Amgen Inc. (AMGN) Earnings Call Transcript & Summary

Welcome to the third day of the first annual Citi Global Healthcare Conference. My name is Geoff Meacham. I'm the senior biopharma analyst here at Citi. We're thrilled today to have Amgen with us on stage. And so we have a lot of folks here. So we have Jay Bradner, Executive VP, R&D and Chief Scientific Officer; Susan Sweeney, EVP of Obesity and Related Conditions. We have Peter Griffith, EVP and CFO, and we have Justin from the IR team. So welcome, guys. Appreciate the time.

Thank you.

Let's kick it off. It's been a quiet month for you guys. -- past couple of weeks. You wanted to...

Geoff, are you okay if we jump in? We've got a few thoughts we wanted to share with our colleagues.

Yes, let's do it.

Yes, do it. Look, listen, good morning, everyone, wherever you might be, on the webcast, Geoff, thank you. We're always glad to be with Citi. Citi has been a great partner for Amgen over the past number of years. We wanted to take a few minutes this morning, and I'll give you an update on our overall business. A couple of quick thoughts on MariTide. Susan has got a couple of quick observations about the Obesity business, which we've had a little bit of questioning and we think some great news on recently, great data for patients, and then Jay will give you some thoughts, too, about the overall pipeline and also obesity. But first of all, Geoff, I just wanted to say, Amgen continues to innovate at speed and scale across all 4 of our therapeutic areas and breadth of depth. Our revenues grew 23% in the third quarter, so another very strong quarter, 29% volume growth. 10 products delivered double-digit sales growth in the third quarter, 14 products are annualizing at over $1 billion per year based on third quarter product sales. So strong breadth and strong depth. Maybe just a quick look at our 4 therapeutic areas: First, in oncology, the innovative oncology portfolio grew 17% to over $2 billion in the third quarter. We're very pleased with that. Anytime we see strong growth like that, what's most important is that means a lot more medicines are getting to a lot more patients around the world. So we're pleased with that. And then oncology, I'm sure Jay will speak about some of the strong progress in the pipeline. I just cite xaluritamig, our bispecific T-cell engager. Right now, we've moved it into Phase III after advanced prostate cancer, and that's exciting, a lot more though in that portfolio. I would turn to a rare disease. We closed Horizon on October 6, 2023. We're delighted that we had an opportunity to work with Citi on that in terms of raising the bonds. We have our ex-treasurer here today, our former Treasurer, Justin Claeys. And he and I worked on that and delighted to do that. But we closed that. We are happier to be in rare disease today, Geoff, than we were when we announced that deal than we were when we closed it. It's such a great strategic fit for Amgen. And I would say a great proof point is that TEPEZZA just launched in Japan for thyroid eye disease. And our international infrastructure that we've worked on building out and investing it at Amgen over the past 10-plus years was a key part of the strategic thinking behind that opportunity for us. So a great move forward in rare. TEPEZZA, KRYSTEXXA, UPLIZNA and TAVNEOS, 4 medicines early in their life cycle, each doing really, really well. That was up to $1.2 billion in product sales in the third quarter, rare, up about 21%. Swinging over to inflammation, up to almost $2 billion, TEZSPIRE, medicine for severe asthma very innovative medicine, up 67% in the quarter, and we have suggested we're moving forward into Phase III in chronic obstructive pulmonary disorder in the first half of 2025. Over to Gen Med, a lot going on in Gen Med as you know. And so I would actually -- before we have the solar eclipse here of MariTide and obesity, which is fantastic, just to take a moment on olpasiran, Lp(a). I know Jay says this is one of his favorites. It's one of my favorites. We enrolled over 7,200 patients this year faster than we've ever enrolled in an outcome study and we're excited about that. We think that enrollment was as fast as anybody has been able to enroll that study in the industry. So we're excited about that. Repatha, up 40%, LDL-C. EVENITY, up 30% in the bone portfolio. So -- and that's early in its life cycle. It's going to go a long time, and we're excited about EVENITY and what that's doing in the bone portfolio. I would just say biosimilars continues to be strong. We saw the launch of Pavblu there, and so we're encouraged by that. We've got priority review now. For UPLIZNA in rare in IgG4-related disease, and we think that's a big move. And we're very excited about that, a PDUFA date of April 3, 2025. Let me make just a couple of points on the MariTide. We had big news last week, Geoff, as you know, and we're very pleased with the data. But I wanted to just reiterate 7 really important points about the differentiation of that product. Number one is roughly 20% average weight loss at 52 weeks without a weight loss plateau, patients were still losing weight. And I'm sure you'll interrogate those curves with Susan and Jay, but we're very pleased with those curves and what they indicate in terms of efficacy. Number two, first obesity treatment with monthly or less frequent dosing. Every other month was studied in Part 1 of Phase II, and we've indicated we're studying in Part 2 of Phase II quarterly dosing. We think amongst many differentiating opportunities there, that's one that highlights persistence, and we think can really help in improving persistence in these medicines for patients with obesity, obesity-related conditions in type 2 diabetes. Substantial improvements in cardiometabolic parameters, low discontinuation rates, 11% in the dose escalation arms due to adverse events. And of the 11, 8 of those percentage points actually less than 8 were due to GI tolerability. So we think that was very favorable. More than 90% of eligible patients enrolled in Part 2 of Phase II. So that we thought that was a great sign also. 17% average weight loss in patients with type 2 diabetes, lowered HBA1c by 2.2 percentage points huge move there. It looks like a great medicine maybe works its way towards best-in-class in that area. Last, dose escalation works. We'll talk a lot about that today, I'm sure. So I'm not going to belabor that anymore. But the last point, which is really, really important that we want to share with our investors and with you, Geoff on the device. A lot of people have been asking about that we want to reemphasize Amgen's long-standing world-class expertise in combining our devices with our biotherapeutic medicines. Number one, strength in protein engineering and our process development group world-class. Strength and understanding how to work through viscosity issues. We've been doing that for many years. Strength and how we incorporate those excipients into these medicines and doing that and absolutely the optimal way. And finally, proprietary device innovation itself with a clear focus on patient safety and experience. So I wanted to share those comments, take a few more minutes and we usually do. But also just -- I want to let Susan have a couple of thoughts to here to share with you and with the group. And Susan, please.

