Stevanato Group S.p.A. Q4 FY2024 Earnings Call

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. 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 website, 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 the 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 biosimilars. The increasing availability of sensitive biologic treatments and patient adoption of administered medicines are two key areas driving growth in integrated solutions 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 vials. 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 inventories. As a result, our thoughts remain unchanged and we still anticipate a gradual recovery in vial demand in 2025, which we built into our guidance. We still expect that the market will continue to stabilize throughout 2025 with a faster recovery in bulk vials. During 2024, we also made significant progress on our growth investments and we achieved two important milestones. First, we generated our first commercial revenue in Fisher, Indiana. Second, our Latina project in Italy turned profitable at a gross profit margin level in the third quarter. Please turn to Page 6 for a review of our expansion projects. In Latina, our teams are focused on the ongoing ramp-up of syringes capacity as part of Phase 1. Throughout 2025, we will continue installing, validating, and launching additional manufacturing lines to help satisfy growing customer demand. We are still in the early phase of scaling up this important growth investment. As you may recall, the next phase of our expansion in Latina will be dedicated to expanding EZ-fill cartridges capacity. This is a part of a larger program for an anchor customer expanding into ready-to-use cartridges. The design and planning are completed and the core infrastructure build-out is expected to continue through 2025. As part of this project, the engineering team will be delivering our next-generation EZ-fill cartridge lines. We currently expect the line installation to begin in early 2026. This is a market area where the demand environment has been more robust than we previously anticipated. We believe that our global leadership position and long history, both legacy and new GLP-1s, position us as a partner of choice in this growing market. Turning to Fisher. We are making great progress and activities are advancing as planned. Our world-class facility is supporting US customers across the full value chain and our investment is strategically focused to meet the high market demand for biologics. Alongside the launch of commercial production last quarter, we are installing and validating new syringe lines throughout 2025 as we scale this multi-year approach investment. In parallel, construction is underway on the build-out of our device manufacturing operation in Fisher. This effort is supporting a large customer with multiple device programs across a range of biologic treatments. We will support this global customer with a fully integrated solution with both our Nexa syringes and our device manufacturing. Commercial activities related to this new contract manufacturing work are expected to begin sometime between late 2026 and early 2027. Please turn to the next slide for a status update on our optimization plan for the Engineering segment. The team made major strides during the quarter. We are on track to complete the previously delayed projects in 2025 with the majority expected to be completed mid-year. Right now, we are squarely focused on the successful completion and installation of these manufacturing lines at our customer sites. I'm confident that we are moving in the right direction and our near-term efforts are yielding results. The next phase of our plan has a longer horizon. This includes optimizing our operational footprint, increasing efficiency by harmonizing our industrial processes and streamlining activities into more defined structures. Our customers value our innovation and our top-tier products. We continue to see a favorable demand environment for our engineering segment underpinned by the rise in biologics. Our efforts are designed to drive efficiency and productivity gains to best position the segment for long-term success. In summary, while 2024 was challenging, it prompted us to take action to improve execution, drive operational improvements through footprint optimization, increase our efforts to streamline processes, and look for further areas to gain production efficiencies. These ongoing efforts will improve our setup for long-term growth. Looking ahead, we believe we are uniquely positioned with an integrated value proposition to better serve customers' wide-ranging needs. Our long history of embedding science and technology to drive continuous advancements has led to a differentiated product portfolio. We operate in attractive end markets and have an increasing presence in biologics, which is the fastest-growing market segment. We have developed next-generation products, such as our Alba portfolio that are ideally suited to meet the scientific demands of highly sensitive drug products. We see a great opportunity driven by favorable macro tailwinds, such as an aging population, the growth in biologics, and the rising patient adoption of self-administered injectable drugs. We're positioning the company to take advantage of these opportunities to drive long-term sustainable growth. I will hand the call over to Marco for a review of our fourth quarter results.

