Amgen, Inc. (NASDAQ:AMGN) 40th Annual J.P. Morgan Healthcare Conference January 11, 2022 11:15 AM ET
Company Participants
Robert Bradway - Chairman and Chief Executive Officer
Conference Call Participants
Cory Kasimov - JPMorgan
Cory Kasimov
Great. Good morning, everyone, from the 40th Annual JPMorgan Healthcare Conference. My name is Cory Kasimov. I'm the senior large-cap biotech analyst, and it's my pleasure to introduce Amgen, and Chairman and CEO, Bob Bradway.
Please note that following the presentation, we will move right into a Q&A session where you can send in questions via the conference portal, and I'll do my best to work them into the conversation. So with that, Bob, thanks, as always, for joining us today, and let me turn things over to you for an update.
Robert Bradway
Okay. Cory, thanks very much. Happy New Year to you and thanks for having us again this year. We're excited to be here. As we look at 2022 and beyond, we think things are setting up pretty well for us to be able to deliver attractive long-term growth for our shareholders. And so I'd like to talk a little bit about that in our time together this morning. If I could ask you to advance the slides, you'll see on our first slide, of course, is our customary safe harbor statement. Let's move beyond that to what is Slide 3, which is titled Amgen is well positioned to deliver attractive long-term growth. And there are really seven fundamental elements that give us confidence that we're on track to deliver long-term growth for our shareholders.
The first is the birds that we have in hand, if you will. The leading brands that are already on the market, that are already generating significant market shares and significant volume growth and have considerable potential still to grow. So we're excited about those brands. I'll talk more about that during the course of our presentation today.
We're also focused on what biosimilars represent for us as a source of growth. We have a leading biosimilar business already today, and we anticipate a steady flow of launches that should enable us to grow that business as well through the end of the decade.
In addition, we obviously have strengthened our growth outlook with several important product approvals this year or over the last of the last year. LUMAKRAS, of course, which is our exciting drug for non-small cell lung cancer; Tezspire, just approved for severe asthma; and of course, with respect to Otezla, we received approval to expand our label to include mild and moderate patients suffering from psoriasis as well. So 3 important new launch opportunities for us heading into 2022.
In addition, as we look at our portfolio, we see an innovative pipeline advancing now quite rapidly across oncology, immunology and cardiology. And I'll share some perspectives view on that as well this morning. In addition, you may have noticed just this morning and earlier in the week, we made a few investments in our research capabilities, and we're excited about how we're deploying what we consider to be the next-generation research capabilities in our business, technologies that enable us to feel more confident that we can drug targets that were historically considered undruggable.
Business development has continued to be an important feature of our strategy at Amgen. We will look to continue to deploy capital on transactions that fit well with our areas of strategic focus, and that should enable us to drive growth during the course of the decade as well.
And finally, I hope that when we report our 2021 results, you'll agree that we've maintained our track record of solid execution really across the business, whether from a financial perspective, an operating perspective, R&D perspective, strategic perspective, we feel we operated really well during the course of 2021.
So if we go to the next slide, Slide 4, I want to just spend a few moments on the strong portfolio of innovative growth brands that we have and we expect to form the basis of our growth through the balance of the decade. It starts, of course, with Repatha, which is worldwide leader in the PCSK9 class for heart disease. We have leading shares for that product globally, and that's a product that was growing volume at 42% through the first 9 months of 2021.
Similarly, Prolia is a worldwide leader in this case, in osteoporosis. And Prolia generated 15% volume growth through the first 9 months of 2021.
Many of you are aware also that we launched EVENITY, which is also a bone health product, a product which is helping us considerably strengthen our osteoporosis franchise. And EVENITY generated 43% volume growth through the first 9 months of 2021.
Otezla is, of course, the worldwide leader in oral therapies for psoriasis. We generated 7% volume growth for Otezla during the first 9 months of 2021. But importantly, we have now, as I said a few moments ago, been granted approval to promote that product to a much broader range of patients, and we will continue to grow the product through international launches as well.
In hematology and oncology, we generated volume growth of about 9% through the first 3 quarters of the year, and that was driven by KYPROLIS, Vectibix, BLINCYTO, Nplate and XGEVA. If you look at the company's portfolio altogether, all the products at Amgen in the first 9 months of the year, we grew volume by 7%. So strong volume growth on which to continue to expand for the balance of the decade.
