My name is Julianne, and I will be your conference facilitator today for the Amgen Q2 Earnings Conference Call. I would now like to introduce Casey Capparelli, Vice President of Investor Relations. Mr. Capparelli, you may now begin.
Thank you, Julianne. Good afternoon, everyone, and welcome to our second 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.
Robert Bradway
Chairman & CEO
Good afternoon, and thank you for joining us. Our strong results were driven by the breadth and depth of our portfolio and once again demonstrate our ability to grow through patent expirations and increased competition. We're pleased with the momentum across our business and expect to reach more patients with our innovative medicines and biosimilars in the second half of the year than ever before as volume demand for our products continues to grow strongly.
This broad-based performance is exactly what our strategy is intended to deliver and it's why we remain confident in our ability to deliver durable growth well into the next decade. Turning to the quarter. Total revenues exceeded $10 billion, a 10% year-over-year increase.
Notably, 22 products delivered double-digit sales growth and 17 products annualized at more than $1 billion based on second quarter sales. These results, including strong earnings and margin performance were achieved while we increased our investment in innovation, reflecting the sound financial structure of our business. That sound financial structure also gives us the flexibility to invest with discipline in both our internal pipeline and external innovation while supporting the long-term needs of the business.
As we've discussed for some time, our 6 key growth drivers are propelling the business forward. Together, they grew at an aggregate rate of 26% year-over-year and represented nearly 70% of our second quarter product sales. Importantly, many of our first-in-class and best-in-class medicines address large and underpenetrated disease areas, giving us confidence that significant opportunities remain to reach many more patients and contribute to durable long-term growth.
For example, while more than 1 million people in the U.S. are on Repatha, there are tens of millions more who would benefit from the therapy. As our products continue to grow, we're also investing in expanding their long-term potential. We're adding indications, broadening geographic reach, improving dosage administration and expanding payer access across our medicines.
Our late-stage pipeline is progressing well and also provides additional opportunities for growth. MariTide, Olpasiran and Xaluritamig are advancing through Phase III development and have the potential to address areas of significant unmet medical need. We remain focused on disciplined execution and generating high-quality evidence required to bring these medicines to patients.
Jay will discuss our progress there in a few moments. Underpinning these efforts are our investments in technology, data and artificial intelligence, which are helping us advance promising medicines more efficiently from discovery through development and manufacturing. In summary, the business continues to perform well and we're excited about the future and our ability to deliver durable growth well into the next decade.
Let me take a moment to thank my Amgen colleagues around the world for their dedication to our mission to serve patients and for the quality of their work every day. I'll now turn over to Murdo.
Thanks, Bob. Our second quarter results reflect not only the breadth of our portfolio, but the strength and consistency of our execution across key brands and geographies. The next phase of Amgen's growth is fueled by 6 key drivers: Repatha, which grew 37% in the second quarter, EVENITY at 38%, TEZSPIRE at 42%, Rare Disease at 21%, Innovative Oncology at 18% and Biosimilars at 29%.
As Bob mentioned, this combined portfolio of products is now representing approximately 70% of sales. These growth drivers are delivering strong performance with the majority of these medicines addressing large areas of public health. In Rare Disease and Innovative Oncology, we're sustaining growth through additional indications, international expansion and disciplined pricing.
Together, they're driving durable performance and positioning Amgen for sustained growth well into the next decade. Starting with General Medicine, Repatha delivered $953 million in second quarter sales, growing at 37% year-over-year. Momentum continues to build for Repatha with new-to-brand prescriptions growing more than 50% year-over-year in the U.S., supported by increased urgency to treat both in secondary prevention and high-risk primary prevention patients.
The clinical evidence supporting Repatha is unrivaled in its class. Repatha is the only PCSK9 inhibitor with Phase III outcomes data in both primary and secondary prevention. Our landmark VESALIUS-CV trial reinforces that earlier and more intensive LDL-C lowering before cardiovascular events occur can deliver meaningful risk reduction.
These data further strengthen the case for Repatha to be the first therapy considered when intensifying LDL-C treatment beyond statins. Repatha should be central to an aggressive LDL lowering strategy for the estimated 100 million patients worldwide who are still above their LDL-C goals. Repatha has broad access and is uniquely positioned to close the treatment gap and drive sustained growth into the next decade.
EVENITY sales increased 38% in the second quarter to $714 million, building on 27% growth in the previous quarter. In the U.S., the opportunity remains significant with approximately 2 million women at very high risk of a fracture and EVENITY reaching only mid-single-digit penetration to date. EVENITY continues to lead the U.S. bone builder market and is well positioned to reach even more patients.
In Japan, EVENITY holds category leadership with more than 55% volume share. 1 million patients have now been treated in Japan alone, representing a major milestone in clinical adoption. Moving to Inflammation. TEZSPIRE sales grew 42% year-over-year, reaching $486 million, driven by strong demand in severe uncontrolled asthma.
In the second quarter, TEZSPIRE was the market leader in new-to-brand prescription share in severe uncontrolled asthma among allergists and continues to grow with pulmonologists. TEZSPIRE is reaching more patients today through expanded Medicare access, including coverage for self-administration with additional opportunity ahead as Part D access improves. Uptake in chronic rhinosinusitis with nasal polyps is encouraging and is already extending TEZSPIRE's impact beyond severe asthma.
