Lilly (LLY) to Supply More Doses of COVID-19 Antibody to US

Eli Lilly & Company LLY announced that the U.S. government has purchased an additional 6,50,000 doses of its newly approved (emergency use) COVID-19 antibody drug, bamlanivimab (LY-CoV555) amid rapid increase in COVID-19 cases and hospitalizations in the United States.

Last month, the FDA had granted Emergency Use Authorization (EUA) to bamlanivimab as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization.

The doses will be delivered through Jan 31, 2021. However, Lilly will deliver at least 3,50,000 doses this month. The purchase deal is worth $812.5 million. With the latest purchase, the U.S. government has now purchased a total of 9,50,000 doses of bamlanivimab from Lilly.

We remind investors that in October, Lilly had signed an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (700 mg) for $375 million if the candidate gets FDA’s EUA.

Lilly said that the expanded purchase deal with the U.S. government will positively impact its previously issued 2020 guidance by approximately $500 million ibn additional revenue and approximately 25 cents of additional earnings per share.

Lily’s adjusted earnings outlook for 2020, provided in October, is in the range of $7.20-$7.40 per share while total revenues are expected in the range of $23.7-$24.2 billion.

Lilly’s BLA for bamlanivimab was based on data from the phase II BLAZE-1 study. The study also evaluated bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, a phase III study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities, is also ongoing.

So far this year, Lilly’s stock has risen 10.5% compared with an increase of 1.4% for the industry.

 

 

In November, the FDA also granted EUA to Lilly and Incyte’s INCY oral JAK inhibitor, Olumiant for use in combination with Gilead’s GILD remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study.

Meanwhile, Regeneron’s REGN novel investigational antibody "cocktail”, casirivimab and imdevimab, administered together (formerly known as REGN-COV2 or REGEN-COV2) was also granted EUA by the FDA last month for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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