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Morgan Stanley 22nd Annual Global Healthcare Conference

Sep 4, 2024

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Great. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. I'm Terence Flynn, the U.S. Biopharma analyst here at Morgan Stanley. Very pleased to be hosting Amgen this morning. Joining us from the company today, we have Robert A.Bradway, who's the Chairman and CEO. Thanks so much, Bob. Always appreciate the opportunity to speak with you, and thanks for taking time out of your busy schedule to join us on the East Coast today. Maybe I'll turn it over to you to see if you had any prepared remarks before I go into my questions, just to frame things for us and we can go from there. But thanks again.

Robert A.Bradway
Chairman and CEO, Amgen

Yeah. Well, first, Terence, thank you for including us again this year. We appreciate having the opportunity to be here and to update all of you on the developments at Amgen, and I suppose I would just start by saying that, you know, we're excited about the future. We've been talking about our strategy, which is to develop a business that can produce long-term growth, and we think we're well on our way to successfully doing that, and, of course, you know, at Amgen, that starts with innovation and a focus on where the unmet medical need is for patients, and that focus has led us into four areas where we're very active. Those four areas, of course, include general medicine, oncology, inflammation, and rare disease, which is a recent commitment for us.

But across each of those four areas, we have medicines that are on the market at an early stage of their life cycle, growing very well. And then we have what we think are attractive, innovative programs in the pipelines of those four areas, and then biosimilars that augment our activities again in each of those four categories. At the same time, we have a commitment to growing internationally. We were a little late to the international game compared to some of our competitors, but we are now well established globally. And in fact, some of our fastest-growing markets include markets in Asia, and outside of the United States.

You know, if I were to just briefly highlight the momentum that we've reported so far during twenty twenty-four, I think in general medicine I would highlight Repatha and Evenity. Two medicines again continue to grow very strongly. I think Repatha in the second quarter was up 25%. And Evenity was up, I think it was 40% in the quarter. And so that business continues to perform well for us. Oncology also performing well. The whole oncology portfolio was up 12% on the quarter, which gives you a sense that we're growing across a number of different medicines there. Inflammation, perhaps highlighted by the growth in Tezspire. I think Tezspire was 75% on the second quarter, so again, recently launched and performing very well.

Has the potential, I think, to be a game-changing medicine in the respiratory field, and then, of course, rare diseases. Rare diseases are performing well. Tepezza was up 8% on the quarter. Tepezza, Krystexxa, and Uplizna are three important rare disease medicines that are biologics and at an early stage of their life cycle, so we're excited about what we can do there, then, if we go through the pipeline, you know, each one of those areas has a pipeline molecule that's visible to you and exciting, and maybe it's going in reverse order. In rare disease, the Uplizna data in a rare disease known as IgG4-related disease were truly spectacular earlier this year, and we're waiting to see whether we can recapitulate those stunning data in myasthenia gravis.

Rare disease, current portfolio pipeline look, looks strong. If we talk about oncology, again, there's a lot of excitement about our recently launched bispecific against lung cancer, Imdelltra, and we think that that's warranted. There's a lot of development work still ongoing for Imdelltra and another molecule that we hope will remind you of Imdelltra, that's xaluritamig against prostate cancer. So tarlatamab in phase III trials. A lot going on in oncology. In inflam, of course, rocatinlimab, which is a novel approach to depleting pathogenic T-cells, also rapidly progressing through a broad clinical development portfolio.

And then finishing up in general medicine, Lp(a), which is for that fragment of the population, about 20% in number, who are genetically at risk for having high levels of Lp(a) and therefore at risk for cardiovascular disease and even early cardiovascular disease. So that's an exciting molecule. And then, of course, MariTide, our obesity asset, which is rapidly moving through phase II development, and which we look forward to developing in a broad phase III program. So across the board, business feels good. There's momentum, plenty of opportunities to invest for long-term growth, and we're excited about what we think we can deliver.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Great. Well, looking forward to unpacking a lot of that, but thanks for framing it all out, Bob. You know, maybe you wanted to start high level. Obviously, it's a presidential election year, and so we get a lot of questions on the policy front. You guys are very plugged in in DC. Any proposed policies from either camp that you're keeping your eye on with respect to, you know, the industry or Amgen, that we should think about? Obviously, IRA was passed into law, you know, in 2022. We've seen the first list come out, but you know, that and beyond that, anything that you're watching on the DC side right now?

