PolyPeptide Group AG (PPGN) Earnings Call Transcript & Summary

Good morning, everybody. Many thanks for joining this call on short notice. As you have seen in our press release this morning, PolyPeptide Group has provided a market update, and in the next few minutes, our CEO, Raymond De Vre; and CFO, Jan Miller, will give you an overview of the situation. The presentation is based on the slide deck, which we will display in this webcast and which is also available on our website. As usual, I point you to the disclaimer on Page 2. And with this, I hand over to Raymond.

Thank you, Michael. Good morning, everyone, and thank you for taking the time for joining this conference. I thought it was very important to have this call, given the fact that today's news is disappointing for our shareholders, but also for me personally and for all of us here at PolyPeptide. Hence, we do want to take some time to explain where we stand today. And we've summarized the issues that we have recently encountered and lay out the measures that we are taking to swiftly address them. Then Jan will provide a financial update, and we'll then be happy to take a few questions from the audience. Let me start on the next page, page 4, of the presentation. We knew that we had an ambitious second semester in 2022, we had a full detailed manufacturing schedule in place to deliver what we promised to our customers for the second half of the year. In fact, things did progress very well, and we were on track with our plan as of end of October. Then early November, we did face technical equipment as well as manufacturing process issues. To give you a little bit of color, on the equipment side, we had malfunctioning sensors that led to the suspension of production on 2 manufacturing lines. But we have by now found the root cause. We have resolved the technical problem. We have finished all the required testing and finalized all the documentation. As a result, the commercial production has resumed on both lines. Regarding manufacturing process, as you know, these are complex manufacturing process. We have experienced lower yields than planned on a few products, resulting in extraordinary costs. As a priority for us, given the circumstances, it was first and foremost important for -- to stay close to the affected customers, and to immediately agree with them on a new production and delivery schedule for 2023, meaning that the corresponding revenues that we have lost due to these events are all now pushed into 2023. Let me turn to Slide 5. What are we doing? At PolyPeptide, we do produce hundreds of batches every year. By far, the largest part of those batches are produced and delivered on time to our customers, and our manufacturing teams across the site are doing a fantastic job doing this. As a reminder, on the left side, we are showing our overall integrated strategy, and I show it to -- I emphasize the fact that we already have ongoing initiatives to improve processes under the umbrella of One PolyPeptide approach. But, as I explained in the previous slide, the issues that we have faced do reveal additional areas of improvement that need to be addressed urgently. Let me comment on these measures. First, as I mentioned, we need to stay and are staying closely engaged with the affected customers. Only a small number of them have been affected. We have long-standing -- sorry, relationship with them, and we are confident that with our proactive approach, we are able to cover all their needs and their requirements through 2023 and beyond. Secondly, we are taking targeted actions to improve operational reliability and delivery performance, including launching specific initiatives in upstream, downstream to improve yields on a few specific products. We have put our best chemists and process engineers to work on these complex scientific problems, have already identified levers to improve and are very confident that we can improve reliability and expected output in 2023. We're doing a full review of our preventive maintenance program across the entire group to minimize risk and are accelerating also the implementation in '23 of a new plant maintenance tool across all our sites. Thirdly, under our 1 PolyPeptide strategic initiative, we already work on the group-wide harmonization of key processes and systems. I said it before, and I strong -- keep believing that it's absolutely critical to build strong systems and strong foundations if we want to grow in a sustainable and profitable way. The recent events, if at all, indicate the need to accelerate some of these initiatives, especially around our ongoing implementation, for example, of our global quality plan. Fourth, we have announced Jens Fricke, who is currently the Head of Our Site in Malmö as the new Director Global Operation and as a member of the EC with immediate effect. Jens joined PolyPeptide in 2013. Jens has been with us for 9 years. He has relevant experience at PolyPeptide, but also from his previous professional background. Jens has been doing an outstanding job with his team. And the Board and I are excited to have him part of the leadership of PolyPeptide. We look forward to working with him closely in the near future in order to keep building our operational capabilities to sustain the volume growth that we expect in the future. With this, I now hand over to you, Jan, for the financial impact.

