Good morning. Thank you for joining us. It's my pleasure to introduce the Amgen team. With us, we have Peter Griffith, Chief Financial Officer, Murdo Gordon, Head of Global Commercial Operations, Andrew Martin, Head of U.S. Business Operations, and Casey Capparelli, Head of Investor Relations. With that, I'm going to turn it over to you, Peter, for some opening remarks.
Great. Thank you, Salveen. Good morning, everyone. Salveen, congratulations on that Knicks win last night. I understand you're now one of the top Knicks fans around. Good. Well, we will be too today when we're with you. It's great to be here. We appreciate your interest in Amgen. I wanted to share a few thoughts before we get into the Q&A session. I think most importantly, we believe there are lots of ways to win for Amgen, especially for patients. We're pleased with our strong first quarter performance, which reinforces our view that 2026 is a springboard year for Amgen. It's a year in which we expect our rapidly growing products to offset the impact of increased competition for the denosumab franchise, and we saw that dynamic play out in the first quarter. Revenue increased 6% year-over-year.
Non-GAAP earnings per share were up 5% year-over-year, demonstrating the disciplined financial management that has long been a hallmark of Amgen. We had 16 products deliver double-digit or better sales growth, and 17 products now annualizing at more than $1 billion in product sales based on first quarter results. Importantly, our six key growth drivers, Repatha, EVENITY, TEZSPIRE, our innovative oncology portfolio, our rare disease portfolio, and our biosimilars portfolio, represented about 70% of product sales in the first quarter and grew 24% as a group year-over-year. We expect those growth drivers to continue supporting our performance through the end of the decade. Within oncology, IMDELLTRA now annualizing at more than $1 billion in sales and continues to establish itself as an important treatment option in small cell lung cancer.
Within rare disease, UPLIZNA continues to build momentum across NMOSD, IgG4-related disease, and generalized myasthenia gravis. We're very encouraged by the progress we're seeing across these franchises. Let's turn to the pipeline then. Confidence continues to build in MariTide as a potential new paradigm for the treatment of obesity, Type 2 diabetes, and obesity-related conditions. We're executing across the enterprise from clinical development to manufacturing as we advance MariTide's broad phase III program and continue to build and optimize manufacturing capacity ahead of launch. Our manufacturing preparations continue to progress well, and we believe MariTide has the potential to play a very important role across weight loss induction, long-term weight maintenance, and patients transitioning from weekly GLP-1 injections and therapies with the potential for as few as four to six injections per year based on our extended dosing. Our approach reflects how obesity care may evolve.
Patients need effective weight loss, but they also need practical and durable maintenance options. Again, that extended dosing should help meet patients with those unmet needs. Beyond MariTide, we have a robust phase III pipeline, including olpasiran for the reduction of cardiovascular risk in patients with elevated Lp(a), dazodalibep in Sjögren's disease, and xaluritamig in late-stage prostate cancer. Also exploring and investigating xaluritamig in earlier stage prostate cancer. We're investigating, as I said, xaluritamig in earlier stages of prostate cancer. In addition, we continue to pursue new indications for several approved products, including UPLIZNA in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy, TEZSPIRE in COPD and eosinophilic esophagitis, and IMDELLTRA in early stage small cell lung cancer. Salveen, let me just take a couple moments to provide some additional context around the tax dispute and litigation.
We believe some of the framing since our first quarter call overstates the potential cash impact. First, we firmly believe the IRS's proposed adjustments are without merit, and our tax reserves are appropriate. We haven't changed that position in the last four years. We will continue to vigorously defend our position as we have throughout this dispute with the Internal Revenue Service. Our position has been consistent, as I said, for many years and reflects the substantial value, capabilities, investments, risks, and contributions of our Puerto Rico operations. Puerto Rico is 220 acres or so, 1.7 million sq ft, and 2,500 colleagues, that many of them have technical degrees. It's a very, very important flagship operation manufacturing for us. Moving on to 2010 through 2015, the headline numbers from the IRS, they don't translate directly into cash exposure.