We expect additional indications to deliver continued catalysts for growth in the future, and Jay will share more about those in a moment. Prolia and XGEVA combined delivered $1.1 billion in second quarter sales, a decrease of 33% year-over-year. This is in line with our expectations given several biosimilar competitors have now launched.
Turning to our Rare Disease portfolio, which grew 21% year-over-year to $1.6 billion, you can clearly see our strategy coming to life. Growth is driven by additional indications, international expansion and disciplined pricing. And we're highly encouraged by the value these products continue to deliver for patients and for Amgen's long-term growth.
UPLIZNA sales increased 90% year-over-year to $335 million in the second quarter, reflecting sustained momentum across all 3 approved indications. The compelling biology of UPLIZNA's CD19 targeted mechanism, which is designed to deplete the B cells driving autoimmune pathology is resonating with both physicians and patients. UPLIZNA's durable efficacy and convenient twice yearly dosing further reinforce this impact.
These attributes, along with broad payer coverage and Amgen's comprehensive patient access services are enabling rapid initiation and continuity of care across indications. Uptake in gMG continues to build, supported by an almost even mix of bio-naive and switch patients with a doubling of U.S. prescribers since the previous quarter. We believe UPLIZNA is well positioned to establish market leadership in this category.
Growth also continues in IgG4-related disease, where significant under-diagnosis remains and increased disease awareness is helping more physicians identify appropriate patients. Recent long-term follow-up data illustrate the durable efficacy profile for patients with IgG4-related disease. And as you'll hear from Jay, we see meaningful opportunity to extend UPLIZNA's growth trajectory through additional indications.
These clinical programs further leverage the advantages of CD19-directed B-cell depletion across a broader range of autoimmune diseases. TEPEZZA sales grew 14% year-over-year to $576 million in the second quarter. We're seeing strong uptake globally with solid execution in Japan following last year's launch.
TEPEZZA is now launched in 13 countries around the world with an additional 6 planned in the coming months. Since approval in the U.S., more than 25,000 patients have been treated with TEPEZZA. We're continuing to build momentum by expanding awareness and broadening the prescriber base, including endocrinologists and ophthalmologists to reach more eligible patients.
Looking ahead, the advancement of our subcutaneous on-body injector for TEPEZZA represents a meaningful step forward. The Phase III data demonstrated comparable efficacy to IV TEPEZZA, supporting a clear path to subcutaneous administration without compromising clinical benefit. This option enhances convenience, enables more sites of care for patients and has the potential to drive long-term growth.
Turning to Innovative Oncology. The portfolio grew 18% year-over-year, generating approximately $2 billion of sales in the second quarter. IMDELLTRA sales increased 115% year-over-year to $288 million.
After years with little meaningful innovation for patients with small cell lung cancer, IMDELLTRA has emerged as the best-in-class treatment option to improve overall survival in the second-line setting. We're seeing strong clinical conviction, rapid adoption across sites of care and clear differentiation from other available therapies. And IMDELLTRA is supported by NCCN recommendations.
While we have made important inroads, there's still significant opportunity to further penetrate the second-line patient population. Too many patients are still being treated with chemotherapies that do not offer the survival benefit demonstrated by IMDELLTRA. As we continue to expand in the second-line setting, we look forward to data in the first-line extensive stage small cell lung cancer, which has the potential to further expand IMDELLTRA's impact and unlock additional growth.
BLINCYTO sales increased 23% year-over-year to $472 million in the second quarter, driven by broad prescribing across both academic and community settings in the U.S. and 64% growth outside the U.S. International performance was led by broader first-line adoption, robust treatment duration and strong demand across Europe and Japan. Our biosimilar portfolio delivered 29% year-over-year growth, generating $855 million in sales in the second quarter. PAVBLU, our biosimilar to EYLEA, increased sales 121% year-over-year to $287 million in the quarter.
Adoption continues to expand among retina specialists who value PAVBLU's ready-to-use prefilled syringe format and Amgen's track record of quality and biologics manufacturing and delivering reliable supply. Since our first biosimilar approvals in 2018, the portfolio has generated more than $15 billion in sales. Amgen's deep biologics expertise, global manufacturing scale and commercial capabilities differentiate us and support reliable supply for patients around the world.
Our next wave of biosimilars candidates for EYLEA HD, OPDIVO, KEYTRUDA and OCREVUS are in late-stage clinical development and represent large market opportunities with the potential to further expand patient access. Our second quarter results reflect focused high-quality execution, portfolio strength and continued progress in expanding the impact of our medicines for patients worldwide. Reflecting on these results and the broader set of portfolio opportunities, it's clear that we are delivering a level of consistent, compelling performance that's rarely seen in our industry.
This performance is grounded in a portfolio anchored by first-in-class or best-in-class medicines, a team that executes with urgency and a disciplined approach to access that reduces friction for patients. These efforts position us to unlock future growth and drive durable impact in areas of significant unmet need well into the next decade. And I'd like to now hand it over to Jay.
Thank you, Murdo, and good afternoon, everyone. In the second quarter, we enjoyed continued progress advancing our late-stage pipeline and expanding the impact of our in-line medicines. Starting with cardiovascular disease, where Amgen is a global leader in developing medicines that target remaining often genetically defined cardiometabolic risk factors for heart disease.
