Amgen Inc. (AMGN) Earnings Call Transcript & Summary

Hello, everyone. I'm Jay Olson, one of the biotech analysts at Oppenheimer, and it's a pleasure to welcome you to Oppenheimer's 35th Annual Healthcare Conference. And our discussion with Amgen, a company is bringing innovative solutions to a diverse range of diseases with high unmet medical needs. It's my pleasure to introduce Narimon Honarpour, Head of Global Clinical Development; Justin Claeys, Head of Investor Relations; and Casey Capparelli, also from Investor Relations. Thank you so much for joining us here today.

Thanks, Jay. It's a pleasure.

Likewise. Well, we appreciate the opportunity to catch up with you in close proximity to your fourth quarter update.

Do you want to maybe just get us started by sharing some of the highlights of that update with us?

Absolutely. I'll take that one, Jay. And thanks again for hosting us. It's always a pleasure to partner with Oppenheimer, and thanks to everyone on the line for joining us today. Fourth quarter was strong across the business. We feel really good about the momentum we have coming into 2025. From a revenue point of view, as I'm sure folks caught, our full year revenues increased 19% to $33.4 billion. Obviously, that was helped by the acquisition of Horizon Therapeutics and the various rare diseased products that we acquired through that acquisition. If you exclude that, sales were still up by 7%, driven by volume growth of 11%. So we see strength really across the board here. I talked about the momentum we have going into 2025, just a few highlights or stats to really amplify that. The first one is that we had 10 products growing at double-digit rate in the fourth quarter. We also had 14 products annualizing at a sales rate of $1 billion coming out of the fourth quarter, and we had 21 products for the full year achieved record sales. So again, really breadth and depth across the portfolio. I'll just hit a few of the highlights. I think Repatha and EVENITY might be #1 and 2 on the list. Those combined grew 35% year-over-year last year. I think what's really exciting is that we're just scratching the surface of the addressable patient populations there. And I think with Repatha, Murdo made the point in our earnings call that we expect some press stabilization this year, in particular, price declines of mid-single digit or less. So it's nice to see both those products reaching more patients with a lot more room to go. TEZSPIRE is another highlight that obviously is approved for the treatment of severe asthma. That grew nearly $1 billion -- I'm sorry, grew 71% year-over-year and achieved nearly $1 billion in sales last year. Obviously, we're pursuing a number of new indications there, which I'm sure Narimon might talk to later in the discussion today. The innovative oncology portfolio contributed almost $8 billion and grew 11% year-over-year. I mentioned the rare disease portfolio. That actually grew 5% year-over-year for TEPEZZA. And in total, those products contributed $4.5 billion in sales. And again, earlier in the last cycle and some exciting new developments there, again, which Narimon might touch on, in particular regarding UPLIZNA. And then finally, the biosimilar franchise is doing well with $2.2 billion of sales in '24 with a 16% year-over-year increase. So I think, as I said, Jay, I feel like we have a lot of good momentum coming into 2025.

Excellent. Thank you, Justin. It's a great setup. And maybe just one follow-up question that we get a lot from investors around some of the assumptions that went into your 2025 revenue guidance. And then, I guess, in particular, the potential impact of Medicare Part D changes and how that may have been incorporated into your 2025?

