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AmgenD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-09-03
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Earnings documents stored for AMGN.

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Investor releaseQuarter not tagged2026-09-03

Why Is Amgen (AMGN) Up 8.6% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for Amgen (AMGN). Shares have added about 8.6% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Amgen due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Amgen reported second-quarter 2026 adjusted earnings of $6.29 per share, up 4% year over year. Earnings beat the Zacks Consensus Estimate of $5.60 as higher revenues were partially offset by higher operating costs and higher taxes.Total revenues increased 10% to $10.1 billion and surpassed the consensus estimate of $9.44 billion.Total product sales increased 9% year over year to $9.54 billion, driven by higher volumes.Other revenues were $517 million in the quarter, up 26.7% year over year.Broad-based volume growth across Repatha, Evenity, Tezspire, Uplizna and oncology products more than offset biosimilar erosion for Prolia and Xgeva and weakness in mature brands like Otezla and Enbrel. New biosimilar products are also contributing to sales growth.  Twenty-two products achieved double-digit sales growth in the quarter.Amgen’s key growth drivers, which include Repatha, Evenity, Tezspire and oncology and rare disease drugs, as well as biosimilar products, rose 26% year over year in the second quarter. These key growth drivers represented almost 70% of Amgen’s total product sales. Repatha sales surged 37% year over year to $953 million, exceeding the Zacks Consensus Estimate of $907 million. The increase was driven by volume growth. New-to-brand prescriptions in the United States rose more than 50%, supported by increased use in secondary prevention and high-risk primary prevention patients.Evenity sales climbed 38% to $714 million, driven by solid volume growth. Evenity sales beat the Zacks Consensus Estimate of $636 million. Prolia sales declined 32% to $759 million but exceeded the estimate of $728 million as multiple biosimilars affected volumes and pricing. Xgeva revenues fell 34% to $352 million, slightly missing the consensus mark of $356 million.Patents for Prolia and Xgeva expired in 2025. Sales of these best-selling drugs are eroding significantly in 2026 as several biosimil…Read full document

A month has gone by since the last earnings report for Amgen (AMGN). Shares have added about 8.6% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Amgen due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Amgen reported second-quarter 2026 adjusted earnings of $6.29 per share, up 4% year over year. Earnings beat the Zacks Consensus Estimate of $5.60 as higher revenues were partially offset by higher operating costs and higher taxes.Total revenues increased 10% to $10.1 billion and surpassed the consensus estimate of $9.44 billion.Total product sales increased 9% year over year to $9.54 billion, driven by higher volumes.Other revenues were $517 million in the quarter, up 26.7% year over year.Broad-based volume growth across Repatha, Evenity, Tezspire, Uplizna and oncology products more than offset biosimilar erosion for Prolia and Xgeva and weakness in mature brands like Otezla and Enbrel. New biosimilar products are also contributing to sales growth.  Twenty-two products achieved double-digit sales growth in the quarter.Amgen’s key growth drivers, which include Repatha, Evenity, Tezspire and oncology and rare disease drugs, as well as biosimilar products, rose 26% year over year in the second quarter. These key growth drivers represented almost 70% of Amgen’s total product sales. Repatha sales surged 37% year over year to $953 million, exceeding the Zacks Consensus Estimate of $907 million. The increase was driven by volume growth. New-to-brand prescriptions in the United States rose more than 50%, supported by increased use in secondary prevention and high-risk primary prevention patients.Evenity sales climbed 38% to $714 million, driven by solid volume growth. Evenity sales beat the Zacks Consensus Estimate of $636 million. Prolia sales declined 32% to $759 million but exceeded the estimate of $728 million as multiple biosimilars affected volumes and pricing. Xgeva revenues fell 34% to $352 million, slightly missing the consensus mark of $356 million.Patents for Prolia and Xgeva expired in 2025. Sales of these best-selling drugs are eroding significantly in 2026 as several biosimilars have been launched globally with more biosimilars expected.Inflammation and Oncology Drugs’ Mix PerformanceTezspire sales rose 42% year over year to $486 million, marginally exceeding the Zacks Consensus Estimate of $483 million. Demand increased in severe uncontrolled asthma, while the uptake of its new indication of chronic rhinosinusitis with nasal polyps was encouraging.Otezla sales declined 21% to $491 million, missing the consensus estimate of $562 million, due to lower pricing and volume.Enbrel revenues decreased 4% to $580 million due to lower selling prices (including the impact from increased 340B program mix and Medicare Part D redesign), partially offset by favorable changes to estimated sales deductions. Enbrel sales topped the estimate of $466 million.Nplate sales rose 17% year over year to $430 million. In oncology, Blincyto sales increased 23% to $472 million, surpassing the consensus estimate of $457 million. Growth reflected broader prescribing in U.S. academic and community settings and strong international demand. Kyprolis recorded sales of $314 million, down 17% year over year, due to lower volumes.  Vectibix revenues came in at $338.0 million, up 11% year over year. Lumakras/Lumykras sales rose 23% year over year to $111 million.New cancer drug Imdelltra’s sales rose 11.6% sequentially to $288 million, supported by increased adoption in second-line small-cell lung cancer. In oncology biosimilars, sales of Mvasi were $153 million in the quarter, down 20% year over year, due to lower selling prices and lower volume. Amgen’s rare-disease portfolio generated $1.6 billion in quarterly revenues, up 21%, supported by international expansion, additional indications and pricing.Uplizna revenues increased 90% year over year to $335 million, beating the Zacks Consensus Estimate of $306 million. Performance reflected sustained momentum across its three approved indications, aided by broader physician adoption and the drug’s twice-yearly maintenance dosing.On the conference call, Amgen said that growth continues for Uplizna in IgG4-related while uptake for Uplizna in generalized myasthenia gravis or gMG is increasing across both bio-naive and switch patients.Tepezza sales advanced 14% to $576 million, driven by higher volumes and pricing. On the call, the company mentioned that uptake in Japan following last year's launch remains strong. The company has launched Tepezza in 13 countries and expects to launch it in six additional markets in the near term.Krystexxa revenues rose 15% to $400 million driven by higher pricing, partially offset by lower inventory levels. Tavneos sales increased 36% to $150 million driven by volume growth.Ultra-rare products generated revenues of $149.0 million in the quarter, down 19% year over year. Total biosimilar sales were $855 million in the quarter, up 29% year over year.Sales of Wezlana were $61 million, compared with $47 million in the previous quarter, entirely from ex-U.S. markets. Pavblu generated sales of $287 million in the quarter, up 2.5% sequentially, driven by increased adoption among retina specialists. Sales of Amjevita/Amgevita were $155 million in the quarter, up 17% year over year. Total sales of established products, which include Aranesp, Parsabiv and Neulasta, increased 19% year over year in the second quarter to $632 million. Adjusted operating margin declined 0.5 percentage points year over year to 48.4% in the second quarter.Adjusted operating expenses increased 11% to $5.44 billion. R&D expenses rose 10% year over year to $1.85 billion, reflecting higher spending on late-stage clinical programs, particularly MariTide. SG&A expenses increased 4% to $1.72 billion, mainly due to higher general and administrative expenses and increased commercial product-related spending.The adjusted tax rate was 15.6% in the quarter, up 1.4 points from the year-ago quarter. Amgen raised its financial outlook for 2026 for the second time this year.Amgen raised its total revenue guidance for 2026 to a range of $38.2 billion to $39.4 billion. The company previously expected revenues between $37.1 billion and $38.5 billion.Adjusted earnings guidance was increased to $22.30-$23.50 per share from the prior range of $21.70-$23.10. The improved outlook reflects strong first-half execution and continued momentum across the company’s key growth products.Other revenues are expected to be approximately $1.9 billion compared with the prior expectation of being in the range of $1.7 billion to $1.8 billion in 2026.Adjusted R&D is expected to increase in a high single-digit range year over year in 2026. Amgen expects a meaningful sequential increase in operating expenses in the third quarter.Adjusted operating margin is expected to be roughly 45% to 46% for 2026.The adjusted tax rate is expected to be in the range of 15.0% to 16.5%. Capital expenditures are expected to be approximately $2.6 billion.Share repurchases are expected not to exceed $3 billion in 2026. Amgen announced that it will discontinue further development of AMG 513, while its ongoing phase I obesity study will continue until all enrolled participants complete the study. In the past month, investors have witnessed a downward trend in estimates review. Currently, Amgen has a nice Growth Score of B, though it is lagging a bit on the Momentum Score front with a C. Following the exact same course, the stock was allocated a score of C on the value side, putting it in the middle 20% for value investors. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Amgen has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Amgen is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Krystal Biotech, Inc. (KRYS), a stock from the same industry, has gained 13.3%. The company reported its results for the quarter ended June 2026 more than a month ago. Krystal Biotech reported revenues of $119.22 million in the last reported quarter, representing a year-over-year change of +24.1%. EPS of $1.79 for the same period compares with $1.29 a year ago. Krystal Biotech is expected to post earnings of $1.91 per share for the current quarter, representing a year-over-year change of -28.2%. Over the last 30 days, the Zacks Consensus Estimate has changed +0.8%. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Krystal Biotech. Also, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amgen Inc. (AMGN) : Free Stock Analysis Report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-09-02

TEZSPIRE’s Positive EoE Phase 3 Results Could Be A Game Changer For Amgen (AMGN)

