Stevanato Group S.p.A. (STVN)
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Jefferies Global Healthcare Conference

Jun 6, 2024

Dave Windley
Managing Director, Jefferies

Okay, I'll introduce. This is Dave Windley with Jefferies Healthcare Equity Research. Welcome to our second day of our June Healthcare Conference here in New York. Appreciate your attendance and interest, support of our conference. Also appreciate Stevanato Group being here, and Franco Stevanato, the company's newly named CEO. I was gonna say chairman, but I'm not sure if that's even right now, but newly named CEO of the company to present. So I'll turn it over to him to present a little bit, and then if we have some time at the end, we'll throw a couple of questions your way. So Franco, again, thank you for being here.

Franco Stevanato
CEO, Stevanato Group

Thank you.

Dave Windley
Managing Director, Jefferies

I'll turn it over to you. Thanks.

Franco Stevanato
CEO, Stevanato Group

Thank you, Dave, and thank you to Jefferies to host Stevanato Group in this important conference. Let me introduce Stevanato Group. At Stevanato Group, we play a mission-critical role for the pharma-biopharmaceutical diagnostic industry. Over the last years, Stevanato Group has delivered steady double-digit revenue and marginality growth. We closed 2023 with EUR 1,085 million and almost 27% EBITDA margin. That grew by over 600 basis points since 2019. Our track record of excellence put Stevanato in a leading position in our core market. We are market leader worldwide in pen cartridges and EZ-fill vials, and we are number two worldwide on prefillable syringes, where we are really growing a lot in these last years. Also, we are the market leader in glass converting. That is the critical technology to manufacturing the containment solution.

We are actually the global partner of choice, working with the top high-growth clients of the biopharma, pharma, diagnostic industry worldwide. We are serving today more than 700 customers worldwide, in particular, the major customers in any region of the world. So sorry. We have to go to the next slide.

Speaker 3

Can you-

Dave Windley
Managing Director, Jefferies

Are you able to advance the slides from the back?

Franco Stevanato
CEO, Stevanato Group

Okay. Thank you. Sorry. In Stevanato Group, we have a long history of success. We've been in business for more than 70 years. This year, we're going to celebrate the 75-year anniversary. For the last 50 years, we focus exclusively in the pharmaceutical industry, and this is why, in 1971, we made a strategic decision to internally develop our Engineering division for developing and manufacturing the glass forming in order to have more speed to market, to more productivity, and also to better serve our pharmaceutical customer. This is still today one of our main competitive advantage that is recognized by the customer like an industry standard. Over the last 25 years, Stevanato has become a global company in response to the demand of our global customer.

So first, we focus 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, we've been developing integrated research and development in order to better develop our proprietary drug containment solution, drug delivery system. Then, we have also been performing a successful acquisition and integration of competencies through acquisition in plastic injection molding, company in inspection and assembly of drug delivery devices. Third, we have been expanding our production worldwide, building state-of-the-art manufacturing plants and scientific tech center all around the world. We decided to become a public company in 2021 in order to raise capital through primary offering, to invest in business, to meet the increasing demand for a high-value solution program.

So practically, we set all the ingredients in order to become the global partner of choice of our global biotech customers. We have, in Stevanato Group, a global diversified manufacturing footprint. Through 16 sites in 9 different countries, we offer our customers outstanding security of supply, a high quality standard from all the plants, and we offer scientific analytical services through our tech centers, one in Boston and one in Italy. Today, we are focused on building our new facility in Fishers, Indiana, expanding our capacity in Italy in two different locations, and longer term, progressing our new development in China. All this acceleration that you can see in this slide is driven by customer demand, in particular, for our high-value solution program, focused for our biotech customers. Services and solutions, covering the entire life cycle of the drug, from early stage development to high volume commercial.

At Stevanato Group, we look at our business as a single value proposition delivered through two segments in particular: Biopharma Diagnostic Solutions business that represents 81% of our revenue in 2023, and Engineering, which is 19% of our revenue. Starting from the left, we have like Nexa, Alba, EZ-fill Smart, meet the most stringent performance and quality requirements for biologics. In drug delivery devices, we offer a full range of platforms, and this is an area where more and more Stevanato is involved by our bio customers, and we are an area where we are continuing to more and more in growth. In vitro diagnostic solutions, we develop and manufacture tailor-made consumables for in vitro diagnostics, including molecular diagnostics. Our Engineering segment, you can see on the right, includes manufacturing lines-...

manufacturing line that ranges from glass forming, to visual inspection, to assembling and packaging of devices. Our range of product are supported by our scientific analytical service with our tech center, both in Europe and United States, where we are working with our client in the very early stage, in Phase 1, Phase 2, Phase 3, in order to really to build a very rich pipeline that will transfer in commercial in next year to come. Let's drill down to a customer case study that illustrates how we bring all our capability to bear to deliver a fully integrated solution. In this case, we would like to represent the experience that we have done with Merck Serono. First, we work with them in the early stage to design and execute custom test protocols to select the right primary packaging solution for a specific therapy.

