Biogen Inc.

Please stand by. Good morning. My name is Ruth, 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 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, Ruth, and good morning, everyone. Welcome to Biogen's fourth quarter and full year 2025 earnings call. During this call, we'll make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results, as well as reconciliations between GAAP and non-GAAP results discussed in this call, can be found in the Investor section of Biogen.com. We've also posted the slides to our website that we'll be using during the call. On today's call, I'm joined by our President and Chief Executive Officer, Chris Viebacker, Dr. Priya Singhal, Head of Development, and Robin Kramer, our Chief Financial Officer. We'll make some opening comments and then we'll move to the Q&A session. And to allow us to get through as many questions as possible, kindly ask that you limit yourself to just one question. And I'll now hand the call over to Chris.

Thank you, Tim. Good morning, everybody, and welcome to Biogen's Fourth Quarter Earnings. We finished the year strongly with a very good fourth quarter. And I think finished the year in a very satisfactory manner. We finished slightly above the upper end of our guidance. And I think as we look at the business here, we've principally focused on our growth products. And they generated 3.3 billion in fiscal 25. That's up 19%. Now, you notice we actually include Vumerity now in our growth products. We've tended to just look at MS as one group. But actually, when you look at the oral segment, Vimerity is about the only branded medicine left in that. And we have found that actually with intelligent investments, we've been able to grow that brand very nicely. And so we're including that in our growth products going forward. When you look at just the products we've launched since 2023, the four, Lekembe, Skyclaris, Sersive, and Calzadi, They are now generating over a billion dollars, around a billion dollars in revenue, and they have also grown very strongly. And even the MS business actually still generated $3 billion. So from a commercial performance point of view, I think Biogen is functioning and firing on all cylinders and doing very well. I think the big story of 2025 is really the advance we've made in our pipeline. You know, Priya will show a chart later on. on our pipeline, and that chart has really expanded over the course of the year. In this year, we expect to see a number of key readouts. The Kimby iClick, and I'll come back to that, that's under review in the U.S., Japan, and China. In the U.S., as you know, we got a priority review and have a PDUFA date of May 24th. Mitofilamab, which is an important new medicine in lupus, has been granted FDA breakthrough designation for the cutaneous form of lupus. And, you know, we are actually starting to expand our early stage pipeline. We put a VTK degrader into the clinic early this year. But I'd also point out the acquisition of Alcyone Therapeutics, which will which will really, I think, improve the experience of patients who get intrathecal injections. You know, I think Spinraza, in the eyes of many physicians I talk to, has the highest efficacy, but at some point, patients do consider that the intrathecal is a problem. And this is an opportunity to replace the intrathecal with a much more convenient delivery mechanism. We also have been active in business development, and in the fourth quarter, we had new collaborations with Banqua and Dera Therapeutics. We'll go to the next slide. So, Lekembe is still the market leader and continues to be the market leader with over 60% of the anti-amyloid therapy market share. I would remind everybody that we tend to want to look at new RXs as a measure of a launch. And this is one of those areas where that might not be the most appropriate thing to look at because the competitor product really is only in therapeutic use for a limited period of time. And only Lecambi actually has a maintenance indication. So I think in this case, actually looking at total prescriptions is the most appropriate way, and that's where Lecambi clearly continues to be the market leader. Now, this year, we're going to see, hopefully, the approval of the iClick. We've had the iClick approved for maintenance last year, along with getting the maintenance indication. That's already important. We're seeing a lot of patients come to the end of the plaque removal phase, and the persistency data suggests that we have about a 70% persistency rate. So, that's people who are continuing on with therapy even after the plaque removal position. The iClick was introduced in October of last year. Now, that's a Part D reimbursement, and we won't have that reimbursed fully until 1-1-27. However, patients who want that are able to request formulary exemptions, and from what we've heard, that virtually everybody who has been asking for that seems to be getting that. We don't have obviously very clear data on that. Now, the game changer could be really the iClick for induction. One of the competitive aspects of Denanumab is that it has once monthly infusions where we have once every two week infusions. Once you move to a subcutaneous injection, Now we're not talking about infusions at all anymore. And, you know, we're hearing certainly stories that people want to travel and people don't necessarily aren't always able to drive long distances to infusion centers. So we think that the iClick could actually create a whole new opportunity and certainly reduce the burden for neurologists. Remember, there are about 500,000 new patients diagnosed every year with Alzheimer's. and only really 13,000 neurologists. So to the extent that we can make this care pathway more convenient for both the physician and the patient, we hope that that can increase the throughput. We're already seeing with the increased use of blood-based diagnostics that those patients who have their diagnosis validated and who are actually eligible for therapy has actually increased from about 50% to 70%. So, you know, all of these things – I think they're moving in the right direction. Remind everybody that the, you know, the market has more than doubled for anti-amyloid therapy. And I think we're seeing a growing, we're certainly hearing a number of stories from the physicians that they're actually seeing benefit in patients. You know, the CDR sum of boxes is really only used in clinical trials and not in actual practice. And so, I think this all