Amgen Inc. (AMGN) Earnings Call Transcript & Summary

Hello. My name is Krista, and I will be your conference facilitator today for Amgen's Investor Call from the European Society for Medical Oncology Congress 2026. [Operator Instructions] I would now like to introduce Casey Capparelli, Vice President, Investor Relations. Mr. Capparelli, you may begin.

Thank you, Krista, and thank you all for joining our call from ESMO here in Madrid. The slides that we'll be reviewing are now available on our Amgen IR website. Please see Page 5 of the slides that accompany this presentation on our safe harbor statement. I'll now turn it to Murdo Gordon to get us started.

Casey, thank you, and thanks, everybody, for being on the call this evening or this afternoon, if you're on the West Coast of the United States. It's our pleasure here at Amgen to host this discussion, which will recapitulate some really exciting and important data that were presented, as Casey mentioned, here in Madrid at the '26 edition of the ESMO medical congress. So joining me this evening is our Head of Oncology Development, Jean-Charles Soria, our Senior Vice President of Oncology Global Development. Also joining me is Kave Niksefat, our Senior Vice President of Global Markets and Access. And we're privileged to be joined by Dr. Charles Rudin, Director of the Memorial Sloan-Kettering Cancer Center, who's one of the world's preeminent small cell lung cancer physician researchers, who joins us to lend us perspective. Dr. Rudin led the pivotal second-line Phase III DeLLphi-304 study that established IMDELLTRA as a standard of care for relapsed small cell lung cancer and is here today to provide his perspective on the first-line maintenance Phase III study, the DeLLphi-305 results that were presented just a few hours ago here in Madrid. And of course, Casey will be here to answer questions as well, who you are all familiar with. Today is one of those days where, at Amgen, we are able to live the company mission. And our mission at Amgen is very simple. It's to serve patients. And in my experience, I've been to many congresses and many ESMO meetings over the last few decades, but this meeting has been a special one, an extremely special one. And today was the kind of day that, here at Amgen, we all appreciate because it allows us to fulfill that company mission, that allows us to work on a devastating type of cancer in that small cell lung cancer and transform survival expectations. Our BiTE platform has demonstrated transformative survival benefit in hematologic malignancies and now in solid tumors. IMDELLTRA clearly demonstrates durable survival benefit in small cell lung cancer. IMDELLTRA is becoming the cornerstone therapy for extensive stage small cell lung cancer, regardless of the combination choice, including PD-L1s. We have a broad global development program that has the potential to further expand the impact that IMDELLTRA can have on patients. And our innovative oncology portfolio is well positioned as one of our core 6 key growth drivers. And so it is our pleasure to be able to delve into these data with a bit more detail. Now before we do that, just a reminder of the strength of Amgen's portfolio of first-in-class and best-in-class medicines with Repatha in cardiovascular disease, EVENITY in osteoporosis, TEZSPIRE in severe asthma and nasal polyps, and soon, esophagitis. UPLIZNA for rare autoimmune diseases, BLINCYTO in ALL, and IMDELLTRA in small cell lung cancer. We're committed to delivering these first-in-class and best-in-class medicines. We have a broad innovative pipeline across these therapeutic areas. And these differentiated medicines are in leadership positions in populations with strong opportunities where we address significant unmet need. In oncology, of course, BLINCYTO and IMDELLTRA illustrate our ability to translate biology and deep biological insight into differentiated medicines. And just as a reminder, as we reported our second quarter results, we have a very strong portfolio with these medicines, delivering over 26% year-over-year in Q2 and comprises now 70% of our second quarter sales. So we are definitely building strong momentum with these growth drivers. We are enthusiastic about the outlook given the momentum for these patients -- for these products with patients that still continue to be underserved across these diseases. So without further ado, I do want to transition to Jean-Charles so that we can delve deeper into the [ meat ] of our program.

