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MariTide Phase 3 studies to begin in first half of year

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FDA places hold on AMG 513 obesity drug trial

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Amgen's ( AMGN ) Q4 earnings beat estimates, revenue up 11%

(Adds company comment paragraphs 4 and 9, analyst comment in

paragraph 11, updates share price)

By Deena Beasley

Feb 4 (Reuters) - Amgen ( AMGN ) posted a higher

quarterly profit on Tuesday as product sales rose 11% 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 company's shares, which have gained more than 11%

year-to-date, were down about 1% at $285.50 in after-hours

trading.

Amgen ( AMGN ) investors are 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 ) research and development head Jay Bradner said the

full study results will be presented in June at the annual

meeting of the American Diabetes Association in Chicago.

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.

"We're excited about the program and the molecules that are

coming forward to the clinic out of the obesity portfolio," CEO

Bob Bradway said on a conference call.

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. Revenue rose 11% to $9.1 billion, also exceeding

analyst estimates.

"This quarter was decent, but we believe that most investors

are looking past earnings results until the upcoming release of

more data from the mid-stage trial" of MariTide, said Edward

Jones analyst John Boylan.

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.

The guidance "looks OK, bracketing consensus on top and

bottom," Mizuho analyst Salim Syed said in a research note.

Amgen CFO Peter Griffith said the outlook is "demonstrative of

our confidence and conviction of being able to grow through the

denosumab loss of exclusivity this year," 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.

The company's fourth-quarter sales of Prolia, also known as

denosumab, rose 5% to $1.2 billion. Sales of

cholesterol-lowering medication Repatha rose 45% to $606

million, while 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.