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 initiatives 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 were $0.18. On an adjusted basis, net profit was €51.5 million and adjusted diluted EPS were $0.19 for the fourth quarter of 2024. Adjusted EBITDA increased 5% to €90.9 million and adjusted EBITDA margin increased 50 basis points to 27.5%. Let's review segment results on Page 11, starting with the Biopharmaceutical and Diagnostic Solutions segment. As Franco noted, we see ongoing signs of stabilization in the vial market with improvements in the second half of 2024 compared with the first half, both in revenue and order intake for bulk and EZ-fill vials. For the fourth quarter, revenue from the BDS segment grew 7% and 8% on a constant currency basis to €279.4 million. This was driven primarily by growth in high-value syringes, which offset a 14% revenue decline related to bulk and EZ-fill vials. As expected, the drop was larger in our more accretive EZ-fill vials. Revenue from high-value solutions grew 9% to a record of €130.6 million in the fourth quarter, reaching 47% of BDS segment sales. Revenue from other containment and delivery solutions increased 6% to €148.8 million, mostly due to higher sales tied to contract manufacturing activities. A strong fourth quarter contribution from high-value solutions and improvements in Fishers and Latina as we continue to scale helped to partially offset the margin impact from vial destocking. As a result, in the fourth quarter gross profit margin declined 250 basis points to 31.1%. For the fourth quarter of 2024, actions we took during the year helped to moderate the decline in operating profit margin, which decreased 40 basis points to 23.3%. For the fourth quarter of 2024, revenue from the Engineering segment decreased 16% to €51.2 million. Performance in the business was mixed with expected revenue declines in glass conversion and visual inspection, offsetting growth in assembly and packaging. As expected, gross profit margin for the fourth quarter decreased to 18.6%. Optimization and cost management initiatives helped to maintain operating profit margin consistent at 15.3% compared with the same period last year. As our results demonstrate, the steps we are taking are helping to improve the segment's operating and financial results. We believe these actions will better position the segment to capture future opportunities and improve the overall health of the business. Please turn to the next slide for a review of balance sheet and cash flow items. We ended the year with cash and cash equivalents of €98.3 million and net debt of €335 million. With our current cash on hand, available credit lines, cash generated from operations, and our ability to access additional financing, we believe we have available liquidity to fund our strategic and operational priorities over the next 12 months. For the full year 2024, capital expenditures totaled €286.6 million. 89% of CapEx was deployed for growth projects to meet rising demand for high-value solutions. For the full year 2024, net cash from operating activities totaled €155.8 million, a substantial improvement from the previous periods. Cash used in the purchase of property, plant, equipment, and intangible assets was €313.6 million. The combination of increased cash flow from operations and lower CapEx helped drive a significant year-over-year improvement in free cash flow. For fiscal 2024, this resulted in a negative free cash flow of €148.5 million compared with a negative €333.9 million in fiscal 2023. Lastly, on Slide 13, we are establishing 2025 guidance. We expect revenue in the range of €1.160 billion to €1.190 billion, adjusted EBITDA in the range of €293 million to €306.3 million and adjusted diluted EPS in the range of €0.51 to €0.55. Our 2025 guidance considers headwinds and tailwinds, and we have assumed the following factors; revenue will be stronger in the second half compared with the first half; we expect a step down in revenue in the first quarter of 2025 compared with the fourth quarter of 2024, with revenue expected to grow sequentially throughout the year; the BDS segment is expected to grow mid to high single digits, driven principally by growth in high-value syringes; for the Engineering segment, we have assumed that neutral to low single-digit growth compared with 2024 as we focus efforts on execution; we expect that high-value solutions will range between 39% to 41% of full year total revenue. Turning to gross profit margin. On a consolidated basis, we currently expect that gross profit margin will improve by approximately 100 to 140 basis points compared with 2024, driven by continued improvement in Latina and Fishers as our capital investment projects scale as well as increased contribution from high-value solutions. We also anticipate some headwinds. While Latina and Fishers are expected to improve year-over-year, they will still be dilutive to margins and we expect higher depreciation in 2025. We expect depreciation and amortization will range between 8.7% to 9% of expected sales, which reflects the range of revenue in our guidance. Currency is expected to be neutral compared to 2024. We are assuming a tax rate of approximately 23% and weighted average shares outstanding of 272.9 million. And finally, capital expenditures and free cash flow. For 2025, we have assumed CapEx in the range of €310 million to €340 million before customer contributions and prepayments. Our 2025 plan reflects an acceleration of CapEx related to the build-out for EZ-fill cartridges at the request of a large customer. We had previously expected this spending to occur in future periods. Net of contributions and prepayments, CapEx is expected to range between €250 million and €280 million. Regarding free cash flow, in 2025, we expect increased operating cash flows and higher contributions for CapEx. This will help drive continued improvement in free cash flow in 2025 with an expected range between negative €40 million and negative €60 million for the full year.

