Stevanato Group - Earnings Call - Q3 2025

Transcript

Operator (participant)

Good afternoon, this is the Chorus Call conference operator. Welcome and thank you for joining the Stevanato Group Third Quarter 2025 Financial Results Conference Call. As a reminder, all participants are in listen-only mode. After the presentation, there will be an opportunity to ask questions. Should anyone need assistance during the conference call, they may signal an operator by pressing star n zero on their telephone. At this time, I would like to turn the conference over to Ms. Lisa Miles, Chief Communication Officer. Please go ahead, Madam.

Lisa Miles (Chief Communication Officer)

Good morning, and thank you for joining us. With me today, I have Franco Stevanato, Chief Executive Officer, and Marco Dal Lago, Chief Financial Officer. A presentation to accompany today's results is available on the Investor Relations page of our website under the Financial Results tab. As a reminder, some statements being made today are forward-looking and based on current expectations. Actual results may differ materially due to risks outlined in Item 3D, Risk Factors, of our most recent annual report on Form 20-F filed with the SEC. Please review the safe harbor statement included at the beginning of today's presentation and in our press release. The company undertakes no obligation to revise or update these forward-looking statements except as required by law. Today's presentation may include non-GAAP financial information. Management uses these measures internally to assess performance and believes they may be helpful for investors in.

Evaluating the quality of our financial results, identifying trends in our performance, and providing meaningful period-to-period comparisons. For reconciliation of these non-GAAP measures, please refer to the company's most recent earnings press release. I will hand the call over to Franco Stevanato.

Franco Stevanato (CEO)

Thank you, Lisa, and thanks for joining us. Today, we will review our third quarter performance, share updates on our investment projects, and discuss the current market environment. We deliver another solid quarter of financial results driven by revenue growth, a record mix of high-value solutions, and continued margin expansion. Our third quarter financial results exceeded our expectations. We benefited from favorable timing of some product shipments in the BDS segment that were previously scheduled to occur in the fourth quarter. Relative to the same period last year, we also faced headwinds from foreign currency, asserting tariff calls that were not mitigated, which tempered margins in the third quarter. These impacts were already assumed in our guidance. As a result, we remain on track to meet our 2025 guidance.

This underscores the momentum we are experiencing from executing our strategic roadmap, as we leverage and scale our growth investment in capacity expansion to meet the increased demand for high-value products. Third quarter revenue increased by 9% year-over-year, driven by the continued strong performance of our BDS segment, which grew by 14%. This was primarily fueled by demand in our core drug containment business. As expected, revenue from the engineering segment declined as we continue implementing our business optimization plan. Our solid performance in the third quarter was underpinned by a remarkable 47% growth in high-value solutions, driven primarily by Nexa syringes and, to a lesser extent, EZ-fill vials. The Nexa platform is optimized for sensitive biologics, and its high mechanical resistance makes it ideal for the seamless integration of autoinjectors.

Our core pillar, or our long-term strategy, is built around meeting the demands of high-growth markets such as injectable biologics, which require premium containment and delivery solutions. These are often sensitive drugs that require specialized glass or ready-to-use containers to maintain stability and integrity and ensure patient safety. Our EZ-fill portfolio and our ongoing investments in growth capacity are intended to support customers' innovation programs in drug development and lifecycle management. As the pharma industry shifts to ready-to-use platforms that deliver superior quality, simplify processes, and enhance operational flexibility, our EZ-fill cartridges are setting a new standard. Most recently, they were selected by a leading manufacturer for use with a GLP-1 biosimilar for type 2 diabetes, one of the first to receive FDA approval and launch commercially in the United States.

Engineered for optimal performance in handheld injection devices, EZ-fill cartridges offer seamless compatibility with pen injector systems, helping accelerate time to market while ensuring reliability and patient convenience. The continued growth in biologics, rising pharmaceutical innovation, and the increasing trend towards self-administration of medicine remain strong secular tailwinds for our business. Solid demand for high-value solutions and collaboration with customers on ready-to-use products illustrate why we believe we are well-positioned to meet evolving industry demands and support patient-centric solutions. Turning to the engineering segment. The team continues to make meaningful operational progress against our business optimization plan. Over the past year, we have been squarely focused on executing effectively and meeting our customer commitments. While the steps we have taken have yielded operational improvements, our financial performance is below our expectations.

We believe that getting the segment back to historical performance levels is going to take more time as we refresh the workload with new projects and reposition the segment for stronger profitability. We have a healthy pipeline of new opportunities across the engineering segment. However, converting that pipeline into new orders has been slower than we anticipated. First, as I mentioned during last call, we are strengthening the sales organization with fresh expertise and refining our commercial processes. We expect to harvest the benefits of these initiatives in the coming quarters. Second, several pending opportunities in our pipeline are repeat orders from existing key customers. The good news is that we have received positive feedback on the performance of recently installed manufacturing lines. We are cautiously optimistic that the current slowdown in order flow is only temporary.

