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What changed in Stevanato Group S.p.A.'s 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of Stevanato Group S.p.A.'s 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+352 added−329 removedSource: 20-F (2026-03-04) vs 20-F (2025-03-06)

Top changes in Stevanato Group S.p.A.'s 2025 20-F

352 paragraphs added · 329 removed · 294 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeHISTORY AND DEVELOPMENT OF THE COMPANY 37 B. BUSINESS OVERVIEW 38 C. ORGANIZATIONAL STRUCTURE 68 D. PROPERTY, PLANTS AND EQUIPMENT 69
Biggest changeHISTORY AND DEVELOPMENT OF THE COMPANY 38 B. BUSINESS OVERVIEW 39 C. ORGANIZATIONAL STRUCTURE 68 D. PROPERTY, PLANTS AND EQUIPMENT 69
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 A. OFFER STATISTICS 1 B. METHOD AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 A. RESERVED 1 B. CAPITALIZATION AND INDEBTEDNESS 1 C. REASONS FOR THE OFFER AND USE OF PROCEEDS 1 D. RISK FACTORS 1 ITEM 4. INFORMATION ON THE COMPANY 37 A.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 A. OFFER STATISTICS 1 B. METHOD AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 A. RESERVED 1 B. CAPITALIZATION AND INDEBTEDNESS 1 C. REASONS FOR THE OFFER AND USE OF PROCEEDS 1 D. RISK FACTORS 1 ITEM 4. INFORMATION ON THE COMPANY 38 A.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

105 edited+25 added−8 removed465 unchanged
Biggest changeThese requirements include, but are not limited to: • compliance with the auditor attestation requirements in the assessment of our internal control over financial reporting; and • compliance with any requirement that may be adopted by the Public Company Accounting Oversight Board. 34 Due to the complexity and logistical difficulty of implementing the standards, rules and regulations that apply to a large accelerated filer, there is an increased risk that we may be found to be in non-compliance with such standards, rules and regulations.
Biggest changeCompliance with such additional requirements also will likely increase our legal, accounting and financial compliance costs. These requirements include, but are not limited to: • compliance with the auditor attestation requirements in the assessment of our internal control over financial reporting; and • compliance with any requirement that may be adopted by the Public Company Accounting Oversight Board.
In addition, such problems or failures subject us to other litigation claims, including claims from our customers for reimbursement of the cost of lost or damaged materials.
In addition, such problems or failures subject us to other litigation or claims, including claims from our customers for reimbursement of the cost of lost or damaged materials.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026) with prices that can be negotiated subject to a cap; imposed rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025), all factors which could impact our business by affecting our ability to achieve value-based price, maintaining an acceptable return on our investments in R&D of our products, creating a potential financial impact to the Company to the extent our products are used in connection with drugs that are impacted by the IRA pricing provisions under the IRA and impacting our ability to research and develop new products.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026) with prices that can be negotiated subject to a cap; imposed rebates under Medicare Part B and Medicare Part D to penalize price increases 10 that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025), all factors which could impact our business by affecting our ability to achieve value-based price, maintaining an acceptable return on our investments in R&D of our products, creating a potential financial impact to the Company to the extent our products are used in connection with drugs that are impacted by the IRA pricing provisions under the IRA and impacting our ability to research and develop new products.
Our internal controls may not be determined to be effective, which may adversely affect investor confidence in us and, as a result, the value of our ordinary shares. 3 • We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses. • The obligations associated with being a public company require significant resources and management attention. • Investors may experience future dilution as a result of future equity offerings. • We may need to raise additional funds to finance our future capital needs, which may dilute the value of our outstanding shares or prevent us from growing our business. • If we fail to comply with requirements relating to being a public company in the United States when obligated to do so, our business could be harmed and the price of our ordinary shares could decline.
Our internal controls may not be determined to be effective, which may adversely affect investor confidence in us and, as a result, the value of our ordinary shares. • We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses. • The obligations associated with being a public company require significant resources and management attention. • Investors may experience future dilution as a result of future equity offerings. • We may need to raise additional funds to finance our future capital needs, which may dilute the value of our outstanding shares or prevent us from growing our business. • If we fail to comply with requirements relating to being a public company in the United States when obligated to do so, our business could be harmed and the price of our ordinary shares could decline.
The key elements of our growth strategy include, among other things, the expansion of our global market position in drug containment solutions and drug delivery systems, accelerating penetration in life sciences systems, increasing our investments in research and development, building on our expertise in manufacturing, assembly and inspection systems for drug containers and complex, multi-component systems, leveraging our scientific and engineering capabilities, increasing our penetration in the North American region and selectively pursuing acquisitions and technology partnerships to augment and expand our product and service portfolio.
The key elements of our growth strategy include, among other things, the expansion of our global market position in drug containment solutions and drug delivery systems, accelerating penetration in life sciences systems, increasing our investments in research and development, building on our expertise in manufacturing, assembly and inspection systems for drug containers and complex, multi-component systems, leveraging our scientific and engineering capabilities, increasing our penetration in the North American region and 11 selectively pursuing acquisitions and technology partnerships to augment and expand our product and service portfolio.
Finally, the current national laws that implement the e-Privacy Directive are highly likely to be replaced across the EU (but not the UK) with a EU regulation known as the e-Privacy Regulation which, though still in development, will if adopted, impose new obligations on the use of personal data in the context of electronic communications, particularly in relation to online tracking technologies, and significantly increase regulators’ ability to impose fines for non-compliance.
Finally, the current national laws that implement the e-Privacy Directive are highly likely to be replaced across the EU (but not the UK) with a EU regulation known as the e-Privacy Regulation which, though still in development, will if adopted, impose new obligations on the use of personal data in the context of electronic communications, particularly in relation to online tracking technologies, and significantly 23 increase regulators’ ability to impose fines for non-compliance.
Our backlog represents, as of a point in time, estimated future revenue for work not yet completed under (i) specific purchase orders or long-term contractual agreements, with regards to our Biopharmaceutical and Diagnostic Solution segment, and (ii) certain one-off agreements, with regards to our Engineering segment, where we typically recognize direct revenue over the life of the contract based on our performance of services under the contract.
Our backlog represents, as of a point in time, estimated future revenue for work not yet completed under (i) specific purchase orders or long-term contractual agreements, with regards to our Biopharmaceutical and Diagnostic Solution segment, and (ii) certain one-off agreements, with regards to our Engineering segment, where we typically 5 recognize direct revenue over the life of the contract based on our performance of services under the contract.
Further, we seek out acquisitions of companies that maintain the same high-quality standards that we maintain, and if we misjudge or overestimate a company’s product quality standards, we may not be able to use these products or implement the strategies that were the primary reason for the acquisition, which would lead to a significant loss both financially and in time spent by our 12 teams trying to integrate the product or implement the strategy.
Further, we seek out acquisitions of companies that maintain the same high-quality standards that we maintain, and if we misjudge or overestimate a company’s product quality standards, we may not be able to use these products or implement the strategies that were the primary reason for the acquisition, which would lead to a significant loss both financially and in time spent by our teams trying to integrate the product or implement the strategy.
A number of jurisdictions globally have introduced (or are looking to introduce) additional value added tax (or similar tax) calculation requirements as well as additional reporting, record-keeping, collection and remittance obligations on businesses like ours. There can be no assurance that we will not be a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes.
A number of jurisdictions globally have introduced (or are looking to 20 introduce) additional value added tax (or similar tax) calculation requirements as well as additional reporting, record-keeping, collection and remittance obligations on businesses like ours. There can be no assurance that we will not be a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes.
The market price of our ordinary shares may fluctuate significantly due to a variety of factors, including: • operating results that vary from our financial guidance or the expectations (including financial estimates and projections) of securities analysts and investors; • the financial performance of the major end markets that we target; • our voting control is concentrated, which can impact an investor's decision to invest in us versus other companies with non-concentrated voting control, ultimately affecting share price; • the operating and securities price performance of companies that investors consider to be comparable to us; • announcements of strategic developments, acquisitions and other material events by us or our competitors; • issuance of new or updated research or reports by securities analysts; • changes in government regulations; • financing or other corporate transactions; 31 • the loss of key personnel; • sales of our shares by us, our executive officers and board members, holders of our shares or other shareholders in the future; • price and volume fluctuations in the overall stock market, including as a result of trends in the economy as a whole; and • other events and factors, many of which are beyond our control.
The market price of our ordinary shares may fluctuate significantly due to a variety of factors, including: • operating results that vary from our financial guidance or the expectations (including financial estimates and projections) of securities analysts and investors; • the financial performance of the major end markets that we target; • our voting control is concentrated, which can impact an investor's decision to invest in us versus other companies with non-concentrated voting control, ultimately affecting share price; • the operating and securities price performance of companies that investors consider to be comparable to us; • announcements of strategic developments, acquisitions and other material events by us or our competitors; • issuance of new or updated research or reports by securities analysts; • changes in government regulations; • financing or other corporate transactions; 32 • the loss of key personnel; • sales of our shares by us, our executive officers and board members, holders of our shares or other shareholders in the future; • price and volume fluctuations in the overall stock market, including as a result of trends in the economy as a whole; and • other events and factors, many of which are beyond our control.
The ability of our Chinese subsidiaries to operate may be impaired by changes in its laws and regulations, including those relating to taxation, land use rights, foreign investment limitations, and other matters. As a multinational corporation, we are exposed to fluctuations in currency exchange rates and interest rates, which could adversely affect our cash flows and results of operations.
The ability of our Chinese subsidiaries to operate may be impaired by changes in its laws and regulations, including those relating to taxation, land use rights, foreign investment limitations, and other matters. 15 As a multinational corporation, we are exposed to fluctuations in currency exchange rates and interest rates, which could adversely affect our cash flows and results of operations.
If problems in preparation or manufacture of a product, failure to meet required quality standards for that product or other product defects are not discovered before such product is released to our customers, we may be subject to adverse legal or regulatory actions, including halting of manufacturing and distribution, 4 restrictions on our operations, civil sanctions (including monetary sanctions), and criminal actions.
If problems in preparation or manufacture of a product, failure to meet required quality standards for that product or other product defects are not discovered before such product is released to our customers, we may be subject to adverse legal or regulatory actions, including halting of manufacturing and distribution, restrictions on our operations, civil sanctions (including monetary sanctions), and criminal actions.
However, we may be unable to identify or complete promising acquisitions for many reasons, including any misjudgment of the key elements of an acquisition, competition among buyers, the high valuations of businesses in our industry, the need for regulatory and other approvals, lack of internal resources to successfully pursue all attractive opportunities and availability of capital.
However, we may be unable to identify or complete promising acquisitions for many reasons, including any misjudgment of the key elements of an acquisition, competition among buyers, the high valuations of businesses in 12 our industry, the need for regulatory and other approvals, lack of internal resources to successfully pursue all attractive opportunities and availability of capital.
We approved and adopted the current (fifth) version of our organization, management and control model provided by Decree 231 (“ Model 231 ”) by means of a resolution of the board of directors dated February 28, 2024, and appointed the current supervisory body (the “ Supervisory Body ”) that supervises the functioning of and compliance with Model 231, and monitors and assesses the implementation status of preventive measures, with regular yearly reports to the board of directors.
We approved and adopted the current (fifth) version of our organization, management and control model provided by Decree 231 (“ Model 231 ”) by means of a resolution of the board of directors dated February 28, 2024, and appointed the current supervisory body (the “ Supervisory Body ”) that supervises the functioning of and compliance with Model 231, and monitors and assesses the implementation status of preventive measures, with regular yearly reports to the 13 board of directors.
Now that we are no longer an emerging growth company, our independent registered public accounting firm is required to attest to the effectiveness of our internal control over financial reporting. 36 In order to achieve and maintain compliance with the requirements of Section 404(a), we need to expend significant resources and provide significant management oversight.
Now that we are no longer an emerging growth company, our independent registered public accounting firm is required to attest to the effectiveness of our internal control over financial reporting. In order to achieve and maintain compliance with the requirements of Section 404(a), we need to expend significant resources and provide significant management oversight.
