Amgen at BofA Securities Conference: Strategic Growth and Innovation

Published 15/05/2025, 00:04
Amgen at BofA Securities Conference: Strategic Growth and Innovation

On Wednesday, 14 May 2025, Amgen Inc. (NASDAQ:AMGN) presented at the BofA Securities 2025 Healthcare Conference, showcasing a strong start to the year with a 9% revenue increase driven by 14% volume growth. While the company emphasized its commitment to innovation and expansion in key areas, it also acknowledged potential challenges from policy changes. Amgen remains optimistic about its growth prospects and pipeline potential, underscoring its strategic focus on innovation and patient access.

Key Takeaways

  • Amgen reported a 9% year-over-year revenue growth in Q1 2025, driven by 14% volume growth.
  • Significant investment in late-stage programs like Meritide and Opasiran, with R&D spending set to increase by 20%.
  • Biosimilars portfolio saw a 35% increase, with strong performance from new launches.
  • Potential disruptions from policy changes were acknowledged, but the company remains resilient.
  • Amgen is actively exploring business development opportunities, particularly in obesity-related assets.

Financial Results

  • Q1 2025 revenue grew by 9% year-over-year, with a 14% increase in volume.
  • General Medicine products Repatha and Evenity generated over $1 billion, up 28% from the previous year.
  • Biosimilars portfolio achieved $735 million in Q1, a 35% year-over-year rise.
  • Non-GAAP operating margin exceeded expectations, with a full-year target of approximately 46%.
  • R&D spending is projected to grow by 20%, focusing on late-stage program investments.

Operational Updates

  • Euplisna launched as the first approved therapy for IgG4-related disease, with a PDUFA date for generalized myasthenia gravis on December 14.
  • Hespyr continues to perform well in treating severe uncontrolled asthma.
  • Ongoing enrollment in two Phase 3 COPD studies.
  • DELPHI 304 Phase 3 trial showed significant survival benefits for Imdelta.
  • Continued investment in manufacturing facilities in Ohio and North Carolina.

Future Outlook

  • Increased R&D investment to support late-stage programs such as Meritide for obesity.
  • Expansion of biosimilars with candidates against OPDIVO, Keytruda, and OCREVUS in Phase 3.
  • Active pursuit of business development opportunities, focusing on novel obesity treatments.
  • Aim to return to pre-Horizon capital structure by year-end.

Q&A Highlights

  • Amgen is monitoring policy changes, including tariffs and IRA impacts, while maintaining guidance.
  • Commitment to US manufacturing with investments in Ohio and North Carolina facilities.
  • Phase 3 trials for Meritide modified for better tolerability, based on GLP-1 learnings.
  • High confidence in Olipasiran’s potential for reducing Lp(a) levels.
  • Acknowledged the growing impact of the biosimilars portfolio.

Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - BofA Securities 2025 Healthcare Conference:

Tim, Host, BofA: Excited to have Amgen with us this morning. Three speakers: Peter Griffith, Executive Vice President and Chief Financial Officer since 2020. He joined from Sherwood Canyon Group, a private equity advisory firm And he was at Ernst and Young prior to that. We have Doctor. Jay Bradner, Executive Vice President of R and D and he’s responsible, of course, for everything in the pipeline.

He was with Novartis prior to that. And we have Justin Clays, Vice President, Investor Relations, who’s been in that role since 2023, been with Amgen for a long So it’s part time chat. And I think, Peter, you might make a few comments to kick things off.

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: Thank you, Tim. And thank you, BofA, for inviting us. We’re delighted to be here and thank all of you for your interest and attending this morning. So at Amgen, we started 2025 with strong momentum. Financially and across the enterprise, our performance this year reflects the growing global need for our innovative medicines and our team’s relentless focus on execution.

We are seeing strength across our portfolio and our pipeline and we expect to deliver strong growth in the near term and through the long term also. In the first quarter, revenue increased 9% year over year driven by 14% volume growth. The momentum was broad based with 14 products delivering double digit growth across our key therapeutic areas: General Medicine, Rare Disease, Inflammation and Oncology. So a few areas I’d like to highlight for you. In General Medicine, Repatha and Evenity together delivered over $1,000,000,000 in the first quarter.

