Healthcare conference. My name's Geoff Meacham. I'm the Senior BioPharm Analyst. I have Jarway Fang with me from my team as well. So we're thrilled to have Amgen with us today. We have a couple of folks here. We have Peter Griffith, EVP and CFO. We have Kave.
Niksef at.
Niksef at, Senior VP, Global Marketing and Access, and then Casey Capparelli from the IR team. So guys, welcome. Thanks for joining us.
Thank you, Geoff. Thanks for having us.
So I guess, Peter, we'll start off with you, just with respect to the trends this year. You've had some standouts. It doesn't look like the denosumab headwinds were as bad as people originally thought. It looks like Repatha is still growing very nicely. So how do you kind of look at the momentum going into 2026 on the back of them? Are these trends sort of extrapolatable to 2026?
I'm good. Thank you, Geoff. Great to be here, and I would introduce our colleague, Omari Wise, our Treasurer is in the audience too, so we brought the full team.
All right.
Yeah.
Yeah.
Here for Citi. And maybe what I'll do is I'll answer a little bit of that question and then flip it over to Kave. And then Casey's got a quick add on R&D, just to kind of kick things off a little bit if we could. Would be fantastic. Look, we've got good momentum in the business. So to answer your question, 10% revenue growth through the first nine months of the year, and that is inclusive of 11% product sales growth driven by 14% volume growth. What I would also add is in the third quarter, we had 12% revenue growth driven by 14% volume growth also. My point being is the volume growth is very strong, and that's been our strategy since about 2019 when prices started declining in the industry, net prices, and we adopted a really volume-driven growth strategy. So that's going well this year.
It means more patients are getting more medicine. We continue to invest in innovation and science at Amgen and our capital allocation hierarchy, enabling longer, healthier lives, and we also have a strong long-term growth outlook that's driven by the four therapeutic areas and the breadth and the depth in those four therapeutic areas, so we think we've got a strong foundation and good momentum this year. Geoff, as you point out, we're encouraged by momentum in the business. We're encouraged by momentum in the pipeline. We feel great about that, and Casey can explain a little bit more about that, but so far, so good. Strong debt paydown on the debt we took down in connection with the Horizon acquisition. We're delighted to be in rare disease. Kave, I'll fill you in on that. Our capital allocation hierarchy that I mentioned before continues to be strong.
We spend where we should. This year, Geoff, in addition to strong performance on the top line, we're investing in the business. So 31% up year over year in the third quarter in non-GAAP research and development. We had roughly $200 million of business development in that third quarter. So without that, we were about 19% up. Still a strong allocation of capital innovation. Our guide for the year in non-GAAP R&D, you're familiar with, is in the mid-20%. So we continue to do what we want to do, which is work on innovation. Having said that, Kave, I'll flip it over to you for maybe a drive-by on the in-market portfolio, which is doing so well.
Yeah, thanks, Peter. As Peter mentioned, we've got six major growth drivers that we have in hand. The first three address major public health concerns, so starting with Repatha, we've had 30% year-over-year growth over the first nine months of the year, and we have recently shared the VESALIUS-CV primary prevention data in hand that will drive our continued growth going forward. There's over 100 million patients in the world that have uncontrolled LDL-C. Penetration rates of PCSK9 therapy remain quite low, which offers plenty of opportunity for future growth. Moving on to Evenity, it also had 30% growth year over year, with particular strength in the U.S. and Japan.
In the U.S., we've got a 60% share of the bone builder market with Evenity, but over 90% of the 2 million women who are at very high risk of fracture still are untreated today, again, leaving ample room for growth going forward. Finally, Tezspire grew 50% year over year in 2025, and we've now achieved $1 billion of sales within the US within this year in severe asthma. We recently got approval for chronic rhinosinusitis with nasal polyps and have ongoing phase three trials in COPD and eosinophilic esophagitis, which will continue to add to the growth story. Moving on to our fourth growth driver, rare disease. We're now annualizing at close to $5 billion a year and grew 12% year over year. This is a very young portfolio of four products: Uplizna, Tepezza, Krystexha, and Tavneos.
