Stevanato Group S.p.A 6-K, filed May 6, 2022
Stevanato Group S.p.A. (STVN)
About this 6-K
Stevanato Group S.p.A filed this 6-K on May 6, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2022
Commission File Number: 001-40618
Stevanato Group S.p.A.
(Translation of registrant’s name into English)
Via Molinella 17
35017 Piombino Dese – Padua
Italy
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ☐ No ☒
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ☐ No ☒
EXPLANATORY NOTE
This report on Form 6-K (the “report”) and the exhibits to this report contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current views of Stevanato Group S.p.A. (“we”, “our”, “us”, “Stevanato Group” or the “Company”). These forward-looking statements include, or may include, words such as “raising”, “believe”, “potential”, “increased”, “future”, “remain”, “growing”, “expect”, “foreseeable”, “expected”, “to be”, “includes”, “estimated”, “assumes”, “would provide”, “anticipate”, “will”, “plan”, “may”, “forecast”, and other similar terminology. Forward-looking statements contained in this report and the exhibits to this report include, but are not limited to, statements about: our future financial performance, including our revenue, operating expenses and our ability to maintain profitability and operational and commercial capabilities; our expectations regarding the development of our industry and the competitive environment in which we operate; the expansion of our plants and our expectations to increase production capacity; the global supply chain and our committed orders; the global response to COVID-19 and our role in it; our geographical and industrial footprint; and our goals, strategies and investment plans. These statements are neither promise nor guarantee but involve known and unknown risks, uncertainties and other important factors and circumstances that may cause Stevanato Group’s actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements, including conditions in the U.S. capital markets, negative global economic conditions, inflation, potential negative developments in the COVID-19 pandemic, the impact of the conflict between Russia and Ukraine, supply chain challenges and other negative developments in Stevanato Group’s business or unfavorable legislative or regulatory developments. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: (i) our product offerings are highly complex, and, if our products do not satisfy applicable quality criteria, specifications and performance standards, we could experience lost sales, delayed or reduced market acceptance of our products, increased costs and damage to our reputation; (ii) we must develop new products and enhance existing products, adapt to significant technological and innovative changes and respond to introductions of new products by competitors to remain competitive; (iii) our backlog might not accurately predict our future revenue, and we might not realize all or any part of the anticipated revenue reflected in our backlog; (iv) if we fail to maintain and enhance our brand and reputation, our business, results of operations and prospects may be materially and adversely affected; (v) we are highly dependent on our management and employees. Competition for our employees is intense, and we may not be able to attract and retain the highly skilled employees that we need to support our business and our intended future growth; (vi) our business, financial condition and results of operations depend upon maintaining our relationships with suppliers and service providers; (vii) our business, financial condition and results of operations depend upon the availability and price of high-quality materials and energy supply and our ability to contain production costs; (viii) the current conflict between Russia and Ukraine and the financial and economic sanctions imposed by the European Union, the U.s., the United Kingdom and other countries and organizations against officials, individuals, regions and industries in Russia and Belarus may negatively impact our ability to source gas at commercially reasonable terms or at all and could have a material adverse effect on our operations; (ix) significant interruptions in our operations could harm our business, financial condition and results of operations; (x) as a consequence of the COVID-19 pandemic, sales of syringes and vials to and for vaccination programs globally increased resulting in a revenue growth acceleration. The demand for such products may shrink, if the need for COVID-19 related solutions declines; (xi) our manufacturing facilities are subject to operating hazards which may lead to production curtailments or shutdowns and have an adverse effect on our business, results of operations, financial condition or cash flows; (xii) we may face significant competition in implementing our strategies for revenue growth in light of actions taken by our competitors; (xiii) 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; (xiv) 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; (xv) if relations between China and the United States deteriorate, our business in the United States and China could be materially and adversely affected; and (xvi) Cyber security risks and the failure to maintain the confidentiality, integrity and availability of our computer hardware, software and internet applications and related tools and functions, could result in damage to our reputation, data integrity and/or subject us to costs, fines or lawsuits under data privacy or other laws or contractual requirements. This list is not exhaustive.
These forward-looking statements speak only as at their dates. The Company undertakes no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible to predict all of these factors. Further, the Company cannot assess the impact of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statements. We caution you therefore against relying on these forward-looking statements, and we qualify all of our forward-looking statements by these cautionary statements.
For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, refer to the risk factors discussed in our Annual Report on Form 20-F/A for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission on April 5, 2022 and our other filings with the U.S. Securities and Exchange Commission.
EXHIBIT INDEX
The following exhibits are furnished as part of this Form 6-K:
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Stevanato Group S.p.A. | ||||||
| Date: May 6, 2022 | By: | /s/ Franco Moro | ||||
| Name: | Franco Moro | |||||
| Title: | Chief Executive Officer and Chief Operating Officer | |||||
Exhibit 99.1
Stevanato Group S.p.A.
Ordinary and Extraordinary Shareholders’ Meeting
on June 1, 2022
Explanatory report on the items on the agenda
This report (the “Explanatory Report”) was drafted by the board of directors of Stevanato Group S.p.A. (respectively, the “Board of Directors” and “Stevanato” or the “Company”) in relation to the ordinary and extraordinary meeting of the Company’s shareholders convened, on single call, on June 1, 2022, at 4 p.m. CEST (10 a.m. EDT), by notice published on April 12, 2022 (the “Convening Notice”), to discuss and resolve on the following agenda:
Ordinary session
| 1. | Approval of the annual financial statements for the financial year ended on December 31, 2021; presentation of the reports of the Board of Directors and of the External Auditor EY S.p.A.; presentation of the consolidated financial statements for the financial year ended on December 31, 2021; presentation of the consolidated non-financial statements (Sustainability Report) for the financial year ended December 31, 2021; presentation of the reports of the Audit Committee, of the Compensation Committee, of the Nominating and Corporate Governance Committee; related resolutions. |
| 2. | Allocation of annual net profits and distribution of dividends and reserves to the shareholders; related resolutions. |
| 3. | Compensation of the members of the Board of Directors; related resolutions. |
| 4. | Additional remuneration of the External Auditor EY S.p.A. for the auditing of the consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, to be conducted in accordance with the standards of the Public Company Accounting Oversight Board (PCAOB); related resolutions. |
| 5. | Revocation of the authorizations for the purchase and the disposal of ordinary and class A treasury shares approved by the shareholders’ meetings of March 4, 2021, May 28, 2021, and July 1, 2021; authorization for the purchase and the disposal of ordinary and class A treasury shares; related resolutions. |
Extraordinary session
| 1. | Amendments to Articles 21.2 and 25.2 of the By-laws; related resolutions. |
(the “Agenda” and the “Shareholders’ Meeting”).
