Amgen Inc. (AMGN) Earnings Call Transcript & Summary

Hello. Good afternoon, everybody. I'm Dan Lundquist, healthcare -- U.S. health care specialists at Bank of America, and thank you for joining day 2 in London. Very pleased today to be hosting Amgen. From Amgen, we have Peter Griffith, the CFO; as well as Arvind and Justin from the Investor Relations team. I have a number of questions, but do feel free out in the audience if you have questions to raise your hand. We'll bring the microphone over to you and we can have your question answered. With that, let me just open it up to you, Peter, just in terms of kind of your thoughts around 2Q. Any comments you want to make, and then we'll launch right into Q&A.

Fantastic. Thank you, Dan, and welcome, everybody. It's great to see you. We're so glad to be here, make the trip over. And as we always do at Amgen, we start with patients and our mission to serve patients through discovering, developing, manufacturing and delivering first-in-class and best-in-class medicines to patients with serious and grievous illnesses all over the world. We're creating value for patients, staff and shareholders and are well positioned on any number of fronts to deliver long-term growth. We're driving a successful integration, beginning off an early fourth quarter close with Horizon Therapeutics based on the exceptional strategic fit. We're driving the best innovation through our pipeline, and we're driving results as we did in the second quarter with record non-GAAP earnings per share and record revenue for the quarter. We remain well positioned for continued volume growth with 11% year-over-year, volume growth in the second quarter. Underneath that was 16% year-over-year volume growth outside the United States and underneath that was 46% volume growth in our JPAC region. Based on our strong second quarter and for all of 2023, we raised our financial guidance for the year, just as we did after the first quarter. We're excited about moving forward on Horizon. We expect to close early in the fourth quarter and it's a terrific strategic fit for us. And so why is it a great strategic fit? Their products are innovative, first-in-class biologics that make a big difference for patients who receive them. And that is exactly the focus of our research and development strategy. Second, these products treat autoimmune disorders, which have been a core focus for us for decades. And third, these products are added early stage in their life cycle. And there's lots of ways for us to add value. So how do we expect to add value across life cycle management, including in global development, manufacturing process development, new formulations, delivery devices and so on. Also, we expect to add value in international markets. They haven't yet built out those capabilities. Ours are in place and prepared to go with these new products and especially with TEPEZZA. And ongoing research and development, Sjogren's and other potentially attractive markets for Horizon, including those identified in our review of the genetics behind their targets, through our deCODE subsidiaries. So where will they add value to Amgen? Horizon's industry-leading rare disease capabilities will be an immediate benefit to TAVNEOS, which we acquired in connection with ChemoCentryx about a year ago. Finally, as we've consistently said, we expect this deal to be accretive to our financials and additive to our long-term outlook. So we'll talk more about driving results in the business in a moment. But before that, let's cover our innovation and our pipeline where momentum is building, where multiple Phase III trials position us well for long-term growth. Our oncology pipeline includes any number of late-stage opportunities. We announced positive potentially registrational results from tarlatamab in small cell lung cancer, where we see annual incidence of 65,000 to 75,000 -- to 70,000 patients across major markets. This is the first bispecific T-cell molecule to show unequivocal activity in a common solid tumor. And we're excited to share these data later in the year and are rapidly moving tarlatamab into earlier lines of treatment to maximize the opportunity for patients. Later this fall, we'll be sharing exciting initial data from [indiscernible], our STEAP1 bispecific T-cell engager being studied in prostate cancer, and AMG 193, our MTA cooperative PRMT5 inhibitor, where we've seen responses again across multiple solid tumor types. We've announced positive top line Phase III results from LUMAKRAS in combination with Vectibix and metastatic colorectal cancer. So now let's turn to inflammation and general medicine. We continue to explore the potential of TEZSPIRE in multiple and additional indications, and then rocatinlimab in atopic dermatitis continues to enroll Phase III very well as [ disopasiram ], our LP(a) molecule, also in Phase III. Maridebart cafraglutide or Mari, as Arvind has got us calling it now, hereafter, known as Mari, AMG 133 and AMG 786 or 2 of our obesity assets in our evolving obesity platform and are in Phase II and Phase I trials, respectively. Mari is enrolling well. The goal of the study is to generate data that's going to provide broad optionality to design a Phase III program or programs. And now turning to commercial performance. Our priority products within each therapeutic area performed well in the second quarter. Our innovative hematology/oncology portfolio grew 10% year-over-year in the quarter, with continued growth opportunities in BLINCYTO KYPROLIS and Vectibix. We saw a strong sequential growth across our innovative inflammation brands, including ENBREL, Otezla, TEZSPIRE and TAVNEOS. We're making additional investments into Otezla this year from a position of strength. Now in our General Medicine portfolio, Repatha grew 30% year-over-year with 35% volume growth. We continue to see upside opportunity for Repatha. We're also making additional investments into Repatha this year also from a position of strength. The bone franchise continues to grow, with Prolia growing 11% year-over-year and delivering $1 billion in the quarter for the first time ever, and EVENITY grew 47% year-over-year, also in the bone portfolio. Now our biosimilars portfolio continues to generate meaningful sales and continues to create meaningful returns for our shareholders. As we've consistently said, we see long-term growth in biosimilars, driven by launches of new products and into new markets. We're excited about our recent initiation of a pivotal study evaluating ABP 206 with OPDIVO, 1 of 6 planned new biosimilars. Finally, we continue to execute on multiple capital allocation priorities in the second quarter investing over $1 billion in internal innovation, investing $300 million in capital expenditures into any number of artificial intelligence use cases and increasing our dividend by 10% year-over-year. So Dan, we're creating value for patients, staff and shareholders well positioned on any number of fronts to deliver long-term growth through driving the successful integration with Horizon based on that great strategic fit driving the best innovation in our pipeline and driving results as we did in the second quarter with record revenue and record non-GAAP earnings per share. With that, I'll turn it over to you to drive some Q&A.