Thank you. Amgen oncology R&D strategy is focused on delivering differentiated and transformative therapies for patients with hard-to-treat solid tumors and hematological malignancies. Our strategy is anchored in 2 core pillars: the T-cell engagers and precision therapies, which include small molecules directed at difficult-to-drug targets and antibody drug conjugates. Today we will focus on the T-cell engager platform called BiTE. T-cell engagers are bispecific antibodies that physically connect the patient's T-cell directly to cancer cells, forcing an artificial synapse that allows the immune system to recognize and destroy the tumor. One arm of the T-cell engager, which is an antibody, latches onto a specific protein, which is a tumor-associated antigen, on the cancer cell, while the other arm of this bispecific antibody binds to the CD3 receptor on the T cell. This close physical link activates the T cell to release cytotoxic molecules that will kill the cancer cell or aim at least at killing the cancer cell. At Amgen, we are pioneers of [ BITE ] medicines. The column on the left is where we started this story of bispecific T-cell engagers or BiTEs. When the technology plus new and the impact was uncertain, we have learned and built up on the innovation that brought us BLINCYTO, which show us the first ever T-cell engager approved. And we have expanded the impact of BITE medicines into some tumors. We had engineered second-generation bites with convenient IV infusions and are exploring the potential for subcutaneous administration. We have navigated treatment concerns and have achieved mostly outpatient administration and reduced monitoring for our BITE medicines, improving the overall patient experience. And we have also improved the tolerability of our medicines through effective management strategies. These were not trivial undertakings, and we have generated a high degree of institutional knowledge and expertise along the way for how to develop, manufacture and commercialize BITE medicines. This is clearly a strong platform for the company. The evolution of our BiTE platform is what brought us an insight [indiscernible] targeting BiTE that has revolutionary survival in B-cell [ limoplastic ] leukemia. BLINCYTO was our first approved BiTE medicine and has dramatically changed the treatment on PALL. IMDELLTRA, a [ TLT ] targeting BiTE has revolutionized survival in small cell lung cancer. Xaluritamig is an investigational STEAP1 targeting BiTE that is rapidly advancing through Phase III in prostate cancer. Xaluritamig, as you can see, is designed to bind STEAP1 on tumor cells and CD3 on T cells, directing T-cell activity towards STEAP1 expressing prostate cancers. Xaluritamig is being developed for all comers with no biomarker testing needed as a STEAP1 is highly expressed in prostate cancer. Xaluritamig development is significant and encompasses brought different stages of prostate cancer. With xaluritamig, we're covering the waterfront of prostate cancer by pursuing a parallel development path across various prostate cancer [indiscernible] stages with the remaining large patient populations with significant unmet need. The Phase III MCRPC, metastatic statin-resistant prostate cancer program, is testing 2 chemo-free regimens: xaluritamig as monotherapy and xaluritamig in combination with abiraterone in [ existing ] late-stage treatment settings. We are also quickly moving to the earlier stage of prostate cancer, following the approach we pioneered first with BLINCYTO and now with IMDELLTRA. Our conviction in xaluritamig potential has led us also to this parallel investment approach. We have introduced the BiTE strategy and platform and now let's return to IMDELLTRA, a medicine that is transforming the standard for survival in small cell lung cancer. Now small cell lung cancer is a devastating and rapidly progressing disease with survival often counted in months. There has been limited innovation in the field and recent advancements have generated modest improvements in overall survival in the first-line setting. The question for us, when designing the DeLLphi-305 study was whether adding IMDELLTRA to continue durvalumab treatment could improve outcomes in patients whose disease had not progressed after induction therapy. We gained initial insight into this approach from a Phase Ib first-line maintenance study DeLLphi-303. Some of you may recall that data from this study were presented last year and provided us insights into IMDELLTRA's ability to improve survival. Today we are pleased to share updated survival that are available in an e-poster and will be presented on Monday here at ESMO. With an additional year of data, we have now observed, in the first line [indiscernible] setting a median overall survival of 37.9 months. This is remarkable data in this difficult-to-treat disease. It is now my pleasure to introduce Dr. Charles Rudin, a world expert physician scientists in small cell lung cancer, to walk you through the transformative data from DeLLphi-305 first-line maintenance Phase III trial that was just presented a few hours ago during the Presidential Symposium here in Madrid at ESMO.

