Amgen

Refresh delta (since 2026-06-18)

1. Q2 2026: total revenues $10,054M, +10% YoY (Q2 2025: $9,179M); product sales $9,537M, +9% on volume [10-QForm 10-QThe quarterly version of the annual report. Lighter, and not audited., statements of income; 8-KForm 8-KA filing for something that happened between reports and matters enough to tell shareholders now. Q2]. GAAP operating income $3,514M (Q2 2025: $2,656M), GAAP operating margin 36.8% of product sales; GAAP EPS $4.37 against $2.65; non-GAAP EPS $6.29 against $6.02 (+4%); non-GAAP operating margin 48.4%, down 0.5 point [8-K Q2]. Free cash flowFree cash flowCash left after paying to run and maintain the business. Unlike profit, it is hard to flatter with accounting choices. $3.5B against $1.9B a year earlier, the company attributing the rise partly to the absence of a repatriation-tax payment made in Q2 2025 [8-K Q2]. The release says six key growth drivers grew 26% and were nearly 70% of Q2 product sales, and that 17 products annualize above $1B.

2. 2026 guidance (as given in the release): total revenues $38.2B to $39.4B; GAAP EPS $15.80 to $17.08; non-GAAP EPS $22.30 to $23.50; capexCapital expenditureMoney spent on long-lived things — buildings, machines, servers — rather than on running costs. about $2.6B; share repurchases not to exceed $3.0B [8-K Q2, 2026 Guidance]. The GAAP-to-non-GAAP bridge lists acquisition-related expenses of $6.04 to $6.12 per share [8-K Q2, guidance reconciliation]. No prior guidance is on the shelf (our figures is header-only), so no change is stated.

3. Product sales, Q2 2026 against Q2 2025 [8-K Q2, product table]: growth products: Repatha $953M (+37%), EVENITY $714M (+38%), TEZSPIRE $486M (+42%), UPLIZNA $335M (+90%), IMDELLTRA $288M (more than doubled), PAVBLU $287M, TEPEZZA $576M (+14%), KRYSTEXXA $400M (+15%), BLINCYTO $472M (+23%). Legacy and exposed products: Prolia $759M (−32%; volume −20%, net price −12%, as multiple biosimilars launched), XGEVA $352M (−34%), Otezla $491M (−21%), Enbrel $580M (−4%; net selling price −22% from IRA Medicare Part D price setting effective 2026-01-01 and 340B mix, partly offset by deduction estimates), KYPROLIS $314M (−17%), MVASI $153M (−20%). TAVNEOS sales were $150M (+36%) [8-K Q2]; the FDA process around it is in fact 3a.

3a. TAVNEOS: the withdrawal process is live and documented in the 10-Q. On 2026-01-16 the FDA asked Amgen to withdraw TAVNEOS voluntarily over questions about the analysis and adjudication of study data behind the original approval; Amgen declined on 2026-01-28. The FDA issued a Drug Safety Communication on 2026-03-31 on serious liver injury including fatal cases; the US label's hepatotoxicity warning was updated in May 2026. On 2026-04-27 CDER proposed to withdraw approval, alleging new information of lack of substantial evidence of effectiveness and untrue statements of material fact in the original application; the Federal Register notice followed on 2026-04-30. Amgen requested a hearing on 2026-06-01 and submitted supporting data, including a blinded re-adjudication, on 2026-07-23; if no hearing is granted the FDA may enter summary judgment and withdraw approval. The 10-Q says TAVNEOS remains on the market during the process and that the carrying value of the TAVNEOS developed-product-technology rights, $2.4B at 2026-06-30 ($2.3B for the US), remains recoverable on the company's evaluation, with future cash-flow changes able to affect that [10-Q, intangible assets note and risk factors]. The prior seed lists "TAVNEOS FDA withdrawal process" as a 2026 catalyst and cites intangible/TAVNEOS impairment as a risk; the prior dossier text is not edited.

