Super excited to have Amgen Management with us. I'll let you guys kick things off, and we'll jump right in.
Great. Umer, thank you so much for inviting us again. We're always pleased to be here with you and with Evercore and at Amgen, you know our mission. Our mission is to discover, develop, manufacture, and deliver innovative, first-in-class and/or best-in-class medicines to patients with serious illnesses all over the world, so we're glad to be here today. We continue to invest in innovation and science that enables longer, healthier lives with a strong long-term growth outlook driven by breadth and depth across our four therapeutic areas. We're entering the final stretch of the year, I think we can say that, since it's December 3rd, with great momentum across the business. We delivered 10% revenue growth through the first nine months, ending in September, inclusive of 11% product sales growth, and that was driven by 14% volume growth.
And for the first nine months of the year, we had 12 products growing double digits and 14 products annualizing at greater than $1 billion. I would note, too, in the third quarter, we had 16 products with double-digit growth over the prior year. So strong momentum. We've got a strong foundation going forward. We are successfully working through the DMAB full year of competition we're going to face on Prolia and XGEVA. We continue to fund our pipeline. We're excited about that. Casey will share with us some updates on the pipeline, and we're excited about that, and other potential medicines that are coming in the pipeline that contribute to that momentum. As we said in February on our fourth quarter call, we expected our growth drivers to be Repatha, EVENITY, TEZSPIRE, our innovative oncology portfolio, our rare disease portfolio, and biosimilars.
We've been able to do what we said we would do, which is have those drive the momentum of the company. Kave, I'll share more with you on those. We're encouraged by the momentum in the business. You know we've paid our debt down to where we said we would relative to the acquisition from Horizon about a quarter early in the third quarter. Our capital allocation continues to remain consistent. We allocate first to innovation, the best innovation internally and externally. Our current guide for research and development year over year is in the mid-20s% year over year. We're executing and putting our spend where we believe it should be, which is in innovation. With that, I will turn it over to Kave, and he'll give you an update on what's happening in the end market portfolio.
Casey will give you a couple of quick thoughts on the pipeline, and then we'll be back to Umer for some Q&A.
Perfect. Thanks, Peter. Three of our innovative growth brands are addressing major public health challenges, beginning with Repatha, which has grown over 30% year over year in the first nine months of 2025 and is now annualizing at almost $3 billion, supported by broad U.S. access. As you'll hear from Casey in a moment, we've compelling data from the Vesalius-CV cardiovascular outcomes trial further reinforces the urgency to treat with Repatha. With nearly 100 million patients still not at their LDL-C goal globally, we're excited about the potential to reach additional patients. Moving on to EVENITY, which has delivered 30% year over year growth in the first nine months of 2025, with continued strength in both the U.S. and Japan.
In the U.S., EVENITY leads the bone builder segment with over 60% market share, yet roughly 90% of the 2 million women at very high risk of fracture remain untreated, providing significant future runway. Third, TEZSPIRE grew nearly 50% year over year in the first nine months of 2025 and has exceeded $1 billion year to date, driven by strong performance in severe asthma. The recently approved indication in chronic rhinosinusitis with nasal polyps, along with ongoing Phase III programs in COPD and eosinophilic esophagitis, position TEZSPIRE for additional potential growth across several disease areas. Moving on to our rare disease portfolio, now annualizing at almost $5 billion per year, grew 12% year over year in the first nine months of 2025. The rare disease portfolio is driven by four products early in their life cycle, including UPLIZNA, TEPEZZA, KRYSTEXXA, and Tavneos.
UPLIZNA delivered over 50% growth in the first nine months of 2025, supported by a strong U.S. launch in IgG4-related disease and continued momentum in NMOSD. We remain excited about UPLIZNA's potential and generalized myasthenia gravis, with launch preparation well underway in advance of a December 14th PDUFA date. Our innovative oncology business grew 11% year over year in the first nine months of 2025, led by our Bispecific T-cell engagers, IMDELLTRA and BLINCYTO. IMDELLTRA has rapidly become the standard of care in second-line small cell lung cancer, with adoption across more than 1,400 sites of care in both the community and academic setting. We expect that IMDELLTRA's recent full approval in the U.S. in the second-line setting, along with multiple Phase III studies in earlier lines of small cell lung cancer, will continue to drive growth.
