Stevanato Group S.p.A. Q3 FY2025 Earnings Call

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. At this time, I would like to turn the conference over to Ms. Lisa Miles, Chief Communication Officer. Please go ahead, madam.

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 a reconciliation of these non-GAAP measures, please refer to the company's most recent earnings press release. And with that, I will hand the call over to Franco Stevanato.

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 delivered 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 and certain tariff costs 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 up 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 auto-injectors. Our core pillar of our long-term strategy is built around meeting the demands of a high-growth market, 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 life cycle 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 the 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. So 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 Annex 1. Many major pharmaceutical players have announced extraordinary investments dedicated to 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 Fisher 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 validations 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 R400 EZ-fill cartridge lines. They have a fully automated, ready-to-use process designed to ensure aseptic integrity, increase production capacity, and provide superior container quality. Our capital investments are helping us meet the 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 embedding sustainability into our operations and strengthening our ESG practice. I will now turn the call over to Marco.

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 $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 constant currency basis, revenue grew 11%. Overall, financial results were better than expected in the third quarter, primarily due to 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 Latin and Fishers facilities as we scale our multiyear investment plan. While both sites are currently margin dilutive, we expect to continue to gain operating leverage as volume and revenue growth, and the ongoing recovery in vial demand as the effects of destocking 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%. And 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 $36.1 million with diluted EPS of $0.13. On an adjusted basis, net profit was $38.5 million and adjusted diluted EPS increased 17% to $0.14. In the third quarter of 2025, adjusted EBITDA increased to $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 $266.7 million. On a constant currency basis, BDS revenue grew by 17%. The segment outperformed our expectations by approximately $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 $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 delivery solutions decreased by 10% to $118.8 million due to a decline in low-value syringes and in vitro diagnostics as we transition 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 Latin and Fishers as the site scale, 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 $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 negative 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 $113.3 million and net debt of $333 million. For the third quarter of 2025, capital expenditures totaled $54.9 million. Net cash from operating activities increased to $47.2 million. Cash used for the purchase of property, plant, equipment, and intangible assets totaled $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 $1.16 billion to $1.19 billion, adjusted EBITDA between $288.5 million and $301.8 million, and adjusted diluted EPS between $0.50 and $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% and 44% of total revenue compared with our prior assumption of 40% to 42%. Currency translation was worse than anticipated in the third quarter, and we now expect that the impact from currency will be approximately $15 million to $16 million compared with our prior range of $12 million to $15 million. We have fully offset this with higher organic growth. Thank you. I will hand the call back to Franco.

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 delivery, and meaningful progress across our investment projects. While challenges remain within the Engineering segment, we've 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 advanced 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 our 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.

First question is from Larry Solow, CJS Securities.

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

Yes, sure. Marco speaking. Thank you for the question. So the $10 million is an acceleration to accommodate customer supply chain needs of sales that were previously expected in Q4. So basically, based on the needs, we decided together with the customer to ship in Q3. Everything is BDS, predominantly in high-value solution, high-performance syringes.

And then high-value solutions. What drove the strong growth in the quarter? And how does the trajectory look going into next year?

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, and also important to underline the fact that we can see some recovery in sterile vials following the last year destocking. We see traction in physical vials that is improving compared to the same period last year. Those are the main drivers for high-value solution growth. And this is also the main reason why we decided to update our guidance with respect of high-value products. We now expect high-value products share between 43% and 44% of company revenue.

If I may add, Marco, we observe a strong trajectory. Our large international clients, especially in the biotech sector, are showing significant demand, particularly for EZ-fill products like Nexa syringes. We're noticing increasing interest and traction for Alba syringes as well. Additionally, there is a notable rise in demand for ready-to-fill cartridges in various formats from 1 ml to 10 ml, as they are ideally suited for self-administration with auto-injectors or wearable devices.

Next question is from Matt of William Blair.

On the margin improvement story here, last quarter, you referenced that Latina was positive gross profit margins, but Fishers was not yet those seeing 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.

