Awesome. Thank you very much for joining us again today. My name is Mohit Bansal. I am one of the biotech and pharma analysts here at Wells Fargo, and I have a pleasure to introduce Amgen management team with us today. We have Thomas Dittrich, Chief Financial Officer of the company. We have Paul Burton, the Chief Medical Officer of the company. We have Kaveh, he is the SVP Global Marketing and Access. Casey, you all know, he is the Head of IR at Amgen. Thank you very much Team Amgen for joining us today. I will give the podium to Thomas for prepared remarks.
Thank you, Mohit. It is really good to be here. Before we get into Q&A, I would like to take some time to introduce myself briefly and share a few thoughts on how we see the business today. As many of you know, it is actually my second chapter at Amgen. I spent nearly a decade here earlier in my career working very closely with Bob and with the team at Amgen. I have had the opportunity to serve in the meanwhile, while away, as the CFO of three public listed companies, where my responsibilities actually extended beyond finance into things like strategy, transformation, operations. I gained quite some experience in a more consumer-focused healthcare environment as well. I come back to Amgen knowing the company well, but at the same time, looking at it through fresh eyes, informed by my experiences over the last 12 years.
Given my recent background with a private equity-led IPO of a fast-growing company in a more consumer-focused healthcare setting, my focus will be on working together with my fabulous colleagues at Amgen as one team, driving execution and financial discipline to enable growth acceleration, both commercially and of the pipeline. I will focus on cash and cash returns, which is very consistent with Amgen's long-standing approach to capital allocation. On Q2, our second quarter results were driven by the breadth and depth of our portfolio. Once again, demonstrated our ability to grow through patent expirations and increased competition. Our six key growth drivers, Repatha, EVENITY, TEZSPIRE, rare disease, innovative oncology, and the biosimilar portfolios continued to deliver. Together, they grew 26% year-on-year and represented nearly 70% of total second quarter product sales.
Overall in the quarter, total revenues exceeded $10 billion, up 10% year-on-year, and 22 products delivered double-digit sales growth. These results, including strong margin and earnings performance, were achieved while increasing our investment in innovation, reflecting the sound financial structure that Amgen has as a business. Many of our medicines, and that is what is behind it here is, many of our medicines address large under-penetrated disease areas, giving us confidence that there are significant opportunities ahead of us to serve many more patients. We are adding new indications to some of our products like TEZSPIRE, UPLIZNA, and IMDELLTRA, while also broadening our geographic reach with these medicines and others. We have recently announced exciting phase III results from two of our approved medicines.
As you have seen earlier this week, we announced landmark phase III results from DeLLphi-305 evaluating IMDELLTRA in combination with durvalumab as first-line maintenance treatment in patients with extensive stage small cell lung cancer. The study demonstrated statistically significant and clinically meaningful improvements in overall survival, progression-free survival, and objective response rate compared with durvalumab alone. We view these data as important inflection point for IMDELLTRA. In the second-line setting, IMDELLTRA is becoming a standard of care supported by strong survival benefit, clinical differentiation, NCCN recommendations, and rapid adoption across sites of treatment. These landmark results from DeLLphi-305 suggest IMDELLTRA will further revolutionize the standard of survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease.
That's why we're advancing IMDELLTRA through a broad phase III program across first-line extensive stage and limited stage SCLC, while also pursuing more convenient administration. Together, these programs represent a combined addressable population of approximately 28,000 patients in the U.S. We believe IMDELLTRA has the potential to become a foundational medicine across the small cell lung cancer continuum and will continue to be an important growth driver for our innovative oncology portfolio. We also recently announced positive top-line results from the phase III study of TEZSPIRE in people living with eosinophilic esophagitis, EoE. A very challenging disease, as you know, which affects more than 470,000 people in the U.S.