Well, thank you, Jean-Charles. It's a pleasure to be able to review these data, which I think are really quite spectacular. This data was presented by [ Jacob Sands ] in the meeting today. I was not part of the study directly, but I am quite familiar with the data and happy to go through it. The DeLLphi-305 trial was designed as a randomized Phase III trial comparing a backbone, which is a current standard of care, in the maintenance setting, that is Imfinzi, versus the combination of adding IMDELLTRA to Imfinzi. The trial was one-to-one randomization quite straightforward with the primary endpoint of overall survival. Patients were randomized after completing 4 cycles of induction chemotherapy with immunotherapy and, patients had to at least have stable disease at that point to be eligible for enrollment. Key [indiscernible] criteria are listed here. I'll just point out that patients with brain metastases, both untreated and treated, asymptomatic brain metastases, were allowed on study. The protocol was randomized and stratified for the presence or absence of brain and liver metastases, the response to first-line chemo [ IO ] and the type of platinum used in that regimen. The secondary endpoints were progression-free survival and then, subsequently, overall survival. And the trial was designed to first analyze OS, overall survival. If meeting that endpoint, progression-free survival was analyzed and subsequently response rate and safety were considered. Next slide. This slide shows the baseline characteristics of patients enrolled in this trial. And you can see that in general, these are well-balanced arms. I'll point out that about 20% of the patients have brain metastases going into the study, and about 1/3 of the patients had liver metastases on both arms. Next slide. This is the data on the primary outcome on overall survival. And you can see a clear separation of the curves here. Hazard ratio of 0.42 with a p-value of less than 0.001. The curve separated early, and that separation looks like it will be maintained, essentially consistent in the shape of the curve with the Phase Ib data that Jean-Charles showed earlier. Dramatic results and a clear improvement. Next slide. Subsequent analysis looking at prespecified subgroup suggested benefit really across the board in all relevant subsets, including those patients with or without brain metastases, with or without liver metastases. So really a clear benefit across the board. Next slide. This slide shows the data for progression-free survival, which I think is also quite striking in the maintenance setting on small cell lung cancer patients began to progress pretty quickly. You can see on the [indiscernible] curve the control curve. In contrast, the combination really extends things out, a median of 7.4 months versus 1.9 months in the control arm. Here the hazard ratio was 0.34 with a P value of less than 0.001. Again, clear benefits. And I would point a little bit to the tail of the curve. This is still early data with median follow-up for progression-free survival in the order of 14 months. But clearly, it looks like these curves are pulling off. Next slide. Again, if we look at prespecified subgroups, clear benefit across the board, brain metastases, liver metastases, et cetera. In the maintenance setting, we rarely see responses. Patients have had their major cytotoxic therapy as induction maintenance is really a time when patients are continuing on immunotherapy. And the goal there is really to avoid progression. But here we can see that on the Imfinzi control arm, responses we're seeing in only 4% of patients. I think that's what we would sort of expect. In contrast, the addition of IMDELLTRA here leads to an overall response rate, in the maintenance setting, which is remarkable, 26%. On the right, the durability of their response is also, I think, striking, with over half of the patients who are responders still in response 1 year later. Quite an important result, I think, for patients. At the time of data cutoff, about 44% of the patients on the combination arm are still on drug, in contrast, only 11% for drug on Imfinzi alone. Safety is a clear concern here. And of course, adding 2 drugs, you do see more adverse events. But I would point out that those adverse events were quite manageable really across the board. If we look at treatment-related adverse events that led to discontinuation or holding of the drug, it's really a small minority. 3% for each of the 2 drugs. No fatal events in the combination arm attributable to the drug. Next slide. Two of the key toxicities that we think about with BiTE molecules like IMDELLTRA are cytokine release syndrome and iCAN. And you can see here that those were observed on the combination arm, but really at strikingly low rates. And again, this was, to me, a very striking data. Only a single patient on the combination had Grade 3 CRS. And none of the patients had Grade 3 or above iCAN. This is actually a better safety data than what we've seen previously in patients who had recurrent disease treated with IMDELLTRA. I think the reason for that, if I can speculate, is that we're really treating and minimal residual disease at this point as maintenance rather than progressive disease, which is quite aggressive in patients with small cell lung cancer when it occurs. The [indiscernible] were quite manageable, as noted here, with very low rates of use of drug [indiscernible]. Next slide. So in conclusion, this combination strikingly and significantly improves overall survival, progression-free survival and leads to objective response in maintenance in contrast to Imfinzi alone for patients with extensive [indiscernible] for lung cancer who has not had progression on first-line chemotherapy. 58% reduction in the risk of death, 56% reduction in risk of disease progression or death, and an overall response rate in the maintenance setting of 26%. The survival path really extends to all subgroups analyzed, including those patients with brain metastases, liver metastases and irrespective of the chemotherapy combination used in induction. I think these are practice-changing data. This clearly defines a positive benefit-risk profile for patients with this otherwise very lethal disease. And I'll stop there. The patient -- the study was published concurrently with the presentation today in the New England Journal of Medicine. Additional details can be found in that manuscript. We, of course, like to thank the patients, the families, the investigators and clinical site support. This was a big effort involving many people around the world, and was supported by Amgen and AstraZeneca.

