Well, I think we're ready to get started. On behalf of Leerink Partners, I wanted to welcome you all to the session with Amgen. Very much my pleasure to welcome Peter Griffith, the company's CFO. Actually in between Jasper and Peter is Casey, who runs IR. Jasper van Grunsven, is that how you pronounce your last name?
It's very good.
My apologies. I got Jasper right at least.
Exactly.
He runs Rare Disease for Amgen.
Exactly.
I thought we'd have Peter Griffith with some opening comments.
Dave, thank you, and good morning, everyone. We're so glad to be here, as we always are, here in South Beach. I have a few prepared thoughts that I'd like to share. 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 rare disease, innovative oncology, and the biosimilars portfolios. Repatha, Evenity, and Tezspire all grew 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 that 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 or our BiTE platform.
IMDELLTRA, our DLL3-targeting BiTE, has rapidly become the standard of care in second-line or later small cell lung cancer. With three phase III studies in earlier-stage small cell lung cancer underway, IMDELLTRA has the potential to reach many additional patients. We're also progressing Xaluritamig, our first-in-class STEAP1 bispecific T-cell engager, with two ongoing phase III studies in metastatic castrate-resistant prostate cancer. We're also actively evaluating opportunities to expand Xaluritamig into earlier lines of prostate cancer. Our biosimilars portfolio generated $13 billion. It's accumulated cumulatively about $13 billion in sales, and in 2025 it generated $3 billion of product sales, growing 37% year-over-year. The momentum here is in part due to the strong uptake of Pavblu, our biosimilar EYLEA.
Future growth is going to be driven by our biosimilar candidates to OPDIVO, KEYTRUDA, and OCREVUS, which are all currently in phase III development. Let's turn to the pipeline. 2026 is gonna 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 very strong based on the genetic and epidemiologic evidence that has established elevated Lp as an independent risk factor to heart disease. Finally, we're 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. Turning to a few financial updates. We see strong momentum in the business for the full year. However, in terms of quarterly phasing, historically, Q1 is lighter for us relative to subsequent quarters, and we expect that to be the case this year as well. Let me remind everyone of a few points from our recent earnings call on the outlook for the first quarter.
As we typically see with the United States insurance cycle, we expect a seasonal Q1 headwind from benefit plan changes, reverifications, and higher patient co-pays. We also expect Otezla and IMRALDI to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters. I'd also add, 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 in 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 product 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 was approximately 43%. I also provided some commentary on the full year outlook on our recent earnings call, and I'd encourage you to reference the Q4 transcript for my full remarks. In closing, as we enter 2026 with strong commercial momentum across our diversified set of six key growth drivers and a phase III pipeline that spans four therapeutic areas with meaningful depth and breadth, we're well-positioned to deliver sustained long-term growth. With that, Dave, I'll turn it over to you.
Excellent. Well, thank you very much for that, Peter. Would love to have you talk a little bit about opportunities for growth beyond 2026 and what you think, you know, the investment community may be underappreciating?
Thanks. Great question, Dave, and I'll invite Casey and Jasper to hop in when they'd like to. They certainly have plenty to add here. I would recap those six key growth drivers. I always think about those, and they're doing so well. Repatha, we can talk about the VESALIUS study and the outcomes data there. We can get deep into that. Jasper actually worked Repatha for a number of years and did a great job getting it going, starting about five years ago, he was involved in that. Evenity, what a great medicine. Went through $2 billion last year, and there's so many, that's such an under-penetrated market. Postmenopausal women, this is a great medicine for that.
Certainly Tezspire getting through $1 billion last year, severe uncontrolled asthma. I would also add that I can't resist mentioning the chronic obstructive pulmonary disease study underway, phase III. That's, I think, the third leading killer of humans on the planet. So that's super important. I think about the rare disease portfolio too, Dave, and I just think about those medicines. I look at UPLIZNA, and it's just doing so well, and Casey and Jasper can talk about even some of the additional studies beyond the successful GMG approval into the autoimmune area that we're thinking about with Inebilizumab.
