Amgen’s newer medicines gain momentum despite pressure on Prolia and XGEVA

Newer medicines drive Amgen’s quarterly growth

Amgen Inc. (NASDAQ:AMGN) grew third-quarter revenue 8% to US$10.4 billion, with higher product volumes helping lift GAAP diluted earnings per share 19% to US$7.08. Product sales reached US$9.9 billion, while 17 medicines delivered double-digit sales growth and 17 products are now annualising at more than US$1 billion based on quarterly sales.

The company’s strongest commercial performers included Repatha, up 37% to US$1.085 billion; EVENITY, up 39% to US$751 million; UPLIZNA, up 191% to US$451 million; and IMDELLTRA, up 128% to US$406 million. TEZSPIRE sales rose 43% to US$538 million, while BLINCYTO increased 27% to US$496 million. Management attributed most of those gains to volume growth.

Biosimilar competition exposes the portfolio’s weak spots

The growth story is not uniform. Prolia sales fell 45% to US$632 million as multiple biosimilars launched globally, with volume down 23% and the remainder of the decline split between lower net selling price and changes to estimated sales deductions. XGEVA, another denosumab product, fell 47% to US$288 million, primarily reflecting a 32% volume decline and an 11% reduction in net selling price.

Otezla sales also declined 18% to US$481 million, while TEPEZZA slipped 6% to US$526 million. Amgen’s established products generated US$606 million, up 14%, although that increase was largely driven by higher net selling price rather than volume. The quarterly numbers therefore show both sides of the portfolio transition: newer products are gaining scale, but mature medicines remain exposed to pricing and competitive erosion.

GAAP profit expands while research spending rises

GAAP operating income climbed to US$3.7 billion from US$2.5 billion, taking operating margin to 37.5% from 27.6%. The improvement reflected lower amortisation expense on acquisition-related assets and lower manufacturing costs, while total GAAP operating expenses fell 5% to US$6.7 billion.

On Amgen’s non-GAAP measure, diluted EPS increased 14% to US$6.45 and operating margin edged up to 47.3%. Non-GAAP operating income was US$4.7 billion, compared with GAAP operating income of US$3.7 billion; the difference primarily reflects acquisition-related costs and other excluded items. Research and development spending increased 11% on both reported measures, driven by research, early-pipeline and business-development activity.

Cash generation softens as Amgen maintains 2026 targets

Free cash flow was US$3.7 billion, down from US$4.2 billion a year earlier, as the prior-year comparison benefited from the timing of rebates and collections. Cash and equivalents stood at US$13.2 billion at September 30, against US$54.0 billion of debt. Amgen paid a quarterly dividend of US$2.52 per share, a 6% increase from the corresponding period last year, and made no share repurchases during the quarter.

The company’s stated full-year 2026 targets call for revenue of US$38.9 billion to US$39.7 billion, GAAP diluted EPS of US$18.34 to US$19.28 and non-GAAP diluted EPS of US$22.90 to US$23.70. Capital expenditure is expected to be about US$2.6 billion, with repurchases not to exceed US$3.0 billion. The release presents those targets as the current outlook, but does not say whether the ranges changed from the previous update.

MariTide and IMDELLTRA headline the pipeline update

Amgen’s pipeline is moving on several fronts. Its obesity candidate MariTide remains in multiple Phase 3 studies, including trials in people with and without type 2 diabetes, cardiovascular disease, heart failure and obstructive sleep apnoea. The company has also started a Phase 3 study comparing MariTide with semaglutide in type 2 diabetes and plans to initiate two more Phase 3 studies in that disease in the fourth quarter.

In oncology, the company reported that the Phase 3 DeLLphi-305 study showed a 58% reduction in the risk of death and a 66% reduction in the risk of disease progression or death when IMDELLTRA was added to IMFINZI in first-line maintenance treatment for small-cell lung cancer. Those are company-reported trial results and remain subject to the relevant regulatory processes. Amgen also said the US Food and Drug Administration had shortened monitoring for the first two IMDELLTRA doses from 22 to 24 hours to six to eight hours in an appropriate healthcare setting, potentially making administration less burdensome.

Regulatory uncertainty remains for TAVNEOS

Not every pipeline and product update was favourable. Amgen continues to engage with the FDA after the agency’s Center for Drug Evaluation and Research requested voluntary withdrawal of TAVNEOS from the US market. The company requested a hearing in June and submitted supporting materials in July, while TAVNEOS sales fell 2% to US$105 million in the quarter.

The next test for Amgen is whether volume-led growth in Repatha, UPLIZNA, TEZSPIRE and IMDELLTRA can keep compounding quickly enough to absorb biosimilar losses in Prolia and XGEVA. The financial outlook is intact for now; the more consequential question sits further out, with MariTide’s late-stage trials and IMDELLTRA’s expanding indications carrying the burden of proving that today’s portfolio momentum can last.