Regeneron Gets EU Approval for COVID-19 Antibody Cocktail, Announces $3B Share Repurchase Program

The European Commission (EC) has approved New York-based biotechnology company Regeneron Pharmaceuticals, Inc.’s (REGN) casirivimab and imdevimab antibody cocktail for people aged at least 12 years with COVID-19.

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The antibody cocktail, which is known as Ronapreve in the European Union (EU) and REGEN-COV in the U.S., is to be administered to patients who do not require oxygen supplementation.

CHMP Recommendation

The approval follows a positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the antibody cocktail.

The committee’s positive opinion was based on two positive Phase 3 clinical trials that studied the safety and efficacy of the antibody cocktail to treat non-hospitalized patients with COVID-19. The two trials enrolled more than 6,000 people.

Management Comments

The President and Chief Scientific Officer of Regeneron, George D. Yancopoulos, said, “With today’s approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19. For non-hospitalized infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%; and in the prevention setting it reduced the risk of symptomatic infections by 82%.”

About the Antibody Cocktail

Regeneron has collaborated with Swiss research healthcare firm Roche (RHHBY) for the development and sale of the antibody cocktail outside the U.S.

The company plans to seek the EMA’s approval to expand the use of the drug to treat patients hospitalized because of COVID-19.

U.S. Status of the Antibody Cocktail

The U.S. Food and Drug Administration (FDA) accepted Regeneron’s first Biologics License Application (BLA) for REGEN-COV for priority review last month. The BLA is seeking approval to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

Furthermore, the company plans to submit a second BLA later this year, seeking approval to treat patients hospitalized because of COVID-19.

Status of the Antibody Cocktail in Other Countries

The antibody cocktail has emergency or temporary pandemic use authorizations in over 40 nations, including the U.S., India, Switzerland and Canada. It has conditional approval in Australia and the U.K. and full approval in Japan.

Share Repurchase Program

Meanwhile, the Board of Regeneron has approved a share repurchase program of up to $3 billion. (See Insiders’ Hot Stocks on TipRanks)

The Executive Vice-President, Finance and Chief Financial Officer of Regeneron, Robert E. Landry, said, “This share repurchase program is part of our broader capital allocation strategy to maximize shareholder value for years to come.”

Moreover, the company has $1.8 million remaining under the $1.5 billion share repurchase program, which was authorized in January.

Following this announcement, Regeneron’s shares gained 1.4% in the extended trading session on Friday. The stock had closed 0.7% up during market hours.

Wall Street’s Take

Last week, Cantor Fitzgerald analyst Alethia Young reiterated a Buy rating on the stock and raised the price target to $760 from $700 (20.4% upside potential).

After the company reported higher-than-guided third-quarter revenues for its eczema drug Dupixent, the analyst, in a research note to investors, said, “Dupixent’s pipeline potential may still remain underappreciated and that recent, positive late-stage readouts underscore that potential.”

Analyst Recommendation

Overall, the stock has a Moderate Buy consensus rating based on 9 Buys and 4 Holds. The average Regeneron Pharmaceuticals price target of $726.27 implies 15.1% upside potential. Shares have gained 30.7% year-to-date.

Blogger Opinion

TipRanks data shows that financial blogger opinions are 96% Bullish on the stock, compared to the sector average of 68%.