Earnings roundup: Amgen vs. FDA, Pfizer’s defense and Merck’s $70B-in-sales plan

Core Insights - Amgen reported $35.1 billion in annual product sales for the previous year, marking a 10% increase, with 14 medicines exceeding $1 billion in sales and 18 achieving their best commercial year [2] - In the fourth quarter, Amgen's product sales reached nearly $9.4 billion, surpassing Wall Street expectations, and the company provided optimistic financial guidance for 2026, projecting total revenue between $37 billion and $38.4 billion and earnings per share between $15.45 and nearly $17 [3] - Despite strong performance, Amgen faced challenges as the FDA requested the withdrawal of Tavneos, a drug acquired through a $4 billion purchase, due to concerns over liver health risks and trial result handling [4][5] Financial Performance - Amgen's annual product sales of $35.1 billion represented a 10% increase year-over-year, with significant contributions from multiple high-performing drugs [2] - The fourth quarter sales of almost $9.4 billion were described as "very high quality," exceeding market expectations [3] - Financial guidance for 2026 indicates potential revenue growth, with estimates suggesting a range of $37 billion to $38.4 billion [3] Regulatory Challenges - The FDA's request to withdraw Tavneos was based on concerns regarding its safety profile and the clinical trial process [4][5] - Amgen remains confident in Tavneos, stating it will not withdraw the drug and will work with the FDA to find a path forward [6] - The financial impact of Tavneos is expected to be limited, as it generated $459 million last year, accounting for less than 1% of overall revenue [7]