Yes. Thanks, Peter. Just to put in context from a commercial standpoint, we think that the attributes that Peter just went through really placed MariTide well for competing in the marketplace, large heterogeneous market, billion patients worldwide, barely patients just being treated now. We're still in the low single percentage points. And what we do know is that patients need to get to goal and be able to stay on therapy to be able to maintain their weight. And we think the profile of MariTide plays really well there. On getting to goal, we have efficacy of 20% with out of plateau, which means that you might be able to get to a lower -- a more substantial weight loss, but that trip to get to goal is really important. Long dose escalation with the weeklies, what we've seen with MariTide dose escalation is important, but that shorter period of dose escalation means less revisits to their physician as they need to change their dose less changes in the prescription as they're going through it. And as a result of that, probably an easier experience being able to get to goal. And the other thing we're really encouraged by is, from a maintenance standpoint, the ability to potentially look at monthly as well, we think we'll go into monthly certainly, but then also the ability to go quarterly. What we do know now is that at about 9 to 10 months is average when patients are dropping therapy. And so really, without managing obesity is being able to get to that goal and maintain that goal, and we feel MariTide Is set up well for that.

Great. No. Thanks, Geoff. I couldn't agree more with what you just heard. We've seen in MariTide already very competitive efficacy reflecting on the data we saw yesterday tirzepatide versus semaglutide, 20% at 72 weeks with the latest data on tirzepatide, we're seeing 20% at 52 weeks with curves that have yet to reach a plateau. As we enter into part 2 of this study, we're very interested to look at continued weight loss through that period as well as different maintenance strategies that would allow much less frequent dosing, maybe quarterly as well as lower doses. So a lot to love about MariTide in its direction, and we couldn't be more confident in the profile that's rising. Beyond the MariTide portion of the portfolio, I would just 3 quick bullets, things to keep aware of. Though we're in a bit of a quiet period with olpasiran right now, as Pete mentioned, completing an event-driven Phase III clinical trial in Lp(a) as secondary prevention for atherosclerotic cardiovascular disease complications. This is one of the last clearly genetically defined otherwise unmodifiable cardiovascular risk factors, and we have a medicine with real best-in-class potential there. Second, in inflammation, the CD19 opportunity, which is take a biotech world by storm. We have 2 approved assets there with blinatumomab, presently used for cancer and stay tuned for a presentation at this ASH weekend. We have a plenary presentation with blinatumomab in pediatric ALL. Tarlatamab or IMDELLTRA for small cell lung cancer, the first bispecific T-cell engager in common advanced solid tumor, now in multiple Phase III studies. And then xaluritamig in prostate cancer, which we're hopeful for in another refractory solid tumor setting. So between CD19 and its portfolio of opportunity in autoimmunity, between the T-cell engagers, now we're working in solid tumors. And between siRNA, we have 3 platforms that really can be, I think, quite durably delivering first-in-class assets for very serious diseases. So anyway, I don't want to take any time. I'm looking forward to the questions.

