Good afternoon. This is the Chorus Call conference operator. Welcome and thank you for joining the Stevanato Group Fourth Quarter and Year End 2024 Conference Call. As a reminder, all participants are in listen only mode. After the presentation, there will be an opportunity to ask questions [Operator Instructions]. At this time, I would like to turn the conference over to Ms. Lisa Miles, Senior Vice President, Investor Relations. Please go ahead, madam.

Good morning. And thank you for joining us. With me today is Franco Stevanato, Chairman and Chief Executive Officer; and Marco Dal Lago, Chief Financial Officer. You can find a presentation to accompany today's results on the Investor Relations page of our Web site, which can be located under the Financial Results tab. As a reminder, some statements being made today will be forward-looking in nature and only predictions. Actual events and results may differ materially as a result of the risks we face, including those discussed in Item 3D entitled Risk Factors in the company's most recent Annual Report on Form 20-F filed with the SEC. Please read our Safe Harbor statement included in front of the presentation and in today's press release. The company does not assume any obligation to revise or update these forward looking statements to reflect subsequent events or circumstances, except as required by law. Today's presentation may contain non-GAAP financial information. Management uses this information in its internal analyses and believes this information may be informative to investors in gauging the quality of our financial performance, identifying trends in our results and providing meaningful period to period comparisons. For a reconciliation of these non-GAAP measures, please see the company's most recent earnings press release. And with that, I will now hand the call over to Franco Stevanato.

Thank you, Lisa. And thanks for joining us. Today, we will review our 2024 performance, address current market dynamics, discuss our fourth quarter results and provide 2025 guidance. We finished fiscal year 2024 with a positive fourth quarter that was in line with our expectations. In 2024, revenue grew 2% compared to last year, driven by 6% growth in Biopharmaceutical and Diagnostic Solutions segment, which offset the expected 70% decline from the Engineering segment. Growth in the BDS segment was driven primarily by robust market demand for high value syringes. This helped drive a 15% increase in high value solutions, which represented 38% of the total company revenue for fiscal 2024. We believe the success we are experiencing in high value solutions also demonstrates that we are investing in the right markets at the right time as we ramp up syringes in Fishers and Latina to match customer demand. We expect that these investments will continue to drive near term growth and allow us to capitalize on growing patient demand for biologic treatments, such as GLP-1s, monoclonal antibodies and biosimilar. The increasing availability of sensitive biologic treatments and patient adoption offset administered medicines are two key areas driving growth in integrated solution and high value solutions. In 2024, revenue from injectable biologics increased 24% year-over-year and represented 34% of the BDS revenue compared to 30% of BDS revenue last year. Additionally, in fiscal 2024, strong revenue growth in syringes coupled with growth in other product categories helped to offset a 34% decline in revenue related to bulk and EZ-fill vial. As you know, this temporary soft vial demand stems from the industry wide vial destocking. We saw modest improvements at the end of the year with some customers slowly returning to more normalized ordering, while other customers are still managing…

Thanks, Franco. Before I begin, I want to clarify that all comparisons refer to year-over-year changes unless otherwise specified. Starting on Page 10. For the fourth quarter of 2024, revenue grew 3% to €330.6 million. The impact of currency was neutral. Growth was driven by a 7% increase from the Biopharmaceutical and Diagnostic Solutions segment, which offset the expected 16% decline in the Engineering segment. Revenue from high value solutions grew 9% to a record €131 million in the fourth quarter and represented approximately 40% of total revenue. This was driven by growing our premium performance syringes, and to a lesser extent, other product categories. The solid performance in the fourth quarter helped boost our full year mix of high value solutions to 38% of total company revenue, in line with our expectations. For the fourth quarter of fiscal 2024, a strong mix of high value solutions and year-over-year improvements in Fishers and Latina, partially offset the unfavorable gross profit margin impacts from vial destocking, including lower revenue from EZ-fill vials, underutilization of vial lines and the under-absorption of costs, and lower gross profit margin in the Engineering segment as we continue to execute our optimization plan. As a result, gross profit margin for the fourth quarter of 2024 declined by 210 basis points to 29.7%. Our new manufacturing plants in Fishers and Latina improved year-over-year, but they are still expected to be dilutive to gross profit margin in the near term. In response to industry wide soft vial demand, we launched initiative to curtail overhead costs without compromising future growth. We saw the benefits of these in the fourth quarter, and operating profit margin increased 20 basis points to 20.2% for the fourth quarter of 2024. As a result, net profit totaled €48.3 million and diluted earnings per share…