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 the Engineering segment. All in all, the fundamentals of our business remain strong. We have an excellent market position and we continue to innovate 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.

The first question is from Michael Ryskin at 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, continue 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 2025 will be much better than 2024. How we are going to translate this? Because we see signs that everywhere where we see customer, big international customers and regional customers, that are starting to restore and normalize ordering patterns. So overall, we see that during this 2025, there will be a gradual recovery throughout the year.

Regarding your comments on gross margins, you are indicating some significant margin improvements year-over-year. However, there were challenges last year, and you are still experiencing some margin dilution this year. Considering the ramp-up of Fishers and Latina, as well as the additional capital expenditures related to the new customer, could you explain how these projects need to develop for them to transition from being margin dilutive to margin accretive? What is the timeline or the volume requirements for that new capacity to shift from 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 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 or three quarters of delay in the program compared with Latina. We are fully in line with our plan but it's about three quarters later. There, we are very happy with the results in Q4. We started generating a 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 signals 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 growth in vials for 2025 from mid-single digits to high single digits. And as Franco mentioned, we see progress 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 are building an R&D capability for many customers, and we have plants that are able to serve Nexa syringes and Alba syringes, like in the case we have in Fishers. We are going also to serve this device with this program. So today, we have a certain number of programs through the CMO business model and some 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 and EZ-fill, but also as a holistic partner where they can buy both 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 Q1 stepped down from Q4 on revenue, 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 the 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 on 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 is build 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, the United States, and Asia, able to sell to our customers the same product from different regions. On 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 to review the supply chain with our customers from the different regions. So we are putting a lot of attention together with our customers on how to approach any potential evolution. The good news is that we have a good footprint with the same standard of quality everywhere. The fact that we decided to approve this big investment in Fishers, Indiana three years ago 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 the 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 a similar situation with cartridges, but I will let Franco explain more about the EZ-fill cartridges project. About vials, obviously, after going down 34% last year, we have available capacity both in bulk and in EZ-fill, of course, for obvious reasons. So we will still have the 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 requests about Alba ranges for particular applications. There is an increase in demand for cartridges ready-to-fill. In particular, we have one big customer that has decided to increase their capacity in the next year around this type of product. Even more, there are several kinds of programs around cartridges. Our big focus is really to implement capacity for high-value products where we see the higher demand in 2025 and also next year.

Regarding the cartridge program for the specific customer, will that involve dedicated capacity, or do you anticipate being able to diversify that?

Both. We have one big anchor customer that is placing a big contract where they want to serve a big quantity on cartridges to fill. And also, we see more and more mid-sized customers, biologics, and biosimilars 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 for 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 to be ready to approach these favorable tailwinds.

I have a question about capacity. I noticed the mention of devices in Fishers and the addition of capacity there. Could you clarify your strategy of providing clients with both the glass and the device? What are your long-term expectations regarding the margin contribution from the devices? In other words, is pursuing the supply of these devices a positive shift in your business mix, or do you expect the margins from these devices to be lower than your higher-value glass margins?

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

If I can, David, give you a different angle more from a business point of view. If you look at the growth of biologics in the next years, we will see nice double-digit growth on syringes like Nexa and Alba. In parallel, there are equivalent growth in pen and auto-injectors. Our goal is to go to our customers and to show the full value proposition, no matter if it's through our IP products or through the CMO business model, because this will help us to capture more market share and more growth. This is why the plants we have in Fishers have this flexibility. It's considered by our US customers as 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-next year. But the further step, as Franco was explaining, is further optimization to improve our profitability in the segment.

If I can further add more business color, the team made a significant improvement during this quarter. Today, we are on track to deliver our complex designs to our customers. Our target is to complete this delivery by mid-year. This will help to further improve our revenue marginality. In the meantime, together with the organization, we are going to review the cost structure. We will also review the size of our plants to make more efficient operations, both in Denmark and Italy, and prepare for future growth. Today, the products we are serving to our customers from an engineering point of view are very well-received because there is a significant growth in biologics and there's a high demand for assembly technology in the industry due to this device trend. More from a regulatory point of view, there are stricter requirements from new sophisticated inspection lines, 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 behalf of 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 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 by increasing also after-sales activities. We expect to be more accretive than we were before these progress we faced in 2024, keeping on improving also through the optimization plan Franco mentioned in his remarks. 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 years high single-digit growth, thanks to the fact that we want to further reinforce our position in inspection systems, in assembly technology with high-speed machines, and increase the percentage of after-sales to our major customers.

