributable to competition among the impacts from generic TECFIDERA. I’d like to now provide just a couple of quick updates to the MS business during the fourth quarter. First, for TECFIDERA, in Europe, in December, the European Commission revoked the centralized marketing authorization for generic versions of TECFIDERA, and in reaching this decision, the European Commission affirmed that Biogen is entitled to marketing protection for TECFIDERA until February of 2025, which makes TECFIDERA the only dimethyl fumarate treatment for MS that may be lawfully placed on the market for sale in the EU until that date.

Also, a TYSABRI biosimilar is now launched in a small number of countries in Europe. We expect that biosimilars will continue to launch in the first-half of 2024 in other European geographies, as well as in the U.S. Biogen has patents related to TYSABRI, and we will continue to seek to enforce our IP. And although VUMERITY grew modestly in 2023, we are seeing continued effects from pricing pressure and an overall contraction of the oral segment of the market in the U.S., which we expect to continue to see in 2024. Now an update on our rare disease portfolio, which includes SPINRAZA, SKYCLARYS, and QALSODY. In the fourth quarter, we reported revenue $472 million, which is an increase of 3% at actual currency and 6% at constant currency. On our third quarter call, we noted that SPINRAZA outside the U.S. benefited from the timing of shipments in certain markets.

This prior period benefit negatively impacted fourth quarter performance. While we expect continued shipment timing impacts for SPINRAZA in 2024, we remain encouraged by its overall performance. SPINRAZA outside the U.S. was also modestly impacted by pricing pressure and competition in Europe in the fourth quarter. As the market leader in SMA, we continue to believe that we can return SPINRAZA to growth over time. SKYCLARYS delivered $56 million of revenue in the first full quarter as a Biogen product, and we are encouraged by the continued patient growth that we’ve seen. Biosimilars fourth quarter revenue of $188 million increased 8% at actual currency and 10% at constant currency. We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders.

Our anti-CD20 revenue of $436 million included a $12 million operating loss related to our economics for LUNSUMIO. Contract manufacturing, royalty and other revenue of $118 million in the fourth quarter was notably lower year-over-year, mainly driven by the timing of batches, and I’ll provide some additional detail on this dynamic shortly when I discuss our 2024 guidance. Now, a few things to note regarding fourth quarter expenses. Fourth quarter non-GAAP cost of sales was 25% of total revenue, and that includes $52 million of idle capacity charges. Fourth quarter non-GAAP R&D expense decreased $34 million and that’s notwithstanding approximately $45 million related to our portion of the LEQEMBI collaboration and approximately $60 million in closeout costs relating to ADUHELM.

Non-GAAP SG&A expense decreased $44 million in the fourth quarter, which was driven by approximately $110 million in cost savings initiatives, and that was partially offset by an increase in commercialization expenses related to the launches of SKYCLARYS and LEQEMBI. Next, a brief update on our balance sheet. We ended the year with $1 billion in cash and marketable securities and $6.9 billion in debt, which puts us in a net debt position of $5.9 billion. In the fourth quarter, we utilized approximately $1.3 billion of cash for final acquisition payment obligations related to the Reata transaction. We also paid down roughly $350 million of the $1 billion term loan that we put in place at the time of this acquisition. It’s important to note that, included in the $1.3 billion I just mentioned, $393 million was reflected in cash flow from operations for a one-time payment related to equity-based compensation for the Reata transaction.

So absent this, full-year 2023 free cash flow of $1.3 billion would have been approximately $1.7 billion. We expect to continue to generate strong cash flow this year and expect to receive a payment of $437 million from Samsung in early Q2 of this year. So now I’m going to discuss our full-year 2024 guidance ranges and assumptions. We expect full-year 2024 non-GAAP diluted earnings per share of between $15 and $16, and that reflects expected EPS growth of approximately 5% at the midpoint of the range, compared to 2023. While total revenue is expected to decline by a low to mid-single-digit percentage, we expect our core pharmaceutical revenue or product revenue plus Biogen’s 50% share of LEQEMBI revenue net of cost of sales and royalties to be relatively flat for 2024 as compared to 2023.