Now shifting to the next slide, Slide 5, I want to talk for a few moments about our biosimilars business, which we consider to be an industry-leading franchise already and a franchise that we expect to be accretive to our long-term growth. We've launched 5 biosimilars already. Those products were annualizing at some $2 billion in revenues through the first 9 months of 2021. We will launch AMGEVITA, which is our biosimilar to Humira in January of next year. So that will be an exciting opportunity for us to build on our biosimilar franchise. And then in the period that follows, we expect to be in the first wave of biosimilar launches for STELARA, EYLEA and SOLIRIS.
In addition, we have 3 other biosimilars under development, and so we have a total portfolio of 11 biosimilars. And when we look at those products, what we've said is that we expect to be able to grow the franchise as we launch new products and as we enter new geographic markets for those products. And as we look at the profile, we think that we ought to be able to more than double our 2021 biosimilar revenues by the year 2030. So clearly, we see this as an attractive franchise for us from a revenue standpoint and the efficiency of this business means that it's not dilutive to our corporate margin. So we expect this to be accretive to pretax earnings, obviously, and then cash flows as well. So overall, we're excited about the position we have and the opportunity that we think this represents for patients and for our shareholders.
And I would just, again, quickly note that we're talking about biosimilars that address a marketplace for the innovative products, which is now in excess of $86 billion. So we're talking about a portfolio of 11 or so medicines that have very significant opportunity for us to expand.
If we go to the next slide, Slide 6. Slide 6 is some further detail on the approvals that we received over the course of the last year that give us confidence in our ability to continue to grow our business. So obviously, the most recent approval was for Tezspire, which is our first-in-class biologic developed to treat patients suffering from severe uncontrolled asthma. This is the only biologic that's ever been approved without a phenotype or a biomarker limitation. And we believe that there are some 2.5 million patients worldwide who have severe asthma that is uncontrolled and that there are 2.5 million patients who are biologic eligible. And we think that of that 2.5 million, there are about 1 million such patients in the U.S. alone. So we think this has the potential to be a big market for us. But importantly, that this therapy has the potential to make a big difference for those patients who suffer from this uncontrolled severe asthma.
Otezla, as I've already mentioned, is our first-in-class oral systemic therapy for plaque psoriasis. Psoriasis is caused by a systemic autoimmune disorder. And we're now able, for the first time, to promote this product to all those patients who suffer from psoriasis across all severities including mild, moderate and severe. So we see that as an important opportunity for us to continue to expand that product. In fact, in the U.S. alone, that label expansion will enable us to reach an incremental 1.5 million patients.
LUMAKRAS is a product that has attracted quite a bit of attention, including this week following its approval in the EU. This is a first-in-class therapy that offers real hope for patients that have non-small cell lung cancer, and in particular, for those patients that are suffering from the mutation of the G12C protein. And this is a product that, again, is already approved in 35 countries. It's a product that has regulatory reviews underway in a number of other countries around the world. And a product that we're studying in more than 11 different combinations in lung cancer, and we're also studying this product extensively in other tumor types. So we're excited about LUMAKRAS and indeed, Otezla and Tezspire as well as we head into 2022.
If we turn now to the next slide, I want to just spend a few moments talking about our pipeline in more detail. So I'm on Slide 7, and I want to start with our oncology pipeline, which, again, we think offers significant opportunity for growth, particularly as we look at the second half of this decade. So there are 3 areas in particular that I want to draw your attention to, lung cancer, prostate cancer and gastrointestinal cancer where we have quite a bit of activity underway.
In lung cancer, we have 3 novel therapies that are under evaluation across a range of different lung cancers: LUMAKRAS, which I've already discussed; bemarituzumab, which is a first-in-class antibody directed against the FGFR2b receptor for squamous non-small cell lung cancer; tarlatamab, which is our -- known as AMG 757, that's our first-in-class BiTE directed at the DLL3 target, and we think that looks very interesting in small cell lung cancer. So we have those 3 programs that are advancing inside the area of lung cancer.
