Biogen Inc. (BIIB) Earnings Call Transcript & Summary

Great. Good morning, everyone. Thank you so much for joining us. I'm Salveen Richter, biotechnology analyst at Goldman Sachs and really pleased to have with us Robin Kramer, CFO of Biogen.

To start, Robin, you recently moved within the financial team to take on the CFO role at the same time as the company has been working through a Fit for Growth program and other changes to the organization. Maybe help us understand as we look at Biogen today and the outlook from here with regard to your various levers? How do you think the foundation is at this point with regard to overall structure? And then we can jump into the programs from here?

Great. Thank you for having me, Salveen. Just a little bit of business to do. I have to say that before we begin, I'd like to note that we're going to be making forward-looking statements, which may involve risks and uncertainties that may cause actual results to differ materially. And I encourage you to review the Risk Factors section of the SEC filings, so I could put that business aside. So it really has been an interesting journey for me at Biogen. So as Salveen mentioned, I joined the company about 6 years ago, but transitioned into the CFO role in March. And really, since Chris has joined us, it's been really exciting to see the evolution of Biogen and executing the revised strategy that we had. And as I think about the activities that we've done over the last 2 years, whether that's really investing in the 4 launches that we have underway as well as rightsizing and derisking our pipeline and really moving from being really focused on neuroscience to branching out to cover immunology and nephrology. And so that's been a big initiative for us to really take a look at what we had in the pipeline. But then importantly, also deploying capital to bring new assets into the pipeline as part of that derisking. And then as you mentioned, we did take a look at our cost structure and look to rightsize that. But almost more importantly, think about how we rotate our investments in OpEx from supporting the MS business to supporting the new areas of growth opportunities for the company. So it was as much about that redeployment of our capital as it was to get our cost base and structure into a more foundational standpoint. An element of that is also bringing a new culture to Biogen about how we think about the pipeline and risk, and it's really been exciting to see that transition happen over the last 2 years. So as I look at where we stand today, I think we're in a really good, sound foundational standpoint to then look at in the future, deploying our capital to focus on near-term growth opportunities as well as investing in the pipeline for that medium to longer-term growth.

So in the context of that medium- to longer-term growth, recognizing that you are trying to offset some of the MS franchise here, how do you feel about the R&D effort as it currently stands with the various reads that are going to start playing out next year, but also speak to BD as a lever here in the context of what you could do on the forward?

Yes. So it's pretty exciting to have 9 programs that are in Phase III or Phase III ready, which I think is a pretty unique opportunity for us. And part of that has been fostered by the business development. For example, we completed the HI-Bio acquisition last year. And that brought us into the area of nephrology and kidney disease. And with that acquisition, we ended up with 3 indications and potential for more. So we're looking for -- as we're deploying capital in the future across the full spectrum of the pipeline. So Jane Grogan, who heads up our research organization, in the first quarter rightsized the internal resources we had allocated to pre-IND development activity so that we can then also partner externally. So some of our capital deployment will be looking to bring assets in, in that pre-IND stage through partnership as well as bringing -- acquiring assets. And then additionally, as we look at the medium to longer term, bringing in additional assets that will support that medium- to longer-term growth focused in the new spectrum that we have, which is the focus on not only neuroscience but nephrology and immunology. And then also in contemplating where we stand today and when the timing of those assets in the pipeline will be reading out, also looking for potential opportunities that have near-term growth opportunity as we think about the growth trajectory of the company, both near and mid and long term.

And how is the firm, I guess, balanced now in terms of these various verticals of disease areas versus just being kind of a neuro disease-focused company in the past? Do you feel that you've kind of filled it vertically with regard to talent?