This Explanatory Report was drafted to the benefit of (i) the holders of Class A shares and of ordinary shares registered on the Company’s US Shareholders’ Register and/or on the Company’s Shareholders’ Book (Libro Soci) and entitled to attend and vote at the Shareholders’ Meeting as specified in the Convening Notice (respectively, the “Class A Shareholders” and the “Registered Shareholders”) and of (ii) the holders of the beneficial ownership of the ordinary shares deposited with the Depositary Trust Company registered on the Company’s US Shareholders’ Register and on the Company’s Shareholders’ Book (Libro Soci) in the name of Cede&Co. and entitled to give voting instructions to Computershare S.p.A., in its capacity as substitute proxy specifically appointed by Cede&Co., in relation to all or part of the items on the Agenda, as specified by the Convening Notice (the “Beneficial Shareholders”), and includes certain information concerning the items on the Agenda and the proposals submitted to the Shareholders’ Meeting.
In particular, this Explanatory Report aims at providing the Class A Shareholders, Registered Shareholders and Beneficial Shareholders with the information necessary - together with the reports of the Board of Directors, of the Committees and of the External Auditor EY S.p.A. referred to below – to fully and effectively exercise their voting rights.
Please note that Stevanato’s ordinary shares are exempt from the proxy rules of the United States Securities Exchange Act of 1934, as amended, and that this Explanatory Report does not constitute a proxy statement or a solicitation of proxies.
* * *
Ordinary session
| 1. | Approval of the annual financial statements for the financial year ended on December 31, 2021; presentation of the reports of the Board of Directors and of the External Auditor EY S.p.A.; presentation of the consolidated financial statements for the financial year ended on December 31, 2021; presentation of the consolidated non-financial statements (Sustainability Report) for the financial year ended December 31, 2021; presentation of the reports of the Audit Committee, of the Compensation Committee, of the Nominating and Corporate Governance Committee; related resolutions. |
Pursuant to Italian law and to the Company’s by-laws (the “By-laws”), Stevanato’s shareholders shall annually resolve, at the ordinary shareholders’ meeting, on the approval of the Company’s individual financial statements related to the previous financial year, within a six months term from its ending.
Therefore, we submit to Stevanato’s shareholders, for their examination and approval at the Shareholders’ Meeting, the Company’s draft annual financial statements as of December 31, 2021, approved by the Board of Directors on April 11, 2022, which show net profits amounting to Euro 5,309,863.00.
Moreover, in compliance with the applicable Italian law provisions, we present to Stevanato’s shareholders, for their examination and acknowledgment, the following documents, containing more information on the Company’s draft annual financial statements, as well as on the Company’s current and prospective situation and on the activities carried out by Stevanato, individually and through its controlled companies, in the financial year ended on December 31, 2021:
| – | Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, approved by the Board of Directors on April 11, 2022; |
| – | Stevanato’s non-financial statements (Sustainability Report) for the financial year ended on December 31, 2021, approved by the Board of Directors on April 11, 2022; |
| – | Directors’ Report for the financial year ended on December 31, 2021, approved by the Board of Directors on April 11, 2022; and |
| – | Report of the External Auditor, to be issued by EY S.p.A. within the voting record date of May 6, 2022. |
As provided for by the Charters of the Audit Committee, the Compensation Committee, and the Corporate Governance and Nominating Committee, we also present to Stevanato’s shareholders, for their examination and acknowledgment, the following documents, containing more information on the activities carried out by the mentioned Committees, as well as on the current directors and management compensation structure and policy, and on the current corporate governance system of the Company:
| – | Report of the Audit Committee for the financial year ended on December 31, 2021, approved by the Audit Committee on April 8, 2022; |
| – | Report of the Compensation Committee for the financial year ended on December 31, 2021, approved by the Compensation Committee on April 6, 2022; |
| – | Report of the Nominating and Corporate Governance Committee for the financial year ended on December 31, 2021, approved by the Nominating and Corporate Governance Committee on April 7, 2022. |
Stevanato’s draft annual financial statements for the financial year ended on December 31, 2021, together with the other above mentioned documents, will be made available in accordance with the applicable law provisions (and, in any case, by the voting record date of May 6, 2022) to Class A Shareholders and Registered Shareholders, at the Company’s registered office, at Via Molinella, 17, 35017 Piombino Dese – Padua (Italy), and, also to the Beneficial Shareholders and the public, on the Company’s website www.stevanatogroup.com, in the section “Investors - Corporate Governance - Shareholders’ Meetings”.
Based on the above, Stevanato’s shareholders are asked to approve the following resolution:
“The Shareholders’ Meeting
| – | having examined Stevanato’s annual financial statements for the financial year ended on December 31, 2021, in the draft presented by the Board of Directors, which show net profits amounting to Euro 5,309,863.00; |
| – | having examined the Directors’ Report; |
| – | having examined the Report of the External Auditor EY S.p.A.; |
| – | having examined Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021; |
| – | having examined Stevanato’s non-financial statements (Sustainability Report) for the financial year ended on December 31, 2021; |
| – | having examined the Reports presented by the Audit Committee, the Compensation Committee, and the Corporate Governance and Nominating Committee; |
resolves
| 1. | to approve the annual financial statements of Stevanato for the financial year ended on December 31, 2021, which report net profits amounting to Euro 5,309,863.00; |
| 2. | to acknowledge the Directors’ Report presented by the Board of Directors; |
| 3. | to acknowledge Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, as presented by the Board of Directors; |
| 4. | to acknowledge Stevanato’s non-financial statements (Sustainability Report) for the financial year ended on December 31, 2021, as presented by the Board of Directors; |
| 5. | to acknowledge the Reports presented by the Audit Committee, the Compensation Committee, and the Corporate Governance and Nominating Committee”. |
| 2. | Allocation of annual net profits and distribution of dividends and reserves to the shareholders; related resolutions. |
Pursuant to Italian law, Stevanato’s shareholders shall resolve, at the ordinary shareholders’ meeting, on the allocation of the Company’s net profits resulting from the annual financial statements for the financial year ended on December 31, 2021.
Since the Company’s legal reserve is currently lower than one fifth of the Company’s share capital, the Shareholders’ Meeting shall earmark at least 5 per cent of the Company’s net profits resulting from the annual financial statements for increasing the legal reserve. Moreover, the shareholders’ meeting may not distribute profits’ components resulting from gains unrealized at the end of the accounting period, such as unrealized gains deriving from foreign currency exchange rates.
