Good morning, everyone. I'm Michael Yee, a senior biotechnology analyst here at Jefferies, and very excited to continue on with our next fireside discussion here at the Jefferies Healthcare Conference. I am quite pleased to have members of the Amgen team up here with us. That includes the CFO, Peter Griffith, Executive Vice President, Murdo Gordon, and, of course, one of the best IR leaders out there, Justin Claeys, who we all know. I would love to give maybe Peter or Murdo an opportunity just to make some opening comments. Obviously, the company has a lot going on commercially, been executing quite well and crushing numbers on some of the legacy stuff, but obviously some of the R&D pipeline is a big focus, and I'm sure everyone will be at ADA in a couple of weeks.
Maybe Peter or Murdo, you'd love to give some opening comments about the state of Amgen, and then we'll go into some key questions.
Mike, thank you. Murdo, Justin, we have Adam, our treasurer, here with us today. We are really glad to be here. We really appreciate it, Mike. Mike, I cannot let it go, the video this weekend, right? I cannot let the video go. I had to, my four-year-old grandson, Cameron, walked in. He looked at the video and he said, "Is that Mike Yee?
Planning for the next year.
He said, "That's not okay." In all seriousness, we're glad to be here.
You got a shout-out in the video, too.
Thank you. Look, we are really excited about the business. We're excited to be here. With that, we're seeing strong momentum in the breadth and the depth of what we're doing. We're seeing innovation at speed and scale at Amgen. First quarter revenues increased 9%, and non-GAAP earnings per share were up 24% year- over- year. The strength was broad-based, as you saw, with 14 products delivering double-digit growth. Many of the near-term growth drivers were very strong in the quarter. We have exciting pipeline advances across the therapeutic areas. Let's start with general medicine, Repatha and Evenity. Together, they delivered over $1 billion in revenue in the first quarter, up 28% year over year. Significant opportunity ahead for both brands, and I'm sure you'll hear a lot from Murdo on that.
With 100 million patients globally in need of further LDL cholesterol lowering and 90% of very high-risk patients for postmenopausal osteoporosis not receiving appropriate therapy. In obesity, our two phase III studies for MariTide in chronic weight management are initiated and enrolling. At the ADA meeting in June, we look forward to sharing further details of the 52-week MariTide data from part one of our phase II trial, along with additional data from our previously discussed phase I pharmacokinetic study testing lower starting doses of MariTide. For our Lp(a) therapy, olpasiran, our secondary prevention phase III cardiovascular outcomes trial is fully enrolled. Now let's go over to rare disease. Uplizna , recently launched, is the first FDA-approved therapy for IgG4-related disease, and we're now on track for December 14 PDUFA date and generalized myasthenia gravis for Uplizna.
Mike, I know you're interested in Tepezza, and which addresses a complex patient journey. Many patients with low clinical activity scores, or CAS scores, are undiagnosed or not referred for appropriate treatment. Educating physicians across specialties, particularly endocrinologists and general ophthalmologists, is essential. We've expanded our field force and are executing our commercial strategy to better reach these prescribers. Now let's go over to inflammation. Tezspire continues to grow in severe uncontrolled asthma. We have an October 19th PDUFA date for chronic rhinosinusitis with nasal polyps, and we're enrolling patients in phase III studies in both COPD and eosinophilic esophagitis. Now let's go to oncology with ASCO last weekend. Our industry-leading bispecific T-cell engager platform is progressing very well, and we're excited about the potential patient benefits from Lyncido in B-cell acute lymphoblastic leukemia, Imdelltra in small cell lung cancer, and Xaluritamig in advanced prostate cancer.