Robert A.Bradway
Chairman and CEO, Amgen

I think all of us are watching carefully what's happening in D.C. I think it's still, ironically, you know, an election campaign that seemed to never end, ironically, it's still early in the game. As much as we don't really have any visibility into what one of the candidates' points of view are in healthcare, I haven't heard anything from her since she talked about single-payer environment many years ago. I don't think we know what one candidate's views are. I think the other candidate's views were well known previously, and you know, I think it seems that he's focused in other areas at the moment.

But, you know, the good news is that, as you said, we're active and our industry is active in Washington, trying to make sure that everybody understands what it takes to have an innovative biopharmaceutical industry and doing our best to help politicians and other policymakers understand how things like the Inflation Reduction Act really undermine innovation. So again, I think that's an example of, you know, what bad looks like when there isn't proper, you know, bipartisan engagement in big, wide, sweeping legislation. Because what we got there is, I think, a bill that's not very well understood and a bill which will undermine innovation in our industry. Yep.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Are you surprised that there wasn't maybe more of a halo effect post-COVID from... You know, as you said, I mean, I think the world recognized the importance of having a robust domestic biopharma industry, but are you surprised that halo effect didn't last longer here in the U.S.?

Robert A.Bradway
Chairman and CEO, Amgen

I think, yeah, probably. I think, you know, people recognized that it was an innovative biopharmaceutical industry moment, you know, that thanks to the innovative biopharmaceutical industry, we were able to wrestle around this virus at a speed and with a level of success that was unprecedented. So you know, it almost seems trite now to remind us, but, you know, prior to this, vaccine, wave of vaccines, the fastest vaccine development program was four years. So thankfully, in the setting of COVID, we didn't have to wait a full four years. We waited, in fact, a little less than one. So it was it really was a spectacular accomplishment. But, you know, what have you done for me lately?

I think, you know, with COVID wrestled to the ground and with the, you know, consequential increase in healthcare costs, not just here in the United States, but around the world, it was inevitable that there would be a return to a focus on healthcare costs, and I think that's what we've seen.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Okay. Maybe just on the IRA side, obviously, you know, you have a strong view here. Amgen had one drug included on that list, Enbrel, in terms of the first Medicare Part D drug that were negotiated here. Just any insight or learnings from that coming out the other side now that the discount has been disclosed? And anything you're doing strategically at Amgen in a post-IRA world to kind of adapt the business model to kind of navigate that?

Robert A.Bradway
Chairman and CEO, Amgen

I think the Inflation Reduction Act creates incentives or perhaps distorted incentives across the landscape of potential development opportunities. So, I think molecules, for example, small molecules, in oncology, to select one area, are disadvantaged relative to what were the facts before the Inflation Reduction Act. So it's I think we and everybody else in the industry have to adapt to that and allocate capital accordingly. So, you know, anybody who thinks that a wide-sweeping piece of legislation like the Inflation Reduction Act isn't going to have an impact on investment in the industry, isn't paying attention to what we've learned across the economy over the last two hundred and fifty years.

Because it's clear when you remove, you know, reward from an industry, it will have the effect of chasing capital elsewhere, and that's what the Inflation Reduction Act did. It reduced the ability to earn a return on innovative biomedicines, in particular, small molecules. And as I've already said, in particular, in cancer, where the nature of drug development is such that, that's where the pain will be born most clearly or very clearly. And so capital will flow elsewhere, and that's inevitably happening already and will continue to happen.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Then any thoughts on implications for the commercial side of the business? I know there's still some debate about, you know, if this is gonna be ring-fenced to Medicare, could spread more broadly, but now that we have the kind of first round here, any, any perspective on that question?

