Workflow
Xgeva
icon
Search documents
Amgen Inc. (NASDAQ:AMGN) Maintains Strong Outlook Despite Challenges
Financial Modeling Prep· 2026-02-04 19:06
Core Viewpoint - Amgen Inc. is experiencing strong performance and positive analyst outlook despite facing some challenges, with a maintained "Buy" rating and an increased price target from Cowen & Co. [1][5] Financial Performance - Amgen's fourth-quarter performance in 2025 exceeded expectations for both revenue and earnings per share, supporting a positive outlook from analysts [2][5] - The stock price is currently $338.59, reflecting a 1.80% decrease or $6.20 drop, with a market capitalization of approximately $182.32 billion [4] Growth Prospects - Key products like Repatha and Uplizna are expected to drive future growth, offsetting losses from Prolia and Xgeva [2][5] - Despite regulatory uncertainties and pipeline attrition, Amgen's long-term prospects remain strong, bolstered by positive data from Repatha and progress with MariTide [3][5] Market Activity - The stock has fluctuated between $338.59 and $349.50 today, with a yearly high of $353.25 and a low of $261.43 [4]
Amgen Tops Buy Zone On Positive 2026 Outlook Amid Sharpening Obesity Focus
Investors· 2026-02-04 21:04
Amgen Stock Hits Buy Zone On Positive 2026 Outlook Amid Sharpening Obesity Focus | Investor's Business DailyBREAKING: [Eli Lilly Surges As Obesity Drugs Fuel Strong Earnings, Guidance]---Amgen (AMGN) stock popped Wednesday — surging back into a buy zone — on its surprisingly upbeat 2026 guidance despite biosimilar competition for bone health drugs Prolia and Xgeva. Prolia is an osteoporosis treatment. Xgeva aims to prevent fractures and spinal cord compression in patients who have bone metastases from cance ...
AMGN's Q4 Earnings & Sales Beat Estimates, Obesity Candidate in Focus
ZACKS· 2026-02-04 16:22
Core Insights - Amgen (AMGN) reported Q4 2025 adjusted earnings of $5.29 per share, exceeding the Zacks Consensus Estimate of $4.76 per share, with total revenues of $9.9 billion, a 9% year-over-year increase, surpassing the estimate of $9.5 billion [2][7] Revenue Performance - Total product revenues increased by 7% year-over-year to $9.37 billion, with a 10% rise in volume offset by a 4% negative impact from pricing [3] - Other revenues reached $499 million, up approximately 35% year-over-year [3] Key Drug Performance - Evenity sales were $599 million, a 39% increase year-over-year, surpassing the estimate of $565 million [4] - Repatha generated $870 million, up 44% year-over-year, exceeding the estimate of $812 million [4] - Prolia revenues were $1.05 billion, down 10% year-over-year but still beating the estimate of $975 million [5] - Xgeva revenues fell 20% year-over-year to $447 million, missing the estimate of $454 million [8] - Blincyto sales were $413 million, an 8% increase year-over-year, but missed the estimate of $435 million [9] - Otezla sales were $625 million, flat year-over-year, beating the estimate of $621 million [9] - Enbrel revenues declined 48% year-over-year to $532 million, missing the estimate of $636 million [10] - Tezspire recorded sales of $474 million, a 60% increase year-over-year, exceeding the estimate of $421 million [10] Cost and Margin Analysis - Adjusted operating margin decreased by 3.5 percentage points to 42.8% in Q4 [14] - Adjusted operating expenses rose 16% to $5.86 billion, with R&D expenses increasing by 26% to $2.13 billion [14] Full-Year Results - For the full year 2025, sales rose 10% to $36.8 billion, beating the estimate of $36.4 billion [15] - Adjusted earnings for 2025 were $21.84 per share, a 10% increase year-over-year, surpassing the estimate of $21.29 per share [15] 2026 Guidance - Amgen expects total revenues in the range of $37.0 billion to $38.4 billion for 2026, with adjusted earnings projected between $21.60 and $23.00 per share [17] - Adjusted operating margin is anticipated to be approximately 45% to 46% for 2026 [17] Pipeline Developments - Amgen is advancing MariTide, a GIPR/GLP-1 receptor, with six phase III obesity studies underway [19][20] - Enrollment has been completed in two pivotal studies for MariTide, with ongoing studies for cardiovascular disease and heart failure [21] - Plans to initiate phase III studies for MariTide in type II diabetes are set for later in 2026 [22]
Amgen Set to Report Q4 Earnings: What Investors Should Know
ZACKS· 2026-01-28 17:27
Core Insights - Amgen (AMGN) is set to report its fourth-quarter and full-year 2025 results on February 3, with earnings expected to be $4.74 per share and sales at $9.46 billion, reflecting a 12.8% earnings surprise in the last reported quarter [1][10]. Group 1: Sales Performance - Product sales are anticipated to be driven by strong volume growth from drugs like Evenity, Repatha, and Blincyto, although prices are expected to decline due to increased rebates [2]. - The Zacks Consensus Estimate for sales of Evenity, Repatha, and Blincyto is $559 million, $798 million, and $434 million, respectively [3]. - Newer drugs such as Imdelltra, Tavneos, and Tezspire are expected to contribute to top-line growth, alongside sales from rare disease drugs like Uplizna, estimated at $183 million [4]. Group 2: Patent Expirations and Competitive Pressures - Patents for key drugs Prolia