Amgen Inc — Earnings Call Q3 2026

Operator: My name is Julianne, and I will be your conference facilitator today for the Amgen Q3 2026 Earnings Conference Call. [Operator Instructions] I would now like to introduce Casey Capparelli, Vice President of Investor Relations. Mr. Capparelli, you may now begin. Casey Capparelli: Thank you, Julianne. Good afternoon, everyone, and welcome to our third quarter of 2026 earnings call. Bob Bradway will lead the call today and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner and Thomas Dittrich. Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results can vary materially. Over to you, Bob. Robert Bradway: Good afternoon, and thank you for joining our call. Our results through the first 3 quarters of the year reflect the strength of our business across a broad range of products and pipeline molecules. This is exactly the kind of performance our strategy was designed to achieve. Strong commercial and operations execution and continued innovation from our research and development organization reinforce our confidence in Amgen's ability to deliver durable long-term growth. For the latest quarter, total revenues grew a strong 8% year-over-year to $10.4 billion. Our 6 key growth drivers grew 27% year-over-year and represented over 70% of our third quarter product sales. Across the portfolio, 17 products delivered double-digit sales growth and 17 products are now annualizing at more than $1 billion based on third quarter sales. We see significant opportunity to build on this momentum. Many of our medicines address large, underpenetrated disease areas where the majority of patients remain untreated. Repatha, EVENITY and TEZSPIRE are clear examples of that. Our strong financial performance gives us the flexibility to invest in innovation and the capabilities needed to support future growth while delivering attractive returns to shareholders. In the third quarter, we generated $3.7 billion in free cash flow, increased our investment in research and development by 11% year-over-year and invested another $600 million in the business through capital expenditures. This was another productive quarter for our R&D organization. We reported positive Phase III results from 3 important programs: IMDELLTRA, in small cell lung cancer, where we are working to establish it as the cornerstone therapy; TEZSPIRE, in eosinophilic esophagitis, an area with significant unmet need; and dazodalibep, in Sjogren's disease, where no approved disease-modifying therapies currently exist. I would note that each of these represents an established or potential first-in-class medicine with the opportunity to make a meaningful difference for patients while providing additional sources of long-term growth for Amgen. Likewise, our progress reflects the strength of our science and our commitment to pursuing novel approaches for serious diseases. That same focus guides our investment in programs such as MariTide, which is advancing through Phase III development. Jay will discuss these programs and our other clinical advances in more detail shortly. We're also leveraging technology, data-driven insights and artificial intelligence across Amgen to improve the speed and efficiency of how we discover, develop, manufacture and deliver medicine to patients. We're encouraged by our performance this quarter, and our broad portfolio, continued investment in advancing pipeline give us confidence in Amgen's ability to deliver durable growth well into the next decade. I want to thank our colleagues around the world for their dedication to our mission to serve patients and for the quality of their work every day. With that, I'll turn it over to Murdo. Murdo Gordon: Thanks, Bob. Looking back at the third quarter, what stands out for me is the remarkable progress we've made across our late-stage pipeline and broad in-line portfolio. We've seen important positive clinical readouts, regulatory milestones and record sales performance for several of our key medicines. The consistency of these achievements reflects the breadth and strength of Amgen today and reinforces our confidence in the growth opportunities ahead. Our commercial performance reflects this progress. Product sales grew 8% year-over-year, and we have 17 products annualizing at more than $1 billion in sales. All 6 of our key growth drivers delivered double-digit growth in the quarter, together growing 27% year-over-year and now representing more than 70% of product sales. Starting with General Medicine, Repatha delivered $1.1 billion in third quarter sales, growing 37% year-over-year. Repatha's momentum continues to accelerate with U.S. average weekly new-to-brand prescriptions increasing over 60% compared with the prior year. This growth is supported by increased urgency to treat in both secondary prevention and high-risk primary prevention patients. With the landmark VESALIUS-CV results, Repatha is now the only PCSK9 inhibitor with Phase III cardiovascular outcomes evidence in both primary and secondary prevention. We're seeing deepening conviction and adoption among cardiologists and accelerating use in primary care. The updated ACC and AHA guidelines reinforce earlier, more intensive LDL cholesterol lowering and support the use of PCSK9 inhibitors without requiring prior treatment with ezetimibe. The new guidelines, supported by Repatha's differentiated outcomes data, strengthen clinical conviction that Repatha should be the first choice when additional LDL-cholesterol lowering is needed beyond statins. This year alone, we expect more than 3 million additional patients globally to start treatment with Repatha. With an estimated 100 million patients worldwide still above their LDL-C goals, we are only beginning to address the significant unmet need, giving us confidence in Repatha's growth potential into the 2030s. EVENITY sales increased 39% in the third quarter to $751 million, building on 38% year-over-year growth in the previous quarter. In the United States, robust patient demand continues to drive momentum, supported by an expanding prescriber base and deeper adoption among treating physicians. We're increasing investment to expand our reach among physicians and to help more patients access treatment with EVENITY. The opportunity remains significant, particularly when we consider the devastating consequences of osteoporotic fractures. 