No. I mean the -- if it were not for the prepared remarks, like I probably would have been 90% MariTide. So thanks for...

Now you'd be 97.6%.

Right. Exactly. I want to follow on.

Geoff, I'm sorry, I missed 1 point is shortly before we started this morning, Amgen put out a press release that we're investing an additional $1 billion in the North Carolina to our manufacturing facility there, that just crossed the wire. I'm sure that the team is on that. But we're excited about that. We're excited about North Carolina. We're grateful for a wonderful diverse workforce there. We're grateful for the support of the local community, and we're really looking forward to a fantastic drug substance.

Seems to be GLP-1 sort of manufacturing ground zero.

Well, we don't look at our plants that way. We think about our entire network across the globe and optimizing it. And our manufacturing group led by Arleen Paulino is just spectacular at that. So we're excited about North Carolina what's going to happen there.

I wanted to ask you something that -- I think all you guys have mentioned that the weight loss in the MariTide study continues at 52 weeks? Like where would you -- what do you think is sort of commercially impactful? And where do you think that could go if you continue to lose weight, like is that -- does that add risk, right? In other words, if you get to like 30% and then you start to lose potentially lean muscle. Like what -- where would you like to see sort of the plateau kind of be from a -- from a clinical standpoint?

I'll start with medical and then maybe you could speak to the commercial opportunity. So quite a lot is known about the association of body mass and health outcomes. It's known as the population, it's known from outcomes of bariatric surgery. These medicines do a lot more, as everybody knows, than just promote losing weight, impacts on inflammation, hemoglobin A1c, et cetera. But just focusing on body mass, as you mentioned, clinical benefit is -- begins to arise at about 5% of a change in body mass index. And that's why we were very proud that the vast majority of patients on this study received clinical benefit of that magnitude. It turns out that there is no [indiscernible] distribution, where on the other end, it starts to be less beneficial. And so we and others in the field -- experts in the field believe that you can drive significant additional medical benefit between 20% and 25% and 30%. And it's for this reason that when we're finally in a position to share these data publicly, which we've been very excited about 1.5 week ago, we were able to talk to a lot of investigators in the field that we're working with on our Phase III program that -- we pay very close attention to their guidances and experiences as we refine the presentation of this medicine for the marketplace. And they all said the same thing. Their immediate reaction was look at the shape of those curves, and the fact that the curves aren't plateauing at 52 weeks, for sure predicts that additional weight loss should be expected into part 2 of the study, which is second 52 weeks. But moreover, the slope and trajectory of the curves is stable. It's predictable. It's consistent. 140, 280, 420, all delivered significant and steady weight loss. On these clinical trials and in press releases and on stages just like this, we talk a lot about 20 versus 22 versus 25, and those things matter because additional weight losses, additional medical benefit, and we want to deliver that quickly to the patient. But in clinical practice, what the doctors want is steady and consistent weight loss without a need for a ton of new prescriptions or tweaking and adjusting doses, maybe endocrinologist like that. But primary care doctors don't like that and cardiologists just won't do that. And so having a medicine with such simple dosing, to be honest with you, with such stable drug exposure, all reads through to the steady and consistent weight loss. And so I look forward to sharing part 2 when we have that data, and we can really learn where if ever this curve starts to taper.