Great. You answered all my questions.

There we go. We'll you have Arvind, he can answer even more.

So maybe we'll go through the different therapeutic areas, but let me first start with financials, kind of capital allocation coming to a conclusion here to a lengthy process with Horizon. How should investors think about the new Amgen in terms of capital structure and margin profile going forward?

Well, let's not call it the new Amgen. I think Amgen is now in a position of strength as we talked about it. So going forward, our capital structure is very clear. We've stated that we intend to delever through paying down about $10 million of debt between now and the end of 2025 and by the end of 2025 to get back to the levels of debt that we had before the announcement. We like to think of that as an efficient capital structure. And so we'll work our way back to that and stay very focused on that. And when we think about the rest of Amgen and our capital structure, we believe we still have the flexibility to execute on multiple capital allocation priorities. We increased our dividend 10% year-over-year. We look forward to continue to look at opportunities and business development. Dave Reese suggested and mentioned to you that we invested $30 million in TScan Therapeutics in the second quarter, which is a preclinical molecule that's focused on Crohn's disease. So we'll continue to look at any number of opportunities and believe we have a capital structure that makes sense for us going forward at this point, Dan.

And maybe to just kind of touch on that last point, you mentioned the TScan transaction. What specific I would say, areas of unmet needs, diseases, modalities, et cetera, would you say it would fit well within the Amgen portfolio that maybe you would build out further exposure to or bring in it maybe you're under [indiscernible]?

Well, right now, and this is -- we're in a position of strength in the pipeline. And so we have any number of opportunities to work with what we have. And as you know we've got a lot of assets right now in Phase III. So we're focused on rocatinlimab in Phase III. In my opening remarks, we talked about rocatinlimab. We talked about Olpasiran enrolling. Also for Phase III, we talked about AMG 133 enrolling for Phase II. We've got bemarituzumab focused on gastric cancer in Phase III. So we've got -- and [ carlatumab ] just finished a potentially registration-enabling Phase II. So really, any number of assets stand kind of later right now in our own innovation that we're going to remain very focused on and make sure that we explore all the opportunities for patients in those assets right now. We're always open to new innovation. Our first capital allocation priority is investing in the best innovation, and we find that internally, and we find that externally. And as I said in my remarks, we've invested over $1 billion in the second quarter in our own innovation. We raised our guidance for our non-GAAP research and development spend this year to 5% of an increase over last year as opposed to 3% or 4%. So we'll continue to invest in innovation. The world needs more innovation, not less. And Amgen is well positioned to help work towards that objective.

