Afternoon, everybody, thank you once again for joining us for the 46th Annual TD Cowen Healthcare Conference. I'm Yaron Werber from the biotech team, 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 our SVP of Global Marketing and Access. To his right, needs no introduction, Casey Capparelli, the new Head of IR and our guru on everything Amgen. Gentlemen, thanks so much. Let me turn it over to you maybe for some opening remarks, we'll go into Q&A.
Yeah. Thank you, and thank you, Yaron, again for having us back at Cowen. We're glad to be here. 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 six 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 multi-billion 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 small-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 PAVBLU, 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 disciplined data year of disciplined data generation across multiple phase 2 and phase 3 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 as an independent risk factor for heart disease. Finally, we are also advancing dazodalibep, our CD40 ligand-targeting biotherapeutic, with two phase III studies in Sjögren'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. 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 wanna 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. 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. 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 3 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, that was good to know. I... That's, I think, news about the Otezla generic as well. Maybe Kave to you, first question since we have you on market access, which is critical. Amgen has done very well financially. Pricing has been variable across assets, and you obviously have both rare to oncology to mass market. What, what's the secret sauce? What's Amgen's secret sauce on access and negotiations and formulary placement?
I think, from my perspective, Amgen has experience and access across a wide number of therapeutic areas. We're in four 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 healthcare system.
It's how you negotiate access on an annual basis or how you negotiate access even on a portfolio basis? What, you know, what sets you apart?
Again, I think access negotiations in general happen at a product level within a category versus the other therapeutic options that are there. 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?
Okay. you know, Repatha, I think, is really has been one of the examples, right? I think access was tough. There was two 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. Now you have AmgenNow at a monthly price of $239. How important is Amgen One? Or is it just another vehicle, but overall, it's really the rest of the channels are gonna be really the most important?
Yeah. Thanks, Yaron. We've named our program AmgenNow, not Amgen One, 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. 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 copay is down to less than $50 a month. Over half of Medicare patients no longer need a prior authorization to get the medicine. 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.
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. 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. We introduced that program in October, so we've been on the market now for about five months. We've been very pleased with the uptake thus far.
We've got over 5,000 patients in the U.S., using AmgenNow to get their Repatha, and we see that as an additional channel, Yaron, to goes beyond the very well, 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 Q 6 months. I think the access there has been improving, and there's gonna be a couple of orals, one a little bit more differentiated from the other. One's from Merck, the other one's from Astra. Any thoughts about, you know, how does that work in a competitive dynamic? Again, we're aware that the other 3 don't have outcomes yet.
Yeah. 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. We think 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 two 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 ourself. 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 TEZ? TEZ 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. Now CRS with nasal polyps was approved in October. For DUPIXENT, CRS is now more than $1 billion in that brand. Where, d o you have any sense what % of new patients is Tezi getting and maybe overall share in asthma right now?
Yeah. Yaron, I don't have those numbers off the top of my head. What I would say is that TEZ 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 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.
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. Then UPLIZNA launched, I think, since it's launched, 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, the data looks really good. There was one question about what is its sequence relative to RITUXAN, 'cause RITUXAN is obviously a lot cheaper. Now you just got GMG approval too. Maybe we'll start with IgG4. Do you have a sense how is it being used? Is there a large patient population that is now getting tapped, or is it mostly for new patients?
Yeah. 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 10-15 years old. Coding for it in the U.S. is only 2 years. We do expect 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. 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. 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.
For myasthenia gravis, any sense where the drug is gonna get used?
We got approved for myasthenia gravis in December. We've been now on the market for about 2.5 months overall. MG to 100,000 patients field, obviously, other biologics in the market already. Launched to date, about 50% of our prescriptions are from bio-naive patients, about are coming from bio-experienced patients. The market is reacting well in advance. This was a marketed in reliable that had durability and convenient extended dosing. With UPLIZNA being twice a year after an initial induction dose of induction 2 doses, we think we've met the. We're seeing upwards the board as well that typically in the bio-experience that given the frequency by which other therapies are offered, it's offering us a number of opportunities to play for switch.
That frequency is giving us additional shots as well as progress and need to back the evaluation treatment.
Does it make sense to switch study to help inform of the drug?
Yeah. We remain interested in things on UPLIZNA. We're not gonna announce a switch study today, but we do know that is an area of interest. Like I said, the community is already appears to be switching without study.
Yeah. The We've done a fair amount of work position or introducing it broad, 60 now are going on very right away. The feedback's the one challenge with the fans of the durability is that it's action. Not all qualifying. How do you think that, you know, fairly get stable in terms of trend?
Yeah. I think on the market exactly plays out. Look, physicians to be getting experience with this medicine. We're excited to bring another option overall to patients around. Of course, we'll see how it plays out the marketplace.
Let me actually. When we talk access overall, I neglect about Europe, you know, the Europe is not as big a part of the market these days. Are things stable in Europe now? Are they continuing to get more challenging? Are you beginning to see that they are willing to pay a little bit more for medicines?
