Hello, and welcome to EUROAPI conference call. My name is Alan, and I'll be your coordinator for today's event. Please note, this call is being recorded, and for the duration, your lines will be on listen only. However, you have the opportunity to ask questions at the end. This can be done by pressing star one on your telephone keypad. If you require assistance at any time, please press star zero, and you'll be connected to an operator. I'll now hand you over to your host, Sophie Palliez, to begin today's conference. Thank you.
Thank you, and good evening, everyone. Welcome, and first of all, thanks for joining so late. Together with me tonight, we have Ludwig de Mot, EUROAPI Chief Executive Officer, and Antoine Delcour, EUROAPI Chief Financial Officer. We will go through a short presentation by Ludwig on the press release that we just issued, and then we are open to your questions. Ludwig?
Thank you, Sophie. Good evening, everyone, and thank you for joining on this call on such a short notice. Our objective today is to go through the information that we just released and to answer your questions. As you may have read, we have decided to suspend the release and production of all APIs and intermediates in our Italian site in Brindisi. This decision follows an internal audit that has identified quality control deficiencies, including integrity deficiencies in documentation and quality data related to API quality control. These deficiencies could result from potential misconduct, and further investigations are ongoing. The production will remain suspended until further notice, and the company has initiated a forensic audit to delve deeper into the matter. Of course, the relevant health authorities have been informed, and we will inform our customers.
In Brindisi, we produce 11 APIs and intermediates, mostly anti-infectives, for a total EUR 63 million sales in 2023, of which 43% is sold to Sanofi. This situation is expected to impact the group's operational and financial performance. So consequently, we have decided to suspend our full-year 2024 guidance. The revised outlook will be provided in Q2 2024, along with the planned communication on the implementation and financing of the FOCUS-27 project. I want to stress here that there is no correlation between the strategic review disclosed at the end of February 2024 and the current situation in Brindisi. Having said that, we are ready to answer your questions, of course, keeping in mind that some elements are still being assessed and not finalized.
If you'd like to ask a question or make a contribution on today's call, please press star one on your telephone keypad. To withdraw your question, please press star two. You'll be advised when to ask your question. Our first question come from the line of Zain Ebrahim, JP Morgan. Your line is open. Please go ahead.
Hi, everyone. Thanks for taking my questions. I've got three, if possible. So my first question is just on the expected timeline for the shutdown in production. When could we expect to see resolution and restart in API supply? I think the prostaglandins took about five months, but you didn't need further inspection by the health authorities. So if you could use that as benchmark to steer us, that would be really helpful. My second question is just on... You've helpfully put in the release the revenue contribution for Brindisi site in 2023. But could you give us a sense of how to think about the impact for Core EBITDA? Presumably, these are relatively low margin products, but then there's a significant fixed cost base in Brindisi.
So how should we think about that for when we're trying to think about the impact on 2024? And then my third and final question is just on the covenant for the revolving credit facility. Are you comfortable that after taking into account the disruption, that you're still comfortably below the covenant for this year?
Okay. So I think thank you for that. So I will take the first question, and then Antoine will take the two other questions. So on the timeline of the suspension, that was your first question, again, we are still doing the investigation. We hope to be able to get the investigation report, as soon as we can, but this will take, an amount of time. So the timeline of suspension, we can't, give a definite answer here, but we've been talking in terms of months.
Regarding the question on the impact on the Core EBITDA and the FCF covenants, at this stage, we are still currently assessing the operational and financial impact on the stop of productions and potential impacts, not knowing yet the number of months during which the plant will be stopped and the time it will take to remediate. We'll then provide more information in the upcoming communication on the FOCUS- 27 project.
Thank you.
Our next line of question come from Fynn Scherzler, Deutsche Bank. Your line is open. Please go ahead.
Yeah. Hi, it's Fynn Scherzler from Deutsche Bank. Thanks for taking my questions. If I can maybe follow up on the margin question asked before. So is it, is it correct that these products are rather lower margin compared to other APIs that you provide?
And then on the quality issues themselves, can you comment on the nature of those issues? So, last time it was on documentation, is it this time related to the actual, final API formulation, so, to the actual product? And then, one more question. Why were the non-current assets in the site already, fully impaired last year? So have you had any knowledge of these, potentially existing issues at the site beforehand? That would be my question. Thank you.
And so maybe, Antoine, you can comment on the impairment questions and on the margin-
Yeah.
Question.
