Good morning, everyone, and welcome back to the 2025 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. Joining us from the company is Kave Niksefat, who is the Senior Vice President of Global Market and Access. It's great to have you. Also alongside Kave is Justin Claeys, Head of Investor Relations. Gentlemen, it's great to see you. Great to have you at our conference. Look forward to a nice discussion. To that, Justin, I'm going to spin it over to you for some opening remarks.
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 9%, 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 oncology. Before I turn it over to Kave for a few product highlights, let me acknowledge that the macro and policy environment remains fluid, specifically around tariffs, taxes, and pricing. As a U.S.-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. Kave, over to you.
All right. 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&A. Starting with general medicine, Repatha and Evenity together delivered over $1 billion in revenue in Q1, 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 olpacerin, targeting Lp(a), a genetically defined cardiovascular risk factor, with the phase III outcomes trial and secondary prevention fully enrolled. Turning to obesity, Maritide is moving very quickly. Two phase III studies in chronic weight management are enrolling, and we look forward to sharing the 52-week data from part one of our phase II trial, along with the data from a phase I PK study at ADA in June.
Turning to rare disease, Eplizna recently launched as the first FDA-approved therapy for IgG4-related disease, and we're now on track for a December 14th PDUFA date in generalized myasthenia gravis. In inflammation, Tezspire continues to grow in severe asthma, and we have an October 19th PDUFA date for chronic rhinosinusitis with nasal polyps and are enrolling patients in phase III 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 and B-ALL, Emdeltra in small cell lung cancer, and Xaluridamide in advanced prostate cancer. We are also looking forward to two phase III readouts this year for bimaratuzumab in gastric cancer. Finally, our biosimilars portfolio generated $735 million in revenue in Q1, up 35% year over year, driven by our latest U.S. launches, Pavblu and Weslana.
We also launched Beckenvy, a biosimilar to Soliris in the U.S. on April 1st, and are advancing our next wave of biosimilar candidates, including biosimilars to Opdivo, Keytruda, and Ocrevus, all of which are now in phase III. As Justin mentioned, innovation is our top priority, and we're excited to continue our focus on these and other important medicines across our portfolio. With that, Greg, thank you again to you and the RBC team for having us, and we'll go to Q&A.
Thank you, Kave. Certainly, with respect to your experience at Amgen and the position that you have 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 getting medicines to patients, something core, of course, to the Amgen mission.
As you think about Amgen's positioning and preparing for many of these macro and policy-related changes that Justin alluded to, can you talk about what Amgen is doing to stay ahead of the curve and how you're managing either A, that exposure, or B, maybe that proactive reaction to many of the changes that could be coming down the pike?
Yeah, 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.
Yeah, Greg, maybe going back to our prepared comments, innovation is the number one priority. It really 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 we are a U.S.-based company that's made significant investments in the United States. Since the 2017 Tax Cuts and Jobs Act, we've actually invested over $5 billion in CapEx in the U.S. We've announced another $2 billion of new investments that's supporting in part the new facilities in Ohio and North Carolina. Of course, we have substantial investments in R&D and other parts of the operation. We feel like we're definitely contributing to the U.S. innovation environment. Also the fact that our medicines do deliver value to patients and the system is important as well.
Excellent. Certainly a lot of chatter even in the past several weeks, maybe even post your earnings update when it comes to normalization of pricing internationally, the most favored nation chatter and discussion. It's always early, and actionability is an open question.
How are you seeing this play out, and what either mitigation strategies would you be employing to understand maybe that correctiveness when it comes to global pricing across various markets?
Yeah, this one, I'm probably not going to get into any specifics. It's still an evolving situation. We're obviously watching it carefully, but probably not much more to say at this moment.
When it comes to manufacturing, Justin, you certainly referenced just the onshoring efforts and well-diversified across not just the U.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 of our heritage in manufacturing. There's a mantra throughout the company. It's called every patient, every time. We work tremendously hard as a company to ensure that we meet that.
In terms of the footprint, it's a global footprint with, as you mentioned, quite a substantial presence in the U.S. In terms of 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 Singapore and the Netherlands and some in Ireland as well. It is quite a diversified set of operations, but again, a substantial proportion of that is in the United States.
