Amgen Inc. (AMGN) Earnings Call Transcript & Summary

Good afternoon, everybody, and thank you once again for joining us for the 46th Annual TD Cowen Healthcare Conference. I'm Yaron Werber from the biotech team, and it's a great pleasure to moderate the next fireside chat with Amgen. With us today, returning from a hiatus from IR in an expanded role is Justin Claeys, Senior Vice President of Finance. To his right, really for the first time with us is Kave Niksefat, who is SVP of Global Marketing and Access. And to his right, needs no introduction, Casey Capparelli the new Head of IR and our guru on everything, Amgen. So gentlemen, thanks so much. Let me turn it over to you maybe for some opening remarks, and then we'll go into Q&A.

Yes. Thank you, and thank you, Yaron, again, for having us back at Cowen. We're glad to be here. So a few prepared remarks for us to open, and we'd like to share before moving over to Q&A. We exited 2025 with strong momentum across the portfolio, 13 products delivered double-digit growth, 14 exceeded $1 billion in annual sales and 18 delivered record performance. That breadth supported double-digit growth in both revenue and earnings per share in 2025. The momentum is underpinned by our 6 key growth drivers, Repatha, EVENITY, TEZSPIRE and our rare disease, innovative oncology and biosimilars portfolios. Repatha, EVENITY and TEZSPIRE all grew at over 30% year-over-year in 2025 and delivered record sales with each representing a multibillion-dollar global franchise. These medicines address large unmet needs where there are millions of patients yet to be treated and represent growth drivers not just for 2026, but for the rest of the decade. Our rare disease portfolio delivered $5 billion in 2025 sales, up 14% year-over-year, driven by reaching new patients, geographic expansion and launching new indications. UPLIZNA is a great example of this, growing 73% in 2025, supported by the IgG4-related disease launch. We expect continued growth in 2026 as the launch progresses and we build on the recent generalized Myasthenia Gravis approval and launch. We also plan to initiate additional Phase III studies of UPLIZNA in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy later this year. Our innovative oncology growth is being driven by our bispecific T-cell engager platform or BiTE. IMDELLTRA, our DLL3 targeting BiTE has rapidly become the standard of care in second-line or later small cell lung cancer with 3 Phase III studies in early stage small cell lung cancer underway. IMDELLTRA has the potential to reach many additional patients. We are also progressing xaluritamig, our first-in-class STEAP1 bispecific T cell engager with 2 ongoing Phase III studies in metastatic castrate-resistant prostate cancer, and we are actively evaluating opportunities to expand xaluritamig into earlier lines of prostate cancer. Our biosimilars portfolio generated $3 billion in 2025 sales, growing 37% year-over-year. Momentum here is in part due to strong uptake of [indiscernible] our biosimilar to EYLEA. Future growth will be driven by our biosimilar candidates to OPDIVO, KEYTRUDA and OCREVUS, which are all currently in Phase III development. Turning to the pipeline. 2026 will be a year of disciplined data generation across multiple Phase II and Phase III programs that support long-term growth. We remain confident in MariTide's potential as a differentiated treatment for obesity, type 2 diabetes and obesity-related conditions. In a field featuring dozens of potential daily oral and weekly injectable medicines, MariTide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month or even quarterly dosing. The fully enrolled OCEAN(a)-Outcome study of olpasiran, our potentially best-in-class small interfering RNA medicine targeting Lp(a) continues to progress. This is an event-driven study and the aggregate endpoint accrual rate remains lower than initial predictions. While we recently pushed out our estimated completion date, our conviction in olpasiran remains strong based on the genetic and epidemiologic evidence that has established elevated Lp(a) as an independent risk factor for heart disease. Finally, we are also advancing dazodalibep, our CD40 ligand targeting biotherapeutic with 2 Phase III studies in Sjogren's disease now fully enrolled and study completion expected in the second half of 2026. I'll now turn it over to Justin for a few financial updates.

