Amgen (AMGN.US) Q3 Conference Call: Annual Revenue Increase and EPS Guidelines Management Expect IMDELTRA's First-Line Volume to Be Very Rapid

The Zhitong Finance App learned that after the US stock market on November 3 (Tuesday), Amgen (AMGN.US) announced results for the third quarter of 2026. Total revenue was US$10.365 billion, up 8% year on year, higher than market expectations of about US$10.05 billion to US$10.07 billion; of these, product sales were US$9.883 billion, up 8% year on year. Non-GAAP earnings per share were $6.45, up 14% year over year, above expectations of $5.77-5.79; GAAP earnings per share were $7.08, up 19% year over year. Non-GAAP operating margin was 47.3%, up 0.2 percentage points year over year; free cash flow was US$3.7 billion (US$4.2 billion in the same period last year).

The six key growth products for the quarter increased 27% year over year, accounting for more than 70% of product sales. Repatha, EVENITY, TEZSPIRE, UPLIZNA, BLINCYTO, and IMDELLTRA all achieved double-digit growth. A total of 17 products had an annualized sales scale of more than 1 billion US dollars in the third quarter. The company also raised its guidance for the full year of 2026: total revenue was raised to US$38.9 billion to US$39.7 billion (previously US$38.2 billion to US$39.4 billion), and non-GAAP EPS was raised to US$22.90-23.70 (previously US$22.30-23.50). The stock price was not boosted after the results were announced: Amgen closed down 0.90% to $461.26 during the regular trading session on Tuesday, and fell further after the market. At 17:28 ET, it reported $454.90, down 1.38%.

The issue that received the most attention during this call was not the extent that exceeded expectations, but the first-line maintenance treatment data announced by IMDELLTRA (taratamumab) at the ESMO conference. The DellPHI-305 study showed that IMDELLTRA and IMFINZI compared IMFINZI single drug for first-line maintenance treatment. The median overall survival time was 21.1 months versus 12.7 months, which was extended by more than 8 months; R&D director Jay Bradner said this result “is changing clinical practice” and the company will “expedite the submission of applications to global regulators.” Evercore ISI analyst Umer Raffat asked: Assuming that more than 20,000 patients in the US use the drug, is it realistic to maintain a business of more than 5 billion US dollars on the front line alone? Murdo Gordon, head of global commerce, made it clear: “Everyone knows me and the Amgen team; we don't give guidance on individual products,” but added that after entering earlier treatment, the number of patients with small cell lung cancer in the US was 35,000, and “clinical behavior changes are expected to be very rapid”, adding that oncologists are “shocked by the magnitude and safety of these data”. The FDA has shortened the recommended monitoring time for the first two doses of IMDELLTRA from 22-24 hours to 6-8 hours, and to 1-2 hours in the DellPHI-305 plan. Management believes this will significantly lower the threshold for use in community oncology clinics.

Finance and capital allocation: New CFO debuts, profit margins are not expected to be downgraded in 2027

This quarter was the first earnings call for new CFO Thomas J. Dittrich. He proposed two major priorities: driving long-term growth and operational efficiency through teamwork, and maintaining strict capital allocation discipline. Non-GAAP R&D expenses increased 11% year over year, and SG&A expenses decreased 1% year over year; capital expenditure of 600 million US dollars was invested in US production sites in North Carolina, Ohio, and Puerto Rico. The annual capital expenditure guide was about 2.6 billion US dollars to prepare production capacity for commercial growth and MariTide's potential listing. The third quarter dividend was $2.52 per share, up 6% year over year, and share repurchases for the whole year were no more than $3 billion. He also gave a forward-looking statement: “Looking ahead to 2027, we don't expect operating profit margins to drop below the 2026 guidelines.” At the same time, it was reminded that operating expenses in the fourth quarter will rise markedly from month to month, in line with the company's established rules of centralized investment at the end of the year. The sales cost ratio will increase due to the increase in sales structure and profit sharing expenses, and SG&A will also increase month-on-month.

Growth engine: Six major products were promoted across the board, and UPLIZNA increased 191% year over year

The six key growth products combined increased 27% year over year. Revenue from the rare disease portfolio was US$1.6 billion, up 21% year on year: UPLIZNA's revenue was US$451 million, up 191% year on year; the number of patients with new treatment and continuing treatment for systemic myasthenia gravis in the US increased 45% month-on-month, and has already been listed in 25 overseas markets; TEPEZZA's revenue was US$526 million, down 6% year on year, mainly due to the increase in channel stocking base during the same period last year, and it has already been listed overseas in more than 20 countries. In terms of generic drugs, Repatha's revenue was US$1,085 million, an increase of 37% over the previous year. The VESALIUS-CV results made it the only PCSK9 inhibitor with evidence of stage III cardiovascular outcomes in both primary and secondary prevention. The company expects more than 3 million new patients worldwide to start treatment this year; EVENITY's revenue was 751 million US dollars, an increase of 39% over the previous year, and maintained a share of nearly 60% in the Japanese bone building agent category. TEZSPIRE's revenue in the field of inflammation was $538 million, an increase of 43% year over year, and reached a major end point in the phase III study of eosinophageal inflammation. BLINCYTO's revenue in oncology was US$496 million, up 27% year on year, and IMDELLTRA revenue of US$406 million, more than doubling year on year.

The patent cliff became apparent: Prolia and XGEVA fell by more than 40% year on year

Old varieties were significantly impacted by biosimilars: Prolia's revenue was US$632 million, a year-on-year decrease of 45%; XGEVA's revenue was US$288 million, a year-on-year decrease of 47%; and Otezla's revenue was US$481 million, a year-on-year decrease of 18%. On the hedging side, the company's biosimilar portfolio revenue was US$977 million, up 26% year on year, with EYLEA similar drug PAVBLU revenue of US$300 million, up 41% year on year; the company revealed that the next wave of biosimilar drugs, such as OPDIVO, KEYTRUDA, and OCREVUS, is in advanced clinical development. In response to the question of whether to shrink the biosimilar business and relinquish production capacity for MariTide, CEO Bob Bradway said, “We are evaluating all options, but we are very confident that we will continue to be a reliable supplier of high-quality biosimilars”, and that the scale design for production capacity expansion is far greater than what is needed for biosimilar drugs.