Next question is from Tejas Savant, Morgan Stanley.

Franco, I have a question for you regarding high-value solutions. I think Patrick asked something similar earlier, but I am curious about your HVS revenues. What percentage of those are sold in the US, and what percentage of that US HVS revenue is manufactured locally? This relates to the potential impact of tariffs that I’m trying to understand. Additionally, do you see an opportunity in the next few years to utilize your global footprint and adjust your supply sources depending on tariff regulations? Is this becoming a competitive advantage that is recognized in requests for proposals?

First of all, we are generating in North America about 26% of our revenue. The concentration of high-value solutions is stronger in North America, but we don't disclose the exact number. 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. This is also why we are, as Franco mentioned before, confident to manage the tariff issue because we are becoming local and domestic in many different countries. Please underline if I missed a piece of your question…

From a business perspective, our strategy for several years, especially since our IPO in New York, has been to invest and concentrate Stevanato Group on high-value products. Currently, we are significantly investing in capacity for high-value products in Piombino Dese, Latina, and Fishers to meet the growing demand in biologics from our international customers who prefer a supplier and partner in various regions. Our investment in Latina last year was aimed at the Nexa ranges, which are high-value products. We are now increasing our capacity for cartridge and EZ-fill, which are also high-value products. We are applying the same strategy in Fishers by building capacity for syringe and Nexa configuration, and we will also increase capacity for vial ready-to-fill for Alba technology. Our objective is to establish ourselves as a global partner with a worldwide presence, equipped with a sophisticated and flexible supply chain that adheres to the same quality standards, while focusing on high-value products in the coming years.

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 scrutiny under the Trump administration?

Correct. During COVID, we signed this contract to build dedicated capacity for vials in bulk and 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.

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, and 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 clarify, today, we have contracts and we don't see any issues with our customers. We are just executing all the contracts we have already signed last year and two years ago with our customers. Today, the focus is together with them to install capacity to do the validation and execute, particularly in Europe and particularly in the United States. So with respect to Fishers, our goal is to be in full capacity by late 2028, and we are continuing to install this capacity for high-value products in terms of syringes, as I mentioned to you, and for what is related to vials, EZ-fill. We also mentioned before we had this agreement with BARDA regarding EZ-fill vials as well as bulk vials. You also have to remember that with Fishers, we have conducted Phase 1. Once we acquired, we decided to install capacity in Fishers. We purchased a big piece of land because we decided to become domestic in the United States with a long-term vision, similar to what we have done in Europe. Therefore, we are now executing through 2028 the Phase 1, and now we are in the next years to go to Phase 2 to be able to be flexible and proactive to approach any market opportunities in the United States with our biologic customers.

Next question is from Hugo Marticorena, BNP Paribas.

I've got two questions. Firstly, could you clarify the 34% decline in vial sales, particularly regarding the difference between EZ-fill and bulk vials? Can you share the split or at least the magnitude of the difference between the two? Secondly, regarding the CapEx guidance, how will the customer contribution be recognized? Can we assume that the expected reported figure for free cash flow next year will be between €250 million and €280 million?

So I'll start from the second question. We are receiving balance sheet contributions in the form of prepayments or contributions to our investment during 2025. We expect to receive approximately €60 million between prepayments and contributions to help us finance the expansion on important high-value projects. So the guidance is between €250 million to €280 million net of prepayments and contributions. 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 fluctuations 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 configurations. There is a very high demand for injectables. More and more, we see a very high demand from customers to have integrated solutions. We are continuing to see positive signals, well spread in all the regions, about the recovery of the vials. This is also important. The Engineering division has made meaningful progress in delivering this complex line. So we are happy for 2025. Even more, we are confident to confirm what we shared during the Market Capital Day in New York, our ability to target 30% of EBITDA and to have 40% to 45% of our high-value solutions in the next year in 2027. 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.