Great. Thank you, Kave. And Yaron, it's great to see you again. Great to be back and join the conference. As Kave mentioned, we see strong momentum in the business in 2026. Given that we're now into March, I did want to remind everyone of some points on our quarterly phasing. Historically, Q1 is lighter for us relative to subsequent quarters. I'll highlight a few points on this from our recent earnings call where we gave some commentary on the outlook for the first quarter. As we typically see with the U.S. insurance cycle, we expect a seasonal first quarter headwind from benefit plan changes, reverifications and higher patient co-pays. We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters. I would also add that as of January, Otezla now faces European generic entry. For reference, European sales of Otezla were $282 million in 2025. We continue to expect accelerated erosion in 2026 for Prolia and XGEVA, including the first quarter because of a full year of biosimilar competition. Additionally, we saw approximately $250 million of inventory build in the fourth quarter of 2025 that could potentially impact first quarter sales. And consistent with lower Q1 sales, we expect first quarter non-GAAP operating margin to be the lowest of the year and roughly consistent with the fourth quarter of 2025, which, as a reminder, was approximately 43%. Peter provided commentary on the full year outlook on our recent earnings call, and I'd encourage you to reference the fourth quarter transcript for his full remarks on that. In closing, we entered 2026 with strong commercial momentum across our diversified set of 6 key growth drivers and a Phase III pipeline that spans 4 therapeutic areas with meaningful breadth and depth. We're well positioned to deliver sustained long-term growth. Yaron, over to you for Q&A.

Great. Thank you so much. That was good to know. I think news about the Otezla generic as well. Okay, maybe, Kave, to you, first question since we have you on market access, which is critical. So Amgen has done very well financially and continue to -- pricing has been variable across assets, and you obviously have both rare, to oncology, to mass market. What's the secret sauce? What's Amgen's secret sauce on Access and negotiations and formulary placement?

Yes. I think from my perspective, Amgen has experience and access across a wide number of therapeutic areas. We're in 4 therapeutic areas now. We've got experience and access in over 100 markets around the world. We build in access as part of our strategies from early on in our pipeline to make sure we're generating the evidence that we believe makes our products competitive not just from a physician choice standpoint, but from a payer choice standpoint and evidence that helps us justify the economic value that our medicines bring going forward. I think that integrated approach from molecule inception all the way to on market and LOE has allowed us to perform very well from an access perspective, making sure that our medicines that we invent are accessible to patients at prices that are affordable to the health care system.

And is it -- it's how you negotiate access on an annual basis or how you negotiate access even on a portfolio basis? What sets you apart?

Yes. So again, I think access negotiations in general happen at a product level within a category versus the other therapeutic options that are there. And again, I think that body of evidence that we create either through clinical trials, the real world that we're able to bring the fact that we're forthright in thinking about access allows us to navigate those potential headwinds as a forethought rather than afterthought, Yaron?

Repatha, I think, is really -- has been one of the examples, right? I think Access was tough. There was 2 different SKUs. One of them was pulled and then Access has really improved dramatically plus the data continues to get enhanced. Obviously, the latest data is primary prevention. Technically, that was on the label already. But now you have Amgen 1 (sic) [AmgenNow ] at a monthly price of $239. How important is Amgen 1 (sic) [ AmgenNow ] ? Or is it just another vehicle, but overall, it's really the rest of the channels are going to be really the most important?

