Emergent BioSolutions Hopeful To Restart Vaccine Production, Plans To Submit Response To FDA Within Days

Emergent BioSolutions Inc EBS said it hopes to respond to U.S. regulators within days on how to resolve the problems at its Baltimore plant, which have forced Johnson & Johnson JNJ to halt U.S. manufacturing of their COVID-19 vaccine essentially.
The FDA stopped J&J's vaccine production at the plant earlier this month while investigating an error that led to 15 million doses being ruined last month.
The U.S. has put J&J in charge of the plant and has stopped AstraZeneca plc AZN from using it.
"We appreciate constructive, ongoing dialogue with Johnson & Johnson and their support as we work on a path forward," said Robert Kramer President & CEO, in a conference call with investors. "If the FDA is comfortable with the approach we propose, I am hopeful that we can soon return to producing tens of millions of doses per month."
Kramer also said he does not expect the FDA to re-inspect the plant after the company submits its response but conceded that it was still a possibility.
The company also disclosed that Sean Kirk, one of the executives in charge of the company's manufacturing operations, was taking a leave of absence. Another executive, Syed Husain, who runs the company's contract development and manufacturing unit, is leaving Emergent.
Despite the issues, Emergent beat first-quarter profit estimates, helped by U.S. government funding for vaccine production.
It reported EPS of $1.53, better than the consensus of $1.12 but revenues of $343 million missed the consensus estimate of $358.47 million.
Overall sales increased around 78% over sales of $192.50 million a year ago.
Full-year forecasts were trimmed due to the issues at the plant.
Emergent lowered its 2021 revenue forecast to a range of $1.7 billion to $1.95 billion from its previous forecast of $1.95 billion to $2.05 billion.
It also lowered its net income forecast for the year to $395 million to $470 million, from $475 million to $525 million previously.
Price Action: EBS shares are down 1.85% at $61.98 during market hours on the last check Friday.

Market News and Data brought to you by Benzinga APIs

Comments

Popular Channels

Tools & Features

Partners & Contributors

About Benzinga