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Yahoo
15-05-2025
- Business
- Yahoo
AMGN Q1 Earnings Call: Product Pipeline and Margin Expansion Drive Outperformance
Biotech company Amgen (NASDAQ:AMGN) reported Q1 CY2025 results topping the market's revenue expectations , with sales up 9.4% year on year to $8.15 billion. The company expects the full year's revenue to be around $35 billion, close to analysts' estimates. Its non-GAAP profit of $4.90 per share was 15% above analysts' consensus estimates. Is now the time to buy AMGN? Find out in our full research report (it's free). Revenue: $8.15 billion vs analyst estimates of $8.03 billion (9.4% year-on-year growth, 1.5% beat) Adjusted EPS: $4.90 vs analyst estimates of $4.26 (15% beat) Adjusted EBITDA: $4.99 billion vs analyst estimates of $4.67 billion (61.2% margin, 6.7% beat) The company reconfirmed its revenue guidance for the full year of $35 billion at the midpoint Management reiterated its full-year Adjusted EPS guidance of $20.60 at the midpoint Operating Margin: 14.5%, up from 13.3% in the same quarter last year Free Cash Flow Margin: 12%, up from 6.2% in the same quarter last year Market Capitalization: $141 billion Amgen's first quarter results were shaped by broad-based volume growth and new product launches across general medicine, rare diseases, inflammation, and oncology. Management highlighted the performance of 14 products with double-digit growth, as well as strong uptake of new biosimilars. CEO Robert Bradway emphasized, 'We delivered multiple positive Phase III readouts, initiated four new Phase III studies, and launched three new products or indications.' Looking ahead, Amgen's full-year guidance centers on further execution in its late-stage clinical pipeline and continued momentum in recently launched therapies. CFO Peter Griffith noted increased R&D investment to support assets such as MariTide, a potential obesity therapy, and ongoing expansion in the biosimilars portfolio. Management also acknowledged uncertainties from tariffs and tax policy, stating the company's manufacturing investments position it to adapt as needed. Amgen's management attributed the quarter's performance to the breadth of its product portfolio and significant progress in clinical development. Key growth areas included cardiovascular, bone health, rare disease, and oncology, with biosimilars delivering meaningful contributions. Broad product portfolio growth: Fourteen medicines delivered double-digit sales growth, spanning cardiovascular, bone health, rare disease, and oncology. Amgen's biosimilars segment generated over $700 million in revenue, up 35% year over year. General medicine expansion: Products like Repatha and EVENITY benefited from improved patient access, expanded prescriber base, and direct-to-consumer initiatives. Management cited ongoing clinical trials targeting large, underserved populations in cardiovascular and obesity-related diseases. Rare disease launches: UPLIZNA launched as the first FDA-approved treatment for IgG4-related disease, with early physician adoption. TEPEZZA expanded internationally, including approvals and launches in Japan and a positive regulatory opinion in Europe. Oncology pipeline momentum: Bispecific T cell engagers such as BLINCYTO and IMDELLTRA showed continued adoption and positive clinical data. IMDELLTRA demonstrated survival benefits in small cell lung cancer, with new Phase III studies underway. Biosimilars market penetration: Recent biosimilar launches, including PAVBLU and WEZLANA, were met with positive reception from prescribers. The company's approach focused on early U.S. launches and reliable supply to capture market share. Management's outlook for the remainder of the year is anchored by ongoing clinical advancement and new launches, while cautioning about external factors such as tariffs and increased R&D investment. Pipeline advancement: Significant late-stage studies for therapies like MariTide in obesity and Olpasiran in cardiovascular disease are expected to drive future growth, with management increasing R&D spending to support these programs. Expanding biosimilars: New biosimilar launches and further commercialization efforts are anticipated to diversify revenue streams and address pricing pressures in core therapy areas. External policy risks: Management flagged potential headwinds from evolving tax and tariff policies, emphasizing Amgen's historical ability to adapt through manufacturing investments and operational agility. Terence Flynn (Morgan Stanley): Asked about key data expectations for MariTide at the ADA meeting. Management said data would focus on 52-week efficacy and tolerability but not new long-term results. Salveen Richter (Goldman Sachs): Inquired about UPLIZNA's commercial strategy for IgG4-related disease. Amgen outlined targeted outreach to rheumatologists and plans for broader physician engagement. Michael Yee (Jefferies): Pressed on MariTide's tolerability and competition from oral obesity drugs. Management expressed confidence in design for efficacy and tolerability, with ongoing development of oral options. Trung Huynh (UBS): Questioned Repatha's position amid new competition. Amgen stressed product profile advantages and improved patient access, with room for multiple therapies in the market. David Amsellem (Piper Sandler): Asked what will drive growth for TEPEZZA. Management pointed to expanded prescriber education and international launches, with potential future benefit from a subcutaneous form. In coming quarters, the StockStory team will monitor (1) progress and data releases from late-stage clinical trials, especially for MariTide and bemarituzumab; (2) commercial adoption and prescriber uptake of newly launched therapies like UPLIZNA in IgG4-related disease and PAVBLU in biosimilars; and (3) updates on international expansion of key rare disease drugs. Execution in R&D and navigating policy changes will also be important indicators of Amgen's trajectory. Amgen currently trades at a forward P/E ratio of 13×. In the wake of earnings, is it a buy or sell? Find out in our free research report. Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 5 Strong Momentum Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. 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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.
