Thank you, everybody, for being here today. I am Paul Knight, the analyst on Stevanato and the life science industry. We have today Franco Stevanato, Chairman, Marco Dal Lago, Chief Financial Officer, Lisa Miles, Investor Relations, and I believe I see Giacomo Giudici in the room as well. Thank you for being here. I think you have a few slides first, Lisa.
That's correct. So, we're going to kick it off with just a handful of slides. So, thanks, Paul. I'm going to hand the floor over to our Executive Chairman, Franco Stevanato.
Thank you, Lisa. And thank you, Paul, for hosting us in your office. We really appreciate it. So, I would like to really have the chance to introduce, through some slides, Stevanato Group at a higher level. So, our business model has created the foundation for long-term sustainable growth. Our business fundamentals are strong. Leveraging our 70-year history of excellence, we have delivered consistent growth and expanding margins. We closed 2023 with EUR 1.085 billion of revenue and almost 27% EBITDA margin that grew by over 600 basis points since 2019. For more than 20 years, Stevanato Group has delivered steady double-digit revenue and marginality growth, driven mainly by demand for our high-value solutions, our unique value proposition provides us strong competitive advantages to meet increasing demand, driven by secular tailwinds in high growth markets 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. We have a long history of success. We've been in business for more than 70 years. For the last 50 years, we focused exclusively on the pharmaceutical industry. And this is why, in 1971, we made the strategic decision to internally develop our engineering division for developing the technology of glass forming in order to own the technology, improve speed to market, flexibility, quality, and productivity for our pharma customers. This is still today one of our main competitive advantages, recognized as an industry standard. Over the last 25 years, Stevanato Group has become a global company in response to the demand from a global customer.
First, we focused on people, and a big portion of our time has been dedicated to pull together a leadership team and a board of directors that can guide Stevanato in the future. Then, altogether, we've been accelerating our growth through three main axes. First, we've been developing an integrated research and development, and we expanded our offering on proprietary drug containment solutions and drug delivery systems. Second, we've been performing successful acquisition and integration of competencies in high precision plastic injection molding, inspection, and assembly of drug delivery systems. Third, we've been expanding production worldwide, building state-of-the-art manufacturing plants and scientific tech centers all around the world. We became a public company in 2021 in order to raise capital through primary offering, to invest in the business, to meet the increasing demand for high-value solutions.
At Stevanato, we look at our business as two main segments: biopharma and diagnostic solution business, which account for 89% of our revenue last year, and engineering, which is 90% of our revenue. For our customers, we offer solutions by combining products across two segments to create a really unique value proposition with integrated systems, processes, and service, covering the entire life cycle of a drug, from early-stage development to high-volume commercial manufacturing. Our products include a full portfolio of cartridges, vials, and syringes. Our engineering system includes equipment that ranges from glass forming to visual inspection to assembling, and packaging of devices. This unique integrated offer means that when a customer chooses to work with one of our products or solutions, we are with them for the entire life cycle of the treatment. Our track record of excellence puts us in a leading position in our core markets.
We are market leaders worldwide in pen cartridges and fill vials, and we are number two in prefillable syringes. We are the market leader in glass converting the critical technology for manufacturing containment solutions. Owning this technology represents a key competitive advantage that is unique to Stevanato. If you make the example on the last history experience that we had with COVID, even more today with the GLP-1 opportunity, this again is going to reinforce the competitive advantage that we have. We are also number two in visual inspection technology for the pharmaceutical industry. We are a global partner of choice, working with the top high-growth clients on the biopharma, pharma, and diagnostic industries. We are serving more than 700 customers globally, including the leading player in the market.
Our wide range of capabilities and expertise, combined with our expanding global footprint, will help us to meet growing customer demand. We are targeting high-growth markets where large-scale macro trends are driving demand growth, especially in high-value products. The biggest of these trends are aging populations, increasing prevalence of chronic disease, and access to healthcare around the world. Alongside that, there is considerable growth in biologics and biosimilars, which have more sophisticated packaging and delivery requirements. Next, the increase of self-administration and the movement of healthcare delivery from hospital to home environment are driving the need for high-performance containment delivery solutions. Finally, biopharmaceutical companies are choosing to outsource non-core capabilities, allowing them to focus on drug development. All of these factors are driving demand for our products and services. We are well positioned to capitalize on these secular tailwinds thanks to our unique integrated value propositions.
