Track market-moving stories before they get noisy

Key Takeaways Amgen is testing MariTide across obesity, diabetes and obesity-related conditions in phase III.MariTide delivered up to 20% average weight loss at 52 weeks without a plateau in phase II.Its once-monthly or less-frequent dosing could offer a niche based on convenience and adherence. Amgen’s (AMGN - Free Report) key pipeline candidate MariTide is a closely watched drug in the obesity market. The drug can give Amgen exposure to one of the industry's fastest-growing therapeutic markets at a time when the company is looking for new growth drivers.

Unlike the current leaders, Wegovy (semaglutide) from Novo Nordisk (NVO - Free Report) and Zepbound (tirzepatide) from Eli Lilly (LLY - Free Report) , MariTide combines GLP-1 receptor activation with GIP receptor blockade and, importantly, is designed for once-monthly or potentially even less-frequent dosing, which may help reduce treatment burden and improve persistence on treatment over time. Wegovy and Zepbound are both weekly injections.

Amgen is evaluating MariTide in type II diabetes, obesity and obesity-related conditions as part of its comprehensive MARITIME phase III program. Amgen has nine global phase III studies underway with MariTide in obesity and other obesity-related conditions like obstructive sleep apnea, cardiovascular disease and heart failure. Three phase III studies of MariTide in type II diabetes will be initiated later this year.

In phase II studies, MariTide resulted in up to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau in people who were obese or overweight but without type II diabetes. In patients with type II diabetes who were obese or overweight, the weight loss reduction was approximately 17% at 52 weeks.

An interesting study is a new phase III switch study that will assess patients transitioning from weekly tirzepatide or semaglutide therapy to MariTide administered once every eight weeks or once every 12 weeks. In other words, the study will evaluate switching from Zepbound and Wegovy injections given 52 times a year to a medicine that can be injected four or six times a year. Meanwhile, Amgen’s 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 four or six doses per year.

Can AMGN’s MariTide Carve Out a Niche in the Obesity Market?With MariTide, Amgen is entering a market that is heavily dominated by Lilly and Novo Nordisk. LLY and NVO already enjoy enormous commercial scale and brand recognition in the obesity space.

Moreover, to maintain their prowess in the lucrative obesity market, both Novo Nordisk and Lilly are developing several next-generation, more powerful and more convenient GLP-1-based treatments, including oral options and multi-acting candidates. Lilly and Novo Nordisk have also launched oral GLP-1 pills for obesity called Foundayo and Wegovy pill, respectively.

Lilly's next-generation candidate, retatrutide, a GLP-1/GIP/glucagon triple agonist, has demonstrated approximately 28% weight loss in a phase III study, significantly above MariTide's approximately 20%. Lilly plans to submit the treatment to the FDA in the first quarter of 2027.

Amgen currently trails Lilly and Novo Nordisk by several years in the obesity space. However, the obesity market is huge and can support multiple players based on different patient needs, and even a mid-single-digit market share could translate into billions of dollars in annual revenues. The global obesity drug market is projected to grow dramatically, reaching nearly $114 billion by 2030, according to Goldman Sachs estimates.

MariTide’s less frequent dosing is its biggest competitive advantage, and, if successfully developed and launched, MariTide could carve out a meaningful position around convenience, adherence and durability and does not necessarily need to dethrone Zepbound or Wegovy or the new oral pills to become a blockbuster product.

Competition Heating Up in the Obesity SpaceWhile Lilly and Novo Nordisk currently dominate this space, smaller biotechs like Structure Therapeutics and Viking Therapeutics are also developing oral GLP-1 drugs for treating obesity.

Others, such as Roche, Merck, AbbVie, AstraZeneca and Pfizer (PFE - Free Report) , have strengthened their obesity pipelines through licensing deals and acquisitions involving smaller biotechs.

Pfizer’s key obesity candidate is berobenatide (MET-097i), a long-acting GLP-1 receptor agonist, added from last year’s Metsera acquisition. Berobenatide, which is in a late stage of development, is designed for monthly maintenance dosing.

AbbVie entered the obesity field by licensing GUB014295 (now ABBV-295), a long-acting amylin analog, from Gubra in 2025. Roche strengthened its obesity presence through the acquisition of Carmot Therapeutics and its obesity assets, such as enicepatide (previously CT-388), as well as the exclusive collaboration with Zealand Pharma, which added petrelintide, a long-acting amylin analog.

AstraZeneca’s most important obesity candidate is oral GLP-1 receptor agonist elecoglipron, which it licensed from Eccogene in 2023 and is now in phase III.

AMGN’s Price Performance, Valuation and EstimatesAmgen’s stock has risen 35.7% so far this year compared with an increase of 15.6% for the industry.

Image Source: Zacks Investment Research

From a valuation standpoint, Amgen is reasonably priced. Going by the price/earnings ratio, the company’s shares currently trade at 18.59 forward earnings, which is lower than 18.95 for the industry. The stock is also trading above its five-year mean of 13.87.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for earnings has risen from $22.29 per share to $22.97 per share for 2026 over the past 30 days. For 2027, the consensus mark for earnings has risen from $23.64 per share to $24.39 per share over the same timeframe.

Image Source: Zacks Investment Research

Amgen has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Jim Cramer is flagging an Amgen drug that Wall Street has largely ignored, and he thinks the cardiovascular opportunity behind it could rival the most valuable pharmaceutical market ever created.

Jim Cramer used his August 31 CNBC Stop Trading segment to argue that Amgen (NASDAQ:AMGN | AMGN Price Prediction) has rallied in 2026 due to a catalyst Wall Street had overlooked:

“People are talking about the incredible movement in Amgen, which is up about 31% this year. And a lot of it has to do with a particular drug that people aren’t talking about, which is Repatha.“

Amgen recently pushed to a new 52-week high of $447.03, and the company has a market cap of roughly $233 billion.

Cramer Says Repatha Is the Catalyst Investors Are Missing Jim Cramer described Repatha as “A shot that you take every other week, and what it does is reduce the risk of death by 20% in people who have high risk for a heart attack or stroke.” Cramer also said the drug “works against diabetes and high cholesterol.”

Cramer noted how cardiologists are increasingly pushing LDL cholesterol as low as possible, an evolving practice pattern that, in his view, expands the pool of patients who could be candidates for intensified lipid-lowering therapy over time. He paired that with a commercial caveat: “This Repatha is so revolutionary, but it was hard. You had to fight the insurance companies.” Efficacy and reimbursement are separate issues, and payer resistance can gate the revenue ramp-up.

Repatha Sales Jumped 37% to $953 Million On Amgen’s Q2 2026 earnings call held August 4, CEO Robert A. Bradway said, “Starting with general medicine, Repatha delivered $953 million in second-quarter sales, growing 37% year over year.” Management flagged that U.S. new-to-brand prescriptions are growing more than 50% year over year, split roughly evenly between expanded cardiologist use and adoption by primary-care physicians treating high-risk primary-prevention patients.

Repatha is one of six growth drivers that grew 26% in aggregate and represented nearly 70% of second-quarter product sales. Amgen raised full-year guidance to $38.2-$39.4 billion in revenue and non-GAAP EPS of $22.30 to $23.50. On August 31, Amgen published fresh cardiovascular data from the ESC Congress 2026 tied to Repatha’s primary-prevention profile, the same day Cramer’s segment aired.

Why Cramer Is Comparing the Opportunity to Eli Lilly Cramer said Repatha could be the biggest opportunity behind what Eli Lilly (NYSE:LLY) is targeting with its GLP-1: “That’s going to be the biggest market of all time, with the exception of what Eli Lilly has tapped into.” On August 27, in the Am I Diversified segment, Cramer called Lilly “the trillion dollar drug company that I like so much.”

Lilly carries a market cap around $1.05 trillion and trades at a forward P/E of 32, versus Amgen’s forward P/E of 19. Lilly shares are up 9.83% year to date after a 6.44% pullback in the past week.

Key Takeaways Repatha is becoming a big piece of Amgen’s story. With quarterly sales approaching $1 billion and growing 37% annually, the drug is becoming a meaningful growth engine for the company. Cramer argues that investors may still be underestimating how large that cardiovascular opportunity can become.

Contact [email protected] for any questions or corrections.

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

, /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 

CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity 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 Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage
Do 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) Infection
It 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. SOURCE Amgen

Blue Edge Capital LLC purchased a new stake in Amgen Inc. (NASDAQ:AMGN – Free Report) during the second quarter, according to its most recent filing with the Securities & Exchange Commission. The institutional investor purchased 1,714 shares of the medical research company’s stock, valued at approximately $621,000.

Several other hedge funds have also recently bought and sold shares of the stock. Adell Harriman & Carpenter Inc. boosted its position in shares of Amgen by 7.9% during the fourth quarter. Adell Harriman & Carpenter Inc. now owns 22,008 shares of the medical research company’s stock worth $7,204,000 after purchasing an additional 1,609 shares in the last quarter. Fideuram Intesa Sanpaolo Private Banking S.P.A. acquired a new position in shares of Amgen in the 4th quarter valued at $22,441,000. Sigma Planning Corp increased its position in shares of Amgen by 24.0% in the 4th quarter. Sigma Planning Corp now owns 17,992 shares of the medical research company’s stock valued at $5,889,000 after buying an additional 3,488 shares in the last quarter. National Pension Service increased its position in shares of Amgen by 4.7% in the 4th quarter. National Pension Service now owns 1,239,549 shares of the medical research company’s stock valued at $405,717,000 after buying an additional 55,489 shares in the last quarter. Finally, Integrated Advisors Network LLC raised its stake in Amgen by 50.5% during the 1st quarter. Integrated Advisors Network LLC now owns 18,941 shares of the medical research company’s stock worth $6,664,000 after buying an additional 6,356 shares during the period. 76.50% of the stock is currently owned by institutional investors and hedge funds.

Wall Street Analyst Weigh In Several research firms have weighed in on AMGN. Royal Bank Of Canada lifted their target price on Amgen from $370.00 to $400.00 and gave the stock an “outperform” rating in a report on Wednesday, August 5th. Morgan Stanley reaffirmed an “overweight” rating and set a $362.00 price target on shares of Amgen in a research report on Wednesday, August 19th. Erste Group Bank reiterated a “hold” rating on shares of Amgen in a report on Tuesday, May 5th. TD Cowen boosted their price objective on Amgen from $420.00 to $452.00 and gave the company a “buy” rating in a research report on Wednesday, August 5th. Finally, Truist Financial increased their target price on Amgen from $340.00 to $362.00 and gave the stock a “hold” rating in a research note on Wednesday, August 5th. One analyst has rated the stock with a Strong Buy rating, thirteen have given a Buy rating, fourteen have given a Hold rating and three have assigned a Sell rating to the stock. According to MarketBeat, Amgen presently has a consensus rating of “Hold” and a consensus price target of $380.43.

Read Our Latest Research Report on AMGN Insider Transactions at Amgen In other news, SVP Nancy A. Grygiel sold 2,970 shares of the firm’s stock in a transaction dated Thursday, August 6th. The stock was sold at an average price of $402.16, for a total value of $1,194,415.20. Following the completion of the transaction, the senior vice president owned 7,340 shares in the company, valued at $2,951,854.40. This trade represents a 28.81% decrease in their position. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is available at the SEC website. Also, SVP Rachna Khosla sold 2,000 shares of Amgen stock in a transaction dated Tuesday, August 11th. The shares were sold at an average price of $412.57, for a total value of $825,140.00. Following the completion of the sale, the senior vice president directly owned 6,404 shares in the company, valued at approximately $2,642,098.28. This represents a 23.80% decrease in their position. The SEC filing for this sale provides additional information. Over the last 90 days, insiders have sold 6,222 shares of company stock valued at $2,540,926. Company insiders own 0.85% of the company’s stock.

Key Headlines Impacting Amgen Here are the key news stories impacting Amgen this week:

Positive Sentiment: Tezspire posted strong Phase 3 results in eosinophilic esophagitis (EoE). The drug met both co-primary and all key secondary endpoints, producing statistically significant and clinically meaningful improvements in tissue inflammation and difficulty swallowing. Benefits were sustained through 52 weeks, supporting a potential third approved indication beyond asthma and chronic rhinosinusitis with nasal polyps. Tezspire Phase 3 results Positive Sentiment: The EoE opportunity could materially expand Tezspire’s commercial potential. Analysts and industry commentators view EoE as a possible blockbuster market, potentially allowing Amgen and partner AstraZeneca to compete more directly with established biologics such as Dupixent. Regulatory filing and approval remain necessary before the opportunity can translate into revenue. Tezspire EoE market opportunity Neutral Sentiment: Amgen began a Phase 1 study of AMG 691 aimed at a potentially important Asian market. The trial could add a long-term growth asset, but it is at an early stage and provides limited near-term earnings visibility. AMG 691 Phase 1 trial Negative Sentiment: Amgen ended its Crohn’s disease research collaboration with TScan Therapeutics. The decision removes an exclusive effort to identify and develop T-cell targets in inflammatory bowel disease, narrowing one element of Amgen’s early pipeline and highlighting uncertainty around its partnership strategy. Amgen ends Crohn’s disease partnership Amgen Price Performance NASDAQ AMGN opened at $436.99 on Friday. The company has a quick ratio of 1.13, a current ratio of 1.37 and a debt-to-equity ratio of 4.44. Amgen Inc. has a 12-month low of $269.77 and a 12-month high of $447.03. The company has a market capitalization of $236.25 billion, a PE ratio of 27.16, a price-to-earnings-growth ratio of 3.18 and a beta of 0.41. The firm’s 50 day moving average is $386.75 and its 200-day moving average is $364.23.

Amgen (NASDAQ:AMGN – Get Free Report) last announced its earnings results on Tuesday, August 4th. The medical research company reported $6.29 EPS for the quarter, topping the consensus estimate of $5.62 by $0.67. The business had revenue of $10.05 billion during the quarter, compared to analysts’ expectations of $9.43 billion. Amgen had a net margin of 22.95% and a return on equity of 124.14%. The firm’s revenue was up 9.5% on a year-over-year basis. During the same quarter in the prior year, the company posted $6.02 earnings per share. Amgen has set its FY 2026 guidance at 22.300-23.500 EPS. Equities research analysts anticipate that Amgen Inc. will post 22.92 earnings per share for the current fiscal year.

Amgen Dividend Announcement The firm also recently disclosed a quarterly dividend, which will be paid on Friday, September 11th. Stockholders of record on Friday, August 21st will be paid a dividend of $2.52 per share. This represents a $10.08 dividend on an annualized basis and a dividend yield of 2.3%. The ex-dividend date is Friday, August 21st. Amgen’s dividend payout ratio is currently 62.65%.

Amgen Profile (Free Report)

Amgen Inc (NASDAQ: AMGN) is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen’s work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.

Amgen’s commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.