We believe the long-term demand landscape for our manufacturing technologies remains strong as the industry expands its capacity to satisfy growing demand for injectable biologics and devices. Customers are investing in new capital projects as they onshore more core operations in the United States and upgrade their technology to meet higher quality standards and more stringent regulations, such as our next one. Many major pharmaceutical players have announced extraordinary investments dedicated to the U.S. manufacturing operations. This, coupled with organic growth from on-cycle investments and growth in emerging markets, provides us with added confidence in the demand outlook. Let's turn to an update on our capital investment projects in Fishers and Latina. In Fishers, we have several syringe lines running commercial production at various stages of ramp-up.

At the same time, we will continue to install additional syringe lines and validate customers for the rest of this year and throughout 2026. Our first vial lines are being installed and qualified with customer validation expected to begin in mid-2026. We are also advancing the build-out for contract manufacturing activities in support of a couple of large device programs. The new clean room is nearly completed. The first injection molding machines are on site and scheduled for installation in the coming months. We still expect commercial activities to begin at the end of 2026 or early 2027. In Latina, we are scaling commercial production for Nexa syringes, which will continue into 2026. Preparations are underway for the next phase of EZ-fill cartridge production. To meet the rising demand for ready-to-use cartridges, this next phase will be powered by our new RTU 400 EZ-fill cartridge lines.

They have a fully automated, ready-to-use process designed to ensure accepting integrity, increase production capacity, and provide superior container quality. Our capital investments are helping us meet rising market demand for our core drug containment products amid the growth in biologics, which continue to become a large portion of our portfolio each year. Before closing, I would like to thank our teams around the world on our important ESG milestone. We were recently awarded the EcoVadis Silver Medal. This puts us in the top 15% of companies assessed globally and the 92nd percentile in our industry. This recognizes our strong performance and reflects our commitment to embed sustainability into our operations and strengthen our ESG practice. I will now turn the call over to Marco.

Marco Dal Lago (CFO)

Thanks, Franco. Before I begin, I want to clarify that all comparisons refer to the third quarter of 2024, unless otherwise specified. Let's start on page 9. Revenue for the third quarter of 2025 grew 9% to EUR 303.2 million, driven by a 14% increase in the BDS segment, which offset a 19% decline in the engineering segment. As Franco mentioned, foreign currency translation was a headwind, and on a cost and currency basis, revenue grew 11%. Overall, financial results were better than expected in the third quarter, primarily due to a favorable timing of product shipments in the BDS segment, which were previously anticipated to occur in the fourth quarter. Revenue from high-value solutions grew 47% and represented 49% of total company revenue. Strong performance in the BDS segment led to a 240 basis point increase in consolidated gross profit margin, reaching 29.2% in the third quarter of 2025.

This was due to a favorable mix of more accretive high-value solutions, the expected financial improvements at our Latina and Fishers facilities, as we scale our multi-year investment plan. While both sides are currently margin-dilutive, we expect to continue to gain operating leverage as volume and revenue grow. The ongoing recovery in vial demand has the effects of de-stocking abate. These positive trends were partially offset by a lower gross profit from the engineering segment and, to a lesser extent, the impact of currency translation and certain tariff costs that were not mitigated. In the third quarter of 2025, operating profit margin increased to 17.4%. On an adjusted basis, operating profit margin rose 220 basis points to 18.5%. This improvement was driven predominantly by an increase in gross profit. Net profit totaled EUR 36.1 million, with diluted EPS of EUR 0.13.

On an adjusted basis, net profit was EUR 38.5 million, and adjusted diluted EPS increased 17% to EUR 0.14. In the third quarter of 2025, adjusted EBITDA increased to EUR 77.8 million, and the adjusted EBITDA margin improved 280 basis points to 25.7%. Moving to segment results, starting with the BDS segment on page 10. In the third quarter of 2025, our BDS segment delivered strong results, with revenue rising 14% to EUR 266.7 million. On a cost and currency basis, BDS revenue grew by 17%. This segment outperformed our expectations by approximately EUR 10 million in revenue from product shipments that we previously expected to occur in the fourth quarter. Top-line growth was driven by a record level of high-value solutions, which reached EUR 147.9 million and represented 55% of segment revenue for the third quarter.

