Great. Good morning, everyone. Thank you so much for joining us. I'm really pleased to have with us the Amgen team today. Next to me is Jay Bradner, Head of R&D, Justin Claeys, Head of IR, and Peter Griffith, CFO, and Salveen Richter uncover the biotechnology sector. Thank you for joining us. To start here.
Could you maybe, Peter, could start with a few opening comments if that works?
Peter, turning it over to you.
Thank you so much.
Salveen, thank you. It is great to be here. It is great to see you and the Goldman team. We always appreciate the invitation. Look, good morning and thank all of you for being with us today. With the first half of 2025 nearly over, which I think is surprising to all of us, we are encouraged by the momentum we have built across the business. First quarter revenues grew 9% and non-GAAP EPS increased 24% year over year, supported by strong performance across the portfolio with 14 products delivering double-digit growth in the first quarter. Let me highlight key drivers across the in-market products and also across the rapidly advancing pipeline. Let us start with general medicine. Repatha is now a multi-billion-dollar run rate with Q1 2025 revenue up 27% to $665 million. Excuse me, $656 million.
Cardiovascular disease remains the leading cause of mortality worldwide, and we see continued robust growth for Repatha, supported by broad access and growing adoption in both primary care and cardiology. Bone Builder Evenity also delivered in the first quarter with revenue up 29% year over year. Despite its strong growth, more than 90% of very high-risk postmenopausal women remain untreated for osteoporosis, highlighting substantial remaining opportunity for impact. In terms of the pipeline in general medicine, our two phase three studies for MariTide in chronic weight management are initiated and rapidly enrolling. We are looking forward to the phase three readout from Repatha's Vesalius cardiovascular study in the second half of the year, evaluating primary prevention in high-risk patients. Olpasiran is progressing in a fully enrolled phase three outcomes trial for secondary prevention in patients with elevated Lp(a). Let's turn over to rare disease.
We recently launched Euplisna as the first FDA-approved therapy for IgG4-related disease, and we're preparing for December 14th PDUFA date in generalized myasthenia gravis. We had over $1 billion in product sales in the first quarter in our rare disease portfolio. Please keep in mind the four major products in our rare disease portfolio are earlier in their life cycle. Now let's look at inflammation. Tezspire in severe uncontrolled asthma was up 65% year over year in the first quarter. We're advancing Tezspire in additional indications with a PDUFA date in October in Chronic Rhinosinusitis with Nasal Polyps and phase three studies now enrolling patients in both COPD and eosinophilic esophagitis. Now let's go to oncology. Specific T-cell engager platform continues to advance much to the benefits of patients.
We began this journey with Blincyto, our first approved T-cell engager therapy, which has transformed the treatment landscape in B-cell acute lymphoblastic leukemia and delivered 52% year over year growth in the first quarter of 2025. Building on that foundation, we recently presented compelling phase three data for Tarlatamab at ASCO, showing a 40% reduction in the risk of death and extended median overall survival by more than five months compared to standard of care chemotherapy in relapsed small cell lung cancer. These data support the potential for Tarlatamab to redefine standard of care in second line small cell lung cancer. We are also progressing Tarlatamab into earlier lines of small cell lung cancer and continue to expand the T-cell engager platform with Xaluridomig in advanced prostate cancer. Finally, in oncology, we look forward to two phase three readouts this year for Bemarituzumab in gastric cancer.
Biosimilars portfolio continues to do well. A very important contributor to our business generated $735 million in product sales in the first quarter, up 35% year over year. Recent U.S. launches, including Pavlu, Wezlana, and Vikembi, are performing well. We are advancing the next wave of biosimilars, including against the innovators Keytruda, Opdivo, and Ocrevus, now all in phase three. Just finally, we know we are all focused on the policy and macro environment. We are closely tracking developments related to tariffs, taxes, and pricing. We are not going to speculate on specific outcomes. We continue to engage with policymakers and advocate for a policy environment that fosters innovation, access, and sustainable research and development investment, which we believe are critical to addressing the needs of patients globally. The world needs a lot more innovation, not less.