Thank you, Marco. In closing, we remain focused on executing our key priorities and achieving our long term objectives. We operate in growing end markets with favorable secular tailwinds and we have several reasons to be confident in our strategic direction. First, we continue to deliver organic growth, driven by solid demand for high value solutions, the main pillar of our long range construct. We are investing in the right areas to meet the rising customer demand and we have a growing presence in biologics. Second, we expect to increasingly benefit from the new capacity projects as we advance our ramp-up activities and drive profitable growth. In 2025, we expect that these projects will be dilutive to gross profit margin and, in 2026, we will begin to realize the benefits of scale and productivity gains as the projects mature. Third, the vial market continues to gradually recover and stabilize. We remain optimistic that as the vial demand continues to normalize, we will see a return to historical market volumes and growth rates. Finally, we are making meaningful progress on a clear and actionable plan to improve our operational and financial performance in Engineering segment. All in all, the fundamentals of our business remain strong. We have an excellent market position and we continue to innovate each and every day. Our unique value proposition and integrated offerings make us a partner of choice for customers. As CEO, I'm firmly committed to putting the business on the right path to return to double digit growth, expand margins and build shareholder value. We believe we have all the ingredients in place. Operator, we are ready for questions.

[Operator Instructions] First question is from Michael Ryskin, Bank of America.

I've got two questions. I'll go through them quickly. First, on the vial recovery. It sounds like vials, especially bulk vials continues to gradually normalize. You've kind of talked about that trend for a number of quarters now and it's moving in the right direction. Any additional color you can provide on when you think things will be fully back to normal? Do you expect the vial environment to sort of be fully recovered in the middle of 2025 or are you still working through it for the rest of the year? And then I've got a follow-up.

So our main takeaway after having a very strong interaction with practically all our customers, big customers and also the regional customer is that we are confident that in 2025 to be much better than 2024 how we are going to translate this. Because we see signs that everywhere where we see customer, big international customer and regional customers, that are starting to restore, to normalize ordering pattern. So overall, we see that during this 2025, there will be a gradual recovery throughout all the year.

And then on some of your comments on gross margins, I mean, you're pointing to pretty significant margin gains year-over-year. But you've had some headwinds last year. You still have some margin dilution next -- this year. If I think about Fishers, Latina coming up to speed and maybe some of that incremental CapEx you talked about with that new customer. Can you just talk about how those projects need to ramp and how those facilities need to ramp for them to go from being margin dilutive to margin accretive? What's the time scale on that or sort of the volumes needed to be pushing through those new -- that new capacity where that goes from being a headwind to a tailwind?

First of all, as you know, Latina is a little bit ahead compared with Fishers. We started generating positive gross profit in Q3 2024 in Latina and we are keeping on improving and ramping up the revenues. We expect that by the end of the 2025 to have a normal gross profit margin with respect to the high value products that we are producing there. Fishers is a little bit different because it's a larger plant. It's a greenfield. And basically, as you know, we have two, three quarters of delay in the program compared with Latina. We are fully in line with our plan but it's about three quarters after. There, we are very happy with the results in Q4. We started generating good amount of revenue in Q4. And we are keeping on improving through validations with customers. We expect to turn positive gross profit in Fishers in the second half of 2025. So matter of fact, 2025 will still be dilutive for our gross profit margin in the combination of the two new plants.

Next question is from Matt Larew, William Blair.

I wanted to follow up on Mike's first question around vials. And obviously last year, you guided us to down 35% for the year and generally in line with that. Is there anything you can help us with what we should expect for 2025? And maybe as part of that, when are you assuming a return to positive growth in vials, do you get that in the second half of this year?

