Excited to have Amgen with us this morning. Three speakers: Peter Griffith, Executive Vice President, Chief Financial Officer since 2020. He joined from Sherwood Canyon Group, a private equity advisory firm. He was at Ernst & Young prior to that. We have Dr. Jay Bradner, Executive Vice President of R&D. He is responsible, of course, for everything in the pipeline. He was with Novartis prior to that. We have Justin Claeys, Vice President of Investor Relations, who has been in that role since 2023. Been with Amgen for a few decades.
That's right.
A long time.
It's a fire side chat. I think, Peter, you might make a few comments to kick things off.
Thank you, Tim. Thank you, B of A, for inviting us. We're delighted to be here. Thank all of you for your interest in attending this morning. At Amgen, we started 2025 with strong momentum financially and across the enterprise. Our performance this year reflects the growing global need for our innovative medicines and our team's relentless focus on execution. We're seeing strength across our portfolio and our pipeline. We expect to deliver strong growth in the near term and through the long- term also. In the first quarter, revenue increased 9% year- over- year, driven by 14% volume growth. The momentum was broad-based, with 14 products delivering double-digit growth across our key therapeutic areas: general medicine, rare disease, inflammation, and oncology. A few areas I'd like to highlight for you.
In general medicine, Repatha and Evenity together delivered over $1 billion in the first quarter. That was 28% year-over-year growth. Both brands have significant growth potential, serving large patient populations that are still predominantly untreated despite the availability of these impactful therapies. Our cardiovascular candidate, Olpasiran, targeting Lp(a), which Dr. Bradner will speak to you about, I'm sure. A genetically fixed risk factor for cardiovascular disease is fully enrolled and continues to progress. In obesity, we're advancing MariTide, with two phase III studies in chronic weight management rapidly enrolling, and we're excited to share the underlying details at 52 weeks from part 1 of our phase II study, along with data from a phase I PK study at the American Diabetes Association in June. In rare disease, we're excited to have recently launched UPLIZNA as the first and only approved therapy for IgG4-RD .
This is a serious, chronic, and debilitating immune-mediated inflammatory condition. Feedback from both patients and physicians has been very encouraging. We also have a PDUFA date for UPLIZNA in generalized myasthenia gravis on December 14. Our progress with UPLIZNA, as well as Glenitumamab, underscores Amgen's ongoing leadership in developing innovative treatments targeting CD19- positive B cells in cancer, inflammation, and in rare disease. More generally, in rare disease, where only 5% of the estimated 10,000 rare diseases have available treatments. In inflammation, TEZSPIRE continues to deliver in severe uncontrolled asthma. We are looking forward to our PDUFA date for chronic rhinosinusitis with nasal polyps, which is October 19, 2025. We're also enrolling patients in two phase three studies in chronic obstructive pulmonary disease, an area with enormous unmet need, and in a phase III study of TEZSPIRE in patients with eosinophilic esophagitis.
In oncology, our BiTE platform is delivering. [Lenkicta] is expanding into earlier lines of treatment. Imdelltra continues its strong momentum with over $80 million of sales in the first quarter and being well accepted both by academic and community oncology groups. We recently announced compelling results from our DeLPhi- 304 phase III trial, where at a planned interim analysis, the study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit. These data will be presented at ASCO in June. Our first-in-class [STEEP 1 ]CD3 bispecific T cell engager, Xaluritamig, is advancing in phase III clinical development, where we are rapidly enrolling patients with metastatic castrate-resistant prostate cancer who have progressed following taxane-based therapy. We are also exploring Xaluritamig in combination therapy and in earlier stages of prostate cancer, with multiple phase Ib studies progressing.
Collectively, Imdelltra, [Lenkicta], and Xaluritamig exemplify the significant growth potential of our robust bispecific T- cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide. Now on to our biosimilars portfolio, generating $735 million in the first quarter, up 35% year-over-year, driven by the launches of Pavblu and Wezlana in the United States. We also recently launched [VEKLURY] in the United States. These results exemplify our strategy of delivering long-term biosimilars growth through waves of new products. To this point, we are also advancing the next wave of biosimilar candidates, including against innovators Opdivo, Keytruda, and Ocrevus, which are all of ours are in phase III development and progressing well. Before turning to Q&A, I'd like to remind you of a few points on the 2025 outlook from our earnings call.