Yes. Thanks, Yaron. And we've named our program AmgenNow, not Amgen 1, but that's okay. We know there's a lot of these that are coming up. Let me talk a little bit about Repatha, and I'll build in the AmgenNow answer there, if you don't mind. I think Repatha is a great example of how Amgen's Access skills have come to really unlock a really critical medicine in the U.S. and around the world. There's over 100 million individuals around the world with elevated LDL despite the fact that they're on standard of care therapy. Only about 5% of them today are on a PCSK9. As the market leader, most of those 5% are on Repatha. By opening up Access, we think we can continue to penetrate that very large population that is underserved today. And by bringing the changes that we've done in the U.S., for example, Repatha is now listed as a preferred therapy on virtually every formulary regardless of whether it's Medicare or commercial. Average co-pay is down to less than $50 a month. The over half of Medicare patients no longer need a prior authorization to get the medicine. And we've now got great data with primary prevention, 36% reduction in first heart attack, 25% reduction in MACE, 20% reduction in all-cause mortality that with that good access environment is allowing us to scale. Now despite that great Access environment, we know that some patients remain uninsured or are in high deductible health plans or are on one of the limited number of plans that are still making it challenging to get Repatha. And that's where Amgen now comes in. It's a direct-to-patient offering, $239 a month, in line with the lowest price around the world for Repatha. And we introduced that program in October. So we've been on the market now for about 5 months. We've been very pleased with the uptake thus far. We've got over 5,000 patients in the U.S. using Amgen now to get their Repatha. And we see that as an additional channel, Yaron, that goes beyond the very well-covered insurance channel to make sure that any patient who wants Repatha, whose physician wants them to have Repatha is able to get and afford Repatha in the U.S.

There is increased competition. Leqvio is now waiting for its outcomes. It's Q6 months. I think the access there has been improving. And there's going to be a couple of orals, one a little bit more differentiated from the other, one is from Merck, the other one is from Astra. Any thoughts about how does that work in a competitive dynamic? And again, we're aware that the other 3 don't have outcomes yet.

Yes. So let's just start. If we look back at cardiometabolic markets, the history of them, we would say that, first and foremost, the goal here of us, and we think the goal of the field is to improve penetration into that 95% that is not yet on therapy rather than just fight over the relatively small patient population that has access to therapy today -- is on therapy today. When we look overall -- these additional entrants, we expect will grow the overall penetration of the market at a rate that's faster than share is consumed by them. And so we think that, that increased share of voice will increase focus on LDL and increase treatment rates overall. In terms of the competitive dynamic, as you've said, we're really proud to have 2 outcome studies, both primary prevention and secondary prevention. These add to the mountain of data that's been created on Repatha. We've done over 30 clinical trials ourselves. There's hundreds of clinical trials that have been run with Repatha. We think that, that primary prevention data, which is unique to Repatha is a huge differentiator and allows us to continue to hold our competitive position as new competitors enter.

Can we maybe move to Tezi? So Tezi posted $1.5 billion to Amgen. The accounting is a little complicated, as everybody knows, because of the AstraZeneca relationship. It obviously sold more than that globally. That was up 52% year-over-year. And now CRS with nasal polyps was approved in October. For Dupi, CRS is now more than $1 billion in that brand. Where -- do you have any sense what percentage of new patients is Tezi getting and maybe overall share in asthma right now?

Yes. Yaron, I don't have those numbers off the top of my head. What I would say is that Tezi is the one molecule in the severe asthma class that can be used irrespective of eosinophilic or allergic status overall. It's the one medicine that can be used for all patients with severe asthma. That's been a differentiating factor for us. It's been very competitive across the different phenotypes of patients that the other competitors are targeting overall. When we look at polyps, polyps is a really important indication. One, it's highly comorbid with severe asthma. And so it helps us continue to penetrate and win additional share of the asthma patients that also happen to have nasal polyps. It's also representative of a highly eosinophilic disease. And so with the great data that we showed with its high efficacy to prevent surgery, we think it helps us in both of those populations and further penetrate the market.

Okay. And then UPLIZNA launch, I think since its launch, more than 500 unique prescribers have written it for IgG4. The market right now based on claims is thought to be around 35,000, so not small at all. The feedback from clinicians, data looks really good. There was one question about what does it sequence relative to Rituxan because Rituxan is obviously a lot cheaper. And now you just got gMG approval, too. So maybe we'll start with IgG4. Do you have a sense how is it being used? And is there a large patient population that is now getting tapped? Or is it mostly for new patients?

