Stevanato Group S.p.A.

Good afternoon, this is the Coruscall conference operator. Welcome and thank you for joining the Stevanato Group fourth quarter and full year 2025 financial results conference call. As a reminder, all participants are in listen-only mode. And 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 and zero on their telephone. At this time, I would like to turn the conference over to Ms. Lisa Miles, Chief Communications Officer. Please go ahead, Madam.

Good morning, and thank you for joining us. With me today is Franco Stevanotto, Chairman and Chief Executive Officer, and Marco De 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 are 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 20F filed with the Securities and Exchange Commission. Please read our Safe Harbor Statement included in the 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 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 Stevanotto.

Thank you, Lisa, and thanks for joining us. Today, we will review our 2025 performance, address current market dynamics, discuss our fourth quarter results, and provide 2026 guidance. We finished fiscal 2025 with another solid quarter that led to positive full-year performance and positive momentum as we start 2026. For the fiscal 2025, total company revenue increased by 9% at constant currency rates and 7% on a reported basis compared with 2024. This growth was consistent with our expectations and reflects the execution of our strategic priorities throughout 2025. The biopharmaceutical and diagnostic solution segment delivered another solid year with double-digit top-line growth for fiscal 2025. This offset the expected revenue decline from the engineering segment. Revenue growth in the BDS segment was driven primarily by strong market demand for high-value solutions, which increased 29% in fiscal 2025 and represented 46% of the total company revenue for the year. The strong performance in high-value solutions was also the main driver for margin expansion in the year. with gross profit margin rising by 160 basis points compared to 2024. These results demonstrate the company's ability to execute against our strategic priorities and to grow our innovative premium offerings, positioning the business for sustained success in the evolving market environment. At the same time, as we continue to move up the value chain, we are pivoting away from certain non-high-value product categories that we consider not aligned with our strategy, and we might consider additional action in the future. Since our IPO in 2021, we remained committed to meeting customer demand for high-value solutions, which meant investing in key projects in Fishers Indiana and Latina Italy to expand capacity for high-value syringes. In 2025, the Nexus syringe was our fastest-growing product, driven primarily by growth from GLP-1s. This should come as no surprise as this range is by far the most prevalent format for GLP-1s in the United States today. There's no doubt that we've been successful in winning our fair share of the GLP-1 market. This success is rooted in our long history of being a trusted partner to customers. Our global footprint, which provides supply chain security and the quality of our products, which have characteristics that resonate with our customers. For example, our Nexa platform features high mechanical resistance. It can be produced at scale, and it is ideally suited for an anti-injector. In fiscal 2025, our revenue from GLP-1s accounted for approximately 19% to 20% of total company revenue, growing more than 50% compared with 2024. We currently expect that GLP-1s will serve as a meaningful tailwind as patient demand continues to grow in the years to come. With the launch of the Wigobi pill, patients now have more options for GLP treatments. The general consensus among industry experts and our customers is that injectables are expected to be the preferred format for treatments like obesity, while oral GLPs will enable market expansion and support patients with specific needs. We also anticipate the market for GLP-1 will continue to evolve over the next decade primarily driven by the different commercial and supply chain strategies among the originators, biosimilar launches, the expected expansion of treatment indications, and next-generation incretins still in clinical phases. We are already seeing some of these dynamics play out in the market today. As we noted on prior calls, recent demand for cartridges has outpaced our prior expectation, and we are expanding our capacity to satisfy demand. We see this trend align with the introduction of new pen injector formats, with various treatment plans, as well as the expected growth of