This was underpinned primarily by strong demand for high-value Nexa syringes, along with the continued recovery in EZ-fill vials. Meanwhile, revenue from other containment and delivery solutions decreased by 10% to EUR 118.8 million, due to a decline in low-value syringes and in vitro diagnostics, as we transitioned to a larger portfolio of high-value projects. This was partially offset by growth in bulk vials and contract manufacturing activities for drug delivery devices. In the third quarter of 2025, gross profit margin increased 400 basis points to 32%. Margin expansion for the BDS segment was driven by the favorable mix of high-value solutions, the financial improvements in Latina and Fishers as the size scaled, and the market recovery in vial demand. These tailwinds were partially offset by the impact of foreign currency and certain tariff costs, which were not mitigated.

As a result, operating profit margin for the BDS segment rose to 22.1%, up from 16.9% in the same period last year. In the third quarter of 2025, revenue from the engineering segment decreased 19% to EUR 36.4 million. This was driven by lower revenue from glass conversion and assembly lines. This offset revenue growth in visual inspection and after-sales services. As expected, the segment's gross profit margin declined year-over-year to 10.4% due to lower revenue and the current project mix, which included a higher proportion of revenue from the complex legacy projects in Denmark and fewer new orders. In the third quarter, operating expenses were higher due to certain R&D activities. This was tied to the ongoing development and launch of our next-generation EZ-fill cartridge lines at our Latina plant. As a result, segment operating profit margin was -1.1%.

Please turn to the next slide for an overview of the balance sheet and cash flow. As of September 30, 2025, the company had cash and cash equivalents of EUR 113.3 million and net debt of EUR 333 million. For the third quarter of 2025, capital expenditures totaled EUR 54.9 million. Net cash from operating activities increased to EUR 47.2 million. Cash used for the purchase of property, plant, equipment, and intangible assets totaled EUR 48.4 million for the third quarter of 2025. The improvement in net cash flow from operating activities and lower capital expenditures in 2025 led to a positive free cash flow of approximately EUR 260,000 in the quarter and EUR 16.9 million on a year-to-date basis. We believe we have adequate liquidity to fund our strategic priorities and satisfy our working capital needs through a combination of cash on hand.

Cash generated from operations, available credit lines, and our ability to assess additional financing. Please turn to the next slide for guidance. Despite the larger unfavorable impact from currency, we are reiterating our fiscal 2025 guidance and still expect revenue in the range of EUR 1.160 billion-EUR 1.190 billion. Adjusted EBITDA between EUR 288.5 million-EUR 301.8 million and adjusted diluted EPS between EUR 0.50-EUR 0.54. I want to call out a few updates to our assumptions for the full-year guidance. First, with the strength of high-value solutions, we now expect the revenue from high-value solutions will range between 43%-44% of total revenue, compared with our prior assumption of 40%-42%. Currency translation was worse than anticipated in the third quarter, and we now expect that the impact from currency will be approximately EUR 15 million-EUR 16 million, compared with our prior range of EUR 12 million-EUR 15 million.

We have fully offset this with higher organic growth. Thank you. I will hand the call back to Franco.

Franco Stevanato (CEO)

Thank you, Marco. In closing, our year-to-date performance demonstrates the strength of our long-term strategy and business fundamentals. We continue to deliver solid results, driven by growth in high-value solutions, innovation in drug containment and delivery, and meaningful progress across our investment projects. While challenges remain within the engineering segment, we have taken decisive steps to improve execution, reinforce our commercial teams, and unlock long-term value. Our commitment to supporting the evolving needs of our customers, especially in high-growth areas such as injectable biologics and self-administrated medicines, positions us well to meet the rising demand and deliver differentiated value. The strategic investments we have made, the innovation we have delivered, and the trust we have built with our customers are the foundation of the strong momentum as we look towards fiscal 2026.

With a healthy pipeline, strong market tailwinds, and a clear strategic focus, we are confident in our ability to drive growth, enhance patient outcomes, and deliver lasting value for our customers, employees, and shareholders. Thank you again for your time and continued support. Operator, we are ready for questions. Thank you.

Operator (participant)

Thank you. This is the Chorus Call Conference Operator. We will now begin the question-and-answer session. Anyone who wishes to ask a question may press star and one on their touch-tone telephone. To remove yourself from the question queue, please press star and two. Please pick up the receiver when asking questions. Anyone who has a question may press star and one at this time. We kindly ask you to limit to one question and one follow-up only, and join the queue again for any further questions. We will pause for a moment as participants are joining the queue. First question is from Larry Solow, CJS Securities.

Charlie Strauzer (Managing Director)

Hello. This is Charlie Strauzer on for Larry. Could you perhaps give us some more color on the EUR 10 million outperformance in the quarter and on the top line, and then also talk a little bit more about the mix?

Marco Dal Lago (CFO)

Yeah, sure. Marco speaking. Thank you for the question. The EUR 10 million is an acceleration to accommodate customer supply chain need of sales that were previously expected in Q4. Basically, based on their needs, we decided together with the customer to shift in Q3. Everything is BDS, predominantly in high-value solutions, high-performance syringes.