Well, overall, we are happy about the execution of the 2 plants. We keep on improving quarter after quarter. As you remember, we started commercial production in Latina in Q4 2023. While in Fisher, we started about 3 quarters later. In Latina, we keep on improving also the financial performance beside the operational KPIs, and we are getting closer to a normalized gross profit margin compared with the segment, still dilutive. About Fisher, as mentioned, is we started commercial production 3 quarters after Latina is a bigger plant, 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 lines and better leveraging our fixed expenses. And we plan to go to positive gross profit margin towards the end of this year.

In the last quarter, you mentioned that the KPI for site acceptance has significantly increased, which seemed like a positive indicator. Now it seems you're indicating that it will take more time to return to historical performance. What is the expected timeline for a return to growth? Can that segment achieve growth in 2026? If not, will the recovery period show flat revenue, or will it resemble the down 20% guidance you provided for the second half of 2025?

Yes. To provide a broader perspective, last year's Q3 saw our engineering efforts coming off a record high in orders, which has led to increased complexity. In response, we initiated an optimization plan with our leadership team to resize our two operational plants in Italy and Denmark, where we received a surge in orders for Cal. Currently, we are making significant operational progress. We've strengthened our leadership and enhanced execution in our supply chain and project management. This improvement is evident in the increased number of successful site acceptance tests delivered to customers, surpassing last year's figures. Our clients are providing positive feedback as they start using our lines. The pipeline with both existing and new clients remains robust. However, we are experiencing delays in converting leads into orders for two main reasons. Our key customers are awaiting final acceptance of line #1 before placing orders for lines #2 and #3. Additionally, some customers are taking extra time to reassess their manufacturing strategies. Despite this temporary headwind, we are seeing continuous progress in our engineering execution, and the positive feedback from our pipeline bodes well for the future. It's worth noting that the industry is currently very dynamic, with many major customers expanding their capacity and upgrading their technology due to new regulations. Onshoring in the United States is prompting some customers to increase their investments as well. This is a favorable environment for our growth in the coming quarters.

Next question is from Michael Ryskin, Bank of America.

In your prepared remarks, I think you made a callout about a biosimilar opportunity or essentially winning some biosimilar business, specifically for GLP-1s. I was wondering if you can talk bigger picture about biosimilars and how you see that opportunity contributing to Stevanato's 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, whether that's incremental margins or top line? And just broadly, how important are biosimilars to you today?

Yes. Typically, when biosimilars enter the market as the original product is going off patent, it benefits companies like Stevanato by increasing revenue from individual therapeutic drugs. Stevanato's strategy has always emphasized being involved with the originator from the start. This approach has applied to products like insulin, heparin, and anesthetics, and is particularly relevant for GLP-1s, where our long-term insulin customer engaged us years ago. We are heavily committed to our entire product portfolio with our originator. Simultaneously, Stevanato is very active with our tech centers in Italy and Boston, aiming to maximize validation in biosimilars. Currently, we are deeply involved with our EZ-fill high-value product platform, including Nexa syringes and cartridges ready to fill. In fact, we recently won a significant program related to biosimilars, specifically for JP-1, and have a new program in the pipeline for our Alina Pen. So, in response to your question, yes, biosimilars are helping to further boost revenue. Typically, when a product goes off patent, 70% of the revenue remains with the originator while 30% historically shifts to biosimilars. This aligns with Stevanato's strategy to be present in everything related to injectables, both originators and biosimilars.

And then a follow-up, if I can, on the guide for the year, and you called out FX 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 talk about organic offsetting it. So just kind of means that 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 in engineering?

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 EUR 1.17, the euro-dollar 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 the second quarter. On the other side, we are giving priority to high-value syringes rather than accelerating the non-value syringes. And this is also moving the mix. As Franco mentioned, order intake in Engineering is not at the speed that we were anticipating. So in our model, we took into account of the risk of softer second quarter, but we prefer to adjust our model with a couple of million less. So overall, we see impact from currency, some slowdown in engineering, and acceleration in high-value products, bringing more margin to BDS segment.

The next question is from Paul Knight, KeyBanc.

Could you tell us what is utilization rate in Fishers and utilization rate in Latina? And with it how many years to get to full capacity, if that's possible to answer?