That was 28% year over year growth. Both brands have significant growth potential, serving large patient populations that are still predominantly untreated despite the availability of these impactful therapies. Our cardiovascular candidate opaciran targeting Lp which Doctor. Brandner will speak to you about I’m sure, a genetically fixed risk factor for cardiovascular disease is fully enrolled and continues to progress. And in obesity, we’re advancing Meritide.

With two Phase three studies in chronic weight management rapidly enrolling and we’re excited to share the underlying details at fifty two weeks from Part one of our Phase two study along with data from a Phase one PK study at the American Diabetes Association in June. In rare disease, we are excited to have recently launched Euplisna as the first and only approved therapy for IgG4 related disease. This is a serious chronic and debilitating immune mediated inflammatory condition and feedback from both patients and physicians has been very encouraging. We also have a PDUFA date for Euplisna in generalized myasthenia gravis on December 14. Our progress with Euplisna as well as blinatumomab underscore Amgen’s ongoing leadership in developing innovative treatments targeting CD19 positive B cells in cancer, inflammation and in rare disease.

More generally in rare disease where only five percent of the estimated ten thousand rare diseases have available treatments. In inflammation, Hespyr continues to deliver in severe uncontrolled asthma. And we are looking forward to our PDUFA date for chronic rhinosinusitis with nasal polyps which is 10/19/2025. We are also enrolling patients in two Phase three studies in chronic obstructive pulmonary disorder, an area with enormous unmet need and in a Phase three study of TESSPIRE in patients with eosinophilic esophagitis. And in oncology, our Bi Platform is delivering.

BLINCYTO is expanding into earlier lines of treatment. INVELTRA continues its strong momentum with over $80,000,000 of sales in the first quarter and being well accepted both by academic and community oncology groups. We recently announced compelling results from our Delphi three zero four Phase three trial where at a planned interim analysis the study met its primary endpoint demonstrating a significant and clinically meaningful overall survival benefit. These data will be presented at ASCO in June. Our first in class STEAP1 CD3 bispecific T cell engager, zaluritamab is advancing Phase three clinical development where we are rapidly enrolling patients with metastatic castrate resistant prostate cancer who have progressed following taxane based therapy.

We are also exploring zaluritamab in combination therapy and in earlier stages of prostate cancer with multiple Phase 1b studies progressing. Collectively, Imdelta, Blincyto and zaluritamab exemplify the significant growth potential of our robust bispecific T cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide. Now on to our biosimilars portfolio generating $735,000,000 in the first quarter, up 35% year over year, driven by the launches of Pavblue and Wevlana in The United States. We also recently launched the Bekemvy in The United States. These results exemplify our strategy of delivering long term biosimilars growth through waves of new products.

To this point, we are also advancing the next wave of biosimilar candidates including against innovators OPDIVO, Keytruda and OCREVUS which are all in all of ours are in Phase three development and progressing well. Before turning to Q and A, I’d like to remind you of a few points on the 2025 outlook from our earnings call. Namely, our first quarter non GAAP operating margin came in above expectations, driven in part by the timing of R and D spend, including milestone payments and other investments, which are now largely expected in the second quarter. And we expect full year non GAAP research and development spend to grow 20% now year over year reflecting increased investment in late stage programs including Meritide and Opasiran. So we recognize it’s a dynamic environment, whether it’s evolving policy and prices, taxes and tariffs, and also general macro uncertainty and geopolitical.

We’ve built a business with flexibility and resilience and we have the operating discipline to manage through this. So our mission remains clear at Amgen, serving patients by delivering innovative medicines to patients with serious and grievous illnesses. We believe we’re well positioned to do that. Tim, back over to you for Q and A.

Tim, Host, BofA: Okay, great. So we have limited time here. Let’s just jump straight in. We’re going to ask policy questions, of course. And I know that it’s hard to have solid answers here, but we really need to ask every company that we’re talking to.