Thank you, Raymond, and good morning to everyone. As mentioned, our manufacturing challenges started to accumulate towards early November. None of these various individual events were material by itself. It is, in fact, the accumulation and the combination that turned into this significant negative impact for the group's 2022 financial performance. We had to trim our growth expectations, with a revenue reduction for 2022 of EUR 20 million, resulting in a flattish revenue development in 2022 versus 2021. Now this expects the 2022 revenue to be at a level of around EUR 285 million. Our profitability is impacted by 2 key factors. So firstly, we lost sales in 2022 from the 2 suspended manufacturing line, therefore, also losing margin. In addition, we lost sales, including margin and half extraordinary costs related to the manufacturing process issues, as mentioned earlier by Raymond. These 2 factors explain the significant adverse impact on our profitability, which is going to be approximately EUR 25 million at the level of adjusted EBITDA. With regards to our margin expectations, we expect it will reach a clearly disappointing EBITDA margin of around 15%. So now let's move to the next page, next slide, which is Slide #7. Our recent issues obviously affect our performance this year in 2022, but it does not change our confidence in our opportunities for the midterm. We continue to observe elevated levels of customer R&D activities, which also is reflected in the many positive clinical results that you see announced recently. And in our own case, we also see consistent progress in our active custom project pipeline. That also includes the 30 projects in Phase III, as previously highlighted. Driven by these Phase III projects, we expect the growth of the peptide business next year in 2023 to more than offset the previously announced drop in our pandemic-related sales. Let me take the opportunity now also to briefly update you on the status of our pricing measures that we announced with our half year results. The implementation here is ongoing. All new quotes provided to our customers include updated rates based on the current economic environment. Also, our new large-scale facility in Braine, Belgium, is on track and is a key investment to meet our growth projections in 2024 and beyond. While pursuing our growth plans, we are fully committed to also improving our profitability. We will formally announce our guidance for 2023 in connection with our full year 2022 result on the 14th of March next year. With this, I would like to hand back to Raymond.

Thank you, Jan. Before we take questions, I would like to sum up. The unexpected and unfortunate issues we did experience over the last few weeks, already late in the year, as Jan explained, made it impossible to recover our performance in 2022. However, and this is the important message I want to convey, technical issues have been resolved. As we said, our manufacturing lines are back online, and we have worked closely with our customers so that we have shifted all production and sales to 2023. As a result, we are confident that we will grow our revenue as well as improve our profitability in 2023. With this, I thank you for your attention, and we'll now take your questions.

The first question comes from Daniel Buchta from ZKB.

Maybe 3 questions from my side. The first one, coming back on the manufacturing issues. I mean, maybe again, what exactly happened? And why did this happen now and maybe not already in prior years, I mean, at least also in the pre-IPO time, the numbers never revealed any bigger problems in that sense and was directly affected as well by this problem? Then maybe the second question on the midterm guidance for you, Jan. I mean you don't mention it anymore in your presentation. But how should we think about the high-teens sales growth excluding the COVID business and also the ambition to reach an EBITDA margin in the midterm of around 30%, again? And then the last one on slide mention -- on Slide 5, you mentioned harmonize processes. I mean obviously, PolyPeptide has quite several sites in its history and has 6 sites now. But the last acquisition in that sense is already a few years ago in Braine. And so why is this increased effort of harmonization needed now and why it wasn't or less so the case in the last couple of years already?

Thank you, Daniel. These issues have happened. As we've mentioned, this is a series of operational issues that are unrelated and happened at various sites. So we are working on them. We are resolving them, and we are confident that we will be able to execute as per plan in 2023. In terms of -- I will comment on the last question and then let Jan comment. In terms of the harmonize processing system, this is an ongoing journey. This is something that we've always continued. It started a few years ago and that needs to continue as we continue to grow and need to build strong foundation and systems. So this is forever an ongoing project and an ongoing initiative that we need to continue as we grow.

And for your second question, Daniel, so for the midterm guidance, we are going to come back, of course, with the full year result, with an update of the 2023 guidance and the midterm as well. We mentioned that the sales is shifted from 2022 to 2023, but we will come back at the previous level.

The next question comes from James Quigley from Morgan Stanley.

I've got 2, please. So the first one is on the split of the EBITDA impact. So can you give us an idea -- obviously, the EBITDA, obvious growth in the sales. But can you give us the idea of how much of that EBITDA impact related to those lost sales? How much related to one-off costs? And if there is anything within that, that might relate to future ongoing costs that may be inflation related or anything like that in order to give us a bit of a framework of how we should think about the impact in 2023? Similarly, consensus has got a 24.5% margin for FY 2023, which would be a 950 basis points improvement. So to what extent is that still achievable? And then second question, you mentioned that the fourth quarter had a quite an ambitious manufacturing schedule. So how are you thinking about the manufacturing schedule into 2023? You've got EUR 20 million more of revenues coming into 2023 as well, which will have to be manufactured. So is 2023 looking just as ambitious? How are you thinking about a potential maintenance period next year as well? And do you have any additional capacity coming online to help alleviate any potential risks around that?