Robert A.Bradway
Chairman and CEO, Amgen

I think you're right. This was intended to be related to a government program, so, you know, that's the nature of the legislation. That's what it's focused on.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yeah. Okay, great. You know, you talked about a number of your key growth franchises here, Repatha, Evenity, Oncology, Rare Disease. You know, maybe the one that you know is always an interesting case study to think about is Repatha, is that you know probably has implications for both you know your Olpasiran Lp(a) program, also MariTide. You know, that was one of the earlier primary care biologics. It did take some time to you know see that asset deliver upon commercial expectations. I mean, I remember my estimate used to be you know $5 billion you know several years post-launch.

As you think about the learnings from Repatha, as you think of some of these other programs, like, what were the kind of keys to really get that asset moving, you know, to 20% growth that you're now seeing?

Robert A.Bradway
Chairman and CEO, Amgen

I think the key is the quality of the molecule, and you know, both Repatha and you can include Prolia in your thinking here. You know, both of them have become large, successful drugs, and they will benefit millions of patients, and that's a reflection of the benefits that the molecules provide and the appropriate safety window in which the benefits can be achieved. So if you have molecules like Repatha and Prolia, which demonstrate over and again in large populations that they're safe and effective in addressing what are otherwise, you know, potentially very grievous issues for individuals, the molecules can succeed. Now, there are lots of ways that, you know, the...

in particular in the U.S. and even in international markets, that the rate of adoption can be influenced by the middlemen and the steps that doctors and patients have to go through, and that's clearly something that we had to deal with with Prolia, we had to deal with Repatha. But eventually, if the quality of the molecule is as strong as the case with those two, eventually, you know, we break through, and prescribers are willing to prescribe it, patients recognize the importance of taking it. And, you know, payers, I think, are focused on other things now. So some of the, you know, the original barriers to prescription have lapsed over time.

You know, to go right back to the beginning, you know, there were utilization management forms that were fourteen pages long, that doctors had to fill in, for Repatha. Well, doctors had never seen anything like that before, so they just assumed, you know, "Maybe it's not worth it. We'll give you something else instead." But, you know, largely, those problems have been worked through, and as you said, Repatha is now performing very well, as reflected in the growth in the second quarter, and we expect, you know, that medicine to continue to reach more and more patients around the world.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yeah. Okay, great. Maybe just on the rare disease side, maybe just talk to us about, you know, the Horizon integration. And then I think one question we get frequently is the future opportunity for Tepezza growth. So where you see that coming from as we look on the forward here for Tepezza specifically?

Robert A.Bradway
Chairman and CEO, Amgen

I think the integration is going well. We're on track for all the metrics that we've talked about publicly. I think our CFO, Peter Griffith, has been very clear and in communication with all of you that what our objective was in the way of financial targets for the transaction, and I think he's reported regularly that we're on track with that. The good news is, in terms of the measurables of the integration, working well. Love the team. I think there's a really good fit between our team and theirs. I think we're very encouraged about the future potential of those medicines and the things that we can do together with those medicines to make them even better for patients, and by what's, you know, making its way through the pipeline.

So I would reiterate that, you know, the data that we have shown for patients suffering from a rare disorder called IgG4, which is a very, very challenging problem for patients that have it, were really spectacular, and so, you know, we're excited about how Uplizna can grow there, again we think in myasthenia gravis, if we can demonstrate anything like what we did in IgG4, that again, we'll be sitting on another very, very important opportunity for Uplizna, but back to Tepezza. Again, Tepezza is still reaching a small fraction of the patients that we think will benefit from it ultimately.