biosimilars, especially in APAC. We currently expect that we will continue to benefit from gel piece in the future. We also believe that the market will continue to evolve and mature. We see a pipeline of opportunities where we are well positioned with a deep expertise, a global footprint, and a comprehensive portfolio of products from primary packaging to our platform drug-delivered devices. While JLPs represented the largest top-line growth contributor in 2025, we continue to increase our participation in other injectable biologics with our premium best-in-class high-value product portfolio. In fiscal 2025, we realized a 40% increase in the number of customers ordering premium syringes, both ALBA and NEXA platforms, for biological applications that were unrelated to GLP-1s. These new customer projects are expected to play an important role in future growth. We continue to expand our participation in the broader set of biological applications, with new customer programs unlocking incremental value and setting the path for sustainable growth in the coming decade. As a result, in fiscal 2025, biologics represented 41% of BDS revenues, up from 34% in 2024. Turn to the next slide for an update on our strategic growth investments. In Latina, the past year was dedicated to the installation and production of syringe capacity and customer validations, all of which will continue in 2026. The next phase in Latina is devoted to increasing capacity for easy-fill cartridges to meet rising global demand. Turning to features, throughout 2025, the teams were focused on core activities including the ongoing line installations. In parallel, customer validations and audits continue and in 2025, we doubled the number of customers that are now validated in features. Looking ahead, Line installations and customer validation activities are expected to continue all year. We continue to advance the build-out for contract manufacturing activities in support of a couple of large device programs for a key U.S. customer. The build-out is going well. Nearly all of the injection molding machines are installed, and we started producing components for qualification activities. The first phase of new clean room is completed. We still expect commercial activities to begin at the end of 2026 or early 2027 for the first device program. Please turn to the next slide for a status update on the engineering segment. Over the past 12 months, we've made meaningful progress advancing our optimization efforts and improving execution. In 2025, we right-size operations, streamline processes, and increase standardization across delivery teams. we reinforce our project management office, driving improvements in project planning, process harmonization, content management, and customer engagement. We also consolidate offices in Denmark, move the visual inspection activities to Italy, and acquire a new location in Bologna to access strong technical talent. These actions have contributed to double-digit growth in site acceptance rates, an important KPI. Nevertheless, Our 2026 guidance assumes a revenue decrease from the engineering segment due to lower order intake in the prior months. While our efforts in 2025 were focused on execution, we recently stepped up our sales and marketing efforts, which has led to a more robust opportunity pipeline. Converting opportunities into new firm orders has been slower than we anticipated. But our pipeline is especially strong in pharmaceutical visual inspection, underpinned by innovation and superior technology. All in all, getting the business back to historical performance is taking longer than we expected, and we're working to best position the segment for long-term success. In summary, 2025 was a successful year, characterized by robust top-line growth, a favorable mix, and ongoing margin expansions. Double-digit growth in our BDS segment more than offset the expected revenue reduction in engineering and enabled us to navigate the unfavorable effects from foreign currency. High-value solutions were the primary driver of revenue growth and margin expansions, reflecting our ability to scale our main investments and perform in full alignment with the strategic direction set at the time of our IPO. We expect that GLPs will remain an important tailwinds having anchored our position as a market leader in high-value products. Importantly, our diverse products set enable us to achieve strategic position beyond GLPs, allowing us to participate in the broader global market for injectable biologics and biosimilars. Looking ahead, we will continue to execute our strategic priorities, including aligning gross investments with customer demand trends. I will hand the call over to Marco.