Repatha anchors our cardiovascular efforts as the only PCSK9 targeting therapy with outcomes data in both primary and secondary prevention, supported by 51 clinical trials involving more than 57,000 patients and over 100,000 patient years of exposure. We continue to generate additional insights from VESALIUS-CV, the landmark study of Repatha in pre-event cardiovascular disease. We recently reported that for patients with high-risk diabetes with and without atherosclerosis, Repatha reduced 3-point major adverse cardiovascular events by 29% and produced a nominal 21% reduction in the risk of all-cause death.
Also based on the positive VESALIUS-CV study, we recently received a positive CHMP opinion supporting a broader label for Repatha in the EU. Our cardiovascular leadership further extends to Olpasiran, targeting lipoprotein (a) or Lp(a). Elevated Lp(a) is an independent genetically defined risk factor for cardiovascular disease affecting approximately 1 in 5 people.
Having demonstrated greater than 95% reduction in Lp(a) level in Phase II, Olpasiran advanced into 2 ongoing Phase III outcome studies in both primary and secondary prevention. Deep Lp(a) suppression and quarterly dosing position Olpasiran for a potentially best-in-class profile. A third widely prevalent and modifiable risk factor for cardiovascular disease is, of course, obesity.
Our lead obesity asset, MariTide, is fundamentally different from other GLP-1 therapies as MariTide is uniquely designed for monthly therapy with the potential for as few as 4 or 6 doses per year. Clinical development of MariTide continues to progress rapidly with 9 ongoing and 3 additional planned Phase III studies across obesity and related serious chronic diseases. Beyond establishing efficacy, these studies will guide how to start and stay on MariTide and how to switch from other GLP-1-based therapies and stay on MariTide.
One, start and stay on MariTide. MariTide Phase III dosing features a simple 3-step dose escalation, allowing patients to start MariTide to reach their target dose in only 2 months, followed by monthly dosing thereafter. MariTide's unique monoclonal antibody backbone with appended GLP-1 peptides is designed for extended dosing.
Our Phase III maintenance extension studies will evaluate how patients stay on MariTide to maintain weight loss while transitioning from monthly dosing to as few as 4 or 6 doses per year. Two, switch and stay on MariTide. The next chapter in obesity treatment is not simply greater weight loss, but achieving long-term persistent benefit.
We are, therefore, evaluating switching from weekly GLP-1 therapies to MariTide in a dedicated Phase III study with the goal of enabling patients to move from weekly injections to a maintenance schedule with again as few as 4 or 6 doses per year. Through this comprehensive program, we aim to establish MariTide as the first monthly or less frequent obesity therapy and make long-term treatment easier for patients to sustain weight loss and enjoy durable health benefits. Closing out our cardiometabolic pipeline, we have decided to stop development of AMG 513, a Phase I asset.
As I've said before, the bar is high at Amgen for obesity medicines. Our next generation of differentiated preclinical programs continues to progress, featuring both incretin and non-incretin mechanisms of action. Let me now turn to rare disease, where we are focused on challenging and rare autoimmune diseases with UPLIZNA, dazodalibep and blinatumomab.
UPLIZNA has established the benefit of CD19-directed B-cell depletion in severe autoimmune diseases, including NMOSD, myasthenia gravis and IgG4-related disease with strong efficacy, durable benefit and twice yearly maintenance dosing. In IgG4-related disease, we recently completed a 1-year open-label extension of the Phase III MITIGATE study. Building on the remarkable 87% reduction in flare risk versus placebo in year 1 of UPLIZNA therapy, 100% of patients who continued UPLIZNA treatment remained flare-free at year 2 and 71.4% achieved complete remission without glucocorticoids.
Based on the emerging profound clinical impact of UPLIZNA in autoantibody-mediated disease, we have initiated the registrational MERCURY study in autoimmune hepatitis, a disease affecting as many as 150,000 patients in the U.S. We are also planning a Phase III study in chronic inflammatory demyelinating polyneuropathy, a rare and debilitating autoimmune condition that attacks the myelin sheath on peripheral nerves affecting about 35,000 patients in the U.S. For patients suffering from Sjögren's disease, we are developing dazodalibep. Dazodalibep targets CD40 ligand mediated signaling between activated T cells and B cells and has been artfully designed to avoid the platelet-related adverse events observed with first-generation CD40 ligand targeting agents. We are conducting 2 dedicated Phase III studies in symptomatic and in systemic disease.
Results are expected later this year. Turning to inflammation. TEZSPIRE has validated targeting TSLP and the alarmin pathway in severe asthma and chronic rhinosinusitis with nasal polyps.
We are now extending its potential to other diseases where epithelial-driven inflammation plays a key role. Our Phase III study in eosinophilic esophagitis or EoE, is expected to complete in the second half of the year. EoE is a chronic progressive inflammatory disorder characterized by epithelial-driven inflammation, remodeling and dysfunction of the esophagus, affecting over 400,000 patients in the U.S. Building on the impact of TEZSPIRE, we are developing sunakiment, previously AMG 104 as an inhaled anti-TSLP fragment antigen-binding protein or Fab.
In the Phase II LEVANTE dose-ranging study of sunakiment, we observed numerical reductions in composite asthma exacerbation events or CompEx as the primary endpoint at 12 weeks. Although the primary endpoint was not statistically significant, we are encouraged by the overall profile and are planning a Phase III program with AstraZeneca. In oncology, we continue to expand our bispecific T cell engager or BiTE platform across tumor types and earlier lines of treatment.
