Hi, this is Paul Knight, the life science analyst at KeyBanc. It's a pleasure to have today Marco Dal Lago, the Chief Financial Officer of Stevanato Group, and Lisa Miles, Head of Investor Relations. You know, you can ask questions via the screen and/or you can email myself at paul.r.knight@key.com. I believe we're going to start with a brief overview on Stevanato Group. Lisa and Marco, thank you for being here today.
Thank you, Paul. At Stevanato, we have 70 years of operational excellence, and we are today a leading player for the biopharmaceutical and diagnostic industry, providing mission-critical solutions. At Stevanato, we look at our business as a single value proposition delivered through two segments, Biopharmaceutical and Diagnostic Solutions segment business that is representing about 88% of our revenue for 2025, and Engineering, which are representing 12% of our revenue. From our customers, we offer solutions by combining products across these two segments to create a powerful combination of end-to-end solutions. Starting on the left, we have full portfolio of pharmaceutical glass products, including cartridges, vials, and syringes, which is our core market, where we offer a wide range of performance levels.
Our portfolio of high-value products have the highest marginality, like Nexa, Alba, EZ-fill Smart, and meet the most stringent performance and quality requirements of biologics. In drug delivery device, we offer a full range of platform solutions. This is an important tool in our toolkit, particularly as the trend toward the self-administration of medicine continue to unfold. Our Engineering segment includes manufacturing lines that range from glass forming to visual inspection to assembly and packaging of devices. Our range of products are supported by our scientific and analytical services with our Technology Excellence Centers, both in Europe and in the U.S., where we are working with customers in the very early stage of their pipeline and development activities. This unique offer means that we are with our customer for the entire drug life cycle, and in many cases that can last decades.
Our solutions are built into the regulatory filing, like the Drug Master File, which means that we have long-lasting customer relationship where switching costs are high. We are market leader in pen cartridges and ready-to-use vials, and we are number two in prefilled syringes. We are also market leader in glass converting, the critical technology for manufacturing containment solutions. Our business model has created the foundation for long-term sustainable growth. Our business fundamentals are strong, leveraging our 70 years history of excellence. We have delivered consistent growth and positioned Stevanato Group as leading player in the industry. For more than 20 years, Stevanato Group has delivered steady double-digit organic growth and margin expansion, driven mainly by demand for our high-value solutions. In fiscal year 2025, we continued to deliver solid results that reflected the strong demand in the market and our ability to capitalize on long-term secular tailwinds.
In 2025, the group posted a growth of 9% on a constant currency basis, driven by a double-digit growth from our BDS segment. In 2025, we also met our record high revenue from high-value solutions that grew approximately 30% year-over-year and are representing approximately 46% of total revenue. The strong mix driven by high-value solution sales was also the main driver for expanding margins. Our Nexa prefilled syringes were the fastest-growing product category for the year. This should come as no surprise as prefilled syringe is the main format adopted for GLP-1 applications. Our Nexa is particularly suited for delivery device application, thanks to high mechanical resistance. Revenue from GLP-1s accounted for approximately 19%-20% of total company revenue, growing more than 50% compared to 2024.
We are also expanding our participation to the broad biologic market that remain our fastest growing market. In 2025, we increased the number of customers ordering high-value prefilled syringes more than 40% in the biologic non-GLP-1 applications. This resulted in a higher margin as we expanded gross profit margin by 160 basis points, and operating profit margin grew by 220 basis points compared to 2024. It is important to remind that we deliver growth and margin expansion while also offsetting temporary headwinds such as euro-dollar exchange rate and tariffs that were unfavorable to us. For fiscal year 2026, we guided a top-line growth at 8%-10% on the constant currency basis that will remain a headwind for the year. We expect high-value solution to represent 47%-48% of the total company revenue.
This is expected to drive margin expansion with Adjusted EBITDA margin expected to expand another 150 basis points compared to 2025. We remain firmly committed in executing our unique value proposition provide us with a strong competitive advantage to meet the increasing demand, driven by secular tailwinds in high-growth end market, especially for high-value products such as biologics. Our demand-driven capacity expansion projects are progressing as planned, and we are in an excellent position to keep growing this business for many years to come. About Q4 2025, we grew slightly more than planned with a 7% growth on a constant currency basis and a 5% on a reported basis. The growth was driven again by our BDS segment that grew more than 10%, 13% on a constant currency basis, which offset the expected decline in the engineering segment.
