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Amgen, founded in 1980 as Applied Molecular Genetics, is a major biopharmaceutical company. Its top-selling drugs treat autoimmune diseases like rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis; anemia; osteoporosis; and osteoarthritis. It also makes a number of oncology treatments, including Neupogen and Neulasta, which reduce infection risks for cancer patients undergoing chemotherapy, and Imdelltra, a recent treatment for extensive-stage small-cell lung cancer. The company works with doctors, medical clinics, dialysis centers, hospitals, and pharmacies, as well as distributes treatments through direct-to-consumer channels.

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Amgen (AMGN): Company Profile, Stock Price, News, Rankings

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My name is Julianne, and I will be your conference facilitator today for the Amgen Q1 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&A session. To ask a question, please press star, then the number one on your telephone keypad. To withdraw your question, please press star one again. I would now like to introduce Casey Caporilli, Vice President of Investor Relations. Mr. Caporilli, you may now begin.

Thank you, Julianne. Good afternoon, everyone, and welcome to our first 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 Peter Griffith. 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.

Okay, good afternoon, and thank you for joining us. We had a strong first quarter and are well-positioned to achieve our objectives for the year. Recall, we previously described 2026 as a springboard year for Amgen, a year in which we expect our rapidly growing products to offset the financial impact of patent expirations and increased competition while our next generation of molecules progress through the R&D pipeline, setting the stage for sustained long-term growth. As you can see from our progress thus far, we're on track to achieve these objectives. With steady execution through the rest of the year, we expect, once again, to demonstrate that we can grow through a period of patent expiration and deliver attractive performance for our shareholders with a strong portfolio of innovative medicines and biosimilars that meet the needs of patients with serious diseases.

As you listen to Murdo's presentation in a moment, note the momentum of our six key growth drivers. Together, they generated 70% of our sales in the quarter and grew in aggregate by 24%. That strong performance sets us up well for the year and well beyond. Turning to the pipeline, our focus this year is on disciplined data generation and execution across a number of important phase III programs which, again, we expect will drive attractive long-term growth for Amgen. Our confidence in MariTide as a differentiated treatment for obesity, type two diabetes, and obesity-related conditions continues to build. We're executing effectively across the company, building the capabilities we need to bring this medicine to market.

As Jay will discuss in a moment, we're disclosing additional phase III studies of MariTide, one of which will evaluate switching from the weekly injectables to MariTide on an every eight or 12 week schedule. In other words, we'll evaluate switching from medicines which are injected 52x a year to one which can be injected as few as four or 6x  a year. In addition, we'll evaluate weight maintenance for MariTide on a schedule of four or six injections a year as well. We expect there'll be a great deal of interest in these data. Beyond MariTide, we see strong potential across a number of other programs in late-stage development, including Olpasiran and other innovative programs in phase III. We've talked about the excitement we feel about the convergence of technology and biology, including the application of artificial intelligence across the company.

Here too, we're making great progress, there's no question we're in a period of tremendous change, we're encouraged by the progress we're making in embedding new capabilities. We're doing this across the company, we took steps early on to have David M. Reese lead these efforts, we're grateful to him for the success he's achieved with this initiative. We're encouraged that James Bradner will build on David's accomplishments, leading our artificial intelligence and data activities across the company. I'll have more to say about David at the end of the call. Before we turn to Murdo Gordon, let me just thank my Amgen colleagues around the world for their dedication to our mission to serve patients and the quality of their work again this year. Murdo Gordon, over to you.

Thanks, Bob. As mentioned in the first quarter of 2026, 16 products achieved double-digit or better sales growth, and 17 products are now annualizing at sales of $1 billion or more. Overall, we delivered 4% growth in product sales, driven by a diversified portfolio of fast-growing products that continues to outpace the impact of losses of exclusivity. The evolution of our business is now well underway, with our six key growth drivers, which include Repatha, Evenity, and Tezspire, three innovative medicines delivering significant clinical benefit for large populations of undertreated patients. Also included are our rare disease, innovative oncology, and biosimilars portfolios. Collectively, these growth drivers delivered 24% year-over-year sales growth and generated $5.6 billion in sales in the first quarter, representing almost 70% of total product sales.

Starting with general medicine, Repatha delivered $876 million of first quarter sales, up 34% year-over-year. Growth was driven by increased urgency to treat patients in both secondary prevention and high-risk primary prevention, where intensive LDL-C lowering with Repatha significantly reduces major cardiovascular events. The ACC/AHA updated their dyslipidemia guidelines, now reinforcing earlier risk identification, lower LDL-C level and targets, and earlier uses of therapy like Repatha. These guidelines do not yet reflect the practice-changing VESALIUS-CV data, leaving a clear opportunity to further evolve clinical guidelines and quality measures. We expect these additional changes will further encourage cardiologists and primary care physicians to manage LDL-C levels below 50 milligrams per deciliter, alongside lifestyle modification, to reduce cardiovascular risk in both primary and secondary prevention.

