BIIB - NASDAQ

Good morning. My name is Bettina and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen First Quarter 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.

Thank you, Bettina. Good morning and welcome to Biogen's First Quarter 2023 Earnings Call. Before we begin, I encourage everyone to go to the investors section of biogen.com to find 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 on the call. 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 slides on our website that follow the discussions related to this call. I would like to point out that we will be making forward-looking statements, which are based on our current 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 am 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 opening comments and then we'll move to the Q&A session. To allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question. I'll now turn the call over to Chris.

Thank you, Chuck. Good morning, everybody. I'll start by first welcoming Chuck Triano as our new Head of Investor Relations. Great to have you on the team, Chuck. On our last call, we described five priorities for the business that you see on the first slide here. And during the first quarter, I think we made a lot of good progress against those five priorities. We are continuing to work toward the potential launches of LEQEMBI in Alzheimer's disease and

Thank you, Chris. Last quarter, we made important progress advancing key pipeline programs. As Chris just pointed out, we now have the opportunity to deliver three potential new drug launches across four indications this year, all in areas of high unmet need, including Alzheimer's disease, major depressive disorder, postpartum depression and SOD1-ALS. We also continue to evaluate potential opportunities for geographic and indication expansion for

Thank you, Priya. Good morning, everyone. So I'll provide some highlights of our financial performance for the first quarter and please note that all financial comparisons that you will hear are versus the first quarter of 2022. Total revenue for the first quarter was $2.5 billion and that's a decrease of 3% at actual currency and flat at constant currency. Non-GAAP diluted earnings per share in the first quarter was $3.40, a decrease of 6%. Total MS product revenue was $1.1 billion, a decrease of 19% at actual currency and 17% at constant currency. I'd like to provide a few points here regarding MS during the quarter. In the U.S., we continue to see the impact of TECFIDERA generics declines in the interferons and competition for TYSABRI. As we noted in our last call, Q1 is typically a seasonally weaker quarter for our MS business in the U.S., and that's driven by higher discounts and allowances and some channel dynamics. And as it relates to channel dynamics, we did see a greater-than-expected decrease in channel inventory which added a few percentage points to the overall global decline. And we believe this is likely related to tighter working capital management in wholesalers and specialty pharmacies, due to the rising interest rate environment. In addition, VUMERITY is being impacted by both pricing pressure and a contraction of the oral segment of the market in the U.S. And as a reminder, in Q1 of last year, VUMERITY did benefit from a favourable Medicaid-related sales adjustment which also impacts the year-over-year comparison. As far as Europe, as you know, we received a favourable decision relating to the TECFIDERA regulatory data and marketing protection in the EU and that was assumed in our guidance. So we believe that TECFIDERA is entitled to regulatory marketing protection in EU until at least February of 2024 and we are working to enforce this protection. I would add that we did expect it would take some time following the decision for all generic products to be off the market and we are assuming that this exit will accelerate in the near term. Separately, we continue to enforce our patent which expires in 2028. So as we look toward the remainder of the year, we do expect to see a slower rate of decline on a year-over-year basis versus what we saw in Q1. We've taken some actions which aim to improve the underlying revenue trajectory for our MS portfolio in the second half, including for VUMERITY in the U.S., and we're continuing to closely monitor the underlying market dynamics in MS closely. Moving to SMA. Global SPINRA

Thank you. [Operator Instructions] Our first question comes from Phil Nadeau of TD Cowen. Please go ahead.

Good morning. Thanks for taking our question. Our question is on LEQEMBI reimbursement. What is Biogen's expectation for reimbursement post full approval? Do you expect coverage with evidence development or some other form? And second, when do you think that will be clear? CMS has suggested that the coverage will be revised on the day of approval. Is that going to be the final determination or will there be subsequent revisions after that? Thank you.

Chris, do we have you? Do you want to start?

Yes. I hope if I got off mute. Yes, thanks, Phil. Nothing really new to report there, at least as far as CMS. CMS has said that following full approval that they will be making sure that the product is broadly available. I think there will be a question of existing registry, what type of registry, is there a cap on the registry that hasn't been defined at the moment. I think what really is encouraging is that we're seeing an awful lot of support being mustered and encouragement of CMS to reimburse. As I noted earlier, the American Association of neurologists has come out strongly in favour. As a reminder, they sided more with CMS at the time of ADUHELM. So this is a change in position. Over twice as many members of Congress have written to CMS and did for ADUHELM. And some of you may have been following the budget discussions in Washington and Congress with also an encouragement for CMS to make the product available. So we continue to believe that the product will be made available. We would hope that it's not with a registry. There's no real need for a registry. And we don't really see why this product wouldn't be reimbursed like any other product for Medicare. But we're probably not going to see anything until after the PDUFA date.

