Latest news with #AMG513


Reuters
01-05-2025
- Business
- Reuters
Amgen quarterly profit tops Wall Street view, sales up 11%
May 1 (Reuters) - Amgen (AMGN.O), opens new tab on Thursday said its first-quarter profit rose 24%, handily exceeding Wall Street expectations, as product sales increased 11% and profit margins widened. The biotechnology company reported adjusted earnings per share of $4.90 for the quarter, sailing past the average analyst estimate of $4.30, as compiled by LSEG. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Overall revenue rose 9% to $8.1 billion, which was in line with Wall Street estimates. "Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," Amgen CEO Robert Bradway said in a statement. The company is slated to present at a medical meeting next month full results from a mid-stage trial of its experimental weight-loss drug MariTide, viewed by many investors as a potential blockbuster. Amgen is conducting late-stage trials of the drug in patients with and without diabetes, and said results from a Phase 2 diabetes trial will be announced in the second half of this year. The company also said the U.S. Food and Drug Administration has lifted its clinical hold on an early-stage trial of a different experimental weight-loss drug known as AMG 513. For the full year, Amgen said it still expects adjusted earnings per share of $20.00 to $21.20 on revenue of $34.3 billion to $35.7 billion. Analysts, on average, have estimated earnings of $20.63 per share on revenue of $35.1 billion. Amgen said its 2025 outlook includes the impact of implemented tariffs, but does not account for any future levies, including potential sector-specific tariffs. U.S. President Donald Trump's administration has opened a national security investigation into pharmaceuticals in a bid to demonstrate why the U.S. needs tariffs to boost domestic manufacturing. Amgen's first-quarter sales of bone drug Prolia rose 10% to $1.1 billion, but the company said it expects lower sales of the medication later in the year as biosimilar competitors are launched. Sales of cholesterol-lowering medication Repatha rose 27% to $656 million, while sales of much older arthritis drug Enbrel fell 10% to $567 million. In the rare disease space, sales of thyroid eye disease drug Tepezza fell 10% to $381 million, and sales of gout treatment Krystexxa were flat at $236 million. Both drugs were acquired with Amgen's purchase of Horizon Therapeutics. Net operating income for the quarter rose 20% to $1.2 billion.
Yahoo
01-05-2025
- Business
- Yahoo
Amgen quarterly profit tops Wall Street view, sales up 11%
By Deena Beasley (Reuters) -Amgen on Thursday said its first-quarter profit rose 24%, handily exceeding Wall Street expectations, as product sales increased 11% and profit margins widened. The biotechnology company reported adjusted earnings per share of $4.90 for the quarter, sailing past the average analyst estimate of $4.30, as compiled by LSEG. Overall revenue rose 9% to $8.1 billion, which was in line with Wall Street estimates. "Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," Amgen CEO Robert Bradway said in a statement. The company is slated to present at a medical meeting next month full results from a mid-stage trial of its experimental weight-loss drug MariTide, viewed by many investors as a potential blockbuster. Amgen is conducting late-stage trials of the drug in patients with and without diabetes, and said results from a Phase 2 diabetes trial will be announced in the second half of this year. The company also said the U.S. Food and Drug Administration has lifted its clinical hold on an early-stage trial of a different experimental weight-loss drug known as AMG 513. For the full year, Amgen said it still expects adjusted earnings per share of $20.00 to $21.20 on revenue of $34.3 billion to $35.7 billion. Analysts, on average, have estimated earnings of $20.63 per share on revenue of $35.1 billion. Amgen said its 2025 outlook includes the impact of implemented tariffs, but does not account for any future levies, including potential sector-specific tariffs. U.S. President Donald Trump's administration has opened a national security investigation into pharmaceuticals in a bid to demonstrate why the U.S. needs tariffs to boost domestic manufacturing. Amgen's first-quarter sales of bone drug Prolia rose 10% to $1.1 billion, but the company said it expects lower sales of the medication later in the year as biosimilar competitors are launched. Sales of cholesterol-lowering medication Repatha rose 27% to $656 million, while sales of much older arthritis drug Enbrel fell 10% to $567 million. In the rare disease space, sales of thyroid eye disease drug Tepezza fell 10% to $381 million, and sales of gout treatment Krystexxa were flat at $236 million. Both drugs were acquired with Amgen's purchase of Horizon Therapeutics. Net operating income for the quarter rose 20% to $1.2 billion. (Reporting By Deena BeasleyEditing by Bill Berkrot) Sign in to access your portfolio
Yahoo
04-02-2025
- Business
- Yahoo
Amgen profit beats estimates, next MariTide studies start by mid-year
By Deena Beasley (Reuters) - Amgen 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 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 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 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, 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 sales of thyroid eye disease drug Tepezza rose 3% to $460 million, and sales of gout treatment Krystexxa rose 27% to $346 million. (Reporting By Deena Beasley; Editing by Aurora Ellis) Sign in to access your portfolio


Reuters
04-02-2025
- Business
- Reuters
Amgen profit beats estimates, next MariTide studies start by mid-year
Feb 4 (Reuters) - Amgen (AMGN.O), opens new tab 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 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 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 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, 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 sales of thyroid eye disease drug Tepezza rose 3% to $460 million, and sales of gout treatment Krystexxa rose 27% to $346 million. here.