IMDELLTRA or tarlatamab is becoming a standard of care after first-line treatment for small cell lung cancer, supported by a strong survival benefit. We are actively advancing IMDELLTRA into earlier treatment lines, where we hope to further impact survival with 3 Phase III studies well underway. Success in these early-stage settings would allow IMDELLTRA to reach as many as 28,000 addressable patients in the U.S. We are also pursuing more convenient administration.
DeLLphi-309 is informing our strategy for extended interval dosing, while the new Phase III DeLLphi-315 study is evaluating subcutaneous tarlatamab. Building on the success of our BiTE platform in solid tumors, Xaluritamig is advancing in two Phase III studies of metastatic castration-resistant prostate cancer, while we also evaluate opportunities in earlier stages of this disease. Shifting gears before closing, I'll briefly comment on artificial intelligence.
Amgen has a differentiated foundation in proprietary human data, high-performance computing and deep scientific expertise. We are applying AI strategically across discovery, development, manufacturing and access to medicines to improve insight, speed and decision quality. The impact and insight from these investments are already proving valuable.
For example, in Amgen research, we recently established a frontier AI laboratory that combines advanced models with proprietary data and scientific capabilities unique to Amgen. Bringing agentic workflows to discovery research powerfully augments the insights and ideas of our brilliant research scientists. We look forward to sharing more over time.
In closing, I'd like to thank my colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. I'll now turn it over to Peter for the financial update.
Thank you, Jay. Our strong second quarter performance reinforces confidence in our 6 key growth drivers and our ability to grow through losses of exclusivity. Together, they demonstrate the breadth and the depth of our business and continue to provide a strong foundation for sustained long-term growth.
Our non-GAAP operating margin was 48%. We continue to invest in our portfolio and pipeline while achieving strong operating results, with non-GAAP R&D spending increasing 10% year-over-year in the second quarter. This reflects continued investment in the innovation that will drive future growth, including MariTide, Xaluritamig and Olpasiran as well as our marketed medicines, including UPLIZNA, TEZSPIRE and IMDELLTRA.
Our non-GAAP cost of sales as a percentage of product sales was 19.6%. The year-over-year increase primarily reflected higher profit sharing and royalty expenses as well as changes in sales mix. These factors reflect the continuing evolution of our product portfolio and momentum from several of our growth drivers.
We remain focused on operational efficiency, execution excellence and continue to benefit from our leadership in high-quality, world-class biologics manufacturing at scale. We generated $3.5 billion in free cash flow in the second quarter, reflecting continued momentum across the business and enabling us to continue investing for future growth. We spent $500 million in the second quarter on capital expenditures, driven by investments across our United States manufacturing sites, including North Carolina, Ohio 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's launch. Our commitment to investing in our business and enabling additional capacity supports our long-term growth well into the next decade. In addition, we returned capital to shareholders through competitive dividend payments of $2.52 per share, representing a 6% increase compared to the second quarter of 2025.
Let's turn to the outlook for the business for the remainder of 2026. We are pleased with our strong execution in the first half of the year, and we are raising our 2026 guidance ranges for both revenue and non-GAAP earnings per share. We now expect 2026 total revenues in the range of $38.2 billion to $39.4 billion and non-GAAP earnings per share between $22.30 and $23.50.
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 approximately $1.9 billion. We expect full year non-GAAP R&D expense to grow high single digits year-over-year, which includes 9 ongoing global Phase III clinical trials for MariTide.
This outlook also includes a business development transaction, resulting in a $100 million upfront payment that will increase our non-GAAP R&D expense in the third quarter. We now anticipate non-GAAP other income and expense to be in the range of $2.1 billion to $2.2 billion of expense in 2026. And let me remind you of 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%. Our commercial performance allows us to continue investing behind the next generation of growth drivers while maintaining strong operating margins. In addition to the third quarter business development transaction noted earlier, our strong revenue performance has enabled us to make incremental third quarter investments in the pipeline and our commercial brands to drive continued momentum into 2027.
As a result and consistent with 2025, we expect a meaningful sequential increase in operating expenses in the third quarter. We expect a non-GAAP tax rate in the range of 15.0% to 16.5%. We expect share repurchases not to exceed $3 billion.
We remain focused on executing our strategy, staying focused on our growth drivers, investing in the best innovation and maintaining our rigorous financial discipline that enables us to deliver sustained long-term growth and create value for patients, staff and shareholders. I'm grateful to work with all of our colleagues worldwide in our mission to serve patients. And with that, this concludes our financial update.
I'll now hand it over to Bob for Q&A.
Robert Bradway
Chairman & CEO
Okay. Thank you for that strong report, Pete. And before we open up to questions, let me just remind you that this is Pete's [indiscernible] earnings call with us.
So I'll take a few minutes at the end of our Q&A to thank him and recognize his contributions to our firm. But now Julianne, let's open the line up for questions.
Our first question comes from Michael Yee from UBS.
This is Dina on for Mike. Just a quick question on the Lp(a). Two-part question.
Just thinking about how you design the protocol, is that involving an interim? And then maybe just I know that you guys are doing a MACE-3 endpoint opposed to Novartis is doing MACE-4. Just given that, do you see that the exclusion of strokes to be affecting the time of your study versus having a MACE-4 endpoint?
