Amgen Inc. (NASDAQ:AMGN) Wells Fargo 2024 Healthcare Conference Call September 5, 2024 9:30 AM ET

Company Participants

Justin Claeys - Vice President of Investor Relations
Jay Bradner - Executive Vice President, Research and Development & Chief Scientific Officer
Peter Griffith - Executive Vice President & Chief Financial Officer

Conference Call Participants

Mohit Bansal - Wells Fargo

Mohit Bansal

Great. Thank you very much for the third session of the day. My name is Mohit Bansal. I am 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 is EVP and Chief Scientific Officer; we have Peter again with us, three years in a row now.

Peter Griffith

Three years in a row.

Mohit Bansal

Awesome. So Peter Griffin, 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.

Peter Griffith

It's great to be here, Mohit. I could give a couple of remarks.

Mohit Bansal

Of course.

I think three years in a row in Boston is a hat trick, isn't it doctor?

Mohit Bansal

Yes, it's a hat trick.

Peter Griffith

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 4 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, an IgG4-related disease. We announced exciting Phase II data with TEZSPIRE in patients with chronic obstructive pulmonary disorder, 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 2 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 heme/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. And we'll also talk I'm sure about xaluritamig and our new bispecific 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 inflam 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 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 pipeline. So with that, let me turn it back to you and I'm sure you've got some questions. If I were a gambling person which I'm in a casino but I don't gamble, I guess that you're going to spend some time with Jay which you should because our innovative pipeline is so exciting.

Mohit Bansal

No, definitely. I only have like 500 questions, so let's see how many we can get to today. But I have -- 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?

Jay Bradner

Nine months, yes.

Mohit Bansal

Nine months, right? Nine months 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 that we have a question that how much pipeline Amgen has and it seems like you have a ton now. What is your assessment in the last 9 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 had this last three 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, James.

Jay Bradner

I mean the first I'd say is that the pipeline is maturing, it's growing and in particular, are growing in impact. We have just a ruthless approach to prioritization 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 derisked pipeline. It is maturing with a very high probability of success.

I think we're doing a very excellent job in making the most of each opportunity to expand the impact to do indication expansion in parallel. MariTide would be a great example of that, how we're going into 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 at 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, MariTide, 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 four therapeutic areas where we play, cancer, inflammation, cardiometabolic disease and rare disease, we have a very compelling research and development strategy.

And 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 but 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 how hard it is what we do, perfectly undistracted by ego, a great and collegial vibe, we work from one P&L, a real enterprise mindset. So a great time to be at a great company.

Mohit Bansal

Awesome. So peter anything to add here?

Peter Griffith

Mohit, that is such a wonderful question. For me, our capital allocation priorities haven't changed. 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 and organic internal innovation. And we've consistently done that. And 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, our 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 to our operating margin, we would slightly flex it to 48 percentage points. And remember, our operating margin as a percentage of product sales. So we flexed it down a couple of points from where has it 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 going to flex it to roughly 47% for the year, our operating margin. So we're excited to be able to invest shareholder capital to support the number one capital allocation priority.

I would say at the same time, Mohit, we're focused on deleveraging the company from the horizon a 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 all in all, we want to generate capital to invest in innovation. We're very pleased with the four therapeutic areas: general medicine, oncology, hematology, immunology, inflammation and certainly general medicine. So we're very focused on all 4 therapeutic areas, fourth being rare disease.

Rare disease has been really excellent. 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 going to talk to Jay about our STEAP1 in prostate, right? Six-Transmembrane Epithelial Antigen of the Prostate 1 but that's an important medicine, right? That's the second bispecific T cell engager to address the common solid tumor. And so we're feeling very confident in that. KRYSTEXXA in rare disease, chronic refractory gout doing -- annualizing well over $1 billion, Mohit. And then TAVNEOS, putting up great numbers for ANCA-associated vasculitis.

So it's patients, patients, patients, patients and innovation. I could go on and on about it but I want to turn it back to you and just tell you I'm excited about this. And again, I would say it's for patients, millions of patients that are receiving the medicines. It's for the future patients that will come in the future with Jay and the team in Discovery Research are going to 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 through our discussions and approvals with regulators as possible.

Mohit Bansal

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're not in and you could be getting in there with the 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 expectation for the investors?

Jay Bradner

No, thank you. We're very excited about MariTide. MariTide as you know it to be as an antibody peptide conjugate that inhibits the GIP receptor with an antibody core and then delivers concurrently to append the 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 and we are well on track to deliver a conclusion to Part one of the study which is the 52-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. We expect some 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.

Mohit Bansal

And there is one question we get a lot on this is that -- of course, you saw a decent amount of weight loss in the Phase I/II trial, albeit in the smaller set of patients. But how important it is to show benefit on other parameters such as blood pressure, A1c and lipid lowering as well because ultimately, you may have to do these outcome trials as well. So how do you think about those parameters?

Jay Bradner

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.

Mohit Bansal

And I mean, theoretically, I mean, I'm sure you have answered this question multiple times and I had a fortune of talking to [indiscernible] as well earlier this year. In terms of like there's this thought that because of GIP antagonist versus agonistic there could be some interference which is different versus a drug like Mounjaro and they could be interfering with -- this could be interfering with other parameters other than weight loss. Do you agree with that notion that because it is antagonist, the effect could be slightly different than agonist?

Jay Bradner

Well, you bring up a really interesting aspect of our research is that we've taken a decision to inhibit the GIP receptor. And tirzepatide and other medicines in this space are agonists of the GIP receptor. And in drug hunting that almost never happens, right? We're two elite discovery units, both quite expert and well healed 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 across 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 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. 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 adipocyte by an independent group resourced by, interestingly enough, the Novo Foundation. This work hasn't has yet been conducted in the brain but suffice it to say that GIP agonist might actually be antagonist. And if wanting GIP antagonism, just inhibit the receptor.