R&D pipeline: Three Phase III readings, MariTide completes sleep apnea study enrollment

The company reported three phase III positive results this quarter. DazodaliBEP reached the main end point in the phase III OASIS-301 study of systemic dry syndrome. The monthly administration group improved 5.6 points from the baseline, 5.2 points for the quarterly administration group (1.8 points and 1.4 points, respectively, after placebo correction), and reached key secondary endpoints such as dry mouth reported by patients; the second phase III study on symptomatic patients is expected to be read within the year. Management emphasized that the two groups were enrolled separately and “difficult to directly extrapolate from the 301 study to the 303 study”. TEZSPIRE simultaneously achieved the two main endpoints of histological remission and swallowing symptoms in the phase III study of eosinophilic esophagitis, and the efficacy was maintained for 52 weeks. Daxdilimab reached the primary end point in both dose groups in the discoid lupus erythematosus phase II study and will advance to phase III. In the field of weight loss, MariTide's MariTide Phase III program completed enrolment in two studies of sleep apnea and the cardiovascular outcome study this quarter, and initiated the first of three type 2 diabetes phase III studies; the company said MariTide is expected to be the first weight loss treatment that requires only 4 to 6 injections per year with monthly administration, and is currently conducting research on household autoinjector pens.

Below are the details of Amgen's third quarter earnings call.

I. Executive speeches

Casey Capparelli (VP of Investor Relations): Thank you Julianne. Good afternoon everyone, and welcome to our 2026 third quarter results conference call. Bob Bradway will host the conference call today, after which Murdo Gordon, Jay Bradner, and Thomas Dittrich will each give more comprehensive presentations on our results. In today's discussion, we will be using non-GAAP financial measures to describe performance, and the corresponding reconciliation statements have been provided in the materials provided with the call. We will also make some forward-looking statements, all subject to the Safe Harbor Statement, so please be aware that actual results may vary materially. I'll leave it to you, Bob.

Robert Bradway (CEO): Good afternoon, and thank you all for attending our conference call. The results for the first three quarters of this year reflect the strength of our business across a broad range of products and pipeline elements. This is exactly the performance that our strategic design aims to achieve. Strong commercial and operational execution, as well as continued innovation in the R&D organization, further strengthened our confidence in Amgen's ability to achieve lasting long-term growth. For the most recent quarter, total revenue increased 8% year over year to $10.4 billion. Our six key growth products grew 27% year over year, accounting for more than 70% of product sales in the third quarter. Multiple products in the portfolio have achieved double-digit sales growth. Based on third-quarter sales, 17 products now have annualized sales of more than 1 billion US dollars.

We see significant opportunities to build on this momentum. Many of our medicines target large disease areas where penetration is low and most patients are not being treated. Repatha, EVENITY, and TEZSPIRE are obvious examples. Our strong financial performance gives us the flexibility to invest in innovation and the ability to support future growth while delivering attractive returns to shareholders.

In the third quarter, we generated $3.7 billion in free cash flow, increased our R&D investment by 11% year over year, and invested an additional $600 million in the business through capital expenses. It's been another productive quarter for R&D organizations. We have reported positive phase III results for three important programs: IMDELLTRA in the field of small cell lung cancer, where we are working to establish it as a cornerstone therapy; TEZSPIRE in the field of eosinophilic esophagitis, an area where there is significant unmet need; and dazodalibep in the field of Sjogren syndrome, where there is currently no approved disease-modifying therapy. I would like to point out that each of these three programs represents an established or potential first-in-class (first-in-class) drug, which may not only bring substantial changes to patients, but also provide an additional source of long-term growth for Amgen.

Similarly, our progress reflects the strength of our science and our commitment to exploring new approaches to critical illness. This focus has also guided our investment in projects such as Maritide, which is progressing in Phase III development. Jay will be covering these programs and our other clinical advancements in more detail later. We're also using technology, data-driven insights, and artificial intelligence across Amgen to improve the speed and efficiency of our discovery, development, production, and delivery of medicines to patients.

We are encouraged by this quarter's performance. Our broad portfolio and continued investment in propulsion pipelines convinced Amgen's ability to achieve lasting growth over the next ten years and beyond. I want to thank my colleagues around the world for their dedication to our mission of serving patients and the high quality of their work every day. Now it's up to Murdo.

Murdo Gordon (Head of Global Commerce): Thank you Bob. Looking back at the third quarter, I was most impressed by the remarkable progress we made in our late-stage pipeline and sales mix. We've seen significant positive clinical data, regulatory milestones, and record sales performance for several key drugs. The consistency of these results reflects the breadth and strength of Amgen today, and strengthens our confidence in future growth opportunities.

Our commercial performance reflects this progress. Product sales increased 8% year over year, and 17 products already have annualized sales of more than 1 billion US dollars. All six key growth products achieved double-digit growth in the quarter, with a combined year-on-year increase of 27%, and currently account for more than 70% of product sales.

Let's start with generic medicines. Repatha's third-quarter sales were $1.1 billion, up 37% year over year. Repatha's momentum continues to accelerate, with the average weekly increase in the number of prescriptions from new prescription brands in the US by more than 60% year over year. This increase is due to increased urgency in treating secondary prevention and high-risk primary prevention patients. Based on the results of the landmark VESALIUS-CV study, Repatha is currently the only PCSK9 inhibitor with evidence of stage III cardiovascular outcomes in both primary and secondary prevention. We are seeing increased penetration and adoption among cardiologists, accelerated use in primary care, and support the use of PCSK9 inhibitors without requiring the first use of ezetimibe. Relying on Repatha's differentiated outcome data, the new guidelines reinforce clinical consensus: Repatha should be the first choice when it is necessary to further reduce LDL cholesterol based on statins. This year alone, we expect more than 3 million new patients worldwide to start using Repatha. It is estimated that approximately 100 million patients worldwide still have LDL-C above target levels, and we are only just beginning to touch this huge unmet demand, which gives us full confidence in Repatha's growth potential into the 2030s.