First of all, as Franco mentioned, we can see some signal of improvement in the last quarters. Both revenue and order intake were better in the second half of 2024 compared with the first half. You're right, we went down 34% in the year. In the last quarter, we went down 14% year-over-year. So we can see some signal of improvement. Going to your question, we are currently modeling a growth in vials for 2025 from mid single digit to high single digit. And as Franco mentioned, we see progresses throughout the year or quarter-after-quarter we expect a sequential improvement.

And then you referenced in the script the investments you're making in your device manufacturing operations and called out both Nexa and Alba, I think some heightened attention on devices and where they fit for the traditional packaging players long term. Can you just talk a little bit about your success there as well as your efforts and expectations around scale and the ability to profitably scale those programs over time?

Practically, our strategy for Stevanato Group is really to serve an integrated solution and product portfolio to our biologic customers. In the last years, we developed our IP auto injector and pen, Also, we -- more and more, we -- for many customers, we are building an R&D even more, some plants that are able to serve Nexa syringes, Alba syringes, like with the case that we have in Fishers, we are building also a lot of capacity for our -- one of our big customers in United States. We are going also to serve this device with this program. So today, we have a certain number of programs on through the CMO business model and also a certain number of progress through our IP pen auto-injector that we will serve from the German plants in order to fulfill this increasing request from our biologic customers that is looking to Stevanato not only for glass syringes, not only for cartridges, EZ-fill, but also like a holistic partner that can -- where they can buy the glass and the devices.

Next question is from Patrick Donnelly, Citi.

Marco, maybe one for you just on the pacing of the year. It sounds like just seasonally 1Q stepped down from 4Q on rev, a big surprise there. Can you just help frame up the quarters, the progression as we go through the year both revenue and then the margin side would be helpful as well, just to think about the cadence of the year as we work our way through here?

We expect sequential growth quarter-after-quarter in 2025 with a stronger second half of the year compared with the first half mainly for three reasons. First, we can see strong demand in high value syringes and the sterile cartridges. But at the same time, we are ramping up capacity. We expect to install several lines in Fishers between May and June. As a matter of fact, after the validation we will have available capacity to satisfy the strong demand. So for this reason, we expect stronger revenue in second half. The other reason is related to vials. We mentioned before the fact that we expect the market will be sequentially better toward the end of the year. And the third reason is related to Engineering. We are working hard and obtaining good success in recovering the delay. We are delivering several complex projects in this period of time and we expect to complete the recovery around the mid of the year. So we have the opportunity in the second half of the year to take more workload and increase our revenue also in Engineering. That's why we are confident that in the second part of the year, the revenues will be strong.

And then Franco, maybe one for you. Just as you think about the administration change here in the US. Can you just talk about any impact? I mean, there's the tariff side, obviously, with things like Mexico. We'll see what happens with Europe. Just what you think there. And then on the back of that some of these trial cancellations, HHS going after things like bird flu and maybe some of the BARDA contracts. Would be curious just on your perspective on some of these recent changes, what your guys' exposure is, how you think about that?

Today, practically, what we have done in Stevanato Group since the last 15 to 20 years, we built a sophisticated supply chain where we try to be domestic in the major growing pharmaceutical areas all around the world. Today, we have several plants in Europe, United States, in Asia, able to sell to our customers the same product from different regions. So on the top of this, we can add that we have a very strong partnership in a proactive way with our customers and we are trying to monitor in the best way how eventually to review the supply chain with our customers from the different regions. So we are putting a lot of attention together with our customers how to approach if there will be some evolution. But the good news that we have, a good footprint with the same standard of quality everywhere. And the fact that we have decided to approve this big investment in Fishers, Indiana three years ago, it will make us even more proactive to react to any type of changes.

Then Patrick, I don't know if your question was about vaccine. Just to make sure, it's a limited risk for us because we are generating about 8% of our revenue of BDS in vaccine but the focus is predominant in Europe. We are today generating around 1% of our revenue in US with the vaccine. So it's not a big risk for us today.

Next question is from David Windley, Jefferies.