Sure. Absolutely, Jay. And I know that coming into the earnings call, there was some question about what the growth outlook might look like, given that this year we are fitting the loss of exclusivity per denosumab, which is one of our larger franchises. So we're pleased that we were able to give guidance, which indicates year-over-year revenue growth, both for -- growth of revenues as well as for earnings per share. On the revenue side, as I mentioned, we are expecting and we have incorporated some range of outcomes in terms of possible erosion from denosumab, but again, that's more than offset by the growth that we have across the portfolio and across a number of the drivers that I mentioned, really highlighting Repatha, EVENITY, TEZSPIRE, innovative oncology, rare and biosimilars. So when you put all those together, again, it's more than enough to overcome the headwinds that we're facing. From a pricing point of view, we, as an industry, experienced year-over-year net price declines for some number of years now, and that's part of what's baked into our usual thinking. As you mentioned, we do have the Part D redesign this year, which I think is impacting manufacturers to different degrees. On our call, we indicated that we see some puts and takes there between price and volume, but then that we don't see that as a meaningful or overall headwind of a significant size. We'll obviously watch that carefully, and we'll need to see how that plays out. But I think while we do have some higher price concessions that we'll need to make for certain products. We also expect some uplift to volumes as patients don't have to deal with the donut hole, and you have fewer drop-offs there. So again, net-net, we'll see how that plays out, but we feel like that shouldn't be a significant driver for us in 2025.

Okay. That's helpful. And I'm glad you mentioned Repatha and EVENITY, those are super exciting growth stories. We also have been getting a lot of questions about olpasiran, and that seems like a really important area of investment for Amgen. And we're excited about your Phase III primary prevention study starting later this year or early next. Can you just talk about the rationale behind that study? And then any learnings from clinical development and commercialization from Repatha that can be applied to olpasiran?

Yes. Thanks, Jay. I'll be happy to take that question. And thanks again for having us here today. Olpasiran is one of these medicines that we find incredibly exciting at Amgen. And partly for the reason that it does follow so closely in the footsteps of Repatha, starting with the very compelling human genetic evidence that laid the foundation for very aggressive LDL reduction as a result of blocking PCSK9, which was for Repatha, we have very compelling human genetic evidence from our colleagues at deCODE and elsewhere that shows when patients have lower Lp(a), they have a lower incidence of cardiovascular adverse events like heart attacks, et cetera. And so following on that same line of evidence, we embarked early upon aggressive ways of reducing Lp(a). In contradistinction to the LDL story where things started out initially with therapeutics that could reduce levels by 10%, 15% that eventually 30%, 50% with Lp(a) right out of the gate. Our therapeutic reduced -- olpasiran reduced Lp(a) by 95%. That was our Phase II result. And so it was incredibly gratifying as a prior health care provider to see that we could develop an effective medicine to essentially solve the Lp(a) problem for those patients that have high Lp(a). And that's 20% of us. A lot of us don't know what our LP(a) number is. A lot of us haven't had it tested, but 20% of us have a high Lp(a) number, and we don't even know it. So having an opportunity to do something about that because there's no current therapeutic that has been approved for Lp(a) reduction, we'll go a long way in helping public health, to be honest with you with those types of numbers. So in that classic fashion, we started with those patients in studying Lp(a) that were at highest cardiovascular risk. These are people who have already had a cardiovascular event. There is no greater predictor of a future event than if you've already had one, right? So that was our first swing with olpasiran and the secondary prevention study that we have on the books and that we enrolled in record time, which also was on the basis of the types of learnings that we had with Repatha and cardiovascular outcomes. Enrolling over 7,000 patients in about a year is really record-breaking speed for enrollment of studies like this, and we were very proud to accomplish that. Looking ahead to what's on the next page for olpasiran, again, we took a look at our Repatha playbook. And as we have our high-risk primary prevention study for Repatha reading out later this year, for olpasiran, we started thinking early, what's going to be the next step, and it's going to be looking at those patients that have not yet experienced a cardiovascular event like a heart attack, but are very, very vulnerable to having those types of events as a result of other cardiovascular risks that they carry. And this is an important and fundamental element of medical evidence that we build on to help make that compelling story visible to all providers. Cardiologists are quick to pick up on these messages, right? Person had a heart attack or was at risk, you need to give a medicine pretty quickly to deal with that. It takes a lot more evidence to be compelling and convincing to the broader health care community including primary care practitioners that look at the totality of evidence, often times before they take a first step in prescribing a novel medicine like Repatha as it had been before and what we'll be able olpasiran.

