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A.History and Development of the Company
Overview
Stevanato Group S.p.A. was incorporated on July 15, 1980, and the Company has a duration set until December 31, 2100 which may be subsequently extended by the shareholders of the company. We are a joint stock company (società per azioni) incorporated in the Republic of Italy and our corporate affairs are governed by our articles of association, certain provisions of the Italian Civil Code, which we refer to as the Civil Code below, and the laws of the Republic of Italy. On July 16, 2021, we completed an Initial Public Offering and our Shares were listed on the New Stock Exchange under the symbol “STVN”.
Our principal executive offices are located at Via Molinella 17, 35017 Piombino Dese – Padua, Italy and our telephone number is +39 049 931811. We have appointed Ompi of America, whose address is 9701 Giovanni Stevanato Drive, Fishers, Indiana 46038, as our agent upon whom process may be served in any action brought against us under the laws of the United States. Please see the section entitled “Enforceability of Civil Liabilities Against Foreign Persons” for more information.
For further information on important events in the development of our business, please see the section entitled “—B. Business Overview—Our Business.” For further information on our principal capital expenditures please see the section entitled “Item 5. Operating and Financial Review and Prospects—Liquidity and Capital Resources.” We have not been the subject of any public takeover offers by any third party.
The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC, which can be found at http://www.sec.gov. Our internet address is www.stevanatogroup.com.
The information contained on our website is not incorporated by reference and does not form part of this annual report.
History
In 1949, Giovanni Stevanato founded Soffieria Stella, a specialty glass manufacturer, in Venice, Italy. Soffieria Stella, the precursor to Stevanato Group, operated until 1959, when Stevanato Group was established in Piombino
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Dese (Padua). Over the last 75 years, we have evolved from an Italian glassware manufacturer to a leading global provider of integrated solutions for the healthcare industry focused exclusively on pharmaceutical-grade products. Our growth has been driven by the internal development of advanced drug containment and delivery solutions, increases in production capacity to support growing customer demand, and strategic acquisitions, enabling us to broaden our offering, our technical know-how and our international footprint.
Our international expansion has been carried out through a combination of acquisitions and organic expansion. We began our international expansion in 2005, with the acquisition of Medical Glass, a Slovakia based primary packaging manufacturing company. Subsequently, in 2007 and 2013, we acquired an Italian company, Optrel, and a Danish company, Innoscan, both specialized in the production of pharmaceutical visual inspection machines. These acquisitions marked our entry into the technology and equipment manufacturing business. In 2016, we pursued further expansion of our offering through the acquisition of: (i) Balda, a company specialized in developing and manufacturing plastic diagnostic consumables, drug delivery systems and medical components; (ii) Medirio, a start-up developing patents and other intellectual property for the wearable injectors business; and (iii) SVM Automatik, a company specialized in the production of high-technology machines and systems for assembly, packaging and serialization of pharmaceutical products. In 2022, Innoscan merged with and into SVM Automatik which then changed its corporate name in Stevanato Group Denmark. In late 2023, we acquired Perugini S.r.l., an Italian company specializing in the manufacturing of consumables and mechanical components for industrial machines.
In parallel with our acquisition strategy, we regularly review our global industrial operations to ensure that we have ample manufacturing capacity to match customer demand. As a result of these ongoing assessments, we continue to make investments in expansions, including through new departments, new laboratories, new offices and new plants.
Since 2008, we have launched commercial production in four greenfield sites including (i) Monterrey, Mexico in 2008; (ii) Zhangjiagang, China in 2012; (iii) Sete Lagoas, Brazil in 2017; and (iv) Fishers, Indiana, U.S. in 2024.
In addition, through brownfield expansions, we expanded capacity in Piombino Dese in 2019 to increase our syringe production, and added a new building in Latina, Italy, which began commercial production of syringes in 2023.
B.Business Overview
We are a leading global provider of drug containment, drug delivery and diagnostic solutions as well as engineering solutions to the pharmaceutical, biotechnology and life sciences industries.
We deliver an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug product life cycle from development to clinical and commercial stages. Our core capabilities in scientific research and development, our commitment to technical innovation and our engineering excellence are central to our ability to offer value-added solutions to our clients.
We have secured a leadership position within the drug product development and delivery value chain through our investment in research and development and the expansion of our global footprint and capabilities. Over our 75-year history, we have earned a reputation for high quality and reliability that has enabled us to become a partner of choice for more than 700 companies globally, including 23 of the top 25 pharmaceutical companies, and six of the top ten in-vitro diagnostic companies, as measured by 2024 revenue, according to data collected by Pharmacircle and public companies’ information. We also serve seven of the top ten biotechnology companies (by market capitalization listed in the Nasdaq Biotechnology Index), and over 100 biotechnology customers in total.
Our priority is to provide flexible solutions that preserve the integrity of pharmaceutical products and enable our customers to deliver safe and effective treatments to patients while reducing time to market, total cost of ownership (i.e., logistics, drug product waste, storage and personnel costs) and supply chain risk. We achieve this by developing our products and solutions in close collaboration with our customers, leveraging our scientific research capabilities, technical expertise, and engineering and manufacturing excellence to meet the quality and performance requirements of pharmaceutical and biotech customers.
Our solutions are highly integrated into the entire drug product product life cycle, from development, production and the commercialization processes of our customers. In addition to manufacturing drug containment and delivery
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solutions, we provide a full set of services across all stages of drug development, from pre-clinical to clinical and commercialization. We also supply engineering machinery and manufacturing equipment for the production of drug containment and delivery systems that can be integrated into both our customers’ and our own manufacturing processes, such as pharmaceutical visual inspection systems. Our involvement at each stage of a drug product life cycle, together with our comprehensive, integrated offering, enables us to serve as a one-stop-shop for our customers, which we believe represents a significant competitive advantage and makes us uniquely positioned.
The chart below illustrates our mission-critical presence across the pharmaceutical value chain.
We operate across the healthcare industry and serve some of its fastest growing segments, including biologics (such as GLP1s and peptides, antibodies, proteins and RNA-based drugs), biosimilars, vaccines and molecular diagnostics. We are closely integrated in the drug product production and delivery supply chain, and we are well-positioned to benefit from secular trends within our target industries, such as increases in demand resulting from pharmaceutical innovation, growth of biologics and biosimilars, the self-administration of medicines, aging demographics, increasing complexities in health conditions and co-morbidities, increasing global access to vaccines and advanced healthcare in developing countries, and increasing global quality standards and regulation.
Based on a market report provided by IQVIA Ltd. in 2024, we estimate the total addressable market for our current products, which primarily consists of solutions for biopharmaceutical injectables and in-vitro diagnostic products, to exceed $14 billion in 2025. Within each of these markets, we operate in some of the fastest growing segments, including pre-fillable syringes, ready-to-use vials and cartridges, drug delivery systems, molecular diagnostics and assembly equipment. We believe there are opportunities to further expand our addressable markets, including by targeting (i) complementary containment solutions, (ii) additional delivery systems, (iii) complementary engineering solutions, and (iv) aftersales support and other services.
We operate our business in two segments:
•The Biopharmaceutical and Diagnostic Solutions Segment, which includes all the products, processes and services developed and provided for the containment and delivery of pharmaceutical and biotechnology drugs and reagents, as well as the production of diagnostic consumables, medical devices and drug delivery systems; and
•The Engineering Segment, which includes all of the manufacturing equipment and technologies developed and provided to support the end-to-end pharmaceutical, biotechnology and diagnostic manufacturing processes (pharmaceutical visual inspection, device assembly and packaging, glass converting, and after sales).
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The figure below provides a breakdown of our segments, and the business lines included within each segment.
In 2025, we generated 88% of total revenue from our Biopharmaceutical and Diagnostic Solutions Segment and 12% from our Engineering Segment. The principal markets in which we operate and compete include EMEA, Asia (with a focus on China) and the Americas (with a focus on Brazil, Mexico, and the U.S.). Our two main business segments (Biopharmaceutical and Diagnostic Solutions, and Engineering), combined with our global footprint, allow us to sell products and provide services in approximately 65 countries worldwide which we achieve mostly through business‑to‑business marketing channels and selected distributors. Please see the section entitled “Item 5. Operating and Financial Review and Prospects” for a more detailed description of our revenue generating activities.
We refer to premium products in the Biopharmaceutical and Diagnostic Solutions Segment as our high-value solutions. High-value solutions are products and services for which we hold intellectual property rights or have strong proprietary know-how, and are characterized by technological advancements, process complexity, and high performance. Our high-value solutions deliver significant benefits to customers including, faster time-to-market, lower total cost of ownership, increased quality, and higher flexibility. Among our key high-value solutions is our EZ- fill® line of ready-to-use drug containers for injectable products, which can be customized to clients’ needs. For additional information on EZ-fill® see “Business—Business Segments—Biopharmaceutical and Diagnostic Solutions— Drug Containment Solutions (DCS)”.
We have 13 manufacturing plants, including (i) ten production plants for manufacturing and assembly of bio-pharma and healthcare products (in Italy, Germany, Slovakia, Brazil, Mexico, China, and the United States), and (ii) three plants for the production of machinery and equipment (in Italy and Denmark). In addition to the manufacturing plants we have two sites for analytical services (one in Italy and one in the United States) and five commercial offices in Italy, China, Japan, and India. Additionally, we are expanding our production in Piombino Dese (Italy), Latina (Italy), and Fishers (Indiana, the U.S).
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Our Industry and Growing End Market
We are a key partner to leading companies in the pharmaceutical, biotechnology and life sciences industries, serving as one of the preeminent providers of drug containment, drug delivery and diagnostic solutions as well as engineering systems to these end markets.
We estimate that our total addressable market, based on our current portfolio of products and services comprising drug containment solutions, drug delivery systems, IVD solutions, and engineering, exceeds $14 billion in 2025. Our addressable market estimation is based on data gathered by IQVIA Ltd in 2024.
Drug containment solutions and drug delivery systems represent mission-critical components of the pharmaceutical and biotechnology value chain for injectable drugs, which are produced for the treatment of a wide range of diseases from diabetes and obesity to cancer and other chronic conditions. Due to our competitive standing, we believe that we are well positioned to capitalize on several major demographic and technological trends generating growth in the global healthcare markets, including:
•an aging population globally;
•a population experiencing more complex health conditions and the increasing incidence of chronic diseases (e.g., diabetes, obesity) and co-morbidities;
•the continued innovation in biologic-based therapies which are often administered by injection and the upcoming wave of injection-based biosimilars;
•expanded access to advanced healthcare in developing countries;
•an increasing propensity of biotechnology companies to outsource non-core competencies such as washing and sterilization of drug containers; and
•the growth in the self-administration of medicines that utilize self-injection systems such as a pen injector or autoinjector that have a primary container (i.e., glass containers such as cartridge or syringe) integrated into the delivery device.