Physician response to our landmark VESALIUS-CV study has been strong, with sustained increases in new-to-brand prescribing across cardiology and primary care, particularly in support of high-risk primary prevention patients with diabetes. At the recent ACC meeting, the VESALIUS-CV subgroup analyses in patients with diabetes and without non-significant atherosclerosis was presented and simultaneously published in JAMA. These data further reinforce the consistent and significant benefit of Repatha, delivering a 31% reduction in cardiovascular events. A trend in lowering mortality rates was also observed. The body of evidence is now very clear. Treating patients earlier with Repatha can lower cardiovascular events. In the U.S., Amgen now is further strengthening access to Repatha by offering a simplified cash pay option to patients. We're seeing encouraging patient interest in this direct access model, which now also includes Xembify, TEPEZZA, Aimovig, and AMGEVITA.

Repatha is now the only PCSK9 inhibitor with positive outcomes data in both high-risk primary and secondary prevention patients. These data, along with Repatha's broad access, create an imperative to close the treatment gap for millions of patients for whom Repatha can help reduce heart attacks and strokes and potentially save lives. Evenity sales increased 27% in the first quarter to $562 million. U.S. sales grew 35% year-on-year, and Evenity maintains leadership of the U.S. bone builder market with a 65% market share. To date, approximately 320,000 U.S. patients have been treated with Evenity, supported by increased investment and an expanded field force.

However, the unmet need remains significant, with more than 90% of the 2 million women at very high fracture risk remaining untreated, presenting a clear opportunity to expand the market and drive additional Evenity growth and impact. In Japan, Evenity has been prescribed to more than 900,000 patients since launch, and it leads the bone builder category with over 55% market share. We see a positive reaction to the treatment guideline updates by the Japan Osteoporosis Society, which further improves Evenity's positioning and potential. Moving to inflammation, Tezspire sales grew 20% year-over-year, reaching $343 million in the first quarter, driven by robust patient demand and solid execution across both pulmonology and allergy specialties, partially offset by a burn in channel inventory.

Tezspire remains well-positioned to reach more patients in the U.S., given its differentiated TSLP mechanism that targets multiple inflammatory pathways driving severe uncontrolled asthma, including in those patients with coexisting chronic rhinosinusitis with nasal polyps. This new indication is gaining traction and helping expand Tezspire's reach across a broader patient population. Prolia and Xgeva combined delivered $1.1 billion in sales in the first quarter, a decrease of 32% year-over-year. Erosion since loss of exclusivity remains in line with our expectations. We anticipate accelerated sales erosion over the remainder of 2026, driven by increased competition from multiple biosimilars. Our rare disease portfolio grew 25% year-over-year to $1.2 billion. Uplizna sales increased 188% year-over-year to $262 million in the first quarter, reflecting growing demand across all three approved indications.

We're encouraged by the pace of growth and the potential that Uplizna has to help patients living with rare autoimmune conditions with significant unmet need. Uplizna's uptake in GMG has been strong across both bio-naive and switch patients, supported by broad access for most covered patients without requiring a step through another approved biologic. Given this momentum, we see a meaningful opportunity for Uplizna to become the first-line and first-switch choice for appropriate patients living with GMG. Momentum in IgG4-related disease continues, with Uplizna adoption led by rheumatologists and increased prescribing by GI specialists and nephrologists. In NMOSD, Uplizna continues to maintain its leadership as the most prescribed FDA-approved therapy in the U.S. TEPEZZA sales grew 29% in the first quarter to $490 million.

In the U.S., more than 25,000 patients have been treated since launch, with growing interest from both new and returning prescribers, increased prescribing from endocrinologists, and a broadening specialist base. We see rising awareness of moderate thyroid eye disease in the U.S. This positions TEPEZZA for growth, supported by its best-in-class efficacy, well-established safety profile, industry-leading patient services, and broad payer coverage. We are also encouraged by the positive Phase III data for the on-body injector, which demonstrated comparable efficacy to IV TEPEZZA and supports a clear path to subcutaneous administration without compromising clinical benefit. This convenient dosing option will enable TEPEZZA administration at additional sites of care and expand access for more patients in the future. Following our launch in Japan in 2025, we expect additional global launches of TEPEZZA in 2026 and beyond.

Tavneos sales were $119 million in the first quarter, up 32% year-over-year, driven by strong volume growth. Since its launch in 2021, more than 8,000 patients have been treated with Tavneos. Jay will comment on recent regulatory events in just a few moments. Our innovative oncology portfolio, which consists of BLINCYTO, IMDELLTRA, Vectibix, KYPROLIS, LUMAKRAS, and Nplate, grew 25% year-over-year, generating $1.8 billion of sales in the first quarter. IMDELLTRA delivered $258 million in first quarter sales, driven by deep clinical conviction and continued adoption across care settings. More than 1,800 U.S. sites now administer IMDELLTRA, with a majority of doses delivered in the community setting.

This progress has been supported by the combined efforts of our commercial, medical, and access teams to remove operational barriers that physicians encounter in practice, helping expand patient access to treatment. IMDELLTRA has become the standard of care in second line small cell lung cancer, an aggressive disease with poor survival outcomes and few effective options to extend life. BLINCYTO sales were $415 million in the quarter, increasing 12% year-over-year, driven by broad prescribing across both academic and community settings. BLINCYTO is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome negative B-cell ALL. Our biosimilar portfolio delivered 14% year-over-year growth, generating $835 million in sales in the first quarter. Pavblu, our biosimilar to EYLEA, delivered $280 million in first quarter sales.