We're also looking forward to two phase III readouts this year for bimuratuzumab in first-line gastric cancer. Biosimilars generated $735 million in revenue in the first quarter, up 35% year- over- year. Driven by our latest United States launches of Pavblu and Wezlana, we're also advancing BKEMV, a biosimilar to Celeris, in the United States on April 2nd. We're also advancing our next wave of biosimilar candidates, including biosimilars to Opdivo, Keytruda, and Ocrevus, all of which are now in phase III. With respect to the second quarter 2025 and specifically the outlook for operating expenses, let me remind our audience and you of our comments from the first quarter earnings call that we had certain research and development expenses previously expected in the first quarter that we now expect in the second quarter, including milestone payments and other investments.
With that said, we expect the second quarter of 2025 year- over- year non-GAAP total OpEx growth in the low teens. Finally, let me acknowledge the interest in the macro and policy environment, including the tariffs, taxes, and pricing. It is a fluid situation. We are not speculating on any specific policy proposals or implementation mechanisms at this stage. With that said, we firmly believe that society needs more innovation, not less, and we remain actively engaged with policymakers on policies that improve patient access while supporting sustainable and important innovation in research and development and in manufacturing. With that, Mike, back to you.
A lot to unpack there. Let me start with the fact that one of the big surprises is that the commercial business, certainly for the last few quarters, it seems quite evident that people who are not even looking at some of these things because there's so much focus on MariTide has been doing quite strong. Evenity, Repatha, some of these numbers are up significant double digits, and nobody thought that was going to be the case a couple of years ago, and these are crossing multibillion now. Maybe for Murdo or for Peter, do you expect that that type of significant growth can continue, and that's why you feel so confident about the numbers this year, even in the face of a biosimilar of denosumab, which was a thing that people were quite concerned about like a year ago? Here we are now.
I think one just launched like yesterday. I saw an announcement. Where are you with the risks of the biosimilar offset by the fact that you've got strong growth of your products that are going to offset that? You're going to grow through a biosimilar against your biggest drug. Can you comment on that dynamic?
Yeah, thanks, Mike. We're really pleased, obviously, with the execution of our commercial and medical and all our customer-facing teams around the world. If you look at our portfolio, and Peter went through it pretty rapidly, if you look at the major growth drivers that are already approved and in market and in line, you've got Repatha, you've got Evenity, you've got Tezspire. They're the very large market products with a lot of untapped growth potential. You go into innovative oncology, think Lyncido, think Imdelltra, which we just put.
Tarlatumab now, which is a big thing at ASCO.
Yeah, big data at ASCO showing for the first time ever a 40% improvement in overall survival in second-line small cell lung cancer. You go into the rare disease portfolio with four key products, growth driving there and expanding international. You look at our biosimilars portfolio, which is also growing nicely through the time period that you mentioned the last few quarters. We have a portfolio that isn't just one big product or two big products. It's a very broad portfolio of growth drivers. Very pleased with that. You mentioned Repatha specifically. Yes, it's been a long journey. I can attest to that. We are very pleased now with the way we've opened up access in the U.S. and the way Repatha is also growing around the world. In the U.S., we're seeing over 40% growth through the first quarter.
That will continue in terms of being able to expand the volume of patients that we treat. We've substantially improved access now with over 50% of commercial lives having no prior authorization. You can prescribe Repatha with no attestation, no prior authorization at retail. It's a very easy product now for patients to get. We have a catalyst for Repatha in the back half of the year with the VESALIUS trial that is in a primary prevention high-risk patient population. We are trying to prevent that first heart attack or stroke by adding Repatha for aggressive LDL management in that patient population. There are a number of really good catalysts. The other thing with Repatha this year is we will see less year-on-year price erosion. For the last few years, price erosion has taken some of that volume growth out when it comes to net sales evolution.
This year, we'll see more of that top-line volume growth come all the way through. Evenity, untapped patient population, very low penetration so far. We have the responsibility of selling that product and booking sales in the U.S. and Japan. The Japan market's way ahead of the U.S. in terms of patient penetration. If we just catch up to that, that will be an impressive thing.