That's close enough, which is the molecule itself for UPLIZNA. A lot going on there. We like to think about that. I would say when you get to innovative oncology, I just have to pause for a moment and mention IMDELLTRA. You know, this is a bispecific T-cell engager addressing a horrible disease, small cell lung cancer, where survival rates have been very challenging. This medicine has had a very rapid uptake. It's the first medicine to address a common solid tumor, and it's done it really well. I think we launched that in about May of 2024, and it's been very successful. That one, I certainly would hope over the long run, really continues to do well for patients with this very, very serious disease. Biosimilars.
$3 billion last year, a strong year certainly, Pavblu was a contributor to that. Going forward, you know, thinking about our molecules relative to KEYTRUDA and OPDIVO and OCREVUS that I talked about, that's strong too. We've got the six key growth drivers. We've got a strong phase III pipeline, so we're busy, we're investing. Of course, you know, we'll talk about MariTide. We know we'll do that. As CFO, I'd just remind you, we've got six phase III studies underway, and I'm glad we do, and they're important. That certainly is a significant investment our shareholders are making in what we expect to be a really important medicine in the battle against obesity disease and all the related indications.
Type 2 diabetes. I think there's a lot. It's the breadth and depth.
It's the 18, the 14, the 13. You know, certainly the 14 products that generated greater than $1 billion last year and, so, you know, we're just really 18 record, 13 double digit. Did I get that right?
It's kind of that. That's how I think about it, Dave. Breadth and depth, driving innovation at speed and scale. That's what the company's doing. You know, we're busy, and we see this year as a super important year of execution excellence. We've got a great portfolio. We're fortunate to have a great pipeline, and myself and our colleagues, we're focused on sustainability of that growth rate over the long term.
Excellent.
Did you fellows have anything you want to add?
I'd love for maybe Casey to talk a little bit about MariTide. You had mentioned, you know, monthly, every other month, or quarterly dosing.
Could you just provide a little bit more color, Casey, on how you get there? I think the first phase IIIs just have monthly dosing that are reporting out early next year. So maybe if you could share some insights on how we should think about you know, the potential for, you know, different dosing in the future?
Yep, sure. Happy to do so. Yeah, just to set the context, Dave, MariTide, as Peter said, has six global Phase III studies underway. We anticipate additional phase III studies coming online this year in Type 2 diabetes. The two that are most advanced are our two chronic weight management studies. That's where we're looking at monthly dosing over the course of 72 weeks. There's a short three-step dose escalation period to initiate those studies. Think about that as driving patients towards their weight loss goal over the first 72 weeks with monthly dosing.
With MariTide, we established this through Part two of our phase II chronic weight management study. We observed that with lower monthly dosing or with quarterly dosing, we were able to maintain weight loss that was achieved over the first 52 weeks for a subsequent 52 weeks. We feel like there's many options once the patient is at their weight loss goal with MariTide to stay on lower monthly dose, to potentially move to every eight-week dosing, to potentially move to quarterly dosing to maintain the weight that they've lost. Interestingly, particularly with the quarterly dosing in that second 52-week period, we saw MariTide was very well-tolerated at quarterly dosing. That was a question that we thought was important to answer since it was such a long time between doses.
You could imagine tolerability kind of coming back to, you know, almost a treatment-naïve situation, and that wasn't the case. We saw a very well-tolerated molecule, and that's been consistent with MariTide, where it is. Once you're at target dose with larotide, it's a very well-tolerated medicine and obviously we're quite encouraged by the data we've seen thus far and are investing heavily behind it, as Peter had indicated.
Excellent. That's great. Maybe we could pivot to UPLIZNA, Jasper? Would love to hear you talk about the long-term potential, including which indication, you know, is your favorite, i.e., might be the biggest percentage of the pie longer term?
That's an interesting question. Let me start where Peter left off.
Please.