EVENITY's third-quarter sales increased 39% to $751 million, continuing the 38% year-on-year increase in the previous quarter. In the US, strong patient demand continues to drive growth, the pool of prescribers continues to expand, and the adoption of treatment physicians continues to expand. We are investing more to expand doctor coverage and help more patients receive EVENITY treatment. The opportunities are still huge — given the serious consequences of osteoporotic fractures: 1 in 2 hip fractures cannot recover the ability to move before the fracture. This highlights the importance of earlier intervention and strengthens our confidence that EVENITY helps more women at extreme risk of fractures (including those who have not yet had one). In Japan, EVENITY maintains a leading position in the bone building agent category, with a sales share close to 60%. Updated treatment guidelines and increased use for first-time patients support its continued growth and further confirm EVENITY's important role in osteoporosis treatment.

Go to the field of inflammation. TEZSPIRE sales increased 43% year over year to $538 million, mainly driven by strong demand for severe uncontrolled asthma. TEZSPIRE's growth continues to outperform the severe uncontrolled asthma market: the number of prescriptions for new US prescription brands increased 15% year over year, while the overall market grew 3%. TEZSPIRE received a 34% share of new prescriptions among US allergy specialists and continues to increase its share among respiratory physicians, and there is still plenty of room for further penetration. Continued strong clinical data continue to confirm the differentiated efficacy of TEZSPIRE in various inflammatory diseases. Phase III results for chronic sinusitis with nasal polyps showed improved disease control and reduced need for surgery. More recent positive eosinophageal esophagitis (EOE) phase III results showed significant improvements in key indicators of disease activity and symptoms, opening up another potential new opportunity for TEZSPIRE to help more patients.

Turn to rare diseases. This group of contracts grew 21% to $1.6 billion, reflecting the continued momentum of new indications and strict implementation of international expansion. We see opportunities to expand coverage of these treatments, improve patient outcomes, and continue meaningful growth into the next decade.

UPLIZNA's third-quarter sales increased 191% year over year to US$451 million, thanks to strong payer demand across all approved indications. UPLIZNA has highly differentiated clinical characteristics: it has both excellent efficacy approved by doctors and a convenient twice-a-year dosing regimen that benefits patients. This feature is supported by extensive payer coverage and Amgen's complete patient support services to help doctors initiate treatment and ensure continuity of treatment. In the US, UPLIZNA showed significant growth in the field of systemic myasthenia gravis (gMG), with a 45% month-on-month increase in the number of patients treated with new treatment and continued treatment. Adoption is expanding, whether for first-time biologics patients or those switching from other treatments, which strengthens our confidence in establishing market leadership in this category. In the field of IgG4-related diseases, long-term follow-up data from the phase III study showed the persistence of efficacy characteristics: in the first year of the open label extension period, none of the patients who continued to receive UPLIZNA recurred, and more than 70% of patients achieved complete remission without the use of glucocorticoids. These long-lasting results, along with increased disease awareness and improved diagnosis, support our confidence to help more patients. UPLIZNA's international expansion continues and is currently listed in 25 markets outside the US. As we bring UPLIZNA to more patients around the world and advance the development of more autoimmune diseases, we see tremendous growth opportunities that continue.

TEPEZZA's third-quarter sales were $526 million, down 6% year on year, mainly affected by channel stocking during the same period last year. International adoption continues to expand, and adoption since entering the Japanese market last year is particularly encouraging. TEPEZZA is currently listed in more than 20 countries, and plans to enter 3 new markets for the rest of 2026.

Our biosimilar contracts increased 26% over the same period, with third-quarter sales of US$977 million. Sales of the EYLEA similar drug PAVBLU increased 41% year over year to US$300 million. Retinal specialists approved PAVBLU's convenient pre-filled injectable dosage form, which is behind Amgen's proven ability in biosimilar production and supply. Our next wave of biosimilar candidates for EYLEA HD, OPDIVO, KEYTRUDA, and OCREVUS are in late clinical development, representing a huge market opportunity.

Go to the field of innovative oncology. This group of contracts increased 21% over the same period, with third-quarter sales of $2.1 billion. BLINCYTO sales increased 27% year over year to $496 million. This growth continues to reflect widespread prescriptions in academic centers and community healthcare institutions, as well as an increase in international adoption. BLINCYTO's mature position in treating B-cell acute lymphocytic leukemia demonstrates the strength of our bispecific T-cell adapter (BiTE) platform and its ability to bring meaningful outcomes in different cancers.

IMDELLTRA's sales more than doubled year over year to $406 million. Behind this commercial momentum is a drug that is expected to bring profound changes to patients with small cell lung cancer. These patients and their families have faced limited treatment options and poor survival outcomes for decades, and IMDELLTRA is changing that. The landmark DellPHI-304 study showed a 40% reduction in the risk of death in second-line treatment compared to chemotherapy. IMDELLTRA provides convenient biweekly administration after the initial dose escalation period. We're working to reduce the burden of treatment: the FDA recently reduced the recommended monitoring time for the first two doses from 22 to 24 hours to just 6 to 8 hours. Looking ahead, we are promoting alternative administration options and subcutaneous administration, which is expected to further improve patient convenience and expand accessibility to community healthcare scenarios. Helping patients benefit earlier in their treatment journey is even more exciting. As Jay will detail, we recently published the results of a Dellphi-305 phase III study evaluating Imdelltra combined with imfinzi for first-line maintenance treatment. I was there when these data were announced at the European Society of Medical Oncology (ESMO) Annual Meeting in Madrid. I was deeply moved by the standing and applause. The oncologists' enthusiasm for significantly extending the life potential of patients was amazing. The magnitude of this result cannot be overstated — the median overall survival period increased by more than 8 months, an extraordinary advance for patients with this devastating disease. We are stepping up registration communication with various health supervisory authorities and supporting clinical guidelines organizations, including NCCN, to review as soon as possible so that these findings can be translated into clinical practice as quickly as possible. We believe IMDELLTRA has the potential to change the treatment landscape for small cell lung cancer, and with subsequent regulatory approval, it will become a cornerstone therapy throughout the multiple stages of small cell lung cancer.