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Allstate Corp reduced its holdings in shares of Amgen Inc. (NASDAQ:AMGN – Free Report) by 6.7% during the 2nd quarter, according to its most recent 13F filing with the SEC. The fund owned 52,252 shares of the medical research company’s stock after selling 3,763 shares during the period. Allstate Corp’s holdings in Amgen were worth $18,921,000 as of its most recent filing with the SEC.

Other institutional investors also recently bought and sold shares of the company. Dogwood Wealth Management LLC boosted its holdings in shares of Amgen by 275.0% in the fourth quarter. Dogwood Wealth Management LLC now owns 75 shares of the medical research company’s stock valued at $25,000 after acquiring an additional 55 shares in the last quarter. Anfield Capital Management LLC raised its stake in shares of Amgen by 1,000.0% during the 4th quarter. Anfield Capital Management LLC now owns 77 shares of the medical research company’s stock worth $25,000 after buying an additional 70 shares in the last quarter. Tower View Wealth Management LLC lifted its holdings in shares of Amgen by 331.6% in the 1st quarter. Tower View Wealth Management LLC now owns 82 shares of the medical research company’s stock valued at $29,000 after buying an additional 63 shares during the period. Manning & Napier Advisors LLC lifted its holdings in shares of Amgen by 49.2% in the 4th quarter. Manning & Napier Advisors LLC now owns 97 shares of the medical research company’s stock valued at $32,000 after buying an additional 32 shares during the period. Finally, Ares Financial Consulting LLC purchased a new stake in shares of Amgen in the fourth quarter valued at approximately $34,000. 76.50% of the stock is currently owned by institutional investors and hedge funds.

Amgen Stock Performance NASDAQ AMGN opened at $439.33 on Monday. Amgen Inc. has a 1-year low of $269.77 and a 1-year high of $443.20. The company has a market capitalization of $237.51 billion, a P/E ratio of 27.30, a PEG ratio of 3.17 and a beta of 0.41. The business has a 50 day moving average price of $379.03 and a 200 day moving average price of $362.07. The company has a debt-to-equity ratio of 4.44, a current ratio of 1.37 and a quick ratio of 1.13.

Amgen (NASDAQ:AMGN – Get Free Report) last issued its quarterly earnings data on Tuesday, August 4th. The medical research company reported $6.29 earnings per share (EPS) for the quarter, topping the consensus estimate of $5.62 by $0.67. Amgen had a return on equity of 124.14% and a net margin of 22.95%.The firm had revenue of $10.05 billion during the quarter, compared to analysts’ expectations of $9.43 billion. During the same period in the previous year, the firm posted $6.02 earnings per share. Amgen’s revenue was up 9.5% on a year-over-year basis. Amgen has set its FY 2026 guidance at 22.300-23.500 EPS. Sell-side analysts expect that Amgen Inc. will post 22.92 EPS for the current fiscal year. Amgen Announces Dividend The firm also recently disclosed a quarterly dividend, which will be paid on Friday, September 11th. Investors of record on Friday, August 21st will be given a $2.52 dividend. The ex-dividend date is Friday, August 21st. This represents a $10.08 annualized dividend and a dividend yield of 2.3%. Amgen’s payout ratio is currently 62.65%.

Insider Transactions at Amgen In other Amgen news, SVP Nancy A. Grygiel sold 2,970 shares of Amgen stock in a transaction dated Thursday, August 6th. The shares were sold at an average price of $402.16, for a total transaction of $1,194,415.20. Following the completion of the transaction, the senior vice president owned 7,340 shares in the company, valued at approximately $2,951,854.40. The trade was a 28.81% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the SEC, which is accessible through this link. Also, SVP Rachna Khosla sold 1,252 shares of the company’s stock in a transaction dated Thursday, August 13th. The shares were sold at an average price of $416.43, for a total transaction of $521,370.36. Following the completion of the sale, the senior vice president directly owned 6,404 shares in the company, valued at $2,666,817.72. This trade represents a 16.35% decrease in their position. The SEC filing for this sale provides additional information. Over the last three months, insiders sold 6,222 shares of company stock worth $2,540,926. 0.85% of the stock is owned by corporate insiders.

Analyst Upgrades and Downgrades A number of research analysts recently weighed in on AMGN shares. Wells Fargo & Company upped their price objective on Amgen from $390.00 to $400.00 and gave the stock an “equal weight” rating in a report on Wednesday, August 5th. Sanford C. Bernstein raised their target price on Amgen from $335.00 to $345.00 and gave the company a “market perform” rating in a report on Thursday, August 6th. Cantor Fitzgerald boosted their target price on shares of Amgen from $350.00 to $400.00 and gave the stock a “neutral” rating in a research report on Tuesday, August 18th. TD Cowen upped their price target on shares of Amgen from $420.00 to $452.00 and gave the stock a “buy” rating in a research note on Wednesday, August 5th. Finally, Bank of America increased their price target on shares of Amgen from $312.00 to $317.00 and gave the company an “underperform” rating in a report on Wednesday, August 5th. One equities research analyst has rated the stock with a Strong Buy rating, thirteen have issued a Buy rating, fourteen have issued a Hold rating and three have assigned a Sell rating to the stock. According to MarketBeat.com, the stock currently has a consensus rating of “Hold” and an average target price of $380.43.

Check Out Our Latest Stock Analysis on Amgen

Key Amgen News Here are the key news stories impacting Amgen this week:

Positive Sentiment: Solid operating performance and dividend support the valuation. Amgen’s second-quarter results exceeded expectations, with revenue rising year over year and earnings per share topping consensus. Continued growth and the company’s dividend are helping support investor confidence. Amgen stock holds close to record high as Q2 2026 growth and dividend support valuation Positive Sentiment: Analysts raised their outlook. Argus increased its price target to $460 from $375 while maintaining a Buy rating, citing the latest quarterly performance and progress across Amgen’s drug portfolio. Separate reports also highlighted favorable forecasts from Mizuho and Cantor Fitzgerald, reinforcing the bullish analyst sentiment. Amgen gets a fresh target Positive Sentiment: Tarlatamab development advanced. Amgen’s Phase 3 DeLLphi-315 study is evaluating a subcutaneous injection of tarlatamab against the current intravenous infusion approach in lung cancer. A successful shot formulation could improve convenience and broaden the commercial potential of the drug. Amgen advances tarlatamab shot versus infusion in Phase 3 lung cancer study Positive Sentiment: Trading momentum and options activity were unusually strong. Amgen was identified as a momentum stock after a substantial recent share-price rally, while call-option volume surged well above typical levels, suggesting increased bullish positioning. Neutral Sentiment: Valuation is becoming a consideration. With the stock near its recent high and analysts raising targets, some commentary questioned whether much of the favorable news is already reflected in the share price, which could limit near-term upside. Amgen Company Profile (Free Report)

Amgen Inc (NASDAQ: AMGN) is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen’s work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.

Amgen’s commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.

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Alpine Woods Capital Investors LLC lifted its position in shares of Amgen Inc. (NASDAQ:AMGN – Free Report) by 8.5% during the second quarter, according to the company in its most recent filing with the SEC. The institutional investor owned 25,029 shares of the medical research company’s stock after buying an additional 1,965 shares during the quarter. Amgen makes up 2.0% of Alpine Woods Capital Investors LLC’s holdings, making the stock its 8th largest holding. Alpine Woods Capital Investors LLC’s holdings in Amgen were worth $9,064,000 at the end of the most recent quarter.

A number of other institutional investors have also bought and sold shares of AMGN. Anfield Capital Management LLC lifted its position in shares of Amgen by 1,000.0% in the fourth quarter. Anfield Capital Management LLC now owns 77 shares of the medical research company’s stock valued at $25,000 after acquiring an additional 70 shares in the last quarter. Dogwood Wealth Management LLC raised its stake in Amgen by 275.0% during the 4th quarter. Dogwood Wealth Management LLC now owns 75 shares of the medical research company’s stock valued at $25,000 after purchasing an additional 55 shares during the period. Tower View Wealth Management LLC lifted its holdings in Amgen by 331.6% in the 1st quarter. Tower View Wealth Management LLC now owns 82 shares of the medical research company’s stock worth $29,000 after purchasing an additional 63 shares in the last quarter. Manning & Napier Advisors LLC lifted its holdings in Amgen by 49.2% in the 4th quarter. Manning & Napier Advisors LLC now owns 97 shares of the medical research company’s stock worth $32,000 after purchasing an additional 32 shares in the last quarter. Finally, Ares Financial Consulting LLC bought a new position in Amgen in the 4th quarter worth approximately $34,000. Hedge funds and other institutional investors own 76.50% of the company’s stock.

Amgen News Roundup Here are the key news stories impacting Amgen this week:

Positive Sentiment: Amgen was highlighted as one of the best-performing U.S. large-cap drugmakers in 2026, outperforming peers Merck and Pfizer despite lacking an obesity drug. The comparison reinforces investor confidence in Amgen’s existing portfolio and operating execution. Which Drugmaker Stock Has Dominated in 2026: Merck, Pfizer, or Amgen? Positive Sentiment: Healthcare-sector strength and a rotation toward profitable drugmakers helped lift Amgen, while renewed enthusiasm for biotechnology also improved sentiment across the industry. Amgen Stock Surges as Healthcare Hits Record High Positive Sentiment: Argus raised its Amgen price target from $375 to $460 and maintained a “buy” rating, citing additional upside for the shares. Argus price-target update Neutral Sentiment: Amgen’s latest quarterly results beat consensus estimates for earnings and revenue, with revenue growth accelerating year over year. Full-year earnings guidance and expectations for continued growth remain important supports for the investment case. Neutral Sentiment: The obesity-drug market is becoming more selective, and Amgen is reportedly trimming some early-stage efforts. This could improve capital discipline, but it also highlights execution risk as the company competes in a crowded field. Obesity investing’s way forward, mapped Negative Sentiment: Although Cantor Fitzgerald and Mizuho raised their price targets, both retained “neutral” ratings and set targets below the current trading level, signaling valuation concerns after Amgen’s strong run. Analyst price-target updates Wall Street Analysts Forecast Growth A number of brokerages have issued reports on AMGN. Daiwa Securities Group cut their price objective on shares of Amgen from $410.00 to $390.00 and set an “outperform” rating for the company in a report on Wednesday, May 13th. Argus upped their target price on shares of Amgen from $375.00 to $460.00 and gave the stock a “buy” rating in a research report on Wednesday. Oppenheimer raised their target price on shares of Amgen from $400.00 to $450.00 and gave the company an “outperform” rating in a research note on Wednesday, August 5th. Wells Fargo & Company lifted their price target on shares of Amgen from $390.00 to $400.00 and gave the company an “equal weight” rating in a report on Wednesday, August 5th. Finally, Canaccord Genuity Group boosted their price target on shares of Amgen from $366.00 to $384.00 and gave the stock a “hold” rating in a research note on Wednesday, August 5th. One investment analyst has rated the stock with a Strong Buy rating, thirteen have issued a Buy rating, fourteen have assigned a Hold rating and three have assigned a Sell rating to the stock. According to data from MarketBeat.com, Amgen currently has an average rating of “Hold” and an average target price of $379.36. View Our Latest Stock Analysis on Amgen

Amgen Price Performance Amgen stock opened at $442.36 on Thursday. Amgen Inc. has a 52-week low of $269.77 and a 52-week high of $443.20. The company has a quick ratio of 1.13, a current ratio of 1.37 and a debt-to-equity ratio of 4.44. The firm’s fifty day moving average is $375.75 and its 200 day moving average is $360.76. The company has a market cap of $239.15 billion, a price-to-earnings ratio of 27.49, a PEG ratio of 3.95 and a beta of 0.41.

Amgen (NASDAQ:AMGN – Get Free Report) last issued its quarterly earnings data on Tuesday, August 4th. The medical research company reported $6.29 EPS for the quarter, topping analysts’ consensus estimates of $5.62 by $0.67. Amgen had a net margin of 22.95% and a return on equity of 124.14%. The business had revenue of $10.05 billion during the quarter, compared to analysts’ expectations of $9.43 billion. During the same period last year, the company posted $6.02 EPS. The business’s revenue was up 9.5% on a year-over-year basis. Amgen has set its FY 2026 guidance at 22.300-23.500 EPS. Sell-side analysts forecast that Amgen Inc. will post 22.78 EPS for the current fiscal year.

Amgen Announces Dividend The business also recently disclosed a quarterly dividend, which will be paid on Friday, September 11th. Shareholders of record on Friday, August 21st will be paid a dividend of $2.52 per share. This represents a $10.08 annualized dividend and a yield of 2.3%. The ex-dividend date of this dividend is Friday, August 21st. Amgen’s payout ratio is presently 62.65%.

Insider Buying and Selling In other news, SVP Nancy A. Grygiel sold 2,970 shares of the business’s stock in a transaction that occurred on Thursday, August 6th. The stock was sold at an average price of $402.16, for a total transaction of $1,194,415.20. Following the transaction, the senior vice president owned 7,340 shares of the company’s stock, valued at approximately $2,951,854.40. The trade was a 28.81% decrease in their position. The transaction was disclosed in a document filed with the SEC, which can be accessed through the SEC website. Also, SVP Rachna Khosla sold 1,252 shares of the stock in a transaction on Thursday, August 13th. The shares were sold at an average price of $416.43, for a total value of $521,370.36. Following the sale, the senior vice president owned 6,404 shares in the company, valued at $2,666,817.72. The trade was a 16.35% decrease in their position. The disclosure for this sale is available in the SEC filing. Over the last 90 days, insiders have sold 6,222 shares of company stock worth $2,540,926. Company insiders own 0.85% of the company’s stock.

About Amgen (Free Report)

Amgen Inc (NASDAQ: AMGN) is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen’s work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.

Amgen’s commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.

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Cane Capital Partners LLC raised its position in Amgen Inc. (NASDAQ:AMGN – Free Report) by 73.2% during the second quarter, according to the company in its most recent disclosure with the Securities & Exchange Commission. The firm owned 3,259 shares of the medical research company’s stock after purchasing an additional 1,377 shares during the quarter. Cane Capital Partners LLC’s holdings in Amgen were worth $1,180,000 as of its most recent SEC filing.

Other hedge funds and other institutional investors have also modified their holdings of the company. Anfield Capital Management LLC raised its holdings in shares of Amgen by 1,000.0% in the 4th quarter. Anfield Capital Management LLC now owns 77 shares of the medical research company’s stock valued at $25,000 after buying an additional 70 shares during the period. Dogwood Wealth Management LLC lifted its stake in Amgen by 275.0% during the 4th quarter. Dogwood Wealth Management LLC now owns 75 shares of the medical research company’s stock worth $25,000 after acquiring an additional 55 shares in the last quarter. Tower View Wealth Management LLC boosted its holdings in Amgen by 331.6% during the 1st quarter. Tower View Wealth Management LLC now owns 82 shares of the medical research company’s stock valued at $29,000 after acquiring an additional 63 shares during the period. Manning & Napier Advisors LLC boosted its holdings in Amgen by 49.2% during the 4th quarter. Manning & Napier Advisors LLC now owns 97 shares of the medical research company’s stock valued at $32,000 after acquiring an additional 32 shares during the period. Finally, Ares Financial Consulting LLC acquired a new position in Amgen in the 4th quarter valued at about $34,000. 76.50% of the stock is currently owned by hedge funds and other institutional investors.