Bu siness 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 life cycle from development to clinical and commercial stages.
Bu siness 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.
Therefore, the application of the golden powers regime could have a material adverse effect on our business, results of operations, financial condition or prospects. Furthermore, in the future, our shareholders’ ability to enter into change of control or takeover transactions may be impacted by the exercise by the Italian Government of its special powers under the golden power regime.
Therefore, the application of the golden powers regime could have a material adverse effect on our business, results of operations, financial condition or prospects. 17 Furthermore, in the future, our shareholders’ ability to enter into change of control or takeover transactions may be impacted by the exercise by the Italian Government of its special powers under the golden power regime.
We may be required in the future to record additional charges to earnings if our goodwill, amortizable intangible assets, property, plant and equipment or other investments become impaired. Any such charge would adversely impact our financial results. If the military conflict in Israel and Gaza continues, our business could be materially and adversely affected.
We may be required in the future to record additional charges to earnings if our goodwill, amortizable intangible assets, property, plant and equipment or other investments become impaired. Any such charge would adversely impact our financial results. 19 If the military conflict in Israel and Gaza continues, our business could be materially and adversely affected.
The PIPL regulates how business operators may collect, use, process, share, 23 and transfer personal information in China and supplements the existing data protection regime previously established by the Cybersecurity Law (“ CSL ”) and other fragmented national guidelines. Under the PIPL, personal information handlers must adopt necessary measures to safeguard the security of personal information.
The PIPL regulates how business operators may collect, use, process, share, and transfer personal information in China and supplements the existing data protection regime previously established by the Cybersecurity Law (“ CSL ”) and other fragmented national guidelines. Under the PIPL, personal information handlers must adopt necessary measures to safeguard the security of personal information.
As of December 31, 2023, we are no longer an “emerging growth company.” As a result, we are now required to comply with the independent auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (“Section 404”), beginning with our annual report on Form 20-F for the year ended December 31, 2023.
As of December 31, 2023, we are no longer an “emerging growth company.” As a result, we are required to comply with the independent auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (“Section 404”), beginning with our annual report on Form 20-F for the year ended December 31, 2023.
Failure to anticipate and react to particular geographic requirements and sensitivities may have a negative impact on our brand and reputation, which may result in a decrease in sales or sales growth in such countries, which may adversely affect our business, prospects, financial condition and results of operations. We are highly dependent on our management and employees.
Failure to anticipate and react to particular geographic requirements and sensitivities may have a negative impact on our brand and reputation, which may result in a decrease in sales or sales growth in such countries, which may adversely affect our business, prospects, financial condition and results of operations. 6 We are highly dependent on our management and employees.
On July 11, 2023, the European Commission entered into force its adequacy decision for the EU-US Data Privacy Framework (a new framework for transferring personal information from the EEA to the United States), having determined that such framework ensures that the protection of personal information transferred from the EEA to the US will be comparable to the protection offered in the EU.
On July 11, 2023, the European Commission entered into force its adequacy decision for the EU-US Data Privacy Framework (a new framework for transferring personal information 24 from the EEA to the United States), having determined that such framework ensures that the protection of personal information transferred from the EEA to the US will be comparable to the protection offered in the EU.
As a result, our revenue is exposed to risks inherent to the country where we operate or intend to operate including risks related to differing political, legal, regulatory and economic conditions and regulations. 14 If relations between China and the United States deteriorate, our business in the United States and China could be materially and adversely affected.
As a result, our revenue is exposed to risks inherent to the country where we operate or intend to operate including risks related to differing political, legal, regulatory and economic conditions and regulations. If relations between China and the United States deteriorate, our business in the United States and China could be materially and adversely affected.
Furthermore, we rely on information technology systems to process, transmit, store and protect electronic information, including confidential customer, supplier, employee or other business information. Through our online platform, we collect and store confidential information that website users provide to us when submitting queries or job applications or information that third party vendors relay to us.
Furthermore, we rely on information technology systems to process, transmit, store and protect electronic information, including confidential customer, supplier, employee or other business information. Through our online 21 platform, we collect and store confidential information that website users provide to us when submitting queries or job applications or information that third party vendors relay to us.
Tax audits, changes in tax laws, their application and interpretation or imposition of any new or increased tariffs, duties and taxes could increase our tax burden and materially and adversely affect our sales, profits and financial condition and could have an adverse effect on our business, net assets, or results of operations.
Tax audits, changes in tax laws, their application and interpretation or imposition of any new or increased tariffs, duties and taxes could increase our tax burden and materially and adversely affect our sales, profits and financial condition and could have an adverse effect on our business, net assets, or results 9 of operations.
Customers may also claim loss of profits due 16 to lost or delayed sales, although our contractual arrangements typically place limits on such claims. There can be no assurance that any such contractual limitation will be applicable or sufficient or fully enforced in any given situation.
Customers may also claim loss of profits due to lost or delayed sales, although our contractual arrangements typically place limits on such claims. There can be no assurance that any such contractual limitation will be applicable or sufficient or fully enforced in any given situation.
Substantial, complex or extended litigation on any claim could cause us to incur significant costs and distract our management. For example, lawsuits by governmental authorities, employees, shareholders, suppliers, collaborators, distributors, customers, 18 competitors or others could be very costly and substantially disrupt our business.
Substantial, complex or extended litigation on any claim could cause us to incur significant costs and distract our management. For example, lawsuits by governmental authorities, employees, shareholders, suppliers, collaborators, distributors, customers, competitors or others could be very costly and substantially disrupt our business.
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 development and delivery value chain through our investment in research and development and the expansion of our global footprint and capabilities.
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.
Competitors range from smaller, specialized companies, which may be able to more quickly respond to customers’ specific needs, to large multinational companies who provide a full suite of products, which may have greater financial, marketing, operational and research and 9 development resources than we do.
Competitors range from smaller, specialized companies, which may be able to more quickly respond to customers’ specific needs, to large multinational companies who provide a full suite of products, which may have greater financial, marketing, operational and research and development resources than we do.
Our declaration and payment of future dividends is subject to risks and uncertainties, including: deterioration of our financial performance or position; inability to declare a dividend in compliance with applicable laws or debt covenants; an increase in our cash needs or decrease in available cash; and the business judgment of the board of directors that a declaration of a dividend is not in our best interest. 33 As a foreign private issuer, we are exempt from a number of rules under the Exchange Act, we are permitted to file less information with the SEC than domestic companies, and we are permitted to follow home country practice in lieu of the listing requirements of NYSE, subject to certain exceptions.
Our declaration and payment of future dividends is subject to risks and uncertainties, including: deterioration of our financial performance or position; inability to declare a dividend in compliance with applicable laws or debt covenants; an increase in our cash needs or decrease in available cash; and the business judgment of the board of directors that a declaration of a dividend is not in our best interest. 34 As a foreign private issuer, we are exempt from a number of rules under the Exchange Act, we are permitted to file less information with the SEC than domestic companies, and we are permitted to follow home country practice in lieu of the listing requirements of NYSE, subject to certain exceptions.
For example, if we were to lose one of our sites where new product development is undertaken, we may not be able to transfer or replicate that product development 8 at another site, with the result of lost time and financial costs of developing the new product.
For example, if we were to lose one of our sites where new product development is undertaken, we may not be able to transfer or replicate that product development at another site, with the result of lost time and financial costs of developing the new product.
Government enforcement actions can be costly and interrupt the regular operation of our business, and 24 data breaches or violations of data privacy laws can result in significant fines, reputational damage and civil lawsuits, any of which may adversely affect our business, financial condition and results of operations.
Government enforcement actions can be costly and interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in significant fines, reputational damage and civil lawsuits, any of which may adversely affect our business, financial condition and results of operations.
In the event a customer terminates a contract, we are generally entitled to be paid for services rendered through the termination date and for services provided in winding down the project. However, we are generally not entitled to receive the full amount of direct 5 revenue reflected in our backlog in the event of a contract termination.
In the event a customer terminates a contract, we are generally entitled to be paid for services rendered through the termination date and for services provided in winding down the project. However, we are generally not entitled to receive the full amount of direct revenue reflected in our backlog in the event of a contract termination.
If this occurs, we could expend substantial resources and time in re-establishing relationships with third-party suppliers that meet the appropriate quality, cost and regulatory requirements needed for commercially viable manufacturing of our products.
If this occurs, we could expend substantial resources and time in 7 re-establishing relationships with third-party suppliers that meet the appropriate quality, cost and regulatory requirements needed for commercially viable manufacturing of our products.
Even after any underlying concerns or problems are resolved, any lingering concerns regarding our technology, product defects or performance standards could continue to result in lost sales, delayed market acceptance and damaged reputation, among other things.
Even after any underlying concerns or problems are resolved, any lingering concerns regarding our technology, product defects or performance standards could continue to result in lost sales, delayed market acceptance and damaged 4 reputation, among other things.
We must also maintain sufficient production capacity in order to meet anticipated customer demand, which carries fixed costs that we may not be able to offset if orders slow, which would adversely affect our operating margins.
We must also maintain sufficient production capacity in order to meet anticipated customer demand, which carries fixed costs that we may not be able to offset if orders 8 slow, which would adversely affect our operating margins.
Movements in the invoiced currency relative to the functional currency could adversely impact our cash flows and our results of operations. As our international sales grow, exposure to 15 fluctuations in currency exchange rates could have a larger effect on our financial results.
Movements in the invoiced currency relative to the functional currency could adversely impact our cash flows and our results of operations. As our international sales grow, exposure to fluctuations in currency exchange rates could have a larger effect on our financial results.
We operate our business in two segments: • Biopharmaceutical and Diagnostic Solutions, 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 • Engineering, 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). 39 The figure below provides a breakdown of our segments, as well as the business lines included within each segment.
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). 40 The figure below provides a breakdown of our segments, and the business lines included within each segment.
In that event, we may be required to expend significant time and resources to redesign our products, potential products or technologies or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis, which could adversely impact our business, financial condition, results of operations and prospects. 27 Disputes may arise regarding intellectual property subject to a license agreement and certain provisions in such agreements may be susceptible to multiple interpretations.
In that event, we may be required to expend significant time and resources to redesign our products, potential products or technologies or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis, which could adversely impact our business, financial condition, results of operations and prospects. 28 Disputes may arise regarding intellectual property subject to a license agreement and certain provisions in such agreements may be susceptible to multiple interpretations.
Moreover, any such litigation or the threat thereof may adversely affect our reputation, our ability to form strategic alliances, engage with scientific advisors or hire employees or consultants, any of which could adversely affect our business, including in terms of substantial cost, reputational loss and/or a distraction to our management and other employees. 30 If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies and protect our intellectual property rights.
Moreover, any such litigation or the threat thereof may adversely affect our reputation, our ability to form strategic alliances, engage with scientific advisors or hire employees or consultants, any of which could adversely affect our business, including in terms of substantial cost, reputational loss and/or a distraction to our management and other employees. 31 If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies and protect our intellectual property rights.
Accordingly, there may be less publicly available information concerning us compared with issuers that are U.S. domestic issuers. • We are obligated to maintain effective internal control over financial reporting.
Accordingly, there may be less publicly available information concerning us compared with issuers that are U.S. domestic issuers. 3 • We are obligated to maintain effective internal control over financial reporting.
Any reduction in research and development budgets or a shift 10 of any funding source currently allocated to our business sector to different areas of research, could adversely affect our business, financial condition and results of operations.
Any reduction in research and development budgets or a shift of any funding source currently allocated to our business sector to different areas of research, could adversely affect our business, financial condition and results of operations.
Our success largely depends on the skills, experience and continued efforts of our management, including our Chief Executive Officer and our senior leadership, as well as of our research and development and highly skilled 6 employees.
Our success largely depends on the skills, experience and continued efforts of our management, including our Chief Executive Officer and our senior leadership, as well as of our research and development and highly skilled employees.
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 2023 revenue, according to data collected by Pharmacircle and public companies’ information.
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.
