Amgen profits rise, next MariTide studies start by mid-year

• MariTide Phase 3 studies to begin in first half of year
• FDA places hold on AMG 513 obesity drug trial
• Amgen's Q4 earnings beat estimates, revenue up 11%

Feb 4 (Reuters) - Amgen AMGN.O 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 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 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, 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 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 sales of thyroid eye disease drug Tepezza rose 3% to $460 million, and sales of gout treatment Krystexxa rose 27% to $346 million.