So any disruption to how you guys are running the business at the moment from everything that’s been put forth, MFN, tariffs, IRA, FDA changes? Are you gating the hiring of employees? Are you thinking about clinical trials differently, M and A differently?

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: Well, Tim, there’s a lot in the question. But let me just say, first of all, when we gave guidance for 2025, we were very clear that, that included expectations around what we needed to deal with currently implemented or enacted tariffs. And so first of all, that’s where we’re at in terms of how we view the rest of the year right now. So when we think about future or specific tariffs, they’re not included in that outlook. And Tim, I would just remind our colleagues here today with us that we are very committed to The United States.

So after the first TCJA of twenty seventeen, we went out and we acquired significant land in Ohio and North Carolina and we built a finished drug product plant in Ohio, which was up licensed and running in January of twenty twenty four, clearly our most automated plant going very well. We’ve recently announced almost another $1,000,000,000 into that to put another facility on that land. In North Carolina, Holly Springs, North Carolina, Tim, we announced that we were putting up a drug substance plant. And then we’ve also recently announced in addition to that plant, which we expect up and licensed in 2017 or 2018, we expect and are starting work on a second plant. We’ve announced another $1,000,000,000 into that facility there.

So we’ll have two facilities there. So we’ve doubled down on The United States and what we’re doing here. We’re actively looking, as you can imagine, we’re Amgen and all mitigation strategies, but we’re not trying to guess where the puck is going. We’re being very thoughtful. We continue to monitor the environment.

We’re not speculating on best or worst case scenarios. We remained engaged certainly in industry wide policy discussions. We continue to execute. At Amgen, we had a very solid first quarter. We continue to deliver the medicines we have to our patients around the world and we’ll stay focused on that first and foremost.

Just one last point. During COVID, we were able with our supply chain to work very, very thoughtfully through COVID, and we didn’t miss a beat. We were able to help colleagues in the industry with manufacturing when they needed some help. We were happy to do that. So we want to continue to remain on the balls of our feet and do what we need to do to get medicines to the patients.

Tim, Host, BofA: So when you’re running a business, forecasting where the puck is going to go is just part of the day to day job. So you have to do that to some degree. So on the most favored nation stuff that’s being talked about, real or absolute nothing but better? Well, you

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: used the word stuff. So that’s probably an operative word to think about a little bit. We read everything. We’re very active. And we like to think when we go to Washington, we’re active on behalf of the patients and patients around the world.

And we want to stay focused on that first and foremost. But we certainly want to make sure that we’re doing everything we can do to stay focused on how can we get more medicine to the patient. We want great access. We want great value for those patients. And we always continue to remain focused on that.

So let’s see where that all shakes out. And we’re going to read the details with you and everybody else as soon as they’re available, and we’ll respond accordingly. But we certainly are planning and thinking about whatever we need to do to make sure that supply continues uninterrupted.

Tim, Host, BofA: When you guys think about prices in The U. S. Versus ex U. S. Prices, just whether it’s an Amgen data point or just an industry wide data point, I mean, I’ve always heard a rough rule of thumb that ex U.

S. Prices are, especially in Europe, 20 Percent to 40% lower, somewhere in that range. So you don’t have to answer it from the Amgen perspective. But there’s a lot of other information out there that talks about much bigger pricing disparities that I’m not sure are real. So can you give any sort of industry commentary, U.

S. Net prices versus European net prices, whether it’s an Amgen data point or anyone else?

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: Yes. I don’t think we’re prepared to do that today. I think that’s probably something best left to maybe chat GPT-four or something like that at this point in time. But I would suggest it’s important. We need to think about it.

I completely understand the question, but we also want to remain very, very grounded right now and not get ahead of our skis and stay focused on our mission, which is to serve patients. And we have a fantastic commercial group. We have a fantastic public policy group. They’re literally working 20 fourseven right now to make sure we interrogate all this and we share our views and opinions on behalf of patients with those that are not making the rules and thinking about it and we’ll continue to stay focused on that right now, Tim.

Tim, Host, BofA: The last question on this is, just play forward a scenario where there is some impact on just government programs on Medicare and Medicaid. Do you think, does Amgen think, there would be any commercial spillover to the commercial book of business?