And in prostate, we also have 3 novel therapies under evaluation: we have AMG 160, which is our half-life extended BiTE, and that's targeting PSMA, and we're generating data very rapidly for that program. Similarly, we have another bispecific program known as AMG 340, which is another bispecific-targeting PSMA and we're very rapidly enrolling patients in that program as well. And then finally, also in prostate cancer, we have another BiTE, a half-life extended by which is targeting STEAP1, which is a novel target, and we are intrigued by the early data that we're seeing there as well. So several interesting programs in prostate that we look forward to reporting on during the course of the year.
And then finally, in gastrointestinal disease, of course, we have bemarituzumab and that's the lead indication gastric cancer for that molecule that we acquired last year from Five Prime. And we have initiated 2 Phase III studies already for that molecule in gastric cancer. And I wanted to note as well that based on the recent data that we've generated for LUMAKRAS in combination with our monoclonal antibody, Vectibix, we're intrigued about what this combination could represent for patients suffering from colorectal cancer, and so we're expecting to initiate a Phase III study in that setting.
Turning now to the next slide, Slide 8, I'd like to just spend a moment on our inflammation and cardiovascular pipelines. In inflammation, we have a broad range of innovative products under development. Last year, as you're probably aware, we in-licensed from our colleagues in Japan, Kyowa Kirin. We in-licensed a first-in-class dual-action anti-OX40 antibody and we have plans to initiate our Phase III study for that molecule in 2022. And we're excited about what that could represent for patients suffering from atopic dermatitis.
We have several Phase II studies underway in systemic lupus erythematosus as well as in ulcerative colitis and nonresponsive celiac disease. AMG 570 is a multispecific antibody peptide conjugate which is targeting 2 different axes that we think are relevant on the ICOSL, the ICOS ligand and the BAFF axis, and we think that targeting those together could have a significant effect for patients who are suffering from lupus.
In addition, we have AMG 592, which is our IL-2 mutein, and that is a product that we're interested in exploring in lupus and ulcerative colitis. And then finally, we have AMG 714, which we're developing with a partner, which is our IL-15 monoclonal antibody for nonresponsive celiac disease.
And then in cardiovascular, we have several interesting programs underway, but I want to call to your attention Olpasiran, which is our small interfering RNA molecule, which targets lipoprotein(a), and we're expecting to generate Phase II data for that program in the course of 2022. So we'll be excited to see those results as LP(a) remains an area of significant need in cardiovascular disease.
I want to just turn on Page 9 to say a few words about our research capabilities. As I said earlier, we have, over the course of the last week or so, announced 2 transactions that are both designed to help advance what we consider to be the next generation of discovery research capabilities and technologies. We're already quite advanced inside Amgen progressing our platforms in this area. You're familiar with some of this.
For example, most of you are familiar with the enormous resource that we have in human data, starting with our genetics databases, which we've continued to build out considerably since acquiring deCODE in 2012. And over the course of the last 10 years in anticipation of a moment when it might be possible to use the tools of computational biology or machine learning, AI to help generate biologic molecules, we have been automating our wet labs. And so we're now in a position to be able to try to bring our wet and dry lab capabilities together to shorten the cycle time and hopefully increase the success rate for discovering and developing new biologic molecules. So to that end, earlier this week, we announced the partnership with Generate, which we're very excited about. We'll be advancing 5 targets with them during the course of this year.
We think sequence-based design and engineering will be an important part of how we approach our business over the coming decade, and we're excited about the capabilities that we have already assembled in that regard. And then finally, I want to note as well that we've made a significant commitment to multispecific or what we call Induced Proximity drugs, and that includes the transaction that we announced earlier today with Arrakis, a collaboration where we expect to try to develop medicines that are designed to degrade RNA and in doing that to prevent harmful proteins from being assembled in the body. So that's another approach that we're taking to try to make druggable certain targets that were historically considered to be undruggable. So we're excited about, again, the progress that we've made, and we're going to set aside some time to talk to our investors on February 8. In particular, we look forward to sharing in more detail the work that we've been doing in research to reshape our capabilities for what we see as the coming couple of decades of opportunity.
