Today, so we have Paul Burton. He's the Chief Medical Officer of the company, and, for the first time, Adam Elinoff, the new IR at Amgen, and then we also have Casey to help him out here. Thank you very much for joining us today.
Thank you for having us. If you don't mind, I'll kick off with some opening remarks, and then we'll go to Q&A from there.
Sure.
So the business is delivering strong results, and we're very pleased about that. We're also well positioned to deliver growth today and then well into the future. And that's driven by four things. The first is our breadth and depth, and that's across our four therapeutic areas. And that's both inline and pipeline. And I would just highlight in the second quarter, if you recall, 12 of our products delivered double-digit or better sales growth. So that's important. The second piece is our commitment to innovation. And that runs through the molecules and medicines we make for patients, how we enable and leverage tech and AI, and then how we drive continuous improvement through the business. And then the third thing is our focus on execution excellence. And then lastly, as you know, our disciplined capital allocation.
In the second quarter, we're pleased to report at the time that we delivered 9% year-over-year revenue growth, 13% volume growth. We're very excited about the 21% Non-GAAP earnings per share growth year-over-year. With that, I'll move in to talk a little bit more about the breadth, and then I'll pass on the marketed product side, and then I'll pass it to Paul.
Right.
He'll talk a little bit more about the pipeline.
Sure.
In general medicine, I'll talk about Repatha and Evenity. Repatha delivered $689 million in sales, grew at 31% year-over-year. Evenity delivered $518 million in sales and grew at 32% year-over-year. It's now annualizing at over $2 billion. We're pleased about that. More importantly, these medicines serve large patient populations with substantial unmet need. What that translates into, of course, is a substantial opportunity to serve more patients and more growth for those products. Next, I'll move into rare disease. Rare disease is now annualizing at over $5 billion based on the second quarter. I'll highlight just two of the medicines. Uplizna, this is turning into a true pipeline in a product. Number one, FDA-approved biologic in NMOSD. Then we recently launched an IgG4-related disease. That launch is going very, very well, and we're very excited about it.
It delivered substantial growth in the second quarter. Then Paul will talk about an upcoming PDUFA date for myasthenia gravis. I want to talk about Tepezza. We continue to be confident in Tepezza and optimistic about Tepezza. That's driven by three, excuse me, four things. The first is that there's still a substantial unmet need in thyroid eye disease. Second, we're the only therapeutic approved for patients in thyroid eye disease. The third is that we recently expanded our field force to enable us to reach patients where they're at. That's either via ophthalmologists, oculoplastic surgeons, or endocrinologists. Then lastly, I just wanted to mention our launch in Japan is going very well. So that is an exciting opportunity. Next, I'll move to oncology. Our oncology portfolio, as you know, is broad. I'm going to focus on the BiTE platform here.
Blincyto, our original BiTE, delivered 45% year-over-year growth. Imdelltra, which is an important medicine for patients in, it's now in second line small cell lung cancer, grew at 65% year-over-year, excuse me, quarter over quarter, and delivered $134 million in sales. But what's also important about those sales is where they came from. So they weren't just in the academic setting. It was also in the community setting. And what that means is that there's a broad adoption, and there's a demand for it from both clinicians and patients. So very excited about that medicine. It serves patients facing a very grievous illness. Lastly, I want to just talk about inflammation and Tezspire, another portfolio in, excuse me, pipeline in a product, grew at 46% year-over-year in severe uncontrolled asthma.
We have several indications to come, as Paul will talk about shortly, including a PDUFA date in chronic rhinosinusitis with nasal polyps later this year. I'd be remiss though if I didn't talk about our biosimilar platform or programs, which run through those therapeutic areas, which I just mentioned. They generate meaningful value because we're able to efficiently leverage the infrastructure we have in place. On capital allocation, we have a history and a culture of disciplined capital allocation. That's founded in our prioritization of our capital allocation priorities. The first is investing in the best innovation, either internally or externally derived. As you know, we increased our guidance on R&D spend to over 20% this year. Second is to fund the CapEx required to support the business. The third is to return capital to shareholders.