High-value solutions increased significantly compared to the same period of the previous year. We increased 31% revenue in high-value products to EUR 171.4 million, representing almost 50% of the total company revenue. We expanded margin also in Q4. We went up 120 basis points compared to Q4 2024, driven by the favorable mix of high-value products. Very important, the improvement of the financial performances we have been doing quarter after quarter in our Latina and Fishers plant that are brand-new plant under ramp-up. We can see also recovery compared to 2024 in vial demand. All these positive trends in Q4 was partially offset by the strong euro against dollar and the tariffs obviously that impacted our profit in 2025 Q4.
As anticipated, we had in the year an impact for approximately EUR 4 million that was mainly concentrated in Q4. Operating profit was 20.2% in line with prior year. We delivered higher-than-expected earnings per share and adjusted diluted earnings per share. Our Adjusted EBITDA went up 7% to EUR 97.7 million, with an Adjusted EBITDA margin increased 70 basis points to 28.2%. This is basically the evolution we had in the past, what we had in 2025, in particular in Q4 2025. What is more important, in our opinion, is the trajectory is intact, and our guidance for 2026 assumes a sales growth 7.5%-9% on a constant currency basis at the center point of our guidance.
We anticipate gross profit margin expansion, 0-30 basis points. We anticipate Adjusted EBITDA margin expansion by another 150 basis points. We are continuing our growth, expanding the share of high-value products, and improving the profitability and the financial performance of the two new greenfield plants. Our guidance are including a currency headwind for approximately EUR 20 million for next year in the top line. This is something that we are offsetting through the growth, particularly in BDS segment, that is the core business of our company.
Paul, I think we're ready for questions.
Marco, you know, just going through guidance a little bit, starting with about 32% of the business is vials, other things besides engineering, besides high-value solutions.
This 32% that I think is a lot of it is vials. You've talked lately that it is growing again and will grow in 2026.
Yeah.
Is the vial market still depressed in 2025 from COVID and hospital destock?
Vial market in 2025?
Thanks, Paul, for the question. Let me also frame the situation about the non-high value solutions in general. You remember we are also number one in bulk cartridges. We are market-
Yeah
... leaders, it's another important piece that we see growing for 2026. We are continuing our journey in becoming an established player in drug delivery system, and with respect to that, we have specific contract with one important customer in Fishers, the CMO, that is growing also. We see, as you said, a normalization of the vials industry. We experienced growth in 2025 compared to the 2024 year of destocking. We anticipate further growth in 2026 when we expect the market will be normalized compared to the pre-pandemic situation. This is just to stay on the non-high value products.
About vials, particularly, yes, we see growth in bulk vials where we can see more traction, both in 2025 and we anticipate in 2026, is about the sterile vials where we see conversion and, but then sterile vials are growing more, much more rapidly than bulk vials. Overall, 2025 was in line with our expectations. We grew about 6% in vials with more traction in sterile vials as mentioned. We expect similar performances in 2026, with the mid- to high-single-digit growth in the overall vial market.
Okay. The other is you landed a 40% increase in customers outside of GLP-1.
Yeah.
Why are you winning that level of customer?
We really believe biologics is our future. We see strong market and relevant growth in the biologics industry, besides GLP-1s obviously. Particularly, we see traction in monoclonal antibodies, and also biosimilars are starting to play an important role. We see market growing in biosimilars, particularly in India, China and Asia-Pacific. Our strategy is to work both with the originators that are obviously our main customers, but also covering the market, staying close to the biosimilars and leveraging the future growth of them. Typically, biosimilars, you know, tend to adopt the same container solution as the originator to accelerate their time to market. We can play an important role also in the biosimilars industry.
How fast do you think the biosimilar market grows?
We see as a second wave, very interesting, also in the GLP-1s. We see some already good opportunities, as mentioned, particularly in India, China and Asia-Pacific, not only for glass containment solution, but also for our proprietary solutions in drug delivery systems, particularly Alina Pen is gaining traction. We have many opportunities in front of us in the biosimilars space.
Okay. You're guiding to the GLP-1 growth rate of mid-teens this year.
Yeah.
It's slower than last year. Is this destocking? Is this you being conservative? What's your kind of assumption on the GLP-1 market 2026?