Analysts Set New Price Targets A number of analysts have issued reports on AMGN shares. Scotiabank boosted their price target on shares of Amgen from $385.00 to $450.00 and gave the stock an “outperform” rating in a research note on Wednesday, August 5th. Truist Financial raised their price objective on shares of Amgen from $340.00 to $362.00 and gave the company a “hold” rating in a research note on Wednesday, August 5th. Cantor Fitzgerald restated a “neutral” rating and issued a $350.00 price objective on shares of Amgen in a report on Monday, July 6th. Robert W. Baird upped their target price on shares of Amgen from $215.00 to $230.00 and gave the stock an “underperform” rating in a research note on Wednesday, August 5th. Finally, Erste Group Bank reiterated a “hold” rating on shares of Amgen in a report on Tuesday, May 5th. One investment analyst has rated the stock with a Strong Buy rating, twelve have given a Buy rating, fifteen have assigned a Hold rating and three have given a Sell rating to the stock. According to MarketBeat.com, the company currently has an average rating of “Hold” and an average target price of $372.39.

View Our Latest Stock Analysis on Amgen Amgen Price Performance AMGN stock opened at $419.38 on Tuesday. The business’s 50-day moving average is $372.05 and its two-hundred day moving average is $359.47. The company has a debt-to-equity ratio of 4.44, a current ratio of 1.37 and a quick ratio of 1.13. The firm has a market capitalization of $226.73 billion, a P/E ratio of 26.06, a P/E/G ratio of 3.86 and a beta of 0.41. Amgen Inc. has a 1 year low of $269.77 and a 1 year high of $421.79.

Amgen (NASDAQ:AMGN – Get Free Report) last announced its quarterly earnings data on Tuesday, August 4th. The medical research company reported $6.29 EPS for the quarter, topping analysts’ consensus estimates of $5.62 by $0.67. Amgen had a return on equity of 124.14% and a net margin of 22.95%.The business had revenue of $10.05 billion during the quarter, compared to the consensus estimate of $9.43 billion. During the same period in the previous year, the company posted $6.02 earnings per share. The business’s revenue for the quarter was up 9.5% on a year-over-year basis. Amgen has set its FY 2026 guidance at 22.300-23.500 EPS. Analysts anticipate that Amgen Inc. will post 22.78 earnings per share for the current fiscal year.

Amgen Dividend Announcement The company also recently declared a quarterly dividend, which will be paid on Friday, September 11th. Investors of record on Friday, August 21st will be paid a $2.52 dividend. The ex-dividend date is Friday, August 21st. This represents a $10.08 dividend on an annualized basis and a yield of 2.4%. Amgen’s payout ratio is currently 62.65%.

Insider Activity at Amgen In other news, SVP Nancy A. Grygiel sold 2,970 shares of the firm’s stock in a transaction on Thursday, August 6th. The shares were sold at an average price of $402.16, for a total value of $1,194,415.20. Following the sale, the senior vice president directly owned 7,340 shares in the company, valued at approximately $2,951,854.40. This trade represents a 28.81% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this link. Also, SVP Rachna Khosla sold 2,000 shares of Amgen stock in a transaction on Tuesday, August 11th. The stock was sold at an average price of $412.57, for a total transaction of $825,140.00. Following the sale, the senior vice president directly owned 6,404 shares of the company’s stock, valued at approximately $2,642,098.28. This trade represents a 23.80% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. Insiders have sold a total of 6,222 shares of company stock valued at $2,540,926 in the last quarter. 0.85% of the stock is currently owned by company insiders.

Amgen Profile (Free Report)

Amgen Inc (NASDAQ: AMGN) is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen’s work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.

Amgen’s commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.

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Amgen Inc. (AMGN) Q2 2026 Earnings Call August 4, 2026 4:30 PM EDT

Company Participants

Casey Capparelli - Executive Director of Investor Relations
Robert Bradway - Chairman & CEO
Murdo Gordon - Executive Vice President of Global Markets and Policy
James Bradner - EVP of Research & Development, Artificial Intelligence and Data
Peter Griffith - Executive VP & CFO

Conference Call Participants

Dina Elmonshed - UBS Investment Bank, Research Division
Salveen Richter - Goldman Sachs Group, Inc., Research Division
Taylor Hanley - JPMorgan Chase & Co, Research Division
Umer Raffat - Evercore ISI Institutional Equities, Research Division
Yaron Werber - TD Cowen, Research Division
Edward Polglase - Bernstein Institutional Services LLC, Research Division
Manoj Eradath - Jefferies LLC, Research Division
Susan Chor - Wells Fargo Securities, LLC, Research Division
Alexandria Hammond - Wolfe Research, LLC
David Risinger - Leerink Partners LLC, Research Division
Jay Olson - Oppenheimer & Co. Inc., Research Division

Presentation

Operator

My name is Julianne, and I will be your conference facilitator today for the Amgen Q2 Earnings Conference Call.

[Operator Instructions]

I would now like to introduce Casey Capparelli, Vice President of Investor Relations. Mr. Capparelli, you may now begin.

Casey Capparelli
Executive Director of Investor Relations

Thank you, Julianne. Good afternoon, everyone, and welcome to our second quarter of 2026 earnings call. Bob Bradway will lead the call today and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner and Peter Griffith. Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call.

We will also make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results can vary materially. Over to you, Bob.

Robert Bradway
Chairman & CEO

Good afternoon, and thank you for joining us. Our strong

, /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the second quarter of 2026.

"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. 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," said Robert A. Bradway, chairman and chief executive officer.

Key results include:

For the second quarter, total revenues increased 10% to $10.1 billion in comparison to the second quarter of 2025. Product sales grew 9%, driven by volume growth. Twenty-two products delivered at least double-digit sales growth in the second quarter. Seventeen products are annualizing at more than $1 billion based on second quarter sales. GAAP earnings per share (EPS) increased 65% from $2.65 to $4.37 for the second quarter, driven by higher revenues. For the second quarter, GAAP operating income increased from $2.7 billion to $3.5 billion, and GAAP operating margin increased 6.5 percentage points to 36.8%. Non-GAAP EPS increased 4% from $6.02 to $6.29 for the second quarter, primarily driven by higher revenues, partially offset by higher operating expenses and higher income tax expense. For the second quarter, non-GAAP operating income increased from $4.3 billion to $4.6 billion, and non-GAAP operating margin decreased 0.5 percentage points to 48.4%. The Company generated $3.5 billion of free cash flow in the second quarter of 2026 versus $1.9 billion in the second quarter of 2025. The increase reflects the final repatriation tax payment in the second quarter of 2025 and current period business performance, partially offset by timing of working capital. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

General Medicine

Repatha® (evolocumab) sales increased 37% year-over-year to $953 million in the second quarter, driven by volume growth EVENITY® (romosozumab-aqqg) sales increased 38% year-over-year to $714 million in the second quarter, driven by volume growth. Prolia® (denosumab) sales decreased 32% year-over-year to $759 million in the second quarter, driven by 20% lower volume and 12% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected. Rare Disease

TEPEZZA® (teprotumumab-trbw) sales increased 14% year-over-year to $576 million in the second quarter, primarily driven by 6% higher net selling price and 6% volume growth. KRYSTEXXA® (pegloticase) sales increased 15% year-over-year to $400 million in the second quarter, driven by 23% higher net selling price, partially offset by lower inventory levels. UPLIZNA® (inebilizumab-cdon) sales increased 90% year-over-year to $335 million in the second quarter, primarily driven by volume growth. TAVNEOS® (avacopan) sales increased 36% year-over-year to $150 million in the second quarter, driven by volume growth. We continue to engage with the U.S. Food and Drug Administration (FDA) and believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile. Inflammation

TEZSPIRE® (tezepelumab-ekko) sales increased 42% year-over-year to $486 million in the second quarter, driven by volume growth. Otezla® (apremilast) sales decreased 21% year-over-year to $491 million in the second quarter, primarily driven by 9% lower net selling price and 6% lower volume. Enbrel® (etanercept) sales decreased 4% year-over-year to $580 million in the second quarter, primarily driven by 22% lower net selling price, partially offset by 16% favorable changes to estimated sales deductions. The decline in net selling price reflects the impact of U.S. Medicare Part D price setting under the Inflation Reduction Act, effective January 1, 2026, as well as an increased 340B Program mix. AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales increased 17% year-over-year to $155 million in the second quarter, primarily driven by volume growth. PAVBLU® (aflibercept-ayyh) sales increased 121% year-over-year to $287 million in the second quarter, primarily driven by volume growth based on its position as the only commercially available biosimilar to EYLEA® in the U.S. during this period. Oncology

BLINCYTO® (blinatumomab) sales increased 23% year-over-year to $472 million in the second quarter, primarily driven by 16% volume growth. IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) sales increased 115% year-over-year to $288 million in the second quarter, primarily driven by volume growth. Vectibix® (panitumumab) sales increased 11% year-over-year to $338 million in the second quarter, primarily driven by volume growth. KYPROLIS® (carfilzomib) sales decreased 17% year-over-year to $314 million in the second quarter, driven by lower volume. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 23% year-over-year to $111 million in the second quarter, primarily driven by volume growth. Nplate® (romiplostim) sales increased 17% year-over-year to $430 million in the second quarter, driven by 13% volume growth and higher net selling price. XGEVA® (denosumab) sales decreased 34% year-over-year to $352 million in the second quarter, primarily driven by 22% lower volume and 8% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected. MVASI® (bevacizumab-awwb) sales decreased 20% year-over-year to $153 million in the second quarter, driven by 16% lower net selling price and lower volume. Established Products

Our established products, which consist of Aranesp® (darbepoetin alfa), Neulasta® (pegfilgrastim), and Parsabiv® (etelcalcetide), generated $632 million of sales in the second quarter. Sales increased 19% year-over-year, driven by 15% higher net selling price and 2% volume growth. Product Sales Detail by Product and Geographic Region

$Millions, except percentages

Q2 '26

Q2 '25

YOY Δ

U.S

ROW

TOTAL

TOTAL

TOTAL

Repatha®

$          510

$          443

$          953

$          696

37 %

EVENITY®

550

164

714

518

38 %

Prolia®

478

281

759

1,122

(32 %)

TEPEZZA®

520

56

576

505

14 %

KRYSTEXXA®

399

1

400

349

15 %

UPLIZNA®

317

18

335

176

90 %

TAVNEOS®

143

7

150

110

36 %

Ultra-Rare products(1)

144

5

149

183

(19 %)

TEZSPIRE®

486

—

486

342

42 %

Otezla®

431

60

491

618

(21 %)

Enbrel®

574

6

580

604

(4 %)

AMJEVITA®/AMGEVITA™

26

129

155

133

17 %

PAVBLU®

280

7

287

130

*

WEZLANA®/WEZENLA™

—

61

61

35

74 %

BLINCYTO®

285

187

472

384

23 %

IMDELLTRA®/IMDYLLTRA™

233

55

288

134

*

Vectibix®

167

171

338

305

11 %

KYPROLIS®

201

113

314

378

(17 %)

LUMAKRAS®/LUMYKRAS™

62

49

111

90

23 %

Nplate®

275

155

430

369

17 %

XGEVA®

187

165

352

532

(34 %)

MVASI®

106

47

153

191

(20 %)

Aranesp®

94

258

352

359

(2 %)

Neulasta®

164

15

179

82

*

Parsabiv®

54

47

101

92

10 %

Other products(2)

304

47

351

334

5 %

Total product sales

$       6,990

$       2,547

$       9,537

$       8,771

9 %

* Change in excess of 100%

(1) Ultra-Rare products consist of PROCYSBI®, RAVICTI®, ACTIMMUNE®, BUPHENYL®, and QUINSAIR®

(2) Other products consist of Aimovig®, AVSOLA®, KANJINTI®, EPOGEN®, BKEMV®/BEKEMV™, RIABNI®,
IMLYGIC®, NEUPOGEN®, RAYOS®, DUEXIS®, Sensipar®/Mimpara™, Corlanor®, and PENNSAID®. Biosimilars
total $199 million in Q2 '26 and $172 million in Q2 '25. Rare Disease products total ($3) million in Q2 '26 and $4 million in Q2 '25

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses remained relatively unchanged year-over-year for the second quarter. Cost of Sales as a percentage of product sales decreased 4.8 percentage points, driven by lower amortization expense from acquisition-related assets, partially offset by higher profit share expense, higher manufacturing costs and changes in our sales mix. Research & Development (R&D) expenses increased 7% driven by higher spend in both Later-Stage Clinical Programs, primarily those related to MariTide and Marketed Product Support. Selling, General & Administrative (SG&A) expenses increased 3% driven by higher general and administrative expenses and higher commercial product-related expenses. Other operating expenses for the second quarter included litigation expenses. Operating Margin as a percentage of product sales increased 6.5 percentage points to 36.8%. Tax Rate increased 5.5 percentage points for the second quarter, primarily driven by the change in earnings mix, including lower amortization expense from acquisition-related assets. On a non-GAAP basis:

Total Operating Expenses increased 11% year-over-year for the second quarter. Cost of Sales as a percentage of product sales increased 1.9 percentage points, driven by higher profit share expense, higher manufacturing costs and changes in our sales mix. R&D expenses increased 10%, primarily driven by higher spend in both Later-Stage Clinical Programs, primarily those related to MariTide, and Marketed Product Support. SG&A expenses increased 4%, primarily driven by higher general and administrative expenses and higher commercial product-related expenses. Operating Margin as a percentage of product sales decreased 0.5 percentage points for the second quarter to 48.4%. Tax Rate increased 1.4 percentage points for the second quarter, primarily driven by the change in earnings mix and net unfavorable items in the current-year period. $Millions, except percentages

GAAP

Non-GAAP

Q2 '26

Q2 '25

YOY Δ

Q2 '26

Q2 '25

YOY Δ

Cost of Sales

$   2,811

$   3,011

(7 %)