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, we ended fiscal 2025 with positive financial results for the fourth quarter. Total company revenue grew 7% at cost and currency. and 5% on a reported basis to $346.5 million for the fourth quarter of 2025. Foreign currency translation was an headwind throughout fiscal 2025, with an higher impact in the second half of 2025 due to a weaker U.S. dollar. Our BDS segment delivered another solid fourth quarter with revenue increasing 13% at the cost of currency, and 10% on a reported basis. This offset the expected 23% revenue decline in the engineering segment. For the fourth quarter of 2025, revenue from high-value solutions grew 31% to $171 million and represented approximately 49% of total company revenue in the quarter. The strong performance was driven by continued growth in our premium performance nexus syringes and, to a lesser extent, easy-fill cartridges. For the fourth quarter of 2025, gross profit margin increased 120 basis points to 30.9%. This was mostly driven by three factors. First, a favorable mix of high-value solutions. Second, the year-over-year improvements in Latina and Fishers as we scale production in our new facilities. But together, they remain dilutive to the corporate margin. And third, the improved market landscape for vials, which led to higher vial production and better utilization. This was partially offset by tariffs and unfavorable effects of foreign currency. For the fourth quarter of 2025, operating profit margin was 20.2%. As a result, net profit totaled 47.6 million and diluted earnings per share were 17 cents. On an adjusted basis, net profit was 49.8 million and adjusted diluted EPS were 18 cents for the fourth quarter of 2025. Adjusted bid increased 7% to 97.7 million. And adjusted EBITDA margin increased 70 basis points to 28.2%. Let's review segment results on page 11. The BDS segment finished strong with double-digit growth in the fourth quarter. Revenue grew 13% at the constant currency. and 10% on a reported basis to $307.1 million. Segment growth was led by a 31% revenue increase from high-value solutions to $171 million, which accounted for 56% of segment revenue. This offset the 9% revenue reduction in other containment and delivery solutions as we prioritized the production of premium products. For the fourth quarter of 2025, gross profit margin for the BDS segment improved 50 basis points to 31.6%, led by a favorable mix, operational gains in our new facilities as we scale commercial production, and an improved vial market. Dispositive trends were offset by the unfavorable impact of tariffs and foreign currency translations. This resulted in an operating profit margin of 23.8%, which improved 50 basis points in the fourth quarter of 2025. The BDS segment continues to perform well, reflecting the successful execution of our strategic priorities and the strong position to capitalize on future opportunities. For the fourth quarter of 2025, Revenue from the engineering segment decreased 23% to 39.4 million due to lower revenue in glass conversion and assembly, offsetting growth in pharmaceutical visual inspection. For the fourth quarter of 2025, segment gross profit margin decreased to 15.8% and, as a result, operating profit margin was 9.1%. Ongoing efforts under our business optimization plan have yielded improvements in execution and meaningful operational progress. However, the unfavorable portfolio mix, coupled with slow order intake, continues to put pressure on margins. The team has been very focused on securing new orders, which will help refresh and reposition the portfolio for long-term success. Please turn to the next slide for a view of balance sheet and cash flow items. We ended the year with cash and cash equivalents of 130.6 million and net debt of 337.7 million. With our current cash on hand, cash generated from operations, available credit lines, 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 fall year 2025, capital expenditures totaled $294.9 million, of which approximately 89% were deployed for growth projects to support customer demand. These investments are related to capacity expansion for high-value solutions, and supporting future DDS commercial activities. For the full year 2025, cash from operating activities totaled $286.1 million. Cash used in the purchase of property, plant, equipment, and intangible assets was $275.1 million. The combination of increased cash flow from operations and lower capex helped drive a significant year-over-year improvement in free cash flow. And we exit the fiscal 2025 with positive free cash flow of $18.4 million for the full year. Lastly, turn to the next slide. We are establishing 2026 guidance. We expect revenue in the range of $1,260,000,000 to $1,290,000,000. On a constant currency basis, revenue will range between 1,278,000 and 1,308,000. Adjust EBITDA in the range of 331.8 million to 346.9 million and adjust the diluted EPS in the range of 59 cents to 63 cents. Our 2026 guidance considers headwinds and tailwinds, and we have assumed the following factors. Revenue will be stronger in the second half of 2026 compared with the first half. The effects from foreign currency translation are expected to be a headwind of approximately 18 million for fiscal 2026, with an impact of approximately 10 million in Q1. As a result, in the first quarter, we expect mid-single digit revenue growth on a reported basis, compared to last year based on the midpoint of our guide. For the full year, the BDS segment is expected to grow on a reported basis, high single to low double digits, and double digits on a constant currency rate. Engineering is expected to decline by mid-single digit to low double digits. For fiscal 2026, high-value solutions are expected to range between 47% to 48% of total company revenue. And in 2026, we are assuming a tax rate of approximately 26.8%. And finally, capital expenditures and free cash flow. We have assumed CAPEX in the range of 270 million to 290 million before customer contributions and prepayments. Net of contributions and prepayments, CAPEX is expected to range between 240 and 260 million. Regarding free cash flow in 2026, we are modeling breakeven to positive free cash flow of approximately 20 million. I will hand the call back to Franco.