Today, we are pleased at this point, this podium here, we are pleased to announce the phase III OPTIC-J study of TEPEZZA in Japanese patients with thyroid eye disease met both primary endpoints with no new safety findings observed. These results reinforce our efforts to reach more patients in Japan as we continue to broaden TEPEZZA's reach and footprint outside of the U.S. Beyond these programs, our late-stage pipeline is progressing well and provides additional opportunities for growth. We're advancing MariTide, dasotralimab, and xaluritamig in phase III development, and all of these programs have the potential to address areas of significant unmet medical need and to drive long-term growth for us. We continue to develop olpasiran, targeting Lp(a) for cardiovascular risk reduction. Recently, as you have seen, a competitor announced top-line results from their phase III program targeting Lp(a), raising many questions for the field.
We look forward to seeing the detailed presentation of these data to better understand the potential implications for the field and for our ongoing clinical research with olpasiran. Now moving on to our biosimilar portfolio, we're advancing a third wave of biosimilar candidates to KEYTRUDA, OPDIVO, Ocrevus, and EYLEA HD. We recently completed a phase III study of ABP 234, our biosimilar candidate to KEYTRUDA, which met both primary and secondary endpoints. These full results will support our planned regulatory submission in the second half of this year. Additionally, for ABP 206, our biosimilar candidate to OPDIVO, our Biologics License Application with the FDA has been submitted and accepted for review. We expect an FDA action on that BLA by end of the year.
As we look ahead, the business continues to do well, and we are excited about the future and our ability to deliver growth, durable growth, well into the next decade. With that, Mohit, we are happy to take your questions.
Thank you. Thank you very much for this. I have to ask this question. How is Amgen different in your second act versus the first act?
Yeah, Amgen is a very different company in the sense that it has grown significantly. It is more than twice the size.
Right.
The portfolio has expanded significantly. It has much more depth and breadth, as I said earlier, compared to when I joined 20 years ago for the first time. I am also a different executive coming back.
Right.
As I said earlier, I did other stuff, three companies. I was interim CEO in one. The common thread there was all growth acceleration.
Right.
It is really good to come back and bring understanding of what the company is and what its core is, which I always had huge respect for, which is really driving innovation and driving science, and then complement that with the experiences I have made elsewhere and bring that back home. It is good to be back.
Awesome. Good to have you back. Let's just start with the Lp(a). I am sure, let's just get it out of the way, because that is the question I am sure
Let's get it out of the way.
everybody is thinking about. Even from a failed trial, we learn a lot. So what do you want to learn from the detailed data when they come out, whenever they come out? What, as investors, we should be focusing on when the data come out, in terms of endpoints, in terms of patient selection, what are you focused on?
Yeah. So I can just start briefly. Look, as you say, and as Thomas said, we need to have a thorough review of the data. Hopefully it will be presented, published. We will get a lot more insight then. I think we need to see how the components of the primary endpoint, which was a four-point primary endpoint, fall out. What were the baseline characteristics, particularly in terms of Lp(a)? What was the reduction? I think those are going to be the key things.
Okay.
Obviously, we are somewhat differentiated in our design mechanism of action and impact on Lp(a) lowering with olpasiran, but we will learn a lot, and hopefully we will see the data very soon.
Got it. Very helpful. Now, coming to Amgen, congrats on the data, but this is an access slash. The question of community physicians treating a lot of small cell lung cancer, because this is the disconnect we saw when you were approved in second-line plus, that academic doctors love it, but then community centers were. They found it to be difficult. How can you bridge that gap, and what can you do to make sure that it gets adopted more widely?
Yes, it's a great question, Mohit. Look, I'm really proud of the work that we've done with IMDELLTRA, again, to Thomas' point, really revolutionizing the standard of survival in small cell lung cancer. I got the opportunity to meet one of our early clinical trial patients when I was in Europe over the summer, who's been on a survival curve of greater than five years now.
Great.