1. MariTide programme status per the release: Phase 3 MARITIME-1 (without type 2 diabetes) and MARITIME-2 (with it) are ongoing; MARITIME-CV, MARITIME-HF, MARITIME-OSA-1 and -2, MARITIME-SWITCH and the two extension studies are enrolling; three Phase 3 studies in type 2 diabetes will start in 2026; a Phase 2b liver-fat study is enrolling; future development of AMG 513 will be discontinued, its Phase 1 study continuing [8-K Q2, product and pipeline update]. The release gives no Phase 3 obesity readout date. Higher R&D for later-stage programmes, "primarily those related to MariTide," is cited as a driver of operating expense growth [8-K Q2].

2. IRS dispute: the Tax Court decision timing moved out, and a further assessment is in draft. The 10-Q states the 2010-2012 notices seek about $3.6B of additional federal tax plus interest and the 2013-2015 notice about $5.1B plus interest and about $2.0B of penalties, each reducible by repatriation tax already paid (up to about $0.9B and $2.2B); supplemental closing briefs were filed on 2026-05-20; and "The Company expects a decision from the U.S. Tax Court no earlier than late 2026 or early 2027." For 2016-2018, the IRS issued a draft notice of proposed adjustment in April 2026, reissued in May and July 2026 in substantially the same form, which the 10-Q says "could have a material impact" if sustained in full and which Amgen intends to contest; the IRS began auditing 2019-2022 in Q2 2026 [10-Q, income taxes note]. The prior seed's catalyst reads "US Tax Court decision... 2H 2026" and its bear line cites "~$10.7B"; $10.7B is the sum of the three amounts above before interest and credits.

3. Balance sheet, 2026-06-30 against 2025-12-31 [10-Q balance sheet and debt note]: cash and equivalents $13,989M ($9,129M); trade receivables $10,227M ($9,570M); inventories $6,220M ($6,225M); intangible assets $20,487M ($22,276M); total debt carrying value $57,304M ($54,604M), of which $5,445M current; stockholders' equity $11,688M ($8,658M). The company issued $4.0B of notes in Q1 2026 and repurchased $324M of debt principal in the first half; no share repurchases in Q2; the Q2 dividend was $2.52 per share, +6% [10-Q; 8-K Q2]. The prior seed cites equity of "just $8.7B"; that was the 2025-12-31 figure.

4. Cybersecurity incident, 8-K Item 1.05, filed 2026-07-31. Amgen says that in July 2026 it identified unauthorized activity involving data stored in cloud environments hosted by third-party providers, that some data, "including proprietary data, patient protected health information, and other information," was exfiltrated, that on 2026-07-29 it determined the incident to be material, and that as of the filing it believes the incident is not reasonably likely to have a material impact on its financial condition or results. It reports no identified impact on products, manufacturing, financial reporting systems or patient supply; the investigation is ongoing and notifications, including to affected patients, will follow, with an 8-K amendment promised for information not yet determined [8-K 1.05]. The 10-Q text was searched for "cloud environments" and "third-party cloud" and has no match; its cyber risk factor mentions earlier incidents that were closed after forensic review [10-Q, Item 1A].

5. Other 10-Q items: the 10-Q describes IRA Medicare price setting for Otezla beginning 2027-01-01 [10-Q, intangible assets note], consistent with the prior seed's "Otezla IRA negotiated price effective, Jan 1 2027." The December 2025 company statement that it is taking actions satisfying the July 2025 MFN letter is repeated in the 10-Q's regulatory text [10-Q, MD&A].

What held

• The patent-cliff relay race the verdict describes is visible in the product table: growth products up 14% to 121% while Prolia, XGEVA and Otezla fell 21% to 34% (fact 3).
• The IRS exposure the seed names is still unresolved and has not shrunk: the decision is not expected before late 2026 or early 2027, and a 2016-2018 draft adjustment is outstanding (fact 5).
• MariTide remains in Phase 3 with no readout date given (fact 4); the seed's catalyst "MariTide Phase 3 obesity readouts begin, 2026-2027" is not settled by anything read.
• The dividend grew 6%, there were no share repurchases in Q2, and the company repurchased $324M of debt principal in the first half (fact 6).