Thank you, Marco. In closing, we remain focused on executing our key priorities supported by strong business fundamentals. We operate in attractive, growing end markets with favorable secular tailwinds. Innovation across the industry continues to advance patient care and we remain mission critical to the delivery of biologics, supporting new therapeutic areas, expanding global access to treatments, and improving standards of care. Demand for innovative drug products remains strong. There are more than 9,000 injectable assets in the global drug pipeline undergoing clinical evaluation or being registered, and more than 60% are biologics. We believe we are well positioned to serve this demand through our integrated value proposition, differentiated portfolio, and long-standing commitment to science and technology-driven innovation. Biologics, our fast-growing segment, is expected to remain a key driver of top-line growth and margin expansion as we continue to move up the value chain. At the same time, we are making meaningful operational progress, and we expect to increase in benefit from new capacity coming online, productivity gains, and improvements within our engineering segment. Together, we expect these efforts position us to deliver long-term sustainable growth and share other value. Operator, we are ready for questions.

Thank you. This is the Coruscall conference operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star N1 on their touch-tone telephone. To remove yourself from the question queue, please press star N2. Please pick up the receiver when asking questions. Anyone who has a question may press star N1 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 Michael Riskin, Bank of America.

Great. Thanks for taking the question and congrats on the strong end to the year. I want to start on sort of parsing out your guide for 2026. I appreciate you provided a lot of color in the deck and in your prepared remarks. I'm curious if you would comment on your expectations for GLP-1s in 2026. I think you said for 2025 it was up to 19% to 20% of revenues and grew 50% year over year. So at the midpoint of your guide for 2026, what is your assumption for GLP-1 growth next year? And I have a follow-up. Thanks.

Thank you. Franco speaking. Revenue from the GLP-1s accounted in 2025 approximately between 19% to 20%. And we have delivered our growth in 2020 compared to the 20% for about 50%. If you do an estimation and look at our outlook on 2026, we think that will be a growth in the range of mid-teens.

Okay, mid-teens. Okay, that's great. Thanks. And then follow up on the engineering segment. I mean, on the one hand, encouraging. It sounds like you're making a lot of progress in terms of the operational plan, the optimization, moving some of the facilities around, right-sizing operations. All of that is encouraging, but then The guide for engineering for 2026 and the color on low order intake, that's a disappointing update. So on the order intake side, we'd just love to, this is engineering specific, we'd just love to get a better sense of what you think is behind that. Is that some weakness in the market? Is it, you know, as simple as you guys were so focused on getting the operational things right that you missed a few opportunities? Just get a sense of why that suddenly turned bad in the second half of 2025 and And how quickly can you regain the momentum on the commercial side of things? Thanks.

So, first of all, the pharmaceutical market, in particular biologics, is also robust in terms of demand for new machine. For inspection machine, assembly technology is very robust. Today, most of the biologic market, it will move to injection, and when there is also self-administration, and it's going to require an inspection machine. So today the order intake and the pipeline that we have in the engineering is healthy, is rich. What is the big, the nice KPI is the fact that there are repetitive orders with our historical big clients. So what was the pain point is the fact that the sales cycle, because of technicality of this line, is taking a little bit longer than was expected, translating water. Instead, to maybe receive the order, the confirmation of the order, in January or February can be easily postponed a few months. This is why we took some more prudent approach. Another important element that we like to underline, in 2025, the big focus of the engineering division is really to make strong operational progress in terms of management and execution. And the good KPI that we can translate and share with you is the number of site acceptance tests that increase and more than double in 2025 compared to 2024. This is extremely important. At the end of the game, the company in 2025 focused our attention to execute and deliver this line. Now we are entering the new ways to new orders, repetitive orders with our clients. This is taking a little bit more months than what are our expectations. but the outlook in the medium term is strong also in the engineering division.

Thanks so much. Appreciate the call.

Next question is from Patrick Donnelly, CT.

Thank you guys for taking the questions. Maybe one of the high value solution side, it seems like you guys are guiding 47, 48% of revenue for that segment. Can you just talk about where we are on kind of the utilization capacity side? I know you guys are ramping Fisher's, you're ramping Latina in terms of utilization. Are you still capacity constrained with the high value side? Just wondering where we are on the capacity side versus the demand. Are there areas where demand is outpacing capacity? It would be helpful just to talk through that piece.

So capacity in Stevanato Group, in particular for preferential ranges through the format of nexa syringes, alba syringes, cartridges, rate of fill, is playing a role. In 2025, practically, we run approximately in full capacity in Sternato Group, and also this is translated in the ramping up that we are doing in Latina in particular, with good success, the ramp up that we are doing in Fischer. So also in 2026, we will follow this this nice positive moment where the demand is robust practically in all our high-value product, but the capacity has played a role in 2025. It will play a role also in 2026 for Stevanato Group.

Okay, that's helpful. And then maybe one for Marco. Just on the margin expansion here, again, obviously the mix helps to a degree with some of the high-value stuff that is helpful here, the GOP growth. Can you just talk about, you know, the moving pieces on the margins, you know, the right way to think about the path forward here as high value becomes a bigger and bigger piece of the pie? And then I guess flowing that into just the cash flow piece, you know, how you continue to drive an inflection there. It seems like a little bit positive this year. Thank you, guys.

Patrick, just to clarify, I think you're asking about 26 or are you asking about 25?

Yes, 26 margin expansion and just the drivers of cash flow into 26 as well.