And that's in the form of a growing dividend, share repurchases, or debt paydown. And so as the treasurer of the company, I'm very pleased to say here today that we've largely completed the deleveraging from the Horizon transaction. And we're on track to return to the efficient capital structure, which we had prior to the transaction by the end of the year. So with that, I'll turn it over to Paul, who will give us an update on the other half of the breadth, and that's the pipeline.
Great. Thank you, Adam. Thank you, Mohit, for having us. Good morning, everybody. Look, I'll start with MariTide. As you all know, our investigational therapy for obesity and obesity-related conditions. We now have four phase III studies ongoing, two of them in chronic weight management, one in cardiovascular disease, and one in heart failure. We expect to initiate a study in obstructive sleep apnea later this year. Enrollment across all of these studies is going extremely well. That really represents broad investigator interest in the molecule and in the program, participant interest in these trials, and obviously significant remaining unmet medical need. In Q4 of this year, we should have data from part two of our phase II study in chronic weight management, data coming out there. We'll also have data from a phase II study in type 2 diabetes.
Now, beyond MariTide, but staying in general medicine, as Adam mentioned, we have Olpasiran, our Lp(a) targeting medicine for the reduction of cardiovascular risk, and that is progressing in phase III as well. In rare disease, Adam touched on this as well, but the growth we're seeing with Uplizna in NMOSD and IgG4-related disease continues to go very well. We have a PDUFA date coming up in December for the indication of generalized myasthenia gravis for Uplizna. We think it really has the potential to address a very significant unmet medical need. This molecule has durable efficacy, the ability for steroid tapering, and following a loading dose, very convenient twice-yearly dosing regimen. Let me switch to oncology now, perhaps with Imdelltra to begin with. This is our DLL3 targeting bispecific T-cell engaging molecule.
We're very pleased to announce that the FDA has accepted the submission of Imdelltra in the DeLLphi-304 study, our confirmatory phase III study for the second line use of Imdelltra in small cell lung cancer. And that was awarded priority review with a PDUFA date of December 18. So we're excited about Imdelltra. And we're obviously rapidly advancing this medicine into earlier lines of therapy. Similarly, now Xaluritamig, our STEAP1 targeting bispecific T-cell engaging molecule, enrolling in phase III study of advanced metastatic prostate cancer. And again, trying to move that molecule as quickly as possible into earlier lines of therapy. I'll turn now to Bemarituzumab, our FGFR2b receptor antibody. In June, we announced the results of our phase III FORTITUDE-101 study. That tested Bemarituzumab plus chemotherapy, Modified FOLFOX-6 chemotherapy, in the first line setting in gastric cancer.
We announced that the study had met its primary endpoint of overall survival at a pre-specified interim analysis. However, at the recently completed final analysis for this study, the magnitude of survival benefit has decreased. The full results from both the interim analysis and that final analysis will be presented at an upcoming major medical meeting. In addition, we anticipate that results either in the second half of this year or the first half of 2026 will become available from the ongoing FORTITUDE-102 study, our phase III study there testing bemarituzumab in combination with nivolumab and chemotherapy, so the triplet setting. That combination with a standard of care option will help us further characterize bemarituzumab's profile in gastric cancer. A decision on our regulatory filing will follow as the availability of data from both of those two studies comes through the fall.
Finally, our fourth therapeutic area, inflammation, Tezspire continues to advance with multiple indications beyond severe asthma. We have a PDUFA date for chronic rhinosinusitis with nasal polyps in October. We're enrolling in our phase III studies in COPD. We've recently completed enrollment in our phase III study in eosinophilic esophagitis. So in closing, as Adam reiterated, we have breadth and depth across our four therapeutic areas. We have a commitment to innovation, a focus on execution or excellence, a culture of disciplined capital allocation. And taken together, this positions us to be able to deliver innovation and growth not only in 2025, but over the long term as well. So thank you, Mohit, with that. I'll hand back to you for questions. Thank you. I don't know where to start. There's so many questions to ask now. So maybe let's just start with MariTide.