Charlie Strauzer (Managing Director)

Great. What drove the strong growth in the quarter, and how does the trajectory look going into next year?

Marco Dal Lago (CFO)

I will start with saying that. We see strong demand in high-performance syringes, particularly Nexa, as Franco was commenting. Also, Alba has good traction. It is also important to underline the fact that we can see some recovery in steroid vials. Following last year, the stocking, we see traction in EZ-fill vials that is improving compared to the same period last year. Those are the main drivers for high-value solution growth. This is also the main reason why we decided to update our guidance with respect to high-value products. We now expect high-value products' share between 43%-44% of company revenue.

Franco Stevanato (CEO)

If I can complement Marco, we see that the trajectory is robust. Our big international clients, in particular the bio customers, also many relative biosimilar, they have a strong demand. In particular, on EZ-fill products like Nexa syringes, we see more and more interest and traction on Alba syringes. More and more, we see a lot of increasing demand for the cartridges ready-to-fill on the different formats, from 1 ml up to 10 ml, because they are perfectly fitting for their self-administration for their autoinjector or wearable devices.

Charlie Strauzer (Managing Director)

Thank you very much.

Operator (participant)

Next question is from Matt Larew, William Blair.

Matt Larew (Research Analyst)

Hi. Thanks for taking the question. On the margin improvement story here, last quarter, you referenced that Latina was positive gross profit margins, but Fishers was not yet. Those seen quarter-on-quarter improvement in both. I was wondering if you could update us as to where those stood today if Fishers had crossed over to gross profit margin positive yet.

Marco Dal Lago (CFO)

Overall, we are happy about the execution of the two plants. We keep on improving quarter after quarter. As you remember, we started commercial production in Latina in Q4 2023. While in Fishers, we started about three quarters later. In Latina, we keep on improving also the financial performance beside the operational KPIs. We are getting closer to a normalized gross profit margin compared with the segment, still dilutive. About Fishers, as mentioned, we started commercial production three quarters after Latina. It is a bigger plant, it is a greenfield. We are keeping on improving every quarter. We are not positive yet in Fishers in Q3. We are continuously improving also the financial performance, installing more line and better leverage in our fixed expenses. We plan to go to positive gross profit margin toward the end of this year.

Matt Larew (Research Analyst)

Okay. Thanks for that. On engineering, last quarter, you called out sort of a KPI. Site acceptance had significantly increased. It seemed like maybe a positive indicator. Now you're saying it's going to take more time to get back to historical performance. What's the right timeline to think about a return to growth? Can that segment grow in 2026? If not, does the recovery period look like flat revenue, or does it look more like the down 20% that you guided to in the back half of 2025?

Franco Stevanato (CEO)

Yes, if I can start from the bigger picture of the engineering. On the Q3 of last year, we shared with all of you that the engineering was coming from a big record high in terms of orders. This has also generated an increase in complexity. Immediately, with the leadership team, we launched a sort of what we call optimization plan, in particular, in order to resize the two operation plans. One is related to Italy. The other one was related to Denmark because at that time, we received a lot of orders focalized in Denmark. Today, we continue to make meaningful positive operational progress from an operational point of view. We further reinforce the leadership. We increase the execution on supply chain after service, in particular, on project management.

This was translated in Q1, Q2, and Q3 in an evident increase in the number of positive site acceptance tests that we have delivered to our customers that have outpaced the number compared to last year. Even more, the positive signal that our customers, once they start to run the line, they give very positive feedback to all of us. Today, where we are. The pipeline that we have with our clients, both on historical clients and also new clients, is healthy, all the pipeline. What we see, however, is a slow delay in the conversion into orders for many two reasons. To our big clients, key customers, they were waiting the final positive acceptance test of the line number one before placing the order number two and number three.

Second, also, we start to see some of our customers that are taking a little bit more time to reevaluate their manufacturing footprint. So all overall, this temporary headwind of the engineering, we see that is month after month progressive, even more from an execution point of view. Also, looking at the pipeline that we have with our customers, it's giving very positive feedback for the future. Just to underline the last comment, the industry in this moment is very dynamic. We see more and more big customers expanding capacity. We see even more a lot of clients all over the world upgrading their technology because the new regulation mostly linked to our next one. And also, we see a vision we want to take even more benefits. So thanks to the onshoring in the United States, some customers are going to add even more investment.

This is a good environment where we continue to grow in the next quarters.

Matt Larew (Research Analyst)

Okay. Thank you.

Operator (participant)

Next question is from Michael Ryskin, Bank of America.