Yes. So I think the great thing is that the areas that we're looking to focus on are leveraging some existing expertise that we have, both in the R&D and the commercial footprint because we do have an expertise in rare. And so as we're looking at assets and we're contemplating how does it fit into the portfolio both from development, but as we think about go-to-market opportunities. The newer area for us in sort of nephrology and immunology, we have -- through the HI-Bio acquisition, we actually dealt with that acquisition a bit differently than we have others. We didn't fully integrate it, but rather created our West Coast hub and sought to retain the personnel that came with that acquisition, including Travis and Uptal, who -- the CEO and the Head of Development there, and that was a twofold benefit. One, we're bringing in expertise in that vertical that we're looking to go into. But also, we had the 2 pipeline programs we're going into Phase III, and we wanted to make sure that we didn't disrupt that submissions that are associated with the Phase III and getting those trials executed. So in a combination with retaining that talent from that acquisition, but also looking to fill out the go-to-market early prelaunch activities. We're starting to hire people that are in those verticals as we move forward and because of the conviction we have around these assets that are in the pipeline.

Can you also touch on your strategy with regard to what's playing out on potential changes to -- with regard to tariffs and drug pricing policies? So on the manufacturing side, LEQEMBI is manufactured to a degree in Switzerland. So maybe help us understand how you're thinking about that, but also 2 launches that, one which is underway right now in Europe with SKYCLARYS and then a second launch that could play out with LEQEMBI. So help us think about that pricing dynamic for Europe?

Yes, a bit of pretty exciting time to come into the CFO role between tariffs and the most-favored-nation pricing. So as we discussed on our Q1 earnings call, we benefit from the fact that we have significant manufacturing presence in North Carolina as well as in Switzerland. And what we noted on the call is that a significant portion of the revenue we generate in the U.S., the product is actually largely manufactured in the U.S. So we have a little bit of a sort of a natural between the owned plants as well as the CMO and CDMO relationships. So based on the tariffs that were enacted in that April time frame, we don't expect that they will have a material impact to us -- on us in 2025. Some of that is the manufacturing footprint, but also strategically on where we had inventory placed. So -- but it's an area that is evolving and changes almost by the day. So, we are continuing to monitor that and really look to supply chain agility and how we think about going forward. And as it relates to the pricing side, and you're right, we're in the midst of launching ex U.S. on SKYCLARYS, and we're in various stages of discussion and dialogue on the reimbursement side on a country-by-country basis there. And what I would say is we are embarking on that with an understanding of what the current environment is in the U.S. and considering the fact that there is this reference pricing potentially out there. So it's a consideration as we go into the discussion.

Just curious, when you are having these discussions within the EU, are they understanding and receptive to potential change that could play out here?

What I would say is that I don't think it weighs heavily into how they're negotiating with us. So I would say it's more on how we strategically are thinking about how we're negotiating with them. And it's -- the ecosystem there and the budgets that they have don't -- are not necessarily flexible. So as they -- they're not -- they are understanding of what's going on here, but it's -- I would say that it's not as though they're changing their mindset as they're in the negotiations. But it reflects on how our perspective is as we're doing our side of the negotiation.

So pivoting over here to LEQEMBI and the launch here, you -- while the drug is inflecting steadily, as you've noted, there have been logistical challenges that have played out, and I kind of want to break them down based on some of the changes that are playing out with offerings from -- on the Alzheimer's side, but access to neurologists, how do you see yourself working through that in the context of opening up the PCP market with the -- both the blood-based biomarker test, but also subcutaneous dosing versus even being able to kind of expand the neurologist effort, I guess, in a broader way? Like how do you think these 2 populations will work symbiotically on the forward?

