Published
# Amgen Inc. (AMGN): Business, Risks and Management's Discussion
Sources: the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (accession 0000318154-26-000010, filed February 13, 2026); the Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (accession 0000318154-26-000126, filed August 5, 2026); and Forms 8-K as cited in each section.
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## Business
*From the FY2025 Form 10-K (accession 0000318154-26-000010), unless otherwise noted.*
Amgen discovers, develops, manufactures and sells medicines, mostly biologics, for serious illnesses in cardiovascular and bone health, rare diseases, inflammation and oncology. It also sells biosimilars of other companies' biologics. Almost all of its revenue is product sales. In 2025 product sales were $35.1 billion of $36.8 billion total revenues. The remaining $1.6 billion of "other revenues" was mainly royalty income and revenue from corporate partners. The United States generated 73% of 2025 product sales ($25.7 billion) and the rest of the world 27% ($9.5 billion). Europe is the largest market outside the United States. Amgen reports a single operating segment, human therapeutics.
**How it sells.** In the United States substantially all sales go to pharmaceutical wholesalers. Three of them, McKesson, Cencora and Cardinal Health, together accounted for 77% of worldwide gross revenues in 2025. Outside the United States Amgen sells mainly to healthcare providers and wholesalers. Price is set through negotiation with government programs (Medicare, Medicaid, the 340B Program) and with commercial insurers and PBMs, and rebates and discounts are a large part of the gap between list and net price. Amgen also sells some products directly to patients through AmgenNow (Repatha, Aimovig and AMJEVITA).
**Portfolio.** In 2025 the largest products were:
| Product (2025) | Product sales | Change vs 2024 | What it treats |
|---|---|---|---|
| Prolia | $4.41B | +1% | Osteoporosis (denosumab) |
| Repatha | $3.02B | +36% | LDL cholesterol / cardiovascular risk (PCSK9 inhibitor) |
| Otezla | $2.27B | +7% | Psoriasis, psoriatic arthritis (oral PDE4 inhibitor) |
| ENBREL | $2.23B | -33% | Rheumatoid arthritis, psoriasis (U.S. and Canada only) |
| EVENITY | $2.10B | +34% | Osteoporosis (romosozumab; co-marketed with UCB) |
| XGEVA | $2.08B | -6% | Bone complications of cancer (denosumab) |
| TEPEZZA | $1.90B | +3% | Thyroid eye disease |
| BLINCYTO | $1.56B | +28% | B-cell acute lymphoblastic leukemia (CD19 BiTE) |
| Nplate | $1.52B | +5% | Immune thrombocytopenia |
| TEZSPIRE | $1.48B | +52% | Severe asthma, nasal polyps (co-developed with AstraZeneca) |
| KYPROLIS | $1.41B | -6% | Multiple myeloma |
| Aranesp | $1.39B | +4% | Anemia |
| KRYSTEXXA | $1.34B | +13% | Chronic refractory gout |
| Vectibix | $1.18B | +12% | Colorectal cancer |
| Other products | $7.26B | +29% | Includes PAVBLU, UPLIZNA, IMDELLTRA, MVASI, AMJEVITA, TAVNEOS, Neulasta, LUMAKRAS, WEZLANA and others |
In its 2026 earnings releases Amgen groups the portfolio into General Medicine (Repatha, EVENITY, Prolia), Rare Disease (TEPEZZA, KRYSTEXXA, UPLIZNA, TAVNEOS and ultra-rare products), Inflammation (TEZSPIRE, Otezla, ENBREL, plus the AMJEVITA, PAVBLU and WEZLANA biosimilars), Oncology (BLINCYTO, IMDELLTRA, Vectibix, KYPROLIS, LUMAKRAS, Nplate, XGEVA, MVASI) and Established Products (Aranesp, Neulasta, Parsabiv) (Form 8-K, accession 0000318154-26-000124). Amgen has launched eight biosimilars since 2018. They include PAVBLU (a biosimilar of EYLEA) and, in 2025, WEZLANA (STELARA) and BKEMV (SOLIRIS) in the United States.