Thank you, Dr. Rudin for a great presentation. And now let's look at our overall IMDELLTRA clinical development program. As you can see, we are pursuing a growth global clinical program with IMDELLTRA, establish it as the cornerstone therapy in small cell lung cancer. Our ongoing Phase III studies are intended to move earlier in the treatment paradigm. And we are optimistic that these studies will demonstrate transformative first-line survival. In addition to the original registration-enabled study in second line or later small cell lung cancer and the data we have presented today, we are also investigating IMDELLTRA in 2 frontline settings: as first-line induction and maintenance with IMDELLTRA combined with chemo immunotherapy in the randomized Phase III trial, DeLLphi-312. In the limited stage, we are studying IMDELLTRA following concurrent chemoradiotherapy in the randomized Phase III trial, DeLLphi-306. We are also pursuing flexible dose to align IMDELLTRA with other treatment regimens and to further improve the patient experience, with expanded IV dosing regimens, have presented at World Lung Cancer in [ DeLLphi-309 ] and with subcutaneous dosing as being explored in DeLLphi-315. We are establishing IMDELLTRA as the cornerstone therapy in small cell lung cancer. It is already a standard of care based on the Phase III second-line data DeLLphi-304. But we are also evaluating novel combinations of IMDELLTRA with [ B7-H3 ADC, DC10 ] and with [ DLL3ADC ] DeLLphi-313 with the DLL3 AC. Additionally, we are exploring IMDELLTRA's impact beyond small cell and cancer. IMDELLTRA's profound data in small cell lung cancer provides us confidence to explore IMDELLTRA neuroendocrine carcinomas as we seek to extend IMDELLTRA's impact into other [ DLL3 ] expressing maintenances. We plan to evaluate IMDELLTRA both as a monotherapy and in combination in neuroendocrine malignancies beyond small cell lung cancer, and in other DLL3 expressing malignancies. There is clearly more to the IMDELLTRA story. But let's look at the progress we have made today in IMDELLTRA's currently approved indications. IMDELLTRA is an established standard of care in second line or later extensive-stage small cell lung cancer. IMDELLTRA has revolutionized survival in second line plus extensive stage small cell lung cancer, extending the median overall survival by more than 5 months. IMDELLTRA is currently approved in over 15 markets globally, with over 18,000 patients treated since launch. In the U.S. IMDELLTRA is available in more than 2,000 U.S. sites of care, with over 65% of sites that have used IMDELLTRA that are in the community setting. Recent reductions in monitoring time will hopefully allow us to reach additional patients in this approved indication. Significant opportunity remains in the second-line setting as chemotherapy continues to be a common treatment option. Moving IMDELLTRA earlier in the small cell continuum is important. In the currently approved indication, there are 40,000 eligible patients in the U.S. Moving IMDELLTRA earlier will potentially allow us to reach a significantly larger population, and given IMDELLTRA's observed durability to also treat patients for a longer periods of time. As you can see in this slide, IMDELLTRA has redefined survival for small cell lung cancer. The evidence is clear and compelling. And we hope all of you are as excited about what this means for patients with small cell lung cancer as we are today. Given the transformative benefit observed, we are working to rapidly file with the Phase III data we have shared today with regulatory authorities around the world. In summary, IMDELLTRA is revolutionizing the treatment of small cell lung cancer across multiple dimensions of care. We have observed unprecedented durable survival with additional Phase III studies underway. We are working on reduced monitoring times and exploring alternative dosing regimens and subcutaneous delivery. We are rapidly advancing a broad global [ think ] and development program to firmly establish IMDELLTRA as the cornerstone therapy for small cell of cancer. And we really would like to take the time to thank all the patients, the investigators and the staff that have made all of this possible. With that, I will turn it back to Murdo for Q&A.