Yes, thanks for the question. So overall, stevanato group level, we are assuming our guidance as mentioned at the center point of the guidance, 7.5% revenue growth and 8.3% on a cost and currency basis. About margin, we see margin expansion from 0 to 30 basis points on consolidated level. Operating profit margin expanding 50 basis points at the center point of our guidance and adjusted bidder margin expanding for approximately 150 basis points. Gross profit margin, we can put together some headwinds and tailwinds. On the headwind side, For sure, we can mention higher depreciation compared with 2025. We expect approximately 150, 170 pesos more in depreciation on industrial business. We have currency headwind embedded in our guidance. And on the positive side, instead, we have from top of the two new facilities where we can see quarter after quarter, the financial performance is improving both in Latina and fishers. So we are on the right track there to keep on expanding profitability. I touched briefly also engineering. Franco already mentioned the market and revenue guidance. What I can tell you is that we anticipate better margin in 2026 compared to 2025, mainly driven by the project mix. We are targeting more repetitive contracts with the repetitive customers, so not really customized lines as we did in the past. And also, we leverage the optimization plan we executed in 2024 and 2025, so we have This is embedded in our model and in our guidance for 2026.

Great. Thank you.

Next question is from Doug Shankill, Wolf Research.

Good day, everybody, and thank you for taking the questions. I have three. I'll just throw them out there and then listen to your answers. Is there any change in how you are thinking about the long-term growth outlook for GLP-1s for your business? Two, more near-term, how strong is your visibility on demand pursuant to the assumption you embedded into guidance for GLPs, which I think is high teens growth in 2026? And then third, thinking about Lilly's multi-dose quick pen format, how do the economics differ between formats for Stevanato and, you know, really getting at vials versus cartridges? Thank you.

So what is related to the GLP-1 in 2026? Practically, we're just executing the forecast that we share with our clients today, and already everything is embedded in our guidance that we are sharing with you. We have already all the problems that were clear with our clients. For what is beyond the 2026, it's a little bit too early to make any type of plan because there are a lot of moving pieces in the GFP1. We see the big originator that are moving between also the pen, the out-injector. They're launching also cartridges, new requirements, thanks to their fixed-dose pen. Also, we see a lot of biosimilar in the market that continues to be very, very active to put capacity both for syringes, for cartridges, also for the devices. So the GLP-1 in the next decade, it will continue to be a powerful tailwind for Stevanato, for all the industry, but it's a little bit too early to understand what will be the final configuration between originator, biosimilar, pain versus out-injector?

I think that answer covers all of your questions, Doug, just to confirm.

Yeah, I think the only thing, Lisa, was just the economics of the different formats.

Oh, in terms of syringes, cartridges, vials, so on and so forth.

Also here, we will... Oh, go ahead, sorry. Most of the GLP-1 product are under syringe and nexa, that's a high-value product, or cartridges ready to fill, that is also a high-value product. We have in Biosimilar a lot of requirements to our Alina pen that is a high-value product. This is practically the same. The tendency is to answer to you that GLP-1 is going to be in a configuration of high-value product because of high easy fill or to Alina for Stevanato Group.

Okay. Thank you again. Have a great day.

Next question is from David Windley, Jefferies.

All right, thanks. I just wanted to clarify definitionally, when you are talking about GLP-1s, are you including the full gamut of mechanisms that are kind of pursuing obesity? So GLP-1, GIP, glucagon, you know, non-increting glucagon, you know, are we kind of generally bucketing all of that together for definitional purposes? Thanks.

Correct.

I confirm. And then... As you think about, I think you talked about Nexus syringe being the strongest driver of growth in 25. Franco, you just commented to Doug's question about the kind of 27 and beyond outlook being a little less clear because of the transition. I guess in 26, on that guidance that you're giving for this GLP-1 or obesity category, is that still driven by Nexus syringe? Or do you see that starting, you mentioned in the prepared remarks, some uptake in capacity and cartridge in your next phases of capacity, is cartridge kind of overtaking the growth lead as we move into 26 and beyond?

In 2026, NEXA syringes will continue to play an important role in the GLP-1s, David. Beyond the 2026, it's also true that we are building a lot of capacity on the cartridges rate to fill, still minor compared to syringes in NEXA, but we are starting also to see that the customer originator and also biosimilar, they are starting to put new capacity not only on syringes, but also for cartridges in the next year to come. beyond 26.