Thanks, James. I'll address the first one on the EBITDA and the split. So 2 key factors driving the drop in the EBITDA, as I mentioned. The first one is, again, the loss of the -- or the shift of the revenue, the shift of the sales from '22 to '23, the EUR 20 million as mentioned. This is obviously also impacting the loss margin. So this is the majority of the impact. This is over 50% of the impact. Then the remaining impact is, as you also alluded to, the extraordinary costs associated with the manufacturing process issues.

In terms of the plan, it's a good question, James. But yes, we can do it in 2023. We have ways to ensure that we have enough capacity, for example, by adding additional shifts. We have a derisking plan in place. We've, anyway, also planned for plant shutdown for maintenance, that's absolutely critical in order to ensure that the equipment is reliable. All this has been integrated in 2023 plan to ensure that we can indeed provide the deliveries that we have promised.

The next question comes from Laura Pfeifer from Octavian.

So I'm just wondering, again, on the shift of the revenue into next year, I mean, does it mean we should think of adding this on top of kind of a normal sales growth? Or will it mean that the new base will be the EUR 285 million. And then on top of that, we just expect maybe a low single-digit growth and not a low single-digit growth on top of the previous guidance? So maybe that's the first question. And then the other one, in terms of your pipeline and just working on new collaboration. Can we expect maybe an announcement in the near term either for a new collaboration or potentially also the extension of an existing contract?

Thanks, Laura. On the first one -- on the first question, the response is what you said, which is we should expect this on the previous mix. We had a plan for 2023 internally, the EUR 20 million is being shifted at top and above that. In terms of the second one, as you know, we have 30 projects in Phase III. Several of these projects are in late-stage Phase III. And indeed, we are working, in fact, on several commercial agreements related to our Phase III projects pipeline right now. And in due time, we'll be announcing if and when relevant the signature of these commercial agreements.

The next question comes from Andy Schnyder from zCapital.

I would like to go back to Dani's question regarding what happened. Can you be more specific? Can you tell us what the specific problems were just to understand what happened there?

Yes, Andy. So as I mentioned, in terms of the technical problem, we had malfunctioning sensors inside the equipment, and that -- as a result of that, we had to suspend the production in these 2 lines. It took us a few weeks to resolve the issues, but also to then test and finalize all the documentation. And that's the 2 weeks. But as I said, this has been resolved and the commercial production has resumed. In terms of the manufacturing process, this is complex chemistry, as you know. And we did have a few products where we saw lower yields, lower output than we've been expected. And this is why we are working and have to work on these specific products on improving the conditions in the upstream and in downstream with much to make sure that we are recovering the yield that we expect and the output that we expect from the manufacturing process.

But these lower yields weren't connected to the malfunctioning equipment. That's a separate issue, right?

That's correct, Andy.

And the lower yields are these for new product you started this year and didn't get to the expected levels? Or did you see a yield drop in existing products?

It's not in both.

Okay. That's quite strange. With existing products -- I would understand it with new products, but...

With new products -- I won't say it's typical, but you do see it, especially when you scale up new products, given the uncertainties and the complexities of new processes. Some of the old process also, to a lesser extent, but also have been affected. So these are actually easier to solve.

The next question comes from come from Konstantin Wiechert from Baader-Helvea.

A lot of them partly answered already. Still on the malfunction, do you think this is partly an issue of underinvesting in the past? And do you see there also risk at other existing capacities that you have to increase your maintenance CapEx there to prevent this from happening again? And then, again, to be -- to try to get more precise on the EBITDA loss. So maybe you can share a bit more information how much of that is coming from the extraordinary costs, especially now where we also heard that it's also about probably lower yields from existing products that were unrelated to the manufacturing shutdown there. So maybe you can give us a bit more split of this EUR 25 million, that would be great.

The issues that we had on those specific lines are not related to overall low maintenance or not enough maintenance, they are not. Having said that, obviously, we do need to take a hard review at on our equipment to make sure that it doesn't happen. But I would not associate this to low historical maintenance. That would not be correct.