As we've said before, the proposed amounts include $2 billion in penalties that we believe are wholly unwarranted. We believe the IRS calculations contain approximately $2 billion in errors, and in addition, any potential payment would be reduced by up to $3.1 billion in repatriation taxes that have been previously accrued and paid. The last payment was actually last year of about $1.85 billion on repatriation taxes, and also reduced by $1.9 billion in cash deposits that we've already made with the IRS. In 2010 through 2015, which we don't believe. Proposed adjustment from the IRS and the potential incremental cash impact to Amgen. For 2016 through 2022, those years involve a different tax framework following U.S. tax reform, different tax rates beginning January 1, 2018 forward, lower differences.
In particular, any extrapolation that starts with the 2010 through 2015 year would need to account for the calculation errors that I previously mentioned, as well as those different tax rates and the repatriation tax payments already made. Let's get all that out of the way. Overall, we're executing against the plan we laid out for 2026. First quarter demonstrates that progress. Key growth drivers performing really well. We've got Murdo and Andrew with us today. I hope you'll explore that. That phase III pipeline continues to advance three new phase III programs with Mirati, a couple of extension or maintenance studies, plus a switch study that we've announced, and we're maintaining that rigorous financial discipline that we always do. Lots of ways to win with Amgen. We're very excited about the opportunities ahead for patients and for shareholders. With that, over to you.
Thank you for allowing me to share a few thoughts.
Thanks, Peter. One of the key investor debates for Amgen continues to center around the degree to which the company can offset the losses of exclusivity over the coming years. Walk us through, at a high level, the degree to which you believe that Amgen can execute on this front and continue to drive top-line growth with the current portfolio and pipeline.
Well, listen, let me flip it to Murdo and Andrew here real quickly. I just say, somebody asked us earlier this morning about what we said a number of years ago about the long-term growth prospects, and boy, we've hit those hard. Repatha continues to be a fantastic franchise. I'm sure you'll that exists. Primary and secondary prevention with Repatha, with EVENITY in the bone franchise and how well that's doing with our BiTE portfolio. Thank goodness for the BiTE portfolio in small cell lung cancer patients in IMDELLTRA. We're going to go earlier on IMDELLTRA. We think lower tumor burden early lends itself exceptionally well to the bispecific T-cell engagers. That's why we're promptly getting into xaluritamig and investigating that and investing behind that. There's lots of ways to win with Amgen. It's growing really, really well. Look, the first quarter is the evidence.
Look, we've got to continue to execute at Amgen, and we talk about execution excellence all the time, Salveen. Up 6% on the top, up 5% non-GAAP earnings per share in the first quarter. We expect it and we'll work really, really hard to earn that throughout 2026 and going forward. Let me turn it over to Murdo and Andrew because we're fortunate to have them with us today. I would just add that Andrew mentioned he's headed down to Puerto Rico because he hasn't had a chance to see those operations yet. I forgot to mention on Puerto Rico, I think we announced another $300 million going in there this year in investments. Last year, I think we announced about $650 million more going in down there.
Andrew and I had a chance to catch up, and I was just sharing with him, I've been down there a number of times. It's just a great experience to go down and see the commitment of our colleagues down there, 2,500 +, to creating medicines for people around the world. Murdo, Andrew, please.
I think you framed it well, Peter. We've got a nice story brewing at Amgen, given that we have a set of prioritized growth drivers, three large products with Repatha, EVENITY, TEZSPIRE, our innovative oncology portfolio, our rare disease portfolio, and of course, our biosimilars. That story of breadth and that focus on those durable growth drivers gives us a real opportunity to sustain the loss of exclusivities that we will face currently with cinacalcet and Otezla in Europe which a lot of people forget we lost exclusivity there. That business of growth drivers accounts for about 70% of our revenues in Q1 and is growing at 24% year-over-year. That durable portfolio of growth drivers will allow us to continue to grow through losses of exclusivity through our long range.
That's a nice place to be, and given the number of catalysts for additional growth in that set of growth drivers, we're in good shape. Andrew, as you see your business, what are you excited about there?
I'm excited about Repatha, IMDELLTRA, PAVBLU, and TEZSPIRE for me are the principal areas of excitement, and largely is a byproduct of the enormity of headroom available to us in each of those categories. If you start with Repatha, there's $100 million or more people globally with elevated LDL. About $50 million of those sit here in the U.S. Approximately one-fifth of those have their LDL today at levels expected as a result of the new ACC and AHA guidelines. PCSK9s have only penetrated about 10% or slightly less than that of that population. It makes clear the enormity of the opportunity in front of us. In fact, the momentum that we've created, we are confident is durable and will sustain through the end of the decade for Repatha. Same story for IMDELLTRA.