Thanks. And if I could just sneak in a follow-up on the margin question, would you be able to size, maybe this is a Marco question, but size the tariff and FX headwinds to margin so we kind of understand what the gross improvement was from the mixed shift to HVS, but offset by tariffs and FX, please?

Yeah, sure. We mentioned the top line about 80 million currency headwinds. Assuming our model 1.20 euro dollar change rate that you know in the very last days there was volatility but this is what we have in our model. You can assume about 30% of that is impacting margins for 2026. About tariffs we have been able to have a good dialogue with our customers mainly in predominantly transferring the effect of tariffs to customers. In 2025, we had about 4 million headwinds, but it was mainly related to supply chain and the time to transfer the different scenario. So we are assuming limited impact from tariffs in 2026.

Okay, that's great. Thank you.

You're welcome. Next question is from Paul Knight, KeyBank.

Hi, Franco. After the 50% growth in GLP-1s last year, your mid-upper teams guide on 26 seems a bit conservative. Is it because Fishers is just ramping or what's behind this guide on GLP-1s for this year?

No, I think it's coherent because of the The pharmaceutical industry, in particular, all the originators, they launched the product on the market in 2025. It was a massive preparation of the supply chain. Now, to have a mid-teens growth in this category of drugs is still very important. I think it's a realistic number for When there is a takeoff of the product, when starting the product has to really go commercial. So this is what we see through our originator and also through our biosimilar clients.

Paul, perhaps it's best to think about an initial surge followed by a period of normalization where growth slows a bit.

Yeah. Yeah. And then you had mentioned earlier a 45% increase in customers using high-value product. What's driving that? Is it share gain? Is it Annex I regulations? Is it recent approvals that have been the right ones for you? What's behind that 45% customer gain?

On the non-GP1 biologic, you mean, Paul? Yes. Yeah, this is our most important KPI in Stenato Group. So the strategy that we're building since the day of the IPO in Stenato Group is to become the partner of the pharmaceutical industry and everything that is around biologic work. the good news that more than 60% of biologic, it will be through injection, through a certain medication for devices. This has to become our big number one strategy. And this is exactly what we are executing. Today, we are deeply engaged on Nexa syringes program. We are deeply engaged on ALBA program. Syringes can move from 1 ml to 2.25 ml to 3 ml to 5 ml. Cartage is the same format because both cartridges and syringes are going to be inserted on pen or not injector. Also, we are heavily investing in capacity for device space through our Alina clean room that we're building up in Germany, and also for other selected program of CMO in Germany. Also, we have a big contract with an American client in Fisher. So everything is going to summarize that where there is an injection, they're not going to be in it. And the real future in the next one, two, three, four, five years are the incremental value that will be able to generate spread to several tens of hundreds of programs worldwide through biologic and biosimilar. Most of the United States, in Europe, and also for it is growing rapidly. This is the big long-term strategy of Stevanato.

Thank you. Next question is from Callum Tickmarsh. Morgan Stanley.

Hey, guys. Thanks for taking the questions. Beyond GLP-1s, I'd love to get a better sense of what you're seeing across the biologic category today. You know, I realize there's a lot of GLP focus just given the relative growth profile, but curious how other biologic categories have been performing, how customer discussions have been trending, you know, any positives, any pressure points, and then what's just being assumed from these categories in the guide for 26. Thank you.

So the category are practically monoclonal antibodies. We have a wide range of biosimilars spread in the different regions of the world. We are focused on immunogenic, inflammatory, rare diseases, all products that are going to require an injection or a self-medication. So there is a combination for stevanato of an excess ranges, cartridges to fill with a pen or auto-injector.

It's

It would be great to hear your latest thoughts as well on U.S. on shoring. Obviously, fishers should be well positioned for that. Any early discussions or insights you could share with us to just better understand the timeline for benefits here and when we could expect something to appear in the P&L?

You're referring to the shore, you mean?

That's right.

Yes, today, the plants of fisheries play an important role. When we decided in 2020, and we started to develop these plants in 2021, it was really the purpose to build a campus that was going to mirror exactly the same capability that we have in Europe, in particular, for easy-fill technology, with a different range of syringes, via a rate of fillers from devices. Today, what we see that many clients, they are re-addressing their supply chain at the States. And the fact that we are present in Fisher with this wide capability is play a role. What translating what? We can really accelerate additional opportunity for customer want to the US supply chain.

Next question is from Larry Solo, CJS Securities.