These events have in the past adversely impacted the Italian economy, causing credit agencies to lower Italy’s sovereign debt rating, and could decrease outside investment in Italian companies.
These events have in the past adversely impacted the Italian economy, causing credit agencies to lower Italy’s sovereign debt rating, and could 14 decrease outside investment in Italian companies.
The information contained on our website is not incorporated by reference and does not form part of this annual report. 37 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 Dese (Padua).
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 38 Dese (Padua).
Our global operations are subject to international market risks that may have a material effect on our liquidity, financial condition, results of operations and cash flows. We operate manufacturing facilities in Italy, Slovakia, Denmark, Germany, United States, Mexico, China and Brazil, and sell and distribute our products in approximately 70 countries.
Our global operations are subject to international market risks that may have a material effect on our liquidity, financial condition, results of operations and cash flows. We operate manufacturing facilities in Italy, Slovakia, Denmark, Germany, United States, Mexico, China and Brazil, and sell and distribute our products in approximately 65 countries.
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 inspection machines. These acquisitions marked our entry into the technology and equipment manufacturing business.
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 the event that we or our licensors fail to maintain the patents and patent 29 applications covering our products and potential products or if we or our licensors otherwise allow our patents or patent applications to be abandoned or lapse, it could create opportunities for competitors to enter the market, which would hurt our competitive position and could impair our ability to successfully commercialize our products.
In the event that we or our licensors fail to maintain the patents and patent 30 applications covering our products and potential products or if we or our licensors otherwise allow our patents or patent applications to be abandoned or lapse, it could create opportunities for competitors to enter the market, which would hurt our competitive position and could impair our ability to successfully commercialize our products.
Our management has taken actions to remediate the previously identified material weaknesses as of December 31, 2023 by implementing our remediation plans throughout the fiscal year ending December 31, 2024; however, for certain of the items, remediation has not been fully completed to-date resulting in an extension of our remediation plans through the fiscal year ending December 31, 2025.
Our management has taken actions to remediate the previously identified material weaknesses as of December 31, 2024 by implementing our remediation plans throughout the fiscal year ending December 31, 2025; however, for certain of the items, remediation has not been fully completed to-date resulting in an extension of our remediation plans through the fiscal year ending December 31, 2026.
Our two main business segments (Biopharmaceutical and Diagnostic Solutions, and Engineering), combined with our global footprint, allow us to sell products and provide services approximately in 70 countries worldwide which we achieve mostly through business‑to‑business marketing channels and selected distributors. Please see the section entitled “
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 “
If we lose our foreign private issuer status on this date, we will be required to file with the SEC periodic reports and registration statements on U.S. domestic issuer forms beginning on January 1, 2026, which are more detailed and extensive than the forms available to a foreign private issuer.
If we lose our foreign private issuer status on this date, we will be required to file with the SEC periodic reports and registration statements on U.S. domestic issuer forms beginning on January 1, 2027, which are more detailed and extensive than the forms available to a foreign private issuer.
If we are unable to enter into a license on acceptable terms, we could be prevented from commercializing one 28 or more of our products, potential products or technologies, or forced to modify such products or potential products, or to cease some aspect of our business operations, which could harm our business significantly.
If we are unable to enter into a license on acceptable terms, we could be prevented from commercializing one 29 or more of our products, potential products or technologies, or forced to modify such products or potential products, or to cease some aspect of our business operations, which could harm our business significantly.
We would lose our foreign private issuer status if, for example, more than 50% of our shares were held by U.S. residents, and more than 50% of our total assets are located in the United States as of December 31, 2025.
We would lose our foreign private issuer status if, for example, more than 50% of our shares were held by U.S. residents, and more than 50% of our total assets are located in the United States as of December 31, 2026.
The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter, and, accordingly, the next determination will be made with respect to us on June 30, 2025.
The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter, and, accordingly, the next determination will be made with respect to us on June 30, 2026.
Our existing patents may have been issued with claims that fail to cover our relevant proprietary products and technology, including current 26 products, potential products and any future potential products we may develop, in whole or in part.
Our existing patents may have been issued with claims that fail to cover our relevant proprietary products and technology, including current 27 products, potential products and any future potential products we may develop, in whole or in part.
We operate across the healthcare industry and serve some of its fastest growing segments, including biologics (such as GLP1s and peptides, monoclonal antibodies, and RNA-based drugs), biosimilars, vaccines and molecular diagnostics.
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.
Excluding treasury shares (which voting right is suspended), Stevanato Holding S.r.l. holds 93.11% of the voting rights of the Company. 32 As a result, the Company qualifies as a “controlled company” pursuant to the NYSE listing rules and, therefore, Stevanato Holding S.r.l. potentially has the ability to control the outcome of matters submitted to our shareholders for approval, including the election and removal of directors and any arrangement or sale of all or substantially all of our assets.
Excluding treasury shares (which voting right is suspended), Stevanato Holding S.r.l. holds 93.09% of the voting rights of the Company. 33 As a result, the Company qualifies as a “controlled company” pursuant to the NYSE listing rules and, therefore, Stevanato Holding S.r.l. potentially has the ability to control the outcome of matters submitted to our shareholders for approval, including the election and removal of directors and any arrangement or sale of all or substantially all of our assets.
We also serve eight of the top ten biotechnology companies (by market capitalization listed in the Nasdaq Biotechnology Index), and over 100 biotechnology customers in total.
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.
We are closely integrated in the drug 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/biosimilars, self-administration of medicines, aging demographics, increasing complexities in health conditions and co-morbidities, increasing global access to vaccines, and increasing quality standards and regulation.
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.
We also supply engineer 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 inspection systems.
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.
In addition, through brownfield expansions, we expanded capacity in Piombino Dese in 2019 to increase our syringe production, and one new building in Latina, Italy, which began commercial production of syringes in 2023. B.
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.
A number of factors may affect backlog and the direct revenue generated from our backlog, including (i) the size, complexity and duration of projects, and (ii) the cancellation or delay of projects. Our backlog at December 31, 2024 was approximately €853 million compared to €945 million at December 31, 2023.
A number of factors may affect backlog and the direct revenue generated from our backlog, including (i) the size, complexity and duration of projects, and (ii) the cancellation or delay of projects. Our backlog at December 31, 2025 was approximately €871 million compared to €853 million at December 31, 2024.
If relations between China and the United States deteriorate, our business in the United States and China could be materially and adversely affected. • As a multinational corporation, we are exposed to fluctuations in currency exchange rates and interest rates, which could adversely affect our cash flows and results of operations. • We are required to comply with a wide variety of laws and regulations and are subject to regulation by various federal, state and foreign agencies. • Given the relevance of our activities in the healthcare sector, investments by non-Italian entities in the Company, as well as certain asset disposals by the Company, may be subject to the prior authorization of the Italian Government (so called “golden powers”). • If the military conflict in Israel and Gaza continues, our business could be materially and adversely affected. • Our business depends on our ability to use and access information systems, and any failure to successfully maintain these systems or implement new systems to handle our changing needs could materially harm our operations. • 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 2 reputation, data integrity and/or subject us to costs, fines or lawsuits under data privacy or other laws or contractual requirements. • As a consequence of the COVID-19 pandemic, global sales of vials to and for vaccination programs has fluctuated.
If relations between China and the United States deteriorate, our business in the United States and China could be materially and adversely affected. • As a multinational corporation, we are exposed to fluctuations in currency exchange rates and interest rates, which could adversely affect our cash flows and results of operations. • We are required to comply with a wide variety of laws and regulations and are subject to regulation by various federal, state and foreign agencies. • Given the relevance of our activities in the healthcare sector, investments by non-Italian entities in the Company, as well as certain asset disposals by the Company, may be subject to the prior authorization of the Italian Government (so called “golden powers”). • If the military conflict in Israel and Gaza continues, our business could be materially and adversely affected. • Our business depends on our ability to use and access information systems, and any failure to successfully maintain these systems or implement new systems to handle our changing needs could materially harm our operations. • 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 2 reputation, data integrity and/or subject us to costs, fines or lawsuits under data privacy or other laws or contractual requirements. • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability. • As a consequence of the COVID-19 pandemic, global sales of vials to and for vaccination programs has fluctuated.
Trump administration may in the future pause, reimpose or increase tariffs, and countries subject to such tariffs, or other potentially impacted countries, have and in the future may impose reciprocal tariffs or other restrictive trade measures in response. Any of these actions could increase uncertainties and associated risks relating to the Company's global operations.
Trump administration may in the future pause, reimpose or increase tariffs, and countries subject to such tariffs, or other potentially impacted countries, have and in the future may impose additional and/or reciprocal tariffs or other restrictive trade measures in response. Any of these actions, which we cannot predict, could increase uncertainties and associated risks relating to the Company's global operations.
As a result, our customers’ needs continue to evolve and our products and services may be superseded by new technologies (for instance, if certain drugs are no longer administered through injection) or their demand may decline.
As a result, our customers’ needs continue to evolve and our products and services may be superseded by new technologies (for instance, if certain drugs are no longer administered through injection or alternative methods of administration are available) or their demand may decline.
Our involvement at each stage of a drug’s 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. The chart below illustrates our mission-critical presence across the pharmaceutical value chain.
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.
Due to the evolving nature of cyber threat actors and the frequency and sophistication of the cyber activities they carry out, the determination of the severity and potential impact of a cyber incident may not become apparent for a substantial period of time following discovery of the incident and we may not be able to address these threats proactively or implement adequate preventative measures.
Due to the evolving nature of cyber threat actors and the frequency and sophistication of the cyber activities they carry out, the determination of the severity and potential impact of a cyber incident may not become apparent for a substantial period of time following discovery of the incident and we may not be able to address these threats proactively or implement adequate preventative measures, and with the use of artificial intelligence, threats may become more advanced and detection become increasingly difficult.
Our revenue is fairly well distributed, with 51.4% of our revenues deriving from our top ten customers and one individual customer representing 10.3% of revenues in 2024. However, consolidation within our customer base, including, in particular, among pharmaceutical companies, may give larger customers greater bargaining and buying power and operational sophistication, which can enable them to operate with reduced inventories.
Our revenue is fairly well distributed, with 53.6% of our revenues deriving from our top ten customers and one individual customer representing 12.0% of revenues in 2025. However, consolidation within our customer base, including, in particular, among pharmaceutical companies, may give larger customers greater bargaining and buying power and operational sophistication, which can enable them to operate with reduced inventories.
Implementing any appropriate changes to our internal controls may require specific compliance training of our directors and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of time to complete and divert management’s attention from other business concerns. These changes may not, however, be effective in maintaining the adequacy of our internal controls.
Implementing any appropriate changes to our 37 internal controls may require specific compliance training of our directors and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of time to complete and divert management’s attention from other business concerns.
Trump administration recently announced tariffs on products manufactured in several jurisdictions, including China, Mexico and Canada, and has made announcements regarding the potential imposition of tariffs on other jurisdictions. While certain of the announced tariffs have been delayed, the U.S.
Trump administration recently has implemented tariffs on products manufactured in several jurisdictions, including among others China, Mexico, the EU and other European countries, and Canada, and has made announcements regarding the potential modification of existing tariffs and imposition of tariffs on other jurisdictions. While certain of the announced tariffs have been delayed, the U.S.
Failure to comply with Decree 231 could result in the imposition of administrative sanctions such as monetary sanctions and other types of sanctions, if applicable (e.g., interdictory sanctions, including prohibitions such as participation in public tenders or the termination of a public contract already awarded, confiscation of the price or profits deriving from the crime and publication of the judgment) and loss of confidence of our customer base, which could have a material adverse effect on the business, financial condition, results of operations and prospects of the Group. 13 In addition, a government may seek to hold us liable as a successor for violations committed by companies in which we invest or that we acquire.
Failure to comply with Decree 231 could result in the imposition of administrative sanctions such as monetary sanctions and other types of sanctions, if applicable (e.g., interdictory sanctions, including prohibitions such as participation in public tenders or the termination of a public contract already awarded, confiscation of the price or profits deriving from the crime and publication of the judgment) and loss of confidence of our customer base, which could have a material adverse effect on the business, financial condition, results of operations and prospects of the Group.