Yes. Thanks for your question. As you know, our development of Olpasiran, which is a potentially best-in-class siRNA for modifying the risk of cardiovascular disease attributable to Lp(a) elevations affect 1 in 5 patients.
It's a serious and profound unmet need, and it's terrific to see so much attention for what is one of the last known and well-defined genetically modifiable risk factors. We have a terrific study design with OCEAN(a). This is a double-blind randomized controlled trial, as you asked. 7,297 patients have been enrolled in record time.
And there are distinguishing features of our design. One is the requirement for elevations of Lp(a) above 200, that's nanomoles per liter. And with this every 12-week dosing in an event-driven study, we'll read out a primary event, as you shared, of 3-point MACE.
We focused on 3-point MACE after extensive human genetics and population science analysis indicated to us that the association of ischemic stroke and Lp(a) elevation was not as compelling as other cardiac-specific cardiovascular endpoints. And this is, therefore, a potentially important distinction between this study and others. And you asked, does the stroke -- the lack of inclusion of stroke and the endpoint influence the event rate, not by our modeling.
Robert Bradway
Chairman & CEO
Julianne next question please.
Our next question comes from Salveen Richter from Goldman Sachs.
On business development, you have reiterated a focus on securing the best innovation and a pure agnostic on size and structure as long as the deal meets your criteria. Walk us through how your latest thinking here is playing out currently and the capital allocation strategy more broadly? And how much of the near-term BD strategy depends on outcomes from clinical readouts from MariTide and Lp(a)?
Robert Bradway
Chairman & CEO
Salveen, I think our business development strategy is pretty consistent. We've articulated it, I think, in that way now over a number of years. So we're focused on the therapeutic areas where we think we can add value in research and in development.
We're focused in the 4 areas that you've heard us discuss on this call, and we're continuing to look at interesting opportunities there. And we frequently repeat that our objective is to find and advance the best innovation, whether it's generated internally or externally, and that's what we're doing. I would just observe that we're seeing some exciting early-stage progress in our industry right now.
So I suspect we're not the only ones that are interested in some of the emerging shoots that look intriguing. So we are looking, but primarily in smaller earlier-stage assets. And the answer to your question about the late Phase III trials is not directly.
Obviously, our operational plate is pretty full in the late-stage clinical development right now, for example, in cardiometabolic disease. But we try to be mindful of that as we look for external opportunities, but it's not linked as directly as your question implies. Move on to next question, Julianne.
Our next question comes from Chris Schott from JPMorgan.
This is Taylor Hanley on for Chris, JPMorgan. We had a follow-up on Lp(a). So there's competitor Lp(a) data that's expected shortly.
What will you be looking for when this data set reads out? And specifically, if we do see a 13% to 15% type benefit from that study, how would you think about the potential read-throughs to Olpasiran?
Thanks for the interest, Taylor. Again, with a huge unmet need affecting so many humans globally and the American Heart Association recommending testing it's understandable that there will be so much attention on Lp(a), and we quite like our chances with Olpasiran and its profile. What can we expect from the pelacarsen data?
We're following it with interest. We can expect perhaps some directional insight, but not decisional perspective owing to the superior properties of our molecule that delivers 95% Lp(a) reduction compared to, say, 70% with that molecule and also some differences in the study design, which we just described.
Our next question comes from Umer Raffat from Evercore ISI.
Jay, I have 2, if I may, for you. One, based on everything you know right now and all the titration that's been put into place, how confident are you that the vomiting rates in Phase III trials of MariTide will be mid-20s or better? And secondly, are you tracking malignancies on a blinded basis in the ongoing [indiscernible] get it wrong on the CD40 trial, I'd be very curious.
Dazodalibep Umer. Dazodalibep just rolls right off the tongue. Yes.
First, regarding the MariTide clinical development program, we are noses down delivering a very compelling Phase III data package right now. 2026 is a year of very disciplined data generation. Trial enrollment is strong. I think a clear sign of the remaining unmet need and also an interest in the MariTide profile.
We're executing a broad therapeutic program very well, and we are very confident in the profile of this medicine. Second, around dazodalibep, as appropriate for any medicine in Phase III clinical investigation, especially immunomodulatory medicines, we have a data safety monitoring committee associated with these studies that is just doing their job perfectly. As we would expect, they're capturing all high and potentially associated as well as really any incident effects of the medicine.
And we'll learn more about dazodalibep in H2 of this year.
Robert Bradway
Chairman & CEO
Next question please Julianne.
Our next question comes from Yaron Werber from TD Cowen.
A quick question on dazo as well. You're the only company running both systemic and symptomatic studies and a lot of the feedback from KOLs is that, that's obviously a huge areas of interest for them. A lot of the patients that are systemic naturally obviously have glandular manifestations.
And so the symptomatic are really extra glandular manifestations. Can you talk about the difference? And at the end, how much of a differentiated label can you get relative to companies who are only working on systemic disease?
Yes, Yaron, thank you. This is a terrific question. As you know, dazodalibep is a potentially first-in-class CD40 ligand Fc chimeric protein.
