Hi, good morning, everyone. Thanks for joining us at Jefferies Healthcare Conference in London. I'm Dave Windley with Jefferies Healthcare Equity Research, excuse me, based in the States. I cover the CRO space, CRO and CDMO space, as well as the container suppliers, West and Stevanato, in the drug supply area. I'm very happy to have Stevanato Group here with us today. We've been involved with the company and followed the company since their IPO, which has been a pretty successful run. The company's CEO, Franco Stevanato, is going to present a little bit of a background or overview of the company for a few minutes, and then we'll have Q&A following that. Giacomo, I should also mention, is here with us as well. Franco, thanks for being here, and I'll let you take it away. Thanks.
Good morning, David. Thank you to you, and thank you to Jefferies to host Stevanato Group, to have the chance to present our company. I would like to start to share a few slides with you. Who is Stevanato Group? Stevanato Group is a company that is present in the industry since more than 70 years. In particular, in the last 25 years, we try to focus all our competence, our investment, our energy in order to become the partner for the pharmaceutical industry. In fact, today we can say that Stevanato Group is the global leader provider of mission-critical products for the pharmaceutical industry. What does it mean, this? Most of our products are products that are going to serve molecules for the biopharmaceutical industry and most related to what is around injection.
In fact, what we try to develop, in particular in the last 25 years, is what we call an integrated platform in order to enhance Stevanato to serve what we call the full integrated system to our bio customer for everything that is around injection, no matter if it's originator or biosimilar. Today, Stevanato Group serves the pharmaceutical industry, in particular with this end-to-end value proposition through two segments. One is the biopharmaceutical diagnostic solution segment that provides service and product to our pharma customer, in particular with what? With the traditional vial, both in bulk or easy fill configuration, syringes in the easy fill configuration with different types of quality that we developed and patented in the last year, like Nexa, Alba, or particular double chamber syringes for sophisticated drugs for our customer, cartridge-ready to fill, where we are the market leader worldwide.
What we see is that more and more of our pharmaceutical industry, they evolve their type of self-administration through also particular devices. We developed our platform with our R&D center in Milano that we own today, some patent around the pen auto-injector wearable device, with a clear goal really to go to our pharma customer and to build a tailor-made product and process and service for their drugs. It's exactly what we are doing today. We have our engineering division that developed also the inspection machine and assembly technology for our product, like syringes or devices. Our goal is really through this segment, entering the true intimacy of the supply chain of our customer. Today, our big goal, our customer, is to have sophisticated product, constant quality with a very strong global player that can provide and can mirror their supply chain on a worldwide basis.
In the last years, in particular in the last 10 years, we developed what we call analytical service. We developed a technological excellence center in Italy, and we have a second technological excellence center in Boston. What is the scope of this group of engineers? It's to support our pharma customer when they are in phase II and phase III at the early stage in order to be filed together with them. In fact, today we have several hundred of molecules that Stevanato Group is going to file our product in the FDA file together with our drugs in order really to start from the very early stage to serve our customers. In terms of also reputation, we are actually the market leader worldwide on cartridges.
We are the second player worldwide on syringes, and we are the market leader on vial to fill and the market leader worldwide in glass forming. We try always to be the best in what we do and specialize all our energy in our competence. Again, like I mentioned to you, we are in a very dynamic, positive momentum in the pharmaceutical, in particular in the biopharmaceutical industry. The market is growing. We see there is a lot of energetic dynamic through our big top 25 global customers and relative biosimilars, where they have a very rich pipeline of product that they have in phase II and phase III and they are launching commercial. Most of we see that our big clients are heavily investing in building the new facility that will host their drugs in the next 10-20 years. What is doing Stevanato Group?
It just focuses on our core business. We try really to capture all these tailwinds that are coming from the pharmaceutical industry in order to become the partner that everything that there is an injection, Stevanato wants to be present with glass, with devices, with technology, and to sell the full integrated system to our customer. In fact, this is exactly the reaction and also the feedback that we receive from our customer. It's translated also to number. Stevanato, despite some tail headwinds that we had in the last year, like the stocking, like the forex, like tariff, we were able to double our revenue in the last five years. We were able to double our percentage of revenue on high-value product. And even more, we were able to more than double our EBITDA in the last year.
