Biogen Inc.

Good morning. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter 2025 Earnings Call and Business Update. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1 on your telephone keypad. Please limit yourself to one question to allow other participants time for questions. If you require any further follow-up, you may press star 1 again to rejoin the queue. Today's conference is being recorded. Thank you. I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

Thanks, Cynthia, and good morning, everyone. Welcome to Biogen's third quarter 2025 earnings call. During this call, we make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our S&P filings, which I encourage you to review. Our earnings release and other documents related to our results, as well as reconciliations between GAAP and non-GAAP results discussed on this call, can be found in the Investors section of Biogen.com. We've also posted the slides for our webcast, or I beg your pardon, we've posted the slides on our website that will be used during this call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Biebacher. Dr. Priya Singhal, head of development, Alicia Alimo, our president and head of North America, and Robin Craver, our chief financial officer. We'll make some opening comments and then move to Q&A session. And to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question. And I'll now turn the call over to Chris.

Good morning, everyone. Thank you, Tim. Can I have the first slide, please? So I think we've delivered a very strong third quarter. I'm very happy to see our growth on launch products delivering year-on-year growth of 67% in the third quarter. The launch products, again, in this quarter, and if I look at this year-to-date as well, more than have offset the MS decline on a year-to-date basis. LeCambie continues to show good, strong, sustained, sequential global demand growth with sales globally of $121 million. You may recall that we disclosed in the second quarter that we had increased inventory levels in China, and so we had higher Q2 sales and with some offset now in Q3. But when you look at this on a rolling 12-month basis, we're very happy with the progress we're making on Lecambi. The approval of the iClick subcutaneous injection for maintenance is now approved in the US and has rolled out and patients are benefiting from that. Skyclarus is now available in 34 markets globally. We've got 30% year-over-year revenue growth. That is actually not as high as even the patient growth because we have a number of early access programs in countries making sure that patients benefit from the product while we negotiate with pricing and governments around the world. And Zerzivay, 150% revenue growth year over year. This is just an amazing product. One of the most interesting things is I think we are actually changing the perception of postpartum depression. Every day there are media stories about this terrible condition from others. Jennifer Lawrence is the most recent person to talk about her experience with postpartum depression. So Zerzuve is not just a product. I think we are really revolutionizing how people look at this, and that's important, but it's also driving a lot of revenue growth for us. If I look at the pipeline, again, very good, strong progress. We have litophilumab phase 3 studies now are fully enrolled. And both are now expected to read out in the second half of 2026. Now, I look at this as not just an acceleration. Lupus is an extremely competitive area. There are a lot of studies ongoing. And one of the things when you look commercially at a new product is can I recruit patients in clinical trials? That's kind of a harbinger of how things are going to work commercially. So if we can accelerate, and we can accelerate in a competitive environment, That tells me that already physicians are seeing something special about lidophilumab, and I'm certainly encouraged by that, not just from the fact that we're going to get the data earlier, but as I say, I think it's a good sign for the commercial success longer term of the product. We continue to build out our early stage pipeline. As we'll see in a minute, we've got, I think, an extremely robust late stage pipeline. Now's the time to turn to an earlier stage pipeline. We've started a phase one study for BIB142. It's an ARAC4 degrader for autoimmune disease. We actually expect to put another three to four molecules into our early stage pipeline over the coming 18 months. And then we continue to be active on the BD side. We announced the agreement to acquired Alcyon Therapeutics. This is a very strategic acquisition for us. You know, ASOs continue to be a mode of administration that is necessary to treat a number of diseases. We ourselves have other products such as Selenersen, Viv80, Zoravanersen. And so this is a mode of administration that will be much more convenient for patients. And we're seeing other companies obviously also developing ASOs. So this is This is really going to be a breakthrough, we believe, for patients who are taking intrathecal injections. And then we have just added a C5A-R1 antagonist through our licensing agreement with Anquibio. One of the nice things about immunology drugs is that they tend to offer you an opportunity to create a portfolio in a product. As you follow these immunological pathways, they can lead to a number of different indications. And the beauty of that is, of course, that once you've been able to demonstrate safety, you can then very efficiently go into other indications. And again, we expect to announce