We categorize our addressable market by direct markets and end markets. Our direct markets are comprised of products and product categories in which we directly participate, such as drug containment solutions. Our end markets include the broader sectors from which we see demand for our products and services, such as biologics.
Direct Markets:
The below chart illustrates the direct markets we serve.
Drug Containment Solutions (“DCS”)
The DCS market includes the markets for pre-fillable syringes (“PFS”), standard/bulk and ready-to-use EZ-fill® vials, standard/bulk and ready-to-use EZ-fill® cartridges, ampoules, and related analytical services. Based on data collected by IQVIA, we estimate the total addressable market of DCS solutions to be approximately $4.7 billion as of 2025. We expect the market to grow at a Compounded Annual Growth Rate (“CAGR”) of approximately 8 % through 2030. Growth in the DCS market is driven by the growing number of injectable drug launches – both innovator and generics/biosimilar – and increased treatment access globally which are expected to generate continued demand for
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pre-fillable syringes, vials, and cartridges. Customers in this market increasingly seek out “ready-to-use” products which include pre-sterilized offerings and ready-to-use packaging (PFS, vials, and cartridges) that provide pharmaceutical customers with higher flexibility, lower total cost of ownership and reduced time to market. We are well positioned to capitalize on the highest-growth segments of the DCS market, with pre-fillable syringes, and ready-to-use vials and cartridges sub-segments estimated to grow at a CAGR of approximately 14 %, 16 %, and 16 %, respectively, towards 2030.
Drug Delivery Systems (“DDS”)
Our addressable market in DDS, including both Contract Manufacturing Organizations (CMO) and Contract Development and Manufacturing Organizations (CDMO), consists of pen-injectors, dry powder inhalers, auto injectors, and non-insulin on-body delivery systems. Based on data collected by IQVIA, we estimate the total addressable market for DDS, including proprietary and contract development manufacturing services, to be approximately $3.6 billion in 2025, and the market is expected to grow at a CAGR of 9% through 2030. Growth in the DDS market is driven by increased demand for pen-injectors, autoinjectors, on-body delivery systems and dry powder inhalers for large, established drug classes such as insulin, as well generics and biosimilars. The increasing prevalence of diabetes and asthma, as well as expanded access to treatments that improve patient care and flexibility support continued growth in these markets. Novel treatments for diabetes and obesity are currently sustaining demand for injectable drug delivery systems as well.
In-Vitro Diagnostic (“IVD”) Solutions
The IVD solutions market consists of diagnostic devices and consumables for point-of-lab and point-of-care use. According to IQVIA, our addressable market for diagnostic solutions is estimated to be $4.9 billion, as of 2025. The market is expected to grow at a CAGR of approximately 8% through 2030.
Our IVD solutions are mainly utilized in molecular diagnostics, immunoassays and clinical chemistry development and manufacturing. Molecular diagnostics growth is primarily driven by technological advancements, with the increasing need for sensitivity and specificity in testing. Immunoassay growth is driven by the increasing impact of infectious disease and oncology testing. Finally, clinical chemistry consists of testing conducted by established large market participants. Both growing and established companies increasingly utilize cost-efficient manufacturing partners with expertise in design and manufacturing. We increasingly target the market for molecular diagnostics within IVD solutions, which we estimate to be growing faster than the broader market for IVD solutions at a CAGR of approximately 9 % through 2030, based on IQVIA analysis.
Pharmaceutical Engineering ("Engineering")
Our pharmaceutical engineering addressable market consists of drug device assembly, visual inspection, packaging and serialization. According to IQVIA analysis, the total addressable market of pharmaceutical engineering was approximately $1.7 billion as of 2025, and the market is expected to grow at a CAGR of 8 % to 9% through 2030. This market requires critical engineering know-how developed over numerous years as well as regulatory approvals to market machinery. We believe there will be increasing regulatory scrutiny, growing trends toward more complex manufacturing systems, and a rising need for digitalization and automation of manufacturing. The market is expected to experience continued growth as the industry shifts towards enhanced service offerings and aftersales support. Consequently, aftersales services, including spare parts provisioning, machinery upgrades, periodic maintenance and warranty extensions, represent a critical portion of our growth derived from this segment. Within the pharmaceutical engineering market, we are increasingly targeting the market for assembly equipment, which we estimate to be growing at a CAGR of approximately 9 % through 2030, based on IQVIA analysis.
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Key End Markets Segment:
The key end market segments that we serve include biopharmaceutical injectables, which represent the majority of our business, as well as the rapidly growing in-vitro diagnostic sector.
Biopharmaceutical Injectables
The biopharmaceutical injectables end market comprises multiple distinct injectable drug categories such as biologics, vaccines, small molecules and generics, and insulin. Out of the over 9,000 injectable drug products in the global drug pipeline undergoing clinical evaluation or being registered, more than 60% are biologic drug products according to Pharmacircle. According to data collected by IQVIA, the market for biopharmaceutical injectables – in terms of volume of primary container standard units – is expected to grow at a CAGR of approximately 2 % through 2030.
We increasingly serve some of the fastest growing segments within biopharmaceutical injectables, such as:
•Biologics: a segment which, based on data collected by IQVIA, is expected to grow at a CAGR of over 10% through 2030 and includes (i) antibodies, including ADCs (Antibody-Drug Conjugates), the highest-value sub-segment of the biologics market, driven by multiple product launches – both breakthrough therapies and biosimilar segments – in niche and specialty markets, such as Oncology and Immunology, characterized by high unmet needs; (ii) novel protein and peptide-based therapies such as GLP-1s, a treatment originally developed for diabetes and adopted for obesity, which is one of the fastest growing therapeutic areas; and (iii) advanced therapies – including cell-based therapies, gene therapies, and RNA-based therapies – one of the fastest growing market sub-segments in the pharmaceutical and biotechnology sectors; and
•Vaccines: we have been serving the vaccine market for decades. International efforts around epidemic preparedness and broader focus on vaccine access are expected to drive continued growth in the vaccine injectables market. According to IQVIA, the injectable vaccines market is estimated to grow at a CAGR of approximately 5 % through 2030.
We also serve more mature and established markets such as:
•Insulin: where we continue to observe steady growth in insulin injectables, driven by rising incidence and prevalence of diabetes. Diabetes prevalence is expected to grow at a rate exceeding global population growth, driven by aging demographics and economies shifting from low-to-middle income status. According to IQVIA, the market for insulin-based treatments is estimated to grow at a CAGR of approximately 2% through 2030 and we are the recognized number one producer of pen cartridges; and
•Small Molecules & Generics: which according to data collected by IQVIA, is expected to grow at a CAGR of approximately 2 % through 2030;
•Other / Other Injectables: includes other injectables such as heparin and water for injection.
In-Vitro Diagnostic
In-vitro diagnostics are a growing end-market where we participate with a focus on molecular diagnostics, point-of-care diagnostics and, increasingly, infectious diseases and oncology. With an increasing number of diseases to which molecular diagnostic technology and rapid advances in genomics can be applied, the molecular diagnostics end market is expected to continue to experience growth.
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Based on market data from IQVIA, the in-vitro diagnostics end market is expected to grow at a CAGR of approximately 7% to 8% through 2030, with molecular diagnostics showing a growth rate of approximately 8% to 9%.
The following chart provides a revenue breakdown by end market for the Biopharmaceutical and Diagnostics Solutions Segment:
Our Competitive Strengths
We have secured a leadership position as a mission-critical solutions provider in the drug development and delivery value chain. Our integrated offering and track record of operational excellence has made us a partner of choice in the pharmaceutical, biotechnology and life sciences industries.
We benefit from several competitive advantages that we believe will allow us to continue to deliver value-added products and services to customers and remain at the forefront of the markets in which we operate. The following are our key competitive strengths:
Leading global provider of mission-critical drug containment, delivery and diagnostic solutions for the pharmaceutical, biotechnology and life sciences industries and a trusted partner for the production of world-class manufacturing equipment to support customers worldwide
We are a recognized leader in providing mission-critical drug containment, delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. We operate on a global scale, offering our products, processeses, and services in approximately 65 countries. We serve a large and diversified customer base, including many of the world’s largest pharmaceutical, biotechnology and diagnostics companies, contract manufacturers and producers of glass packaging. Over our 75-year history, we have earned a leading reputation for high quality and reliability that has enabled us to become a partner of choice for more than 700 customers globally, including 23 of the top 25 pharmaceutical companies, and six of the top ten in-vitro diagnostic companies, as measured by 2024 revenue, according to data collected by Pharmacircle and public companies’ information. We also serve seven of the top ten biotechnology companies (by market capitalization listed in the Nasdaq Biotechnology Index), and over 100 biotechnology customers in total.
As a partner of choice to the pharmaceutical and biotechnology industries, our solutions have been widely adopted, giving us a leading position in several high growth segments of the pharmaceutical and biotechnology injectables market, including in biologics, biosimilars and vaccines. Within each of these markets, we operate in some of the fastest growing segments, where, based on available market data, we believe we are a global top three player by revenues, including number two in pre-fillable syringes, number one in pre-sterilized, ready-to-use vials, and number one in bulk and ready-to-use pen cartridges which is the global standard for diabetes care. Our decades-long expertise in the design and development of manufacturing equipment for customers through our Engineering Segment differentiates us from our competitors, allowing us to offer comprehensive end-to-end services.
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Integrated end-to-end platform spans the drug product lifecycle, from design and development through commercialization
We offer products and solutions to our clients at each stage of the drug product development process, from research and development, through clinical trials and commercialization. Our fully integrated, end-to-end value proposition allows us to reduce lead times, total cost of ownership (i.e., logistics, drug product waste, storage and personnel costs) and supply chain risk for our customers, while improving the reliability and safety of drug products.
The breadth of our integrated capabilities differentiates us from our competitors as we believe we are the only player in the industry to be active in drug containment, drug delivery systems and medical devices, diagnostic solutions, as well as the production of pharmaceutical manufacturing equipment. Our comprehensive product portfolio makes us an attractive partner to both small, emerging biotech, which may look to outsource a portion of their manufacturing process, as well as to mature, commercial stage drug development organizations, that require complex engineering and manufacturing technologies that can be integrated into their own production processes. By partnering with customers in the early drug development phase, we are in a prime position to play a key role as they add products to their drug pipelines and seek more advanced technical solutions. Our ability to seamlessly integrate our drug containment and delivery solutions with our engineering capabilities allows us to deliver significant value to our customers by reducing lead times, total cost of ownership (i.e., logistics, drug product waste, storage and personnel costs) and supply chain risk, while improving the reliability and safety of drug products and reducing the time necessary to market them.