Exactly this is the trend, the trajectory that we were able to deliver in the last 25 years. Thanks to the IPO that we have done in 2021, we raised $1.1 billion, and most of this proceed we re-inject immediately in order to build, to boost our R&D, to increase capacity in Europe and increase capacity in the United States. In Fisher, outside of Indianapolis, we decided to invest more than $0.5 billion that we will translate at the end of 2028 to $0.5 billion of revenue in order to become the domestic partner for our bio customer worldwide. This is the goal, and this is the focus we will do in the next years. The company at the beginning of 2000, we were less than EUR 20 million company.
We want just to be focused and to serve the pharma company and everything that we have an injection, we want to become the partner for our customers. Lastly, another element that was a requirement of our pharma company from the beginning of 2000 is our big pharma customer and relative biosimilar became global. They have one quality approach to the pharma company. One of the requisites to become the true partner for them was first to develop the full set of product portfolio for everything that is around injection, but second to build a global footprint in order to enhance, to have a very solid and safe supply chain for them. In fact, today, this is the result. Sorry, I had to change the slide. This is the result.
We invested a few billion dollars in the last 25 years in order to build a global footprint that is going to mirror the global footprint of our pharma company. Mostly in the last four years, we are squarely focused to build up capacity for our EZ-f ill product in terms of syringes, Nexa, Alba technology, double chamber syringes, vial to fill, and cartridge-ready to fill, in particular in Europe, United States, in order to follow the incremental revenue that our customers are giving to us. We are just executing some strong long-term contract with our customer in order to really follow their incremental demand. This is exactly at a very high level what is Stevanato, 70 years present in the industry, last 25 years focused on the pharmaceutical industry.
Our goal is to become in the next 10 years the humble partner of the pharma company, where our goal is to really more and more scale up the supply chain of the pharmaceutical industry. The customer must focus on the development of the molecule. We have to take care about all the supply chain for them on a worldwide basis. Thank you.
All right. Do you want to stay there? Would you like to join us over here, or do you care?
Sure.
While you're making your way, let me start, Franco, with a question around your, so you've seen your high-value product or high-value solution revenue grow really, I think, faster than you originally expected in 2025. Is capacity, is your internal capacity the governor on your growth in high-value solutions, or do you have room to drive revenue growth in high-value without adding more capacity?
Today, David, we are adding capacity. We have space to grow in Piombino Dese with capacity for cartridges to fill and Alba technology for syringes. We are intensively increasing capacity in our plants in Latina. We will continue to add capacity in the next year for our Nexa syringes, syringe with bypass. We are starting a big program to start to install from the end of 2026, several hundred million of capacity for cartridges to fill. We see more and more the shift to our pharmaceutical customer, the adoption of cartridges to fill. Even more, we see there is a big trend in biologic for this type of product that is going to be inserted in the pen. In Fisher, also, like I mentioned to you, the full perimeter of the investment is $0.5 billion.
It will be full up and running at the end of 2028. We are constantly increasing and validating high-speed technology for syringes. We will install next year one Alba Technology. We will install next year one ready-to-fill syringes. Also, we have, like I mentioned to you, a program on auto-injector for one of our big clients. Overall, we see the demand of biologic is robust, and more and more we see the shift to our big bio customer to this, what we call high-value product, David. We see, we are confident, besides certain quarterly fluctuation, that we are in the higher range of our target to deliver revenue around the high-value product.
Very good. Maybe as we're talking about this, how would you describe the balance of demand in this area in your high-value product solutions area between GLP-1 as a driver and non-GLP-1?
GLP-1 is a very strong tailwind for Stevanato Group. Our goal, my goal in the next 10 years is to maximize opportunistically these tailwinds exactly in the same way that we have proceeded with insulin, with heparin, with anesthetic, and with vaccine. There is a new therapeutic drug. Let's go directly to maximize our validation penetration into the originator and in parallel maximize our penetration in all the biosimilar with all our value proposition. It is also true that, like I mentioned just a couple of minutes before in my presentation, the space of biologic is growing. If you look, our revenue around biologics in the BDS segment has delivered more than 40% of our revenue in the first nine months. Why? Because there are several hundred new programs that our pharma company is launching on the market, and most of these are going in what?
On injection, like cartridges ready to fill, like syringes in different formats, like auto-injectors. In Stevanato, GLP-1 will be a very strong contributor in the next 10 years in order to contribute to our incremental revenue, but it will be well compensated by many other programs on biologics. The goal just to finish on Stevanato is never depends too much on one customer, one region, or one therapeutic drug. We want always to balance our portfolio between originator, biosimilar in order to have a safe program to grow for our plants, our employees.