We know there's a lot of interest in the upcoming ADA meeting, so let me turn it over to Jay for a couple of brief comments on that. We'll flip it back over to you for Q&A, Salveen.
Thank you.
Sure. Thank you, Peter. In terms of the MariTide data at the American Diabetes Association meeting a little bit later this month, you'll be hearing about the underlying details to part one of the phase two study, along with some additional data from the phase one pharmacokinetic low-dose initiation study. As a reminder, this second study characterized dose escalation at even lower starting doses, where we observed substantial improvements in tolerability to MariTide. The ADA discussion of these data will be split into two parts. First, there will be a session for an hour and a half on Monday afternoon, June 23, with key opinion leaders, experts in the field of metabolism and obesity. This will be followed by a company-sponsored virtual call with the investment community, where we'll have a chance to recap the important findings as well as take questions thereafter.
Salveen, we'll turn it over to you.
Great. Thank you so much for the overview here. Peter, to start, you touched on the businesses, but help us understand what your key priorities are for the company today and what the forward strategy is.
Sure. Thank you, Salveen. I'd say number one, the key strategy for Amgen, we feel like our strategy is going very well. Our strategy right now is execution, and we are focused on execution both in the in-market portfolio and in our rapidly advancing pipeline, a laser focus right now. Let's just think about what we have going on. You asked the question on the fourth quarter call about what are the growth drivers. Growth drivers in the market, Repatha, we talked about that, Evenity, Tezspire, then the innovative oncology portfolio, up 10% in the first quarter year over year, includes Linzido, as I mentioned, up 52% year over year. Into Rare. Rare was up over $1 billion in the first quarter. Euplisna, Tabneos, and Krystexxa continue to be strong. We're optimistic about Tepezza too.
We think our expansion and the sales force and working hard with general ophthalmologists and with endocrinologists to penetrate that highly unpenetrated market. I mean, 20,000 patients or so in the United States we think that are acute, 20,000 that are chronic according to their clinical activity score, the CAHS. We're becoming optimistic about our belief that we can penetrate that in a thoughtful way. Rare, we really like that Rare business. Of course, Euplisna. It's great to be in IgG4 with a PDUFA date also in generalized myasthenia gravis. Then we turn over into, excuse me, into inflammation, Tezspire again, up 65% in the quarter. We really see that as a great opportunity to explore and continue in those indications in COPD and continuing into the chronic rhinosinusitis with eosinophilic esophagitis.
We think Tezspire, as well as Euplisna, represent opportunities far beyond just the one product and the one indication, so to speak, pipelines in a product, so to speak, with both of those. We think those are very strong. Biosimilars, that continues to execute. We had the six we talked about, Repatha, Evenity, Tezspire, innovative oncology, Rare, and strengthen the biosimilars, and more coming there. We are focused on that from an execution standpoint. You will certainly explore the pipeline with Jay. Of course, that all goes in addition to MariTide in general medicine, which we continue to allocate capital to. We continue to expand capacity. We have state-of-the-art manufacturing. We continue to work on and expand throughout our network system. We announced another $1 billion this year in North Carolina for a second drug substance plant.
We announced another $900 million into Ohio for a second finished drug product plant. We're sitting on a CapEx guide of $2.3 billion this year. We're allocating capital behind our volume increase, which includes MariTide. A lot of activity going on. I've had an opportunity to visit our facilities recently throughout the United States. The capacity increases are going very, very well. We continue to be very focused on yield management too and the science of manufacturing and how do we do that. Because if we can improve the yields, then that means it's less bricks, mortar, and dirt that we have to use. We can utilize that in terms of our volume growth. We continue to be very focused on what we're doing around the world too. All in all, the strategy set, we're focused on execution.
We're very excited about the innovation we have coming. That always is capital allocation priority number one at Amgen and it'll always stay that way.