Our portfolio has significant potential for deeper market penetration, new indications, and global expansion. We are confident that we will continue our sustainable growth into the next decade while benefiting more patients around the world. Now it's up to Jay.

James Bradner (Head of R&D): Thank you, Murdo, and good afternoon everyone. This quarter, we reported three phase III positive results in three critical disease areas: IMDELLTRA in small cell lung cancer; TEZSPIRE in eosinophilic esophagitis; and dazodalibep in Sjogren's syndrome. These results reflect our strategy to focus on pioneering and best-in-class drugs for serious diseases with high unmet demand. Every advance means meaningful progress for patients and physicians, and also has the potential for long-term growth.

As described by Murdo, IMDELLTRA is our bispecific T-cell adaptor targeting DLL3. It is currently approved for backline small cell lung cancer and is the second approved drug developed on our Bite platform. At the ESMO conference, we presented the results of IMDELLTRA's “Changing Clinical Practice” — the DellPHI-305 study to evaluate IMDELLTRA combined with IMFINZI versus IMFINZI as a first-line maintenance treatment. IMDELLTRA added IMFINZI to bring the median overall survival time of 21.1 months, compared to 12.7 months with IMFINZI alone. This result is noteworthy in a difficult clinical environment where existing medications provide only limited overall survival improvements. The median follow-up time at the end of the data was 15.9 months, and we will report ultimate survival benefits as the data matures. Longer 30-month follow-up data from the phase IB study of imdelltra combined with anti-PD-L1 first-line maintenance treatment was also published in ESMO, with a median overall survival of 37 months — an unprecedented result for small cell lung cancer. The safety of ImdellTra in DellPhi-305 is consistent with clinical experience to date. Cytokine release syndrome and ICANS are mainly low levels and mainly occur when the first two doses are administered. The DellPHI-305 allows for 1 to 2 hours of monitoring, which can support outpatient administration and wider adoption. In light of the transformative benefits we have observed, we are working to quickly submit applications to regulators around the world. If approved for first-line maintenance treatment, 23,000 patients in the US alone would benefit — earlier on the treatment journey and longer treatment time.

We are advancing extensive clinical development projects to establish IMDELLTRA as a cornerstone therapy for small cell lung cancer, including evaluation in earlier disease, novel combination therapies including antibody drug conjugates (ADCs), and other DLL3 expressing tumors.

Turn to TEZSPIRE. It targets TSLP — an upstream driver of inflammation in the airways and other tissues. We recently published positive results from its CROSSING study on eosinophageal esophagitis (EOE). EOE is another epithelial cell-driven eosinophilic inflammatory disease following severe asthma and chronic sinusitis with nasal polyps. EOE affects more than 470,000 people in the US, and nearly half of patients are still not fully controlled after current treatment. The phase III CROSSING study evaluated adolescent and adult patients treated with TEZSPIRE for symptomatic, uncontrolled EOE. At week 24, the study simultaneously reached two main endpoints: improved histologic relief and improved swallowing symptoms compared to placebo. These benefits continued until week 52. This is the first time that a biologic has shown efficacy for 52 weeks in a placebo-controlled EOE trial. A number of secondary endpoints were also achieved, and TEZSPIRE improved various indicators of inflammatory inflammation, swallowing symptoms, and endoscopic disease activity. Coupled with administration every 4 weeks, these results support TEZSPIRE's potential to be an important treatment option for EOE patients, and reinforce evidence that TSLP targets severe diseases driven by eosinophilic inflammation.

For patients with Sjogren syndrome, we are conducting two phase III studies in systemic Sjogren syndrome and symptomatic Sjogren syndrome by targeting the CD40 ligand signaling pathway through dazodaliBEP. Sjogne syndrome can affect multiple organ systems, causing persistent dryness, fatigue, and pain. There are currently no approved disease-modifying treatments. In systemic dry syndrome, we are excited about the positive, clinically significant results of dazodaliBEP in the placebo-controlled phase III OASIS-301 study. The study reached the main end point: the monthly administration group improved 5.6 points compared to baseline SDI, 5.2 points for the quarterly administration group, and an improvement of 1.8 points and 1.4 points respectively after placebo correction, all of which were statistically significant. Treatment effects were observed as early as week 4 and continued until the end of the 48th week of the study. Importantly, dazodalibep also reached key secondary endpoints such as dry mouth reported by patients, and there were statistically significant improvements in DASPRI and ESSPRI scores in the monthly administration group. Whether given monthly or quarterly, dazodalibep is generally well tolerated. We will publish detailed data at the ACR annual meeting on November 11 and await completion of the second phase III study on symptomatic Sjogren syndrome within the year.

In addition to these three important phase III developments, we recently reported positive phase II data on daxdilimab for discoid lupus erythematosus (DLE) at the EADV conference. Daxdilimab targets ILT7 to reduce plasmacytoid dendritic cells, targeting type 1 interferon-mediated inflammation. DLE can cause permanent scarring, skin pigmentation changes, and hair loss. In this study, both dosage groups reached the primary endpoint, and improvements in active skin lesions occurred as early as week 4 and continued until week 24. At week 24, daxdilimab improved the lower dose group by 10.2 points and 9.9 points from the baseline, respectively, and the corresponding placebo correction improvements were 6.0 points and 5.7 points, respectively, all of which were statistically significant. daxdilimab is well tolerated, and no serious adverse events have been reported. Based on these results, we will push Daxdilimab into Phase III development.

As you can see, we worked very hard on the implementation of the late-stage pipeline, and this quarter was very rewarding. On other aspects of the pipeline, we are focusing on developing important new drugs in the late-stage pipeline. For prostate cancer patients, we are rapidly advancing the development of Xaluritamig in early and advanced disease, and expanding the coverage of our T-cell connector platform. For patients with obesity and related diseases, we are advancing a comprehensive MariTIDE Phase III development program. This quarter, we completed enrollment in two phase III sleep apnea studies and cardiovascular outcome studies, and initiated the first of three type 2 diabetes phase III studies. MariTide is becoming the first monthly treatment for obesity, requiring only 4 or 6 doses per year. The Maritide project aims to clarify how individuals start and stick to Maritide, and how others can switch from other GLP-1 drugs and stick to Maritide. Our goal is to make long-term treatment easier to maintain and help patients maintain weight loss results and achieve long-lasting health benefits.