Finally, our biosimilars portfolio grew over 40% year over year in the first nine months of 2025 and is now annualizing at roughly $3 billion, with nearly $13 billion in cumulative sales since its inception in 2018. Pavblu, in particular, continues to gain traction as the only approved biosimilar of EYLEA. Let me turn it over to Casey to briefly discuss our pipeline.
Thanks, Kave. Thanks, Peter. Maybe we'll start with Repatha. So we're extremely excited by the results of the Vesalius-CV Phase III outcomes study. This is a study in high-risk patients without a cardiovascular event. Repatha, when added to optimized lipid-lowering therapy, reduced the risk of cardiovascular events by 25% and the risk of heart attack by 36%. Truly remarkable results on a background of optimized lipid-lowering therapy. These findings reinforce the urgent need to treat patients with elevated risk and inadequately controlled LDL-C with Repatha. Sticking with general medicine, MariTide is rapidly advancing with six global Phase III studies underway. Our two chronic weight management studies are fully enrolled. We have Phase III studies in cardiovascular disease, heart failure, and obstructive sleep apnea that are all progressing very well.
Turning to part 2 of the Phase II study and the Type 2 Diabetes Phase II study for MariTide, we are working through the data for both studies and expect to provide an update in the new year. Shifting gears to another molecule in our general medicine portfolio, we have strong conviction with Olpasiran, our Lp(a) lowering therapy. That is in Phase III development and continuing to progress very well. As Kave mentioned, we have IMDELLTRA rapidly advancing in Phase III studies, where we've seen impressive survival benefit in recently reported Phase 1B results in the front-line setting and in the front-line maintenance setting in small cell lung cancer. And then lastly, in Xaluritamig, our STEAP1 targeting bispecific T-cell engager is in Phase III with two studies progressing well. We also have a number of Phase I studies where we're exploring Xaluritamig in earlier stages of prostate cancer.
We're excited about the potential of Xaluritamig, our third bispecific T-cell engager, to be progressing into later stage development. With that, Peter, I'll turn it to you and then to Umer.
Great. Umer, we'd love to turn it over to you. I would note just there at the end on that bispecific T-cell engager, we've got BLINCYTO and acute lymphoblastic leukemia. But IMDELLTRA was the first BiTE that was very effective and is doing really well against the common solid tumor pathogen. So we're extremely excited about what might happen with Xaluritamig there. So Umer, over to you.
Excellent. Peter, I think one of the philosophies on Amgen's side has been, especially around February, that the initial round of guidance will come in somewhat conservative, and then you let the year play out. And I think that formula has worked very well, candidly, for Amgen over many, many years. I guess the one question I have is, as I look at some of the consensus numbers over the next few years, the amount of revenue change modeled into next year is less than what we've had in the past or what should expect going forward. And part of that is some of the year-over-year impact of the bone franchise as well.
I guess, how are you sort of setting the stage for how we should think about Amgen into next year, knowing that there are some pushes and pulls, there are some launches which need spend, but also then there are some expiries that you're working away as well?
No, thanks for the question, Umer, and I'll invite Kave to jump in in a moment, too. But I think I would look to what I mentioned about the beginning of the year. So the six growth drivers that we've spoken about all year long, we've been very consistent on this: Repatha, EVENITY, TEZSPIRE Kave shared with us, those are up over 30% year over year in the first nine months. The innovative oncology portfolio up around double digits year over year. And again, kind of the anchor there, BLINCYTO has been doing well. IMDELLTRA is now growing very, very well in the innovative portfolio. Let's move over to Rare. Rare now annualizing up around $5 billion, as Kave shared with us, and I think double-digit growth year over year. And so we continue to be very excited about what we see in Rare and some opportunities there.
As we talked about with you, UPLIZNA, we've got a PDUFA date coming up on December 14th for GMG, and then finally, six is the biosimilars, so $3 million is what we're annualizing at right now on the biosimilars for 2025, $13 billion since inception for the biosimilars. We continue to think that's a very strong allocation of capital for us, and we've said it's not dilutive to our margins, and so we're excited about what we have going on. Those six growth drivers continue. We continue to be consistent on that. What we guided in February, it's been good momentum in those, and so we're excited about that, and so when we kind of think about what we have going into 2026, yeah, we feel good about it, and so we continue to think our volume growth, 14% through the nine months and 14% in the third quarter.
