Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly (NYSE: LLY) announced a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of bamlanivimab and etesevimab for COVID-19 treatment in patients aged 12 and older. This agreement enables EU countries to purchase these treatments directly, enhancing access before formal marketing authorization. Bamlanivimab and etesevimab have shown efficacy against COVID-19 variants like Delta. Although some countries have already ordered doses, this agreement allows for additional supplies as needed. Lilly does not anticipate a change to its 2021 financial guidance.

Eli Lilly and Company (NYSE: LLY) announced the early tender results of its cash tender offer for up to $1.5 billion in outstanding debt securities. The result showed that $2,016,575,000 in notes were validly tendered before the early tender date of September 20, 2021. Notably, Lilly removed the previously announced caps on its 4.150% Notes due 2059 and 3.950% Notes due 2049, allowing for larger acceptance amounts. The settlement date for accepted notes is set for September 22, 2021, and the tender offer is expected to expire on October 4, 2021.

The FDA has expanded the Emergency Use Authorization (EUA) for Eli Lilly's bamlanivimab and etesevimab to include post-exposure prophylaxis for COVID-19. This authorization targets high-risk individuals aged 12 and older who are either unvaccinated or might not respond adequately to vaccination. Data from the BLAZE-2 study indicated that bamlanivimab significantly reduced symptomatic COVID-19 risk in nursing home residents. Since the pandemic's onset, over 535,000 treatment courses have been provided, helping avert thousands of hospitalizations and deaths.

Eli Lilly and Company (NYSE: LLY) announced a contract with the U.S. government to supply 388,000 doses of etesevimab, which will complement previously purchased bamlanivimab doses. This agreement is expected to generate approximately $330 million in revenue during the second half of 2021. The rise in COVID-19 cases has driven increased demand for monoclonal antibody therapies like these, especially in areas with low vaccination rates. Shipments of the doses are scheduled for Q3 and Q4 2021.

Eli Lilly and Company (NYSE: LLY) will participate in the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021. Patrik Jonsson, senior vice president and president of Lilly Immunology, will engage in a virtual fireside chat at 1:20 p.m. ET. Interested parties can access a live audio webcast on Lilly's Investor website, with a replay available for 90 days.

Lilly is dedicated to advancing healthcare through innovative medicines and remains committed to its founding mission of improving lives globally.

New research from Eli Lilly Company (NYSE: LLY) will be showcased at the ESMO Congress 2021 (September 16-21). Key findings include:

• Verzenio: Studies on high-risk early breast cancer and advanced breast cancer.
• Retevmo: Real-world data on medullary thyroid cancer and RET testing patterns in Europe.
• CYRAMZA: Insights on metastatic NSCLC and the impact of TP53 status.
• Sintilimab: Phase III trial results for esophageal and gastric cancers.

Posters available starting September 16, with mini-oral presentations on September 17.

The FDA has granted Breakthrough Therapy designation for Jardiance (empagliflozin) for treating adults with heart failure with preserved ejection fraction (HFpEF). This follows promising results from the EMPEROR-Preserved trial, showing a 21% relative risk reduction in cardiovascular death or hospitalization. Jardiance is already approved for heart failure with reduced ejection fraction. HFpEF affects around 3 million adults in the U.S., with no proven treatment options available until now.

Eli Lilly has pledged nearly $1 million over three years in collaboration with the Helmsley Charitable Trust to enhance access to resources for children with type 1 diabetes (T1D). This initiative aims to provide camperships for low-income youth, ensuring inclusivity in diabetes camps nationwide. The funding will also assist camps in adapting to COVID-19 requirements. Lilly's long-term commitment to diabetes care emphasizes equity and improved access for communities, reflecting its ongoing mission to better lives affected by diabetes.