The net of those is that you are very confident about the strength of some of these volume growth businesses that you just mentioned. They definitely have been beating numbers. I think people are concerned that this year, certainly for the next six months and going into 2026, that there is a biosimilar denosumab that is launched, I think two. What are you seeing out there? Are things within your expectations? I do not know if prices of these things have been announced yet, but what should we expect? What should we expect to hear and what should we expect to happen because denosumab biosimilar is available?
Yeah, I think I'm not sure what all the competitors will do, but so far we've seen nominal differences in WAC pricing, so slightly lower than the innovator.
Is it the first one I think is out there from?
Sandoz.
Sandoz.
Sandoz launched yesterday. I think 10%-14% depending on whatever the.
So [modest].
Yeah, they have two brands out, one to XGEVA and one to Prolia. But again, this is something that we've been saying all along. We understand the biosimilars business. We're a biosimilar competitor. We understand the dynamics of it competitively. We understand provider preference, particularly in the buy-and-build space, which is where we are here with denosumab. Obviously, our roots in oncology have helped us understand the XGEVA picture. And then we are unique in that we're the only company with the footprint that we have in osteoporosis for Prolia. So I think we're in a good competitive position.
In the osteoporosis standpoint, as part of what Wall Street sees, somewhere there's a biosimilar price that's going to collapse and maybe it falls by 50%, but you think that there is a particular advantage because in osteoporosis, which is I think 65% or 70% of the sales of denosumab, that's unique because these are buy-and-build centers treating elderly women with this injection. It's not just like a cancer biosimilar where everyone just swaps over. Is that an advantage?
I think it's different mostly in how the product flows through the supply chain. In oncology, you've got a concentration of GPOs and networks in the community that are relatively easy for a biosimilar competitor to cover with a field force, with a contracting team. In osteoporosis, it's a little bit different in that there are a lot of individual clinics that are buying small amounts that add up to a large amount.
There's not going to be a salesperson coming over to them from San Diego or whatever.
There will be some, but the footprint that we have is just a little more competitive than what we think the biosimilars will be able to deploy.
When you take strong growth on your branded products that we've mentioned, some offset on denosumab this year. We're going to look for the second and the third quarters coming up. You said 10%-14% discount. That's at least the gross price. There could be some rebating. And expenses, Peter, what was in the expectation at the beginning of the year? I don't recall exactly what you did to guidance, but I don't think there was much raising of guidance in the first quarter post-EPS. As you get more visibility, you're going to look at your guidance this year. Based on what you guys are saying, which seems bullish, you'll come back to the guidance.
Mike, we always look at guidance. We're very thoughtful, and we've got a very strong, well-controlled process on that at Amgen. When we look at our operating margin as a percentage of product sales, that's something we're very focused on. We've been thinking about that for many, many years, all the way back to when Justin Claeys was in corporate FP&A 12 or 15 years ago. That's important to us because our investors expect us to be very efficient with the capital we deploy. Having said that and having had a guiding principle of about 50% of product sales for our operating income percentage for any number of years now, this year we guided about 46%. We said, "We need to earn that flex, that flex down." We've got a pipeline that's really important to patients. Murdo covered some of that.
I covered some of that in my opening remarks, whether it's Opatron phase III, absolutely Meritide, whether it's our oncology medicines. We think about that. That's the number one allocation is innovation. In this case, we're grateful for patients, for staff, and for shareholders, how strong that pipeline is to allocate that capital into that. As we go along here in the next few years, look, we're going to have we've got an opportunity to do a great launch on IgG4-related disease and Uplizna. We've got a great opportunity to get Imdelltra out, what Murdo said, this important medicine. We'll stay focused on that. We're also at the same time, it's not OpEx, Mike, it's CapEx. We're deploying capital to build capacity, 14% volume growth in the first quarter. We're continuing to deploy capital there.