In 2024, we generated 85% of total revenue from our Biopharmaceutical and Diagnostic Solutions segment and 15% from our Engineering segment. The principal markets in which we operate and compete include the EMEA, the U.K., Asia (with a focus on China) and the Americas (with a focus on Brazil and Mexico in South America, and the U.S. in North America).
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.).
A lower rate of increase or a decline in sales of vials to and for vaccination programs, plastic diagnostic consumables for COVID-19 testing, and related products and services could adversely affect our business, financial condition and results of operations. 25 Risks Relating to our Intellectual Property Our trade secrets may be misappropriated or disclosed, and confidentiality agreements with directors, employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
A lower rate of increase or a decline in sales of vials could adversely affect our business, financial condition and results of operations. 26 Risks Relating to our Intellectual Property Our trade secrets may be misappropriated or disclosed, and confidentiality agreements with directors, employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
As a foreign private issuer, we are exempt from certain rules under the Exchange Act, including certain disclosure and procedural requirements applicable to proxy solicitations under Section 14 of the Exchange Act, our board of directors, officers and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act, and we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as companies whose securities are registered under the Exchange Act but are not foreign private issuers.
As a foreign private issuer, we are exempt from certain rules under the Exchange Act, including certain disclosure and procedural requirements applicable to proxy solicitations under Section 14 and certain other Sections of the Exchange Act, and we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as companies whose securities are registered under the Exchange Act but are not foreign private issuers.
In addition, we would lose our ability to rely upon exemptions from certain corporate governance requirements under the listing rules of the NYSE, some of which we currently voluntarily comply with even though exemptions might be available.
We will also have to comply with certain additional U.S. federal proxy requirements to which we are not currently subject. In addition, we would lose our ability to rely upon exemptions from certain corporate governance requirements under the listing rules of the NYSE, some of which we currently voluntarily comply with even though exemptions might be available.
In this context we have provided: (i) glass vials and syringes to approximately 90% of marketed vaccine programs, according to our estimates based on public information (WHO, EMA, FDA); and (ii) plastic diagnostic consumables for the detection and diagnosis of COVID-19. COVID-19 generated increased demand for our products and services.
During COVID-19, we increased production capacity to support our customers’ efforts in rapidly responding to COVID-19. In this context we provided: (i) glass vials and syringes to approximately 90% of marketed vaccine programs, according to our estimates based on public information (WHO, EMA, FDA); and (ii) plastic diagnostic consumables for the detection and diagnosis of COVID-19.
We employ approximately 5,521 employees, as at December 31, 2024, in multiple jurisdictions (approximately 57% based in Italy, 9% based in Germany, 7% in each of Mexico and the U.S., 6% in Slovakia, 5% in each of Denmark and Brazil and 4% based in China).
We employ approximately 6,010 employees, as at December 31, 2025, in multiple jurisdictions (approximately 58% based in Italy, 10% in Germany, 8% in the U.S., 7% in Mexico, 5% in Brazil, 4% in each of Slovakia and Denmark, and 3% in China).
Complying with Section 404 requires a rigorous compliance program as well as adequate time and resources. The Section 404 assessment must include disclosure of any material weaknesses identified by our management in our internal controls over financial reporting.
Complying with Section 404 requires a rigorous compliance program as well as adequate time and resources. The Section 404 assessment must include disclosure of any material weaknesses identified by our management in our internal controls over financial reporting. In addition, our independent registered public accounting firm is required to attest to the effectiveness of our internal control over financial reporting.
We are subject to product liability and other claims in the ordinary course of business. Our business involves risk of product liability claims related to providing incorrect product information at the time of purchase, claims for defective containment solutions which may impair drug efficacy and other claims in the ordinary course of business.
Our business involves risk of product liability claims related to providing incorrect product information at the time of purchase, claims for defective containment solutions which may impair drug efficacy and other claims in the ordinary course of business. Furthermore, there may be product liability risks that are unknown or which become known in the future.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeIn particular, such dividends are included for (i) 58.14 percent of their amount as to dividends paid out of profits realized in the tax years following the one in progress on December 31, 2016, (ii) 49.72 percent of their amount as to dividends paid out of profits realized from the tax year following the one in progress on December 31, 2007 up to the one in progress on December 31, 2016, and (iii) 40 percent of their amounts as to dividends paid out of profits realized in the tax years up to that in progress on December 31, 2007.
Biggest changeIn particular, dividends received by: 1. partnerships and similar entities as referred to in article 5 of the TUIR (e.g., società in nome collettivo or società in accomandita semplice ), as per the 2026 Italian Budget Law are wholly included in the relevant taxable and then proportionally allocated to the relevant partners on a look-through basis, only when the shareholding meets at least one of these conditions (i) a >5% director or indirect interest, or (ii) acquisition cost/value >€500,000, such dividends are included for (i) 58.14 percent of their amount as to dividends paid out of profits realized in the tax years following the one in progress on December 31, 2016, (ii) 49.72 percent of their amount as to dividends paid out of profits realized from the tax year following the one in progress on December 31, 2007 up to the one in progress on December 31, 2016, and (iii) 40 percent of their amounts as to dividends paid out of profits realized in the tax years up to that in progress on December 31, 2007.
Holder” is a beneficial owner of Shares that is, for U.S. federal income tax purposes: o an individual who is a citizen or resident of the United States; o a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created in, or organized under the laws of, the United States or any political subdivision thereof; o an estate the income of which is includible in gross income for U.S. federal income tax purposes regardless of its source; or o a trust (i) if a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all of the trust's substantial decisions, or (ii) the trust has validly elected to be treated as a domestic trust for U.S. federal income tax purposes.
Holder” is a beneficial owner of Shares that is, for U.S. federal income tax purposes: • an individual who is a citizen or resident of the United States; • a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created in, or organized under the laws of, the United States or any political subdivision thereof; • an estate the income of which is includible in gross income for U.S. federal income tax purposes regardless of its source; or • a trust (i) if a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all of the trust's substantial decisions, or (ii) the trust has validly elected to be treated as a domestic trust for U.S. federal income tax purposes.
Dividends paid to individual shareholders who have entrusted the management of their financial assets, including the Shares, to an authorized intermediary and have expressly elected for the discretionary investment portfolio regime (Regime del Risparmio Gestito, set forth by article 7 of Legislative Decree No. 461 of November 21, 1997 (“Decree 461/97”), as illustrated below) are not subject to WHT, and are included in the computation of the accrued annual increase in value of the managed assets, subject to an ad hoc 26 percent substitute tax withheld by the authorized intermediary pursuant to article 7(4) of Legislative Decree No. 461 of November 21, 1997.
Dividends paid to individual shareholders who have entrusted the management of their financial assets, including the Shares, to an authorized intermediary and have expressly elected for the discretionary investment portfolio regime (Regime del Risparmio Gestito, set forth by article 7 of Legislative Decree No. 461 of November 21, 1997 (“Decree 461/97”), as illustrated below) are not subject to WHT, and are included in the computation of the accrued annual 138 increase in value of the managed assets, subject to an ad hoc 26 percent substitute tax withheld by the authorized intermediary pursuant to article 7(4) of Legislative Decree No. 461 of November 21, 1997.
Subject to certain exceptions, transfers of assets and rights (including the Shares) on death or by gift are generally subject to inheritance and gift tax: o at a rate of 4 percent in case of transfers made to the spouse or relatives in direct line, on the portion of the global net value of the transferred assets, if any, exceeding, for each beneficiary, Euro 1,000,000; o at a rate of 6 percent in case of transfers made to relatives to the fourth degree or relatives-in-law to the third degree (in the case of transfers to brothers or sisters, the 6% rate is applicable only on the portion of the global net value of the transferred assets, if any, exceeding, for each beneficiary, Euro 100,000); and o at a rate of 8 percent in any other case.
Subject to certain exceptions, transfers of assets and rights (including the Shares) on death or by gift are generally subject to inheritance and gift tax: • at a rate of 4 percent in case of transfers made to the spouse or relatives in direct line, on the portion of the global net value of the transferred assets, if any, exceeding, for each beneficiary, Euro 1,000,000; • at a rate of 6 percent in case of transfers made to relatives to the fourth degree or relatives-in-law to the third degree (in the case of transfers to brothers or sisters, the 6% rate is applicable only on the portion of the global net value of the transferred assets, if any, exceeding, for each beneficiary, Euro 100,000); and • at a rate of 8 percent in any other case.
References to “Italian White List” are to the list of countries and territories allowing a satisfactory exchange of information with Italy (i) currently included in the Italian Ministerial Decree of September 4, 1996, as subsequently 135 amended and supplemented or (ii) once effective in any other decree or regulation that will be issued in the future to provide the list of such countries and territories (and that will replace Ministerial Decree of September 4, 1996), including any country or territory that will be deemed listed therein for the purpose of any interim rule.
References to “Italian White List” are to the list of countries and territories allowing a satisfactory exchange of information with Italy (i) currently included in the Italian Ministerial Decree of September 4, 1996, as subsequently amended and supplemented or (ii) once effective in any other decree or regulation that will be issued in the future to provide the list of such countries and territories (and that will replace Ministerial Decree of September 4, 1996), including any country or territory that will be deemed listed therein for the purpose of any interim rule.
The Shares are expected to constitute foreign financial assets subject to these requirements unless the Shares are held in an account at certain financial institutions. Significant penalties may be imposed for failure to comply with these reporting requirements.U.S. Holders should consult their tax advisors regarding the application of these rules. F. Dividends and Paying Agents Not applicable. 147 G.
The Shares are expected to constitute foreign financial assets subject to these requirements unless the Shares are held in an account at certain financial institutions. Significant penalties may be imposed for failure to comply with these reporting requirements.U.S. Holders should consult their tax advisors regarding the application of these rules. F. Dividends and Paying Agents Not applicable. G.
The application of the above-described tax relief, WHT reduction under the double tax treaties or WHT exemption, is subject to conditions required under the applicable laws and/or treaties, which may vary depending on the case, as well as to the fulfillment by the shareholders of certain formalities, such as the timely provision to the withholding tax agent of affidavits, self-statements and tax residence certificates.
The application of the above-described tax relief, WHT reduction under the double tax treaties or WHT exemption, is subject to conditions required under the applicable laws and/or treaties, which may vary depending on 141 the case, as well as to the fulfillment by the shareholders of certain formalities, such as the timely provision to the withholding tax agent of affidavits, self-statements and tax residence certificates.
Therefore, capital gains realized are subject to substitute tax at the rate of 26 percent (under one of the regimes described above for “Italian resident individuals not carrying out business activities”). The tax regimes described above will not prevent the application, if more favorable to the taxpayer, of any different provisions of any applicable double taxation treaty with Italy.
Therefore, capital gains realized are subject to substitute tax at the rate of 26 percent (under one of the regimes described above for “Italian resident individuals not carrying out business activities”). 144 The tax regimes described above will not prevent the application, if more favorable to the taxpayer, of any different provisions of any applicable double taxation treaty with Italy.
Holders to make a qualified electing fund election, which, if available, would result in tax treatment different from the general tax treatment for PFICs discussed above. If we are considered a PFIC, a U.S. Holder also will be subject to annual information reporting requirements. If we are a PFIC for any taxable year during which a U.S.
Holders to make a qualified electing fund election, which, if available, would result in tax treatment different from the general tax treatment for PFICs discussed above. If we are considered a PFIC, a U.S. Holder also will be subject to annual information reporting requirements. 149 If we are a PFIC for any taxable year during which a U.S.
Holder for that year, and such amounts will be increased by an additional tax equal to interest on the resulting tax deemed deferred with respect to such years; and o an additional tax equal to the interest charge generally applicable to underpayments of tax will be imposed on the tax attributable to each prior taxable year, other than a pre-PFIC year.
Holder for that year, and such amounts will be increased by an additional tax equal to interest on the resulting tax deemed deferred with respect to such years; and • an additional tax equal to the interest charge generally applicable to underpayments of tax will be imposed on the tax attributable to each prior taxable year, other than a pre-PFIC year.
