Good morning, everybody. Everybody hear me okay? All right, excellent. All right, good morning, everybody. I'm Doug Schenkel. I lead Wolfe's Life Science Tools and Diagnostics effort. It's my pleasure to have you all here with us this morning and to welcome Stevanato Group. From the company, we have Marco Dal Lago, the company's Chief Financial Officer. We have Lisa Miles, Chief Communication and Investor Relations Officer. Thank you both for taking the time. I am sure many on the line and many in the room know Stevanato well. For those of you who aren't familiar with the company, I guess if I were to basically describe the company in a nutshell, Stevanato is a key pharmaceutical packaging supplier that offers glass primary packaging components like vials, cartridges, and syringes for the administration of injectable therapies, as well as, on the other side of the business, providing modular automated production machinery.
A really well-positioned company as we think about some of the key drivers to tools in healthcare over the next several years. Just to pause for a second and really share our framework for this morning's discussion, we're gonna start with, first, we're gonna start with some high-level topics in terms of key drivers for growth within the company and more broadly, talk through some of the recent policy developments and how those affect the company. Secondly, after maybe folding in a little bit of some Q3 recap questions, we'll move to our second topic, which is really, really digging in on the biggest part of the business, the Pharmaceutical and Diagnostic Solutions business, and really talk about how policy dynamics are playing into the growth outlook there. We'll close with a few questions on the Engineering segment.
Thanks to you both for being here. We really appreciate it. Just to kick off, as I described a minute ago, you are a key supplier and actually a key innovation partner with highly regulated customers in biotech and pharmaceuticals. I think over the long run and historically, we tend to view businesses like this as being very predictable, compounders, you know, companies that are tied to volume growth development amongst your customers. We have not seen that, not just for Stevanato, but, you know, more broadly for your peers and even broader than that, the tools companies. That has been for a variety of reasons. Where do you think we are in, you know, basically turning the corner and moving into, you know, maybe I guess what I would describe as what is more normal, which is more predictable growth?
Thanks. Thanks for the summary. It's a very good summary, in my opinion. We are very well positioned to leverage the growth, particularly in biologics. We have a long track record of double-digit organic growth in the years, and we have almost completed the execution of a large cycle of CapEx to be ideally positioned to serve the market demand. Particularly, we have been investing in two new plants. One is in Fishers, Indiana, probably the biggest investment Stevanato Group has done in the years. We have been investing there, $500 million in CapEx, and we expect to fully ramp up the plant in 2028. Similarly, we are doing a plant in the center of Italy, slightly smaller size, but both of them are dedicated to a value product in the initial phase, mainly dedicated to high-performance syringes.
This is where we can see higher demand from the customer. We are working today with almost every big pharma company in the world. We are serving 23 of the 25 biggest pharma companies together with serving some emerging biotech. We invested, covered by customers' demand. We have a multi-year agreement in place with some of the customers in order to sustain the growth and the demand in the coming years. This is, in our opinion, very important because to summarize what you said, there is a high barrier to enter because of the CapEx, because of the know-how of the process and how to make consistent quality drug containment solutions, especially moving more and more toward biologics. The requirement is about more sophisticated containers, and this is where we can play an important role.
Another barrier to enter is this cost to switch, the container because we work together with the customer hand in hand in order to find the right solution for the container and the interaction between the container and the drug. We have a very good visibility for the years to come. About the overall market situation, we, as mentioned, we have a long-term agreement in place. We have very good visibility with respect of high-performance syringes and easy-fill cartridges, for example. We are number one in bulk cartridges for pen injectors, where we have a very good visibility too. Talking about vials, the number of customers is very high. It's a very spread market. As you know very well, last year we went through the destocking effect, so vials went down significantly last year compared with 2023.
We can see in 2025 a nice mid to high single-digit growth with a better traction in sterile, in sterile configuration. We believe the situation will keep on normalizing. We expect normalization in 2026, still with some situation to be fully normalized, but overall we are positive about the trend in 2026.
That's super helpful. I have a series of follow-up questions there.
Okay.
Maybe starting just because it's fresh in mind on destocking, it sounds like at this point, which we've talked about on the last few earnings calls, largely done at this point with, as you described it, there's a few instances, but for the most part, that's behind us.
Let's say today, in our view, we are still below the pre-pandemic demand, much better than in 2024, but we are still below that point. We see the market recovering, and we expect the normalization soon. When we say normalization, we are assuming a low single-digit growth compared to the pre-pandemic situation year over year. We should be there next year with still some air pockets in some specific situation.