In addition, to the extent the legal reserve (by itself or combined with other available reserves) is at least equal to one fifth of the Company’s share capital, the Shareholders’ Meeting may also resolve to distribute to shareholders all or part of the reserves the distribution of which is not prohibited by Italian law.
As indicated in paragraph 1 above, based on the annual financial statements for the financial year ended on December 31, 2021, the Company’s operations resulted in net profits of Euro 5,309,863.00.
In light of the foregoing, we propose to the shareholders to:
| - | earmark an amount of Euro 339,296.00 of the Company’s net profits, as resulting from the financial statements for the financial year ended on December 31, 2021, to the legal reserve, which, as a consequence of such increase, shall reach the total amount of Euro 4,339,696.00, equal to one fifth of the Company’s share capital, thereby fulfilling in advance the minimum requirement set forth by Italian law; |
| - | earmark an amount of Euro 483,524.00 of the Company’s net profits, as resulting from the financial statements for the financial year ended on December 31, 2021, to the special reserve named “Unrealized Exchange Rate Gains”; |
| - | earmark for distribution to the shareholders of a gross dividend in cash of Euro 0.051 for each outstanding Class A and ordinary share of the Company, net of the treasury shares that will be held by the Company as of the Dividend Record Date (as defined hereinafter), an amount of Euro 4,487,043.00 of the Company’s net profits and, for the remaining portion, a maximum amount of Euro 10,585,498.84 of the reserve named “extraordinary reserve”, as resulting from the annual financial statements for the financial year ended on December 31, 2021, for a total maximum amount of Euro 15,072,541.84. |
Therefore, assuming that Company continues to hold the current number of 30,840,555 treasury Class A shares at the Dividend Record Date, the amount of net profits and of the extraordinary reserve to be used for distribution of dividends to shareholders would be equal to, respectively, Euro 4,487,043.00 and Euro 9,012,630.53, for a total amount of Euro 13,499,673.53,
In such connection, based on the resolution of the Board of Directors of April 11, 2022, and pursuant to Article 28.4 of the By-laws, we propose to set on June 14, 2022, the date for identifying the holders of the Class A shares of the Company and the registered holders and the beneficial holders of the ordinary shares of the Company entitled to receive payment of the dividends which the Shareholders’ Meeting should resolve to distribute (the “Dividend Record Date”).
Therefore, assuming that the Shareholders’ Meeting approves the above proposals, the ex-dividend date will fall on June 13, 2022 (Ex-Date), whereas it is expected that the dividends will be paid to the Class A and ordinary shares as from July 13, 2022 (Payment Date).
Based on the above, Stevanato’s shareholders are asked to approve the following resolution:
“The Shareholders’ Meeting
resolves
| 1. | to earmark an amount of Euro 339,296.00 of the Company’s net profits, as resulting from the financial statements for the financial year ended on December 31, 2021, to the legal reserve; |
| 2. | to earmark an amount of Euro 483,524.00 of the Company’s net profits, as resulting from the financial statements for the financial year ended on December 31, 2021, to the special reserve named “Unrealized Exchange Rate Gains”; |
| 3. | to earmark for distribution to the shareholders of a gross dividend in cash of Euro 0.051 for each outstanding Class A and ordinary share of the Company, net of the treasury shares that will be held by the Company as of the Dividend Record Date, an amount of Euro 4,487,043.00 of the Company’s net profits and, for the remaining portion, a maximum amount of Euro 10,585,498.84 of the reserve named “extraordinary reserve”, as resulting from the annual financial statements for the financial year ended on December 31, 2021, for a total maximum amount of Euro 15,072,541.84; |
| 4. | to set the date for identifying the holders of the Class A shares of the Company and the registered holders and the beneficial holders of the ordinary shares of the Company entitled to receive payment of the aforementioned dividends on June 14, 2022 (Dividend Record Date), with the ex-dividend date (Ex-Date) falling on June 13, 2022; |
| 5. | to set the date for payment of the dividends, before withholding tax, if any, in execution of resolutions no. 3 and 4 above, as from July 13, 2022 (Payment Date); |
| 6. | to grant mandate to the Board of Directors and, on behalf of the latter, severally, to the Executive Chairman and the Chief Executive Officer to carry out all the activities related, consequent to or connected with the implementation of the resolution no. 5 above”. |
| 3. | Compensation of the members of the Board of Directors; related resolutions. |
Pursuant to Italian law and Article 19 of the Company’s By-laws, Stevanato’s shareholders shall establish, by resolution adopted at the ordinary shareholders’ meeting, the compensation of the directors for their office as members of the Board of Directors.
It must be noted that, without prejudice to the remuneration established by the shareholders’ meeting, the Board of Directors may provide an additional compensation of the directors entrusted with specific functions, which may consist of a fixed part and/or a variable part, related to the achievement of certain objectives, or of the right to subscribe for ordinary shares or other financial instruments of the Company at a given price.
Alternatively, shareholders may determine an aggregate amount for the compensation of all directors, including those holding specific functions, to be allocated by the Board of Directors.
In any event, the members of the Board of Directors shall also be entitled to reimbursement of expenses incurred in the performance of their duties.
At the meeting of May 28, 2021, the Company’s shareholders appointed the current directors for the period of three financial years and established the relevant compensation for the period of one financial year, thus until the approval of the financial statements for the financial year ended on December 31, 2021, as well as, pursuant to Article 19.4 of the By-laws, a fixed additional annual compensation of Euro 20,000.00 and of Euro 10,000.00 for, respectively, the chairman and each member of the Audit Committee, for their entire term of office.
Therefore, at the next shareholders’ meeting, Stevanato’s shareholders are asked to establish the compensation of the Company’s directors for their office as members of the Board of Directors or, alternatively, to determine an aggregate amount for the compensation of all directors, to be allocated by the Board of Directors, for the period of one or two financial years.
In such respect, upon recommendation of the Compensation Committee, we propose to the shareholders to establish for all directors (with the exception of Mr. Franco Moro, for the reasons detailed below), as remuneration for their office as members of the Board of Directors, a fixed compensation to be paid partially in cash and partially in Company’s shares, as specified below, for the period elapsing from the Shareholders’ Meeting date to the date of the shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2022, determined in consideration of the market standards, of the practices of the Company’s main competitors, and of the Board of Directors members’ professional skills and experience.