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: I don’t think we’re going to speculate on that right now. I think there’s a pretty well established commentary out there on that now that our colleagues can view and others that will write more articulately on that right now. We just don’t get in the business of speculating on that. Look, we think the most important thing is to make sure those patients continue to get the medicines and get the right value and access when they get up to that pharmacy counter and to the doctor’s office. And so let’s stay focused on that right now and let those who are making the rules pay attention to all the input they’re receiving right now and do what they need to do to make sure The United States continues to drive innovation.

I mean we have Jay with us today and I just love thinking about innovation, Tim. And what do we need in The United States and everywhere else? We need more innovation. We’re raising our R and D spend this year 20% year over year and that’s what we’re going to stay focused on. It’s the number one capital allocation at Amgen.

We intend on continuing to do that. We intend on continuing to interrogate these four therapeutic areas. We talked about the BiTE platform and we talked about what we’re doing with Euplisnet. We talked about rare disease and we’ve invested behind innovation. We’re going to continue to do that.

Tim, Host, BofA: So maybe that’s a good segue into some certain disease area questions I have. You just mentioned R and D spend kicking up 20% this year. Part of that is spending on obesity and the trials that you guys are beginning. And then there’s just underlying inflation too in R and D. I was talking to an executive yesterday from one of the companies who said that they were really battling just underlying inflation inflationary pressures over the last year or one point years.

So my question one of the questions I have is, as you think about broadening Meritide, we know what the R and D spend looks like in 2025 per year guidance. How should we think about that as you go forward in 2026? Because you guys have articulated running a broad development program, rule of thumb, those are $100,000,000 trials. You run 10 trials, that’s $1,000,000,000 That’s a lot of incremental R and D spend coming into the organization.

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: So let me spend a moment because I think, Tim, that gives me an opportunity to speak to a moment to our operating margin. So we’ve said all along at Amgen, I’ve been in the seat five point five years, if we can generate after tax cash flows for our shareholders in excess of our hurdle rates, that’s what we want to accomplish. And if there are times we need to flex that operating margin objective, which those of you who are familiar with Amgen and I hope all of you are and we want you to be, we generally shoot for about a 50% operating margin. We were there for ten years or so, but we flexed it last year. We dropped down to about 47%.

This year, we’ve guided to about a 46% margin. And incorporated into that as we said at our first quarter earnings call is this increase in research and development of about 20% year over year. We call it earning the flex. So when we do flex down below that, we want to make sure we’re earning it. We are fortunate right now as a company, but we’re fortunate on behalf of patients to be able to have some late stage pipeline activities that demands investment to make sure that we get those trials done.

We’re focused on that. We’re going to invest that money. We’ve given you numbers and guidance for 2025. We don’t go beyond that, but we’re going to make sure that these trials get done in a way that satisfies Jay as our Head of Research and Development and that we investigate these as deeply as we possibly can to make sure we get them done as quickly as possible and get the medicines out to patients. So operating margin is something we think about.

We use that as a guide. We’ve given you specifics on ’25. We don’t go beyond that generally. But I can tell you we’re committed to doing what it takes to move this forward and create the after tax cash flows for our shareholders above our hurdle rate that makes sense as we create these and investigate these medicines for patients. Peter, if could just jump in, Justin, please.

Justin Clays, Vice President, Investor Relations, Amgen: Yes. I think something that’s maybe not totally obvious from the outside is the really strong culture of productivity and efficiency that’s built into the company. We actually Amgen was running at an operating margin in the high 30s, and we actually brought that to over 50%. And a large part of that was a companywide effort to really just take a fresh look at how we do everything soup to nuts. So in terms of your comment about underlying inflationary pressures and just how do you find the room to spend, I wanted the folks to be reassured that that’s an ongoing effort of the company to make sure we’re doing everything as efficiently as possible.

Maybe, Tim, on

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: inflation, because I actually think that’s an important point. I would remind our colleagues that when we constructed both Ohio and North Carolina, it was in the midst of COVID and the high inflation year was it ’22, Justin? Yes, ’22. We went right through that. We were on budget on time.

