Amgen at RBC Capital Markets: Strong Start and Strategic Focus

On Wednesday, 21 May 2025, Amgen Inc. (NASDAQ:AMGN) presented at the RBC Capital Markets Global Healthcare Conference 2025, showcasing a robust start to the year with notable growth in revenue and earnings. The company highlighted its commitment to innovation and strategic investments, while also addressing challenges in the macroeconomic environment.

Key Takeaways

• Amgen’s Q1 2025 revenue rose by 9% year-over-year, with non-GAAP EPS increasing by 24%.
• The company plans significant investments in US facilities, with $2 billion earmarked for Ohio and North Carolina.
• Amgen’s Repatha saw a 42% volume growth in the US, exemplifying successful patient access strategies.
• The firm is advancing its obesity program with two Phase 3 studies for Maritide and expanding its biosimilars portfolio.
• Amgen is actively exploring external opportunities for growth and aims to return to its pre-Horizon capital structure by year-end.

Financial Results

• Q1 2025 revenue increased by 9% year-over-year.
• Non-GAAP EPS rose by 24% compared to the previous year.
• 14 products achieved double-digit growth, with Repatha and Avenity surpassing $1 billion in combined revenue, up 28%.
• The biosimilars portfolio generated $735 million, marking a 35% increase.

Operational Updates

• Amgen’s product pipeline includes the fully enrolled Phase 3 trial for Opaciran and ongoing Phase 3 studies for Maritide.
• Aplisnow was launched for IgG4-related disease, with a PDUFA date for generalized myasthenia gravis set for December 14.
• Tesfire continues to grow in severe asthma, with a PDUFA date for chronic rhinosinusitis with nasal polyps on October 19.
• The company maintains a strong manufacturing presence in the US and globally, with facilities in Ohio, North Carolina, Rhode Island, Puerto Rico, Singapore, The Netherlands, and Ireland.

Future Outlook

• Amgen prioritizes innovation, investing heavily in both internal and external research and development.
• The company anticipates sharing 52-week data from its Phase 2 trial of Miratide at the ADA in June, with a two-year data readout expected by year-end.
• Amgen is expanding its biosimilars business by entering new global markets and introducing additional products.
• A focus on deleveraging aims to restore the company’s capital structure to pre-Horizon levels by the end of the year.
• The firm is actively evaluating external opportunities for strategic growth.

Q&A Highlights

• Amgen is monitoring tariffs, taxes, and pricing policies in the macroeconomic environment.
• The company emphasizes its contributions to the US innovation landscape and the value its medicines provide to patients.
• Repatha’s success in increasing patient access is seen as a model for other therapeutic areas.
• Amgen believes the obesity market will fragment, creating opportunities for multiple players.
• The company leverages its infrastructure for efficient biosimilar development and commercialization.

For a detailed account of Amgen’s presentation, please refer to the full transcript below.

Full transcript - RBC Capital Markets Global Healthcare Conference 2025:

Greg Renza, Biotech Equity Research Analyst, RBC: Good morning, everyone, and welcome back to the twenty twenty five RBC Global Healthcare Conference. My name is Greg Renza, one of the biotech equity research analysts here, and we’re pleased to be joined now by Amgen. And joining us from the company is Kave Nixafed as well, who is the senior vice president of global market and access. It’s great to have you. And also alongside, Kaveh is Justin Klaas, head of investor relations.

Gentlemen, it’s great to see you. Great great to have you at our conference. Look forward to a nice discussion. And to that, Justin, I’m gonna spin it over to you for some opening remarks.

Justin Klaas, Head of Investor Relations, Amgen: Great. Thanks so much, Greg. It’s great to be here. 2025 is off to a strong start for Amgen with momentum from the breadth and depth of our portfolio. The first quarter, revenues increased nine percent and non GAAP earnings per share increased 24% year over year.

That strength was broad based with 14 products delivering double digit growth across general medicine, rare disease, inflammation, and ecology. Before I turn it over to Kaveh for a few product highlights, let me acknowledge that the macro and policy environment remains fluid, specifically around tariffs, taxes, and pricing. As a US based innovator, Amgen firmly believes that society needs more innovation, not less, and we remain focused on delivering important medicines that address serious illness and make a real difference for patients. Kaveh, over to you.