In Fishers, we are continuing to install high-speed lines for syringes. We install the line, conduct internal validation, perform customer validation, and then start to ramp up. This installation will also continue through 2026 to 2027. In addition, we are starting to add capacity for vials in both bulk EZ-fill configuration, and next year we will add capacity for Alba technology. As previously mentioned, we are expanding a significant program to support the production of auto-injectors in the coming year. Over the next 1 to 3 years, until the end of 2028, we will keep ramping up capacity, aiming to achieve full potential by the end of 2028. Our goal was to invest $0.5 billion to generate $0.5 billion in revenue by the end of 2028.

You're discussing onshoring quite a bit. It seems that due to tariffs and pricing, your customers are considering where their factories might be located in the future, which suggests there could be a potential increase in demand.

Yes. We start to see starting from after this year was end of March of 2025, many clients that came in to raise interest to our U.S. facility with 2 types of interest, or because they were reevaluating their footprint, because maybe the region they were looking to produce in a different region of the world. And now they are thinking to put capacity in the United States, and they are even more interested in boosting and speeding up the validation of our plants. And this is, let's say, what was already inside 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 opportunities 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 plans in Fisher in particular for our EZ-fill product.

Next question is from Mac Etock, Stephens Inc.

Maybe just a follow-up on the order pull-through. Can you confirm if that's a single customer that's pushing forward $10 million in orders? And secondly, as you look towards Q4, do you expect those volumes to continue from there? Or is that more of a one-time item?

No, we are not confirming that. We are not so concentrated on a single 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.

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

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

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

And then secondly, on engineering. You mentioned the 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, and 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.

In the Engineering segment, we observe that some clients are reevaluating their operations. Initially, we planned to invest in capacity in Europe through certain contract manufacturing organizations, but now some clients are reconsidering and have already decided to expand their capacity in the United States. This is one reason why we are taking additional time to finalize orders and specifications. Additionally, other customers are altering their supply chains, potentially increasing their outsourcing to U.S. contract manufacturers or boosting the capacity of their existing facilities. Overall, we are witnessing a positive trend in the United States where customers are increasingly enhancing their filling platforms domestically. Once they establish new factories, there will be more opportunities for our Fisher plants, particularly for syringes Nexa, syringes Alba, and EZ-fill devices.

Next question is from David Windley, Jefferies.

I wanted to follow up on Paul's question on capacity, put maybe a slightly different spin on it. On the HBS guidance for the year, the previous guidance for the year at, I believe you said 40% to 42% and 1Q started off pretty favorable to that. And I think at the time, the commentary was that your ability to see HBS continue to rise as a percentage from that first quarter favorable level was somewhat gated by capacity and when lines were coming on. So this quarter, obviously, you were able to pull that $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 HBS 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 HBS continue to move higher?

Today, David, in recent years, most of our investments have been focused on building capacity for high-value products in both Italy and our two plants in the United States. Is that accurate? The demand is indeed driven by the capacity we've established across all locations, and we are likely to maintain this approach. It’s important to note that we have an ongoing program to enhance capacity across all formats to meet demand. In Latina, we are increasing our capacity for Nexa syringes and will also be expanding for double chamber syringes. We have a significant initiative to boost capacity for ready-to-fill cartridges by several hundred million. Similarly, in Fisher, we continue to expand Nexa syringe capacity and will also add capacity for Alba and Ready-to-Fill. This initiative specifically targets EZ-fill. Additionally, in Germany, we are launching a large clean room for the production of the Alina Pen, with future expansion potential in the United States. We are committed to efficiently executing all our investments, aiming to add several hundred million in additional capacity for high-value products by 2028 to fulfill our programs and customer contracts.

Follow-up question around vials. So you had highlighted that the particular pressure on vials, I believe, if we go back to '24 was acute on your margin and 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?

Yes. David, let's make a parallel. Bulk vials, you have to consider like a big ocean with several hundred customers that in the last 2 years, they started to normalize their inventory. And today, since the last 4 quarters, we continue to see positive signals to go back on the normalization. And in fact, I think throughout 2026, most probably we can say that we'll be back to pre-pandemic period for Bulk vials. EZ-fill vials are more of 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 vial. So we also have seen a positive traction with particular also increase of orders with new customers on EZ-fill vials because remember, we shared that the customers were looking to clean the inventory of bulk vials, and then because they have EZ-fill flexible lines for filling EZ-fill vials, they are starting to place new orders. So all overall, bulk, we are moving to a normalization. On EZ-fill, we see also a new molecule that are going to use this type of primary configuration, EZ-fill.