Stevanato Group is strategically and operationally positioned to capitalize on these macro trends and turn them into growth drivers for our business. We have four clear operational priorities. First, we are expanding our industrial footprint to meet increasing demand and hence our proximity to customers and provide customers with localized supply chains. Second, our capital investments are targeted at increasing our capacity for high-value solutions, which is where we see the most demand in the market. Third, we continue to invest in research and development organically but also via partnerships to drive innovation across all the elements of our solution. Fourth, we are building a multi-year pipeline by partnering with most of our strategic customers as well as emerging biotech companies to support our growth for the years to come, with most of the CHROMA program linked to our high-value solution.
In the end, this is a crucial moment in the pharmaceutical industry for Stevanato Group. For us, this is a moment decades in the making. Over the last two decades, we experienced double-digit growth but also we brought together an extraordinary leadership team, developed and matched technical expertise, and we built the infrastructure to take us well into the future. The biologics market is set to grow exponentially in the next year to come, and we will work side by side with our customers to help them make the most of this growth. Our ambition is to become a partner of choice of the biopharmaceutical industry, and we are laser-focused on delivering for our customers, shareholders, and patients around the world. Thank you.
Okay, Paul, I think we're ready to open it up for questions.
Thank you. Thank you, Franco. Franco, I remember when we initially met the company. I think in your industry history there were hundreds of glass suppliers in the industry. It now seems like there's five in pharmaceutical glass of size. What happened in that 20- to 30-year time span to have such a limited group of companies such as Stevanato today?
Thank you. Yes, in fact, Paul, when we started our business in 1970, in Europe only in Europe there were approximately 200 competitors, and only in Italy were 64 competitors. By the way, we were probably the smaller one, the last one. Let's say one competitive advantage that is still today one of our strengths is the fact that we have decided to develop the technology. The technology for glass forming, the technology for siliconization, for sterilization, to do the bypass. And today, thanks to this long journey, allowed Stevanato to become the number one on cartridges, the number two on syringes, and number one on EZ-fill vials. And this is the result of decades of investment in combination between technology, primary packaging, technology of coating and sterilization.
Today we were able to build a process, Paul, that allowed Stevanato to serve a big customer from 16 plants, and it will become 18 plants from nine different countries. It's exactly what is looking at the customer today: to have a safe, stable, high-quality partner that can be able to serve from all the parts of the globe but be able to enhance the quality for their patients. It's exactly the type of reputation that we have built in the last year, and this is the reason why today the big greenfield plants that we were building in Italy, in Fishers, we're talking about EUR 700 million investment, are dedicated with the program, with our customer, all in biologics, all on high-value products. It was a long journey, but it takes a lot of merit and a lot of satisfaction around this long journey.
And then, Franco, you know Novo is trying to acquire the Catalent fill-finish near Indianapolis and also one near, I believe it's Anagni, near Latina. Is this good or is this bad for Stevanato? What's your opinion?
It's neutral positive. Both were our historical partners that we worked together, both from the BDS segment and the engineering segment. So, we see that it's going to be further, from a logistic point of view, further enforce eventually the relationship, or the fact that Novo is going to acquire Catalent, I can imagine that there will be more requirements in the market for inspection system assembly technology because at a certain point the existing customer of Catalent, they will look for alternatives.
You know, it seems like with your CapEx, it largely what? It seems committed to your capacity has been committed for by your customers?
Yes, mostly. Let's say that in the last years, most of our investment on high-value products, in particular Nexa syringes, Alba syringes, cartridges ready to fill and vials ready to fill, all the programs that are inside, most of the programs are for biologics. I'm referring to monoclonal antibody, GLP-1, and also for what is biosimilar, that is another growth market that is going to be considerable in the next years.
Okay. And then you know also, I forgot to mention at the beginning of this, participants can ask questions from the screen, you know the chat option on your screen, or you can email me, paul.knight@key.com, as well. But you know continuing on, the Indianapolis facility, now that's probably what? Inspections this year, revenue generating late in 2024, Franco?
Yes. Yes. Today, the major priority that we have in Fishers is really to collect, visit, and validation and audit for the customer. We have an intense program with all our US bio customers to come and to do the audit, the validation, and then stability, in particular for syringes, and then it will be for the other products. For sure, this will generate revenue, mostly in the second part of the year. But today, the big target, Paul, is really to do all the validation because earlier we can do this validation with all our US customers, more rapidly we can do the takeoff of revenue in 2025, 2026.