We've clearly solidified ourselves as the standard of care in second-line treatment for small cell lung cancer. We frequently hear from oncologists that the durability of response and overall survival rate demonstrated in DeLLphi-304 have completely transformed the way oncologists think about the treatment of small cell lung cancer. The NCCN guidelines and excellence in execution in the field have allowed us to open up more than 1,800 sites of care across the country. Notably, half of those, or more than half of those are in the community setting, which means we're bringing access to IMDELLTRA closer to the patients and where they sit.
Last, I'll touch on EVENITY. EVENITY is an incredible growth story in a massively undertreated and under-penetrated category of osteoporosis. More than 2 million women in this country have been diagnosed with post-menopausal osteoporosis that are either at very high risk of fracture or high risk of fracture, and penetration of the anabolic into that cohort is less than 10%. Again, another reflection of the significant headroom we have and why we're so confident in our ability to grow through the loss of exclusivity for denosumab.
Thank you. Peter, you just spoke to the tax situation that's playing out with the IRS here, you've also noted that the 2010 to 2015 tax court decision is expected no earlier than the second half of this year. Walk us through the scenarios that could play out when that outcome does come.
Well, I think, Salveen, on that, I would just say we've consistently said that we have confidence in our reserves, and we have all along. We have confidence in our positions, especially after the tax court case itself, which ran from November of 2024 to January 2025. By the way, it's not unusual that tax courts is different court system, that it takes a long time to get a decision, because if we do the math, it might be around two years before we get a decision, give or take. I think it's important to think about that. All along we've said, we continue to have strong confidence where we're at, both in our reserves and in all the merit of what we have litigated with the IRS. We're going to stay right there. We look at our reserves every quarter. We think about those.
Our reserves include everything in them. We calculate both. The reserves are for everything in the company, not just the tax case with the IRS. They're for all jurisdictions, all tax issues and so forth. We're very thoughtful about that. We're very confident in the tax leadership of the company, and spent a lot of time on that. That's really where we sit on it. People ask, well, gee, does it perhaps preclude you from thinking about transactions? Does it somehow affect what we might call our dry powder, so to speak? I would just remind all our colleagues that in December of 2022, when we announced Horizon, that case was underway, and we worked through it with the bond holders. We had a $24 billion issuance of investment-grade debt, which at the time, I believe, was about the ninth largest issuance ever.
We had no issues there. We don't expect any. We've got plenty of powder to do what we need to do. We're going to vigorously defend this.
On the capital allocation strategy here. How are you prioritizing internal investments such as R&D and manufacturing scale-up versus business development opportunities in return to shareholders?
Thank you. The number one capital allocation priority at Amgen is to get to the best innovation, whether it's internal or external. We're agnostic. We understand we don't have a monopoly on the greatest innovation in the world. We also understand that our shareholders expect us to go out and find it, and if we do find it, we're looking for are we the best buyer? Are we the best licenser? Are we the best collaborator? Are we the best partner? In other words, when we model that up, what does Amgen specifically bring to that's accretive and additive? Number two, cash on cash returns in excess of our hurdle rates. Number three, do we have research in the area? Do we have science in the area that's proven?
We've found over the years that when we compare where we have science and where we have research to where we execute on transactions broadly defined, we actually perform better, and we get better returns. Finally, is it something we can integrate quickly? Because being a student of M&A in the capital markets, there's no question the data says faster the integration, the higher the return. Look at Horizon. That's what happened. We got after that quickly. That was a world-class integration by the entire enterprise at Amgen, and the results speak for themselves. We are so happy to be in rare disease today, when we went into it in a big way in December of 2022. I would just say internal is fantastic. We are working hard on the BiTEs. They're going really well. We'll continue to invest in MariTide.
That is an internal asset. We're backing that up. We'll have nine phase IIIs on that coming up here as soon as we're underway.
With three more after that.