And so we’ve got a very strong global sourcing group. We play hard. We want to make sure we get in front of inflation and we stay in front of it. We can’t do it forever. But sure, can play hard, create productivity, use technology and artificial intelligence as best we can to make sure that we’re stretching our shareholders’ dollars as best we possibly can.

But inflation is we watch it carefully.

Tim, Host, BofA: Jay, some questions for you. So data coming up at ADA, there’s a widely held view on the street. I’m sure you’ve heard it that the nausea and vomiting rates and the tolerability that we’re going to see out of this data set coming up is not going to look pristine. You guys have modified dosing for Phase three. So kind of who cares what the Phase two shows in a way because you might be able to change it in Phase three and improve upon that.

So what do you want to say about the data coming up? And then just kind of related to that, mechanistically, obviously, your compound is a GIP antagonist, Lilly’s is a GIP agonist. And Lilly talks about GIP agonism as one of the things that makes their drug more tolerable than Wegovy, PURGLIP1. So as an antagonist, that something that’s a structural thing to consider with miratide? And in your view, does GIP agonism or antagonism play a role in tolerability?

Well, thanks, Tim. There’s three aspects to

Jay Bradner, Executive Vice President of R and D, Amgen: your question then. One is quite mechanistic, one concerns the ADA and another is just how we’re thinking about the program in Phase III clinical investigation. We indeed have two chronic weight management Phase III clinical trials open and enrolling very well for Meritide, one with diabetes and one without. I’ll take the mechanistic question first because I think

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: it lays the groundwork for

Jay Bradner, Executive Vice President of R and D, Amgen: what would come next. The pharmacology, the genetics and the biology of this pathway are very, very, very well mapped out. So this isn’t sort of an emerging area of research, it’s an old one. But still as you cited in your question, there can be learnings from different medicines in different settings. We’ve undertaken with meridotide to inhibit the GIP receptor because of experiments of nature.

It turns out that there are genetic polymorphisms, variations amongst all of us. And if you’re so lucky as to have one mutation that decreases activity through that pathway, expression of that receptor and its activity, you’re protected from obesity. Where you might know a leading human genetics group with our Amgen Deco Genetics facility in Reykjavik and all. And so we chose to inhibit it experiments of nature, human genetics told us to. And I think this is playing out quite favorably with respect to the remarkable efficacy that we saw from Miratide in the Phase two clinical trial with almost approximately 20% weight loss in only fifty two weeks without a weight loss plateau in that Phase two study.

You asked about tolerability though, and we believe firmly that miratide will be very well tolerated in the context of the Phase three study because there’s been number one, incredible learnings from the field. People have been tinkering with GLP-one agonism, the other pharmacologic activity of miratide for a very long time. So low index dosing, careful dose titration, guided by clinical investigation in the human experience, we’ve applied all those principles and have arrived at a Phase three dose escalation plan that will onboard this medicine to patients we think in a very tolerated, well tolerated and competitive manner. But now back to your mechanistic question because I find it so interesting and there’s data from just this week that shine a light on that. Recently at the European Congress for Obesity, the Surmount five study was presented.

I’m sure you followed this announcement, believe it was Monday, Spain time midday where semaglutide and tirzepatide were studied head to head. Semaglutide, pure GLP-one agonist, no other activity. Tirzepatide, GLP-one agonist that also can agonize or activate the GIP receptor, the opposite of what we’re doing. Nausea rates between the two medicines, identical, forty four percent. And so it does remain to be seen, I believe, whether GIP agonism influences nausea at all.

And it made us feel, I think, pretty confident and maybe even a little validated that the choice that we’ve taken around DIP inhibition and GLP-one agonism makes for a well informed genetically validated approach to obesity. But as you point out, we’re in Phase three now. And so does Phase two matter? It matters insofar as it helps to explain the choices that we’ve taken going into Phase three. And there’s been understandably a lot of interest in our Phase two study.

