Amgen (NASDAQ:AMGN) reported third-quarter financial results on Tuesday. Benzinga APIs provide real-time access to earnings call transcripts and financial data.
Full TranscriptJulieann (Operator)My name is Julieann and I will be your conference facilitator today for the Amgen Q3 2026 earnings conference call. All lines have been placed on mute to prevent any background noise.
There will be a question and answer session at the conclusion of the last speaker’s prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q and A session.
To withdraw your question, please press Star one again. I would now like to introduce Casey Caporelli, Vice President of Investor Relations.
Mr. Casey Caporelli (Vice President of Investor Relations)Thank you, Julieann.
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 Dietrich.
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. Bob Bradway (Chairman and Chief Executive Officer)Good afternoon and thank you for joining our call.
Our results through the first three 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.
4 billion. Our six 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.
Repatha, Evenity and Tezspire are clear examples of that. Our strong financials give us the flexibility to invest in innovation and the capabilities needed to support future growth while delivering attractive returns to shareholders.
This was another productive quarter for our R&D organization. We reported positive Phase 3 results from three 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 Sjögren’s disease, where no approved disease-modifying therapies currently exist.
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 3 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. Our broad portfolio and continued investment in the advancing pipeline give us confidence in Amgen’s ability to deliver durable growth well into the next decade.
Murdo Gordon (Executive Vice President Global Commercial Operations)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 inline portfolio.
We’ve seen important positive clinical readouts, regulatory milestones, and record sales performance for several of our key medicines. 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 six 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.
1 billion in third-quarter sales, growing 37% year over year. 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.
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.
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. One in two patients who experience 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. Moving to inflammation, Tezspire sales grew 43% year over year, reaching $538 million, driven by strong demand in severe uncontrolled asthma.
S. new-to-brand prescriptions growing 15% year over year versus 3% market growth.
S. The consistent flow of strong clinical data continues to reinforce Tezspire’s differentiated efficacy across inflammatory diseases.
Phase 3 results in chronic rhinosinusitis with nasal polyps demonstrated improvements in disease control and a reduction in need for surgery. 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 offers a highly differentiated clinical profile combining outstanding efficacy that resonates with physicians and convenient twice-yearly dosing that benefits patients.
S. Adoption is expanding among both biologic-naive patients and those transitioning from other therapies, reinforcing our confidence in Uplizna’s potential to establish market leadership in this category.
In IgG4-related disease, long-term follow-up data from the Phase 3 Mitigase study continued to reinforce Uplizna’s durable efficacy profile. These durable results, together with growing disease awareness and improved diagnosis, support our confidence in Uplizna’s potential to reach many more patients.
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.
Our biosimilar portfolio delivered 26% year-over-year growth, generating $977 million in sales in the third quarter. Pablo, our biosimilar to Eylea, increased sales 41% year over year to $300 million in the quarter.
Retina specialists recognize the benefits of Pablo’s convenient pre-filled syringe presentation, supported by Amgen’s established capabilities in biosimilar manufacturing and supply. 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.
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.
Imdelltra also offers convenient every-two-week dosing following the initial step-up period. We’re making progress in reducing the burden of treatment.
The FDA recently shortened the recommended monitoring period for the first two doses from 22 to 24 hours to just six to eight hours. 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 3 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 magnitude of these results is difficult to overstate.
More than eight additional months of median overall survival represents an extraordinary advance for patients facing this devastating disease. 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.
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Thank you, Myrto, and good afternoon.
This quarter we reported three positive Phase 3 readouts across three serious diseases: IMDELLTRA in small cell lung cancer, Tezspire in eosinophilic esophagitis, and Dazodalibep in Sjögren’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.
As Myrto 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 arising 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 results are notable in a challenging clinical setting where current medicines deliver only a modest improvement in overall survival. 9 months, and we will report final survival benefit as these data mature.
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 two doses. DeLLphi 305 permitted one- to two-hour monitoring time, which could support outpatient administration and broader uptake.
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. 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.
The Phase 3 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.
Together with every-four-week dosing, these results support Tezspire’s potential as an important treatment option for patients with EoE and add to the evidence for targeting TSLP across serious diseases driven by eosinophilic inflammation. For patients with Sjögren’s disease, we are targeting CD40 ligand signaling with Dazodalibep in two Phase 3 trials in systemic and in symptomatic disease.
Sjögren’s can affect multiple organ systems and cause persistent dryness, fatigue, and pain. There are no approved disease-modifying therapies for Sjögren’s disease.
4-point placebo-adjusted improvement, respectively. The treatment effect was observed as early as week four and sustained through the end of study at week 48.
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 3 study in symptomatic Sjögren’s disease expected later this year.
Beyond these three important Phase 3 advances, we recently reported at EADV the positive Phase 2 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. 9 points at the higher dose.
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 3 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.
This quarter we completed enrollment of both Phase 3 sleep apnea studies, our cardiovascular outcome study, and initiated the first of three Phase 3 studies in type 2 diabetes. MariTide is emerging as the first monthly therapy for obesity with the potential for as few as four or six doses per year.