Adoption continues to expand among retina specialists who appreciate Pavblu's ready-to-use prefilled syringe and Amgen's track record of manufacturing biologics and delivering reliable supply. Since our first product approvals in 2018, our biosimilars have generated more than $14 billion in cumulative sales, contributing meaningful growth while expanding patient access to high quality, lower cost biologics. Our first quarter results reflect both the strength of our key growth drivers and the commitment of our commercial, medical, and policy colleagues globally to improving the lives of patients facing serious diseases. We remain focused on extending the reach of our medicines to even more patients in 2026. Now I'll hand it over to Jay.

Thank you, Murdo, good afternoon, everyone. Let me begin with MariTide, a new paradigm in the management of obesity-related conditions, and type two diabetes. The unique antibody peptide conjugate design of MariTide delivers the potential for strong efficacy with monthly or less frequent dosing and favorable tolerability to improve long-term treatment. With existing obesity medicines, treatment burden and dosing frequency remain barriers to long-term persistence on therapy. For individuals with chronic conditions, sustained treatment is often required to realize the full health benefit of therapy. MariTide's unique properties, particularly its potential for monthly or less frequent dosing, may help reduce treatment burden and improve persistence on treatment over time. Towards this objective, we are excited to announce two new phase III studies that focus on longer-term maintenance therapy with MariTide.

We have initiated two long-term extensions of our ongoing Phase III chronic weight management studies to evaluate MariTide maintenance for durable weight loss. Participants who completed 72 weeks of treatment in the parent trial will enter a 48-week extension treatment period where they will receive a monthly, every 8-week, or quarterly dose of MariTide. To date, our clinical trials have studied MariTide in the initial management of obesity and overweight. We recognize that many patients may wish to switch to MariTide from weekly injectables. Today, we announced the initiation of another new Phase III study that will evaluate switching from weekly injectable GLP-1 therapies to MariTide following dose escalation to a convenient every eight week or quarterly dosing schedule.

Combined with our ongoing pivotal chronic weight management phase III trials, the MariTide program will inform physicians on how to start a new patient on MariTide and how to switch to a more convenient, less frequent dosing. Previously, we described the benefit of dose escalation for improving initial tolerability with MariTide. We observed marked improvements in GI symptoms progressing from one step to two step dose escalation. Our accumulating experience with three step dose escalation is quite positive. For example, we recently completed one of our standard phase I physiology studies in preparation for potential regulatory filings that utilize three step dose escalation. As anticipated, three step dose escalation further decreased the rates of nausea and vomiting as compared to prior experience with two step dose escalation. We believe that three step dose escalation and less frequent dosing are effective and well-tolerated because of the unique antibody backbone of MariTide.

The long-lived stability of an antibody creates a gentle and smooth stepwise increase in sustained drug exposure. Stable drug levels avoid the frequent peaks and troughs of daily orals and weekly injectables that may contribute to intolerability. We remain confident and excited by MariTide and are focused on delivering high-quality clinical data to support future regulatory filings. The studies are enrolling well, indicating strong physician and patient interest in MariTide. MariTide is emerging as a new paradigm for patients with obesity, diabetes, and related conditions as a well-tolerated first monthly or less frequently administered medicine. Turning from one major public health challenge to another, we continue to build on the landmark findings from Repatha in the prevention of cardiovascular events.

In March, a new pre-specified subgroup analysis from the phase III VESALIUS-CV trial was presented at the American College of Cardiology and simultaneously published in the Journal of the American Medical Association. In this subset of high-risk patients with diabetes and without known significant atherosclerosis, Repatha demonstrated a significant 31% reduction in major adverse cardiovascular events, including heart attack. Repatha also demonstrated a nominal 32% reduction in the risk of cardiovascular death and a nominal 24% reduction in all-cause death. Taken together with the VESALIUS-CV data presented last fall, these findings reinforce the breadth and magnitude of benefit from Repatha in the primary prevention of cardiovascular disease. We look forward to sharing additional insights and analyses from VESALIUS-CV with the scientific community, notably at the upcoming American Diabetes Association annual meeting.

Olpasiran, our potentially best-in-class small interfering RNA medicine that delivers greater than 95% reduction in Lp with a quarterly dosing schedule, continues to progress in phase III clinical investigation for secondary prevention of cardiovascular events. We have recently initiated the OCEAN(a)-CCTA study that evaluates the effect of Olpasiran on the burden of non-calcified plaque in coronary arteries as measured by coronary CT angiography. Attention to Lp in medical practice is rising, reflected by the recently updated ACC/AHA lipid guidelines that now recommend broader Lp testing. Moving to rare disease, we continue to build strong momentum across our portfolio. For Uplizna, we recently received European Commission approval for generalized myasthenia gravis. Supported by a strong biological rationale, we expect to initiate two pivotal phase III studies of Uplizna in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy by the second half of this year.