With three more after that. We're going to get to a dozen. I said to Jay Bradner, I said, Jay, you need one more. We'll have a baker's dozen. We're going to invest behind that. Capital allocation. Let me tell you, this company's doing a great job. Rigorous financial discipline, 45%-46% operating margin guide this year, and we'll be up to 12 phase IIIs on MariTide. We've got phase III going on olpasiran . I think we got about 7,200 patients in there. We got xaluritamig going full speed in phase III for pre-taxane and post-taxane. We got a lot going on, companies exhibiting strong, rigorous financial discipline to reallocate back up into innovation. After that, in our capital allocation hierarchy, if I go down one more notch, we're investing in the business. $2.6 billion guide in CapEx this year.
We need the capacity to hit the volume requirements that Murdo and Andrew are creating through the opportunities they're getting as they get medicine to these patients. We'll continue to vigorously fund that. Last year, we put some money behind UPLIZNA and to the couple of new launches. We're excited. We've got capital to allocate. We're going to do it prudently, thoughtfully, and in a disciplined manner. The capital allocation hierarchy is not going to change.
Just given that you are at pre-Horizon debt levels here, how willing or interested are you in doing a similar size transaction? What are the therapeutic areas of focus right now for the company?
Well, I'll comment on size, but I think it's a great question for me to send over to Murdo. He and I and Jay and Rosh and I all work really closely together in BD, he's more articulate than I am on the specific areas, he's deep into them. In terms of size, look, our aperture is always open. It was open when Horizon showed up. We had thought about rare and Horizon well over a year before it showed up. We didn't know that it would become actionable. It became actionable, we were ready to go, we were able to execute and get it done. We're always ready to do whatever we need to do. Again, we go to that capital allocation hierarchy. Is it a company with innovation that we're excited about? Might be really small.
We'll go out and spend the time and invest in that. Might turn into a great opportunity. If it's of a different size and small, medium, large, we're agnostic on size, agnostic on structure. We'll do what we need to do if it's going to hit those four criteria I talked about for BD, we'll take a good look at it, if it benefits our patients and our shareholders, we'll get after it. Murdo should talk a little bit about where we're thinking in terms of the therapeutic areas and different opportunities there, too.
I think Peter's covered it really well. We look at areas of complementarity, whether that be in our research and development capabilities or in our commercial capabilities. If you look at the presence that we had in autoimmune from larger disease areas translated really well into rare disease when we looked at the Horizon transaction. As Peter said, we have a really well-honed process to integrate new organizations into Amgen and retain the talent as best we can when we do that. As you look forward, the strength here, we have a very nice growth plan now with the integration of a rare disease business with the products that Andrew mentioned and with our biosimilars portfolio. We can look at a long horizon at earlier opportunities. We can look at mid-stage or even late-stage development assets.
We're not looking to plug a big hole in revenues anywhere. We've got a nice growth story from the in-line portfolio and the mature late-phase pipeline that we have. We're looking in all therapeutic areas. We continue to see oncology, obesity, cardiovascular metabolics, rare disease, rare autoimmune, all as really exciting areas for us. We do look at everything. We have a large aperture when we look outside the company. We have an opinion on whatever may transact and whether or not we want to jump in.
Great. Murdo, jumping into the commercial portfolio here. UPLIZNA significantly outperformed in 1Q, driven by the launches in IgG4-mediated diseases and myasthenia gravis. Can you highlight how you're thinking about the key launch dynamics to date and the trajectory in both of these indications on the forward?
I'm glad you think it's outperforming. It's always interesting. That's in the eye of the beholder. Internally, we were excited about this asset when we did the acquisition, and obviously with positive data in IgG4, overwhelmingly positive data in IgG4-related disease, and then very strong data in the MINT trial in GMG. We see we have a differentiated product in both of those indications. Strong foundation in NMOSD, that continues to provide growth. IgG4-related disease, we're creating the market as we're satisfying it with the only FDA-approved agent there. That's hard when you're doing both, when there's no kind of existing big market where you have a relatively new ICD-10 diagnostic code, and you're creating awareness, and you're fulfilling that awareness. That's harder than going into GMG, where there's an established market with incumbent products. The growth outlook for IgG4 is very strong.