Michael Ryskin (Managing Director)

Great. Thanks for taking the question. In your prepared remarks, I think you made a call out about a biosimilar opportunity or essentially winning some biosimilar business, specifically for GLP-1s. I was wondering if you could talk a bigger picture about biosimilars and how you see that opportunity contributing to Stevanato growth in the coming years. Specifically, if you could talk to what part of the portfolio benefits that. Does that tend to be high-value Nexa, or does that tend to be more bulk products or more routine products, standard products? Whether that's incremental margins or top line, and just broadly, how important are biosimilars to you today? Thanks.

Franco Stevanato (CEO)

Yes. Usually, when biosimilars are entering into the market, when the product is going out of patent, usually it is a benefit for a company like Stevanato because this can help to enlarge revenue in the single therapeutic drugs. On the strategy of Stevanato, it always was extremely important to be part of the originator from the very beginning. This was valid on insulin, on heparin, anesthetic, MAPs, and also even more on GLP-1s that our big historical insulin customer engaged us many years ago. We are deeply engaged with all our product portfolio, with our originator. Also, in parallel, Stevanato is extremely active with our tech center, both here in Italy and in Boston, to try to maximize the validation in all the biosimilars. In fact, today is exactly what is going to happen. We are deeply involved with all our EZ-fill high-value product platform.

We have a program on Nexa syringes. We have a program on cartridges ready-to-fill. In fact, we were just sharing that we win a big program. Even more, we have on biosimilar, on GLP-1, a new program on pipeline for our Alina pen. To your question, yes, the biosimilars are helping to further increase the revenue. Usually, when the product is going out of patent, 70% would be revenue around originator, 30%. Historically, the revenue that we're moving inside of biosimilars is exactly the strategy of Stevanato, to be present in everything that is injectable, originator and biosimilars.

Michael Ryskin (Managing Director)

Okay. Okay. A follow-up, if I can, on the guide for the year. I think you called out effects. Currency is a little bit more of a headwind by, I think, EUR 2 million at the midpoint. It sounds like our assumptions for engineering should be a little bit worse, and you talked about organic offsetting it. Just kind of means the BDS is coming out a little bit better. You saw the pull forward into 3Q, but am I interpreting correctly that we should expect a little bit of a better pull forward and better result in BDS 4Q as well, even despite the pull forward, just to offset currency and engineering? Thanks.

Marco Dal Lago (CFO)

Very good points, Michael. We are reiterating our guidance. Nevertheless, there are some moving pieces. You mentioned a couple of million more headwinds in currency effect because Q3 was average 1.17, the EUR/USD exchange rate, a little bit higher than our expectations. We are doing better in high-value products. We expect now to have high-value products as a range of overall revenue between 43% and 44%, so significantly higher than after second quarter. On the other side, we are giving priority to high-value syringes rather than accelerating the non-high-value syringes. This is also moving the mix. As Franco mentioned, orders in taking engineering is not at the speed we were anticipating. In our model, we took into account the risk also after second quarter, but we prefer to adjust our model with a couple of million less. All overall, we see.

Impact from currency, some slowdown in engineering, and acceleration in high-value products bringing more margin to BDS segment.

Michael Ryskin (Managing Director)

Okay. Thanks so much.

Operator (participant)

The next question is from Paul Knight, KeyBanc.

Paul Knight (Managing Director)

Hi, Franco. Could you. What is a utilization rate in Fishers and utilization rate in Latina? And how many years to get to full capacity, if that's possible to answer?

Franco Stevanato (CEO)

In Fishers, we are continuing to install high-speed line for syringes. Practically, we install the line, we do the internal validation, we do the customer validation, we start to ramp up. This installation of line will continue throughout also 2026 to 2027. On the top of this, we are starting also to add capacity for vials in both bulk and EZ-fill configuration in the next years. We are adding capacity. We will add capacity for Alba Technology. Like we already mentioned to you, we are extending a big program in our building for hosting a production of our injector in the next year. In the next one to three years, until the end of 2028, we will continue to ramp up capacity. The goal is to be in full potential at the end of 2028.

You remember, the goal was to invest EUR 500 million to translate the end of 2028, EUR 500 million of revenue.

Paul Knight (Managing Director)

You were mentioning onshoring quite a bit. I guess what you're hearing is that because of tariffs and pricing, etc., your customers are evaluating where their factories may be in the future, but it seems like it's a step higher, I guess, for possible demand.

Franco Stevanato (CEO)

Yes. We start to see, starting from after the decut this year in the end of March of 2025. Many clients that are coming to raise the interest to our U.S. facility. With two types of interest: or because they were reevaluating their footprint, because maybe the origin they were looking to produce in a different region of the world, and now they are thinking to put capacity in the United States, there are even more interest to boost and speed up the validation of our plants. And this is, let's say, what was already inside of our guidance.