$   1,874

$   1,551

21 %

% of product sales

29.5 %

34.3 %

(4.8) pts

19.6 %

17.7 %

1.9 pts

Research & Development

$   1,868

$   1,744

7 %

$   1,851

$   1,685

10 %

% of product sales

19.6 %

19.9 %

(0.3) pts

19.4 %

19.2 %

0.2 pts

Selling, General & Administrative

$   1,745

$   1,691

3 %

$   1,717

$   1,650

4 %

% of product sales

18.3 %

19.3 %

(1.0) pts

18.0 %

18.8 %

(0.8) pts

Other

$      116

$        77

51 %

$        —

$        —

N/A

Total Operating Expenses

$   6,540

$   6,523

0 %

$   5,442

$   4,886

11 %

Operating Margin

Operating income as % of product sales

36.8 %

30.3 %

6.5 pts

48.4 %

48.9 %

(0.5) pts

Tax Rate

14.2 %

8.7 %

5.5 pts

15.6 %

14.2 %

1.4 pts

pts: percentage points

N/A = not applicable

Cash Flow and Balance Sheet

The Company generated $3.5 billion of free cash flow in the second quarter of 2026 versus $1.9 billion in the second quarter of 2025. The increase reflects the final repatriation tax payment in the second quarter of 2025 and current period business performance, partially offset by timing of working capital. The Company declared a second quarter 2026 dividend on March 4, 2026 of $2.52 per share that was paid on June 5, 2026 to all stockholders of record as of May 15, 2026, representing a 6% increase from the same period in 2025. During the second quarter of 2026, there were no repurchases of shares of common stock under our stock repurchase program. Cash and cash equivalents totaled $14.0 billion and debt outstanding totaled $57.3 billion as of June 30, 2026. $Billions, except shares

Q2 '26

Q2 '25

YOY Δ

Operating Cash Flow

$         4.0

$         2.3

$         1.7

Capital Expenditures

$         0.5

$         0.4

$         0.1

Free Cash Flow

$         3.5

$         1.9

$         1.6

Dividends Paid

$         1.4

$         1.3

$         0.1

Share Repurchases

$         0.0

$         0.0

$         0.0

Average Diluted Shares (millions)

544

541

3

Note: Numbers may not add due to rounding

$Billions

6/30/26

12/31/25

YTD Δ

Cash and Cash Equivalents

$       14.0

$         9.1

$         4.9

Debt Outstanding

$       57.3

$       54.6

$         2.7

Note: Numbers may not add due to rounding

2026 Guidance

For the full year 2026, the Company expects:

Total revenues in the range of $38.2 billion to $39.4 billion. On a GAAP basis, EPS in the range of $15.80 to $17.08, and a tax rate in the range of 14.5% to 16.0%. On a non-GAAP basis, EPS in the range of $22.30 to $23.50, and a tax rate in the range of 15.0% to 16.5%. Capital expenditures to be approximately $2.6 billion. Share repurchases not to exceed $3.0 billion. Second Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

General Medicine

MariTide (maridebart cafraglutide/AMG 133)

MariTide is a differentiated antibody-peptide conjugate that activates the glucagon-like peptide-1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR). MariTide's long-acting design supports starting with monthly dosing, and staying on MariTide with as few as 4 or 6 doses per year. MARITIME-1, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, without Type 2 diabetes (T2D). MARITIME-2, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, with T2D. MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes, is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight. MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity. MARITIME-OSA-1, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight. MARITIME-OSA-2, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight. MARITIME-SWITCH, a Phase 3 study of MariTide, is enrolling adults living with obesity or overweight who will be switching from weekly tirzepatide or weekly semaglutide to MariTide on an every eight-week or quarterly dosing schedule. MARITIME-1 EXTENSION, a Phase 3 long-term extension study of MariTide, to evaluate the maintenance of weight loss with monthly, every eight-week or quarterly dosing, is enrolling adults living with obesity or overweight without T2D who completed the MARITIME-1 study. MARITIME-2 EXTENSION, a Phase 3 long-term extension study of MariTide, to evaluate the maintenance of weight loss with monthly and every eight-week dosing, is enrolling adults living with obesity or overweight with T2D who completed the MARITIME-2 study. Three Phase 3 studies of MariTide in people living with T2D will be initiated in 2026. A Phase 2b study of MariTide to assess the effect of MariTide on liver fat reduction and weight loss is enrolling adults living with obesity or overweight with elevated liver fat. AMG 513

Future development of AMG 513 will be discontinued. A Phase 1 study of AMG 513 in adults living with obesity will remain ongoing to follow enrolled participants through completion of the study. Repatha

In May, results from a new analysis of the Phase 3 VESALIUS-CV pre-cardiovascular event trial in a subgroup of patients who had a prior percutaneous coronary intervention (PCI) were presented at the European Paris Course on Revascularization (EuroPCR) and simultaneously published in Circulation. In this subset of 3,627 patients who had prior PCI, Repatha: demonstrated a 30% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE). demonstrated an 18% relative reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE). reduced the relative risk of heart attack by 50%, with the effect seen as soon as 6 months after randomization. was associated with nominal 34% decreased risk of cardiovascular death and 24% decreased risk of all-cause death. In June, results from a new analysis of VESALIUS-CV in a subgroup of patients with high-risk diabetes with and without known atherosclerosis were presented at the American Diabetes Association Scientific Sessions and simultaneously published in Diabetes Care. In this subset of 6,002 patients with high-risk diabetes with and without known atherosclerosis, Repatha: demonstrated a 29% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE). demonstrated a 21% relative reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE). was associated with a nominal 21% decreased risk of all-cause death. Further data from three new pre-specified analyses of the VESALIUS-CV study demonstrating the protective effects of Repatha on total cardiovascular events, myocardial infarction and fatal outcomes, will be presented as oral abstracts at the European Society of Cardiology (ESC) Congress in August 2026. EVOLVE-MI, a Phase 4 study of Repatha initiated within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular events, is ongoing. Olpasiran (AMG 890)

Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. The OCEAN(a)-Outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with established atherosclerotic CV disease and elevated Lp(a). The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, is enrolling patients with elevated Lp(a) at high risk for a first major CV event. The OCEAN(a)-Coronary Computed Tomography Angiography (CCTA), a Phase 3 coronary artery plaque study, is enrolling patients with atherosclerotic CV disease and elevated Lp(a). Rare Disease

UPLIZNA

In June, new open-label extension data from the Phase 3 MITIGATE study in patients with immunoglobulin G4-related disease (IgG4-RD) were presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. Key findings included: sustained response and disease control with continued UPLIZNA treatment at Year 1 of the open label period (OLP). 100% of patients remained flare-free and 71.4% of patients achieved both flare-free and glucocorticoid-free complete remission with continued UPLIZNA treatment through Year 1 of the OLP. UPLIZNA continued to demonstrate a safety profile consistent with the established safety profile of UPLIZNA across all approved indications. efficacy and safety outcomes support the longer-term use of UPLIZNA for the treatment of IgG4-RD. MERCURY, a Phase 2/3 study of UPLIZNA, was initiated in patients with autoimmune hepatitis (AIH). A Phase 3 study of UPLIZNA in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) will be initiated H2 2026 - H1 2027. TEPEZZA

A Phase 3 study of TEPEZZA in Japan is ongoing in patients with chronic/low clinical activity score thyroid eye disease (TED). TAVNEOS

TAVNEOS (avacopan), a product the Company acquired in connection with its acquisition of ChemoCentryx, Inc. in 2022, was approved by the FDA in October 2021. TAVNEOS is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids. The Company continues to engage the FDA regarding the Center for Drug Evaluation and Research's request to voluntarily withdraw TAVNEOS from the U.S. market. On June 1, 2026, the Company requested a hearing to discuss this topic and submitted supporting materials to the FDA on July 23, 2026. The Company believes that these materials support a favorable benefit-risk profile of TAVNEOS for patients with AAV. A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, has completed enrollment of patients from 6 years to < 18 years of age with active AAV (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)). Dazodalibep

Dazodalibep is a fusion protein that inhibits CD40 ligand (CD40L). Two Phase 3 studies of dazodalibep in Sjögren's disease are underway. The first study is ongoing in patients with moderate-to-severe systemic disease activity. The second study is ongoing in patients with moderate to high symptom burden with low systemic disease activity. Completion of both studies is expected in H2 2026. Daxdilimab

Daxdilimab is a first-in-class plasmacytoid dendritic cell (pDC) depleting monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). The Company is taking steps to advance daxdilimab to a registrational phase of development. AMG 732

AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody. A Phase 2 study of AMG 732 has completed enrollment of patients with moderate-to-severe active TED. Inflammation

TEZSPIRE

A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026. Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a blood eosinophil count (BEC) ≥ 150 cells/µL. Blinatumomab

Blinatumomab is a bispecific T-cell engager (BiTE®) molecule targeting CD19. A Phase 2 study of blinatumomab in autoimmune disease is enrolling adults with refractory rheumatoid arthritis. A Phase 2 study of blinatumomab in autoimmune disease is ongoing in adults with systemic lupus erythematosus (SLE) with and without nephritis. Inebilizumab

Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19. A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis. Sunakiment (AMG 104/AZD8630)

Sunakiment is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab) protein. LEVANTE, a Phase 2 study of sunakiment in patients with asthma, is complete. The results of this dose-ranging study were encouraging and informative for dose selection. In collaboration with AstraZeneca, the Company is planning a Phase 3 development program in asthma. Oncology

BLINCYTO/blinatumomab

Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, has completed enrollment of older adult patients with newly diagnosed CD19-positive Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL). A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab in both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA. A Phase 1b/2 study of subcutaneous blinatumomab in pediatric patients with relapsed or refractory and minimal residual disease positive (MRD+) B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA. Discussions are underway with the FDA on a path forward to reopen both subcutaneous blinatumomab studies. IMDELLTRA/tarlatamab

IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule. In May, the European Commission approved IMDYLLTRA as a monotherapy for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line platinum-based chemotherapy. Also in May, the China National Medical Products Administration (NMPA) granted full approval to IMDELLTRA for the treatment of second-line ES-SCLC and will be commercialized by BeOne in China. The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC: DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC. DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is ongoing in first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is ongoing in patients with LS-SCLC. DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second-line or later ES-SCLC. DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens of IMDELLTRA, has completed its primary analysis. The primary analysis demonstrated that extended dosing intervals can result in durable responses with encouraging survival, with a safety profile in line with expectation. The Company will discuss these new data with regulators and detailed results will be presented at an upcoming medical congress. DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate (ADC), with or without a PD-L1 inhibitor, has completed enrollment of patients with ES-SCLC. DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), is enrolling patients with second-line or later ES-SCLC. DeLLphi-312, a Phase 3 study of IMDELLTRA in combination with carboplatin, etoposide and durvalumab, is enrolling patients with first-line ES-SCLC. DeLLphi-313, a Phase 1b study of IMDELLTRA in combination with zocilurtatug pelitecan, a DLL3 targeting ADC, with and without a PD-L1 inhibitor, is enrolling patients with ES-SCLC DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab, was initiated in patients with second-line ES-SCLC. Xaluritamig (AMG 509)

Xaluritamig is a first-in-class BiTE molecule targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1). XALute, a Phase 3 study of xaluritamig, has completed enrollment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy. XALience, a Phase 3 study of xaluritamig in combination with abiraterone, is enrolling patients with chemotherapy-naïve mCRPC. A Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone is enrolling patients with mCRPC who have not yet received taxane-based chemotherapy. This study is ongoing in patients with mCRPC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer. A Phase 1b study of xaluritamig is ongoing in patients with high-risk biochemically recurrent prostate cancer after definitive therapy. A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors is enrolling patients with metastatic hormone-sensitive prostate cancer. A Phase 1b study of xaluritamig is enrolling adults with mCRPC to evaluate an additional dosing regimen. A Phase 1b study of xaluritamig is enrolling adult, adolescent and pediatric patients with relapsed or refractory Ewing sarcoma. LUMAKRAS/LUMYKRAS

CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic colorectal cancer. CodeBreaK 202, a Phase 3 study of LUMAKRAS plus platinum doublet chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced non-small cell lung cancer (NSCLC). Nplate

PROCLAIM, a Phase 3 study of Nplate for the treatment of chemotherapy-induced thrombocytopenia (CIT), is ongoing in patients with NSCLC, ovarian cancer or breast cancer. ROMISTER, a Phase 3 study of Nplate plus predniso(lo)ne compared with predniso(lo)ne alone, was initiated in patients with untreated primary immune thrombocytopenia (ITP). Biosimilars

A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO® (nivolumab) is ongoing in patients with treatment-naïve unresectable or metastatic melanoma. A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is ongoing in patients with early-stage non-squamous NSCLC as adjuvant treatment. A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared with KEYTRUDA is ongoing in patients with advanced or metastatic non-squamous NSCLC. A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 compared with OCREVUS® (ocrelizumab) has completed enrollment of patients with relapsing-remitting multiple sclerosis. A randomized, double-blind, comparative clinical study of ABP 938 (8 mg) compared with EYLEA HD® (aflibercept) was initiated and is enrolling patients with neovascular age-related macular degeneration. TEZSPIRE is being developed in collaboration with AstraZeneca.

Sunakiment (AMG 104/AZD8630) is being developed in collaboration with AstraZeneca.

Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.

YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.

Zocilurtatug pelitecan is an investigational DLL3 targeting antibody-drug conjugate being developed by Zai Lab Limited.

Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2 being developed by Asher Biotherapeutics.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

KEYTRUDA is a registered trademark of Merck & Co., Inc.

OCREVUS is a registered trademark of Genentech, Inc.

EYLEA HD is a registered trademark of Regeneron Pharmaceuticals, Inc.

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the second quarters of 2026 and 2025, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2026 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2026 and 2025. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

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.

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. 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. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. 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. 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, 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.

CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407 (media)
Annik Allen, 917-288-9136 (media)
Casey Capparelli, 805-447-1746 (investors)

Amgen Inc.

Consolidated Statements of Income - GAAP

(In millions, except per-share data)

(Unaudited)

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

Revenues:

Product sales

$    9,537

$    8,771

$  17,755

$  16,644

Other revenues

517

408

917

684

Total revenues

10,054

9,179

18,672

17,328

Operating expenses:

Cost of sales

2,811

3,011

5,555

5,979

Research and development

1,868

1,744

3,587

3,230

Selling, general and administrative

1,745

1,691

3,347

3,378

Other

116

77

3

907

Total operating expenses

6,540

6,523

12,492

13,494

Operating income

3,514

2,656

6,180

3,834

Other income (expense):

Interest expense, net

(673)

(694)

(1,330)

(1,417)

Other (expense) income, net

(73)

(394)

2

1,124

Income before income taxes

2,768

1,568

4,852

3,541

Provision for income taxes

393

136

658

379

Net income

$    2,375

$    1,432

$    4,194

$    3,162

Earnings per share:

Basic

$      4.40

$      2.66

$      7.77

$      5.88

Diluted

$      4.37

$      2.65

$      7.71

$      5.84

Weighted-average shares used in calculation of earnings per share:

Basic

540

538

540

538

Diluted

544

541

544

541

Amgen Inc.