**Exclusivity.** The RANKL-antibody patents covering Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select European countries, and multiple denosumab biosimilars have since launched. Other dates in the 10-K patent table:
- **EVENITY:** the U.S. antibody patent is listed as expiring April 25, 2026. Formulation and method patents run to 2031–2033.
- **KRYSTEXXA:** the U.S. polypeptide patent is listed as expiring April 11, 2026. Method-of-treatment patents run to 2040.
- **Repatha:** U.S. antibody patent to August 2029, method patents to 2032.
- **Otezla:** U.S. compound patent to February 2028, with pediatric exclusivity to August 16, 2028.
- **ENBREL:** U.S. fusion-protein and DNA patents to 2028–2029, formulation patents to 2037–2038.
- **TEPEZZA:** U.S. biologic exclusivity to 2032.
**Collaborations.**
- **AstraZeneca (TEZSPIRE):** the two companies share global costs and profits equally after AstraZeneca pays Amgen a mid-single-digit royalty. Amgen books U.S. sales and makes and supplies the product worldwide.
- **UCB (EVENITY):** UCB leads commercialization in most of Europe and Amgen everywhere else. Development costs and commercial profits are shared equally.
- **BeOne Medicines (formerly BeiGene):** Amgen bought an equity stake in January 2020 for about $2.8 billion. The stake was about 17%, worth $5.4 billion, at June 30, 2026 (10-Q). BeOne sells XGEVA, BLINCYTO and KYPROLIS in China, and under a November 11, 2025 amendment it keeps those rights for as long as the products are sold there.
- **Kyowa Kirin (rocatinlimab):** in January 2026 Amgen agreed to end the collaboration and hand the program back to Kyowa Kirin. HSR clearance came in February 2026, and Amgen continues to manufacture the product during a transition period (also Form 8-K, accession 0001193125-26-030518).
**Manufacturing.** The commercial network spans Puerto Rico, Rhode Island, Ohio, California, Ireland, the Netherlands and Singapore, and a substantial majority of commercial manufacturing is done in Puerto Rico. Most clinical manufacturing is in Thousand Oaks, California. The Horizon acquisition added more than 30 contract manufacturers, many of them single-source. Amgen opened a drug-substance plant in Holly Springs, North Carolina, in January 2025, broke ground on a second plant there, and announced expansions in Ohio and Puerto Rico. In December 2025, in recognition of its U.S. manufacturing investment, Amgen received relief from Section 232 pharmaceutical tariffs for approximately three years.
**R&D and pipeline.** R&D expense was $7.3 billion in 2025, up from $6.0 billion in 2024. Of the 2025 total, $4.3 billion went to later-stage clinical programs. The main late-stage programs are:
- **MariTide** (maridebart cafraglutide): a monthly-or-less-frequent GLP-1 agonist / GIPR antagonist antibody-peptide conjugate for obesity. Six global Phase 3 studies started in 2025, covering weight management with and without type 2 diabetes, cardiovascular outcomes, heart failure and obstructive sleep apnea.
- **Olpasiran:** an siRNA that lowers Lp(a).
- **Xaluritamig:** a STEAP1 BiTE for prostate cancer.
- **Dazodalibep:** a CD40L inhibitor for Sjögren's disease.
- **Life-cycle programs:** TEZSPIRE in COPD and eosinophilic esophagitis, and IMDELLTRA in earlier-line small cell lung cancer.
- **Biosimilar candidates:** versions of OPDIVO, KEYTRUDA and OCREVUS.
- **Dropped:** in February 2026 Amgen said it would not seek approval of bemarituzumab in first-line gastric cancer.
**People.** About 31,500 staff in more than 50 countries at December 31, 2025, of whom about 13,000 were outside the United States.
**How the portfolio was assembled.** Several growth products were acquired:
- Otezla, from Bristol Myers Squibb in November 2019.