This assumption is driven by the expected increase in revenue from new product launches over the course of the year, roughly offsetting the declines in our MS product revenue. As has been the case in previous years, we expect Q1 to be seasonally weaker quarter, as compared to Q4 for our MS business in the U.S., and that’s driven by higher discounts and allowances and some channel dynamics. We also expect contract manufacturing revenue to be significantly lower throughout 2024, as compared to 2023. This is in part due to completing certain batch commitments in 2023, as part of the 2020 sale of Hillerod, which is located in Denmark. We had manufacturing operations there. And these batch commitments contributed roughly $320 million in 2023, which will not recur in 2024.

The increase in revenue from new product launches and decrease in contract manufacturing revenue, along with lower idle capacity charges, are expected to have a favorable impact on cost of sales as a percentage of revenue for 2024. We also believe we can grow our operating income at a low-double-digit percentage and operating margins by a mid-single-digit percentage, as compared to 2023. We expect this to be driven by improved cost of sales as a percentage of revenue, as well as lower expected operating expenses, resulting from our Fit for Growth initiative. On Fit for Growth, we continue to expect to generate approximately $1 billion in gross savings and $800 million in savings net of reinvestments by 2025. We have achieved approximately $200 million of savings in 2023 and are on track to realize another $200 million in 2024, which would put us at $400 million or half of the overall net savings by the end of this year with the remainder in 2025.

In 2024, we expect our 50% portion of SG&A spend for LEQEMBI, which, as a reminder, is not included in our Fit for Growth assumptions and the reallocation of resources for ADUHELM to roughly offset. With all of these considerations in mind, we expect our full-year 2024 combined R&D and SG&A spend to total approximately $4.3 billion. We expect our other income and expense line to continue to be a headwind this year, given the reduction in interest income and increase in interest expense as a result of the Reata acquisition. And so in 2024, we expect an improving revenue profile, improved margins, and a return to non-GAAP EPS growth. Our number one goal remains to return to sustainable growth, and we remain committed to this goal and to creating long-term value for our shareholders.

And now back to Chris for some closing remarks.

Chris Viehbacher: Thanks, Mike. So we have a number of milestones this year that we’ll all be watching carefully. You’ve seen we have a scientific advisory group for LEQEMBI in the first quarter, and assuming a positive result for the CHMP, that should hopefully lead to an approval in — by the European Commission in the first-half — later in the first-half of this year. SKYCLARYS in the European Union, of course, we’ve just achieved, as we announced last night, and the European approval for QALSODY, there is an expected decision by the CHMP and the European Commission in the first half. We have regulatory submissions coming up, as you know, with the subcutaneous formulation for LEQEMBI and IV maintenance dosing also for LEQEMBI.

And then, as Priya has noted, we have four data readouts expected sometime mid-year for four programs. As I said earlier, I think we are going to be spending an increasing amount of time focusing on our pipeline and building out that pipeline. So Chuck, I turn that back [Technical Difficulty] and see if there’s any questions.

Chuck Triano: Right. Thanks, Chris. Katie, could you please open polling for questions? Thank you.

Operator: Thank you. [Operator Instructions] Our first question comes from the line of Marc Goodman with Leerink Partners.

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Q&A Session

Marc Goodman: Yes. Good morning. Can you walk us through just the subcu and the maintenance approvals? Obviously, timelines, I guess, would be around the end of the year, but just talk about the impact into the market. Let’s assume Lilly’s on the market as well with a — they’re going to get approved soon. So how do you expect this to change the dynamics and the uptake? And just give us a sense of that, please. And then also, maybe you could just talk about the uptake in Japan that you expect? Thanks.

Chris Viehbacher: Yes. Thanks, Marc. Priya, you want to just start with kind of the timelines? And I can hit the commercial.

Priya Singhal: Sure. Thanks, Marc, for that question. So overall, we shared our six month data for the subcutaneous formulation at CTAD last year. We believe we’ve achieved the bioequivalence with the IV formulation. Eisai has communicated very recently about the FDA meeting that is on the book to finalize strategy for submission. And currently, the aim is still to file by end of March 2024 for the subcutaneous formulation. In addition, there is data on the potential and need for IV maintenance, and that is also being aimed to file by Q1 2024. So that’s the plan currently. I’m going to turn it over to Chris for the dynamics and the commercial implications.