Just absolutely incredible. When we look at the U.S., while there was a lot of talk in advance of the challenge potentially for community, we actually see very good community adoption of IMDELLTRA thus far. We've got over 2,000 sites that are using the product actively today. One of the remaining barriers to access in the community setting is the label currently identifies that we require 22 hours of monitoring on the first two doses, which often is dealt with in a partnership with a local hospital to initiate therapy. We're really proud that in Europe we've already achieved a six to eight hour monitoring requirement, a significant reduction. In the U.S., we filed and have a PDUFA date for a similar six to eight hour monitoring reduction, which will continue to help that community physician process more and more patients.
But importantly, when we look to DeLLphi-305 and the frontline maintenance data that we just announced, very importantly in that study, in the U.S. setting, monitoring was reduced to one to two hours overall. We are looking to expand on that great basis of overall survival use across all sites, but the reduced monitoring requirement will help that community even more going forward, especially as the patient population significantly expands to the 28,000 a year that Thomas mentioned in the frontline setting.
Got it. Very helpful. The other part I want to really focus on is the rare disease program. You have found a lot of success with the rare disease assets. I mean, some of them you got from Horizon acquisition. The trial that is reading out fairly soon is Sjögren's trial.
Yes.
Talk a little bit about your approach there. It has been a difficult disease.
Yeah
What should be our expectation? You have two different types of trials there.
Yes
Just talk a little bit about that.
Yeah, I can start and Kaveh maybe add some color. Sjögren's disease, 350,000 patients in the U.S. We know it's an autoimmune, B-cell-driven disease. Cardinal features are attack of the tear glands, the lacrimal glands, and the salivary glands, debilitating features. Now, about 30%-40% of patients outside of the tear and salivary glands have systemic features. The kidney is involved, the lung is involved, and somewhere between 60% and 85% of patients are symptomatic. Okay, so those are the two populations, systemic and symptomatic. We have published data on a phase II trial where we looked at both of those populations, and we saw clinically important, statistically significant reductions in both of the endpoints. For systemic patients, it's the ESSDAI, D-A-I.
For the symptomatic patients, it's a reduction in ESSPRI, P-R-I. We now have these two phase III studies that are ongoing that will test both of those populations. I think patients and physicians will want to see reduction in those two types of endpoints. We have our phase II data that we've built this program on, and so we remain optimistic that we'll get a positive clinical outcome.
Is there a reason to believe one trial has a better shot versus the other?
As I say, we saw benefit in both populations in the phase II study. Biomarkers were reduced as well. There's a publication in Nature Medicine that talks about that. So, as you said at the start, this is a high unmet medical need, very few effective therapies today, debilitating disease. So we're excited about this medicine and the benefit it could have here.
Got it. Do you think you have to be successful in both trials here, or why is it-
No, I think they can probably stand on their own.
Okay.
As you say, we'll have the data in the coming months, and we'll be able to go from there.
Exciting times.
Exciting times.
Right. Going back to you, Thomas , the question, I think like a broken record, I ask this question and I know the answer already. Amgen takes the margins very seriously. That's the answer. You have been sitting at a very good margin profile, like 48% in second quarter of 2026. There's a lot of investment coming, and there's a little bit of LOE period as well with some of the assets. Would love to understand how you balance the investments and those things, I mean investments and pipeline? The related question is, do you think you have enough in the pipeline, or do you think you want to add more at this point?
Okay. Well, that's two questions, but let's take them one by one.
Yeah.
There is an umbrella answer across both of them, and that is that at a high level, we see significant opportunity across our six key growth drivers to drive growth forward and on our pipeline that we already have. We are busy, and we see a lot of potential to grow. On the first question is, how do you now get that growth and that value creation going? There margins do matter. I mean-
Right
Margins matter to us because they matter to you, our owners, our investors.
Right.