Yes. So we are seeing improvement in the ecosystem, but there's still a fixed number of neurologists and a very large patient population. So we do think that the introduction of the blood-based biomarkers as a mechanism for diagnostic, potentially in lieu of the PET scans allows potentially the physicians that are in the primary care role to be doing some of the triage so that the potential patients flowing into the neurologist office are those more likely to be able to come on drug. So that's one potential opportunity as well as during -- the neurologists having a more efficient diagnostic process even within the neurologist side. I think that complemented with the potential for the subcutaneous maintenance and induction opportunities for LEQEMBI with maintenance potentially here in the next quarter or so and then induction in the first part of next year can also both be a better patient experience and journey, but also potentially create a situation where the neurologists have a more efficient means of getting the patients on drug and maintaining them on drug. So we do think it has an opportunity to make it a smoother process and help to get more throughput on the number of patients that are able to be diagnosed and have -- get neurologist appointments.

And with the approval of blood-based biomarker tests or diagnostics here, do you see a coexistence with PET scans and to what degree on the forward? So how much of this will come from the physicians needing to monitor the patients and wanting checks with regard to this versus infrastructural aspects that could be playing out by various players beyond you and the diagnostic manufacturer? I'm just trying to understand if there's any way that bottleneck can be alleviated to as we look forward?

I think that the potential is that like any diagnostic or a new mechanism coming into play that -- over a period of time, that -- people become more comfortable and confident that, that can be used in lieu of the PET scan. I think initially, it's probably a transition and a level of being able to build that confidence within the neurologist community, likely with those that are doing more treatment or have more patients being those that are sort of early adopters in the realm of introducing the blood-based biomarker testing. And we and Azi are connected with the diagnostic companies as we're looking to get that fully deployed because we have the expertise as it relates to working with neurologists, but we're taking a proactive approach and thinking about how those might be introduced into the standard of care.

So how are you working with a company like Fujirebio or others that get their tests approved here with -- in terms of using their tests or recommending use of their tests?

Yes. So we're in the, I would call it, the early stages of working with them and partnering with us and Azi and partnering with them to get that adoption going with the neurologists, but it's in the sort of early planning stage as they are just now seeking and getting the approvals from the FDA.

Got it. Since the approval in January, what is the uptick for IV maintenance look like?

Yes. So it's early going. The patients sort of eligible for transitioning to maintenance is a fairly limited pool of patients. So it's a few hundred that we're seeing, but making progress and having them continue on drug. So early going, though.

Just going back to the diagnostic here of the blood-based biomarker test. What do you -- what is the comfort level among PCP providers with the use of this as a diagnosis for Alzheimer's based on your field checks?

Well, in many cases, they're using it currently, even with the PET scan. And so I think there's an element of that already being in the care process. So I think we think that that's an opportunity to launch and set in motion using them in a more fundamental way as an alternative for PET scan. So it's -- they are currently being used. Just I think the opportunity is that having 2 potential tests that receive FDA approval and have that correlation, I think, will set in motion an opportunity to have it as an alternative for the PET scan.

Okay. And how are you thinking about the longer-term trajectory from here? As you look to these tests as well as subcu entering the market, do you think we'll see a deeper inflection growth?

Yes. I think in the near term, what we've said is we expect steady progression in growth as we've been seeing quarter-over-quarter and that the combination of these -- both the blood-based biomarkers testing and the subcutaneous administration have the opportunity at a point in the future to create more of an inflection from a patient progression standpoint.

Maybe moving to the preclinical Alzheimer's disease opportunity. Can you frame this opportunity for us logistically? How does diagnosis of patients without symptoms work? And how are you thinking of the patient motivation to start treatment in this population?

Yes. So we're excited about our study AHEAD 3-45 that we and Azi are embarking on, that's focused on that presymptomatic population. We've completed enrollment. It's about 1,400 patients. And we think that it has an opportunity to really make a difference in thinking about the possibility of preventing the onset of the disease. And so based on the endpoints that we've set, we think it can provide that answer to the question of can you prevent the actual deterioration and cognitive deterioration have really an opportunity to prevent the disease actually manifesting itself.

And thoughts on the read-through from the Eli Lilly study that could read out as well with regard to your program?