Yes. And just to add to that, I think part 2 is going to be really important to answer your question. In that study, we are taking patients that have gone through the 52-week period, those that have lost 15% weight loss and then re-randomizing them in the other arms. And those arms of understanding what maintenance looks like are really important because, Geoff, to your point, if a patient is continuing to lose weight, we'll know if that patient moves to a lower dose, what's the impact of that, and does that stabilize the weight. We'll also know for patients that do we reach their weight goal, what does it look like from a quarterly standpoint. And we'll also have data on patients that stop completely, how long does that -- how long does the period of weight regain come back? We did see from our Phase I trial that there was a long period of time before weight regained. We do expect patients will regain weight if they completely go off therapy, but we'll have a better idea of how long that is and then look at eventually what would happen if they reinitiate it again.

Right. I guess one of the questions that we've been getting post the data, I mean, you guys are obviously very enthusiastic about it. The data in totality support like a major derisking event. But then the details of it, I think we're maybe that investors were expecting. Like help us reconcile that? Like are you -- is it that you want to -- is it competition? Is it something that you want a little bit more granularity before you start the Phase III in terms of the parameters of the study? I'm just trying to get a sense for the pooling piece of it versus like you guys obvious like excitement.

Geoff, I'm sorry, I have 5 grandchildren. I read them in the book if you give a mouse a cookie. And I think our investors and analysts, and I totally understand this. If you give them a cookie, they're going to want milk. If you give milk, they're going to want a sandwich, so I don't want to jump in here and make light of this. But I think the point is we feel like we gave a really complete top line data package. And Jay and Susan have both emphasized, this is Phase II and this is a great top line data package. So having said that, I'll now back out of the way with my little anecdote and allow Jay and Susan to answer this in a serious way we should answer it.

I'm going to answer it a serious way, but I think the message is the same. This was a very thorough presentation of top line data. I mean we see top line data released in this domain all the time with just an efficacy number, no tables, figures, legends, differentiation of data, tolerability data. I mean this was a 30-minute science presentation. I think it's just shy of a podium presentation, but it isn't a podium presentation. I mean that will need to happen in the scholarly venue with the full data set. We sought to include -- and I still believe this way about that data set, we sought to include all of the actionable insights derived from the study. These are the same insights that we've used to design Phase III around dosing and the use of dose escalation in particular. These are many of the same insights that drive us to have confidence for a potentially once a month or less frequently administered diabetes medicine, which is a long-standing, if not historic goal of that field as well as early insights into what maintenance could look like, remarking that every other month dosing produce the same amount of weight losses every month. So I think in the fullness of time, it will become clear that the actionable insights are all released, but this science is so exciting for the field, that from investigators to analysts, to people within our organization, there's a natural inclination to want more and more and more, and that's why we're here to welcome that dialogue.

And I wanted to ask you on the -- so the Part B will have more extended dosing. Would you want to have absolute clarity on that prior to starting the Phase III? Or would you start multiple Phase IIIs with different doses and strategies, right?

Thanks for the question. We have all the guidance that we need for Phase III clinical investigation from the data set that's in hand. And so part 2 will be very interesting and informative around the ultimate achievable weight loss in those that continue on their current dose. It will be very informative about whether a maintenance mindset matters for this field. You never hear about maintenance in this field. But these are chronic conditions. People don't suffer from obesity for 52 or 72 weeks. It's a lifelong condition. And we believe the properties of our medicine are such that with a low dropout rate and the 90% curiosity to roll over into another year of MariTide on study, that patients are voting with their feet. They're quite happy with this medicine. As we shared that Manhattan plot, there's 51 weeks where patients are essentially without those gastrointestinal symptoms at a target dose. And so with these properties, there's more that we can learn from Part 2. But none of that learning is essential to conduct the Phase III -- the first flight of Phase III studies.

Yes. The only other thing I would add on the Phase III study is coming up. We did announce the MARITIME program. And in the context of the Phase II, which was in chronic weight management, there were some components of it that are really important across any of the programs that we do, understanding dose escalation. And we think that we've learned a lot about dose escalation. And as Jay has said, it's very clear. We know MARITIME needs dose escalation. That will pull through into those other studies as well as the metabolic parameters, really seeing those significant impact in LDL, blood pressure, in HbA1c. That also helps us get more information as we move into those other obesity-related conditions, too.

And just I wanted to ask you on that, too. So you -- I mean most companies in this space are obesity and diabetes and the Novo's and Lilly's of the world have moved on to the related ones. But there are dramatically more that haven't really been addressed like a lot of cardiovascular conditions, a lot of adjunctive therapies to surgery, et cetera. So the question is like what does the potential for extended dosing mean in those other indications? Or are you just thinking about the differentiation in extended dosing being valuable in just the core obesity and diabetes?

