AMGN Amgen 10-Q 2026-09-30 section summaries

Amgen — Q3 and nine months ended September 30, 2026

Unaudited; dollars in millions except per-share amounts.

Consolidated results

Revenue increased 8.5% in Q3 and 8.0% in 9M. Lower cost of sales and other operating expense supported operating-income growth; other operating expense was $76 versus $329 in Q3 and $79 versus $1,236 in 9M, with the prior-year 9M amount including $1,200 of intangible-asset impairment charges. R&D rose to $2,111 from $1,900 in Q3 and to $5,698 from $5,130 in 9M; SG&A was $1,680 versus $1,720 and $5,027 versus $5,098, respectively. Net interest expense declined to $653 from $685 in Q3 and $1,983 from $2,102 in 9M. Other income fell to $1,629 from $2,080 in Q3 and $1,631 from $3,204 in 9M, primarily reflecting lower equity-security gains. Effective tax rates were 17.5% versus 18.0% in Q3 and 15.5% versus 14.5% in 9M.

Product sales

Growth was particularly strong in UPLIZNA, IMDELLTRA/IMDYLLTRA, Repatha and TEZSPIRE, while Prolia and XGEVA declined substantially. U.S. product sales were $7,259 versus $6,751 and rest-of-world sales were $2,624 versus $2,386. Amgen reports one human-therapeutics segment, managed on a consolidated basis.

Cash flow and capital allocation

Amgen issued $4.0 billion of long-term notes in 9M and repaid $3.9 billion of debt, versus $5.0 billion repaid in 9M 2025; Q3 repayments were $3.1 billion versus $1.5 billion. It had no borrowings on its $4.0 billion revolving facility, extended to March 2029. No shares were repurchased; $6.8 billion of repurchase authorization remained. Shares outstanding increased from 538.8 million at December 31, 2025 to 540.9 million at September 30, 2026 (540.6 million to 540.9 million during Q3). 9M stock-based compensation expense was $368 versus $369. Dividends declared were $2.52 per share versus $2.38 in 9M 2025.

Balance sheet and investments

Other intangible assets comprised developed-product-technology rights of $18,451 (prior $21,051), licensing rights of $276 ($395), R&D technology rights of $99 ($120), marketing-related rights of $0 ($0), and indefinite-lived in-process R&D of $710 ($710). Equity less goodwill and other intangible assets implies negative tangible common equity of $23,848. Debt principal was $55.765 billion, including $2.398 billion current and $51.609 billion long-term. Interest-bearing securities had $12.621 billion fair value at September 30, all maturing within one year, versus $8.525 billion at year-end.

Amgen’s approximately 17% BeOne Medicines stake was valued at $6.9 billion, versus $5.8 billion at year-end. Unrealized gains on the stake were $1.5 billion in Q3 versus $1.9 billion and $1.2 billion in 9M versus $3.0 billion, contributing to volatile non-operating income. The stake is subject to sale restrictions, including a 5% rolling-12-month limit while ownership remains at least 5%.

Significant risks and other developments

The IRS transfer-pricing disputes concern profit allocation between U.S. entities and Puerto Rico. The 2010–2012 adjustments could result in about $3.6 billion of additional federal tax plus interest, potentially offset by up to $0.9 billion of repatriation tax already paid. For 2013–2015, the IRS seeks about $5.1 billion of tax plus interest and $2.0 billion of penalties; tax could be reduced by up to $2.2 billion of previously paid repatriation tax. The trial concluded in January 2025, supplemental briefs were filed in May 2026, and a decision is not expected before late 2026 or early 2027. Amgen disputes proposed 2016–2018 adjustments and is under examination for 2019–2022; it warns ultimate payments could materially exceed accruals. Gross unrecognized tax benefits increased $45 million in Q3 and $125 million in 9M; substantially all would affect the effective tax rate if recognized.

TAVNEOS had a $2.2 billion U.S. developed-product-technology carrying value. The FDA proposed withdrawing approval after reports of serious, including fatal, liver injury and questions about efficacy evidence. Amgen sought a hearing and submitted supporting data; the product remains on the market pending the FDA process, but withdrawal or reduced expected cash flows could impair the asset. Related ANDA litigation is stayed pending the FDA decision. Medicare price setting for Otezla, effective January 1, 2027, drove $800 million of impairment in Q1 2025 and a further $400 million in Q3 2025. Finite-lived intangible amortization was $889 million in Q3 versus $1.1 billion and $2.7 billion in 9M versus $3.4 billion.

Recurring fair-value financial assets totaled $20.204 billion and liabilities $1.334 billion at September 30. Contingent consideration, based on judgment-sensitive development and commercial assumptions, rose to $367 million from $161 million. Amgen uses derivatives for currency and interest-rate risk, not speculation; foreign-currency forward and interest-rate swap notionals were $8.1 billion and $7.4 billion, respectively. Derivative fair-value liabilities were $967 million, primarily reflecting a $277 million increase in interest-rate-swap liabilities.