Great. Good afternoon. I guess just lots of information, GLPs and all that. I really appreciate it. I guess from your seat today, and I want to hold you to this, but as we look out over the next five years, do you think the GLPs in summary will, you know, in aggregate will still be driving 10% plus growth to Stephanata on a top-line basis? What's your confidence level on that?

So I think it will continue to benefit on the GLP-1 in the future like a tailwind. So the good news of the GLP-1 is these are information that we share constantly with our clients. quarters after quarters that the number of patients are going to increase and then larger. So this is the good news. So from the moment that they launched, we saw all our clients that they see more upside than downside in number of new customers. More and more what we see, that there are new opportunities for stevanato on excess ranges, new opportunity for cartridges to fill, and also for our device pacers. So I can see that it will be a long-term tailwind for Stevanato that we help to further boost our biologic revenue. I don't know if after five years it will continue to be in double-digit because in parallel, Stevanato is also rapidly growing in other therapy that is so-called biologic. And these are all high-value products like Alba syringes, our pen-like Kalina, or high-format on cartridges.

That's all fair. What about just the RTU vials? You mentioned 2025 obviously had a nice rebound. 23, 24 were down years. Can you give us a little more granularity on sort of how the year finished up and your outlook for 26 in that market?

Yes, Marcus speaking. As a forecast, let's say we went up about 6% in 2025. The predominantly we grew in sterile configuration. And this is where we see more traction also for 2026, where we expect mid to high single-digit growth, predominantly driven by sterile configuration. And under that point, orders intake in 2025 was double-digit higher than in 2024. So we see the recovery is not the sharp increase, but we see the increasing variance demand.

Gotcha. And then if I could just squeeze one more in, just Latina, Fishers, the trajectory of profitability, where do we kind of stand? And I know Latina is a little bit ahead and Fishers is larger, but where do we stand and when do we kind of hit you know, full run rate profitability. Where do you, when do you think we can start closing in on that? Thanks.

We are going to the right direction. We see quarter after quarter, better financial performances, the side, the operational performance. We are growing quantities and better leverage our fixed expenses. We are a, very well positioned in Latina, where we are getting close to our average gross profit margin. Fishers, we are a little bit behind, but we see steady improvement also in fishers. There's a difference, as mentioned many times, between the two plants. Latina is a smaller plant, is a brown field, and we ramp up more rapidly than in fishers. is a more complex plant with different type of products, syringes, vials, the drug delivery system. So we are progressing, we are improving, going to the right direction, but it will take longer compared with Latina. Today, the gross profit margin is positive on the combination of two plants, still diluted compared to the average of the company, the average of the segment.

If I can give a sort of business angle, in Latina, we have continued the installation of a line for high-speed line for syringes, NEXA, and we have continued to perform validation to our regional customers and national customers. And this year, we're going to install the first high-speed line for cartridges ready to fill. But the goal is to do the validation this year to start to do commercial revenue in the beginning of 2027. And in Fisher, we continue to perform audit with our big international clients in order to become a particular domestic United States. In fact, we have doubled the number of audits and validations in 2025. important milestone that we are advancing with the build-out of this big department production that is still expected to produce an out-injector for one big U.S. client at the end of this year.

Great. I appreciate all that, Colin. Thank you, guys.

Next question is from Matt Laro, William Blair.

Hi. Thanks for taking my questions. Matt, I'm sorry.

We cannot hear you at all. Can you speak up a little bit?

Sure. Can you hear me now?

A little bit better.

Go ahead.

Yes.

Okay.

Thank you. So you've historically said that you expect orals to be about 30% or one third of the market. And I would say investor expectations on that metric have moved quite a bit since the oral will go relaunched. So you've addressed JLP growth for next year and referenced for the next couple of years. But how do you feel about that metric? And I guess in discussions with your customers, how are they viewing that metric?

Yes. So, For sure, we are putting a lot of attention on this evolution of the pills, and we have a lot of point of contact with our clients, both the originator and the biosimilar. We look at what the key opinion leaders are sharing, our peers, our customers. Also, I know that all the banks are very well prepared on this. Again, we are going to confirm that The share between injection spread between cartridges or syringes represented the majority in the range of 70% and oral to be the minority in the range of 30%. Now, what also we see, like I was mentioning to all of you before, we see, this is information that we received from the market, the number of total patients worldwide, it will continue to increase month after month. And we don't see cannibalization between injection to the oral because they are targeting two different type of patients today. So this is our internal estimation. From a supply chain point of view, what do we do? Because this is another important target. If you look at the number of lines that the pharmaceutical industry is installing for syringes, for cartridges, and the number of lines for assembly technology for penultimate injectors, both into the originator, into the biosimilar, and to the CMO is still high. There is a big program of massive investment for injection in the next year to come on a worldwide basis.