We are committed, have worked really hard before my time, to become a top-tier margin company, and we are committed to remaining one. At the same time, and that comes to your trade-off question here is, we would be prepared to flex margins slightly downwards, as we have done from the peaks that it was up in the 50s or so, if we see real opportunities to invest behind drivers that create long-term value. When we say value, it's cash-on-cash returns, right? Really hard value. There, we would do that and trade that off against growth and value creation going forward. Look, this year is even a very good example. We are guiding to roughly 45%-46% non-GAAP operating margin while doing all those investments.
Right.
What the missing link in here, or the key thing to focus on is actually productivity. It is productivity through process streamlining. Yes, of course, systems, AI very strongly to free up funds over here that you can invest them over there to drive growth, to drive value creation, not have an either/or. It is actually an and. On the second part of your question, pipeline, yeah, of course, a pipeline can always be full and even fuller. But honestly, here, when you look at it, what we have, we have a lot to work on. Look at my prepared remarks earlier.
Right.
I lined up a few for you. That allows us to maintain a high bar for external innovation. We have very clear criteria on those. I can walk you through what those are, but they are the same that we had before. When an asset comes around that we feel meets those criteria, then we would go after it, but it is not something we need to do to fill a gap here.
Right
per se.
Got it. This is your chance, Paul, to ask your CFO, do you have enough pipeline or do you need more?
Do we need more funding? We always need more funding.
Right.
We do have an amazing pipeline.
Right.
We have amazing in-line medicines. We help millions of patients a year around the world.
Right.
I think we have great sustainable growth for the remainder of this decade and into next decade as well.
Okay. Very helpful. Thomas, you mentioned that you are willing to flex the margin if you have good opportunities. At 45%-46%, do you think you are at the low end of that range that you want to be or?
Yeah, as I said, we're committed to remaining a top-tier margin company, and we have so many levers to pull. We give guidance annually. 45%- 46% is the guidance we have for this year, and we are very careful because margins are a surrogate, as close as you get to a cash equivalent. So we are very thoughtful of it. It matters to you, it matters to us. But we are not chasing the percentage per se, which would also be a problem because you know companies that chase margin percentages and then sacrifice growth and value creation stops. So we're doing both.
Got it.
We are conscious around it.
Completely makes sense. Kaveh, a question for you. Now that we have really good data, FOURIER-OLE data with Repatha in hand, what are you seeing in marketplace because are you seeing increased use in primary care or primary prevention plus primary care, two separate things here, because statins are predominantly used in primary care segment, and that is the market which was a little bit late to adopt the injectable. So what are you seeing in this marketplace and how do you see Repatha going from here?
Yeah, no, it is a great question, and again, we are super pleased with Repatha overall. If I remember correctly, and Casey correct me if I am wrong, 37% year-over-year growth.
Yeah. After so many years.
last quarter. Last quarter we announced also over 50% growth in new-to-brand prescriptions for the product. Overall, we are seeing an inflection in use following the publication of the FOURIER-OLE data in the primary prevention setting, and that inflection, Mohit, is frankly coming from every segment that we're operating in. In the third quarter alone, in the last several weeks, according to the IQVIA data, we've surpassed not only 15,000 new patients per week, but now 16,000 new patients per week at the end of August. We are seeing incredible growth. That growth is coming from both segments. It's coming from the primary care segment and the cardiology segment as the product gains greater and greater use backed by guidelines, which Paul can talk to you a little more as well.
Importantly, just at the end of August, we also received our approval for primary prevention in the E.U., and so we are starting that launch cycle as well. This is a global brand, and this data will help power the growth well into the next decade across that global brand. Paul, do you want to add anything further on the guidelines and the data?
Yeah. No, thanks, Kaveh. The only thing, Mohit, I would add is clearly we have the ACC/AHA multi-society-
Right
lipid guideline that came out. Everybody should be below 100 if you have risk factors, below 70 or even 55 if you have more risk factors. The American Academy of Family Physicians, to Kaveh's point, is now endorsing that guideline as well, which is new, and I think will be very important as we continue to get further penetration into the primary care setting. Very important.
