Great! Thank you very much for the third session of the day. My name is Mohit Bansal. I'm one of the biopharma analysts here at Wells Fargo, and I'm very happy to have another year with Team Amgen at this conference. So we have Jay Bradner with us. He's the EVP and Chief Scientific Officer. We have Peter again with us, three years in a row now.
Three years in a row.
Right. Awesome. So Peter Griffith, the CFO of the company, and we have Justin Claeys, the head of IR of the company. Thank you very much for joining us today.
It's great to be here, Mohit. I could give a couple of remarks.
Of course.
I think three years in a row in Boston is a hat trick, isn't it, doctor?
It is.
It's a hat trick, so look. Thank you. Thank Wells Fargo for having us. Thank all of you for your interest in Amgen. As we always do at Amgen, let's start with our mission to serve patients through discovering, developing, manufacturing, and delivering innovative medicines that are first-in-class and best-in-class to patients with serious and grievous illnesses all over the world. We have a long-term growth outlook that's strong, with breadth and depth across our four therapeutic areas, including our innovative pipeline and our end-market products, serving patients, as I said, all over the globe. We have momentum with a number of key brands, including Repatha, Evenity, Blincyto, and Tezspire, which will help drive growth in the next several years through the end of the decade and beyond.
Our promising research and development pipeline reflects our commitment to innovation as our first capital allocation priority across all of our therapeutic areas. We've already achieved several significant milestones in 2024, with additional milestones to come in the second half of the year. So in the second quarter alone, we received accelerated approval of Imdelltra for small cell lung cancer. We received approval for Blincyto in the frontline treatment for B-cell precursor acute lymphoblastic leukemia. We announced impressive phase III data for Uplizna in IgG4-related disease. We announced exciting phase II data with Tezspire in patients with chronic obstructive pulmonary disease, the third leading cause of death around the globe. Our business performed well in the second quarter. Revenues were up 20% to $8.4 billion, marking the highest quarterly revenues in our history, with 12 products achieving double-digit sales growth.
In general medicine, we're focused on providing leading therapies to serve large, underserved patient populations. We're particularly excited about the upcoming top-line data from the ongoing phase II study of MariTide, expected in late 2024. We're encouraged by the emerging data in this field, particularly in cardiovascular and renal disease, areas of long-standing strategic focus for Amgen. We're laser-focused on preparing to launch a broad phase III program for MariTide that includes obesity, obesity-related conditions, and Type II diabetes. We're advancing our phase III outcome study of Olpasiran to reduce Lp(a), and Repatha and Evenity were key treatments in the second quarter, meeting significant unmet medical needs around the world, with second quarter growth of 25% for Repatha and 39% for Evenity.
Our innovative hem-onc portfolio grew 12% in the second quarter to almost $2 billion, and we've got many drugs in the oncology pipeline that have the potential to alter the natural history of the disease. We mentioned Imdelltra earlier. We're advancing that into earlier frontline therapy. I'm sure, Mohit, you want to talk to Jay about that. Blincyto grew 28% in the second quarter, with further growth opportunity from the recent approval into the front line. Both Blincyto and Imdelltra have shown tremendous results emanating from our BiTE, or Bispecific T-cell engaging platform. We'll also talk, I'm sure, about Xaluritamig and our new BiTE specific T-cell engager there for prostate cancer. Our inflammation programs are focused on difficult-to-treat diseases with high unmet need and contributed nearly $2 billion of sales in the second quarter.
First-in-class Tezspire in severe asthma contributed sales up 76% year over year. We expect initial phase III data later this year in inflammation and immunology from the Rocatinlimab phase III data. Our rare disease portfolio surpassed $1 billion in the second quarter with Krystexxa, Uplizna, Tavneos, and importantly, Tepezza, all demonstrating robust growth. Tepezza was up 8% year over year and 13% quarter over quarter. That represents an expanding prescriber base and improving payer coverage, and we expect a launch in Tepezza in early 2025 in Japan, which is demonstrative of our efforts to expand that around the globe. For Uplizna, as noted earlier, the phase III data in IgG4-related disease met its primary endpoint.