I mean, there's a lot of focus on this for the right reasons. We saw the profile, we saw the data, and it does seem like it is hitting the mark with the efficacy side of it. On the safety side, you can do some work on dose escalation. Can you talk a little bit about those efforts and what is your understanding in terms of how you can manage with the milder doses in the beginning? Any of that, could we learn some of that from the part two this year?
Yeah. So the phase II part 2 study, which enrolled people after they had been in the study for 48 weeks and 15% weight loss, will really address three big buckets. One is what happens when you stop MariTide, what happens when you go to lower doses, and less frequent every three monthly dosing. And then what happens if you just continue monthly dosing. So that will be very important. MariTide is different from the weekly injectables. It obviously has an antibody backbone. And that allows us to have very steady pharmacokinetic characteristics versus the weekly injectables, which tend to have high peaks and low troughs. And we think that that pharmacokinetic characteristics of MariTide allows us to have smooth titration to a target dose over, for example, eight weeks. And so we're pursuing that obviously as our escalation pathway to the target doses.
That's with a two-step dose escalation regimen where we have on par tolerability around vomiting, certainly compared to the other agents. In the chronic weight management studies, again, because of our smooth pharmacokinetic characteristics, we're now also able to implement a three-step titration regimen. We think that we can even further improve on our tolerability profile there. We're very pleased with that.
Let me just talk about the part two first. Basically, it will tell you when you stop the drug, how long the benefit lasts, probably. That's number one. Number two is every three months, similar to every month, probably that will be interesting learning there, right? It still doesn't like, the tolerability is probably with the milder dosing, probably we won't see a lot here, but that would be something subsequent. Is that fair?
Yeah. We think that we can manage the tolerability with the dose escalation, with the titration to a target dose. We've learned so much about MariTide within this phase II study, our other ongoing phase II studies. What the part two of that study will do is really now address some of those key questions that patients and physicians and payers will want to know about, assuming that the medicine is ultimately approved and then they begin to use it. So what happens if you stop it? How can you go to maintenance therapy, either on lower doses, but monthly dosing, or with extended treatment duration?
Got it. So do you envision a scenario where it could become an induction maintenance kind of approach where patients actually go on more frequent dosing, followed by a milder dosing or less frequent dosing over time?
Yes. I mean, we certainly think that the characteristics of MariTide support it certainly for induction. But also, again, going back to that phase II, part two of the data, will support its use in maintenance as well. And clearly, as I said in the opening comments, we then have the broad MariTide program of other phase III studies in cardiovascular disease, heart failure, chronic weight management, obstructive sleep apnea starting later this year. So really broadening its use across those indications as well.
Got it. Very helpful, and then, so we have seen some data from the cardiometabolic and other cardiometabolic endpoints as well, which is the hallmark of GLP-1. I mean, if you look at the front runners, Lilly and Novo, they are running trials in multiple indications. You are also talking about some of these indications. How are you thinking about broadening the program and which other indications you think MariTide makes sense?
For our other indications, as I mentioned, we have the broad MariTide program, cardiovascular disease, weight management, obstructive sleep apnea. I think what is so encouraging about the data that we have seen from the phase II studies to date is in the diabetic population, a 2.2% reduction in HbA1c, with 50% of patients being able to achieve an HbA1c of under 5.7, so essentially normalizing their glucose metabolism. We have a 28% reduction in triglycerides, 72% reduction in high sensitivity CRP levels, and then an 11 mm Hg reduction in blood pressure. When you take all of that together, significant reduction, improved on biomarkers of cardiovascular risk, we think that the profile, not only within the management of weight, but in this broader population of cardiovascular metabolic risk reduction, really is very encouraging indeed.
Got it. Very helpful, and then, I mean, you have some pipeline candidates in this portfolio as well. I mean, 513 comes up a lot, but again, anything else that you would highlight to investors where you are going beyond MariTide here?