You touched on Repatha maybe as a nice case study when it comes to leveraging the data, leveraging access, driving new uptake and market share has really been one of the crown jewels of the portfolio. Maybe just walk us through that as a case study and how that can be potentially leveraged.
What has worked so well, and how can that translate to other segments of the business?
Yeah, 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. If 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. Today, nearly every Medicare formulary includes Repatha at a low fixed copay for patients. Then on the commercial side, to make it much easier to access from a process standpoint. As of today, nearly 50% of commercial plans have Repatha on formulary without a prior authorization. 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. That has led to us achieving, I believe, 42% volume growth year over year within the U.S. We're seeing that growth continue going forward. Looking at that, that serves as a blueprint for our strategy going after these large category diseases like cardiovascular, like osteoporosis, and hopefully in the future, like obesity.
Greg, I just have to add a few years ago, we had made the comment or the outlook that we thought Repatha was a multi-billion dollar opportunity. At the time, there was some controversy and perhaps skepticism about that. We were very happy to put up $656 million in the first quarter. We feel like we're delivering on that commitment. Right, great.
Kave, you mentioned just the extension of other areas in cardiovascular, cardiometabolic. You touched on obesity in your opening remarks and just with that 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 Maritide and that broader program that you're running.
Yes, maybe I'll start, and then I'll ask Justin to add as well. When we look at Maritide, we see a product that's delivered consistent, predictable, and sustained weight loss across all doses with no plateau at 52 weeks, which was 20 weeks earlier than the phase III studies on the weeklies. We see very clinically meaningful impact on the cardiometabolic factors, including HbA1c.
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. We released a substantial amount of data earlier this year when we announced the phase II results. We will be, again, sharing further data at the ADA. Justin, can I ask you to add to that?
Yeah, absolutely. Just as Kave said, 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.
I think in our view, we've really shared what the key headlines and takeaways were from the data set. Of course, ADA is a great opportunity at a medical forum to share maybe the next level of detail. That would be 52 weeks through part one of the phase II study, as well as some insights from the phase I pharmacokinetic study, which particularly looked at some alternate dosing approaches. 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. You'll 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.
Yeah. And as you're watching just the current commercialization of the GLIPs, how are you tying the evolving opportunities? You've mentioned the maintenance setting. You've mentioned the convenience of administration. You've mentioned maturing effects for current patients. You've commented about how vast the opportunity is. How are you tying the quest for differentiation for Maritide with the ultimate out-year commercial opportunity and the ability 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. We are 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. That profile from the top line that I shared with you, that we shared again in our phase II substantial data release earlier, is really attracting a lot of attention and excitement from opinion leaders around the world. We think that those areas of differentiation will allow us to play in several of those subcategories.
In addition to the large phase III maritime programs you have running, how important to you is the two-year data that we could be seeing at the end of the year as far as delineating and establishing that profile?
Justin, do you want to comment on that part two data?
Yeah, thanks for reminding on that one, Greg. Just to level set with folks, as I mentioned, we'll be sharing 52-week data from the phase II study at ADA in further detail. We've already toplined the key findings from that result. We did design the study so that patients who met certain criteria could continue on for another 52 weeks. Over 90% 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. In terms of the insights that we hope to gain, there's several. One is that some people will be re-randomized back to placebo. 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 Kave mentioned, we haven't seen a plateau at 52 weeks. That will be an important finding. Finally, we're also testing an even less frequent dosing. Actually, there's an every 12-week arm, and we'll get to see how those patients do. You could think of that almost as sort of a maintenance approach. We're going to get some important insights towards the end of this year on that.
That's great. Maybe we'll turn a bit to the inflammation and INI franchise and maybe a broader question for you. When it comes to Amgen evaluating and prioritizing, they'll call them legacy franchises that are sort of worth investing in for additional growth opportunities. We've had successes with Tezspire.
Maybe that serves as a nice example as running trials and 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.
It's a great question, Greg. 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 we're convinced will have a large effect size and multiple additional indications. Second, we look at the existing clinical data for the drug. Again, we're looking for that very large effect size that can be leveraged across.
We are looking to see, can we expand the depth of penetration within a disease that we are already in or move over to adjacent diseases to use the medicine throughout? We evaluate the whole portfolio for this, and then we pick what we think are the best kind of winners out of that and invest heavily behind them. Tezspire 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 asthma market. We had a very good base asset that we were working with. We looked adjacent.