We will now take a question from Paul Matteis of Stifel. Please go ahead.

Thanks so much for taking my question. I wanted to follow up a little bit more on external investments as it relates to reshaping your pipeline. Chris, you've outlined rare disease, psychiatry and immunology historically. It would seem like if you're going to decrease the risk profile of your R&D strategy that immunology and rare would be more on the developmental side, whereas for a psychiatry asset you want something that was either clinically de-risked or commercial. Is that the right way to think about it? And what's your appetite today for transacting before shoring up everything in-house? Thank you.

Thanks, Paul. No, I think, you've got that correct. I mean, you could certainly look at some tuck-in acquisitions on the rare side. We have, as I noted earlier, appointed Adam as Head of Corporate Development and Business Development. I think another key figure will be the appointment of a new Head of Research and I would hope to have that person in place at least by the end of the summer. And that person, along with Priya and Adam, are really going to be the three that I'll be working with to think about certainly from a licensing point of view. In terms of more transactions, I think we would be more inclined to find something that is revenue generating in the near term. If you look at Biogen, really from 2025 onwards, I think the company has an ability to grow pretty significantly. But in the next couple of years, that's where we're in this -- the tide going out on MS and the tide coming in on new products. We obviously have a lever with cost that we can use, but external growth could also help us to manage that transition period.

We will now take a question from Geoff Meacham of Bank of America.

Good morning, guys. Thanks so much for the question. Chris or Priya on BIIB080, we've seen a lot of tau assets underwhelmed in trials as a monotherapy and you guys are in a unique position to assess tau along with LEQEMBI. So the question is, what do you need to see in Phase II to advance a combo? And strategically, how much of a priority do you think this would be? Thank you.

Priya?

Yes. Thanks, Geoff. Great question. So I'll just step back and say, obviously, Alzheimer's disease is a very complex disease with multiple biologies and complex pathophysiology. We do see ourselves as pioneers in this space and we have been successful with demonstrating the A-beta plaques as being central. And now we've kind of shifted gears to looking at tau. As you know, we had a lot of experience with extracellular tau and this was actually not successful because BIIB092 didn't work which was gosuranemab. And we have really focused now on knocking down all post-translational isoforms of tau. So that's what BIIB080 is aiming to do. As we've shared, I mean, obviously, these numbers are small in the Phase Ib study that went online in a publication yesterday in major medicine. But very encouraging because we have seen close to 50% reduction of total tau and the sustained reduction post dosing. So this is very encouraging. As we kind of think about Alzheimer's leadership and we think about multiple therapies, we have to first assess how tau knockdown kind of translates into clinical outcomes, how much is fired. Because when you look at the mouse models, transgenic mouse models for tau, you do see that about 50% actually can rescue neuronal cell loss and memory. So it's encouraging, but we need to see more data from Phase III. That's exactly how we're approaching it. Eventually, I think we do believe strongly that this is going to be a multimodality space and patients will probably need more than one therapy. Now whether it will be combination or which way you have to determine whether it's synergistic or whether it could be additive that remains to be seen. And I think we're going to let the data drive us on many of these questions. But we're looking at all of this very, very carefully. Right now, we're focusing on tau knockdown, all isoforms, as well as our Phase I asset, which has been 113 which is looking at preventing tau aggregation. So that's how we're focusing our efforts.

If I could just follow up on that though, I think, Priya, I mean this is -- Priya noted that we've been through the pipeline and we have deprioritized some programs. But that's not just in an effort to reduce cost, it's really to be able to focus resources on those assets that we think are most promising. I can tell you, following the announcement of these results in Sweden and then also publication of the article in Nature. There's been a lot of attention on BIIB080 particularly from neurology community. And I think this is one of those assets that we really want to focus on. We've actually already allocated more resources to accelerate this program. And as Priya said, this is really one of the first manifestations of what it means to build a leadership position in Alzheimer's as opposed to just launching one product in this space. So most complex diseases do end up being combination therapies and there is some likelihood that will be the case in Alzheimer's. And to your point, I think Biogen is pretty well placed in that regard. And we're certainly getting even external interest in this program.

We will now take a question from Salveen Richter of Goldman Sachs. Please go ahead.