It's just beautifully designed in order to maximize inhibition of CD40 ligand signaling from activated T cells to B cells and epithelial cells that are enriched for CD40 in the milieu of lymphocytic infiltrated glandular tissue like the salivary glands that you mentioned in your question. We are pursuing the Phase III clinical investigation of dazodalibep in both the systemic population as well as the symptomatic population because there is tremendous unmet need. There's 350,000 or more patients with Sjögren's disease.
There's a few effective therapies. Those therapies that are FDA approved are, by and large, local and symptomatic management therapies. And the signal that we saw in our Phase II clinical study, you'll recall, there were 2 populations.
Population 1 had 74 patients with systemic disease. And at day 169, we saw significant movement of the ESSDAI score of 6.3 versus 4.1 on placebo. Population 2, we had 109 patients with symptomatic disease at day 169, the ESSPRI score in that case, appropriate for that constellation of symptoms, was also superior to placebo, negative 1.8 versus negative 0.5.
So a big unmet need and activity in these 2 populations that are rightly studied distinctly because there are different clinically useful scores that physicians use to follow them. It's just a very nice data package to build upon for Phase III. Now we're deep in Phase III.
We have 621 patients on the systemic study, 434 on the symptomatic. They need to be studied differently for the reasons I've mentioned, and we'll learn more about the impact of this medicine in that disease in H2 of this year. So we're very hopeful, but humbled.
It's a very challenging disease.
Next question comes from Courtney Breen from Bernstein.
This is Woody Polglase on for Courtney. I wanted to ask what you guys are seeing on [ SOTYKTU's ] impact in the dermatology market with regard to Otezla. Are you seeing a slowdown in volumes and prescribing Otezla?
And how should we think about the future of this drug, especially in light of IRA selection next year?
Robert Bradway
Chairman & CEO
Sure. Murdo, why don't you [ answer ] this question, please.
Yes. One of the things to remember about Otezla is given the extensive clinical experience with this medicine, the broad label that we have that includes the milder forms of psoriasis and the really clear coverage from payers, we generally are used as a first stop systemic agent. And what we're seeing is the new entrants are competing with each other after Otezla has tried.
And so we're not really necessarily seeing direct competition from the new entrants. We are seeing definitely some pressure on price with Otezla given some 340B exposure on that product. But overall, the volume in Otezla is actually holding up quite good.
Our next question comes from Terence Flynn from Morgan Stanley.
Great. This is Chris on for Terence. Just a 2-part question on PCSK9.
Merck's oral PCSK9 recently got approved. Can you compare and contrast the key label language differences from Repatha's? And also, can you comment on the contract dynamics now that there's an oral option?
Robert Bradway
Chairman & CEO
Sure. Murdo, why don't you...
Yes. Let me take that one. Obviously, the 2 labels really just don't compare.
You have Repatha, as Jay mentioned, over 50,000 patients on clinical trial experience reflected in a broad label that includes primary and secondary prevention. Repatha can be used as monotherapy or in combination with statins. 10 years of real-world experience reflected in data that we've presented at recent scientific meetings. So as we say, the data behind Repatha are unrivaled.
It is the category leader and indeed, the data are unrivaled. I think, though, what's important to remember is that this is a huge market with a lot of patients that are still not at their LDL cholesterol goal and additional therapies, much like when inclisiran entered the market, are treating other patients. They're not necessarily competing for share with Repatha.
And so we think there's a lot of education that still needs to be done. We think that the guidelines are important in this market. And we think that we are able to drive utilization in this market more effectively given the compelling data that we generated on VESALIUS.
The other thing that we've experienced with Repatha as we look at persistency data in the market and the real-world analysis is an every 2-week injection is a really easy regimen for patients to adhere to. And we've seen limitations with orals, including with statins, where daily oral therapy does have some compliance and some adherence challenges to it. We're also seeing in the label with the new PCSK9 approval that there are indeed food restrictions that you have to be careful with what you eat in the first 30 minutes after you take that medicine.
So I think this oral versus injectable is too simplistic a compare and you really have to look at why do you take an LDL-cholesterol medicine in the first place and it's to prevent a first or second heart attack, and we've demonstrated that with very clear evidence for Repatha.
Our next question comes from Akash Tewari from Jefferies.
This is Manoj on for Akash. Just one from [ us ]. One of the concerns around the HORIZON Lp(a) trial is around the extent of LP(a) effect independent of LDL-C. In HORIZON trial, we see the baseline LDL-C is around like 65 milligram per deciliter.
What's the baseline LDL-C in the OCEAN trial you are planning? Or, like, is it in the same level? And also, is there a possibility that Lp(a) effects manifest only in presence of a relatively higher baseline LDL-C effect?
Just trying to understand that one.
Well, thank you for the question. As I shared a moment ago, we're enrolling the OCEAN(a) study to target an Lp(a) that's a little bit higher than the HORIZON study. By targeting 200 or higher in OCEAN(a), we biased towards a slightly higher risk group of patients.
We believe and have seen data from population studies that Lp(a) elevation to this extent is just firmly independent as a risk factor of LDL-C. And if I understand all aspects of your question, correct me, forgive me if I did not, the reduction of LDL-C, even with improving standard of cardiovascular care to which Repatha contributes meaningfully, would not be sufficient to drop Lp(a) meaningfully from this elevation to protect patients adequately. So Lp(a)-directed therapy, we believe, is urgently needed, and we're conducting the studies to assess that.
