Amgen Q2 2026: Strong Beat and Raised Guidance, but TAVNEOS Withdrawal Threat and Tax Dispute Loom
AMGN sits 46% above its 52-week low of $269.77.
Summary
Amgen beat Q2 estimates and raised guidance, but the FDA's proposal to withdraw TAVNEOS and the unresolved $10.7B IRS tax dispute create major overhangs.
Key Events · Earnings and Guidance · AMGN
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Q2 Earnings Beat and Raised Guidance
Revenue of $10.1B and non-GAAP EPS of $6.29 exceeded consensus estimates of $9.9B and $5.62, respectively. Full-year guidance was raised, driven by volume growth across key products.
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TAVNEOS FDA Withdrawal Proposal
The FDA proposed withdrawing TAVNEOS, a $2.4B intangible asset, citing lack of effectiveness evidence and data integrity issues. Amgen requested a hearing and submitted additional data; the drug remains on the market pending the process.
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IRS Tax Dispute Update
The IRS issued a NOPA for 2016–2018 seeking additional taxes related to profit allocation. The Tax Court trial for 2010–2015 concluded; a decision is expected no earlier than late 2026. Total potential liability exceeds $10.7B plus penalties and interest.
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AstraZeneca Collaboration Amendment
Amendment No. 10 added AMG883 as a product under the collaboration, with Amgen as initial development lead and Partner as commercial lead. The amendment includes new intellectual property and termination provisions.
Analysis · AMGN · Life Sciences
A strong Q2 beat—revenue of $10.1B and non-GAAP EPS of $6.29, both above consensus—and raised full-year guidance highlight Amgen's operational momentum. Yet the quarter was overshadowed by the FDA's formal proposal to withdraw TAVNEOS, a $2.4B intangible asset, over safety and data integrity concerns. Adding to the uncertainty, the ongoing IRS tax dispute, with a potential $10.7B liability, remains unresolved, and a new NOPA for 2016–2018 introduces further risk. The company also disclosed a material cybersecurity breach and amended its AstraZeneca collaboration to add AMG883. Strong operational performance is tempered by significant regulatory and legal headwinds.
At the time of this filing, AMGN was trading at $393.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $210.5B. The 52-week trading range was $269.77 to $398.00. This filing was assessed with neutral market sentiment and an importance score of 8 out of 10.