Eli Lilly & Co. (LLY) to Supply Additional 150K Doses of bebtelovimab to US Govt

Eli Lilly and Company (NYSE: LLY) today announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million. The existing U.S. government supply of bebtelovimab, including the new purchase, is expected to meet present demand through late August 2022. Bebtelovimab continues to maintain neutralization activity against the most common, and fastest growing, Omicron variants (BA.2.12.1 and BA.4/BA.5) in the United States, in addition to all known variants of interest and concern.

"Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies," said David A. Ricks, Lilly's chair and CEO. "While Congress works toward additional COVID-19 funding, Lilly and the U.S. government will continue to work together to support the availability of bebtelovimab to maximize equity and accessibility in the U.S. market."

Delivery of doses will begin immediately and complete no later than August 5, 2022. The 2022 estimated financial impact of this agreement is approximately $275 million of revenue and approximately $0.08 of EPS. An option for an additional 350,000 doses to be exercised no later than September 14, 2022 will remain in the agreement.

This purchase has been supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number W58P0522C0012.

Important Information about bebtelovimab Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

The emergency use of bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab.

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