So when we think about that, that's our network optimization, Umer, and what we need to do there. We've spent a lot of time on that. We've raised our CapEx guide up to $2.2-$2.3 billion for 2025 to respond to capacity needs, including MariTide going forward. So we're taking all the steps we need to take to be prepared to move forward with our revenue expectations over the coming years. Kave?
Yeah, Umer, maybe I'll address your point on the bone franchise in particular. So we did see earlier this year biosimilars to both Prolia and XGEVA enter the U.S. We now have four on the market. It remains to be early days, but thus far the impact and competitive dynamics are pretty much exactly in line with our expectations. And those expectations are built on over 10 years of experience, both competing against and with biosimilars in the marketplace.
The expectation is you see a little more erosion on XGEVA, a little less so on Prolia, given the infrastructure. Is that still consistent?
That is still consistent. We expect the XGEVA degradation curve to look a little sharper, a little faster than Prolia, primarily because large oncology clinics have consolidated buying power in the XGEVA marketplace and a lot of familiarity with biosimilars. On the other hand, Prolia is administered by a wide array of physicians across a broad spectrum of specialties where they may not have that familiarity and infrastructure that we see in the oncology market.
Okay, got it. And you guys are holding the gross to net, so you're not letting that expand while holding on to these volume shares.
We haven't discussed publicly how we're competing. What I'd say is that we're competing in the marketplace using the various tools and methods that we have learned and sharpened over 10 years competing in the biosimilar market.
Okay, so everything's on the table. Okay, got it. So that's very interesting because there's a part of me, if you asked me three years ago, I would have thought 2026 could be a bit of a trough-ish year in terms of the growth profile, given that that's when some of the bone biosimilars that are going to hit. And it could even be a flat year for that matter. But it sounds like you guys feel reasonably comfortable. The totality of the portfolio supports continued growth. We can discuss what the magnitude of growth is, but it continues to support that franchise remain intact in terms of growth perspective.
As we think about it, Umer, we expect it. We always do give guidance for 2026 off the fourth quarter call. And I think the point Kave and I and Casey would make and Amgen is our momentum is strong.
Got it.
We feel really good about the growth drivers. We feel good about what's coming in in the pipeline. IgG4 launched earlier this year. We feel like we like what we're seeing there. IMDELLTRA has done really, really well, thankfully. What a fantastic medicine for patients with an awful disease, small cell lung cancer. That's going well. We look at TEZSPIRE. We talked about that. So there's a lot going on, well, we are working really, really hard to get the medicines to the patients, and we'll continue to do that. So we'll guide 2026 when we get there, but we feel good about our momentum right now.
And Peter, for your team, I'm sure this question has come up internally. There's a very dated guidance now for 2030 that's out there. There were completely different sets of drivers that were contributing into that. Does Amgen intend to revisit that at any point? Are those numbers, are the goals still broadly intact, but the makeup of that has changed? I realize it's fairly dated now. So where is that?
It was February of 2022.
Correct.
Which of course seems ancient at this point. I think we were still talking about COVID back then.
That's right.
I think you're referring to what was generally spoken about, for those of you who aren't familiar with it, a slide that became well known as either the lasagna, the spaghetti, or we called it the mountain chart. And it was the strata that built up Amgen over the coming years. And essentially, when you looked at it, you kind of saw what's happened, which is the therapeutic areas have performed well. That particular slide didn't articulate therapeutic areas, but it articulated different categories. And that's gone well. But we have not, we haven't updated that guidance, but it's gone really, really well. When you look at our growth rate since then, they've done really, really well. And a couple of points I would make. I think at that point we said Repatha was going to be a multi-billion dollar.
There was a lot of investor pushback on the Repatha number. I remember.
I think the technical term is a couple of folks burped at us on that one. Thank goodness it's out there, right? Thank goodness LDLs being addressed in a powerful way. And as Casey articulated, we've got data: 36% reduction in heart attacks in primary prevention market, primary prevention patients. So that guidance was out there then. We are really, as I said when I opened up, we're going to continue to invest and just make sure that we're getting these medicines out there.