1 in 2 patients who experienced a hip fracture do not regain their pre-fracture mobility. This reinforces the importance of earlier intervention and our conviction in EVENITY's potential to help more women at very high fracture risk, including those who have not yet experienced a fracture. In Japan, EVENITY maintains leadership in the bone-builder category with nearly 60% volume share. Updated treatment guidelines and increasing use among treatment-naive patients are supporting continued growth and reinforcing EVENITY's important role in osteoporosis care. Moving to inflammation, TEZSPIRE's sales grew 43% year-over-year, reaching $538 million, driven by strong demand in severe uncontrolled asthma. TEZSPIRE's growth continues to outperform the severe uncontrolled asthma market with U.S. new-to-brand prescriptions growing 15% year-over-year versus 3% market growth. TEZSPIRE has achieved 34% new-to-brand prescription share among allergists in the U.S. and continues to gain share among pulmonologists with substantial room for further adoption. The consistent flow of strong clinical data continues to reinforce TEZSPIRE's differentiated efficacy across inflammatory diseases. Phase III results in chronic rhinosinusitis with nasal polyps demonstrated improvements in disease control and a reduction in need for surgery. More recently, positive Phase III results in eosinophilic esophagitis, or EoE, demonstrated meaningful improvements in key measures of disease activity and symptoms, highlighting another potential new opportunity for TEZSPIRE to help more patients. Turning to rare disease, this portfolio grew 21% year-over-year to $1.6 billion, reflecting continued momentum from additional indications and disciplined execution of international expansion. We see opportunity to extend the reach of these treatments, improve outcomes for patients and sustain meaningful growth well into the next decade. UPLIZNA sales increased 191% year-over-year to $451 million in the third quarter, driven by strong patient demand across all approved indications. UPLIZNA offers a highly differentiated clinical profile, combining outstanding efficacy that resonates with physicians and convenient twice-yearly dosing that benefits patients. This profile is supported by broad payer coverage and Amgen's comprehensive patient support services, helping physicians initiate treatment and support continuity of care. In the U.S., UPLIZNA is demonstrating significant growth in generalized myasthenia gravis, or gMG, with new and continuing patients increasing 45% quarter-over-quarter. Adoption is expanding among both biologic-naive patients and those transitioning from other therapies, reinforcing our confidence in the business potential to establish market leadership in this category. In IgG4-related disease, long-term follow-up data from the Phase III MITIGATE study continued to reinforce UPLIZNA's durable efficacy profile. All patients who continued treatment with UPLIZNA remained flare-free through the first year of the open-label extension, with more than 70% achieving complete remission without glucocorticoids. These durable results, together with growing disease awareness and improved diagnosis, support our confidence in UPLIZNA's potential to help many more patients. UPLIZNA continues to expand its reach internationally and is now launched in 25 markets outside the U.S. We see substantial opportunity for continued growth as we bring UPLIZNA to more patients around the world and advance its development across additional autoimmune diseases. TEPEZZA generated $526 million in third quarter sales, a 6% decline year-over-year, impacted by an inventory build in the third quarter of last year. International adoption continues to build, with particularly encouraging uptake in Japan since entering the market last year. TEPEZZA has now launched in more than 20 countries worldwide with 3 additional markets planned for the remainder of 2026. Our biosimilar portfolio delivered 26% year-over-year growth, generating $977 million in sales in the third quarter. PAVBLU, our biosimilar to EYLEA, increased sales 41% year-over-year to $300 million in the quarter. Retina specialists recognize the benefits of PAVBLU's convenient prefilled syringe presentation, supported by Amgen's established capabilities in biosimilar manufacturing and supply. Our next wave of biosimilar candidates for EYLEA HD, OPDIVO, KEYTRUDA and OCREVUS are in late-stage clinical development and represent large market opportunities. Turning to Innovative Oncology, the portfolio grew 21% year-over-year, generating $2.1 billion in sales in the third quarter. BLINCYTO sales increased 27% year-over-year to $496 million in the third quarter. This growth continues to reflect broad prescribing across academic and community settings and increasing international adoption. BLINCYTO's established role in treating B-cell acute lymphoblastic leukemia demonstrates the strength of our bispecific T-cell engager platform and its ability to deliver meaningful outcomes across different cancers. IMDELLTRA sales more than doubled year-over-year to $406 million. Behind this commercial momentum is a medicine with the potential to make a profound difference for patients facing small cell lung cancer. These patients and their families have faced limited treatment options and poor survival outcomes for decades. IMDELLTRA is changing that. Our landmark DeLLphi-304 trial demonstrated a 40% reduction in the risk of death compared with chemotherapy in second-line treatment. IMDELLTRA also offers convenient every 2-week dosing following initial step-up period. We're making progress on reducing the burden of treatment. The FDA recently shortened the recommended monitoring period for the first 2 doses from 22 to 24 hours to just 6 to 8 hours. Looking ahead, we are advancing alternative dosing schedules, subcutaneous administration and has the potential to further improve convenience for patients and expand access in community settings. The potential to help patients earlier in their treatment journey is even more exciting. And as Jay will discuss in more detail, we recently presented Phase III results from the DeLLphi-305 study evaluating IMDELLTRA in combination with IMFINZI in first-line maintenance treatment. I was at the European Society for Medical Oncology Congress in Madrid when these findings were presented, and I was moved by the standing ovation from the audience. The excitement we heard from oncologists about the potential to significantly extend patients' lives was remarkable. The magnitude of these results is difficult to overstate. More than 8 additional months of median overall survival represents an extraordinary advance for patients facing this devastating disease. We're moving with urgency to advance regulatory