Let me say that we are in the GLP-1 space since many years for the diabetes care. We are growing the GLP-1s for more than 10 years. That positioned us as a key player in the ramp up of the GLP-1 capacity. We are playing an important role in several different formats, like Nexa syringes, dual chamber, EZ-fill cartridges. We have many formats to work with our customers. What we experience is clearly a strong ramp up at the beginning of the GLP-1s in creating the capacity and also the inventories, as you said, to attack the market from the originators. We believe it's normal that after the ramp up, there is a normalization phase. I mean, starting from small numbers is easy to grow 50%.
When the market is establishing, it's not as easy at the beginning. What is important for us is that we see a growing market, not only for 2026, but also for the years to come. Where you know very well, probably better than me the numbers, where the expectation are with the potential market of 1.5 billion people affected by diabetes or obesity in the years to come. This is representing for us, for sure, a tailwind for the long term. As mentioned, we are not focused only on GLP-1s because we are mapping the market, trying to win as much as possible in the other biologics, besides the GLP-1s. This has been our strategy for many years.
We were not, let's say, a COVID company during the pandemic where we reached about, if I'm not wrong, 13%-14% of our revenue in COVID business. GLP-1s is even stronger, but it's not the only therapeutic areas where we are working.
Yeah. Your capacity expansions have been very active.
Talk to the status of its facility opening. Is manufacturing running in Indianapolis and factory running in Latina?
Yes. Do you want to know about the status of the two projects, I believe? Yeah. We increase our capacity in Europe and North America, mainly driven by the decision we took together with our customers to satisfy their need about supply chain. That's why we decided to invest so significantly in these two areas to, let's say, follow the priorities of our customers. We are investing almost everything in high-value solutions capacity that are more accretive for us and exactly in line with our strategic direction. Let me also say that we have a very strong visibility in these two plants because we have multiyear contracts in place with our customers for many different formats, where we are installing capacity in high-value solutions.
This is the very high level story why we decided to invest, how we are covered and what we plan for the future. We plan to fully ramp up Fishers by 2028, as mentioned many times. Today, we are working predominantly in Nexa syringes. We have been successful in 2025 in validating with the customers main line. We can now leverage our capacity to generate commercial revenues. Latina is ahead compared with Fishers. It's a smaller plant. The ramp up was much more rapid with respect to the Nexa syringes in Latina. We have started the second steps of creating capacity mainly related to sterile cartridges.
That is a very important step for us because we can see the market starting switching from bulk to sterile configuration. That is very powerful for us because we are talking about high-value products with the price per unit much higher compared to the bulk cartridges. Overall, it's in line with our expectation in terms of ramp up, and we have a very good visibility for the future.
Marco, I think capital expenditure is targeted at around EUR 180 million in 2026. That's a lot higher than, you know, maintenance capital spending.
Yeah.
Which I think is what? 60. The question I have is, assuming those numbers are close, this capital probably doesn't produce revenue for two or three years. What is this capacity targeting? Is it for engineering? Is it for biologics? Is it for GLP-1s? Is there a way to talk about what this capital is going to be used for?
Yeah. Let me say that, we still anticipate a high level of CapEx in 2026, in the range of EUR 250 million, at the center point of our guidance. You are right, it's mainly driven by further expansion with the, let's say, three main areas in the following order. I was mentioning before, we are establishing capacity in Latina for sterile cartridges, where we are basically managing the installation both of bulk cartridge and the second step to sterilize the cartridges. It's an important investment with multi-year visibility.
Okay
... for customer. This is the number one project for 2026. We are going on with the ramp-up in Fishers. That is the second project in terms of spending. As mentioned before, we see traction in our proprietary solutions for drug delivery system. Here we are creating capacity in Germany besides the capacity we are creating in Fishers for the important customer we have with the CMO contract. Those are the projects we are dealing with in 2026. That is still an important year. After that, we anticipate CapEx going down, and we will start fully leveraging the capacity we created in this year in Latina, Fishers, and Germany to serve the market. Our target for the midterm is to have a 10% CapEx to keep on growing high single digit, low double digit.
You're right, maintenance CapEx are limited. We are around 3%-4% of our revenue. All the rest is about the capacity increase. Again, in the last three years, we invested approximately EUR 1.1 billion, but most of them went to create capacity to grow, particularly in high-value products.
in the market right now. If there's questions, go ahead and shoot them onto the screen. I will look at emails as we speak as well. In the world of your competitors, do you think you've gained share in the last year or so, Marco?