Beyond IgG4-related disease and myasthenia gravis, we've initiated a phase II clinical study to explore Uplizna and blinatumomab in autoimmune disease. And, in summary, I'd just say, Mohit, it's a very exciting time at Amgen, and we're really excited not just for current patients, but for future patients and for patients who are waiting for our medicines, that are in our pipelines. So with that, let me turn it back to you, and I'm sure you've got some questions.
Oh, yeah.
If I were a gambling person, which I'm in a casino, and I—but I don't gamble, I'd guess that you're gonna spend some time with Jay, which you should, because our innovative pipeline is so exciting.
No, definitely. I only have like five hundred questions, so let's see how many we can get to today. But I have like I want to start with a question for both you and Jay, and maybe starting with Jay here. So it has been, what, one year for you?
Nine months, yeah.
Nine months, right? And this is a long time. So when you look at your pipeline now, I mean, there was like, I think a couple of years ago, and Peter would agree, there was a question that how much pipeline Amgen has, and it seems like you have a ton now. What is your assessment in last nine months that about the pipeline and excitement level there? And then that's where I want to bring Peter in as well. Like, how do you think about, from the investment point of view, that, you know, you had this last two years, we have been hearing that your priority is internal first. So, like, do you think that strategy is evolving into having a good pipeline? So maybe starting with you, sir.
I mean, the first I'd say is that, the pipeline is, maturing-
Mm-hmm
... is growing, and in particular, are growing in impact. We have just a ruthless approach to prioritization-
Mm-hmm
... to ensure that we're putting investment behind those medicines that can have the greatest impact for patients with serious diseases and to grow this business. And if you look at our phase II and phase III pipeline right now, like, down to every individual indication of every project, these are important medicines. We have probably, in the history of the organization, the most de-risked pipeline. It is maturing with a very high probability of success. I think we're doing a very excellent job at making the most of each opportunity to expand the impact, to do indication expansion in parallel. Mirati would be a great example of that, how we're going in to our phase III program across many indications. The same is true for Tarlatamab in DLL3-positive cancers. So maturing very nicely, very high impact.
It's a growth phase for Amgen, not just as an organization with respect to top line, but also with how we operationalize phase II and phase III clinical investigation, and so we're investing a lot in our development operations organization and how we're going to expertly and compliantly operationalize such a large phase III and phase II effort, so a very exciting time to be in the company. On the research side, it's an amazing place to do science, I have to say.
Very creative. The group that made the very first G12C-directed KRAS inhibitor, the very first and hopefully very best MTA cooperative PRMT5 inhibitor, Mirati, perhaps the most advanced antibody-drug conjugate outside of the cancer world. This is a very creative group, and now with this rare disease pillar in the fourth therapeutic areas where we play, cancer, inflammation, cardiometabolic disease, and rare disease, we have a very compelling research and development strategy. Then the last thing I'll say is just the talent and just kind of the vibe. It's just an outstanding group of people. I credit Pete and our leadership, my predecessor, Dave Reese. The people around the table come from all different arenas, some great and illustrious academics, like Ray Deshaies, brilliant industry-trained drug developers like Jean-Charles Soria, homegrown talent like Narimon Honarpour.
It's just an outstanding group, and this company, knowing, you know, how hard it is, what we do, perfectly undistracted by ego, a great and collegial vibe. We work from one P&L, you know, a real enterprise mindset, so, a great time to be at a great company.
Awesome. So Peter, anything to add there?
Mohit, that is such a wonderful question for me. Our capital allocation priorities haven't changed.
Right.
So when I came into the seat five years ago, I followed and said to all of you, to our investors and to our analysts, I wanted to be predictable and consistent. Our capital allocation hierarchy, number one, is to invest in innovation-
Right
...and or, and organic internal innovation, and we've consistently done that. When I look at the pipeline now, I think Jay articulated it in a very important way for everyone, which is we ruthlessly prioritize everything in the company. We don't want any white space between management. We get together, and we make sure we're allocating those dollars to our capital allocation priorities. Number one, internal innovation. So this year, at the end of the second quarter, we raised our guide for non-GAAP R&D that we said it will be greater than 25% growth year over year. This year, we started the year in February on our call by giving guidance that our operating margin we would slightly flex it to 48 percentage points. Remember, our operating margin is a percentage of product sales.