If we move to the Slide 10, I want to just speak briefly about business development. External innovation has and will remain an important part of our strategy. And as you are aware, in 2021, we were quite active. In fact, completing 7 important transactions, 2 of which were late-stage transactions acquiring bemarituzumab and in-licensing AMG 451. Both of those are now in Phase III development. We did 4 earlier-stage transactions. We acquired Rodeo based on our interest in that genetically validated target. We acquired Teneobio, which we think significantly enhances our multi-specific capability with biologics. And then as I just mentioned, we did a transaction with Generate and Arrakis as well. And finally, we entered into a collaboration with Neumora Therapeutics where we'll advance our neuroscience assets as well as use our genetic insights to try to identify targets or relevance in that therapeutic category.
If we turn now to the next page, Page 11, again, I hope that when we report our results for 2021, you'll agree that we maintain our strong track record of execution across the business. I've already talked about our strong volume-driven growth. That's an important part of our strategy and something I think we delivered on over the course of the year.
In R&D, again, our focus has been on novel first-in-class medicines that have large effect sizes for patients suffering from serious unmet medical needs. And we think the molecules that we registered in 2021 do just that. So LUMAKRAS, obviously Tezspire, obviously, in Otezla as well. And though I haven't said anything about it, label expansions for molecules like KYPROLIS and BLINCYTO as well further, I think, enhance our confidence in our ability to drive growth through our innovative research and development programs.
I've talked about business development, the 7 transactions that we completed during the course of the year to strengthen our business. We were able to leverage our world-class manufacturing in the battle against COVID-19 with our partners at Eli Lilly. And we did all of that while growing the dividend by 10% and repurchasing some $3.6 billion of shares through the third quarter. We exit the year with a strong balance sheet and financial flexibility as well.
Let me just also note that we're proud of the accolades that we received for our commitment to ESG we are clearly already seen as an established leader in the ESG area in biotechnology, and we look forward to continuing to advance our commitments in that regard.
And let me just conclude by saying, again, end with what I started with, which is that we think we're well positioned for long-term growth. As we look at the pieces that we have set now for 2022 and beyond, we're excited about what we see as the opportunity for us to drive growth through our innovative brands is through the advancement of our molecules in research and development through the ongoing commitments that we're making to innovative discovery research. And finally, I will commit that we'll continue to be disciplined about allocating capital across strategic transactions as well as returning capital to our shareholders in the form of growing dividends and continuing to repurchase shares.
So we're excited to have an opportunity in February, on February 8 to share more with our investors about the progress that we're making and to share more perspective about the outlook for the business through the end of the decade.
But Cory, with that, why don't we open it up for questions? And happy to answer any questions that you might have. Thank you.
Question-and-Answer Session
Q - Cory Kasimov
Perfect. Thank you, Bob. And as a reminder to our audience, you can engage in the Q&A as well by submitting questions via the portal, and we'll work them into the conversation.
So Bob, why don't I think, start big picture and work our way down from there. So you kind of just touched on this towards the end. But as we head into 2022, can you just talk about your latest views on Amgen's capital allocation priorities and maybe specifically where business development might fall within this?
Robert Bradway
Sure. Well, our capital allocation priorities remain consistent with the past, which is to say we will look at investing in innovation, in particular. We're agnostic as to whether that investment is from internal innovation or external innovation. What we want to do is back and deploy capital to the very best innovation opportunities. For us, that means innovation in inflammation, oncology, cardiology or general medicine opportunities. So we'll be looking to invest again, both internally and externally in those areas. We feel very good about the 7 things we were able to do in 2021. And I hope we'll have an opportunity to do a number of transactions like that in 2022 as well.
Cory Kasimov
Okay. And is there any desire to engage in larger scale M&A? How complicated does that get? Or should we just think more about opportunistic bolt-on deals as you've been doing?
Robert Bradway
I don't know what you mean by larger scale. But what I would observe is that, obviously, there are fewer large opportunities than there are small opportunities just by virtue of the numbers. So there are a large number of interesting innovative smaller opportunities in the industry. And by virtue of there being more of those, those tend to be the things that we look at or that we transact with more frequently.
Obviously, if you go back to 2020, we acquired Otezla. We feel very good about that transaction, better about it now even than we did at the time that we did it. So that was a larger transaction. If we were able to find one like that in 2022, we'd be very excited. But we try to look, Cory, across the spectrum of opportunities to add value for our shareholders. Our focus is to try and understand how we can add value even after a transaction premium, whether that's in the form of a licensing premium or an acquisition premium, our focus is on how can we earn a return for our shareholders and not just for the target shareholders.
