Temporary and proactive suspension of prostaglandin production activities at the Budapest site following a routine internal assessment
Prostaglandin products on the market are within specification and are suitable for their intended use
No impact on the other activities of the Budapest site, including CDMO activities
Updated 2022 guidance: EUROAPI now anticipates Net Sales reaching circa € 980 million and a Core EBITDA margin between 12% - 13% in 2022
PARIS, December 07, 2022--(BUSINESS WIRE)--Regulatory News:
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.
EUROAPI’s management will hold a conference call today at 8:30 AM CET (Paris time). Please click here to join the live audio webcast. A replay of the event will be available on the Investor Relations webpage.
EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.
Taking action for health by enabling access to essential therapies inspires our 3,350 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn.
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the results of the Group’s internal assessment of the prostaglandin production process and ongoing and future assessments and actions potentially taken by regulatory authorities, as well as the Group’s current and future strategy, financial and non-financial future results and the macroeconomics and business environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 "Risk factors relating to the issuer" of the prospectus approved by the French Financial Markets Authority (Autorité des marchés financiers, AMF) on March 31, 2022, under number 22-076. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.
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