Mm-hmm.
So we flexed it down a couple of points from where it had been for a number of years because of the opportunities to invest primarily in the pipeline. And then at the end of the second quarter, we see additional opportunities. We see, frankly, additional success in the internal pipeline, and we want to fund that. So we indicated to you and to investors that we're gonna flex it to 47%, roughly 47% for the year operating margin. So we're excited to be able to invest shareholder capital to support, you know, the number one capital allocation priority. I would say at the same time, Mohit, we're focused on deleveraging the company from the Horizon transaction. We're on schedule for that.
We expect to be back to where we were at when we announced the transaction in December of 2022, in terms of our leverage ratios at the end of 2025. We're on track in terms of our synergies, maybe slightly ahead, as we shared at the end of the second quarter, so you know, all in all-
... We want to generate capital to invest in innovation. We're very pleased with the four therapeutic areas, you know, general medicine, oncology, hematology, immunology, inflammation, and certainly general medicine. So we're very focused on all four therapeutic areas, the fourth being rare disease. Rare disease has been really excellent. You know, we're so excited about what we see with Tepezza for thyroid eye disease, rolling it out around the world, as I said, early approval next year in Japan. We're so excited about oncology, hematology. You're gonna talk to Jay about our STEAP1 in prostate-
Right.
- right? Six-transmembrane epithelial antigen of the prostate 1.
Unbelievable.
But, you know, that's an important medicine, right?
That's the second bispecific T cell engager to address a common solid tumor, and so we're feeling very confident in that. We're Krystexxa in rare disease.
Right.
Chronic refractory gout, doing, you know, annualizing well over $1 billion, Mohit. And then Tavneos, putting up great numbers for ANCA-associated vasculitis. So it's, you know, it's patients, patients, patients, patients, and innovation. You know, and we... You know, I could go on and on about it, but I want to turn it back to you-
Right.
And just tell you, I'm excited about this. And again, I would say it's for patients, you know, millions of patients that are receiving the medicines. It's for the future patients that'll come in, you know, in the future. With Jay and the team in Discovery Research, you're gonna have great medicines next decade, and it's for the patients who are waiting for what we have in the pipeline. That's why we want to allocate the capital in there and get it through the pipeline as thoughtfully and through our discussions and approvals as regulators as possible.
Awesome. I mean, let's just turn to another medicine which could actually help add another millions of patients, is MariTide, right? I mean, that's an area you are not in, and you could be getting in there-
Yeah
with the top-line data. So maybe, like, before... Let's just set the stage for people who are looking forward to the data by the end of the year. How would you frame expectations? What are you looking for when you see the phase II data from the top-line point of view, and what should be the expectations for the investors?
No, thank you. We're very excited about MariTide.
Right.
MariTide, as you know it to be, is an antibody-peptide conjugate that inhibits the GIP receptor with an antibody core and then delivers concurrently two appended GLP-1 agonist peptides. The performance in phase I clinical investigation for prompting weight loss was very impressive as at the planned interim analysis of the phase II. Our expectations of the phase II is, number one, that it's perfectly executed.
Right.
And we are well on track to deliver a conclusion to part one of the study, which is the fifty-two-week endpoint for weight loss among diabetic and non-diabetic patients suffering from obesity. This will be in hand by the end of the year.
Mm-hmm.
We expect strong guidance from this study regarding the target product profile and therapeutic index, and we'll use this information, and we're confident that we'll be able to for dose selection entering into phase III clinical investigation.
Got it, and there's one question we get a lot on this, is that, of course, you saw decent amount of weight loss in the phase I/II trial, albeit in a smaller set of patients. But how important it is to show benefit on other parameters such as blood pressure-
Mm-hmm.