Chris Viehbacher: Yes, so Marc, I mean, the main benefit of subcutaneous is going to be convenience for patients. And as we talked about earlier, over time, we’re looking at the AHEAD study where we could potentially one day get an indication for much earlier-stage patients. We’re looking at maintenance where patients should continue on, if we get approved, to prevent the recurrence of plaque. So the time on drug is expected to expand as we do these studies, and having a subcutaneous formulation at any stage of this disease could be quite beneficial. In terms of the actual competitiveness with donanemab, I think there’s going to be a number of points. We do know that physicians are highly sensitive to ARIA and safety, and we have a significantly better safety profile with LEQEMBI than donanemab.

There’s an interesting thing with donanemab study, which — their study actually followed patients until there was a decrease in plaques. So where Clarity looked at an endpoint for everybody at the same time point after 18 months, there was a variable endpoint in terms of time on donanemab. And so the stopping criteria are not quite clear. And I think we need to see what those are if you need a PET scan, for instance, that could be quite onerous. Now we don’t know whether that’s going to be the case or not. But I think we’re going to have a number of variables with which we can compete with donanemab. And subcutaneous at some point will be helpful. Obviously, if think it these guidance, looks like donanemab is an indicated is going to be on the market before the subcutaneous formulation is.

So we’re going to be focused on some of those non-subcutaneous factors and competition. And then once we see the label for Lily, once we see the label for the subcu then we’ll develop our commercial strategy accordingly.

Chuck Triano: Do you want to comment on Japan?

Chris Viehbacher: Oh, Japan. Yes, I think we certainly have a — Eisai is basically putting all of its field force, not just the ones for LEQEMBI behind this. And you’ve got a government managed healthcare system. So I think some of the complexity that we have in the United States with reimbursement and different actors could be simpler. We do expect that there will be some of the same constraints in terms of access to neurologists, the PET scans. They’ll probably use a lot more of the CSF markers and PET scans in Japan, but I think we could potentially see a faster uptake in Japan than we saw even in the United States, just because of the current system. So we’re just out there since January and we’ll give an update, obviously, again at first quarter, but certainly from what we’re hearing from our own people from the field, that there’s been a very positive reception by physicians in Japan.

Chuck Triano: Great. Thanks, Chris. Next question, please, operator.

Operator: Thank you. We’ll go next to Salveen Richter with Goldman Sachs.

Salveen Richter: Good morning. Thanks for taking my question. I have one with regard to the bottlenecks on the LEQEMBI launch. Could you speak to maybe two of those aspects? One is your expectations for Medicare Advantage to get to the same level of coverage as traditional Medicare and over what timeframe? And then secondly, just an update on the patient access to neurologists. Thank you.

Chris Viehbacher: Yes, so I’ll have to get back here on the — I haven’t heard anything that Medicare Advantage is any different than Medicare. So I haven’t ever asked that question before, but I’ll go check. But as far as I know, it’s the same. The bottlenecks, I still — if you think about it, if the data from the patient registries are accurate, and again, we don’t have direct access to that, but it suggests that we’ve got almost twice as many people on the registry as we do on treatment. And so that says that in addition to the bottleneck of getting into the neurologist, that there’s — when you get to the registry, you’ve got a clear intent to prescribe, because on the registry, at least for CMS, you have to describe how you actually validated the diagnosis.

So by then, you’ve triaged the patient, you’ve done either the PET scan or the CSF markers, and you’re looking for reimbursement. And what we’re hearing a little bit is, is that there is some challenge in just scheduling the first MRI, because when we initiate the infusion, you have to have the first MRI within the first two weeks. So people don’t want to initiate the infusion until they’ve got that MRI scheduled. And the MRI — there isn’t an MRI capacity constraint per se, but you are looking for a specific date, and then you have to back up the infusion. So there’s just, I think, until people get the hang of this, getting all that coordination, I think that seems to be where the — where one of the bottlenecks is.

Chuck Triano: Great. Thank you, Chris. Let’s move to the next question please.

Operator: We’ll go next to Umer Raffat with Evercore ISI.