The good news is that we see more and more clients that are looking to totally change their supply chain, and this is going to become more new opportunity for Stevanato because we are already in a very advanced stage of ramping up capacity in Fishers, and they like the idea to speed up the validation of our plants in Fishers, in particular for our EZ-fill product.

Paul Knight (Managing Director)

Thank you.

Franco Stevanato (CEO)

You're welcome.

Operator (participant)

Next question is from Mac Etoch, Stephens Inc.

Mac Etoch (Analyst)

Good morning. Thank you for taking my questions. Maybe just to follow up on the order pull-through, can you confirm if that's a single customer that's pushing forward EUR 10 million in orders? Secondly, as you look towards Q4, do you expect those volumes to continue from there, or is that more of a one-time item?

Franco Stevanato (CEO)

No, we are not confirming that. We are not so concentrated as a customer revenue. It's a bunch of customers, especially in high-value products, that are accelerating some supply chain needs, but it's not a single customer.

Lisa Miles (Chief Communication Officer)

I'm sorry, Mike. I missed the second part of your question.

Mac Etoch (Analyst)

I was just curious if those orders are going to repeat in Q4. Just given the pull forward.

Lisa Miles (Chief Communication Officer)

Oh, I see. No, that's not expected. It's a pull forward from Q4 into Q3 on that batch of orders from those customers.

Mac Etoch (Analyst)

I appreciate the context. Thank you. Secondly, on engineering. You mentioned these United States manufacturing announcements. I'd just like to get a sense of what you're hearing within your engineering segment and the customer conversations you have there. When that might translate to more meaningful order growth for engineering, and maybe also the BDS segment as well. Obviously, these are longer-dated opportunities, but I just want to get a sense of what you're hearing.

Franco Stevanato (CEO)

On the engineering segment, what do we see? There are, again, very similar to the question that Paul asked to us. Certain clients, they are reevaluating their footprint. Maybe originally they were looking to invest capacity in Europe or through certain CMO, and now they are seriously reevaluating, or they have already approved to extend their capacity in the United States. This is also one of the reasons why we are taking a little bit more time to confirm the order and the specifications. Other customers, they are also changing their type of supply chain. Maybe they are starting to further increase the outsourcing through U.S. CMO or to use, to further increase the capacity of their existing plants.

Overall, we see a positive trend in the United States where customers are starting to more and more increase their platform for fill in the United States. Automatically, once they will build the factory, there will be even more opportunity for our Fishers plants because automatically we will have more opportunity for syringes Nexa, syringes Alba, vials ready-to-fill all devices.

Mac Etoch (Analyst)

I appreciate the context. I'll leave it there.

Operator (participant)

Next question is from David Windley, Jefferies.

David Windley (Managing Director)

Hi. Can you hear me okay?

Franco Stevanato (CEO)

Yes.

Lisa Miles (Chief Communication Officer)

Hi, Dave.

David Windley (Managing Director)

All right. Hi. Good afternoon. Thank you. I wanted to follow up on Paul's question on capacity for maybe a slightly different spin on it. On the HVS guidance for the year, the previous guidance for the year, I believe you said 40-42. And 1Q started off pretty favorable to that. I think at the time, the commentary was that your ability to see HVS continue to rise as a percentage from that first quarter favorable level was somewhat gated by capacity and when lines were coming on. This quarter, obviously, you were able to pull that EUR 10 million forward. The trends have been pretty favorable. I guess I'm coming back again to Paul's question about capacity and utilization.

Are lines in place to continue to support HVS outperformance, but for the pull forward, I guess, in the near term, or are you kind of in a position where you have to wait for additional lines to be validated before you can see HVS continue to move higher?

Franco Stevanato (CEO)

Today, David. The demand, let's say, in the last years, most of our investment were just fully dedicated to build capacity in a high-value product, both in Italy, in the two plants, and in the United States. Today, is it true? The demand is really driven by the capacity that we have put in place in all the locations. Most probably, we will continue in this way. What is important to know is that there is an intense program to continue to install capacity in all the formats just to translate it in facts. In Latina, we continue to install capacity for syringes Nexa. In Latina, we will install capacity for syringe with double chamber. We have this huge program to install several hundred million for capacity for cartridges ready-to-fill. In Fishers, it's the same. We continue to add capacity for Nexa syringes.

We will add capacity for Alba, and we will add capacity for also via ready-to-fill. This is only for EZ-fill. On the top of this, in Germany, we are launching a new big-size clean room that is going to host the produce Alina pen. Also, we have space to further duplicate in the future in the United States. We are so focused to intensively execute all our investment. We will add several hundred million EUR of additional capacity in a high-value product until 2028 in order to really meet all the programs and execute the contract that we have with our customers.