We are also advancing Tepezza, where we recently reported positive phase III top-line data for subcutaneous administration via an on-body injector. These data demonstrated robust efficacy in patients with thyroid eye disease consistent with intravenous administration alongside a favorable safety profile. Subcutaneous administration of Tepezza represents an important step forward in improving convenience and expanding treatment options for patients with thyroid eye disease. Dazodalibep, our first-in-class CD40 ligand-targeting fusion protein, continues to progress with two phase III studies in Sjögren's disease now fully enrolled. These studies address both systemic and symptomatic disease, both are expected to complete later this year. As publicly disclosed, the FDA proposed to withdraw the approval of Tavneos. We continue to believe that Tavneos is an important medicine for patients with ANCA-associated vasculitis, a rare and life-threatening disease with limited treatment options.

We are confident in the benefit-risk profile of this medicine and expect to engage further with the FDA on this topic. Turning to oncology, our bispecific T-cell engager or BiTE platform continues to deliver meaningful impact for patients with advanced cancer. IMDELLTRA is emerging as a standard of care in second-line extensive-stage small cell lung cancer, delivering an unprecedented survival benefit in a disease that has seen very little innovation for decades. As we work to advance IMDELLTRA into earlier lines of therapy, we are encouraged by the apparent improvement in median overall survival in the first-line maintenance setting to 25.3 months observed in the phase I-B DeLLphi-303 study. Frontline maintenance with IMDELLTRA is now being evaluated in the ongoing phase III DeLLphi-305 study.

xaluritamab, our first-in-class STEAP1-targeting bispecific T-cell engager, is advancing rapidly with two ongoing phase III studies in metastatic castration-resistant prostate cancer. Multiple ongoing phase I-B studies are underway, where we've taken a deliberate and differentiated approach toward earlier stages of disease to maximize long-term patient benefit. First, in biochemical recurrence, where patients experience a rising PSA without clinically evident disease, we are evaluating xaluritamab as monotherapy without androgen deprivation therapy. Second, we are advancing into metastatic hormone-sensitive prostate cancer, where we are evaluating xaluritamab on top of standard of care hormonal therapy with the goal of developing a more effective regimen without chemotherapy. One last but important note about our oncology portfolio. Following a comprehensive review, we've taken the decision to discontinue development of AMG-193, our MTA-cooperative PRMT5 inhibitor.

Over the last several years, amidst the rapid advances in artificial intelligence, we have taken a principled approach to reconsidering and augmenting drug discovery and therapeutic development. At the intersection of powerful AI models developed both externally and internally with Amgen Research and insight-rich proprietary datasets, we are beginning to see meaningful, tangible advances across Amgen R&D. Integrated multi-omics data resources at Amgen deCODE genetics identify new targets for therapeutic consideration, in particular within non-coding regions of the human genome studied at population scale. Antibody lead optimization has accelerated by 50% from contributions both to lead discovery and lead optimization. In clinical development, we have designed and implemented a proprietary site selection model that improves clinical trial enrollment with a significant, and in some cases, up to three fold improvement in enrollment rates.

Leveraging large language models and agentic AI for regulatory filing preparation, we are seeing early promising results in data ingestion, integration, and document drafting. These are early innings, but we are captivated by the potential for AI and data science to deliver measurable impact and value in R&D and across the enterprise, as Peter will highlight in a few moments. With the retirement of our revered and beloved colleague, David Reese, I'm excited to lead the AI and data transformation across our business at the enterprise level, working in partnership with our leadership, staff, and collaborators. Let me close by saying that we are encouraged by the progress we've made in the first quarter with a continued focus on disciplined data generation across the portfolio.

With a robust pipeline and meaningful breadth and depth across four therapeutic areas, we are well-positioned to deliver continued innovation for patients with long, sustained value. I want 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 Peter for the financial update.

Thank you, Jay. We are pleased with our strong first quarter performance, executing through a full quarter of the patent expirations and losses of exclusivity. Our non-GAAP operating margin was 45%. We continue to invest in advancing our pipeline with non-GAAP R&D spending increasing 16% year-over-year in the first quarter. This reflects increased spending on our late-stage pipeline, including continued investments in MariTide, IMDELLTRA, and Olpasiran. Our non-GAAP cost of sales as a percentage of product sales was 19.5%, driven by higher profit share and royalty expenses and changes in our sales mix. We expect these factors will continue to negatively impact the cost of sales in future quarters. We further expect the second quarter operating margin to be in line with the first quarter operating margin.

Our non-GAAP OI&E resulted in $480 million of expense for the quarter, including a gain of about $90 million from retiring debt through open market repurchases. Our non-GAAP tax rate decreased 1 percentage point year-over-year to 13.6%, primarily due to net favorable items in the current year period, partially offset by the change in earnings mix. We generated $1.5 billion in free cash flow in the first quarter, reflecting continued momentum across the business. We spent $700 million in the first quarter on capital expenditures, driven by investments across our U.S. manufacturing sites, including Ohio, North Carolina, and Puerto Rico. We continue to expect capital expenditures of approximately $2.6 billion in 2026, reflecting significant investment in our business to scale manufacturing capacity for volume growth, including for MariTide launch.

