Eli Lilly & Co. develops and commercializes medicines across cardiometabolic disease, oncology, immunology, neuroscience and genetic medicine. Company news commonly covers product and pipeline developments for medicines such as Mounjaro, Zepbound, Foundayo, Omvoh, Verzenio, Jaypirca and Taltz, including clinical data, regulatory approvals and treatment-indication updates.
Lilly updates also include operating results, financial guidance, dividends, business development agreements and manufacturing expansion. Recent company communications highlight investment in active pharmaceutical ingredient capacity and genetic medicine production, alongside recurring disclosures about demand for diabetes, obesity, immune-disease and cancer therapies.
The EMPEROR-Preserved phase III trial revealed that Jardiance (empagliflozin) significantly reduces the risk of cardiovascular death or hospitalization for heart failure and slows kidney function decline in adults with heart failure and left ventricular ejection fraction (LVEF) over 40%. Presented at the American Society of Nephrology Kidney Week 2021, findings showed consistent benefits regardless of chronic kidney disease (CKD) status. The trial included nearly 6,000 adults, with results highlighting the potential for Jardiance as a viable treatment option. Fast Track and Breakthrough Therapy designations have been granted for its cardiovascular applications.
Loxo Oncology at Lilly announced the upcoming presentation of data from the pirtobrutinib development program at the ASH Annual Meeting, scheduled for December 11-14, 2021. Pirtobrutinib is a reversible BTK inhibitor currently undergoing clinical trials for chronic lymphocytic leukemia and mantle cell lymphoma. Oral presentations will feature updated results from the Phase 1/2 BRUIN trial, focusing on patients previously treated for these conditions. The trials highlight the drug's potential efficacy and innovative mechanism against acquired resistance.
Eli Lilly announced an agreement with the U.S. government to supply 614,000 doses of bamlanivimab with etesevimab, a COVID-19 treatment, for $1.29 billion. The deal is expected to add approximately $840 million in revenue and 25 cents per share to Lilly's 2021 earnings. The doses will be delivered by January 31, 2022, with a minimum of 400,000 by December 31, 2021. Bamlanivimab and etesevimab are authorized under Emergency Use Authorization for specific COVID-19 cases but are not FDA-approved. The supply is supported by federal funds under a BARDA contract.
Eli Lilly and Company (NYSE: LLY) will participate in Bernstein's Second Annual Operational Decisions Conference on Thursday, Nov. 4, 2021. Key executives including Jake Van Naarden, Mark Mintun, and Jamie Croaning will engage in a virtual fireside chat at 12:30 p.m. Eastern time. Investors can access a live audio webcast via Lilly's Investor website, with a replay available for 90 days. Lilly aims to improve global health care through innovative medicines and community support, continuing a mission established over a century ago. For more details, visit www.lilly.com.
On October 28, 2021, Eli Lilly announced the publication of overall survival data from the Phase 3 monarchE study of Verzenio (abemaciclib) in the Annals of Oncology. This study explores the effectiveness of Verzenio in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. Notably, the FDA approved Verzenio in combination with endocrine therapy for specific patient populations earlier in the month. Although the overall survival data are still immature, they are pivotal for ongoing evaluations of Verzenio's efficacy.
Eli Lilly reported third-quarter 2021 revenues of $6.773 billion, an 18% increase from 2020, driven by a 35% rise in revenue from newer medicines. Net income was $1.110 billion, with reported EPS of $1.22, an 8% decline year-over-year. Non-GAAP EPS increased 38% to $1.94. The company announced several drug approvals and regulatory submissions, enhancing its growth potential. Lilly expects full-year revenue between $27.2 billion and $27.6 billion, reflecting strong performance in key products despite a projected decline in certain older therapies.
Eli Lilly's tirzepatide demonstrates significant efficacy in managing type 2 diabetes, showcasing superior reductions in A1C and body weight compared to insulin glargine in the SURPASS-4 trial. Over 52 weeks, the highest dose of tirzepatide resulted in a 2.58% A1C reduction and an 11.7 kg weight loss. Safety profiles remained consistent with gastrointestinal side effects being most common. The trial, involving 2,002 participants, confirmed tirzepatide's effectiveness and safety over 104 weeks, indicating promising long-term management for patients with increased cardiovascular risk.
The board of directors of Eli Lilly and Company (NYSE: LLY) has declared a fourth-quarter dividend of $0.85 per share on outstanding common stock. This dividend is scheduled for payment on December 10, 2021, to shareholders on record as of November 15, 2021. Eli Lilly continues its commitment to improving healthcare through innovative medicines while balancing business growth and shareholder returns.
Eli Lilly and Company (NYSE: LLY) has announced promising results from the Phase 3 monarchE trial for Verzenio® (abemaciclib) in treating high-risk early breast cancer. The study demonstrated a statistically significant improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) after a median follow-up of 27 months. At three years, IDFS improved by 5.4%, while DRFS improved by 4.2%. The data suggests that adding Verzenio to endocrine therapy could revolutionize treatment for patients at high risk of recurrence. Safety profiles remained consistent with known data.
Eli Lilly's Verzenio® (abemaciclib) has received FDA approval for the adjuvant treatment of adult patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This marks it as the first CDK4/6 inhibitor approved for this indication. The approval stems from the positive results of the monarchE trial, demonstrating a statistically significant improvement in invasive disease-free survival (IDFS) among patients treated with Verzenio in combination with endocrine therapy.