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: All right. So first, thanks, Justin, and thanks to Greg and the entire RBC team for having us today. As Justin mentioned, I’ll touch on a few portfolio highlights before we turn it over to q and a. So starting with general medicine, Repatha and Avenity together delivered over $1,000,000,000 in revenue in q one, up 28% year over year. These brands have significant runway given the large number of patients with cardiovascular disease and osteoporosis that remain untreated.

We’re also progressing opaciran, targeting LP, genetically defined cardiovascular risk factor with the phase three outcomes trial and secondary prevention fully enrolled. Turning to obesity, meridide is moving very quickly. Two phase three studies in chronic weight management are enrolling, and we look forward to sharing the fifty two week data from part one of our phase two trial, along with the data from a Phase one PK study at ADA in June. Turning to rare disease, Oplisnow recently launched as the first FDA approved therapy for IgG4 related disease, and we’re now on track for a December 14 PDUFA date in generalized myasthenia gravis. In inflammation, test fire continues to grow in severe asthma, and we have an October 19 PDUFA date for chronic rhinosinusitis with nasal polyps and are enrolling patients in phase three studies in both COPD and eosinophilic esophagitis.

In oncology, our industry leading bispecific T cell engager platform is progressing well, and we are excited about the potential patient benefits from BLINCYTO in B ALL and BELTRA in small cell lung cancer, and zaluritamab in advanced prostate cancer. We are also looking forward to two Phase III readouts this year for Bimarotuzumab in gastric cancer. Finally, our biosimilars portfolio generated $735,000,000 in revenue in Q1, up 35 year over year, driven by our latest U. S. Launches, HavBlue and Weslana.

We also launched Bekemvi, a biosimilar to Soliris, in The U. S. On April 1 and are advancing our next wave of biosimilar candidates, including biosimilars to Opdivo, Keytruda, and Ocrevus, all of which are now in phase three. As Jeff Justin mentioned, innovation is our top priority, and we’re excited to continue our focus on these and other important medicines across our portfolio. And with that, Greg, thank you again to you and the RBC team for having us, and we’ll go to q and a.

Greg Renza, Biotech Equity Research Analyst, RBC: Thank you, Kaveh. And and certainly, with respect to your experience at at Amgen and and the position that that you you have in the in the organization, you take a very unique view and experience that when it comes to patient access, when it comes to policy related decisions and and getting medicines to patients, something core to, of course, to to the Amgen mission. So as you think about Amgen’s positioning and preparing for many of these macro and policy related changes that that Justin alluded to. Can you can you talk about what Amgen is doing to stay ahead of the curve and how you’re managing either, a, that exposure or or or, b, maybe that proactive reaction to many of the changes that that could be coming down the pike?

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: Yeah. And, Justin, maybe I’ll turn it over to you to start and then maybe potentially add some of the access considerations that we have, especially for Repatha potentially. That’s great, Justin.

Justin Klaas, Head of Investor Relations, Amgen: Yeah. Greg, so maybe going back to our prepared comments, innovation is the number one priority, and it really, you know, comes back to that when you think about pricing, when you think about access. In terms of the macro environment, we’re definitely engaged with policymakers. What we’re trying to reinforce is the fact that, you know, we are a US based company that’s made significant investments in The United States. Since the 02/2017 Tax Cuts and Jobs Act, we’ve actually invested over $5,000,000,000 in CapEx in The US.

We’ve announced another $2,000,000,000 of new investments that’s supporting, in part, the new facilities in Ohio and North Carolina. And, of course, we have substantial investments in r and d and other parts of the operation. So, you know, we feel like we’re definitely contributing to the The US innovation environment, and and also the fact that our medicines do deliver value to patients of the system is is important as well.

Greg Renza, Biotech Equity Research Analyst, RBC: Excellent. And certainly a lot of chatter even in in the past several weeks, maybe even post your, your your earnings update when it comes to, call it, normalization of pricing internationally, the most favored nation, chatter and and and discussion. It’s always early, and actionability is is an open question. How are you seeing this play out and what either mitigation strategies would you be employing to to understand maybe that correctness when it comes to global pricing across various markets?