But we shouldn't necessarily be expecting an investor day coming up to sort of re-go through that again for a month.
Yeah. Look, if that happens, we'll let you know. But that's why we're here today. We love to come see you and colleagues and share what we see as the strength of the story here, which is investing in innovation and science and continuing that effort.
As you guys thought through your build into next year, obviously there's all these growth drivers that are intact. One of the ones gets a meaningful competition at some point next year. It's not a full year competition, but the PCSK9 franchise from the oral side. What's the feedback you're hearing from the medical conferences on how that dynamic plays out in terms of do orals take a big NBRx share or not? Now Merck is hinting at access and expanding access. So what does all that mean to you on a volume basis and price basis and the totality of it?
Yeah. So as I mentioned in my opening remarks, there's over 100 million people in the world that have uncontrolled LDL-C still. Of that 100 million, currently PCSK9 inhibitors have only penetrated in the mid-single digits. So we see the market going forward and the additional entrants as more expanding the pie versus just grabbing a small percentage share of the existing pie that's out there. When we think about Repatha, we've got a ton of commercial momentum right now on the back of great data, great acceptance by physicians, and very good access. Right now, Repatha is on virtually every commercial and Medicare formulary that's out there, Umer. 95% of Medicare patients are paying a fixed copay, low fixed copay. 50% of commercial patients face no prior authorization at all.
In addition to that, we recently launched our Amgen Now direct-to-patient program, which makes Repatha available to American patients for $239 a month or about $8 a day. On top of that, average copay for an insured patient is only $50 a month, less than $2 a day, and a commercial patient using our copay card is paying $15 a month, $0.50 a day. So access is no longer a barrier for PCSK9 therapy. Looking at the competition that's coming, I would just point that Amgen has built a mountain of data around Repatha. I believe we've sponsored nearly 100 total studies, including two landmark outcome studies, the most important and most recent of which was Vesalius CV with a 36% reduction in first heart attack, 25% reduction in MACE. We're seeing a ton of excitement from the community on the back of that data, so we will compete.
But again, at the end of the day, this is about serving more patients. And we believe each of these different players will offer an option for these patients that are unserved.
So it doesn't sound like you envision a scenario where orals can take. I'm going to extremes. Could orals do 80% of NBRx in the PCSK9 market? Is that a realistic possibility?
I don't want to speculate on the future for competitive reasons, Umer, but I would just say that that mountain of data that we've created, including those outcomes, is very compelling to physicians, especially compared to a couple of grains of sand of LDL data that's out there on everyone else. We'll also have to see how the food effect plays out in the real world, which I know there are a number of studies going on to understand fasting requirements along with how adherence is on a daily oral versus a very convenient biweekly injectable.
Got it. I would have said outside of the mountain of data, the commercial infrastructure, as well as the rebate structure you guys have, is also another, I don't want to say line of defense, but it's also a big barrier for some of the new launches to overcome. How relevant is that in your calculus?
Yeah, maybe I'll speak to the commercial infrastructure. We obviously have a lot of relationships built with our field forces across both cardiology and primary care. We feel like we are addressing a large portion of the market. Of course, these new entrants will add to that. In terms of PBM contracting and access, I think that's more of a question for them than us overall, but we're very satisfied with our access position today.
Got it. And Kave, maybe one last also on this is all the PCSK9 and the competition conversation tends to focus on what you have and what Merck might launch. But there's a former Amgen molecule, which is also launching from New Amsterdam, the CETP inhibitor, which also shows LDL reductions using their method of something approaching 40% as well. And they may even have outcomes data. Now, that's not the 2027 perhaps. Do you see that as a credible competitor as well, or is Merck mainly where your focus is at?
Look, again, I think in both of these cases, it's more about expanding the market. I think Vesalius CV, where we showed that you could get those great results by getting the LDL down to 45, way below what you can get with any mechanism outside a PCSK9, speaks for itself in terms of the outcomes.
Okay, got it. So you guys sound reasonably comfortable on durability of this franchise. Durability in volumes or durability in growth with all this competition coming up?
I'd say we're quite excited that the data that we have in hand, the product profile and the momentum will continue to drive growth for Repatha into the future as one of the major six growth drivers that Peter mentioned.
