In the context of a temporary suspension of some of its production activities at its Budapest site, EUROAPI (Paris:EAPI) today provides an update on its financial guidance for 2022.

During an internal assessment, the Group identified some Good Manufacturing Practices deficiencies related to documentation management. These are associated with Production Records for certain prostaglandin products which are manufactured in a segregated production unit at its Budapest site. Upon identification, out of an abundance of caution, EUROAPI proactively decided on November 30, 2022, to pause batch release and as a second step to temporarily suspend prostaglandin production.

As transparency and quality are the Group’s highest priorities, we endeavor to keep our clients, partners and the market regularly informed. EUROAPI is still finalizing the assessment and is building the action plan to remedy this situation at our Budapest unit. In parallel, the Group has informed the relevant health authorities. EUROAPI does not anticipate any impact on the other activities of its Budapest site, including Contract Development and Manufacturing Organization (CDMO) activities and, based on the Group’s internal assessment, considers that the prostaglandin products on the market are within specification and are suitable for their intended use.

This temporary and targeted pause of production will affect EUROAPI’s business activities and financial performance. As a result, based on information available today, the Group anticipates Net Sales circa € 980 million and a Core EBITDA margin between 12% – 13% in 2022, due to loss of sales, related provisions, and remediation costs. The Group estimates that prostaglandin production could remain suspended for a few weeks.