Holder’s holding period prior to the first taxable year in which we are classified as a PFIC (each, a “pre-PFIC year”) will be subject to tax as ordinary income; o amounts allocated to each prior taxable year, other than a pre-PFIC year, will be subject to tax at the highest marginal tax rate in effect applicable to the U.S.
Holder’s holding period prior to the first taxable year in which we are classified as a PFIC (each, a “pre-PFIC year”) will be subject to tax as ordinary income; • amounts allocated to each prior taxable year, other than a pre-PFIC year, will be subject to tax at the highest marginal tax rate in effect applicable to the U.S.
This requirement must be met at the time when the capital gain is realized, without interruption, from at least the beginning of the third tax period preceding the one in which the gain is realized. If the aforementioned requirements are met, the capital losses made on holdings are not deductible from business income.
This requirement must be met at the time when the capital gain is realized, without interruption, from at least the beginning of the third tax period preceding the one in which the gain is realized. 143 If the aforementioned requirements are met, the capital losses made on holdings are not deductible from business income.
Based on our income and assets, and the value of our Shares, we do not believe that we were a PFIC for U.S. federal income tax purposes for the taxable year ended December 31, 2022 and we do not expect to become a PFIC 146 for the current taxable year or in any future taxable year.
Based on our income and assets, and the value of our Shares, we do not believe that we were a PFIC for U.S. federal income tax purposes for the taxable year ended December 31, 2022 and we do not expect to become a PFIC for the current taxable year or in any future taxable year.
This summary is based on the tax laws of the Republic of Italy and published case law / practice (unpublished case law / practice is not included) as it stands at the date of this annual report. The law upon which this description is based is subject to change, potentially with retroactive effect.
This summary is based on the tax laws of the Republic of Italy and published case law / practice (unpublished case law / practice is not included) as it stands at the date of this annual report. The law upon which this description 137 is based is subject to change, potentially with retroactive effect.
This summary does not address all aspects of U.S. federal income taxation that may be relevant to a particular holder in light of that holder’s particular circumstances or that may be relevant to certain types of holders subject to special treatment under U.S. federal income tax law, such as: o banks and other financial institutions; o insurance companies; o pension plans; o cooperatives; o regulated investment companies; o real estate investment trusts; o broker-dealers; o traders that elect to use a mark-to-market method of accounting; o certain former citizens or long-term residents of the United States; o tax-exempt entities (including private foundations); o persons holding Shares through individual retirement accounts or other tax-deferred accounts; 144 o persons who acquire Shares pursuant to any employee share option or otherwise as compensation; o persons who hold Shares as part of a straddle, hedge, conversion, constructive sale or other integrated transaction for U.S. federal income tax purposes; o persons whose functional currency is not the U.S.
This summary does not address all aspects of U.S. federal income taxation that may be relevant to a particular holder in light of that holder’s particular circumstances or that may be relevant to certain types of holders subject to special treatment under U.S. federal income tax law, such as: • banks and other financial institutions; 146 • insurance companies; • pension plans; • cooperatives; • regulated investment companies; • real estate investment trusts; • broker-dealers; • traders that elect to use a mark-to-market method of accounting; • certain former citizens or long-term residents of the United States; • tax-exempt entities (including private foundations); • persons holding Shares through individual retirement accounts or other tax-deferred accounts; • persons who acquire Shares pursuant to any employee share option or otherwise as compensation; • persons who hold Shares as part of a straddle, hedge, conversion, constructive sale or other integrated transaction for U.S. federal income tax purposes; • persons whose functional currency is not the U.S.
Holder in an amount equal to the U.S. Dollar value of the Euros received calculated by reference to the exchange rate in effect on the date the dividend distribution is received, regardless of whether the payment is in fact converted into U.S. Dollars on such date. 145 If the Euros are converted into U.S.
Holder in an amount equal to the U.S. Dollar value of the Euros received calculated by reference to the exchange rate in effect on the date the dividend distribution is received, regardless of whether the payment is in fact converted into U.S. Dollars on such date. If the Euros are converted into U.S.
Under these special tax rules: o the excess distribution or gain will be allocated pro rata over the U.S. Holder’s holding period for the Shares; o amounts allocated to the current taxable year and to any taxable years in the U.S.
Under these special tax rules: • the excess distribution or gain will be allocated pro rata over the U.S. Holder’s holding period for the Shares; • amounts allocated to the current taxable year and to any taxable years in the U.S.
This provision applies with reference to shares acquired during the 36 month period prior to the realization of capital losses or negative differences, provided that the conditions under (c) and (d) above are met; such a provision does not apply to parties who prepare their financial statements in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board referred to in Regulation (EC) No. 1606/2002 of the European Parliament and Council of July 19, 2002.
This provision applies with reference to shares acquired during the 36 month period prior to the realization of capital losses or negative differences, provided that the conditions under (c) and (d) above are met; such a provision does not apply to parties who prepare their financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board referred to in Regulation (EC) No. 1606/2002 of the European Parliament and Council of July 19, 2002.
Dollar; o persons who actually or constructively own 10% or more of our stock (by vote or value); and o partnerships or other entities or arrangements subject to tax as partnerships for U.S. federal income tax purposes.
Dollar; • persons who actually or constructively own 10% or more of our stock (by vote or value); and • partnerships or other entities or arrangements subject to tax as partnerships for U.S. federal income tax purposes.
Holders should consult their tax advisors regarding the tax consequences to them if a foreign tax is imposed on their disposition of Shares, including with respect to the availability of the foreign tax credit in their particular circumstances.
Holders should consult their tax 148 advisors regarding the tax consequences to them if a foreign tax is imposed on their disposition of Shares, including with respect to the availability of the foreign tax credit in their particular circumstances.
Partnerships holding our shares and their partners should consult their tax advisors regarding an investment in our shares. Distributions The gross amount of any distributions received by a U.S.
Partnerships holding our shares and their partners should consult their tax advisors regarding an investment in our shares. 147 Distributions The gross amount of any distributions received by a U.S.
To parties who prepare their financial statements in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board the shares not accounted as “held for trading” are deemed as fixed financial assets; (c) residence for tax purposes of the participated entity in a country other than those with a privileged tax regime in accordance with the criteria set out in article 47-bis(1) of the CITA.
To parties who prepare their financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board the shares not accounted as “held for trading” are deemed as fixed financial assets; (c) residence for tax purposes of the participated entity in a country other than those with a privileged tax regime in accordance with the criteria set out in article 47-bis(1) of the CITA.
Under the “risparmio amministrato” regime, the shareholder is not required to declare capital gains in its annual tax return. (c) Discretionary investment portfolio (“risparmio gestito”) regime (optional).
Under the “risparmio amministrato” regime, the shareholder is not required to declare capital gains in its annual tax return. 142 (c) Discretionary investment portfolio (“risparmio gestito”) regime (optional).
Based on the specific FTT regulations, on the assumption that the NYSE is considered a regulated stock market for FTT purposes, the transfer of the Shares should be subject to 0.10 percent FTT tax rate. Shareholders are recommended to consult their independent advisors with respect to the application of FTT.
Based on the specific FTT regulations, on the assumption that the NYSE is considered a regulated stock market for FTT purposes, the transfer of the Shares should be subject to 0.20 percent FTT tax rate. Shareholders are recommended to consult their independent advisors with respect to the application of FTT.
However, if the recipient is a company applying the International Financial Reporting Standards as issued by the International Accounting Standards Board , dividends arising from securities accounted for in the financial statements as held for trading purposes only, would be fully included in the recipient’s taxable income for IRES purposes.
However, if the recipient is a company applying the IFRS Accounting Standards as issued by the International Accounting Standards Board , dividends arising from securities accounted for in the financial statements as held for trading purposes only, would be fully included in the recipient’s taxable income for IRES purposes.
(ii) Italian resident individuals shareholders holding the Shares in connection with a business activity and partnerships and similar entities (excluding non-commercial partnerships) Capital gains realized by partnerships and similar entities or Italian residents on the sale or disposal of the Shares held in connection with a business activity, are included in the recipients’ overall taxable income for the entire amount in the tax year in which they are realized, subject to income tax at ordinary rates.
(ii) Italian resident individuals shareholders holding the Shares in connection with a business activity and partnerships and similar entities (excluding non-commercial partnerships) Capital gains realized by partnerships and similar entities or Italian residents on the sale or disposal of the Shares held in connection with a business activity, as per the 2026 Italian Budget Law are wholly included in the recipients’ overall taxable income for the entire amount in the tax year in which they are realized, subject to income tax at ordinary rates.
(iii) Italian companies and commercial entities Capital gains realized by Italian resident commercial companies subject to IRES, private and public entities and trusts whose sole or principal purpose is to carry out a business activity, are included in their taxable income and are subject to IRES according to the ordinary rules.
(iii) Italian companies and commercial entities Capital gains realized by Italian resident commercial companies subject to IRES, private and public entities and trusts whose sole or principal purpose is to carry out a business activity, as per the 2026 Italian Budet Law, are wholly included in their taxable income and are subject to IRES according to the ordinary rules.
The audited financial statements are prepared in accordance with IFRS and include an “Operating and Financial Review and Prospects” section for the relevant periods. I. Subsidiary Information Not applicable. J. ANNUAL REPORT TO SECURITY HOLDERS The Company intends to submit any annual report provided to security holders in electronic format as an exhibit to a current report on Form 6-K.
The audited financial statements are prepared in accordance with IFRS. I. Subsidiary Information Not applicable. J. ANNUAL REPORT TO SECURITY HOLDERS The Company intends to submit any annual report provided to security holders in electronic format as an exhibit to a current report on Form 6-K.
Under certain conditions, capital gains on the Shares realized by certain companies and commercial entities are also subject to IRAP, at ordinary rates. 141 (iv) Non-commercial entities, which are resident in Italy for tax purposes Capital gains realized on the sale or disposal of the Shares by Italian-resident public or private non-commercial entities and trusts are subject to the tax regime described in connection with capital gains realized by Italian resident individual shareholders otherwise than in connection with a business activity.
(iv) Non-commercial entities, which are resident in Italy for tax purposes Capital gains realized on the sale or disposal of the Shares by Italian-resident public or private non-commercial entities and trusts are subject to the tax regime described in connection with capital gains realized by Italian resident individual shareholders otherwise than in connection with a business activity.
No Italian tax is levied at source on Italian entities that are excluded from income taxation pursuant to article 74(1) of the CITA. 137 (v) Italian pension funds and OICR (other than real estate investment funds or real estate SICAF) Dividends received by Italian pension funds established pursuant to article 17 of Legislative Decree No. 252 of December 5, 2005 are not subject to WHT and are included in the annual net accrued results of the pension fund, which is subject to a substitute tax of 20 percent.
(v) Italian pension funds and OICR (other than real estate investment funds or real estate SICAF) Dividends received by Italian pension funds established pursuant to article 17 of Legislative Decree No. 252 of December 5, 2005 are not subject to WHT and are included in the annual net accrued results of the pension fund, which is subject to a substitute tax of 20 percent.
Prospective investors should consult their advisers in case any distributions of such capital reserves occur. 139 Tax Regime for Capital Gains Realized Upon Transfer of Shares (i) Italian resident individuals not carrying out business activities Capital gains, other than those realized in connection with the carrying out of a business activity, realized by individuals resident in Italy for tax purposes upon transfer for consideration of shares are subject to the same tax regime whether they are realized upon Transfer of Qualified Shareholdings or Transfer of Non-Qualified Shareholdings.
Tax Regime for Capital Gains Realized Upon Transfer of Shares (i) Italian resident individuals not carrying out business activities Capital gains, other than those realized in connection with the carrying out of a business activity, realized by individuals resident in Italy for tax purposes upon transfer for consideration of shares are subject to the same tax regime whether they are realized upon Transfer of Qualified Shareholdings or Transfer of Non-Qualified Shareholdings.