discussions with health authorities and support timely consideration by clinical guideline organizations, including the NCCN, so these findings can translate into clinical practice as rapidly as possible. We believe IMDELLTRA has the potential to transform the treatment of small cell lung cancer and, with additional regulatory approvals, become a cornerstone therapy across multiple stages of small cell lung cancer. Our portfolio has significant potential for deeper market penetration, additional indications and global expansion. We're confident in our ability to deliver sustained growth well into the next decade while reaching more patients around the world. And now I'll turn it over to Jay. James Bradner: Thank you, Murdo, and good afternoon. This quarter, we reported 3 positive Phase III readouts across 3 serious diseases: IMDELLTRA in small cell lung cancer; TEZSPIRE in eosinophilic esophagitis; and dazodalibep in Sjogren's disease. These results reflect our R&D strategy that focuses on first-in-class and best-in-class medicines for serious diseases with high unmet need. Each advance represents meaningful progress for patients and physicians and meaningful potential for long-term growth. As Murdo introduced, IMDELLTRA is our DLL3 targeted bispecific T-cell engager currently approved in second line or later small cell lung cancer and the second approved medicine arriving from our BiTE platform. At the European Society for Medical Oncology Conference, we presented practice-changing results for IMDELLTRA from the DeLLphi-305 study that evaluates IMDELLTRA plus IMFINZI versus IMFINZI alone as first-line maintenance treatment. The combination of IMDELLTRA to IMFINZI brought a median overall survival of 21.1 months versus 12.7 months with IMFINZI alone. The results are notable in a challenging clinical setting where current medicines deliver only a modest improvement in overall survival. Median follow-up at the data cutoff was 15.9 months, and we will report final survival benefit as these data mature. Longer follow-up of 30 months from the Phase Ib first-line maintenance study of IMDELLTRA with anti-PD-L1 therapy was also presented at ESMO, remarkably featuring a median overall survival of 37 months. These results are unprecedented in small cell lung cancer. The safety profile of IMDELLTRA in DeLLphi-305 was consistent with the clinical experience to date. Cytokine release syndrome and ICANS were primarily low-grade and occurred mostly after the first 2 doses. DeLLphi-305 permitted 1- to 2-hour monitoring time, which could support outpatient administration and broader uptake. Given the transformative benefit observed, we are now working to rapidly file with regulatory authorities around the world. If approved in first-line maintenance, IMDELLTRA could address the needs of 23,000 patients in the U.S. alone, importantly used earlier in the treatment journey and for a longer duration of therapy. We are pursuing a broad clinical program to establish IMDELLTRA as the cornerstone therapy for patients with small cell lung cancer. This program includes evaluating IMDELLTRA in earlier-stage disease, novel combinations, including antibody-drug conjugates, and in other DLL3 expressing cancers. Turning to TEZSPIRE, which targets TSLP, an upstream driver of inflammation in airways and other tissues, we recently presented positive results from the CROSSING study in eosinophilic esophagitis, or EoE. EoE is another epithelial driven eosinophilic inflammatory disease alongside severe asthma and chronic rhinosinusitis with nasal polyps. EoE affects more than 470,000 people in the U.S. Nearly half of patients with this devastating disease remain inadequately controlled with existing treatments. The Phase III CROSSING study evaluated TEZSPIRE in adolescents and adults with symptomatic, uncontrolled EoE. At week 24, the study met both co-primary endpoints, demonstrating improved histologic remission and improved swallowing symptoms compared with placebo. These benefits were sustained through week 52. This is the first time sustained efficacy through 52 weeks has been shown for a biologic in a placebo-controlled EoE trial. Multiple secondary endpoints were also met as TEZSPIRE improved measures of underlying inflammation, swallowing symptoms and endoscopic disease activity. Together with every 4-week dosing, these results support TEZSPIRE's potential as an important treatment option for patients with EoE and to add to the evidence for targeting TSLP across serious diseases driven by eosinophilic inflammation. For patients with Sjogren's disease, we are targeting CD40 ligand signaling with dazodalibep in 2 Phase III trials in systemic and in symptomatic disease. Sjogren's can affect multiple organ systems and cause persistent dryness, fatigue and pain. There are no approved disease-modifying therapies for Sjogren's disease. In systemic Sjogren's disease, we are excited by the positive, clinically meaningful results of dazodalibep in the placebo-controlled Phase III OASIZ-301 study. The study met its primary endpoint with statistically significant improvement from baseline ESSDAI of 5.6 points with monthly dosing and 5.2 points with quarterly dosing, or 1.8 and 1.4 point placebo-adjusted improvement, respectively. The treatment effect was observed as early as week 4 and sustained through the end of study at week 48. Importantly, dazodalibep also met key secondary endpoints for patient-reported dryness with statistically significant improvements in DASPRI and ESSPRI scores with monthly dosing. Dazodalibep was generally well tolerated, whether administered monthly or quarterly. We'll present the detailed data at ACR on November 11 and await the completion of our second Phase III study in symptomatic Sjogren's disease expected later this year. Beyond these 3 important Phase III advances, we recently reported at EADV the positive Phase II data for daxdilimab in primary discoid lupus, or DLE. Daxdilimab targets ILT7 to reduce plasmacytoid dendritic cells and address type 1 interferon mediated inflammation. DLE can cause permanent scarring, skin pigment changes and hair loss. In this study, both doses of daxdilimab met the primary endpoint with improvement in active skin disease observed as early as week 4 and sustained through week 24. At week 24, daxdilimab improved baseline CLASI-A by 10.2 points at the lower dose and 9.9 points at the higher dose. The corresponding placebo-adjusted CLASI-A improvements of 6.0 and 5.7 points, respectively, were both statistically significant. Daxdilimab was well tolerated with no serious