Thank you, Jean-Charles. Thank you, Dr. Rudin. And I'd like to thank one more group of people, Jean-Charles, and that's you and your development organization. Thank you for working so hard to deliver a profound data set and for conducting an exceptional clinical trial. Much appreciated. So with that, let's turn it over to Kista for our first question. Krista?

[Operator Instructions] Our first question comes from Salveen Richter with Goldman Sachs.

Congratulations on the data. It's [indiscernible] on for Salveen. Maybe if you could help the average duration of therapy under the expected first-line maintenance label compared to what you are currently seeing in the approved second-line setting? And how does this level of efficacy here in 305 help to derisk the ongoing Phase III induction study? Or do you think that this type of high bar may be specific to maintenance alone?

Okay. Kave, why don't you start with the first question on duration of therapy, and then we'll have Jean-Charles comment on, is there a read-through from 305 to the ongoing limited stage trial?

Yes, [ Salveen ] , thanks for the question, and thanks for calling on a Saturday. We appreciate it. To give some comparison from the trial setting, in DeLLphi-305, we saw that average duration of treatment was 46 weeks. To put that in comparison, in DeLLphi-304 in the second-line, we saw a median duration of therapy of 18 weeks. Now obviously, in 305, we're still continuing to follow those patients. And as you saw in 303, we saw an extended use from those patients going out all the way to 38 months. So we think there's going to be a meaningful step-up overall duration of therapy as we move into the earlier line -- the earlier lines and extend survival even longer than we were in the second line. Jean-Charles?

Yes. Thank you. Well, it's [indiscernible] that hits 2 consecutive Phase III trials achieving all primary and secondary endpoints in heavily pretreated patients and then in patients who are in the first-line setting who have been [indiscernible] by the induction chemo immunotherapy. So I don't know the future and would not predict it, but I feel very confident and feel very well about what the induction maintenance Phase III trial will bring to the patients.

Your next question comes from the line of Evan Seigerman with BMO Capital Markets.

Congrats on the data. Kind of a follow-up to the prior question. So clearly, we know that there's a great impact of the drug in the kind of maintenance study. But as you move towards the Phase III induction that you've been talking about, how do you think about the importance of the cytotoxic chemotherapy kind of reducing tumor burden and then use of the BiTE to kind of continue the immune effect versus having it all done at once kind of in the front line, first induction type therapy? And do you think that's kind of the effect changes as you move forward in treatment?

Yes, I would take that, and thank you for the question. We started with the maintenance setting because it was very rational to bring tarlatamab after debulking the tumor because we knew we were very likely to have higher efficacy and better tolerability, and is exactly what we saw in a very profound manner and consistent across every single subgroup analyzed. In the induction and maintenance setting, we would like to reach all the patients, as you know. Around 20% of the patients that start induction don't make it to maintenance and it can vary across trials, that is in that range, 20%, 25%. So there is a desire to make sure every patient with metastatic small cell lung cancer has access to the drug. And the reason to combine the 3 of them is that they are highly complementary and might act in ways that allow a broader number of cancer cells to be addressed. The chemotherapy is debulking, the PD-L1 is calling the immune system by making it visible and trying to recruit T cells from the broad systemic nature of immune system. But IMDELLTRA per se is bringing T cells into the tumor to directly fight against the cancer cells. So you are adding a way to tackle the disease by 3 complementary angles that make a lot of sense and might allow us to treat them for the global number of patients with small cell lung cancer.

Your next question comes from Matt Phipps with William Blair.

This is Madeline on for Matt. In the presentation at the conference, the ability to treat beyond progression was discussed. Does Amgen plan to generate data to support that with IMDELLTRA? And with that in mind, how could that impact the average duration of treatment in maintenance setting?

Yes, interesting question. Maybe I can ask Dr. Rudin to comment on treatment beyond progression.