A common operating model in all our manufacturing facilities provides a single, consistent quality standard worldwide
Our manufacturing approach is based on the relentless pursuit of maximum efficiency and highest quality. Our manufacturing methods and processes are standardized across all of our production facilities, utilizing the same technology and implementing common quality controls. This allows us to provide uniform products, processes and services, both in terms of quality and time to market, to all of our customers from each of our manufacturing locations worldwide. It also gives us the flexibility, where needed, to distribute and balance production across our facilities reducing waste and maximizing our efficiency as a group. Many of our customers depend on a diversified supply chain and access our products and services from multiple facilities globally.
As a result of our commitment to manufacturing excellence and the breadth of our footprint, our customers view us as a functional extension of their operations. We are subject to rigorous audits by certification bodies and our customers, who perform more than 180 audits a year on our manufacturing facilities. Further, given our reputation for reliability and our ability to establish new manufacturing facilities with the same standards as our existing ones anywhere in the world, our customers often coordinate with us to support their regional and global demand and supply chain needs. We strive to match these demand needs through modular geographic expansion. This, in turn, provides us access to customers and allows us to further secure our long- term relationships with them.
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Highly collaborative approach resulting in deeper strategic partnerships with clients and leading to high customer retention
We approach every customer relationship with the goal of partnering and adding value over a long-term horizon, leveraging our technical expertise and our ability to collect analytical data to fully understand our customers’ objectives, needs, and limitations. Drug containment and delivery solutions are often borne out of years of collective effort with customers to develop the optimal manner of containing and delivering a drug product to patients. The customized solutions we provide vary depending on the characteristics and chemical composition of the pharmaceutical products, logistical needs (for example, ease of transport and shelf- life), patient community to which the drug product is primarily addressed (including, potentially, its geographic location) and specific regulatory requirements. The containment and delivery solutions that we provide are an integral part of the drug product itself and are included as part of the regulatory filings required to approve drug product marketing and commercialization. Providing high-quality products with specificity, sensitivity and consistency, coupled with extensive product validation data are fundamental drivers of customer loyalty. The quality and dependability of our drug containment and delivery solutions are critical to obtaining commercialization and marketing approval from regulatory agencies. As a result, it is often the case that drug product containment and delivery arrangements cannot be changed without amending the regulatory filing with the relevant agency. High switching costs and significant time delays are meaningful deterrents to a change in suppliers, which reinforces customer loyalty and strengthens customer retention. Extensive scientific and engineering capabilities enable continuous innovation of proprietary products and processes.
During our 75-year history, we have differentiated our company from others by making significant ongoing investments in research and development to build our scientific, technical and engineering capabilities. We believe that customers rely on us because of our technical expertise, as well as our ability to design high quality containment formats with the best possible processes to meet their needs and the specifications required to effectively contain and deliver their specific drug products. As the needs of our clients evolve, we drive innovation within our proprietary products and processes to develop specialized or customized solutions. As a result of our investments in internal engineering capabilities, we own the most critical processes behind the drug containment products we manufacture and can respond faster to customer needs for new or customized products. Our engineering capabilities also allow us to scale up our production rapidly, where required, thereby reducing lead times for commercialization of drugs. Our research and development team is comprised of approximately 150 highly skilled and specialized employees based in our facilities in Italy (Piombino Dese and Milan), Germany (Bad Oeynhausen) and the U.S. (Boston). We have an active pipeline of approximately 80 ongoing R&D projects. Our targeted investment in innovative products and technologies allows us to capture incremental pipeline opportunities and drive attractive growth, while delivering on our firm-wide commitment to provide the highest quality to customers.
Experienced board and executive leadership team with proven track record of excellence
We are led by an experienced and highly motivated Board of Directors and executive leadership team with a proven track record of operational excellence. Our leadership team must anticipate and respond to market developments and capitalize on opportunities for organic and inorganic growth. While our founding family continues to support our success and future growth, we have, over the last several years, added to our Board and executive team a number of professionals with decades of experience in the pharmaceuticals and life sciences sectors, with a particular emphasis in drug containment and packaging, delivery and diagnostics industries from all over the world. We believe that this has contributed greatly to our long-term strategy of moving up the value chain and boosting our execution capabilities by allowing us to gain a broader and more nuanced understanding of the markets in which we operate, strengthening our ability to anticipate market trends and enhancing our competitive advantages. Our strong corporate culture allows us to continuously expand these perspectives by adding diverse talent with deep knowledge and broad experience to our team.
Our Growth Strategy
We believe that the breadth and quality of our products and services offerings, our technical understanding of the drug-material interface, our innovative engineering and manufacturing excellence, positions us well to serve our global pharmaceutical, biotechnology and life sciences customers. We believe that our integrated solutions resonate with our customers, and we work with customers to move them up the product value chain as they bring new treatments to market that require more complex, integrated solutions. We believe that we will continue to benefit from favorable macro trends such as aging demographics, with more complex health needs; pharmaceutical innovation and the
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growing demand for biologics and biosimilars; increasing quality to meet market expectations and higher regulatory demands; and an increasing trend towards outsourcing non-core functions by our customers which helps to reduce the total cost of ownership for a treatment, increase flexibility and reduce the time it takes to get a new treatment to market.
We focus on our customer needs and the market trends described in the “Our Industry and Growing End Market” section and tailor our growth strategy to such needs and trends.
Our growth strategy currently focuses on the following areas:
Expand our global market position in primary containment solutions and grow our mix of high value solutions
We pursue attractive, organic growth trends in our core primary container business by investing in additional capacity to meet the growing demands of the expanding pharmaceutical, biotechnology, and life sciences markets. As more complex treatments are developed, customers are transitioning up the product value chain to high-value solutions which offer superior quality and performance. In response to customer demand trends, our current geographic and capacity expansion plans are mainly focused on investments in our high-value solutions product portfolio. We rely on a unique set of proprietary manufacturing processes to drive product innovations in our primary container business that benefit our customers. For example, EZ-Fill® containers enable our customers to reduce the time necessary to market a drug, while lowering their overall total cost of ownership. We reduce our supply chain risk by expanding our development capabilities and manufacturing capacity in North America, Europe and Asia to better serve our customers in our key end markets and meet the demand for high-value solutions. We believe we will be able to continue developing our offering, particularly in biologics, to generate above-market growth and capture market share across our business segments. Our ongoing expansion in Italy, and the U.S. offers our customer base faster response time and supply chain redundancy, reducing risk for just in time manufacturing.
Leverage leadership in primary containment and engineering solutions to build market position in drug delivery systems
We see a significant opportunity in the fast-paced evolution of drug delivery systems, especially in connection with biologic based therapies administered by injection as patient adoption continues to grow. We believe that we can leverage this favorable trend in the drug delivery systems market by investing in and strengthening the integration of our drug containment solutions, engineering expertise – specifically, assembly and packaging technologies – and drug delivery capabilities in an effort to have the most compelling value proposition for our customers. In particular, we believe that by increasing the integration of our offering we can attract business from emerging biotechnology customers who have an increasing inclination to outsource the non-core phases of their development and manufacturing processes. We continue to strengthen our design and development capabilities to secure high-value contract development and manufacturing programs for drug delivery devices, also leveraging our positive track-record in the space and our ability to develop and acquire proprietary systems. We believe we offer an efficient value proposition through our fully integrated end-to-end product solutions that offer customers the ability to streamline their DDS manufacturing and assembly through a single partner.
Ongoing investments in research & development to address unmet market needs
Through continued investment in our R&D programs, we see opportunities to leverage our scientific and technological capabilities to drive revenue and margin growth through processes that improve the quality and sustainability of our existing products. These investments are targeted at maintaining the stability, potency and purity of our customers’ products prior to administration. New therapies for diabetes, cancer and auto-immune diseases are based on large, complex molecules that are extremely sensitive to their storage environment. In many cases, our customers’ finished product formulations are viscous and require drug delivery devices for administration to patients. Our products, such as EZ Fill®, reduce our customers drug containment risks, such as the ones mentioned above. We also see growing interest within our customer base in systems that detect tampering, anti-counterfeiting, inventory track and trace capability, and in the case of devices, smart systems that allow patient data capture.
Easy-to-use, accurate, reliable self-injection systems for complex pharmaceutical and biotechnology products represent a particularly attractive market opportunity. We have built a portfolio of devices for this market that can be used off the shelf or customized to the specific needs of the customer.
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We also see a growing market need for innovative containment and delivery systems for advanced therapies, including cell and gene therapies. Effective solutions for these products will require innovative materials and coatings, system design and stability and compatibility testing, all of which are areas of strength for our development teams.
Build on our expertise in manufacturing, assembly and inspection systems for primary containers and complex, multi-component systems
Our market leading expertise in the design and manufacturing of glass converting systems for drug containment offers the opportunity to grow in complex, multi-component systems. Working closely with our customers, we can offer custom designed systems complete with artificial intelligence-enabled vision inspection technology to assure the highest quality products. The enhanced scalability and flexibility of our assembly and packaging solutions are well suited to match emerging biotechnology customers’ requirements such as smaller production batches with higher variability in dosage formats. We see future opportunities to apply these solutions to manufacturing multi-component devices for in vitro diagnostics, including point-of-care and self-injection devices for pharmaceutical and biotechnology customers.
Leverage our scientific and engineering capabilities across the drug development timeline
We have created an integrated, end-to-end, flexible portfolio of products, processes and services that offers early entry in the drug development stages. We collaborate with customers from the preclinical phase through Phase III testing, regulatory filing and eventual commercialization. We believe that our ability to assist from the early stages of preclinical development is an important element in pursuing the opportunity to gain new customers.
Such close collaboration allows us to leverage our scientific and engineering capabilities to strengthen and expand our business relationships. By assisting customers through their production processes, we gain the visibility and knowledge that, combined with our skills and capabilities, allow us to anticipate their emerging needs and intercept new demands. We address these needs by continuing to expand our product offering and making new solutions available. Through close collaboration with our customers, we gain invaluable insight into system requirements and industry trends and challenges, which we re-deploy for our future development projects, or to secure new business. For instance, we intend to pursue new opportunities driven by the trend of biotechnology companies toward outsourcing non-core activities of their business.
Leverage our global geographical presence as a platform to increase our penetration in the North American and Asia Pacific regions
The North American and APAC regions are two of the fastest growing markets and represent significant growth opportunities for our Company. Both markets have well established research and manufacturing capabilities for biologic therapies covering both innovator and biosimilar products. We launched commercial production in our new plant in Fishers, Indiana in 2024 where we are currently ramping up capacity. We have a relatively small but rapidly growing position in APAC, where we believe we can accelerate our recent growth by further expanding our manufacturing footprint. By providing locally sourced products, we believe we can deliver supply chain security, just in time delivery, and reliable sourcing in terms of surge capacity to both existing and new customers. For example, our plant in Indiana (U.S.) represents a strategic location for us in proximity to key emerging biopharma players, enabling us to access an attractive biologics market. We believe that we are well-positioned to expand our footprint and market share in the North American and Asia Pacific regions. In an effort to grant access to treatments to a higher portion of their population and, therefore, improve their quality of life, APAC countries are showing a consistently growing demand for biologics, biosimilars, and cell and gene therapy solutions. We believe that our global footprint will allow us to take advantage of these favorable growth trends. We intend to further invest in the North American and APAC regions to increase our market penetration in these regions across the business segments in which we operate.