I think the extended dosing can have profound impact across all the different indications. I mean think of that again about maintenance for all of the areas that we're going into, these are chronic diseases in which you need patients to be able to stay on therapy long term and having different options from a convenience standpoint in many of the areas that we're looking at, there haven't been dosing schedules that we're looking at. For example, in diabetes, it's been an area type 2 diabetes that's been under investigation for a long time to try to find a monthly. And now not only is there a potential for a monthly, but maybe for less frequent dosing, and we'll need to do the studies to see how that plays out.

And I think you mentioned the semaglutide versus tirzepatide head-to-head. So is that under consideration in a formal Phase III is to do a head-to-head versus one of the existing agents?

A key part of our go-to-market strategy is to really understand the performance of this medicine also to understand its performance to as it relates to other medicines in the space, really lean into its differentiated profile. We're in a phase right now where we're in very advanced discussions with regulators about each of the indications that we've prioritized in the MARITIME program. So I can't speak too much to it. But can't wait to share the outcome of those discussions that will define our Phase III and our regulatory strategy. Looking at these data, as you mentioned, tirzepatide market leader a 20.2% weight loss at 72 weeks, we're already at 20% at 52 weeks. I think in that study, if I'm not mistaken, as yet not published, but released in top line, semaglutide was like 13.7% weight loss. Again, 20% weight loss that we're seeing is a very long and competitive efficacy signal. So surely would welcome a chance to study this medicine in the context of other established emerging standards of care as relevant to regulators and the need to highlight and reveal the absolute efficacy of the molecule.

And Jay, I want to follow up on one of your comments. You said that the Part 2 is not necessarily needed to start into Phase III. But what would you say from a presentation and sort of to get broader scientific sort of buy-in to give you momentum as you start the Phase III, like are you -- is there some sort of framework you can give us for the presentation or a publication or something like that?

Well, I mean, I can only speak for myself. There's 3 things that I'm just very curious to learn about MariTide in Part 2. This is one of those cases where time just can't move fast enough. I'm so curious about these 3 things. One is, where will these smooth and descending curves ultimately terminate? Just how much weight loss is this medicine capable of? We report 20% as an average. You know how averages work. Everyone on this call is sort of a math person, there are some patients that enjoyed significant weight loss on this medicine could others with more time, enjoy the same. So enduring efficacy. The second is rebound. It's just characteristic of this field, its characteristic, honestly, of all medicine that when you drop off of effective therapy for whatever reason that you can have a recrudescence of your disease. The rebound on the weekly obesity medicines has been very tricky. Every time this has been reported or studied as well as real-world evidence will support that the rebound is quite brisk. And our Phase I after 3 doses, we held dosing as intended on that trial. And for 150 days, patients failed to really rebound significantly from their loss body mass. And there's a lot I could go into around adipogenic epigenetic memory and why that could be putting all that aside, the long-acting nature, the stable and durable exposure to receptors through a 52-week period, I think there could be something to durability that's unique to MariTide. And so those patients randomized to placebo in part 2 will give us that teaching. And then the third is the dose and schedule required to deliver the weight loss, the same as required to sustain it. And wouldn't that be something if we were able to reach 4x, 6x as many patients by after a period of time, stably dosed on the medicine, you could drop back. So maybe 70 milligrams monthly to maybe 420 milligrams quarterly or something in between. And so I think these 3 learnings, sustained weight loss, durability of weight loss achieved and the capacity for a different maintenance mindset will be really interesting learnings. Now none of those are important to establish the immediate efficacy of the molecule at target dose. And so off we go on Phase III as these other data start to cook and deliver insights 52 weeks from now.

Last question here from a mechanism standpoint, so your mechanism is unique. What is the level of comfort, I guess, that you guys have in the totality? Like could the mechanism with more patients longer follow up, does that add any risk or uncertainties on, say, tolerability or discontinuations or general adverse event profile of the medicine?