We've got the nasal polyps data that's now been 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. 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. We've also extended that TSLP franchise with AMG 104, which is in phase II studies as an inhaled TSLP option for asthma. 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. It's not just Tezspire. You look at Eplizna with where we've gone with IgG4, MG, and we think there's additional potential within Eplizna.
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.
Maybe as a follow-up, we've spoken about the unmet need across all of these layers of indication opportunities. How do you factor in the potential value and pricing gradients when it comes to indication expansion, whether they're larger markets, smaller ones, and those which you've already established a price position?
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 into. We believe strongly that we price our products for the value that they bring. In many of these cases, price has not been a constraint 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.
You have mentioned Eplizna, of course, and just the emerging rare disease pillar of Amgen. Maybe talk about the great deal of heterogeneity, of variability, of segmentation. How do you approach that from a scalability perspective? Of course, many products taken in from Horizon and others maybe in the pipeline that you have and maybe have not spoken about. How do you approach that more holistically?
Yeah, when we look at rare disease overall and Eplizna specifically, this is kind of an economies of scope versus an economy of scale 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, of which rare disease patients see seven doctors before ultimately getting on treatment and pulling that through. When we look at Eplizna, we apply those economies of scope to the additional indications. You look at IgG4-related disease, for instance, small patient population, rare disease seen by 11 different specialties. We pull the Tavneos playbook 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 database alerts to identify patients in the other specialties and deploying our resources based off those alerts.
We have had great success with Tavneos since bringing that asset in from ChemoCentryx, growing, I think, nearly triple digits every single year since that acquisition. We are applying that playbook going forward. 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.
That is great. I also want to do some quick hits and just touch on the biosimilars franchise and just ask really how, if the philosophy of sort of starting with an anchor and building out, applies there. Many products on market now, maybe seeing a potential light of day on future approvals. What is the overall portfolio approach? Maybe what will the biosimilars franchise look like in the next three or five years?
Yeah, 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&D, operations, commercial, and medical. 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. First, let's just start with the R&D side. Every single biosimilar that Amgen has brought into the clinic has a 100% success rate of getting approved by the FDA. That type of low-risk adventure really helps us earn a return. Where we have had great success is by bringing biosimilars to marketplaces that we already exist in. If you look at the oncology market, we've been in that market for 25 plus years now overall. We know how to operate in that market.
We have scale and capacity in that market. 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. As we look to scale this business opportunity, we've just launched three new biosimilars in the U.S.: Pavblu, Weslana, and Beckenvy. Now we're going after and adding with phase III trials to biosimilars in Ocrevus, in Keytruda, and Opdivo. 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.
I can just add, Greg, you know a few years ago when I started in the IRO, some of the investors kind of pulled me aside and asked me, you know, I don't get it. Why are you in biosimilars?
Isn't this a little bit different than your core business? Isn't this somewhat of a distraction? To Kave's point, absolutely not. Quite the opposite. It integrates so well with the core operations of the company. Also from an innovator side, we get to see both sides of the playbook. We have a good sense of what it means to go to market with biosimilar, how to defend as you're facing that sort of competition. It has been a great fit and very creative to our business.
That's great. Justin, maybe I'll ask you on capital allocation. Peter's not here, so perhaps you can channel him and that Amgen maybe is open for business. In the current environment, some of your peers have highlighted that there could be a bargain out there within the biopharma sector. What's the Amgen current view and strategy?
Yeah, it's been remarkably consistent. As Peter 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. Then you have return to shareholders either in the form of share repurchases or in dividends as well. As folks know, with the Horizon acquisition, we did take on some additional debt. We were very clear in our plans for deleveraging. We're on a great track with that. Actually, by the end of this year, we expect to get back to our pre-Horizon capital structure. 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.
The 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 proper return, et cetera? I think we continue to evaluate things, of course, as we get through the deleveraging that will even give us even more flexibility going forward. In the meantime, we continue to be very active in that space.
That's great. I think it's a great place to leave it. Gentlemen, thanks for joining us. Congrats on the progress. I'm looking forward to ABA.
Great. Thanks so much.
Thanks so much, Greg.