Very helpful.
It was in last week.
Thank you for that. Kaveh, one more question for you then. How do you see oral PCSK9s impact your market? Do you see it as an expander, or do you see it as a competitor here?
Yeah, I think here, Mohit, it's probably good to zoom out and just look at the overall marketplace. Right now we know that there's at least 100 million individuals out there that are not at guideline-based LDL, despite the fact that they're on standard of care small molecule therapy. Despite that incredible growth I've talked about with Repatha, PCSK9 penetration is still in the low to mid-single digits. We're seeing, in particular with the orals coming in and other players, that it's growing the market much faster than taking share away from any one molecule or the other. We think that trend will continue going forward, just given the size of the market to still be penetrated is so much larger than the size of the market treated today.
Got it. Very helpful. MariTide is one topic which comes along a lot. You are definitely excited about this. Investors are still questioning, not so much the clinical profile of the drug, but also it is more because of the competitive market, there are a lot of offerings out there. The question here is that how do you differentiate the clinical trials in a way where you can actually establish that there is a benefit of MariTide into the marketplace? This is probably where your sales and marketing team is also helping you. Talk a little bit about that, and then where do you see the room in the market where you can actually place MariTide in this space?
Well, I can start. Maybe Kaveh will add some detail as well. Look, MariTide is a highly differentiated medicine.
We believe. The opportunity for every eight-week or even quarterly dosing. We are in multiple phase III clinical trials now across a whole variety of different indications spanning chronic weight management all through cardiovascular disease and sleep apnea, diabetes as well. Our phase II study clearly showed that we can get 20% weight loss.
We have instituted now in our phase III program a simple three-step dose escalation at the time of initiation. We've tested that in a phase III study as well and looked at rates of nausea and vomiting. It meaningfully improves those rates. We think that will be a very attractive offering, and we know from our phase II data that once patients get to their target maintenance dose, has a very acceptable tolerability profile.
Look, we think the opportunity for extended dosing, robust weight loss and management of weight with the potential for all of the other additional cardiovascular benefits we know, again, from phase II, reductions in triglycerides, high sensitivity CRP reduction of 11 millimeters of mercury in blood pressure. That surround sound of cardiovascular risk reduction is really important.
Right.
We see this as a highly differentiated medicine, and a huge population of people out there-
Right
who are looking for that kind of an offering. We should be able to provide it with an easy-to-use injection device. We think it will be very attractive for patients and systems as well.
What are you hearing from payers/the marketplace?
Yeah, look, I think it's a little early for conversations specifically with payers, but what we hear universally is that this is a really big market, Mohit. There's a lot of different needs within that marketplace.
Right.
The entirety of the profile of MariTide that we believe is coming is going to fit really well into that marketplace. One of the things that I do think is a very large unmet need that, to Paul's point, MariTide is uniquely positioned to potentially solve is this idea of how do you keep the patients that have started on GLP-1 on GLP-1 for a longer period of time.
In the U.S., there is now more patients that have started and stopped taking the medicine than there are on the medicine today. We think that this unique profile of this antibody drug conjugate that could be used as little as four to six doses per year could offer an interesting solution in that longer-term maintenance setting after the initial weight loss, and we are studying as such. We have got two long-term extensions studying this lower dosing in a maintenance setting.
We also, of course, have a switch study that shows how someone could switch to and stay on MariTide over the longer period. That entire package we do think is going to be quite attractive in this very large marketplace that is going to have multiple options available within it.
Very helpful. I want to touch upon UPLIZNA as well. Your growth products, I can probably have a half an hour or one-hour conversation with you alone, but the question is, what are you seeing in the marketplace for UPLIZNA now? The gMG launch is well underway. Is it new patient? Is it second line? What exactly are you seeing there?