Selectively pursue acquisitions and technology partnerships to augment and expand our product and service portfolio
Our acquisition strategy is opportunistic and focused on adding complementary or adjacent offerings. We have a proven track record of successfully identifying, completing and integrating newly acquired complementary businesses and technologies. Our extensive knowledge of the competitive landscape and deep understanding of the evolving
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needs of our customers and end markets enable us to identify actionable opportunities to expand our portfolio. We employ a disciplined process to evaluate the strategic fit and financial prospects of acquisitions using a well-established set of criteria.
Business Segments
Our business operations are organized into two reporting segments: (i) Biopharmaceutical and Diagnostic Solutions, which includes all the products and services developed and provided for the containment and delivery of pharmaceutical and biotechnology drugs and reagents, as well as the production of diagnostic consumables, and (ii) Engineering, which includes all the equipment and technologies developed and provided to support the end-to-end pharmaceutical, biotechnology and life sciences manufacturing processes (visual inspection, assembly, packaging and serialization and glass converting). In 2025, we generated 88 % of total revenue from our Biopharmaceutical and Diagnostic Solutions Segment and 12 % from our Engineering Segment.
Biopharmaceutical and Diagnostic Solutions Segment
Through our Biopharmaceutical and Diagnostic Solutions Segment, we offer a wide range of development and manufacturing solutions to our pharmaceutical, biotechnology and life sciences customers. This segment comprises drug containment solutions (DCS), in-vitro diagnostic (IVD) solutions and drug delivery systems (DDS). We also provide analytical services and regulatory support exclusively to our customers, as ancillary services to the supply of containment and drug delivery solutions.
The Biopharmaceutical and Diagnostics Solutions Segment includes our high-value solutions. These solutions are products, processes, and services for which we hold intellectual property rights and have proprietary know-how and are characterized by particular complexity and high performance. Our high-value solutions represent a cross-section of our portfolio, including glass drug containment solutions such as NEXA®, LDP, ALBA® and a significant proportion of our EZ-Fill® line, as well as other drug delivery devices, molecular diagnostic solutions and analytical services.
Due to the technical complexity of our high-value solutions, and the significant value these generate for our customers, we enjoy premium pricing on these products, services and processes. Over time we have expanded our offering of high-value solutions, enabling us to drive significant growth from this category. Over the last five years, revenue from our high-value solutions has steadily grown and represented 46% of our total revenue for the year ended December 31, 2025.
By developing high-value solutions using our proprietary intellectual property, we are able to create unique and innovative products, processes, and services that can be used across different clients. For example, our “high- value” drug containment solutions, such as ALBA® and NEXA®, are particularly well-suited to address the needs of customers in the biologics end market, as they:
•reduce drug product waste in the pharmaceutical process by increasing the mechanical resistance of the containers;
•maintain the integrity of drugs through reduced presence of extractables, leachables and visible / sub-visible particles in the containers;
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•minimize the interaction between the container and the drug;
•optimize the administration of biologics to patients, particularly with systems for the administration of viscous biologics products; and
•seek to reduce the total cost of ownership for customers’ treatments.
The strong relationships we have developed with our customers and our ability to work alongside them across each stage of the drug product development process, from pre-clinical to clinical stage and commercialization, allow us to understand their specific needs at an early stage of the drug product development and production process and provide appropriate solutions for such needs. Our strong relationships, our ability to provide a full set of solutions across the drug product development process, and our expertise in developing and assembling machinery and equipment for the production of drug containment and delivery systems make us a partner of choice for our customers.
Drug Containment Solutions (DCS)
DCS are mission-critical components in the production of pharmaceutical and biotechnology products. Our drug containment systems are complex and rely on multiple sophisticated industrial processes to form, treat, inspect and package these products. We provide high-value DCS in pharmaceutical grade glass. We believe that the breadth and variety of our DCS offering represents one of our key competitive advantages. Our portfolio of DCS products includes:
•Pre-fillable Syringes (PFS): a wide range of sterile ready-to-fill (EZ-Fill®) syringes, available in a range of sizes from 0.5 ml to 5 ml with staked needle, Luer cone or Luer lock adapter, and bypass syringes or double-chamber systems. We also offer bulk syringes, which are available with or without staked needle;
•Cartridges: a diversified offering of cartridges with bypass and multi-bypass systems (i.e. double and multi-chamber system) suitable for both liquid and powder formulations, for the pharmaceutical, biotechnology and dental sectors. Cartridges are offered both in ready-to-use EZ-Fill® and bulk formats;
•Vials: a broad range of vials, differentiated by size and capacity as well as ready-to-use EZ-Fill® and bulk formats. Our vials can be fully tailored to meet the different needs of pharmaceutical and biotechnology customers, including special formats such as micro-vials; and
•Ampoules: a wide spectrum of ampoules.
High Value Solutions: Our DCS portfolio comprises several innovation-driven “high-value” solutions, illustrated below:
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Our most innovative DCS solutions, some of which include integrated safety systems, are:
•EZ-fill®: EZ-fill® solutions are ready-to-fill products that are provided to our customers after having already been washed, depyrogenated and sterilized in-house. We believe our EZ-fill® solution positions us well, as it allows us to provide maximum value to our pharmaceutical and biotechnology customers by: (i) reducing their capital investments in washing and sterilization equipment; (ii) being flexible and processable across different containers (i.e., syringes, vials, cartridges) on the same filling line; (iii) guaranteeing no glass-to-glass contact between different containers; (iv) delivering fewer breakages in the filling process of our pharmaceutical and biotechnology customers; and (v) being completely compatible with existing filling lines, in order to minimize disruption for customers. As the developers of EZ-fill® systems, which we first started producing in 2007, we believe that our manufacturing technologies are the industry standard for ready-to-fill vials and cartridges, with more than 400 fill & finish lines capable of processing ready-to-use vials, and over 200 fill & finish lines capable of processing ready-to-use cartridges.
•Nexa®: an innovative DCS solution for pre-fillable syringes, cartridges and vials providing high mechanical resistance which is ideally suited for use with an auto-injector and a superior cosmetic quality.
•Alba®: Launched in 2019, our Alba® platform is an innovative DCS solution for pre-fillable syringes, cartridges, and vials targeting protein (biologics) and RNA-based drugs (biologics). The Alba platform helps to minimize adsorption, aggregation and inorganic extractable interactions, enabling a significant reduction in silicone particles.
In-Vitro Diagnostics (IVD) solutions
Within the life sciences industry, we operate as a contract design manufacturing organization (CDMO) and contract manufacturing organization (CMO) focusing on customized diagnostic consumables for both Point of-Lab
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and Point-of-Care applications, as well as complete component sets for IVD systems. These products are used globally across laboratories, hospitals, primary care facilities, and in-home-care settings.
The life sciences sector is complex as it requires constant cooperation with each customer for the development of the specific products they need. We support the industrialization process by providing the required manufacturing environments, qualifying molding and assembly sets, developing efficient logistical flows, and establishing a robust supply chain. During the commercial production phase, we utilize proven manufacturing services and quality controls as well as on-going product-lifecycle-support to develop long-term customer relationships.
Drug Delivery Systems (DDS)
Our DDS portfolio includes three proprietary product platforms and Contract Manufacturing (CMO) service categories:
•Autoinjectors: high-value, disposable devices containing a pre-filled syringe enabling an intuitive single-dose injection of medication. Applicable to GLP-1’s, biologics and other drug products. Some highlights include:
•Aidatpus® is a 2-step, disposable autoinjector platform that can accommodate both 1mL and 2.25mL pre-filled syringes in the same form factor.
•In March 2022, we entered into an exclusive collaboration agreement with Owen Mumford for the joint manufacturing and commercialization of the Aidaptus® autoinjector platform.
•The collaboration aims to provide customers with a unique value-adding solution combining world-class device expertise, an established global manufacturing capabilities, market-leading primary container solutions, and assembly equipment.
•Both organizations have active customer engagements; the lead program is expected to launch in 2027.
•Pen Injectors: disposable devices with variable or fixed dose selection that contain a pre-filled cartridge and require user attachment of the needle. Extensively used in diabetes treatments and, more recently, adopted for broader range of therapies, including weight management treatment with GLP1 applications. Some highlights include:
•The Group’s pen injector portfolio features two devices: Alina®, a variable dose pen injector, and Deora™, a fixed dose pen injector. Both devices are disposable and compatible with standard 3mL glass cartridges.
•In 2019, the Group signed an exclusive licensing agreement with Haselmeier for use of Axis-D technology, which is the basis for the Alina® pen injector platform. In January 2022, we extended this agreement to enable platform customization for a broader range of therapeutic areas, including obesity, cardiovascular diseases, gastrointestinal disorders, pain management, neurological disorders, and arthritis.
•In January 2026, we announced the introduction of Deora™ as the latest internally developed device added to our portfolio.
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•We currently have several active customer engagements across both GLP-1 and non GLP 1 therapeutic areas; for Alina® we are approaching the final regulatory phase in 2026.
•On-Body Delivery Systems: semi-reusable wearable patch injection devices that enable the delivery of large volumes and/or controlled dosing of medication over extended durations. Relatively novel technology potentially applicable to a wide range of therapies. Some highlights include:
•Vertiva® is Stevanato Group’s on-body delivery system platform that is pre-loaded with either 3mL or 10mL pre-filled glass cartridges. Composed of a single-use injection unit and multi-use electro-mechanical controller.
•In 2023 we announced a strategic collaboration with Thermo Fisher Scientific who will provide fill-and-finish and final assembly services related to Vertiva®.
•We currently have several active customer engagements that range from platform evaluations to development programs.
•Contract Manufacturing: design, industrialization and manufacturing services for customer-owned drug delivery devices. Some highlights include:
•The Group provides CMO services specializing in DfX activities to ensure robust, repeatable manufacturing processes including high-precision injection molding and assembly.
•We have experience in sourcing, operating & managing automation equipment from a range of leading suppliers as well as our own internal resources.
•We currently have several active customer engagements for customer owned pen injectors, autoinjectors, inhalers and other complex devices, leveraging our comprehensive manufacturing network in the United States and Europe.