Got it. While we're on this topic, I think biosimilar growth, we're actually expecting, I think, in the next year or so to see biosimilar launches in the GLP-1 class outside the U.S. Is the opportunity in biosimilars similar economically to you as in the originator product? In other words, are they also using your high-value solution?
Correct. Usually, how does it work? When biosimilar enters the market, usually this is going to enlarge the revenue of the therapeutic drugs. When the product is becoming mature, 70% of the revenue is in the hand of the originator, 30% is on the hand of the biosimilar. What the biosimilar usually does in order to speed up their validation, the FDA, they try to replicate the same type of primary packaging, no matter if it's the glass or if it's the container closure. For Stevanato, once we are filing in the originator, we have fast access to be immediately validated into biosimilars. This is exactly what we have done already with other therapeutic drugs. Net-net it will represent additional revenue for Stevanato in the next years.
Okay. I want to go back.
And maybe.
Go ahead.
Let me complement in terms of economics, given that usually those are contracts or engagements associated with lower value volume. We usually tend to have higher unit pricing for biosimilar compared to high-volume originator. There are some puts and takes, but we are able to deliver the same level of marginality as of the originator.
Got it. In your prepared remarks, Franco, you mentioned, I think under your analytical services part of your discussion, did I hear you correctly say you're filing or in line to file with clients' molecules on 700?
Several hundred.
Several hundred. Okay.
My English.
Sorry.
I spend a lot of money.
My ear is not very good either.
English courses. I have still issue with the S, several hundred of molecules.
Got it. Okay. So several hundred, still several hundred is a good number.
Still a big number. Powerful number.
In 2020, really, I guess in 2024 and continuing into 2025, you were feeling the effects of the kind of depression or the unwind of COVID vaccine in vials and the destocking after that impact on your vial volume and the vials are a really good product for you. Describe how you've seen that stabilize and maybe begin to recover in both bulk and easy fill vials.
See, COVID was a big tailwind for Stevanato, but also was a very painful headwind for us in particular in 2023 to 2024. Today, if you look at 2025 to 2024, we are + 12% in terms of revenue around vial in a blended mix between bulk and easy fill. Based on our exchange with all our clients on a worldwide basis, both the big clients and regional, we see that quarter by quarter, there are some improvements in terms of the forecast and the order intakes. Based on our estimation throughout 2026, besides certain situations, we will be around a sort of normalization for bulk vial.
Better it is for easy fill because easy fill was, we received a double hit during the COVID for easy fill vial because many clients that have in stock a lot of bulk vial, they just stopped to order easy fill vial because they were looking to clean up the inventory of bulk vial. Now we see that most of these customers, they are starting to reactivate orders in easy fill vial. Also thanks to the continuous installation of flexible line to the market and many clients are launching the product in easy fill, we see that this product is starting to grow in double digit.
Got it. Maybe take a minute to describe, so these products are specced in. How is the client able to interchange between bulk and easy fill vials?
It is case by case. When a client is launching a new product on the market, we see that most of the time it's going with what we call easy fill configuration, or ready-to-fill configuration for the reason that I already mentioned to you, there is some more, they have the new technology for filling, and also they can really in the total cost of ownership save a lot of money. We have other clients that for existing commercial product, they are also going to validate the ready-to-fill vial. For example, we have big clients on vaccine that have already for their existing platform for vaccine, they have done the validation on easy fill. They have the flexibility to use both bulk and easy fill.
Okay. Okay. To recap what you said, by 2026, you expect to be back to a normalized order?
Normalization, that means 1%-2% growth on bulk vial worldwide and double-digit, low double-digit on the easy fill vial.
Okay. Earlier in your answer, you gave a number. I want to make sure I heard right. You said 2025 is up three across both bulk and easy fill combined.
2025 compared to 2024, we are + 12%.
12%.
Of revenue, yes, on the vial segment, blended between bulk and easy fill.
Got it. Okay. I think you had in the third quarter, you called out a little bit of weakness in your bulk syringe and IVD solutions. Can you describe what the dynamics are in that space?