Other litigation includes biosimilar patent matters involving Prolia/XGEVA, PAVBLU, KYPROLIS and ABP 206; key proceedings have hearings or trials scheduled from December 2026 through July 2027, while some have no trial date. In Ventura County antitrust actions, complaints were dismissed with leave to amend. Amgen states that adverse outcomes in pending matters could materially affect results, financial position or cash flows.

Amgen — Q3 and nine months ended September 30, 2026

Amgen operates as one human-therapeutics segment. Growth was driven by product volume and newer brands, while established products faced biosimilar and generic competition, Medicare price setting, and other pricing pressure.

Consolidated results

Revenue increased 8% in both Q3 and 9M. Product-sales volume rose 8% in Q3 (U.S. 8%, ROW 16%) and 10% in 9M (U.S. 8%, ROW 12%); lower net price partly offset volume growth. Amgen expects brand-volume growth to continue to be partly offset by lower net selling prices. Other revenue growth reflected higher royalty and corporate-partner revenue.

Cost of sales declined as a share of revenue to 26.9% from 32.2% in Q3 and to 28.7% from 33.7% in 9M, reflecting lower acquisition-asset amortization and manufacturing costs, partly offset by profit-share expense and sales mix. R&D increased 11% to $2.111B in Q3 and 11% to $5.698B in 9M, reflecting Research and Early Pipeline and business-development spending, and later-stage programs including MariTide in 9M. SG&A was $1.680B vs. $1.720B in Q3 and $5.027B vs. $5.098B in 9M. Other operating expense was $76M vs. $329M in Q3 and $79M vs. $1.236B in 9M; 2025 included Otezla impairment charges of $400M and $1.2B, respectively. Lower expenses helped drive higher operating income.

Net interest expense was $653M vs. $685M in Q3 and $1.983B vs. $2.102B in 9M. Other income was $1.629B vs. $2.080B in Q3 and $1.631B vs. $3.204B in 9M, mainly reflecting lower unrealized equity-investment gains, particularly BeOne. Effective tax rates were 17.5% vs. 18.0% in Q3 and 15.5% vs. 14.5% in 9M.

Selected product sales

Prolia’s Q3 sales fell 45% as biosimilars launched; volume declined 23%, with the remaining decline reflecting lower price and sales-deduction estimates. XGEVA fell 47% in Q3 as biosimilars reduced volume and price; further erosion is expected through 2026. U.S. and select European RANKL-antibody patents expired in February and November 2025, respectively. Otezla fell 18% in Q3 on lower volume, price and unfavorable deduction estimates; European generic competition began after loss of exclusivity in certain countries. Medicare price setting applies to ENBREL beginning in 2026 and Otezla beginning in 2027. ENBREL’s 9M sales declined 11%, including a 19% decrease in net price.

Growth brands included Repatha (+37% in Q3), driven by volume; TEZSPIRE (+43%), BLINCYTO (+27%) and UPLIZNA (to $451M from $155M), primarily on volume; and IMDELLTRA/IMDYLLTRA (to $406M from $178M), also volume-driven. Nplate’s Q3 included $65M of U.S. government orders vs. $90M; excluding those orders, global sales rose 11%. Other products increased 14% in Q3, with U.S. sales up 21% and ROW down 4%.

Cash flow and financial position

Operating cash flow rose 24.9%, partly because 2025 included the final $1.8B repatriation-tax payment, and also reflecting higher current-period net income after noncash adjustments; working-capital timing partly offset the increase. Investment in plants and manufacturing capacity drove higher capital expenditures; full-year 2026 capital-project investment is estimated at approximately $2.6B.

Amgen issued $4.0B of debt in 9M 2026 and repaid $3.9B, including repayment of a $1.8B term loan. Debt repurchases totaled $324M principal at an aggregate cost of $233M, generating $90M of extinguishment gains recorded in other income. Dividends paid were $4.1B vs. $3.8B; the quarterly dividend increased 6% to $2.52 per share. No shares were repurchased, and $6.8B of authorization remained. The $4.0B revolving credit facility was undrawn and extended to March 2029; Amgen reported covenant compliance, including with its minimum interest-coverage covenant.

Risks and developments

IRS disputes over Puerto Rico/U.S. income allocation seek approximately $3.6B of additional tax plus interest for 2010–12 and $5.1B plus interest and $2.0B penalties for 2013–15. Previously paid repatriation tax could offset up to $900M and $2.2B, respectively. The IRS has proposed similar adjustments for 2016–18 and began auditing 2019–22; Amgen disputes the positions but warns ultimate payments could substantially exceed accruals and materially affect results.