David Windley (Managing Director)

That's very helpful. Thank you. Follow-up question around vials. You'd highlighted that the particular pressure on vials, I believe, if we go back to 2024, was acute on your margin. Kind of post the pandemic and post the decline in vaccine-related activity, you're seeing recovery in that. I'm wondering what the drivers are of recovery in vials. Is it kind of the recovery of orders from your traditional clients, or are you seeing new products, perhaps participation in GLP-1s or something like that that are driving an uptick in vial orders? Thank you.

Franco Stevanato (CEO)

Yes. David, let's make a parallel. Bulk vials, you have to consider a big ocean with several hundred customers that in the last two years, they started to normalize their inventory. Today, since the last four quarters, we continue to see positive signals to go back on the normalization. In fact, I think throughout 2026, most probably, we can say that we'll be back to the pre-pandemic period for bulk vials. EZ-fill vials is more a niche. It's more, let's say, we have some big commercial customers, but it's where we see new molecules launching on the ready-to-fill vials. We also have seen a positive traction with particular also increase of orders with new customers on EZ-fill vials because you remember we shared that the customers were looking to clean the inventory of bulk vials.

Because they have the EZ-fill flexible line for filling EZ-fill vials, they are starting to place new orders. Overall, bulk, we are moving to a normalization. On EZ-fill, we see also new molecules that are going to use this type of primary configuration, EZ-fill.

David Windley (Managing Director)

Okay. Thank you.

Franco Stevanato (CEO)

You're welcome.

Operator (participant)

Next question is from Doug Shankell, Wolf Research.

Doug Schenkel (Managing Director)

Thank you for taking my questions. You had a really strong high-value solutions quarter that was partially offset by standard bulk coming in a bit light of our model. I'm just wondering, based on your commentary, it seems like this is just timing. Is that right, or is there some other more durable shift in mix and demand that we should be contemplating as we update our models?

Marco Dal Lago (CFO)

Beside what Franco just said about the long-term view and the adoption of the sterile configuration, for the year, there are a couple of factors to be mentioned. First of all, we mentioned the acceleration in the BDS. Volumes previously expected in Q4. This is mainly in high-value products, so it's a pull forward from Q4 to Q3. In Q3, we mentioned also the fact that other containment delivery solutions are going down compared to the same period last year. This is mainly driven by in vitro diagnostic and non-high-value syringes. More specifically on syringes, we have some flexible lines. Our priority is to switch the production and the revenue to our high-value Nexa syringes rather than staying in the low-value syringes. We have this type of acceleration in Q3 with the Nexa syringes and EZ-fill vials's recovery compared with the same period last year.

Franco Stevanato (CEO)

If I can add a little bit more in a broader picture, the goal of Stevanato Group in the next 5, 10 years is to become a fully solution provider for our customers where we want really to sell the full integrated system. This is why, for example, the plant of Fishers is a campus that is going to provide multi-capability only, all in high-value product. Also, this is in combination with the fact that in the last year, most of our investments are fully dedicated to high-value products. You can see some fluctuation quarter by quarter, but the clear goal of Stevanato Group in the next years is really to be laser-focused on serving the full system on high-value product to our clients.

Doug Schenkel (Managing Director)

Okay. Super helpful. I was trying to parse out trend versus transitory, so that's great. An unrelated follow-up. There have been a number of recent headlines around large pharmaceutical companies. Essentially making deals with the U.S. government around drug pricing. And recently, it's been speculated that Lilly and Novo may announce a deal as soon as today. Is it logical to assume that a significant price drop and thus some elastic response in terms of market expansion via Medicare and Medicaid could be an absolute good guy for packaging suppliers? I'm just wondering, as you think about these settlements potentially leading to an increase in volume, wouldn't that by extension be good for Stevanato? Thank you.

Franco Stevanato (CEO)

Yes. We saw this announcement. I think also today. Later today, there will be a further announcement. What we can say is very similar to the question that we received before about the biosimilar. Every time the biosimilar is coming on board, this can help to further enlarge revenue for all the industry. Usually, what we say, just to put in the Stevanato position, with our clients, we have a long-term contract in place. The cost of primary packaging, also EZ-fill product or auto injector, is really minor compared to the overall cost of goods of the drugs. Usually, this we see more like a net positive effect for companies like Stevanato because they will translate in more orders for our products.

Operator (participant)

Next question is from Patrick Donnelly, Citi.

Patrick Donnelly (Managing Director)

Hey, guys. Thank you for taking the questions. Franco, maybe to follow up on Dave's question there on the vials, can you just talk about where we are on the inventory side? I mean, it feels like destocking far less of an impact. Are we fully past that? What's the latest you're hearing from customers on that front and confidence on the go-forward there?

