Amgen (AMGN) Q1 2026 earnings review
Growth Engine Outruns the Patent Cliff—Barely
Amgen delivered a 6% revenue increase in Q1, driven by 9% volume growth that successfully absorbed pricing headwinds. The underlying story is a fierce tug-of-war: 16 newer brands achieved double-digit growth, but the company's legacy pillars are collapsing fast. Prolia (-34%) and Enbrel (-37%) are bleeding revenue due to biosimilars and the Inflation Reduction Act. Despite these massive drags, strong momentum from Repatha, IMDELLTRA, and TEZSPIRE pushed earnings up 5%, leading management to slightly raise 2026 guidance. However, a surprise FDA proposal to withdraw the rare-disease drug TAVNEOS creates a serious regulatory overhang.
🐂 Bull Case
Volume growth of 9% indicates strong real-world demand. 16 products are growing at double-digit rates, proving Amgen's transition away from its aging blockbuster drugs is working.
IMDELLTRA is rapidly becoming a standard of care in small cell lung cancer, skyrocketing 219% YoY to $258M, while the broader BiTE oncology platform continues to gain share.
🐻 Bear Case
The combined $400M+ YoY quarterly revenue loss from Prolia and Enbrel shows how violently biosimilars and Medicare negotiations can destroy legacy cash cows.
The FDA's unexpected proposal to withdraw approval for TAVNEOS ($119M Q1 sales) over effectiveness and liver toxicity concerns puts a fast-growing asset—and the $3.9B ChemoCentryx acquisition thesis—in jeopardy.
⚖️ Verdict: ⚪
Neutral to slightly Bullish. Amgen is executing well on its new product launches, but the severe declines in Prolia and Enbrel mean the company is running hard just to stay in place. The TAVNEOS situation requires close monitoring.
Key Themes
The Patent Cliff and IRA Reality
Management highlights that 16 brands achieved double-digit growth, but the actual total top-line growth is a Decelerating 6% YoY. Why? Because legacy segments are Reversing violently. Prolia sales crashed 34% YoY to $727M due to accelerating global biosimilar competition. Worse, Enbrel collapsed 37% to $320M—a direct result of Medicare Part D price setting under the Inflation Reduction Act (IRA) and an unfavorable 340B program mix. These macroeconomic and competitive headwinds will remain a massive drag on top-line growth.
TAVNEOS Regulatory Crisis
A major new risk emerged: The FDA proposed withdrawing approval for TAVNEOS (a drug acquired via the ChemoCentryx buyout). The FDA cited a lack of substantial effectiveness and alleged 'untrue statements of material facts' from the prior owner, alongside known liver toxicity risks. While Amgen is fighting the decision and keeping the drug on market for now, this threatens an asset that grew 32% YoY to $119M this quarter.
Targeted Oncology is Surging
Amgen's oncology portfolio is Accelerating rapidly, validating its R&D strategy. IMDELLTRA (tarlatamab) surged 219% YoY to $258M, driven by strong uptake in small cell lung cancer. BLINCYTO also grew 12% to $415M. The BiTE (bispecific T-cell engager) platform is successfully creating new standards of care and replacing the revenue lost from older supportive care drugs.
General Medicine Volume Offsets Price Compression
The core cardiovascular and bone health portfolio remains highly Stable and robust. Repatha sales grew 34% YoY to $876M, entirely driven by volume (+35%) which easily absorbed a 7% net price decline. EVENITY grew 27% to $562M. New Phase 3 data from the VESALIUS-CV trial (showing a 31% risk reduction in major cardiovascular events for high-risk diabetes patients) should further cement Repatha's growth trajectory.
MariTide Pipeline Maximization
Amgen is betting heavily on its obesity drug candidate, MariTide. Instead of just pursuing weight loss, the company is actively enrolling Phase 3 trials across an array of indications: cardiovascular outcomes, heart failure, and sleep apnea. Furthermore, they are initiating trials specifically targeting patients switching from competitor drugs (tirzepatide/semaglutide) to capitalize on MariTide's more convenient monthly/quarterly dosing schedule.
Other KPIs
Accelerating significantly from $980 million in Q1 2025. This was driven by underlying business performance and favorable working capital timing, even though Capital Expenditures increased to $712 million (up from $411 million a year ago). The strong cash generation easily supported $1.4 billion in dividend payments.
Stable compared to 45.7% a year ago. While GAAP operating margins surged due to rolling off Horizon acquisition-related amortization, the core non-GAAP margin compressed slightly as Amgen aggressively reinvested into R&D (up 16% YoY) to fund its late-stage pipeline, particularly MariTide.
Guidance
Accelerating slightly at the midpoint. This is an upward revision from the initial $37.0B - $38.4B guidance issued at the end of FY25. It reflects confidence that volume growth from newer assets will outpace the accelerating erosion of Prolia and Enbrel.
Accelerating slightly versus the previous $21.60 - $23.00 forecast. The raise comes despite heavy R&D investments, pointing to strong cost discipline in SG&A (which declined 4% YoY in Q1).
Accelerating dramatically. In 2025, guidance was capped at $500 million as the company focused on paying down Horizon acquisition debt. With $3.0 billion now authorized, management is signaling that the balance sheet is repaired and excess cash will flow back to shareholders.
Key Questions
TAVNEOS Defense Strategy
Given the FDA's aggressive stance on withdrawing TAVNEOS and citing 'untrue statements' from the prior owner, what is the exact legal and clinical roadmap to defend the drug, and how much of the $3.9B ChemoCentryx acquisition value is at risk?
Prolia / XGEVA Floor
Prolia sales collapsed 34% this quarter. At what point in 2026 or 2027 do you expect the biosimilar erosion curve to flatten, and what is the terminal value assumption for the denosumab franchise?
MariTide Maintenance Strategy
You are initiating Phase 3 trials specifically for patients switching from weekly tirzepatide/semaglutide. What level of weight retention on an every-8-week or quarterly MariTide dose do you believe is required to convince payers to support a switch?