at least another one, if not two, further research stage deals by the end of the year. So if we can move to the next slide, please. Now, I love this slide. When I look at this and I look at the lines that are extending all the way across the page, I mean, a company our size, 10 phase 3, or phase three ready programs. And that covers five phase three NMEs. And we've got a lot of conviction around this pipeline. We've seen a lot of good data in phase two. And we're getting close to now seeing a lot of the readouts out of that. Now, one of the things that you probably don't think about is that these are not just 10 phase three programs. This is also 10 launches. You know, if I take just, you know, felzartamab as an example, there are four indications of that. Two of those, AMR and MVI, are transplant. Two of those are in nephrology. And then, of course, we've got lupus coming along with three indications in lupus. And, of course, we're still in rare disease with zorvanursin. We have a next generation of Spinraza with felinursin. And we're quite excited about what's coming along with bid 80 in Tau. But all of those require now that we start building up commercial teams, building insights, thinking about pricing, thinking about value propositions. So a lot of activity going on inside the company. Another thing I like to look at in terms of trying to predict whether things are going to be a success or not is can we attract strong talent? Because people bet their careers when they come to a company, and especially if it's a new product. And I have to say, I've been super impressed with the talent that we've been bringing into Biogen. And that sort of says to me that people are willing to bet their careers on these exciting new products. And I have seen time and time again over my career that that often translates into commercial success. Market research is important, but I think some of these other other indicators are even more important. So let's go to the next slide. So what have we been trying to do over the last three years? You know, the first is obviously let's grow our new product launches. And, you know, again, 67% revenue growth says this is a very strong performance. We've got McKendree, SkyClarus, Zerjuve, even CalSati. And when I look over the last 12 months, that's almost $1.2 billion in revenue. So, and obviously these products all have long runways in terms of market exclusivity. And, you know, in each of these, these are first in, not only first in class, but first ever treatments in these areas. So we're actually doing an awful lot of market creation. For those of you who've got a lot of commercial experience, you know that creating markets is a lot tougher than just going into established markets and taking market share. And I think that speaks to a lot of the commercial strength of our teams at Biogen. Then, you know, let's look at the profitability of our legacy business. And yes, I think we beat on the top line this quarter because of MS, but that's not all by accident. And I think we are beating just about every analog when you're looking at products that have come to the end of their market exclusivity periods. I think that speaks to the strong customer care. I think it speaks to the strong loyalty of patients to Biogen's product. We are still the company that treats more patients with MS than any other company out there. And, you know, one of the things that we shouldn't forget is it's not all legacy. There's an amazing product out here called Bumerity that has been growing very strongly this year. It's almost a half a billion dollar sales in the first nine months of this year. And this is a product that has market exclusivity well beyond the end of the decade. And we're proud to see particularly our U.S. team investing more into this business, and that is responding well. And it is really the only patent-protected product still in the oral segment, which is an extremely important part of the MS market. And then we've been very conscious of being efficient. We are going to deliver this $1 billion of gross savings. We were clear right from the get-go that we would be investing some of that as part of the launch in our new products, but also in research and development. You've seen our revenue growing, but our OPEX growth was still flat over this year. Despite a lot of new investments we have, added products to our late stage development, and we are doing all of this recruitment for the commercial preparation of all these launches that are now in phase three. And then, you know, obviously, if I look at our pipeline, you know, we have cut development costs by almost 25% and research by 40%. And I would argue that we have a stronger pipeline than we did before. And that's really a lot of what Priya has done in terms of being very careful about which products we put into development, building conviction behind those. I think as I look at the pipeline, I'd say we've got a very exciting and a high conviction late stage pipeline. One of the reasons that we're doing these early stage deals is I think we now need to build an early stage pipeline and BankWiz is just one example of that. We continue to generate strong cash flow, and we continue to look at where are the opportunities across the entire spectrum about how we can grow our business. I think we are very disciplined about where we put that cash flow. Everything that we want to invest in has to be something that contributes to growth. And so with that, perhaps we can learn a little bit more about our pipeline, and I'll pass it over to Priya.