So, regarding the margin questions, you are totally right. The products which are made in Brindisi are a low margin, have lower margins than the average margin of the company. Regarding the impairment, I want to make it clear that this issue was not known at the time of the impairment. It was based on the future cash flow, which will be generated by the company in the upcoming years, which were negative. And also, this is the reason why we announced, as part of the strategic review a few weeks ago, our intention to divest at Brindisi, but also other reason for the same reason.
And then on your question on the nature of the quality issues, I think it's important that we mention that we have a number of confirmed data integrity failure situations in the stability studies. As you could also read in the announcement, we will initiate, as of tomorrow morning, a forensic audit, yeah. So you all know what a forensic audit means, yeah? So that means that we are going to investigate misconduct that has been happening in the site of Brindisi. But you will also understand that this is also very normal in forensic situations, that we cannot disclose any information for good reasons on this audit until we have the results of the audit.
But you also know that these audits go rather quick, and we'll have some forensic results over the next period of time. But we don't know yet when.
Our target is to come back to you in the course of Q2, at the same time, and for the results and the timing on cost, benefits, and financing the strategic review on the financial consequences of the event which just occurred in Brindisi.
Absolutely.
Ladies and gentlemen, please press star one to ask for question. We'll take our next question from Marion Lefebvre from APM News. Your line is open. Please go ahead.
Hello. Thank you. I'm a journalist for APM News. I want to know which markets will be impacted by the suspension of the production, and do you know the impact on Sanofi? Also, you talked about anti-infectives, which are already under supply shortages in Europe, so will it be worse? And, also can you talk a little bit louder because we can't hear you very well? Thank you very much.
Okay. So on your first point, which is to understand exactly what are the geographies which are impacted, we are supplying these APIs to multiple clients in different geographies, so there isn't any specific geography which is impacted by this event. Regarding Sanofi, as we mentioned, in 2023, Sanofi net sales were representing 43% of the net sales of the plant. So this is the ratio of the sales to Sanofi versus the other clients. And the last question?
Shortages.
Yeah, shortages. So what I can tell you is that, so the shortages, so this site is currently underutilized. And so as a consequence on our side, meaning we don't- we do not expect to have any shortages for the time being, linked to this stop of production.
Our next line of question come from Zain Ebrahim, JP Morgan. Your line is open. Please go ahead.
Great. Thank you for taking my follow-ups. I had two follow-ups. My first one was just you mentioned that you just, the cash flows for Brindisi were, you just already assumed they were declining, and that's what triggered the impairment. So the EUR 63 million revision revenues in 2023, could you give us an indication of what level of decline you'd assumed for when you were giving 2024 guidance, or your previous 2024 guidance? And then my second question is what... Just to get a better understanding of what's triggered this internal audit, was this just an annual routine audit? And then prior to that, have you now completed all the internal audit for all of your sites? Are you and are you confident that these issues are sort of isolated to Brindisi?
So, what I can tell you, even if we do not provide guidance to 2024 guidance by site, is that indeed, the net sales for the sites are declining. So, you know, we have just mentioned the 60, the 2023 net sales. So as a consequence, we need to, 2024 we're expected to be lower. Regarding how this was discovered, this was discovered as part of our quality system. It didn't arise through a formal audit at site level, but through our regular procedure in terms of quality and internal controls, during which many investigations were done, which helped us to discover this quality issue.
In order to ensure that we will not face such a problem in the other sites of the group, we will launch quality audits in all the sites to ensure that the problem that we discovered in Brindisi is not occurring anywhere else, and that we maintain the quality at the right level to meet the standard of our clients, and also now because quality is our first priority as a pharma industry service provider.
Just to follow up on that, so those quality audits that you will launch on the other sites, will that be complete by Q2, when 2024, when you provide the 2024 guide?
No, these audits will not be yet fully finalized. They will be done by external. It won't be internal audit, but external audit, and which are taking a few weeks. So obviously, we will not have the results, meaning for the other sites, when we will communicate more on the impact on 2024. However, today, meaning we did already such an audit after the Budapest quality documentation issue. And we strongly think that the other sites are not really impacted by such because this quality issue in Brindisi is due to potential local misconduct. Okay?
Understood. Right. Thank you very much.
As a final reminder, if you'd like to ask a question, please press star one now. There are no further questions on the line, so I will now hand you back to your host to conclude today's conference.
Okay. Thank you. Thank you very much, and once again, thank you for joining in such a short notice and so late in the day, at least in Europe. We remain at your disposal. For any follow-up questions, please don't hesitate to send us emails or give us a call tomorrow. Thank you very much. Bye.
Thank you for joining today's call. You may now disconnect.