Hello, good afternoon, everybody. I'm Daniel Lundquist, the healthcare, US healthcare specialist at Bank of America, and thank you for joining day two 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, just to raise your hand. We'll bring a 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 JAPAC 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. 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 at an 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 lifecycle 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, Sjögren's and other potentially attractive markets for Horizon, including those identified in our review of the genetics behind their targets through our deCODE subsidiary. 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 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 xaluritamab, 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 in metastatic colorectal cancer. So now let's turn to inflammation and general medicine. We continue to explore the potential of TEZSPIRE in multiple additional indications, and then rocatinlimab in atopic dermatitis continues to enroll phase III very well, as does olpasiran, 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, are two 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 gonna provide broad optionality to design a phase III program or programs. 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. 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, one 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, and to 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.
So maybe we'll-
Well, you have Arvind. He can answer even more.
So maybe we'll go through, you know, 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, 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 de-lever 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, 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 continuing to look at opportunities and business development. Dave Reese suggested and mentioned to you that we invested $30 million in T-Scan 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.
Maybe to just kind of touch on that last point you mentioned, the T-Scan transaction. What specific, I would say, areas of unmet needs, diseases, modalities, et cetera, would you say would fit well within the Amgen portfolio that maybe you would build out further exposure to or bring in that maybe you're under weight in terms of before?
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 tarlatamab just finished a potentially registration-enabling phase II.
So really any number of assets, Dan, kind of later right now in our own innovation that we're gonna 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's 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 area. So during your business review day that you'd hosted last year, you talked about a mid-single-digit revenue CAGR through 2030 and high single- to low double-digit EPS CAGR. Based on performance, you know, 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, you know, we wanna get Horizon closed and think about that. So we're not. We haven't made any commitments as to what we intend on doing there, so we'll continue to think about that. But 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 in Repatha. We've said we see, as I said in my opening remarks, continued upside in Repatha. Cardiovascular disease is the number one killer around the world, and we're gonna remain, you know, 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, excuse me, grew 47% year-over-year, so we continue to see that as, 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, has... 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, in the potentially registration-enabling phase 2 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 as, as a company at Amgen to deliver to patients with serious and grievous illnesses all over the world.
Good. Thank you, 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, you know, obesity. You have two obesity assets, AMG 133, AMG 786. What would you say are 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 kinda go through timing of those readouts you mentioned, enrolling phase 2, and maybe just can go through timelines at the end.
Let me ask Justin to take that.
Sure.
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 to 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.
Yeah.
Thanks, Justin.
Yeah, and first of all, stating the obvious, it's been an area of great investor interest. You know, we've had a chance to speak with a number of investors over the last, you know, week or so and at the conference, and it's really come up in, you know, almost all the meetings. So it's something that has gotten a lot of attention. Just first wanna start with what Peter said. We feel like it's very early days here. You know, I think to the to Peter's point, we really see obesity as something that is... You know, there's so many associations with with serious disease in other areas that still is to be fully understood. So, you know, 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, you know, a single asset or two assets, but really, you know, a whole combination of things. In terms of the maybe just going through the various ones, you know, we talked about 133. I think one thing to highlight there is, you know, that is a monoclonal, it has a monoclonal antibody component to it, which does change the PK profile. Obviously, that's something that we're studying in phase 2. We've purposely designed a broader phase 2 program, you know, over 570 patients in that program. And, you know, in terms of the timing, you know, if you look on clinicaltrials.gov, what you would see is October 2024.
We haven't updated that in some time, but, you know, that's something that we'll, you know, 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, with AMG 133 is we're gonna continue to learn more, as more data comes out from others in the field. And so we feel like that will give us, you know, a lot of optionality as we look at what the phase 3 program might look like. Next one to talk about is AMG 786. So that's a phase 1 product. We expect data in the first half of next year. That's an oral, and while we haven't talked about the specific mechanism, we have said it works differently than, the...
You know, it's a non-incretin-based, it works differently than the other products that are on the market. We have a few others in earlier stage that we haven't talked about, but, you know, rest assured, we're continuing to advance those quickly. So I think, you know, again, maybe the takeaway point is, we see this as early days. We're gonna learn a lot more as the data comes out, and, you know, we're certainly leaning hard into this.