Our next question comes from Mohit Bansal from Wells Fargo.
This is Susan on for Mohit. A quick question on Repatha and then a longer one on dazodalibep. On Repatha, what portion of growth is coming from broader primary care adoption versus existing prescribers?
And how do you see that changing over time? And then on dazo, historically, symptomatic Sjögren's trials have struggled with endpoint sensitivity and placebo effect. I noticed for the Phase III trial that there's 2 primary endpoints measuring symptom improvement.
Can you discuss the rationale for using 2 endpoints here and what the level of concordance is just based on your trial design?
All right. Thanks, Susan, for the question. It's Murdo.
I'll take the first one on Repatha and then hand it over to Jay for the second. We are pleased to see that Repatha is growing very nicely, particularly in new-to-brand prescriptions, so new patient starts. We grew about 50% year-over-year in the quarter in new-to-brand prescriptions and it's being driven by 2 dynamics.
One, cardiologists who already use Repatha for some patients are broadening their use of Repatha. So they're increasing the number of prescriptions they generate on a per-physician basis, treating more patients mostly in secondary prevention or in very high-risk primary prevention. So that's roughly about half of our growth.
And then the other half of our growth is coming from primary care physicians and expansion in the number of primary care physicians, in particular, who are prescribing Repatha for their high-risk primary prevention patients. And there, I would highlight one specific patient type, and that's -- those patients who have diabetes. The primary care community see that as a patient that they should manage for their cardiovascular risk.
And given the VESALIUS data and then the subsequent diabetes substudy, the data there for adding Repatha for intensifying LDL cholesterol lowering are pretty compelling, and we're seeing more and more primary care physicians adopt Repatha for those patients, in particular, for primary prevention.
And your second question around the endpoint selected for the Phase III clinical investigation of dazodalibep in Sjögren's disease. As I shared moments ago, and as you clearly understand from your question, we have undertaken to do separate Phase III studies in each of 2 populations, the systemic population. And in this case, we use the ESSDAI score, which is a physician-observed score that reports on systemic manifestations of Sjögren's disease, a single endpoint.
And in the second study, we are studying the symptomatic population that can have a more localized disease, but symptomatic and measurable for sure. And there, our interactions with regulators and with trialists in the community as well as our own internal guidance was to collect both the ESSPRI score as well as the diary for assessing Sjögren's, patient reported with a ESSDAI score at week 48. In this way, we have 2 measures, both validated in other late-stage clinical studies that report on the subjective or [ lived ] experience of the patients on this medicine on this study.
Our next question comes from Alex Hammond from Wolfe Research.
So on IMDELLTRA, given you have a number of Phase II trials underway to bring it into earlier lines. Can you provide a little bit of detail on what Amgen is doing to kind of improve those monitoring requirements? Should we view the reduced monitoring in Europe as a good sign?
And as a follow-up, could we potentially see amendments to later line monitoring requirements for IMDELLTRA in the future?
Yes. Alex, thanks for the question. This is Jay again.
The development of T-cell engagers is an area of significant expertise here at Amgen, having pioneered the field with BLINCYTO and now bringing IMDELLTRA forward for patients with small cell lung cancer, truly the first T cell engager to address a common solid tumor. And so building on this experience of establishing strong efficacy of survival benefits to receiving IMDELLTRA in the second line of small cell lung cancer, we're now doing the work needed to expand the impact of this medicine. And part of that work is combination studies and part of that work is bringing the medicine forward into frontline therapy and preparing the medicine for combination utility.
And as you asked, for sure, making the experience of receiving IMDELLTRA for the patient easier and less burdensome for healthcare providers or institutions with regard to monitoring. The second-line Phase III used 16 hours of monitoring at that time appropriate for that stage of development. We now have real-world experience and ongoing clinical study experience all the way down to 1 to 2 hours of monitoring, say, in the context of our limited stage.
With this medicine, [ ICANS ], the neurologic consequence, thankfully, is quite infrequent and predominantly was observed at the 100-milligram dose. And so this really opens the door towards sequential reductions in monitoring through prospective clinical investigation as well as longitudinal engagement with federal regulators, actually global regulators with our accruing safety database. Murdo, anything to add here?
Yes. Thanks, Jay. We're obviously excited, Alex, about the additional data generation that Jay and his team are leading.
In the market right now, we've actually been quite successful in getting more and more accounts operationally ready to treat patients with IMDELLTRA. We've got over 2,000 accounts in the U.S. currently using IMDELLTRA, the opportunity for growth is to treat even more patients in the second line in the near term. And of course, we've been able to establish an overall survival benefit there against commonly used chemotherapies.
And given the operational complexities, we've been able to get quite a large base with those 2,000 accounts ready to be able to treat more and more of those patients. So with an almost doubling of revenues in the quarter, obviously, we're on a nice pace with this medicine and helping give small cell lung cancer patients a shot at real survival benefit, which they -- prior to IMDELLTRA in the second line, were unable to achieve.
Our next question comes from Dave Risinger from Leerink Partners.
Thanks for all the details today and all the commentary on the pipeline. So my question is for Jay, please. Regarding MariTide's construct, so it's GLP-1 peptides conjugated to a GIP antagonist antibody, of course.
