Emergent BioSolutions (EBS) Tops Q1 EPS by 6c, Comments on Ongoing Internal Manufacturing Investigation

Emergent BioSolutions (NYSE: EBS) reported Q1 EPS of $0.75, $0.06 better than the analyst estimate of $0.69. Revenue for the quarter came in at $148 million versus the consensus estimate of $147 million.

Ongoing Internal Manufacturing Investigation

Beginning on January 28, 2015, during standard quality inspections performed in accordance with customary procedures, the company discovered foreign particles in a limited number of vials in two manufactured lots of BioThrax. In order to determine the source of the foreign particles, the company has been investigating its operations as well as those of its suppliers and contract manufacturers. Under the company's quality standards, these two BioThrax lots will be rejected. Currently, there is no evidence that any other BioThrax lots have been affected, but as a precautionary measure, the company has quarantined 13 additional lots in inventory pending the findings of its investigation. It is the company's goal to complete this investigation within the next 60 days. Consequently, no BioThrax deliveries will be made in the first quarter. Based upon current information and depending on the disposition of the quarantined lots, the impact on previously forecasted 2015 BioThrax revenues is anticipated to be between $0 and $65 million. This ongoing investigation does not impact any of the company's other products or manufacturing operations, including the company's Building 55 operations and plans for licensure. Furthermore, there is no current evidence that product in distribution is impacted. Since the investigation is ongoing and the full scope of the issue has not been determined with certainty, the actual impact may be greater than anticipated. As the company is unable to definitively assess the impact to 2015 financial results, it is suspending previously issued 2015 guidance. Guidance will be forthcoming following completion of the ongoing investigation.

For earnings history and earnings-related data on Emergent BioSolutions (EBS) click here.

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