We see technology and artificial intelligence as increasingly important tools to help Amgen operate with greater speed, productivity, and scale across the enterprise. Beyond what Jay described, we are also seeing tangible benefits in other parts of the business. In AI-enabled automation, it has reduced production line clearance time at one of our manufacturing sites from approximately 30 minutes to about two minutes per batch run. We are also seeing promising results as our colleagues across Amgen use AI to enhance productivity. In addition, we return capital to shareholders through competitive dividend payments of $2.52 per share, representing a 6% increase compared to the first quarter of 2025. Let's turn to the outlook for the business for the remainder of 2026. As we said last quarter, we expect 2026 to be a springboard year for future growth.

Our strong first quarter performance reinforces that outlook, and we're raising our 2026 guidance ranges for both revenue and non-GAAP earnings per share. We expect 2026 total revenues in the range of $37.1 billion-$38.5 billion and non-GAAP earnings per share to be between $21.70 and $23.10. These ranges reflect our confidence that the emerging growth drivers will more than offset the outgoing legacy brands. Note, our guidance does not include any potential business development transactions that may occur throughout the remainder of the year. Let me highlight a few updates to our outlook for the remainder of the year. For the full year, we now expect other revenue to be in the range of $1.7 billion-$1.8 billion.

We now anticipate non-GAAP OI&E to be in the range of $2.2 billion-$2.3 billion of expense in 2026. We now expect a non-GAAP tax rate in the range of 15.0%-16.5%. Let me remind you of prior items that have not changed. We continue to expect the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45%-46%. This reflects our commitment to investing in the best innovation as we continue to rapidly advance the MariTide phase III program and additional key late-stage assets. We expect share repurchases not to exceed $3 billion.

Finally, in regard to our ongoing tax litigation, the Tax Court litigation covering tax years 2010 through 2015 remains ongoing, and while we expect a decision no earlier than the second half of 2026, we remain confident in the case we presented at trial. We are currently under audit by the IRS for the 2016-2018 tax years. In April 2026, we received a draft notice of proposed adjustment, or NOPA, from the IRS for 2016-2018, asserting significant adjustments primarily related to the allocation of profits between the United States and Puerto Rico. The approach taken by the IRS is similar in nature to our 2010-2015 dispute with the IRS currently pending in Tax Court.

If sustained in full, the adjustments set forth in the draft NOPA could have a material impact on our financial statements. We disagree with the draft NOPA and have informed the IRS audit team that its draft calculation methodology is inconsistent with the positions asserted by the IRS and the tax court, which positions were more favorable to Amgen than the draft calculation methodology taken by the IRS audit team. We firmly believe that the IRS positions are without merit, and we also believe that our tax reserves are appropriate. We intend to continue to vigorously defend our position, just as we have throughout our entire dispute with the IRS.

We remain focused on delivering sustained long-term growth and creating value for patients, staff, and shareholders by doing what we said we would do, executing on our growth drivers, advancing innovation in areas of high unmet medical need, and maintaining rigorous financial discipline. I'm grateful to work with all of 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.

Thank you, Peter. Julianne, why don't we open up the lines for questions? I know it's been a long day for many of our callers, let's jump straight in and try to get to everybody's or as many questions as we can. We'll try to limit you to one question each, please. Let's get started, Julianne.

Thank you. If you'd 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 Yaron Werber from TD Cowen. Please go ahead. Your line is open.

Great. Thanks so much. Maybe, Jay, unsurprisingly, first question on the MariTide switch studies. Can you give us a little bit of a sense? Are you switching sort of 1-1-1 to monthly every two months and every three months? Are you looking at superiority or non-inferiority? What's the non-inferiority sort of margin? Thank you.

Yeah, Yaron, thank you for the interest. As I just shared, you know, people naturally very interested to know what will it take to switch from a weekly injectable to a medicine potentially quite a bit more convenient and quite active. The switch study is designed to provide that experience. There'll be 300 subjects on study with obesity or overweight. There'll be a run-in on weekly semaglutide or tirzepatide, then they'll switch to MariTide, as I said, on a every eight week or quarterly basis. The primary endpoint of this trial will be a change from baseline body weight after 52 weeks of MariTide treatment. We look forward to these results.

Thank you, Yaron. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Good afternoon. Thanks for taking my question. Could you just comment on the MariTide switching study and why it only evaluates the every two month and three month and not every one month? As you think about the profile today, how significant do you expect the maintenance opportunity to be for MariTide? Thank you.

Thanks. Why don't I start with the question around the design of the switch study, Murdo, and then you can talk about the opportunity thereafter. We have a lot of experience with monthly MariTide in this program, which is featured in to date, all of the enrolling

Phase III programs. We've had a really good experience in the maintenance setting in our phase II/Part II. In that regard, the long-term extensions that we've just described, where we switch from MariTide to MariTide, give us a chance to explore less frequent dosing after effective dosing. Comparably, in the switch study, we're focusing that trial on the learnings of going from weekly, to an every eight week and an every 12 week treatment regimen, which can make MariTide quite attractive to patients, if successful. Murdo?