Justin Klaas, Head of Investor Relations, Amgen: Yeah. This one, I’m I’m probably not gonna get into any specifics. It’s still evolving situation. We’re obviously watching it carefully, but probably not much more to say at this moment. Mhmm.

Greg Renza, Biotech Equity Research Analyst, RBC: And then when it comes to manufacturing, Justin, you certainly referenced just the onshoring efforts and well diversified across S. But also globally. Maybe just remind us how that mix and distribution of manufacturing works for Amgen. Sure.

I mean, we’re definitely proud

Justin Klaas, Head of Investor Relations, Amgen: of our heritage in manufacturing. There’s a mantra throughout the company. It’s called every patient every time, and we work tremendously hard as a company to ensure that that we meet that. In terms of the footprint, it’s it’s a global footprint with, as you mentioned, quite a substantial presence in The US. In terms of our our various sites, we have operations, as I mentioned, Ohio, North Carolina, Rhode Island.

Puerto Rico is one of our flagship facilities. We also have global operations, including, you know, Singapore and The Netherlands and and some in Ireland as well. So it’s quite a diversified set of operations, but, again, a substantial proportion of that is in The United States.

Greg Renza, Biotech Equity Research Analyst, RBC: And you touched on Repatha maybe as a nice case study when it comes to leveraging the data, leveraging access, driving new uptake in market share. It’s really been one of the the crown jewels of the portfolio. Maybe just walk us through that as a case study and how how that can be potentially leveraged. What has worked so well, and how can that translate to other segments of the business?

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: Yeah. So so Repatha is a really good example of how opening up access can lead to substantial volume growth, especially in very large categories like cardiovascular disease. You turn back for the last five to seven years, we’ve highlighted that we were trying to do two things from an access standpoint. One, for Medicare patients, make the product more affordable, and today, nearly every Medicare formulary includes Repatha at a low fixed co pay for patients, and then on the commercial side, to make it much easier to access from a process standpoint, and as of today, nearly 50% of commercial plans have Repatha on formulary without a prior authorization, and so we’re seeing that ease of access now opening up prescribing. We’re seeing increased depth in the cardiovascular I’m sorry, in the cardiology segment, but also increased breadth across primary care where the majority of these patients are treated today.

And that’s led to us achieving, I believe, 42% volume growth year over year within The US, and we’re seeing that growth continue going forward. So now looking at that, that serves as a blueprint for our strategy going after these large category diseases like cardiovascular, cardiovascular, like osteoporosis, and hopefully in the future like obesity. And Greg, I just have to

Justin Klaas, Head of Investor Relations, Amgen: add, few years ago we had made the comment or the outlook that we thought Repatha was a multibillion dollar opportunity, and at the time there was some controversy and perhaps skepticism about that. So we’re very happy to put up 656,000,000 in the first quarter. Mhmm. We feel like we’re, delivering on that commitment.

Greg Renza, Biotech Equity Research Analyst, RBC: Great. Great. And, Kevin, you you mentioned just the the extension of other, areas in in cardiovascular, cardiometabolic. You you touched on obesity in your opening remarks and just did with tying the Repatha case study. With respect to ADA coming up and some data updates here, maybe just put that into context of how that could add to the differentiation of Meritide and that broader program that you’re running.

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: Yes. Maybe I’ll start, then I’ll ask Justin to add as well. When when we look at at Miratide, we see a product that’s delivered consistent, predictable, and sustained weight loss across all doses with no plateau at fifty two weeks, which was twenty weeks earlier than the phase three studies, on the weeklies. We see very clinically meaningful impact on the cardiometabolic factors, including HbA1c, and we have that really strong efficacy profile in a very convenient form of monthly dosing or less frequent for patients, which we believe is going to simplify the experience and offer patients an additional option within this very large market category with 75% fewer injection days and post injection days that come with it. So we’ve released a substantial amount of data last year or I’m sorry, earlier this year when we when we announced the phase two results, and we will be, again, sharing further data at the the ADA.