I was hoping you could comment on the utilization levels or maybe relative utilization of your lines across the different form factors, so syringe, cartridge and vials. What I'm digging for is with vials down as much as they are, I'm sure the utilization is low and how much that can recover and how we should think about that translating to margin? But then also, on the other end of the spectrum, you're adding capacity for cartridge. And should I correctly interpret that as you're being at very high levels of utilization in your existing cartridge capacity? So just again, trying to understand your relative utilization levels of each of the different types of production.

So first of all, we have strong demand in syringes. So we are utilizing a lot of the syringes line. And as you know, we are also ramping up capacity to match the long term demand we have with the key customers. We have similar situation with cartridges but I will let later Franco to explain more the EZ-fill cartridges project. About vials, obviously, after going down 34% the revenue last year, we have available capacity both in bulk and in EZ-fill, of course, for obvious reasons. So we will still have ability to grow there. We expect to grow in 2025 compared with '24 but we still have available capacity.

David, we can say that for what is related to the high value product, our demand is driven by the capacity that we have put in place. We started Piombino Dese years ago. Now we are heavily investing in Latina and also in Fishers. Today, we have a lot of requirements from around the Nexa ranges and a request about Alba ranges for particular application. There is more and more an increase in demand for cartridges ready-to-fill. In particular, we have one big customer that really have decided to increase their capacity in the next year around this type of product. Even more, there are several kinds of program around cartridges basically. So our big focus is really to implement capacity for high value products where we see the higher demand in 2025 and also the next year.

Is that -- on the cartridge program for the specific customer, is that going to be dedicated capacity or do you expect to be able to diversify that?

Both. We have one big anchor customer that is placing a big contract where we want -- they want to serve a big quantity on cartridges to fill. And also that we see more and more, we have several of kinds of mid-sized customer, biologic and biosimilars, they are going through this type of application, for example, because they have put in place capacity but they want to outsource to a partner like us [indiscernible] sequentialization. So this is why we are heavily investing. We have already capacity here in Piombino Dese. We are going to invest also in Latina with a lot of capacity in order to be ready to approach these nice tailwinds.

And if I could ask one more on capacity. I think maybe I missed it, but relatively new to my eyes was the mention of devices in Fishers and adding capacity there for that. Could you help us to understand -- I understand the kind of strategy of being able to provide the client with both the glass as well as the device. Can you help us understand what your longer-term expectations are for the margin contribution of the devices? Or said differently, is that a positive evolution of your business mix to pursue supply of those devices or are those device margins eventually going to be lower than your glass -- your high value glass margins?

We have a different situation in device when we talk about CMO contract and proprietary solutions. We are working on both. And our strategy is obviously to become a reliable partner on both. When we talk about proprietary device, it's a high value product and the range is the normal one in high value product, so about 40% speaking. In CMO space, the margin are lower. We are talking between 15% to 35% in line with other containment delivery solutions.

If I can, David, give you the different angle more from a business point of view. We -- if you look at the growth in biologics in the next years, we will be a nice double digit growth on syringes like Nexa, Alba. In parallel, there are equivalent growth on pen and auto-injectors. So our goal is to go to our customers and to show the full value proposition, no matter it is through our IP products or through the business model of CMO, because this will help us to capture more market share and more growth. And it's a reason why the plants that we have in Fishers have this flexibility. It's considered by our US customers like a hub where they can have the integrated solution service that is a little bit unique in this moment in the United States, and we are taking benefit from this.

Next question is from Larry Solow, CJS Securities.

It's Pete Lukas for Larry. You covered most of my questions. Just on the Engineering segment, recovery sounds like it's progressing. Can we expect segment operating margins to return to mid-teens levels over the course of the next few quarters and perhaps build on that? If you could just give us some color there.

You have noticed we reached mid-15% in Q4. So we are happy with the progress that we are making. We are not yet at the level we were in 2023 but we are progressing. Our goal is to complete the, let's say, delay issue by mid of next year. But the further step, as Franco was explaining, is further optimization to further improve our profitability in the segment.