Simply Wall St.
Amgen and AstraZeneca recently reported positive Phase 3 CROSSING results showing TEZSPIRE improved histologic remission and dysphagia symptoms in patients with eosinophilic esophagitis, with effects sustained through week 52 and a safety profile broadly consistent with prior use. Because EoE remains poorly controlled for nearly half of patients on existing therapies, TEZSPIRE’s epithelial-targeting mechanism could meaningfully expand its role beyond severe asthma and nasal polyps if regulators ultimately grant an additional indication. We’ll now explore how TEZSPIRE’s encouraging EoE Phase 3 data might influence Amgen’s existing investment narrative around pipeline execution. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own Amgen, you generally need to believe its broad biologics portfolio and late‑stage pipeline can offset pricing pressure, biosimilar erosion, and rising R&D and manufacturing spend. TEZSPIRE’s strong EoE Phase 3 data is encouraging for pipeline execution, but it does not clearly change the near‑term balance between new launches as a growth catalyst and intensifying biosimilar and pricing risks as the biggest overhangs right now. In this context, the recent Repatha VESALIUS‑CV results, showing reduced death risk in high‑risk adults without prior heart attack or stroke, feel especially relevant. Together with TEZSPIRE’s EoE readout, they highlight how clinical outcomes data could influence how much of Amgen’s future growth story rests on expanding indications for existing biologics versus entirely new assets. Yet, against these medical wins, investors still need to weigh emerging regulatory threats around key rare‑disease assets that could materially affect... Read the full narrative on Amgen (it's free!) Amgen's narrative projects $41.5 billion revenue and $10.3 billion earnings by 2029. Uncover how Amgen's forecasts yield a $371.93 fair value, a 15% downside to its current price. Some of the lowest‑priced analysts were assuming roughly flat revenue near US$38.9 billion and earnings of about US$8.7 billion, which is far more cautious than believing TEZSPIRE’s EoE success and your chosen catalyst can easily offset long term pricing and biosimilar pressure. Explore 5 other fair value estimates on Amgen - why the stock might be worth 18% less than the current price! Disag…Read full document

Amgen and AstraZeneca recently reported positive Phase 3 CROSSING results showing TEZSPIRE improved histologic remission and dysphagia symptoms in patients with eosinophilic esophagitis, with effects sustained through week 52 and a safety profile broadly consistent with prior use. Because EoE remains poorly controlled for nearly half of patients on existing therapies, TEZSPIRE’s epithelial-targeting mechanism could meaningfully expand its role beyond severe asthma and nasal polyps if regulators ultimately grant an additional indication. We’ll now explore how TEZSPIRE’s encouraging EoE Phase 3 data might influence Amgen’s existing investment narrative around pipeline execution. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own Amgen, you generally need to believe its broad biologics portfolio and late‑stage pipeline can offset pricing pressure, biosimilar erosion, and rising R&D and manufacturing spend. TEZSPIRE’s strong EoE Phase 3 data is encouraging for pipeline execution, but it does not clearly change the near‑term balance between new launches as a growth catalyst and intensifying biosimilar and pricing risks as the biggest overhangs right now. In this context, the recent Repatha VESALIUS‑CV results, showing reduced death risk in high‑risk adults without prior heart attack or stroke, feel especially relevant. Together with TEZSPIRE’s EoE readout, they highlight how clinical outcomes data could influence how much of Amgen’s future growth story rests on expanding indications for existing biologics versus entirely new assets. Yet, against these medical wins, investors still need to weigh emerging regulatory threats around key rare‑disease assets that could materially affect... Read the full narrative on Amgen (it's free!) Amgen's narrative projects $41.5 billion revenue and $10.3 billion earnings by 2029. Uncover how Amgen's forecasts yield a $371.93 fair value, a 15% downside to its current price. Some of the lowest‑priced analysts were assuming roughly flat revenue near US$38.9 billion and earnings of about US$8.7 billion, which is far more cautious than believing TEZSPIRE’s EoE success and your chosen catalyst can easily offset long term pricing and biosimilar pressure. Explore 5 other fair value estimates on Amgen - why the stock might be worth 18% less than the current price! Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Amgen research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision. Our free Amgen research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Amgen's overall financial health at a glance. Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: The latest GPUs need a type of rare earth metal called Dysprosium and there are only 29 companies in the world exploring or producing it. Find the list for free. Uncover the next big thing with 22 elite penny stocks that balance risk and reward. Find 50 companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AMGN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-08-28

AstraZeneca (LSE:AZN) Reports Positive TEZSPIRE Phase 3 Results, Is The Discount Too Wide?

Simply Wall St.
Amgen and AstraZeneca (LSE:AZN) reported positive top line Phase 3 results for TEZSPIRE in eosinophilic esophagitis, with clinically meaningful improvements through week 52. That kind of readout often prompts investors to revisit AstraZeneca stock. Even with a steady stream of late stage trial updates around TEZSPIRE, Tagrisso combinations and Enhertu, AstraZeneca’s share price has drifted, with a year to date share price return down 10.87% at £121.14. The 5 year total shareholder return of 56.06% points to a stronger longer term record, with momentum that currently looks more muted. Compare AstraZeneca's current setup with other large caps in a similar position by scanning our hand picked list of solid balance sheet and fundamentals (20 results). With AstraZeneca shares drifting despite a stream of positive trial updates, the gap between the current £121.14 price and fair value estimates near £156 creates a wide spread. How does that range really stack up? The most followed AstraZeneca narrative points to a fair value of £159.11 against the latest £121.14 close, which is a sizeable gap for a large cap. Read the complete narrative. Want to understand why this narrative supports a higher AstraZeneca valuation? It leans on steady top line expansion, rising margins and a richer earnings multiple over time. Result: Fair Value of £159.11 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this AstraZeneca narrative could be knocked off course if key late stage trials disappoint, or if tighter price controls hit blockbuster drugs harder than expected. Find out about the key risks to this AstraZeneca narrative. With the AstraZeneca story pulling in both optimism and concern, it makes sense to look at the full picture quickly and form your own view. You can weigh both sides in one place by checking the 4 key rewards and 1 important warning sign. If you stop at AstraZeneca, you could miss other opportunities that fit your style. Use the Simply Wall St screener to quickly surface ideas worth a closer look. Target potential value opportunities by scanning our hand picked 11 high quality undervalued stocks that combine quality fundamentals with prices that may not fully reflect them. Prioritise resilience by reviewing a 7 resilient stocks with low risk scores that focuses on companies with sturdier risk profiles when m…Read full document

Amgen and AstraZeneca (LSE:AZN) reported positive top line Phase 3 results for TEZSPIRE in eosinophilic esophagitis, with clinically meaningful improvements through week 52. That kind of readout often prompts investors to revisit AstraZeneca stock. Even with a steady stream of late stage trial updates around TEZSPIRE, Tagrisso combinations and Enhertu, AstraZeneca’s share price has drifted, with a year to date share price return down 10.87% at £121.14. The 5 year total shareholder return of 56.06% points to a stronger longer term record, with momentum that currently looks more muted. Compare AstraZeneca's current setup with other large caps in a similar position by scanning our hand picked list of solid balance sheet and fundamentals (20 results). With AstraZeneca shares drifting despite a stream of positive trial updates, the gap between the current £121.14 price and fair value estimates near £156 creates a wide spread. How does that range really stack up? The most followed AstraZeneca narrative points to a fair value of £159.11 against the latest £121.14 close, which is a sizeable gap for a large cap. Read the complete narrative. Want to understand why this narrative supports a higher AstraZeneca valuation? It leans on steady top line expansion, rising margins and a richer earnings multiple over time. Result: Fair Value of £159.11 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this AstraZeneca narrative could be knocked off course if key late stage trials disappoint, or if tighter price controls hit blockbuster drugs harder than expected. Find out about the key risks to this AstraZeneca narrative. With the AstraZeneca story pulling in both optimism and concern, it makes sense to look at the full picture quickly and form your own view. You can weigh both sides in one place by checking the 4 key rewards and 1 important warning sign. If you stop at AstraZeneca, you could miss other opportunities that fit your style. Use the Simply Wall St screener to quickly surface ideas worth a closer look. Target potential value opportunities by scanning our hand picked 11 high quality undervalued stocks that combine quality fundamentals with prices that may not fully reflect them. Prioritise resilience by reviewing a 7 resilient stocks with low risk scores that focuses on companies with sturdier risk profiles when markets feel uncertain. Spot potential future standouts early by checking a 9 high quality undiscovered gems that highlights quality businesses still flying under most investors' radar. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AZN.L. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-08-27

TEZSPIRE® DEMONSTRATES POSITIVE PHASE 3 RESULTS IN EOSINOPHILIC ESOPHAGITIS ACROSS BOTH CO-PRIMARY AND ALL KEY SECONDARY ENDPOINTS

PR Newswire
Statistically Significant and Clinically Meaningful Disease and Symptom Improvements Compared to Placebo Maintained Through Week 52 Efficacy in a Third Epithelial-Driven Inflammatory Disease Supports Broad Potential of TEZSPIRE THOUSAND OAKS, Calif., Aug. 27, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). The safety profile of TEZSPIRE was generally consistent with its approved indications. EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the U.S., with the prevalence increasing five-fold since 2009.1,2 Esophageal inflammation can lead to dysphagia, food impaction and esophageal narrowing.2 For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.3 Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.4-6 "We're pleased that TEZSPIRE showed efficacy in a third epithelial-driven inflammatory condition, eosinophilic esophagitis," said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. "In this Phase 3 trial, TEZSPIRE improved both the underlying inflammation and the swallowing difficulties that can make eosinophilic esophagitis so disruptive for patients. That combination is important for patients and builds confidence in TEZSPIRE as a potential new treatment for people struggling with EoE." CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as…Read full document