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.

Mohit Bansal

Got it. Very helpful. And then actually, in the interest of time, I think I want to turn it to another cardiovascular drug maybe a little bit under the radar but Lp(a). I mean, again, it was like there was a lot of excitement back in the days. And then obviously, -- now we are -- I mean you're waiting for Novartis data.

Jay Bradner

Yes.

Mohit Bansal

So how do you think about this particular asset? Is there a threshold effect there that once you cross a certain level of Lp(a) lowering them 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 data would be, next year probably?

Jay Bradner

Yes. No, 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 it 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 delivers capacity to manufacture Lp(a). Lp(a) is a genetically defined fully independent cardiovascular risk factor, 1 in 5 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.

And so 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. And 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 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. I know that molecule well, as you may know. And 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 endpoint of the study. So this is a very expertly designed study that I think will thoroughly test this hypothesis.

Mohit Bansal

Got it. And maybe quickly, do you have any thought on ASO versus siRNA? Because long-term safety could be important for these kind of medicines.

Jay Bradner

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. 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. There are benefits to siRNAs in their capacity to be loaded into liver tissue, recirculate it through the lysosomal system and the risk complex and they just work at much, much, much lower doses. And 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.

Mohit Bansal

Got it. Very helpful. I mean, I think one question before I move to oncology side, I want to ask you, Peter, so now that Repatha, you have a cardiovascular franchise and then you will have some kind of similar kind of franchisees coming with MariTide and then Lp(a), how much leverage is there in the business to launch these drugs eventually? Like I mean this is -- do you see some synergies there? Or do you think it will be quite a lot of investment when you launch these products?

Peter Griffith

Very insightful question. Mohit, when we think about our experience with Repatha, we think about all our experience also with Prolia, the bone franchise and going out to all the patients and primary physicians and endocrinologists and so forth. It's a really -- 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.

So with that, Justin, what are your thoughts around that?

Justin Claeys

Yes. 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 to that point, go ahead, I think as you think about potential opportunity in obesity that definitely would create some leverage for us.

Peter Griffith

Awesome.

Mohit Bansal

So maybe let's just talk a little bit about the oncology pipeline. I mean because, I mean, Peter mentioned STEAP1, I mean, so just tell us about your excitement level? And are we going to see any data near term from the STEAP1 side?

Jay Bradner

Yes. So 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 is on the surface of prostate cancer cells. And so we have designed with our partners at Xencor 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 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. So 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, knock on wood, for xaluritamig, this has been quite manageable. We're pleased with what we've seen regarding the PSA50 and PSA90 response rates. They have correlated very well to what we observe radiographically, where available for prostate cancer patients by RECIST criteria. And you can expect to hear more updates on this work at upcoming medical congresses ESMO and others.

Mohit Bansal

So we'll see something in that at ESMO, right?

Jay Bradner

Yes, I believe so.

Mohit Bansal

Super helpful. Maybe another trial that is reading out is UPLIZNA in MG. I think you have a placeholder there for October, something from that sort of I heard from people. But let's just talk about your confidence level there and there are two subsets, right? 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?

Jay Bradner

Well, the unmet need in myasthenia gravis, in particular, for the Class II to Class IV patient is significant. And though there are any number of immunosuppressing medicines that have demonstrated low double-digit response rates in this disease. The majority of patients really struggle. They're on chronic steroids ineffectually treating the disease and also presenting the challenges of chronic steroid use. It is 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. 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 Rituxan and the likes.

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 selective. And then you also get the plasmablast and the plasmablast manufacture a portion of the immunoglobulin compartment. Within 8 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 in a selective way just to the B cell compartment.

The success that we observed initially in NMOSD most recently in IgG4-related disease, the first ever Phase III clinical trial in that disease to read out positive hazard ratio of 0.13 P5 to the minus 7 [ph] makes you wonder if it could have been a smaller study. We hold read through to the biology of myasthenia gravis which is you nicely said, mapped directly to auto antibody elaboration, the anti-MuSK antibodies as well as the anti-acetylcholine receptor antibodies. We have stratified for both types of patients. And 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. And by the way, this medicine is given every 6 months. 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.

Mohit Bansal

Yes, every 6 months, IV would not matter as much because it's fine.

Jay Bradner

No, they need to see their physicians, 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.

Mohit Bansal

I mean, one question I want to ask you, Peter, about manufacturing of MariTide. This is -- manufacturing is kind of a big task with incretin, especially in your case, monoclonal antibody. So how do you think about, one, the effort you are putting in right now? Number two, the -- I mean, it could be 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?

Peter Griffith

Well, I think let's go back and recall that for several decades, Amgen has been a leader in not just manufacturing but the science of manufactured process development. 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 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 to think about the future. But we're clear-eyed, this is a big task. I mean we're talking tens of millions of people, if not hundreds of millions of people and 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. And so we started to prepare in many ways a long time ago. During COVID, we bought land in Ohio. 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. So we're -- I don't know if 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 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. And so I've been there, I've spent the time there. It's very exciting. I mean we can get into a long discussion about our commitment to technology and artificial intelligence. Jay's predecessor, Dave Reese, becoming our Chief Technology Officer and how we're going to leverage that and 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 the 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 come in 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 that's important to us. 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 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.

Mohit Bansal

Thank you very much. I really appreciate you coming here. Thank you.

Jay Bradner

Thank you.

Question-and-Answer Session

End of Q&A