augurs well for continued growth in this business. And perhaps going into next year, we might even see an acceleration of that growth. Go to the next slide. So, here's where, you know, what we've been trying to do really is build a bridge to growth. And really, the growth we see in three different ways. The first is, you know, obviously to grow those new medicines that we have. And you see them on the chart. That's the today. And, you know, when you actually look at this chart, with the exception of Vimerity, all of these were not only first in class, but also first ever treatments for diseases. So that's meant that we actually are going in with breakthrough medicines, but we also have to create those markets. The Kenbee we've talked about. Spinraza, we've been able to launch the high dose in Japan. Early signs from the Japanese market are that we're actually going ahead of expectations on adoption. and actually seeing some switchbacks. You know, we look forward to seeing more data as it comes along. Europe will be next up. And, of course, we have a PDUFA date in April for high dose in the U.S. Zerjuve has really been a surprise to all of us. Again, we more than doubled sales in 2025. This is really, I think, also opening opportunities opening people's understanding to the real burden of postpartum depression. And we're seeing a number of prominent people, like Jennifer Lawrence, and we were just featured in people magazine. And this is not only leading to some commercial success, but I think really changing the perception of postpartum depression This is still highly undiagnosed. Approximately half a million mothers every year suffer from this, and only about 80,000 are diagnosed, and still fewer, obviously, treated on Zerzivay. So there's a real opportunity to both grow this market, but I think also really make a real difference in postpartum depression. SkyClarus continues to grow. We saw approval in Brazil this past year, and we're looking for launching that this year. launching this product pretty much everywhere around the world except in Asia, of course, where this disease doesn't really exist for genetic reasons. You know, we often are running ahead on the numbers of patients versus sales because we're providing the product through early access programs and then negotiating as we go along. So I think we'll continue to see steady progress. You know, like Spinraza, these are medicines that tend to have a bit of a lumpy sales trajectory. Personally, I like to look at rolling four quarters of these. We're in the low-volume, high-value products. If you take Spinraza, there are some countries we only ship once or twice in the year. So the timing of shipments can distort actual trends if you're just looking at a single quarter. But then, you know, now that we've got those growing, and I just told you about how strong those products have been, We've got a whole next layer, next wave of potential growth with lidophilumab, the SLE data coming hopefully by the end of the year. Felzartumab will show data in AMR potentially next year. Zorvanursin, our partner Stoke has indicated that they might be able to be having a data readout in 27 as well. Dipyrrolizumab, we already have one positive phase three and we're executing on a second phase three. Salonersen had extremely interesting results after phase two. We were administering the drug in children who had already had gene therapy, for example, in infancy. But at age four or five, we're still not able to sit or stand. And, you know, we saw some examples of that. Obviously, all of this has to be confirmed in a phase three study, which we have ongoing. And then the can be preclinical is also potentially a real game changer. You know, we all have to remember that this disease is really a silent disease for many, many years before people ever get symptoms. And throughout that period of time, people are losing neurons. And so, it would seem to make sense that treating patients earlier and being able to preserve a maximum number of neurons should have a benefit. And that's really what this clinical trial is designed to show. is going into early stage patients, can we see that we can either prevent potentially ever getting symptoms or at least deferring the disease into much later into the future? That's a huge undertaking. We began recruiting for that study in 2020. It's been fully recruited, and we would expect to see results in 2028. So, you can see that this is going to be a very rigorous study. It'll be a landmark study. This will be not only from a commercial point of view, but this is really groundbreaking science and will inform the entire neurology community. And then, of course, we still are investing in earlier stage. We have potential readouts for some high-risk, high-reward projects like the LARP2 in Parkinson's. We have A new modality, which it could be extremely interesting, which is the anti-tau ASO that we'll also read out of phase two this year. And we're really focusing on our research portfolio. I talked about some of the collaborations we've been doing. We've got the DTK. We've got an ARAC4 for lupus going into the, that went into the clinic. And we're looking to add more early-stage BD deals, but I think we've also got a few more INDs that could come into the clinic over the next 18 months. So, next slide, please. So, what are we focusing on, really, in 2026? Obviously, you know, we have an important date with the Lekembe approval for the subcutaneous AI initiation coming up on May 24th, and we'll obviously hope to see that get approved. We also have the, hopefully, the approval of the high-dose regimen for Spinraza in the U.S. that has a CADUFA date in April. We've got the two phase three studies in Lidofilumab and SLE, and I want to congratulate Priya because there are about 55 other clinical trials ongoing in lupus, and Priya and her team were actually able to accelerate. Originally, this was not going to read out until 2027. So, for me, I always, from a commercial point of view, I like to see accelerated development because it augurs well for later stage commercial potential. And finally, you know, we're advancing that high-risk, high-reward pre-POC pipeline. I would say today we feel pretty good about where our late-stage pipeline is, but we do need to build up our earlier-stage pipeline. And that's going to lead to our full year guidance on the non-GAAP diluted EPS basis of about $15.25 to $16.25. So, I think with that, I'm going to be turning that over to Priya.