We want to be very predictable and disciplined on our capital allocation, innovation, investing in the business, returning capital to shareholders and to our debt holders. We're on track to get back to our pre-horizon capital structure by the end of the year. All in all, we are very disciplined. You'd probably ask me the next question would be, "What are you doing to be as efficient as possible?" I would just make one note that as most companies our size, regardless of industry, we're pushing ourselves very, very hard on technology and AI. We're not going to work beyond the speed of accuracy and controls, but we're going to push ourselves on that. We've been doing that for a long time. We moved our head of R&D, as you know, Dave Reese, over as our chief technology officer.
We have high expectations of ourselves, and we know our investors do also on this. We are going to stay focused on that.
Your branded drugs are growing. The impact of denosumab, you think, is manageable in that you should be able to grow through that. We will see that, I think, when you look at this year's numbers. The guidance was for growth, I believe, in the exact numbers. Therefore, you'll take a look at the guidance this year after we get past denosumab, and we'll see what the numbers look like. Okay. Therefore, one of the other developments, if the numbers are strong, are going to be based on what also the opportunity is for MariTide. In just a few weeks, we'll be at ADA. You guys are going to be presenting, I think, in a one-hour session. It's all sort of split up, but there's a one-hour session on MariTide. What should the takeaways be for people going to ADA?
What is the messaging from Amgen about how MariTide is going to compete against tirzepatide and some of these other big programs? Because I think people are still trying to scratch their head. How is MariTide going to compete? Lilly is a formidable competitor, right, Murdo? I do not know. What is the takeaway coming away from ADA?
We respect all of the incumbents in the market, but our product is highly differentiated from what's available.
Okay. Tell us about that.
It starts with that. I mean, as a marketer, if you don't have a differentiated offering, it is hard to compete. We have a differentiated offering, the only peptide antibody conjugate in the category. We've obviously given the top line. Jay's been very clear with what we've presented so far on the phase II trial that we'll read out on the 52-week data in its entirety at ADA. A couple of things just to keep in mind that are very clear. Weight loss up to 20%. Very clear that dose escalation is important for the tolerability of the product. We had a number of cohorts in this trial where we didn't dose escalate. You'll see those data. You'll see in the same presentation, a phase I PK study, which we've alluded to publicly already.
You'll see that dose escalation actually significantly improves tolerability of the product. We will take those learnings and apply them into phase III.. This is the tricky part. We're going to show 52-week data from a phase II trial that was intended to cover the range of possible ways of treating patients with MariTide, many of which we have not taken into phase III, many of which we have taken into phase three. The real challenge will be for people to look at what we present at ADA and then look at our phase III program and from that deduce what the profile of MariTide could be in the market.
To be clear, you've started phase III , two big studies, but you haven't disclosed the doses or the titration.
That's correct.
Okay. When we go to ADA, people are going to see the original phase II design, which was designed to cover a whole range of different doses, including a titration. To be fair, Wall Street initially saw some of that data. It has been verbally said on that conference call what the GI and nausea rates were. Wall Street was a bit sour on those numbers, and the stock went down. You have disclosed that you have a further titration enhancement in phase I that you think significantly lowers those numbers. To be fair, I think those numbers have also been disclosed, but the weight loss has not been disclosed yet. People think like, "Well, Murdo, you're going to lower dosing." Lower dosing. Maybe that improves tolerability, but how are you going to get more weight loss?
You guys are saying you will see good weight loss with that.
Yeah. I think what you're going to see, just to remind everybody, you're going to see some cohorts in the phase II with no dose escalation. And then you're going to see a phase I trial where we did a two-step dose escalation. And what we've learned from that will allow us then to optimally design the dose escalation in the phase III. We are still confident, though, that our dose escalation, given the profile of MariTide, will be a good patient experience and will not compromise maximum weight loss.
Will we have some weight loss follow-up numbers on that new titration that was initially disclosed back in November?
It was a phase I trial, so we weren't really looking for efficacy in that.
How do we know that you can get good weight loss with a lower step titration? How do we know that?
You can see in the kinetics of the efficacy of the product, and you can model from that.