Well, we believe we leverage the fastest growing market of biologics. We have been very successful in the new businesses like biologics, like GLP-1s, rather than grabbing shares to competitors. You know, in cartridges we are market leader. We see a good evolution in moving to sterile configuration. Yes, we experience more competition in bulk vials for the reason we know the stock and so on, so far. More than grabbing shares, it's we believe we have been successful in the fast-growing biologics market.
Okay. You're building dedicated clean room in Fishers. What are you producing now in Indiana? Is it vials or cartridges?
Today in Fishers, we are generating commercial revenue through Nexa syringes predominantly. We are well on track with the project for a drug delivery system with an important customer. About the CMO in drug delivery system space, we are taking a very selective approach. I mean, we take contracts if and only if we have the ability to leverage integration, for example, between our Nexa syringes and device. We also do it only for very important customers. In this specific case, we believe it's also improving our ability to produce and do drug delivery system. You know, we enter recently in the space. We started working on drug delivery system in 2020 with some R&D activities for proprietary products. We are relatively new in the space, but we see very good growing already.
More important, very interesting opportunity for the future, especially in biosimilar and what I mentioned before.
When you have a discussion with a customer about them needing capacity, is that discussion about capacity they need, is it one or two, or is it five years away that you have this kind of horizon with your customers?
This is typically what happened for the capacity expansion we have been doing in Latina and Fishers. We have multi-year agreement in place with very clear visibility for the future and many clauses to protect us in doing this type of investment. Yes, this is the case for sure for sterile cartridges, for Nexa syringes, for Dual Chamber Syringes, and all the key products that we're talking about.
kind of last to wrap this up, I think we have a minute or two. On Engineering systems, you're guiding negative high single-digit% to negative low double-digit.
Is the delivery of legacy systems complete? Is this business now pretty de-risked, or where do you think we are?
Yeah, we de-risk a lot. First of all, we are happy about the execution we have done in 2025, not only with the optimization plan we put in place. We have much clearer industrial footprint today with a cost basis that is much more efficient. We have been able to significantly increase our, let's say, the completion of the project with the SAT step. It's the Site Acceptance Test, SAT. We completed the most critical projects, both in assembly and packaging, but also in visual inspection machine. This has been completed. The industrial footprint has been reviewed. The cost basis is lower. Our guidance is taking into account the risk of the slower-than-anticipated order intake because what we can see in the market is a large number of very good opportunities.
We have repeated customers here, but it's more a project-by-project decision. We are well-positioned. What we experienced is a slowdown, let's say, between the decision, the verbal decision and the really execution of the project. This is probably driven by some location decision also in the previous month. There has been a lot of discussion about where to put the new plants either in North America rather than different area of the world. This is probably slowing down a little bit the decision-making process, but we are very confident. We are winning business currently as we speak. It's not, how can I say, a slowdown of the market. We see more a slowdown in the decision-making that is impacting 2026.
Nevertheless, we are much better positioned than one year ago with respect to the project mix, the footprint, and the cost basis. That's why we are confident we will be able to expand the margin in 2026 compared to 2025, in spite of lower volumes. We are targeting now more established technology where we are very stronger, both in visual inspection and assembly and packaging, particularly for drug delivery systems.
Okay. Last question. Indianapolis, we've heard from investors that have visited that site, that it's a very automated facility.
Yes.
Is Indiana capacity going to be some of the highest margin capacity at Stevanato?
Let's put it this way. We have similar technology in Latina, Fishers, and Piombino. We have very well-standardized technology. Also because, you know, we are doing the machine manufacturing in the Engineering division. We are targeting in U.S. probably the most interesting market. Medium term, we see very profitable Fishers, Latina, and the part of Piombino that is dealing with high-value products. We don't see difference between the three plants. We see difference in the, you know, type of products we are producing. When we talk about high-value products, the gross profit margin is usually between 40%-70%. We expect from Fishers, that is predominantly in high-value products, a very good profitability.
Wonderful. Well, we really appreciate your time. Thanks, Lisa. Thank you, Marco. I know you're doing a bunch of meetings today, but enjoyed the fireside this morning with you.
Thank you very much, Paul.