Yeah. I think, last year was 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 progress, constants with governments around the world that they understand looks like in a post most setting over and just like before that, you're in particular is the value since that bring. We're seeing some governments start to react and start to think differently. We're seeing that or not. There's 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, I mean, not gonna remain the only similar. It's a question of when the next ones will come, whether it's starting next year. The, you know, 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 gonna take to really expand it further?
Yeah. We're really pleased with PAVBLU thus far. We've 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.
Yeah. 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.
Okay. Is that this year in the U.S. or mostly ex-U.S.?
Casey?
I think time will tell, Yaron. There's a lot of factors that affect how and when biosimilars enter and, you know, I think we'll just have to watch how that landscape evolves.
Yeah. maybe from a peer perspective also or a marketing perspective for MariTide, pricing in general is to continue to come down. 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?
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 with its monthly or less frequent do-dosing. 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 two, part two tested this for, you know, it's obviously competitive.
We'll have an update with how you 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 two questions. One is, by the time you get on the market, which I'm assuming is in the U.S. three to four years from now, how do you see the competitive dynamics having changed, assuming the only two other products on the other two companies are Lilly and Novo, but with expanded product lines? Oh, thank you so much. 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 seven 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, Justin.
Yeah. I mean, just to summarize. 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 timelines, so we'll let you make your own assertions there. I think the second part of the question we caught.
Yeah. The second part of the question was, how do you plan on competing against other companies that have multiple offerings?
Do you think that it's important to have approvals not for obesity or I personally don't care about the 16% or 19% weight loss, or 22%. I think insurer interests, the doc, seven chronic condition that obesity is related to, where you can have a reduction in morbidity, mortality, and cost.
Yeah. Let me address that then in two parts. One, to be bringing a differentiated molecule to the marketplace, we think that differentiation earns a spot at the competitive table with what we're doing. We're really focusing on, you know, efficacy that is in the mid-20s on weight loss and big impact on cardiometabolic parameters, including HbA1c. Tolerable medicine, we're looking to improve the titration protocol with 3-step titration then finally monthly or 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 phase 3 clinical trial then we were also looking to add Type 2 diabetes. Our clinical trials for the related conditions are ASCVD, heart failure, and sleep apnea.
We believe that the whole suite of evidence will be important, not just for payers, but to compete in the class.
Thank you.
Maybe a question against Kave, while we have you, on Sjögren's. It's an area we're doing a lot of work on. Technically, it's not an orphan market. Once you look at the patient population being RF and Ro positive, moderate to severe, naturally it becomes an orphan market. Can a market like that? You're looking at both systemic and symptomatic, and you're the only company right now, and that's critical 'cause 60%, 70% of patients are actually symptomatic. Everybody else is going for the smaller segment, albeit obviously important. Can it support premium pricing?
Yaron, let me give how we see the market, which I think might be just slightly different than the, than as you see it. We see about 350,000 patients that are Ro or RF positive diagnosed. 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 lines, some will go for the whole population, some will go for smaller populations. Obviously, we'll have different value propositions depending on exactly where they sequence overall. 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%-40% of the market. The symptomatic population, we see that as 60%-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. 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 Sjögren's patient. 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, when they see a moderate to severe Sjögren's patient, they can hopefully, depending on the data, pull for dazodalibep. 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. Both of those studies read out at the end of the year. Based off the readouts of those studies, we'll understand exactly what our path to market is, and really, are we, you know, are we positioning for a broad population or a smaller orphan subset population?
The symptomatology is fairly variable. Anything from dry eye to fatigue to some arthralgias. It could be a lot more systemic, and has a real tissue involvement. That's why I'm trying to figure out the price. If you look at some of the other companies working in this space, Sjögren's is probably gonna be an add-on indication, and they are deep in orphan pricing. I guess Novartis will be first, and we'll have to see how they price. By virtue of the competition, it looks like they're going orphan, and maybe that's the opportunity. The question, is it severe enough?
Yeah, I think again, time will tell based off that phase three 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.
Yeah. 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. To your point, Repatha 239 times 12, it's about $3,000, just under $3,000 a year. MariTide and obesity drugs now are anywhere between $300 and $400, $500 a month. They require a lot of injections and a lot of injectors. I guess my question with Amgen, I mean, you're making drugs that are costing $150, $200, $300, drugs that cost and work on margin.
Yeah. Yaron. I would start by saying that this evolution is exactly what we wanted. Certainly, I think for years now have seen that U.S. prices in the U.S. and around the world would face pressure over time, our strategy has been volume-driven growth. You're right, to kinda square that circle, what you need is a manufacturing footprint and the capability where you can, you know, keep your cost structure under control and manage that. That's something we've been doing for years. If you look at, you know, Prolia and denosumab, I mean, that's a primary care medicine where we've been able to, you know, earn a very nice return.
And you know, I think credit to the manufacturing and the operations team, what they're, you know, very focused on year after year is driving more, you know, productivity and efficiency gains. That's definitely part of the, part of the game plan.
When Amgen launched a 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, you know, kinda case by case.
Is it maybe final question, fair to assume that Amgen's making money on every drug?
I don't know. I mean, we don't disclose the gross margin by product. I think if you look at our overall results, you know, I think they speak for themselves.
All right. Well, team, thank you so much. Good to see you. We appreciate it.