Cory Kasimov
Understood. And last question on this front, just given the broader potential for industry consolidation, if you think about the evolution of this M&A environment, how competitive is the landscape given the number of parties that are looking and while at the same time, you've had a lot of added volatility in the market that changes valuations around quite a bit and the companies you might be interested in have perhaps a different sense of [self-worth], if you will.
Robert Bradway
Yes. I don't know whether the dislocation in the marketplace that you're referring to has already reset mindsets amongst the universe of targets. But if it hasn't yet, that probably will happen over time. But what I would say is it's still a very fragmented market for the number of companies that are doing interesting innovative things is very large relative to the number of companies that are looking to acquire entities that match that description. So yes, there are a number of us that are looking to use our capabilities to make acquisitions or in-licensing. But again, the number of targets that we're looking at is vast. So that plays into the transaction dynamic.
Cory Kasimov
Right. Okay. So as Amgen continues to go even more global, do you expect to be able to maintain your attractive overall corporate margin profile?
Robert Bradway
Sure. We're often asked, Cory, whether our, for example, our growth in Asia is going to have a negative effect on our margin. I'd just point out that even though we are growing very rapidly in Asia, and we're very happy with the business that we have there. It's still as a percentage of total, it's still very small. So the margins at Amgen are leading margins in our industry. And we've worked hard to build efficiency and productivity into how we run the business, and we're going to continue to do that.
Cory Kasimov
Okay. And then last big picture one I want to make sure I work in. I think I ask you this every year during the session just to get your latest views on health care reform. And I guess specifically now this idea of the Build Back Better. How important is it from an industry perspective to get something done once and for all that has attributes that everybody can kind of find some satisfaction with.
Robert Bradway
Well, I think what's important is to do the right thing. And we have been advocating now for many years, both as a company and as part of the industry association for changes that would make drugs more affordable for, in particular, our senior citizens. So we think that changes that help improve access by, for example, changing the out-of-pocket dynamic, changing the amount of co-pay that patients are having to pay for medicines as compared to other parts of the health care economy. Changes like that make a lot of sense. So we're advocating have been for some time, and we'll continue to do advocate for changes that continue to make medicines more accessible.
There's nothing more frustrating to all of us in the industry than developing a great innovative medicine that can make a difference for people who are either suffering from or at risk of a serious disease and then finding that they can't afford it. And one of the reasons that can't afford it in our system today is that more than half of every pharmaceutical dollar is in the hands of middlemen in our industry. And so we'd like to see changes that move some of those savings into the pockets of the patients themselves and out of the hands of middleman, for example.
Cory Kasimov
Okay. Makes sense. All right. So I want to talk about some specific products and start with your 2 newest commercial assets. There's a lot of interest and excitement around both LUMAKRAS and Tezspire. So maybe LUMAKRAS first, from a commercial point of view. Just your overall impressions of how the launch has gone. Is there any aspect of it that has been surprising to you. And kind of your enthusiasm for that going forward.
Robert Bradway
Well, I think what's been pleasantly surprising is the extent to which clinicians have embraced this new therapy in an area where for decades, there's been a desire but nothing available. So we had hoped that physicians would very quickly come to understand the biology of our product and the role that it can play in patients that have the relevant mutation. And that's what's happened. And that's happened globally. So we were delighted to have an early approval for the product in the U.S., and we're delighted to have early approvals now across a number of different countries around the world. We're now at 35 approvals.
So I think the most consistent theme, Cory, would be the clinical excitement about finally having a product that addresses this specific need. And obviously, we're enthusiastic about the 11 development programs that we have underway, exploring combinations for this molecule. And we're excited about the role that this molecule might play outside of lung cancer as well.
Cory Kasimov
Yes. On that point, how much should we anticipate to learn in 2022 on the combination approach with LUMAKRAS with the variety of other assets you're exploring?
Robert Bradway
Well, we'll clearly be generating data during the course of 2022, and we'll be excited to see those data and to share those when we have it. But we -- as I said, we have 11 programs underway. And so the development program for this molecule will be going on for a while. We won't finish the development efforts for this molecule in 2022.