Namely, our first quarter non-GAAP operating margin came in above expectations, driven in part by the timing of R&D spend, including milestone payments and other investments, which are now largely expected in the second quarter. We expect full-year non-GAAP research and development spend to grow 20% now year-over-year, reflecting increased investment in late-stage programs, including MariTide and Olpasiran. We recognize it's a dynamic environment, whether it's evolving policy and prices, taxes, and tariffs, and also general macro uncertainty and geopolitical. We've built a business with flexibility and resilience, and we have the operating discipline to manage through this. Our mission remains clear at Amgen, serving patients by delivering innovative medicines to patients with serious and grievous illnesses. We believe we're well positioned to do that. Tim, back over to you for Q&A.
Okay. Great. We have limited time here. Let's just jump straight in. We're going to ask policy questions, of course. I know that it's hard to have solid answers here, but we really need to ask every company that we're talking to. Any disruption to how you guys are running the business at the moment from everything that's been put forth, MFN, tariffs, IRA, FDA changes? Are you gating the hiring of employees? Are you thinking about clinical trials differently, M&A differently?
Tim, there's a lot in the question. Let me just say, first of all, when we gave guidance for 2025, we were very clear that that included expectations around what we needed to deal with with currently implemented or enacted tariffs. First of all, that's where we're at in terms of how we view the rest of the year right now. When we think about future or specific tariffs, they're not included in that outlook. Tim, I would just remind our colleagues here today with us that we are very committed to the United States. After the first TCJA of 2017, we went out and we acquired significant land in Ohio and North Carolina. We built a finished drug product plant in Ohio, which was up, licensed, and running in January of 2024. Clearly, our most automated plant going very well.
We've recently announced almost another $1 billion into that to put another facility on that land in Holly Springs, North Carolina. Tim, we announced that we were putting up a drug substance plant. We have also recently announced, in addition to that plant, which we expect up and licensed in 2027 or 2028, we expect and are starting work on a second plant. We've announced another $1 billion into that facility there. We will have two facilities there. We have doubled down on the United States and what we're doing here. We're actively looking, as you can imagine, we're Amgen and all mitigation strategies, but we're not trying to guess where the puck's going. We're being very thoughtful. We continue to monitor the environment. We're not speculating on best or worst-case scenarios. We remained engaged, certainly, in industry-wide policy discussions. We continue to execute.
At Amgen, we had a very solid first quarter. We continue to deliver the medicines we have to our patients around the world. We will stay focused on that first and foremost. Just one last point. During COVID, we were able, with our supply chain, to work very, very thoughtfully through COVID. We did not miss a beat. We were able to help colleagues in the industry with manufacturing when they needed some help. We were happy to do that. We want to continue to remain on the balls of our feet and do what we need to do to get the medicines to the patients.
When you're running a business, forecasting where the puck is going to go is just part of the day-to-day job. You have to do that to some degree. On the most favored nation stuff that's being talked about, real or absolute nothing but rudder?
You use the word stuff. That is probably an operative word to think about a little bit. We read everything. We are very active. We like to think when we go to Washington, we are active on behalf of the patients and patients around the world. We want to stay focused on that first and foremost. We certainly want to make sure that we are doing everything we can do to stay focused on how we can get more medicine to the patient. We want great access. We want great value for those patients. We always continue to remain focused on that. Let us see where that all shakes out. We are going to read the details with you and everybody else as soon as they are available. We will respond accordingly.
We certainly are planning and thinking about whatever we need to do to make sure that supply continues uninterrupted.