Okay, got it.
And Umer, I just, again, I always go back to just to close this one out. 100 million people around the world. It's a way underpenetrated market for this.
Makes sense.
It's just a miss, right? I mean, we got to get on this as a society.
Great. Look, Peter, I think even I was somewhat skeptical when some of the 2022 guidance came out on how large Repatha could get, and it's clearly surprised to the upside, but I do wonder, especially in your seat right now, Kave has clearly an opinion on the market, but in your seat, you have to run those scenarios through and what can happen from a competitive perspective, and are you sort of looking through that as you map out the next three years for the P&L and where it's going in terms of what could happen to Repatha? What if it's not a growth asset, et cetera?
Umer, I would just say we work very closely together as a CEO, staff, and management so we think about what's going on out there. My job is to allocate capital to the highest opportunities and thank goodness we allocated capital to Repatha over the past four or five years, even back. I know somebody mentioned earlier today, even back 10 years so we've stuck with this and thank goodness because LDL is such a critical issue for patients all over the world, 100 million patients. Lower is good, lowest is best, early is good, earliest is best with Repatha so we'll continue to do that. As the CFO and the one who works on allocating capital, this has been a wonderful allocation for our shareholders and importantly for patients so a double benefit there and we're good at making it.
We've got great manufacturing facilities, and we're always working on opportunities to do better and better at that, and we're excited about the opportunities we have there.
Sure. Yeah. I mean, Kave, clearly you guys have a mountain of data, but others are producing a lot of data as well. I guess is part of your confidence on the Repatha franchise driven by the fact that a twice-annual shot came to the market as well and you guys just continued to grow and so did they? Is that partially what's informing it too, that some of the recent market developments on different dosing options have basically just grown the market, not necessarily come at your expense?
Yeah, I think so. And I think if we look back at cardiovascular as well, that the markets grow over time. And so we believe that these incremental additions, again, will continue to grow the market based off both the ones that are in the PCSK9 market today, but also look back through history.
Okay. So is it a reasonable conclusion for me that it's Amgen opinion that I think you used the words momentum will continue on the growth side? But what that means to me is perhaps it's Amgen opinion that PCSK9 market's growing. It might even grow a little faster now with more options and chip away at the Lipitor a little faster. But from the Amgen side, the growth just continues as a journey and the newer products can probably find their own niche with additional oral switches perhaps. So the PCSK9 penetration continues to grow.
I think that's a reasonably fair summary of our position, Umer, that again, given the low penetration of the market today, these additional entrants will continue to grow the market and Repatha will continue to be a market leader in that ever-expanding market for PCSK9 inhibitors.
Okay. Maybe just one last on this, not to harp on this, but Kave, do you see the former Amgen molecule, the new Amgen drug as an LDL-Lowering drug?
I see it as another molecule entering general cardiology practice. We'll have to see exactly how it's used in practice once it's out.
Okay, great. Maybe just sticking to cardiometabolic for a second, Lp(a), maybe Casey, if you could remind us when could we hear on that trial in terms of there's a sense that the event rates are a little slower across these trials? So when can we realistically expect an update from Amgen on that?
Yeah, so we're monitoring event rates just as others are. And you may have heard us say previously that event rates are accruing slower than anticipated. And so we'll continue to look at those event rates, Umer, and as the end of the study comes into focus, I'd expect we provide an update on when data would ultimately be available.
This is not a 2026 event by any stretch of the imagination.
We haven't indicated it as a 2026 event.
Okay. Kave, do you think this is a bigger opportunity than Repatha?
I think that the Lp(a) market will certainly have a significant opportunity out there. You've got 20% of the population with elevated Lp(a). There's no other treatments available today. You can't go on diet and exercise or a $4 statin to lower it overall. I think it's to be determined exactly based off the data that we see, exactly where the market size comes in. I will say that from my own observation of patients and physicians that individuals with high Lp(a) are activated in a meaningfully different way than patients that have high LDL, primarily because it's a genetic disease. And therefore, they see treatment option potentially faster than they would for a disease that they believe is modifiable by something they have done.