There's large headroom there. The numbers on epidemiology are a little fuzzy, but let's say between 30,000 and 40,000 patients that are eligible for treatment with UPLIZNA. It's a horrible disease. It goes undiagnosed. Physicians often are unaware as to what it is they're looking at. We're helping with diagnosis and awareness. We're helping patients activate, and that will be a good source of durable growth for the product. GMG, a little quicker, right? We're seeing good source of business coming in from bio-naive patients as well as switch patients. The switch patients are coming from multiple places, not just one specific product or product category. Very good launch so far. We did, as Peter mentioned, expand the field resources in both medical and commercial to be ready in advance of the GMG approval. That's helped, I think, as well, being ready.
We're looking at further investments to help activate more patients who are looking for improvements in their activities of daily living, despite being on treatment. We're helping build awareness of the convenience of UPLIZNA and its durable efficacy. Really exciting and a lot of headroom for growth still there.
How do you think the competitive dynamics will evolve with the entry of Regeneron C5?
I think the experience in complement inhibition in general has been mixed. We are sourcing business from the existing complement inhibitors, and we'll see what the Regeneron profile brings. I think given that we're highly differentiated in our mechanism and very convenient in how I really don't see that as a direct competitive threat for us. I think there's so much bio-naive and switch patient sourcing that we're doing that we should be able to grow through that. I should say we're also in the clinic in two additional indications with AIH and CIDP. Peter mentioned it in his opening remarks. We're excited about how that profile, that highly differentiated and convenient profile of UPLIZNA, can help patients with those conditions as well.
2027 looks to be a big year for Amgen with regard to cardiometabolic and MariTide and Obesity being one of them. Given the broad phase III program is underway, including switch and maintenance studies, how is your team preparing to launch in this highly dynamic and competitive market? What do you see as the most important aspects of the commercial strategy?
Yeah. Look, we are planning on going to market to establish ourselves as a leader in that category. We have continued to expand, and I'll ask Andrew to comment in a moment here, but we've continued to expand our cardiology and primary care presence for Repatha. We will grow that even further given the momentum that we're seeing with Repatha in primary care. We also just presented some data at the ADA on a subgroup analysis from [VASCEPA] for diabetes patients and being able to reduce their risk of an event. We've got very nice overlap there. That helps, but we'll expand even beyond that for MariTide. We're already expanding our medical effort, and we will be ready well in advance of those phase III data coming out for the medical team, and then obviously in advance of the FDA approval.
I think it serves us well to have people in territory ready to go well in advance of when the approvals occur. We're planning on being very competitive in that market with a highly differentiated profile. That's really the thing that we started this journey with was anticipating in the timeframe for when we would launch, there would be a very busy, very competitive market, and that's played out. We've seen that just with a number of new original data presentations at the ADA. Nothing seems to compare to the differentiated profile that we've got. What we said years ago when we started the early phase I and phase II clinical trials on MariTide, that differentiation has held up, we're in really good shape there. Differentiated product, the scale of Amgen to be able to go to market, the foundation of Repatha and cardiovascular.
I think we've done a really good approach to the opportunity that MariTide represents.
As we look to olpasiran data next year as well, Novartis has pointed to about a 13%-15% MACE benefit from pelacarsen as meaningful for Lp(a) control. In the context of just that commercial outlook here, how do you think about what would ultimately drive uptake for a drug of that profile, but also your drug as you look to? We've seen deeper knockdown.
Yeah. Look, I like what we've done in our clinical program. We showed in phase II that we've got a very potent reducer of Lp(a). 95%-100% reduction in Lp(a). If the hypothesis can be validated, olpasiran is the drug that can validate it given its ability to lower Lp(a). Our patient inclusion criteria, we chose a slightly higher cut point than others did in their clinical trials. Again, slightly higher risk population if the Lp(a) hypothesis bears fruit. I like our chances to be able to deliver a strong hazard ratio at the end of that trial. If pelacarsen reads out favorable, I like that we'll be able to positively differentiate beyond what they show. That you have to look at the cluster of cardiovascular risk factors here.
Physicians are looking to do more and more for their patients, Lp(a) gets a mention now in the guidelines. It is moderately lowered by Repatha and PCSK9s, but not really. If we are trying to further reduce cardiovascular risk, this genetically defined biomarker needs a specific. Again, olpasiran looks like potentially.
You also have phase III data in Sjögren's coming by year-end. How are you thinking about the likelihood of success here and the size of the opportunity?