In particular, without prejudice to the right of the Board of Directors to establish an additional compensation for the directors entrusted with specific functions, we propose to establish for each director (with the exception of Mr. Franco Moro), for the period elapsing from the date of the Shareholders’ Meeting to the date of the Company’s shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2022, a gross total compensation of Euro 148,000.00, to be paid as follows:
| - | as to the gross amount of Euro 74,000.00 (i.e., 50% of the total proposed compensation), in cash, in twelve equal monthly instalments; |
| - | as to the residual gross amount of Euro 74,000.00 (i.e., 50% of the total proposed compensation), in kind, through the assignment of a number of Company’s ordinary shares to be determined by the Board of Directors by dividing such amount by the average closing market price of the Company’s ordinary shares during the 30 calendar day period preceding the Shareholders’ Meeting, based on the average Euro/USD exchange rate during such period; provided that (i) such compensation in kind shall not be paid to directors ceasing for any reason to hold office before expiration of the relevant term (i.e., the date of the shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2023) and (ii) the number of ordinary shares so determined shall be transferred to the directors on the business day following the date of the shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2023, within the limits of the authorization to the disposal of such ordinary shares which shall be granted to the Board of Directors pursuant to the resolution envisaged in the next item 5 of this Explanatory Report. |
As to Mr. Franco Moro, since the remuneration package granted by the Board of Directors to the latter in his capacity as Chief Executive Officer is intended to cover all services performed to the benefit of the Company, we propose not to establish any further remuneration for Mr. Moro’s service as member of the Board of Directors.
Based on the above, Stevanato’s shareholders are asked to approve the following resolution:
“The Shareholders’ Meeting
resolves
| 1. | to establish for each Company’s director – with the exception of Mr. Franco Moro and without prejudice to the right of the Board of Directors to establish an additional compensation for the directors entrusted with specific functions under Article 2389 of the Italian Civil Code and Article 19.1 of the Company’s by-laws -, for the period elapsing from the date of this meeting to the date of the Company’s shareholders meeting approving the financial statements for the financial year ending on December 31, 2022, a gross total compensation of Euro 148,000.00, to be paid as follows: |
| - | as to the gross amount of Euro 74,000.00 (i.e., 50% of the total proposed compensation), in cash, in twelve equal monthly instalments; |
| - | as to the residual gross amount of Euro 74,000.00 (i.e., 50% of the total proposed compensation), in kind, through the assignment of a number of Company’s ordinary shares to be determined by the Board of Directors by dividing such amount by the average closing market price of the Company’s ordinary shares during the 30 calendar day period preceding the date of this meeting, based on the average Euro/USD exchange rate during such period; provided that: (i) such compensation in kind shall not be paid to directors ceasing for any reason to hold office before expiration of the relevant term (i.e., the date of the shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2023) and (ii) the number of ordinary shares so determined shall be transferred to the directors on the business day following the date of the shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2023, within the limits of the authorization to the disposal of such ordinary shares which shall be granted to the Board of Directors pursuant to the resolution adopted in relation to the next item 5 of the Agenda”. |
| 4. | Additional remuneration of the External Auditor EY S.p.A. for the auditing of the consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, to be conducted in accordance with the standards of the Public Company Accounting Oversight Board (PCAOB); related resolutions. |
Pursuant to Article 13 of the Italian Legislative Decree no. 39/2010, Stevanato’s shareholders, at the ordinary shareholders’ meeting, upon substantiated proposal submitted by the Audit Committee, shall appoint the Company’s statutory External Auditor for a period of three financial years and establish the relevant compensation for the entire term of office.
At the meeting of June 11, 2020, Stevanato’s shareholders appointed EY S.p.A. as Company’s External Auditor for the financial years 2020 – 2022 and established the total compensation of Euro 315,000.00, on a yearly basis, for the activities carried out by the latter under such appointment, which include the auditing of the Company’s individual and consolidated financial statements, respectively prepared in accordance with Italian GAAP (as issued by the Organismo Italiano di Contabilità (OIC)) and with International Financial Reporting Standards (IFRS) (as issued by the International Accounting Standards Board (IASB)), to be conducted according to the International Standards of Auditing (ISA Italia) as issued by the International Auditing and Assurance Standards Board (IAASB).
Following the listing of the Company’s ordinary shares on the New York Stock Exchange (NYSE), Stevanato’s External Auditor is also required to conduct an audit on the Company’s annual consolidated financial statements in accordance with the auditing standards set out by the Public Company Accounting Oversight Board (PCAOB) and to express an opinion—based on such PCAOB standards and therefore different from the opinion issued for Italian law purposes—on whether such statements are presented fairly and, in all material respects, in conformity with IFRS, which must be included in the Company’s annual report to be filed with the Security and Exchange Commission (SEC) on Form 20-F.
In such respect, on October 25, 2021, EY S.p.A. presented to Stevanato an offer to perform, in addition to the auditing services carried out under Italian law, the audit of the annual consolidated financial statements for the financial year ended on December 31, 2021, in accordance with the PCOAB standards and under the terms of the applicable SEC and PCOAB provisions, and express the relevant opinion, for an annual additional compensation estimated in Euro 380,000.00.
Additionally, on March 3, 2022, EY S.p.A. presented to Stevanato an offer to perform, in addition to the auditing services carried out under Italian law, the audit of the annual consolidated financial statements for the financial year ending on December 31, 2022, as well as the review of the quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and under the terms of the applicable SEC and PCOAB provisions, and express the relevant opinions, for an annual additional compensation estimated in Euro 635,000.00.
As set forth by both the Italian Legislative Decree no. 39/2010 and the SEC and PCOAB provisions, and in compliance with the Audit Committee Charter, at the meetings of November 5, 2021, and April 8, 2022, the Audit Committee expressed a positive opinion on the offers presented by the External Auditor EY S.p.A. and resolved to submit to the Shareholders’ Meeting the proposal to extend the appointment of EY S.p.A. to perform the audit of the annual consolidated financial statements as of December 31, 2021, and of the annual consolidated financial statements as of December 31, 2022, and the review of quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and under the terms of the applicable the SEC and PCOAB provisions, and increase the compensation to be paid to the same, as consideration for the performance of such additional services, as per the offers as of October 25, 2021, and March 3, 2022.