Got it. I want to transition to. I'll come back to obesity in a bit because I think that can open up a very large set of questions. And I had a lot more prepared for Jay, so I'm sparing those out. But if I may, for this conversation, maybe spend a quick second perhaps on a UPLIZNA opportunity in myasthenia gravis. First of all, IgG4 versus MG, would you agree MG is bigger than the first or not necessarily?
MG has a significantly larger population that's eligible for treatment than IgG4-related disease based off the epidemiology that we know today. Obviously, MG is a more competitive marketplace with additional therapies that are available versus IgG4-related disease, which we launched earlier this year where the first and only treatment for the disease was the UPLIZNA.
Okay. The part on this, and I think I've discussed this with Justin and Casey in the past as well, was around what happens with pricing dynamics because I know your competitor molecules on the FcRn side and MG, they're dosed intermittently and yet they have a certain price point. And apparently, there are doctors that are just dosing right through, meaning double the dose. In that case, their price points go well north of $500,000. Could you remind us what the pricing dynamics look like for the competitor molecules if they're dosed as if it's constantly, so it's not relapse remaining on the scores? And then what does that mean for your pricing and does that have commercial ramifications?
Yeah, so UPLIZNA is already on the market. There's an established price. The dosing for MG is the same as IgG4 and NMOSD right now. So at this point, we don't see any price changes coming for UPLIZNA with the launch into MG. In terms of the FcRns, in that dosing regimen that you describe, Umer, you are correct, the pricing does go quite high.
Is it just 500 or is it even north of that?
I can't recall off the top of my head, but it is, what I can say, quite a bit above the price for a UPLIZNA in that case. At this point, we don't see in rare disease significant payer management. So it may not make a lot of difference from a payer standpoint at this point, but from a factual basis, UPLIZNA would be cheaper than a fully dosed FcRn.
Are payers appreciating there could be like being on UPLIZNA could deliver 60%-70% discount versus FcRn? Is that a selling point or not much?
So at this point, we don't see payer involvement significantly in rare disease, including in GMG. So in my experience, we haven't seen that type of question back. Is it possible some payers asking? Certainly, but not broadly.
Oh, I see. Okay. So I guess what that means then is the commercial battle will then come down to dosing convenience and some of the data sets you guys have produced. What's the type of feedback you're getting? Is this a post-Vyvgart drug or there's some patients just looking for dosing convenience or what's the type of patient that's most eligible? Or are you going upfront and just competing for fresh patients?
We're getting very positive feedback from the community on Prolia's profile. As a reminder, the drug is only dosed twice per year. The data that we've shown shows very consistent and potentially improving reductions in the key data set over time at both 26 weeks and 52 weeks. We intend to compete at all lines of therapy, Umer, for upfront patients along with patients looking for another option. As a reminder, patients on average only try one or two therapies in this category and only stay on therapy for roughly two to three years overall, despite the fact that this is a lifetime disease. We think Prolia has a very high likelihood of addressing the patient needs here with that convenient dosing, consistent efficacy over time.
Okay, got it. So, okay, great. So you're not pinning it down necessarily to a certain type of patients. You'll go after the market more broadly and see where it lands.
We intend to compete fully with our data set, understanding it's a competitive marketplace. But again, it is a fairly large population compared to where we otherwise promote BLINCYTO and we believe we'll be competitive on both front-line and second-line.
So on this product, I want to sort of throw a number out. So you guys are going to do something close to $600 million in 2025. And consensus has you basically on a $1.5 billion peak. This is with the new indication and everything. And I sometimes wonder, is that too conservative if you truly have an MG product and IgG4? Am I simplistically overestimating what it could do or?
Yeah, so Umer, I'm not going to give long-term guidance on a product basis. At this point, what I'll just say is that UPLIZNA continues to be one of our growth drivers in rare disease and a growth driver we're really excited about given the additional indications that are coming online.
Okay.
Early in the life cycle too.
Correct.
Early in the life cycle. Maybe you just summed it up right there. Fantastic. Okay, great. So I want to transition to MariTide, but let me also take a quick pause because I know there's folks in the audience if there's any questions on anything we've discussed so far. Okay. So Casey, what's the next data point coming up on MariTide? Could you just remind us on the cadence of readouts because there's a lot coming up and I want to make sure we're going through that very carefully.