Excellent. Very clear. Thank you. Last financial question, then we'll dig a little bit into the pipeline and your therapeutic areas. So during your business review data that you hosted last year, you talked about a mid-single-digit revenue CAGR through 2030 and how to single to low double-digit EPS CAGR. Based on performance since then and to date, what areas would you say have done well and have differed from your expectations in a positive way? And how should we think about long-term guidance moving forward?

Well, on long-term guidance, we want to get Horizon closed and think about that. So we're -- we haven't made any commitments as to what we intend on doing there. So we'll continue to think about that. Going back to the business review day, we've shared with you that we remain confident in achieving our long-term objectives. So when we look in line in the portfolio, we're very excited and Repatha, we've said we see, as I said in my opening remarks, continued upside in Repatha. Cardiovascular disease is the #1 killer around the world, and we're going to remain very focused on getting Repatha out there. 35% volume growth around the globe in the second quarter with Repatha, 30% increase in product sales. We'll continue to move forward on the bone portfolio. That portfolio is doing very well. EVENITY, grew 47% year-over-year. So we continue to see that as a really important opportunity for patients all over the world. When we look at the pipeline, between February of 2022, when we shared with you our view through 2030, our pipeline, we feel like as things have gone well. And most importantly, they've gone well for patients. we have the announcement about tarlatamab and the potential -- the data that we think is in the potentially registration-enabling Phase II trial. We've moved into Phase III, as I mentioned during my opening remarks, so I won't repeat myself. But we feel like the pipeline has performed well, and we'll continue to invest in that as we just spoke about a moment ago in response to your first question. So we feel like we're on track. It was an organic only plan that we shared in February 2022. So Horizon is additive to that. And we just are very confident that horizon adds to the breadth and the depth of what we have is as a company at Amgen to deliver to patients with serious in grievous illnesses all over the world.

Peter. So maybe shifting now to cardiovascular and metabolic. It's been a big topic throughout the duration of the last couple of days here around obesity -- 2 obesity assets, 133, 786. What do you say the target profiles you're looking for here? Would you say they have to be superior versus Wegovy and Mounjaro? And then maybe we can kind of go through timing of those readouts you mentioned enrolling in Phase II. And maybe just -- you can go through timeout at the end.

Let me ask Justin to take that. But before I turn it over to him, just to share with you and our colleagues in the audience that we see obesity as an evolving market. So we're very excited about what we have to contribute to that evolving market and the patients that suffer from obesity. And so we're confident moving forward on an accelerated basis as fast as we possibly can for those patients. So with that, let me turn it over to Justin and have him share with you why we're excited about what we see in our obesity platform. Justin?

Yes. And first of all, stating the obvious, it's been an area of great investor interest. We've had a chance to speak with a number of investors over the last week or so and at the conference, and it's really come up in almost all the meetings. So it's something that has gotten a lot of attention. Just first, I want to start with what Peter said. We feel like it's very early days here. I think to Peter's point, we really see obesity as something that is -- there are so many associations with serious disease and other areas. So that still is to be fully understood. So in terms of our approach then that kind of leads us to more of a platform approach. So it's not just looking at it as a single asset or 2 assets, but really a whole combination of things. In terms of the -- maybe just going through the various ones, we talked about 133. I think 1 thing to highlight there is that has a monoclonal antibody component to it, which does change the PK profile. Obviously, that's something that we're studying in Phase II. We've purposely designed a broader Phase II program, over 570 patients in that program. And in terms of the timing, if you look on clinicaltrials.gov, what you would see is October 2024, we haven't updated that in some time. But that's something that we'll update in due course as we get better visibility to the study end date. But I think that really the key point with 133 is we're going to continue to learn more as more data comes out from others in the field. And so we feel like that will give us a lot of optionality as we look at what the Phase III program might look like. Next 1 to talk about is AMG 786. So that's a Phase I product. So we expect data in the first half of next year. That's an oral, and what we haven't talked about the specific mechanism, we have said that we're [indiscernible] then -- it's a [indiscernible] based, and works differently in other products that are on the market. We have a few others in earlier stage that we haven't talked about, but rest assured, we're continuing to advance those quickly. So I think, again, maybe the takeaway point is we see this as early days. We're going to learn a lot more as the data comes out, and we're certainly leaning hard into this.

