Alleged Quality Issues at Indiana Plant Causes Catalent to Sink in Stocks

Catalent (NYSE:CTLT) declined 2.3%, partly due to reported safety and quality issues at its Indiana plant, which manufactures the popular weight loss injection Wegovy, according to the US Food and Drug Administration.

Inspectors from the FDA visited the Bloomington, Indiana, plant in October and November and documented some issues the regulator had with the facility, according to a Bloomberg report on Tuesday, which cited an FDA document the news organization obtained from a Freedom of Information request.

On Monday, Novo Holdings, which owns ~77% voting shares in the Danish drugmaker, announced it had agreed to buy Catalent for $16.5B, Shortly after the all-cash deal closes later this year, Novo (NVO) will acquire three CTLT fill-finish sites located in Anagni, Italy, Bloomington, Indiana, and Brussels, Belgium, from Novo Holdings. The Indiana plant is one of the facilities Novo is acquiring.

“Catalent takes all regulatory inspections and any resulting observations very seriously,” Laura Hortas, a spokeswoman, told Bloomberg News. Following the company’s “comprehensive response and action plans stemming from the November 2023 inspection,” Catalent is being given the chance to voluntarily fix the issues identified in the report.

In April, Catalent said it expected productivity issues and higher-than-expected costs at three of its facilities, including two of its largest manufacturing sites, to materially and adversely impact its FQ3 results and outlook for the remaining fiscal year 2023.

Separately, on Tuesday, the WSJ reported that Eli Lilly (LLY) is concerned about Novo Holdings planned takeover of contract drug manufacturer Catalent (CTLT), as it also produces drugs for Lilly.