Pricing and access risks include IRA provisions, expanded 340B discounts, reduced federal Medicaid spending and potential increases in uninsured people. The GENEROUS Model would require supplemental Medicaid rebates; all states, D.C. and Puerto Rico had applied by September 2026. Amgen says its December 2025 actions addressed the July MFN Letter requests and expanded its direct-to-patient program. Tariffs imposed in April 2026 on certain patented pharmaceuticals and APIs add uncertainty; Amgen received roughly three years of tariff relief from December 2025 in recognition of U.S. manufacturing investment.

Pipeline updates included positive Phase 3 results for TEZSPIRE in eosinophilic esophagitis and dazodalibep in Sjögren’s disease, EU expansion of Repatha’s cardiovascular-risk-reduction indication, and positive overall-survival results for IMDELLTRA/IMDYLLTRA plus IMFINZI in first-line maintenance small-cell lung cancer. The FDA accepted ABP 206, an OPDIVO biosimilar candidate, for review.

For the nine months ended September 30, 2026, Amgen reported no material changes to the market-risk disclosures in its Form 10-K for the year ended December 31, 2025. Those disclosures are incorporated by reference.

Disclosure Controls and Internal Control

As of September 30, 2026, Amgen’s CEO and CFO concluded, based on management’s evaluation, that the company’s disclosure controls and procedures were effective. No changes during the fiscal quarter materially affected, or were reasonably likely to materially affect, internal control over financial reporting. The filing cautions that controls provide reasonable, not absolute, assurance.

Principal risks

Pricing, reimbursement and government policy

Amgen’s sales and profitability depend on government and commercial coverage and reimbursement. Payers are seeking lower drug costs through reduced reimbursement, narrower coverage, greater patient cost-sharing, utilization controls, and larger rebates, discounts and fees. These pressures can constrain prices and patient access, reduce product use, and adversely affect sales and profitability. Internationally, reference pricing, rebates, revenue clawbacks, sales caps, cost-effectiveness assessments and competitive tenders can reduce prices, limit reimbursed populations or concentrate sales with a competing product. For example, despite EMA approval for Repatha in established atherosclerotic disease, France restricted reimbursement to a narrower population, including patients with HoFH.

In the U.S., the Inflation Reduction Act (IRA) introduces Medicare price setting for selected drugs: 10 drugs effective January 1, 2026; 15 additional drugs in each of 2027 and 2028; and 20 annually beginning in 2029. Approximately 100 drugs could be subject to set prices by 2031. CMS-set Part D prices for ENBREL began January 1, 2026, at a significantly lower level, reducing and expected to continue reducing its profitability. A lower CMS-set price for Otezla is scheduled for January 2027; Repatha could be selected as early as January 2029. CMS may reset prices already set, and the implications of an April 2025 executive order concerning small molecules versus biologics remain uncertain. IRA Part D redesign increases manufacturer discount obligations, and inflation rebates apply when Medicare price increases exceed inflation; several Amgen products have incurred these rebates. Amgen expects the IRA’s effects to increase through the end of the decade, depending on product selection, Medicare exposure, inflation, and generic or biosimilar competition.

Following the May 2025 Most-Favored-Nation (MFN) executive order and July 2025 letter, Amgen announced in December 2025 that it was taking actions to address the letter’s components, including MFN pricing requests, and expanding its direct-to-patient program. The CMS GENEROUS Model calls for participating manufacturers, including Amgen, to provide supplemental rebates to participating state Medicaid programs to align net prices for covered drugs with prices in selected countries. Effects depend on participation, products, benchmarks and implementation; potential legislation codifying MFN terms could extend requirements. More broadly, evolving federal policy—including IRA, OB3 and trade measures—creates uncertainty.

OB3, enacted July 4, 2025, changes Medicare, Medicaid and ACA policies, including eligibility. Potential reductions in federal Medicaid spending could increase the uninsured population, strain state budgets and hospitals, reduce medicine access, intensify discount pressure and encourage greater 340B use. States are pursuing drug price controls and related measures, including prescription drug affordability boards (PDABs), importation, reference pricing, Medicaid spending caps and rebate negotiations. Seven states have enacted PDAB laws, four authorizing upper payment limits (UPLs). Colorado’s PDAB deemed ENBREL unaffordable and set a UPL substantially below its wholesale acquisition cost, effective no earlier than January 1, 2027; implementation is preliminarily enjoined while litigation continues. Washington selected ENBREL for affordability review in July 2025 and Otezla in September 2026, but cannot establish a UPL before January 1, 2027.