A1C, and then, and lipid loading as well? Because ultimately, you may have to do these outcome trials as well. So how do you think about those parameters?
We care a lot about those parameters. As you're well aware, there are diseases that run with obesity, and there are metabolic disturbances that run with obesity: excursions of blood sugar, excursions of lipid handling, inflammation. And we're making indeed all of these measurements in the ongoing phase II study, and over the course of one year, one would rightly expect many of these parameters to change favorably for the patient, especially if the medicine is able to deliver sustained, durable, meaningful weight loss. And so I look very much forward to learning about these data and then sharing them more broadly with the community.
I mean, theoretically, I mean, I'm sure you have answered this question multiple times, and I had the fortune of talking to Manuel as well, earlier this year. In terms of, like, there's this thought that, you know, because of GIP antagonist versus agonist, there could be some interference, which is different versus a drug like Mounjaro, and this could be interfering with the other parameters other than weight loss. Do you agree with that notion that, you know, because it is antagonist, the effect could be slightly different than agonist?
You know, you bring up a really interesting aspect of our research, is that we've taken a decision to inhibit the GIP receptor.
Mm-hmm.
And, Tirzepatide and other medicines in this space are agonists of the GIP receptor. And in drug hunting, that almost never happens.
Right.
Where two elite discovery units, both quite expert and well-heeled in metabolism research, would take an opposite approach to a target. We're very comfortable with our decision to approach GIP with an inhibitory therapeutic agent because, number one, experiments of nature.
Right.
Across populations, different ethnic backgrounds, individuals who have suppressed signaling through GIP or low expression of the GIP receptor, have lower body mass index. It were these sorts of findings out of our deCODE Genetics unit, and much of this is published, that led us to want to inhibit PCSK9 as opposed to giving people-
Right.
PCSK9. Second, knockout animals, both in systemic knockout of the GIP receptor as well as in the brain itself, where appetite is, of course, sensed and transmitted to behavioral response. When you lose the GIP receptor altogether, those mice are protected from a high-fat diet, and most importantly, either peptide molecules or antibodies that block the GIP receptor do the same in preclinical animals. But we're in humans now, and the phase II data, of course, trumps all of these inferences. But there's strong mechanistic and human genetic support for inhibition of GIP, which begs the question, why would people activate it? One answer to that would be that activating the GIP receptor runs with the type of peptide that would also activate the GLP-1 receptor. That would imply that in that instance, GLP-1 is dominant over GIP. That is possible.
A second, and I find more compelling, theory, is that as for many, G protein-coupled receptors, and as for many GPCRs that recruit beta-arrestin, like GIP, tonic activation can lead to receptor desensitization and pathway inhibition. And this has been now published in adipocytes, by, an independent group resourced by the, interestingly enough, the Novo Nordisk Foundation. This work hasn't as yet been conducted in the brain, but suffice it to say that GIP agonists might actually be antagonists.
Okay.
If wanting GIP antagonism, just inhibit the receptor.
Got it.
So, your question asked, could things be different? And indeed, it could be. It's for these reasons that we're measuring really all metabolic parameters of relevance to these patients and to the mechanism of action. And so more will be revealed at the end of the year.
Got it. Very helpful. And then, actually, in the interest of time, like, I think I want to turn it to another cardiovascular drug, maybe a little bit under the radar, but Olpasiran.
Ah.
I mean, again, it was like... There was a lot of excitement back in the days, and then obviously, now, I mean, you're waiting for Novartis data.
Yeah.
How do you think about this particular asset? Is there a threshold effect there, like once you cross a certain level of Lp(a) lowering, then it would be very effective, or is that more is better, like LDL here? Like, how do you think about that, and how informative would Novartis's data would be next year, probably?