Analytical Services and Regulatory Support
We have two Technology Excellence Centers (TECs) for analytical testing, in Piombino Dese, Italy and Boston, Massachusetts focused on investigating the physical and chemical properties of primary packaging materials and components, and the functional characterization of drug delivery devices. By studying the interaction between drug containment solutions and drug products, we provide valuable data to customers toward the definition of the optimal drug containment or delivery solution. This allows us to engage with our clients earlier in the development phase of their drugs and position ourselves well to become a supplier for their containment solution and potentially their drug delivery systems and related process equipment.
The containment and delivery solution that we provide is an integral part of the drug product itself, and it is included as part of the regulatory filings required before commercialization. We also assist our customers in this phase of their drug product development by providing the analytical and scientific support required to obtain the relevant regulatory authorizations.
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Our key analytical services, supported by our regulatory know-how, include:
•Primary Container Compatibility and Functionality with Drug Product: this series of characterization protocols and methodologies aim to fully understand how the primary packaging behaves in the presence of the drug product and/or under specific applications or conditions with a deterministic approach;
•Drug Delivery System Testing: extensive testing to ensure the robustness of product functionality (device compatibility, functionality, engineer, and design verification testing) and ease of use;
•Developmental (Not For Human Use) Fill & Finish Service: small, flexible Fill & Finish equipment to perform preliminary work on drug product, process, or container optimization;
•Consultancy (Regulatory, Compliance Support, Test Method Development & Transfer): ensuring all the technical, regulatory, and documental support for developing a drug product throughout its life cycle;
•Tailored Services: customized testing based on the specific need of each client.
Engineering Segment
Our Engineering Segment produces machinery for both in-house use and sale to customers. In our Piombino Dese (Italy), Bologna (Italy) and Silkeborg (Denmark) plants, we produce equipment and machinery for all phases of the glass production process, as well as for the assembly of medical devices and for the inspection of primary containers. We drive continuous technological advancements so that our equipment can consistently meet our client’s exact specification requirements. Our engineering services span all phases of the machinery production process from development and design, including the development of software and artificial intelligence models, to construction, assembly and testing. With approximately 90 specialists and technicians located worldwide, we provide after sales support to our customers with interactive tools and technical expertise, to ensure performance of their production sites. We are currently engaging in initiatives to consolidate our engineering operations in order to streamline our operations and improve operational efficiencies.
Our engineering products include:
•Assembly & Packaging Equipment: we provide GMP-compliant automation technology for assembling and packaging pharmaceutical products, such as drug delivery and medical devices. Our modular drug and medical device assembly solutions are engineered to meet the current market needs and deliver precision assembly of a wide variety of medical devices, including pen injectors, auto-injectors, nasal sprays, inhalers, and, on-body delivery systems. Our assembly equipment is highly automated and includes extensive in-line controls around product safety and functionality. Our secondary packaging solutions include cartoning machines, packaging machinery, and palletizing modules thereby ensuring traceability through serialization.
•Pharmaceutical Visual Inspection Equipment: we provide pharmaceutical visual inspection manufacturing lines for ampoules, vials, cartridges, syringes or bottles, filled with clear or opaque liquids, emulsions, viscous gels, lyophilized products and other difficult-to-inspect solutions. Our diversified portfolio of products, which includes manual, semi- automatic and high-speed automatic equipment, also
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featuring artificial intelligence, allows us to deliver flexible inspection solutions at any stage of the product life-cycle, from lab development to high volume production;
•Glass Converting Equipment: we develop and own the technology required to convert glass tubing in our core drug containment products within our BDS Segment. These manufacturing lines are fully automated, high-speed, precision glass forming lines that produce accurate processing of ampoules, vials, cartridges and syringes. To cover all steps of production, we also manufacture glass tube loaders, after forming lines and annealing ovens.
•After Sales Support Services: We also provide customized after-sales service for optimal machine maintenance, performance, and utilization. Our comprehensive post-sales support offerings include maintenance support, line optimization and line conversions, training, spare parts and logistical services, and digitization leveraging AI.
As a result of the experience gained designing our greenfield plants in Italy, China, Mexico, Brazil, and the United States, our offering includes support and consultancy around: (i) plant design, (forming lines, clean room areas and laboratory layout); (ii) plant construction (production flow, piping and instrumentation diagrams); and (iii) plant engineering (preliminary plant studies).
Customers
We serve a large and diversified customer base of more than 700 companies worldwide, including many of the world’s largest pharmaceutical and biotechnology companies, life sciences companies, drug product and fill and finish contract manufacturers.
Our customer base includes 23 of the top 25 pharmaceutical companies, and six of the top ten in-vitro diagnostic companies, as measured by 2024 revenue, according to data collected by Pharmacircle and public companies’ information. We also serve seven of the top ten biotechnology companies by market capitalization in the Nasdaq Biotechnology Index and over 100 biotechnology customers in total.
Drug containment and delivery solutions are an essential element in our customers’ manufacturing processes but generally represent a small fraction of the total cost of producing drugs. We therefore believe our customers choose our products, processes and services based on quality, reliability, innovation, speed to market and consistency rather than on costs.
We seek to maintain high levels of engagement with our customer base in order to deepen our relationships over time. These customer relationships are often supported by multi-year contracts which may contain cost pass-through provisions and have resulted in large recurring revenue streams. We engage with our customers through a variety of touchpoints, including direct visits, third-party and proprietary educational events, webinars, digital and social media communication channels designed to gauge consumer satisfaction with our products, technologies and services.
In 2025, our ten largest customers accounted for 53.6% of our consolidated revenue, and one customer accounted for 12% of consolidated revenue.
Customer Categories
We believe that quality, breadth of services and innovation are the main factors enabling us to deliver significant value to our customers, making us a partner of choice for them. Our main customer categories include:
Pharmaceutical and Biotechnology Companies
Our pharmaceutical and biotechnology customers include large, international companies, as well as smaller, regionally focused companies and manufacturers. We provide a diverse range of products, processes and services to these customers, both within our Biopharmaceutical and Diagnostic Solutions and our Engineering Segment. These products include drug containment such as syringes, cartridges, and vials, drug delivery systems such as pen injectors and contract manufacturing for devices in our BDS Segment, as well as manufacturing lines for pharmaceutical visual inspection, and device assembly and packaging within the Engineering Segment. Over time, we have invested in developing innovative products, services and solutions to serve pharmaceutical and biotechnology customers, which
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has enabled us to form long lasting relationships underpinned by the reliability and quality of our offering, processes and services.
The validation process for suppliers of pharmaceutical and biotechnology solutions, for drug containment, drug delivery systems and engineering technologies requires rigorous evaluation of multiple quality and compliance criteria and can sometimes last several years.
For this reason, we believe that we are well-positioned to enjoy durable long-lasting relationships with our customers, as we are deeply embedded in their production processes.
Life Sciences Companies
Our main life sciences customers are in-vitro diagnostic companies. We provide life sciences companies with contract development and manufacturing (CMO and CDMO) services for the plastic consumables used in their diagnostic tests and containment solutions for their reagents as well as machinery for the production, assembly and visual inspection of such products.
Drug Product / Fill & Finish Contract Manufacturers
We provide our solutions to drug product / fill & finish contract manufacturers. We provide these customers with glass and plastic containers as well as engineering solutions for the assembly, visual inspection, secondary packaging and serialization of their products.
Customer Service
We have a customer service team that works in parallel with the sales, supply chain, operations, technical and quality teams at our plants to collect feedback at every stage of our production process. Our centralized customer service is headquartered in Italy to ensure that our global team of customer service professionals applies consistent processes and procedures to guarantee high-quality and superior service levels.
Customer Contractual Arrangements
We have different contractual arrangements for different business segments. In our Biopharmaceutical and Diagnostic Solutions segment, many of our relationships with our customers are governed typically by master supply agreements the terms of which apply to each purchase order or product schedule through which customers place their request for the supply of our products. These are normally multi-year contracts generating consistent and recurring revenue streams, often times over the life cycle of a drug. We negotiate different master supply agreements with each customer and, although similar, there are no standardized terms across all agreements. Many of our agreements contain provisions which allow us to pass through cost increases from raw materials, logistics or energy.
Sales in our Engineering segment relate to individual machinery and contracts and are therefore negotiated on an individual basis. Pursuant to these equipment sale agreements, the intellectual property rights developed during the production of the relevant equipment and services remain our exclusive property save for cases of co-development with our customers.
Backlog
Our backlog represents, as of a point in time, estimated future revenue for work not yet completed under (i) specific purchase orders, with regards to our Biopharmaceutical and Diagnostic Solutions Segment; and (ii) certain one-off agreements, with regards to our Engineering Segment. As of December 31, 2025, our total backlog was approximately €871 million compared to approximately €853 million as of December 31, 2024
In our Biopharmaceutical and Diagnostic Solutions Segment we generally aim to operate under long-term supply and/or framework agreements. Our backlog represents, as of a point in time, estimated future revenues from work not yet completed under specific purchase orders.
In our Engineering Segment we generally have one-off agreements and our backlog represents, as of a point in time, estimated future revenues from work not yet completed under those agreements.
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To the extent projects are delayed, accelerated, or changed the timing of our revenue could be affected. If a customer cancels or modifies an order, we may be reimbursed for the costs and often for the missing profit we have incurred. For orders that are placed inside a contractual firm period, we generally have a contractual right to payment in the event of cancellation. Fluctuations in our reported backlog levels also result from the timing and order pattern of our customers who often seek to carefully manage supply chain risk and their level of inventory on hand. Because of customer ordering patterns, our backlog reported for certain periods may fluctuate and may not be indicative of future results.
Competition
We compete across a broad spectrum of products, processes and services for integrated containment and delivery solutions as well as engineering solutions. The breadth of our integrated capabilities differentiates us from our competitors as we believe we are the only player to be active in both the drug containment and delivery systems and engineering segments. We maintain constructive relationships with our competitors and in some cases, we acquire production inputs for our primary packaging from them. Similarly, we sell our equipment and machinery and license certain intellectual property rights to competitors for use in their production processes.
Given the breadth of our offering, we have different competitors for different products, and we consider the main competitors in each segment to be:
•Drug Containment Solutions: Schott Pharmaceutical Systems (bulk and ready to use vials and cartridges, pre-fillable syringes), Becton Dickinson and Wego (pre-fillable syringes), Nipro and Gerresheimer AG (bulk and ready-to-use vials and cartridges, pre-fillable syringes);
•Drug Delivery Systems: SHL, Ypsomed, West Pharmaceutical Services and Becton Dickinson;
•Contract Development and Manufacturing: Jabil Packaging Solutions, Flex, Phillips Medisize, Gerresheimer AG, and West Pharmaceutical Services; and,
•Engineering: Syntegon, Korber, ATS, IMA, Brevetti CEA and Mikron.
Marketing
We market and sell our products both directly and, to a lesser extent, through a limited number of third-party partners globally.