Great. Thank you, Justin. 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, you know, been a very good story with Repatha.
Justin, why don't you take that, too, and stay within our cardiometabolic-
Perfect
... area of general medicine?
Yeah, absolutely. And you know, just to reiterate the point that Peter made earlier, you know, we gave the business review guidance last year, and we talked about our outlook for growth through 2030, and Repatha was really a key part of that story. You know, at the time we said a multi-billion opportunity. And I think, you know, really where it starts is, 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, you know, both now and in the future. You know, 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% were reaching or less than 30% were reaching their cardiovascular target. So if you just step back, I mean, you're talking about millions and millions of patients, you know, 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, you know, previously there was some idea that maybe there's some kind of, you know, threshold target that you want to achieve, and then you're done or that's good enough. What we're seeing is, you know, 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, you know, with Repatha, one 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, you know, 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 to going forward.
Dan, just the one point that I would add is that with Leqvio, they have yet to generate and publicize 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 peer community in particular.
You know, Dan, as long as we're on general medicine and cardiometabolic, you know, 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's meeting their LDL targets, but Lp(a) has some different dynamics-
Yeah.
that we think we've addressed with A90.
No, I think this could be a significant advance, Dan, in terms of, you know, managing cardiovascular disease, in that when you think about elevations of, lipoprotein(a) or Lp(a), you know, this affects about 20% of the population, and, you know, this is a non-modifiable risk factor. So regardless of the measures or the steps you take to control diet, you know, to exercise, I mean, this is a genetically fixed. And with the data that we have now shown with, olpasiran, our Lp(a) inhibitor, is profound. I mean, demonstrating a 95%+ 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, it's a 6,000 patient phase 3 study, in which we are trying to assess, you know, 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 in NSCLC, following it based on the CodeBreaK 200 results? And maybe then just a kind of broader comment as to, you know, how the experience continues to be with that launch.
Mm-hmm. Yeah, I'd be glad to take that one, Dan.
Great. Thanks, Justin.
So just to first kind of level set with everyone. So, you know, LUMAKRAS is our, you know, very novel kind of, oncology product that treats, late-stage non-small cell lung cancer for patients who have the, G12C mutation. You know, this was really just a medical breakthrough, something that, scientists were aware of the target for decades, but were 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 full approval, and the FDA granted a standard review timeline with a review date, in towards late December of this year.
Then they've called an advisory committee on October fifth to convene a group of experts to talk further about the beta-available dataset to help inform that discussion. It's a bit too early for us to comment on what might be discussed there. You know, 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, you know, 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, you know, I think overall, we feel like the data we have a lot of data for LUMAKRAS that highlights, you know, it's, it's kind of risk profile, you know, which has been, a risk-benefit profile, which is favorable, and, you know, we look forward to having those discussions. I guess, to your broader question, Dan, about, you know, 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, you know, various bits of exciting data. The first one 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, you know, subset of data that was positive in patients who were PD-1 negative, and which is an area where we've announced that we're doing a phase 3 trial. So I think the broader picture here is that we continue to explore LUMAKRAS in earlier lines of therapy, in non-small cell lung 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?
Yeah, I think the point there is that, you know, we've kind of segmented the earlier lines of non-small cell lung cancer into two various types, kind of a third, a third sort of PD-1. You know, PD-1, you know, higher expressers, lower expressers, 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, you know, trying to conduct additional studies where we, you know, see the best utility for the product.
Mm-hmm.
Dan, just on your question about CodeBreaK 200. So let me just add one other point. If you go back to this particular study, which is going to be the subject of this, you know, review by the advisory panel, you know, let's keep in mind that the primary objective and endpoint in this study was duly met, you know, and that was PFS or progression-free survival. And as I recall, the hazard ratio was, you know, 0.66. If you look at some of the other metrics, you know, within the study, the objective response rate, you know, it well exceeded docetaxel, which of course, has been the standard of care in this particular setting.