adverse events or deaths reported. Based on these results, we are advancing daxdilimab into Phase III development. As you can see, we've been working hard to execute the late-stage portfolio and enjoyed terrific results this quarter. Elsewhere in the portfolio, we are focused on developing important new medicines in our late-stage pipeline. For patients with prostate cancer, we are rapidly advancing xaluritamig in both early-stage and advanced disease, extending the reach of our T-cell engager platform. For individuals with obesity and related conditions, we are advancing our comprehensive Phase III MARITIME development program. This quarter, we completed enrollment of both Phase III sleep apnea studies, our cardiovascular outcome study and initiated the first of 3 Phase III studies in type 2 diabetes. MariTide is emerging as the first monthly therapy for obesity, with the potential for as few as 4 or 6 doses per year. The MARITIME program is designed to establish how individuals can start and stay on MariTide and how others can switch from other GLP-1-based medicines and stay on MariTide. Our goal is to make long-term treatment easier for patients to sustain weight loss and enjoy durable health benefits. I'd like to thank my colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. I'll now turn it over to Thomas for the financial update. Thomas J. Dittrich: Thank you, Jay. As many of you know, this is my second chapter at Amgen. I spent nearly a decade here earlier in my career working with Bob and the team. Since then, I've served as CFO of 3 public companies with responsibilities spanning finance, strategy, transformation and operations. I also gained experience in a more consumer-focused health care environment and in a rare disease setting. So I come back to Amgen knowing the company well, but also looking at it with fresh eyes, informed by my experiences over the past 12 years. Today, I am pleased to join you for my first quarterly earnings call as Amgen's CFO. I look forward to maintaining Amgen's active engagement with the investment community and the financial discipline that investors expect. My top priorities are straightforward. One, working with my colleagues as a team to drive long-term growth through consistent execution of our strategy and operational efficiency. Two, maintaining Amgen's disciplined approach to capital allocation. You should expect continuity here as we balance investment in the best innovation and future growth with returning capital to shareholders. Let's now turn to our third quarter financial results. Our strong third quarter performance reinforces confidence in our 6 key growth drivers. Together, they reflect the breadth and depth of our business and continue to provide a strong foundation for durable growth well into the next decade. We continue to invest in advancing our pipeline while delivering strong operating results. In the third quarter, our non-GAAP operating margin was 47%. Non-GAAP R&D spending increased 11% year-over-year, driven by higher spend in research and early pipeline, including business development activity. We continue to invest in the innovation that will drive future growth, including MariTide, dazodalibep and xaluritamig as well as our marketed medicines, including IMDELLTRA, Repatha and UPLIZNA. SG&A expenses decreased 1% year-on-year, mainly driven by the timing of investments and to a lesser extent, our ongoing productivity efforts. We generated $3.7 billion in free cash flow, reflecting continued momentum across the business and enabling us to continue investing for future growth. Capital expenditures were $600 million in the quarter, including investments across our U.S. manufacturing sites in North Carolina, Ohio and Puerto Rico. We continue to expect capital expenditures of approximately $2.6 billion in 2026 to scale manufacturing capacity for commercial growth and to prepare for a potential MariTide launch. In addition, we returned capital to shareholders through attractive dividend payment of $2.52 per share, representing a 6% increase compared to the third quarter of 2025. Turning now to the outlook for the business for the remainder of 2026, we are pleased with the strength of our execution and are raising our 2026 guidance ranges for both revenue and non-GAAP EPS. We now expect 2026 total revenues in the range of $38.9 billion to $39.7 billion and non-GAAP earnings per share between $22.90 and $23.70. And let me highlight several additional guidance items. We now anticipate non-GAAP other income and expense to be in the range of $2 billion to $2.1 billion of expense in 2026. We continue to expect the full year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. As we look to the fourth quarter, we expect a meaningful sequential increase in operating expenses, consistent with our established pattern of higher spending in the final quarter of the year. Specifically, we expect a sequentially higher cost of sales margin due to changes in our sales mix and higher profit share expenses and higher SG&A expense due to the aforementioned timing of investments in the third quarter and continued investment in our marketed products. We expect other revenue to be approximately $1.9 billion for the full year. We expect a non-GAAP tax rate in the range of 15% to 16.5%. We expect share repurchases not to exceed $3 billion. Looking ahead to 2027, we do not anticipate a step-down in operating margin compared with our 2026 guidance. We will continue to allocate resources efficiently, balancing investment in growth with disciplined expense management. As we close out the year, we remain focused on executing our strategy, advancing our growth drivers, investing in the best innovation and maintaining our rigorous financial discipline that supports our ability to deliver durable growth well into the next decade. I am grateful to work with all our colleagues worldwide in our mission to serve patients. This concludes our financial update. I will now hand it over to Bob for Q&A. Robert Bradway: Okay. Let's open up the line for questions. And why don't you remind our callers of the procedure. Operator: [Operator Instructions] Our first question comes from Salveen Richter from Goldman Sachs. Salveen Richter: On the back of the positive Phase III results in systemic Sjogren's disease, could you help us think about the confidence or kind of handicap how we should think about the readout here in the symptomatic patients and then speak to the regulatory path for this program overall? James Bradner: Thanks, Salveen. This is Jay. We're delighted by the