Thank you to Amgen colleagues for their continued focus on patients and their unwavering commitment to advancing innovative medicines for critical illness. Now it's up to Thomas for the financial update.

Thomas J. Dittrich (Chief Financial Officer): Thank you Jay. As you probably already know, this is my “second chapter” at Amgen. Early in my career, I worked here for almost a decade, working with Bob and the team. Since then, I've been the CFO of 3 listed companies, with responsibilities covering finance, strategy, transformation, and operations. I have also gained experience in a healthcare environment and rare diseases that are more consumptive. So I came back to Amgen with many years of knowledge of the company and a fresh perspective from the past 12 years of experience. Today, I am excited to attend my first quarterly results conference call as Amgen CFO. I look forward to maintaining close communication between Amgen and the investment community, as well as the financial discipline investors expect. My top priorities are straightforward: first, working as a team with colleagues to drive long-term growth through consistent strategic execution and operational efficiency; second, maintaining Amgen's rigorous capital allocation approach. You should look forward to continuity here—we will balance investment in optimal innovation and future growth with return on capital to shareholders.

Now let's take a look at the financial results for the third quarter. Strong third-quarter performance further strengthened our confidence in the six key growth products. Together, they reflect the breadth and depth of our business and continue to lay a solid foundation for continued growth over the next decade. We continue to deliver strong operating results while advancing pipeline investment. The third quarter non-GAAP operating margin was 47%. Non-GAAP R&D spending increased 11% year over year, mainly due to increased investment in research and early-stage pipelines, including business development activities. We continue to invest in innovations that will drive future growth, including MariTide, dazodaliBEP, and xaluritamig, and the drugs IMDELLTRA, Repatha, and Uplizna. SG&A expenses fell 1% year over year, mainly due to timing factors of investment, followed by our ongoing productivity initiatives.

We have generated $3.7 billion in free cash flow, which reflects the continued momentum of the business and allows us to continue investing in future growth. Quarterly capital expenditure of $600 million was invested in US production sites in North Carolina, Ohio, and Puerto Rico. We continue to anticipate capital expenditure of approximately $2.6 billion in 2026 to expand commercially-increased manufacturing capacity and prepare for MariTide's potential listing. Additionally, we returned capital to shareholders through a dividend of $2.52 per share, an increase of 6% over the third quarter of 2025.

Looking ahead to the business outlook for the rest of 2026. We are satisfied with the intensity of implementation and are increasing the 2026 full-year revenue and non-GAAP EPS guidance range. We now expect total revenue of $38.9 billion to $39.7 billion in 2026, and non-GAAP earnings per share of $22.90 to $23.70.

Let me highlight a few more guiding points. We now expect non-GAAP other income and expenditure to be $2 billion to $2.1 billion in 2026. We continue to expect the full year's non-GAAP operating margin (as a percentage of product sales) of approximately 45% to 46%. Also, looking ahead to the fourth quarter, we expect operating expenses to increase significantly month-on-month, in line with the established rule that the company's year-end expenses are high. Specifically, we expect the sales cost ratio to rise month-on-month due to changes in the sales structure and increase in profit sharing expenses; SG&A expenses will also rise month-on-month due to the factors I mentioned in the third quarter investment timing and continued investment in products on sale.

We expect around $1.9 billion in other revenue for the full year. We expect the non-GAAP rate to be between 15% and 16.5%. We expect share repurchases of no more than $3 billion.

Looking ahead to 2027, we don't expect operating profit margins to level down from the 2026 guidance. We will continue to allocate resources efficiently and balance growth investments with strict cost management.

As the year comes to an end, we will remain focused on implementing strategies, advancing growth products, investing in the best innovations, and maintaining strict financial discipline that will sustain our ability to continue into the next decade. I would like to thank all of my colleagues around the world for their dedication in our mission to serve patients. This concludes the financial update. Now turn it back to Bob, open to questions.

II. Q&A session

Moderator: (Operator Tip) Our first question came from Goldman Sachs's Salveen Richter.

Salveen Richter (Goldman Sachs Research): Based on the positive results of systemic dry syndrome stage III, how should we evaluate the findings of the study on symptomatic patients and grasp its credibility? Also, can we talk about the overall regulatory path of this project?

James Bradner: Thanks Salveen, I'm Jay. We are pleased with the results of the Systematic Study 301 and the observed efficacy — both the improvement in placebo correction for the primary endpoint SDI and the effect on secondary dry mouth symptoms are quite encouraging. However, it is difficult to extrapolate directly from 301 to 303, that is, extrapolate from systematic studies to symptomatic studies. These are two different patient groups, and it is important that we conducted separate studies to clarify the possibility that these 434 patients were affected in the 303 studies. So we'll have more to say soon after seeing the data for the fourth quarter of this year. As for regulatory pathways, this is an area that has been very competitive lately — which is good for patients because there has been little progress over the years. dazodalibep is actually the first treatment that shows efficacy in a systemic environment, also acts on symptoms, and continues until the end of the study. We don't have much more to say today, but we look forward to careful consideration of this data.

Moderator: The next question comes from Morgan Stanley's Terence Flynn.

Terence Flynn (Morgan Stanley Research): Congratulations on all the progress. Thomas, I know you're talking about capital expenditure investments in preparation for MariTide's listing. Have you considered shrinking the biosimilar business to free up more production capacity for this launch? Would this be within the scope of consideration? A related question is, Jay, do you have access to blind tolerance data from the ongoing MariTide phase III trial?

Robert Bradway: Terence, I can answer that, I'm Bob. Obviously, we'll consider all options when it comes to capacity management. But we are very confident that we will continue to be a reliable supplier of high-quality biosimilars. So it's not a burden for us, and our capacity expansion is designed on a scale based on greater protein production than biosimilar drugs. As for the other question, Jay, would you like to try it?