Yes. So as you said, Yaron, we see the market the same way. We see about 35,000 patients diagnosed with IgG4 disease as of right now. This designation of IgG4-related disease is only about 10 to 15 years old, coding for it in the U.S. is only 2 years. So we do expect that, that could -- that number could evolve over time as additional treatments are used in the field. As you've said, to date, we've had about 500 unique prescribers prescribe UPLIZNA. This is a very diverse disease that is viewed by a diverse set of physicians. And we see this as a patient finding and physician activating game -- ground game, which we've done quite well with TAVNEOS, for example. In terms of where it's being used, we see it used at all lines of therapy right now. We're seeing it as a first-line therapy. We're seeing Rituxan-experienced patients come in. This is an area where UPLIZNA is the first and only approved medicine for IgG4 with an 83% reduction, if I'm remembering my number correct, reduction in overall flares. And so we are seeing the community respond very positively to the disease, and we think uptake will continue across activating additional prescribers and finding additional patients.

And then for myasthenia gravis, any sense where the drug is going to get used?

Yes. So we got approved for myasthenia gravis in December. And so we've been now on the market for about 2.5 months overall. MG has about 80,000 to 100,000 patients. Competitive field, obviously, other biologics in the market already. Launch to date, about 50% of our prescriptions are coming from bio-naive patients, about 50% are coming from bio-experienced patients. We think the market is reacting to what we saw in ADVANCE, which was this was a market that was interested in a reliable therapy that had durability, efficacy and convenient extended dosing. And with UPLIZNA being twice a year after an initial induction dose of -- induction 2 doses, we think we've met that bar. And so we're seeing uptake across the board, Yaron. I'd highlight as well that specifically in the bioexperienced market, given the frequency by which other therapies are offered, it's offering us a number of opportunities to play for switch. And that frequency is giving us additional shots on goal as patients progress and need to come back for reevaluation and retreatment.

Does it make sense to run a SWITCH study to help inform how to use the drug?

Yes. I think we remain interested in a number of things on UPLIZNA, Yaron. We're not going to announce a SWITCH study today, but we do know that, that is an area of interest. And like I said, the community is already appears to be switching without that study.

We've done a fair amount of work with physicians, and they are interested in using it broadly. 6 out of 10 right now are going on Vyvgart right away. And so the feedback -- the one challenge with UPLIZNA and their fans of the durability is that it's slower action. And so not all patients would qualify. Does -- how do you think that's going to ultimately fit into where you really get stable in terms of traction?

Yes. I think time will tell on the market exactly how that plays out. Look, physicians right now are excited to be getting experience with this medicine. We're excited to bring another option overall to patients around. And in due course, we'll see exactly how it plays out across the marketplace.

Let me actually zoom out. And when we talked about access overall, I neglected to ask about Europe because sadly, Europe is not as big a part of the market these days. Is -- are things stable in Europe now? Are they getting -- continuing to get more challenging? And are they -- are you beginning to see that they are willing to pay a little bit more for medicines?

Yes. I think last year was a bit of a wake-up call across the ex-U.S. markets around where the U.S. sits within the drug innovation ecosystem and how some of their systems have progressed. I'd say we're in constant discussions with governments around the world, making sure that they understand what the world looks like in a post most favored nation setting overall and advocating just like we've been advocating before that Europe, in particular, should recognize the value of medicines that we bring. We're seeing some governments start to react and start to think differently. We're seeing some that are not. But there's definitely -- the challenges remain in terms of access across Europe, and we're looking forward to engaging on those.

With PAVBLU was off to a really strong launch, but it's probably not going to remain the only biosimilar. It's a question of when the next ones will come, whether it's starting next year. As much as the launch has gone well, I think it's got less than a 10% share right now, roughly in the U.S. What is it going to take to really expand it further?