- TAVNEOS, through the ChemoCentryx acquisition in October 2022.
- TEPEZZA, KRYSTEXXA and UPLIZNA, through the $27.8 billion acquisition of Horizon Therapeutics on October 6, 2023. Horizon was funded largely with $24.0 billion of senior notes and a $4.0 billion term loan.
The 10-K risk factors also name Dark Blue Therapeutics among Amgen's acquisitions. The filings reviewed do not disclose terms for that transaction. Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987.
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## Risk factors
*From the FY2025 Form 10-K (accession 0000318154-26-000010), Item 1A, as updated by Part II, Item 1A of the Q2 2026 Form 10-Q (accession 0000318154-26-000126).*
**1. U.S. drug-pricing policy is cutting net prices on specific products.**
- **IRA Medicare price setting:** CMS-set Medicare Part D prices took effect for ENBREL on January 1, 2026 and take effect for Otezla in January 2027, "in each case at significantly lower levels". Other Amgen products may be selected in later cycles. The Part D redesign shifts costs to manufacturers, and IRA inflation penalties have already applied to several products.
- **MFN pricing:** Amgen received the July 2025 MFN Letter, and in December 2025 it said it is taking actions that satisfy the letter's components, including MFN pricing requests. It also participates in CMS's GENEROUS Medicaid supplemental-rebate model. The Administration has asked Congress to write these terms into law, possibly with broader reach.
- **340B Program:** expanded use of 340B discounts has already hurt sales. Twenty-two states have enacted laws imposing mandates on manufacturers in the program.
- **State PDABs and importation:** Colorado's prescription drug affordability board set an upper payment limit for ENBREL effective no earlier than January 1, 2027, though implementation is preliminarily enjoined. Washington's PDAB has selected ENBREL for an affordability review. The FDA authorized Colorado's drug-importation program in June 2026, which could affect small-molecule products.
**2. Biosimilar and generic competition.**
- **Denosumab:** Prolia and XGEVA are now in "accelerated sales erosion" from multiple biosimilar launches in the United States and abroad.
- **Otezla:** generics entered certain European countries in the first quarter of 2026.
- **Speed of losses:** the company warns it can lose the majority of a product's revenue very quickly after exclusivity ends. Sensipar is its own example.
- **Regulatory trends:** regulators are loosening biosimilar pathways (for example, dropping comparative efficacy trials and expanding interchangeability), which could speed competition.
- **Defense:** Amgen is defending exclusivity in court, including BPCIA suits against denosumab biosimilar makers and ANDA suits over KYPROLIS and TAVNEOS.
**3. The IRS transfer-pricing dispute.** The IRS says too much profit was allocated to Amgen's Puerto Rico operations.
- **2010–2012:** the IRS seeks about $3.6 billion of additional federal tax plus interest, reduced by up to about $900 million of repatriation tax already paid.
- **2013–2015:** the IRS seeks about $5.1 billion plus interest and about $2.0 billion of penalties, reduced by up to about $2.2 billion of repatriation tax already paid.
- **Tax Court timing:** the consolidated case was tried from November 2024 to January 2025. Supplemental closing briefs were filed May 20, 2026, and Amgen expects a decision no earlier than late 2026 or early 2027.
- **2016–2018:** a draft notice of proposed adjustment (NOPA) for these years arrived in April 2026. The 10-Q says that if it were sustained in full it "could have a material impact" on the financial statements.
- **2019–2022:** the IRS began auditing these years in Q2 2026.
- **Other tax exposure:** the OECD minimum tax, the 2025 U.S. tax law ("OB3"; foreign earnings now taxed at 12.6%), and Puerto Rico (incentive grants through 2050) and Singapore (grant through 2036) tax incentives.