Maybe two follow-ups here. One is you'll be at pre-Horizon debt levels in the second half of the year. How important is BD to you as a lever, be it sizable deals or just doing maybe collaborations and in-licenses as you've always done. Secondly, you also touched on some of the discussions that are playing out around tariffs and drug pricing policy here. How are you as a company communicating with the administration, but also kind of positioning yourself around these various scenarios should they play out?
Sure. First on business development. We always expect ourselves to have that aperture open, looking at all opportunities. Number one, capital allocation, best innovation, internal and external. So aperture is always open. We look at all sizes. We look at all shapes. We look for structurally agnostic, as you mentioned, collaborations, licensing, partnerships, mergers and acquisitions. We expect to have an opinion on all of that. As you so importantly note, we've been focused on returning to the pre-acquisition capital structure by the end of this year. We've now paid down about $10.8 billion of debt since we announced that transaction, which is about what we said we would pay down. We expect to be right where we wanted to be and what we indicated to our investors, to where we indicated to our investors we would be by the end of this year.
We feel good about that. If opportunities come around, we'll certainly engage in them. Jay is very active with our business development group, with our commercial group, making sure that we continue to secure the best innovation, whether external or internal. Now, flipping over kind of to the other side of the world, how are we engaging with policymakers? I would share with you, I think most of you who know us know we're always engaged with policymakers and we always have been. We want to be able to shape that story for innovation. We want to be able to shape it for patients, for access, for value for patients. There is really no change in how we approach that. We certainly are making sure we're swinging by and seeing the policymakers and speaking directly to them.
I was in Washington, D.C. last week expressing our advocacy for patients and how we want them to have that access and value, how we want more innovation. We want to make sure that from a research and development standpoint, not just Amgen, but the industry continues to be the leader in the world. That is very, very important to us. You asked about how are we running scenarios. Are we thinking about that? We are Amgen. We expect a lot out of ourselves. We want to be prepared. We want to be on the balls of our feet. We are there all the time. We want to make sure we have the capital to allocate to innovation so that Jay and the team continue to come up with innovative, first-in-class and best-in-class medicines for patients in the United States and all around the world.
That's how we're approaching that right now. We shared with you that we've baked into our thinking this year, enacted and implemented tariffs. We're not going to speculate beyond that. We are looking at what's happening on a tax standpoint. We're reasonably optimistic that it'll be neutral to maybe just slightly negative, but we'll see. We always think through that very carefully. Going forward, we'll keep our eyes and ears open and make sure we're doing everything we need to do to consider what's happening out there in the environment and do a great job at making sure we keep our margins healthy, as healthy as we can. If we need to flex them a little bit to provide a little bit more capital into innovation, we'll share with you and all of our investors where we are there.
We guided to about a 46% operating margin this year, down from 47% last year, but that's due to great opportunities in the pipeline and research and development. It is a longer answer maybe than you wanted, but we're excited about the business. We're okay taking anything on out there in the environment, and we think we can take it on as well as anyone. It is always patients first at Amgen.
Thank you. Jay, maybe jumping into MariTide here with the presentation at the American Diabetes Association. It's going to be the first time that we see full data after your top-line phase two presentation. Maybe help us understand in a 90-minute presentation what we should hope to better understand about the profile of this drug.
Thanks, Salveen. For sure, we've already had a chance to share last fall the most salient and directional insights from the part one of the phase two MariTide chronic weight management study. You'll recall this is a large 592-patient phase two study that sought to characterize the effect of MariTide with a monthly or less frequent dosing. We have an every eight-week regimen in there as well, over 52 weeks. That study continues with part two that we'll share data. We intend to share data later this year.