Statistically Significant and Clinically Meaningful Disease and Symptom Improvements Compared to Placebo Maintained Through Week 52 Efficacy in a Third Epithelial-Driven Inflammatory Disease Supports Broad Potential of TEZSPIRE THOUSAND OAKS, Calif., Aug. 27, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). The safety profile of TEZSPIRE was generally consistent with its approved indications. EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the U.S., with the prevalence increasing five-fold since 2009.1,2 Esophageal inflammation can lead to dysphagia, food impaction and esophageal narrowing.2 For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.3 Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.4-6 "We're pleased that TEZSPIRE showed efficacy in a third epithelial-driven inflammatory condition, eosinophilic esophagitis," said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. "In this Phase 3 trial, TEZSPIRE improved both the underlying inflammation and the swallowing difficulties that can make eosinophilic esophagitis so disruptive for patients. That combination is important for patients and builds confidence in TEZSPIRE as a potential new treatment for people struggling with EoE." CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue. The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean change from baseline in DSQ score.7 "Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food and emotional and daily-life impacts of the disease," said Arjan Bredenoord, M.D., gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, the Netherlands, and primary investigator in the trial. "The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating EoE, with the potential to help more patients achieve remission and symptom improvement." Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. TEZSPIRE® (tezepelumab-ekko) U.S. Indication TEZSPIRE is indicated for: the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). TEZSPIRE® (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONSKnown hypersensitivity to tezepelumab-ekko or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity ReactionsHypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Acute Asthma Symptoms or Deteriorating DiseaseTEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Abrupt Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) InfectionIt is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 3%) are: Asthma: pharyngitis, arthralgia, and back pain. Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia. USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Please see the full  Prescribing Information including Patient Information and Instructions for Use. You may report side effects related to AstraZeneca products by clicking here. About TEZSPIRE® (tezepelumab-ekko) TEZSPIRE is a first-in-class human monoclonal antibody that works on a primary source of inflammation: the airway and gut epithelia, which are the first points of contact for many viruses, allergens, pollutants and other environmental triggers and insults. Specifically, TEZSPIRE targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of epithelial-driven inflammation associated with severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).7,8-11 TSLP is released by the epithelium in response to inhaled or swallowed environmental inflammatory triggers. Across these disease states, the expression of TSLP is increased and correlates with disease severity.8-12 TEZSPIRE is currently approved for the treatment of severe asthma in the U.S., EU, China, Japan and more than 70 countries across the globe, and for the treatment of inadequately controlled CRSwNP in the U.S., EU, China and Japan. Beyond severe asthma and CRSwNP, TEZSPIRE is also in development for other potential indications including COPD and EoE.13-15 About Eosinophilic Esophagitis (EoE) EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus with prevalence growing across the world.1,2 It is characterized by inflammation, remodeling and esophageal epithelial dysfunction. Epithelial dysfunction and inflammation are important characteristics of EoE and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment.2 The most common symptoms of EoE include difficulty and pain swallowing, food becoming stuck in the esophagus (which may require emergency medical interventions), nausea and vomiting, abdominal or chest pain, poor appetite and difficulty sleeping.2,16,17 Many patients, including adolescents, experience a substantial impact on their quality of life including significant anxiety related to swallowing and choking, depression and decreased work/school productivity.18,19 Patients are often treated with proton pump inhibitors or swallowed topical corticosteroids to manage inflammation.2,4 Nearly half of patients with EoE will not respond to standard first-line therapies or dietary treatment.5,6 Existing treatment options, including those targeting downstream mediators, may not fully address epithelial-driven inflammation.20,21 About the Phase 3 CROSSING Trial CROSSING is a randomized, double-blind, placebo-controlled, multi-center, parallel-group, Phase 3 trial designed to evaluate the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks, compared to placebo in patients aged 12-80 years with symptomatic and histologically active EoE. A total of 368 patients were randomized in a 1:1:1 ratio to receive either a low or high dose of TEZSPIRE or placebo.7 The co-primary endpoints analyzed at week 24 were the proportion of patients with histologic remission, defined as a peak esophageal eosinophil count less than or equal to six eosinophils per high-power field, and mean changes from baseline in the Dysphagia Symptom Questionnaire (DSQ). The peak eosinophil count is obtained when biopsies of the tissue of the esophagus are examined under a microscope. A count of 15 or more peak eosinophils per high power microscopic field measured by esophageal biopsy is often the cutoff used to diagnose EoE.22,23 The DSQ captures the presence and severity of dysphagia symptoms in a daily diary with a four-item patient-reported questionnaire; the score is calculated over 14-day periods, ranging from zero to 84, with a higher score indicating more severe dysphagia. Key secondary endpoints assessed histologic remission and dysphagia symptoms at week 52; changes in endoscopic disease features (EoE-EREFS) and histologic severity and extent (EoE-HSS) at weeks 24 and 52, as well as endoscopic response, inflammatory remission and total endoscopic remission at week 52.7 In the trial, patients were allowed to remain on background medications for EoE, including proton pump inhibitors and swallowed topical corticosteroids, provided that they were stable prior to entry and during the treatment period.7 About the Amgen and AstraZeneca Collaboration Amgen is in a collaboration with AstraZeneca for the development and commercialization of TEZSPIRE. Under the collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca leads global development. In North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada. AstraZeneca leads commercialization for TEZSPIRE outside North America. Amgen manufactures and supplies TEZSPIRE worldwide. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average® and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads. Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. Any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media)Casey Capparelli, 805-447-1746 (investors) REFERENCES Biedermann L. & Straumann A. Mechanisms and clinical management of eosinophilic oesophagitis: an overview. Nature Reviews Gastroenterol & Hepatol. 2023;20(2):101-119. Thel HL, et al. Prevalence and costs of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2025;23(2):272-280.e8. Cleveland Clinic. Eosinophilic Esophagitis (EoE): Symptoms & Treatment. Available at: https://my.clevelandclinic.org/health/diseases/14321-eosinophilic-esophagitis. [Last accessed August 2026.] Hirano I, et al. AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158(6):1776-1786. Strauss AL, Falk GW. Refractory eosinophilic esophagitis: what to do when the patient has not responded to proton pump inhibitors, steroids and diet. Curr Opin Gastroenterol. 2022;38(4):395-401. Lucendo AJ, et al. Efficacy of proton pump inhibitor drugs for inducing clinical and histologic remission in patients with symptomatic esophageal eosinophilia: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2016;14(1):13-22.e1. ClinicalTrials.gov. Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227. [Last accessed August 2026.] Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595. Ying S, et al. Thymic stromal lymphopoietin expression is increased in asthmatic airways and correlates with expression of Th2-attracting chemokines and disease severity. J Immunol. 2005;174:8183-8190. Calderon AA, et al. Targeting interleukin-33 and thymic stromal lymphopoietin pathways for novel pulmonary therapeutics in asthma and COPD. Eur Respir Rev. 2023;32(167):220144. Nagarkar DR, et al. Thymic stromal lymphopoietin activity is increased in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2013;132(3):593-600.e12. Sherrill JD, et al. Preferential Secretion of Thymic Stromal Lymphopoietin (TSLP) by Terminally Differentiated Esophageal Epithelial Cells: Relevance to Eosinophilic Esophagitis. PLoS One. 2016;11(2):e0148216. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007) (JOURNEY). Available at: https://clinicaltrials.gov/study/NCT06878261. [Last accessed August 2026]. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) (EMBARK). Available at: https://clinicaltrials.gov/study/NCT06883305. [Last accessed August 2026]. ClinicalTrials.gov. Tezepelumab COPD Exacerbation Study (COURSE). Available at: https://clinicaltrials.gov/ct2/show/NCT04039113. [Last accessed: August 2026]. Gold BD, et al. Health-Related Quality of Life and Perceived Stigma in Eosinophilic Esophagitis: A Real-World, US, Web-Based Survey. Gastro Hep Adv. 2024;3(8):1087-97. MedlinePlus. Eosinophilic esophagitis. Bethesda (MD): National Library of Medicine (US). Available at: https://medlineplus.gov/eosinophilicesophagitis.html. [Last accessed August 2026]. Taft TH, et al. Anxiety and depression in eosinophilic esophagitis: a scoping review and recommendations for future research. J Asthma Allergy. 2019;12:389–99. Harris RF, et al. Psychosocial dysfunction in children and adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2013;57:500–5. Underwood B, et al. Breaking down the complex pathophysiology of eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2023;130(1):28-39 Gautam R, et al. Eosinophilic esophagitis: mechanisms of disease and approach to treatment. Curr Allergy Asthma Rep. 2026;26:21. Lucendo AJ, et al. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut. 2022;71(8):1459-1487. Dellon ES, et al. ACG Clinical Guideline: Diagnosis and Management of Eosinophilic Esophagitis. Am J Gastroenterol. 2025;120(1):31-59. View original content to download multimedia:https://www.prnewswire.com/news-releases/tezspire-demonstrates-positive-phase-3-results-in-eosinophilic-esophagitis-across-both-co-primary-and-all-key-secondary-endpoints-302861404.html

Investor releaseQuarter not tagged2026-08-13

BeOne Medicines Ltd (ONC) (Q2 2026) Earnings Call Highlights: Revenue Surges 30% to $1. ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue: $1.7 billion, representing 30% growth year over year. GAAP Earnings per ADS: $2.05, up 144% compared to the prior year. BRUKINSA Global Revenue: Over $1.2 billion, representing 31% year-over-year growth. US BRUKINSA Sales: $893 million, representing 31% growth. TEVIMBRA Global Sales: $229 million, representing 18% growth versus the prior period. Amgen In-Licensed Portfolio Revenue: $157 million, growing 25% year over year. US Revenue: Approximately $899 million, growing 31% year over year. China Revenue: Approximately $500 million, growing 17% year over year. Europe Revenue: Approximately $208 million, growing 37% year over year. Rest of World Revenue: Approximately $73 million, more than doubled year over year. Gross Profit: $1.5 billion with gross margin of just under 90%. Operating Expenses: $1.2 billion, representing 13% growth. Income from Operations: $325 million. Net Income: $237 million, including an approximate $60 million impact from a tax audit settlement. Adjusted Income from Operations: $503 million, representing growth of more than 80% year over year. Adjusted Net Income: $444 million. Adjusted Diluted EPS: $3.84, compared with $2.25 a year ago. Free Cash Flow: $435 million, doubling from the prior year period. 2026 Revenue Guidance: Raised by $300 million to a range of $6.6 billion to $6.8 billion. 2026 GAAP Operating Income Guidance: Raised by $250 million to a range of $1 billion to $1.1 billion. 2026 Non-GAAP Operating Income Guidance: $1.7 billion to $1.8 billion. Warning! GuruFocus has detected 5 Warning Sign with ONC. Is ONC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BeOne Medicines Ltd (NASDAQ:ONC) delivered a strong Q2 2026 with total revenues of $1.7 billion, up 30% year-over-year, and GAAP EPS of $2.05, up 144%. BRUKINSA continues to outperform, with global revenues exceeding $1.2 billion (31% growth) and the highest level of sustained new patient starts since launch. The company raised its 2026 revenue guidance by $300 million to $6.6-$6.8 billion and operating income guidance by $250 million to $1.0-$1.1 billion. The Phase 3 MANGROVE study showed BRUKINSA plus rituximab as the first chemo-free regimen for frontline mantle cell l…Read full document