Yes, I think the trajectory of disease when patients are on industry seems a little bit different than what we're used to with patients with [indiscernible] 1 cancer. We are seeing evidence of what we call oligoprogression, meaning progression a few sites, 1, 2 sites, without global progression. And we've begun treating those patients with things like stereotactic radiation to control sites of disease progression, while continuing on the BiTE to allow the patient to continue to benefit from that. And we have seen patients who continue to benefit for many, many cycles after local therapy. That's not something we have traditionally used in small cell, but I think the landscape seems to change. And as Dr. [ Sand ] pointed out, we're seeing that more and more.

Yes. Thank you, Dr. Rudin. I would just add that it is something that is routine in EGFR mutant and non-small cell lung cancer, that has teached us that when you have systemic control and just a site of progression, there is no reason to give that up, and you treat luckily and continue. And that has allowed [indiscernible] non-small cell lung cancer to be continuing on treatment sometimes for extra years.

Your next question comes from Michael Yee with UBS.

Two-part question for Dr. Rudin. Maybe in thinking about the all-important first-line induction study, which obviously, it would be great to have as well as the positive maintenance study you now have. Can you just maybe comment about how we should think about the overall safety and AE profile of the triplet combination in first line, and think about that, obviously, as why the maintenance study you're reading out here today makes a whole lot of sense? So I just wanted to think about the induction safety profile and maybe how relevant induction is if you already have a maintenance label. That's the first question. And the second is, obviously, Dr. Rudin, you must be aware that there was also ADC PD-L1 [indiscernible] data for DLL3, that seemed quite attractive, very high response rates. Maybe you could just comment about that, because I do think Amgen is doing a combination with ADCs as well. So I just wanted to think about how ADCs fit into the mix.

Yes, 2 great questions. So first, the first-line induction, this -- one of the basic fundamental rules in oncology is to give your best drug first. And this is one of the best drugs, if not the best drug, that we have for this disease. So we really want to push it into the first-line setting. As Jean-Charles, we want all patients to be able to benefit from this. The safety data with the IO-IO combination that was used in maintenance in this study really supports that we're not going to see additional toxicity. I think if we were going to see major tox signal, it would be because of the combination of 2, if you will, inflammatory molecules. So of course, the proof's in the pudding, we'll need to see that. But the initial data that we've seen in the first-line setting has been reassuring in that context, and we'll see how that plays out. But I actually think the data we saw today helps to reinforce that this should be a safe combination. You're right, there's a lot of exciting data with the ADCs and ADCs in combination with PD-1s and PD-L1s in small cell lung cancer and really across the board in oncology. I think that is an exciting area and something to build on. Some of the ADCs do seem to have a higher response rate in recurrent disease than any standard chemotherapy, and there's a lot of interest in pushing those into the first-line regimen. And I think it can be an important backbone for those studies.

Yes, I would just add to that, that we rejoiced when innovation was made available to small cell lung cancer patients. ADCs are sophisticated and elegant way to deliver chemotherapy at the door of the cancer cell. They debulked. We have demonstrated that debulking with chemo followed by IMDELLTRA PD-L1 works. But we are also contemplating doing that with chemo induction. That absolutely can be done also, in our opinion, with ADCs, with IMDELLTRA in PD-L1, that will lead you to a regimen that is pretty innovative. We are excited and actively enrolling in our DLL3 ADC IMDELLTRA [indiscernible] in the [indiscernible] ADC IMDELLTRA, and a few more to go.

Exciting. Thank you, Jean-Charles. Thank you, Dr. Rudin.

Your next question comes from the line of Geoff Meacham with Citigroup.

This is Jarvy on for Geoff. Maybe just 2 questions for us. I guess, first of all, on the earlier question on IMDELLTRA's treatment duration, I guess, could there be any evidence, whether it be now or later on, that can support a finite course that reserves benefit while reducing burden in capacity requirements and costs? And then also maybe just thinking about commercial expansion, I guess, what lessons from the high number of treated patients and existing community footprint are most relevant as IMDELLTRA expands in the first-line maintenance? And where do you still see the greatest access for capacity constraints?

Jarvy, I apologize, but we're having a little trouble picking that question up. If you wouldn't mind just repeating for us. Because we think we're picking up static on the long-distance line here.