But, Justin, can I ask you to add to that?

Justin Klaas, Head of Investor Relations, Amgen: Yeah. Absolutely. Just as Kaveh said, we it it was interesting. We referred to that as a top line release in late November. That was quite a substantial disclosure with a full PowerPoint presentation and lots and lots of information.

So I think, in our view, we’ve really shared what the key headlines and takeaways were from the dataset. Of course, ADA is a great opportunity at a medical forum to share maybe the next level of detail, so that would be fifty two weeks through part one of the phase two study as well as some, insights from the phase one pharmacokinetic study, which particularly looked at some some alternate dosing approaches. Mhmm. So, you know, we’ll be again, it’s sort of a double click on what we’ve already shared. I think what will be interesting is in the formal session that will be led by the key opinion leaders, and so you get to hear, I think, from the voice of practitioners how they view the data.

We’ll also be having an IR event afterwards. Again, that’s just so that folks can hear from the company’s mouth and have a chance to ask us any questions following the main presentation.

Greg Renza, Biotech Equity Research Analyst, RBC: Yeah. And as you’re watching just the the the current commercialization of of of of the Glipse, how are you tying the evolving opportunities? You’ve mentioned the maintenance setting. You’ve mentioned the convenience of of administration. You’ve mentioned maturing, effects for for for current patients.

You you’ve commented about how vast the opportunity is. How are you tying, the quest for differentiation for Miratide with the ultimate out year commercial opportunity and the ability

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: to help patients? Yeah. So, look, obesity is a global health crisis. It’s got tens of millions, if not hundreds of millions of patients worldwide. We believe this market is going to fragment into subcategories along the way.

For those of you that are following closely and looking at the patient research around this, you already see this occurring. That’s going to offer the opportunity given the substantial size of this market for multiple players in each one of these various subcategories. And so we’re monitoring the entire marketplace quite closely. We are identifying those points of differentiation and building those into the study and data packages that we have coming forward. But that profile from the top line that I shared with you that we shared again in our phase two substantial data release earlier is really attracting a lot of attention and excitement from opinion leaders around the world, and we think that those areas of differentiation will allow us to play in several of

Greg Renza, Biotech Equity Research Analyst, RBC: those subcategories. And in addition to the the large phase three maritime programs you have running, how important to you is the is the two year data, that that you that we could be seeing at the at the end of the year as as far as delineating and establishing that that profile. Justin, you wanna comment on the part two data?

Justin Klaas, Head of Investor Relations, Amgen: Yeah. Thanks for reminding on that one, Greg. So it’s just, to level set with folks, as I mentioned, we’ll be sharing fifty two week data from the phase two study at ADA in further detail. We’ve already top lined the key findings from that result. We did design the study so that patients who met certain criteria could continue on for another fifty two weeks.

Mhmm. Over ninety percent of the people eligible to continue chose to do so. We think that’s a really positive sign in terms of their experience on the medicine. And then in terms of the insights that we hope to gain, there’s several. One is that some people will be rerandomized back to placebo, so we’ll get to see how quickly the weight rebounds or not after stopping treatment.

We’ll also learn for those who continue on active treatment where the weight loss eventually gets to. As Kavi mentioned, we haven’t seen a plateau at fifty two weeks, so that will be an important finding. And then finally, we’re also testing an even less frequent dosing, so actually there’s an every twelve week arm, and so we’ll get to see how those patients do. So you could think of that almost as as sort of a maintenance approach. So we’re gonna get some important insights, you know, towards the end of this year on that.

Greg Renza, Biotech Equity Research Analyst, RBC: That’s great. And maybe we’ll turn a bit to the to to the inflammation and INI franchise, and and maybe a broader question for for you. When when it comes to Amgen evaluating and prioritizing, I’ll call them legacy franchises that are sort of worth investing in for additional growth opportunities, We’ve had successes with TestSpire. Maybe that serves as a nice example as running trials in other indications. Just talk to us about that sort of hub and spoke when it comes to establishing a key product franchise and then growing within that brand.