This article first appeared on GuruFocus. Total Revenue: $1.7 billion, representing 30% growth year over year. GAAP Earnings per ADS: $2.05, up 144% compared to the prior year. BRUKINSA Global Revenue: Over $1.2 billion, representing 31% year-over-year growth. US BRUKINSA Sales: $893 million, representing 31% growth. TEVIMBRA Global Sales: $229 million, representing 18% growth versus the prior period. Amgen In-Licensed Portfolio Revenue: $157 million, growing 25% year over year. US Revenue: Approximately $899 million, growing 31% year over year. China Revenue: Approximately $500 million, growing 17% year over year. Europe Revenue: Approximately $208 million, growing 37% year over year. Rest of World Revenue: Approximately $73 million, more than doubled year over year. Gross Profit: $1.5 billion with gross margin of just under 90%. Operating Expenses: $1.2 billion, representing 13% growth. Income from Operations: $325 million. Net Income: $237 million, including an approximate $60 million impact from a tax audit settlement. Adjusted Income from Operations: $503 million, representing growth of more than 80% year over year. Adjusted Net Income: $444 million. Adjusted Diluted EPS: $3.84, compared with $2.25 a year ago. Free Cash Flow: $435 million, doubling from the prior year period. 2026 Revenue Guidance: Raised by $300 million to a range of $6.6 billion to $6.8 billion. 2026 GAAP Operating Income Guidance: Raised by $250 million to a range of $1 billion to $1.1 billion. 2026 Non-GAAP Operating Income Guidance: $1.7 billion to $1.8 billion. Warning! GuruFocus has detected 5 Warning Sign with ONC. Is ONC fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BeOne Medicines Ltd (NASDAQ:ONC) delivered a strong Q2 2026 with total revenues of $1.7 billion, up 30% year-over-year, and GAAP EPS of $2.05, up 144%. BRUKINSA continues to outperform, with global revenues exceeding $1.2 billion (31% growth) and the highest level of sustained new patient starts since launch. The company raised its 2026 revenue guidance by $300 million to $6.6-$6.8 billion and operating income guidance by $250 million to $1.0-$1.1 billion. The Phase 3 MANGROVE study showed BRUKINSA plus rituximab as the first chemo-free regimen for frontline mantle cell lymphoma, with a hazard ratio of 0.57 versus standard of care. The pipeline is advancing rapidly, with five solid tumor programs achieving proof of concept and moving to pivotal trials, including CDK4, B7-H4 ADC, and GPC3 x 4-1BB. Real-world data from over 10,500 Medicare patients showed BRUKINSA significantly reduced risk of death by 24% vs acalabrutinib and 36% vs ibrutinib. The company achieved FDA approval for BEQALZI, the first BCL-2 inhibitor for mantle cell lymphoma, expanding its hematology franchise. Free cash flow doubled year-over-year to $435 million, demonstrating strong cash generation and financial health. The CELESTIAL-301 study of zanubrutinib plus sonrotoclax did not meet the uMRD superiority endpoint versus venetoclax plus obinutuzumab, raising questions about the regimen's comparative efficacy. The company remains unblinded to the hazard ratio data from CELESTIAL-301, creating uncertainty about the PFS endpoint. Competition from fixed-duration regimens like acalabrutinib plus venetoclax (AV) is emerging, though the company downplays its near-term impact. The company faces potential biosimilar competition for XGEVA from its Amgen in-licensed portfolio, which could impact future revenue. Operating expenses are expected to grow at a similar year-over-year rate in 2027, indicating continued high investment levels that may pressure margins. The company's narrative on BRUKINSA's safety and efficacy is challenged by cross-trial comparisons, which may not fully account for differences in patient populations and study designs. The tax audit settlement had a $60 million impact on net income, reducing reported profitability. Q: Can you provide more color on the growth of BRUKINSA sales, specifically quantifying growth from indications outside CLL versus CLL itself, and the impact of the Acala-ven (AV) launch? Also, any color on the hazard ratio from the CELESTIAL-301 study? A: Aaron Rosenberg (CFO) noted that BRUKINSA growth was driven by strong demand across all regions, with the highest level of sustained new patient starts since launch. Growth is broad-based across CLL and non-CLL indications, with the company "punching a little bit above our weight" in non-CLL indications where it holds strong share. Duration of therapy continues to be highly constructive yet immature, reinforced by real-world data showing meaningful long-term benefits on discontinuation versus acalabrutinib and ibrutinib. John Oyler (CEO) stated they are not seeing much impact from the AV AMPLIFY launch in the US yet. Amit Agarwal (CMO, Hematology) added that AV only has three-year data, which shows the lowest rate of uMRD and landmark PFS among Ven-based regimens, and highlighted that in unmutated IGHV patients, BRUKINSA shows 70% PFS at six years versus low 40s for Ven-based regimens. On CELESTIAL-301, the company remains blinded to the data and does not have details on the hazard ratio, but remains confident in achieving the PFS superiority endpoint. Q: Can you provide early physician feedback regarding the MANGROVE study results, thoughts on the study not including a rituximab maintenance arm, and how physicians interpret the data relative to the approved ECHO regimen? A: Amit Agarwal (CMO, Hematology) explained that MANGROVE was designed to test a chemo-free regimen in frontline MCL and show it is better than standard-of-care chemotherapy regimens, unlike other BTK inhibitor studies like ECHO which added the BTK inhibitor to chemotherapy. The ZR regimen showed a hazard ratio of 0.57 versus BR, which is "really unprecedented" for a chemo-free regimen. While OS data is immature, the results have generated significant excitement among physicians and KOLs who treat MCL, who understand the impact of avoiding chemotherapy toxicities. There is also high interest in understanding the rituximab maintenance-free regimen. Q: How are you tracking towards completing the first registration study for the BTK degrader (tacabrutideg) in relapsed/refractory CLL, and how do you see the program positioned relative to competitors like Nurix/Roche? A: Amit Agarwal (CMO, Hematology) confirmed the company remains on track for a potential accelerated approval submission in Q4 2026, supported by Fast Track designation from the FDA. Phase 1 data has shown encouraging response rates and durability across different patient populations, which the company believes supports accelerated approval. The Phase 3 head-to-head study of tacabrutideg versus pirtobrutinib is enrolling very well, and a tacabrutideg + sonrotoclax relapsed/refractory study is planned to initiate early next year. This reflects growing confidence in tacabrutideg becoming a foundational asset in CLL. Q: When could we see an additional data cut from MANGROVE, and what are the design elements for the KAT6 program to overcome safety limitations and combine with the CDK4 selective program? A: Amit Agarwal (CMO, Hematology) stated the company is excited to present the MANGROVE data at an upcoming congress and will share details soon. Lai Wang (President, Global Head of R&D) explained that the KAT6 molecule was designed to be more selective for KAT6 while sparing KAT7, which is the main differentiation versus Pfizer's program and could lead to less hematological toxicities. The first Phase 1 study in breast cancer is designed to combine with the CDK4 inhibitor, and a second Phase 1 study in AML was initiated last month based on interesting preclinical translational data. Q: What can we expect to see from the PRMT5 inhibitor data at ESMO, and is pancreatic cancer moving to Phase 3 next year as well? A: Mark Lanasa (CMO, Solid Tumors) stated the ESMO disclosure will be the initial disclosure for the PRMT5 program, which entered the clinic in Q1 2025. It will include monotherapy Phase 1a dose escalation data plus a significant number of expansion patients, with an emphasis on non-small cell lung cancer due to the molecule's CNS-penetrant design. The data will show early evidence of clinically meaningful CNS coverage and will include data across tumor types including NSCLC, pancreatic cancer, and others. The company intends to have a broad development plan for the molecule. Q: What changed most materially relative to your expectations when you last updated guidance, and can you talk in broad strokes about the Phase 3 you envision for the CEA ADC in lung cancer next year? A: Aaron Rosenberg (CFO) cited areas of strength for BRUKINSA including the level of new patient starts, strength across all indications, and improvements in understanding duration of therapy, all of which were ahead of expectations at the beginning of the year. Mark Lanasa (CMO, Solid Tumors) stated the CEA ADC will have its initial data disclosure at ESMO, including Phase 1 dose escalation and expansion data, showing first-in-class proof of concept in NSCLC that compares favorably to other investigational ADCs. The initial registration opportunities will be in a later line setting, but the company is actively working to generate evidence in an earlier line setting given the strength of emerging data. Q: Can you provide more detail on the PRMT5 and RAS strategy, including whether the Phase 3 for PRMT5 in lung cancer would be a combo or monotherapy, and details on the RAS-ON inhibitor? A: Mark Lanasa (CMO, Solid Tumors) stated the company is deeply committed to innovation in RAS inhibition. A highly potent RAS-ON inhibitor will enter the clinic before the end of this year and was designed to be CNS penetrant, making it particularly exciting for NSCLC. The company is aware of and excited about data combining RAS-ON inhibitors with PRMT5 inhibitors in MTAP-deleted pancreatic cancer and will look to generate evidence in that regard swiftly. Additional RAS targeting molecules are being advanced, including a KRAS targeting degrader and a RAS-ON ADC where the RAS-ON inhibitor serves as the payload. Q: How should we think about the Amgen in-licensed portfolio's contribution, given it continues to outperform expectations with 25% growth? A For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-13

Amgen’s Q2 Earnings Call: Our Top 5 Analyst Questions

StockStory
Amgen’s second quarter results reflected broad-based portfolio momentum, with management crediting double-digit growth in key products like Repatha, EVENITY, and TEZSPIRE for the company’s outperformance versus Wall Street estimates. CEO Robert Bradway highlighted that 22 products achieved double-digit sales growth, and 17 products annualized over $1 billion in sales, noting, “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.” Management also pointed to the performance of its biosimilars and innovative oncology franchises as important contributors this quarter. Is now the time to buy AMGN? Find out in our full research report (it’s free). Revenue: $10.05 billion vs analyst estimates of $9.40 billion (9.5% year-on-year growth, 6.9% beat) Adjusted EPS: $6.29 vs analyst estimates of $5.62 (12% beat) Adjusted Operating Income: $4.61 billion vs analyst estimates of $4.15 billion (45.9% margin, 11.1% beat) The company lifted its revenue guidance for the full year to $38.8 billion at the midpoint from $37.8 billion, a 2.6% increase Management raised its full-year Adjusted EPS guidance to $22.90 at the midpoint, a 2.2% increase Operating Margin: 35%, up from 28.9% in the same quarter last year Market Capitalization: $225.6 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Dina Elmonshed (UBS) asked about Olpasiran’s trial design and endpoints. Executive Vice President James Bradner clarified the rationale for using a three-point MACE endpoint, noting it should not impact event rates compared to studies with different endpoints. Salveen Richter (Goldman Sachs) inquired about business development and capital allocation. CEO Robert Bradway reiterated a focus on smaller, early-stage assets in core therapeutic areas, noting late-stage pipeline progress does not directly constrain business development activity. Umer Raffat (Evercore ISI) questioned the tolerability profile of MariTide and safety monitoring in ongoing trials. Bradner expressed confidence in current trial design and oversight, stating the…Read full document