Yeah. I mean, just to say we have an early pipeline. It consists of incretins, non-incretins, oral agents, and injectables. We'll obviously update with data as those programs continue and generate data. And then AMG 513 in phase 1 now. And again, as data mature and data become available, we'll obviously update you on that as it comes out.
Is that the area where you are looking at BD as well since Adam's group has managed the balance sheet properly now? Or the balance sheet is much more stable now?
Yeah. No. So it's a great question. And as we said, our number one capital allocation priority is innovation. And that's either internally or externally derived. So the answer to the question is yes. We're exploring all avenues of BD, and that may mean an acquisition, that may mean licensing, that may mean partnership as we're looking to expand the portfolio. So we have the internal development, but if there's something better or more interesting out there, we would certainly pursue it.
Got it, so basically, you are in the obesity market for a long run, basically.
Yes. We're very excited about it.
Got it. Very helpful. Thank you for this, so maybe moving on to the other interesting asset in cardiovascular disease. I mean, you have had success with Repatha. I mean, again, comparatively, but at the same time, now you have an interesting readout coming up with, I can never pronounce it, but VESALIUS-CV trial, so how do you think about the opportunity it opens up? Does it open up a big opportunity? I mean, payers have been the challenge. I mean, drug works, but how do you think about this?
Yeah. So VESALIUS-CV is our study examining Repatha in primary prevention, in essence. I think, look, one, it will add to the growing body of evidence around the value of reducing substantially LDL levels, which Repatha does. Clearly, guidelines now call for sooner, lower is better. We've made great strides with payers, but I think it will give them reassurance around the use of the molecule in that setting. And there are still prior authorizations, so I think it will be valuable data for that. I would say Murdo actually commented on this in the last earnings call, that about 40% of the new-to-brand prescriptions written for Repatha are in the primary care setting already. So I think taken together, it will be an important data set.
It will build on the already very strong evidence base that we have around the use of Repatha and should shore up that use in the primary care setting.
Got it. Very helpful. Obviously, the big one is Olpasiran. Sorry, I'm just like a little late probably. The easy way is, can we get that? So Olpasiran, of course, there's a lot of excitement there. You have a siRNA-based approach versus the ASO, which is going on, which is reading out fast. It is an independent indicator or biomarker, right? So I mean, when we talk to experts, they say that there is so much going on in cardiovascular, which drug fits where is a challenge, but I mean, a GLP-1 is not going to solve for that, or exercise diet is not going to solve for this. So with this backdrop, I mean, how are you looking at the opportunity? Where does the drug fit in? And when we see the Novartis data, I mean, how much informative would it be for your program?
Yeah. So we have Repatha, MariTide, and Olpasiran. I think we're uniquely positioned to be able to address really all of the key drivers of cardiometabolic risk and cardiovascular disease. You mentioned it, Repatha, profound reduction in LDL. Olpasiran, we think potentially best in class, reduction of 95%-100% in the level of Lp(a), with very convenient every 12-week dosing. I think that differentiates it in the space as well. As you said, Lp(a) is a genetically determined, really non-modifiable risk factor. So as we now will get the results of the OCEAN(a) study that is exploring Olpasiran in cardiovascular disease, that clearly would be an opportunity to reduce the risk of cardiovascular disease driven by that risk factor, Lp(a). And then, of course, we have MariTide and all of the cardiometabolic risk reduction features that we just went through.
So when you bring those three things together, we really think it underpins Amgen's broad and long-lasting commitment to manage cardiometabolic risk. And we would now have three different approaches to be able to do that, taking out independent, clearly established risk factors for cardiovascular disease.
Got it. Very helpful. And then in terms of, I mean, are there any key differences or similarities with the Novartis program that we should, as investors, know?