Could you discuss the duration of effect of each mechanism and potential implications for duration of efficacy, obviously, since the peptide component will last a lot shorter than the antibody. And then if you could also comment on whether you expect real-world patient-led dosing selection for every 1, 2 or 3 months maintenance dosing based upon individual experience. Is that the right way that we should be thinking about it?
Well, Dave, thank you for the question. I wish we only we had more time in a whiteboard to take you through the answer. I'll be succinct.
MariTide is truly a singularity. It's the only of its kind antibody peptide conjugate. And because of the antibody design, unlike peptides that through miracle of chemistry last maybe a week in the bloodstream, the antibody design affords a half-life of approximately 21 days, and that's the half-life of the intact molecule, MariTide.
MariTide's appending peptides were designed and appended in order to maximize stability to tissue proteinases and to serum esterases and other xenobiotic-metabolizing enzymes in tissues and in circulation. And because of this, the duration of effect of the GIPR inhibitory variable chains of the antibody and the GLP-1 receptor agonizing peptides on MariTide is preserved through this long period of exposure. And what that means is that with monthly dosing as used with starting MariTide and with the transition to less frequent dosing, maybe 4 to 6 doses per year as you start and stay on MariTide or as you switch from another medicine and then stay on MariTide, that the GLP-1 agonism and GIP receptor antagonism is quite persistent as the molecule is quite persistent.
Why is this important? Because were that to, say, burn off with metabolism or elimination of the drug, then rechallenge with the therapeutic dose of the drug would be very hard. And that's not what we're seeing on our clinical studies.
As we've shared, with less frequent dosing, MariTide at target doses proved very, very well tolerated. And so this design is reading through to a truly differentiating clinical activity and a different experience for patients. Your second question is a little harder.
I can't predict the way in which MariTide in the fullness of time will be utilized by prescribing physicians and by patients. But what we're seeing is activity in our Phase II for chronic weight management as for diabetes is observed at multiple different doses. And as we've shared that maintenance MariTide can be administered on different schedules.
And so this would, I can say as a physician, this would seem to imply real flexibility in approaching how best to take MariTide. Murdo, what would you add?
Well, I think your team is doing a nice job, Jay, of generating data that will inform the clinical practice and, of course, patient optionality with 12 doses, 6 doses and perhaps even 4 doses a year. And I think that is different for MariTide than the current weekly injectables that have to be dosed 52 times a year. And there are scant data describing how you can maintain weight when you dose stretch on those therapies for various obvious reasons.
So I think it's a good thing for patients that we're doing those trials, and I think it will be really interesting when the data are available to see how it changes patient behavior.
Robert Bradway
Chairman & CEO
Okay. Julianne, why don't we take one more question?
Our last question today will come from Jay Olson from Oppenheimer.
Congrats to Peter for a great run at Amgen and all the best in retirement. Our question is about your cardiovascular portfolio as you look across Repatha, olpasiran and MariTide. Amgen is building a comprehensive cardiovascular risk reduction franchise.
So how are you thinking about leveraging those 3 assets with a coordinated strategy? And what are the advantages that creates versus competitors who might be pursuing only 1 or 2 components of cardiovascular risk?
Robert Bradway
Chairman & CEO
Why don't you share your thoughts?
Well, Jay, thank you for the acknowledgment of the breadth and depth of the cardiovascular portfolio. I think it's obviously a nice opportunity given the foundational strength we have in the LDL-cholesterol lowering market and cardiovascular risk reduction market with the leadership position we've established with Repatha. I think what you've heard even on today's call, you've heard from us prior to this is the experience that we've gained from Repatha has been applied to the clinical development and the design of the clinical programs behind olpasiran and behind MariTide.
We're not just developing olpasiran for secondary prevention. We're looking at primary prevention. We're not just developing MariTide for weight loss.
We're developing it for diabetes and for heart failure and for ASCVD. We're looking at all of the different independent metabolic risk factors that travel with losing weight. And so it's our intent to fully explore each of these unique medicines, these best-in-class -- potentially first-in-class of their kind molecules as well as potential combinations thereof.
So this is an exciting time for us. We continue to develop additional molecules in the clinic, and we continue to look outside for additional external innovation that could be brought in. So it's an important part of our long-term growth strategy and one that we expect to be durable well into the next decade.
Robert Bradway
Chairman & CEO
Great. Thank you, Murdo. Thank you, Jay, for the question.
Well, as I said, let me just take a minute to thank all of you for joining our call. I hope you can see that our business is in strong shape. And that is indeed a fitting way for Pete to pass the baton to Thomas Dittrich, who will be in the CFO role for our next call.
Recall that Thomas returns as a veteran of the Amgen finance team. We're delighted to have him back and grateful to Pete for ensuring another smooth transition of responsibilities at Amgen. I know many of you have worked closely with Pete since he joined us at the end of 2019, and we've all had fun working with him in his role here and are grateful to him for his many ways or the many ways in which he has strengthened our financial foundations.
His disciplined financial leadership has enabled our largest-ever investments in research and development, acquisitions and manufacturing capacity expansion. And he's also helped prepare Amgen for the future through our investments in technology, cybersecurity and data capabilities that will serve us well in the years to come. So Pete, on behalf of all of Amgen, thank you for your many contributions.
You've been a great colleague and a good friend, and we wish you all the best in your next chapter of life. Thank you all. Bye-bye.
This concludes our Amgen Q2 2026 Earnings Conference Call. You may now disconnect.
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