International expansion will be an important part of the future of that molecule, and I would remind our shareholders that that's something Amgen can bring to the party that the original owners, Horizon, were unable to do on their own. And so, for example, Japan, we think will be an important market for Tepezza, and we're making our way through the registration process there, as well as in other international markets now. So it's a combination of expanding internationally, reaching patients here in the U.S. who haven't yet been treated for this disorder, and in particular, people who are afflicted with what's called so-called chronic disease. So we think many of them would benefit from therapy, and we're increasingly trying to reach them through the endocrinologists and others who treat their disease.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yeah. Okay, great. I want to move on to the pipeline now. Obviously, you know, the asset that I think is front and center for a number of investors is MariTide, just given, you know, the size of the opportunity as we've seen from some of the early days in the obesity ramp here, but maybe just take a step back and kind of remind us how you're thinking about the target profile here. One question we get from investors is, obviously, we kind of know the current opportunity set with Wegovy and Zepbound, but Lilly and Novo are both aggressively investing to develop next gen assets and kind of continue to advance the field.

So, as you think about, you know, the profile that you need to deliver against, maybe just think through or talk us through how you're thinking about the kind of medium- to long-term here.

Robert A.Bradway
Chairman and CEO, Amgen

Yeah. Well, I guess I would think of MariTide as a next-gen asset in the sense that, you know, this is a medicine that's different from the two that you referred to. First, the mechanism of action is different. Second, the dosing advantage that accrues from that is different. As we've said many times, we were very intrigued by the phase one data and intrigued by what we know from the phase two program. It leads us to believe that this will be a differentiated medicine, potentially across a number of dimensions, and that's what we intend to study in the phase three clinical trial.

Again, I think we've been very clear that we are planning for a robust, wide-ranging phase three clinical program for that medicine, and that's what we look forward to do. We look forward to generating data that will show what we can achieve in patients that are obese or living with overweight, and what we can do in that context for patients that are at high risk of heart disease, renal disease, liver disease, et cetera. So, you know, we think this represents an exciting opportunity for our organization and hopefully for all of our shareholders.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

On the next disclosure, you provided the interim data back on the first quarter call. It was six-month data. We're waiting on the full one-year data here later this year. Maybe just high level, kind of how much data, how little data should we expect there versus a medical conference where we get everything? I mean, how do you walk that balance, I guess?

Robert A.Bradway
Chairman and CEO, Amgen

You know, again, I would say stay tuned. Obviously, it's a highly competitive field, so we'll be very thoughtful about sharing information appropriately with our shareholders, but also not sharing information that prevents us from being able to feature the medicine in the right way with the clinical community that's coming to know the benefit of incretins in managing so many of these different diseases. So we'll get the data in hand. Right now, our focus is on successfully executing that trial, making sure that we have a robust data set from which we can launch into phase three.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yep. And you referenced the broad phase 3 program that you're gonna conduct. Again, another question is: when we get the phase 2 disclosure, is that the time where you might provide more details around kind of the design and scope of that phase 3, or are those kind of two independent disclosures?

Robert A.Bradway
Chairman and CEO, Amgen

Yeah, again, as you can appreciate, this is a competitive field, and I'm sure as soon as we begin our phase three clinical trials, the design of those trials will be very well known so-

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yeah.

Robert A.Bradway
Chairman and CEO, Amgen

I don't think that'll be any secret once we get it underway.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Okay. And how... I mean, another question we get is, again, as we think about the control arm, you know, motivating patients to stay in a placebo-controlled trial in this kind of an environment, where maybe they aren't seeing weight loss or there's other options. So how do you think about that dynamic when you're running these, you know, larger trials here across a range of indications, knowing there are potentially some other options out there, or that patients can actually see the end result of the therapy, which in some cases, you know, they can. You know, we were talking about Enbrel before. Other therapies, you can't, like a PCSK9, necessarily. You don't feel it. So how do you, how do you think about that in the context of phase III?

Robert A.Bradway
Chairman and CEO, Amgen

... Again, it's not the first time that we or other companies in our industry have had to deal with this. This is often an issue. You know, if you go back more than twenty years now, more than twenty-five years, to, for example, the Enbrel clinical trials. You know, the Enbrel patients who were on an active arm knew they were benefiting from something special and you know, if they were talking to people on the placebo arm, the placebo arm understood they weren't, so this is not a new phenomenon. It is particularly an issue in studies of symptomatic diseases and you know, in as much as you can see the weight or the loss of weight in the mirror, you know, the issue that you're raising is one that we have to be thoughtful about.