Uplizna has grown 50% year over year on the back of a strong launch in IgG4-related disease and continued strength in NMOSD. And we've got an upcoming PDUFA date on December 14th in generalized myasthenia gravis, which we expect will continue to drive the growth of Uplizna going forward. Innovative Oncology has grown 11% year over year on the back of our bispecific T-cell engagers, Blincyto, and Imdeltra. Imdeltra has now become the standard of care in second-line small-cell lung cancer, with over 1,400 sites of care, both in the academic and community setting, now leveraging the product in the United States. We've got ongoing phase three trials to extend Imdeltra's impact to earlier lines of therapy. And then finally, our biosimilar portfolio grew 40% year over year, is now annualizing at roughly $3 billion. Since its inception in 2018, the biosimilar portfolio has produced $13 billion of cumulative revenues.
Pavblu, in particular, continues to gain traction as the only approved biosimilar to Eylea. So with that, those are our six major growth drivers in the in-line portfolio. I'll turn it over to Casey for a drive-by on the pipeline.
Yeah, perfect. Thanks, Kave. And just one clarification on Tezspire: 50% growth year over year through the third quarter.
Correct.
Shifting gears, though, to the pipeline. So Repatha, Kave mentioned the VESALIUS phase three study. That's an outcome study in high-risk patients who have yet to have a cardiovascular event. Repatha, when added to optimized lipid-lowering therapy, reduced the risk of cardiovascular events in this population by 25% and reduced the risk of heart attack by 36%. Really remarkable results that were quite well received by the field, and we think provide a lot of momentum for Repatha going into the primary care setting. If we shift gears to Maritide, Maritide is rapidly advancing in phase three. We have six global phase three studies underway: two in chronic weight management that are both fully enrolled. Additional studies in cardiovascular disease, heart failure, and obstructive sleep apnea are also progressing very well.
Turning to part two of the phase two study, as well as the type 2 diabetes phase two study for Maritide, we're working through the data for both of those studies and expect to provide an update in the new year. If we stick in general medicine but move to another product, Olpaceran, that's our Lp(a) targeting siRNA molecule, also in phase three development, we continue to have strong conviction behind Olpaceran and its potential to reduce cardiovascular risk by reducing Lp(a), another way to further reduce the risk of cardiovascular disease in those individuals that have elevated Lp(a). As Kave mentioned, Imdeltra advancing in phase three studies. We presented some very impressive data earlier this year demonstrating almost a doubling of survival relative to existing standard of care through phase one B studies in frontline and also in the frontline maintenance setting of small-cell lung cancer.
Really impressive data there. We have ongoing phase three studies in those settings that we're really hopeful will demonstrate a benefit for patients. And then lastly, to round out our bispecific T-cell engagers that are continuing clinical development, we have Xyritamig, which is in phase three in prostate cancer. Two studies ongoing and enrolling well, as well as additional phase one studies underway where we're exploring Xyritamig in earlier stages of prostate cancer, similar to how we've approached Imdeltra going late stage first and then looking to advance the program into earlier stage settings. With that, Geoff, we'll turn it back to you.
Yeah, perfect. That's a great background, guys. Thank you. I guess we'll have a couple of commercial questions and some pipeline questions, but maybe we'll still keep it a bit higher level.
Peter, from a policy perspective, I know some companies have announced the agreements with the administration on manufacturing and all the MFN kind of stuff. Where is Amgen as of now with respect to that? Talk a little bit about capital allocation priorities with regard to kind of internal versus external too in that context.
Good. Let me cover the capital allocation internal and external, Geoff, and how we're contextualizing that. And then I'll turn it over to Kave, who's been on point for us for a lot of the activities in Washington, D.C.
Okay.
And so when we think about capital allocation internally and externally, you're all familiar with Amgen in the sense that our number one capital allocation priority is innovation, the best innovation, whether it's internal or external. So in the environment we're in, Geoff, and we think about the tailwinds of demographics and so forth going forward, innovation is more important than ever. The world needs more innovation, not less. So we're continuing to put our number one allocation to that. I mentioned research and development and how we are allocating that this year, mid-20s% year over year to R&D.