Yes. So we're really pleased with PAVBLU thus far. We -- last year, we think we did $700 million of total sales as the only biosimilar on the market.

I was thinking, by the way, of all anti-VEGF and bispecifics, not just EYLEA.

Yes. And overall, Yaron, I think the way we see this market continuing to evolve primarily based off new biosimilars entering, which, as you've said, we're expecting from what we've seen externally to occur at some point this year. Until that comes, we continue to be the only biosimilar on the market and compete with the innovator.

And is that this year in the U.S. or mostly ex U.S.?

I think time will tell you, Yaron. There's a lot of factors that affect how and when biosimilars enter, and I think we'll just have to watch how that landscape evolves.

Yes. Any -- maybe from a payer perspective also or a marketing perspective for MariTide, pricing in general has continued to come down. The Access has gotten more resolved, and now it's really about differentiation. As you think about MariTide maybe for maintenance, what do you think you need to show in any sense, how do you weave that into a clinical program?

Yes. So maybe I'll just start by saying that we're obviously aware of the pricing changes that have been underway. The price has evolved in line with our expectations. We continue to be very excited about MariTide. We think we have a differentiated asset, especially whether it's monthly or less frequent dosing. And as you got to see in Ohio, we're proud of the manufacturing capabilities that we have and think that those will give us the ability to continue to compete as price evolves. In terms of the maintenance setting, it's obviously something that we're quite excited about. We provided some update earlier this year on our phase -- our Phase II, Part 2 data, which tested less frequent dosing. It's obviously a competitive market. In due course, we'll have an update with how we plan on using that data and how we plan on approaching the market from a maintenance standpoint in light of pricing and competitive dynamics.

As it relates to MariTide, I had 2 questions. One is by the time you get on the market, which I'm assuming is 3 to 4 years from now, how do you see the competitive dynamics having changed, assuming the only 2 other products on the -- other 2 companies are Lilly and Novo with expanded product lines? And how important do you think it is to be able to have approvals not for obesity or weight loss, but from an insurance standpoint to have approvals for the 7 chronic conditions that obesity is related to that result in a reduction of morbidity, mortality and cost.

Maybe we'll just restate the question for those on; the webcast.

Please go ahead.

Yes. I mean just to summarize. So I think the first question was how would we plan on competing given that there are folks on the market today, and we would be coming later. Just to clarify, we haven't commented on launch time lines. So we'll let you make your own assertions there. And I think the second part of the question we caught.

Yes. So -- and the second part of the question was, how do you plan on competing against other companies that have multiple offerings. So...

And do you think that it's important to have approvals not for obesity or weight. I don't personally don't care about the 16% or 19% weight loss or 22%. I think that the insurers are more interested in the docs in the 7 chronic conditions that obesity is related to where you can have a significant reduction in morbidity, mortality and cost.

Yes. So let me address that then in 2 parts. One, we're excited to be bringing a differentiated molecule to the marketplace. And we think that differentiation earns us a seat at the competitive table with what we're bringing, really focusing on efficacy that is in the mid-20s on weight loss and big impact on cardiometabolic parameters, including HbA1c, a tolerable medicine that we're looking to improve the initiation protocol with 3-step dose escalation and then finally, monthly or less frequent dosing. In terms of the obesity-related conditions, that's an area we're very interested in. As we shared earlier, we are on 6 Phase III clinical trials, and then we were also looking to add type 2 diabetes. But our clinical trials for the related conditions are ASCVD, heart failure and sleep apnea. And then we believe that the whole suite of evidence will be important, not just for payers, but to compete in the class.

Maybe a question again, Kave, while we have you on Sjogren's. It's an area we've done a lot of work on. Technically, it's not an orphan market. But once you look at the patient population being RFRO positive, moderate to severe, naturally becomes an orphan market. Can a market like that, and you're looking at both systemic and symptomatic and you're the only company right now, and that's critical because 60%, 70% of patients are actually symptomatic. So everybody else is going for the smaller segment, albeit obviously important. Can it support premium pricing?