Consolidated Balance Sheets - GAAP

(In millions)

June 30,

December 31,

2026

2025

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$              13,989

$                9,129

Trade receivables, net

10,227

9,570

Inventories

6,220

6,225

Other current assets

4,525

4,133

Total current assets

34,961

29,057

Property, plant and equipment, net

8,547

7,913

Intangible assets, net

20,487

22,276

Goodwill

18,668

18,680

Other noncurrent assets

12,976

12,660

Total assets

$              95,639

$              90,586

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable and accrued liabilities

$              20,057

$              20,890

Current portion of long-term debt

5,445

4,599

Total current liabilities

25,502

25,489

Long-term debt

51,859

50,005

Long-term deferred tax liabilities

1,301

1,366

Long-term tax liabilities

2,844

2,690

Other noncurrent liabilities

2,445

2,378

Total stockholders' equity

11,688

8,658

Total liabilities and stockholders' equity

$              95,639

$              90,586

Shares outstanding

541

539

Amgen Inc.

GAAP to Non-GAAP Reconciliations

(Dollars in millions)

(Unaudited)

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

GAAP cost of sales

$       2,811

$       3,011

$       5,555

$       5,979

Adjustments to cost of sales:

Acquisition-related expenses (a)

(937)

(1,460)

(2,078)

(3,008)

Non-GAAP cost of sales

$       1,874

$       1,551

$       3,477

$       2,971

GAAP cost of sales as a percentage of product sales

29.5 %

34.3 %

31.3 %

35.9 %

Acquisition-related expenses (a)

(9.9)

(16.6)

(11.7)

(18.0)

Non-GAAP cost of sales as a percentage of product sales

19.6 %

17.7 %

19.6 %

17.9 %

GAAP research and development expenses

$       1,868

$       1,744

$       3,587

$       3,230

Adjustments to research and development expenses:

Acquisition-related expenses (b)

(17)

(59)

(25)

(70)

Non-GAAP research and development expenses

$       1,851

$       1,685

$       3,562

$       3,160

GAAP research and development expenses as a percentage of product sales

19.6 %

19.9 %

20.2 %

19.4 %

Acquisition-related expenses (b)

(0.2)

(0.7)

(0.1)

(0.4)

Non-GAAP research and development expenses as a percentage of product sales

19.4 %

19.2 %

20.1 %

19.0 %

GAAP selling, general and administrative expenses

$       1,745

$       1,691

$       3,347

$       3,378

Adjustments to selling, general and administrative expenses:

Acquisition-related expenses (c)

(6)

(30)

(12)

(62)

Certain net charges pursuant to our restructuring and cost-savings initiatives

(22)

(11)

(35)

(11)

Total adjustments to selling, general and administrative expenses

(28)

(41)

(47)

(73)

Non-GAAP selling, general and administrative expenses

$       1,717

$       1,650

$       3,300

$       3,305

GAAP selling, general and administrative expenses as a percentage of product sales

18.3 %

19.3 %

18.9 %

20.3 %

Acquisition-related expenses (c)

(0.1)

(0.3)

(0.1)

(0.3)

Certain net charges pursuant to our restructuring and cost-savings initiatives

(0.2)

(0.2)

(0.2)

(0.1)

Non-GAAP selling, general and administrative expenses as a percentage of product sales

18.0 %

18.8 %

18.6 %

19.9 %

GAAP operating expenses

$       6,540

$       6,523

$      12,492

$      13,494

Adjustments to operating expenses:

Adjustments to cost of sales

(937)

(1,460)

(2,078)

(3,008)

Adjustments to research and development expenses

(17)

(59)

(25)

(70)

Adjustments to selling, general and administrative expenses

(28)

(41)

(47)

(73)

Impairment of intangible assets (d)

—

—

—

(800)

Certain net charges pursuant to our restructuring and cost-savings initiatives

(1)

(24)

(21)

(23)

Certain other expenses (e)

(115)

(53)

18

(84)

Total adjustments to operating expenses

(1,098)

(1,637)

(2,153)

(4,058)

Non-GAAP operating expenses

$       5,442

$       4,886

$      10,339

$       9,436

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

GAAP operating income

$       3,514

$       2,656

$       6,180

$       3,834

Adjustments to operating expenses

1,098

1,637

2,153

4,058

Non-GAAP operating income

$       4,612

$       4,293

$       8,333

$       7,892

GAAP operating income as a percentage of product sales

36.8 %

30.3 %

34.8 %

23.0 %

Adjustments to cost of sales

9.9

16.6

11.7

18.0

Adjustments to research and development expenses

0.2

0.7

0.1

0.4

Adjustments to selling, general and administrative expenses

0.3

0.6

0.3

0.3

Impairment of intangible assets (d)

0.0

0.0

0.0

4.9

Certain net charges pursuant to our restructuring and cost-savings initiatives

0.0

0.2

0.1

0.2

Certain other expenses (e)

1.2

0.5

(0.1)

0.6

Non-GAAP operating income as a percentage of product sales

48.4 %

48.9 %

46.9 %

47.4 %

GAAP other (expense) income, net

$          (73)

$        (394)

$             2

$       1,124

Adjustments to other (expense) income, net:

Net losses (gains) from equity investments (f)

189

591

291

(700)

Non-GAAP other income, net

$          116

$          197

$          293

$          424

GAAP income before income taxes

$       2,768

$       1,568

$       4,852

$       3,541

Adjustments to income before income taxes:

Adjustments to operating expenses

1,098

1,637

2,153

4,058

Adjustments to other (expense) income, net

189

591

291

(700)

Total adjustments to income before income taxes

1,287

2,228

2,444

3,358

Non-GAAP income before income taxes

$       4,055

$       3,796

$       7,296

$       6,899

GAAP provision for income taxes

$          393

$          136

$          658

$          379

Adjustments to provision for income taxes:

Income tax effect of the above adjustments (g)

207

401

383

618

Other income tax adjustments (h)

32

1

33

(5)

Total adjustments to provision for income taxes

239

402

416

613

Non-GAAP provision for income taxes

$          632

$          538

$       1,074

$          992

GAAP tax as a percentage of income before taxes

14.2 %

8.7 %

13.6 %

10.7 %

Adjustments to provision for income taxes:

Income tax effect of the above adjustments (g)

0.6

5.5

0.7

3.8

Other income tax adjustments (h)

0.8

0.0

0.4

(0.1)

Total adjustments to provision for income taxes

1.4

5.5

1.1

3.7

Non-GAAP tax as a percentage of income before taxes

15.6 %

14.2 %

14.7 %

14.4 %

GAAP net income

$       2,375

$       1,432

$       4,194

$       3,162

Adjustments to net income:

Adjustments to income before income taxes, net of the income tax effect

1,080

1,827

2,061

2,740

Other income tax adjustments (h)

(32)

(1)

(33)

5

Total adjustments to net income

1,048

1,826

2,028

2,745

Non-GAAP net income

$       3,423

$       3,258

$       6,222

$       5,907

Note: Numbers may not add due to rounding

Amgen Inc.

GAAP to Non-GAAP Reconciliations

(In millions, except per-share data)

(Unaudited)

The following table presents the computations for GAAP and non-GAAP diluted earnings per share:

Three months ended

June 30, 2026

Three months ended

June 30, 2025

GAAP

Non-GAAP

GAAP

Non-GAAP

Net income

$        2,375

$        3,423

$        1,432

$        3,258

Shares (Denominator):

Weighted-average shares for diluted EPS

544

544

541

541

Diluted EPS

$          4.37

$          6.29

$          2.65

$          6.02

Six months ended

June 30, 2026

Six months ended

June 30, 2025

GAAP

Non-GAAP

GAAP

Non-GAAP

Net income

$        4,194

$        6,222

$        3,162

$        5,907

Shares (Denominator):

Weighted-average shares for diluted EPS

544

544

541

541

Diluted EPS

$          7.71

$        11.44

$          5.84

$        10.92

(a)

The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business combinations.

(b)

For the three months ended June 30, 2026, the adjustment related primarily to acquisition-related expenses related to our Horizon acquisition. For the six months ended June 30, 2026, the adjustment related primarily to noncash amortization of intangible assets acquired from business combinations. For the three and six months ended June 30, 2025, the adjustments related primarily to acquisition-related expenses related to our Horizon acquisition.

(c)

For the three and six months ended June 30, 2026 and 2025, the adjustments related primarily to acquisition-related expenses related to our Horizon acquisition.

(d)

For the six months ended June 30, 2025, the adjustment related to an intangible asset impairment charge for Otezla®.

(e)

For the three and six months ended June 30, 2026, the adjustments included litigation expenses and settlements, respectively.

(f)

For the three and six months ended June 30, 2026 and 2025, the adjustments related primarily to our BeOne Medicines Ltd. equity fair value adjustment.

(g)

The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization and impairments of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and six months ended June 30, 2026, was 16.1% and 15.7%, respectively, compared to 18.0% and 18.4%, respectively, for the corresponding periods of the prior year.

(h)

The adjustments related to certain acquisition-related, prior-period and other items excluded from GAAP earnings.

Amgen Inc.

Reconciliations of Cash Flows

(In millions)

(Unaudited)

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

Net cash provided by operating activities

$    4,002

$    2,280

$    6,191

$    3,671

Net cash used in investing activities

(569)

(389)

(1,285)

(836)

Net cash used in financing activities

(1,482)

(2,673)

(46)

(6,780)

Increase (decrease) in cash and cash equivalents

1,951

(782)

4,860

(3,945)

Cash and cash equivalents at beginning of period

12,038

8,810

9,129

11,973

Cash and cash equivalents at end of period

$   13,989

$    8,028

$   13,989

$    8,028

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

Net cash provided by operating activities

$    4,002

$    2,280

$    6,191

$    3,671

Capital expenditures

(513)

(369)

(1,225)

(780)

Free cash flow

$    3,489

$    1,911

$    4,966

$    2,891

Amgen Inc.

Reconciliation of GAAP EPS Guidance to Non-GAAP

EPS Guidance for the Year Ending December 31, 2026

(Unaudited)

GAAP diluted EPS guidance

$ 15.80

—

$ 17.08

Known adjustments to arrive at non-GAAP*:

Acquisition-related expenses (a)

6.04

—

6.12

Net losses from equity investments

0.42

Other

(0.04)

Non-GAAP diluted EPS guidance

$ 22.30

—

$ 23.50

* The known adjustments are presented net of their related tax impact, which amount to approximately $1.29 per share.

(a) The adjustment primarily includes noncash amortization of intangible assets and fair value step-up of inventory acquired in business combinations.

Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments.

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP

Tax Rate Guidance for the Year Ending December 31, 2026

(Unaudited)

GAAP tax rate guidance

14.5 %

—

16.0 %

Tax rate of known adjustments discussed above

0.5 %

Non-GAAP tax rate guidance

15.0 %

—

16.5 %

SOURCE Amgen

Key Takeaways Amgen's Q2 sales and earnings estimates are $9.45 billion and $5.60 per share, respectively.AMGN may see volume-driven growth from key drugs, offset by pricing pressure and patent-related declines.Amgen investors will watch MariTide pipeline updates and trends in biosimilars and legacy product sales. We expect Amgen (AMGN - Free Report) to beat expectations when it reports second-quarter 2026 results on Aug. 4 after market close. In the last reported quarter, the company's earnings beat expectations by 8.88%. The Zacks Consensus Estimate for second-quarter sales and earnings is pegged at $9.45 billion and $5.60 per share, respectively.

Factors to Consider for AmgenIn the second quarter, Amgen’s product sales are expected to have been driven by strong volume growth of products like Repatha, Tezspire, Uplizna and Evenity, among others. However, price declines for some products and increases in 340B program utilization are likely to have offset some of the gains from volume increases.

The Zacks Consensus Estimate for Repatha, Tezspire, Uplizna and Evenity sales is pegged at $907.0 million, $483.0 million, $306 million and $636.0 million, respectively.

Sales of key drugs, Prolia and Xgeva, are likely to have declined as they have lost patent exclusivity.

Patents for Prolia and Xgeva expired in February 2025 in the United States, while the same expired in some European countries in November 2025. The erosion in their sales was in line with expectations in the first quarter. Accelerated sales erosion is expected over the remainder of 2026 as several biosimilars have been launched globally. The Zacks Consensus Estimate for Prolia and Xgeva is pegged at $728.0 million and $356.0 million, respectively.

Sales of some other drugs like Kyprolis, Vectibix, Nplate and Lumakras/Lumykras are likely to have risen in the quarter. Sales of new cancer drug Imdelltra (tarlatamab) are likely to have risen sequentially, driven by volume growth. The drug was approved by the name of Imdylltra in the EU in June.

In Amgen’s inflammation portfolio, Enbrel sales are likely to have declined due to declining prices. Otezla sales are likely to have been hurt by lower pricing in the United States and generic erosion in the EU.

The Zacks Consensus Estimate for Otezla is $562.0 million, while that for Enbrel is $466.0 million.

Amgen’s new biosimilar products like a biosimilar version of J&J’s Stelara called Wezlana and Regeneron’s (REGN - Free Report) Eylea called Pavblu are also likely to have contributed to sales growth like the past few quarters.  Wezlana’s sales are expected mostly from ex-U.S. markets while Pavblu’s sales are expected to have risen sequentially, driven by volume growth.

Lower revenues from oncology biosimilars (Kanjinti and Mvasi) due to increased competitive pressure are expected to have hurt the top line. Sales of legacy established products are also expected to have declined.

In the second quarter, adjusted operating margin is expected to be in line with the first-quarter operating margin of 45.3%.

Investors will look for updates on Amgen’s important pipeline candidate, MariTide (maridebart cafraglutide), a GIPR/GLP-1 receptor for obesity, on the second-quarter conference call.

AMGN’s Earnings Surprise HistoryThis large biotech’s performance has been strong, with earnings beating estimates in the trailing four quarters. The company delivered a four-quarter earnings surprise of 11.82%, on average.

Amgen’s stock has risen 18.4% so far this year compared with an increase of 2.8% for the industry.

Image Source: Zacks Investment Research

What Our Model Says for AMGNOur proven model predicts an earnings beat for Amgen this time around. The combination of a positive Earnings ESPand a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat, which is the case here.

Earnings ESP: Amgen’s Earnings ESP is +0.70%. The Zacks Consensus Estimate is pegged at $5.60 per share, while the Most Accurate Estimate is pegged higher at $5.64 per share. You can uncover the best stocks to buy or sell before they’re reported with our  Earnings ESP Filter.

Zacks Rank: Amgen has a Zacks Rank #3.

Other Stocks to ConsiderHere are two drug/biotech stocks that also have the right combination of elements to beat on earnings this time around:

Jazz Pharmaceuticals (JAZZ - Free Report) has an Earnings ESP of +0.41% and a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here.

Jazz stock has risen 52% so far this year. JAZZ beat estimates in three of the last four quarters while missing in one. The company has a four-quarter earnings surprise of 10.73%, on average. Jazz is scheduled to report second-quarter results on Aug. 3.

Pfizer (PFE - Free Report) has an Earnings ESP of +2.07% and a Zacks Rank #3 at present.

Shares of Pfizer have risen 0.1% so far this year. Pfizer beat earnings estimates in each of the last four reported quarters, delivering an average earnings surprise of 21.93%. Pfizer is scheduled to report second-quarter results on Aug. 4.