Sure. As you heard me say in the opening remarks, we for our part 2 of the Phase II study and the Type 2 Diabetes.
That's the obesity study.
Yes.
Right. So obesity study part two, right?
Mm-hmm.
That's coming when?
We said we're working through the data and we expect to provide an update in the new year.
New year. Okay, got it. So it doesn't happen. So you don't want to necessarily do it on December 24th. So you're just saying let's do it fresh new year.
We're working through the data and we'll have an update in the new year.
Obesity part two. And remind me, Casey, wasn't previously we thought it could be December, but so you're just saying new year to not jam it onto holidays.
For both of those studies, the part two of the Phase II obesity study as well as the Type 2 D iabetes Phase II study.
Type 2 Diabetes study.
We would expect to provide an update in the new year.
Okay, got it. Okay. So the obesity part two and the Type 2 D iabetes, both in the new year. Okay, that's number one. The second thing is I think on several different occasions, I've gotten investor emails putting together a grid of part two shows this much weight loss or that much weight loss and what type of scenarios do we expect on stock move. And one of the questions I thought to myself was these are patients that have already lost north of 15%. So the incremental could be as low as only 5% weight loss in part two. So I just want to make sure we level set what we can actually get in efficacy in that part two.
Let's talk about what part two is. And in part two, it's really a maintenance study. And so just as context for everyone, you had to have lost 15% or more of your body weight in part one of the Phase II study. And this is both whether you are an obese patient with or without Type 2 Diabetes. If someone met that criteria, they were offered the opportunity to participate in part two of the study. Over 90% of individuals chose to continue. We thought that was actually a strong point of individuals signing up for a second year of MariTide treatment. Then what happened was those individuals were re-randomized into one of seven different arms. And depending upon where they were in part one of the Phase II study, those seven different arms include a placebo treatment. They include a lower monthly dose of MariTide.
They include a continued high monthly dose of MariTide as well as a quarterly dose of MariTide, so there was a number of different arms that we're exploring there, all of which is to help us understand how a second year of MariTide treatment may play out and what that may mean from a maintenance of weight loss perspective. I'd also highlight, given the number of patients enrolled and the re-randomization, this study is very descriptive in nature in terms of what we can expect to conclude. Umer, it wasn't designed to necessarily compare arm to arm in terms of weight loss achieved or help us to understand weight loss beyond 52 weeks. The way that we're answering the question of is there continued weight loss of MariTide beyond 52 weeks is in our ongoing Phase IIII studies that go out to 72 weeks.
Those are fully enrolled, as I said earlier. That's really where we'll definitively answer that question.
Okay, got it. But I just want to be clear. So you're emphasizing this is maintenance. Don't be thinking 10%-20% weight loss numbers all over again in this sort of part two, perhaps.
The study is designed to really help us understand a second year of treatment with MariTide and maintenance of weight loss that was lost in the first year.
Okay, got it. Will you guys break out, Casey, the patients that went from 420 monthly to 420 monthly? Will that be broken out necessarily? These patients were on 420 previously, they stayed on 420, or that wouldn't necessarily be done because we only chose the over 15% weight loss? You can't read into the continued second year of weight loss.
I think that's correct. It's, given the re-randomization and the small numbers of patients, that anything that we see from this study will be descriptive in nature and certainly informative, but descriptive in nature, and it will help us to understand how we may think about MariTide in that maintenance setting and how to think about MariTide beyond 52 weeks.
Casey, also just to clarify, and I realize some of these questions were directed at Jay, so I'm putting them your way. There's a placebo arm in the part two. So theoretically, nobody should be on placebo because only 15% weight loss people could have been on placebo. However, on the 140 mg dose, there could have been some patients with a 15% weight loss. They could have moved on to placebo. So that's effectively a randomized withdrawal. So there could be a placebo that's gaining weight here. Am I thinking through that right?
There were individuals that were treated with MariTide for 52 weeks, then moved to placebo treatment in part two of the study.
So like randomized withdrawal effectively.
We will, again, in a descriptive fashion, understand what happens if you stop MariTide treatment for some of these individuals.
So it will answer that. So that's technically a separate answer. This part two will provide us. What if you pull the drug and what?