From there, we identify and provide the most appropriate containment solution for the product with Nexa platform. And finally, we work with them to develop an automated assembly system with the flexibility built for all their device configuration. So it was our ability and competence to provide all that to a customer as a single organization, that allowed them to operate in a much more efficient to extract more value for their collaboration. This is what we try to more and more replicate to all our bio customer. Our wide range of capabilities and expertise, combined with our expanding global footprint, will help us meet our growing customer demand. We are targeting high growth end markets, where large-scale macro trends are driving demand growth, especially for our high-value products.

The biggest of these trends are aging population, increasing prevalence of chronic disease, and expanding access to the healthcare all around the world. Alongside that, there is a considerable growth in biologics, biosimilar, that move more sophisticated packaging and delivery requirements. Next, increase in self-administration, and the movement of healthcare from hospital to home environment, are driving the need of a high-performance containment and delivery solution. Finally, biopharmaceutical companies are choosing to outsource non-core capability, allowing them to focus more on their drug development, drugs. 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 value, value proposition on process, service, and systems. With this, Stevanato Group is strategically, operationally positioned to capitalize on these trends and turn them into the growth driver for our business.

We are expanding our industrial footprint to meet the increasing demand worldwide, in particular today in Europe, United States, in order to enhance our proximity to customers and provide customer with a redundant, localized supply chain. Our priority capital investments are targeted at increasing our capacity for high-value solutions, which is where we see the most demand in the market. We continue to invest in research and development organically, but also via partnership, to drive innovation across all the elements of our solution. In particular, glass, device, engineering, and process automation. We're building a pipeline by partnering with most of our strategic customers, as well as an emerging biotech company, to bring to the market a number of new programs and assets that will support our growth for the year to come, in particular, focused on the high-value program. Here you are.

After the IPO that we have done in 2021, we are really heavily make big investment in order to build a global footprint for our bio customer. If you look starting from the left, you can see that the headquarters in Piombino Dese, that now is filled with new line for high-value product, in particular, for syringes, Alba technology, and tomorrow also for the cartridges ready- to- fill. Then you can see the plants in Latina, that we have started to ramp up last year. Last week, we have performed a celebration where we have hosted all our 50 active customers that will start to purchase from us Nexa syringes, syringe with bypass, and also cartridges ready to fill.

And the biggest investment in Fishers, Indiana, that is the biggest in the history of Stevanato, because we are going to invest half a billion euro in order to support our American customer, in particular, for syringes Nexa, syringes Alba, syringe with bypass, and vials ready-to-fill. And also, we have big program of auto-injector. So what is our target with the big investment we're performing in Fishers, is really to replicate all the capability that we have in Europe, in order really to become the best partner for our high-value value solution for our biologic customer. This was a request that we start to receive at the end of 2019, 2020, with our American customer. And today, together with them, we are growing in order really to become domestic in the American market.

We are very excited for this investment that we are performing. As I was mentioning, I will reiterate, as this is a key, we are investing in demand-driven CapEx and almost entirely in a high-value EZ-fill capacity. Have in your mind, so what we anticipate is a 1-to-1 proportion. EUR 1 invested, we will generate EUR 1 revenue per year when fully ramped up. It is important also to underline the return that we are seeing. EZ-fill product is much more accretive products that will be the main driver for our margin expansion at group-Stevanato Group level. We are expecting a return of investment north of 20% for each project, like what we did already in Piombino Dese in our headquarters. We are carefully managing this large capital cycle, and we have several risk mitigation factors.

Again, I want to remind that all our investment that we are performing are demand-driven investment, and we are a critical supplier with a legacy relationship with our customer, because our product is a critical product, because it's going to get in touch with the drugs. And this will require a lot of sophisticated validation and also a lot of sophisticated validation, their FDA filing. So with the rise of biologics, we are also experiencing an increasing demand for high-value solution that meet the scientific requirements of highly sensitive treatments. These are high-performance, best-in-class technology that deliver value to our customer by reducing the total cost of ownership, delivering high-quality, higher-safety products, shortening and de-risking the time to clinical market, and even more mitigating the supply chain risk.