**4. Regulators can revisit approvals.**
- **TAVNEOS:** this is the live example. On April 27, 2026, the FDA's drug center (CDER) proposed withdrawing approval. It alleged a lack of substantial evidence of effectiveness and untrue statements in ChemoCentryx's original application, and the proposal followed a March 2026 Drug Safety Communication about serious and fatal liver injury. TAVNEOS stays on the market while the process runs. Its intangible asset carried $2.4 billion at June 30, 2026, $2.3 billion of it attributable to the U.S. market.
- **LUMAKRAS:** still on accelerated approval after a 2023 Complete Response Letter.
- **EVENITY:** carries a postmarketing cardiovascular-safety requirement.
- **FDA capacity:** staffing and budget cuts at the FDA could slow reviews.
**5. Litigation.**
- **Regeneron antitrust:** in May 2025 a jury found for Regeneron on antitrust and tortious-interference claims over Amgen's bundled contracting of Repatha with ENBREL and Otezla. The damages total $406.8 million under either alternative theory, and the antitrust portion is subject to trebling. As of the 10-K, Amgen had not accrued a liability, judging a loss not probable.
- **ENBREL patent antitrust:** a CareFirst class action, a Sandoz suit and several insurer suits allege that a 2004 patent arrangement with Roche delayed ENBREL biosimilars.
- **Securities and IP:** the parties to the shareholder class action over the IRS disclosure have agreed to settle, subject to court approval (see Subsequent events), and Regeneron's patent suits target PAVBLU.
**6. Manufacturing concentration and supply.**
- **Puerto Rico:** the plant there handles a substantial majority of commercial production.
- **Contract manufacturers:** many are single-source. One of them produces all KRYSTEXXA drug substance in Israel and is exposed to the Middle East conflict.
- **Recalls:** in June 2026 Amgen recalled certain lots of KYPROLIS in Türkiye and of Corlanor and Sensipar in the United States. The company says these recalls were not significant.
- **Expansion projects:** these carry construction, validation and tariff-cost risk.
**7. Customer and payer concentration.** Three wholesalers account for most U.S. sales. The six largest PBMs, all now part of major insurers, handle 94% of prescription claims according to an FTC interim report, which gives them leverage over rebates and formulary access.
**8. Cybersecurity and AI.** Attacks on cloud-hosted data, third-party vendors and AI-enabled threats are rising. Amgen reported a material cybersecurity incident on July 31, 2026 (see Subsequent events).
**9. Acquisitions and leverage.** Large deals bring integration and impairment risk. Otezla's intangible asset has already been written down after its early Medicare price-setting selection. Debt-funded deals can hurt credit ratings, as the Horizon financing did. Senior notes were rated BBB+ (S&P), Baa1 (Moody's) and BBB+ (Fitch) at December 31, 2025.
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## Management's discussion: fiscal 2025
*From the FY2025 Form 10-K (accession 0000318154-26-000010), Item 7.*
| ($ millions, except EPS) | 2025 | 2024 | Change |
|---|---|---|---|
| Product sales | 35,148 | 32,026 | +10% |
| Other revenues | 1,603 | 1,398 | +15% |
| Total revenues | 36,751 | 33,424 | +10% |
| Operating expenses | 27,671 | 26,166 | +6% |
| Operating income | 9,080 | 7,258 | +25% |
| Net income | 7,711 | 4,090 | +89% |
| Diluted EPS | $14.23 | $7.56 | +88% |
**Sales.** Product sales grew 10% on 13% volume growth, partly offset by a 3% decline in net selling price. U.S. volume rose 13% and ROW volume 14%. The growth came mainly from:
- **Repatha:** +36% to $3.0 billion.
- **EVENITY:** +34%.
- **TEZSPIRE:** +52%.
- **BLINCYTO:** +28%.
- **IMDELLTRA and PAVBLU** also contributed.
The main drag was ENBREL, down 33% to $2.2 billion. Its net selling price fell 36% because of a higher 340B mix, the Medicare Part D redesign and higher commercial discounts. Prolia still grew 1% despite the February 2025 U.S. patent expiry. Other revenues rose 15%, mainly on royalties.