Yeah. Thanks, Jay, and thanks, Salveen. Obviously, the goal here for weight loss is to lose weight and then sustain it over multiple years so that you can get the full medical benefit of the treatment. Given that, you know, we are coming later into this market, and there will be many patients already on other weekly treatments, we thought it would be helpful to prescribers, to clinicians and patients to understand how to convert, how to switch from those weekly agents to, as Jay mentioned, a more convenient regimen, like MariTide. Importantly, it'll also be necessary to describe once you reach your weight loss goal on monthly MariTide, how you would want to modify that dose interval either to q 8 week or to q 12 week for even more convenience.

We've taken the opportunity, given the timing of our launch and order of entry, to fully describe how to start patients on MariTide and then how to switch from other treatments that patients may be on and they may be dissatisfied with.

Our next question comes from Luca Issi from RBC Capital Markets. Please go ahead. Your line is open.

Hey, team. Thanks so much for taking our question. This is Cassian for Luca. We have a question for IMDELLTRA. The drug has clearly done very well so far in the second-line setting. Can you tell us more about what's next for IMDELLTRA, not only in terms of the opportunity you get once you move to the frontal lines, but also now with IMDELLTRA selected as part of the Real-Time Clinical Trial Pilot Program? Could you help us understand the processes? The idea, basically, FDA will look at your data, scientists, together as the study is going and for indications with no healthy volunteers. You essentially can go straight from first in human to approval without pausing for safety or end-of-phase reviews. Curious what made FDA pick IMDELLTRA as the pilot program. Thanks so much.

Let me please start, Luca. Thank you for the question. IMDELLTRA has really emerged as the standard of care for patients with second-line small cell lung cancer because, as I mentioned moments ago, the unprecedented efficacy afforded by IMDELLTRA on just the most important endpoint, overall survival. As for so many medicines in advanced cancer, medicines that work in later stages of the disease tend to confer even more clinical benefit when they've moved to earlier lines of therapy and earlier stages of lower disease burden, especially when they're used in combination. So we are advancing IMDELLTRA quite actively and aggressively into frontline induction as well as frontline induction and maintenance. The maintenance experience with IMDELLTRA and the frontline experience will be in extensive stage small cell lung cancer, and these studies are rapidly progressing.

Further, we have the DeLLphi-306 study, which studies tarlatamab versus placebo after chemotherapy and radiation in frontline limited-stage small cell lung cancer. We're so hopeful for these trials and just cannot wait to read them out. As you've described, we have had a chance to collaborate with Commissioner McCary and members of the FDA on imagining what a clinical study might look like in the real-world prospective practice. We have a very fine design coming together with the FDA that will give us a chance to characterize IMDELLTRA in a clinical trial setting, but in the real world, leveraging things like electronic health records and real-time data capture as opposed to the way the clinical trials are conducted today.

This could be a very important experiment for us and for others, because so many clinical trials initiated don't complete. Enrollment is very challenging. Managing data and packaging it and then submitting it to regulators is quite a big book of work. If there's a way to do this in more real time, we would all benefit from having this learning. We're looking forward to working with them on that. Murdo?

Yeah. Thanks, Jay. The other thing that I would add here is we've seen very good progress in where patients are treated for their small cell lung cancer with IMDELLTRA, and we've seen really good uptake in the U.S. in community oncology. We've seen a very good launch in Japan. We expect to be launching in the second-line indication across multiple markets this year. Then, as Jay said, we have a nice randomized clinical program reading out through the balance of this year into next to further expand the use of this product. IMDELLTRA seems to have very durable survival, as we've seen in our Phase I data.

Importantly, in these innovative trial designs that the FDA is in discussion on, this will further help the physicians, primarily those in community settings, in regional hospitals or in community oncology practices, better care for their patients closer to their homes, which is a really exciting opportunity. Thank you.

Our next question comes from Michael Yee from UBS. Please go ahead. Your line is open.

Thank you. Great. Maybe a question on Olpasiran. You guys have a well-designed study and a potentially superior drug. I'm wondering if you think that, background therapies such as GLP-1 or PCSK9 either would impact your trial design or your competitor trial design, and how you think about that impacting the overall, results of what we might see from a competitor soon? Thank you.

Yeah. Thank you for the question. We see it the same way. The OCEAN(a) study is a very well-designed study, a randomized control trial of almost 7,300 patients with Lp(a), over 200 and a medicine, Olpasiran, with best-in-class performance characteristics as you cite, 95% reduction in Lp(a) with every 12-week dosing. We're really looking forward to reading out this event-driven trial. We have built this study around a very high-risk group of patients. Elevations in Lp(a) are genetically defined, as such, one in five individuals will have elevated Lp(a). Unfortunately, to your question, you can't take a GLP-1 medicine or a statin or even Repatha and meaningfully reduce levels of Lp(a).