But again, it's not something new for us or for the industry. And when you said other agents available on the market, yes and no, right? I think, you know, I'm not sure how much of the agents are available in the market right now, but that's the kind of thing that we will, and anybody else developing an obesity therapy, will have to be thoughtful about.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Okay, great. Before we get to some of the, you know, the kind of manufacturing questions, just, you know, another area of pushback that we get is just, you know, the size of the commercial opportunity and what it represents for total U.S. healthcare spend. And so can the system support it? And so would be curious to kind of get your view from kind of top down on how to think about that question as obviously this, you know, even by our numbers, would be one of the largest therapeutic categories ever in the history of the industry, but would place some pressures on the healthcare system. So how do you think about that?

Robert A.Bradway
Chairman and CEO, Amgen

I think I would turn that around. I would say the pressure on the healthcare system is being created by people suffering from chronic diseases and morbidity and mortality that is perfectly predictable and preventable. So it's mortality and morbidity created by excess weight, and the consequence of that excess weight is showing up in the emergency room as a heart attack, or it's showing up in the doctor's office as a chronic kidney disease. It's showing up for a liver transplant due to, you know, diseased liver caused by excess accumulation of fat.

You know, right now our economy is bearing an enormous strain from the fact that we have tens and maybe even more than just tens of millions of people who are accruing risk for serious disease, much of which cost will later be picked up by you know the government that could be prevented, so you know again we particularly like the paradigm of predicting and preventing, and where you have medicines that enable you to prevent diseases in people who you can predict are at high risk of developing them, that we think is an important sweet spot for society, so again just to go back to Repatha for a moment, or and Prolia. You know, the...

In a room full of just, you know, a room full of individuals, those who have had a heart attack recently are likely at more risk of having another heart attack than people in the room who haven't. So if you just start with people who had a heart attack, or just start with people who have very high levels of LDL, you can predict which people in your room should be on therapy to prevent either the next heart attack or a first heart attack. So predicting and preventing is not difficult, and when you can predict and prevent, and therefore focus the use of the medicine where the returns will likely be highest, you know, it seems to us that's a proposition that works for society. Same thing with osteoporosis.

A woman who has fractured after transitioning through menopause has declared herself to be a candidate for another fracture. And so if all you do is treat the women who have previously fractured after again entering menopause with an agent like Prolia, you are, you know, very likely to prevent more fractures, and you can do it in a very targeted way. And similarly, in the setting of obesity, you know, you can predict which people in a room like that that we find ourselves in now are at greatest risk of accumulating you know chronic diseases through their lifetime if they don't manage their weight. And so you know I think the economics of not predicting and preventing are creating a strain that our health system is buckling under.

I think, you know, the future will involve more of our willingness to invest in medicines that prevent those downstream costs, and to see that, again, as an investment. So, you know, the consequences to GDP, for example, of cardiovascular bad cardiovascular health in the United States are huge. You know, the American Heart Association estimates $600 billion a year of costs attributed to, and therefore, lost productivity to cardiovascular disease. When you consider that a large fraction of that disease could be prevented, and an even larger fraction you know, with the incretins now available to help address the problem, you know, it seems to me a very large economic prize to play for. To narrowly think about drugs expenditures is a mistake.

You know, if it's not seen in the context of what it does to the broader healthcare cost and what it does to, you know, the GDP for our nation, I think you make a mistake.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yeah. Okay, great. The obviously, the investments you're making are sizable here on... You know, you announced a step up in R&D growth and also CapEx, and so, you know, this is a biologic medicine right in your wheelhouse, but maybe just help us think about those investments, and then what are those barriers to entry look like? Because obviously, you're probably one of few companies that has the balance sheet and the infrastructure to kind of make those kind of investments and build this out and make the global supply chain work. So how do you think about the near-term investment, and then what does that mean from a barrier-to-entry perspective?

