Amgen Inc. ($AMGN)

We're ready to get started. On behalf of Leerink Partners, I wanted to welcome you all to the session with Amgen. So very much my pleasure to welcome Peter Griffith, the company's CFO. And 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. So he runs rare disease for Amgen. So I thought we'd have Peter kick it off 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. So 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 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 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 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 3 Phase III studies in its early-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 2 ongoing Phase III studies in metastatic castrate-resistant prostate cancer. And we're also actively evaluating opportunities to expand xaluritamig into earlier lines of prostate cancer. Our biosimilars portfolio generated $13 billion -- excuse me, 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 to 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 going to 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)-Outcomes 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(a) as an independent risk factor to heart disease. Finally, we're 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. 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 Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters. I'd also add that as of January, Otezla now faces European generic entry. And for reference, European sales of Otezla were USD 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. And 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. And in closing, as we enter 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 depth and breadth, we're well positioned to deliver sustained long-term growth. And 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 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 6 key growth drivers. I always think about those, and they're doing so well. So 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, about -- starting about 5 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 underpenetrated market. postmenopausal women. This is a great medicine for that. And certainly, TEZSPIRE, getting through $1 billion last year, severe uncontrolled asthma. I would also add on that, I can't resist mentioning the chronic obstructive pulmonary disease study underway, Phase III. And 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. And so 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 IMDELLTRA. 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 on our -- 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 '24, and it's been very successful. And that one, I certainly would hope over the long run, really continues to do well for patients with this very, very serious disease. And then biosimilars. So through $3 billion last year, a strong year, certainly, PAVBLU was a contributor to that. But going forward, thinking about our molecules relative to KEYTRUDA and OPDIVO and OCREVUS that I talked about, that's strong, too. So we've got the 6 key growth drivers. We've got a strong Phase III pipeline. So we're busy. We're investing. And of course, we'll talk about MariTide. We know we'll do that. As CFO, I'd just remind you, we've got 6 Phase III studies underway, and I'm glad we do, and they're important. But that certainly is a significant investment our shareholders are making in that -- what we expect to be a really, really important medicine in the battle against obesity disease and all the related indications and type 2 diabetes. So I think there's a lot. It's the breadth and depth. It's the 18, the 14, the 13. So certainly, the 14 products that generated greater than $1 billion last year. And so we're just really 18 record, 13 double digits. Did I get that right? So it's kind of -- that's how I think about it, Dave, breadth and depth, driving innovation at speed and scale. That's what the company is doing. And 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 are focused on sustainability of that growth rate over the long term. Do you fellows have anything you want to add?

I'd love for maybe Casey to talk a little bit about MariTide. So you had mentioned monthly, every other month or quarterly dosing. But 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 the potential for different dosing in the future.

Yes, sure. Happy to do so. Yes. So to set the context, Dave MariTide, as Peter said, has 6 global Phase III studies underway. We anticipate additional Phase III studies coming online this year in type 2 diabetes. The 2 that are most advanced are our 2 chronic weight management studies. That's where we're looking at monthly dosing over the course of 72 weeks. There's a short 3-step dose escalation period to initiate those studies. But think about that as driving patients towards their weight loss goal over the first 72 weeks with monthly dosing. Then with MariTide, and we established this through Part 2 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. And so 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 8-week dosing to potentially move to quarterly dosing to maintain the weight that they lost. And interestingly, particularly with the quarterly dosing in that second 52-week period, we saw MariTide was very well tolerated in the 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 almost a treatment-naive 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 of MariTide, 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. So maybe we could pivot to UPLIZNA, Jasper. Would love to hear you talk about the long-term potential, including which indication is your favorite, i.e., might be the biggest percentage of the pie longer term?

That's an interesting question. Let me start with where Peter left off. Like if you think about Amgen's growth portfolio, 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. And 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, which where we saw very good new patient growth, very strong adherence, which is important. And so it's driven by NMO and, let's say, 8 months of the IgG4-RD launch, which is a very exciting new indication, a very big unmet need, like we're the first FDA-approved therapy in that indication. And UPLIZNA has a fantastic profile there. I can talk about that a little later. But what we see is very good strong uptake there. So 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. But even beyond that, we start to see prescribing. So we feel very good about that. So that's our 73% growth last year is NMO full year, 8 months of IgG4. And then as Peter said, we have the gMG approval December last year, which basically means a launch this year. And that uptake has been very exciting as well. gMG, of course, it's a busy area. 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. But 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. So that tells you there's still a significant unmet need. And when we talk to physicians and patients, they talk about unmet need in a way, hey, we need a durable therapy that doesn't have additional flash between dosing. And that's exactly what UPLIZNA offers in our opinion. And we see since launch, and it's very early, we see very good uptake, and we're particularly excited by the breadth of uptake. So we see both bio-naive patients, probably 50% of our new patients are bio-naive and 50% come from switch. So 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. And then, of course, as we deeply believe in upstream CD19-directed B-cell depletion has a very good mode of action in autoimmune disease, we also have these other indications that Peter mentioned. So we think UPLIZNA is set for a very, very strong future growth.

Excellent. That's great. And so 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?

Yes. So I just explained already that we still see that as a big unmet need. I explained that. And I just also explained what our insights were around what physicians and patients want. And what UPLIZNA offers, if you think about 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. And three, we have, in maintenance, twice-a-year dosing. And then we have a pretty broad set of sub indications in gMG as well. So 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. And that's what we see because we get patients uptake in bio-naive and we get patients uptake in switch.

Excellent. Excellent. So why don't we turn to TEPEZZA. So 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?