This independent risk factor maps to a very atherogenic and inflammatory characteristic of the Lp containing particle, which is actually six times more inflammatory and atherogenic than the LDL-C containing particle which of course, you know, we and others have shown to be a dramatically and an importantly modifiable risk factor. Though we observe improvements in the standard of care for patients with cardiovascular disease, and we contribute to that with Repatha, we're very confident in the study as defined, which focuses on a high-risk, high-leverage elevated Lp population treated with direct and targeted therapy to Lp itself.

Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Great. Thanks for taking the question. Bob, I was just wondering, we've seen a pretty active M&A year thus far in the sector. Just as you think about Amgen's needs, you know, potential size of opportunity, how are you thinking about the BD and M&A landscape right now, given, you know, your current needs, but also your strength of your balance sheet? Thank you.

Yeah. I think, Terence, not sure I'd use the word needs the way you have in your question, but we're very active in business development, as we always have been, looking for innovation that we think we can add value to. That remains the case. I think the areas where we're interested are very clear to you and to our investors. We'll continue to see if there are things that again, that line up in a way that we can take over programs and still add value to our shareholders.

Thank you. Julie, our next question. Our next question comes from Jeffrey Meacham from Citi. Please go ahead. Your line is open.

Great. Thanks for the question, guys. Murdo, Repatha has been consistently strong, but I wanna get some perspectives from you on penetration into primary prevention and where could it go. As you look to the olpasiran data, how do you think primary prevention looks as a key market within the Lp(a) segment? Thank you.

Thanks for question, Jeff. We're really excited about what's happening in primary care. As you'll recall, we expanded the promotion and coverage of our primary care sales team at the beginning of last year. We expanded our medical teams in anticipation, of course, of some of the news flow that we've seen from new data from the VESALIUS-CV trial that we presented last November at the AHA meeting. As Jay mentioned, the subsequent sub-study in diabetes patients without atherosclerosis also showing significant benefit with a 31% reduction in  three point MACE and a 31% reduction in four point MACE. We have a clear opportunity to help these patients who are in the care of the primary care physician.

You know, the average diabetes patient without documented atherosclerosis is someone who's not being referred to a cardiologist. Since the change in our label, which occurred actually just prior to the VESALIUS-CV trial being presented, we've been out there talking to primary care physicians. We've seen really, really good uptake. In the quarter, we had, you know, strong overall growth in Repatha globally. If you look at new-to-brand prescription evolution in the U.S., we were up 44% in the quarter, and that's being driven by increased depth of prescribing by cardiologists and increased breadth of prescribing by primary care physicians. Very strong foundation, very pleased with the momentum, but we still have a huge opportunity ahead of us in primary prevention promotion of Repatha, the only PCSK9 with that data generation now. Real opportunity for us.

When we look at Lp(a), the one thing I will say that helps us is the new treatment guidelines that came out from the AHA/ACC. They have recommended that everyone who is at risk of cardiovascular disease be tested. As you know, this is a genetically determined level, so you really only need to do the test once. It's affordable, it's accessible. That bodes well for having

Some population of patients who will know their Lp(a) level. I do think that primary care physicians will play a significant role in treating those patients in lowering their Lp(a) levels with hopefully a product like Olpasiran, and should the data bear out.

Okay, good. Let's move on to the next question.

Our next question comes from David Risinger from Leerink Partners. Please go ahead. Your line is open.

Thanks very much. My question is for Murdo, please. Congrats on the launch of AmgenNow. I think that occurred last fall. Could you provide some quantification on the uptake of Repatha by cash pay patients? I don't know if it's meaningful enough yet, but possibly the current mix of sales between cash pay and covered, given the strong ramp of AmgenNow. Is Amgen considering leaning into offering Repatha as a cash pay product ex-U.S.? Thanks so much.

Thanks for the question, David Risinger. We've been pleased with overall response to the AmgenNow offering. As you'll recall, Repatha is offered at a $239 a month price point. We are seeing cash-paying patients interested in pursuing Repatha. Now, at the same time, however, it's important to note we've opened up access substantially for Repatha. So many patients now can access Repatha without much friction. Their physician can simply attest that the patient meets the criteria for the indication of the product. I wouldn't expect the cash-paying component of patients going through AmgenNow to be substantial. We are in the kind of the 8,000-9,000 patient range of patients moving through the AmgenNow program.

We continue to see more and more interest there. It's been a success, but as a percentage of total Repatha, as you'll note, it's relatively small.

Our next question comes from Matt Phipps from William Blair.

Thanks for taking my questions. You know, I was wondering on some of the blinatumomab updates. First off, you noted in the press release that enrollment has stopped in the SLE trial. Can you give us any updates on that status? It also looks like you're pausing enrollment of the sub-Q administration in ALL. Any additional reasoning for that pause? Thank you.

Sure. Thanks, Matt, happy to take the question. blinatumomab is proving to be an important component of standard of care for adults and children with relapsed and refractory B-cell acute lymphoblastic leukemia. Its current instantiation is delivered by intravenous continuous infusion. We have studied and characterized subcutaneously administered blinatumomab in the past, there is a chance with this medicine for even higher remission rates. As we have previously shown at a EHA presentation, we observed 89%-92% remission rates with manageable safety in adults with relapsed and refractory B-ALL. We're very encouraged by the efficacy seen with subcutaneous blin and are moving subcutaneous blin to earlier lines. As you shared, we have a potential registration-enabling phase II initiated in adults and adolescents.