Umer Raffat: Hi, guys. Thanks for taking my question. I thought I’d ask for something a little different today, your CD40 Phase 3 in lupus. And my question is, two things. One, the trial size, this was shrunk from 450 down to 320. Could you speak to the recruiting challenges and whether they bode well or not well on efficacy? And then secondly, the primary endpoint, this one has three components, but the FDA guidance appears to want one clear index like a BILAG or SELENA-SLEDAI et cetera. Is there alignment with regulator on that? Thank you.

Priya Singhal: Thank you, Umer. I’ll take that. So just starting off, I think we expect our results from the first Phase 3 mid-2024. We expect that we’ll need a second Phase 3, if this is positive, to generate the safety and efficacy to support a Reg filing. We did make a protocol amendment, and this was really working very closely with Biogen and UCB, looking at the study design, balancing our commitment to execute a well-designed, informative study with a desire to potentially expedite the delivery of dapi, if positive, to patients in need. So we do think it’s appropriately powered, and we continue with regulatory engagements and facilitate a discussion on the next step. So we think, yes, we — it is positioned to give us a clear readout on the therapeutic potential as of now. Yes.

Chuck Triano: Thanks, Priya. Let’s go to our next question, please.

Operator: We’ll go next to Evan Seigerman with BMO Capital Markets.

Evan Seigerman: Hi, all. Thank you so much for taking my question. Chris, maybe can you walk me through some of the rationale for adding more Biogen resources to the LEQEMBI launch and maybe kind of what’s changed or evolved with your partnership with Eisai where you think you needed to add more Biogen resources in the United States? Thank you.

Chris Viehbacher: Yes. Thanks, Evan. I mean, to be clear, we’re adding both more Biogen as well as more Eisai. A year ago, the CEO of Eisai and I talked about the launch of LEQEMBI, and for the U.S., just discussed the complexity of the launch, and we’ve been through all that, and I won’t necessarily bore everybody again with that complexity, but we just felt that we wanted to really make sure we understood the go-to-market model. In addition to these neurology account specialists, you’ve got MSLs, you’ve got some patient care navigators, you’ve got some people looking after KMEs in the region, and there’s probably — for every NAS, there’s another two or three people who are actually out there in the field. And there’s an awful lot of coordination that is needed.

And even the role of the NAS is quite complex because you’ve got to go in there, you’ve got to work with the office around helping them to understand the safety. You have to help them understand what the care pathway is. You have to help them to understand the reimbursement, not just for LEQEMBI, but there is the reimbursement for the PET scans, the MRIs, and for the care. And then finally, there’s what people in the field are — have as a principal objective, why LEQEMBI? So we wanted to make sure we understood all of that. And to be honest, whenever you do these copromotions, they require an awful lot of coordination between the companies. And we just felt that it would be simpler if one company went out at the start. We were sure that we knew exactly how the role of the NAS was going to work in relation to the other accompanying roles that are out there in the field.

And we also needed to get a certain number of core IDNs ready and signed up because there’s not a lot of point in increasing the number of people out in the field unless you’ve got enough sites that are activated and ready. So now we’re more than six months into the launch. I think we feel very comfortable about how the role of the NAS works. We understand how long it takes between going to visit a neurologist or an IDN and how long it’s going to take for them to be activated, because, as I say, there’s — you can put an awful lot of resource out there, but if you’re not able to pull the drug through, it’s not a very efficient process. So that’s just where we are. We’re confident in that model. Obviously, it is — we need to now reach out to more sites.

So we’re looking at this from both a geographic expansion, but also, I think, even within certain geographies, perhaps reducing the territory side, because when these NASs go in, they spend quite a long time with the specialists. So it was always the agreement between the two CEOs that when we scale up that Biogen would come in, but we both — our objective is to make the joint venture as efficient as possible. And so we just felt that the efficiency at the start would be maximized if we just had one company on the field. Now, we’ve obviously learned from that, and that’s what also gives us the confidence to put two companies out into the field immediately in Japan, for example, because while there are differences in the market, a number of the dynamics would be the same pretty much in those markets.

So it is an increase. Eisai is increasing their resource and so — and Biogen will be out there as well. And that could still evolve over time. We’re going to be in this business together for many years to come.

Chuck Triano: Right, thanks, Chris. Now let’s move to our next question, please.

Operator: We’ll go next to Paul Mattias with Stifel.