Growth and expanded application of the 340B Program have increased Amgen’s discounts and risks of duplicate discounts or discounts for ineligible patients or settings. Twenty-three states have enacted laws governing manufacturer practices in 340B channels, and at least 17 states introduced similar legislation in 2026, commonly addressing contract pharmacies, drug-channel restrictions and claims modifiers. HRSA approved Amgen for a one-year rebate pilot beginning January 2027 for ENBREL and Otezla, but Amgen believes such efforts may not fully mitigate exposure. Court rulings on state laws are mixed and litigation continues. Colorado received FDA authorization for an importation program in June 2026; although federal law exempts biologics, Amgen’s small-molecule products may be affected.

Consolidation among insurers, PBMs, integrated health systems and related organizations increases their negotiating leverage. PBM reforms could shift economics from rebates to explicit fees and lead to more restrictive formularies and utilization management. Fiscal pressure and efforts to reduce drug spending and intellectual-property protections also threaten international sales. Proposed EU pharmaceutical-law changes could shorten data and orphan-drug exclusivity; full implementation is not expected before 2027. Complex U.S. government price-reporting rules create further risk of corrections, fines, enforcement actions, rebates or discounts.

Regulatory, clinical and product-safety risks

Amgen’s products and candidates require regulatory approval. Agencies can demand additional testing, change labels, delay or deny approvals, suspend trials, or require recalls or withdrawals. Changing requirements and potential reductions in HHS, FDA and NIH budgets or staffing, as well as government shutdowns, could delay reviews, clinical programs and research funding. Reduced NIH support or research-overhead caps could also slow discovery and pipeline innovation. Regulators may reject surrogate endpoints, require outcomes studies or evidence of superiority, and impose conditions on accelerated or conditional approvals. LUMAKRAS, which received accelerated approval for KRAS G12C-mutated advanced or metastatic NSCLC, received an FDA Complete Response Letter after Amgen submitted CodeBreaK 200 confirmatory data in March 2023; FDA required an additional confirmatory study. Failure to satisfy approval conditions may lead to restrictions, further studies, nonrenewal or withdrawal.

TAVNEOS is subject to a significant, unresolved regulatory and safety challenge. Approved in October 2021 as adjunctive treatment for adults with severe ANCA-associated vasculitis, it carries a hepatotoxicity warning. After Amgen submitted a proposed label update in 2024 concerning serious postmarketing liver-injury cases, FDA requested voluntary U.S. withdrawal on January 16, 2026, citing questions about the analysis and adjudication of data supporting approval. Amgen declined on January 28, citing confidence in its effectiveness and benefit-risk profile. FDA issued a Drug Safety Communication on March 31, 2026, regarding serious, including fatal, drug-induced liver injury based on data through October 9, 2024. Postmarketing reports of potentially fatal vanishing bile duct syndrome (VBDS) have been reported, largely in Japan and none in the United States; most affected patients were at least 65, and most cases occurred within 90 days of treatment initiation. Following Amgen’s April 29 CBE-30 supplement, the U.S. label was updated in May 2026 to describe VBDS, fatal cases, liver monitoring and discontinuation guidance.

On April 27, 2026, CDER proposed withdrawing TAVNEOS approval, alleging new information showed a lack of substantial evidence of effectiveness and that the original application contained untrue material statements. Amgen requested a hearing June 1 and submitted supporting information July 23, including real-world evidence and an independent blinded re-adjudication of ADVOCATE study data; CDER had not responded to that submission. FDA may decide without a hearing, and any decision is appealable. TAVNEOS remains on the U.S. market during the process, but the outcome is uncertain. In August 2026, the European Commission revoked its EU marketing authorization; other jurisdictions have initiated reviews, discouraged new starts, or taken or announced revocation actions. Further restrictions, studies, litigation or withdrawal could harm TAVNEOS sales and Amgen’s results.

Other safety signals or manufacturing issues can prompt restrictive labels, risk-management requirements, studies, recalls, manufacturing changes, approval delays or withdrawal. EVENITY was approved in April 2019 with a postmarketing requirement following a cardiovascular serious-adverse-event imbalance in one Phase 3 trial but not a larger trial. The requirement includes a five-year observational feasibility study, potentially followed by a comparative safety study or trial. Failure to meet REMS, pharmacovigilance, pediatric-study or quality requirements, and impurity limits such as nitrosamine testing requirements for certain small-molecule drugs, could also disrupt approvals, manufacturing or distribution.

Biosimilar and generic competition

Amgen faces current and expected increasing competition from biosimilars and generics. Uncertain or changing regulatory pathways and evidence standards can delay approvals, increase development costs and reduce the value of Amgen’s biosimilar investments. Policy changes could affect approvals, marketed products and interchangeability designations. Failure to launch on time or secure first-to-market or other advantageous positions could materially harm future biosimilar sales and results.

During Q3 2026, no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements. No financial or business developments were reported in this section.