**Costs.**
- **Cost of sales:** fell to 32.8% of revenues from 38.5%, as amortization of Horizon intangibles and the inventory step-up declined.
- **R&D:** rose 22% to $7.3 billion, driven by later-stage programs including MariTide. The 10-K notes the increase includes the impact of 2025 business development activity.
- **Other operating expenses:** $1.3 billion, including $1.2 billion of Otezla intangible impairments after its selection for Medicare price setting.
**Below the line.**
- **Interest expense:** fell to $2.8 billion as Amgen paid down debt.
- **Other income:** rose to $2.7 billion, mainly unrealized gains on the BeOne stake.
- **Tax rate:** 14.1%.
**Cash and capital.**
- **Cash flow:** operating cash flow was $10.0 billion, down from $11.5 billion, largely on working-capital timing. Capital expenditures were $1.9 billion, and the 2026 capital budget is about $2.6 billion.
- **Debt:** Amgen retired $6.0 billion of debt, made up of $5.0 billion of repayments and $1.0 billion of repurchases bought for $683 million, a $264 million gain.
- **Dividends and buybacks:** dividends paid totaled $5.1 billion, at $2.38 per quarter. There were no buybacks in 2025, and $6.8 billion of authorization remained.
- **Year-end balance sheet:** at December 31, 2025, cash was $9.1 billion, total debt (carrying value) $54.6 billion and stockholders' equity $8.7 billion. The equity figure is low because cumulative buybacks and dividends have left an accumulated deficit.
- **Commitments:** purchase obligations were about $6.9 billion, and potential milestone payments to partners could total up to about $7.2 billion.
**2026 outlook (as stated in the 10-K).** Management expects volume growth to be partly offset by net price declines, and accelerated erosion of Prolia and XGEVA. It also expects the usual seasonally weak first quarter for ENBREL, Otezla, Repatha, TEZSPIRE and KRYSTEXXA, and a mid-single-digit decline in Repatha's net selling price.
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## Current quarter: Q2 2026 (three months ended June 30, 2026)
*From the Q2 2026 Form 10-Q (accession 0000318154-26-000126); free cash flow, therapeutic-area groupings, pipeline updates and guidance are from the second-quarter earnings release furnished on Form 8-K (accession 0000318154-26-000124).*
| ($ millions, except EPS) | Q2 2026 | Q2 2025 | Change | H1 2026 | H1 2025 | Change |
|---|---|---|---|---|---|---|
| U.S. product sales | 6,990 | 6,324 | +11% | 12,763 | 11,986 | +6% |
| ROW product sales | 2,547 | 2,447 | +4% | 4,992 | 4,658 | +7% |
| Total revenues | 10,054 | 9,179 | +10% | 18,672 | 17,328 | +8% |
| Operating income | 3,514 | 2,656 | +32% | 6,180 | 3,834 | +61% |
| Net income | 2,375 | 1,432 | +66% | 4,194 | 3,162 | +33% |
| Diluted EPS | $4.37 | $2.65 | +65% | $7.71 | $5.84 | +32% |
**Volume, not price, drove the quarter.** Product sales rose 9%, all from volume: U.S. volume grew 9% and ROW volume 8%. Other revenues rose 27% to $517 million on higher partner revenue and royalties. Amgen says 22 products grew at least at a double-digit rate and 17 are on a run rate above $1 billion a year.
**Growth products:**
- **Repatha:** $953 million, +37%.
- **EVENITY:** $714 million, +38%.
- **TEZSPIRE:** $486 million, +42%.
- **UPLIZNA:** $335 million, +90%, after its 2025 approvals in IgG4-related disease and generalized myasthenia gravis.
- **IMDELLTRA/IMDYLLTRA:** $288 million versus $134 million.
- **PAVBLU:** $287 million versus $130 million. The release attributes this to PAVBLU being the only commercially available EYLEA biosimilar in the United States during the period.