Okay. Great. That's super helpful. And then I guess just recognizing that these event-driven trials are very difficult to predict. Novartis did recently comment on the potential delay of the pelacarsen readout to 2026. And which I suppose is probably a good thing for patients if it suggests that the event rate is accruing more slowly than expected. But a lot of investors do try to read across from pelacarsen to olpasiran. So is there anything that we can learn from that or any implications for the time line of the olpasiran secondary prevention Phase III study results?

Well, we feel very confident in the assumptions that we put forth into the design of our secondary prevention trial. So we're going to continue to monitor the progress of our study. We feel very comfortable with the progress that our study has made to date. With regards to the competitors' data that comes in the progress of their trials, one, you're quite right, event rates are difficult to predict, and they represent a mix of things, including potentially the efficacy of your own medicine. Because if the medicine is very effective, the event rate will go down. There are a variety of other things that could contribute to the event rate reduction, but it's also important to contextualize when we're talking about delays, what is a significant delay or change from those assumptions. These trials tend to be several years long. And so an event rate difference that is a fraction of a whole number. We're talking about maybe 0.2%, 0.3% different than what you expected can result in a quarter or 2-quarter shift in time lines. So we took note of that. Obviously, we'll be keen to learn whatever is possible from that information that's made public, but we feel very comfortable and confident in the assumptions that we've put forth in our own study.

Okay. Great. I know a lot of patients are waiting for therapeutic options. So...

For sure. For sure.

So can you just remind us some of the key differentiating features between olpasiran and other Lp(a) programs and other modalities?

Yes, absolutely. There are a variety that have been looked at in the field, which is, again, gratifying to see. It's good to have competition in a field that is new, that will be best for patients, and it helps keep industry partners like ourselves on our toes. But olpasiran is potentially a first in best-in-class therapeutic in that it is first an siRNA that has progressed. This gives us an advantage of frequencies of dosing that can go from every 3 months to even longer. And the other piece has to do with the efficacy of reduction of Lp(a). So as I'd mentioned earlier, Jay, we had seen reductions in excess of 95%. In fact, some of the doses that we have looked at in Phase II got close to 100% reduction. And we even looked at reductions from administrations a year out roughly from the last time that the drug was given the last shot that patients got. And you still appreciated a reduction in Lp(a). So that durability of effect, the significance and the magnitude of that effect and the tolerability of those medicines, obviously, is very helpful, particularly when you are exploring patients that have very high Lp(a) values to begin with, which is also what we have done in Phase II. So we put forth a very rigorous program to put olpasiran to the test, if you will, and it had done very well. So we have been very excited about accelerating that program, and that's part of the rationale for us not only to look at secondary prevention, but again, to look at that next level of high risk in those patients vulnerable to having heart attacks.

Okay. Great. All right. So maybe shifting gears to MariTide. You mentioned last week that the team has been actively engaged with KOLs and you received a lot of positive feedback on the profile. Can you just share with us some of the feedback that you've received from KOLs and some of the key differentiating features for MariTide?