In particular, the Audit Committee considered it advisable to propose to the Shareholders’ Meeting to extend the appointment of the External Auditor EY S.p.A. to perform also the aforementioned auditing services and accept the offer presented by the latter in connection thereto for the following reasons:
| - | it is appropriate that the audit of the consolidated financial statements of the Company is performed by the same External Auditor for both Italian law and US regulations purposes, in order to avoid the redundancy of auditing activities and reviews on the same by the Audit Committee, along with the inefficiencies and expenses which would derive from the appointment of two different external auditors; |
| - | the additional remuneration requested by EY S.p.A. for the auditing of Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, as well as for the reviewing of the quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and under the terms of the applicable the SEC and PCOAB provisions, as specified in the offers presented to the Company on October 25, 2021, and on March 3, 2022, is adequate in light of the complexity of the activity to be carried out and of the responsibilities to be assumed by the External Auditor and in line with the market standards, based on the knowledge of the Audit Committee members. |
The substantiated proposal of the Audit Committee is available on the Company’s website www.stevanatogroup.com, in the section “Investors - Corporate Governance - Shareholders’ Meetings”.
Based on the above, Stevanato’s shareholders are asked to approve, upon substantiated proposal presented by Audit Committee, the following resolution:
“The Shareholders’ Meeting
| - | based on the offers presented by the External Auditor EY S.p.A. on October 25, 2021 and on March 3, 2022, and on the substantiated proposal presented by the Audit Committee; |
resolves
| 1. | to extend the appointment of the Company’s External Auditor EY S.p.A. to the performance, in addition to the auditing services carried out following the appointment resolved by the shareholders’ meeting of June 11, 2020, of the audit of Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, as well as of the review of quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and under the terms of the applicable the SEC and PCOAB provisions; |
| 2. | to grant to EY S.p.A., as consideration for the performance of the audit of Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, referred to under resolution n. 1 above, the additional annual compensation of Euro 380,000.00, as specified in the offer presented by EY S.p.A. on October 25, 2021, and, as consideration for the performance of the audit of Stevanato’s consolidated financial statements for the financial year ending on December 31, 2022, and of the review of quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, referred to under resolution n. 1 above, the additional estimated annual compensation of Euro 635,000.00, as specified in the offer presented by EY S.p.A. on March 3, 2022”. |
| 5. | Revocation of the authorizations for the purchase and the disposal of ordinary and class A treasury shares approved by the shareholders’ meetings of March 4, 2021, May 28, 2021, and July 1, 2021; authorization for the purchase and the disposal of ordinary and class A treasury shares; related resolutions. |
Pursuant to Italian law, the purchase of treasury Class A and ordinary shares must be authorized by the ordinary shareholders’ meeting of Stevanato, which shall establish the methods, the maximum number of shares to be purchased, the duration (not exceeding eighteen months) for which the authorization is granted, and the minimum and maximum purchase price.
In any case, Stevanato may not purchase treasury Class A and ordinary shares for a consideration exceeding the limits of the distributable net profits and reserves resulting from the latest financial statements approved by the shareholders’ meeting, provided that the nominal value of the treasury shares to be purchased shall not exceed one fifth (i.e., 20 per cent) of the Company’s share capital, taking into account also any Stevanato’s shares held by the subsidiaries.
Furthermore, it is provided that, upon purchase of treasury shares, (i) a negative reserve shall be entered and maintained in the Company’s financial statements for an amount equal to the value attributed to the treasury shares, (ii) the voting rights connected to such shares shall be suspended as long as they are held in treasury and (iii) the dividends and other reserve or rights distributions pertaining to such treasury shares shall be allocated proportionally to the other shares.
Similarly, the Board of Directors may dispose of the shares held in treasury only upon authorization of the shareholder’s meeting, which shall also establish the relevant modalities of such dispositions.
As of the date of this Explanatory Report, the Board of Directors has been granted different authorizations to purchase or dispose of the Company’s shares. In particular:
| - | upon resolution of the shareholders’ meeting of March 4, 2021, the Board of Directors was authorized to dispose of (i) a number of treasury shares not exceeding 0.5% of the Company’s share capital for assignment to the beneficiaries of the “Restricted Stock Grant Plan Stevanato Group S.p.A. 2021-2027”, according to the provisions of the regulation approved by the same shareholders’ meeting and of (ii) all the shares purchased from the beneficiaries of the “Stock Option Plan Stevanato Group S.p.A. 2012-2021” by December 31, 2021, without limitations; |
| - | upon resolution of the shareholders’ meeting of May 28, 2021, the Board of Directors was authorized to dispose, for a period of 18 months elapsing from the meeting’s date, of (i) a maximum of no. 15,000 treasury shares for assignment to the strategic consultants of the Company, as payment in kind for the services performed to the benefit of the latter, (ii) a maximum of no. 23,000 treasury shares for assignment to some members of the Board of Directors as part of their compensation in kind, as provided for by the resolution approved by the same shareholders’ meeting, and (iii) a maximum of no. 150,000 treasury shares for assignment to part or all of the employees of the Company, as compensation in kind; |
| - | upon resolution of the shareholders’ meeting of July 1, 2021, the Board of Directors was authorized, in compliance with all applicable law and regulatory provisions, to (a) purchase Company’s Class A or ordinary shares, for a period of 18 months elapsing from the meeting’s date, at certain conditions, up to a maximum number of shares determined from time to time in relation to the applicable limits of law, and (b) dispose of the Class A or ordinary shares held in treasury for the purposes of, inter alia, carrying out extraordinary transactions (such as the transfer, exchange, contribution or other act of disposition of such shares for the acquisition of shareholdings in other companies, of business operations, of real estate assets or other transactions instrumental to the pursuit of industrial projects of the Company), fulfilling the obligations deriving from option agreements on the Company’s shares, assigning the shares to the members of the Board of Directors or employees of Company or of its subsidiaries, and supporting the market liquidity of the Company’s shares, at the terms and conditions, and according to the modalities, that the Board of directors deems more appropriate in the Company’s interests. |
As of the date of this Explanatory Report, Stevanato holds in treasury no. 30,840,555 Class A shares, equal to approximately 10.43 per cent of the Company’s share capital.
In light of the above and, especially, of the time-limits to which the aforementioned authorizations are subject and of the Company’s interest that the Board of Directors be at any time vested with the authority to purchase Stevanato’s shares and dispose of the shares held in treasury with flexibility and for all transactions and purposes deemed to be advantageous for the Company, in consideration of the foreseeable necessities of the latter, we propose to the
shareholders to grant to the Board of Directors – upon prior revocation of the authorizations currently in place, without prejudice to the acts of acquisition or disposition that have been carried out in compliance therewith up to the Shareholders’ Meeting date – a new authorization to purchase Company’s shares and dispose of the shares in treasury, at the terms and conditions detailed below, for the period elapsing from the Shareholders’ Meeting date to the date of the shareholders’ meeting approving the financial statements for the financial year ending on December 31, 2022.