Okay. I think one of the parts too is that in the phase II, there was an initial titration, and that weight loss is similar to no titration. That is part of the messaging.
Yeah. I think the curves for us look very good, and that's why we made the choice that we've made for phase III.
You guys have not disclosed too much on the actual injection, but in the phase III, are you using a pen injection or that comes later? What is the administration in the phase III ?
We'll be talking about that at the ADA.
Okay.
Yep. Mike, on that, we've been really clear.
People are like, "This is like, yeah, is this a simple injection?
We've been really clear on that. This device can be very patient-friendly and incorporates in Amgen's long experience on use of devices. We have a fantastic process development group. We think it's as good as there is worldwide. Best protein engineers, best at viscosity, best at excipients, good on patient-friendly devices all the way from the device we use for our Eylea biosimilar to what we do in Repatha gets delivered to well over a million patients. We understand what needs to be done on that, and we'll talk about it at the right time, but we're very confident in terms of how that's going to get delivered.
The most important part of this device is that the patient will only have to use it once a month or potentially even less frequently. I think they'll enjoy the experience.
You said pen and simple and these things. People are skeptical, but you say you have it. By the way, Lilly just announced a collaboration to do a long-acting, I think, yesterday. They're trying. You have that, and you're going forward in phase III with it. A lot of investors, particularly generalists, just seem to believe that if you're giving this dose once a month, it's either a lot of drug or that there's tolerability issues. What are the things that will come out later this year?
Because there is two-year data, guys, that we are going to get more information on MariTide that is going to say, "Hey, look, see how this is more differentiated?" What would we get later this year that could be scenarios that help people understand how good this product could be?
I think you're referring to what we call part two.
Part two. Okay.
Of the phase II, where we follow patients out beyond 52 weeks for an additional year. Just a couple of things to keep in mind on that trial. The way that works is anybody who lost at least 15% weight loss or more is re-randomized into a prospective trial. The data from that second part of that trial will be available by the end of the year. We'll make sure that we characterize the design of that trial because it's a little different than what people are used to. It's not just taking the existing part one and following everybody for another year.
Right. They do get randomized to their own risk. Stay on a monthly. In some cases, one arm comes off. That's cool because you see what goes on. In some cases, they just stay on for a monthly. They could have more weight loss.
Yeah. Because we didn't see a plateau in the first 52 weeks. So we're curious to see. The challenge will be not having continuity of cohorts through that period.
Right. Because they were re-randomized.
There you go. We will see at least what different dosing intervals and/or different doses, including placebo, will do to that weight loss maintenance over time.
One of the arms is quarterly.
Yes.
Is that a totally plausible, viable scenario?
We'll see. Given the kinetics of MariTide and given that we're maintaining weight loss, it's possible that quarterly is a suitable dose for many patients.
Mike, I would just add one point that in terms of the part one to part two, over 90% of the patients who were given the choice to continue did continue. In terms of the patient experience, we think that's a good.
Right. Yeah. First of all, the discontinuation rate, which a lot of people say, "That was very small to begin with," and then you're saying people continued on.
That's right. It was 8% discontinuation rate in the dose escalation arms due to GI, 11% due to any other reason.
I mean, Murdo, that's a commercial question or over-beater. People say, "Well, the numbers, they look at the incidence table and they see this and they stack it at tirzepatide." But you guys have tried to emphasize that you think that the onset or the time course of that adverse event, if we have the plot, is all like in the first dose and you don't really see it in the second dose. Is that true? Is that a fair way to characterize it?
It is what we have seen. We see the tolerability of the product in the dose escalation cohorts. All of the, not all, but the vast majority of the nausea and vomiting was peri-first dose and on subsequent doses was very, very low. That is another good reason for the persistency of this product to potentially be better and for the patient experience to be better. Let us level up here. We have got a product that we know we can dose escalate to improve that tolerability, even on that first dose, because we have not optimized that yet. We do not think the phase two is the best we can do.
Right. You've started at a lower dose.