Yes. So Yaron, let me give you how we see the market, which I think might be just slightly different than as you see it, but we see about 350,000 patients that are RO or RF positive diagnosed. And we see this as a serious but also highly heterogeneous disease. Given that heterogeneity, we see room for multiple therapies in this market. And we think some will go in the first line, some will go in second or later line, some will go for the whole population, some will go for smaller populations. And obviously, we'll have different value propositions depending on exactly where they sequence overall. So we see a lot of different routes to make this a viable marketplace. As you shared, we are studying in both the systemic and symptomatic populations separately. The systemic population, we see that as roughly 30% to 40% of the market. And then the symptomatic population, we see that as 60% to 85% of the market. Now that doesn't add to 100%. That's because some of these patients are both systemic and highly symptomatic overall. But we decided to run 2 different Phase III trials to cover the waterfront to understand the effect this medicine can have on both those populations. The reality is when we talk to physicians, for the most part, they tell me, first, it's a Sjogren's patient. And you kind of have to really dig under to see how they're subclassifying between those 2 population types. We thought -- given the data we saw in Phase II, we'd study the entire population. So when they see a moderate to severe Sjogren's patient, they can hopefully, depending on the data, pull for dazodalibep. So it's an opportunity we're excited about. We've been excited about since the time of the Horizon acquisition, where we got this molecule. And both of those studies read out at the end of the year. And based off the readouts of those studies, we'll understand exactly what our path to market is. And really, are we positioning for a broad population or a smaller orphan subset population?

To your point, the symptomatology is fairly variable, anything from dry eye to fatigue to some arthralgia, -- it could be a lot more systemic and has a real tissue involvement. So that's why I'm trying to -- for me, it's a little hard to try to figure out the price -- if you look at some of the other companies working in this space, Sjogren's is probably going to be an add-on indication, and they're deep, deep in orphan pricing. I guess Novartis will be first, and we'll have to see how they price. But by virtue of the competition, it looks like they're going orphan, and that's maybe that's the opportunity. But the question is it severe enough?

Yes. I think, again, time will tell based off that Phase III data exactly where this product gets positioned and the size of the population that addresses to the opening point you made, I think this is an area where we will wait for the data and follow the data before making any commercial decisions.

Yes. Maybe finally, just a broad question. In general, pricing for biologics is going down. I'm talking about mass market and volumes are going up a lot. So to your point, Repatha $239 x 12, it's about $,3000 -- just under $3,000 a year. MariTide and obesity drugs now are anywhere between $300 and $400, $500 a month. And they require a lot of injections and a lot of injectors. So I guess my question with Amgen, I mean, you're making drugs that are costing $150, $200, $300 and making drugs that cost $3,000. How do you work on the margins?

Yes. Thanks, Yaron. I would start by saying that this evolution is exactly what we've expected. We certainly, I think, for years now, have seen that U.S. prices -- prices in the U.S. and around the world would face pressure over time. And our strategy has been volume-driven growth. So you're right to kind of square that circle, what you need is a manufacturing footprint and a capability where you can keep your cost structure under control and manage that. So that's something we've been doing for years. If you look at Prolia and denosumab, I mean, that's a primary care medicine where we've been able to earn a very nice return. And I think credit to the manufacturing and the operations team, what they're very focused on year after year is driving more productivity and efficiency gains. And so that's definitely part of the game plan.

When Amgen launched the new sort of high-yield perfusion and high-yield manufacturing, does it normally go into all products or certain products get that and some of the other ones don't.

It's really product by product, kind of case by case.

But is it -- maybe final question, fair to assume that Amgen is making money in every drug?

I don't -- I mean we don't disclose the gross margin by product, but I think if you look at our overall results, I think they speak for themselves.

Well, team, thank you so much. Good to see you. We appreciate it.