I think we can get started, everyone. Kallum Titchmarsh here from the Life Sciences team at Morgan Stanley. Really pleased today to be joined by Franco Stevanato, CEO of Stevanato , and Lisa Miles, Chief Communications and Investor Relations Officer. Just before we get started, the exciting stuff. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. Thank you both for joining me here today. Franco, maybe just to set the stage, can you talk about how 2025 has played out so far versus your initial expectation at the start of the year? Just beyond the numbers, what are you most proud of? Maybe talk about some of the challenges that you encountered that you perhaps weren't envisioning at the start of the year.
First of all, thank you. And thank you for Morgan Stanley to host the group for this important conference. For what is related to 2025, we'll get on track with our target in terms of numbers. Even more, 2025 for Stevanato Group is an important year because we are deeply focused on building capacity for our bio customers. Like you know, we have started a few years ago to build greenfield plants in Italy. Now, even more, we are approaching a big investment here outside Indianapolis in Fishers. We are laser focused on executing this program and we are on track. What does it mean on track? We have installed a lot of lines. The training of our operators is on track. The quality system is high. Also, we are proceeding with a lot of customer validation every week for our U.S. customers. This was the main goal.
We have set some big priorities in Stevanato Group and we are monitoring this every week and we are proceeding in the right way.
Great. I wanted to talk about product differentiation. Your number one, number two positions in many of your core business lines—what do you think the drivers of market leadership have been? Is it product differentiation, brand value, pricing, relationships? Just maybe talk through that if possible.
Yes. Already at the beginning of 2000, we have decided to focalize Stevanato Group to serve the pharmaceutical company, biologic market in particular, and everything that is around the injectable. What does it mean? We invest a lot in building state-of-the-art greenfield plants in the different areas all around the world. Today, we are present in 13 state-of-the-art plants in nine different countries, including the new greenfield plants that we're doing here in the United States. We have boosted the research and development in terms of product and process in order to build superior quality through our internal technology. Today, one of the main factors when one big client is going to define a partner is when they have the same footprint, with the same quality system, with the same level of technology.
The quality of our product, because of the injection, is going directly into the patient, is fundamental in order to enhance sterility and for the safety of the patient. Today, we have built this leadership position. We are number one worldwide on cartridges. We are the second player worldwide on syringes. We are the market leader on [bioreticulture]. Just because in the last 20 years, we have laser focus to invest in quality, in process, and we have patented a lot of products for our injectable customers. This has enhanced us, Stevanato, to arrive where we are. Even more, allowed Stevanato to enter in the pipeline of this new molecule that our clients are launching in the market.
Great. BDS, maybe let's transition there. Nice acceleration so far in 2025. You raised the outlook last quarter to high single-digit growth, I believe, for the year. Maybe just talk through the drivers of that confidence boost and what you're seeing from customers right now.
Today, the dynamic is from the biologics market that is all of us, we are perfectly aware. Our big bio customers, biologic customers, biosimilars that are heavily invested in new capacity worldwide, also with a big focus in the last quarters in the United States. We also have a rich pipeline of molecules in II, phase III. Today, through our tech center that is in Italy and Boston, we are approaching our customers at the early stage in order to be filing in the FDA together with the drugs. When the product got commercial, we started to serve with our big plants in Europe, in Asia, even more in the United States. The dynamic of the pharma customer is very, there is a lot of energy.
We are practically mirroring the investment in order to build the supply chain together with them, in order to continue to allow the growth in the same percent that we were able to deliver in the last years. Before, to be a public company, the revenue of Stevanato Group was approximately EUR 0.5 billion. Today, the guidance is targeting to be close to EUR 1.2 billion, so a little bit less. The nice future to be when our greenfield plants will be up and running in the next years.
On the de-stocking side, a lot of discussion about the food industry. I think you commented earlier in the year you expect that to fully normalize in 2025. Sitting here today, do you feel confident that's still the case?