Great. So another asset you've talked about it numerous times, Peter, in your opening remarks, but 35% volume growth for Repatha in the recent quarter. How are you seeing the competitive dynamic play out versus Novartis' Leqvio as well as just any thoughts on other potential new mechanisms of action, modalities, how could oral PCSK9 play out over time? Maybe just kind of give us that quick snapshot of landscape and then what's been very -- a very good story with Repatha?

Justin, why don't you take that, too? Stay with us in our cardio metabolic area, general medicine.

Yes, absolutely. And just to reiterate the point that Peter made earlier, we gave the business review guidance last year, and we talked about our outlook for growth through 2030 and Repatha is really a key part of that story. At the time, we said a multibillion opportunity. And I think really where it starts, as you mentioned the competitive landscape. I think I would even step back and start with the huge unmet medical need here. I mean, because really that's what's the driver of growth is both now and in the future. Murdo Gordon, our Head of Commercial, shared what I thought was a really interesting data point. He said there was a real-world analysis of 38 million Americans at high risk of cardiovascular disease. Within that group, only 30% will reach -- or less than 30%, we're reaching a cardiovascular target. So if you just step back, I mean, you're talking about millions and millions of patients who are not achieving the goals in terms of cholesterol reduction. And in terms of why that matters, I mean, the other data that I would point you to is that we obviously did a very large FOURIER trial. And then we've had this open label extension where we follow these patients over time. So that's been going on for years and years now. And the data that we've shared with the medical community is very compelling. What it tells you is that previously there was some idea that maybe there's some kind of threshold target that you want to achieve and then you're done or that's good enough. What we're seeing is the lower you go, the better and also the sooner you treat the better. So in terms of millions of patients who aren't reaching goal and patients who would benefit from being treated sooner, I mean it really points to this huge unmet medical need that we're just starting to tap into. And just the last point I'd make is with Repatha, 1 of the things we've been working hard on is the access picture. And I think good news there in the U.S., we're now at the point where we've got over 90% of eligible patients covered. So when you look at huge unmet need, a drug that really works and has a lot of track record plus really good reimbursement. We feel like it's very well positioned going forward.

Dan, just the 1 point that I would add is that with Leqvio, they have yet to generate and publicizes their outcomes data. And I think the earliest that's anticipated is 2025, and this was a significant factor in terms of Repatha's uptake with the [ payer ] community in particular.

Dan, as long as we're on General Medicine and cardio metabolic, maybe it just makes sense to give you a brief overview on our LP(a) or Olpasiran product. I think that's super important. Arvind, do you want to do that? I mean, I just think it's -- this is big progress. And as Justin said, nobody is meeting their LDL targets but LP(a) has some different dynamics that we think we've addressed with 890.

No, I think this could be a significant advance, Dan, in terms of managing cardiovascular disease, in that when you think about elevations of lipoprotein A or LP(a), this affects about 20% of the population. And this is a nonmodified risk factor. So regardless of the measures or the steps you take to control diet to exercise. I mean this is just genetically fixed. And with the data that we have now shown with Olpasiran our LP(a) inhibitor is profound, I mean, demonstrating a 95% plus reduction in LP(a) levels. Now here, I think what's also going to be critical is outcomes data, and we have commenced a rather large as a 6,000 patient Phase III study in which we are trying to assess what are the implications of controlling or lowering LP(a) levels in terms of cardiovascular outcomes. So that's also going to be very important from a reimbursement standpoint down the road.

Excellent. Thank you, Justin and Arvind. Maybe shifting a little bit to oncology. So how should we think about the upcoming AdCom meeting in October for the full approval of G12C and SCLC following based on the CodeBreaK 200 results? And maybe then just a kind of broader comment as to how the experience continues to be with that launch?