So to Justin's point, of course, you know, we don't know at this point in time, you know, exactly what's going to be included in the briefing document, but we feel, you know, comfortable and good in the fact that the objective of the study, you know, that was originally put in place, you know, was met. In terms of overall survival, yeah, it was comparable, you know, to docetaxel, but you might also recall that we had to pare back the patient enrollment in this particular study because of the fact that there's an approved therapy for this setting.
Great. Thank you all. Maybe shifting a little bit to, I and 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?
Well, 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+ 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 one is worth interrogating for a little while here, because of the importance to patients with a serious disease.
Mm-hmm. Yeah, a couple of other items, Dan, that I would add. You know, first of all, the fact that this is, you know, a product which is applicable, you know, across the board to all comers, regardless if the patient has low eosinophil counts or high eosinophil counts. You know, I think that has helped, you know, tremendously in terms of its commercial uptake. You know, majority of the adoption of TEZSPIRE kind of in the initial phases and even today, you know, still remains in the form of administration by a healthcare professional. But, you know, subsequent to our initial launch, we have also launched a version, a form that lends itself to self-administration by the patient.
And, you know, that also has been a meaningful factor in terms of the very strong uptake that you saw, you know, particularly in the second quarter, when we had 37%, you know, close to 40% unit volume growth with TEZSPIRE. And lastly, from a, you know, from a payer/reimbursement perspective, again, we have very good adoption. We have a preferred formulary position with three of the largest PBMs in the U.S. So again, we, we enjoy a very good reimbursement position with this product.
Excellent. And maybe shifting from asthma, kinda, can you discuss the similarity and differences in trial design, patient populations with the phase 2 COPD study, I think, data is expected in the first half of 2024, particularly versus Dupixent?
Yeah. So, you know, first of all, I think it kind of, you almost have to go back down to the mechanism of TEZSPIRE, which is inhibition of TSLP. And TSLP, as I think you may be aware of, you know, is one of the upstream pro-inflammatory markers, and there are, you know, a number of, sequelae or disorders, if you will, which are further downstream. So I think to the extent that you can intervene TSLP, you know, I mean, theoretically, in an academic, you know, kind of a form, you know, you should be able to address some of the ancillary, you know, disorders that go along with that. And one of them, of course, is, COPD. And in COPD, you know, there's notable evidence that, you know, patients do express TSLP, you know, patients who have COPD.
Now, one of the differences that we have in terms of the clinical trial that we are conducting is that it's open to all comers. You know, we are not screening out smokers. You know, they are included, you know, in the trial. Patients with high eosinophil levels, low eosinophil levels, you know, those are all included in this phase two study. So of course, you know, ultimately the profile of TEZSPIRE vis-à-vis, you know, Dupixent, is going to be defined by, you know, by the data. So we are anxious to to kind of turn the card and see what the data shows.
Excellent. Maybe last one on I and I, and then I'll look to the crowd if there's any questions we, we should go back to on cardio oncology as well. But atopic dermatitis, crowded space, how should we think about OX40? You've mentioned it a couple of times, just from, you know, versus competitors from positioning standpoint.
Mm-hmm. So, yeah. So first of all, rocatinlimab is, you know, the product that you're referring to, which is our, you know, OX40 antibody. It basically binds activated pathogenic T cells, you know, which express OX40. So, you know, the underlying mechanism is well understood. We have a very comprehensive trial, which is ongoing, and we refer to that as the ROCKET Trial, which is, you know, which basically constitutes of seven 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, you know, different age from a demographic standpoint, different ages, I should say.
Also looking at combination approaches, you know, versus monotherapy. So again, this is a very comprehensive program that we are investigating. You know, what's interesting, Dan, is that, in the phase II data, we had about 14%, biologic failures, and, majority of them were actually you know, these are patients, you know, who had failed, Dupixent, or dupilumab. So, you know, and we didn't see any differences from an efficacy standpoint. Again, you know, 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, you know, 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 are using this versus Prolia, XGEVA, maybe kinda give us some insight into those trends?
Mm-hmm. You wanna run with it? Yeah, sure. So I think the key point with Evenity is, you know, it's a... I'm sure folks know this, but, you know, it works in very different mechanism than Prolia, is very complementary. So, you know, Evenity is provides the bone growth, and then Prolia, you know, helps kinda lock in those gains. You know what we said in our business review last year is that we would expect, you know, low double-digit growth over time. As Peter mentioned, the performance has been, you know, very strong so far. We're seeing, you know, really great uptake. You know, that's both in the U.S. and then in other markets as well.