IRPEF is generally levied at progressive rates ranging from 23 percent to 43 percent, plus local surcharges. 136 Dividends received by resident individual shareholders not engaged in a business activity, in connection with a Qualified Shareholding not held in the context of the discretionary investment portfolio regime, are subject to the same 26 percent WHT applicable in connection with dividends received on Non-Qualified Shareholding and do not have to be reported in the shareholders’ annual income tax return.
Dividends received by resident individual shareholders not engaged in a business activity, in connection with a Qualified Shareholding not held in the context of the discretionary investment portfolio regime, are subject to the same 26 percent WHT applicable in connection with dividends received on Non-Qualified Shareholding and do not have to be reported in the shareholders’ annual income tax return.
Non-Italian resident shareholders may be subject to tax in Italy as a result of the distribution of such reserves pursuant to the same tax regime applicable to dividends as described at section “Tax Regime for Dividends” above.
Non-Italian resident shareholders may be subject to tax in Italy as a result of the distribution of such reserves pursuant to the same tax regime applicable to dividends as described at section “Tax Regime for Dividends” above. Prospective investors should consult their advisers in case any distributions of such capital reserves occur.
For these purposes (taxation of the recipient), profits realized in the tax years up to the tax year in progress on December 31, 2007, and then profits realized in the tax years up to the tax year in progress on December 31, 2016 are deemed to be distributed with priority; 2. entities subject to IRES as referred to in article 73(1) sections a) and b) of CITA (e.g., commercial and non-commercial entities such as società per azioni or società in accomandita per azioni ), are included in the entities’ total taxable income for an amount equal to 5 percent of the received dividend amount and subject to the corporate income tax (“IRES”, currently levied at a rate of 24 percent).
For these purposes (taxation of the recipient), profits realized in the tax years up to the tax year in progress on December 31, 2007, and then profits realized in the tax years up to the tax year in progress on December 31, 2016 are deemed to be distributed with priority; 2. entities subject to IRES as referred to in article 73(1) sections a) and b) of CITA (e.g., commercial and non-commercial entities such as società per azioni or società in accomandita per azioni ), as per the 2026 Italian Budget Law, are wholly included in the entities’ total taxable income only when the shareholding meets at leastd one of these conditions (i) a >5% director or indirect interest, or (ii) acquisition cost/value >€500,000, 139 then the inclusion in total taxable income is limited for an amount equal to 5 percent of the received dividend amount and subject to the corporate income tax (“IRES”, currently levied at a rate of 24 percent).
The FTT rates are equal to 0.10 percent for transfers of shares executed in regulated stock markets or through multilateral trading facilities and 0.20 percent for all other taxable transfers.
After the changes introduced by the 2026 Italian Budget Law, the FTT rates are equal to 0.20 percent for transfers of shares executed in regulated stock markets or through multilateral trading facilities and 0.40 percent for all other taxable transfers.
Only 5 percent of the dividends are included in the overall income subject to IRES, unless the Shares are booked as shares held for trading by holders applying the International Financial Reporting Standards as issued by the International Accounting Standards Board. In this case, dividends would be fully included in the recipient’s taxable income for IRES purposes.
Only 5 percent of the dividends are included in the overall income subject to IRES, unless the Shares are booked as shares held for trading by holders applying the IFRS Accounting Standards as issued by the International Accounting Standards Board.
Tax Monitoring Obligations Individuals, non-commercial entities and certain partnerships (in particular, società semplici or similar partnerships in accordance with article 5 of the TUIR) resident in Italy for tax purposes are required to report in their yearly income tax return, for tax monitoring purposes, the amount of securities and financial instruments (including the Shares) held abroad during a tax year, from which income taxable in Italy may be derived. 143 In relation to the Shares, such reporting obligation shall not apply if the Shares are not held abroad and, in any case, if the Shares are deposited with an Italian financial intermediary that intervenes in the collection of the relevant income and the intermediary applied the due withholding or substitute tax on any income derived from such Shares.
Tax Monitoring Obligations Individuals, non-commercial entities and certain partnerships (in particular, società semplici or similar partnerships in accordance with article 5 of the TUIR) resident in Italy for tax purposes are required to report in their yearly income tax return, for tax monitoring purposes, the amount of securities and financial instruments (including the Shares) held abroad during a tax year, from which income taxable in Italy may be derived.
If the Shares were held and accounted for as fixed financial assets in the three-year period preceding the disposal, the shareholder may elect to spread any realized gain on a straight line basis across the five-year period commencing in the tax year in which the gain is realized and the following four pursuant to article 86(4) of the CITA.
However, when the shareholding meets at least one of these conditions (i) a >5% director or indirect interest, or (ii) acquisition cost/value >€500,000 and if the Shares were held and accounted for as fixed financial assets in the three-year period preceding the disposal, the shareholder may elect to spread any realized gain on a straight line basis across the five-year period commencing in the tax year in which the gain is realized and the following four pursuant to article 86(4) of the CITA.
For some types of businesses and under certain conditions, dividends are also included in the net value of production, which is subject to IRAP.
In this case, dividends would be fully included in the recipient’s taxable income for IRES purposes. 140 For some types of businesses and under certain conditions, dividends are also included in the net value of production, which is subject to IRAP.
However, if the conditions indicated in the following paragraph for the partial exemption provided for capital gains realized by Italian resident companies and commercial entities were satisfied, these capital gains would be subject to tax only partially, in an amount equal 140 to 58.14% (49.72% for commercial partnerships) of the capital gains realized.
However, when the shareholding meets at least one of thease conditions (i) a >5% director or indirect interest, or (ii) acquisition cost/value >€500,000 and if the conditions indicated in the following paragraph for the partial exemption provided for capital gains realized by Italian resident companies and commercial entities were satisfied, these capital gains would be subject to tax only partially, in an amount equal to 58.14% (49.72% for commercial partnerships) of the capital gains realized.
Capital gains realized by non-resident shareholders holding the shareholding through a permanent establishment in Italy are included in the permanent establishment’s overall taxable income and are subject to tax in accordance with the tax regime indicated for capital gains realized by Italian resident companies or commercial entities, above. 142 Financial Transaction Tax Article 1(491-500) of Law No. 228 of December 24, 2012 introduced a financial transaction tax (“FTT”) applicable, among others, to the transfers of the ownership of (i) shares issued by Italian joint stock companies ( società per azioni ), (ii) participating financial instruments (as defined under article 2346(6) of the Italian Civil Code) issued by Italian resident corporations and (iii) securities representing equity investments in Italian resident corporations.
Financial Transaction Tax Article 1(491-500) of Law No. 228 of December 24, 2012 introduced a financial transaction tax (“FTT”) applicable, among others, to the transfers of the ownership of (i) shares issued by Italian joint stock companies ( società per azioni ), (ii) participating financial instruments (as defined under article 2346(6) of the Italian Civil Code) issued by Italian resident corporations and (iii) securities representing equity investments in Italian resident corporations.
Under article 10 of the Italy-U.S. double tax treaty (a) treaty entitled U.S. resident shareholders can generally benefit from a reduced WHT rate on dividends equal to 15 percent, (b) treaty entitled U.S. resident companies can benefit, under certain conditions, from a reduced WHT rate on dividends equal to 5 percent, and (c) certain qualified U.S. governmental entities are entitled, under certain conditions, to a full exemption from WHT on dividends. 138 The domestic WHT rate on dividends is 1.2 percent (and not 26 percent) if the recipients and beneficial owners of the dividends are companies or entities that are (a) resident for tax purposes in an EU Member State or in a State that is party to the European Economic Area Agreement (“EEA Member State”) and is included in the Italian White List and (b) subject to corporate income tax in such State.
The domestic WHT rate on dividends is 1.2 percent (and not 26 percent) if the recipients and beneficial owners of the dividends are companies or entities that are (a) resident for tax purposes in an EU Member State or in a State that is party to the European Economic Area Agreement (“EEA Member State”) and is included in the Italian White List and (b) subject to corporate income tax in such State.
Such dividends are partially included in the individual shareholders’ taxable income, subject to personal income tax (“IRPEF”) for (i) 58.14 percent of their amount as to dividends paid out of profits realized in the tax years following the one in progress on December 31, 2016, (ii) 49.72 percent of their amount as to dividends paid out of profits realized from the tax year following the one in progress on December 31, 2007 up to the one in progress on December 31, 2016 and (iii) 40 percent of their amounts as to dividends paid out of profits realized in the tax years up to that in progress on December 31, 2007.
As per the 2026 Italian Budget Law, such dividends are wholly included in the individual shareholders’ taxable income, subject to personal income tax (“IRPEF”),only when the shareholding meets at least one of these conditions (i) a >5% director or indirect interest,or (ii) acquisition cost/value >€500,000 the inclusion to personal income tax is limited for (i) 58.14 percent of their amount as to dividends paid out of profits realized in the tax years following the one in progress on December 31, 2016, (ii) 49.72 percent of their amount as to dividends paid out of profits realized from the tax year following the one in progress on December 31, 2007 up to the one in progress on December 31, 2016 and (iii) 40 percent of their amounts as to dividends paid out of profits realized in the tax years up to that in progress on December 31, 2007.
Tax on the Value of Financial Activities Held Abroad Italian resident individuals, certain partnerships ( società semplici ) and non-commercial entities holding financial activities abroad shall be generally subject to tax on the value thereof (“Ivafe”).
Tax on the Value of Financial Activities Held Abroad Italian resident individuals, certain partnerships ( società semplici ) and non-commercial entities holding financial activities abroad shall be generally subject to tax on the value thereof (“Ivafe”). 145 Ivafe applies at a rate of 0.2 percent on the value of the financial activity and is due in proportion to the percentage of ownership and the holding period.
Such an obligation does not apply to parties who prepare their financial statements in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Such an obligation does not apply to parties who prepare their financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board. Under certain conditions, capital gains on the Shares realized by certain companies and commercial entities are also subject to IRAP, at ordinary rates.
Any such change may invalidate the contents of this description, which will not be updated to reflect this change. Definitions For purposes of this section of this annual report, the terms defined have the meaning described below. References to “CITA” are to Presidential Decree No. 917 of December 22, 1986 (the Consolidated Income Tax Act).
References to “CITA” are to Presidential Decree No. 917 of December 22, 1986 (the Consolidated Income Tax Act).
Removed
In particular, dividends received by: 1. partnerships and similar entities as referred to in article 5 of the TUIR (e.g., società in nome collettivo or società in accomandita semplice ) are partially included in the relevant taxable and then proportionally allocated to the relevant partners on a look-through basis.
Added
Any such change may invalidate the contents of this description, which will not be updated to reflect this change. The Italian 2026 Budget Law introduced changes to the tax framework applicable to financial investments. In particular, it revised the rules governing the taxation of dividends and capital gains, with the aim of updating the existing regime.
Removed
Ivafe applies at a rate of 0.2 percent on the value of the financial activity and is due in proportion to the percentage of ownership and the holding period.
Added
The law also amended certain aspects of the Financial Transaction Tax (FTT), affecting the scope and application of the levy; details of the changes are described in the relevant sections. Definitions For purposes of this section of this annual report, the terms defined have the meaning described below.
Added
IRPEF is generally levied at progressive rates ranging from 23 percent to 43 percent, plus local surcharges.
Added
No Italian tax is levied at source on Italian entities that are excluded from income taxation pursuant to article 74(1) of the CITA.
Added
Under article 10 of the Italy-U.S. double tax treaty (a) treaty entitled U.S. resident shareholders can generally benefit from a reduced WHT rate on dividends equal to 15 percent, (b) treaty entitled U.S. resident companies can benefit, under certain conditions, from a reduced WHT rate on dividends equal to 5 percent, and (c) certain qualified U.S. governmental entities are entitled, under certain conditions, to a full exemption from WHT on dividends.
Added
Capital gains realized by non-resident shareholders holding the shareholding through a permanent establishment in Italy are included in the permanent establishment’s overall taxable income and are subject to tax in accordance with the tax regime indicated for capital gains realized by Italian resident companies or commercial entities, above.