James Bradner: OK, thanks Terence for asking. In 2026, we have just carried out MariTide's work using strict data generation methods. MariTide's research is carried out in strict accordance with drug clinical trial quality management standards. When these studies are read out, we'll share more information on MariTide's efficacy and tolerability.

Moderator: The next question comes from Akash Tewari from Jefferies.

Akash Tewari (Jefferies Research Division): Listening to your team's comparison of systemic stage III and stage II Sjogren's syndrome data, one thing I noticed is that your team was surprised at how quickly it worked, and the results were probably better than phase II. Can you talk about the effectiveness in systematic testing? And how does it indicate the symptomatic studies that are about to be read? Please also comment on the MARITIME-PEN study. I know you've just started the MariTide home autoinjector study, what makes you confident to start it now? Do we have any visibility into the autoinjector dosage that will be used in the study?

James Bradner: Thanks, I'll answer. I'm Jay. As mentioned above, we are happy with the effects of dazodalibep in Sjörn's syndrome, but it's probably not surprising — after all, we stand above the very strong phase II data. The monthly SDI placebo correction improved by 1.8 points and the improvement of 1.4 points every 12 weeks of administration, which was in line with our expectations. It was a strong result, and the effect on dry mouth was what we expected and expected. I've already talked about extrapolation, but you asked it worked. This is a potential advantage of targeting molecules active in inflammatory signaling pathways such as CD40 and CD40 ligands. We are experienced in B-cell scavenging. B-cell clearance may be delayed in some cases — but as far as UPLIZNA is concerned, we have not experienced this in many diseases. As a result, effects were seen in week 4, which is highly consistent with our mechanistic hypothesis that “as a CD40 ligand/CD40 signaling inhibitor can achieve immediate suppression of B-cell-driven inflammation”. Furthermore, since CD40 is also highly expressed on salivary gland ductal epithelial cells and can drive local inflammation through interaction with activated T cells, it makes sense that dazodalibep works as early as week 4 — we did observe statistically significant improvements at week 4, and continued until the end of the study. So thanks for highlighting this feature. For molecules that target active signaling pathways, it works faster in some cases, which is a good characteristic.

Robert Bradway: Akash's second question was an autoinjector. Obviously, we have a lot of experience with autoinjectors, Akash. So I don't think there's anything particularly novel about the study you mentioned. Jay, you can add anything you'd like.

James Bradner: We've always been pretty consistent that MariTide is ultimately expected to be administered via a patient-friendly single-chamber handheld autoinjector pen. As Bob said, we're experienced in this area. We've taken a pretty standard development path, and it's progressing well so far.

Robert Bradway: OK, let's look at the next question. I would also like to remind everyone to limit the questions to one so that everyone can ask questions tonight as much as possible. Casey and his team will stay after the meeting, and all of us will be available later today to answer any additional questions you may have.

Moderator: The next question comes from UBS's Michael Yee.

Michael Yee (Entries marked UBS Research Department): One question to Bob. Bob, Amgen seems to have quieted down a bit when it comes to mergers and acquisitions during a record period of mergers and acquisitions. Can you share your views? Are you not “urgent” and are you busy? Maybe you guys are more interested in what you have? Please also talk about whether we should continue to look forward to small complementary acquisitions or what are you guys thinking?

Robert Bradway: Michael, I'm not sure I agree with the premise of this question. But what I want to say is that our business development focus is very much the same. As we've said for some time, we're looking for opportunities that fit our four core treatment areas. We are focused on achieving consistent long-term growth and are confident that this will happen over time. Obviously, a large portion of our revenue comes from our external licensing or acquisitions, and I think this will always hold true. I would like to think that whether internally or externally, we are self-disciplined in allocating capital, Michael. Especially when we go outside, what I want us to see is a path where our shareholders — not just the shareholders on the selling side — are rewarded.

Moderator: The next question comes from TD Cowen's Yaron Werber.

Yaron Werber (TD Cowen): A question about the upcoming data on Sjörn's syndrome. The results of monthly and quarterly administration seem to be good. DASPRI is a newer endpoint for your validation starting with Phase II — will it support US declarations, and will ESSPRI support symptomatic studies in Europe? Also, since both monthly and quarterly dosing regimens met the primary endpoint (although only one plan met the secondary endpoint in the first study), would you report for both at the same time?

James Bradner: Thank you, especially between these two Phase III readings, and we probably won't dive into the full registration strategy today. But you're right, the US and the rest of the world have different preferences for endpoints, and we took this very seriously when designing the primary and secondary endpoints for these two studies.

Moderator: The next question comes from Chris Schott at J.P. Morgan Chase.

Christopher Schott (J.P. Morgan Chase Research): Ask an IMDELLTRA question. Can you talk more about what you think of 305 data unlocking opportunities? And in this context, how fast can products be released after ESMO data is released? Also, can you talk about the reduction in monitoring requirements — I'd like to know how much of an obstacle monitoring has posed in this frontline indication; of course, this issue also seems to have been solved in more frontline environments.

Murdo Gordon: Thanks Chris, I'm Murdo. First, let's talk about monitoring. We already have an improvement that the FDA has just approved and written into the manual: the monitoring time was shortened to less than 6 hours in second-line indications. Compared to the 22 to 24 hours in the original manual, the monitoring time is now much shorter. This is already helping institutions, mainly community oncology clinics, to start using IMDELLTRA for second-line patients. And as Jay mentioned, in the 305 study, the monitoring time was further reduced to 1 to 2 hours. Therefore, as the drug expands to first-line maintenance indications, further improvements are expected in the instructions, and initiation of IMDELLTRA in the first-line maintenance scenario will become very direct and very simple, and at the same time have obvious profound survival benefits. I think — given the extent of its routine — we have always been very careful to ensure patient safety, and as our understanding deepened, we discovered that BLINCYTO was a much better tolerated drug at an earlier stage of the disease. In DellPHI-305, only 1 patient actually developed grade 3 cytokine release syndrome. The other patients with cytokine release syndrome were grade 1 or 2. What does that mean for opportunities? This means we believe a new cornerstone therapy has been established. So far, no other drug in this category has shown this profound overall survival effect we've seen. As the NCCN guidelines are updated and awareness of these data expands, I expect changes in clinical behavior will be very rapid. Obviously, we are doing our best to advance registration and approval processes, and we are ready to support the pace of change that clinicians will bring. I just want to say that I've been communicating with our medical liaison team for over a week, and they've been on the front line since the ESMO data was released. I am not the only one who is passionate about this data. Frontline oncologists are shocked by the magnitude of efficacy and safety shown by this data at an earlier stage of disease.