Yes. Related to COVID, it was one of the most positive and painful events in the history of the pharmaceutical company because in 2020, most of the players like Stevanato, we received a lot of new orders related to COVID. Vaccine also, there was a lot of tension in the market to build stock for all the molecules, all the programs. Fortunately, the exit of COVID was earlier compared to our expectation. Practically, most of our worldwide customers have a huge stock. We're talking about more than one year on stock on the top of the stock of the COVID. It took two years to clean up the inventory of our clients. We already started to see positive signals in the second part of 2024. In 2025, we see that more and more we are passing through a normalization of order intake for our clients.
I'm going to confirm that within 2025, we'll be back to normalization.
Are there any small ad pockets remaining within the de-stock?
The only add pocket is that there is a lot of capacity in the market for buyers. This is implying that we need to be extremely efficient and to have a very speedy relationship with our clients.
When you look at where we are year to date, in the first half of the year compared to last year, miles were up 3%. When we look at the order book for the back half of the year, we have a lot of confidence that we see the ongoing normalization within the market.
Great. On the high-value solution side of the portfolio, that's also been growing pretty well recently. Raised the outlook there too. Can you just speak about the specific products that you're seeing success with in that portfolio?
Today, you can say from the day that we have launched the IPO of Stevanato Group, the majority of our investments are fully dedicated to investing in capacity for high-value products. We're talking about Nexa syringes. We're talking about Alba syringes. We're talking about cartridges ready to fill. We're talking about also wires ready to fill. We are developing a set of patents around our devices. Today, around high-value products, the big growth is on Nexa syringes because it's perfectly fitting for inserting these syringes in the auto-injector. Today, most of our clients, in particular in the injectable space, they are developing a new modern way to set the administration of the drugs where they're going to use this sophisticated auto-injector. Most of the time, it is our Nexa syringes.
You touched on Alba briefly, I think, highest-performing syringe platform there. Can you just elaborate on how that differentiates from other syringes on the market?
Just to recap, in order to explain why we are having this high success on Nexa syringes and Alba syringes, because we have some, we can offer to our clients superior quality for Nexa. Like I mentioned to you, that the syringe Nexa is going to be inserted in an auto-injector. We have patented a particular silicone inside that is enabled to do a better distribution during the injection. Usually, during the traditional syringes, you inject with a finger. When you have a pen, you push a button. It is fundamental that there is a very homogeneous distribution through the pressure. The silicone injection that we do inside is going to enhance this characteristic. Since it's more detailed, but it's fundamental, in particular when there is a patient who does the self-administration.
Another superior quality that we offer in these syringes is it's much more resistant than normal syringes because you have to take into consideration these syringes are going to be assembled with 12 plastic components. You cannot have any risk of breakage inside of the device for many reasons because this patient is obliged to have one or two injections per day. The process that we have developed through our engineering division enhances this quality superior. Where is the difference compared to our competitors? Most of the time, we have to deliver several hundreds of millions or billions of products every year. This is where we are able to enhance quality because Stevanato has a hub in Italy. Two hubs in Italy. We are going to build a big hub here and we are serving all the clients.
We have a process that is extremely stable that is going to enhance this. It is a small detail, but makes the big difference in order to win the big contract. Alba is even more superior quality because we launched Alba for certain ophthalmic products. We see more and more that clients have a very high attention for what are some high-potent drugs, in particular on mAbs, monoclonal antibodies. They cannot have any risk that there are some particles of silicone that are going to mix with a molecule that can change the chemical composition of the molecule. This particular plasma coating that we have patented and developed inside silicone is one of the best superior syringes that is going to really reduce drastically the risk of visible particles that can be injected. This is going to be discovered by our clients because they put instability in the molecule.
We are instability with tens of products worldwide. This is another big selling winner for Stevanato where we will capture the future. It's only based on superior technical and quality competitive advantage that we offer compared to our competitors.
Understood. Obviously, this high-value solutions mix, that is really nice for gross margins as well. Maybe just talk us through the margin profile of these products versus the standard ones and how that kind of ties into the broader group as well.
Today, we have a high-value product. Our target of gross margin is between 40% - 70%. We are on track on this trajectory. The more we are serving big customers, high runners, we are more on the lower part of this range. The more we are going to sell sophisticated products like Alba, we are more in the high range. For non-high-value products, our target of marginality is between 15% - 35% gross margin. We can share with you that in the last three years, nearly the totality of our investments are focused on investing capacity on high-value products. Why? Because we want step by step in the next five, six years to reposition Stevanato Group to a much more high, sophisticated, rich portfolio in high-value products.