Yes. So this may be one where a rising tide raises all boats, as I said earlier today and that it would be, I think, a positive if they had favorable results. We do think that our study will provide better information as it relates to the presymptomatic population because that's the area of focus for us and that our study is focused on whether or not you can prevent the disease from manifesting rather than just having the study indicate that you can slow the progression. So we think there's a unique aspect to our study, but we're also monitoring and cognizant of Lilly study.

And your trial is expected to read out in 2028. Is there any potential for an interim here earlier than that?

So our base case is that 2028 will be when we'll do the readout, but we create -- we always have the option of considering something else. But right now, we're -- the baseline is 2028 readout.

We're also looking to Novo Nordisk Phase III EVOKE data for semaglutide in Alzheimer's, that's supposed to read out in the second half. What is -- what are the Biogen thoughts here on the GLP-1 mechanism for Alzheimer's disease?

Yes. So we're also interested in seeing what the readout is there, and we're focused on the safety element and understanding sort of the muscle mass elements of that and the safety profile and it doesn't remove plaques. So then the question is, is it more of a complementary to the A-betas. And so we'll be monitoring to see what that outcome is, but that's how we're looking at it is, what's the safety profile and whether or not it is potentially a complement to the A beta.

Outside of Alzheimer's, it does seem like you're set up for a steady cadence of readouts starting next year. So maybe frame for us as we look at the 2 ones that are playing out next year, tau. What's the outlook for this program targeting tau with your ASO but also with lupus, you have 2 assets that you're advancing here. So how do these options, I guess, differ from each other and also just the ability to kind of read through to proof of concept based on what you've seen to date?

Yes. So we were really excited about the early readout on the tau program. And it's -- the opportunity there, we think, is potentially a game changer. And the team is very excited about having that potential card turnover for next year, and having multiple mechanisms of action and focus not only on A beta but tau, we think is really important from our investment and focus in neuroscience and Alzheimer's in particular.

And for lupus? For the lupus program?

Okay. So from a lupus actually, we're pretty excited because there's been so many failures there and the readout on dapi on -- for SLE, really having positive results coming out of that Phase III and then embarking on the second Phase III program. It's a significant area of unmet need. And I think between the dapi program that we have, but also the litifilimab that's focused on SLE and CLE. And basically, you have this population of approximately 5 million patients and there's very little in the way of therapeutics for them, and so a significant unmet need. And then actually, through the HI-Bio acquisition, we also have an additional indication that's focused on lupus. So we've been very excited about the results we've seen to date on those trials. We think it's a significant unmet need, and we're looking forward to the readouts that are underway there.

And you're also hosting a Rare Disease Day shortly. Frame for us what you're looking to get across to the investor base out of that presentation?

Yes. So as we look at the excitement and the conviction that we have in our pipeline assets, we think it's important to spend some time sharing with the investors why we do have that conviction and excitement around the pipeline assets and what the market opportunity is and what the unmet need is. And our first webcast will be actually tomorrow, and I'll be focused on the assets we acquired via the HI-Bio acquisition, so felzartamab and focused on the rare and the kidney diseases. So with AMR, PMN and IgAN. And so the team will spend some time talking about exactly what we believe makes our programs unique, how they fit in the overall therapeutic environment, particularly IgAN because there is competitive -- a lot of competitive activity there, but sharing what we think is unique about our assets and what that market opportunity and unmet need is. So Travis and Uptal will be conducting the majority of the webcast, but it will be opened with Chris and closed with Priya. So this will be one in a series that we're looking to do. So we'll focus first on the felza assets. And then next, we'll focus on the lupus assets in the fall. So -- but more to come, but we're excited about the opportunity to share more about the pipeline to the investor community.

Great. Is there anything else that you want to highlight from the pipeline, including the Stoke program?