I think if you step back for a number, really what part two is about is what happens in a variety of settings after 52 weeks of MariTide treatment. If you withdraw treatment, if you continue treatment, or if you move to a lower monthly or quarterly dose, and as I said, we'll gain some insight into all of those dynamics from part two, and they'll help to inform how we think about continued development of MariTide.
Okay. One last one on this, Casey, because you were really emphasizing this in a prior conversation. Part two also includes diabetic patients. So could you remind us of that and the relevance?
The relevance is there were some type individuals with obesity and Type 2 Diabetes in part one of the study that lost 15% or more of their body weight. They were eligible to be included in part two of the Phase II study. So it is a mixed population to a certain degree. I haven't seen the numbers in terms of how that breaks down arm by arm, but it is just important to know it was both obese and non-obese.
Got it.
Excuse me, obese, diabetic, and non-diabetic patients that were eligible for part two.
Got it. Look, one of the big questions on this obviously is GI tolerability and how that will improve into Phase III. It's my hypothesis that you'll actually get a pretty good read on GI tolerability in this upcoming diabetes trial, actually. And you probably saw what I think about that. So I'm curious how you guys react to whether a very appropriate amount of titration is being tested, or is there even more that's going to be shown in Phase III in terms of, like, is this Phase II not doing all of what that could be done in Phase III?
Yeah, I would say as in any Phase II study, and our Type 2 Diabetes Phase II study is no exception. We sought to explore a number of different dose escalation regimens in the Type 2 Diabetes Phase II study, and we'll see how those ultimately play out.
Okay, great. Kave, I'm curious how much of your day-to-day time is being spent on the obesity opportunity versus everything else?
So I get the pleasure of sitting and working with our teams across our whole portfolio, Umer, and I would say that we are giving an appropriate amount of time to not only obesity, but also to Xaluritamig, to Dazodalibep, to Olpasiran and our existing portfolio overall. It's obviously a very competitive market, and there's a lot of different commercial opportunities, and we're building capabilities to be able to access those.
So, if Amgen goes super aggressive at it, I mean, obviously the enrollment went fast. You guys were fully recruited as of September. So the Phase III readouts are set for January, February 2027. That part we know. I guess my question is, is there an attempt being made within the company to get a priority review voucher? So you could theoretically be on the market on Mid-2027.
I think our view on that, Umer, is we'll have more to say about our regulatory approach once we have the Phase III data in hand. We're not in a position to speculate at this point.
Would you do whatever? Is the organization trying to do whatever it can to acquire a voucher ahead of that? And then you can decide what the.
Let me go back to Amgen. Amgen wants to deliver medicine to patients, innovative, first-in-class and best-in-class medicines to patients as soon as possible. That's our mission.
Okay, fair enough.
And so we think this obesity disease epidemic is enormous. The world is ready, positioned for you. And so we're committed to doing what we can do to get our medicine, which we are very excited about, to patients as quickly as possible.
Makes sense. Kave, do you see Amgen as basically a third to market, or do you see Amgen as a part of the next wave of new obesity meds coming to market? I realize there's also Boehringer Ingelheim. I'm assuming might be slightly ahead, but I'm just saying, realistically speaking, where do you think the market entry positioning is from a timing perspective?
Yeah, look, we obviously have two very large players in the market today that have weekly injectables. Us is having the first, hopefully the first option for a monthly or less frequent option within the marketplace, and that we will enter the market and compete with the weeklies that are out there today.
Okay, got it. And commercially, the organization would be ready if this needs to be a 2027 launch. The commercial side will be ready to deliver whatever the timelines shake up at.
Yeah, so I'm not going to comment on the timing of launch. What I will say is that we are in the process of building our launch capabilities to bring this medicine to market. If you look at Repatha, it's a pretty good blueprint for how we bring medicines to market in large populations where access and breadth are quite important, and we feel like we will be ready to launch this medicine once the R&D team is ready to deliver it.
Fantastic.
Finishing up a little over six years at Amgen, Umer, I know our commercial organization, and they're always ready. They're a great group, so I have enormous confidence. We'll be ready to roll on any of our medicines when they're ready to come out.
Fantastic. Anything in the audience we missed? Fantastic. Well, thank you guys so much for making time.
Thank you.