When you guys think about prices in the U.S. versus ex-U.S. prices, just whether it's an Amgen data point or just an industry-wide data point, I mean, I've always heard a rough rule of thumb that ex-U.S. prices are, especially in Europe, 20%-40% lower, somewhere in that range. You don't have to answer it from the Amgen perspective. There is a lot of other information out there that talks about much bigger pricing disparities that I'm not sure are real. Can you give any sort of industry commentary U.S. net prices versus European net prices, whether it's an Amgen data point or anyone else?
Yeah, I do not think we are prepared to do that today. I think that is probably something best left to maybe ChatGPT-4 or something like that at this point in time. I would just suggest it is important. We need to think about it. I completely understand the question, but we also want to remain very, very grounded right now and not get ahead of our skis and stay focused on our mission, which is to serve patients. We have a fantastic commercial group. We have a fantastic public policy group. They are literally working 24/7 right now to make sure we interrogate all this and we share our views and opinions on behalf of patients with those that are making the rules and thinking about it. We will continue to stay focused on that right now, Tim.
The last question on this is to play forward a scenario where there is some impact on just government programs of Medicare and Medicaid. Do you think, does Amgen think there would be any commercial spillover to the commercial book of business?
I don't think we're going to speculate on that right now. I think there's a pretty well-established commentary out there on that now that our colleagues can view and others that will write more articulately on that right now. We just don't get in the business of speculating on that. Look, we think the most important thing is to make sure those patients continue to get the medicines and get the right value and access when they get up to that pharmacy counter or into the doctor's office. Let's stay focused on that right now and let those who are making the rules pay attention to all the input they're receiving right now and do what they need to do to make sure the United States continues to drive innovation. I mean, we have Jay with us today. I just love thinking about innovation, Tim.
What do we need in the United States and everywhere else? We need more innovation. We're raising our R&D spend this year, 20% year- over- year. That's what we're going to stay focused on. It's the number one capital allocation to Amgen. We intend on continuing to do that. We intend on continuing to interrogate these four therapeutic areas. We talked about the BiTE platform, and we talked about what we're doing with UPLIZNA. We talked about rare disease. We've invested behind innovation. We're going to continue to do that.
Maybe that's a good segue into some certain disease area questions I have. You just mentioned R&D spend kicking up 20% this year. Part of that is spending on obesity and the trials that you guys are beginning. Then there's just underlying inflation too in R&D. I was talking to an executive yesterday from one of the companies who said that they were really battling just underlying inflationary pressures over the last year or year and a half. My question, one of the questions I have is, as you think about broadening MariTide, we know what the R&D spend looks like in 2025 per your guidance. How should we think about that as you go forward in 2026? Because you guys have articulated running a broad development program, rule of thumb, those are $100 million trials. You run 10 trials. That's $1 billion.
That's a lot of incremental R&D spend coming into the organization.
Let me spend a moment because I think, Tim, that gives me an opportunity to speak to a moment to our operating margin. We've said all along at Amgen, I've been in the seat five and a half years, that if we can generate after-tax cash flows for our shareholders in excess of our hurdle rates, that's what we want to accomplish. If there are times we need to flex that operating margin objective, which those of you who are familiar with Amgen, and I hope all of you are, and we want you to be, we generally shoot for about a 50% operating margin. We were there for 10 years or so. We flexed it last year. We dropped down to about 47%. This year, we've guided to about a 46% margin.
Incorporated into that, as we said at our first quarter earnings call, is this increase in research and development of about 20% year- over- year. We call it earning the flex. When we do flex down below that, we want to make sure we're earning it. We are fortunate right now as a company, but we're fortunate on behalf of patients to be able to have some late-stage pipeline activities that demands investment to make sure that we get those trials done. We're focused on that. We're going to invest that money. We've given you numbers and guidance for 2025.
We do not go beyond that, but we are going to make sure that these trials get done in a way that satisfies Jay as our head of research and development and that we investigate these as deeply as we possibly can to make sure we get them done as quickly as possible and get the medicines out to patients. Operating margin is something we think about. We use that as a guide. We have given you specifics on 2025. We do not go beyond that generally. I can tell you we are committed to doing what it takes to move this forward and create the after-tax cash flows for our shareholders above our hurdle rate that makes sense as we create these and investigate these medicines for patients.