In particular, the authorization is requested for:
| (a) | purchasing, within the time period referred to above, up to a maximum number of Class A and ordinary shares equal to 2 per cent of the shares into which Stevanato’s share capital is divided (including the treasury shares at any time held by the Company), through one or more transactions to be executed on or off market at the price, terms and conditions, and according to the modalities, that from time to time the Board of Directors deems more appropriate in the Company’s interests, provided that (i) the purchases shall be made at a price not being more than 10 per cent higher or lower than the closing market price of the ordinary shares on the trading day preceding the day of each relevant transaction, (ii) the relevant transactions must be carried out in compliance with all applicable Italian and US or NYSE law and regulatory provisions, and, following any such purchases, (iii) the overall value of the shares held in treasury shall not exceed the amount of the distributable net profits and reserves resulting, from time to time, from the last financial statements approved by the shareholders’ meeting of the Company; and |
| (b) | disposing, within the time period referred to above, of a maximum number of 3,084,055 Class A or ordinary shares held in treasury (prior, where appropriate, conversion of the Class A shares into ordinary shares), in compliance with all applicable Italian and US or NYSE law and regulatory provisions, through one or more transactions to be executed on or off market at the price, terms and conditions, and according to the modalities, that the Board of Directors deems more appropriate in the Company’s interests. |
As indicated above, the requested authorizations shall be granted to the Board of Directors for the purposes of (i) carrying out extraordinary transactions (such as the transfer, exchange, contribution or other act of disposal of such shares for, inter alia, the acquisition of shareholdings in other companies, of business operations, of real estate assets or other transactions instrumental to the pursuit of industrial projects or, in any event, of the corporate object of the Company), (ii) fulfilling the obligations deriving from option contracts or other agreements concerning the Company’s shares, (iii) assigning the shares to directors or employees of Company or of its subsidiaries as compensation in kind or as benefit, bonus or other premium or incentive, without limitations (also in execution of the “Restricted Stock Grant Plan Stevanato Group S.p.A. 2021-2027”, any amendments thereof, or any other stock option or incentives plans which should be approved by the Board of Directors), and (iv) supporting the market liquidity of the Company’s shares.
Upon purchase of Company’s shares and as long as such shares are held in treasury, the Company shall enter and maintain in the financial statements a negative reserve for an amount at any time equal to the value attributed to the treasury shares and shall not be allowed, in its capacity as holder of such shares, to vote at the shareholders’ meeting and to receive dividends, reserves or other rights being distributed, which shall be allocated proportionally to the other shares.
Based on the foregoing, Stevanato’s shareholders are invited to resolve as follows:
“The Shareholders’ Meeting
| - | having examined the proposal presented by the Board of Directors under point 5 of the Explanatory Report; |
resolves
| 1. | to revoke the resolutions concerning the authorization for the purchase and the disposal of treasury shares approved by the shareholders’ meetings of March 4, 2021, May 28, 2021, and July 1, 2021, without prejudice to the acts of acquisition or disposition carried out in compliance with the provisions of such resolutions to the date of this meeting and to the rights acquired by effect of the execution of such resolutions; |
| 2. | to authorize the Board of Directors, pursuant to Article 2357 of the Italian Civil Code, for the period elapsing from the date of this meeting to the date of the Company’s shareholders meeting approving the financial statements for the financial year ending on December 31, 2022, for the purposes referred to under point 5 of the Explanatory Report, to: |
| - | purchase up to a maximum number of Class A and ordinary shares equal to two per cent of the shares into which Stevanato’s share capital is divided (including the treasury shares at any time held by the Company), through one or more transactions to be executed on or off market at the price, terms and conditions, and according to the modalities, that from time to time the Board of Directors deems more appropriate in the Company’s interests, provided that (i) the purchases shall be made at a price not being more than ten per cent higher or lower than the closing market price of the ordinary shares on the trading day preceding the day of each relevant transaction, (ii) the relevant transactions must be carried out in compliance with all applicable Italian and US or NYSE law and regulatory provisions, and, following any such purchases, (iii) the overall value of the shares held in treasury shall not exceed the amount of the distributable net profits and reserves resulting, from time to time, from the last financial statements approved by the shareholders’ meeting of the Company; and |
| - | dispose of a maximum number of 3,084,055 Class A or ordinary shares held in treasury (prior, where appropriate, conversion of the Class A shares into ordinary shares), in compliance with all applicable Italian and US or NYSE law and regulatory provisions, through one or more transactions to be executed on or off market at the price, terms and conditions, and according to the modalities, that the Board of Directors deems more appropriate in the Company’s interests. |
| 3. | to grant the Board of Directors with all power needed or useful in order to execute the resolutions as per the points above and carrying out all the activities that may be necessary, instrumental or otherwise connected thereto”. |
Extraordinary session
| 1. | Amendments to Articles 21.2 and 25.2 of the By-laws; related resolutions. |
Pursuant to Italian law, the By-laws may be amended by resolution approved by the extraordinary shareholders’ meeting.
The current By-laws were adopted by the Stevanato shareholders’ meeting of July 1, 2021, in connection with the approval of the application for admission of the Company’s ordinary shares to the listing on the NYSE.
Thereafter, the need to amend the By-laws has arisen in respect of Articles 21.2 and 25.2, providing for the requirements according to which, respectively, the Board of Directors’ and the Audit Committee’s meetings may be held via audio- or video-conference.
In particular, such provisions require, for the Board of Directors’ and the Audit Committee’s meetings to be held via audio- or video-conference, inter alia, that the chairman and the secretary of the meeting are present at the same location, where the meeting shall be considered to be held.
In consideration of the actual, geographically diversified, composition of the Company’s Board of Directors and Audit Committee and of the resulting logistic difficulties connected to the physical presence of the chairman and the secretary of the meetings at the same location, we propose to amend the mentioned Articles of the By-laws in order to allow - according to the most recent practices and legal doctrines – for the Board of Directors’ and the Audit Committee’s meetings to be held in presence of all or part of the members thereof or also exclusively by means of distance communication, with no requirement for the chairman, the secretary or any other member of the meeting to be physically present at the same location with other members.