We have a phase I-B-II study of sub-Q blin as well initiated in pediatric patients there with relapsed and refractory and MRD positive B-cell ALL. As you noted, we have paused some of these studies for enrollment. BiTEs are known to have inflammatory side effects. We prioritize patient safety, especially in the conduct of clinical investigation. Observing a handful of inflammatory reactions, we're at this moment collecting some patient data and having a dialogue with the FDA. We expect to be able to open these studies back for enrollment shortly.

Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open.

Great. Thanks so much for the question. I just want to come back to MariTide. Sounds like some encouraging earlier stage data on the titration. Are you able to provide any more color on what levels of vomiting and duration of vomiting you're seeing with the three-step titration from some of these earlier studies? Or if you can't provide specific numbers, just maybe directionally where that's shaking out versus Ozempic or Zepbound. Thanks so much.

Chris, thanks. The level of nausea and vomiting observed with three step dose escalation is lower than we've seen before. Dose escalation works for GLP-1 agonism-based therapies. That is known. In our experience one step improved GI tolerability significantly.  two step improved it further. Today, we share the unsurprising but accumulating data that provide clinical confirmation that three step dose escalation further improves GI tolerability. We await efficacy and tolerability data from the ongoing phase III studies. We're quite encouraged by what we've seen.

Jay, on the question of duration, you may help him understand what we see, help Chris understand what we see and how it's different from what we're observing from the weekly and dailies in terms of the side effect duration.

Side effect profile. Yes. You know, before we started this research, we didn't know would a long-acting medicine like MariTide, that can be delivered monthly or every eight weeks or every 12 weeks, enjoy durable efficacy owing to high time on target. This antibody backbone leads to very smooth and stable exposure over a long period of time, engaging GLP-1 receptors and GIP receptors in the brain and peripheral tissues. Would that durable efficacy be associated when there was a side effect with a long-term side effect? That we don't see. When we do observe nausea and vomiting, it tends to be quite short in its duration over the course of one or several days, no different than the weekly GLP-1s.

Different than the weekly GLP-1s and different than oral GLP-1s that are short half-life medicines, this trough-to-peak spike that's experienced every time these medicines are taken, we believe can be associated with intolerable side effects in the GI and otherwise. This can be avoided with a steady, stable, long-acting medicine like MariTide. We see this at target dosing of MariTide by Manhattan plots versus what's reported in the field with more frequent dosing. In the fullness of time, this could prove to be a very important attribute, keeping patients on the medicine for the length of time that they have these diseases, which is, for many of them, a lifetime.

Julianne, we probably have time for two more questions.

Thank you. Our next question comes from Akash Tewari from Jefferies. Please go ahead. Your line is open.

Hey, thanks so much. For dazodalibep, phase III Sjögren's programs, you're making an interesting bet, splitting it up into systemic and symptomatic patients. What kind of drove that decision, and which one of those trials are you more confident, will work? Can you go over any of the biological difference between dazodalibep and then the Novartis CD40, but also Sanofi CD40L, which both ended up discontinuing their programs? Thank you.

Yeah, Akash, I love your questions because they invite a mechanistic characterization of these molecules. I'll try to keep this brief, though it will be hard for me. We observed in phase II very strong activity of dazodalibep, which, as you comment, is a CD40 ligand FC fusion protein, targeting fusion protein. The performance against the ESSDAI score in Sjögren's syndrome is quite a unique situation. It has proven very hard to develop effective medicines in Sjögren's disease. Seeing movement in the ESSDAI score, that made us very motivated to follow this up in phase III clinical investigation. The presentation of this heterogeneous disease can be quite different clinically.

We thought to segregate, in order to have clear clinical outcomes in these clinical trials into two phase III studies, patients with what we'll call systemic disease, also very sick, a separate study of moderate to high symptomatic disease, but there with low systemic disease activity. In the case that these two populations might be considered differently to observe meaningful differences attributable to those clinical presentations. These studies have completed enrollment. Completion of both studies is expected in the second half of this year. dazodalibep is a product of a long-sought-after drug discovery campaign, honestly, in the field of immunology. CD40 ligand signaling is fundamental to T-cell, B-cell co-stimulation, CD40 ligands on T-cells, CD40s on many different kinds of cells. That makes this molecule very different than CFZ533 from Novartis.

What is true of Sjögren's disease, whether or not it's systemic or symptomatic, is that T and B-cell activation is the primary driver. This isn't a dry gland disease. It's enriched with inflammatory cells. We believe the CD40 ligand is the right lever to press on, as it will impact all downstream signaling by targeting the upstream CD40 ligand on T-cells. We look forward to reading out these studies, one with the ESSDAI score, another with the ESSPRI score appropriate for a symptomatic study, in the second half of this year.

Julianne, let's take one last question, and then I'll have a couple remarks, and we'll be finished.

Thank you. Our last question today will come from Louise Chen from Scotiabank. Please go ahead. Your line is open.

Amgen (AMGN) Q1 2026 Earnings Call Transcript

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