Good morning. Thanks for taking question. On LEQEMBI, could you discuss your strategy here with respect to infrastructure, particularly infusion centers and testing post a potential full approval and assuming broad coverage by CMS?

Sure. Thanks for the question. One of the most interesting things is that the companies actually went through a launch planning process with ADUHELM and actually commissioned a study to actually have a look and understand what the learnings of that are. And there's an awful lot of chicken and egg syndrome going on here. Until there's been an approved therapy and reimbursement, there often isn't enough investment in other areas. We see this with blood based diagnostic for example. They've been around, but there's no market for a blood based diagnostic until you actually have an approved drug and a treatment. And the same is true really for the investment in infusion capacity and PET scans and lumbar punctures and even the neurology capacity. So what we certainly are seeing is that there is a lot more interest. There are a lot of parties who are looking to invest in some of this infrastructure. But right now, the world is almost in a point of, well, the starting gate is really CMS approval. One of the things that we also learned was, you want to flex your commercial investment with the ability of the system to actually meet patients. I think one of the things that we would do differently and are doing differently is that, at the time Biogen ramped up a huge commercial machine in advance of reimbursement and in advance of some of that expansion. As we work with Eisai, we're being a lot more prudent in looking at, okay, let's make sure we're out there, we're educating physicians, we're thinking about who's the right patient for this and working with the different centers to make sure we know which centers are -- have the ability to see patients and process the patients with this complex treatment paradigm. So it will expand. And I think some of that expanded already at the time of ADUHELM. But I but do think that we'll see -- we'll get a better sense of where that's going once we have the confirmation of CMS's reimbursement.

We will now take a question from Umer Raffat of Evercore.

Hi, guys. Good morning. Thanks for taking my question. I thought I would get some clarity on the minus $19 million in collaboration profit share on lecanemab. And specifically, is there any color we can get on what the end user revenues could look like from this minus $38 million for the franchise for 1Q, even if it's a fraction of $1 million. It would just be very helpful. And also has Eisai indicated to you on where they are or what percentage of the commercial build out has already been baked into this 1Q number or not? Because you can imagine there's a lot of investor concern around how much SG&A they could possibly build into this collaboration, especially in light of some of the concerns around the strained relationship from the past, et cetera. Thank you very much.

Thanks, Umer. Mike, do you want to take the first part of the question, and I'll talk about the commercial infrastructure statement.

Sure. No, happy to. So Umer, as you know, the line item that you're referring to is the net of any revenue and commercial expense divided by two, basically, as you noted. And we are -- we don't have a number that we're going to disclose on the revenue. What I can say is there was revenue during the quarter. It was minimal. The majority of patients on drug are cash pay. There's not reimbursement yet, as you know. And I think the real game, so to speak, starts when we have reimbursement should we get approval and get to that point. So, yes, revenue was minimal. The majority of it was cost divided by two. And I'll let Chris speak to the ramp from here.

Yes. Thanks, Mike. Just in terms of relationship, I was in Japan last week and the CEO of Eisai and I had dinner. And I think our view is that the relationship and the partnership is actually working pretty effectively around the world. And as I said earlier, and I've said on a number of occasions, this is not a reach and frequency launch. So let's not think about the fact that we're just sending reps out and then that's going to have some impact directly on sales. There's an awful lot of certainly education that's being done. We actually -- Eisai has already reps out there in the field in the U.S. We, as Biogen, will likely -- will add reps in the -- at some point in the future, perhaps as early as next year, once reimbursement situation is known and the capacity increases. As I say, one of the lessons that we have to learn is that you don't want to get ahead of that. This is -- the initial launch period is going to be really one that's constrained by the capacity. And so there's an awful lot of work working with the neurology community, educate how you diagnose the patient, the whole process in a practice of -- when do you get the PET scan or the lumbar puncture, when are the -- how do you schedule the MRIs, getting the reimbursement, understanding where the infusion centers are. So it's a pretty high touch sell and customer relations at the start. I would say there's an initial investment, there'll be a second wave of investment once the CMS decision is known and then probably a third wave of investment as the capacity builds and the patient numbers increase.

Our next question comes from Tim Anderson of Wolfe Research.

Hi. Thank you for taking our question. This is Alice Nettleton on for Tim Anderson. Just on Alzheimer's, so we're wondering what is Biogen's working assumption on how the profile of Lilly's Donanemab will look relative to LEQEMBI. Past data would suggest it would be less safe with efficacy about the same. Is that how Biogen views the most likely outcome? Thank you.