Amgen’s second quarter results reflected broad-based portfolio momentum, with management crediting double-digit growth in key products like Repatha, EVENITY, and TEZSPIRE for the company’s outperformance versus Wall Street estimates. CEO Robert Bradway highlighted that 22 products achieved double-digit sales growth, and 17 products annualized over $1 billion in sales, noting, “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.” Management also pointed to the performance of its biosimilars and innovative oncology franchises as important contributors this quarter. Is now the time to buy AMGN? Find out in our full research report (it’s free). Revenue: $10.05 billion vs analyst estimates of $9.40 billion (9.5% year-on-year growth, 6.9% beat) Adjusted EPS: $6.29 vs analyst estimates of $5.62 (12% beat) Adjusted Operating Income: $4.61 billion vs analyst estimates of $4.15 billion (45.9% margin, 11.1% beat) The company lifted its revenue guidance for the full year to $38.8 billion at the midpoint from $37.8 billion, a 2.6% increase Management raised its full-year Adjusted EPS guidance to $22.90 at the midpoint, a 2.2% increase Operating Margin: 35%, up from 28.9% in the same quarter last year Market Capitalization: $225.6 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Dina Elmonshed (UBS) asked about Olpasiran’s trial design and endpoints. Executive Vice President James Bradner clarified the rationale for using a three-point MACE endpoint, noting it should not impact event rates compared to studies with different endpoints. Salveen Richter (Goldman Sachs) inquired about business development and capital allocation. CEO Robert Bradway reiterated a focus on smaller, early-stage assets in core therapeutic areas, noting late-stage pipeline progress does not directly constrain business development activity. Umer Raffat (Evercore ISI) questioned the tolerability profile of MariTide and safety monitoring in ongoing trials. Bradner expressed confidence in current trial design and oversight, stating the data safety monitoring committee is fully engaged. Edward Polglase (Bernstein) probed the impact of new competitors like SOTYKTU on Otezla volumes. Commercial head Murdo Gordon said Otezla remains a first-line systemic option, with competitive pressure mainly affecting pricing rather than prescription volumes. Alexandria Hammond (Wolfe Research) asked about reducing monitoring requirements for IMDELLTRA in earlier oncology treatment lines. Bradner and Gordon explained that real-world data and new clinical experience could allow for reduced monitoring times as regulatory agencies review accumulated safety data. Our analysts will be watching (1) the pace and outcome of pivotal clinical trial readouts for MariTide, Olpasiran, and Xaluritamig, (2) the impact of expanded manufacturing capacity on supply reliability and launch execution for new therapies, and (3) the continued uptake and payer access for core growth drivers like Repatha, EVENITY, and TEZSPIRE. Progress on AI integration and business development activity will also be key markers of Amgen’s execution. Amgen currently trades at $415.25, up from $390.02 just before the earnings. In the wake of this quarter, is it a buy or sell? See for yourself in our full research report (it’s free for active Edge members). ONE MORE THING: Top 5 Growth Stocks. The biggest stock winners almost always had one thing in common before they ran. Revenue growing like crazy. Meta. CrowdStrike. Broadcom. Our AI flagged all three. They returned 315%, 314%, and 455%, respectively. Find out which 5 stocks it’s flagging this month — FREE. Get Our Top 5 Growth Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-small-cap company Comfort Systems (+1,154% between June 2020 and June 2025). Find your next big winner with StockStory today.

Investor releaseQuarter not tagged2026-08-11

Amgen (AMGN) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Tuesday, Aug. 4, 2026, at 4:30 p.m. ET Chairman and Chief Executive Officer - Robert Bradway Vice President of Investor Relations - Casey Capparelli Chief Financial Officer - Peter Griffith Representative - Murdo Gordon Representative - James Bradner Operator: 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. Casey Capparelli: 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: 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 supporti…Read full document

Image source: The Motley Fool. Tuesday, Aug. 4, 2026, at 4:30 p.m. ET Chairman and Chief Executive Officer - Robert Bradway Vice President of Investor Relations - Casey Capparelli Chief Financial Officer - Peter Griffith Representative - Murdo Gordon Representative - James Bradner Operator: 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. Casey Capparelli: 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: 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. Murdo Gordon: 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. James Bradner: 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. Peter Griffith: 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: 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. Operator: Our first question comes from Michael Yee from UBS. Dina Elmonshed: 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? James Bradner: 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: Julianne next question please. Operator: Our next question comes from Salveen Richter from Goldman Sachs. Salveen Richter: 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: 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. Operator: Our next question comes from Chris Schott from JPMorgan. Taylor Hanley: 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? James Bradner: 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. Robert Bradway: Next question Julianne. Operator: Our next question comes from Umer Raffat from Evercore ISI. Umer Raffat: 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. James Bradner: 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: Next question please Julianne. Operator: Our next question comes from Yaron Werber from TD Cowen. Yaron Werber: 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? Murdo Gordon: 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. Operator: Next question comes from Courtney Breen from Bernstein. Edward Polglase: 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: Sure. Murdo, why don't you [ answer ] this question, please. Murdo Gordon: 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. Operator: Our next question comes from Terence Flynn from Morgan Stanley. Unknown Analyst: 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: Sure. Murdo, why don't you... Murdo Gordon: 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. Operator: Our next question comes from Akash Tewari from Jefferies. Manoj Eradath: 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. Murdo Gordon: 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. Operator: Our next question comes from Mohit Bansal from Wells Fargo. Susan Chor: 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? Murdo Gordon: 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. James Bradner: 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. Operator: Our next question comes from Alex Hammond from Wolfe Research. Alexandria Hammond: 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? James Bradner: 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? Murdo Gordon: 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. Operator: Our next question comes from Dave Risinger from Leerink Partners. David Risinger: 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? James Bradner: 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? Murdo Gordon: 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: Okay. Julianne, why don't we take one more question? Operator: Our last question today will come from Jay Olson from Oppenheimer. Jay Olson: 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: Why don't you share your thoughts? Murdo Gordon: 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: 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. Operator: This concludes our Amgen Q2 2026 Earnings Conference Call. You may now disconnect. Before you buy stock in Amgen, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Amgen wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $411,427!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,252!* Now, it’s worth noting Stock Advisor’s total average return is 965% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 11, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Amgen. The Motley Fool has a disclosure policy. Amgen (AMGN) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-10

What Analysts Really Pressed LLY On This Quarter

Trefis
Eli Lilly's growth is huge, but on its latest call, analysts tested whether the next chapter can possibly live up to the last one. After around 85% run over the past year, Eli Lilly (LLY) just posted a quarter with 48% revenue growth, numbers that can make a stock feel invincible. But for a company trading at this valuation, the only question that matters is what comes next. On its latest call, analysts repeatedly circled one central worry: with growth this strong, are the first cracks starting to show in the forward-looking story? The sharpest questions were not about the quarter that just closed, but about the new products and guidance that have to carry the momentum from here. The first challenge centered on Foundayo, the company’s new oral obesity drug and a critical piece of its future. If the injectable drugs built the franchise, the pill is supposed to broaden it to millions more. The problem, as one analyst framed it, is that the U.S. launch curve has looked “somewhat slower than anticipated.” This is a direct challenge to execution on a product investors are counting on to be the next large growth engine. The stakes are simple: a blockbuster launch keeps the story going, while a stumble gives competitors an opening and spooks investors in a high-multiple stock. Management’s response was to argue the inflection point is happening right now. The company reported that in the last week of July, it saw a significant uptick, “almost doubling the volume that we had just a month ago.” They added that new patient starts on Foundayo are now approaching one out of every four. It counters the “slow start” narrative by pointing to very recent momentum, but it also implicitly concedes the early weeks were softer. The answer was confident, but the proof will be in the coming months. The second point of pressure came on guidance. Lilly raised its full-year revenue forecast to a range of $85 billion to $87 billion, up from its prior estimate of $82.5 billion to $84.5 billion. But the math behind that raise seemed to imply a revenue deceleration in the second half of the year compared to the rapid pace of Q2. For a growth story this strong, any hint of a slowdown gets scrutinized. It forces the question of whether the current trajectory is truly sustainable. The CFO’s answer was direct and technical. He explained the apparent slowdown was an illusion created by a few…Read full document