If I can further add more business color, the team made a big improvement during this quarter. Today, we are on track to deliver our this complex design to our customers. Our target is to complete this delivery at mid of the year. This will help to further improve the revenue marginality. In the meantime, together with organization, we are going to review what is the cost structure, also we are going to review the size in our plant in order to make more efficiency in our operations, both in Denmark and Italy, also prepare for the future growth. Today, the product we are serving to our customers from an engineering point of view are very well perceived because there is a big growth in biologics and there's high demand for assembly technology in the industry because of this device trend. Maybe more from a regulatory point of view, there are more and more requirements from new sophisticated inspection line, which is exactly where we want to focus the division in the next years.

Next question is from Anna Snopkowski, KeyBanc.

This is Anna on for Paul Knight. First, could you frame the revenue generating capacity of the Fishers facility? I know in the past, you've mentioned you anticipate more meaningful revenue contribution here in fiscal year '25. But what is the utilization rate you expect for '25 and then just how is overall demand trending here versus initial expectations?

If I got your question, it's a matter of the speed we ramp up. So we expect to complete the full capacity ramp up in Fishers by 2028. So we are still progressing. We are pretty happy with the evolution. We reached our milestone in Q4 2024. We are progressing with new lines installed, most importantly, more validation from our important North American customers. About 2025, obviously, we expect a big increase compared to 2024. But we need to underline the fact that in 2024, we generated revenue -- commercial revenue basically in Q4. So we expect a much stronger revenue coming from Fishers in '25, but we still have room to install more capacity in '26, '27 and '28.

And then maybe just looking at the Engineering. Once the operational changes are executed over the next 12 months, what do you think this business could run at in terms of adjusted EBITDA margins over the long term?

Well, in the long term, we confirm our view we shared about multi-medium to long term construct. We basically want to expand our margin, increasing also after sales activities. We expect to be more accretive than we were before this progress we face in 2024, keeping on improving also through the optimization plan Franco mentioned in his remark. But we are confirming the trajectory we shared with you during Capital Markets Day.

Our goal for the Engineering division is to keep in the next year's high single digit growth, thanks to the fact that we want to further reinforce our position in inspection system, in the assembly technology with the high speed machines, most increased percentage after sales to our major customers.

Next question is from Tejas Savant, Morgan Stanley.

Franco, I have a question for you on high value solutions. So I think Patrick asked something along these lines earlier. But I was just curious as to -- in terms of your HVS revenues, what percent is sold in the US and what percent of that US HVS revenue is manufactured locally? It's sort of related to the potential impact of tariffs that I'm trying to get at. And on a related note, is there an opportunity for you guys over the next couple of years here to leverage your global footprint and flex where you supply from depending on tariff regimes? I mean, is that a competitive differentiator that is starting to resonate in RFPs just yet?

First of all, we are generating in North America about 26% of our revenue. The concentration of high value solution is stronger in North America but we don't disclose the exact number. And this is exactly the reason why we are investing so heavily in Fishers to gain customer proximity and serve them through our high value products. And this is also why we are -- as Franco mentioned before, we are confident to manage also the tariff issue because we are becoming local and domestic in many different countries. And please underline if I missed a piece of your question…

Maybe I can -- first from a business point of view. Our strategy since a few years in particular, from the moment that we have done the IPO in New York, is really to invest and to focus Stevanato Group on a high value product. Today, we are heavily investing capacity newly fully dedicated to high value products in the Piombino Dese, in Latina and also in Fishers for the purpose really to follow this growing demand in biologics with our international customers that want a supplier and partner that are placed in a different region. If you look at the investment that we have done in Latina last year are dedicated to Nexa ranges, that is high value products. And now we are adding capacity in cartridge, EZ-fill that also is high value product. We are mirroring exactly the same in Fishers where we're building capacity for syringe and Nexa configuration. Then we will add capacity for vial ready to fill for Alba technology. Our goal is to become the global partner with a global footprint that is able to have a very sophisticated and flexible supply chain with the same standard of quality but our goal is to focus on high value products in the next year.

And then a quick follow-up on Fishers. I think you guys had an agreement with BARDA there for BARDA funding about $95 million of capacity expansion for your standard and EZ-fill vials at the site. Is that contribution essentially derisked or is there a possibility that, that could come under sort of scrutiny under the Trump administration?

Correct. During COVID, we signed this contract in order really to build the dedicated capacity for vial in bulk, EZ-fill configuration dedicated to the US market. Today, we are in execution to build this capacity in alignment with the contract.