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: It’s a great question, Greg. And so at Amgen, we refer to this process as patient impact expansion. We have a very disciplined framework by which we evaluate our molecules to look for those expansion opportunities. It all starts with the science. First, we look for differentiated science that that we’re convinced will have a large effect size and multiple additional indications.

Second, we look at the existing clinical data for the drug, and, again, we’re looking for that very large effect size that can be leveraged across. And then we’re looking to see can we expand the depth of penetration within a disease that we’re already in or move over to adjacent diseases to use the medicine throughout. We evaluate the whole portfolio for this, and then we pick the what we think are the best kind of winners out of that and invest heavily behind them. TestFire is a great example of this. First and only medicine to target TSLP, first and only medicine in asthma to be used in severe asthma to be used irrespective of phenotype or biomarker with very strong interest and uptake across key specialties, both allergists and pulmonologists, especially for those patients that are viewed to have multiple triggers and drivers, which is the largest portion of the of the asthma market.

So we had a very good base asset that we were working with, and then we looked adjacent. So we’ve got the nasal polyps data that’s now been, you know, released and filed with an October PDUFA date. That gives us the opportunity to go into patients with polyps on their own, but importantly, patients with asthma that also have polyps, and that’s a very large population to accelerate the depth of penetration. We’re going adjacent as well with COPD, which we think is a major opportunity, especially in the pulmonology standpoint. And then we’ve also extended that TSLP franchise with AMG one hundred four, which is in phase two studies as an inhaled TSLP option for asthma.

So it’s a really good case study of picking one molecule and figuring out all the different ways that we can help more patients with it through various different changes. But it’s not just TESSPIRE. You look at Aplisna with where we’ve gone with IgG4, MG, and we think there’s additional potential within Aplisna. And then finally, with Repatha, with Vesalius and extending beyond the post event patient population to the high risk primary prevention population. These areas offer meaningful growth for us and meaningful value for our shareholders.

Greg Renza, Biotech Equity Research Analyst, RBC: And maybe as a follow-up, we’ve spoken about the need across all of these layers of of indication opportunities. How do you factor in the potential value and pricing gradients when when it comes to, indication expansion, whether they’re larger markets, smaller ones, and those which you’ve already established a price position?

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: Yeah. So it’s a consideration that we have to look at when we’re evaluating the additional indications and diseases by which we can go we can go into. We believe strongly that we price our products for the value that they bring. And in many of these cases, price has not been a constraint for that for those additional indications that we look at. We can also look to target subpopulations of broader populations to ensure that the value that we’re bringing at the price point meets that overall.

And you’ve mentioned up Lisna, of course,

Greg Renza, Biotech Equity Research Analyst, RBC: and just the the emerging rare disease, the pillar of of of Amgen. And maybe talk about a great deal of heterogeneity, of variability, of segmentation. How do you approach that from a scalability perspective? Of course, many products taken in from from Horizon and others maybe in in the pipeline that you have and maybe have not spoken about. So how do you approach that more holistically?

Yeah.

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: So when we look at rare disease overall and and and aplisna specifically, this is kind of an economies of scope versus an economy of scale type type strategy. We get really good at serving patients with these rare diseases, identifying them at diagnosis, making sure that we’re providing information to clinicians around that time point, and then supporting them through their very long journey. Average rare disease patient sees seven doctors before getting a ultimately getting on treatment and pulling that through. So we look at Eplisneau, we apply that those those economies of scope to the additional indications. If you look at IgG4 related disease, for instance, small patient population, rare disease seen by 11 different specialties.

We pulled the Tavneos playbook for for for really bringing that product to market, first looking for what’s a core specialty that we can get penetration in for rheumatology and gastroenterology, and then using data based alerts to identify patients in the other specialties and deploying our resources based off those alerts. And we’ve had great success with Tavneos since bringing that asset in from ChemoCentryx, growing, I think, nearly triple digits every single year since that acquisition, and we’re applying that playbook going forward. But those are the types of learnings and know how with the Horizon portfolio now fully integrated into Amgen that we think we can apply to our existing rare disease assets and future rare disease assets.