How much room is there to push the margins of the products themselves higher? I mean, it's raw materials a lot of the time, but I'm curious whether there's potential for that to push up.
40% -7 0% gross margin is an outstanding number. We are really, we can compare to the high standard in the industry. You have to consider that the type of value proposition that we deliver to our customers is to secure not only related to the gross margin. What is the plus around this contract on high-value products? We secure a five, ten years contract with the clients. There is most of the time some CapEx contribution or some take-up pay formula. If you look to see a holistic way, the contract is very secure for all Stevanato Group, but also for the investor.
I want to touch on biologics and GLP-1s.
I give you a question. I ask the same question to our sales force. Why don't we go to 100% of gross margin? They say yes, but they don't do it. I don't know why.
Very good. Biologics, GLP-1s, a lot of discussion in recent years around that. Maybe just talk about where Stevanato is positioned in the kind of GLP-1 value chain and what you're seeing today.
GLP-1 is for Stevanato Group a very nice tailwind. It will give you a very nice tailwind in the next years or decades. What was the original [reverties]? We historically serve the top three insulin customers worldwide. We started to serve our clients at the end of 1990, was a standard buyer. Then this client engaged us to sell cartridges 1.5 mL to 3 mL for insulin. Through our tech center, close to 10 years ago, they give us the possibility to be registered and filed in this new opportunity. Today, 2025, I can say what we have done, I want to say in a very humble way, a very good job because practically we are in with all our product portfolio. We serve GLP-1 on cartridges. We serve GLP-1 on cartridges safe to fill. We serve GLP-1 on syringes.
We serve GLP-1 on syringes with bypass on buyers and also on devices, in particular here in Fishers. Our engineering division is involved in serving inspection machines and assembling technology for their devices, both of the so-called legacy projects that we are starting to install this high-speed line for our clients. We are extremely satisfied because we'll be able to capture this growth. It is a nice tailwind to our long-term number. What for me is extremely important to underline is that we consider this like a very strong additional improvement in our revenue. The focus in our organization is to serve all the pharmaceutical markets. What for me is important to understand is that Stevanato has historically the strategy to be the partner for all the biologic industry, not sitting in one to molecule, one to customer.
Today, if you look at the pipeline that we have and we would translate in revenue in the next five, 10 years, are practically with most of our top clients and biosimilars that have an average in the pipeline phase II and phase III between 50 molecules - 100 molecules. Most of these are injectable. It's where really Stevanato is focusing the growth. We want to take opportunistically GLP-1, but also consider that we want also to spread our portfolio in order to be seen in many clients, in order to share the growth and the revenue marginality, and to have also a very safe mix of clients.
Do you keep an eye on the momentum behind the oral formulations for GLP-1s? Obviously, again, there's a huge market to push into on the injectables. Any thoughts on the oral side?
We've captured in our long-term guidance in Stevanato Group that the oral, we're always talking about additional incremental growth. It's not that the oral is going to take out existing market because injectable, it will increase in the next 10 years. Also, oral, based on our estimation, it will take up a market share position around 20%, more preferably 30% of the total demand for GLP-1. This is what we capture in our long-term number.
Great. Outside of GLP-1s, keeping in the kind of biologics theme, I want us to touch on, you know, cell and gene therapies, vaccines. The market obviously is pretty dynamic right now with both of those products. What are you seeing?
Today, we have laser focus on these, like I mentioned to you, these products that everything that is around set injector. We have a big position in mABS, monoclonal antibodies, in particular for our originator clients. They are also biosimilars where Alba technology is perfectly fitting. We practically try to sell all the different types of new molecules. Like I mentioned to you, today, our top clients are building the capacity for their molecules for the future. We are engaged with all our product portfolio and nearly in the totality on the EZ-fill configuration. Monoclonal antibodies, we are present in a new type of therapy, and we develop customized technology or coating around the product in order really to have the best compatibility between the glass, the device, and the medicine.