Next question is from Doug Schenkel, Wolfe Research.

So 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?

Besides 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. Then in Q3, we mentioned also the fact that other containment delivery solutions are going down compared to the same period last year. And this is mainly driven by in vitro diagnostic and non-value syringes. More specifically, on syringes, we have some flexible lines. So our priority is to switch the production and the revenue to high-value syringes rather than staying in the low-value syringes. So we have this type of acceleration in Q3 with the Nexa syringes and EZ-fill vials recovery compared with the same period last year.

If I can add a little bit more in a broader picture, the goal of Stevanato in the next 5 to 10 years is to become a fully solutions provider to our customer, where we want really to sell the fully integrated system. This is the reason why, for example, the Plant in Fisher is a campus that is going to provide multi-capability 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. So you can see some fluctuations quarter-by-quarter, but the clear goal of Stevanato in the next years is really to be laser-focused on serving the full system on high-value products to our clients.

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?

Yes. We saw this announcement also today. What we can say is very similar to the question that we received before about biosimilar. Every time that a 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 is product or auto-injector is really minor compared to the overall cost of goods of the drugs. So usually, this we see more like a net positive effect for companies like Stevanato because it will translate in more orders for our products.

Next question is from Patrick Donnelly, Citi.

Franco, maybe to follow up on Dave's question 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?

What we see is that overall, they are starting to normalize their inventory. In fact, this will translate into more normal forecasts from our customers. Usually, with our customers, we work with what we call 3 to 5 years agreement. Then we have 12 months forecast, and 3 months confirm order if more bulk-related, 6 months confirm order if it's more EZ-fill related. So today, all 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 vials, if you can take a blend between bulk and EZ-fill, we increased 12% compared to last year. So we see continued month after month positive signals practically everywhere. We are talking about Europe, the United States, Latin America, and Asia. We have a portfolio of 700 customers, but all overall, the macro trend is moving slowly in a good normalization direction.

And then I guess looking at next year, I know you guys LRP is out there at 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 wouldn't be in that low double-digit range? I think the Street is around 10% next year. I just wanted to take your temperature on that.

As you know, we will be providing our detailed guidance for 2026 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 towards 2026. We need, obviously, to finalize our internal budget and objectives, but this is what we can tell you today.

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

So 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% to 42% of revenue versus 45% year-to-date or so. 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?

Yes, correct. Our guidance is implying 40% to 41% in Q4, and 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. So as Franco was saying, there can be some quarterly fluctuations or acceleration depending on the mix of orders we have in that specific quarter. Nevertheless, in the medium term, both 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.

If I can also maybe add a little bit more color from a product, customer, and therapeutic area point of view, we see that we are growing in biologics a lot. And inside the biologics, we see traction on Nexa syringes where clients are using some autoinjectors. We see more and more increased demand from products 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 results of reduction of the release of visible particles. Cartridges to fill on different formats from 1 ml up to 10 ml are good because it's very easy to be inserted into the complex device cartridges. Also, our Alina Pen is starting to feel good pipeline, new prospects on particular on biosimilars. So 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 localized in one product or one customer.

And then quickly on contract manufacturing. I know the press release called out strong growth in Q3. And then you mentioned Fishers should start commercial activities for contract manufacturing, I think, end of '26, early '27. So 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?

So we are building in Fisher this production department dedicated for one high runner for auto-injector for one of our big customers that already buy from us the Nexa syringes. Today, our strategy, our approach on drug delivery system is our main goal is to deliver our IP products to our Alina, Aidaptus, and Vertiva products. This is why we're building this big clean room in Germany that is going to host produce Alina Pen. And also, we have space to further duplicate in the future in the United States. So we are so focused to intensively execute all our investment. We will add several hundred million of additional capacity in the high-value product until 2028 in order to really meet all the program and execute the contract that we have with our customers.

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

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