In this, in turn, these same products create more value for Stevanato Group because it, it translates into higher unit price with higher margin, allowing Stevanato Group to grow faster than the market and expand our margin. High-value solution represented 34% of our revenue in 2023, and we expect that this will only continue to grow in the next years to come. Pharmaceutical innovation is driving advancements in more complex biologic drugs and paving the way for new therapies that address chronic disease and more challenging disease management. Biologics are a broad category of products often administered by injection. They can be challenging to stabilize and even more to administer due to their complexity, sensitivity, and viscosity.

As a result, biologics have a unique storage and packaging requirement that our high-value solution program, like EZ-fill, Nexa, and Alba, are specifically designed to address even more the most demanding for biologics. Over the last couple of years, biologics have been an important growth driver for our business. Excluding related COVID revenue, that revenue from biologics accounted for approximately 28% in our BDS segment, compared to with 90% that we are performing in 2022 and 60% in 2021. So we are performing a big growth and where we are really today investing a lot for supporting our customer. This increase in revenue from biologics also coincide with the timing of our target capacity expansion. Let me share now some dynamic that... Sorry. Let me share now some dynamic that we are seeing today in our market.

The pandemic brought some complexity in the supply chain, and we are still in the phase of normalization. During COVID, demand for vial accelerated quickly, both for COVID and non-COVID application. This, coupled with supplier extended lead time, created scarcity in the vial market, and customers stockpile to de-risk their supply chain. As COVID fade out and the lead times are now back to the pre-pandemic level, customer are working down inventories. This resulted in a temporary softening in demand for both bulk and ready-to-use vial. In this context, customer, and us by consequence, face challenges in precisely identifying the right timing and intensity to fade out. In this context, fiscal 2023, we backfill approximately EUR 93 million in COVID-related revenue and deliver double-digit growth, supported by strong growth in high-value solution.

In the market, are used today approximately 13 billion vials globally, and we believe once the market rebounds, that vial will return to normalized market growth rate, low single digit for bulk vial and double digit for RTU vial, which are where we are the global market leader actually today. Moving to the financial result, the revenue decrease in the first quarter was mainly driven by the lower revenue from glass vial in the BDS segment due to the industry-wide destocking, which we believe is just transitory. In the first quarter of 2024, revenue from BDS segment increased by 2%. Segment growth was impeded by the industry-wide vial destocking revenue that decreased in the Q1 2024 by 43%. This was offset by the strong growth on syringes and other product categories.

Our product diversity helped expand our high-margin solution, which represented 33% of our total revenue in the first quarter of this year, and grew 50% year-over-year. In the Engineering segment, for the first quarter of 2024, revenue decreased due to the lower sales of pharmaceutical visual inspection assembly and packaging line. As previously discussed, our main priority in 2024 is executing the large volume of work in progress and shortening the lead time to deliver the machine to our customer. This temporary wide destocking also impacted our margin in the quarter, specifically the lower revenue from the EZ-fill vial where we have the more accretive marginality. I'm sorry. So in closing, Stevanato Group has cemented its leadership position as a mission-critical partner in the pharmaceutical supply chain.

We have experienced significant growth, and we are building the organization to support our long-term objectives. Our number one priority in 2021 is execution. We are laser-focused on ramping up our new capacity to meet the rise customer demand for high-value solutions, such as our Nexa syringes and EZ-fill cartridges. We are also strengthening our process and driving efficiency across our global operation to best manage the future growth. We are very excited for this time, and our value proposition, we are going to recognize that more and more is very well appreciated by our customer. Our big focus is really to continue to execute all the active program that we have today with our customer. Thank you very much.

Dave Windley
Managing Director, Jefferies

... Great. Thank you, Franco. So, let me jump in and pose a few questions to you. You mentioned in the latter part of your comments about the destocking factors that you're working through. The quantification of revenue reduction was about EUR 55 million on the last call. Part of that being destocking, part of that being a specific customer order. In general terms, would you describe that as still reflecting what you see in the marketplace? Has the destocking impact changed at all since we last heard from you?

Franco Stevanato
CEO, Stevanato Group

Yes, but practically, what do we see? When we have performed the new forecast, all our-

Dave Windley
Managing Director, Jefferies

Talk into the mic, yeah.