We did say at the end of the third quarter that while we had a bit of a step change in R&D from 2024 into 2025, because Maritide's six global studies, as Casey referred to, are up and running, we wanted to make sure everybody understood we don't expect the same type of step change going forward because that's a big number. So we've got Xyritamig, we've got Olpaceran, we've got Maritide phase three. If you go back to, we wrapped up VESALIUS and Repatha and studies in Rocatinlimab and Bemarituzumab and so forth. So we still have an increase in R&D, or we're thinking about continuing allocation, rather, is a better way to say it, into R&D in an important way in 2026. And externally is a great question. We had roughly $200 million in some business development activities in the third quarter.
We think it's a great opportunity and a great time to make sure we're on alert, which we always are. We've always got a wide aperture in terms of business development, structurally agnostic as to what we do, size, we're agnostic. And so we'll continue to keep that open and see what's out there. We have kept it open, actually, even during the period after we acquired Horizon. We've just got high standards now, and so we're careful about where we allocate capital. And so that's how we're thinking about capital allocation internally and externally. I would just say internally too, it goes without saying, we've got a capital expenditure guide of $2.2 billion-$2.3 billion this year that we're locking down and finishing up.
We've made some announcements, I think, as you've noted, in North Carolina, Ohio, and continuing to build onto those facilities to make sure that we have a network capacity that's optimized, and certainly, for all of our products, with 14% volume growth, we need to, and so we allocate capital to that, and of course, that includes thinking ahead over the curvature of the earth to Maritide and that coming along, so that's capital allocation. Kave, maybe it'd be great to get an update on how we're thinking about the activities in Washington and so forth.
Yeah, so Geoff, just as we have in prior administrations, we're engaging heavily with this administration. We're obviously in receipt of the president's letter. From July, we've seen the deal announcements that have been made by other companies along with the generous demo. I would say overall, we've had positive relations with this government going back to the first administration where we announced the 60% list price reduction on Repatha the first time around. Following the Tax Cut and Jobs Act, we've invested over $40 billion of capital in both manufacturing and R&D in the U.S. and have largely a U.S.-based manufacturing network today, and of course, a few months ago, we announced the introduction of Amgen Now, our direct-to-consumer program, the first offering of Repatha at $2.39 a month, lowest price in the developed world overall.
What we're continuing to engage and have productive conversations. Nothing to announce at this point other than we continue to have these productive discussions and appreciate the president's goals of trying to increase affordability for patients out of pocket in the U.S. and making sure that foreign nations are paying their fair share for the innovation that we bring.
Yep. Let me follow that up, Kave, with the recent announcement on GLP-1s as of a month ago. So you guys have, I think, what, eight phase threes, eight or nine phase threes for Maritide in the obesity diabetes space. So how does sort of the pricing volume assumptions in that, does that inform kind of your long-term investments in Maritide as you look forward?
Super quick clarification. I think we're six.
Six phase 3s. Sorry.
No, it's phase 3s at this point that have been announced. It's a great question, Geoff. I'd say that Amgen has a long history of being able to navigate the pricing and access space in the U.S. in highly competitive categories going back to inflammation and our original product there, Enbrel. I'd say overall, we have expected pricing to evolve in the marketplace that would go along with additional demand generation. And what's been spelled out from the administration and the current companies thus far is in line with our expectations going forward. And so we remain very confident and very excited about the Maritide opportunity and look to continue to expand the market, which, while large today, continues to be underpenetrated with a new monthly or less frequent option.
Thanks. And maybe earlier you highlighted some of the growth drivers that are in the portfolio with Repatha, Evenity being a few of them. And obviously with Amgen Now highlighting direct-to-consumer access for Repatha, maybe just thinking about how do you see that evolving with Maritide potentially coming into play as well? Is that going to become more of an important driver for you guys going forward, or is the current form of increased access or innovative access models pretty set for the time being?