As we're moving past destocking, we're moving towards normalized volume growth. Can you talk a little bit about the competitive environment? I want to come back to pricing and moving to high volume, high-value solutions momentarily. Before we go there, competitively, it looks like, you know, there's some disruption amongst your competitors, which I think would represent an opportunity. I combine that with, I'm thinking of, you know, the fact we visited your innovation center in Boston earlier this year. It does seem like the company continues to, you know, even in a normal competitive environment, differentiate with new differentiated products. When I combine those two things, your innovation with the competitive landscape, are we moving into a period where you might actually be able to pick up more share than normal?
We saw, we can see a significant growth in biologics. Our share of revenue in biologics is becoming bigger and bigger. There's very high demand in syringes where, more than grabbing shares to PD at the end of the day. It's more about winning new business opportunities. The market overall is growing. This is where we want to take advantage of it, especially, as you said, with the technology we have to move more and more toward more sophisticated syringes. We have Nexa syringes, high mechanical resistance, very suitable for auto injector. So the self-administration of the drug. We have Alba, low silicon content, very suitable for aggressive drug. Sometimes you can have in biologics. This is where we are investing both in R&D, but also in capacity with Fishers and Latina. We believe matching the market needs with our capacity and technology.
All right, I wanna talk more about that, but one quick Q3 question, and it comes to mind as you're talking about, you know, what is the growing attraction and the growing growth that is attributable, attributable to high-value solutions? So I think we're estimating, you know, almost 520 million in revenue, specific to high-value solutions for the year. You grew 50% in the third quarter. Even excluding any timing dynamics that you mentioned on the call, I still think you were growing around 40%. I think that's what we talked about at the time of the call. In a way, I felt like you could have taken more of a victory lap there given how strong that was.
Is the reason you're maybe a little bit, I know you're enthused about high-value solutions, but is it just, is the reason you're not almost more, you know, pounding the table on the success that you're having there just a function of the fact that it's been a tough couple of years for the group and the policy dynamics have presented a challenge?
Yeah, you are right. The quarter, yes, was extremely good with 50% growth compared to the same period last year. Beside the quarter where we can have some acceleration or fluctuation, the consistency of the trajectory we are having is important. We are shifting more and more toward our high-value products. Again, we can see very strong demand in high-performance syringes. We can see recovery in sterile vials compared to last year. The good news is that in vials, we see more traction in sterile vials where we are market leader, rather than in bulk vials.
About sterile cartridges, we can also see a very interesting demand, not only in the short term, but particularly in two or three years when we are currently investing in Latina, let's say in partnership with one of our most important customers to start producing for them sterile cartridges in large quantities. In a market like cartridges dominated by a small number of players, it's very important for us that one of them is switching to sterile configuration. That means for us, again, higher price per unit, better profitability, and consistently move toward high-value products. Overall, we not only can see the consistency in the current period of time, but more importantly, we see for the future further expansion in adoption in sterile configuration.
Obviously, this is partially also sustained by Annex One that we can see as a, as a tailwind, a long-term tailwind, but we expect other customers will follow the transition from bulk to sterile.
For those who don't know the company as well, how meaningful can the margin expansion be if you go from bulk to high-value?
Let's say historically, and today when we talk about high-value products, the gross profit margin range is between 40%-70%, while in non-high-value products it's between 15%-35% gross profit margin. High-value products are much more accretive. Also important, the price per unit is much higher, so we can grow more rapidly with the adoption.
Revenue and margin.
Margin.
I mean, you actually had a good, a relatively good free cash flow quarter, but I think as we think longer term, you know, the combination of price, volume, driving revenue growth, the gross margin improvement via mix and leverage, and then, you know, you're still investing in these facilities, but as you look out a few years, the cash flow yield can get pretty robust.
That's what we expect. We decided in 2020 to enter into a large cycle of CapEx. It's one of the reasons why we decided also to go public in order to finance the growth. The peak of the CapEx has been in 2023 with $430 million of CapEx, building both Fishers and Latina. We are now going toward a normalization of our CapEx after doing the building infrastructure. We are installing machines that, this is linked to engineering, is already in our asset under construction because we do internally the technology for glass forming, but also for the second step of sterilization. We have a large amount of asset under construction, but this is positive because it means in the future there will be more and more installation, but the large amount of money has already gone.