Greg Renza, Biotech Equity Research Analyst, RBC: That’s great. And, also, I’m wanting to do some quick hits and just touch on the biosimilars franchise, and just just ask really how if the philosophy of of of sort of starting with an anchor and and building out applies there? Many products, on market now may be seeing a potential light of day on on future future approvals. What what is the overall portfolio approach? Maybe what will the the the biosimilars franchise look like in the next, say, three or five years?

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: Yeah. So so the biosimilars business is a great and very efficient business for us overall that leverages the existing infrastructure we’ve built across the enterprise, across r and d, operations, commercial, and medical. And we have built over the years, having now launched, I believe, six biosimilars, maybe seven in the marketplace, a know how of how to bring those to market very quickly and efficiently. So first, let’s just start with the r and d side. Every single biosimilar that Amgen has brought into the clinic has a hundred percent success rate of getting approved by the FDA.

That type of low risk adventure really helps us earn a return. Second, where we have had great success is by bringing biosimilars to marketplaces that we already exist in. You look at the oncology market, we’ve been in that market for twenty five plus years now overall. We know how to operate in that market, and we have scale and capacity in that market, and customers really appreciate the fact that they’re getting an Amgen biosimilar from the same teams that are bringing their innovative products to market overall. And so as we look to scale this business opportunity, we’ve just launched three new biosimilars in The US, PAVLU, WESLANA, and BIKEMVY, and now we’re going after and adding with phase three trials to biosimilars in in Ocrevus, in Keytruda, and Opdivo.

And so we see this market for Amgen growing as we add additional global markets to the existing biosimilars and additional products into that biosimilar portfolio right along adjacent to our innovative products.

Justin Klaas, Head of Investor Relations, Amgen: And I can just add, Greg. Yeah. You know, a few years ago when I started in the IR role, some of the investors kind of pulled me aside and asked me, you know, I don’t get it. Why are in biosimilars? Isn’t this a little bit different than your core business?

Isn’t this somewhat of a distraction? And, you know, the to Kabe’s point, absolutely not. Yeah. Quite the opposite. It integrates so well with the core operations of the company.

And then also from a innovator side, you know, we get to see both sides of the playbook. And Mhmm. You know, we we have a good sense of what it means to go to market with biosimilar, how to defend with the you know, as as you’re facing that sort of competition. So it’s been a great fit and very accretive to our business.

Greg Renza, Biotech Equity Research Analyst, RBC: That’s great. And, Justin, maybe I’ll ask you on capital allocation, and Peter’s not not here. So perhaps you can channel channel him and that Amgen maybe is open for business. But in the current environment, some of that your peers have highlighted that that could be a bargain out there within the the biopharma sector. What’s what’s the Amgen current view and strategy?

Justin Klaas, Head of Investor Relations, Amgen: Yeah. It’s been remarkably consistent. I as Peter will will often refer to, we have a capital allocation hierarchy. It really starts with investing in innovation first and foremost, whether that’s internal or external innovation. Capital expenditures is next, and then you have, you know, return to shareholders either in the form of share repurchases or, yeah, in dividends as well.

As folks know, with the Horizon acquisition, we did take on some additional debt. We were very clear on our plans for deleveraging on a a great track with that. Actually, by the end of this year, we expect to get back to our pre Horizon capital structure. So from a BD point of view, the other point we’ve been remarkably consistent on is the fact that we look at everything. As you said, we’re always open for business.

You know, it’s a number of criteria we look at. Is it a right fit with our therapeutic area footprint? Is it something that we can integrate promptly and can fit into the business? Can we earn a, you know, a proper return, etcetera? So I think, you know, we continue to evaluate things.

Of course, as we get through the deleveraging, it that, you know, will even give us, you know, even more flexibility going forward. But in the meantime, we continue to be very active in that space.

Greg Renza, Biotech Equity Research Analyst, RBC: That’s great. Well, I think it’s a great place to to leave it. Gentlemen, thanks for joining us. Congrats on the on the progress and looking forward to ADA.

Justin Klaas, Head of Investor Relations, Amgen: Great. Thanks so much.

Kaveh Nixafed, Senior Vice President of Global Market and Access, Amgen: Thanks so much, Greg. Appreciate it.

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