Added
In relation to the Shares, such reporting obligation shall not apply if the Shares are not held abroad and, in any case, if the Shares are deposited with an Italian financial intermediary that intervenes in the collection of the relevant income and the intermediary applied the due withholding or substitute tax on any income derived from such Shares.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

124 edited+25 added−25 removed106 unchanged
Biggest changeIn-Vitro Diagnostic In-vitro diagnostic is an important and 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 high growth.
Biggest changeWith 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. 44 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%.
By partnering with customers in the early 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.
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.
We provide a diverse range of products, processes and services to these customers, both within our Biopharmaceutical and Diagnostic Solutions segment and our Engineering segment.
We provide a diverse range of products, processes and services to these customers, both within our Biopharmaceutical and Diagnostic Solutions and our Engineering Segment.
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 appropriate quality control measures are established before production starts in the industrialization phase.
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.
The agreement contains customary termination provisions, allowing for termination upon the other party’s default not cured within 30 days and bankruptcy, dissolution, suspension or other similar event. 62 Quality control Providing high-quality products with specificity, sensitivity and consistency, coupled with extensive product validation data are fundamental drivers of customer loyalty.
The agreement contains customary termination provisions, allowing for 62 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.
We are subject to rigorous audits by certification bodies and our customers, who perform more than 180 audits a year on our manufacturing facilities.
We are subject to rigorous audits by certification bodies and our customers, who perform more than 180 audits a year on our manufacturing facilities.
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; • population experiencing more complex health conditions and the increasing incidence of chronic diseases (e.g., diabetes, obesity) and co-morbidities; • 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; • increasing propensity of biotechnology companies to outsource non-core competencies such as washing and sterilization of drug containers; and 41 • 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.
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.
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; • 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.
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; 50 • 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.
Our integrated offering and track record of operational excellence has made us a partner of choice to the pharmaceutical, biotechnology and life sciences industries. 44 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.
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.
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 48 biologic therapies covering both innovator and biosimilar products.
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.
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, which makes us a unique player in the market, enables us to minimize waste and maximize efficiency.
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.
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 45 reducing waste and maximizing our efficiency as a group.
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.
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. To the extent projects are delayed, accelerated, or changed the timing of our revenue could be affected.
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. 57 To the extent projects are delayed, accelerated, or changed the timing of our revenue could be affected.
The strong relationships we have developed with our customers and our ability to work alongside them across each stage of the drug development process, from pre-clinical to clinical stage and commercialization, allow us to understand their specific needs at an early stage of the drug development and production process and provide appropriate solutions for such needs.
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.
Among our key high-value solutions is our EZ- Fill ® line of ready-to-fill 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)” .
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)” .
The molds allow the production of up to 128 parts in a single cycle, which can last between 4 and 30 seconds; 59 (iii) Assembly : injection molded components can be assembled among themselves or with rubber, glass, metal or electronic components.
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.
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 vaccines and biologics.
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.
In our Biopharmaceutical and Diagnostic Solutions segment, 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.
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.
As part of our cybersecurity improvement program, we have: • 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.
As part of our cybersecurity improvement program, we have: 64 • 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.
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 to cancer and other chronic conditions.
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.
Over time, we have invested in developing innovative products, services and solutions to serve pharmaceutical and biotechnology customers, which has enabled us to form long lasting relationships underpinned by the reliability and quality of our offering, processes and services.
Over time, we have invested in developing innovative products, services and solutions to serve pharmaceutical and biotechnology customers, which 56 has enabled us to form long lasting relationships underpinned by the reliability and quality of our offering, processes and services.
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 2023 revenue, according to data collected by Pharmacircle and public companies’ information.
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.
High-value solutions are products and services for which we hold intellectual property rights or have strong proprietary know-how, and that are characterized by technological and 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.
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.
Each glass tube is diverted into forming machines and shaped through a system of flames, blown air and toolings 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.
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.
Our comprehensive product portfolio makes us an attractive partner to both small, emerging businesses, 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.
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.
Our strong corporate culture allows us 46 to continuously expand these perspectives by adding diverse talent with deep knowledge and broad experience to our team.
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 secondary packaging solutions include cartoning machines, packaging machinery, and palletizing modules thereby ensuring traceability through serialization. • Pharmaceutical Visual Inspection Equipment : we provide inspection solutions 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 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.
Throughout 2024, 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.
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.
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 products we manufacture and can respond faster to customer needs for new or customized 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 inspection techniques include visual, mechanical, video and light beam technology; (iv) Packaging : as they leave the production line, the 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 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.
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, 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 43 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.
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.
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 position us well to serve our global pharmaceutical, biotechnology and life sciences customers.
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.
Our EZ-Fill ® process for syringes, vials and cartridges consists of five main steps: (i) Container washing : the 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 assure final user functionality of the system during injection.
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.
We intend 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 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.
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, the facility is expected to produce EZ-fill ® syringes and vials in response to market needs for ready-to-use drug containment products.
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, 61 the facility is expected to produce EZ-fill ® syringes and cartridges in response to market needs for ready-to-use drug containment products.
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 growing demand for biologics and biosimilars; increasing quality to meet market expectations; 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 believe that we will continue to benefit from favorable macro trends such as aging demographics, with more complex health needs; pharmaceutical innovation and the 47 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 will continue to further strengthen our cybersecurity program in 2025. We are not aware of any material cybersecurity incident over the past years, nonetheless the company is covered by a cybersecurity insurance plan.
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.
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 vaccine markets.
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 a result of the experience gained designing our greenfield plants in Italy, China, Mexico and Brazil, our offering includes support and consultancy around: (i) plant design, (forming lines, clean room areas and laboratory 55 layout); (ii) plant construction (production flow, piping and instrumentation diagrams); and (iii) plant engineering (preliminary plant studies).
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).
Drug Delivery Systems (“DDS”) Our addressable market in DDS, including both Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations, consists of pen-injectors, dry powder inhalers, auto injectors, and non-insulin on-body delivery systems.
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.
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 (Americas, EMEA and APAC) and key accounts, and horizontally, by business activity (technical pre-sales, product managers, aftersales and business development).
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).
Each of our plastic 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.
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.
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 2025. • further improved a “data factory” data intelligence solution based on Microsoft Synapse technology, providing business intelligence data.
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.
We believe our EZ-Fill ® solution positions us ahead of many of our direct competitors, 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.
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.
In 2022, we elected to accelerate our investment in the United States in response to increased demand from customers. Under the refined investment plan, the manufacturing facility is expected to be up to 565,000 square-feet and with more than 500 new full-time positions.
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.
Primary Packaging (Syringes EZ-Fill ® ) 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).
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).
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 $13 billion in 2024. Our addressable market estimation is based on data gathered by IQVIA Ltd.
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.
Our high-value solutions represent a cross-section of our portfolio, including glass and polymer drug containment solutions such as NEXA ® , NEXA Flex TM , LDP, ALBA ® and a significant proportion of our EZ-Fill ® line, as well as other drug delivery devices, molecular diagnostic solutions and analytical services.
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.
We also serve eight of the top ten biotechnology companies (by market capitalization listed in the Nasdaq Biotechnology Index), and over 100 biotechnology customers in total.
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.
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 planned expansion in Italy, the U.S., and China also offers our customer base faster response time and supply chain redundancy, reducing risk for just in time manufacturing.
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.
Our customer base includes 23 of the top 25 pharmaceutical companies, and six of the top ten in-vitro diagnostic companies, as measured by 2023 revenue, according to data collected by Pharmacircle and public companies’ information. We also serve eight of the top ten biotechnology companies by market capitalization in the Nasdaq Biotechnology Index and over 100 biotechnology customers in total.
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.
Our sales team, of approximately 160 employees, works closely together in each area and region to ensure a coordinated approach.
Our sales team, of approximately 190 employees, works closely together in each area and region to ensure a coordinated approach.
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 EZ-Fill ® , ready-to-use vials and number one in pen cartridges, the global standard for diabetes care.
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.
We operate on a global scale, offering our products, processes and services in approximately 70 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.
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.
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 l® 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).
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).
Over the last five years, revenue from our high-value solutions has steadily grown and represented 38.3% of our total revenue for the year ended December 31, 2024. 49 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.
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.
We seek to maintain high levels of engagement with our customer base in order to deepen our relationships over time. Our deep, tenured relationships with our customers are supported by multi-year contracts which often contain cost pass-through provisions and have resulted in large recurring revenue streams.
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.
Cartridges are offered both in ready-to-fill (EZ-Fill ® ) and bulk options; • Vials : a broad range of vials, differentiated by size and capacity as well as ready-to-fill (EZ-Fill ® ) and bulk options.
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.
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.
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.
Based on data collected by IQVIA, we estimate the total addressable market for DDS, including proprietary and contract development manufacturing services, to be approximately $3.1 billion as of 2024, and the market is expected to grow at a CAGR of 9% through 2030.
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.
We believe that customers rely on us because of our technical expertise, as well as our ability to design high quality containment format with the best possible processes to meet their needs and the specifications required to effectively contain and deliver their drugs.
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.
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 specifics boxes and then onto pallets to be then shipped to the external sterilization service provider.
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. 59 Following the washing phase, the process is in an ISO 5 environment through final packaging.
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 comprises more than 160 highly skilled and specialized employees based in our facilities in Italy (Piombino Dese and Milan), Germany (Bad Oeynhausen) and the U.S. (Boston).
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).
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.
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.
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, bypass syringes or double-chamber systems, as well as COP and COC pre-fillable syringes through our exclusive agreement with Transcoject.
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 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 2024, our ten largest customers accounted for 51.4% of our consolidated revenue, and one customer accounted for 10.3% of consolidated revenue.
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.
We believe that this has contributed greatly to our strategy building and 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.
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.
In 2024, we generated 85% of total revenue from our Biopharmaceutical and Diagnostic Solutions segment and 15% 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.
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.
Under the agreement, BARDA is making a multi-year investment for up to approximately $95 million (or approximately €90 million) 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.
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.
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 (non-GMP) Fill & Finish Service : small, flexible Fill & Finish equipment to perform preliminary work on drug product, process, or container optimization; • Consultancy (Regulatory, Compliant 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. 54 Engineering Segment Our engineering segment produces machinery for both in-house use and sale to customers.
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. 54 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.
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.
This, in turn, provides us access to customers and allows us to further secure our long- term relationships with them. 46 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.
Similarly, we sell our equipment and machinery and license certain intellectual property rights to competitors for use in their production processes. 57 Given the breadth of our offering, we have different competitors for different products, and in particular we consider the main competitors in each segment to be: • Drug Containment Solutions : Schott Pharmaceutical Systems (bulk and ready to use vials and cartridges), Becton Dickinson (pre-fillable syringes), Nipro and Gerresheimer AG (bulk and ready-to-use vials and cartridges); • Drug Delivery Systems : SHL, Ypsomed, West Pharma and Becton Dickinson; • Contract Development and Manufacturing : Jabil Packaging Solutions, Flex, Phillips Medisize, Gerresheimer AG, and West Pharma; and, • Engineering : Syntegon, Korber, ATS, IMA, Brevetti CEA and Mikron.
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.
Our strong relationships, our ability to provide a full set of solutions across the drug 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. 50 Drug Containment Solutions (DCS) DCS are mission-critical components in the production of pharmaceutical and biotechnology products.
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.
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. In 2017, we began our digital transformation process to facilitate the Group’s growth in a globally competitive market.
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.
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 has consistently achieved results by responding to market developments and by capitalizing on opportunities for organic and inorganic growth.
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.
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.
Additionally, we are expanding our production in Piombino Dese (Italy), Latina (Italy), and Fishers (Indiana, the U.S). 41 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 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.
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.
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 and a superior cosmetic quality. • Nexa Flex TM : state-of-the-art pre-sterilized polymer syringes available in COP (Cyclic Olefin Polymer) and COC (Cyclic Olefin Copolymer) material are suitable for a wide range of applications, including sensitive biologics. • 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).
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).
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.
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. 63 Logistics Our products are delivered to our customers using various third-party freight, haulage transportation and warehousing providers.