Like if you think about Amgen's growth portfolio, I'm like, look at those numbers. I'm very excited about that. If you look at 18 products with record sales, 13 products with double-digit growth, that breadth is very exciting. If you bring that to the rare disease portfolio, we see similar numbers across all our franchises in rare disease, and UPLIZNA is a unique example in that. UPLIZNA in last year grew 73%, and I always have to remember, remind people of that 73%, is driven by our base indication, which is NMOSD, where we saw very good new patient growth, very strong adherence, which is important. It's driven by NMO and let's say eight months of the IgG4-RD launch, which is a very exciting new indication, very big unmet need.
Like, we're the first FDA-approved therapy in that indication. UPLIZNA has a fantastic profile there. I can talk about that a little later. What we see is very good, strong uptake there. We have over 500 active prescribers there in that indication, and that's breadth of prescribing. You expect rheumatologists to prescribe. We see GI specialists prescribe. Even beyond that, we start to see prescribing. We feel very good about that. That's our 73% growth last year is NMO full year, eight months of IgG4, and then as Peter said, we had the GMG approval December last year, which basically means a launch this year. That uptake has been very exciting as well.
GMG, of course, but I always say it's a busy area with competition, but there's still a very big unmet need, and people don't often see that. If you look at the existing therapies, patients cycle through them relatively quickly. Like I think more than 50% of patients only stays on a therapy less than 12 months. That tells you there's still a significant unmet need. When we talk to physicians and patients, they talk about the unmet need in a way, "Hey, we need a durable therapy that doesn't have additional flares between dosing." That's exactly what UPLIZNA offers, in our opinion. We see since launch, and that's very early, we see very good uptake, and we're particularly excited by the breadth of uptake.
We see both biologic-naïve patients, probably 50% of our new patients are biologic-naïve, and 50% come from switch. If you put that together, we expect continued strong growth. It's honestly very difficult to say which of those indications would be biggest. I think all of them will significantly contribute to UPLIZNA and the rare disease portfolio. Then, of course, as we deeply believe in upstream CD19-directed B-cell depletion as a very good mode of action in autoimmune disease, we also have these other indications that Peter mentioned. We think UPLIZNA is set for very, very strong future growth.
Excellent. That's great. In GMG, obviously it is crowded and-
Will become more crowded. Could you talk about UPLIZNA's competitive positioning and just how you see its adoption?
I just explained already that we still see it as a big unmet need.
Yeah.
I explained that. I also explained what our insights were around what physicians and patient wants. What UPLIZNA offers, if you think about that CD19 directed B-cell depletion, what we offer is we offer that very strong, durable efficacy. That's one. Second, we have a very known and well-tolerated safety profile. Three, we have a maintenance twice-a-year dosing. Then we have a pretty broad set of sub-indications in GMG as well. If you put that together, I think we have an extremely competitive profile. If you compare it with existing competition as well as future competition, I think we are very competitive if you just put that together. That's what we see because we get patients uptake in bio and even we get patients uptake in switch.
Excellent. Why don't we turn to TEPEZZA? The company has a forthcoming subcutaneous version. Could you just discuss that product profile and how quickly you might be able to convert the market from IV?
Yeah. So if you look at Thyroid Eye Disease, it's good to know that we also feel there. Again, it's the story that Peter said as well for many of our indications. The penetration for the unmet need is big. The penetration is still only single digits, and that's mostly in the area of the chronic or low Clinical Activity Score disease patients. That's important to know. If you then think about the subq formulation, we feel that subq is a more patient-friendly, sorry, convenient formulation that specifically will help unlock in that chronic patient population. We think it will significantly help.
Of course, we have to wait until our phase three reads out before we can comment more on what the actual profile will be and how we will launch that subq formulation. We feel it will significantly help in unlocking that chronic patient population.
Excellent.
Jasper, is it also fair to say that, Dave, we envision IV continuing.
Yeah.
TEPEZZA continuing, but also bringing online a subcutaneous administration, which will help us, as Jasper was saying, to reach additional patients, particularly in that low Clinical Activity Score setting.
Excellent. Why don't we turn to Dazodalibep, if I'm pronouncing that correctly.