Yeah, I think it's premature at this point to talk about access models for Maritide, especially in such a competitive environment. But I do think Repatha offers a good Amgen blueprint for how we can access large populations from an access-driven growth perspective. We've got coverage on nearly 100% of formularies at this point. 95% of Medicare patients pay a low fixed copay for the product, generally $50 or less, less than two bucks a day. And then in the commercial market, we've got 50% of patients that no longer face a prior authorization for Repatha, and of course, continues to be very affordable with our copay card, 15 bucks a month.
The addition of the direct-to-patient option opens up access for those folks that are not insured or for specifically patients who cannot get access to Repatha in their insurance construct for their intended use, for instance, primary prevention or primary hyperlipidemia, and opens that channel up in a meaningful way. It also gives us experience for direct-to-patient options in the future, would we expand that to other products. So I believe this will be an important attribute going forward. Obviously, in the existing obesity space, it is a very important attribute. Having said that, we still believe that patients with these serious diseases should be covered by their insurance and should be able to access these medicines within the copay constructs that are available within their insured and their insurance marketplace.
Can I just follow that up, Kave, so Amgen Now, some companies have rolled out more of a consumer portal, if you will, and I wasn't sure if the timing of the Amgen Now was sort of kind of in response to maybe the industry doing more of a consumer-facing, or if it was more related to, say, let's preload the market for Maritide and then maybe other products going forward, or maybe it's probably a combination of both.
Yeah, I'd say it's a combination of all of these, Geoff. I think we had long been contemplating a direct-to-patient option for Repatha, knowing that some patients still could not access the product through their insurance or directly. The way we've implemented this is primarily with partners such as GoodRx to make sure that it was available at the local pharmacy rather than direct from a portal. But I think there's an experience set there that will benefit us on multiple products going forward.
That makes sense. And then maybe I know we'll talk more about commercial later, but just wanted to touch real quick on biosimilar headwinds and offsets. I mean, for Q3, the erosion for denosumab really wasn't quite as bad as many had anticipated. So maybe just give us a sense of how expectations should be set looking forward. And then also just as offsets to the erosion, you kind of touched upon assets from the Horizon portfolio and with the upcoming PDUFA for Uplizna coming up as well. How will that further lever up Uplizna's momentum and help offset the erosion on the P&L?
Yeah, so let's start with denosumab. So we had biosimilar entry in the U.S. earlier this year. At this point, we've got four biosimilars that have entered the U.S. market for Prolia and Xgeva. And progression of the competitive dynamics to date have pretty much been exactly in line with how we expected. And reminder, that expectation was built on our experience of being in the biosimilar marketplace, either defending against biosimilars or launching biosimilars ourselves for the last 10 years. Looking forward, we expect the competitive intensity to increase as additional competitors enter the market. And therefore, we would expect that Prolia and Xgeva revenues will decline as that competitive intensity increases. Having said that, as we've shared before, we expect different erosion curves for Xgeva versus Prolia. That's because Xgeva operates in the oncology space, which is highly consolidated and has a lot of experience with biosimilars.
are analogs available both from Amgen and others in that space. Prolia, on the other hand, is administered by a large variety of HCPs, many of whom do not have large consolidated practices or biosimilars experience with biosimilars previously. In addition, and I'd like to remind everyone, we also have Evenity in the bone space. Evenity grew 30% year over year last year and is differentiated from Prolia. Evenity builds bone. Prolia maintains the bone that is built. Therefore, the products are complementary. We continue to promote Evenity to the bone marketplace, including all of the HCPs that are in bone health. And as part of that, we also continue to support Prolia with those physicians. And so we expect those erosion curves to look different going forward, but obviously more intense as competition increases.
Now, to offset that, we would look to all six of the growth drivers I discussed earlier. So Repatha, Evenity, Tezspire continue to grow going forward in those underpenetrated markets. Rare disease continues to grow, especially for Uplizna, with increased use in IgG4, which has only been on the market now for about six to eight months, and myasthenia gravis going forward. In addition, innovative oncology led by Imdeltra and Blincyto, and then finally our biosimilar portfolio. So we see all of those continuing to grow to give us a good springboard for 2026 and beyond.