Then Latina seems to be getting more attention as well. I mean, Latina, you know we read the press release, it's 65,000 square meters, or you know in our view, it's like almost 580,000 sq ft, which seems enormous. Where are you in that build-out at Latina?
In Latina, we already started to do the validation in the first semester of last year, and we were already in revenue generation in the second part of 2023. Now Latina is up and running. They are a big organization. They are working in all the shifts. We think that will be a good, strong revenue contributor in the balance sheet of Stevanato Group in 2024. We already closed a big cycle of European customers that are going to validate Stevanato, in particular for syringes.
Okay. A question.
Latina have 6-9 months in advance compared to what we have in Fishers right now.
Okay. Latina, what? Will be built in stages? Is that what you plan to do?
Sorry, repeat again, Paul?
You'll what? Latina is you'll do stage building, you know one unit here.
Actually, today we have a program to install syringes. There is already space for several high-speed lines. Then we are going to install cartridges ready to fill, and then we are going to install bypass syringes in Latina. This is the program that we will develop, we will execute from 2024 to 2027 in different stages.
Okay. Got it.
Yeah, Paul, just as a reminder, I think it's really important for everyone to remember that these multi-year investments also have multi-year build-out and ramp as we consider validations and ramp-ups. So, I think it's an important consideration for investors to remember.
Yes.
Okay. Yep. And then the other question we've had is that approved therapeutics are delivered with infusion. Do you see therapies going to syringe format from infusion as part of your customer demand?
So, Paul, this is Giacomo. So, the answer is partially yes. I mean, the transition from infusion intravenous to subcutaneous is one of the advancements that we see of approved therapeutics as they move forward with more efficient formulation and lifecycle management. Of course, it doesn't apply to, let's say, across the board, but this is one of the drivers we start seeing within the industry.
Yeah. The other, continuing on that, Giacomo, is the trend in GLP-1s. We hear discussion of dual chamber. What is dual chamber? Are you involved? Is it a significant product?
Yes, correct. Today, the active program that we have, Paul, in GLP-1 are on Nexa syringes, on ready-to-fill cartridges, on bulk cartridges, and also in bypass syringes. These are the active involvement that we have on the BDS side. From the engineering side, we are involved with our customer for GLP-1 on inspection system and assembly from drug delivery system. This is where we have already signed and contractualized our agreement to build up capacity. It's also true that we are actively working with the R&D department of the customer to understand what the evolution of the product could be eventually today . I think it's still not clear what will be the final destination. But today, these are the configurations where we are building capacity.
I know the engineering group, you expect lower or little growth there this year. What's being done with the engineering group this year, Franco?
Practically, Paul, on the engineering segment, there are always, let's say, certain cyclicality. We are coming from a few years of big growth in double digits that, from an operative point of view, have translated installation of many lines to many customers, in particular for inspection systems. So, I make an example. If we have a customer on vaccine that is planning to do a big program to install 16-20 lines, usually they do waves one where we're going to stay 5-6 lines. Then automatically, they're going to stabilize 1 year in order to bring all these lines in high efficiency, and then we start to add other lines. So, this is a little bit normal in the industry of engineering.
Because Stevanato has done really a big growth in the last year, this will be a year where the big focus is really to consolidate, to make up and running all the existing lines that we have done in all our pharmaceutical customers. In parallel, we are also acquiring many new programs, always for inspection systems, and also many new programs for what is related to autoinjector and pen devices. Because today, what is around chronic disease, there is a high demand for pen autoinjector, including GLP-1. Also, our division has a very big order booking for this product.
The de-stocking issue, everybody in the industry has mentioned some de-stocking. Your thought on that, when does it end for Stevanato, Franco?
Let me share my thought. Yes, like anybody else in the industry, we are experiencing this slowdown in vials. We want to underline the fact that we have a differentiated set of products with syringes where we see strong demand and cartridges the same. The stock and the slowdown is only about vials. We started seeing that end of Q3 and in Q4. It's the common situation in the market. About 2024, we designed a guidance in our model that is modeling in the low part of the range and the high part of the range, and the only uncertainty about it is driven by the uncertainty about vials and when we beat the inflection point that is hard to speculate in this moment. So, that's why we have this range for the revenue guidance for 2024.