Franco Stevanato
CEO, Stevanato Group

When we have done to perform our new forecast together with all our leadership team, we have done a deep analysis about the situation, particularly for the vial market. We have discovered that this, the destocking effect was just more pronounced than was our original expectation. So the quantity of stock vial that our customer worldwide, they started to put in stock, starting from 2020, is for COVID product and non-COVID product is very high. And today, we see that they are continuing to try to go to the certain normalization mode. What is our expectation? That this soft demand, it will be more or less close to the end of the year.

So we have already some positive indicator, because certain small or mid-sized customer, more localized, maybe in Latin America, they are starting to reactivate normal, normal order. We are starting to see that big pharmaceutical company, together with big CMO, they are starting to re-discuss multiple programs, starting from the Q1 to 2025. Our estimation that this, the destocking effect, that it will take practically 24 months, so 2023, all the 2024.

Dave Windley
Managing Director, Jefferies

Okay. So, just to be clear on the timing, you're saying that the destocking would be complete by the end of this year?

Franco Stevanato
CEO, Stevanato Group

Based on our estimation, the buyer market is a market that is approximately the bulk market, 13 billion units per year, growing approximately 1%-2% per year, spread approximately with 2,000 customers. Our idea, our estimation, that we will go back to the pre-pandemic level in Q1 of 2025.

Dave Windley
Managing Director, Jefferies

Got it. Okay. And then you mentioned the... or you had a slide that was interesting, that had the percentage of revenue, excluding COVID, progressing from 16 to 19 to 28%, I believe, over the last 3 years. Big jump in 2023. Can you talk about what is driving that? I mean, it's obviously biologics, but is it GLP-1s? Is it, you know, other product categories that you could point to?

Franco Stevanato
CEO, Stevanato Group

Today, if you remember, when we listed the company in 2021, we have decided to approve a big program of investment in order to build greenfield plants in Europe and also United States, in order to support this growth demand for high-value product. In particular, Nexa syringes for our biologic customer, Alba syringes for also for the certain high-potent drugs. And also today, we have particular application, what we call syringes with bypass, because we have certain bio customer that they want to store in the same syringes two liquids. And today, more and more, we have this positive mega trend that we call cartridges ready to fill. So we have big customer that want really to allow to Stevanato to grow together with them, but not anymore on bulk cartridges, but in the ready-to-fill cartridges.

So Dave, this is really well spread to all our existing customer, in particular, in the States, in order that we are really well spread our pipeline with many therapeutic drugs and biologics. It's also true that we are well active also in GLP-1, because our main historical insulin customer that we serve since the end of 1990, today, they are actively involved Stevanato on syringes Nexa, on, cartridges ready to fill, on syringes with bypass, and delivering high speed line for assembly. So the combination of our growth, where we are making our investment in Europe and U.S., are based on all the pipeline biologic. We also, also big focus on GLP-1.

Dave Windley
Managing Director, Jefferies

Okay, and then I kind of stumbled over it at the beginning, but you did make the company did make a leadership change fairly recently. Maybe you could talk about the transition from Franco Moro to Franco Stevanato in the CEO seat.

Franco Stevanato
CEO, Stevanato Group

Yes, and practically, this was Franco's decision, and I have full respect to this Franco's decision, because Franco joined the Stevanato Group at the end of 1988. He was the CEO of a private company before, and he joined Stevanato in the year 2001 in order to be COO and head of HR. So practically, Franco, together with the leadership team and the board and myself, we are really, we prepare the company for the next level. What's up, practically? Franco is 62, 63 this year. He's a father and also grandfather, and the 5 years that we worked together were extremely intense. 2020, we were entering a sort of COVID, where, practically, we live in the company from Monday to Sunday, starting from March 2020 to the end of the year.

Then we have decided to do the IPO at the end of the year, and this was another big exercise, because from end of 2020 to all the 2021, from 3:00 to 11:00, we were together. So it was extremely intense for the life for Franco. I have full respect for his decision, but also I'm extremely grateful to him, because we moved the company from EUR 500 million to more than EUR 1.1 billion revenue.

Dave Windley
Managing Director, Jefferies

Great! Appreciate the, the context there. So thanks for everybody's interest, and we'll hand it over to the next group.

Franco Stevanato
CEO, Stevanato Group

Thank you.

Dave Windley
Managing Director, Jefferies

Thank you.

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