Can I just ask maybe on the rare disease success with Horizon, right? So you guys historically have not been in rare disease, but you've done a number of deals. ChemoCentryx is another one that really has grown your portfolio in quite a dramatic way. When you think about BD or sort of strategies for external growth, where does rare stack up kind of in the priority? Do you feel like you have more commercial capacity to add more assets? There's just a lot. It's a ton more in rare than there are in other, but they're sort of nichier kind of verticals, right?
I think that's a great question, Geoff. As I said earlier of BD, we keep the aperture open. I think you make a really good point is we are really glad we're in rare. I think Amgen was made for rare. We have a lot of the rare diseases are autoimmune related, and Amgen has just terrific research in that area. I think, Kave, correct me if I'm wrong, I think technically Blincyto was a rare drug at one point.
Correct.
I think one of the first drugs at Amgen many, many decades ago was filed as a rare.
Correct.
I don't want to say which one, Ipo or Nupo, but long story short.
We thought a lot about getting into rare.
So going forward, there's opportunities there to integrate. We're very interested in it. We think it's worked out really, really well. We're so happy to have colleagues that came over from the Horizon team. Thank you. And so we're very pleased with that. And we'll continue to keep that aperture wide open in rare. As you know, in the earlier stage companies, not just in rare, but a little more widely, there's quite a bit available right now. There's opportunities for companies like Amgen to go, and we're structurally agnostic, licensing, collaborations, partnerships, acquisitions, all the above. So we're always thinking about that. We'll continue to think about that.
Kave, are those products easier to manage from a market access reimbursement perspective? Fewer competitors, but sometimes it's a much higher price point.
Yeah, I would say in general, in the U.S., rare disease has got lower levels of management than broader diseases. Overall, outside the U.S., there are some incentives available from a market access perspective that can bring those forward. But look, we've built some really nice capabilities for go-to-market on rare disease, and to Peter's point, we're quite confident those capabilities can be applied to additional diseases going forward.
Okay. I know we have a lot of questions, but it's important to touch upon some of the pipeline stuff that you guys have cooking. Maybe Casey wanted to come back to a point you made earlier, which was on Maritide's phase 2, part 2. Expectations previously were for data in 2025. As you mentioned, we can expect that now in 2026. Just wanted to get a sense of maybe what led to the timing change. Then maybe help remind us, what can we expect from the data and what might you present in a step 1?
Yeah, sure. So to take the timing question, as I said in my remarks, we're working through the data for both the type 2 diabetes study as well as part two of the phase two study with Maritide, and we'll expect an update in the new year. Really, nothing more to say beyond that. With respect to part two of the phase two study, it's principally a maintenance study. And the reason for that is several-fold. One, following part one, or 52 weeks of treatment, individuals that had lost 15% or more of their body weight were eligible to continue into part two. Roughly over 90% of individuals offered that opportunity and decided to move forward and participate, which we feel is a good vote of confidence for wanting to receive a second year of Maritide treatment.
All of those individuals were then re-randomized based upon where they were in part one of the study into new arms of part two, and that includes both individuals with and without type 2 diabetes that participated in part one, so you get a little bit of a mixed population, and then you have obviously a subset of the individuals in part one that moved into part two. Because of that, the study is more descriptive in nature. It wasn't designed to drive comparisons of weight loss between the various arms of the study. It will certainly teach us more about Maritide. It will teach us more about what happens after 52 weeks of Maritide treatment if you move to a lower monthly dose, or if you move to a quarterly dose, or if you stop Maritide treatment and move to placebo.
But those findings will help to inform our planning, but as I said, weren't designed necessarily to provide a lot of exquisite detail trying to differentiate between those various arms.
Casey, just a quick follow-up on that. So the dosing and strategy in part two is fully captured in the ongoing phase threes, though, right?
The ongoing phase 3s are what I would call initial treatment with Maritide. Where you go through a three-step dose escalation to a target dose, and then you receive Maritide out through 72 weeks. The difference with part two is it will help us to think about Maritide in a maintenance setting. After you've lost, in this case in part two, 15% or more of your weight, is there an opportunity to maintain that weight loss with Maritide? And it will inform how we think about other aspects of Maritide's profile in addition to what the ongoing phase 3s are exploring.