Yes, definitely we expect a positive cash flow profile driven by high-value solutions with higher profitability, but also the fact that we have invested to grow in the future with more revenue and margin.
I wanna spend a few minutes on policy dynamics and how they are basically what, almost what you're hearing in your conversations with customers as we get towards year end. I wanna talk about MFN reshoring and then, you know, kind of tied to MFN, basically the outlook for your business as it's tied to GLP-1s. Starting with MFN, you know, we have seen a number of announcements out of the White House and large customers like, I think it's Pfizer, AstraZeneca, last week was, I think it was last week, things are blending in a little bit, but we got the announcements from Lilly and Novo on the GLP-1 front. Again, I wanna come back to that in a second.
Simple question though, as your customers have a little bit more certainty on, you know, essentially the world, you know, essentially what the rules of the game are going to be with MFN, is that certainty helping a little bit? Are you sensing any change in tone in your conversations with customers?
I think overall, anytime you remove uncertainty, I think it's extremely helpful. Our conversations with customers obviously continue to be very positive. Obviously, we have the opportunity to leverage the new manufacturing capabilities that we have in Fishers, Indiana, which is very attractive to many customers as they're looking for additional capacity here in the United States. From our perspective, net-net, it's positive. Thinking about reshoring similarly, we view that as a very positive tailwind as well, particularly for our engineering business. As our pharma customers contemplate their footprints globally, where they're going to have new capacity, planning that capacity, we do anticipate in the medium term, tailwinds associated with manufacturing lines for pharma visual inspection as well as for assembly and packaging, particularly for device assembly.
From our perspective, we see some of these policy movements as positive in terms of obviously removing some of those uncertainties, driving investments here in the United States where obviously we can, as I mentioned, leverage our capacity in Fishers, Indiana.
Couple of quick follow-ups. Reshoring, is it a reasonable expectation given how long it takes to build a facility and then the timeline between, you know, when a facility is, you know, when you break ground, when it, clumsy way of asking, this is probably not a 2026 revenue driver. Is that fair?
I think it's fair there can be some opportunity to sign some, start signing some contract in 2026.
Okay.
You are right, machines are following the building and infrastructure. We expect the tailwind will be more in 2027, 2028, and 2029.
When do you typically see orders in comparison to when a facility is finished? Is it about a year, or is the revenue like a year before? Is that a good rule of thumb?
It would depend on the manufacturing line that they're taking.
Okay.
Obviously we have a broad portfolio of lines from essentially standard lines up to fully customized and tailored lines to that specific customer's needs. Obviously it depends on how large is the facility they're building, how long is the build. Typically I would be thinking about if they need, for example, a pharma visual inspection line, they would be ordering that likely 18-24 months in advance depending on the type of line it is.
Do you think it's fair to conclude that, you know, if you're building out something in the United States where labor tends to be higher than, you know, many other places in the world, that you are particularly well positioned because of the automation, the automated attributes of what you offer to customers from the engineering side of the business?
Yes, this is typically the situation we can see in the U.S., but also in other very well-developed countries. The automation is more and more, for many reasons, not only the cost of labor, but also to avoid contamination. We can see more and more automatized lines where, with the past, and we can play an important role in this type of technology.
The engineering side makes a lot of sense to me. Does having more supply coming out of the United States, you know, and, you know, having this facility in Fishers, Indiana, does that help you more broadly in, you know, at least under the current policy environment?
We believe engineering is very important for two reasons. The first one is the internal one. I mean, we are designing and developing the technology for glass forming and for the sterilization process that is helping us to enhance the quality of the product in glass, the quality, but also we can do it efficiently. The fact that our teams are working daily to improve the process and the product together is a very good interaction that is helping us in being successful in delivering high-quality products. This is the first reason. The second reason is because we can work with the customers, having more intimacy with them in the operation with our inspection machines. Assembly packaging lines are very consistent with the drug delivery system business. We can have an integrated offering to the customer providing them many different types of products.
There are cross-selling opportunities.
Cross-selling too, besides integration, yes.
All right. I think one of the big questions of the hour for a lot of our companies, and Austin and I were talking about this earlier, we got a number of emails on this even over the weekend. As investors come out of earning season and think about increasingly 2026 and 2027, one of the key themes I think may be, I mean, we've all been focused on GLP-1s for a while, but post the MFN announcements, the idea that lower pricing could lead to more volume. With that in mind, if that is a key investment theme for the next couple of years, can you talk about how important this is for Stevanato as a key supplier to the GLP-1 companies?