You obviously have good engagement with your customers. There's a lot of policy uncertainty at the moment, a lot of headlines flying around. What's the sentiment like across the groups that you chat with?
In terms of our customers?
The customers, yeah.
I think obviously generally positive. We've seen a lot of announcements by customers, particularly related to new investments in the United States for additional manufacturing capabilities. In those discussions that we've been having with customers, they've been very positive, kickstarting those and looking at what we can do and how we can serve them in the future. We view kind of current sentiment with customers in terms of the move towards U.S. manufacturing as positive. We feel very strong about our competitive advantage in the fact that we have been ahead of the curve. We've got operations in Indiana ramping up now. We also do have the ability to scale in Indiana with an additional building size that we currently have. As we think about longer term and the expansion throughout Indiana, from our perspective, we feel as though we're in a very good position.
Franco, do you have more to add on that?
I just want to confirm that also in the last four or five years, the relationship with our clients evolves in a different way because they are engaging us at the early stage. We talk most of the time with the engineering division of the pharma company. Most of the time, we talk with the people of the manufacturer that are indeed. They are not watching Stevanato anymore like a single supplier of single products or either syringes or cartridge devices. The campus that we are building in Fishers is one of the most modern campuses that can serve the biologics space because we can serve the same clients. We serve the syringes and the devices. We can serve the buyers and the devices. It is going to perceive Stevanato more like an integrated system player. It is exactly the direction that the big clients are looking.
Not anymore a single supplier or component, but a supplier of the full system.
We'll definitely touch on that in more detail in a bit. I wanted to hit on engineering first. There's some headwinds there this year. I think you talked about lower revenue in glass conversion in pharma vision inspection. Can you just elaborate on the softness you're seeing in those areas? Is it kind of temporary speed bumps or something more structural?
Yes, absolutely. Just to recap, the pharmaceutical industry is heavily investing. In the company, the engineering division in the next years has the opportunity to always grow in a high single digit because, again, there is more and more an increase in the demand of inspection machines. Even more, there is an increase in the demand worldwide for technology for assembly of these particular sophisticated devices. We take on the part of the glass. The glass where we produce the glass forming is the engine of Stevanato Group. It's where we develop the technology internally, and also, we sell to some of our competitors. There is always a fluctuation that is not something that is irrelevant. The engineering division in 2022 and 2023, we received some record orders of machines for inspection machines.
It's also related to our next one for assembling technology related to this new increase in demand for self-administration of the product. Many clients ask to develop the new generation of machines, this high sophisticated line. All this technology we plan to produce in Denmark plants. There was a sort of congestion of this complexity in order to deliver all this high number of lines. In parallel, if you remember, in 2022 and 2023, there was also a big problem of supply chain constraints on second electronic components. Proactively, what we have done, we have delivered what we call a 2024 optimization plan in order to use two sites, the site in Denmark and the site in Italy, in order to be backed up and to be able to produce the same product in the two production hubs.
Today, we are on track because we are delivering most of these legacy projects to our clients. This will allow Stevanato to start to go with the order number two and number three because we are inside of some repetitive long-term contracts where the first line, where a little bit complex to deliver, had caused some delays. It's where we have practically done some erosion in terms of revenue marginality. Now, all of these programs are on track. What does it mean on track? Today, we are able to produce from these two plants, and also, we are already delivering with success to this complex line.
Yeah, you noted several new orders that were forecasted for the second quarter that were pushed out. The issue does sound planning-related. When does that revenue come back in?
What we guided to for those particular orders is we would anticipate that they would be secured in the back half of 2025. That is our current plan. As Franco noted, most of these orders are repetitive orders. That gives us the confidence that we think that they're going to come in. You're correct, it is just a matter of timing. We do believe they'll be secured in the second half of the year.
Great. At the investor day, you said you see engineering kind of a mid-single, high single-digit growth business. Not asking for like formal guidance here, but is it possible for engineering to get back to those levels maybe next year?
Yeah, the trend is going to be in this direction because once we deliver what we call this legacy project, we start with a new order. Automatically, we can go back to the same percentage in terms of revenue and also to improve the marginality because the new lines were going to produce in a more efficient way compared to the first prototype.