Our salesforce is organized both vertically, by geography (regionally in the Americas, EMEA and APAC) and key accounts, and horizontally, by business activity (technical pre-sales, product managers, aftersales and business development). Our sales team, of approximately 190 employees, works closely together in each area and region to ensure a coordinated approach.
We typically establish and maintain long-standing, direct relationships with all our customers and our salesforce proactively engages with our current and prospective customers to continuously share information and evaluate their needs, so that we may tailor our solutions in real time. Additionally, we host a series of events such as our Innovation Day and Pharmapack Symposium to provide a forum for collaboration and exchange of ideas with our customers. We work with and learn from our customers, and we develop products around their specific needs to address requirements and market demands.
Manufacturing, Facilities, and Supply Chain Overview
Our Approach to Manufacturing
Our manufacturing approach is based on the relentless pursuit of maximum efficiency and highest quality. We implement top of the line hardware and software solutions to deliver consistent quality standards, in an attempt to minimize human impact in the production chain. Our manufacturing methods and processes allow us to provide consistent products, processes and services, both in terms of quality and time to market, worldwide. Our proactive, data-driven approach to manufacturing together with our careful oversight allows us to mitigate the risk of quality
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issues to customers, thereby reducing additional costs for them and us. At all stages of our manufacturing process, we strive to preserve the integrity of the drug product containers to safeguard the integrity of medicines and protect the safety of patients.
Our ultimate goal is to achieve “zero quality issues” by delivering products and services that never fall short of client specifications, and by operating a quality system capable of preventing a sub-standard product from ever being delivered to our customers.
RAFT (Right At First Time) execution, respect for deadlines and flawless processes enable us to achieve very high customer satisfaction, while fostering loyalty and enhancing our reputation. Moreover, the combination of our scientific skills and engineering capabilities, makes us a unique player in the market, enables us to minimize waste and maximize efficiency.
Digitalization along the manufacturing chain paves the way to make processes faster and more efficient and reduce defective products. Continuing technological innovation allows us to improve process robustness and increase output. By integrating different production steps like injection molding and assembly, we have successfully eliminated intermediate stocks, thereby realizing significant cost savings.
Our glass manufacturing process for the formation of our primary packaging, drug containment solutions such as syringes, vials, and cartridges consists of four main steps:
(i)Forming: the glass tubes are cut into sections to form the primary packaging. Each glass tube is diverted into forming machines and shaped through a system of flames, blown air and tooling to create the primary packaging;
(ii)Treatment: to ensure the solidity of the freshly formed glass products, they undergo a heat treatment and are cooled in a controlled way inside a tunnel furnace known as an annealing lehr. Various treatments to achieve surface protection, water-repulsion or enhanced anti-friction are available to increase the products’ resistance;
(iii)Inspection: each item is checked using various inspection techniques depending on the product and customer requirements. Quality controls during the production process are strict and range from visual inspection, 100% dimensional controls, and other laboratory tests. Such strict quality controls are required for us to meet our customers’ requirements in terms of dimensional precision, mechanical resistance, functional features, visual aspect (cosmetic defects below specification thresholds) and chemical stability. Our inspection techniques include visual, mechanical, video and light beam technology;
(iv)Packaging: as they leave the production line, the drug containment products enter into a clean room (ISO 8 environment) and are packaged. Typically, the products are then placed on pallets and labelled to ensure traceability. Our advanced traceability system allows us to identify and isolate products potentially impacted by a quality issue, minimizing the quantities at risk and the associated impact.
Our EZ-fill® process for syringes, vials, and cartridges consists of five main steps:
(i)Drug Container washing: the drug containers are washed through a process of using “water for injection” to clean them from both particles and microbiological standpoint;
(ii)Inner barrel siliconization and closure assembly (syringes and cartridges): a siliconization treatment is applied to ensure final user functionality of the system during injection. Closure is then assembled to preserve the drug product up to the use;
(iii)Container inspection: by means of automatic inspection system, critical to quality attributes are checked to assure full compliance to specifications;
(iv)Packaging: nesting, tub insertion, tub and steribag sealing operations are automatically performed to obtain a final packing which, once sterilized, will preserve sterility and protect the content during shelf life of the product;
(v)Palletizing: the product is then placed in specific boxes and onto pallets to be shipped to the external sterilization service provider.
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Following the washing phase, the process is in an ISO 5 environment through final packaging. The in-process and quality controls for batch release are performed through specific control plans.
Our In-vitro Diagnostics, Medical Solutions and Drug Delivery Systems manufacturing process consists of six main steps:
(i)Development: As part of our product development activities for DDS and IVD we focus our proprietary platforms and CDMO business on design for manufacturing and process engineering for tooling/molding and assembly. Our facility in Germany serves as the launching site for such products we develop and cover the range from prototype tooling to high cavities and manual to fully automated assembly;
(ii)Injection Molding: this is one of our core competencies within In-vitro Diagnostics, Medical Solutions and Drug Delivery Systems and the majority of production is in Germany and the U.S. At this phase, the relevant mold is set up, the injection molding machine is prepared with the appropriate process parameters, plastic granule is dried and/ or conditioned, and the production is setup according to pre-defined production specifications. Then, the injection mold process is started under validated status. The molds allow the production of up to 128 parts in a single cycle, which can last between 4 and 30 seconds;
(iii)Assembly: injection molded components can be assembled among themselves or with rubber, glass, metal, or electronic components. Assembly processes could be carried out manually, but are almost entirely automated;
(iv)In-line Inspection: based on a risk analysis, all process steps in the value chain are validated, and the appropriate quality control measures are established before production starts in the industrialization phase. In the case of fully automated assembly or packaging, test steps are integrated into the automation process. At this phase, a variety of optical, tactile and electrical tests are carried out;
(v)Quality control: this is an essential part of the production process. We carry out inspections in the form of in-process controls and/or statistical controls. Different procedures such as mechanical tests (forces, torques), dimensional tests, optical tests, etc., are carried out to ensure that only products that meet the required specifications are delivered; and
(vi)Packaging: the final process step is the packaging of the product into primary, secondary or tertiary packaging. Foils, blisters or printed cardboard are used for this purpose. Instruction manuals in different languages are enclosed.
Our engineering manufacturing process consists of nine main steps:
(i)Development: at this phase, intended product use is defined by the subject-matter expert through a User Requirement Specification (URS) technical reference document, product risks are assessed through a failure mode and effect analysis (FMEA) and documented in accordance with relevant function specifications;
(ii)Design: design of the equipment based on the FMEA is reported in a specific format, including a traceability matrix that ties back to the URS;
(iii)Production Base: prepare necessary technical documentation and release specific bill of materials;
(iv)Assembly: relevant equipment is then assembled, the relevant software installed and all data and electrical connections are checked and tested based on ad hoc checklists;
(v)Running-in: the equipment is completed and test plans are prepared to perform Installation Qualification (IQ), Operative Qualification OQ) and Performance Qualification (PQ);
(vi)Factory Acceptance Test: systematic verification with predefined test based on FMEA risk assessment for the specific design. Testing covers all relevant customer requirements;
(vii)Commissioning: the equipment is transported to the customer’s facility and installed based on pre-agreed requirements and specifications. Specific checklists are set to verify and confirm compliance to requirements;
(viii)Site Acceptance Test: systematic on-site verification according to pre-defined protocol and a specific report is prepared; and
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(ix)Closing: project evaluation and monitoring to ensure continuous improvements.
Facilities Overview
Below is a full list of our production facilities divided by business segment with the current products produced as of December 31, 2025.
Biopharmaceutical and Diagnostic Solutions
Location Product(s)
Piombino Dese, Italy Primary Packaging (Vials, Cartridges, Syringes, EZ-Fill®)
Latina, Italy Primary Packaging (Cartridges, Syringes EZ-Fill®)
Bratislava, Slovakia Primary Packaging (Vials, Ampoules)
Monterrey, Mexico Primary Packaging (Vials, Cartridges)
Zhangjiagang, China Primary Packaging (Vials, Cartridges)
Sete Lagoas, Brazil Primary Packaging (Vials, Cartridges, Ampoules)
Bad Oeynhausen, Germany Medical Devices and components for Biopharma and Diagnostics
Ontario, California, U.S. Medical Devices and components for Biopharma and Diagnostics
Fishers, U.S. Primary Packaging (Syringes, Vials, EZ-Fill®), Device contract manufacturing
Engineering
Location Product(s)
Piombino Dese and Bologna, Italy - Glass Converting Equipment- Assembly and Packaging equipment lines- Visual Inspection Equipment
Silkeborg, Denmark - Assembly and Packaging equipment and lines- Visual Inspection Equipment
Martellago, Italy - Mechanical tools and components for industrial machines
New facilities
We engaged in the construction of new plants primarily for the production of our EZ-fill® product suite in Indiana (U.S.) and Latina (Italy).
On October 4, 2021 we announced the construction of a new EZ-fill® hub in Fishers, Indiana. The plant enables us to be in closer proximity to our North America pharmaceutical customers and to provide an additional supply source. The facility houses production lines to produce EZ-fill® syringes and vials. In line with customer demand and as a result of our increased production capacity, we expect to better support customers’ needs for biologics and vaccine treatments. The Indiana hub also houses our after-sales support services which is dedicated to serving our North America engineering customers. Commercial production launched in 2024.
In 2022, we elected to accelerate our investment in the United States in response to increased demand from customers. The manufacturing facility is expected to be up to 565,000 square-feet and with more than 500 new full-time positions. As part of this capital project, in February 2022, we entered into an agreement with the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services, through its partnership with the U.S. Department of Defense. Under the agreement, BARDA is making a multi-year investment for up to approximately $95 million (or approximately €80 million based on the applicable exchange rate at the reporting date) for manufacturing capacity for standard and EZ-fill® vials in support of U.S. national defense readiness and preparedness programs for current and future public health emergencies.
On May 27, 2022, we acquired a brownfield in Latina (Italy) for a total consideration of approximately €16 million. The facility commenced commercial production beginning in the fourth quarter of 2023. When fully ramped,
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the facility is expected to produce EZ-fill® syringes and cartridges in response to market needs for ready-to-use drug containment products.
In March 2025 we entered into a rent to buy agreement with a lessee related to the facility in Zhangjiagang, China, that the Group acquired in 2021. We plan to sell the building following its decision to slow down our capacity expansion in China in order to focus efforts and resources on the ramp up of our manufacturing facilities in the U.S. and Italy where demand has currently outpaced initial expectations.
Seasonality
Our business and results of operations are not materially affected by seasonal fluctuations in the consumption of our products.
Supply Chain
We maintain positive relationships with suppliers across our business. The types of consumables we require differ by product as follows:
•Primary Packaging: our primary packaging production requires the supply of adequate glass tubes, as well as plastic and rubber components. We currently have access to adequate supplies of glass tubes to meet our production needs through agreements with four suppliers: Schott, NEG, Nipro and Corning. We also have access to adequate supply of plastic and rubber components.