We provide life sciences companies with contract development and manufacturing 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. 56 Drug Product / Fill & Finish Contract Manufacturers We provide our solutions to drug product / fill & finish contract manufacturers.
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.

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 94 A. DIRECTORS AND SENIOR MANAGEMENT 94 B. COMPENSATION 97 C. BOARD PRACTICES 100 D. EMPLOYEES 106 E. SHARE OWNERSHIP 106 f. disclosure of a registrant's actionto recover erroneously awarded compensation ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 106 A. MAJOR SHAREHOLDERS 106 B. RELATED PARTY TRANSACTIONS 107 C.
Biggest changeITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 95 A. DIRECTORS AND SENIOR MANAGEMENT 95 B. COMPENSATION 99 C. BOARD PRACTICES 102 D. EMPLOYEES 107 E. SHARE OWNERSHIP 108 f. disclosure of a registrant's action to recover erroneously awarded compensation 108 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 108 A. MAJOR SHAREHOLDERS 108 B. RELATED PARTY TRANSACTIONS 109 C.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeNotwithstanding this, under Stevanato Holding’s articles of association, (i) the sale of the Stevanato Group shares held by Stevanato Holding or of any rights attaching to them, as well as the creation of encumbrances on such shares or on the rights attaching to them, and (ii) any transaction concerning Stevanato Group as a result of which Stevanato Holding would cease to hold the majority of the voting rights in the ordinary shareholders’ meeting of Stevanato Group, require the unanimous vote of the board of directors of Stevanato Holding, which is composed of Sergio Stevanato, Franco Stevanato and Marco Stevanato.
Biggest changeNotwithstanding this, under Stevanato Holding’s articles of association, (i) the sale of the Stevanato Group shares held by Stevanato Holding, and (ii) any transaction concerning Stevanato Group, in each case resulting in the loss, by Stevanato Holding, of direct or indirect control, including also de facto control, over Stevanato Group, require the unanimous vote of the board of directors of Stevanato Holding, which is composed of Sergio Stevanato, Franco Stevanato and Marco Stevanato.
Our Audit Committee then: • reviews the relevant facts and circumstances of each related person transaction, including the financial terms of such transaction, the benefits and perceived benefit (or lack thereof) to the Group, the availability of other sources for comparable products or services, if the transaction is on terms no less favorable to us than those that could be obtained in arm’s-length dealings with an unrelated third party or employees generally and the extent of the related person’s interest in the transaction; and • takes into account the impact on the independence of any independent director and the actual or apparent conflicts of interest.
Our Audit Committee then: • reviews the relevant facts and circumstances of each related person transaction, including the financial terms of such transaction, the benefits and perceived benefit (or lack thereof) to the Group, the availability of other sources for comparable products or services, if the transaction is on terms no less favorable to us than those 109 that could be obtained in arm’s-length dealings with an unrelated third party or employees generally and the extent of the related person’s interest in the transaction; and • takes into account the impact on the independence of any independent director and the actual or apparent conflicts of interest.
Holders of our ordinary shares have the same voting rights and are entitled to one vote per share, while holders of Class A shares (held solely by Stevanato Holding S.r.l. or in treasury by the Company) are entitled to three votes per share. 106 Unless otherwise indicated below, the address for each beneficial owner listed is Via Molinella, no. 17, Padua, Piombino Dese, Italy.
Holders of our ordinary shares have the same voting rights and are entitled to one vote per share, while holders of Class A shares (held solely by Stevanato Holding S.r.l. or in treasury by the Company) are entitled to three votes per share. 108 Unless otherwise indicated below, the address for each beneficial owner listed is Via Molinella, no. 17, Padua, Piombino Dese, Italy.
Registration of such registrable securities would result in registration of ordinary shares under the Securities Act and would result in these shares becoming freely tradable without restriction under the Securities Act immediately upon the effectiveness of the registration, except for shares purchased by affiliates. C. Interests of Experts and Counsel Not applicable. 110 I TEM 8. Financial Information A.
Registration of such registrable securities would result in registration of ordinary shares under the Securities Act and 111 would result in these shares becoming freely tradable without restriction under the Securities Act immediately upon the effectiveness of the registration, except for shares purchased by affiliates. C. Interests of Experts and Counsel Not applicable. 112 I TEM 8. Financial Information A.
SFEM Italia S.r.l. is controlled by Sergio Stevanato, Franco Stevanato and Marco Stevanato, each members of the Stevanato family. Industrial Rent In the years 2022, 2023 and 2024 Stevanato Group Denmark (a subsidiary of Stevanato Group) disbursed €418,714, €434,798, and €221,510. respectively, to E & FKH EjendommeApS in connection with the rental of the plant where Stevanato Group Denmark operates.
SFEM Italia S.r.l. is controlled by Sergio Stevanato, Franco Stevanato and Marco Stevanato, each members of the Stevanato family. 110 Industrial Rent In the years 2023 and 2024 Stevanato Group Denmark (a subsidiary of Stevanato Group) disbursed €434,798 and €221,510, respectively, to E & FKH EjendommeApS in connection with the rental of the plant where Stevanato Group Denmark operates.
As of the date of this annual report, our share capital comprised 302,842,536 shares (including 29,943,911 Class A shares held by the Company in treasury), including two shareholders of record holding Class A shares (being Stevanato Holding S.r.l. holding 223,293,976 Class A shares, and the Company holding 29,943,911 Class A shares in treasury) and shareholders of record holding ordinary shares (for an aggregate of 49,604,649 ordinary shares).
As of the date of this annual report, our share capital comprised 302,842,536 shares (including 29,838,842 Class A shares held by the Company in treasury), including two shareholders of record holding Class A shares (being Stevanato Holding S.r.l. holding 223,293,976 Class A shares, and the Company holding 29,838,842 Class A shares in treasury) and shareholders of record holding ordinary shares (for an aggregate of 49,709,718 ordinary shares).
Stevanato Holding S.r.l. holds approximately, respectively, 73.73% and 93.11% of our share capital and of the voting rights (excluding treasury shares), while other shareholders (excluding the Company) hold in aggregate approximately, respectively, 16.38% and 6.89% of our share capital and of the voting rights (excluding treasury shares).
Stevanato Holding S.r.l. holds approximately, respectively, 73.73% and 93.09% of our share capital and of the voting rights (excluding treasury shares), while other shareholders (excluding the Company) hold in aggregate approximately, respectively, 16.41% and 6.91% of our share capital and of the voting rights (excluding treasury shares).
Payment of Service Fees and Rentals During the years ended December 31, 2022 and 2023 Ompi of Japan disbursed €312,64 and €190,743 respectively, to Winckler & Co., Ltd. in connection with the rental of offices and warehouses and the supply of corporate services.
Payment of Service Fees and Rentals During the year ended December 31, 2023 Ompi of Japan disbursed €190,743 to Winckler & Co., Ltd. in connection with the rental of offices and warehouses and the supply of corporate services.
Donations to Stevanato Foundation In the years 2022, 2023 and 2024 we made aggregate donations to the Stevanato Foundation of €305,000, €240,000, and €180,000 respectively. The Stevanato Foundation is a charitable organization entirely owned by the Stevanato Family.
Incog is majority owned by Stevanato Holding S.r.l.. Donations to Stevanato Foundation In the years 2023, 2024 and 2025 we made aggregate donations to the Stevanato Foundation of €240,000, €180,000, and €290,000, respectively. The Stevanato Foundation is a charitable organization entirely owned by the Stevanato Family.
Insofar as indemnification of liabilities arising under the Securities Act may be permitted to executive officers and board members or persons controlling us pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. 109 Registration Rights Agreement Upon completion of our initial public offering on the NYSE, we and certain of our then existing shareholders entered a the Registration Rights Agreement.
Insofar as indemnification of liabilities arising under the Securities Act may be permitted to executive officers and board members or persons controlling us pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
Drug Containment Solutions and Engineering Revenues During the fiscal year ended December 31, 2022, 2023 and 2024 the Group sold Drug Containment Solutions and pharmaceutical visual inspection equipment to Incog BioPharma Services, Inc. (“Incog”), a U.S. based biopharma services company, for a total amount of €508,937, €544,534, and €5,556,994 respectively. Incog is majority owned by SFEM Italia S.r.l..
Drug Containment Solutions and Engineering Revenues During the fiscal year ended December 31, 2023, 2024 and 2025 the Group sold Drug Containment Solutions, pharmaceutical visual inspection equipment and packaging and assembly machines to Incog BioPharma Services, Inc. (“Incog”), a U.S. based biopharma services company, for a total amount of €544,534, €5,556,994, and €7,581,718, respectively.
The policy covers any transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we, or any of our parent or subsidiary companies, were or are to be a participant, and which are unusual in their nature or conditions, involving goods, services or tangible or intangible assets. 107 Pursuant to this policy, our management presents to our Audit Committee each proposed related person transaction, including all relevant facts and circumstances relating thereto.
The policy covers any transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we, or any of our parent or subsidiary companies, were or are to be a participant, and which are unusual in their nature or conditions, involving goods, services or tangible or intangible assets.
In connection with these services, we paid €383,980, €310,970 and €198,076 during the years ended December 31, 2022, 2023, and 2024 respectively, to Studio Legale SAT. Mr.
In connection with these services, we paid €310,970, €198,076 and €117,612 during the years ended December 31, 2023, 2024, and 2025 respectively, to Studio Legale SAT. Mr. Alvise Spinazzi, member of the board of Stevanato Group, is a Partner of Studio Legale SAT.
The Registration Rights Agreement provides to such shareholders certain registration rights relating to our ordinary shares held by them, subject to customary restrictions and exceptions.
Registration Rights Agreement Upon completion of our initial public offering on the NYSE, we and certain of our then existing shareholders entered a the Registration Rights Agreement. The Registration Rights Agreement provides to such shareholders certain registration rights relating to our ordinary shares held by them, subject to customary restrictions and exceptions.
Alvise Spinazzi, member of the board of Stevanato Group, is a Partner of Studio Legale SAT. 108 Payments in connection with Rent For each of 2022, 2023 and 2024 the Company recognized costs for €19,309, €20,421, and €20,922 respectively to SFEM Italia S.r.l. in connection with certain rental installments.
Payments in connection with Rent For each of 2023, 2024 and 2025 the Company recognized costs for €20,421, €20,922, and €21,115 respectively to SFEM Italia S.r.l. in connection with certain rental installments.
(1) — 223,293,976 93.11 % Stevanato Group S.p.A. — 29,943,911 — Directors and Executive Officers: Sergio Stevanato — — — Franco Stevanato — — — Alvise Spinazzi 3,300 — * Fabrizio Bonanni 119,700 — * Fabio Buttignon 5,011 — * Madhavan Balachandran 63,701 — * Donald Jr Eugene Morel 31,667 — * William Federici 52,823 — * Karen Flynn — — — Luciano Santel — — — Marco Dal Lago 76,524 — * Mauro Stocchi 415,358 — * Ugo Gay — — * Riccardo Butta 30,129 — * All Directors and Executive Officers as a Group (14 persons) 798,213 — * * Less than 1% of voting rights as of the date of this annual report.
(1) — 223,293,976 93.09 % Stevanato Group S.p.A. — 29,838,842 — Directors and Executive Officers: Sergio Stevanato — — * Franco Stevanato — — * Alvise Spinazzi 3,300 — * Fabrizio Bonanni 119,700 — * Sue Jean Lin 2,000 — * Madhavan Balachandran 65,976 — * Donald Jr Eugene Morel 33,942 — * William Federici 52,823 — * Karen Flynn 2,275 — * Luciano Santel 1,787 — * Elisabetta Magistretti — — * Marco Dal Lago 75,000 — * Mauro Stocchi 404,942 — * All Directors and Executive Officers as a Group (13 persons) 761,745 — * * Less than 1% of voting rights as of the date of this annual report.
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Pursuant to this policy, our management presents to our Audit Committee each proposed related person transaction, including all relevant facts and circumstances relating thereto.