results of the systemic study 301 and the efficacy that we observed for both the primary endpoint on ESSDAI placebo-adjusted as well as the impact on secondary dryness are quite encouraging. It is hard to read through, though, from 301 into 303, the systemic to the symptomatic. These are different patient populations. They are being studied separately. And this is important to tease out the possibility of impact on these 434 patients in the 303 study. So we'll have more to say shortly after we see data in Q4 of this year. Regarding the regulatory path going forward, this is a very competitive space of late, which is good for patients because for years, there was very little progress. So really represents the first therapeutic to show efficacy in the systemic setting also on symptoms and durable out to end of study. So we have nothing to say here today, but we look forward to a consideration of these data. Operator: Our next question comes from Terence Flynn from Morgan Stanley. Terence Flynn: Great. Congrats on all the progress. I know, Thomas, you talked about some of the CapEx investments that you guys are making for ahead of the MariTide launch. Is there any consideration to maybe ramping down the biosimilars business to make even more capacity for that launch? Would that also be on the table? And then the kind of related question is, can you tell us, Jay, if you guys have access to the blinded tolerability data from the ongoing MariTide Phase III trials? Robert Bradway: I can answer that for you, Terence. It's Bob. Obviously, we consider all options when it comes to managing capacity. But we feel very confident about our ability to continue to be a reliable supplier of high-quality biosimilars. So that's not a strain for us and our capacity expansion is really designed for larger quantities of protein than what you're referring to with the biosimilars program. On the other question, Jay, do you want to take a shot? James Bradner: Sure. Thanks, Terence, for the question. We are, in 2026, just noses down with disciplined data generation on MariTide, and the MariTide studies are being carried out with a total adherence to good clinical practices. We'll have more to share around the efficacy and tolerability of MariTide at the time that these studies read out. Operator: Our next question comes from Akash Tewari from Jefferies. Akash Tewari: Hearing your team talk about the Phase III Sjogren's data versus Phase II in systemic, I think one of the things I've noticed is your team was surprised with the onset of effect, and it might have been better than what you saw in Phase II. Can you talk about what we are seeing on onset of effect with the systemic trial? And how that reads across to the symptomatic study that's coming up? And then just any comment on the MARITIME-PEN study. I know you just started a study looking at MariTide with an at-home autoinjector. What gave you the confidence to start that study now? And do we have any visibility on what autoinjector dose you would be having in that trial? James Bradner: Thanks. I'll take the question. This is Jay. As I shared a moment ago, we were delighted, but maybe not surprised by the impact of dazodalibep in Sjogren's disease. We were building on a very strong Phase II data set after all. The significant 1.8 placebo-adjusted improvement with monthly dosing on the ESSDAI and 1.4 on the Q12 week are in line with our expectations and strong results. And the effect on dryness as well, we were hoping and expecting to see as well. The read-through, I think I've already covered a moment ago, but you asked about onset. And here is a potential advantage of something that targets active inflammatory signaling like CD40 and CD40 ligand. We got a lot of experience at this company with B-cell depletion. And with B-cell depletion, there can be a delay in onset in some circumstances, though many diseases, we haven't experienced that with UPLIZNA. So to see effect at week 4 is highly consistent with our mechanistic thesis, that as an inhibitor of CD40 ligand, CD40 signaling, you have this chance for an immediate inhibition on B-cell-driven inflammation. But moreover, as CD40 is also highly expressed on salivary gland, ductal epithelial cells and can, therefore, drive local inflammation through interaction with activated T-cells or otherwise, it could be sensible that dazodalibep would work as early as 4 weeks where we saw statistically significant improvement already that prove durable through the end of study. So thanks for calling out that feature. It is a nice feature of a molecule directed at an active signaling pathway that it might, in some circumstances, work faster. Robert Bradway: Akash asked the second question about the autoinjector. Obviously, we've got a ton of experience with autoinjectors, Akash. So I don't think there's anything particularly interesting about the study that you're referencing. But Jay, feel free to add anything more if you'd like. James Bradner: No. We've been pretty consistent in sharing that MariTide is expected ultimately to be delivered in a patient-friendly single-chamber handheld autoinjector. We have significant experience here, as Bob shared. We've taken a fairly standard approach to its development and going well so far. Robert Bradway: Okay. Let's go to the next question and maybe just remind our callers so that we can try to get to everybody tonight, if you could hold yourself to one question, that would be great. Casey and his team will be around and all of us are available if you have other questions you need to get in front of us later in the day. But let's go ahead to the next caller. Operator: Our next question comes from Michael Yee from UBS. Michael Yee: One question for Bob. Bob, Amgen has been quieter, I guess, on the M&A front in a period of record M&A deal making. Could you just comment about your perspective about what you think is going on? Is your desperation factor not high? You're very busy. Maybe you're just more excited about what you've got. Maybe just talk a little bit about that. And whether we should or should not necessarily continue to expect bolt-ons or whatever you're thinking? Robert Bradway: Well, I'm not sure, Michael, that I would acknowledge the premise of the question, but what I would say is our business development focus is very consistent. As we've said for some time, we're looking for opportunities that align well with our 4 therapeutic areas of focus. We're focused on delivering consistent long-term growth, and we feel confident we're on track to do that through time. Obviously, a meaningful