Yes, absolutely. And Justin also and Casey feel free to chime in here. I think what the KOLs have been very impressed with is consistent with what had impressed us about the data from the Phase II, Part 1 of the Phase II data that we have shared, which had been the consistency of the effect of MariTide across the doses, the predictability of the weight reduction that we had seen and the durability as this is the first every month or even potentially less frequent administered medicine for weight reduction. In that time interval that we measured 52 weeks, which is a bit shorter, actually, than Phase III data is typically read out at and where competitors have put their mark, we saw up to 20% reduction in weight for those patients that did not have diabetes but were obese, and we saw no evidence of plateau. And the relevance of that point is that if you carry a study out longer and the weight is still going down, there remains a potential that it will go down even further than that as you extend the study. I mean, those are the types of considerations that go into developing a Phase III program, which we have indicated. We are well on our way in discussions with the regulators in trying to advance this year. In those patients with diabetes, we also saw and the KOLs also commented on the significant weight reduction we saw up to 17% weight reduction in those patients. And the reason why that is significant, Jay, is because patients with diabetes are historically recalcitrant to weight reduction. In other words, it's tough to get way off or more difficult if you're a patient with diabetes. And if you are not, and a 17% reduction there is quite a significant reduction. Other notable that the KOLs commented on were some of the risk factors that were also modified in those patients taking or allocated to MariTide. This included a very significant reduction in A1c. If you were a patient that had diabetes, we had significant reductions in systolic blood pressure, LDL cholesterol, HSCRP. Again, as a provider who looks at patients that are at high risk, these are all the notable factors that you look for to shift if you're expecting a benefit in patients on the clinical outcome side, those factors that are related to weight and you hope to see be reduced as a result of the weight reduction. So that has been very positive. And of course, there's tons to learn in the way that we had designed the Phase II study to really tease out all of the merits of MariTide. So there's still more that we're going to learn yet, but it has been a warm reception to the data that we had, and we're excited to have more to share in the future.

And Narimon, I would just -- add one point you made, I thought is really worth reemphasizing, which is, I think a lot of the analyst notes that we read in a lot of the research that's done, there's a lot of deep analysis around the absolute amount of weight percentage loss at a certain week in time point. And to be honest, the KOLs really didn't focus on that nearly as much as what you would read in some of the reports. It's really more about what Narimon said, predictable, consistent curve, no plateau, comes with cardiometabolic improvements because at the end of the day, you're looking to keep these patients on the therapy to get outcome benefits. And so the sort of plus or minus 1 percentage or 2 percentage or whatever the number is, was not something they really talked about at all or at least that I heard of it are in their discussions.

Great. That's super helpful. Thanks for sharing those insights with us. And then I think you also mentioned last week that you were going to have detailed Part 1 results for MariTide at ADA in June and additional data from Part 2 and type 2 diabetes patients that you mentioned in the second half for MariTide. Can you just talk about how you want to frame expectations for investors and what they should look out for in those data sets?

Sure. I'll be happy to start and please, Justin, Casey chip in where you'd like. We had a very, what I would call, robust data share that happened near the end of last year for our Part 1 results. And so -- we should expect to see consistency with that. Those were really some of the highlights of the data set that we had seen. When we have the full breadth of presentation at ADA, of course, we'll see some of the more detailed data and elements that go into informing those overall results. So the completeness of the data set that we'll be seeing from Part 1 will be there. But I would offer that a lot of the large elements of the news and the results we have shared in November just with our interest in being transparent and keeping you all up to date with how that study had progressed. With regards to the Part 2 data, recall that this study -- this one Phase II study had a first part, which was a year long and it had a second part, which is also a year long. And patients that graduated, if you will, from the first part, meaning that they stayed on their medicine like they were supposed to and they lost weight 15%, I believe, they were offered the option to move into Part 2. So they could have said no, they could have said, I'm done. Thank you for the experience. But we had over 90% of the people that qualified actually volunteered to pursue part 2 of the trial. And as that's a year long, by the end of this year, right, we'll be getting to a place where that data set can be expected to be very near completion. It's a year-long. Part 1 finished last year. Part 2 should finish this year. And what's really notable, I think, from that Part 2 data is that we're going to be testing some different attributes of MariTide. So in Part 1, we looked at different doses and the effects of different doses and a couple of dose escalation schemes. In Part 2, we're going to be looking at maintenance of weight reduction. If you're able to go to a lower dose or even a less frequent dose, even quarterly administered, as opposed to the every 8 weeks or every month that we looked at in Part 1. We're also going to be looking at patients that will continue to reduce weight further beyond week 52. As we mentioned, there was not a plateau by the end of the 52 weeks. So this is an opportunity for us to see patients that continue on their dose of MariTide into Part 2 to lose even more weight. And then, of course, for some patients that will be randomized to the placebo arm, we'll get to see the full maintenance of that weight reduction in the absence of any additional MariTide exposure over that additional 52 weeks, and we'll be taking a look at some of the similar parameters that we looked at, at Part 1 inclusive of the biomarkers. So it's an exciting study. I think it will give us an opportunity to, again, really explore some of the different attributes of MariTide as it's shown itself to be a differentiated medicine from the beginning at Part 1.