So I think, you know, 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, you know, it's driving a very good, volume growth.
Do you think... You know, what do you think the impact will be ultimately post the loss of exclusivity for Prolia?
Yeah, I think to this point, we, you know, we haven't said anything too specific. I think the one general observation that we've made over time is that, you know, biologics tend to have a different erosion curve than you would see with the small molecules. You know, obviously, we'll have to see where things go, you know, with Prolia. But, you know, obviously, that's a medicine that's well known and well adopted, and, but, you know, we'll have to see where it goes.
Dan, just the one point that I would add to clarify is that, again, the positioning of these products, how they are used in clinical practice, is different.
Yeah.
You know, Evenity is an anabolic agent that, you know, promotes bone formation, so it's used for a limited duration of time. It's used for a 12-month period, and after that, the patient is actually transitioned to an anti-resorptive, like, you know, alendronate, but of course, in our case, you know, there's Prolia. So from a commercial standpoint, you know, it's a very effective transition. Start the patient on Evenity and then transition them, you know, over to Prolia. So the two don't necessarily compete with each other. So, you know, despite the fact that at some point in time we have to deal with the, you know, loss of exclusivity, Evenity continues to be very well positioned in that anabolic bone formation space.
Great. Maybe, so shifting finally here to biosimilars. AMJEVITA, how would you say that the, 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 AMJEVITA, Dan, is in an evolving market right now. And I think the way we described it, it was gonna be a gradual uptake. The first quarter, we described revenue as much of it going into 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. AMJEVITA is proven. Outside the United States, AMJEVITA grew 13% in the second quarter, with 23%-24% 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 as strong in our biosimilars. We think about our 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 AMJEVITA, 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 AMJEVITA as for Otezla and Enbrel and TEZSPIRE and other inflammation and immunology products. So we think we're in a good position. We're gonna stick to it and get it out as fast as we can to patients, and we realize it's gonna be a gradual uptake, but we're gonna continue to work hard at it, and we're gonna continue to take advantage of what's going on outside the United States with AMJEVITA.
Excellent.
Maybe just one other point on the biosimilars. I mean, I think more broadly, you know, we've talked about that business being a nice contributor to our growth outlook. Specifically, we said that it would grow more than double from its end of 2021 levels, so that would imply, you know, something over $2 billion to growing to something over $4 billion. And I think, you know, just to Peter's point, you know, 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 these waves of opportunities. So for example, we've talked about Soliris, 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 two other unnamed ones.
I think, you know, more broadly, the overall biosimilar business is one that we feel, you know, remains attractive for us.
And Dan, I think just in summary, on biosimilars, it's an important category for us. We've always said it's gonna 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 it.
So Dan, I think she's got the microphone all warmed up. We should give the audience at least one question. If there is one.
If there is 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 three of us each share one 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 a 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.
Mm-hmm.
I'm going to, I'm gonna stay with oncology BiTEs and go with BLINCYTO. I'm not sure if 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, you know, 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 later line of 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.
Yeah. I would just add, Dan, that there are a couple of earlier stage oncology assets that I think are also very promising. You know, kind of staying with the theme of bispecific T-cell engagers and, you know, particularly what we are seeing now on 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, you know, prostate cancer patients. And we are seeing some, you know, promising responses. We have not communicated the data yet, but we expect to do that this fall at one of the medical conferences, some early-stage data from then.
And the second one that I would add to that is, PRMT5 inhibitor that we are also developing, and this is in patients who have MTAP null tumors. And all that means, I'm not here to, you know, bore you or impress you with the science, but you know, it's basically a tumor suppressor gene that's deleted. And you know, this particular alteration affects about 15% of solid tumors, so a tremendous amount of unmet medical need. And to a large extent, you know, there may be a correlation in terms of our, what our medicinal chemists were able to do effectively in drugging, LUMAKRAS, as far as, you know, KRAS G12C is concerned, and finding an effective way to drug a PRMT5 inhibitor.
You know, 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.