As you get the full data from part two and you have a better idea of the maintenance opportunity, do you think then will that be the tipping point? So okay, let's go after more indications, maybe outside of obesity, diabetes in terms of the number of trials?
Yeah, I would say we're constantly watching the field. I mean, it's remarkable the number of obesity-related comorbid diseases. And so we're in heart failure. We're pursuing obstructive sleep apnea, looking at an outcome study in cardiovascular disease. We'll see where the field and where data that we generate leads us. And I would say more to come there if we see an opportunity to invest and meaningfully benefit patients with Maritide. We'll look to do that.
Okay. And maybe just to expand on some of the opportunities beyond obesity, you mentioned some comorbidities, but there is a presentation at CTAD that'll come later today that I think a lot of the community is going to be focused a lot on. And that's in Alzheimer's disease. And given Maritide's potential for long-term dosing potential, could there be an opportunity for Maritide being investigated in Alzheimer's disease?
Yeah, Charlie, it's a good question. I'd come back to what I said before. We'll watch how the field evolves. And if we do see an opportunity to benefit patients with Maritide outside of where we're currently focused, we'll think about whether to pursue that opportunity or not. It's early days in obesity-related clinical research. And I think we and the field will learn a lot more in the coming years, and we'll look to make the right moves if the opportunity presents itself.
Sorry, maybe just on a clarification point. I'd imagine that the label that you guys would pursue for Maritide would be for chronic weight management, and that may be a specific label for weight maintenance might not be necessary. However, knowing that, would a dedicated weight management study for a phase 3, would that be needed in order to fully elucidate data using the dosing levels in the phase 3?
It's a good question. It's something that we're obviously talking about internally. We'll be informed by ongoing work that we're doing with Maritide and more to come there.
Moving down the pipeline, and there's a ton there. So that's a good place to be. So on Olpaceran, I know you guys have, you don't have meaningful large-scale phase three data for a few more years, but obviously the Novartis data point we're going to get on Lp(a) in 1Q, does that inform, again, the pace of investment or the addition of newer trials for Lp(a), or are you guys sort of set the stage and then we'll see what happens in 1Q? But I mean, I wasn't sure if Amgen's going to react, or I don't think Lilly is either, but based on the initial cut of the Novartis data.
I think we and the field will be interested in seeing data from the first phase three study with driving reduction of Lp(a). There's some differences between Amgen's molecule and others. We have a molecule that reduces Lp(a) levels roughly 95%-100%. We have a molecule that is dosed every 12 weeks or on a quarterly basis. We also have a phase three study that enrolled a higher risk population than some other trials with its Lp(a) cutoff. So we'll be watching eagerly, but I think we'll also be considering Olpaceran's attributes as we think about data that others may generate.
Well-powered study with 7,300 patients.
That's right.
Well-powered study with 7,300 patients.
Yeah.
Casey, we really appreciate you highlighting some of the differences between the trials that you guys are running and Novartis. One of the major differences in our view is the difference in the MACE endpoints, right? Where you guys are targeting MACE 3 versus Novartis as MACE 4. So Casey, for you, maybe just help remind investors what that means for level of success or confidence you guys have. And then Kave, for you, given the long-term, the extended dosing potential for Olpaceran, what does that mean for market access and perhaps adoption in that front?
Yeah, maybe just the context, so the endpoint of our phase three secondary prevention study is a MACE 3. It does not include stroke as one of the endpoints. The reason for that is when we reviewed epidemiology data of where Lp(a) drives the most significant amount of risk, stroke came out lower, and therefore we focused our study on those endpoints where we feel Lp(a) will be driving the greatest risk. We'll have to see how that plays out, obviously, in phase three, so more to come there, but we're stewards of the data and really look to let the data help us understand where to focus our efforts.
Yeah, and so for Olpaceran, to the point, we do believe we have a highly differentiated molecule with, again, Lp(a) knockdown of 95%-100% that will differentiate it from some of the competition. The quarterly self-administered dose we think will be a meaningful increase in convenience to patients, and so the combination of what we expect to be the greater efficacy and the greater level of convenience, we believe gives us a very competitive profile going into launch.