Moderator: The next question comes from Evercore ISI's umer Raffat.

Umer Raffat (Evercore ISI): I want to echo ESMO's admiration for these groundbreaking data. Murdo, then Chris's question, to make it easier for investors to understand the magnitude here — assuming that more than 20,000 patients in the US use taratamab, is this possible or realistic? Do you expect the first-line maintenance business alone to reach more than 5 billion US dollars, and induction treatment research to be launched next year will bring additional room for growth?

Murdo Gordon: Umer, I think you already know me and the Amgen team — we don't publish guidelines for individual products. But as you can see from my answer to Chris, we're extremely excited about the data set that's being generated here. Considering that patients with this disease are progressing very fast, this opportunity is really interesting. In the second tier, the number of patients that can be reached is quite limited, because unfortunately, there are not many patients who can reach the second tier. Their disease progresses too fast, and many people end up in hospice care and eventually die. So if you go to an earlier line count, the number of accessible patients with small cell lung cancer in the US is 35,000. That's a pretty impressive patient population. The question is the extent of each treatment scenario and first-line maintenance. But as I said to Chris, this will be a very rapid adoption, and we would like to see many patients continue to take medication over a long period of time, and the treatment time may also be quite long. I'd like to leave the topic to Jay and talk about our other clinical development work on this molecule.

James Bradner: OK, thanks Umer. The development of IMDELLTRA is still a very active area within Amgen. We are working to complete a limited-time small cell lung cancer study — an event-driven study; at the same time, we have seen the benefits of IMDELLTRA in maintaining treatment after first-line induction. As you all know, we have completed a study to establish IMDELLTRA's alternative dosage capacity, which was very helpful in starting to envision a combination of IMDELLTRA and emerging drugs such as ADC. IMDELLTRA in combination with chemotherapy has shown dramatic data, so ADCs that deliver chemotherapy should be quite active. We have carried out research on B3 and DLL3, and will share more in the future. However, as Murdo said, advances in the application of these combination therapies and IMDELLTRA as the cornerstone of small cell lung cancer treatment will not only improve the rate of remission, but also be durable. We look forward to seeing patients show us the full benefits of this drug as the DellPhi study data — published in the form of a Presidium Report at ESMO and published in the New England Journal of Medicine — matures. Dellphi-303, a phase IB first-line maintenance study also published by ESMO, has matured: when the median follow-up was 30.8 months, the median overall survival reached 37.9 months, which is unheard of in this disease environment. We are very happy with the progress so far, but we still have a lot of work to do to follow up on these patients.

Moderator: The next question comes from Piper Sandler's David Amsellem.

David Amsellem (Piper Sandler): A question for daxdilimab. Will phase III explore a wider range of cutaneous lupus populations? Or is it just limited to discoid lupus? First. Then let's talk about the market: how do you define the size of people with cutaneous lupus? It is two different groups from people with systemic lupus, and how does this affect doctors' reach strategies? Is it a dermatology phone call or rheumatology or both?

James Bradner: Thanks for the question. I'll start. Murdo can talk about the commercial outlook for this drug later. Thanks for following daxdilimab. We are very satisfied with the activity we have observed so far in discoid lupus erythematosus. The prevalence of the disease is 20 to 50 cases per 100,000 people, of which 5% to 10% will progress to systemic lupus erythematosus. You need to know that patients have been disappointed by the myriad mechanisms of action for the various symptoms of lupus. In our phase II study, in terms of CLASI activity scores — a baseline improvement of 7 is considered clinically significant in this population — the low dose group and high dose group improved 10.2 points and 9.9 points, respectively, at week 24 in patients with a baseline greater than or equal to 8 points. We are very optimistic about the performance of this medication in the skin of lupus. We haven't fully described the Phase III design yet and will be announced in the future. But we are well aware that we have stumbled upon a very exciting and promising mechanism — targeting plasmacytoid dendritic cells to treat this disease. Murdo?

Murdo Gordon: I'll add that the group of prescribers here is mostly dermatologists, and Amgen clearly has good abilities and experience in dermatology. For the few rheumatologists who use it, we also have strong medical and frontline commercial teams to cover these clients.

Moderator: The next question comes from Evan Seigerman from BMO Capital Markets.

Evan Seigerman (BMO Capital Markets): Jay, I think you mentioned during the September panel meeting that although MariTide is given monthly or even less frequently, the duration of side effects is comparable to that of weekly doses of pancreatic agents. Can you talk more about how you measure this during phase I of any trial? More broadly, considering the obesity landscape has evolved so rapidly since then, please remind us how MariTide positions itself within this ever-evolving landscape.

James Bradner: I'll talk about the interesting, reassuring, and even exciting “decoupling” between MariTide pharmacokinetics and duration of symptoms, then Murdo will answer the part about market segmentation. First of all, whatever the reason, the truth is that this drug has a very long half-life, is designed to continuously activate GLP-1 receptors and inhibit GIP receptors. It has been shown to have weight loss activity in obesity and type 2 diabetes when administered monthly, every 8 weeks, and every 12 weeks as described. Prospective clinical studies confirm the fact that although the drug's long-lasting efficacy lasts as long as the molecule itself, the symptoms are not — the same holds true for GLP-1 peptides injected weekly. So we're not surprised. How to measure? You asked. We did a very detailed symptom diary in early clinical studies to understand the occurrence, frequency, severity, and duration of symptoms. We've shared some early charts we call “Manhattan maps,” showing the duration of symptoms (if present). MariTide has been very well tolerated so far. Its target dose — like all GLP-1 — benefits from increasing dosage. The long-lasting activity of the drug is not accompanied by long-lasting side effects. Most of the side effects observed so far are mild, sometimes moderate, and last for a short period of time, only a few days. Murdo?