portion of our revenues come from molecules that we license or acquired, and I think that will continue to be true through time. So we would like to think that we're disciplined, Michael, in the way that we allocate capital, both internally and externally. And I'd like to think when -- particularly when we go externally that we see a path for our shareholders to earn a return and not just for the selling shareholders to earn a return. Operator: Our next question comes from Yaron Werber from TD Cowen. Yaron Werber: So maybe a quick question on the upcoming Sjogren's data. The efficacy looks very good on a monthly and Q3 months. DASPRI is sort of a new endpoint that you're validating from the Phase II. Is that going to support the U.S. filing while ESSPRI is going to support the European filing for the symptomatic study? And then if you don't mind, can you file for both Q4 and Q3 months, given they both hit on the primary, but only [indiscernible] months hit on the secondary in the first study on dryness? James Bradner: Yaron, thank you, especially in between the readouts of these 2 Phase IIIs, we're probably not going to go deep today on our full regulatory strategy. But you are correct that there are different preferences around endpoints in the U.S. and rest of world, and we've taken this very much to the heart in the design of these 2 studies in the primary and secondary endpoints. Operator: Our next question comes from Chris Schott from JPMorgan. Christopher Schott: Just had a question on IMDELLTRA. Can you just elaborate a little bit more about how you're thinking about the opportunity unlocked with the 305 data. And maybe as part of that, how quickly you believe the product can ramp following the ESMO data? As part of that answer, can you just talk about the reduced monitoring requirements for the drug as well? I'm trying to get a sense of how much of a hurdle monitoring had been for uptake in the later line settings, that obviously seems to be addressed in this earlier line setting as well. Murdo Gordon: Thanks, Chris. It's Murdo here. So on the monitoring, we've got an improvement already just approved by the FDA that's now in our label in the second-line setting, with monitoring of less than 6 hours now. So that improves from the 22 to 24 hours that were in the original label, and now we're in a much shorter monitoring period. So that's already helping the ability for primarily community oncology clinics to be able to initiate second-line patients with IMDELLTRA. When -- as Jay mentioned, in the 305 study, the monitoring actually goes down to 1 to 2 hours. And so there will be, hopefully, a further improvement in the label as we extend that to the frontline maintenance indication. And then IMDELLTRA becomes a very straightforward, very simple product to initiate in that frontline maintenance setting with, obviously, a profound survival benefit to be had. So I think this is a medicine, given how novel it is, that we've been very careful to ensure patient safety. We're now evolving in our understanding of it. And as with BLINCYTO, as we've moved into earlier disease settings, we see that this is a much, much better tolerated medicine. We really only have 1 patient in DeLLphi-305 with cytokine release syndrome of grade 3. All the other patients that experienced cytokine release syndrome experienced grades 1 and 2. So what does that mean for the opportunity? Well, it means that we believe we've established a new cornerstone therapy. We believe that nothing else thus far in the category has been able to demonstrate the kind of profound overall survival effect that we have. And I would expect that with things like updated NCCN guidelines with additional awareness of these data, the behavior change in the clinic will be rapid. Obviously, we're moving as quick as we can to ensure regulatory filings and approvals and all the rest of it, but we are ready to support the rate of change that clinicians will effect. I'll just say, I've been talking to our field medical teams who have been out there this week and last week post the presentation of the data at ESMO. And I'm not alone in my enthusiasm for these data. Our practicing oncologists are blown away by just the magnitude of effect and the safety profile that we're seeing now in an earlier disease setting. Operator: Our next question comes from Umer Raffat from Evercore ISI. Umer Raffat: I just wanted to echo the sentiment from ESMO on the groundbreaking data. Murdo, maybe just to expand on Chris' question and just to make it easier for investors to understand the magnitude of what we're dealing with here. Is it possible or is it realistic for us to assume something approaching 20,000-plus patients in U.S. being on tarlatamab? And do you envision the maintenance opportunity in first-line alone being $5 billion plus with induction trial next year adding additional upside? Murdo Gordon: Well, Umer, I think you know me by now and you know the Amgen team by now that we don't issue product-specific guidance. But you can tell from the answer to Chris' question, that we're extremely excited about the data set that have been generated here. The opportunity is definitely an interesting one given how rapidly patients progress on in this disease area. And so in second line, you're quite limited as to the addressable patient population. Because, unfortunately, not many patients make it to second line, their disease progresses too rapidly, and they end up in hospice and they end up dying. And so, as you move into the earlier lines, the small cell lung cancer addressable population in the U.S. is 35,000. So, it's a decent size patient population. The question is, how big is it in each setting and frontline maintenance. But as I said to Chris, this is going to be a very rapid adoption, and we're going to see, hopefully, many patients on IMDELLTRA for a long period of time. And so the duration of treatment here might be quite long as well. And I would like to turn it over to Jay on other clinical development work that we're doing on the molecule. James Bradner: Yes. Thanks, Umer. The development of IMDELLTRA remains a source of real activity here at Amgen. We're working hard to complete the limited stage small cell lung cancer study that is an event-driven study as well now having seen the benefit of IMDELLTRA used in the maintenance setting of frontline induction and maintenance use of IMDELLTRA. We've completed, as you may know, a study of IMDELLTRA establishes an alternate dosing capability. And this is very helpful as we start to imagine combinations of