At the ADA meeting, we'll have a chance to go beyond the most directional observations, which we've already shared, that the medicine confers quite clinically meaningful and competitive weight loss of approximately 20%, that performs very well even in the very difficult diabetic population, that delivers very strong efficacy against the Cardiometabolic Parameters that read through, hopefully, to the other serious diseases that track with obesity. The MariTide with dose escalation and low starting doses is very well tolerated. In fact, over the period of these 52 weeks that patients were on drug in part one of the study, after the initial dose escalation phase, tolerability was outstanding. We've shared all of these insights. These are the insights and the dose ranging data that helps us craft, define, draft, and now enroll and open our phase three studies of chronic weight management.
At the ADA meeting, we'll have a chance to unpack additional data from the other arms, the arms that do not feature dose escalation, discussion in more detail on some of these Cardiometabolic Parameters, as well as a mechanistic consideration that is emerging around why inhibition of the GIP receptor proves to be so important. We look forward to sharing the part one insights at the ADA.
Jay, if I could just reiterate the comments you made in your prepared remarks, that 90-minute session will be actually led by key opinion leaders as part of a continuing medical education session, and then there'll be a company-sponsored event after that. We think it'll be informative for investors to hear directly from KOLs on how they view the data also.
Will there be additional information on the Amgen-sponsored call post the KOL?
Just to reiterate what Jay said earlier, it's really more just our summarization of what we shared in the 90-minute session and a chance to take Q&A and for folks to hear from us directly.
It seems when we speak with physicians that there's clearly an interest in further understanding the profile, one from the tolerability standpoint and recognizing that it is a first dose dynamic and seeing how you're able to manage through with titration on the front end. Then secondly, fully understanding the maintenance aspect here. When do you think between this data read and then the presentations in the second half of the year or beyond, we'll be able to fully see that profile emerge to kind of, I guess, reflect that or kind of understand the phase three dynamic in the context of that?
We're in phase three clinical investigation now, and so we'll have a chance to really see the optimized dose escalation and target doses at work when we read out that trial. There will be additional insights for sure at the ADA that help to shape and frame and really underscore these observations that we have made, which can come as no surprise that lower initial dosing and stepwise dose escalation improve the tolerability, honestly, of all GLP-1 receptor agonist-containing medicines. We will read out additional data from our phase two study in type 2 diabetes. There will be some insights there. The rubber meets the road in phase three, and the study is underway. There's intense demand for participation on this trial, and we're seeing excellent enrollment, which I think belies the residual and significant unmet need even with incumbent medicines.
In discussing the outlook for the obesity market, you've often pointed to patient heterogeneity and market segmentation. In this context, where do you think you could position MariTide and see the most commercial success?
I could start on the properties of the medicine, and then Justin, perhaps you could fill in on the commercial positioning. We intend MariTide to be a medicine for both the initiation of chronic weight management therapy as well as for maintenance, and it really has a chance to shine in both. We see progressive and actually very steady weight loss throughout the first calendar year without a weight loss plateau. This is what clinicians really want, is to treat a patient, have them come back to clinic, and their weight is improving without radical excursions of their weight. Second, the flexibility with monthly dosing, the convenience. This will read through to persistence on the medicine we perceive. The recent real-world study was just published this week looking at two incumbent medicines and adherence and persistence and compliance, all integrated together in the real world.
Maybe 50%-60% of patients remain on those excellent therapies at the end of a calendar year. Are they hard to access? Are they not well tolerated through the maintenance phase? There could be many reasons why. We think this is a particular attribute of a monthly or even less frequently dosed medicine. As I shared, we have Q8- week data to share with the community in part one and in part two, which is really more of our maintenance second year of therapy. We're even exploring Q12- week or quarterly dosing, combined with a very competitive profile in Cardiometabolic Parameters. Here, we're talking about reductions of LDL-C, double-digit reductions in systolic blood pressure, improvements in HbA1c , an absolute percentage point of 2.2 in the diabetic population, as well as significant reductions in HSCRP.
These are validated biomarkers in all of the serious and chronic diseases that to benefit, you need to be on therapy a long time. Building a medicine for long-term well-tolerated use that can deliver outstanding efficacy is really coming through with the MariTide program. Justin.