Regarding the ADA meeting, the American Diabetes Association meeting that’s coming up in a couple of months, we will in a series of presentations at ADA through the lens interestingly enough of external opinion leaders and experienced obesity clinicians had a chance to provide the underlying details regarding our Phase two chronic weight management study out to fifty two weeks in Part one of that trial as well as some insights from our Phase one dose escalation study that have both informed our Phase three design. I think that when these presentations are received, there will be a lot of interest in all the arms of the study. We have already shared all the salient aspects of that through a call in the fall that the molecule delivers competitive weight loss, medically important weight loss all the way through fifty two weeks without plateau. The dose escalation arrives at target doses that are very well tolerated throughout the calendar year. And this actually could also be differentiating the Surmount five supplemental data shows a Manhattan plot of nausea and vomiting which really is peppered throughout the fifty two week experience with weekly injections.

We did not see this with Maritime. Furthermore, the outstanding response with hemoglobin A1c in patients with diabetes as well as the strong suppression of inflammatory markers like HSCRP. So we look forward to sharing some of these underlying data. But from my perspective, we’ve already shared all the actionable information that led to the Phase III design of the two open studies.

Tim, Host, BofA: This is more of a business development question. In my opinion, if you’re not Novo or Loewy and you’re trying to enter the space, it’s hard to be a single asset company. I think a company would want to have a portfolio of products and you guys have a main asset now in Phase III, Maritime. So what is the company’s view on hustling and trying to get another late stage asset? There are compounds out there that are deep in Phase II, that are pre Phase III.

There’s other mechanisms out there. What’s the view towards fleshing out the late stage portfolio fairly near term and then also just Amlan as a target?

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: Maybe Jay, you want to start? Yes, I’ll start and then Jay will address the substance of that, Tim, in terms of the strategy around it. But Amgen is always open for business and business development. Our aperture is always open wide. We’re looking for opportunities structurally agnostic and certainly obesity is a critical issue and it’s an unmet need around the world.

So we’re focused on it. As we said off our first quarter call, we expect to get back to our pre horizon capital structure by the end of the year. And so we’re looking forward to continuing to execute on business development. We continue to look at it. We always believe we need to have an opinion on anything out there that’s available in any one of our four therapeutic areas in particular.

So I just want to make it clear, we’re there, we’re looking, we’re active. With that, I’ll turn it back to Jay to speak specifically about what the platform is like in obesity.

Jay Bradner, Executive Vice President of R and D, Amgen: Yes, I’ll be efficient. First, this medicine, we have this medicine, this differentiated and unique medicine because we’ve been studying metabolism and focus on obesity for decades. If you get to know Marielle Vignan who leads this group at Amgen, she’s been working on obesity long before it was fashionable. Second, to reframe your question, is there a need for a second wave of obesity or weight management medicines? I actually believe that there is.

For whatever reason and there are I think several, at the end of a calendar year only thirty percent to forty percent of people who started weekly injectable therapies remain on those medicines. And we’re not reaching the majority of patients to stand to benefit from these drugs. So there’s an apparent disconnect between the efficacy we know we can deliver to patients suffering from obesity and its related conditions and drug effectiveness, the public health benefit that we can deliver to society. And here Meritide fits in not as a singularity, but as one of several medicines that we’ve innovated at Amgen to address the most common killers of humans in the world with cardiovascular disease. Think of Repatha for PCSK9, think of Opasiran for LP.

Now think of Meritide. These are three independent modifiable cardiovascular risk factors: LDL C, LP, obesity and its related conditions and circumstances. And so actually this is a portfolio play. Now within obesity itself as you’ve asked, we are very active with internal innovation and we have seen and have an opinion on everything on the outside in external innovation. What we’re not interested in is a participation trophy.

We’re not interested in another weekly injectable. We’re not interested in a mechanistically distinct, but comparably inaccessible or challenging medicine. And so to take your analogy of skates where the puck is going, I quite like that having started to play hockey five years ago myself. Do believe that there

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: are novel mechanisms

Jay Bradner, Executive Vice President of R and D, Amgen: with strong genetic validation for which there is no index chemical matter and we’re interested in that. And then secondarily, leveraging this platform we have. We are the only biopharma pursuing this peptide antibody conjugate scaffold. And this platform allows for monthly or maybe even less frequent dosing. As you know in Part two, the second fifty two weeks of our Phase two study, which is ongoing right now, On that trial works for even quarterly dosing of Meritide in a maintenance fashion.