Great. Our next one, a lot of discussion about that over the past couple of years. Just frame up what that is maybe for the new investors here and how you see that as a tailwind for your business.
Okay. Our next one, just to if you go, I would like to go a little bit in the big picture. Every five, ten years, there can be new regulatory administration coming from Europe, from Japan, from the United States. They're asking, they're challenging the whole supply chain of the pharma company, including us, the supplier, to put in place more evolution in terms of process and product. I remember at the beginning of 2000, there was a very high attention on the breakages on the glass by the FDA. Practically, many pharmaceutical companies, they changed their filling technology. Also, they asked to the supplier like Stevanato or other to improve the internal process, in particular, the vision control, four-dimensional control, and cosmetic control.
Our next one, what is the critical requirement is to put in place a process that enhances there is not any risk of losses in sterility of the drugs. Practically, most of the pharmaceutical companies, they are doing an assessment of their process in order to see if the process, in any step of the process, there are no risks, in particular on the glass, due to breakages. What it will be answered in light of Stevanato to your question, that many clients, they are going to auto-change their technology, in particular when they are in the glass-to-glass configuration, is where they can have a risk. They are going to what we call the EZ-fill platform. They are going to purchase this sophisticated high-speed line called flexible line, where they're going just to fill under the isolator the drugs. They're outsourcing to partners like Stevanato, washing, siliconization, sterilization, and pre-assembly.
This is where we see a tailwind in the medium term for Stevanato. More adoption on EZ-fill technology for buyers, cartridges, and syringes. For what is related to inspection machines, also this is another element because the technology that we have in our inspection machines has a particular algorithm or artificial intelligence that is going to better detect the first force rejection rate of certain defects that can in the medium term generate some loss of sterility. Also, our clients, they're starting in the medium term to change all their platform or vision inspection. It's where we plan to benefit in the medium term thanks to our next one.
How early are we in that kind of conversion?
We are in the process today, just to make an example. Just last week, a big client on insulin is looking to upgrade or retrofit or change all their platform for cartridges. They are in this analysis. Usually, how does it work? They're going to require six, nine months to do an assessment because they're going to check the supplier. They're going to see what is the technology available. Then they're placing the order. Placing the order to the supplier is maybe 18 months - 24 months to receive the new technology. Six months to do the validation. We are in the two, three, four-year period. The beauty is that they are going to use cartridges safe to fill. This is a customer that we serve since 1998. You can imagine. In our pharma company, it takes time to enter.
When you are in, you are in for all the period of the life of the investment and the life of the molecule.
We would say we're probably in the second or third inning, very early on, as Franco talked about. As customers look at and consider in our next one, it may require some investments on their end as they look at flexible filling lines that have the capability of processing and ready-to-use containers. We think this is considerably a long-term tailwind for us.
Fantastic. On some of the investments you touched on, Fishers, Latina, again, just give us an overview of what's going on there, the lay list. Do you have contracts and prior commitments from customers before you kind of lay down some of those tactics?
Yeah. In particular, Latina and Fishers, this investment that we launched a few years ago is focused to build capacity for high-value products. When we have high-value products, in particular, most of the time are covered by five or up to ten-year contracts. We have decided that also at the leadership level, the Board of Directors, to secure our investment with contract with our customers. Nearly the totality of the investment that we have done in Latina and in Fishers are covered by a long-term contract with our customers.
Fantastic. You mentioned Fishers represent a $500 million revenue opportunity at full capacity sometime in 2028.
End of 2028, correct?
Yeah, what's the revenue potential for your Latina facility once fully ramped up?
The investment for Latina is smaller compared to Fishers. Phase I of Latina, because we see what we have put in place, and then there will be another big important expansion because we are building capacity for cartridges, safe to fill. If you're going to exclude this, we are in the range of a few hundred million, a couple of hundred million of euros.
Understood. I think net CapEx this year is expected to be EUR 250 - EUR 280 million. How do you see this investment evolving in 2026 and 2027?
In Stevanato Group, we passed upon an extraordinary cycle of investment. This is also one of the main reasons why we have decided to list the company in New York in 2021, because we raised money in order to invest together with our customers. Now we are passing this big cycle, and the goal in the next year is to be more or less on the range of what I just mentioned to you. The estimation that we have captured in our long-term business plan is to be on the range between 10% to 15% of the total revenue in terms of CapEx.