Peter, if I could just ask.
Jump in, Justin, please.
Yeah. I think something that's maybe not totally obvious from the outside is the really strong culture of productivity and efficiency that's built into the company. Amgen was running at an operating margin in the high 30s, and we actually brought that to over 50%. A large part of that was a company-wide effort to really just take a fresh look at how we do everything soup to nuts. In terms of your comment about underlying inflationary pressures and just how do you find the room to spend, I wanted the folks to be reassured that that's an ongoing effort at the company to make sure we're doing everything as efficiently as possible.
Maybe Tim on inflation, because I actually think that's an important point. I would remind our colleagues that when we constructed both Ohio and North Carolina, it was in the midst of COVID. And the high inflation year was at 22, Justin?
Yeah.
Yeah, 2022. We went right through that. We were on budget, on time. We have a very strong global sourcing group. We play hard. We want to make sure we get in front of inflation and we stay in front of it. We cannot do it forever. Sure, we can play hard, create productivity, use technology and artificial intelligence as best we can to make sure that we are stretching our shareholders' dollars as best we possibly can. Inflation is, we watch it carefully.
Jay, some questions for you. Data coming up at ADA. There's a widely held view in the street. I'm sure you've heard it that the nausea and vomiting rates and the tolerability that we're going to see out of this data set coming up, there's not going to look pristine. You guys have modified dosing for phase III. Kind of who cares what the phase II shows in a way because you might be able to change it in phase III and improve upon that. What do you want to say about the data coming up? Just kind of related to that, mechanistically, obviously, your compound is a GIP antagonist. Lilly's is a GIP agonist. Lilly talked about GIP agonism as one of the things that makes their drug more tolerable than Wegovy, PureGrip One.
As an antagonist, is that something that's a structural thing to consider with MariTide? In your view, does GIP agonism or antagonism play a role in tolerability?
Thanks, Tim. There are three aspects to your question then. One is quite mechanistic. One concerns the ADA. Another is just how we're thinking about the program in phase III clinical investigation. We indeed have two chronic weight management phase III clinical trials open and enrolling very well for MariTide, one with diabetes and one without. I'll take the mechanistic question first because I think it lays the groundwork for what would come next. The pharmacology, the genetics, and the biology of this pathway are very, very, very well mapped out. This isn't sort of an emerging area of research. It's an old one. Still, as you cited in your question, there can be learnings from different medicines in different settings. We've undertaken with MariTide to inhibit the GIP receptor because of experiments of nature.
It turns out that there are genetic polymorphisms, variations amongst all of us. If you're so lucky as to have one mutation that decreases activity through that pathway, expression of that receptor and its activity, you're protected from obesity, where you might know a leading human genetics group with our Amgen Decode Genetics facility in Reykjavik and all. We chose to inhibit GIP because experiments of nature, human genetics pulled us to. I think this is playing out quite favorably with respect to the remarkable efficacy that we saw from MariTide in the phase II clinical trial with almost approximately 20% weight loss in only 52 weeks without a weight loss plateau in that phase II study. You ask about tolerability, though.
We believe firmly that MariTide will be very well tolerated in the context of the phase III study because there's been, number one, incredible learnings from the field. People have been tinkering with GLP-1 agonism, the other pharmacologic activity of MariTide, for a very long time. Low index dosing, careful dose titration, guided by clinical investigation and the human experience. We've applied all of those principles and have arrived at a phase III dose escalation plan that will onboard this medicine to patients, we think, in a very well-tolerated and competitive manner. Now back to your mechanistic question because I find it so interesting. There is data from just this week that shine a light on that. Recently, at the European Congress for Obesity, the SURMOUNT-5 study was presented. I'm sure you followed this announcement.