Yes. Thanks for the question. I don't think we really look at it that way. When -- I think the world changed with the CLARITY study. If we went back two years ago, three years ago, a lot of still doubt amongst the neurology community, does the amyloid beta hypothesis really hold water. There's been a huge debate within the community about whether that's a valid target or not. CLARITY, I think, really starts to put that debate to rest. And but the studies were done over -- in the case of CLARITY in an 18-month time frame. But actually, what we're seeing is that the world has moved on. Those 18 months, yes, we would dramatically reduce plaque and we actually see that there is a benefit in terms of slower cognitive decline. But that's not where it's going to end. In all likelihood, the way this is shaping up is that you're going to have at some point a plaque clearing phase. Then what happens after you've cleared the plaque? If you don't continue treating, the plaque is going to come back. So there's going to be, in all likelihood, a maintenance phase, that's where also the subcu formulation will be important. And then as we all know, MCI is not really early stage Alzheimer's. By the time you have MCI, by the time you have symptoms, you probably already have a maximum load of plaque. There are probably people on this call who are accumulating plaque in their brains as we speak and they don't know it. And by the time a certain amount of plaque has risen, then you've already had a certain amount of neuronal death. And right now, we don't know how to restore neurons. So there's also going to be, with the advance of blood diagnostics, but also even Eisai Biogen study ahead and looking at earlier patients, as one neurologist said, we're not looking at this any longer as a four to eight year disease, but we're looking at this over the time frame of a 25-year period. So if I look at donanemab finite, in some ways, it will be good if their data are positive, that it further reinforces the amyloid -- the beta amyloid hypothesis. And also there's -- we've always seen in new markets if there's more players that those markets develop faster. But this donanemab thought process of I'm just treating to a certain amount of plaque reduction. Most neurologists I talked to don't believe that fits anymore with the way we're thinking about the treatment of Alzheimer's. So I think it will be there, but I think it's going to be -- it's not really going to be adopted in the same way that people thought when that study was conceived. So let's say, I think, it will be good if there's other players in the market. But I don't think we are too concerned about competing with donanemab.

We will now take a question from Michael Yee of Jefferies. Please go ahead.

Hi. Thank you. Good morning. We had a question around your expectations post reimbursement around the LEQEMBI launch. Appreciating you can't give too many specifics, but how should we think about that in the context of consensus modeling $40 million to $45 million, $400 million for next year? Maybe you could help right-size how things start off, whether there's a bolus or a number of patients already in the queue and in the context of how we should be modeling the next four to six quarters? Thank you.

Yes, I wish I could give you some more guidance on that. As I'd like to say, I'm pretty confident in the three to five year outlook. The next 18 months are a little more difficult to model even for us. There is an awful lot of interest. There probably will be some queuing. There is going to be a question around the -- how quickly can the system flex. The way I would think about it is and the way I look at Biogen is I think

Our next question comes from Robyn Karnauskas of Truist Securities.

Hi. Thanks for taking my question and all the colors has been very helpful. So just on if there is a registry, can you just talk to if you would foresee a registry being how much of a bottleneck it might create? How might it be paid for? And so help us, when we see that decision, understand what the challenges would be or it may not be as cumbersome as some might think? Thanks.

Well, there are certainly versions of a registry that are not particularly cumbersome and the devil is going to be in the detail. That's why, again, we would hope that actually CMS reimburses this product just like any other product. When you think that diverse and underserved patients in the health care system suffer disproportionately more in Alzheimer's, it would seem that increasing the barriers for those patients by the need for navigating a registry would be highly unfair to those patients. But we'll wait and see. Our belief is that the data from CLARITY are extremely clear. The benefits are by no means limited to what you see in the CDR Sum of Boxes. As Priya said, when you look at those activities of daily life, which are evaluated by people who are with these patients every single day and you have half a dozen measures and each one of them individually is statistically significant that says to me that -- and versus placebo, this says to me that the people who see these patients every day understand the benefit of this new medicine and treatment. And so I think the data are compelling and we would hope that there isn't a registry. And if there is a registry that it is minimally cumbersome for patients to act and their caregivers to navigate.

We will now take a question from Marc Goodman of SVB Securities.

Good morning. Priya, maybe you could just help us with what's similar about these programs that were stopped? I mean, obviously, there's a few in stroke and a few others. But what is similar there? And it was interesting, strokes in Phase III, so does that mean that we could see some other late-stage assets that get cold from the pipeline? Just philosophically, just big picture, how you've thought about these decisions? Thanks.