Yeah, I would just make three points on the commercial positioning and opportunity there. I think the first one is that this is, as you pointed out, Salveen, a really unique situation with how large and under-penetrated the overall market is. By some estimates, you're talking about a billion people or more in the world who suffer from obesity or related conditions. It is really a unique situation in terms of the global public health crisis that comes with this and the fact that the penetration is just barely scratching the surface right now. I think the second point is, given the large population, given the heterogeneity, as you pointed out, there will definitely be room for multiple therapies and multiple modalities. We see room for injectables. We see room for orals in different mechanisms as well.
We certainly feel like physicians are looking for more tools in the tool belt. We're definitely getting positive feedback from the opinion leaders that we engage with. I think the third point is that we definitely see MariTide as being competitive and having a differentiated profile that can work in a number of different settings. Jay and the team are generating data and not just in one indication, but across a number of areas that will allow us to be competitive. As Jay pointed out, this is a different molecule. The unique formulation and the durable effect and the data that we continue to generate, we feel like it's going to allow MariTide to compete in a number of areas.
Just with regard to biomarkers for MariTide here, should we expect to see some of these at ADA, including CRP? I do have a question, Peter, about how you're thinking about, I mean, I know it's early days, but how you're thinking about the pricing model for obesity here or how that evolves over time.
First on the biomarkers, as I shared, we've already provided insights to the most salient efficacy and biomarker data that have shaped the phase three program. Additional underlying data, including biomarker data, will be presented at the ADA.
I think it's a little early, Salveen, for us to kind of think about pricing. We'll stay tuned on that. We've got a fantastic commercial group, as you know, and Susan Sweeney is heading our entire obesity effort. So we've got our finger on the pulse here. We'll watch it and see how that develops. I think to Justin's point, the heterogeneous approach to a lot of things involved in obesity, and we'll keep watching it and do what's best for patients and do what's best for shareholders too.
Yeah. Just wanted to jump into the cardiovascular vertical in a bigger way. You clearly have Repatha that's inflecting, and you're going to layer on top MariTide on top of this infrastructure. You do have olpasiran that's in trials now and fully enrolled in the phase three. When might we see initial data from this program, and how will you position this drug in your broader CV portfolio? Also just speak to the read-through that could play out from the Novartis study.
No, thank you. These are very top-of-mind considerations for us right now. Cardiovascular disease is an area of leadership for Amgen. Repatha is proving to be a really important medicine for patients worldwide who suffer from cardiovascular disease and can't achieve adequate LDL-C control. This experience of bringing cardiovascular outcomes, secondary prevention medicine to the marketplace worldwide is a great platform for us to expand our impact and create more value. We'll read out the Vesalius CV primary prevention study. That will be a very exciting moment. I do hope and expect that hypothesis to read through. Regarding olpasiran, which is this next batter up, this is a very exciting medicine. Olpasiran has truly best-in-class characteristics. In our line of work, people throw that term around a lot.
Here, it's unambiguously true that this subcutaneously injectable siRNA that traffics to the liver and shuts down the expression of one of the known and validated remaining cardiovascular risk factors, lipoprotein(a), Lp(a), and an inflammatory lipoprotein, atherogenic lipoprotein, to greater than 95%. Our nearest competitor, Novartis, as you mentioned, about 80% reduction. Our medicine's given every 12 weeks or quarterly versus a more frequent route of schedule of administration with Novartis. Still, we're very interested to see directionally what Novartis will show from their secondary prevention study that I believe the readout was pushed back into the next calendar year. We as well will read out, expect to read out our secondary prevention Lp(a) study next year as well. These data, I think we'll be particularly interested to observe the overall risk reduction. I think that's what everybody's excited about seeing, myself as well.