•Plastic Consumables and Parts: we currently have access to adequate supplies of plastic to meet our production needs. In Germany, most of plastic agreements are driven by the final customers, while in the United States we have a reliable supplier list, and we procure material on a single order approach. Our plastic consumables and parts business also require the supply of molds for the production of the relevant plastic parts.
•Equipment: for our engineering business we need supply of machinery components which we assemble to produce our different engineering products. We meet our production needs with an enlarged supplier base, that allows us to have multiple sources and minimize risks.
For some of the materials we use in our production cycles, we have a limited number of (or a single-source) suppliers worldwide, and selecting new suppliers would be a lengthy and time-consuming process. We have long-term agreements with several of our customers that allow us to recover increased costs related to certain expenses.
Supply Agreements with Schott and NEG
Schott and NEG accounted for a significant percentage of our glass tube supply in 2024.
In 2017 we entered into a Master Supply Agreement with Schott for the supply of glass tubes which was replaced by a new Master Supply Agreement dated November 21, 2019 and effective as of January 1, 2020 ("Master Agreement"). Under the Master Agreement, we are required to purchase minimum quantities. Under the Master Agreement, we must notify Schott in October every year of the desired quantity to be purchased the following year. If the required quantity exceeds the minimum quantity imposed on us under the agreement, Schott approval is required. The Master Agreement also provides for certain price adjustment mechanics based on manufacturing costs. The parties entered into amendments to Master Supply Agreement extending the term of the Master Supply Agreement so that it now expires on December 31, 2026. The Master Supply Agreement contains customary termination provisions, allowing for termination by a party upon a material violation of the agreement or change of control by the other party. We are currently discussing plans to further extend the agreement.
On October 24, 2019, we entered into a Supply and Purchase Agreement with NEG for the supply of glass tubes which became effective on January 1, 2020. The agreement has a term of three years at the end of which the parties may negotiate the terms of the renewal. On December 16, 2022, the agreement was renewed for an additional three-year period (2023 through 2025). Under the agreement, we are required to purchase minimum quantities and NEG is required to supply minimum quantities. The agreement contains customary termination provisions, allowing for
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termination upon the other party’s default not cured within 30 days and bankruptcy, dissolution, suspension or other similar event.
Quality control
Providing high-quality products with specificity, sensitivity and consistency, coupled with extensive product validation data are fundamental drivers of customer loyalty. Customers in our target markets are particularly sensitive to products failing to meet specifications. Our success depends on our customers’ confidence in our ability to provide reliable, consistently high-quality products, which includes our ability to provide validated data to support our customers’ use of our products. In this respect, we believe that our ability to provide consistent quality standards in each of our production facilities, due to our standardized production processes and uniform quality management system, allows us to win our customers’ trust and reliance.
Biopharmaceutical and Diagnostic Solutions
All of our facilities use efficient quality control and quality assurance procedures comparable to those used in the pharmaceutical and biotechnology industries at each stage of the manufacturing process. We are certified according to applicable ISO standards. We are subject to rigorous audits by certification bodies and our customers, who perform more than 180 audits a year on our manufacturing facilities. Our control procedures in our glass manufacturing facilities focus on physical and chemical characteristics, dimensional aspects and product appearance and are carried out on each of: (i) the glass tubes and raw materials; (ii) the various process phases of production; and (iii) the finished products. Along the production line and before packaging each product undergoes an automatic inspection for cosmetic defects. Defective pieces are discarded. Inspection is carried out with highly sophisticated electronic devices using specific defect detection algorithms. At the end of the production line, products are checked using statistical control procedures to test their quality for specific cosmetic, chemical, physical and dimensional parameters. Each of our DDS and IVD manufacturing facilities also follows similar quality control procedures, albeit specific to plastic production. The control procedures include dimensional and functional tests, focused on the mechanic and cosmetic features of the products. In particular, checks are carried out on each of: (i) the raw materials; (ii) dyestuff, additives and components; (iii) the various process phases; (iv) semi-finished products; and (v) finished products.
Engineering
Our quality control systems and related activities are designed to ensure that our manufacturing processes, as well as those of our pharmaceutical customers and the contract manufacturing companies we rely on comply with Good Automated Manufacturing Practice (GAMP) standards based on the GAMP guidelines issued by the International Society for Pharmaceutical Engineering (ISPE). Each individual piece of machinery/ equipment is developed and manufactured as a project, and ad hoc project management tools are utilized to manage every stage and minimize risk.
Our quality activities follow a Stage Gate Model which includes the following ten stages: (i) development: intended product use is defined by the subject-matter expert (SME) through a User Requirements Specifications (URS) technical reference document, product risks are assessed through a failure mode and effect analysis (FMEA) and documented in accordance with relevant function specifications; (ii) design: design of the equipment based on the FMEA is reported in a specific format, including a traceability matrix that ties back to the user requirements specifications; (iii) production base: prepare necessary documentation and release specific bill of materials, whose accuracy is assessed based on ad hoc checklists; (iv) assembly: all components are sourced from approved suppliers and subsequently checked ahead of distribution to the assembly line. The relevant equipment is then assembled, the relevant software installed and all connections are checked and tested based on ad hoc checklists; (v) running-in: the equipment is completed and test plans are prepared; (vi) FAT: systematic verification with predefined test based on FMEA risk assessment for the specific design. Testing covers all relevant customer’s requirements; (vii) commissioning: the equipment is transported to customer’s facility and installed based on pre-agreed requirements and specifications set out in ad hoc checklists; (viii) SAT: systematic on-site verification according to pre-defined protocol and reporting to customer; and (ix) closing: project evaluation and monitoring to ensure continuing improvements.
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Logistics
Our products are delivered to our customers using various third-party freight, haulage transportation and warehousing providers. Each manufacturing facility has its own logistics team that is responsible for managing product storage and delivery accounts.
Intellectual Property and Information Technology
Intellectual Property
Our products, both in the Biopharmaceutical and Diagnostic Solutions and in the Engineering segments, are highly sophisticated and based on the development of specific know-how, processes and procedures. We actively protect our intellectual property rights and know-how through patents, trademarks and trade secrets. We actively map and protect our trade secrets and thus the technology behind our core products and processes is protected by more than 80 patent families, the most important ones being those devoted to the protection of the EZ-fill® solutions, the pre-sterilized drug containment solutions for aseptic manufacturing.
Our most distinctive brands are also protected via registered trademarks, the most important being: (i) SG-toothed wheel logo, (ii) EZ-fill®, (iii) EZ-fill SMART™ (the next generation EZ-fill® product suite), (iv) NEXA® (relating to superior drug containment solutions for mechanical resistance and cosmetic quality), (v) ALBA® (relating to advanced drug containment solutions for optimized drug-containment interaction), (vi) Vertiva™ (relating to wearable injectors), (vii) Alina® (relating to pen injector devices), and (viii) Deora™ (relating to a fixed dose pen injector device).
Information Technology
We keep strengthening our IT framework focusing on improving IT security and best practices. We are reviewing and updating our IT policies to the latest requirements to protect the Group’s information. Stevanato Group is running a Digital Transformation program to support the Group’s growth in a globally competitive market. We employ a continuous improvement approach to expand and develop our digital ecosystem over time. To date, we have:
•migrated all users to the cloud-based Microsoft Office 365, which includes advanced threat protection and data loss prevention functionalities;
•completed the integration of our business divisions into the SaaS cloud-based enterprise resource planning system (ERP). From 2022, we completed the roll out to China, Slovakia, Mexico, U.S. and Denmark facilities. Since January 2023, approximately 95% of our workforce is fully integrated into our cloud-based ERP and we currently expect to integrate the Brazilian facility within the first half of 2026.
•further improved a “data factory” data intelligence solution based on Microsoft Synapse and Databricks technology, providing business intelligence data.
Throughout 2025, we continued to:
•implement a secure digital work platform;
•improve our asset monitoring and lifecycle management;
•migrate the current on premise IT infrastructure and adopt Microsoft Azure Cloud Services and Amazon Web Services.
Our IT infrastructure is hosted by Telecom Italia in a data center in Padua and is replicated in Microsoft Azure Cloud. The data center is connected to Amazon Web Services and Microsoft Azure cloud networks, based in Frankfurt and Amsterdam respectively. Our Group companies are connected to the data centers through multiprotocol label switching networks.
We have also continued to implement a cybersecurity improvement program to strengthen our existing IT security, foster greater cyber resilience of our IT systems, and improve our business continuity and disaster recovery procedures. As part of our cybersecurity improvement program, we have:
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•continued the process of formally documenting our IT security processes and procedures;
•implemented various technologies to improve the security level of the network and infrastructure of the company;
•reviewed our procedures in relation to quality and compliance requirements; and
•reviewed our cybersecurity policy.
We will continue to further strengthen our cybersecurity program in 2026. We are not aware of any material cybersecurity incident over the past years, nonetheless the company is covered by a cybersecurity insurance plan. For a description of the cybersecurity risks we may be facing see “Risk Factors – Risks Relating to our Business and Industry – Cyber security risks and the failure to maintain the confidentiality, integrity and availability of our computer hardware, software and internet applications and related tools and functions, could result in damage to our reputation, data integrity and/or subject us to costs, fines or lawsuits under data privacy or other laws or contractual requirements” and “ITEM 16K. Cybersecurity”.
Research and Development
Research and development investment is a fundamental component of our growth and continued success. Our research and development team comprises approximately 150 highly skilled and specialized employees operating in Italy, Germany and the U.S.
The goal of our research and development effort is twofold: (i) to facilitate the transition from hospital to home care; and (ii) enabling biologics to reach the patient safely by meeting the most critical quality and performance requirements.
We pursue these goals by investing in both the Biopharmaceutical and Diagnostic Solutions segment (with the exception of in-vitro diagnostic products in relation to which we do not conduct research) and the Engineering segment. In 2025, for example, our research and development expenses amounted to €25.4 million, the majority of which was in connection with our Drug Delivery Systems business and our high-value solutions pipeline.
Our Biopharmaceutical and Diagnostic Solutions research mainly focuses on DDS patient-centricity, sustainability and digitalization and improvement of DCS production processes and coating systems. In this segment we conduct our development activities both autonomously and, to the extent our customers require specialized or customized products, in close cooperation with them. We are most frequently asked to produce specialized or customized products by our pharmaceutical and biotechnology clients (in both glass and plastic).
In particular, in the area of containment solutions, the development of new products will be targeted at maintaining the stability, potency and purity of our customers’ products prior to administration. New therapies for diabetes, cancer treatment and auto immune diseases are based on large, complex bio molecules that are extremely sensitive to their storage environment. In the area of drug delivery systems, we will be targeting the development of easy-to-use, accurate, reliable self-injection systems for complex pharmaceutical and biotechnology products. We have developed a portfolio of devices for this market that can be used off-the-shelf or customized to the specific needs of the customer.