We think we can do it even better. First dose experience, improve it. Weight loss up to 20%. Maintenance options of every other month, potentially quarterly, but we're already improving at the monthly option. We're covering the waterfront with a phase III program that will bring in ASCVD indication, CKD, chronic sleep apnea, and on and on. We're going into this market with a full package of clinical trials, a highly differentiated product, and an offering that, quite frankly, by the time we launch, patients will be interested in. Because taking a weekly injection and in some cases, feeling nauseous on the day of your dose on a weekly injection will be an incentive for patients to look for something else.
It's kind of interesting, Murdo, because in many cases, sure, new patients, but there could be a significant amount of swapping. If they've already been on a GLP-1 and they swap versus a de novo, maybe the side effects are even less. It's sort of interesting. Are you planning to start a safety or some sort of design study where people are already on a drug and then they come on to this one?
Yeah. Look, there are a lot of questions to answer with the promise that MariTide offers for patients. We have a group of thought leaders advising us on ideas like that, and we're taking those ideas seriously.
Mike, maybe if I could jump in for a moment.
Please.
Dr. Bradner, Jay Bradner would say you brought the question up of generalists. We have to give them a big slug of drug or this or that once a month. He constantly reminds people that this is a monoclonal antibody. This is different, and with a couple of peptides conjugated to it. He would really make the point that the pharmacokinetics of that are much more stable for us, he believes, than these other medicines, which I think these are my words and he may use them, but are a little bit sawtoothed that may go up and down in their pharmacokinetics.
Just the kinetics of the people who are looking at the doses, like Metsera is an example for those from Metsera, but also the tirzepatide dosing, that is a peptide. That is not an antibody with an FC. You cannot compare 420 milligrams to a peptide.
That's right. Amgen is monoclonal antibody. I mean, that's who we are. 80% plus of our approved medicines, 40 approved medicines, are monoclonal antibodies. That's who we are. I think we're.
We'll show the data. They get around to it. We got to put up the data.
Let's see what it says.
Let's see the data and through this year. Lastly, I want to hit on in the last minute is another important blockbuster because it's right around the corner. Lp(a), you guys are a cardiovascular powerhouse. You're selling billions of dollars of Repatha. Novartis is going to read out a phase 3 Lp(a). Many people think it could be positive. You have a product that's also in phase III. You already completed enrollment. You think it could be better. It could be. What do you see out of Lp(a) in the last minute? We should pay attention to this because Novartis reads out.
Yeah. We definitely think we have an opportunity with olpasiran for a best-in-class profile. We've got a very large ongoing secondary prevention clinical trial. We're looking, obviously, very closely at what the competitors might put out between now and when our trial reads out. I'll just say 30-odd years ago, I was sitting in citywide endocrinology rounds in Toronto, and I heard about this independent atherogenic lipoprotein particle called Lp(a). This is not new science in understanding the correlation between elevated levels of Lp(a) and elevated incidence of cardiovascular events. There is a volume of evidence that shows the correlation. The question is, when you have a drug like olpasiran that lowers Lp(a) by over 95%, can you knock down events? Our hope is that the answer to that is yes, because we are still obviously working very hard to aggressively lower LDL.
You can't do much about your Lp(a). Diet, exercise, lifestyle modification won't bring it down. It's genetically determined. You got to have a drug. I do think that the adoption behavior will be different because you won't have that, "Doc, I'll eat better. I'll exercise. Don't put me on another drug.
That's independent of diet and these other factors.
Yeah. I think there'll be more urgency to treat. We're starting in secondary prevention. If you think about the history of LDL, it usually starts in primary or it starts with just LDL modification. Here, we're starting about hard endpoints. I think the promise of Olpasiran is significant, and it's 100% overlap with what we're already doing with Repatha.
Guys, thank you so much. Look forward to the progress this year and the more data, and we look forward to all of the developments. Thank you guys very much. Appreciate it.
Thank you.