Great. And then so maybe looking into other areas in your pipeline, inflammation, like you mentioned, that Tezspire is doing fantastically well. But then also you have Rocatinlimab in atopic dermatitis. And so maybe just give a sense of how are you envisioning positioning of all of these inflammatory assets across type 2 and non-type 2 biology and how can these data help inform optimizing trial designs and such?
Yeah, so let's start with Tezspire. Tezspire targets TSLP. TSLP is very high in the immune cascade. We showed in the asthma trials that that enables us to treat all different archetypes of patients, irrespective of eosinophilic levels or allergic levels of their asthma. Overall, the first and only product to be able to hit all six individual patient segments that are there. Ongoing studies in COPD and EoE and recent approval in nasal polyps. We see a long runway for Tezspire. I had the pleasure of launching the product in 2021, and the product is performing fantastically in the marketplace with great adoption among allergists and pulmonologists. We're really seeing the polyps data being an additional catalyst for growth. In terms of Rocatinlimab, we now have all eight phase three trials in hand.
We're evaluating the totality of that data in a very competitive atopic dermatitis market, and we'll have further discussions and announcements regarding filing plans in due course.
Kave, I wanted to ask you on switching products. So Imdeltra, help us with kind of what you're seeing in the real world and the launch and small-cell lung cancer. It's been a pretty good trajectory, but I want to get kind of the drivers and the durability of that, and then we get maybe into some economics of the asset.
Sure. So we've had a really strong launch for Imdeltra, both in the U.S. and, as we mentioned earlier in the year, Japan now as well, coming online in the U.S. 1,400 sites of care are now online and using the product. As we look going forward with the new NCCN guidance to make it the most preferred second-line therapy out there, it really comes down to blocking and tackling to activate additional sites in order to access the additional second-line patients that are out there. We're continuing to expand through clinical trials into earlier lines of therapy where we have larger patient populations and would expect a longer duration of therapy in those earlier lines. So very positive launch thus far. Continued data that we see, we see inflections with every new data readout that we put out.
Remind us of the timing of the first line and the next kind of data cards to kind of turnover?
Yeah, so Casey, we will. Yeah, those are event-driven trials. Geoff, one of our studies, Delphi 305, is fully enrolled. We're watching event rates, and then we have others that are continuing to enroll patients. As I was mentioning, both of those, two of our phase three studies are in extensive stage small cell lung cancer in the front-line setting, one in front-line maintenance in combination with a PD-1, one in a true front-line setting in combination with a PD-1 and chemotherapy, and we're excited about both of those based upon some of the really positive phase 1b data that we presented this past fall at WCLC and ESMO, so we think it bodes well for those phase three trials, but we're obviously monitoring event rates, and we'll have more to say when we anticipate data from those studies in due course.
Maybe a reminder, those phase 1b trials, when they read out, both roughly double overall survival versus standard of care that's documented in the marketplace.
Right. So you have built-in interim analyses on these, or are they just straight final?
Yeah, we're just watching event rates at this point in time. So I would say more to come there.
Okay. And just the last one on that, just when you think about the revenue sharing component on that, does that sort of change how you invest in the product beyond these two first-line studies? Do you look at this as just sort of a small cell franchise, or is there mechanism proof that you can move beyond that?
I would say from an investment perspective, we're exploring Imdeltra fully in small-cell lung cancer. The two studies that I mentioned in extensive-stage, we have a study in limited-stage small-cell lung cancer, a phase three study that's also underway. And we're thinking about, is there utility in other tumors that express DLL3 in addition to small-cell lung cancer? So we're quite confident in the asset for the reasons that you heard from all of us and look forward to generating more data.
I would just add, Geoff, that Imdeltra, as Kave said, is life-changing for these patients with small cell lung cancer, just a devastating disease. So this is exactly Amgen is made for these moments. We want to back that up with the capital to explore what we can do to help patients in all aspects of that disease. That's a really important medicine to patients. So it's an important medicine to Amgen. Awesome. Guys, thank you very much. Appreciate the time.
Thank you guys very much.
Thanks .