Yes, I'd be glad to take that 1. So just to first in a level set with everyone. So LUMAKRAS our very novel kind of oncology product that treats late-stage non-small cell lung cancer for patients who have the G12C mutation. This is really just a medical breakthrough, something that scientists were aware of the target for decades, but we're unable to drug it. So I think there was a lot of excitement and that led to its initial approval, which was in 2021. Subsequent to that approval, we submitted for an application for a full approval, and the FDA granted a standard review time line with a review date towards late December of this year. And then they've called an advisory committee on October 5 to convene a group of experts to talk -- further talk about the available data set to help inform that discussion. It's a bit too early for us to comment on what might be discussed there. What's typical practice is that there would be a set of documents published ahead of the meeting where it's laid out what the topics are and what they want to delve more into. We haven't -- those haven't been published yet. So I think at this point, it's a little bit too early to speculate on the discussion. But I think overall, we feel like the data -- we have a lot of data from LUMAKRAS that highlights it's kind of risk profile, which has a risk-benefit profile, which is favorable and we look forward to having those discussions. I guess to your broader question, Dan, about how do we see the longer-term future for LUMAKRAS. We've got a very broad development program going right now, and we've recently shared various specific citing data. The first 1 I'd point to is that on our Q2 earnings call, we talked about positive data in combination with Vectibix in metastatic colorectal cancer. And then additionally, at a recent medical conference, we talked about some subset of data that was positive in patients who are PD-1 negative, which is an area where we've announced that we're doing a Phase III trial. So I think the broader picture here is that we continue to explore LUMAKRAS in earlier lines of therapy and another non-small cell in cancer and also in other tumor types. So it's an area where we're continuing to invest and look to grow.

So on the PD-1 negative patients, can you talk maybe about that frontline opportunity there and kind of compare and contrast that to where you are in the existing refractory setting?

Yes. I think the point there is that we've kind of segmented the earlier line of non-small cell lung cancer into various types kind of 1/3, 1/3, 1/3 sort of PD-1 higher expressers, lower expressors and then PD-1 negative. So this is going after a subset of that earlier line therapy. And again, we're really following the science here and trying to conduct additional studies where we see the best utility for the product.

And just on your question about CodeBreaK 200, so let me just add 1 other point. If you go back to this particular study, which is going to be the subject of this review by the advisory panel, let's keep in mind that the primary objective and endpoint in this study was duly met, and that was PFS or progression-free survival. And as I recall, the hazard ratio was 0.66. If you look at some of the other metrics within the study, the objective response rate, it well exceeded docetaxel, which of course, has been the standard of care in this particular setting. So to Justin's point, of course, we don't know at this point in time exactly what's going to be included in the briefing document, but we feel comfortable and good in the fact that the objective of the study that was originally put in place was met. In terms of overall survival, yes, it was comparable to docetaxel, but you might also recall that we had to [ payer ] back the patient enrollment in this particular study because of the fact that there is an approved therapy for this setting.

Great. Thank you all. Maybe shifting a little bit to I&I. So TEZSPIRE's off to a very strong start. What would you say the physician feedback has been in terms of choosing that therapy versus other therapies?

I'll turn it over to Arvind in a moment, Dan, but TEZSPIRE is a really important medicine for patients with severe asthma. And we are excited about what that's been showing. I think our product sales in the second quarter were about $130-plus million. We see strong growth there. And we see it going to patients up and down the eosinophilic continuum, low to high. And so we're excited about what that has to offer. So with that, let me turn it over to Arvind because I think this 1 is worth interrogating for a little while here because of the importance of patients with a serious disease.

Yes. A couple of other items, Dan, that I would add. First of all, the fact that this is a product which is applicable across the board to all comers, regardless if the patient has low eosinophil counts or high eosinophil counts, I think that has helped tremendously in terms of its commercial update. Majority of the adoption of TEZSPIRE kind of in the initial phases, and even today still remains in the form of administration by a health care professional. But subsequent to our initial launch, we have also launched a version a form that lends itself to self-administration by the patient. And that also has been a meaningful factor in terms of the very strong uptake that you saw, particularly in the second quarter when we have 37% close to 40% unit volume growth with TEZSPIRE. And lastly, from a payer/reimbursement perspective, again, we have a very good adoption we have a preferred formulary position with 3 of the largest PBMs in the U.S. So again, we enjoy a very good reimbursement position with this product.

Excellent. And then maybe shifting from asthma, kind of can you discuss the similarity of differences in trial design, patient populations with the Phase II COPD study with, I think, data is expected in the first half of '24, particularly versus dupi?