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.
Thomas Dietrich (Chief Financial Officer)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 three public companies with responsibilities spanning finance, strategy, transformation, and operations.
I also gained experience in a more consumer-focused healthcare environment and in a rare disease setting. Today I am pleased to join you for my first quarterly earnings call as Amgen 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: 1) Working with my colleagues as a team to drive long-term growth through consistent execution of our strategy and operational efficiency.
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 six 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%.
We continue to invest in the innovation that will drive future growth including MariTide, Dasodalimab, and Zaleiridomic, 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.
7 billion in free cash flow, reflecting continued momentum across the business and enabling us to continue investing for future growth. S.
manufacturing sites in North Carolina, Ohio, and Puerto Rico. 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. 70.
And let me highlight several additional guidance items. 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. 9 billion for the full year.
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.
I am grateful to work with all our colleagues worldwide in our mission to serve patients. This concludes our financial update.
Bob Bradway (Chairman and Chief Executive Officer)Okay, let’s open up the line for questions. Julieann (Operator)Thank you.
If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by one again.
To ask a question, press star one. Our first question comes from Salveen Richter from Goldman Sachs.
Please go ahead. Salveen Richter (Analyst at Goldman Sachs)Thanks.
Good afternoon. On the back of the positive phase 3 results in systemic Sjogren’s disease, could you help us to 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 paths for this program overall?
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)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 SDI 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’re being studied separately. We’ll have more to say, surely, 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. Dazo really represents the first therapeutic to show efficacy in the systemic setting also on symptoms and durable out to end of study.
Julieann (Operator)Thank you, Salveen. Our next question comes from Terrence Flynn from Morgan Stanley.
Please go ahead. Terrence Flynn (Analyst at Morgan Stanley)Great.
Thanks for taking the questions, and congrats on all the progress. I know, Thomas, you talked about some of the capex investments that you guys are making 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?
Bob Bradway (Chairman and Chief Executive Officer)I can answer that for you, Terrence. 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 at the biosimilars program.
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Sure.
Thanks, Terrence, 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 total adherence to good clinical practices.
Bob Bradway (Chairman and Chief Executive Officer)Next question, please. Julieann (Operator)Our next question comes from Akash Tewari from Jefferies.
Please go ahead. Akash Tewari (Analyst at Jefferies)Hey, thanks so much.
Hearing your team talk about the phase 3 Sjogren’s data versus phase 2 and 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 2. 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?
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 E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Thanks.
I’ll take the questions. 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 2 data set.
4 on the Q12 week are in line with our expectations and strong results, and the effect on dryness as well. The read-through I think I’ve already covered a moment ago, but you asked about onset, and, you know, 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 in many diseases we haven’t experienced that with UPLIZNA. 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 four weeks, where we saw statistically significant improvement already that proved durable through the end of study.
So thanks for calling out that feature. Bob Bradway (Chairman and Chief Executive Officer)Akash asked a 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. James E.
Bradner (Executive Vice President of R&D, and Chief Scientific Officer)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.
Bob Bradway (Chairman and Chief Executive Officer)Okay, let’s go to the next question, and maybe just remind our callers so 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.
Julieann (Operator)Our next question comes from Michael Yee from UBS. Please go ahead.
Michael Yee (Analyst at UBS)Great, thanks. One question for Bob.
Bob, Amgen has been quieter, I guess, on the M&A front in a period of record M&A dealmaking. 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? Bob Bradway (Chairman and Chief Executive Officer)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 four 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.
So we 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.
Great. Julieann (Operator)Our next question comes from Jeroen Werber from TD Cowen.
Please go ahead. Jeroen Werber (Analyst at TD Cowen)Great, thanks so much.
So maybe a quick question on the upcoming Sjogren’s data. The efficacy looked very good on Q monthly and Q3 months.
CLASI is sort of a new endpoint that you’re validating from the phase 2. Is that going to support the US filing while ESPRIT is going to support the European filing for the symptomatic study?
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Jeroen, thank you.
Especially in between the readouts of these two phase 3s, 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 US and rest of world. Julieann (Operator)Our next question comes from Chris Schott from JPMorgan.
Please go ahead. Chris Schott (Analyst at JPMorgan)Great.
Thanks so much. 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, just can you also talk about the reduced monitoring requirements for the drug as well?
That obviously seems to be addressed in this earlier line setting as well. Murdo Gordon (Executive Vice President Global Commercial Operations)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 six 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.
As Jay mentioned in the 305 study, the monitoring actually goes down to one to two 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, you know, 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 had one patient in Delphi 305 with cytokine release syndrome of grade 3. 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. But we are ready to support the rate of change that clinicians will effect.
You know, I’ll just say, you know, I’ve been talking to our field medical teams who have been out there this week and last week post presentation of the data at ESMO. And you know, I’m not alone in my enthusiasm for these data.
Julieann (Operator)Our next question comes from Umar Rafat from Evercore ISI. Please go ahead.
Umar Rafat (Analyst at Evercore ISI)Hi guys. Thanks again for taking my question.