Yes. So If you look at thyroid eye disease, it's good to know that we also feel there -- and again, it's the story that Peter said as well for many of our indications, but the penetration, so the unmet need is big. So the penetration is still only single digit. And that's mostly in the area of the chronic or low clinical activities score disease patients. So that's important to know. If you then think about the subcu formulation, we feel that subcu is a more patient-friendly sort of convenient formulation that specifically will help unlock in that chronic patient population, so we think it will significantly help. Of course, we have to wait until our Phase III read out before we can comment more on what the actual profile will be and how we will launch that subcu formulation. But we feel it will significantly help in unlocking that chronic patient population.

Excellent.

And Jasper, is it also fair to say that, Dave, we envision IV continuing, IV 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. So why don't we turn to dazodalibep, if I'm pronouncing that correctly? So...

The CFO way to describe it is daz. You're beyond that, Dave. I just say daz.

Yes, that makes a lot of sense. Keep it simple. So it's clearly an important pipeline opportunity. If you could just share your thoughts on it and news flow ahead.

Yes. So dazodalibep, let's call it daz, indeed, is absolutely a very exciting asset for Amgen. And it starts like in rare disease, it starts with the unmet need. And we know in Sjogren's disease, there is very significant unmet need. We currently have around 350,000 patients diagnosed in the U.S. And if you look at the subset of patients or the subset of patients in that 350,000 diagnosed, we basically have 2 big groups. One is the 30% to 40% systemic disease groups, 30%, 40% of those patients has systemic disease. But another 60% to 80% of patients have some overlap between those groups, obviously, 60% to 80% of patients has only symptomatic disease. But if you talk to physicians and patients, the unmet need there when it comes to dryness, fatigue, pain is very, very significant. And we've seen in our Phase II data that we show initial efficacy in both of those indications. So we feel we feel that looking forward to our Phase III trial that we have potentially a good profile there. And we're very excited about the unmet need is significant there.

Excellent. Excellent. And so you said the timing was second half.

Mm-hmm.

Excellent. Okay. Great. And just so that we understand sort of based upon your prior data, regarding adverse events, what are your expectations for antidrug antibodies and the risk of thromboembolic events?

Yes. Let me jump in on that one, Dave. So daz is a CD40 ligand targeting fusion protein. And 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. And so 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 daz. But 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. But obviously, the data will inform us in terms of the potential of the molecule and its safety profile.

Excellent. That's great. And then why don't we just pivot back to MariTide, just given how important that product can be for the company. There's been a lot of changes in the market recently, obviously, greater pricing pressure. Lilly has had declared earlier this year that it's much more of a consumer market than they originally expected. And I guess would love to hear about -- if we think about the market being in 2 segments, commercial coverage and consumer. I would love to hear your plans for the consumer market. And then 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.

Yes. So let me start and then Peter and Jasper, feel to add on. So it starts with the evidence base that we're generating with MariTide. So 6 global Phase III studies underway, 2 in chronic weight management, 2 in obstructive sleep apnea, 1 in heart failure, 1 in ASCVD, both Outcomes studies and then obviously in type 2 diabetes as well. So 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, 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.

Maybe just for a minute. Casey, talk a little bit about the adherence because 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 the adherence on the weeklies is not as strong probably as we would hope.

Yes, it's a good point. It's really why does monthly dosing matter in a way. And we see that there is -- that currently treatment burden and dosing frequency continue to be barriers to long-term persistence on therapy. I mean we feel like with a monthly or to maintain weight, a less frequently dosed molecule, we have a real opportunity to improve adherence, improve the patient experience. And why does that matter? To your point, Peter, that matters because in order for patients individuals living with obesity-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. And we feel like a medicine with MariTide with its dosing frequency and long-term tolerability at favorable tolerability at target dose really helps to fit what we see is an emerging unmet need in the space.

Maybe just one add on and Jasper, I'll turn it to you then, is when you think about Amgen's history, Dave, with Repatha, with Prolia, the ability to generate delivery of important medicines to areas with significant unmet medical need, millions of patients. 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 to get them to those patients. So we've built our capacity for that. We're building our capacity for that. We've got to guide out this year, $2.6 billion in CapEx. We're working hard on yield management. We're working hard on the science and manufacturing. We're working hard on making sure the devices are just right for doing this. So we're focused on that. The company has been focused on it for a long time. So Jasper, you've been trying to say something?

No, no, but it's like your question was on the commercial launch. And I think, Casey, Peter, you said it very nicely. If the profile of MariTide shapes up the way it does in Phase III, I think we have a very competitive profile. I just want to reiterate what you said, Peter, is like the commercial capability that we built in cardiovascular and cardiometabolic where we have like a track record over 10 years, getting Repatha to a very successful brand, I think, it's a very important base that we launched MariTide of, 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 is really -- will 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. So obviously, you have a strong balance sheet, a lot of flexibility. But how do you see the current M&A environment, meaning there are a lot of companies that are looking for attractive targets. And so it'd just be helpful for -- it would 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. So 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. We're always in the market. We're always looking, but we always stick to our principles. So our capital allocation hierarchy, number one is the best innovation, either internally or externally. And so 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 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. And fourth, can we integrate promptly? We think returns are generated by promptly integrating acquisitions and these other types of partnerships and licensing and collaborations. But acquisitions in particular, and we showed that with Horizon. We were able to achieve accretion in the first full year. We achieved our pretax cost synergies of more than $500 million a little bit early. And as I said, we were able to strengthen that balance sheet early. So moving quickly, that fourth thought in our minds. So we always prosecute these. We want to 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. And if it becomes transactable and it makes sense, 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 great. Right. To wrap up, thanks so much for being here. Appreciate it.

Thank you, Dave. Thanks for the invite.

Thanks for having us.

Thank you.