Great. Lisa, you touched on it earlier, but the onshoring opportunity, I think $300 billion worth of announcement from.
450.
Okay, it's gone out, I guess, from biopharma customers year to date. Maybe just give us some color on those conversations you're having.
We see, in particular, we are starting to see this increasing interest in the beginning of this year, in particular at D-CAT, where we were in March here in New York, that a lot of clients, once they're going to see that we have proactively invested a few years ago, a few hundred million in Fishers, it's helping a lot to be perceived like the domestic player for their new product. Today, on the top of the, all overall, in Europe, in the United States, in Asia, there is a good dynamic of investment from pharma companies. The fact that we have invested, we have done the IPO in New York, we raised money and we invest more than EUR 500 million in Indianapolis in order to build a very sophisticated campus that can serve our customers. EZ-fill product, bulk product, and device is helping a lot to potentially gain new business.
Are these conversations incremental business on top of what you have today, or is it more customers replacing what they have elsewhere and bringing it in here?
Both, because I can throw, I make an example. A few years ago, you were not aware because we planned at the beginning to invest also in China and Shanghai using the same model. Some of our big clients readdressed the investment in the United States for this capacity, particularly for Nexa syringes. Today, what we see is that partially certain clients are asking Stevanato, please go in Fishers because they want to have more supply chain in the United States. We also through that many other customers, the fact that we are already in the U.S. with a huge capacity, they will allow us to further increase market share. There will be a combination of two potentials. We change the mix or increment our business.
Great. I think we have a few minutes left. I'll...
It's important to underline the EUR 500 million investment has approved phase I.
Okay.
We can easily double the size of this investment because we already have purchased the land. Today, we can double the investment in the next years. We also double the revenue. We are proactively ready for this potential incremental revenue next year.
To Franco's point on that, as we talk with our customers about what the future looks like in manufacturing in the United States, the way that we build our facilities is modular in nature. Understanding the type of demand that your product has is very important as we consider what the next phase of Fishers can look like. As you know, manufacturing sites can take up to five years to build, particularly on the client side. We're really in the early phase of these discussions. In Fishers today, we're ramping up syringes. We will be installing vial lines, which is in process, and we have a future consideration for other product categories, such as cartridges as well.
We are here for the long term. The company is 75 years old. When we've done the IPO in 2021, we considered the day one in order to further invest for the pharmaceutical industry. Our goal is to be the humble partner of pharmaceutical companies. Most probably we'll be here for the next decades. Our idea is to not only focus on the quarter, but focus on what will happen in the next 10 - 20 years. Fishers is the best location for us.
Great. Two minutes left. Profitability for next year, I think the street's forecasting a reasonable step up. How are you thinking about that right now?
There are, let's stay at the higher level. The market, the demand for high-value products is high. It's going to be confirmed to our contractor to be high. It's going to grow. Every quarter, we are installing new technology in the capacity in Italy and in Fishers. This will help to contribute to more revenue and more marginality. This normalization of the buyer, it will be increasing. We think that in 2026, we'll be in the full normalization. The engineering, it will be more or less on track. There are all positive KPIs that are going to prove that in 2026, it will be a good year.
Great.
In particular, in Latina and Fishers, I think one thing that's important to remember on the margin trajectory is as we continue to grow volumes and improve utilization, obviously, an improvement in absorption will certainly help gross profit margins. That's one area where I think it may be underappreciated as we think about gross profit margins and the evolution over the next five years.
Perfect. One more question for you, Franco, last one. What's something you wish investors asked you more often? Or what should investors be focusing on that perhaps they don't?
Okay. We have the question around COVID. Every time that they ask this question, I ask them to give me $1. I have already a big pocket at this moment. There is a high attention to what is really the connection about our investment, our high-value product connected with the future of our customers. Practically, we try to explain to our clients that there is a value proposition that we put in place that is making the difference today compared to some of our competitors and allows Stevanato to win more business.
Perfect. Franco, Lisa, thank you so much.
Grazie, thank you.