IMDELLTRA with emerging agents such as antibody drug conjugates. IMDELLTRA is showing dramatic data when with chemotherapy, and there's every expectation then that ADCs delivering chemotherapy should be comparably active. And we have undertaken studies with B7-H3 and DLL3, and we'll have more to share there in the future. But just as Murdo said, not only do these combinations and advances in the use of IMDELLTRA as a cornerstone of small cell lung cancer therapy lead to increased response rates, but durability. And we're very hopeful that as the data from the DeLLphi study presented in the presidential at ESMO and published in the New England Journal recently that as these data mature, that patients will reveal to us the full benefit of the medicine. The Phase Ib frontline maintenance study DeLLphi-303 that was also presented at ESMO has matured. And with a median follow-up of 30.8 months, we saw a median overall survival of 37.9 months, which is just unheard of in this disease setting. So we're very pleased with the development so far, but we have a lot of wood to chop for these patients going forward. Operator: Our next question comes from David Amsellem from Piper Sandler. David Amsellem: So I have a daxdilimab question. On the Phase III, are you going to explore a broader cutaneous lupus population? Or will it be specific to discoid lupus? That's number one. And then just thinking about this market, can you talk about sizing in terms of how you think about cutaneous lupus in that population relative to the SLE population and how these are 2 distinct populations and how that informs your physician targeting? Is this a dermatology call point or a rheumatology call point or a bit of both? James Bradner: Thanks for the question. I'll start, Murdo, and maybe you can weigh in on the outlook for the medicine. Thanks for asking about daxdilimab. We're very pleased with the activity observed so far in discoid lupus, a prevalent disease, 20 to 50 humans per 100,000 and 5% to 10%, they progress to SLE. You surely appreciate that there have been innumerable mechanisms of action that have failed patients with lupus in its various manifestations. And in our Phase II study, the effect on CLASI-A, where an improvement from 7 points from baseline is considered clinically meaningful broadly in this population of those greater than equal to 8 at baseline. Improvements that we saw were negative 10 and negative 9.9 for the lower and the higher doses at week 24. And so we're very taken with this medicine in the cutaneous manifestations of lupus. We have not as yet described completely our Phase III design, and we will do that in the future. But it's not lost on us that we've stumbled upon a very exciting and hopeful mechanism targeting these plasmacytoid dendritic cells in this disease. Murdo? Murdo Gordon: No, I would just add that the prescribing population of physicians here, primarily dermatologists, which obviously, we have good Amgen capabilities and experience there. And for the few rheumatologists that will pick it up again, we have strong medical and field commercial teams covering those customers. Operator: Our next question comes from Evan Seigerman from BMO Capital Markets. Evan Seigerman: I think, Jay, when we met in the small group meeting back in September, you suggested that although MariTide is administered monthly or even less frequently, the side effect duration is comparable in length to what you get with weekly incretins. I would love it if you expand more on how you can measure that in kind of a Phase 1 of any of your trials? And more broadly, just given how much the space in obesity is rapidly evolved even since then, remind us how MariTide fits within kind of this evolving landscape. James Bradner: Thanks. Why don't I start to talk, Murdo, about the interesting and reassuring if not exciting, dissociation between the pharmacokinetics of MariTide and the duration of symptomatology, if you could pick up the back half of the question about segmentation. First, I would just say, irrespective of why I think it is true, it is true that this medicine that has a very long half-life designed for tonic activation of GLP-1 receptors as well as inhibition of GIP receptors, that has conferred activity for weight loss in type 2 diabetes with monthly dosing, every 8-week dosing and as we described, every 12-week dosing. It is a fact borne out of prospective clinical investigation that though the durable disease activity of the medicine is quite long-lived like the molecule, the symptoms aren't. This is true also for a weekly injectable GLP-1 peptides. And so we're not surprised to see it. Now how do we measure it, you asked. Here, we've done very exhaustive diaries in early phase clinical investigation to understand the onset, frequency, severity and duration of symptoms. We've shared some of these early plots that we call Manhattan plots that reveal the duration of symptoms should they arise. To date, MariTide has proven very well tolerated its target doses and like all GLP-1s benefits from dose escalation. But the durable activity of the medicine does not come with a durable side effect profile, where side effects to date are were observed mostly mild, sometimes moderate and rather short-lived for a few days. Murdo? Murdo Gordon: Yes, it's an interesting observation, Evan, on the amount of activity in this category. There are certainly a lot of daily orals being developed. There's a lot of weekly injectable being developed, some even trying to stretch to monthly. But what we've not seen is a bona fide monthly drug in development that could be dosed as infrequently as 6x or 4x a year. And we continue to believe that MariTide is unique and differentiated in that aspect. It's a simple 3-step dose escalation, 2 months, you're up to your first maintenance dose and then you can find the most convenient dose for your weight loss journey thereafter. So I feel like we've got a compelling offering. We're obviously looking forward to seeing the Phase III data when they read out. And we're excited about coming into the market and helping many, many patients reach their weight loss goals. We've also got a broad clinical program, as you know, and that means that we'll also be able to help patients with type 2 diabetes and ASCVD and sleep apnea among others. Operator: Our next question comes from Geoff Meacham from Citi. Geoffrey Meacham: I had a similar one for Jay or for Murdo. So ahead of the MariTide data next year, I wanted to ask how you guys are thinking about the commercial approach. So mostly thinking about the