About this content About Sean Mason Sean Mason is a Senior Journalist at Proactive, having researched and written about Canadian and US equities for 20 years. Sean graduated from the University of Toronto with a BA in history and economics and has also passed the Canadian Securities Course. He previously worked at Investors Digest of Canada, Stockhouse, and SmallCapPower.com. Read more About the publisher Proactive financial news and online broadcast teams provide fast, accessible, informative and action ...

Amgen (AMGN) is one of the stocks most watched by Zacks.com visitors lately. So, it might be a good idea to review some of the factors that might affect the near-term performance of the stock.Shares of this world's largest biotech drugmaker have returned +9.8% over the past month versus the Zacks S&P 500 composite's +4% change. The Zacks Medical - Biomedical and Genetics industry, to which Amgen belongs, has gained 11.9% over this period. Now the key question is: Where could the stock be headed in the near ...

FDA Has Issued New Postmarketing Requirement LUMAKRAS Dosing Confirmed at 960 mg Once-Daily for Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval THOUSAND OAKS, Calif., Dec. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 ...

Amgen Inc. AMGN, -0.67% said Tuesday that the regulatory review of its supplemental new drug application seeking full approval of Lumakras resulted in a “complete response letter” from the U.S. Food and Drug Administration. A CRL means the application will not be approved in its current form. The biotechnology company said the FDA also issued a new postmarketing requirement of an additional study to support full approval, to be completed no later than February 2028. The NDA for Lumakras was based on result ...

Amgen Inc. (NASDAQ:AMGN) 6th Annual Evercore ISI HealthCONx Conference November 29, 2023 9:10 AM ET Company Participants Peter Griffith - EVP and CFO Paul Burton - Chief Medical Officer Justin Claeys - VP, IR Conference Call Participants Umer Raffat - Evercore ISI Umer Raffat It’s pleasure to have Amgen management with us today. I feel like between Sean [ph] and myself covering Amgen for, like, 14 years now, I have not seen this type of setup come up in terms of pipeline readouts for Amgen, in a long time. ...

Q3 ’23 Earnings Call Safe Harbor Statement Thispresentationcontainsforward-lookingstatementsthatarebasedonthecurrentexpectationsandbeliefsofAmgen. Allstatements,otherthanstatementsofhistoricalfact,arestatementsthatcouldbedeemedforward-looking statements,includinganystatementsontheoutcome,benefitsandsynergiesofcollaborations,orpotentialcollaborations,withanyothercompany(includingBeiGene,Ltd.orKyowaKirinCo.,Ltd.),theperformanceofOtezla®(apremilast) (includinganticipatedOtezlasalesgrowthandthetimingofnon-GAAPE ...

Financial Performance - Total revenues increased by 4% year-over-year to $6.9 billion, with non-GAAP earnings per share rising by 6% to $4.96 [38][39] - Volume growth was 11% globally, marking the fourth consecutive quarter of double-digit volume growth [6][10] - Non-GAAP operating expenses increased by 4% year-over-year, with a non-GAAP operating margin of 52% [38][39] Business Line Performance - General medicine revenue grew by 21% year-over-year, driven by a 20% volume increase, with Repatha sales up 31% [11][12] - Prolia sales increased by 14% year-over-year, while EVENITY achieved record sales of $307 million, reflecting 48% volume growth [13][14] - Otezla sales declined by 10% year-over-year, impacted by lower net selling prices and inventory levels [14][15] - Hematology-oncology products saw a 15% volume growth, with BLINCYTO sales growing by 55% to a record $220 million [18][19] Market Performance - U.S. volume growth was 11%, while Asia-Pacific was the fastest-growing region with 27% volume growth [10][11] - The rare disease business, bolstered by the Horizon acquisition, generated $945 million in sales, with Tepezza and KRYSTEXXA showing strong growth [22][27] Company Strategy and Industry Competition - The acquisition of Horizon Therapeutics is expected to enhance Amgen's rare disease portfolio and overall growth strategy [4][5] - Amgen aims to leverage its global presence to expand the reach of its rare disease medicines, which currently have significant potential in the U.S. market [5][22] - The company is focused on innovation and expanding its pipeline, with several first-in-class oncology assets progressing through clinical trials [7][30] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver attractive sales and earnings growth through the end of the decade [9][10] - The integration of Horizon's capabilities is expected to accelerate growth in the rare disease segment [22][29] - Management highlighted the importance of investments in R&D and digitalization to drive future growth [41][42] Other Important Information - The company raised its 2023 revenue guidance to $28.0 billion to $28.4 billion, reflecting the inclusion of Horizon's results starting October 6, 2023 [42][43] - Non-GAAP tax rate for 2023 is expected to be between 16.5% and 17% [47] Q&A Session Summary Question: Insights on the Horizon transaction and obesity treatment - Management discussed the differentiated profile of AMG 133 for obesity and the ongoing Phase 2 trial, expressing confidence in its potential [50][51] Question: Clarification on interest expense and revenue guidance - Management confirmed that the $700 million run rate includes all expenses and highlighted strong performance in the base business contributing to revenue guidance [55][60] Question: Outlook for Tepezza and other Horizon assets - Management provided positive indicators for Tepezza's growth in the U.S. and international markets, emphasizing favorable payer policies and increasing prescriber numbers [63][67] Question: Investments in AI technology - Management expressed excitement about the integration of AI in drug discovery and development, anticipating significant qualitative changes in the process [71][74]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ☑ EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ☐ EXCHANGE ACT OF 1934 Commission File Number: 001-37702 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or ...

Amgen Inc. (NASDAQ:AMGN) Amgen Conference Call Following European Society for Medical Oncology Congress 2023 October 24, 2023 8:00 AM ET Company Participants David Reese – Executive Vice President-Research and Development Taofeek Owonikoko – Division Chief-Division of Hematology-Oncology, UPMC Hillman Cancer Ctr. Tarlatamab Jean-Charles Soria – Senior Vice President-Research and Development Kevin Kelly – Chair, Department of Medical Oncology, Sidney Kimmel Medical College Conference Call Participants Salvee ...

Hematology/Oncology Update ESMO 2023 SAFE HARBOR STATEMENT This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa-Kirin Co., Ltd.), the performance of Otezla ...