In such respect, we propose to the shareholders to amend Articles 21.2 and 25.2 of the By-laws as follows:
| By-laws in force
|
By-laws amended
|
|||||
|
Italian version
|
||||||
| 21.2 Le riunioni del Consiglio di Amministrazione si possono svolgere anche per audioconferenza o videoconferenza, a condizione che: (a) siano presenti nello stesso luogo il presidente ed il segretario della riunione, se nominato; (b) che sia consentito al presidente della riunione di accertare l’identità degli intervenuti, regolare lo svolgimento della riunione, constatare e proclamare i risultati della votazione; (c) che sia consentito al soggetto verbalizzante di percepire adeguatamente gli eventi della riunione oggetto di verbalizzazione; (d) che sia consentito agli intervenuti di partecipare alla discussione ed alla votazione simultanea sugli argomenti all’ordine del giorno, nonché di visionare, ricevere o trasmettere documenti. In tal caso, la riunione si considera tenuta nel luogo ove sono presenti, insieme, il presidente ed il soggetto verbalizzante.
|
21.2 Ai sensi dell’articolo 2388, comma 1, del codice civile, la partecipazione alle riunioni del Consiglio di Amministrazione può avvenire mediante mezzi di telecomunicazione, nei limiti di quanto eventualmente disposto dall’avviso di convocazione e con le modalità consentite da colui che presiede la riunione. Nell’avviso di convocazione può essere stabilito che la riunione del Consiglio di Amministrazione si tenga esclusivamente mediante mezzi di telecomunicazione, omettendo l’indicazione del luogo fisico di svolgimento della riunione. |
|||||
| 25.2 Le riunioni del Comitato per il Controllo sulla Gestione si possono svolgere anche per teleconferenza e/o videoconferenza a condizione che: a) il Presidente e il soggetto verbalizzante siano presenti nello stesso luogo della convocazione; b) tutti i partecipanti possano essere identificati e sia loro consentito di seguire la discussione, di ricevere, trasmettere e visionare documenti, di intervenire oralmente ed in tempo reale su tutti gli argomenti. In tal caso, il Comitato per il Controllo sulla Gestione si considera tenuto nel luogo in cui si trovano il Presidente ed il soggetto verbalizzante.
|
25.2 Le riunioni del Comitato per il Controllo sulla Gestione possono svolgersi anche mediante mezzi di telecomunicazione, secondo quanto stabilito dal precedente paragrafo 21.2. |
|||||
|
English courtesy translation
|
||||||
| 21.2 The meetings of the Board of Directors may also be held by audio or video conference, provided that: (a) the chairman and the secretary of the meeting, if appointed, are present in the same place; (b) the chairman of the meeting is allowed to ascertain the identity of the attendees, regulate the proceedings of the meeting, ascertain and announce the results of the vote; (c) the person taking the minutes is allowed to adequately perceive the events of the meeting being recorded; (d) the attendees are allowed to |
21.2 Pursuant to Article 2388, paragraph 1, of the Civil Code, participation to the meetings of the Board of Directors may also occur through means of distance communication, according to the provisions set out in the relevant convening notice, if any, and to the modalities agreed by the chairman of the meeting.
In the convening notice, it may be provided that the relevant meeting of the Board of Directors is exclusively held by means of distance communication, without specifying a physical location for the meeting. |
|||||
| participate in the discussion and vote simultaneously on the items on the agenda, as well as to view, receive or transmit documents. In this case, the meeting is considered to be held in the place where both the Chairman and the person taking the minutes are present.
|
||||||
| 25.2. The meetings of the Audit Committee may also be held by teleconference and/or videoconference provided that: a) the Chairman and the person taking the minutes are present in the same location where the meeting is held; b) all participants can be identified and are allowed to follow the discussion, receive, transmit and view documents, and intervene verbally and in real time on all topics. In this case, the Audit Committee is deemed to be held in the place where the Chairman and the person taking the minutes are located.
|
25.2. Meetings of the Audit Committee may also be held by means of distance communication, pursuant to the provisions of paragraph 21.2 above. |
|||||
Based on the foregoing, Stevanato’s shareholders are invited to resolve as follows:
“The Shareholders’ Meeting
- having examined the proposal presented by the Board of Directors under point 6 of the Explanatory Report;
resolves
to amend Articles 21.2 and 25.2 of the Company’s by-laws according to the texts set out under point 6 of the Explanatory Report , hereby authorizing each director, separately from each other, to provide for the legal publications of this resolution, with the power to make any further modifications or additions that may be required for registration in the Companies’ Register”.
* * *
Piombino Dese, April 11, 2022.
The Executive Chairman of the Board of Directors
Franco Stevanato
Exhibit 99.2
Sustainability Report 2021 Stevanato Group
Table of contents Letter to Stakeholders IV Methodological note VII STEVANATO GROUP 9 1.1 Highlights 10 1.2 Story and evolution 12 1.3 Mission, Vision and Values 24 1.4 The company structure and main corporate functions 27 1.5 Ethics, integrity and compliance 34 STEVANATO GROUP AND SUSTAINABILITY 37 2.1 Approach to sustainability 38 2.2 Certifications and awards 45 2.3 Participation in organizations and associations 49 ECONOMIC SUSTAINABILITY 52 3.1 Stakeholder value creation 53 3.2 Key financial results 55 RESEARCH, DEVELOPMENT, INNOVATION AND PRODUCT RESPONSIBILITY 60 4.1 Stevanato Group products, technologies and services 61 4.1.1 Biopharmaceutical and Diagnostic solutions 64 4.1.2 Engineering 70 1 2 3 4
Sustainability Report—2021 4.2 R&D and Innovation 71 4.2.1 R&D for Drug containment solutions (DCS) 72 4.2.2 R&D on Drug Delivery Systems (DDS) 73 4.2.3 R&D on Engineering 74 4.2.4 Analytical Services 78 4.3 Product quality and responsibility 80 ATTENTION TO HUMAN CAPITAL 83 5.1 Stevanato Group’s human resources5 84 5.2 Employee management and development 92 5.3 Occupational Health & Safety 100 SUPPLY CHAIN RESPONSIBILITY 108 6.1 Responsible supply chain & procurement 109 ATTENTION TO THE ENVIRONMENT 117 7.1 Stevanato Group’s commitment to the environment 118 7.2 Energy Consumption and GHG Emissions 120 7.3 Water management 124 7.4 Waste management 129 THE LINK WITH THE TERRITORY 133 8.1 Local communities engagement 134 Topic Boundaries 138 GRI Content Index 139 Independent Audit Report 144 5 6 7 8