Yeah, no, thanks, Mohit. As you point out, we have a very exciting ongoing phase III clinical trial that perhaps because it doesn't read out this year, we're not receiving a lot of questions around, and I suppose that's natural. But we are very hard at work on this asset, within Amgen R&D. Olpasiran is a small interfering RNA that durably and profoundly depresses the liver's capacity to manufacture Lp(a). Lp(a) is a genetically defined, fully independent cardiovascular risk factor. One in five of us here in the room today, regrettably, will have Lp(a), and there'll be nothing you can do about it. You can't exercise it away, you can't eat better and have it go away. Only with direct inhibition, or in our case, suppression of its expression, can you modify this risk factor.
We and others are conducting phase III clinical investigation as secondary prevention of cardiovascular risk. It's a massively large cardiovascular outcome study that we're performing, 7,297 patients. It's an event-driven study that will hopefully validate the hypothesis, but it will test the hypothesis whether deep suppression of Lp(a), in our case, better than 95% suppression of Lp(a) on a Q12-week basis, can improve outcomes in cardiovascular disease. It will be interesting-
Mm.
to learn how our competitors' study reads out, also an event-based study that is scheduled to read out ahead of ours. This is not binary for our program.
Right.
I know that molecule well, as you may know, and.
Right
... I will say that, the depth of suppression of Lp(a) achievable with Olpasiran is very special, as is the Q12-month dosing. Now, are there thresholds? We believe that as for LDL-C, Lp(a), area under the curve, the amount of time spent with Lp(a) and how much Lp(a) you have quite matters. We've used real-world evidence and population science to establish the threshold for enrollment on the study, as well as to guide the endpoints of the study. So this is a very expertly designed study that I think will thoroughly test this hypothesis.
Got it. And maybe quickly, do you have any thought on ASO versus antisense, because long-term safety could be important for these kind of medicines?
No, they sure could, and I've had a chance in my career to work on both, antisense oligonucleotides as well as small interfering RNAs. You know, as a class, the siRNAs have exhibited a better therapeutic index, but it is also true that next generation or current generation ASOs can be, on an asset level, well-tolerated.
Right.
There are benefits to siRNAs, in their capacity to be loaded into liver tissue, recirculated through the lysosomal system and the RISC complex, and they just work at much, much, much lower doses.
Sure.
So if there's anything intrinsic about the tolerability of a oligonucleotide that favors as a class siRNAs, but for sure, there are individual ASOs that are very well tolerated.
Got it. Very helpful. I mean, like, I think one question before I move to oncology side, I want to ask you, Peter. So now that, you know, Repatha, you have a cardiovascular franchise, and then you will have some kind of similar kind of franchises coming with MariTide and then Olpasiran. How much leverage is there in the business to launch these drugs eventually? Like, I mean, these are- this is... Do you see some synergies there, or do you think it'll be- it'll require quite a lot of investment when you launch these products?
Very insightful question. We're, Mohit, when we think about our experience with Repatha, we think about all our experience also with Prolia-
Mm-hmm
... you know, the bone franchise-
Right
and, you know, going out to all the patients and primary physicians and endocrinologists and so forth. It, you know, it's a great opportunity for us to take advantage of our experience and our expertise.
... And so we do see an opportunity going forward in the general medicine franchise. I think your interrogation around Lp(a) is a good sign. I mean, certainly, Olpasiran will be an opportunity for us to join forces after the cardiovascular success we've had with Repatha, and so we do see leverage there. Maybe I'd invite Justin to chime in, too, and he's been around the company a long time and has seen the company leverage appropriately and thoughtfully. I mean, that's something we do. I think the word leverage goes with ruthless prioritization.
Right.
So, with that, Justin, what are your thoughts around that?
Yeah, I think just spending another minute on Repatha, we're obviously really pleased with the progress that we're seeing there. And to Peter's point, we've learned a lot through that journey, really the importance of educating the community, engaging with the physicians, getting the sales force out there. We've now expanded to a primary care sales force. So, you know, to that point, Mohit, I think as you think about potential, opportunity in obesity, that, definitely would create some leverage for us.
Awesome. Great. So maybe let's just talk a little bit about the oncology pipeline. I mean, because, I mean, Peter mentioned STEAP1, I mean, so what... Like, just tell us about your excitement level, and are we going to see any data in the near term from the STEAP1 side?