and Xgeva expired in February 2025 in the U.S., leading to expected sales erosion due to the launch of biosimilars, with estimates of $980 million for Prolia and $444 million for Xgeva [5]. - Competitive pressures have negatively impacted volume growth for Kyprolis, with an estimated sales figure of $365 million, while Enbrel sales are likely to decline due to price reductions [6]. Group 3: Biosimilars and R&D Costs - Amgen's biosimilars, including Wezlana and Pavblu, are expected to contribute to sales growth, although Wezlana is not expected to generate U.S. sales in the fourth quarter [7]. - Lower revenues from oncology biosimilars and legacy products are anticipated, alongside higher R&D costs that may negatively impact operating margins [8][9]. Group 4: Earnings Expectations - Amgen's Earnings ESP is -0.40%, indicating a lower likelihood of an earnings beat, with the most accurate estimate at $4.72 per share compared to the consensus of $4.74 [13][14].
Dr. Reddy's Q3 Earnings Match Estimates, Revenues Rise Y/Y
ZACKS· 2026-01-22 15:31
Core Insights - Dr. Reddy's Laboratories Limited (RDY) reported Q3 fiscal 2026 earnings of 16 cents per American Depositary Share (ADS), matching the Zacks Consensus Estimate, but down from 19 cents per ADS in the same quarter last year [1][5] - Revenues increased by 4.4% year over year to $971 million, but fell short of the Zacks Consensus Estimate of $978 million, primarily due to lower growth in global generics revenues [1][5] Revenue Breakdown - Global Generics revenues reached INR 79.1 billion, reflecting a 7% year-over-year increase, driven by growth in key markets and favorable foreign exchange movements, although North America Generics saw a decline [2][5] - Pharmaceutical Services & Active Ingredients (PSAI) revenues totaled INR 8 billion, down 2% year over year due to lower volume uptake in the active pharmaceutical ingredient (API) business [6] - Revenues in the Others segment were INR 0.1 billion, a significant decline of 92% year over year [6] North America Performance - North America segment revenues decreased by 12% due to lower sales of lenalidomide and increased price erosion in key products [3][5] - As of December 31, 2025, there were 73 generic filings pending FDA approval, including 71 abbreviated new drug applications (ANDAs) and two new drug applications, with 43 of the ANDAs being Para IVs [3] Margin and Expenses - Gross margin fell by 505 basis points year over year to 53.6%, attributed to lower lenalidomide sales, price erosion, adverse product mix in PSAI, and one-time provisions related to new Labor Codes in India [7][5] - Research and development (R&D) expenses were $68 million, down 8% year over year, primarily due to reduced spending in biosimilars [8] - Selling, general and administrative expenses rose to $300 million, a 12% increase year over year, driven by investments in branded franchises and adverse foreign exchange movements [9] Strategic Developments - Dr. Reddy's gained approval for AVT03, a proposed biosimilar to Amgen's Prolia and Xgeva, in the EU and the UK, and launched the product in Germany in December 2025 [12] - The company signed a strategic collaboration with Immutep to develop and commercialize the investigational immuno-oncology therapy eftilagimod alfa (efti) outside major markets, involving a $20 million upfront payment and potential milestone payments of up to $349.5 million [17][18]
Amgen Buys Dark Blue Therapeutics to Strengthen Oncology Pipeline
ZACKS· 2026-01-07 14:35
Core Insights - Amgen has acquired Dark Blue Therapeutics for approximately $840 million, enhancing its oncology pipeline [1][8] - The acquisition adds a preclinical small-molecule degrader targeting MLLT1/3 proteins associated with specific types of acute myeloid leukemia (AML) [2][8] - Amgen currently does not market any therapies for AML but has Blincyto approved for acute lymphoblastic leukemia (ALL) and is developing bispecific T-cell engagers for AML [3][8] Amgen's Oncology Pipeline - Amgen has a diverse oncology portfolio, including drugs like Blincyto, Imdelltra, Lumakras, Vectibix, Kyprolis, Nplate, and Xgeva [6] - Key candidates in its late-stage oncology pipeline include bemarituzumab for gastric cancer and xaluritamig for metastatic castrate-resistant prostate cancer [6] - Ongoing phase III studies are evaluating Imdelltra in small cell lung cancer and biosimilars for Opdivo, Keytruda, and Ocrevus [6] Competitive Landscape - Major competitors in the oncology space include Pfizer, AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers [9] - Pfizer's oncology sales account for about 28% of total revenues, with a 7% increase in the first nine months of 2025 [10] - AstraZeneca's oncology segment comprises around 43% of total revenues, with a 16% increase in sales during the same period [11] - Merck's Keytruda, a key oncology drug, generated $23.3 billion in sales in the first nine months of 2025, up 8% year over year [12] - Bristol-Myers' Opdivo accounts for approximately 20% of its total revenues, with sales rising 8% to $7.54 billion [13] - Johnson & Johnson's oncology sales represent around 27% of total revenues, with a 20.6% operational increase in the first nine months of 2025 [14]
Why Is Amgen (AMGN) Up 8% Since Last Earnings Report?