It is a validated hypothesis at the genetic level where a fifth of people, one out of five of us in this room here today, have elevated Lp(a). You can't eat better. You can't exercise more. You can't take a statin and make that go down adequately. These gene-targeted therapies, these truly targeted therapies, I think can usher in a new dimension of targeted treatment for cardiovascular disease. Following on behind Repatha and then olpasiran, we have an opportunity with MariTide, not just in chronic weight management, but in atherosclerotic cardiovascular disease, heart failure, kidney disease that comes with so many of the comorbid conditions, and, and, and. I believe that at Amgen, we're a leader in the field of cardiovascular medicine and intend to be for many years to come.
If I could just add one point on the timing of the phase three readout, we know there's quite a lot of interest there. If you look on clinicaltrials.gov, you'll see a date of December 2026. That was the initial estimate when the study started. As Jay mentioned, it's an event-driven trial, and as we accrue events over time, we'll get a better sense of that. I would say probably stay tuned on the date. That's obviously an initial estimate that you could update in the future.
Great. You also have the Euplisna approval recently in IgG4-related disease, as well as an upcoming approval for myasthenia gravis potentially. Help us understand how big these commercial opportunities are for your drugs and where you will position the MG drug in that competitive landscape.
Yeah, I think I take that one, Salveen. On IgG4, first, just to remind, the data were phenomenal. Hazard ratio of 0.13, so 87% reduction in the risk there. We are very excited to bring that to market and to patients. That recently launched. One thing to note is we've estimated the patient size at 20,000, but to be honest, that diagnosis and even the diagnosis code has only been around for just a few years. Probably more to learn as we better engage with the community and those patients, but so far, so good on the launch. In terms of myasthenia gravis, again, we thought the data were fantastic. Key points to note, you have two doses upfront and then every six months after that. That is a very different durable profile versus other offerings on the market today.
You also have the benefit of the steroid tapering that was built into the trial design. In a real-world setting, when you think about very strong efficacy that grows over time, every six-month dosing, steroid tapering, we think that's a really strong offering for patients. We're excited to get that one to market.
Great. Last question for you, Jay. You have a very broad pipeline here. Is there anything else that you want to highlight that we did not discuss?
Oh, boy. We have incredible strength in line as well as in the pipeline across all four of our pillars. As we did not have a chance to speak significantly about the cancer pipeline, and I am a cancer guy, cancer doctor, I would just remind that this T-cell engager platform, through all of the hype cycles associated with alternative approaches, cell therapies and the like, this T-cell engager platform is reading through to real profound improvements in overall survival in common cancers. We should not lose sight of the potential of these first three medicines, blinatumomab, which marched right to frontline therapy in acute lymphoblastic leukemia and becomes, in my opinion, as a blood cancer doctor, an appropriate standard medicine now in the core treatment of acute lymphoblastic leukemia.
At ASCO, just a couple of weeks ago, a week ago, we had a chance to share data from the second-line small cell lung carcinoma study with Imdeltra, the DLL3 targeting CD3 bispecific antibody. Directionally, when you see a medicine work in third line and then it marches forward to second line and defeats head-to-head standard of care chemotherapy and wins not only with five months of median overall survival, but also wins on grade 3 treatment emergent adverse events, wins on efficacy and tolerability, hopefully this becomes an expected standard for these patients who many of them don't live long enough to get to third line to see a medicine like this. It is indeed already improved after platinum-containing frontline therapy. Time can't move fast enough now as we're studying Imdeltra in frontline treatment of extensive stage and limited stage small cell lung cancer.
Lastly, our SEEP1 bispecific, CD3 bispecific for prostate cancer. This story is shaping up very, very nicely. We've already shared very meaningful responses with a high proportional response rate in metastatic castrate-resistant prostate cancer. Just following the same mantra of working in relapse disease, moving to second line, moving to frontline, indeed, we've already opened neoadjuvant studies of this medicine, anticipating and expecting that its value can be much greater to patients the earlier it's used and used in combination. More to watch and look out for in the CD3 bispecific platform, which remains a very important and active platform within Amgen Research.
Great. With that, thank you so much.
Thank you, Salveen. Thank you.