Franco Stevanato (CEO)

What we see is that overall, they are starting to normalize their inventory. In fact, this would translate in more normal forecast from our customers. Usually, with our customers, we work with what we call 3- to 5-year agreement. Then we have the 12-month forecast, 3 months confirmed order, even more bulk-related, 6 months confirmed order if it is more EZ-fill-related. Today, overall, we see that clients are starting to normalize. One KPI that I can share with you, if you really compare last year with this year, the revenue around vial, if you can take a blend between bulk and EZ-fill, we increased 12% compared to last year. We see continuing month after month positive signal practically everywhere. We are talking about Europe, United States, Latin America, and Asia.

We have a portfolio of several hundred customers, but overall, the macro trend is moving slowly in the good normalization direction.

Patrick Donnelly (Managing Director)

Okay. That's helpful. I guess looking at next year, I know your guys' LRP is out there in kind of that low double-digit range. It sounds like throughout this call, it's been a lot of positives between some of the regulatory stuff, obviously destocking behind you guys, the new facilities ramping. Any reason why next year would not be in that low double-digit range? I think the street's around 10% next year. I just wanted to take your temperature on that. Thank you guys so much.

Marco Dal Lago (CFO)

As you know, we'll be providing our detailed guidance for 2026 and next quarter. Nevertheless, what we can tell you is that we see today positive trends for high-value solution adoption. We see Fishers and Latina ramping up in the right way, in line with our plan. We are executing our plan in engineering, so we have a positive approach toward 2026. We need, obviously, to finalize our internal budget and objectives, but this is what we can tell you today.

Patrick Donnelly (Managing Director)

Understood. Thank you guys so much.

Operator (participant)

The last question is from Curtis Moiles, BNP Paribas Exane.

Curtis Moiles (Equity Research Analyst)

Oh, thanks for taking my questions. First, I wanted to just maybe get a little deeper into the high-value solutions guidance for the year. On my kind of rough math, I think it implies for Q4 a range of 39%-42% of revenue versus 45% year-to-date or so. Could you maybe just give a little more color around the assumptions you have there, and is that kind of based on customer orders or anything else to be aware of?

Marco Dal Lago (CFO)

Yeah, it's correct. Our guidance is implying 40%-41% in Q4. This is driven by the backlog we have in our hands and by the fact that, again, we have been able to accelerate some revenue in Q3 that were previously expected in Q4. As Franco was saying, there can be some quarterly fluctuation or acceleration depending on the mix of orders we have in that specific quarter. Nevertheless, in the medium term, both in the past and in the future, in the past, we saw a steady growth of the share of our high-value products and we expect to keep on installing capacity and keep on growing in the share of high-value products.

Franco Stevanato (CEO)

If I can also maybe add a little bit more color from product, customer, and therapeutic area point of view, we see that we are growing in biologics a lot.

Inside biologics, we see traction on Nexa syringes where clients are using some autoinjectors. We see more and more increased demand from product in phase II and phase III, but also commercial on Alba. This is where we are extremely excited because they have a superior performance in the result of reduction of release of visible particles. Cartridges ready-to-fill on different formats from 1 ml up to 10 ml are good because it is very easy to be inserted in this complex device, the cartridges. Also, our Alina pen is starting to fill good. Pipeline, new prospect on particular biosimilar. What I would like to share with you is that the pipeline is spread with a very nice number of clients and therapeutic drugs in all our product portfolio. We are not just focalized in one product or one customer.

Curtis Moiles (Equity Research Analyst)

Got it. Very helpful. Quickly on contract manufacturing, I know the press release called out strong growth in Q3. You mentioned Fishers should start commercial activities for contract manufacturing, I think end of 2026, early 2027. Can you maybe just give some high-level thoughts about how we should think about this going forward? Is that going to become a more meaningful growth driver for the business?

Franco Stevanato (CEO)

We are building in Fishers this production department dedicated for one high runner for autoinjector for one of our big customers that already buy from us these Nexa syringes. Today, our strategy, our approach on drug delivery system is our main goal is to deliver our IP product through our Alina, Aidaptus, and Vertiva product. That is the reason why we're building this big clean room in Germany that we have already to execute the pipeline with our customer. It's also true that we have already contracted in the selective way that we can provide these autoinjectors or some pen to some customer that they own the IP.

When we are already the supplier with our Alba syringes or cartridges ready-to-fill or syringes Nexa, practically in order to have a bigger contract, we are also serving this product in a form of CMO business model.

Curtis Moiles (Equity Research Analyst)

Great. Thank you.

Lisa Miles (Chief Communication Officer)

Operator, are there any other questions?

Operator (participant)

There are no more questions registered at this time. Thank you.

Lisa Miles (Chief Communication Officer)

That concludes our call for the day. Thank you for joining us, and we appreciate the support. Have a great day.

Operator (participant)

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