Repatha ist der einzige PCSK9-Hemmer, der in einer klinischen Phase-3-Studie nachweislich das Risiko eines ersten Herzinfarkts und Schlaganfalls signifikant senkt und damit neue Maßstäbe bei der Senkung kardiovaskulärer Risiken setzt.

Die Empfehlung stützt sich auf die bahnbrechende globale Phase-3-Studie „VESALIUS-Cardiovascular" mit mehr als 12.000 Patientinnen und Patienten.

, /PRNewswire/ -- Amgen (NASDAQ: AMGN) gab heute bekannt, dass der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, CHMP) der Europäischen Arzneimittelagentur (EMA) eine positive Stellungnahme zu Repatha® (Evolocumab) für Erwachsene mit nachgewiesener oder hohem Risiko einer atherosklerotischen Herz-Kreislauf-Erkrankung zur Senkung des kardiovaskulären Risikos durch Senkung des LDL-C-Spiegels als Ergänzung zur Korrektur anderer Risikofaktoren abgegeben hat. Die Empfehlung stützt sich auf die Ergebnisse der Phase-3-Studie VESALIUS-CV, die gezeigt hat, dass Repatha das Risiko für schwerwiegende unerwünschte kardiovaskuläre Ereignisse (Major Adverse Cardiovascular Events, MACE) bei Erwachsenen mit hohem Risiko, die zuvor weder einen Herzinfarkt noch einen Schlaganfall erlitten hatten, signifikant senkte, wenn es zusätzlich zu Statinen oder anderen LDL-C-senkenden Therapien verabreicht wurde.

„In Europa besteht nach wie vor ein erheblicher ungedeckter Bedarf, da viele Patientinnen und Patienten mit hohem kardiovaskulärem Risiko trotz der verfügbaren lipidsenkenden Therapien nicht in der Lage sind, die empfohlenen LDL-C-Werte zu erreichen", sagte Dr. med. Paul Burton, Ph.D., Chief Medical Officer bei Amgen. „Die positive Stellungnahme des CHMP spiegelt die Aussagekraft der klinischen Daten zu Repatha wider und bringt uns einen Schritt näher, wenn es darum geht, Repatha für mehr Patientinnen und Patienten verfügbar zu machen, die davon profitieren könnten." Repatha ist der einzige PCSK9-Hemmer, der in einer klinischen Phase-3-Studie nachweislich das Risiko eines ersten schwerwiegenden unerwünschten kardiovaskulären Ereignisses senkt. Sollte die Europäische Kommission dieser erweiterten Indikation zustimmen, könnte dies die kardiovaskuläre Versorgung geeigneter Patientinnen und Patienten in Europa grundlegend verändern."

Herz-Kreislauf-Erkrankungen sind weltweit die häufigste Todesursache.1 Aktuelle Forschungsergebnisse zeigen, dass mehr als 99 % der Menschen, bei denen erstmals ein kardiovaskuläres Ereignis auftritt, mindestens einen traditionellen Risikofaktor aufweisen, darunter einen hohen LDL-C-Spiegel, der zu den am besten beeinflussbaren Risikofaktoren für einen Herzinfarkt oder Schlaganfall zählt.2 Während die Leitlinien der Europäischen Gesellschaft für Kardiologie (European Society of Cardiology, ESC) und der Europäischen Gesellschaft für Atherosklerose (European Atherosclerosis Society, EAS) eine intensive Senkung des LDL-Cholesterinspiegels in Abhängigkeit vom kardiovaskulären Risiko empfehlen, liegen viele Hochrisikopatientinnen und -patienten trotz verfügbarer lipidsenkender Therapien weiterhin über den empfohlenen LDL-Cholesterin-Zielwerten.3

Repatha wurde in der Europäischen Union ursprünglich 2015 für die Behandlung von Erwachsenen und Kindern mit primärer Hypercholesterinämie oder gemischter Dyslipidämie sowie zur Senkung des kardiovaskulären Risikos bei Erwachsenen mit nachgewiesener atherosklerotischer kardiovaskulärer Erkrankung (Atherosclerotic Cardiovascular Disease, ASCVD) zugelassen. Es wird erwartet, dass die Europäische Kommission in den kommenden Monaten eine endgültige Entscheidung über den Antrag trifft.

Informationen zur VESALIUS-CV-Studie
VESALIUS-CV ist eine globale klinische Phase-3-Studie, die doppelblind, randomisiert und placebokontrolliert durchgeführt wird und darauf abzielt, den Einfluss einer Senkung des LDL-C-Spiegels durch Evolocumab auf MACE bei Erwachsenen mit hohem kardiovaskulärem Risiko ohne vorangegangenen Herzinfarkt oder Schlaganfall zu untersuchen. Die Ergebnisse wurden im November 2025 im New England Journal of Medicine veröffentlicht. Repatha führte zu einer relativen Risikoreduktion um 25 % für den kombinierten Endpunkt aus Tod durch koronare Herzkrankheit (KHK), Herzinfarkt oder ischämischem Schlaganfall (3-P-MACE) sowie um 19 % für einen erweiterten kombinierten Endpunkt, der zusätzlich jegliche ischämiebedingte arterielle Revaskularisation umfasste (4-P-MACE). Evolocumab senkte zudem das Risiko eines Herzinfarkts um 36 %. Bei allen drei Endpunkten zeigte sich ein konsistenter Vorteil von Evolocumab gegenüber Placebo, einschließlich eines um 36 % verringerten Risikos für einen Herzinfarkt. In einer Lipid-Teilstudie führte die Zugabe von Evolocumab zu einer maximal verträglichen Dosis eines Statins und/oder Ezetimib bei den beobachteten Partientinnen und Patienten zu einer deutlichen Senkung der LDL-C-Werte, wobei der Medianwert bei 45 mg/dl lag, verglichen mit 109 mg/dl in der Placebo-Gruppe.

In die VESALIUS-CV-Studie wurden mehr als 12.000 Patientinnen und Patienten mit bekannter ASCVD oder Hochrisikodiabetes aufgenommen, die keine Herzinfarkte oder Schlaganfälle in der Anamnese aufwiesen, einen LDL-C-Wert von ≥ 90 mg/dl, oder ein Nicht-HDL-Cholesterin (Non-HDL-C) von ≥ 120 mg/dL oder ein Apolipoprotein B von ≥ 80 mg/dL aufwiesen und mit der höchstverträglichen Dosis eines Statins und/oder Ezetimib behandelt wurden. Der Medianwert des LDL-C-Ausgangswerts lag bei lokalen Laboruntersuchungen bei 122 mg/dl (IQR: 104–149 mg/dl). Die Teilnehmenden wurden randomisiert und erhielten zusätzlich zu einer optimierten lipidsenkenden Therapie entweder Evolocumab oder ein Placebo; sie wurden über einen Median von etwa 4,6 Jahren nachbeobachtet.

Amgens Engagement für Innovationen im Bereich Herz-Kreislauf-Erkrankungen
Amgen definiert die kardiometabolische Versorgung neu – mit modernster, auf der Humanbiologie basierender Forschung, die sich mit eng miteinander verbundenen Herz-Kreislauf- und Stoffwechselerkrankungen befasst, die zu schwerwiegenden Folgen oder zum Tod führen können.

Kardiometabolische Erkrankungen treten häufig gemeinsam auf und können zu schwerwiegenden Folgen oder zum Tod führen, obwohl sie behandelbar sind.4 Trotz Fortschritten bei lipidsenkenden und metabolischen Therapien bleibt ein erhebliches kardiovaskuläres Restrisiko bestehen, das durch einen anhaltend erhöhten LDL-C-Spiegel, genetisch bedingtes Lp(a) und eine durch Adipositas bedingte kardiometabolische Dysfunktion verursacht wird.5

Auf der Grundlage von mehr als 40 Jahren Spitzenforschung und Humangenetik definiert Amgen die kardiometabolische Versorgung und das Risikomanagement neu. Nach jahrelangen Erfolgen bei Herz-Kreislauf-Erkrankungen mit Repatha ist Amgen gut aufgestellt, um potenziell bahnbrechende Medikamente wie MariTide und Olpasiran auf den Markt zu bringen, die dazu beitragen, die Bedürfnisse der Patientinnen und Patienten in der kardiometabolischen Versorgung zu erfüllen und die vielfältigen, miteinander verknüpften Ursachen von Herz-Kreislauf- und Stoffwechselerkrankungen anzugehen.

Informationen zu Repatha
Repatha ist ein humaner monoklonaler Antikörper, der die Proprotein-Convertase Subtilisin/Kexin Typ 9 (PCSK9) hemmt. Repatha bindet an PCSK9 und verhindert, dass zirkulierendes PCSK9 an den Low-Density-Lipoprotein (LDL)-Rezeptor (LDLR) bindet. Dadurch wird der durch PCSK9 vermittelte Abbau des LDLR verhindert und ermöglicht, dass der LDLR wieder an die Oberfläche der Leberzellen zurückgeführt wird. Durch die Hemmung der Bindung von PCSK9 an den LDLR erhöht Repatha die Anzahl der verfügbaren LDLR, die LDL aus dem Blut entfernen können, und senkt dadurch den LDL-C-Spiegel.

Repatha ist einer der am umfassendsten untersuchten PCSK9-Hemmer, für den klinische und praxisbezogene Erkenntnisse aus verschiedenen Patientengruppen und mit unterschiedlichen kardiovaskulären Risikoprofilen vorliegen.6 Der klinische Nutzen und die Sicherheit von Repatha wurden über einen Zeitraum von 15 Jahren in 51 klinischen Studien mit über 57.000 Patientinnen und Patienten untersucht.7 Repatha ist der einzige PCSK9-Hemmer, der sowohl in der Hochrisiko-Primär- als auch in der Sekundärprävention eine signifikante Reduktion kardiovaskulärer Ereignisse nachweisen konnte, wobei die Patientinnen und Patienten mit nur einmal alle zwei Wochen verabreichtem Repatha eine drastische Senkung des LDL-C-Spiegels erreichten und aufrechterhalten konnten.8,9

Repatha wurde erstmals 2015 zugelassen und wurde seitdem weltweit bei mehr als 10 Millionen Patientinnen und Patienten angewendet.10  Im August 2025 erweiterte die US-amerikanische Arzneimittelbehörde (U.S. Food and Drug Administration, FDA) den zugelassenen Anwendungsbereich von Repatha auf Erwachsene mit erhöhtem Risiko für schwerwiegende unerwünschte kardiovaskuläre Ereignisse aufgrund eines unkontrollierten LDL-C-Spiegels. Repatha ist in 74 Ländern zugelassen, darunter in den USA, in Japan, in Kanada, in Australien sowie in allen 28 Mitgliedstaaten der Europäischen Union.11 In weiteren Ländern sind Zulassungsanträge anhängig.

Wichtige Produktinformationen für die EU

In Europa ist Repatha für folgende Anwendungsgebiete zugelassen:

Hypercholesterinämie und gemischte Dyslipidämie
Repatha ist bei Erwachsenen mit primärer Hypercholesterinämie (heterozygot, familiär und nicht familiär) oder gemischter Dyslipidämie als Ergänzung zu einer Diät indiziert:

in Kombination mit einem Statin oder einem Statin und anderen lipidsenkenden Therapien bei Patientinneb und Patienten, welche die LDL-C-Zielwerte mit der maximal verträglichen Dosis eines Statins nicht erreichen können, oder allein oder in Kombination mit anderen lipidsenkenden Therapien bei Patientinnen und Patienten, die Statine nicht vertragen oder bei denen die Einnahme eines Statins kontraindiziert ist. Homozygote familiäre Hypercholesterinämie
Repatha ist bei Erwachsenen und Jugendlichen ab zwölf Jahren mit homozygoter familiärer Hypercholesterinämie in Kombination mit anderen lipidsenkenden Therapien indiziert.

Atherosklerotische Herz-Kreislauf-ErkrankungenRepatha ist bei Erwachsenen mit nachgewiesener atherosklerotischer Herz-Kreislauf-Erkrankung oder mit hohem Risiko dafür indiziert, um das kardiovaskuläre Risiko durch Senkung der LDL-C-Werte zu verringern, und zwar als Ergänzung zur Korrektur anderer Risikofaktoren:

in Kombination mit der maximal verträglichen Dosis eines Statins, mit oder ohne weitere lipidsenkende Therapien, oder allein oder in Kombination mit anderen lipidsenkenden Therapien bei Patientinnen und Patienten, die Statine nicht vertragen oder bei denen die Einnahme eines Statins kontraindiziert ist. Dosierung
Primäre Hypercholesterinämie und gemischte Dyslipidämie bei Erwachsenen

Die empfohlene Dosis von Repatha beträgt entweder 140 mg alle zwei Wochen oder 420 mg einmal monatlich; beide Dosierungen sind klinisch gleichwertig.

Homozygote familiäre Hypercholesterinämie bei Erwachsenen und Jugendlichen ab zwölf Jahren

Die empfohlene Anfangsdosis beträgt 420 mg einmal monatlich. Nach zwölf Wochen Behandlung kann die Dosierungshäufigkeit auf 420 mg einmal alle zwei Wochen erhöht werden, falls kein klinisch relevantes Ansprechen erzielt wird. Patientinnen und Patienten, die sich einer Apherese unterziehen, können die Behandlung mit 420 mg alle zwei Wochen beginnen, um sie an ihren Apherese-Zeitplan anzupassen.

Wichtige Sicherheitshinweise
Dieses Arzneimittel unterliegt einer zusätzlichen Überwachung. Auf diese Weise lassen sich schnell neue Sicherheitsinformationen ermitteln. Medizinisches Fachpersonal wird gebeten, alle vermuteten Nebenwirkungen zu melden.

Kontraindikationen: Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile.

Besondere Warnhinweise und Vorsichtsmaßnahmen: Nierenfunktionsstörung: Patientinnen und Patienten mit schwerer Nierenfunktionsstörung (definiert als eGFR < 30 ml/min/1,73 m2) wurden nicht untersucht. Repatha sollte bei Patientinnen und Patienten mit schwerer Nierenfunktionsstörung mit Vorsicht angewendet werden. Leberfunktionsstörung: Bei Patientinnen und Patienten mit mäßiger Leberfunktionsstörung wurde eine Verringerung der Gesamtexposition gegenüber Evolocumab beobachtet, was zu einer geringeren Wirkung im Hinblick auf die Senkung des LDL-C führen kann. Daher kann bei diesen Patientinnen und Patienten eine engmaschige Überwachung erforderlich sein. Patientinnen und Patienten mit schwerer Leberfunktionsstörung (Child-Pugh-Klasse C) wurden nicht untersucht. Repatha sollte bei Patientinnen und Patienten mit schwerer Leberfunktionsstörung mit Vorsicht angewendet werden. Trockener Naturkautschuk: Die Nadelabdeckung der vorgefüllten Glasspritze und des vorgefüllten Pens besteht aus trockenem Naturkautschuk (einem Latexderivat), der allergische Reaktionen hervorrufen kann. Natriumgehalt: Repatha enthält weniger als 1 mmol Natrium (23 mg) pro Dosis, d. h., es ist im Wesentlichen „natriumfrei".