Eli Lilly's growth is huge, but on its latest call, analysts tested whether the next chapter can possibly live up to the last one. After around 85% run over the past year, Eli Lilly (LLY) just posted a quarter with 48% revenue growth, numbers that can make a stock feel invincible. But for a company trading at this valuation, the only question that matters is what comes next. On its latest call, analysts repeatedly circled one central worry: with growth this strong, are the first cracks starting to show in the forward-looking story? The sharpest questions were not about the quarter that just closed, but about the new products and guidance that have to carry the momentum from here. The first challenge centered on Foundayo, the company’s new oral obesity drug and a critical piece of its future. If the injectable drugs built the franchise, the pill is supposed to broaden it to millions more. The problem, as one analyst framed it, is that the U.S. launch curve has looked “somewhat slower than anticipated.” This is a direct challenge to execution on a product investors are counting on to be the next large growth engine. The stakes are simple: a blockbuster launch keeps the story going, while a stumble gives competitors an opening and spooks investors in a high-multiple stock. Management’s response was to argue the inflection point is happening right now. The company reported that in the last week of July, it saw a significant uptick, “almost doubling the volume that we had just a month ago.” They added that new patient starts on Foundayo are now approaching one out of every four. It counters the “slow start” narrative by pointing to very recent momentum, but it also implicitly concedes the early weeks were softer. The answer was confident, but the proof will be in the coming months. The second point of pressure came on guidance. Lilly raised its full-year revenue forecast to a range of $85 billion to $87 billion, up from its prior estimate of $82.5 billion to $84.5 billion. But the math behind that raise seemed to imply a revenue deceleration in the second half of the year compared to the rapid pace of Q2. For a growth story this strong, any hint of a slowdown gets scrutinized. It forces the question of whether the current trajectory is truly sustainable. The CFO’s answer was direct and technical. He explained the apparent slowdown was an illusion created by a few factors: one-off items and prior-period rebate adjustments that artificially boosted first-half results, which won’t repeat. More importantly, he noted the second half of 2025 was unusually strong due to the “bolus” of Mounjaro launches in international markets, making for a tougher year-over-year comparison. This was a credible, numbers-driven explanation that defused the concern by reframing it as an issue of accounting and timing, not a fundamental weakening of the business. Management met the key challenges head-on, arguing that the growth story is fully intact. They answered the guidance question convincingly and provided specific, near-term data to counter worries about the Foundayo launch. But what remains an open question is whether the recent Foundayo inflection is a durable trend or just a short-term blip from new marketing and access programs. The one thing to watch next quarter is that prescription data. It will be the clearest signal of whether Lilly’s next growth engine has truly gained traction. For investors who want to look at a basket of similar names, a healthcare ETF like XLV offers broader exposure to the sector. Every stock carries unresolved questions like these, and no earnings call settles all of them. Owning a sector fund spreads that risk across more names, but it is still one bet on one theme: when the theme wobbles, the whole basket wobbles with it. The Trefis High Quality (HQ) Portfolio takes the next step out. It holds about 30 businesses diversified across sectors, selected not on a theme but on quality itself: consistent cash generation, strong margins, and resilient balance sheets. No single unresolved debate, and no single industry, carries your result. It has a track record of outpacing a benchmark that combines the three major indices - the S&P 500, S&P Mid-cap, and Russell 2000. Track the debates on names you like, on top of a core built on quality rather than any one story.

Investor releaseQuarter not tagged2026-08-05

AMGN Beats on Q2 Earnings, Lifts Outlook Despite Legacy Drug Pressure

Zacks
Amgen AMGN reported second-quarter 2026 adjusted earnings of $6.29 per share, up 4% year over year. Earnings beat the Zacks Consensus Estimate of $5.60 as higher revenues were partially offset by higher operating costs and taxes. Total revenues increased 10% to $10.1 billion and surpassed the consensus estimate of $9.44 billion. Total product sales increased 9% year over year to $9.54 billion, driven by higher volumes, which offset the impact of lower pricing. Repatha sales surged 37% year over year to $953 million, exceeding the Zacks Consensus Estimate of $907 million. The increase was driven by volume growth. New-to-brand prescriptions in the United States rose more than 50%, supported by increased use in secondary prevention and high-risk primary prevention patients. Evenity sales climbed 38% to $714 million, topping the consensus estimate of $636 million. Prolia sales declined 32% to $759 million but exceeded the estimate of $728 million as multiple biosimilars affected volumes and pricing. Xgeva revenues fell 34% to $352 million, slightly missing the consensus mark of $356 million. Patents for Prolia and Xgeva expired in 2025. Sales of these best-selling drugs are eroding significantly in 2026 as several biosimilars have been launched globally. Shares of Amgen have risen 19.6% so far this year compared with the industry’s rise of 0.8%. Image Source: Zacks Investment Research Asthma drug Tezspire sales rose 42% year over year to $486 million, marginally exceeding the Zacks Consensus Estimate of $483 million. Demand increased in severe uncontrolled asthma, while uptake of its new indication of chronic rhinosinusitis with nasal polyps was encouraging. Amgen has a partnership with AstraZeneca AZN for Tezspire. Amgen and AstraZeneca share costs and profits equally after AstraZeneca pays a mid-single-digit inventor royalty to Amgen. While AstraZeneca leads development, Amgen leads manufacturing. Otezla sales declined 21% to $491 million, missing the consensus estimate of $562 million, due to lower pricing and volume. Enbrel revenues decreased 4% to $580 million due to lower selling prices (including the impact from increased 340B program mix and Medicare Part D redesign), partially offset by favorable changes to estimated sales deductions. Enbrel sales topped the estimate of $466 million. In oncology, Blincyto sales increased 23% to $472 million, surpassing…Read full document

Amgen AMGN reported second-quarter 2026 adjusted earnings of $6.29 per share, up 4% year over year. Earnings beat the Zacks Consensus Estimate of $5.60 as higher revenues were partially offset by higher operating costs and taxes. Total revenues increased 10% to $10.1 billion and surpassed the consensus estimate of $9.44 billion. Total product sales increased 9% year over year to $9.54 billion, driven by higher volumes, which offset the impact of lower pricing. Repatha sales surged 37% year over year to $953 million, exceeding the Zacks Consensus Estimate of $907 million. The increase was driven by volume growth. New-to-brand prescriptions in the United States rose more than 50%, supported by increased use in secondary prevention and high-risk primary prevention patients. Evenity sales climbed 38% to $714 million, topping the consensus estimate of $636 million. Prolia sales declined 32% to $759 million but exceeded the estimate of $728 million as multiple biosimilars affected volumes and pricing. Xgeva revenues fell 34% to $352 million, slightly missing the consensus mark of $356 million. Patents for Prolia and Xgeva expired in 2025. Sales of these best-selling drugs are eroding significantly in 2026 as several biosimilars have been launched globally. Shares of Amgen have risen 19.6% so far this year compared with the industry’s rise of 0.8%. Image Source: Zacks Investment Research Asthma drug Tezspire sales rose 42% year over year to $486 million, marginally exceeding the Zacks Consensus Estimate of $483 million. Demand increased in severe uncontrolled asthma, while uptake of its new indication of chronic rhinosinusitis with nasal polyps was encouraging. Amgen has a partnership with AstraZeneca AZN for Tezspire. Amgen and AstraZeneca share costs and profits equally after AstraZeneca pays a mid-single-digit inventor royalty to Amgen. While AstraZeneca leads development, Amgen leads manufacturing. Otezla sales declined 21% to $491 million, missing the consensus estimate of $562 million, due to lower pricing and volume. Enbrel revenues decreased 4% to $580 million due to lower selling prices (including the impact from increased 340B program mix and Medicare Part D redesign), partially offset by favorable changes to estimated sales deductions. Enbrel sales topped the estimate of $466 million. In oncology, Blincyto sales increased 23% to $472 million, surpassing the consensus estimate of $457 million. Growth reflected broader prescribing in U.S. academic and community settings and strong international demand. New cancer drug Imdelltra’s sales rose 11.6% sequentially to $288 million, supported by increased adoption in second-line small-cell lung cancer. Uplizna revenues increased 90% year over year to $335 million, beating the Zacks Consensus Estimate of $306 million. Performance reflected sustained momentum across its three approved indications, aided by broader physician adoption and the drug’s twice-yearly maintenance dosing. Tepezza sales advanced 14% to $576 million, driven by higher volumes and pricing. Krystexxa revenues rose 15% to $400 million. Tavneos sales increased 36% to $150 million. Overall, Amgen’s rare-disease portfolio generated $1.6 billion in quarterly revenues, up 21%, supported by international expansion, additional indications and pricing. Total biosimilar sales were $855 million in the quarter, up 29% year over year. As regards new biosimilars, sales of Wezlana, a biosimilar version of J&J’s Stelara, were $61 million, compared with $47 million the previous quarter, entirely from ex-U.S. markets. Pavblu, a biosimilar of Regeneron’s Eylea, generated sales of $287 million in the quarter, up 2.5% sequentially, driven by increased adoption among retina specialists. Sales of Amjevita/Amgevita, a biosimilar of AbbVie’s Humira, were $155 million in the quarter, up 17% year over year. Adjusted operating margin declined 0.5 percentage points year over year to 48.4% in the second quarter. Adjusted operating expenses increased 11% to $5.44 billion. R&D expenses rose 10% year over year to $1.85 billion, reflecting higher spending on late-stage clinical programs, particularly MariTide. SG&A expenses increased 4% to $1.72 billion, mainly due to higher general and administrative expenses and increased commercial product-related spending. Amgen raised its total revenue guidance for 2026 to a range of $38.2 billion to $39.4 billion. The company previously expected revenues between $37.1 billion and $38.5 billion. Adjusted earnings guidance was increased to $22.30-$23.50 per share from the prior range of $21.70-$23.10. The improved outlook reflects strong first-half execution and continued momentum across the company’s key growth products. Amgen delivered a strong second quarter, beating estimates for both earnings and revenues. Broad-based volume growth across Repatha, Evenity, Tezspire, Uplizna and oncology products more than offset biosimilar erosion for Prolia and Xgeva and weakness in mature brands like Otezla and Enbrel. New biosimilar products are also contributing to sales growth. Twenty-two products achieved double-digit sales growth in the quarter. Amgen’s key growth drivers, which include Repatha, Evenity, Tezspire and oncology and rare disease drugs, as well as biosimilar products, rose 26% year over year in the second quarter. These key growth drivers represented almost 70% of Amgen’s total product sales. Amgen also raised its financial outlook for 2026, for the second time this year, reinforcing management’s confidence in the portfolio. However, declining sales of mature products and intensifying biosimilar competition remain near-term challenges. Amgen faces a significant patent-expiration overhang as key products such as Prolia, Xgeva, Enbrel and Otezla have either already lost exclusivity or are expected to do so within the next few years. Investors are keeping an eye on Amgen’s progress with its obesity candidate, MariTide. Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with monthly and maybe less frequent dosing. This key feature differentiates it from Eli Lilly’s LLY and Novo Nordisk’s NVO popular GLP-1-based obesity drugs, Zepbound (tirzepatide) and Wegovy (semaglutide), respectively, which are weekly injections. A monthly therapy like MariTide may help reduce treatment burden for patients and improve persistence on treatment over time. Amgen has nine global phase III studies underway with MariTide in obesity, type II diabetes and other obesity-related conditions. Along with the earnings results, Amgen announced that it will discontinue further development of AMG 513, while its ongoing phase I obesity study will continue until all enrolled participants complete the study. Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Amgen Inc. price-consensus-chart | Amgen Inc. Quote Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amgen Inc. (AMGN) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-05