I believe it was Monday, Spain time, midday, where semaglutide and tirzepatide were studied head-to-head. Semaglutide, pure GLP-1 agonist, no other activity. Tirzepatide, GLP-1 agonist that also can agonize or activate the GIP receptor, the opposite of what we're doing. Nausea rates between the two medicines, identical, 44%. It does remain to be seen, I believe, whether GIP agonism influences nausea at all. It made us feel, I think, pretty confident and maybe even a little validated that the choice that we've taken around GIP inhibition and GLP-1 agonism makes for a well-informed, genetically validated approach to obesity. As you point out, we're in phase III now. Does phase II matter? It matters insofar as it helps to explain the choices that we've taken going into phase III. There's been understandably a lot of interest in our phase II study.
Regarding the ADA meeting, the American Diabetes Association meeting that's coming up in a couple of months, we will, in a series of presentations at ADA, through the lens, interestingly enough, of external opinion leaders and experienced obesity clinicians, have a chance to provide the underlying details regarding our phase II chronic weight management study out to 52 weeks in part 1 of that trial, as well as some insights from our phase I dose escalation study that have both informed our phase III design. I think that when these presentations are received, there'll be a lot of interest in all the arms of the study.
We have already shared all the salient aspects of that through a call in the fall that the molecule delivers competitive weight loss, medically important weight loss all the way through 52 weeks without plateau, that dose escalation arrives at target doses that are very well tolerated throughout the calendar year. This actually could also be differentiating. The SURMOUNT-5 supplemental data shows a Manhattan plot of nausea and vomiting, which really is peppered throughout the 52-week experience with weekly injections. We did not see this with MariTide. Furthermore, the outstanding response with hemoglobin A1C in patients with diabetes, as well as the strong suppression of inflammatory markers like hs-CRP. We look forward to sharing some of these underlying data. From my perspective, we've already shared all the actionable information that led to the phase III design of the two open studies.
Just as more of a business development question, in my opinion, if you're not Novo or Lilly and you're trying to enter the space, it's hard to be a single asset company. I think a company would want to have a portfolio of products. You guys have a main asset now in phase III. It's MariTide. What is the company's view on hustling and trying to get another late-stage asset? There are compounds out there that are deep in phase II, that are pre-phase III. There are other mechanisms out there. What is the view towards fleshing out the late-stage portfolio fairly near term? Also, just Amlin as a target.
Maybe Jay.
You want to start?
Yeah, I'll start. Jay will address the substance of that, Tim, in terms of the strategy around it. Amgen's always open for business and business development. Our apertures are always open wide. We're looking for opportunity, structurally agnostic. Certainly, obesity is a critical issue. It's an unmet need around the world. We're focused on it. As we set off our first quarter call, we expect to get back to our pre-horizon capital structure by the end of the year. We're looking forward to continuing to execute on business development. We continue to look at it. We always believe we need to have an opinion on anything out there that's available in any one of our four therapeutic areas in particular. I just want to make it clear. We're there. We're looking. We're active.
With that, I'll turn it back to Jay to speak specifically about what the platform's like in obesity.
Yeah. I'll be efficient. First, this medicine, we have this medicine, this differentiated and unique medicine because we've been studying metabolism and focus on obesity for decades. If you get to know Muriel Vignon, who leads this group at Amgen, she's been working on obesity long before it was fashionable. Second, to reframe your question, is there a need for a second wave of obesity or weight management medicines? I actually believe that there is. For whatever reason, and there are I think several, at the end of a calendar year, only 30%-40% of people who started weekly injectable therapies remain on those medicines. And we're not reaching the majority of patients who stand to benefit from these drugs.
There is an apparent disconnect between the efficacy we know we can deliver to patients suffering from obesity and its related conditions and drug effectiveness, the public health benefit that we can deliver to society. Here, MariTide fits in not as a singularity, but as one of several medicines that we've innovated at Amgen to address the most common killers of humans in the world with cardiovascular disease. Think of Repatha for PCSK9. Think of Olpasiran for Lp(a). Now think of MariTide. These are three independent modifiable cardiovascular risk factors: LDL-C, Lp(a), obesity, and its related conditions and circumstances. Actually, this is a portfolio play. Within obesity itself, as you've asked, we are very active with internal innovation. We have seen and have an opinion on everything on the outside in external innovation. What we're not interested in is a participation trophy.