Wechselwirkungen: Für Repatha wurden keine formellen Studien zu Wechselwirkungen mit anderen Arzneimitteln durchgeführt. Es wurden keine Studien zu pharmakokinetischen und pharmakodynamischen Wechselwirkungen zwischen Repatha und anderen lipidsenkenden Arzneimitteln als Statinen und Ezetimib durchgeführt.

Fruchtbarkeit, Schwangerschaft und Stillzeit: Es liegen keine oder nur begrenzte Daten zur Anwendung von Repatha bei Schwangeren vor. Repatha sollte während der Schwangerschaft nicht angewendet werden, es sei denn, der klinische Zustand der Frau erfordert eine Behandlung mit Evolocumab. Es ist nicht bekannt, ob Evolocumab in die Muttermilch übergeht. Ein Risiko für gestillte Neugeborene/Säuglinge kann nicht ausgeschlossen werden. Es liegen keine Daten zu den Auswirkungen von Evolocumab auf die Fruchtbarkeit beim Menschen vor.  

Nebenwirkungen: In zulassungsrelevanten, kontrollierten klinischen Studien wurden die folgenden häufigen (> 1/100 bis < 1/10) Nebenwirkungen berichtet: Grippe, Nasopharyngitis, Infektion der oberen Atemwege, Hautausschlag, Übelkeit, Rückenschmerzen, Gelenkschmerzen, Reaktionen an der Injektionsstelle. Eine vollständige Beschreibung der Nebenwirkungen finden Sie in der  Fachinformation .

Vorsichtsmaßnahmen bei der Einnahme von Arzneimitteln: Im Kühlschrank lagern (2 °C – 8 °C). Nicht einfrieren. Bewahren Sie die Fertigspritze oder den Fertigpen in der Originalverpackung auf, um sie vor Lichteinwirkung zu schützen. Nach Entnahme aus dem Kühlschrank kann Repatha bei Raumtemperatur (bis zu 25 °C) in der Originalverpackung aufbewahrt werden und muss innerhalb eines Monats aufgebraucht werden.

INDIKATIONEN IN DEN USA
Repatha® ist ein PCSK9-Hemmer (Proprotein-Convertase-Subtilisin/Kexin Typ 9), der für folgende Indikationen zugelassen ist:

Zur Senkung des Risikos schwerwiegender unerwünschter kardiovaskulärer Ereignisse (kardiovaskulärer Tod, Myokardinfarkt, Schlaganfall, instabile Angina pectoris, die einen Krankenhausaufenthalt erfordert, oder koronare Revaskularisation) bei Erwachsenen mit erhöhtem Risiko für diese Ereignisse. Als Ergänzung zu einer Diät und körperlicher Bewegung zur Senkung des LDL-Cholesterins (LDL-C) bei: Erwachsenen mit Hypercholesterinämie. Erwachsenen und pädiatrischen Patientinnen und Patienten ab zehn Jahren mit heterozygoter familiärer Hypercholesterinämie (HeFH). Erwachsenen und pädiatrischen Patientinnen und Patienten ab zehn Jahren mit homozygoter familiärer Hypercholesterinämie (HoFH). Die Sicherheit und Wirksamkeit von Repatha® bei Kindern mit HeFH oder HoFH unter zehn Jahren sowie bei Kindern mit anderen Formen der Hypercholesterinämie wurden nicht nachgewiesen. Die vollständigen Verschreibungsinformationen finden Sie auf www.Repatha.com.

 WICHTIGE SICHERHEITSINFORMATIONEN

Kontraindikation: Repatha® ist bei Patientinnen und Patienten kontraindiziert, bei denen in der Vergangenheit eine schwere Überempfindlichkeitsreaktion auf Evolocumab oder einen der Hilfsstoffe in Repatha® aufgetreten ist. Bei Patientinnen und Patienten, die mit Repatha® behandelt wurden, sind schwere Überempfindlichkeitsreaktionen einschließlich Angioödemen aufgetreten. Überempfindlichkeitsreaktionen: Bei Patientinnen und Patienten, die mit Repatha® behandelt wurden, wurden Überempfindlichkeitsreaktionen, einschließlich Angioödemen, berichtet. Sollten Anzeichen oder Symptome schwerwiegender Überempfindlichkeitsreaktionen auftreten, ist die Behandlung mit Repatha® abzubrechen, die Patientinnen und Patienten gemäß den geltenden Behandlungsstandards zu behandeln und sie so lange zu überwachen, bis die Anzeichen und Symptome abgeklungen sind. Nebenwirkungen bei Erwachsenen mit primärer Hypercholesterinämie: Die häufigsten Nebenwirkungen (> 5 % der mit Repatha® behandelten Patientinnen und Patienten und häufiger als unter Placebo) waren: Nasopharyngitis, Infektion der oberen Atemwege, Grippe, Rückenschmerzen und Reaktionen an der Injektionsstelle.Aus einer Zusammenfassung der 52-wöchigen Studie und sieben 12-wöchigen Studien: Lokale Reaktionen an der Injektionsstelle traten bei 3,2 % der mit Repatha® behandelten Patientinnen und Patienten und bei 3,0 % der mit Placebo behandelten Patientinnen und Patienten auf. Die häufigsten Reaktionen an der Injektionsstelle waren Hautrötungen, Schmerzen und Blutergüsse. Überempfindlichkeitsreaktionen traten bei 5,1 % der mit Repatha®behandelten Patientinnen und Patienten und bei 4,7 % der mit Placebo behandelten Patientinnen und Patienten auf. Die häufigsten Überempfindlichkeitsreaktionen waren Hautausschlag (1,0 % gegenüber 0,5 % bei Repatha® bzw. Placebo), Ekzem (0,4 % gegenüber 0,2 %), Erytheme (0,4 % gegenüber 0,2 %) sowie Urtikaria (0,4 % gegenüber 0,1 %).

Unerwünschte Wirkungen in der FOURIER-Studie zu kardiovaskulären Endpunkten: Die häufigsten Nebenwirkungen (> 5 % der mit Repatha® behandelten Patientinnen und Patienten und häufiger als unter Placebo) waren: Diabetes mellitus (8,8 % Repatha®, 8,2 % Placebo), Nasopharyngitis (7,8 % Repatha®, 7,4 % Placebo) sowie Infektionen der oberen Atemwege (5,1 % Repatha®, 4,8 % Placebo).Unter den 16.676 Patientinnen und Patienten, die zu Studienbeginn keinen Diabetes mellitus hatten, betrug die Inzidenz eines neu auftretenden Diabetes mellitus während der Studie bei den mit Repatha® behandelten Patientinnen und Patienten 8,1 %, verglichen mit 7,7 % bei den Patientinnen und Patienten, die ein Placebo erhielten.

Nebenwirkungen bei pädiatrischen Patientinnen und Patienten mit HeFH: Die häufigsten Nebenwirkungen (> 5 % der mit Repatha® behandelten Patientinnen und Patienten und häufiger als unter Placebo) waren: Nasopharyngitis, Kopfschmerzen, Schmerzen im Mund- und Rachenraum, Grippe und Infektion der oberen Atemwege. Nebenwirkungen bei Erwachsenen und Kindern mit HoFH: In einer 12-wöchigen Studie mit 49 Patientinnen und Patienten traten bei mindestens zwei mit Repatha® behandelten Patientinnen und Patienten folgende Nebenwirkungen auf, die häufiger auftraten als unter Placebo: Infektionen der oberen Atemwege, Grippe, Gastroenteritis und Nasopharyngitis. In einer offenen Verlängerungsstudie mit 106 Patientinnen und Patienten, darunter 14 Kinder, wurden keine neuen Nebenwirkungen beobachtet. Immunogenität: Repatha® ist ein humaner monoklonaler Antikörper. Wie bei allen therapeutischen Proteinen besteht auch bei Repatha® das Potenzial für Immunogenität. Die vollständigen Verschreibungsinformationen finden Sie hier.

Informationen zu Amgen
Amgen erforscht, entwickelt, produziert und liefert innovative Medikamente zur Bekämpfung einiger der schwersten Krankheiten der Welt. Amgen nutzt das Beste aus Biologie und Technologie und erreicht mit seinen Medikamenten Millionen von Patienten.

Vor mehr als 45 Jahren trug Amgen an seinem US-Hauptsitz in Thousand Oaks, Kalifornien, zur Gründung der Biotechnologiebranche bei und ist nach wie vor führend in der Innovation, indem es Technologien sowie humangenetische Daten nutzt, um über das heute Bekannte hinauszugehen. Amgen entwickelt eine breite und tiefe Pipeline und ein Portfolio von Medikamenten zur Behandlung von Krebs, Herzkrankheiten, Entzündungen, seltenen Krankheiten sowie Fettleibigkeit und mit Fettleibigkeit verbundenen Krankheiten.

Amgen wurde  wiederholt  für seine Innovationskraft und seine Unternehmenskultur ausgezeichnet, unter anderem von Fast Company und Forbes. Amgen gehört zu den 30 Unternehmen, die den Dow Jones Industrial Average® bilden, und ist auch Teil des Nasdaq-100-Index®, der die größten und innovativsten nicht-finanziellen Unternehmen umfasst, die an der Nasdaq-Börse nach Marktkapitalisierung notiert sind.

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Zukunftsgerichtete Aussagen
Diese Pressemitteilung enthält zukunftsgerichtete Aussagen, die auf den aktuellen Erwartungen und Einschätzungen von Amgen beruhen. Alle Aussagen, mit Ausnahme von Aussagen über historische Tatsachen, sind Aussagen, die als zukunftsgerichtete Aussagen angesehen werden könnten, einschließlich jeglicher Aussagen zu den Ergebnissen, Vorteilen und Synergien von Kooperationen oder potenziellen Kooperationen mit anderen Unternehmen (einschließlich BeOne Medicines Ltd. oder Kyowa Kirin Co., Ltd.), die Geschäftsentwicklung von Otezla® (Apremilast), unsere Übernahmen von ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. oder Horizon Therapeutics plc (einschließlich der voraussichtlichen Geschäftsentwicklung und des Ausblicks für das Geschäft von Horizon, der Geschäftsentwicklung und der Chancen sowie etwaiger potenzieller strategischer Vorteile, Synergien oder Chancen, die infolge einer solchen Übernahme erwartet werden) sowie Schätzungen zu Umsätzen, operativen Margen, Investitionsausgaben, Liquidität, anderer Finanzkennzahlen, erwarteter rechtlicher, schiedsgerichtlicher, politischer, regulatorischer oder klinischer Ergebnisse oder Praktiken, Verhaltensmuster oder Praktiken von Kunden und verschreibenden Ärzten, Erstattungsaktivitäten und -ergebnissen, Auswirkungen von Pandemien oder anderen weit verbreiteten Gesundheitsproblemen auf unser Geschäft, Ergebnisse, Fortschritte sowie anderer solcher Schätzungen und Ergebnisse. Zukunftsgerichtete Aussagen sind mit erheblichen Risiken und Unsicherheiten verbunden, einschließlich der nachstehend erläuterten Risiken und der Risiken, die ausführlicher in den von Amgen bei der Securities and Exchange Commission eingereichten Berichten beschrieben sind, darunter unser jüngster Jahresbericht auf Form 10-K sowie alle nachfolgenden regelmäßigen Berichte auf Form 10-Q und aktuellen Berichte auf Form 8-K. Sofern nicht anders angegeben, stellt Amgen diese Informationen zum Datum dieser Pressemitteilung zur Verfügung und übernimmt keine Verpflichtung, die in diesem Dokument enthaltenen zukunftsgerichteten Aussagen aufgrund neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen zu aktualisieren.

Keine zukunftsgerichtete Aussage kann garantiert werden, und die tatsächlichen Ergebnisse können erheblich von denen abweichen, die wir prognostizieren. Die Entdeckung oder Identifizierung neuer Produktkandidaten oder die Entwicklung neuer Indikationen für bestehende Produkte kann nicht garantiert werden und der Weg vom Konzept zum Produkt ist ungewiss. Folglich kann nicht garantiert werden, dass ein bestimmter Produktkandidat oder die Entwicklung einer neuen Indikation für ein bestehendes Produkt erfolgreich sein und zu einem kommerziellen Produkt werden wird. Außerdem sind die präklinischen Ergebnisse keine Garantie für die sichere und wirksame Leistung der Produktkandidaten beim Menschen. Die Komplexität des menschlichen Körpers kann durch Computer- oder Zellkultursysteme oder Tiermodelle nicht perfekt oder manchmal nicht einmal adäquat modelliert werden. Die Zeit, die wir benötigen, um klinische Studien abzuschließen und die behördliche Genehmigung für die Produktvermarktung zu erhalten, war in der Vergangenheit unterschiedlich lang, und wir erwarten ähnliche Schwankungen in der Zukunft. Selbst wenn die klinischen Studien erfolgreich verlaufen, können die Zulassungsbehörden die von uns gewählten Studienendpunkte als ausreichend für die Zulassung anzweifeln. Wir entwickeln Produktkandidaten sowohl intern als auch im Rahmen von Lizenzkooperationen, Partnerschaften und Joint Ventures. Produktkandidaten, die aus Beziehungen abgeleitet werden, können Gegenstand von Streitigkeiten zwischen den Parteien sein oder sich als weniger wirksam oder sicher erweisen, als wir zum Zeitpunkt des Eingehens einer solchen Beziehung angenommen haben. Außerdem könnten wir oder andere Sicherheits-, Nebenwirkungs- oder Herstellungsprobleme mit unseren Produkten, einschließlich unserer Geräte, feststellen, nachdem sie auf dem Markt sind.