Look, I think the molecule is differentiated. As I say, really profound reduction in Lp(a), 95%-100%. And the dosing regimen of every 12 weeks is also very appealing. Our OCEAN(a) study is fully enrolled. The data will mature and we'll obviously report that out. I think a negative result from the Novartis study, given that we have different trial designs, we have a different molecule, certainly would not invalidate the hypothesis and the validity of reducing Lp(a) for the management of cardiovascular disease. Clearly, a positive result from them would just reinforce that. But again, we think a differentiated molecule with a unique phase III trial design.
Very helpful. And then one question we get a lot about Lp(a), that is there a threshold effect here or more reduction is better? Because with LDL, you have proven that more is better, probably, but with Lp(a), we don't know that yet. So how do you think about it?
I think the epidemiological data and the Mendelian randomization data suggest that there is a continuous relationship, so that as Lp(a) goes up and up and up on a population basis, the risk of cardiovascular disease goes up similarly. Our hypothesis is that the further you can reduce Lp(a), so the greater the reduction in cardiovascular risk would be. And that's why we think that a molecule like Olpasiran, which really does have, we believe, best-in-class Lp(a) reducing capability, could be highly beneficial in that setting. Lower, we think, is better.
Got it. Very, very helpful. Maybe let's just switch gears to Tezspire at this point. I want to talk a little bit about COPD here. I mean, you saw interesting phase II data. I mean, we saw some spectacular failures lately. Again, I mean, so with both the ST2 and IL-33, they are similar mechanisms, though. How are you thinking about this space now after the data? And is your belief stronger in this asset or weaker now, especially in COPD?
Yes.
COPD is a variable disease as well, so we'd love to know more about it.
Yeah. So, COPD, third leading cause of death in the world today. 14 million patients here in the United States with COPD, and probably somewhere around 1.4 million of them are bioeligible. When we think about Tezspire, it's a medicine that clearly has very strong effectiveness in severe asthma. And it's also shown that, again, in the setting of chronic rhinosinusitis with nasal polyps. So I think, in principle, and using those other indications, I think it's very supportive that this molecule could work very well in COPD. When you think about the biology as well, Tezspire targets TSLP, which is high upstream in the disease cascade. It really does convert insult to injury, right? So pathogens, pollutants, so on and so forth, into airway inflammation.
So if you can control TSLP, I think you have a very good chance, and we've shown that in severe asthma of controlling airway inflammation and damage. I think the biology supports it. And then, as you said, we did do the phase II study, and we've learned from that. We've tailored and designed the phase III studies to include patients with eosinophils over 150. We think when you take that together, the biology, the proven effectiveness in severe asthma and CRS with nasal polyps, and then the foundation of phase II data, where we've been able to adapt the design of phase III, we really do feel very confident in the design of the study and the potential therapy that Tezspire will have here in COPD.
Got it. So do you think, I mean, Dupixent is actually, even though the label is broader, but again, it is used in higher eosinophils than 150. So do you think because it is sitting higher up versus IL-33, it can probably have a better effect than Dupixent? I mean, how would you think about that?
I think we'll have to wait now and really see the data, but it's an intriguing possibility.
That's fair. Awesome. So maybe talk a little bit about the gastric trial. And then you said that the benefit in final analysis was even better than the previous one, right? So how are you thinking about the opportunity there for FGFR drug? And I mean, with these cancers, I mean, these trials are just the beginning, and the opportunity could be bigger than that. So can you talk a little bit more about that?
Casey, why don't you take that one?
Yeah. I would say, with respect to bemarituzumab, as Paul said, we have data from FORTITUDE-101, and you heard the comments with respect to that. We have our other phase III study of FORTITUDE-102 ongoing and underway, and I think we'll have to look at the totality of data from when we have data from both of those studies available, and then we'll make a decision on the regulatory filing approach from there.
Got it. Got it. So what is, I mean, is there a specific thing you want to look at before you want to decide, or?
Just with any program, you really look at the totality of evidence that you've generated, the remaining unmet need in the marketplace for patients, and then you understand the best way to address that need with your therapy. And we'll take that same approach with bemarituzumab in this case.