Yes. So first of all, I think it kind of -- you almost have to go back, Dan, to the mechanism of TEZSPIRE, which is the inhibition of TSLP. And TSLP as I think you may be aware of is 1 of the upstream pro-inflammatory markers. And there are a number of Sequel or disorders, if you will, which are further downstream. So I think to the extent that you can intervene TSLP, I mean, theoretically, in an academic kind of form, you should be able to address some of the ancillary unit disorders that go along with them. And 1 of them, of course, is COPD. And in COPD, there's notable evidence that patients do express TSLP, patients who have COPD. Now 1 of the differences that we have in terms of the clinical trial that we're conducting is that it's open to all comers, we are not screening up smokers. They are included in the trial. Patients with high eosinophil levels, low eosinophil levels, those are all included in this Phase II study. So of course, ultimately, the profile of TEZSPIRE vis-a-vis dupi is going to be defined by the data. So we are anxious to kind of turn the card and see what the data shows.

Excellent. And maybe last 1 on I&I, and then I'll look to the cloud if there's any questions we should go back to on cardio-oncology as well. But you talked about dermatitis crowded space. How should we think about OX40, you've mentioned it a couple of times just from -- versus competitors from a positioning standpoint?

So first of all, rocatinlimab is the product that you're referring to, which is our OX40 antibody. It basically binds activated pathogenic T cells which express OX40. So the underlying mechanism is get understood. We have a very comprehensive trial, which is ongoing, and we refer to that as the ROCKET trial, which is which basically constitutes 7 different Phase III studies. And we are looking at many different metrics. We are looking at patients who have previously been exposed to biologics, previously been exposed to JAK inhibitors. And those who are not naive to biologics and JAKs. We are looking at different age from a demographic standpoint, different ages, I should say. Also looking at combination approaches versus monotherapy. So again, this is a very comprehensive program that we are investigating. What's interesting, Dan, is that in the Phase II data, we had about 14% of biologic failures. And a majority of them were actually -- these are patients who had failed DUPIXENT or dupilumab. So -- and we didn't see any differences from an efficacy standpoint. Again, that's not to imply or try to handicap in any way what the Phase III trials will show. But again, it's a very comprehensive development program. And ultimately, the outcome of these Phase III trials will define the profile of rocatinlimab.

Thank you, Arvind. Maybe on EVENITY, it's been doing very well year-over-year, quarter-over-quarter, so both sequential and year-over-year. But can you talk about how doctors using this versus Prolia, XGEVA, maybe kind of give us some insight into those trends?

Do you want to run with that?

Yes, sure. So I think the key point with EVENITY is it's -- and I'm sure folks know this, but works in very different mechanism than Prolia is very complementary. So EVENITY is -- provides the bone growth and then probably helps kind of lock in those gains. What we said in our business last year is that we would expect low double-digit growth over time. As Peter mentioned, the performance has been very strong so far. We're seeing really great uptake. That's both in the U.S. and then in other markets as well. So I think in terms of EVENITY, it's off to a really strong start. I think physicians are seeing the utility of it and it's driving a very good volume growth.

And do you think -- what do you think the impact will be ultimately post the loss of exclusivity for Prolia?

Yes. I think to this point, we haven't said anything too specific. I think the 1 general observation that we've made over time is that biologics can have a different erosion curve than you would see with the small molecules. Obviously, we'll have to see where things go with Prolia. But obviously, that's a sub medicine that's well known and well adopted and we'll have to see where it goes.

Dan, just the 1 point that I would add to clarify is that, again, the positioning of these products, how they are used in clinical practice is different. EVENITY is an anabolic agent that promotes bone formation. So it's used for limited duration of time is used for a 12-month period. And after that, the patient has actually transitioned to an antiresorptive like [ alendronate ], but of course, in our case, there's Prolia. So from a commercial standpoint, it's a very effective transition, start the patient in EVENITY and then transition them over to Prolia. So the 2 don't necessarily compete with each other. So despite the fact that at some point in time, we have to deal with the loss of exclusivity, EVENITY continues to be very well positioned in that anabolic bone formation space.

Great. Maybe -- so shifting finally here to biosimilars, AMGEVITA, how would you say that the launch has been tracking versus your expectations? Have you seen any changes in terms of prescription patterns now that you've seen the launch of competitors' biosimilars as well?