I just want to clarify Tejas that we have had no indication from the government or from BARDA that there is any risk to that existing grant from them.

Correct.

Next question is from Doug Schenkel, Wolfe Research.

I have two. One is just given the change in administration and the current geopolitical environment, I'm wondering if through the first two months of Q1, if you have seen any change in customer behavior, any stalling across different geographies, different product categories. And if so, how you have factored that into your guidance, keeping in mind you did tell us to model more growth in the back half than the first half. That's the first topic. And then the second topic is just another follow-up to a series of the Fishers questions. As Fishers opens up, when it is fully ramped, how much of high value production in the US can be supported by that facility? Again, that relates to the geopolitical environment and tariffs. I'm just wondering when that is fully ramped, how much of your expected US demand you expect could be serviced by that facility?

So just to [indiscernible] today, we have contracts we don't see any [indiscernible] with our customers. We are just executing all the contracts we have already signed last year, two years ago with our customer, today, the focus is together with them to install capacity to do the validation and execute, in particular in Europe, in particular in United States. So what is related to Fishers, our goal is to be in a full capacity at the late 2028 and we are continuing to install this capacity for high value products practically in terms of syringes, like I mentioned to you, in terms of particular configuration of syringes and also for what is related to vials, EZ-fill. We also -- like we mentioned before, we had this agreement with BARDA that is referring to EZ-fill vials also with bulk vials. You have also to remember that Fishers we have done with the Phase 1. Once we have acquired, we have decided to install capacity in Fishers. We purchased a very big land because we have decided to become domestic in the United States with the view of long term like we have done in Europe. So we are now want to execute until 2028, the Phase 1. Now we are phased in the next years to go to Phase 2. So in order to really to be flexible and proactive to approach any type of market opportunity in United States with our biologic customers.

Next question is from [Hugo Marticorena], BNP Paribas.

[indiscernible] on behalf of Hugo. I've got two, please. Firstly, could you provide a clarification on vials and the 34% decline in vial sales, so where it seems like was more pronounced in EZ-fill than bulk vials. Can you share the split of that lines between EZ-fill and an bulk or at least the magnitude of the difference between the two? And secondly, on the CapEx guide, could you clarify how the customer contribution will be recognized? Is it fair to assume that the €250 million to €280 million would be the expected reported figure that we should use for free cash flow the next year?

So I'll start from the second question. We are receiving balance sheet contribution in the form of prepayment or contribution to our investment during 2025. We expect to receive approximately €60 million between prepayments and contribution to help us finance the expansion on important high value product -- project. So the guidance is between €250 million to €280 million net of prepayment and contribution. About the split of the bulk and sterile decline, we don't split exactly the amount. We reinforce the measures that during 2024 the decline was stronger in sterile vials but basically, it depends quarter-after-quarter. There could be fluctuation quarter after quarter but we prefer to disclose consistently with previous quarters the bundle of the vials rather than going into specific details.

There are no more questions registered at this time.

Okay. Thank you, operator. I think Franco Stevanato would like to make a couple of closing comments.

Yes. I would like just to summarize a little bit all the questions you made to us, also to transfer what is the sentiment in Stevanato in 2025. So we are confident that 2025 will be much better than 2024. Also the organization in 2025 is going to be extremely focused on executing our key priorities at where we put our investments in order to fulfill the demand of our customers. From a market point of view, we continue to see high demand for high value products in the different primary packaging configuration. There is a very high demand of injectable. And more and more, we see a very high demand from customers to have integrated solutions system. We see -- we are continuing to see positive signal, well spread in all the regions, about the recovery of the vials. This is also important. And also the Engineering division have done meaningful progress in order to deliver on track this complex line. So we are happy for 2025. Even more, we are confident to confirm what we shared during the market -- Capital Markets Day in New York, our ability to target 30% of EBITDA and to have -- to target 40% to 45% of our high value solution in the next year in 2027. So this is where the company today, is really focused to execute this year.

Thank you. And that concludes the Stevanato Group fourth quarter and year end 2024 conference Call. Thank you for joining us. Have a good day.

Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.