Got it. Very helpful. So let's just talk a little bit about. I mean, the drug has shown really good results in MG. So where do you think the drug fits in? Because, I mean, in first line, you have FcRns, then you have C5s, but you have an advantage of every six-month dosing. And I mean, after Ocrevus experience, I would never discount this every six-month dosing because neurologists love that. So how are you thinking about the positioning of the drug versus what is out there?
Yeah. So why don't I start and then I'll pass it over?
Yeah.
I think the first piece is just I want to start with IgG4-related disease and just think about the size of that market. It's about 20,000 patients. IgG4 really just got an ICD-10 code about two years ago. That can continue to grow. If you go over to GMG, that's more like 80-100,000 patients. A bigger opportunity there. Then there's three things, and then Paul mentioned them, that really differentiate Uplizna, and why we think we have a strong position in the market and a strong value proposition to patients and clinicians. It's that stable, durable efficacy, the steroid tapering, and then after a loading dose, the ability to dose every six months. We're very excited about the opportunity in GMG for Uplizna.
Paul or?
No, just to add, we obviously, it's approved in NMOSD, number one biologic there. And with IgG4-related disease, it's also a very safe medicine. I think that's important. These are difficult to treat patients. It's safe, as Adam said. It's a very attractive dosing schedule. The study results show broad and enduring efficacy, broad across ACh, so acetylcholine, and muscarinic receptor-positive patients. And then that ability to steroid taper as well differentiates. Many of these patients will try just one or two therapies really before they land or they exit into some other kind of treatment pattern. So having something that physicians and patients clearly see the clinical value of, that is easy for them to use, we think is going to potentially be practice-changing, and that would be Uplizna.
Awesome. Maybe one last question, or maybe two last questions. One last question. So in the rare diseases, when you did the Horizon deal, you talked about both geographical expansion because Amgen traditionally has less revenues coming from ex-US compared to their peers. Part of it was how the initial deals were designed for Enbrel and all those early products. But I think with the Horizon acquisition, the goal was one geographical expansion, two rare disease indication expansion. So you have launched in Japan as well now, Tepezza. So how are you progressing in that area at this point, and what more to come?
Yeah. So if you recall, the deal, just like you said, was about getting access to a rare disease capability and being able to leverage our manufacturing capability and help expand those both in the US as well as internationally. So a couple of points. One, you see that we're selling Tepezza in Japan as well as several other markets, and those are going very well. We have approval in Europe, and we're having conversations with payers ongoing. So more to come there. And then, as you know, Uplizna is in several markets in Europe as well. So far, so good. We're excited about it. And the deal thesis is holding, and I would say it's better than when we did the deal. Uplizna is really showing, I would call it a grand slam. So really excited about it.
So yeah, I'll hand the floor back to you. And then if you want to add, one question I ask everyone every time. One year down the line, I hope you are here. I hope I am here. And I'm asking you this question. What would make you look back at the year and say it was a great year?
Yeah, that's a great question. And I think it just continues. For me, when I think about it, and I think if you ask anybody at Amgen, it's about continuing to serve more patients. And we talked about the unmet need there, and those are people with families and children and things like that. And we want to make sure that we're continuing to deliver for them. And that's both in-line, so making sure people are getting their LDL lowered, making sure women at risk, high risk of fracture, are getting their bones, taking a bone-building medicine. And then people with, unfortunately, suffering from cancer are still here today. So for us, that's the in-line products. And then it's bringing the hope of the next wave of molecules to patients. So I hope we have a bunch more pipeline success, a bunch in the early pipeline.
So I'm really optimistic, really excited about where we're at. We have a great platform. And that's where I would conclude this, is we have a great platform. We're well positioned to continue to deliver growth. And the breadth and depth across both the inline and pipeline are going to be exciting for the company for several years to come. So with that, Casey, anything you'd like to add? We kind of kept you quiet up here.
No, I think you and Paul covered it well, Adam, Mohit. I would just say thank you for having us, and thank you all for your interest in the company.
Thank you.
Thank you, everyone.