Sjögren's has been a difficult disease area, kind of intractable for a lot of different mechanisms. I like the purposeful design of dazodalibep. Obviously, the phase II data looked interesting. Horrible disease. Hopefully, in phase III we're able to demonstrate efficacy and safety in that category. It's a large underserved area where a lot of off-label medicines are used with nominal efficacy and some safety baggage. Very attractive for us, as we were talking about before, we've got the rheumatology capabilities both in the research medical and commercial arena. It fits very well with our portfolio.
A last question for you, Peter. You raised 2026 guidance on the 1Q call. What would you highlight here as potential upside or downside drivers for the 2026 range that we should monitor?
Let's go back to those six key growth drivers. Things are going really well with those. I always like to start with those Repatha, EVENITY, TEZSPIRE, innovative oncology disease portfolios, biosimilar portfolio. I would say, as we think about the company and what happens in 2026, Salveen, the breadth of the company in the market is strong. 17 products annualizing at $1 billion or more. There's 16 products with double-digit growth or greater, both of those over the prior year's quarter. I would just say there's a lot of ways to win there. Our commercial group is working with our operations to make sure we get those to patients in every possible way we can. That's strong. I would also say we've got this, in 2026 We want to win it in the pipeline.
It's this disciplined data generation that Dr. Bradner's been talking about for this year. We're working really hard on that. We're going to demonstrate execution excellence in that and make sure we're after that and make the progress we want to make this year in that pipeline also. The breadth of the in-market portfolio and how well that's doing, the depth of the pipeline and what's going on over there, I think it makes 2026 a year that'll be great for patients and strong for our shareholders. Then going out towards the end of the decade and beyond, that strong in-market portfolio, those six key growth drivers, 70% of product sales in the first quarter, 24% growth as a group, then going forward the pipeline will continue to deliver on that.
We've talked about that and you've covered maridebart cafraglutide, also known as AMG 133, or as all of you know it, MariTide. We are excited about the opportunities that that will bring, and we'll continue to invest behind that. Amgen's a great story of rigorous financial discipline coupled with a very clear capital allocation hierarchy. At the end of that hierarchy, every time we talk about it, we're going to talk about innovation, the best innovation, whether it's internal or external, and we're working hard at that. We think we'll continue to be in a position to create value for patient shareholders and also for our staff.
Just one other question I wanted to touch on. You've guided to relatively stable operating margins of about 45%-46% this year as you invest in the late-stage pipeline. How should we think about the evolution of margins as you look to the end of the decade? Could you see expansion back to prior levels?
Well, we don't give long-term operating margin guidance, but in terms of how do we think about the discipline around that rigorous financial discipline. Remember, for many years, and that's what you're referring to, beginning in 2013, 2014 or 2015, I wasn't around then, but we upped our game and took the operating margin up around 50%. I always said when I came into this seat, late in 2019, I said if there are opportunities to achieve cash-on-cash returns in excess of our hurdle rates for our shareholders that made sense we would flex that margin. In the last couple of years, thank goodness we've had the opportunity to do that because that results in, as Casey mentioned, we're going to have 12 phase III trials in MariTide at the end of the year. We've got olpasiran moving along with 7,200 patients. We've got xaluritamig in phase III.
We've got the ability to invest behind that, and we think those are fantastic opportunities. When we have an opportunity to invest behind what's out in the market right now, behind UPLIZNA and make sure that's getting delivered to the patients it should and EVENITY and invest behind that and make sure that's getting to the under-penetrated markets that Andrew, Murdo referred to. Same with Repatha. We had an old saying years ago, boy, back your winners. That is such a great medicine for patients with such a great data set. That's really how we think about op margins, Salveen, It's important to us. We understand there's expectations of Amgen to be a top performer in the operating margin percentage, and we're going to continue that. We are using all the tech and data and AI we possibly can, just like everybody else is.
We have high expectations of ourselves. We've got a CEO that has high expectations of us and what's going to happen there. We're excited about that and the challenge that represents. We'll continue to be efficient, we'll continue to be effective, and we'll continue to make sure that we produce an operating margin that our shareholders think makes sense in light of the opportunities to invest and in light of the opportunities to exhibit strong financial discipline.
Great. With that, thank you so much. Really appreciate the time today.
Thank you.
Thank you, Salveen. Thank you, Goldman Sachs.