Unsere Ergebnisse können von unserer Fähigkeit beeinflusst werden, neue und bestehende Produkte im In- und Ausland erfolgreich zu vermarkten, von klinischen und regulatorischen Entwicklungen bei aktuellen und zukünftigen Produkten, vom Umsatzwachstum kürzlich eingeführter Produkte, von der Konkurrenz durch andere Produkte, einschließlich Biosimilars, von Schwierigkeiten oder Verzögerungen bei der Herstellung unserer Produkte und von den globalen wirtschaftlichen Bedingungen, einschließlich derjenigen, die sich aus geopolitischen Beziehungen und Regierungsmaßnahmen ergeben. Darüber hinaus wird der Absatz unserer Produkte durch Preisdruck, politische und öffentliche Kontrolle sowie durch die Erstattungsrichtlinien von Drittanbietern, einschließlich Regierungen, privaten Versicherungsplänen und Managed-Care-Anbietern, beeinflusst. Er kann auch durch regulatorische, klinische und richtlinienbezogene Entwicklungen sowie durch nationale und internationale Trends in Richtung Managed Care und Kostendämpfung im Gesundheitswesen beeinflusst werden. Darüber hinaus unterliegen unsere Forschungs-, Test-, Preisgestaltungs-, Vermarktungs- sowie sonstigen Tätigkeiten einer umfassenden Regulierung durch in- und ausländische staatliche Aufsichtsbehörden. Unser Geschäft könnte durch staatliche Ermittlungen, Rechtsstreitigkeiten sowie Produkthaftungsansprüche beeinträchtigt werden. Zusätzlich könnte unser Geschäft durch die Einführung neuer Steuergesetze oder durch zusätzliche Steuerschulden beeinträchtigt werden. Weiterhin könnte der Schutz, den unsere Patente und Patentanmeldungen bieten, obwohl wir routinemäßig Patente für unsere Produkte und Technologien erhalten, von unseren Wettbewerbern angefochten, für ungültig erklärt oder umgangen werden, oder wir könnten in gegenwärtigen und künftigen Rechtsstreitigkeiten im Bereich geistiges Eigentum keinen Erfolg haben. Wir führen einen erheblichen Teil unserer kommerziellen Herstellungstätigkeiten in wenigen zentralen Einrichtungen durch, unter anderem in Puerto Rico, und sind zudem für einen Teil unserer Herstellungstätigkeiten auf Dritte angewiesen, und Lieferbeschränkungen könnten den Absatz bestimmter unserer derzeitigen Produkte sowie die Entwicklung bestimmter unserer Produktkandidaten einschränken. Der Ausbruch einer Krankheit oder eine ähnliche Bedrohung der öffentlichen Gesundheit sowie die öffentlichen und staatlichen Bemühungen, die Ausbreitung einer solchen Krankheit einzudämmen, könnten erhebliche nachteilige Auswirkungen auf die Versorgung mit Materialien für unsere Herstellungstätigkeiten, die Distribution unserer Produkte, die Vermarktung unserer Produktkandidaten sowie den Betrieb unserer klinischen Studien haben, und derartige Ereignisse könnten einen wesentlichen nachteiligen Einfluss auf unsere Produktentwicklung, unseren Produktabsatz, unser Geschäft sowie unsere Betriebsergebnisse haben. Wir sind bei der Entwicklung einiger unserer Produktkandidaten sowie bei der Vermarktung und dem Verkauf einiger unserer kommerziellen Produkte auf Kooperationen mit Dritten angewiesen. Zusätzlich stehen wir im Wettbewerb mit anderen Unternehmen, sowohl in Bezug auf viele unserer vermarkteten Produkte als auch bei der Entdeckung und Entwicklung neuer Produkte. Außerdem werden einige Rohstoffe, medizinische Geräte und Bauteile für unsere Produkte ausschließlich von Drittanbietern geliefert. Einige unserer Vertriebspartner, Kunden und Kostenträger haben in ihren Geschäftsbeziehungen mit uns eine erhebliche Kaufkraft. Die Entdeckung signifikanter Probleme mit einem Produkt, das einem unserer Produkte ähnlich ist und eine ganze Produktklasse betrifft, könnte erhebliche negative Auswirkungen auf den Absatz der betroffenen Produkte sowie auf unsere Geschäfts- und Betriebsergebnisse haben. Unsere Bemühungen, mit anderen Unternehmen, Produkten oder Technologien zusammenzuarbeiten oder diese zu erwerben, sowie die Geschäftsabläufe solcher Unternehmen zu integrieren oder die von uns erworbenen Produkte oder Technologien zu unterstützen, könnten nicht erfolgreich sein und könnten zu unerwarteten Kosten, Verzögerungen oder dazu führen, dass die Vorteile der Transaktionen nicht realisiert werden. Ein Ausfall, ein Cyberangriff oder eine Verletzung der Informationssicherheit unserer IT-Systeme könnte die Vertraulichkeit, Integrität und Verfügbarkeit unserer Systeme und Daten gefährden. Unser Aktienkurs ist volatil und kann durch eine Reihe von Ereignissen beeinflusst werden. Unser Geschäft und unsere Aktivitäten könnten durch das Scheitern oder das vermeintliche Scheitern bei der Erreichung unserer Nachhaltigkeitsziele negativ beeinflusst werden. Die Auswirkungen des globalen Klimawandels und der damit verbundenen Naturkatastrophen könnten sich negativ auf unser Geschäft und unseren Betrieb auswirken. Die globale Wirtschaftslage kann bestimmte Risiken, die unser Geschäft beeinträchtigen, verstärken. Unsere Geschäftsentwicklung könnte die Fähigkeit unseres Verwaltungsrats beeinträchtigen oder einschränken, eine Dividende zu beschließen, oder unsere Fähigkeit beeinträchtigen, eine Dividende zu zahlen oder unsere Stammaktien zurückzukaufen. Wir könnten nicht in der Lage sein, Zugang zu den Kapital- und Kreditmärkten zu für uns günstigen Bedingungen oder überhaupt zu erhalten.

KONTAKT: Amgen, Thousand Oaks
Madison Howard, 773-636-4910 (Medien)
Elissa Snook, 609-251-1407 (Medien)
Casey Capparelli, 805-447-1746 (Investoren)

LITERATURVERZEICHNIS

Martin, S. S., Aday, A. W., Allen, N. B., Almarzooq, Z. I., Anderson, C. A. M., Arora, P., Avery, C. L., Baker-Smith, C. M., Bansal, N., Beaton, A. Z., Commodore-Mensah, Y., Currie, M. E., Elkind, M. S. V., Fan, W., Generoso, G., Gibbs, B. B., Heard, D. G., Hiremath, S., Johansen, M. C., & Kazi, D. S. (2025). 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation, 151(8). https://doi.org/10.1161/cir.0000000000001303. MAC: REF-107092 Le, H. et al. (2025). Very High Prevalence of Nonoptimally Controlled Traditional Risk Factors at the Onset of Cardiovascular Disease. JACC, Volume 86 (Number 14) Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal. 2020;41(1):111-188. doi:10.1093/eurheartj/ehz455. Eroglu T, Capone F, Schiattarella GG. The evolving landscape of cardiometabolic diseases. EBioMedicine. 2024 Nov;109:105447. doi: 10.1016/j.ebiom.2024.105447. Online veröffentlicht am 4. November 2024. PMID: 39500010; PMCID: PMC11570325.  Tan SH, Wu JL, Zhuo SX, Zhang Y, Wang M. Residual risk in atherosclerotic cardiovascular disease after statin therapy: Clinical mechanisms and management strategies. World J Cardiol. 26. Februar 2026; 18(2):114960. doi: 10.4330/wjc.v18.i2.114960. PMID: 41694036; PMCID: PMC12897005. Data on File. Amgen, 2025. Data on File. Amgen, 2025. Ndumele, C. E., & Blumenthal, R. S. (2025). VESALIUS and the Anatomy of High-Risk Prevention. New England Journal of Medicine. https://doi.org/10.1056/nejme2515447 Marston, N. A., Bohula, E. A., Bhatia, A. K., et al. (2026). Evolocumab to reduce first major cardiovascular events in patients without known significant atherosclerosis and with diabetes: Results from the VESALIUS‑CV trial. JAMA. https://doi.org/10.1001/jama.2026.3277 Data on File. Amgen, 2026. Data on File. Amgen, 2025.

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Pfizer (NYSE: PFE | PFE Price Prediction) and Amgen (NASDAQ: AMGN) both reported Q1 2026 results this quarter, and the numbers reveal two very different bets on the future of oncology. Pfizer is monetizing its Seagen deal today. Amgen is defending a biosimilar cliff while spending to rebuild growth from scratch.

Padcev Carries Pfizer. Biosimilars Bite Amgen. Pfizer’s oncology franchise pulled in $3.83 billion, up 9% year over year, led by Seagen’s crown jewel Padcev at $591 million (+39%) on first-line urothelial share gains. Lorbrena jumped 37%, Orgovyx 43%, and total launched and acquired products grew 22% operationally. That is real commercial momentum.

Amgen’s story is bifurcated. IMDELLTRA soared 219% to $258 million and UPLIZNA jumped 188%, yet legacy supportive care crumbled. Prolia fell 34% to $727 million, XGEVA dropped 27%, and Enbrel slid 37% under Medicare Part D price setting. CEO Robert Bradway framed it optimistically, noting “16 brands achieving double-digit growth, enabling us to grow through expected patent expirations”. The math is tighter than the tone suggests.

Business Driver Pfizer Amgen Oncology engine Seagen ADCs (Padcev, Tukysa) BiTE platform (IMDELLTRA) Biggest drag COVID: Comirnaty -59% Prolia biosimilars -34% Revenue growth +5.4% +5.76% Monetizing Assets vs. Rebuilding a Base Albert Bourla said Pfizer is “off to a strong start in 2026” and singled out oncology and obesity as areas where he expects Pfizer to lead. That confidence rests on existing revenue streams already booking growth. Padcev’s Phase 3 EV-304 trial showed a 47% reduction in tumor recurrence, progression or death in MIBC patients, with a PDUFA target of August 17, 2026.

Amgen’s counter is capital-intensive. MariTide obesity trials, Xaluritamig in prostate cancer, and biosimilars for KEYTRUDA and OPDIVO all require years of spend before payback. Debt sits at $57.3 billion. Amgen is pivoting heavy capital into high-risk, early-stage platforms just to defend its baseline.

The Padcev PDUFA and MariTide Readouts Will Set the Tone I will be watching Padcev’s August 17 PDUFA decision, Elrexfio’s myeloma expansion, and whether Pfizer can hold its reaffirmed $59.5 to $62.5 billion revenue guide against a $1.5 billion generic headwind. For Amgen, MariTide Phase 3 readouts and the pace of Prolia erosion matter most. Any acceleration there pressures the $37.1 to $38.5 billion full-year guide.

Why I Lean Toward Pfizer for Oncology Alpha Personally, I lean Pfizer here. You are paying a forward P/E of 8 for a business collecting cash today from Seagen assets, versus 17 for Amgen’s rebuild story. The 7.07% dividend yield compensates holders during the wait. Amgen’s stock has run 14.1% YTD while Pfizer is flat at -0.07%, which is exactly why I find PFE more interesting now. Investors focused on the growth narrative who can tolerate biosimilar drag will find Amgen’s setup more compelling. If input costs stay volatile and MFN pricing tightens, the cheaper multiple and the working oncology franchise become more attractive on a relative basis.

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The Amgen logo is seen in this illustration taken August 3, 2025. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights, opens new tab

SummaryCompaniesJudge says Amgen likely to face significant, irreparable harmEnbrel price was capped at $31,200 annually, list price tops $100,000Colorado declined to commentJuly 1 (Reuters) - A federal judge on Wednesday blocked Colorado ​from capping the price of Amgen's (AMGN.O), opens new tab blockbuster arthritis drug Enbrel, a first-of-its-kind ‌move by a U.S. state.

In granting a preliminary injunction, Chief Judge Daniel Domenico of the Denver federal court said Amgen would likely face significant and irreparable harm from charging lower prices, adding that it ​could affect the drugmaker's negotiations for future contracts with wholesalers and distributors.

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Domenico said ​that "as a matter of basic economic logic, Amgen is likely to ⁠be significantly harmed by a cap on the price of its product, even if ​the cap applies unevenly" within the supply chain.

He also said that while Colorado had a ​legitimate interest in helping patients afford Enbrel, and could try doing so through subsidies or negotiations to lower prices as the federal government has done, "capping the price of a patented drug" was not an ​option.

In October, the Colorado Prescription Drug Affordability Board capped Enbrel prices at $600 for a ​50-milligram weekly dose, or $31,200 per year, effective on January 1, 2027.

The list price of Enbrel exceeds $100,000 per ‌year. ⁠Amgen had until July 5 to decide whether to continue selling the drug in Colorado.

Genna Morton, a spokeswoman for Colorado's Division of Insurance, said the agency cannot comment on pending litigation. Amgen and its lawyers did not immediately respond to requests for comment.

The U.S. ​pays about three times ​as much as other ⁠high-income countries for branded drugs, and the federal government and states have pursued policies to keep prices down.

Enbrel, whose chemical name is ​etanercept, is used to treat arthritis and plaque psoriasis. It is ​one of ⁠Amgen's biggest drugs, accounting for $2.23 billion of sales in 2025.

The Thousand Oaks, California-based drugmaker said Colorado's cap conflicted with federal patent law, violated its due process rights under the U.S. ⁠Constitution and ​threatened patients' access to needed treatment.

Domenico was appointed ​to the bench by Donald Trump. The U.S. president has nominated Domenico to join the 10th U.S. Circuit Court of ​Appeals, whose jurisdiction includes Colorado.

Reporting by Jonathan Stempel in New York; Editing by Mark Porter

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Item 1 of 2 The logo of Amgen biopharmaceutical company hangs at the Stripe Young Scientist and Technology exhibition at the RDS, in Dublin, Ireland, January 9, 2026. REUTERS/Clodagh Kilcoyne/File Photo

[1/2]The logo of Amgen biopharmaceutical company hangs at the Stripe Young Scientist and Technology exhibition at the RDS, in Dublin, Ireland, January 9, 2026. REUTERS/Clodagh Kilcoyne/File Photo Purchase Licensing Rights, opens new tab

CompaniesJune 26 (Reuters) - The European Medicines Agency on Friday recommended revoking the marketing authorisation ​for Amgen's (AMGN.O), opens new tab rare autoimmune disease drug, Tavneos, citing a lack of benefits ‌that outweigh its risks.

In April, the U.S. FDA's Center for Drug Evaluation and Research had proposed withdrawing approval of Tavneos, after identifying 76 cases of drug-induced liver injury with ​evidence suggesting a causal link to the drug.

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The EMA said ​the clinical study supporting the medicine's EU approval breached good ⁠clinical practice principles and the data were found to be incorrect, misleading ​and no longer reliable for demonstrating Tavneos' effectiveness.

The data collected after the ​drug was approved, along with additional analyses carried out after the main study, were not enough to prove the medicine's benefits, the EMA said.

Tavneos, approved in 2022 in the ​EU, treats anti-neutrophil cytoplasmic autoantibody-associated vasculitis, a rare group of autoimmune diseases ​that cause inflammation in small- to medium-sized blood vessels.

Amgen said in a statement it ‌was "deeply concerned" ⁠about the potential impact of the recommendation and that it "continues to believe that Tavneos is an important treatment option for people living with AAV."

The company said CSL Vifor, its partner in Europe, is leading interactions with ​the EMA regarding ​the next steps ⁠for patients and healthcare providers in Europe.

The EMA's Committee for Medicinal Products for Human Use has recommended that ​no new patients should start treatment with Tavneos, while ​existing patients ⁠should be switched to suitable alternatives.

Amgen has signed up a research firm to independently review the data on Tavneos, as it seeks to prove the drug's ⁠benefits ​before a hearing with the FDA.

The drugmaker ​said the deadline for submitting the data to the FDA has been extended to July 29 ​from June 29.

Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas

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