ZACKS· 2025-12-04 17:30
Core Insights - Amgen reported strong Q3 2025 earnings, with adjusted earnings of $5.64 per share, surpassing the Zacks Consensus Estimate of $5.00, and total revenues of $9.6 billion, exceeding the estimate of $8.9 billion, reflecting a 12% year-over-year increase [2][3] Financial Performance - Total product revenues increased by 12% year-over-year to $9.17 billion, driven by a 14% rise in volume, although partially offset by a 4% decline in pricing [3] - Other revenues rose by 19.3% year-over-year to $420 million, primarily due to higher royalty income [3] - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with operating expenses increasing by 18% to $5.25 billion [22] Key Product Performance - Prolia revenues reached $1.14 billion, up 9% year-over-year, significantly exceeding the Zacks Consensus Estimate of $911 million [6] - Evenity sales grew by 36% year-over-year to $541 million, surpassing the Zacks Consensus Estimate of $519 million [7] - Repatha generated revenues of $794 million, a 40% increase year-over-year, beating the Zacks Consensus Estimate of $720 million [7] - Biosimilar portfolio sales surged by 52% year-over-year to $775 million [5] Guidance and Outlook - Amgen raised its 2025 revenue and earnings outlook, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [24] - Adjusted operating margin is anticipated to be around 45%, with R&D expenses expected to grow at a mid-20s percentage rate year-over-year [25] Pipeline Developments - Enrollment has been completed in two phase III studies for MariTide, with approximately 5,000 adults enrolled [27] - Ongoing enrollment in two other phase III studies for atherosclerotic cardiovascular disease and heart failure [28]
Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe
Businesswire· 2025-12-01 06:00
INCHEON, Korea--(BUSINESS WIRE)-- #Biosimilar--Samsung Bioepis Co., Ltd. today announced the launch of OBODENCEâ"¢ (60 mg pre-filled syringe) and XBRYKâ"¢ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively. "We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability ch ...
博安生物午后涨超4% 两款地舒单抗注射液上市申请获英国MHRA受理
Zhi Tong Cai Jing· 2025-11-10 06:39
Core Viewpoint - The company, 博安生物, has seen a stock increase of over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities [1] Group 1: Product Development - 博安生物's BA6101 (60mg) and BA1102 (120mg) are key products in its global development strategy, targeting orthopedic and oncology fields respectively [1] - The company plans to submit marketing applications for these products to major international regulatory bodies including EMA, FDA, and PMDA [1] Group 2: Market Potential - There is a significant global market potential for 地舒单抗, with projected combined sales of Prolia and Xgeva reaching approximately $6.6 billion in 2024 [1] - The company has established a comprehensive quality management system that meets international standards to support the global commercialization of its products [1]
港股异动 | 博安生物(06955)午后涨超4% 两款地舒单抗注射液上市申请获英国MHRA受理
智通财经网· 2025-11-10 06:33
Core Viewpoint - The company, Boan Biotech (06955), has seen its stock rise over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities in the orthopedic and oncology sectors [1] Group 1: Product Development - Boan Biotech announced that its self-developed monoclonal antibody injections, BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology, have received acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorization [1] - The company considers BA6101 and BA1102 as core products in its global development strategy and plans to submit applications to other international regulatory bodies, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [1] Group 2: Market Potential - There is a broad market outlook for the monoclonal antibody, denosumab, due to extensive clinical demand and significant clinical value, with global sales for Prolia and Xgeva projected to reach approximately $6.6 billion in 2024 [1] - To support its global commercialization goals, the company has established a comprehensive quality management system that meets international standards in China, Europe, the United States, and Japan, ensuring quality assurance for denosumab and future biopharmaceuticals [1]