Emergent lowers CDMO guidance as J&J assesses COVID vaccine demand

Emergent Biosolutions will bring forward maintenance work at its Bayview plant on the back of customer J&J evaluating its COVID-19 vaccine supply network.

J&J’s so-called ‘Janssen’ vaccine became the third to be approved under the FDA’s Emergency Use Authorization (EUA) in February 2021, and while the firm had plans to produce one billion doses, the single-shot jab has played third fiddle in Europe and the US to Pfizer and Moderna’ mRNA vaccines.

The firm recently told us it has millions of doses in its inventory without confirming reports that it halted production from its Leiden, The Netherlands site. Now, it transpires, J&J has paused supply from contract development and manufacturing organization (CDMO) Emergent Biosolutions.

“Our most recent discussions with J&J have indicated that they are evaluating their global supply chain as they assess the demand for their COVID-19 vaccine,” Emergent’s CEO Bob Kramer said last week during a financial call.

When pushed, he added: “We were recently made aware that [J&J is] evaluating their global demand for their vaccine in the supply chain that is supporting it. I’m not sure when we will hear the results of that, I expect probably in the second quarter, but it’s as simple as that. We’re just made aware recently that they’re doing this evaluation and assessment.”

J&J contracted Emergent early in the pandemic, through an initial $135 million deal in April 2020, that secured large-scale capacity at its site in Maryland. The partnership was tested by an ingredient mix up in 2021, which landed the plant with an FDA Form 483 and a directive to stop production. Production resumed and J&J has remained committed to Emergent.

And, according to Kramer, despite the latest production halt driven by the capacity reassessment, the contract with J&J has not been changed but Emergent is taking the down time to .

“We’re taking the opportunity to begin our normally-scheduled maintenance period for our Bayview facility earlier than anticipated and also to extend it in order to make improvements in modifications,” he told stakeholders.

“These enhancements will enable us to meet the needs of J&J, while planning for Bayview’s future return to non-pandemic work as part of our CDMO network, a key step in enhancing and advancing the growth of our CDMO business.”

As such, Emergent has revised its 2022 CDMO services revenues to $330-$380 million, down from $430 – $480 million.

“Sometime in Q2, I think we’ll have a better idea of what the overall long-term demand for that product is and how our Bayview facility kind of plays into their global supply chain solution going forward.”