Well, I think AMGEVITA, Dan, is in an evolving market right now. And I think the way we described it, it was going to be a gradual uptake. The first quarter, we described revenue as much of it going in the inventory. We knew the second quarter would come off of that. And we believe it continues to be a very important biosimilar for the ecosystem. AMGEVITA has proven, outside the United States, AMGEVITA grew 13% in the second quarter with 23% or 4% volume growth. So it's well proven outside the United States. We'll continue to work with that medicine inside the United States to get it to as many patients as possible. At Amgen, we think about patient experience is strong in our biosimilars. We think a better 40-year history in biologics itself. We think about the reliability of our supply chain. I mean, that's really important to providers and payers and patients, of course. We're vertically integrated. So we go to market with our biosimilars, including AMGEVITA in our commercial therapeutic area. We don't have it sitting in a separate biosimilars group, and that's true up and down the value chain inside the company. And fifth, same patient support systems for AMGEVITA for Otezla and ENBREL and TEZSPIRE and another inflammation and immunology products. So we think we're in a good position. We're going to stick to it and get it out as fast as we can to patients, and we realize it's going to be a gradual uptake, but we're going to continue to work hard at it. And we're going to continue to take advantage of what's going on outside the United States with AMGEVITA.

Excellent.

And maybe just 1 other point on the biosimilars. I mean, I think more broadly, we've talked about that business being a nice contributor to our growth outlook. Specifically, we said that it would growth more than double from its -- in the 2021 level, so that would imply something over $2 billion to growing to something over $4 billion. And I think just to Peter's point, we've got this nice model where it's really leveraging our core capabilities. And so as various products across the industry go off patent, that creates this waves of opportunities. So for example, we've talked about SOLARIS, STELARA and EYLEA all presenting opportunities. On our Q2 earnings call, we talked about moving forward with our biosimilar version of OPDIVO as well as 2 other unnamed lens. So I think more broadly, this -- the overall biosimilar business is 1 that we feel remains active for us.

And I think just in summary on biosimilars, it's an important category for us. We've always said it's going to be driven by new molecules and those new molecules into new geographic markets. So that's the way to think about biosimilars at Amgen. We like the use of capital for our shareholders, and we think it's a very efficient use of capital, and we'll continue to interrogate.

So then, I think she's got the microphone all warmed up. We should give the audience at least 1 question. If there is 1.

If there's one.

Otherwise, the only thing I've not asked and you've mentioned tarlatamab. So just maybe any underappreciated assets that we haven't touched on here, maybe that haven't come up in a lot of conversations that you think are worth flagging?

Well, why don't the 3 of us each share 1 quickly, just looking at the clock, I would share tarlatamab. Unequivocal activity in a common solid tumor by a bispecific T-cell engager for the first time. We've got data off or potentially registrational enabling trial. We're looking forward to discussing that with regulators and looking forward to presenting it at a medical congress later this year.

I'm going to stay with oncology bites and go with BLINCYTO. I'm not sure folks -- or everyone caught that in the second quarter actually grew 48% year-over-year. So for a product that's been on the market for a while, that's not typical. The driver there was we actually had some data that we shared previously, where we saw -- basically, we moved from treating in a lately therapy to an earlier line of therapy and saw a dramatic improvement and that was shared, that was through an ECOG study. So that -- following that data, the NCCN guidelines were updated and it's really changed clinical practice. So it's really nice to see BLINCYTO get a lot of uptake and momentum.

Yes. I would just add, Dan, that there are a couple of earlier stage oncology assets that I think are also very promising, kind of staying with the theme of bispecific T-cell engagers. And particularly, what we are seeing now in the solid tumor side, we have AMG 509. This is a bispecific that targets STEAP1. And STEAP1 is something as a surface protein that's expressed in a bulk of metastatic prostate cancer patients. And we are seeing some promising responses. We have not communicated the data yet, but we expect to do there this fall at 1 of the medical conferences, some early-stage data from there. And the second 1 that I would add to that is PRMT5 inhibitor that we are also developing. And this is in patients who have MTAP NOL tumors. And all that means I'm not here to bore you or impress you with the science. But is basically a tumor suppressor gene that's deleted. And this particular alteration affects about 15% of solid tumors. So a tremendous amount of unmet medical need. And to a large extent, there may be a correlation in terms of what our medicinal chemists were able to do effectively in drugging LUMAKRAS as far as KRASG12C is concerned, and finding an effective rate of drug a PRMT5 inhibitor. So clearly, there's more to come. But some of the initial data will also be presented at a fall medical conference.

Excellent. Well, with that, Arvind, Peter, Justin, thank you very much for your time and enjoy the rest of the conference.

Thank you.

Thank you, Dan.