Now with 52-week data, and we have an accumulated and strong safety database, we've treated over 800 patients with this medicine already, and we're just emerging from Phase II. So we feel very good about the safety of this molecule. You are right that it's a unique mechanism. I mean this isn't like we attached to GLP-1 peptides to an antibody core just to make a long-acting GLP. It's an active antibody that inhibits the GIP receptor. If we break it down to the 2 principal components agonizing GLP-1 and inhibiting the GIP receptor, I take a lot of comfort from the learned safety of what GLP-1 agonism is in the real world. Thousands of patients around these medicines, and they're doing great. The net therapeutic benefit is overwhelming and positive. GIP inhibition -- well, that's new for us. We're leading in that dimension. But there, we take real confidence from experiments of nature that humans born with variants of the GIP receptor that leads to strongly muted signaling, there fertile they reach a ripe old age. They're protected from obesity and they're protected from cardiovascular complications of obesity. So we infer from the one, the pharmacologic experience is reassuring. And then number two, human genetics is reassuring. A lot can happen in Phase III clinical investigation. We approached that study with true equipoise, but from a safety standpoint, we drive a lot of comfort from those 2 learnings.

And Peter, to your comment on manufacturing, so the new announcement today, what -- when you think about down the road, if MariTide is what you guys claim it could be, right, like in the commercial setting. And what you've seen today, like in the other assets out there from a demand perspective, what's the flex to further expand the facility? What's the ability to use other Amgen facilities around the world from a manufacturing context?

Well, let me give you a few thoughts on that, Geoff. Maybe I'll -- when I finish, I'll ask Susan to jump into and talk a little bit about the market where that's going to go, because I don't think we think about if I think we think about when. We expect this to be a really important medicine and currently a potential medicine, but at some point, an important medicine in this unmet -- significant unmet medical need around the world. When we think about manufacturing, Geoff, what we've been saying is Amgen for many, many years has been a leader, maybe the leader in the science of manufacturing. So when you think about what's the yield out of the biologicals. In other words, what -- where are we starting from what base? And how do we do our process development, which we think is world-class? And how do we put that all together to optimize the network around the world in a way that not just optimizes manufacturing and so forth that optimizes where we make it and how we ship it around and how we hold inventories and how we hold our -- make sure that we're trying to meet our objective of every patient every time around the world? And so we think, as I said earlier, with respect to North Carolina, what's the network optimization we want to get to. We're fully committed to the kind of capital expenditures that we need to make. That's our second capital allocation. Our capital allocation hierarchy. First is innovation. So we're going to fund MARITIME. We're going to make sure the development is fully interrogated as investigated. And then secondly, we invest in our business, our CapEx. So the announcement today in North Carolina is important. As you may recall, we finished a finished drug product plant in Ohio in the first quarter this year that's almost entirely automated technologically leading and we'll continue to push really hard in using technology and artificial intelligence in the manufacturing and the process development activities that we have underway. So we're fully focused on that. We think we're a leader. And I think it goes back to COVID, Geoff, when we had colleagues in the industry who look to us for some help in terms of manufacturing some of those antibodies to fight the battle against COVID. And there we were, and we were able to get that done quickly and support our colleagues in the industry and patients. So we're always committed to that. But I think Susan has got some good perspectives on how we're going to integrate manufacturing with where we see the market going because it's the real clinic that's going to drive this demand, we think at some point.

Yes. I mean it's -- MariTide is going to be -- fits very well into our standard platform. So as Peter said, we can use the network that we have in place to bring it to market. The other one, I think, Peter, you might have already mentioned is just from a peptide standpoint, there's significantly less peptide that's going to be required with MariTide, just based on the synergistic nature of the molecule as well as the dosing frequency. So you're going to have less peptide that you go in which some of the other manufacturers have run in -- some of the other companies have run into from a supply standpoint. From a supply standpoint when we get back down to patients, though, what's going to be really important for us is -- and we've said it in the opening remarks, just to make it clear is that we are going to come to market with a convenient handheld patient-friendly auto-injector, single injection per patient. We have experience in providing devices to patients for many years and many thousands of quantities. So we're well prepared of understanding what the needs are for the patient and how we're designing it on our proprietary device approach, but also making sure that we're really focused on what the patient is going to need.

Right. And I guess last question on the category. When you think about MariTide as an injectable, long-acting injectable, what are your thoughts on the other segment of the market that is still yet untapped with respect to orals for this category?