We will continue developing new drug delivery systems based on three pillars: patient centricity, sustainability and digitalization, core capabilities to meet our customers' need for connected health devices. We apply a rigorous “stage & gate” development process, which de-risks our development projects and reduces total development costs. Development timelines for new drug delivery devices typically fall into the range of four to five years to reach the start of initial production. We cooperate with third parties on joint development projects. Pursuant to the relevant joint development agreements with these third parties, we either own, or are entitled to co-ownership of or license rights to, the intellectual property rights developed in connection with these programs.
Our main focus in Engineering is on maximizing our machine performance while reducing total cost of ownership. Further, we are broadening our portfolio of products, processes and services with the aim of creating a stable platform able to minimize planned and avoid unplanned downtime, and developing and integrating artificial intelligence into our machinery.
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In certain research areas, including chemical-physical and morphological characterization of glass surfaces and interactions with drugs, we cooperate with Universities such as Ca’ Foscari University (Venice, Italy), and Federico II University (Naples, Italy). We also have a research collaboration with the University of Colorado to focus primarily on interactions and compatibility of primary packaging with biologics and the University of Padua, to investigate the interaction of our primary packaging with formulations aimed at delivering mRNA which has historically been challenging. Pursuant to the relevant cooperation agreements with these Universities, we either own, or are entitled to co-ownership of, the intellectual property rights developed in connection with these programs.
Employees
As of December 31, 2025, we employed 6,010 employees in multiple jurisdictions (approximately 58% based in Italy, 10% based in Germany, 8% based in the U.S., 7% based in Mexico, 5% based in Brazil, 4% based in each Slovakia, and Denmark, and 3% based in China). The following table provides a breakdown of employees across the various main departments.
Department Total Headcount as of December 31, 2025
Direct Labor 3,881
Industrial / Manufacturing Overhead 1,386
G&A—Corporate Functions 236
Sales & Marketing 191
Research & Development 146
G&A—Accounting Finance Control 100
Human Resources 70
Our success largely depends on the skills and experience of our management, including our Chairman and Chief Executive Officer and our senior leadership.
Our excellence in manufacturing processes derives in part from our employees mastering specific techniques and know-how. Certain roles, such as engineers, designers, and quality controllers can also require lengthy training due to the highly technical and diversified nature of the processes used in our production.
A substantial majority of our employees are covered by collective bargaining or similar agreements, which require periodic renegotiation. We believe we have strong relationships with our employees. We have not experienced any material work stoppages or strikes at any of our manufacturing facilities in recent years. We take a constructive approach to relationships with trade unions and works councils.
Insurance
We maintain product liability, property, cybersecurity and other insurance coverage to the extent we believe necessary to operate our business. We believe that our liability insurance is sufficient to meet our needs in light of expected possible future litigation and claims. We monitor regularly our risk profile and adjust coverage accordingly.
LEGAL PROCEEDINGS
We are involved, from time to time, in various litigation and administrative and other legal proceedings, including potential regulatory actions, incidental or related to our business, including commercial contract and tortious liability claims, among others (collectively, “Legal Proceedings”). While we cannot predict any final outcomes relating thereto, management believes that the outcome of current Legal Proceedings will not have a material effect upon our business, financial condition, results of operations, cash flows.
However, management’s assessment of our Legal Proceedings is ongoing, and could change in light of the discovery of additional facts with respect to Legal Proceedings pending against us, not presently known to us, or determinations by judges, arbitrators, juries or other finders of fact or deciders of law which are not in accord with management’s evaluation of the probable liability or outcome of such Legal Proceedings. From time to time, we are in discussions with regulators, including discussions initiated by us, about actual or potential violations of law in order
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to remediate or mitigate associated legal or compliance risks. As the outcomes of such proceedings are unpredictable, the results of any such proceedings may materially affect our reputation, our business, financial condition, results of operations, cash flows.
Under Italian Law, directors and officers (in their capacity as employers) have a duty of care towards their employees and are therefore responsible for their health and safety. Breaches of this duty of care can result from any non-compliance or accident occurred within the facility, regardless of an actual act or omission of such directors, as they are strictly liable in light of their role (posizione di garanzia).
Some of our directors have been subject to criminal proceedings in connection with their roles as employers, either for the Stevanato Group or for one of its subsidiaries, and in particular:
•Sergio Stevanato was a defendant in two criminal proceedings: (i) before the Court of Padua (Italy) in respect of harm suffered by a former employee of Ompi S.r.l., one of our subsidiaries, allegedly as a result of being exposed to asbestos present in our facilities in the 1970s. The proceedings started in October 2018 and relate to facts that allegedly occurred between 1967 and 1987, when Mr. Stevanato was an officer of Ompi S.r.l. between 1973 and 1979. The employee contracted pleural mesothelioma, allegedly as a result of his exposure to asbestos, which was present in the panels used to protect employees from heat (use of asbestos was not prohibited at the time). The employee died in 2020, and the charges against Mr. Stevanato have changed to manslaughter. The judge asked for the dismissal of the proceedings; and (ii) before the Court of Latina (Italy) in respect of an injury suffered by another employee of Ompi S.r.l. to his finger in 2014. The proceedings commenced in 2014 and in a hearing of February 2, 2022, the judge acquitted the defendant of all alleged charges brought under both proceedings. Particularly: (i) the first trial was closed by a judicial decree of dismissal in February 2022; and (ii) the second trial was closed in April 2022 because it was judicially ascertained that the criminal fact did not exist.
•Franco Stevanato was a defendant in a criminal proceeding before the court of Padua (Italy) in respect of harm suffered by an employee of Nuova Ompi S.r.l., one of our subsidiaries, in a collision between forklifts, resulting in such employee suffering a leg fracture. The proceedings started in May 2019 and relate to facts allegedly occurred when Mr. Stevanato was Responsible for Health and Safety matters of Nuova Ompi S.r.l. Mr. Stevanato was found guilty in a summary judgment, which he appealed. On July 7, 2023, in the appeal, Mr. Stevanato was acquitted in accordance with article 131-bis of the Italian criminal code for particular tenuousness of the fact. On November 16, 2023, an appeal to the judgment was filed. On December 2, 2024, the court of appeal confirmed the acquittal of Mr. Stevanato upholding the previous judgment dated July 7, 2023. A possible appeal in a third judgment trial (Cassazione) for a full acquittal formula is under evaluation.
Regulations
The following paragraphs provide a brief description of the primary Italian, European and international laws and regulations that govern our activities. References and discussions to laws, regulations, directives and treatises and other regulatory acts are entirely qualified by the full texts of laws, regulations, directives and treatises, other administrative and regulatory acts themselves.
Health and safety
At all of our locations, we are subject to national laws, regulations and practices concerning employee health and safety. While each site is responsible for monitoring compliance with local regulations, we have a health and safety network that operates across all of our manufacturing facilities in order to share and promote best practices. Each of our manufacturing facilities is regularly audited and any corrective action required to maintain our global standards is implemented. To date, we have not been subject to any significant fines, penalties or other liabilities under laws and regulations relating to employee health and safety. However, there can be no assurance that we will not be subject to fines, penalties or other liabilities in the future or that changes in such laws and regulations, or interpretations thereof, will not have an adverse impact on our operations.
Product safety regulation
The use, manufacture and importing of chemicals is highly regulated in the European Union. On June 1, 2007, Regulation 1907/2006 concerning registration, evaluation, authorization and restriction of chemicals (“REACH”)
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entered into force. Our products and the raw materials we use in our production processes are subject to various regulations related to product and chemical safety, including the REACH regulation in the European Economic Area. REACH requires that certain substances imported or manufactured within the European Economic Area be registered with the European Chemicals Agency and evaluated for safety. The registration process requires producers to generate and submit data on the environmental and health impacts of substances and, in some cases, obtain authorization for their use within the European Union. Among other things, REACH can result in the imposition of use or marketing restrictions, and may require the phase-out or substitution of certain more dangerous chemicals with suitable alternatives. The European Union is continually adopting additional requirements related to product or substance safety. Although REACH compliance is primarily the responsibility of our suppliers or the producers of chemical raw materials, we are also affected by REACH as a “downstream” user of REACH-regulated substances.
It is possible that the registration process or use restrictions imposed by REACH could increase our costs, affect our raw material supplies or require us to substitute certain materials with alternatives. We utilize a database system that allows us to track and monitor our suppliers and the REACH-compliance status of raw materials used at each of our facilities. We biannually review official databases to ensure that our suppliers have made the required registrations and are in material compliance with REACH, and check that they have efforts underway to prepare for and comply with any additional requirements or upcoming deadlines. We believe that we have the capability to adjust our products and supplies as needed in accordance with any future requirements of REACH.
Environmental
Our operations are subject to a number of European, national and local environmental laws and regulations relating to the protection of the environment and natural resources. These include laws and regulations relating, inter alia, to air and noise emissions and the impact made on air quality through gas and particle emissions, and recycling and packaging waste reduction and prevention. Compliance with these laws and regulations is monitored by local and national authorities and competent agencies and non-compliance with these laws can result in administrative orders, substantial fines and criminal penalties, temporary or permanent plant closures and criminal convictions. Our current and past operations, including our historical waste disposal sites, could also expose us to liability to third parties for property damage, personal injury and clean-up obligations. We believe that our manufacturing facilities currently comply, in all material respects, with the applicable material environmental regulations at each of our locations, and as of the date hereof, we are not aware of any environmental issues requiring investigation or remediation on our behalf. However, there can be no assurance that changes in such laws and regulations, or interpretations thereof, will not require us to incur significant costs, which could have an adverse impact on our operations.
C.Organizational Structure
A full list of our significant subsidiaries is shown in the following diagram and depicts our simplified organizational and ownership structure.
The following diagram illustrates our corporate structure as of the date of this annual report. We conduct business through several direct and indirect subsidiaries operating in Europe, Asia and the Americas.
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D.Property, Plants and Equipment
We are headquartered in Italy and our registered office is located in via Molinella 17, Piombino Dese (Padua, Italy). As of December 31, 2025, we have 13 manufacturing plants, including: (i) ten production plants for manufacturing and assembly of bio-pharma and healthcare products (in Italy, Germany, Slovakia, Brazil, Mexico, China, United States), and (ii) three plants for the production of machinery and equipment (in Italy and Denmark). In addition to the manufacturing plants we have two sites for analytical services (in Italy and United States) and five commercial sites (in Italy, China, Japan, and India, which was incorporated on February 23, 2025). See “—B. Business Overview—Our Business— Manufacturing, Facilities and Supply Chain Overview—Facilities Overview” for a table setting forth a full list of our production facilities divided by business segment as of December 31, 2025.