dynamics of the new Medicare bridge program, payer receptivity, how you're thinking about the OUS markets in advance of data? Murdo Gordon: Thanks for the question, Geoff. Look, I think I would start first with we're very focused on making sure that consumers and patients are very much in the focus of our go-to-market strategy. I think what we've seen in this category is that patients have a much more important role to play in activating and advocating for their own care and their own weight loss journey. So first and foremost, that is absolutely the priority. We will scale and size accordingly. We obviously have a great cardiometabolic team here at Amgen, and we'll be ready to go to market with MariTide. I think on the access and reimbursement front, we expect our unique differentiated profile to help secure access and coverage. And obviously, we're interested in seeing what other government access programs evolve to over time. I think it's good that we've got Medicare access in this category. I think it should be expanded. Ex U.S., I think is going to be tougher. I think it's going to continue to be very much a consumer-driven market ex U.S. But we are hopeful with outcomes data in ASCVD and with type 2 diabetes data and other "hard endpoint" clinical programs then that we will be able to secure reimbursement in many markets outside the U.S. as well. Robert Bradway: Okay. Let's take 2 more questions, and then we'll, as I said earlier, be available if some of you who didn't get a chance to ask questions on the call. Let's go 2 more. Operator: Our next question comes from Matt Phipps from William Blair. Matthew Phipps: Congrats on a good quarter. With both the OPDIVO and KEYTRUDA BLA filed, just curious what your assumptions are around being able to -- when you can commercially launch those? And how do you think about penetrating the market that is kind of being moved a subcutaneous formulation? Robert Bradway: Yes. Obviously, this is a competitive space here. So we're not going to have a whole lot to share with you at this point, Matt. But as you heard from Murdo's remarks, our focus is on developing these medicines, having them available for patients. And again, we've established a pretty good track record here as a leader in biosimilars. But Murdo, feel free to jump in if you want to add any further color? Murdo Gordon: Well, as we always say about our focus on biosimilars will be a first or first wave with those launches, which is really important to establish a decent competitive position, and we believe that we're there. Robert Bradway: All right. Let's go to the last question, please. Operator: Our last question comes from Alex Hammond from Wolfe Research. Alexandria Hammond: So unlike small cell lung cancer, a large share of prostate cancer care occurs in the urology groups and community practices that have low experience managing CRS. So I guess, how are you planning to bring value to make those sites? And how much could the fully outpatient cohort or subcu version change that? And I guess, also how important is it to not need a biomarker to help adoption compared to other treatments that require them? Robert Bradway: Terrific. Thanks for the question. Jay, why don't you share your thoughts? James Bradner: Yes. I'll share on the back two sides. And Murdo, perhaps you could talk about implementing T-cell engagers, where we just have so much experience, truly a leading company in the sector. So for sure, helping the adoption of this medicine is experience with it and building a comfort with T-cell engagers as a therapeutic isn't as much about the doctor as it is about the care environment, I can say as a doctor. The reduced monitoring will go a long way to helping as well as a fully outpatient cohort, which we have presented at ESMO in Phase Ib, which demonstrated for xaluritamig, our STEAP1 CD3 bispecific that you referenced, the feasibility for a more convenient administration setting. I will say this is not trivial, but those same centers approach many other nontrivial medicines, and so we have every expectation that through clinical investigation as well as evidence generation, we will establish confidence and comfort for prescribing urologists as needed. You sort of threw me the basketball right under the hoop with your question around biomarkers, it helps a lot to not need a biomarker in order to enroll patients and bring access to a medicine. We have some medicines that, of course, require it. But here, the quite high, if not characteristic, expression of STEAP1 in prostate cancer affords a chance to bring this medicine to patients without the need for stratification or qualification by a confirmatory biomarker. Murdo? Murdo Gordon: Yes. We've got obviously extensive experience, as Jay mentioned, in bringing bispecific T-cell engagers into different therapeutic context. We've learned a lot from our work in hematology with BLINCYTO, now in solid tumor with IMDELLTRA. And we have established an actual field organization, we call our bispecific operations team who help with the operationalization in clinics on how to make sure that patients get the appropriate monitoring, the appropriate information at point of care. So, that team is up and running. We've had it since before the launch of IMDELLTRA. We're now running at scale for IMDELLTRA, and we would apply that to the GU oncology space as well. We've established a field medical presence with these customers and these clinicians. And we also partner very closely with patient advocacy organizations. This was a key success factor in small cell, where the patient advocates are very good at making patients aware of how to self-monitor and how to identify any type of side effect profile that could be side effect profile related to cytokine release syndrome. So really a lot of experience being applied to the GU space that I think will be very helpful in ensuring patient safety and ease of adoption. Robert Bradway: All right. Well, thank you all for joining our call. I think I can speak for the group here that we're heartened by your focus on sources of long-term growth that have emerged with clinical data over the last few weeks. As again, I hope you can appreciate business is performing well, the leadership executing well, and we're looking forward to finishing the year strong. And we all look forward also to gathering with all of you next year to review the fourth quarter and to get launched into 2027. So thanks for your support. We'll talk to you soon. Operator: This concludes our Amgen Q3 2026 Earnings Conference Call. You may now disconnect.