So we see a differentiated strategy with internal and we’re open of course to external innovation as Pete said.

Tim, Host, BofA: Okay. Shifting to something else in cardiovascular, olicasiran, just level of confidence in this mechanism. I know what the epidemiologic data shows, but there still is not yet a 4S moment that really nails the mechanism in terms of proves that pharmacologically lowering is going lead to event reduction. So if you think about the riskiness of Phase III, whether it’s serous or noviruses, high risk, medium risk, low risk?

Jay Bradner, Executive Vice President of R and D, Amgen: I’d like to answer your question in two ways. The kind of doctor and scientist in me has very high confidence in this mechanism, very high. The human genetics have spoken. The twenty percent of us in this room right now that are so unfortunate as to have genetically defined elevation of Lp for which there can be no lifestyle modification, no pharmacologic intervention, no action we can take to reduce this inflammatory atherogenic lipoparticle. We are living with a risk that’s unmodifiable.

So enterol passerine, quarterly dosed siRNA surgically precise hits just the one gene product dramatically decreases synthesis in the liver to less than 5% residual Lp. This is the very molecule and the very study Ocean A in seven thousand two hundred and ninety seven patients with elevated Lp for secondary prevention in cardiovascular disease. It’s the very molecule and the very study to answer this question. Scientifically and medically everything we’ve learned from genetically defined targets carried into clinical investigation, this molecule should work. As a drug developer, I have also learned to approach late stage drug development with equipoise and to understand that despite all of our leanings we have to adopt probability of technical and regulatory success based on the stage of drug development.

So I have two minds about it, but I do feel very confident that the experiment that we’re performing will be the definitive test of this hypothesis and I feel good about it. So if I had to put a word in

Tim, Host, BofA: your mouth, read him Risk.

Jay Bradner, Executive Vice President of R and D, Amgen: Well listen, enjoy the Amgen because I’m crazy about OPAS. Is what it is. Late stage clinical investigation comes with a sixty percent probability of technical regulatory success. That is increased with human genetic evidence. Some would say by as much as twofold looking at broad literature and here we

Tim, Host, BofA: have very strong genetic evidence. One last question, biosimilars. You guys bring it up. You guys have talked about what your long term vision is from a revenue perspective. The Street is actually quite a bit below that, so it doesn’t seem like you guys get a lot of credit.

Tableau, you’re in the market as the only seller against EYLEA. And U. S. EYLEA is $6,000,000,000 last year. It only saw their price at the end of twenty twenty six.

How is that not a pretty meaningful tailwind of numbers in 2025 and in 2026?

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: And Justin, you haven’t spoken up yet. You’re a biosimilars fan. Yes. I know we’re

Justin Clays, Vice President, Investor Relations, Amgen: out of time, so I’ll just be brief in the answer. I think on PABLO, we’re very pleased with the launch so far. As you know, we’ve

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: got good uptake. We’re in

Justin Clays, Vice President, Investor Relations, Amgen: the privileged position to be

Peter Griffith, Executive Vice President and Chief Financial Officer, Amgen: one of one. So we’re just

Justin Clays, Vice President, Investor Relations, Amgen: going to keep at it with our efforts there. I think more generally, what’s maybe underappreciated is the portfolio effect. It’s true

Tim, Host, BofA: that any individual biosimilar will launch and then

Justin Clays, Vice President, Investor Relations, Amgen: you can face further competition and price erosion. On the other hand, with these waves of launches that build on each other, in aggregate, it’s actually quite a healthy business. So we feel really good about the biosimilars, Pablo and the rest.

Tim, Host, BofA: Great. Okay. Well, we’re going to stop it there. We’re out of time. So thanks so much for Peter, Jay and Justin and Amgen for showing up at our conference this year.

Justin Clays, Vice President, Investor Relations, Amgen: And thank you. Great to be with you.

Jay Bradner, Executive Vice President of R and D, Amgen: Thank you.

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Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
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