So on the second question, again, on the EBITDA impact of EUR 25 million. Again, it's 2 factors, as I mentioned before. First of all, the sales, so the shift up EUR 20 million into 2023. So the loss of the margin connected with that sales, that accounts for the majority of the impact. So that is over 50% of the impact of the EUR 25 million. The remaining is a number of different individual elements, as we mentioned, events causing this extraordinary cost in association with the manufacturing process issues.

Okay. So just to make this clear, that would mean you have above 50% margin on the sales that you lost now in this year? Is that what you're saying with more than half of the EUR 25 million belong to EUR 20 million revenue?

Yes.

The next question comes from Daniel Jelovcan from Stifel.

Just on the regulator, FDA, EMA, Swissmedic whoever, were they notified? Or was there already kind of a warning letter? Or was that an internal issue? How does that work? And the second question, was there also COVID business involved in these issues you had, or was it more of these newer Phase III drugs? Or was it even in the oligos segment? That are 2 questions.

Yes. Let me clear the first -- on your first question, there are no quality issues -- there's no quality issues. So there is -- this is affecting output. It's not affecting quality. There is no issues with our quality system, therefore, there's absolutely no need to contact the regulators. This is irrelevant in this specific case. No quality issues. We have -- this is not around the COVID-related product. As we have announced in the past, we've actually not producing any COVID-related product in this last quarter of this year as this has been pushed to next year.

And oligos or so...

Sorry? I can't year you very well.

Sorry, in oligonucleotides, I guess you're not yet ready. So I guess oligos were not...

Oligos were not affected.

Okay. And just a follow-up. These equipment malfunctions. I mean, is that your own mistake by controlling the equipment? Or was that -- I mean, basically, can you get the reimbursement from the equipment provider? Or what was the mistake?

No, we cannot. This is a situation where we cannot get a reimbursement from the supplier.

So it was your own mistake how to handle the equipment, correct?

It is a malfunctioning of a piece of equipment. It's always -- you can't always associate that root cause to the supplier itself. So we will take that responsibility.

Gentlemen, so far there are no more questions from the phone.

There are a few questions now that came in, in writing. Some of them are covering or addressing the same topic, and I will take them together. So one set of questions relates to how many products have been impacted by the issues and was it directly impacted by this?

So as you know, we will not comment on specific products as to which specific product has been affected, but a handful of products have been affected by this, a handful, meaning 5, around 5.

And there is another question about pricing measures. Can you give us some color on what sort of pricing measures you have taken?

Yes. So I can give a bit of color on that. So there's 2 elements here. So first of all, we have incorporated into our contractual templates some additional elements to accommodate the flexibility or the volatility in the market. That's one. Number 2 is our cost rates have been updated with the current environment, meaning the inflation and also the higher raw material costs.

Good. I think that covers all the themes that came up in the written questions here. I think the other question probably was asked -- already answered, but maybe I can repeat it again. Can you talk about the potential to sign a large new contract on how imminent that would be? But I think that has been covered already so. Okay. Good. So these are all the topics, and I think we now have an additional question on the phone.

We have a follow-up question from Mr. Daniel Buchta from ZKB.

And maybe also asking a bit more on this cost issue because you mentioned it again in the press release this morning. I mean compared to when you gave an update on the half year results, have you seen incrementally further rising costs, especially on the labor side, but also on the input cost side that may postpone really the time horizon until you have passed through everything? And then, I mean it's probably a bit too early to fully answer that question, but what kind of a feedback do you expect from customers, given that the manufacturing issues have now that were not affected by the issue. I mean, a CDMO, a good one typically lives from the reliability as a key USP. Do you expect any negative feedback in that sense from other customers?

So the answer to your first question, Daniel, is no. So there's no additional impact that we did not foresee.

And on the -- we are keeping -- staying close to the customers. Obviously, it is disappointing, but overall performance across our portfolio of customers remain strong. And we are confident that we are able to keep serving our customers as they expect.

Gentlemen, we have a follow-up question from Mr. Andy Schnyder from zCapital.

Just a quick one. Can you tell us how many customers have been affected?

Yes, less than 5.

Okay. And how many batches, can you tell us that, too?

Yes. I will not comment on the number of batches, Andy.

There is one more question that came in, in writing. The yield topic, does that affect one or more sites.

The -- as we said, these are a series of unrelated and separate issues. And yes, a few sites have been affected by that. It's not all in one location. Okay. We are not getting any new questions. I would like, once again, to thank you for your time. Thank you very much.