Cory Kasimov
Are there any particular combinations like you're most excited to see? Or is it just really following the science and see where it takes you?
Robert Bradway
I think we need to follow the science. I think there's a lot of -- we get a lot of questions from investors concentrated on a couple of different combination trials that we have running. But the truth is, we need to see the data. And again, so far, the clinical profile of this medicine looks very attractive, both from a safety and efficacy standpoint. And the question will be, how do we combine it with other agents over time in order to make a big difference for these patients. And that's what we think we can do.
Cory Kasimov
Okay. And then last thing for now on LUMAKRAS, this is obviously a very competitive space. So your overarching confidence in maintaining a very strong leadership position when it comes to targeting KRAS.
Robert Bradway
Well, we have the first and only approved agent for targeting the G12C mutation in KRAS right now. So while there are a number of others coming, they don't have registered products at this point. And the meanwhile, we're continuing to build our experience base and continuing to build confidence in clinicians about what this product, what our product, LUMAKRAS, can do for patients that have a G12C mutation.
Cory Kasimov
Okay. And then with regards to Tezspire, your newest product for asthma with AstraZeneca, obviously, this got a very good label. So can you frame expectations here for the earlier days of this launch? Obviously, a huge market opportunity for you. But what are sort of the pushes and pulls as we think about launching into what's a relatively crowded space?
Robert Bradway
Yes. So Tezspire is, again, completely novel. It's a first-in-class molecule directed at TSLP and TSLP through clinical trials has been shown to be very relevant for the [outcome of] process. And what we've shown is that we can significantly reduce exacerbations in patients that were experiencing regular exacerbations with all the other therapies that were available.
And what we've also shown is that this therapy works across patients irrespective of what their eosinophil level is at the time of the presentation with their severe asthma. And so this is the only biologic, for example, that works for patients that have low levels of eosinophils at the time of diagnosis of their severe asthma.
So yes, we think obviously, in terms of the early days, there'll probably be a more rapid adoption for patients in that category who aren't -- whose needs aren't met by the other therapies that are available. But over time, we would expect there to be an opportunity really across all phenotypes of asthma, severe uncontrolled asthma. And so we're excited about this and what it represents not just in the short term, Cory, but over the long term, as physicians get more comfortable with this novel new way of treating asthma.
Cory Kasimov
Okay. And then still within your new product cycle, but these are products we've been talking about for a long time now. I mean, what are some of the levers that you feel like you can still pull to facilitate more growth in products like Repatha and Aimovig?
Robert Bradway
Yes. Well, we're very excited about the ongoing potential for Repatha. There are many, many millions of patients who are at high risk of heart attack and stroke in the United States and around the rest of the world because their LDL levels are just too high. And so we continue to work to demonstrate that by lowering LDL levels, can lower the risk of heart attack and stroke. We think we have very strong clinical data that shows the efficacy and safety profile of this molecule. We expect this to continue to grow through the balance of the decade. So this is a molecule, which has a profound effect against what is a very serious disease.
In fact, cardiovascular disease, the disease process that this molecule treats is still the leading cause of death in the world. And so there's no reason for the number of heart attacks and strokes that are happening every year to happen when there's an effective product like this that can help prevent that. So we expect many more millions of patients to adopt Repatha during the course of its lifetime.
Cory Kasimov
Okay. And then on the Otezla front, obviously, from an investor point of view, there's quite a bit of focus on competitive dynamics. But when you look at Otezla, it's broadening label now as well as the opportunity outside of the U.S. where you haven't really penetrated a lot within those geographies. How do you see the evolution of Otezla for Amgen over the next few years?
Robert Bradway
Well, again, we continue to expect Otezla to be an attractive growth engine for us through the balance of the decade. And that's through a combination of increased number of patients that we expect to be eligible for the therapy here in the United States and increasingly around the world as well as, as you point out, as we launch into new countries. So there are still a number of countries that we think the product is well suited to where we're only just beginning the launch preparations or in some cases, just beginning to launch the molecule. So we think that this will continue to be an attractive growth driver for us.
Cory Kasimov
Okay. And then on the bone health front, it's pretty remarkable how much of a growth driver Prolia has been given how long you've had it. How do you think about kind of the tail for this franchise though with some LOEs on the horizon but still some pretty impressive growth overall.