Robert A.Bradway
Chairman and CEO, Amgen

I, again, I would say maybe a couple things. First, you said step up in capital expenditures. Remember, you know, we were spending $500 million-$600 million a year, and if we've stepped it up, we've stepped it up a few hundred million dollars at the moment. So just to provide context. I would say that the, you know, the barriers to entry are, you know, perhaps manifold, but starting with the clinical barriers to entry, you know, generating data for these agents is going to require very large, well-controlled, randomized, you know, clinical trials. You know, again, we think these are agents that have, or our medicine will have benefit across a number of different diseases.

So that would entail or imply that we're going to be running clinical development programs across a large number of different diseases. And so those are large, well-controlled phase three studies to demonstrate the safety and efficacy of our medicine. You know, those trials are expensive. They're expensive, and they take time. But our you know, our teams are prevented from promoting the agent to physicians and to patients who might benefit from them without having the data in hand, and without the regulators agreeing that the molecules are safe and effective for the diseases that we want to promote it, promote it for. So you just simply can't get into the game if you don't generate the data. So we plan to generate the data.

Then I think the other question you're asking is, what about the supply? Yeah, I think you're right to ask about, you know, what the supply challenges will be. We have witnessed over the last several years, one of the more extraordinary examples, I think, in our industry, of how hard it can be to supply a medicine when the demand surges the way it has for these agents. So I wouldn't underestimate what that challenge looks like. I would say with respect to Amgen, however, keep in mind a few things. First, our medicine is likely to be administered monthly or less frequently than that. So that means, you know, we're giving a quarter of the number of injections as the two competitors that are on the market now each month.

To the extent that some of their supply challenge is a function of the number of injections that they're having to provide, we start with the benefit of doing a quarter of what they're looking to do. The second thing I would remind you of is that our medicine is on an antibody backbone, which is one of the reasons why we're able to administer it monthly or less frequently. When it comes to antibodies, sure, bricks and mortar are important, but if you look at the history of Amgen, we've achieved tremendous leverage from the science as well, so from the investments in process development and in the biology of production. It's that investment in the biology of production, which often gives us much more leverage than adding, you know, more bricks, mortar, and steel.

So we will go at this challenge, you know, by investing heavily in process development. Those of you who know me know that throughout my tenure I've talked about the fact that I think Amgen's manufacturing is a source of competitive advantage. By which, I mean that we have invested heavily in the science of biologic production since our outset as an organization. And it's those investments that have enabled us to find keys to unlock the throughput or the productivity in our manufacturing process in a way that others have failed to do. And it's again a direct result of our having invested in the science of biologic manufacturing, and in, you know, the innovation that is entailed in that.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yep. Okay, great. And just in the interest of time, I want to get to some other programs as well here. We're expecting initial phase III data for Rocatinlimab, your OX40 antibody here, later this year in atopic dermatitis. Just again, remind us target profile, and then one question we often get is, Dupixent is fairly entrenched. It has a broad label, first-line setting. How do you commercially compete against that asset, or is this more of a second-line opportunity?

Robert A.Bradway
Chairman and CEO, Amgen

Again, let's get the data first, and then we can talk about how we compete. But we will begin to see data. We're going to see the early, I think it's the twenty-four-week data first. So we'll see those data, and we're running a broad clinical program for this molecule. So not just atopic dermatitis, but also prurigo nodularis, also respiratory disease. So we'll see whether this agent does what we hope it will. I would remind you, it's a novel approach, so we need to see the data to know whether this novel idea works. But the notion is that by deleting the pathologic T cells, we can restore balance and help to address these autoimmune conditions in people who are struggling to get the benefits they're looking for from existing therapies.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yep. Okay, the other one, again, you touched on this a little bit, but Olpasiran, your Lp(a) program. Here, your data, CVOT's data is expected in 2026. I think Novartis will have their data next year. Just remind us kind of confidence in this approach and the target, and then what's kind of the difference in commercial opportunity here relative to Repatha?