- **BLINCYTO:** $472 million, +23%.
- **Nplate:** +17%.
- **KRYSTEXXA:** +15%, on a 23% higher net price.
- **TEPEZZA:** +14%.
**Declining products:**
- **Prolia:** $759 million, -32%, from 20% lower volume and a 12% lower net price as denosumab biosimilars spread.
- **XGEVA:** $352 million, -34%.
- **Otezla:** $491 million, -21%, from a 9% lower net price, 6% lower volume and European generics.
- **ENBREL:** $580 million, -4%. Medicare Part D price setting and a higher 340B mix cut its net price 22%, but favorable changes to estimated sales deductions added 16%.
- **KYPROLIS:** $314 million, -17%, on lower volume.
**Margins widened mostly because acquisition accounting is rolling off.**
- **Cost of sales:** fell to 28.0% of total revenues from 32.8%. Intangible amortization dropped to $890 million from $1.1 billion, and the Horizon inventory step-up charge to $60 million from $339 million. Higher profit-share expense, manufacturing costs and mix partly offset the decline.
- **R&D:** rose 7% to $1.87 billion, led by MariTide.
- **SG&A:** rose 3% to $1.75 billion.
- **Other operating expense:** $116 million of litigation costs.
- **Total operating expenses:** essentially flat at $6.54 billion.
- **Non-operating items:** other expense narrowed to $73 million from $394 million because the unrealized loss on BeOne shares was smaller ($227 million versus $570 million).
- **Tax rate:** rose to 14.2% from 8.7% on earnings mix.
**Cash flow and balance sheet.**
- **Operating cash flow:** $6.2 billion in the first half, up from $3.7 billion. The prior-year half included the final $1.8 billion repatriation-tax payment.
- **Capital spending:** first-half capex was $1.2 billion. The release puts second-quarter free cash flow at $3.5 billion, versus $1.9 billion a year earlier.
- **Cash and debt:** cash and equivalents were $14.0 billion at June 30, 2026 and total debt (carrying value) $57.3 billion, of which $5.4 billion is current.
- **Debt activity:** in the first quarter Amgen issued $4.0 billion of notes due 2031–2056 and repaid €750 million of euro notes ($833 million after the swap). It also repurchased $324 million of principal for $233 million, a $90 million gain.
- **Upcoming maturities:** still due in 2026 are the $1.25 billion 2.60% notes, the $1.8 billion term loan due October 2026 and £475 million of 5.50% sterling notes.
- **Shareholder returns:** no shares were repurchased, and $6.8 billion of authorization remains. The quarterly dividend is $2.52, up 6%.
- **Equity:** stockholders' equity rose to $11.7 billion from $8.7 billion at year-end.
**Outlook.** In the 10-Q MD&A management expects volume growth from certain brands to be partially offset by net selling price declines for the rest of 2026. It continues to expect accelerated erosion for Prolia and XGEVA, and further Otezla price declines once Medicare price setting starts in 2027. The August 4, 2026 release set full-year 2026 guidance as follows:
- **Total revenues:** $38.2–$39.4 billion.
- **GAAP EPS:** $15.80–$17.08.
- **Non-GAAP EPS:** $22.30–$23.50.
- **Capital expenditures:** about $2.6 billion.
- **Share repurchases:** up to $3.0 billion.
**Policy backdrop.** The Administration imposed Section 232 tariffs on certain patented pharmaceuticals in April 2026. Amgen's relief, granted in December 2025, runs for approximately three years from December 2025. Management also flags Middle East conflict disrupting energy, transport and supply chains.
**Pipeline in the quarter (release, accession 0000318154-26-000124).**
- **IMDELLTRA/IMDYLLTRA:** the European Commission authorized IMDYLLTRA for adults with extensive-stage small cell lung cancer whose disease progressed on or after first-line platinum-based chemotherapy, and China's NMPA granted IMDELLTRA full approval; BeOne will commercialize it in China. A Phase 3 study of subcutaneous tarlatamab (DeLLphi-315) began.