Okay, thank you. On non-GLP biologics, we're sort of backing into maybe that being up mid-teens. Does that sound right? And then you referenced in the deck the large biologics. global pipeline, I think 60% of the 9,000 molecules. So what's your expectation for non-GLP biologics going forward? And I think that that's generally speaking all high value demand, I guess, if you could confirm that as well.

Usually these non-GLP, these biologic products are a very rich program. program that are maybe not in big size. It's difficult that they go in the range of hundreds of millions and the range of tens of millions. They're looking, because of the specificity of this large molecule, they're looking for particular drugs, particular primary packaging with particular coating. For example, we are engaged with our ALBA syringes because they have a special plasma coating. We are engaged with particular bacon-silicon syringes, with particular nexa syringes, and also different formats. We see more and more moving up to 3 ml or to 5 ml today. That's something that's a little bit new on the market. Usually, the auto-injector or the pen used to stop at 3 ml. So, all over all, we see several hundred of programs spread to many customers the top 25 big customers, and some hundreds of biosimilars that are extremely active to build capacity in this way. So what we are doing, Stevanato Group, we are building a supply chain through our engineering division with a particular line dedicated to be able to be fast and flexible to serve these customers. So we want to keep Piumino-Dese, Latina, in particular the United States, to be able to serve this wide range of products that are moving from syringes to cartridges straight to fields. And through our device colleagues, we are ready with our out-injector, particular, and also with our Penalina, or in a selective way, when we already serve the syringes or the cartridges, we act like CMO. So I want to reiterate our real strategy in Stevanato is really to say when there is an injection, self-administration, we want to be always on the number one, on the number two for this new product.

Okay, thanks. And just one follow-up. You referenced the contract manufacturing opportunities, and maybe that will be ramping end of this year, end of next year. How do you expect the economics of that business to look for you, you know, relative to the BDS business and your engineering segment?

So we are not classifying the CMO as a daily producter. Nevertheless, we see the specific projects in a high range of non-high-value solutions. And as mentioned many times, we are taking here a selective approach with customers, leveraging this particular case, the integration between syringes, auto-injector, and all the capabilities we have to work with very important customers. So we are pushing this strategy, taking a selective approach, especially where we can leverage integration.

Yes. Thank you.

Last question is from Curtis Moyles, BNP Paribas Exxon.

Great. Thank you for taking my questions. I think you've already given a lot of color here, but on the high value solutions guidance for 47 to 48% of revenue, I just wanted to clarify, are you thinking that'll be primarily driven by GLP-1s or maybe can you separate the contribution from syringes versus kind of vials and cartridges?

It's a level of detail we don't provide. What I can tell you is that We are increasing our high-value solution next year, double-digit. Low things if we consider cost and currency rate, so we are growing both GLP-1 and other biologics next year.

And then also just, I think earlier in the call, you mentioned that you could consider some additional actions around pivoting away from the non-HPS categories. Can you maybe give a little color about what you're thinking about there?

I'm sorry, Curtis. We missed a portion of your question as you were dropping out. Can you please repeat?

Sorry about that. Yeah, of course. I think in the beginning of the call, you mentioned that you could consider actions around pivoting away from non high value solutions categories in the future. I was just wondering if you can comment on what you're thinking about there.

Yes. Thank you for clarifying that.

Yes. Today, the focus is on the group. Also, the investment, all the attention of all our colleagues is on building capacity to become the partner of this biologic market for high-value product. And this is a reason why, for example, if you have to select, we are going maybe to to prioritize the inputs. For example, this historical product is good to produce in certain regions of the market, but in particular in the United States, the goal is to focus, to become the number one, number two in the new product. Or for example, another example, In Germany, we have built this new big clean room in order to host the production for Alina Pen. Originally, in this clean room, we used to produce standard in vitro diagnostic for customers. We have decided to use this space, important space, this know-how, to start to ramp up in the next year's Alina. This is the type of deprioritization that we are looking in the next years. Focus on biological high-value product And when there is no strategic customer behind or strategic market, we try really to do some deprioritization.

Got it. Thank you.

Thank you, everyone. That concludes today's call, and we'll be seeing you shortly. Have a good day.