Robert A.Bradway
Chairman and CEO, Amgen

Again, a couple of things. First, this is a medicine that has been developed for people who are genetically born with high levels of Lp(a), which we believe has correlated with atherosclerotic disease and early onset cardiovascular disease. So, these are, you know, people who, you know, unfortunately are born with a high level of Lp(a) in their body. And if you look at such people, you find that they accrue coronary plaques, for example, at a much earlier stage than people that have low levels of that, and as a result, cardiovascular events at an early age in life. They, unfortunately, are unable to moderate that risk factor with exercise, diet, and other medicines. How does it compare to other medicines in cardiovascular disease?

If you take Repatha, Repatha patients had other alternatives, you know, statins, you know, other mechanisms that would lower LDL. Lp(a) patients don't have that luxury, so there is no medicine available today for patients that are at high risk of LDL and the cardiovascular disease that comes from it. We'd like to see data that show that by intervening and reducing the levels of Lp(a) by 95%, as we do with a once a quarter injection, that we can help those patients avoid what has happened to many of their family members through time.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yep. And what, I mean, we were talking about this a little bit before, but just there's the testing component. I mean, is that one of the bigger kind of hurdles to building this market, do you think? Or are there any other things as we think about the ramp of this potential product?

Robert A.Bradway
Chairman and CEO, Amgen

That is certainly a hurdle. Again, this is a novel therapy. Novel therapies always require some amount of effort to educate the public, the payers, the prescribers, so we'll have to do that. It has the added wrinkle that there's no incentive today for Lp testing. As I think you're probably all aware, doctors often resist the idea of spending money on tests for which there's no solution anyway. So why spend the money to test something if there's nothing you can do about it? Lp starts in that hole, so it starts in that category of, you know, most doctors don't bother to ask the question because there's nothing they can do with the answer. So we have to fix that. You know, this again, like any novel medicine, this will have its challenges at the outset.

But if the safety and efficacy are what we hope they will be, then we ought to see, you know, an attractive opportunity for that medicine.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Okay, great. The other area I wanted to talk about, we hosted Dave Reese, your Chief Technology Officer, on a call a couple of months ago. I think you're one of the few companies that created that role. It's pretty unique. So as you think about you know, one question we get from investors is the importance of AI in our industry, the biopharma industry, maybe just high level, kind of the investments you're making now and the confidence on generating a return on those, on the AI side.

Robert A.Bradway
Chairman and CEO, Amgen

We're investing broadly in AI, and you know, we're obviously excited about what it's doing for our business already. What I would say is that many of the leading figures in the world of AI are excited about biology, and so we've been a natural sort of magnet, if you will, for that kind of talent that's interested to explore how to apply their insights to our world. We have lots of examples where we're, you know, at the cutting edge of collaborations with AI scientists because they want to see whether their inventions can help us achieve insights that we can't get without those tools. You know, the good news is there are some problems that are already tractable, some problems where we're already getting answers.

And we think, as a result, moving more quickly and with more confidence than we would've been able to without AI. But you know, again, if you're waiting for us to pull back the curtains and show you a dozen new medicines that came out of a computer this year, I mean, that's probably not gonna happen anytime soon. But don't misunderstand or don't mistake that for suggesting there isn't progress being made by applying the tools of AI. It's happening every day.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Yeah. Well, can you comment at all in terms of, like, the percentage of your budget that's dedicated to AI?

Robert A.Bradway
Chairman and CEO, Amgen

You know, I wouldn't care to give a public number on that.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Okay, fair enough. Maybe just last one is another question is the Puerto Rico tax litigation. Just update us on kind of next steps there and confidence level and favorable outcome.

Robert A.Bradway
Chairman and CEO, Amgen

Again, I think our confidence remains high. You know, our confidence has probably grown over time rather than diminished. That question is headed to tax court later in the year, and so we'll have an opportunity to share with the court why we think the IRS has it wrong and why we think that our approach is appropriate and consistent with how the IRS has looked at this matter in the past.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Okay. Well, I think we're up against time, Bob-

Robert A.Bradway
Chairman and CEO, Amgen

Okay.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

But thank you very much.

Robert A.Bradway
Chairman and CEO, Amgen

Thank you. Appreciate your interest. Thank you.

Terence Flynn
U.S. Biopharma Analyst, Morgan Stanley

Appreciate it.

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