You know.
The CFO way to describe it is DAS.
Yes.
You're beyond that, Dave. I just say DAS.
Yeah. That makes a lot of sense. Keep it simple.
Yeah.
It's clearly an important pipeline opportunity. If you could just share your thoughts on it and news flow ahead?
Dazodalibep, let's call it DAS indeed, is absolutely a very exciting asset for Amgen. It starts like in rare disease. It starts with the unmet need, and we know in Sjögren's disease, there is very significant unmet need. We currently have around 350,000 patients diagnosed in the U.S. If you look at the subset of patients or the subsets of patients in that 350,000 diagnosed, we basically have two big groups. One is the 30%-40% systemic disease groups. 30%-40% of those patients have systemic disease. But another 60%-80% of patients, there are some overlap between those groups obviously.
60%-80% of patients has only symptomatic disease. If you talk to physicians and patient, the unmet need there, when it comes to dryness, fatigue, pain, is very, very significant. We've seen in our phase II data that we show initial efficacy in both of those indications. We feel that looking forward to our phase 2/3 trial, that we have potentially a good profile there, and we're very excited. The unmet need is significant there.
Excellent. You said the timing was second half.
Excellent.
Yeah.
Okay. Great. Just so that we understand sort of based upon your prior data regarding adverse events, what are your expectations for anti-drug antibodies and, you know, the risk of thromboembolic events?
Yeah, let me jump in on that one, Dave. DAS is a CD40 ligand-targeting fusion protein. It's specifically designed and engineered to avoid some of what we saw previously with other monoclonal antibodies that were targeting the CD40 ligand or CD40 pathway, where there was platelet aggregation, thromboembolic events. In our phase II study, we saw a favorable safety profile. It provided us the confidence to advance into phase III. Obviously, in larger number of patients, we'll continue to watch the full safety profile of DAS. The way that we've engineered the molecule hopefully will allow us to avoid some of what others have seen with monoclonal antibodies targeting the same pathway, and we're optimistic for what phase III can bring.
Obviously, the data will inform us in terms of the potential of the molecule and its safety profile.
Excellent. That's great. Then why don't we just pivot back to MariTide, just given how important that product can be for the company? You know, there's been a lot of changes in the market recently. Obviously greater pricing pressure. Lilly had declared early this year that it's much more of a consumer market than they originally expected. I guess would love to hear about, you know, if we think about the market being in two segments, commercial coverage and consumer, would love to hear your plans for the consumer market? On the commercial side, we get questions about how Amgen will compete with the rebate wall from Lilly and Novo, given their current dominance in obesity?
Yeah. Let me start and then Peter, Jasper, feel free to add on.
It starts with the evidence base that we're generating with MariTide. Six global phase III studies underway, two in chronic weight management, two in obstructive sleep apnea, one in heart failure, one in ASCVD, both outcome studies, and then obviously in Type 2 diabetes as well. We are working to establish a very comprehensive evidence base for MariTide, and we feel that's important both to characterize the molecule, but also to characterize the potential of reaching a number of different patients with obesity or obesity-related conditions. That plays into how you think about entering the market. I would say, you know, details to be determined in terms of our exact approach to the market, but we're watching carefully.
We're well aware of the consumer element of this, and thinking through how we can best position MariTide with respect to all of the different aspects of the obesity market, and which as you know, Dave, are rapidly evolving and we feel a little bit advantaged to be watching how things play out as we think strategically about how to ultimately bring MariTide to market.
Excellent.
Maybe just for a minute.
Casey, talk a little bit about the adherence because, you know, we think?
MariTide is characterized and, the data turns out the way that we hope it does, that perhaps it's able to help patients and their adherence.
Given that adherence on the weeklies is not as strong probably as people would hope.