Yes. No, thank you. So Xaluritamig is really our third maturing bispecific T-cell engager therapeutic. STEAP1 is a protein that's as the name would suggest that was brilliantly articulated, Peter.
Pretty good
... is on the surface of prostate cancer cells, and so we have designed with our partners at Xencor a bispecific that binds to STEAP1 with one arm and then binds and activates the T cell with the other arm. It's a CD3 bispecific, and in doing so, it creates an immune synapse that kills the prostate cancer cell. It actually is a serial killer. The circulating antibody continues to recruit T cells to systematically take out, in this case, prostate cancer cells. As you know, we've been working on bispecific T cell engagers for, you know, more than a decade. Initially, through the Micromet acquisition, we have now approved blinatumomab in leukemia. With new approvals this year, we have an approved Tarlatamab , which demonstrated for the very first time that this bispecific T cell engager technology can work in a common solid tumor.
Now enters Xaluritamig. We've completed the expansion cohorts for the Xaluritamig phase I clinical trial. We expect by the end of this year to have full dosing guidance as to how to move forward. That is always important in oncology. It is particularly important for bispecific T cell engagers that can come with some inflammatory risk or cytokine release owing to the activation of the T cell. Thankfully, and knock on wood, for Xaluritamig, this has been quite manageable. We're pleased with what we've seen regarding the PSA 50 and PSA 90 response rates. They have correlated very well to what we observe radiographically, where available for prostate cancer patients by RECIST criterion. You can expect to hear more updates on this work at upcoming medical congresses, ESMO and others.
Got it. So we'll see something in that ESMO, right?
Yeah, believe so, yes.
Got it. Super helpful. Maybe another. There was a trial that is reading out is Uplizna MG. I think you have a placeholder there for October, something. That's what I heard from people. But, like, let's just talk about your confidence level there, and there are two subsets, right? MuSK and AChR-positive patients. So how do you think about these different subsets, and what do you need to see? Like, success is one thing, but then there are quite good drugs out there. So how do you think about the competitive profile there? Thank you.
The unmet need in myasthenia gravis, in particular for the Class Two to Class Four patient, is significant.
Mm-hmm.
Though there are any number of immunosuppressing medicines that have demonstrated, you know, low, double-digit response rates in this disease, the majority of patients are really struggle. They're on chronic steroids ineffectually treating the disease and also presenting the challenges of chronic steroid use. It is a wonderfully per patient, a competitive area, and we feel very competitive in this area. Uplizna, as you know it to be, is an afucosylated monoclonal antibody directed at CD19. Afucosylated enhances the capacity for this antibody, when it engages CD19 positive B cells, to remove those cells from circulation and from tissues. CD19 is a meaningful advance over CD20-directed antibodies, like rituximab and the like.
Mm-hmm.
I'm a hematologist, so forgive me if I double-click on this. But the CD20 compartment is the mature B cell. What you get with CD19 is you get the pro-B cells, the even more immature B cells that are just being immune-stimulated, clonally selected, and then you also get the plasmablasts, and the plasmablasts manufacture a portion of the immunoglobulin compartment.
Right.
Within eight weeks, more than 99% of CD19 positive B cells are eradicated from the body, and so it's a very powerful way to interact with the immune system and a selective way just to the B cell compartment. The success that we observed initially in the NMOSD, most recently in IgG4-related diseases, the first ever phase III clinical trial in that disease to read out positive, has a ratio of 0.13, p five to the minus seventh. Makes you wonder if it could have been a smaller study. We hope reads through-
Right
to the biology of myasthenia gravis, which as you nicely said, mapped directly to autoantibody elaboration, the anti-MuSK antibodies, as well as the anti-acetylcholine receptor antibodies. We have stratified for both types of patients, and, you know, knock on wood, in the second half of this year, we'll read out that phase III study. I've not yet seen the data, but I can't wait.
Got it. Helpful. Maybe one question-
Oh, and by the way, this medicine is given, you know, every six months.
