Feb 4 (Reuters) -
Amgen ( AMGN ) posted a higher quarterly profit on Tuesday,
driven by an 11% rise in product sales, and said late-stage
studies of key obesity drug candidate MariTide will start before
mid-year but regulators have placed a hold on an early-stage
trial of a different experimental weight-loss drug.
The California-based biotech company said adjusted
fourth-quarter earnings rose 13% from a year earlier to $5.31
per share, beating the $5.08 estimated by analysts, according to
LSEG data.
Net earnings fell 18% to $1.16 per share, due mainly to
losses on equity investments.
Quarterly revenue rose 11% to $9.1 billion, which exceeded
analyst estimates of $8.52 billion.
For full-year 2025, Amgen ( AMGN ) said it expects adjusted earnings
per share of $20.00 to $21.20 on revenue of $34.4 billion to
$35.7 billion. Analysts have forecast EPS of $20.82 on revenue
of $33 billion.
The outlook is "demonstrative of our confidence and
conviction of being able to grow through the denosumab loss of
exclusivity this year," Amgen CFO Peter Griffith said, referring
to the expiration of patents on the company's drugs for bone
diseases like osteoporosis. He expects biosimilar competition
sometime in the middle of this year.
Amgen ( AMGN ) investors have been focused on prospects for MariTide,
which activates the appetite- and blood sugar-reducing hormone
known as GLP-1 while blocking a second gut hormone called GIP.
The drug, given by injection once monthly or less often, was
shown in a mid-stage trial to help overweight or obese patients
shed up to 20% of their body weight.
Amgen ( AMGN ) on Tuesday said follow-up data from that study, and
from a trial of the drug in people with diabetes, are expected
in the second half of this year.
The company said the first studies in a broad Phase 3
program for MariTide, which could provide data enabling
regulatory approval of the medicine, are expected to begin in
the first half of this year.
It also said a Phase 1 study of a drug known as AMG 513 in
people living with obesity was placed on clinical hold by the
U.S. Food and Drug Administration. The regulatory agency issues
holds to protect trial participants from unreasonable risk and
to ensure that studies are conducted properly.
Amgen ( AMGN ), which has not disclosed a mechanism of action for AMG
513, said discussions are underway on a path forward to reopen
the study.
The company's fourth-quarter sales of cholesterol-lowering
medication Repatha rose 45% to $606 million, while sales of bone
drug Prolia rose 5% to $1.2 billion and sales of arthritis drug
Enbrel were flat at $1 billion.
In the rare disease space, Amgen's ( AMGN ) sales of thyroid eye
disease drug Tepezza rose 3% to $460 million, and sales of gout
treatment Krystexxa rose 27% to $346 million.