Okay. Great. And then I want to follow up on your comment about starting Phase III for MariTide in sometime in the first half. Is Amgen planning to run multiple Phase III studies in parallel? And then I guess, one specific question we get from investors is if you will be using an auto-injector in your Phase III study and whether or not you need to do a bridging study?

Got it. Well, with regards to Phase III, we've been very optimistic and bullish about moving into Phase III. We have done that. We are in current discussions with regulatory authorities about our program. So there is nothing gating or holding us back into moving into Phase III at this stage. We are in it. We are looking to get that approval status to start our clinical studies and then we will go. In terms of what is comprised of that study package and evidence package? Yes, it will be multiple studies. We have every intention of exploring the full benefits of MariTide in these late phase and registrational studies. This is inclusive of not only the weight reduction that we've seen before. It's inclusive of looking at patients with diabetes and looking at glycemic control. We're also looking at cardiovascular outcomes. You've seen us do that well on a couple of other assets that we talked about earlier today, we'll be doing cardiovascular outcomes with MariTide as well as heart failure outcomes. We'll be looking at renal disease and sleep apnea as well. So we're really trying to turn over every card that we can for MariTide because we believe that there's a lot of promise there. And I think it will be really interesting to see how that data turn out.

And Narimon, maybe I'll just take the second one on the auto-injector and the presentation and whatnot. Yes, Jay, what we've indicated is that we plan to deliver or launch MariTide in a convenient handheld single administration, auto-injector. What we haven't discussed is the exact plan by which we get from Phase III to that, whether it's bridging study or in the trials or whatnot. So I would just say more to come there. But I would just reiterate, we very much have been very consistent and committed to that presentation in terms of what we'll launch within the market.

Okay. Great. It sounds like a super comprehensive development plan. Maybe just to shift gears for a second. There was, I think some information that maybe caused confusion amongst some investors last week. About AMG 513 and the clinical hold. But it sounds like you're still optimistic about it. Can you just talk about anything you can share on the nature of the clinical hold? And then more broadly, I guess, different mechanisms that you would like to target in obesity?

Thanks, Jay. Well, first and foremost, Amgen is a company that is invested in obesity. We have a variety of early assets that we're looking at and have always been on the lookout for another breakthrough. We felt that we really got a strong foothold with that type of approach in MariTide. And we have been very aggressive in progressing MariTide. And as you would expect for every competitive innovative company, we are not satisfied with one innovation, and we want as many of those as we can. So we have an array of assets in our early pipeline. AMG 513 is one of those assets. It had recently gone into first in-human testing. We haven't disclosed the mechanism of AMG 513 or its modality, and we won't today. It's a very competitive field and we try to keep our cards close to our chest while we can. But as you mentioned, the FDA communicated to us that they would put the program on a clinical hold. We have looked at the data that the FDA have looked at. We have not seen anything that gives us concern that it is due to AMG 513, though issues that they are highlighting for us. So we're very motivated to provide the FDA whatever and all the information that they need so that we can get on with the clinical study. And we'll see how the study turns out. But you can count on us taking a look at every potential opportunity for early assets when it comes to obesity and these opportunities to modulate metabolism in ways that can be really helpful to patients.

Yes. And I would just add, and I'm sure some folks know this already, but for those who might not be aware, I mean, Amgen has been in actually metabolic for a number of years. We had a program decades ago that we have pursued and then decided to abandon, but continued basic research in this area for years. So this is not just a new area for us.