Strong Earnings Push the S&P 500 to New Record High

Barchart
The S&P 500 Index ($SPX) (SPY) today is up +0.46%, the Dow Jones Industrial Average ($DOWI) (DIA) is up +0.74%, and the Nasdaq 100 Index ($IUXX) (QQQ) is up +0.51%.  September E-mini S&P futures (ESU26) are up +0.50%, and September E-mini Nasdaq futures (NQU26) are up +0.47%. Stock indices are edging higher today, with the S&P 500 and Dow Jones Industrials posting new all-time highs and the Nasdaq 100 posting a 1-month high.  Some positive corporate earnings results are supporting gains in stock indices today. Booking Holdings is up more than +7% after reporting better-than-expected Q2 gross bookings.  Also, Amgen is up more than +5% after reporting stronger-than-expected Q2 EPS. Jeff Bezos Says He’s Selling $1 Billion In Amazon Stock Every Year to Fund Blue Origin — ‘It’s The Most Important Work I’m Doing’ Apple’s New CEO Is Bringing a Familiar Face Back From Retirement. The Shift Is Happening. Nasdaq Futures Climb as Tech Rally Continues on Palantir Boost, U.S. JOLTS Report and SpaceX Earnings on Tap Tired of missing midday reversals? The FREE Barchart Brief newsletter keeps you in the know. Sign up now! On the negative side, SpaceX is down more than -10% after the company projected higher-than-expected spending on its AI business.  Also, Advanced Micro Devices is down more than -4% after the company’s third-quarter sales forecast underwhelmed investors expecting stronger performance amid healthy demand. Market sentiment also weakened after crude oil prices recovered from overnight losses and moved higher when Yemen’s Houthi militant group threatened to escalate attacks on Saudi vessels in the northern Red Sea. US MBA mortgage applications fell -2.9% in the week ended July 31, with the purchase mortgage sub-index down -3.6% and the refinancing mortgage sub-index down -1.9%.  The average 30-year fixed-rate mortgage rose +5 bp to a 1-year high of 6.81% from 6.76% in the prior week. The US July ADP employment change rose by +44,000, weaker than expectations of +65,000. Tuesday evening, Kansas City Fed President Jeff Schmid said, "Given the strength of demand and investment, I do not see the current stance of monetary policy as restrictive.  As such, I believe that bringing inflation down to the Fed's 2% objective will require tighter policy." Sep WTI crude oil prices (CLU26) rebounded from a 3-week low today and moved higher after a Houthi military spokespers…Read full document

The S&P 500 Index ($SPX) (SPY) today is up +0.46%, the Dow Jones Industrial Average ($DOWI) (DIA) is up +0.74%, and the Nasdaq 100 Index ($IUXX) (QQQ) is up +0.51%.  September E-mini S&P futures (ESU26) are up +0.50%, and September E-mini Nasdaq futures (NQU26) are up +0.47%. Stock indices are edging higher today, with the S&P 500 and Dow Jones Industrials posting new all-time highs and the Nasdaq 100 posting a 1-month high.  Some positive corporate earnings results are supporting gains in stock indices today. Booking Holdings is up more than +7% after reporting better-than-expected Q2 gross bookings.  Also, Amgen is up more than +5% after reporting stronger-than-expected Q2 EPS. Jeff Bezos Says He’s Selling $1 Billion In Amazon Stock Every Year to Fund Blue Origin — ‘It’s The Most Important Work I’m Doing’ Apple’s New CEO Is Bringing a Familiar Face Back From Retirement. The Shift Is Happening. Nasdaq Futures Climb as Tech Rally Continues on Palantir Boost, U.S. JOLTS Report and SpaceX Earnings on Tap Tired of missing midday reversals? The FREE Barchart Brief newsletter keeps you in the know. Sign up now! On the negative side, SpaceX is down more than -10% after the company projected higher-than-expected spending on its AI business.  Also, Advanced Micro Devices is down more than -4% after the company’s third-quarter sales forecast underwhelmed investors expecting stronger performance amid healthy demand. Market sentiment also weakened after crude oil prices recovered from overnight losses and moved higher when Yemen’s Houthi militant group threatened to escalate attacks on Saudi vessels in the northern Red Sea. US MBA mortgage applications fell -2.9% in the week ended July 31, with the purchase mortgage sub-index down -3.6% and the refinancing mortgage sub-index down -1.9%.  The average 30-year fixed-rate mortgage rose +5 bp to a 1-year high of 6.81% from 6.76% in the prior week. The US July ADP employment change rose by +44,000, weaker than expectations of +65,000. Tuesday evening, Kansas City Fed President Jeff Schmid said, "Given the strength of demand and investment, I do not see the current stance of monetary policy as restrictive.  As such, I believe that bringing inflation down to the Fed's 2% objective will require tighter policy." Sep WTI crude oil prices (CLU26) rebounded from a 3-week low today and moved higher after a Houthi military spokesperson said the group will escalate attacks on Saudi oil tankers in the northern Red Sea to prevent them from transiting the area.  However, gains in crude are limited after Axios reported that the US, Iran and Oman were nearing an interim agreement to reopen the Strait of Hormuz.  President Trump has threatened Iran with renewed air strikes and stressed that his latest offer of talks is Iran’s “last chance” as he demanded full reopening of the Strait of Hormuz.  A diplomatic resolution is hanging on talks between Oman and Iran to get more ships moving through the strait, but Iran continues to insist on its authority over the waterway. The outlook for strong Q2 earnings is a bullish factor for stocks. Forecasts compiled by Bloomberg Intelligence suggest Q2 earnings may increase by +23%, close to Q1’s blowout earnings of +30%, which was more than double the +12% analysts had expected. AI spending is expected to account for most of earnings, with AI infrastructure stocks set to contribute nearly 60% of the S&P 500's earnings-per-share growth in Q2.  So far, earnings results have been positive, with 86% of the 372 S&P 500 companies that have reported Q2 earnings beating estimates, according to Bloomberg data. The markets are discounting a 58% chance of a +25 bp rate hike at the next FOMC meeting on September 15-16. Overseas stock markets are higher today.  The Euro Stoxx 50 rose to a new all-time high and is up +0.15%.  China's Shanghai Composite climbed to a 2-week high and closed up +1.47%.  Japan's Nikkei-225 Stock Average rose to a 1.5-week high and closed up +3.66%. Interest Rates September 10-year T-notes (ZNU6) today are down +2 ticks.  The 10-year T-note yield is up +1.6 bp to 4.629%.  Sep T-notes fell from a 2-week high today and moved lower, and the 10-year T-note yield rebounded from a 1-week low of 4.592%.  Strength in stocks today has reduced safe-haven demand for government debt securities and is weighing on T-note prices.  Also, Tuesday evening’s hawkish comments from Kansas City Fed President Jeff Schmid weighed on T-notes when he said tighter Fed policy is needed to reduce inflation.  Losses in T-notes are limited after today’s July ADP employment report showed employers added fewer jobs than expected, a dovish factor for Fed policy. In supportive news for T-note prices, the Treasury today maintained the amount of government securities to be auctioned at next week’s quarterly refunding at $125 billion, unchanged from last quarter, and retained its previous guidance for future debt issuance, signaling no change in note and bond auction sizes well into 2027. European government bond yields are moving higher today.  The 10-year German bund yield rebounded from a 3-week low of 3.088% and is up +0.9 bp to 3.116%.  The 10-year UK gilt yield rebounded from a 3.5-week low of 4.878% and is up +0.9 bp to 4.905%. The Eurozone July S&P composite PMI was revised upward by +0.1 to 52.0 from the previously reported 51.9. Eurozone June PPI eased to 4.6% y/y from 5.9% y/y in May, right on expectations. Markets are discounting an 81% chance of a +25 bp ECB rate hike at its next policy meeting on September 10. US Stock Movers Mining stocks are climbing today with gold and silver prices rallying to 1-month highs and copper prices soaring to a 2-month high.  Anglogold Ashanti (AU) is up more than +8%, and Hecla Mining (HL) is up more than +7%.  Also, Newmont Corp (NEM) and Coeur Mining (CDE) are up more than +6%, and Barrick Mining (B) is up more than +5%.  In addition, Freeport McMoRan (FCX) is up more than +3%, and Southern Copper (SCCO) is up more than +2%. Shopify (SHOP) is up more than +16% to lead gainers in the Nasdaq 100 after reporting Q2 revenue of $3.58 billion, stronger than the consensus of $3.45 billion. Wynn Resorts Ltd (WYNN) is up more than +11% to lead gainers in the S&P 500 after reporting Q2 adjusted EPS of $1.24, better than the consensus of $1.15. Kratos (KTOS) is up more than +10% after raising its full-year revenue forecast to $1.75 billion to $1.81 billion from a previous estimate of $1.70 billion to $1.76 billion, better than the consensus of $1.74 billion. Everus Construction (ECG) is up more than +10% after raising its 2026 revenue estimate to $4.5 billion to $4.7 billion from a previous estimate of $4.3 billion to $4.4 billion. Booking Holdings (BKNG) is up more than +7% after reporting Q2 gross bookings of $51.00 billion, above the consensus of $49.68 billion. Amgen (AMGN) is up more than +5% to lead gainers in the Dow Jones Industrials after reporting Q2 adjusted EPS of $6.29, well above the consensus of $5.62. Compass (COMP) is up more than +5% after reporting Q2 revenue of $4.31 billion, above the consensus of $4.11 billion, and forecasting Q3 revenue of $3.85 billion to $4.05 billion, stronger than the consensus of $3.77 billion. Arista Networks (ANET) is up more than +2% after reporting Q2 revenue of $3.04 billion, well above the consensus of $2.83 billion, and forecasting Q3 revenue of $3.30 billion, better than the consensus of $2.95 billion. Insulet (PODD) is down more than -19% to lead losers in the S&P 500 after cutting its full-year revenue estimate on a constant currency basis to +20% to +2% from a previous estimate of +21% to +23%. DaVita (DVA) is down more than -17% after reporting Q2 dialysis revenue per treatment of $415.87, below the consensus of $417.16, and forecasting full-year adjusted operating income of $2.15 billion to $2.25 billion, the midpoint below the consensus of $2.23 billion. CDW (CDW) is down more than -16% after reporting a Q2 gross profit margin of 20.1%, below the consensus of 21%. SpaceX (SPCX) is down more than -10% to lead losers in the Nasdaq 100 after disclosing higher-than-expected spending on its artificial intelligence business, despite reporting better-than-expected Q2 earnings. Match Group (MTCH) is down more than -7% after reporting Q2 revenue of $853.1 million, below the consensus of $856.6 million, and forecasting Q3 revenue of $885 million to $895 million, the midpoint below the consensus of $891.2 million. Viasat (VSAT) is down more than -5% after reporting Q1 revenue of $1.16 billion, below the consensus of $1.20 billion. Advanced Micro Devices (AMD) is down more than -4% after its Q3 sales forecast underwhelmed investors expecting a stronger performance amid healthy demand. Earnings Reports (8/5/2026) Albemarle Corp (ALB), Allstate Corp/The (ALL), APA Corp (APA), AppLovin Corp (APP), Atmos Energy Corp (ATO), Axon Enterprise Inc (AXON), Block Inc (XYZ), CDW Corp/DE (CDW), Cencora Inc (COR), CF Industries Holdings Inc (CF), Charles River Laboratories International (CRL), Corpay Inc (CPAY), CVS Health Corp (CVS), DoorDash Inc (DASH), eBay Inc (EBAY), Eli Lilly & Co (LLY), Expedia Group Inc (EXPE), Global Payments Inc (GPN), Honeywell Aerospace Inc (HONA), Host Hotels & Resorts Inc (HST), Insulet Corp (PODD), Iron Mountain Inc (IRM), Kraft Heinz Co/The (KHC), McKesson Corp (MCK), MetLife Inc (MET), Motorola Solutions Inc (MSI), News Corp (NWSA), NiSource Inc (NI), Occidental Petroleum Corp (OXY), Phillips 66 (PSX), Realty Income Corp (O), Sandisk Corp (SNDK), Solventum Corp (SOLV), STERIS PLC (STE), Texas Pacific Land Corp (TPL), Uber Technologies Inc (UBER), Walt Disney Co/The (DIS), Western Digital Corp (WDC), Zimmer Biomet Holdings Inc (ZBH). On the date of publication, Rich Asplund did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Barchart.com