Yes. I think the oral data is still coming out of the market, but I think there's plenty of room in the market for both orals and injectables, particularly that the profiles are going to be different. MariTide, again, providing the ability to get to your weight loss goal. We're not seeing that plateau at 20%. I'm not sure if we're seeing orals in that level, but being able to go beyond that in efficacy beyond that. But then also from a maintenance standpoint, a product that provides monthly or potentially quarterly dosing is a really good option for patients in the market. So we see that there's plenty of room for both in there, but we definitely see that MariTide has some unique advantages that none of the other agents really are coming to the market with right now.

We hope to be relevant in the development of oral obesity medicines as well, and we're hard at work on that in our research labs and have ongoing partnering discussions. But it's fair to say that this mechanism has not translated immediately to highly efficacious and well-tolerated medicines. And so I think that will open up some segment of the market. But the very seriously ill patients who most need these medicines are very well suited by these injectables.

Right. Makes sense. So switching gears, we had Scott Gottlieb here yesterday. There's been a lot of talk about policy, IRA, et cetera, et cetera. Just at a high level, maybe, Peter, what is the Amgen kind of positioning for what the landscape could look like looking into next year? Is there an expectation of broad change with regard to IRA or anything related to the biopharma industry?

Well, Geoff, it's a very important question. And what's important to us is our patients are focused on getting their innovative medicines from us. And we're going to be focused on working with the administration working with regulators as we always have in the most constructive productive ways. That's our objective. So that's our first and foremost focus. We'll certainly look at what's transpiring and continue, as Jay said, working very closely with regulators, not just on MariTide, but entire pipeline. That's been very constructive for us over many, many years. We'll continue to think about where we're manufacturing and making our products around the world, where is the right spot to create the most value first for patients and for shareholders and for staff. And so we'll be focused on that. We're excited about next year. And we think while there may be some changes from a regulatory standpoint, maybe there are changes from a tax standpoint, we're very adaptable. I mean when the industry had a change in 2018 or so and as you well know, you followed the industry for many years, prices, net prices started dropping for the manufacturers like ourselves. We adapted quickly. And so we adapted to that. We adapted to the IRA quickly and the implications of that. We run -- one of our key leadership principles is to adapt. And so we'll be ready to go. We look forward to working with new administration, working with new Congress and the Senate, and we're going to do whatever we need to do to get that innovative medicine through development, through manufacturing, delivered and distributed to patients all over the world, just as quickly and safely as we possibly can.

Got you. Makes sense. Final couple of comments. So you mentioned the ASH meeting coming up. And so maybe give us a preview of the frame, I guess, the data that you guys have and kind of from a commercial perspective, how we should think about it?

Yes. Well, the most exciting presentation that we have at ASH, our data in and around our CD19, CD3 bispecific T-cell engager, the first approved bispecific T-cell engager called blinatumomab. And this medicine known as BLINCYTO had a big year. We had approvals this year for the use in frontline acute lymphoblastic leukemia in the adult population with or without minimal residual disease. And by this field, as you must know, I'm a leukemia doctor, we move in our field as sort of like these generational advances that have ratcheted up the cure rate, in children north of 90%. But unfortunately, in adults where the disease is a little bit different, and we know that kids are stronger than adults. We've been stuck between 40% and 60% overall survival. Enter blinatumomab, which for the first medicine in probably a decade, has significantly advanced the sort of core strategy the multiyear induction, consolidation and maintenance strategy required to cure ALL, it has ratcheted the overall survival up yet again. I can't share the outcomes of this study to be presented, but it is a plenary presentation at the ASH meeting that seeks to advance the standard of care in pediatric ALL. And I love that about this company that a lot of scientists in the world, it's hard to get a grant funded sometimes around ALL, because it's perceived as a soft problem. But this 10% of children that are still not cured by ALL therapy is a huge unmet medical need. And so we're proud to contribute to that. I look forward to sharing more on the back end of this. What this means commercially, ALL therapy moves on block. And so as you join frontline standard of care, there is improved access and utilization and benefit from most importantly, this medicine. Our next advance will be to take blinatumomab, which is delivered by IV continuous infusion into a subcutaneous route of administration and those studies are ongoing.

Got you. Okay. With that, guys, thanks a lot for your time. Really helpful.

Thank you. It's great to be here, and we're grateful to Citi for sponsoring such an excellent conference. Thank you.

Sure. Yes. Thank you.