Amgen Inc. reports developments across its biotechnology medicines business, including discovery, development, manufacturing and delivery of human therapeutics. Company updates center on a portfolio and pipeline spanning cancer, inflammatory conditions, rare diseases, heart disease, obesity and obesity-related conditions, with named products and programs such as TEPEZZA, Repatha and IMDELLTRA appearing in clinical and commercial announcements.
Recurring news also covers quarterly financial results, non-GAAP performance measures, manufacturing network investments, supply-chain capacity, research collaborations, medical and investor conference presentations, and executive or organizational changes tied to the integration of biology, technology, artificial intelligence and data across Amgen's operations.
Amgen reported Q2 2021 revenues of $6.5 billion, a 5% increase year-over-year, driven by strong unit demand despite lower net selling prices. GAAP EPS fell 73% to $0.81 due to a significant write-off from the Five Prime Therapeutics acquisition, while non-GAAP EPS rose 4% to $4.38. Operating income on a GAAP basis dropped 64% to $0.8 billion, leading to a 25.8 percentage point decrease in operating margin to 13.5%. Free cash flow was $1.7 billion, down from $2.7 billion in Q2 2020. Amgen reaffirmed its total revenue guidance for 2021 at $25.8 to $26.6 billion, while revising GAAP EPS guidance downwards.
Amgen (NASDAQ: AMGN) has declared a $1.76 per share dividend for Q3 2021, set to be paid on September 8, 2021, to stockholders of record by August 17, 2021. This action reflects the company's ongoing commitment to returning value to its shareholders. Amgen continues to focus on developing innovative therapeutics to address unmet medical needs and improve patient health outcomes. The company, established in 1980, is recognized as a leader in biotechnology, striving to advance its pipeline of medicines.
Amgen announced the appointment of S. Omar Ishrak to its Board of Directors, effective immediately. Dr. Ishrak, a seasoned leader with extensive experience in the healthcare sector, will also serve on the Corporate Responsibility and Compliance Committee and the Compensation and Management Development Committee. With this addition, Amgen's Board now comprises 12 directors, 11 of whom are independent. Ishrak previously served as CEO of Medtronic and has held pivotal roles at GE Healthcare. His expertise is expected to enhance Amgen's focus on innovation and patient care.
Amgen (NASDAQ:AMGN) will report its Q2 2021 financial results on August 3, 2021, after U.S. market close. A conference call is scheduled for 2:00 p.m. PT, featuring CEO Robert A. Bradway and senior management. The call will be broadcast live and accessible to the media and general public. Amgen, a leader in biotechnology since 1980, focuses on developing therapies for serious illnesses through advanced human genetics, with a commitment to improving health outcomes.
Amgen has announced an agreement to acquire Teneobio for $900 million in upfront cash, with potential future milestone payments of up to $1.6 billion. Teneobio specializes in Human Heavy-Chain Antibodies and its advanced bispecific and multispecific antibody technologies will enhance Amgen's capabilities in treating various diseases. The acquisition adds TNB-585, a Phase 1 bispecific T-cell engager for metastatic prostate cancer, along with several preclinical oncology assets. The deal is expected to close in the second half of 2021, pending regulatory approvals.
Amgen (NASDAQ:AMGN) has partnered with the International Federation of Psoriasis Associations to launch the UPLIFT Innovation Challenge, aimed at improving health outcomes for individuals with psoriatic disease. Applicants can submit innovative ideas by August 30, 2021, for a chance to receive a grant of $25,000 USD. This initiative responds to findings from the 2020 UPLIFT survey, which highlighted significant gaps in treatment and patient-provider communication. Notably, it found only 50% of those with psoriatic arthritis saw a healthcare provider within the past year.
Amgen (NASDAQ:AMGN) announced that the FDA has accepted its Biologics License Application for tezepelumab, granting it Priority Review for asthma treatment. This decision was based on the PATHFINDER clinical trial results, particularly the NAVIGATOR Phase 3 trial, where tezepelumab showed superiority over placebo for patients with uncontrolled asthma. The FDA aims to make a decision by Q1 2022. This innovative treatment addresses a significant unmet medical need, as many patients do not respond well to current therapies.
Amgen (NASDAQ:AMGN) has received marketing approval from the Japanese Ministry of Health, Labour and Welfare for Aimovig® (erenumab), the first treatment in Japan targeting the calcitonin gene-related peptide receptor for migraine prevention in adults. This marks Amgen K.K.'s first independent submission and approval. Aimovig demonstrated a significant reduction in monthly migraine days in clinical trials. With approximately 8.4 million migraine sufferers in Japan, this approval aims to increase access to effective migraine treatment.
deCODE genetics, a subsidiary of Amgen, has developed a blood-based predictor to estimate time to all-cause death, outperforming traditional risk factors. The research analyzed nearly 5,000 protein measurements from 22,913 Icelanders, revealing a significant correlation between protein profiles and mortality. The predictor effectively identifies individuals at both high and low risk of death within a decade. Key findings include the role of growth/differentiation factor 15 (GDF15) in predicting mortality.
Amgen has launched the INSIDE LOOK campaign featuring Hollywood makeup artist Allan Avendaño to raise awareness about plaque psoriasis, a chronic autoimmune condition affecting over 8 million Americans. Avendaño shares his personal journey with the disease, emphasizing the importance of understanding and treating the condition from within. The campaign includes a makeup tutorial for Otezla patients and highlights that Otezla can help achieve up to 75% clearer skin in four months. Dermatologist Dr. Jennifer Soung discusses treatment options and urges individuals to consult healthcare providers for personalized treatment plans.