Quality issues at Sanofi’s beleaguered API spinout triggers guidance revision

15 Mar 2024
Executive ChangeAcquisition
EuroAPI said Thursday that it is pausing the production of all active pharmaceutical ingredients (APIs) at its Brindisi facility in Italy. As a result, the Sanofi spinoff has suspended its 2024 guidance and will issue a revision in the second quarter.
According to EuroAPI, an internal audit discovered “quality-control deficiencies due to potential local misconduct” at the site, which is responsible for the production of 11 APIs and intermediates comprising mostly anti-infectives.
The quality issue is the latest in a series of setbacks for the API company. In October, EuroAPI trimmed its full-year outlook, citing lower sales volumes and less demand from biotech clients.
During its quarterly earnings report in February, EuroAPI announced a four-year plan to boost profitability by streamlining its product portfolio, as well as the appointment of new chief executive Ludwig de Mot to guide the transition. He succeeds Viviane Monges, who has served as interim CEO since October, when she took the reins from founding CEO Karl Rotthier.
The API production company brought in just over €1 billion in net sales last year; the Brindisi site was responsible for about €63 million. Sales were up 3.8% from 2022 levels, less than half its originally predicted 8% growth.
Sanofi originally announced the creation of EuroAPI in 2021 as a standalone entity that combines the French drugmaker’s commercial and development activities with six of its European production sites to offer a broad portfolio of 200 APIs. The company went on to make its public debut in 2022 on the Paris stock exchange.
Shares of EuroAPI fell more than 17% on Friday to close at €2.7, which is more than 77% below its trading debut price of €12.
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