Yes, correct. We see this year for our easy fill syringes, non-high-value product, in particular related to heparin, there are some competition. We have partially decreased our revenue on this segment, but we have immediately compensated with Nexa syringes. Just to tell you from a strategic point of view, it's already in our plan to shift more and more our investment, our capacity, what we call high-value product. On diagnostic, what we see is the same. The goal in Stevanato is to change the DNA of our plants in Germany, moving from standard diagnostic product to molecular diagnostic, even more to install capacity for our auto-injector. Here we see one of our big clients, he has started to reduce their forecast on standard diagnostic, and this is where we have seen some reduction in revenue.
This is why this is translated in the Q3, our percentage of high-value product is particularly high.
Okay. Okay. Let's just spend a moment on, you talked about this in your prepared remarks about integrated system strategy. So you're a key player in the glass market. There are other players that are key players in the elastomer part of that closure system. And then a number of folks that want to evolve into a more integrated system provider. What's your strategic reason for that desire? And then how are you positioning yourself to move into that integrated position?
We saw more and more, David, an evolution of the requirement of the pharmaceutical company. In parallel, they are more and more outsourcing what they call non-core competence for them because they want to focalize and fill in the molecule and to find a holistic partner that can provide everything. Practically in Stevanato Group, we try to mirror and we want to acquire this competence. We have many clients, particularly in the United States, that we started to deliver only the syringes in the past. Now, thanks to our tech center, our R&D people, we are engaged also in serving the auto-injector both in the both configuration or through our AP or we act like a CMO in the selective way, but with the goal really to sell the full integrated system to them.
We see a tendency to certain originator, but also even more to many biosimilar to find partners that can provide everything that is around the primary packaging. It's exactly the direction that we want to drive our R&D and our investment in the next 10 years.
Okay. I left this on the table and I want to come back to it. On GLP-1s, how does Stevanato foresee the market evolution to perhaps multi-dose delivery containers, delivery devices, and perhaps the launch of orals? How do you think about how that impacts the volume of demand for your containers?
We are putting, David, a lot of attention in these therapeutic drugs because in this moment, in parallel with our originator, our biosimilar clients, we are building capacity on Nexa syringes where they're using auto-injector, cartridges ready to fill where they will use a pen, on also vial sometimes, also for auto-injector, and also in special machine assembly technology. Today, what we are doing, we are just executing our five- to 10-year contracts with our clients in order to build capacity for them both in Italy and in the United States. It's also true that I think this incremental revenue opportunity for Stevanato, it will continue, but not only for Stevanato, but for all the industry for at least the next five- to 10-year period.
Based on our information, exchange with our clients, and also information that we have from the market, we think that the oral pills in the medium term, it will take a market share that will be approximately around 30% of the total demand for GLP-1.
Okay. Maybe the last topic to touch on for a couple of minutes is your engineering segment. You've been through an operational upgrade, I'll call it, over the last year or so. Where do you stand in completion on that? It seems that you need to stimulate some rejuvenation in the sales effort. Where does that stand?
Like we shared with you, in Q3 of last year, we launched what we call the optimization plan. Why? Because in 2022 and 2023, practically the engineering division more than doubled their revenue. In particular, received a record high of orders of inspection machine assembly technology and new prototype line for assembly in the plants in Denmark. What we have done together with our leadership team, we have rebalanced the two sites in Denmark and Italy. We have enlarged our operation in Padova, and we acquired a new building in Bologna in order to have the two platforms able to host the future growth of the engineering, but in a more flexible way in order to have inspection focalized in Italy, assembly specialized in Denmark, and then for prototype line, we can work like a backup.
In the meantime, we reinforced all the internal project management in order really to upgrade the project management and to further enforce the service to clients. Lastly, we focalized our organization in the last three quarters to deliver all the existing workload of orders to our clients. Today, we have delivered most of the line to our clients, and the site acceptance test is positive, and the clients are starting to move with the order number two and number three. Where we are today, the pipeline is very healthy on new opportunity. The conversion into confirmed order is a little bit slower. Make an example. We have a big US client that we installed the first line in the United States, the line number two and number three.
Now we are reviewing a little bit the specification, and we took a couple of months in order to, he was looking to decide if to install in Europe or install in the United States plants. All overall, from an operational point of view, we are on track, installation of the line on track. This temporary headwind that put the company go up, I think we will stabilize in the next few quarters.
Good. I think we're at time. Franco, Giacomo, thank you for being here. I hope you have a great day. Thanks to the audience for your attention. Enjoy the conference.