Robert Bradway
Yes. I think what I would say, Cory, is that I think we've established ourselves as a leader in the area of bone health. And our bone health franchise is not just Prolia or not just Prolia and XGEVA but also now in EVENITY. And EVENITY is, in its own right, a very important attractive product for patients that are at high risk of fracture. Patients, in particular, suffering from severe osteoporosis. So we expect our leadership in bone health to extend well beyond any near-term LOE challenges that we may face.
Cory Kasimov
Okay. I wanted to ask about biosimilars, and I have a question on this in the portal here. So biosimilars have a very competitive pricing landscape. How is Amgen ensuring long-term competition as prices get more and more aggressive?
Robert Bradway
Well, as I said earlier, we expect to be able to grow that franchise as we launch new products into new products or as we launch into new geographies with existing products. So in a year like 2022, where we don't have any major new product introductions or any major new geographic introductions, we'll see the effect of price. So there will be moments when the revenue reflects the pricing intensity in that segment of our industry.
But as we launch new products, like we will do in 2023, and as I mentioned earlier, we'll follow that with STELARA and SOLIRIS and EYLEA and then a couple of other programs that we have as well towards the back end of the decade. As we launch those new products, we expect that we'll be able to grow revenues and with it to grow earnings and cash flow.
So we think that this is going to be an attractive business. We've positioned ourselves in order to be able to operate very efficiently from a manufacturing and a selling perspective. And even at the level of pricing that we see several years after introduction of a product, we're still able to generate attractive gross margins, and these still are additive to cash flows and earnings in our business.
Cory Kasimov
On the biosimilar front, how much does one's reputation within the biologic landscape, and so Amgen has decades of this, how much does that help in an area like biosimilars? Or is it really becoming just more about the price that you charge?
Robert Bradway
Well, we think it matters that -- our focus has been on providing safe, reliable supply of biosimilars. And we have said from the beginning that we didn't think all of our competitors would be able to do that. And I think the facts have borne that out. Several of our competitors have struggled to maintain adequate supply of their products and in some cases, have even failed to be able to supply tenders that they have won. And so we think that a differentiation for Amgen is the significant investment that we make in manufacturing and in quality. And that's part of what we offer payers who want to choose our biosimilars is reliability of supply and a track record of having supplied every patient every time.
So we think, Cory, that that's important, and that's part of what we have based our approach to the market on. And as you, I think, are aware, we go to the marketplace, certainly in the U.S., we go to the market with the same sales and marketing capabilities that we use for our proprietary products. And so we can go into an account and say, here are our novel oncology drugs and here are the biosimilar drugs that we can offer you. And we want them to have the same confidence in our biosimilar products that they have in our innovative medicines.
Cory Kasimov
Okay. And I purposely avoided a lot of pipeline talk during -- in this type of forum, but I did want to ask you about LP(a) because I know this is something David has been very excited about for some time. I think Sean Harper was even very excited about before David. Can you just -- with Phase II data coming up this year, how informative do you expect it to be from your point of view to let you know whether you're like on the right track and the justifications potentially moving forward?
Robert Bradway
Well, obviously, we think we're running an important set of experiments in Phase II. So we're hopeful that those data will be informative and we'll make it more clear for us what the appropriate Phase III registration-enabling trial needs to look like for that.
But I think our enthusiasm, Cory, is a reflection of a couple of things. One, we know that much of -- or an important part of the residual risk for cardiovascular disease in this country or in this world that we live in is related to LP(a). LP(a) is a genetically determined risk factor. It can't be modified with diet or exercise. It is not meaningfully modified by other therapies that have already been approved for heart disease. So it really is a stand-alone segment of risk. And we think we have a therapy in our siRNA molecule that profoundly lowers that risk by profoundly lowering the levels of LP(a).
So our enthusiasm is a reflection of how much unmet medical need there is and how efficacious our approach to this disease looks to be in the early clinical experiments that we've done.
Cory Kasimov
Okay. Sounds very interesting. Well, unfortunately, we are out of time, but I very much look forward to the deeper dive into the Amgen business in February. So thanks, as always, Bob, for the time.
Robert Bradway
Thanks, Cory.
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