Murdo Gordon: Evan, that's an interesting observation about how active this category is. It is true that many daily oral medications are being developed, many weekly injections are being developed, and some are even trying to extend to every month. However, we have yet to see the development of a real drug for monthly administration, a candidate product that can be administered at a low frequency of 6 or 4 times a year. We continue to believe MariTide is unique and differentiated in this regard. It's a simple 3-step dosage increase, and you'll reach your first maintenance dose after 2 months, after which you can find the most convenient dosage for your weight loss journey. So I think our product proposition is very persuasive. We are obviously looking forward to reading out the Phase III data, and also looking forward to entering the market to help many patients achieve their weight loss goals. We also have an extensive clinical program, which, as you know, means we can also help patients with type 2 diabetes, atherosclerotic cardiovascular disease, and sleep apnea.

Moderator: The next question comes from Citi's Geoff Meacham.

Geoffrey Meacham (Citi Research): Ask Jay or Murdo a similar question. Before the MariTiDE data is released next year, I'd like to know how you view the commercialization path. I mainly want to ask about the dynamics of the new Medicare bridging plan, payer acceptance, and overseas market considerations before the data is released?

Murdo Gordon: Thank you Geoff for the question. I want to start by saying that we are very focused on ensuring that consumers and patients are at the heart of our market entry strategy. We see in this category that patients play a much more important role in activating and advocating their own treatment and weight loss journey. So this is the first priority, and we will scale up our preparations accordingly. We at Amgen clearly have an excellent cardiometabolic team, and we will be ready to launch MariTide. In terms of access and reimbursement, we expect our unique differentiation to help secure admission and reimbursement. Obviously, we're also excited to see how other government entry programs evolve over time. I think Medicare access in this category is a good thing; it should be expanded. Markets outside of the US, I think it will be more difficult. I think overseas will continue to be a very consumer-driven market, but we are hopeful: with hard end clinical programs such as atherosclerotic cardiovascular disease outcome data and type 2 diabetes data, we will be reimbursed in many markets — as I said, the US market too.

Robert Bradway: OK, let's answer two more questions and then, as I said before, we can set aside time for friends who haven't had a chance to ask today. Two more questions.

Moderator: The next question comes from William Blair's Matt Phipps.

Matthew Phipps (William Blair): Both OPDIVO and KEYTRUDA biosimilar BLA have been submitted. What are your assumptions about when they will be commercialized? Also, in a market that is shifting to subcutaneous dosage forms, how do you view penetration?

Robert Bradway: Yes. This is clearly a competitive field, so we don't have much to share at this stage, Matt. But as you've heard in Murdo's talk, our focus is on developing these drugs so patients can use them. And we've established a pretty good track record here and are leaders in biosimilars. Murdo, would you like to add any color?

Murdo Gordon: As we've always said, our focus on biosimilar drugs is getting the first batch or first wave of marketing, which is important for establishing a competitive position, and we believe we already have that position.

Robert Bradway: OK, please take the last question.

Moderator: The last question comes from Alex Hammond of Wolfe Research.

Alexandria Hammond (Wolfe Research): Unlike small cell lung cancer, a large portion of treatment for prostate cancer occurs in urology and community institutions with less experience in CRS management. So how do you plan to bring value to these institutions? To what extent can a complete outpatient queue or subcutaneous dosage form change this? Also, compared to other treatments that require biomarkers, how important is not requiring biomarkers to improve adoption?

Robert Bradway: Great, thanks for asking. Jay, why don't you share your thoughts first?

James Bradner: OK, I'll talk about that first, then Murdo can probably talk about the implementation of bispecificity — we have extensive experience in this field and are indeed an industry-leading company. Undoubtedly, it was the experience of use that helped the drug to land and built the medical community's confidence in T-cell connector therapy—it was more about clinical familiarity than the nursing environment. As a doctor, I can say that shortening monitoring time would help a lot, as would a full outpatient cohort — our Phase IB data published by ESMO shows that for xaluritamig — we target Steap1 and CD3 molecules, as you mentioned — a more convenient dosing scenario is possible. I'd say it's no small thing, but these agencies already use many other drugs that aren't easy, so we're fully confident that through clinical research and evidence generation, we'll build prescription confidence and comfort for urologists in need. Your question about biomarkers is right on the point: biomarkers are not needed to enroll patients and get medication, which is very helpful. Of course, we have some medications that require biomarkers, but in prostate cancer, STEAP1 is quite high — even characteristic — expression, giving us an opportunity to bring this drug to patients without stratification or screening with confirmatory biomarkers. Murdo?

Murdo Gordon: Yes. As Jay mentioned, we are experienced in bringing bispecific T-cell connectors to different treatment scenarios. We have accumulated a lot of experience in the field of hematologic oncology, and now we also have IMDELLTRA in the field of solid tumors. We have established a field organization, which we call a bispecific operations team, to help implement implementation and ensure that patients receive proper monitoring and appropriate information at the point of care. This team is already in operation — it was formed before IMDELLTRA went public, and is now supporting IMDELLTRA on a large scale, and we will also apply it to the field of urological oncology. We have established a field medical layout with these clients and clinicians, and we work closely with patient advocacy organizations. This is a key success factor for small cell lung cancer — patient advocates are very good at teaching patients how to self-monitor and identify any side effects that may be associated with cytokine release syndrome. Therefore, we are applying our extensive experience to the field of uro-oncology, and I think this will be very helpful in ensuring patient safety and promoting smooth adoption.

Robert Bradway: OK, thank you all for joining us on the call. I think I can say on behalf of the team that with the release of clinical data over the past few weeks, the long-term sources of growth that you are concerned about have emerged, which is encouraging. Once again, I hope everyone can experience good business performance and strong management execution. We look forward to a strong end to this year. I'm also looking forward to meeting all of you again next year to review the fourth quarter and start 2027. Thank you all for your support. We keep in touch.

Moderator: This is the end of Amgen's 2026 third quarter results conference call. You can hang up now.