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

Emergent BioSolutions Inc (NYSE: 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 (NYSE: 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 (NASDAQ: 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.

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