And I just wanted to echo the sentiment from ESMO on the groundbreaking data. Murdo Gordon (Executive Vice President Global Commercial Operations)Well, Umer, I think you know me by now and you know the Amgen team by now that we don’t issue, you know, product-specific guidance, but you can tell from the answer to Chris’s question that we’re extremely excited about the data set that have been generated here.
You know, the opportunity is definitely an interesting one given how rapidly patients progress in this disease area. 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 US is 35,000. So it’s a decent-sized patient population.
The question is how big is it in each setting in frontline maintenance. And so the duration of treatment here might be quite long as well.
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Yeah, 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 that establishes an alternate dosing capability. IMDELLTRA is showing dramatic data when combined 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.
9 months, which is just unheard of in this disease setting. Julieann (Operator)Our next question comes from David Amsellem from Piper Sandler.
Please go ahead. David Amsellem (Analyst at Piper Sandler)Hey, thanks.
So I have a Daxilumab question on the phase 3. 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 two distinct populations and how that informs your physician targeting?
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Thanks for the question.
I’ll start, Murdo, and maybe you can weigh in on the outlook for the medicine. Thanks for asking about Daxilumab.
We’re very pleased with the activity observed so far in discoid lupus—prevalent disease, 20 to 50 per 100,000—and 5 to 10% may progress to SLE. You surely appreciate that there have been innumerable mechanisms of action that have failed patients with lupus and its various manifestations.
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.
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. Julieann (Operator)Our next question comes from Evan Segerman from BMO Capital Markets.
Please go ahead. Evan Segerman (Analyst at BMO Capital Markets)Hi guys.
Thank you so much for taking my question. I think, Jay, when we met in that 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.
James E. Bradner (Executive Vice President of R&D, and Chief Scientific Officer)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 a fact borne out of prospective clinical investigation that though the durable activity of the medicine is quite long lived, like the molecule, the symptoms aren’t. This is true also for weekly injectable GLP1 peptides.
And so we’re not surprised to see it. Now how do we measure it, you ask 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.
Today, MariTide has proven very well tolerated at its target doses and, like all GLP1s, benefits from dose escalation. Murdo Gordon (Executive Vice President Global Commercial Operations)Yeah, 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 injectables being developed, some even trying to stretch to monthly. But what we’ve not seen is, you know, a bona fide monthly drug in development that could be dosed as infrequently as six times or four times a year.
It’s a simple three-step dose escalation, two 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 3 data when they read out and we’re excited about coming into the market and helping many, many patients reach their weight loss goals. Julieann (Operator)Our next question comes from Jeff Meacham from Citi.
Jeff Meacham (Analyst at Citi)Hey guys, thanks for taking the question. 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. S.
markets in advance of data. Murdo Gordon (Executive Vice President Global Commercial Operations)Thanks for the question, Jeff.
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 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.
S. Bob Bradway (Chairman and Chief Executive Officer)Okay, let’s take two more questions and then we’ll, as I said earlier, be available.
Some of you didn’t get a chance to ask questions on the call. Julieann (Operator)Our next question comes from Matt Phipps from William Blair.
Please go ahead. Matt Phipps (Analyst at William Blair)Thanks for taking my question.
Congrats on a good quarter with both the Opdivo and Keytruda BLAs 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 to subcutaneous formulation.
Bob Bradway (Chairman and Chief Executive Officer)Yeah, 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, a leader in biosimilars.
Murdo Gordon (Executive Vice President Global Commercial Operations)Well, as we always say about our focus on biosimilars, we’ll be first or first wave with those launches, which is really important to establish decent competitive position. Julieann (Operator)Our last question comes from Alex Hammond from Wolfe Research.
Please go ahead. Alex Hammond (Analyst at Wolfe Research)Hey guys, thanks for squeezing me in.
So unlike small cell lung cancer, a large share of prostate cancer care occurs within urology groups and community practices that have little experience managing CRS. So I guess how are you planning to bring Zaloridomig to those sites?
And how much could the fully outpatient cohort or subcutaneous version change that? Bob Bradway (Chairman and Chief Executive Officer)Terrific.
Thanks for the question. James E.
Bradner (Executive Vice President of R&D, and Chief Scientific Officer)Yeah, 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 the 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 will say this is not trivial, but those same centers approach many other non-trivial 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. We have some medicines that of course require it, but here, however, 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 Gordon (Executive Vice President Global Commercial Operations)Yeah, we’ve got obviously extensive experience, as Jay mentioned, in bringing bispecific T cell engagers into different therapeutic contexts. We’ve learned a lot from our work in hematology with Blincyto, now in solid tumor with Imdelltra.
So that team is up and running. We’ve had it since before the launch of Imdelltra.
We’re now running it 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 a side effect profile related to cytokine release syndrome. Bob Bradway (Chairman and Chief Executive Officer)All right, well thank you all for joining our call.
Julieann (Operator)This concludes our Amgen Q3 2026 earnings conference call. While we strive for accuracy, there may be errors or omissions in this automated transcription.
For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.