Right.
So if we are fortunate enough to witness as transformative an impact there as we did in IgG4-related diseases, this will be a real improvement in the patient experience and quality of life.
Yeah, every six months, IV would not matter as much because it's fine.
No, they need to see their physician-
Right. Right
at least that frequently. And we've designed this study also to test a steroid tapering that would hopefully get patients off steroids and onto a well-tolerated medicine with a cadence of administration appropriate for their chronic disease.
Helpful. Thank you. I mean, one question I want to ask you, Peter, about manufacturing of course, with the MariTide. Manufacturing is kind of a big task with incretins, especially in your case, monoclonal antibody. So how do you think about, one, the effort you are putting in right now? Number two, I mean, it could be a quite costly endeavor as well. Like, how do you think about the cost of manufacturing as well as efforts you're putting in right now to prepare for MariTide?
Well, I think, let's go back and recall that for several decades, Amgen has been a leader-
Mm-hmm
in not just manufacturing, but the science of manufacturing.
Right.
Process development.
Right.
And so it's really important to look at Amgen and recall that we're starting from a position of strength in manufacturing. We believe we have a world-class process development group that studies the science of manufacturing and of these large molecules, and is able to, you know, create opportunities for improving yields and improving how the processes work. So we're very confident, Mohit, in our ability, first of all, to size up and architect the situation in a way that allows us, you know, to think about the future. But we're clear-eyed, this is a big task. I mean, this is... We're talking tens of millions of people, if not hundreds of millions of people, in the greatest global public health crisis that maybe the world's known in terms of getting after it. We're excited about MariTide, as you've interrogated with Jay.
We started to prepare, in many ways, a long time ago. During COVID, we bought land in Ohio.
Right.
We didn't really think about MariTide then. We just knew that we were entering a world of volume-driven growth, and we've been saying that for any number of years. We're fully prepared for that. I don't know that that was volume-driven growth, but so that was volume. But volume-driven growth, so we've been very focused on that for many years. So Ohio, licensed, up, functioning wonderfully, the most automated plant in our system. It's a finished drug product plant. And actually, once the materials go over that receiving line coming into the plant, they really don't touch humans much, if at all, until they leave the plant.
Right.
And so I've been there. I've spent the time there. It's very exciting. I mean, and we could get in a long discussion about-
Sure
-our commitment to technology and artificial intelligence, and Jay's predecessor, Dave Reese, becoming our Chief Technology Officer, and how we're gonna leverage that in this whole manufacturing opportunity for us, and so forth and so on. Then let's go to North Carolina. We also bought a significant amount of land in North Carolina, Holly Springs, North Carolina. We're pushing ahead. We have a drug substance plant that we've shared with you and our investors that we expect to be up and licensed and running in 2026. We've got plenty of land there for additional expansion if and when needed. I got a chance to go visit that just a few weeks ago. Our team there is fantastic, and we're moving ahead. We're on schedule. We're very excited about that. That's a drug substance plant, as I mentioned.
What I would say about Ohio and North Carolina, too, is we have incredible talent. It's diverse talent we're getting, very skilled. I would commend, by way of example, North Carolina for its community college system and training people to be able to come and work in our plant there. We're very excited about that. So we understand the mountain we need to climb in terms of manufacturing capacity. We're fully prepared to do it. We'll allocate the capital to it. We raised our CapEx guide this year from an original $1.1 billion to $1.3 billion, and, you know, that's important to us.
Right.
We think we're starting from a position of strength, so that's an important guide for us. And of course, we'll be back to you off our fourth quarter call with where we see CapEx next year. But we're working hard. We're very confident in our ability to deliver this medicine, when the time comes, and, you know, we're excited and fully committed to be a participant, in this global public health crisis, going forward. So I see we're out of time. I just want to thank you and Wells Fargo again. We're so excited to be here. It's an exciting time to be at Amgen. We're grateful to everyone for listening and being with us this morning. And Mohit, it's always great to see you.
Thank you very much. I really appreciate you coming here.
Thank you.
Thank you.