We're not interested in another weekly injectable. We're not interested in a mechanistically distinct but comparably inaccessible or challenging medicine. To take your analogy of skates where the puck is going, I quite like that, having started to play hockey five years ago myself. I do believe that there are now.
We're not looking at this stuff, by the way.
I do believe there are novel mechanisms with strong genetic validation for which there is no index chemical matter. We are interested in that. Secondarily, leveraging this platform we have, we are the only biopharma pursuing this peptide antibody conjugate scaffold. This platform allows for monthly or maybe even less frequent dosing. As you know, in part 2, the second 52 weeks of our phase II study, which is ongoing right now, on that trial, we are exploring even quarterly dosing of MariTide in a maintenance fashion. We see a differentiated strategy with internal, and we are open, of course, to external innovation, as Pete said.
Okay. Shifting to something else in cardiovascular, Olpasiran. Just level of confidence in this mechanism. I know what the epidemiologic data shows, but there still is not yet a 4S moment that really nails the mechanism in terms of proves that pharmacologically lowering is going to lead to event reduction. If you think about the riskiness of phase III, whether SIRS or Novartis is high risk, medium risk, low risk?
I'd like to answer your question in two ways. The kind of doctor and scientist in me has very high confidence in this mechanism, very high. The human genetics have spoken. The 20% of us in this room right now that are so unfortunate as to have a genetically defined elevation of Lp(a), for which there can be no lifestyle modification, no pharmacologic intervention, no action we can take to reduce this inflammatory atherogenic lipoparticle, we are living with a risk that's unmodifiable. Enter Olpasiran, quarterly dosed, siRNA, surgically precise, hits just the one gene product, dramatically decreases synthesis in the liver to less than 5% residual Lp(a). This is the very molecule and the very study, Ocean A, in 7,297 patients with elevated Lp(a), for secondary prevention in cardiovascular disease. It's the very molecule and the very study to answer this question.
Scientifically and medically, everything we've learned from genetically defined targets carried into clinical investigation, this molecule should work. As a drug developer, I have also learned to approach late-stage drug development with equipoise and to understand that despite all of our leanings, we have to adopt probability of technical and regulatory success based on the stage of drug development. I have two minds about it, but I do feel very confident that the experiment that we're performing will be the definitive test of this hypothesis. I feel good about it.
If I had to put a word in your mouth, medium risk.
I joined Amgen because I'm crazy about Olpasiran. Yeah, it is what it is. Late-stage clinical investigation comes with a 60% probability of technical and regulatory success that is increased with human genetic evidence. Some would say by as much as twofold, looking at broad literature. And here we have very strong genetic evidence.
One last question, [some more] . You guys bring it up. You guys have talked about what your long-term vision is from a revenue perspective. The street's actually quite a bit below that. It does not seem like you guys get a lot of credit. Pavblu, you're in the market as the only seller against EYLEA. And U.S. EYLEA is $6 billion last year. You're the only seller priced at the end of 2026. How is that not a pretty meaningful tailwind to numbers in 2025 and in 2026?
Hey, Justin, you haven't spoken up yet. You're a biosimilars fan.
Yeah, I know we're out of time, so I'll just be brief in the answer. I think on Pavblu, we're very pleased with the launch so far. As you know, we've got good uptake. We're in the privileged position to be one of one. We're just going to keep at it with our efforts there. I think more generally, what's maybe underappreciated is the portfolio effect. It's true that any individual biosimilar will launch, and then you can face further competition and price erosion. On the other hand, with these waves of launches that build on each other, in aggregate, it's actually quite a healthy business. We feel really good about the biosimilars, Pavblu, and the rest.
Great. Okay. We are going to stop it there. We are out of time. Thanks so much for Peter, Jay, and Justin and Amgen for showing up at our conference this year.
Thank you. It's great to be with you.
Thanks.