Yes. So the Stoke acquisition -- or collaboration that we announced in the first quarter, we're excited about that because it's an opportunity. Again, that plays to our sweet spot from -- both from an R&D and a commercial perspective. It's focused on Dravet syndrome. And it's an opportunity for us to bring -- to bear our ex U.S. commercial operations to collaborate with Stoke. So they were looking for a partner to -- as they look to bring the asset potentially to market ex U.S. as well as to partner with them on the Phase III program that's in progress. So it fits right in that sweet spot and the therapeutic areas we're focused on, but also really leveraging what we think are unique assets to the organization and our R&D and our go-to-market perspective from a rare disease side.

Handing back to the operational and business side. You plan to realize about $800 million in net cost savings by the end of the year. What is your goal for Biogen's margin trajectory post?

Yes. So our Fit for Growth program, we're in the last year of execution on that. We've actually executed all the activities necessary to yield the $1 billion gross and $800 million net in savings. I think the great thing about that program is that it was focused on optimizing the cost structure, but almost -- and more importantly taking resources and reallocating from the MS portfolio into the launch -- 4 for launch products. And so our SG&A, when you look at it year-over-year is roughly consistent, but it's one of those still waters run deep because about -- we had a rotation of about $250 million in spend out of the MS and towards the -- supporting the 4 launch products. So we think -- as we look at the cost structure and the base that we're largely where we need to be from a foundational standpoint, but always focused on continuous improvement, including activities around cost of goods and margin optimization. But also as we complete transactions, looking at opportunities for offsets to the extent they come bearing R&D costs. So the margin improvement, and we're -- because we have 4 launches going on and normally in your initial years of launch, your margin is a little more challenged on those products than when you get moving and you get the titers optimized, so we have initiatives around COGS and optimization, including with LEQEMBI. And that will be a continued area of focus, but also continuing to focus on the rest of the OpEx areas on an ongoing basis even after Fit for Growth.

Can you touch on the 3 launches and how those are progressing outside of LEQEMBI and in particular, for SKYCLARYS? Should we really assume more of a steady state at this point with minimal growth from here in the U.S. where it's like your -- the bulk of your growth is coming from an ex U.S.?

Yes. So we're in various stages of the launches, the U.S. launch, where I would call it the steady growth phase, so the initial bolus of patients waiting to get on drug therapy have been brought on therapy. But we are in the initial stages of the launches in Europe. And -- but those are progressing in a similar fashion from bringing those initial bolus of patients onto therapy. And we recently received approval in Brazil, which we think will be another important market for SKYCLARYS. So as it relates to U.S., I would say steady growth. Alicia has been deploying new tactics from a patient finding perspective, and this is one area where we're actually using AI to assist us in thinking about identifying patients using patient data sets. So we're deploying the needle in the haystack thing. So we're using some new technology approaches there. But early stage on the launch is ex U.S. and Brazil to come.

And SPINRAZA and ZURZUVAE, if you want to touch on those?

Yes. So SPINRAZA has actually been very resilient. We believe from both interactions with patients and the health care providers, that efficacy is important to them. And we think that SPINRAZA has a great story as it relates to efficacy. And so it's been very resilient even in light of the competitive dynamics in that area. And we're -- currently, we're in the -- awaiting a PDUFA date for the high dose administration on SPINRAZA, which we think is an opportunity to, again, demonstrate meeting the patients' unmet need in that area. So we think that's an opportunity. And then within our pipeline, we have a program called BIIB115, which is sort of a next gen from an SMA perspective. So it's an area that's critically important to us. We've been very pleased with the performance of SPINRAZA in a very competitive market. So it's been -- so we're continuing to invest in that area. You had another one, right?

ZURZUVAE.

Oh, ZURZUVAE. So -- I'm pretty passionate about this one. So ZURZUVAE is focused on postpartum depression. And we've treated -- at this point, we've treated over 10,000 patients. And so that has actually overperformed what our expectations were from a U.S. launch perspective. And we're in the early stages of considering where we potentially will launch in the EU. So that's under -- assessment is underway.

Great. Well, with that, Robin, thank you so much.

Thank you.