- **MariTide:** nine Phase 3 studies are ongoing or enrolling, and three type 2 diabetes Phase 3 studies are planned for 2026.
- **Discontinued:** Amgen discontinued future development of its second obesity candidate, AMG 513.
- **BLINCYTO:** two subcutaneous blinatumomab studies paused enrollment of new patients under an FDA partial clinical hold.
- **Other programs:** Sunakiment (inhaled anti-TSLP, with AstraZeneca) finished Phase 2 and is moving toward Phase 3 in asthma. Dazodalibep's two Phase 3 Sjögren's studies are expected to complete in the second half of 2026.
**TAVNEOS.** Second-quarter TAVNEOS sales were $150 million. After assessing the FDA proposal and U.S. patient trends, Amgen concluded at June 30, 2026 that the $2.4 billion carrying value of the TAVNEOS intangible asset remains recoverable. It cautioned that future changes in estimated cash flows could change that conclusion.
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## Subsequent events (after June 30, 2026)
*The Q2 2026 Form 10-Q (accession 0000318154-26-000126) has no separate subsequent-events note. The post-quarter developments below come from its notes and MD&A and from Forms 8-K as cited.*
**No acquisitions, divestitures or new financings.** No post-quarter acquisition, divestiture, debt issuance or borrowing is disclosed in the 10-Q or in the Forms 8-K filed through August 5, 2026.
**Dividend.** In July 2026 the Board declared a quarterly dividend of $2.52 per share, payable in September 2026.
**Cybersecurity incident (Form 8-K, accession 0000318154-26-000119).**
- **What happened:** in July 2026 Amgen found unauthorized activity involving data stored in cloud environments hosted by third-party providers. Some data was exfiltrated, including proprietary data and patients' protected health information.
- **Materiality:** on July 29, 2026 the company determined the incident is material because of the volume and possible sensitivity of the files involved.
- **Impact so far:** Amgen has found no impact on products, manufacturing or financial reporting systems. It believes the incident is not reasonably likely to have a material impact on its financial condition or results.
- **Status:** the investigation was ongoing at filing.
**TAVNEOS.** On July 23, 2026 Amgen filed materials supporting its June 1 request for an FDA hearing on the proposed withdrawal. These included new real-world evidence and an independent, blinded re-adjudication of the pivotal-trial data. If the FDA denies a hearing, it may enter summary judgment and withdraw approval.
**IRS.** In July 2026 the IRS reissued its 2016–2018 NOPA in substantially the same form. Amgen intends to contest it.
**Litigation.**
- **PAVBLU / Regeneron:** on July 7, 2026, the U.S. District Court for the Northern District of West Virginia granted in part Regeneron's motion against Amgen's defenses and counterclaims in the '099 patent case.
- Dismissed with prejudice: Amgen's inequitable-conduct defense, its unenforceability counterclaim, its Sherman Act and California unfair-competition counterclaims tied to the '099 patent, and its patent-misuse and unclean-hands defenses.
- Dismissed without prejudice: the antitrust and unfair-competition counterclaims tied to the patents in the 2024 action.
- Surviving: the prosecution-laches defense and counterclaim.
- **Roofers securities class action:** the parties to this suit over the disclosure of the IRS tax dispute have agreed to settle, subject to court approval. On July 20, 2026 the plaintiffs moved for preliminary approval of the class settlement in the Southern District of New York. The settlement amount is not disclosed.
- **ChemoCentryx securities class action:** objections to the settlement were due September 21, 2026, and a final-approval hearing is set for October 29, 2026 in the Northern District of California.
**Management.** Thomas Dittrich, previously CFO of Galderma, was hired to serve as an Executive Vice President effective July 1, 2026 and to become Chief Financial Officer effective September 1, 2026, succeeding Peter H. Griffith, who retires from the role on August 31, 2026 (Form 8-K, accession 0000318154-26-000097).