Investor releaseQuarter not tagged2026-08-05

Amgen gains after strong quarterly results and continued product momentum

Proactive

Amgen Inc (NASDAQ:AMGN, XETRA:AMG) shares rose about 4% on Wednesday after the biotechnology company reported second quarter 2026 results that topped Wall Street expectations, supported by higher revenue and growth across its portfolio of medicines. The company reported adjusted earnings per share of $6.29 for the quarter, ahead of analyst estimates of roughly $5.60 to $5.62. Revenue reached $10.05 billion, exceeding consensus expectations of about $9.40 billion. Amgen reported total revenue increased 10% year over year to $10.1 billion, while product sales rose 9%, driven by higher volumes. The company said 22 products delivered double-digit sales growth during the quarter, with 17 products now generating annualized sales of more than $1 billion based on second-quarter performance. GAAP earnings per share increased to $4.37 from $2.65 a year earlier, while GAAP operating income rose to $3.5 billion from $2.7 billion. The company reported a GAAP operating margin of 36.8%, up 6.5 percentage points from the prior-year period. On an adjusted basis, operating income increased to $4.6 billion from $4.3 billion, while adjusted operating margin was 48.4%, down slightly from 48.9% a year earlier. Amgen reported free cash flow of $3.5 billion for the quarter, compared with $1.9 billion in the same period last year. “Our results demonstrate strong performance across our business. Our six key growth drivers grew 26% year over year, generating nearly 70% of second-quarter product sales,” Amgen CEO Robert Bradway said. “As we expand the potential of our existing medicines through new indications and advance the next wave of pipeline molecules through Phase 3, we remain confident in our ability to deliver growth well into the next decade.”

Investor releaseQuarter not tagged2026-08-05

AMGN Q2 Earnings Call Centers on Raised Outlook and Pipeline

Zacks
Amgen Inc. AMGN used its second-quarter 2026 earnings call to emphasize that broad product growth is funding a heavier late-stage pipeline push while biosimilars pressure older franchises. Management raised full-year guidance, and analyst questions centered on MariTide dosing, Olpasiran trial design, Repatha competition and the path to wider use of IMDELLTRA. AMGN reported non-GAAP earnings of $6.29 per share, above the Zacks Consensus Estimate of $5.60. Revenue of $10.05 billion also surpassed the $9.44 billion estimate. Amgen Inc. price-consensus-eps-surprise-chart | Amgen Inc. Quote Executive vice president and CFO Peter Griffith raised 2026 revenue guidance to $38.2 billion-$39.4 billion and non-GAAP earnings guidance to $22.30-$23.50 per share. Griffith said non-GAAP R&D spending should grow by a high-single-digit percentage. A $100 million business-development payment and incremental investments will lift third-quarter operating expenses sequentially. Amgen maintained a 45-46% non-GAAP operating-margin outlook and approximately $2.6 billion in capital spending. Chairman and CEO Robert Bradway said six key growth drivers grew 26% year over year and generated nearly 70% of second-quarter product sales. Executive vice president of Global Markets and Policy Murdo Gordon highlighted growth of 37% for Repatha, 38% for EVENITY and 42% for TEZSPIRE. Rare Disease, Innovative Oncology and biosimilars grew 21%, 18% and 29%, respectively. The portfolio also showed the cost of competition. Gordon said combined Prolia and XGEVA sales fell 33% as biosimilars launched, a decline management characterized as consistent with expectations. Executive vice president of Research & Development, Artificial Intelligence and Data James Bradner said MariTide has nine ongoing and three planned Phase 3 studies across obesity and related diseases. The program uses a three-step escalation to reach the target dose within two months, followed by monthly treatment. Maintenance studies are evaluating schedules requiring as few as four or six doses annually. A Leerink Partners analyst questioned the durability of MariTide's dual mechanism. Bradner said the intact molecule has an approximately 21-day half-life and retains both GLP-1 agonism and GIP receptor antagonism. In response to Evercore ISI on vomiting rates, he reiterated confidence without giving a forecast. A UBS analyst pressed m…Read full document

Amgen Inc. AMGN used its second-quarter 2026 earnings call to emphasize that broad product growth is funding a heavier late-stage pipeline push while biosimilars pressure older franchises. Management raised full-year guidance, and analyst questions centered on MariTide dosing, Olpasiran trial design, Repatha competition and the path to wider use of IMDELLTRA. AMGN reported non-GAAP earnings of $6.29 per share, above the Zacks Consensus Estimate of $5.60. Revenue of $10.05 billion also surpassed the $9.44 billion estimate. Amgen Inc. price-consensus-eps-surprise-chart | Amgen Inc. Quote Executive vice president and CFO Peter Griffith raised 2026 revenue guidance to $38.2 billion-$39.4 billion and non-GAAP earnings guidance to $22.30-$23.50 per share. Griffith said non-GAAP R&D spending should grow by a high-single-digit percentage. A $100 million business-development payment and incremental investments will lift third-quarter operating expenses sequentially. Amgen maintained a 45-46% non-GAAP operating-margin outlook and approximately $2.6 billion in capital spending. Chairman and CEO Robert Bradway said six key growth drivers grew 26% year over year and generated nearly 70% of second-quarter product sales. Executive vice president of Global Markets and Policy Murdo Gordon highlighted growth of 37% for Repatha, 38% for EVENITY and 42% for TEZSPIRE. Rare Disease, Innovative Oncology and biosimilars grew 21%, 18% and 29%, respectively. The portfolio also showed the cost of competition. Gordon said combined Prolia and XGEVA sales fell 33% as biosimilars launched, a decline management characterized as consistent with expectations. Executive vice president of Research & Development, Artificial Intelligence and Data James Bradner said MariTide has nine ongoing and three planned Phase 3 studies across obesity and related diseases. The program uses a three-step escalation to reach the target dose within two months, followed by monthly treatment. Maintenance studies are evaluating schedules requiring as few as four or six doses annually. A Leerink Partners analyst questioned the durability of MariTide's dual mechanism. Bradner said the intact molecule has an approximately 21-day half-life and retains both GLP-1 agonism and GIP receptor antagonism. In response to Evercore ISI on vomiting rates, he reiterated confidence without giving a forecast. A UBS analyst pressed management on Olpasiran's Phase 3 design. Bradner said OCEAN(a) enrolled 7,297 patients with Lp(a) above 200 nanomoles per liter and uses three-point MACE as the primary endpoint. He said Amgen's modeling showed that excluding stroke should not reduce the event rate. A JPMorgan analyst also asked about competitor data, and Bradner argued that Olpasiran's greater than 95% Lp(a) reduction and study design limit direct read-throughs. On Repatha, Gordon told a Wells Fargo analyst that roughly half of prescription growth came from existing cardiologists treating more patients, while the other half came from broader primary-care adoption, particularly among high-risk patients with diabetes. Gordon said IMDELLTRA sales rose 115% to $288 million, with more than 2,000 U.S. accounts operationally ready to use the therapy. Asked by Wolfe Research about monitoring requirements, Bradner said clinical and real-world experience now extends to one or two hours in some settings compared with 16 hours in the second-line Phase 3 study. Amgen plans further prospective work and regulatory engagement. In rare disease, Bradner pointed to two Phase 3 dazodalibep studies in systemic and symptomatic Sjögren's disease, with results expected in the second half of 2026. Gordon said the programs use distinct endpoints tailored to the two patient populations. A Goldman Sachs analyst asked whether business development depends on upcoming MariTide and Olpasiran readouts. Bradway said the strategy remains focused on four therapeutic areas and primarily on smaller, earlier-stage assets. Management's posture combined higher internal investment with selective external innovation. Bradway stressed growth through patent expirations, while executive vice president and CFO Peter Griffith tied current spending to longer-term portfolio and manufacturing needs. AMGN currently carries a Zacks Rank #3 (Hold), which indicates a Hold rating in the Rank framework rather than the stronger near-term signal assigned to Zacks Rank #1 or #2 stocks. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Its Value, Growth, Momentum and VGM Scores are all C, placing each measure in the middle of the A-to-F scale. Because Style Scores complement the Zacks Rank, this combination lacks the stronger alignment of top ranks with A or B scores. The Zacks Rank can change as analysts revise estimates after the just-reported results. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amgen Inc. (AMGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As of 2026-09-05 • Updated weeklySource: Earnings sourceIngestion runbook