Great. We'll stay tuned. I do want to make sure we touch upon the innovative oncology portfolio, Justin, that you mentioned earlier. One of the key catalysts this year are Phase III readouts from your bema plus chemo and gastric cancer, FORTITUDE-101. Can you just talk about what the opportunity is there? And timing and what we should expect from those readouts?

Well, I'll be happy to speak about FORTITUDE-101. And we also have a second Phase III study 102, both of those are going to be reading out in the first half and second half of this year, respectively. These are studies that are being done in patients with gastric cancer. That is obviously a devastating diagnosis. It's the fifth most common malignancy worldwide. Outcomes are atrocious. This is an area that is begging for innovation, and we're very pleased to have a potential opportunity with bemarituzumab to help these patients out. Our work in Phase III is predicated on our Phase II program, the FIGHT study, which showed that there is a benefit in progression-free survival and encouraging data there as well as with overall survival. So we have converted that into studies where we are looking at the combination of bema with chemotherapy regimens that are used in gastric cancer. And as I mentioned, for FORTITUDE-101, we're dealing with one type of chemo regimen called modified FOLFOX6 chemotherapy. And in 102, our second Phase III study that is going to be reading on the second half of the year, we're looking at bemarituzumab in combination with a PD-1 blocker, nivolumab as we know. So we are quite enthusiastic about how this data will read out over the next year. We will have to stay tuned as we will to see how those cards turn over. But again, just a devastating disease, and we are hopeful that we have an option for those patients here coming soon.

Okay. Excellent. We'll look forward to that. And then maybe just quickly on TEZSPIRE, got potential for label expansion this year. Can you talk about that a little bit?

Yes. This was our study that looked at chronic rhinosinusitis with nasal polyps. So many of us know patients and have friends actually with this condition. And it is also no picnic for people that have all these polyps in their sinuses that grow and obstruct their breathing. It's like they're constantly in allergy season and get horrible sleep. So we have looked at the opportunity of TEZSPIRE to help those patients. Because the biology that belies that phenomenon in that condition is one that's very much rooted in allergy and allergy response. And we had a significant improvement in both patient symptoms, the nasal polyps as well, and we'll be sharing that data here soon with our partners, AstraZeneca. And have submitted that data for review to regulatory authorities. So another exciting development for TEZSPIRE there.

And I just can't miss the opportunity to add that we also announced that we'd be initiating our Phase III study in COPD, first half of this year. That's the third leading cause of death in the world and the Phase II data, we thought were very impressive. So also excited about that one.

For sure.

All right. Excellent. That's super helpful. We're just about out of time. Before we wrap up, are there any other important data readouts or catalysts that investors should watch out for this year?

Maybe the one I'll flag because I know that Narimon has quite a history with Repatha as a cardiologist is we have the VESALIUS study that will be coming this year as well. As folks -- and maybe, Narimon, you could take one second on it. Obviously, we have a tremendous opportunity in the current indication, but this could provide even further boost to Repatha. Maybe Narimon, if you want to take one word on VESALIUS?

Yes, absolutely. So this is -- and if you will, a build on the evidence base that we've had for Repatha, the original FOURIER study that looked at secondary prevention patients. VESALIUS is looking at those patients at high risk but had not yet had a heart attack or stroke, so that so-called high-risk primary prevention patient population. And we've seen such an upswing with the utilization of Repatha in those patients that need it. There is no shortage. There are hundreds of millions of patients in the world that can use a medicine like Repatha. The VESALIUS study is going to be our first opportunity to show in those patients that have not yet had an event what Repatha can do. That will be very exciting.

All right. Well, we're looking forward to that. We'll wrap up there. I want to thank you all so much for joining us. It's always a pleasure to learn more about the impressive work you're doing at Amgen on behalf of patients. So thank you for joining us today.

Thanks so much, Jay. It's a pleasure to be here.

Likewise, thank you, Jay. Appreciate it.

Our pleasure. Thanks, everyone.