Yeah. Yeah, it's a good point. It's really why does monthly dosing matter in a way? We see that currently treatment burden and dosing frequency continue to be barriers to long-term persistence on therapy. We feel like with a monthly or to maintain weight, you know, a less frequently dosed molecule, we have a real opportunity to improve adherence, improve the patient experience. Why does that matter? To your point, Peter, that matters because in order for patients individuals living with obesity or related conditions to experience the long-term benefit of that medicine, they have to remain on the medicine to achieve those health benefits, to improve their diabetes, to improve their cardiovascular outcomes, to improve their sleep apnea.
These are chronic conditions, need to be treated chronically. We feel like a medicine with MariTide, with its dosing frequency and long-term, favorable tolerability at target dose really helps to fit, you know, what we see as an emerging unmet need in the space.
Maybe just one.
Yeah.
...Add on, and Jasper, I'll turn it to you then, when you think about Amgen's history, Dave, with Repatha.
With Prolia, the ability to, you know, generate delivery of important medicines to areas with significant unmet medical need, millions of patients, you know, we have that history. It's not a perfect analog, but it's our commitment to trying to get these medicines that have huge impact where there is a significant unmet need, get them to those patients. You know, we've built our capacity for that. We're building our capacity for that. We've got a guide out this year, $2.6 billion in CapEx. You know, we're working hard on yield management. We're working hard on the science of manufacturing. We're working hard on, you know, making sure, you know, the devices are just right for doing this. We're focused on that. Company's been focused on it for a long time. Jasper, you've been trying to say something.
It's like your question was on the commercial outlook, and I think Casey, Peter, you said it very nicely, like if the profile of MariTide shapes up the way it does in phase III, I think we have a very competitive profile. I just wanna reiterate what you said, Peter. It's like the commercial capability that we build in cardiovascular and cardiometabolic, where we have a track record over 10 years, getting Repatha to a very successful brand, I think is a very important base that we launch MariTide off, which is pretty unique if you look at all the competitors developing in obesity. Of course, we have formidable competitors with Lilly and Novo, but I think Amgen with this cardiometabolic franchise and footprint will really be very competitive commercially as well. Excellent.
Well, we are actually about to run out of time, but I had one more question for Peter. Obviously you have a strong balance sheet, a lot of flexibility.
How do you see the current M&A environment? Meaning, there are a lot of companies that are looking for attractive targets. It'd be helpful to get your perspective on that current environment and opportunities or challenges for Amgen in executing in that environment.
Sure. Just to level set and calibrate, we were able last year by the end of the third quarter to get back to the balance sheet that we committed to, when we announced the Horizon deal in December of 2022, and Jasper and the team in Rare Disease did a great job integrating that and making it all work so well. Let's just start with that and then just say, as we take that, the strong balance sheet, and we think about M&A in terms of inorganic activity, mergers and acquisitions, licensing, collaborations, partnerships, Dave, which we're structurally agnostic, you know, we're always in the market, we're always looking, but we always stick to our principles. Our capital allocation hierarchy number one is the best innovation either internally or externally.
We're committed to finding the best innovation. Now, let's get to your point, which is can you get it at somewhat of an effective value for shareholders? Well, our first principle is are we the best buyer, collaborator, licensor, partner? Which simply means when it's in our hands, can we add to it? Are we accretive to that? Can we model it a little bit better than everybody else in a realistic way? Number two, cash on cash returns. We're always stick to that. Number three, do we have research in the area? If we've got research in an area, we think we do a lot better with any one of those structural inorganic opportunities. Four, can we integrate promptly?
We think returns are generated by promptly integrating acquisitions and these other types of partnerships and licensing and collaborations. Acquisitions in particular, and we showed that with Horizon, we were able to, you know, achieve accretion in the first full year. We achieved our pre-tax cost synergies of more than $500 million a little bit early. As I said, we were able to strengthen that balance sheet early. Moving quickly, that fourth thought in our minds. We always prosecute these. We wanna have an opinion on everything too. We think it's super important at Amgen that we see what's out there and what's available.
You know, if it becomes transactable and it makes sense, you know, we'll certainly participate, but we'll stick to our rigorous discipline in terms of how we look at these opportunities.
Excellent. Well, that's going.