Sure. So the way we've thought about these decisions is really we're looking at every program in great depth and several times over and thinking about what are the options, what are the operational and strategic and regulatory challenges, but also opportunities. And so really, it's an integrated view of where we believe that our resources would be better applied to other programs in our portfolio currently. That is, I would say, the common denominator across all the divisions that you're hearing from us today. We believe that we should be spending time elsewhere. Now having said that, you said the BIIB093 is in Phase III. I can't really comment on what might be the outcome. But for now, we are really discontinuing development.

We will now take a question from Terence Flynn of Morgan Stanley.

Great. Thanks so much for taking the question. Maybe a follow-up for Chris on

Yes. Thanks, Marc. It is interesting, and I look at it, and I take what analysts and investors say very seriously. And -- but I definitely see that, as a company, we see a much higher potential for

Our next question comes from Jay Olson of Oppenheimer.

Thank you for the update and congrats on all the progress. Could you talk about the ideal capital structure for Biogen? And how much incremental debt could you take on for the purpose of business development? Thanks for taking the question.

Mike, do you want to take that one?

Yes, I'll take that one. Thank you for the question, Jay. So we ended the quarter with about $6 billion in cash. And as we mentioned, we received the payment from Samsung for roughly $830 million subsequent to the end of the quarter. So we're approaching $7 billion of cash on hand. Our EBITDA level is roughly $3 billion. And on a gross debt basis, we've got roughly two turns. Obviously, net debt is close to zero, it's actually negative if you pro forma for the Samsung payment. So there is incremental room. I think that just illustratively if you added a turn of leverage, you'd be at three times growth, you'd still be very modest net. And you add that to the cash, that puts you kind of north of or in the

We know you all have other calls to get to, so operator, can we please take one more question.

We now take a question from Colin Bristow of UBS.

Hey, good morning, and thanks for squeezing me in. And also welcome, Chuck. We're excited to be working with you again. On subcut LEQEMBI, what does FDA specifically said is required for approval? And then can you just speak to how important the subcut formulation is to the commercial story? What proportion of patients would it allow you access to the infusion or not? And then just a sort of a subpart on the commercial part. The VHA is excluding APOE4 homozygous. Can you just speak to the risk that you see either as a labeling or commercial risk on full approval as access broadens? Thank you.

Okay. Thanks, Colin. I can start -- yes, I can start with the subcutaneous formulation. So the plan is on track and Eisai has said that they would be filing by Q1 2024. Just to backup, the evaluation is being conducted in the Phase III open-label extension by a subcutaneous sub-study. And Eisai has also stated that they have discussed the requirements for proceeding with this filing and generating the data and then subsequent filing with FDA and other regulators. And they believe that the strategy currently does allow for an evaluation of PK, PD and safety, which would be required. I'll move to the next aspect. I think that you asked was about the APOE4 homozygous. So Eisai presented some of these data at AD/PD and also made comments on this topic. And they believe that really the data set was rather small. The number of APOE4 homozygous was quite small. They don't believe that the overall conclusions are different in terms of CLARITY AD and confidence in the data. The other aspect here to keep in mind is that actually many of the secondary endpoints favoured LEQEMBI. So there could be a component of placebo not declining as much in this comparator group and that was one of the points that they made as well. Now with regards to the commercial view on subcutaneous, I'm going to turn it to either Chris or Mike.

Yes. I mean I think on -- go ahead, Chris.

Go ahead, Mike.

Yes. No, I was going to say on the commercial view of subcutaneous, this will be kind of ground-breaking and then we'll have to see how that plays out over time as patients with Alzheimer's along with their caretakers are maybe moving to more of a maintenance mode for their treatment. This could be something that could be very valuable and particularly for patients who have a distance to travel to get to an infusion center to be able to self-administer at home and something that we think could have a lot of potential. So more to come on that over time. We'll expect to hear more about it over the next nine or so months and we think it could be an important differentiator if it comes together.

Thanks, everybody.

I was just going to add, Chuck, we don't really see that the biweekly infusion as being a limiter right now for that [indiscernible] infusion. But it does, as Mike said, as we think about if we are able to get a maintenance indication and we are able to get blood diagnostics, the length of time that a patient will be on drug potentially will change in future and then therefore the subcu would certainly make a difference in that scenario. Back to you, Chuck.

Thanks, Chris. So thank you all for your attention this morning. You can always follow up with the Investor Relations team and this will conclude our call.