We believe net-net is an advantage for us. The larger is the market, obviously, the more we can take advantage of it. We can provide many different solutions for biologics and GLP-1s like Nexa syringes, dual chamber products, bulk cartridges, easy fill cartridges, vials too. We have a very large set of products to serve the customers. We have a relatively small cost compared with the overall cost of treatment. We do not believe that there will be a significant impact on our prices. At the same time, with the enlargement of the market, there will be more need of containers. We believe it will be a net positive effect for us in the future.
You've never said how big your exposure is to GLP-1s.
No, we don't. We for sure GLP-1 is, one, tailwind for us and for the industry in general in the years to come. We prefer to bundle all together the biologics where we have biosimilars, GLP-1s, monoclonal antibodies, and mRNA applications. We are steadily growing in biologics. We reached 40% of the revenue in the BDS segment after nine months. This is consistent with our strategy started many years ago when we started investing in high-value products for biologics and for more sophisticated containers.
GLP-1s is a great tailwind. Building off of what you just talked about as you broaden out to biologics. Policy-wise, there certainly seems to be more of a push towards biosimilars and a more accommodating, what could be a more accommodating environment for biosimilars. Along the same lines, those are, that, that's a real positive for you as well.
It's positive as well because based on our experience, biosimilars tend to adopt the same format of the originator. They're very interested in time to market. Usually the adoption of the container is the same as the originator. Through biosimilar, we can see an enlargement of the market. This is what we are doing. We are covering the market, both originator and biosimilar. We have experience in the past when there is the patent cliff, we try to take advantage of it, serving the biosimilar markets.
What's your win rate in, in biosimilar situations?
That's actually not a statistic that we share.
All right, I tried.
We did share some information on our last earnings call where we did secure a win for our easy fill cartridges related to a GLP biosimilar that was approved by the FDA and launched in the U.S. in September. I think to the point of anytime you see enlargement and increased market access, it tends to be obviously a net positive for players like us.
One other tailwind, which I can't believe it's taken us this long to get to, but Annex One in Europe, how far along are you in converting customers as part of Annex One? Still early days.
We see Annex One as a long-term tailwind. You know, the adoption of easy fill configuration, we believe, is consistent with Annex One requirements to minimize contamination, ensure the integrity of the container. We do not believe it is an overnight process, but we believe it is a tailwind. It is not an overnight process because it has to do with the technology in place of our customers with respect to fill and filling machines. We can see some good signal also there. We see more and more lines, fill and finish lines, suitable for sterile configuration. We believe in the years to come there will be more and more adoption of the easy fill configuration.
Understood. One thing I do wanna touch on because, you know, we've talked about a lot of the positives, a lot of the tailwinds. I, in my opinion, engineering is an underappreciated participant in, along the lines of what we talked about, what could be a tailwind related to reshoring. That being said, engineering, you know, is probably the one part of the business right now that is coming up a little bit light of expectations. Is that, it's just timing dynamics, right? There's no change in fundamental demand.
We believe it's timing. I believe we described enough the why we are here in this type of problem, the very big workload we had, in terms of order in 2023 and 2024, the fact that we entered into some supply chain issue during the pandemic. When we have such a big workload with the planning that is not so easy, in doing very customized line, we enter in this type of problem. We decide to fix our footprint also. We enter into an optimization plan that we are executing, in line with our plan. We have been able to move all the technology with inspection machine to Italy, concentrating all the activity there. We are gaining efficiency.
The second step will be about assembly and packaging lines where we will keep the center of excellence in Denmark, but we will have a global footprint with acre by solutions depending on the needs. Overall, we are happy about the efficiency we are gaining. We are happy also about the project execution. We deliver a lot of final acceptance by the customer this year, much more than in 2024. Customers are happy about the technology and about the fact that we recover the delays. From the operation point of view, things are going in the right direction. What we are suffering in this period of time is the timing of the orders intake. I mean, we have a very good discussion with the customers. We have a lot of commitments from them to start new lines and new machines.
They are confirming they are happy with our technology, but the timing of the investment has been delayed a little bit, and we are suffering in this, because we have still a project mix more related to the old legacy project in Denmark rather than with the new orders coming. We are very confident because the new orders are repetitive machines, so where we can take advantage of the design already done in the prior projects.
Perfect. All right. Lots of exciting things going on, especially as we think about key drivers to growth over the next few years and how that evolves cash flow and margins in a really attractive way. Thank you both for being here.
Thanks for having us.