Okay. And then the last few minutes here on questions would be one from the audience is you've expanded capital expenditure beyond the original 2021 plan. Where are you with what's the trend in CapEx this year and 2025?
Yeah. First of all, we expand because it's demand driven. We have been able also to overtake our initial plan with respect to revenue in 2021. So, we see strong demand. We decided to accelerate North America and Europe expansion because of customer demand. It was a customer-driven decision and put on hold China. Nevertheless, we believe we reached the peak of our CapEx as a percentage of revenue in 2023. We see 2024 with CapEx between 25%-28% as a percentage of revenue. We see a lower level in 2026 and then the normalization by 2027. As we mentioned during our capital markets day, we see the, let's say, normal level of revenue around 10% of our CapEx, around 10% of our revenue. And with that level of CapEx, we believe we'll keep on growing the top line in low double-digit range.
This is how we built our model, and we are confident to execute like that. It's very important to underline the fact that they are all growth CapEx driven by demand, and we are expanding our capacity in high-value products where we believe it's the best way to invest our money due to the expected high internal rate of return associated to this project because of the very high profitability. High-value products are much more accretive for us compared to other containment solutions.
A question as well is, is Annex 1 creating opportunity, or does Annex 1 create disruption?
It's going to create opportunity, Paul. We were already well involved on the Annex 1 already last year with our engineering department, in particular, the group that is taking care about the high-value product, EZ-fill vial and cartridge syringes because this new requirement that are initially requirements for Europe, but at the end of the game, it will become more and more a standard, is going to give a potential additional opportunity for our EZ-fill product. Why? Because more and more, our EZ-fill configuration allowed really to fix most of the problems that a pharma company can have, in particular, around particles. So, translating in action is pharma companies, they will be obliged to upgrade their line or to change their line with more modern and sophisticated technology. And when the customer is changing the technology, the preferred solution is for the ready-to-fill product.
So, we think that in the next 3-4 years, this is an additional tailwind that can help to adopt the standard of ready-to-fill product. On the top of this, through our engineering division, we translate with more inspection systems because once the customer is purchasing the new filling line, automatically, it's going to change the inspection system. So, positive for us.
Then I guess the most commonly asked question, Franco or Giacomo or Lisa would be or Marco would be, what's your customer saying about oral GLP-1s? To us, it seems like it's early in the development of those types of products, but are they giving you any call or feedback on oral GLP-1?
Yes. I can tell you. I think we are extremely proactive to ask questions to everybody, in particular, to our customer, to our biosimilar customer. Today, the major answer that we received is that the industry of GLP-1, there is a big focus on injectable because for many advantages that it's going to have the injection compared to the pills. Also, for the way that you're going to build the pill, it's going to require a lot of API, for example. Today, we're applying to build a lot of chemical factories all around the world that is not easy. And also, the pills, compared to the injection, the type of efficacy is not big like the injection. The pills, you are also obliged to take quite practically every day compared to the injection that can be every week, every two weeks. So, all overall, it's very positive.
Anyhow, what we have done proactively, Paul, in our industrial plan, we have captured only what is related with contract that we have with GLP-1 in order to really be safe. In our 5-10 years vision, we have put the market share that oral can have in a sort of prudence of 30%-35% that we know that is extremely safe compared to the estimation of the experts that they're taking maybe the role of the pills more around 10%-15%. But we want to really don't underestimate this. So, in our next 5 years, 10 years plan, we already consider that the pills will take our role.
Okay. Are you seeing we had a record number of biologics approvals last year? Are you seeing that in the demand for product this year, or does it take more than a year for ramp to occur or the increase post-approval? Do you see that quickly, or is it really just starting?
See, usually, once a program is approved last year, let's say the first two, maximum three years, the ramp-up is like this now because it's going in conjunction with the capacity that is ramping up the customer does. So, we will see much more big revenue in 2025 or more in 2026. But what is important at the end of the game is to be inside and file with our new high-value product, in particular, what is related to Nexa and Alba. Today, we have a big, rich pipeline on Alba syringe that will not generate a big number maybe in 2024, 2025, but it's going to give a lot of good satisfaction in the next years to come.
Great. Well, with that said, it's been an exciting year. We're looking forward to future growth ahead of us. Franco, thank you for your time today, and thank you to the rest of the management team as well.
Thank you to you, Paul. Thank you for hosting us in your office. We really appreciate it.
Sure.
All.