Yeah. UPLIZNA is a great product from the Horizon acquisition. Casey can correct me, I think 90% year-over-year growth in the second quarter. Three indications, NMOSD, which is the longstanding indication, new indication in IgG4-related disease. First and only medicine approved there, and so we are building a market in that space. Then obviously gMG, an existing and large market that we are competing in. Within the gMG space, we continue to see about half of our patient volume coming from naive patients and about half coming from switch overall.
Mohit, that fluctuates couple points every month, but that generality still comes, and we have now seen enough data where it looks like our switch data is coming pretty much evenly from the other markets and other players in the market based off their use. We are really happy with the broad acceptance of this medicine within the gMG community and how it is seen as a solution irrespective of where the patient starts on therapy.
Got it. Very helpful.
We are, of course, expanding into new indications.
Yeah. Talk about that.
Autoimmune hepatitis and CIDP. We see, as Kaveh says, a very safe medicine with clear clinical benefit, now has many other opportunities to-
CIDP, have you started the trial?
We'll be starting that very soon, and AIH, of course, enrolling.
Awesome. Exciting times. Maybe you don't need BD, but I have to ask this question. The question is, what would be the priorities if you look into external? Your balance sheet is in a good position now. Horizon, I think it's out of the way now, so it's in a good position. What are the priorities if you look externally? What exactly would you be looking at?
Yeah, first off, strategic fit.
Right
to our clear. Then, second, it needs to generate positive cash and cash returns.
Right.
We need to be the best owner.
Right.
The right buyer, best owner. We need to convince ourselves of that. Then finally, we look for can we integrate it promptly?
That's a clear ladder of priorities. Where we are open is deal structures, for instance, right?
Right.
That can take various forms from licensing to M&A. There we're very flexible and have proven that also in the past that we can, with that approach, absorb assets that add to us and that bring us forward in exploring and delivering medicines for situations for huge unmet needs. There we act on those. But four criteria, I think they make complete sense.
Awesome. One last question. This is my fifth year at Wells Fargo. This is your fifth year at Wells Fargo. So thank you very much for that. Hopefully, in my sixth year of Wells Fargo, you're also here. In 2027, September, what would make you look back at the year and say it was a great year for us? Where do I want to start?
Maybe let's start with the commercial person here.
For this year specifically, Mohit? What would make
Well, next year. You are sitting here next year and looking back at this year.
Yeah. I think, again, what would be great for us is to see our six commercial growth drivers keep growing at the pace that they've been growing, Mohit, and hopefully to see, by the time we're here next year, an approval for IMDELLTRA in the first-line maintenance setting and helping those 28,000 patients live longer than they can today.
Paul?
Look, I agree. I think we take on some of the world's toughest diseases, and we bring transformational innovation to them, and we bring profound improvement in clinical outcome. We do that across all of these growth drivers that you've heard about. I think we're well positioned to continue that growth throughout this decade and into 2030 and beyond. I would love to see Repatha continue to grow.
I think the benefit that that medicine can bring to patients is huge. We've brought transformational benefit to small cell lung cancer patients. We have xaluritamig that hopefully we'll see data in prostate cancer patients. Again, I think that BiTE platform can bring tremendous benefit to patients. Then, of course, as Mirati continues to grow, we're able to treat not only massive populations of individuals here in the U.S. and around the world, but we can also continue to treat smaller populations but bring that substantial clinical benefit to both of them. I think that would be an amazing thing to look back on.
Awesome. You want to round it out?
What I would say is, as you all might appreciate, I looked at the company outside in, and now I'm inside. So I have to say, I'm even more excited about the growth potential, not only across the six growth drivers, but there is so much headroom for growth yet even within those. Then the pipeline, looking outside in, and I had to rely, of course, then on data you all see. I would say Amgen is hugely underappreciated, but we're okay with that.
Right.
We'll execute, then in a year's time, we'll sit here again, then we're looking forward to your questions, Mohit.
Awesome. On that high note, thank you very much, hopefully you'll be here next year.
Thank you.