Sustainability Report—2021 Letter to Stakeholders Giovanni Stevanato had a dream and a vision. He wanted to create world-class glass manufacturing activities in Piom-bino Dese, Italy, and set a standard of excellence in the industry. Seventy years ago, we took over his legacy, proudly building a global manufacturing enterprise with an international team of dedicated professionals driven by his same passion and desire to keep learning and improving. In 2021, we joined the New York Stock Exchange and began the next chapter in our storied history. The listing will further strengthen our integrated offerings, increase Stevanato’s market penetration across our business segments and accelerate our growth. We are proud of what we have accomplished and excited for our future as a listed company. As a global operation with 16 sites around the world, we foster a culture that values diversity and respects individual contributions that spark innovation, leadership and exceptional performance. Our strength comes from working together as One Team towards a common goal: enhance the integrity of medicines to help people live a better life. To do so, we work alongside customers, partners and the scientific community to find effective, high-quality solutions to new problems, pushing the limits of knowledge further and further while always keeping the customer and patient at the center of what we do. Along the way, our Values and Guiding Principles provide a framework for our ethical-social responsibilities and ensure our accountability. As with any organization, we have been through some challenging times. There were moments when we modified our plans and changed direction in order to meet the needs of our stakeholders. In those instances, we evaluated, adjusted and altered our approach, reacting to, or sometimes even anticipating, market demands. But we held steadfastly to our belief that the best way to make a difference is by transforming an obstacle into an opportunity for growth. We are now a leading global provider of drug containment, delivery and diagnostic solutions to the biopharma-ceutical 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 at each of the development, clinical and commercial stages. Our core capabilities in scientific research and development, technical innovation and engineering excellence are central to our ability to offer integrated, value-added solutions to our clients. Through our investments in research and development and with our global reach, we have secured a leadership position in the drug development and delivery value chain. Over our 70-year history, we have earned a leading reputation for high quality and reliability, enabling us to become the partner of choice for more than 700 companies globally, including 41 of the top 50 pharmaceutical companies (which comprise all of the top 15), and eight of the top ten in-vitro diagnostic companies, as measured by 2020 revenue data collected by Global Data. We also serve 15 of the top 20 biotechnology companies by market capitalization in the NASDAQ Biotechnology Index and over 100 biotechnology customers in total. IV |
Sustainability Report—2021 Our priority is to provide flexible, integrated, end-to-end solutions that preserve the integrity of pharmaceutical products, enabling our customers to deliver safe and effective drug products to patients quickly and efficiently while reducing the time to market, total cost of ownership (i.e., logistic, storage and personnel costs) and supply chain risk. We achieve this by developing our products in partnership with our customers and leveraging our scientific research, technical expertise, engineering and manufacturing excellence in order to meet the exact specifications and quality standards required for their drug products. In 2021, we significantly ramped up our efforts to align Stevanato’s corporate culture with relevant environmental, social and governance elements. We are committed to embedding sustainability values into policies and practices and establishing a culture of integrity. We are also dedicated to satisfying our sta- keholders’ interests and expectations. In this respect, we strive to grow and support our customers while making a positive impact for the benefit of all, in everything we do. We consider ourselves an interdependent and responsible member of the community we live in and, as such, we do our part to promote initiatives and solutions that foster the health and wellbeing of society and the planet. For the first time, we have voluntarily elected to provide complete, transparent non-financial reporting to our stakeholders and investors. Our 2021 Sustainability Report not only considers the Company’s financial and economic results, but also highlights the environmental, social and governance (ESG) performance of the Group. This is our first published Sustainability Report subject to limited assurance and prepared in accordance with the Global Reporting Initiative (GRI) Standards, which demonstrates our unwavering commitment to sustainability. V |
Sustainability Report—2021 In regards to ESG governance, the Board has shown its strong commitment through the constitution of the ESG Committee. Several functions are involved in the management of ESG matters according to each relevant area of accountability. As a baseline, Stevanato Group tackles ESG risks and opportunities in accordance with current legislation and regulations. In the last quarter of 2021, real GDP growth in the euro area slowed down after two quarters of strong expansion but reached its pre-pandemic level at the end of 2021. Hence, GDP is estimated to have increased by 5.2% in 2021 following a 6.4% decline in 2020. The U.S. economy recovered from the recession caused by Covid-19 with GDP returning to pre-pandemic levels as early as mid-2021. Expansionary growth in China, however, remained weak. In the fourth quarter of 2021, China’s GDP growth rose to 1.6% over the previous quarter, an increase that brought twelve-month growth to 8.1% in 2021. The emergence of the Omicron variant continues to pose risks to growth in the short term. Thus, growth is likely to remain subdued in the first quarter of 2022 as the ongoing pandemic continues to affect economic activity. High uncertainty also stems from the conflict between Russia and Ukraine which erupted at the end of February 2022, posing potentially severe economic consequences. Since the outbreak of COVID-19, we have increased production capacity to support our customers’ efforts to provide a rapid response. In this context, we have been providing: (i) glass vials and syringes to approximately 90% of the currently marketed vaccine programs, according to estimates based on public information (WHO, EMA, FDA); and (ii) plastic diagnostic consumables for the detection and diagnosis of COVID19. COVID-19 has generated increased demand for our products and services, further enabling us to accelerate our growth strategy. Going forward, we expect demand for syringes, vials and related products and services to remain elevated as the COVID-19 vaccine and treatment programs continue to roll-out globally, and as our customers contemplate the transition from mul-ti-dose to single-dose formats. In addition, we expect continued tailwinds as epidemic preparedness, including the ongoing global COVID-19 vaccine rollout, booster shot distribution and new vaccination programs, remains a priority for governments. The Company has made meaningful progress and significant milestones were achieved in 2021. None of this would have been possible without the invaluable contribution of our dedicated and passionate employees. We would also like to express our sincere appreciation to Stevanato Group’s stakeholders—our suppliers, customers, universities and research centers—as well as our shareholders and Board of Directors, communities, local authority and regulators. You have been, and will continue to be, an integral part of our success. Much has been done, but even more is left to do. Challenges are part of our history and the stepping stones to the future we intend to build, day after day. Franco Stevanato Executive Chairman Stevanato Group S.p.A. Via Molinella 17, 35017 Piombino Dese · Padova · Italy Franco Moro Chief Executive Officer & Chief Operating Officer Stevanato Group S.p.A. Via Molinella 17, 35017 Piombino Dese · Padova · Italy VI |
Sustainability Report—2021 Methodological note Our first official and published Sustainability Report is a vehicle for describing, in a transparent and structured manner, Stevanato Group’s environmental, social and economic achievements in the 2021 financial year (January 1-December 31) and shows the commitment and initiatives undertaken towards the goal of sustainable development. Therefore, the purpose of the information contained in this document is to provide internal and external stakeholders with a representation of Stevanato Group’s business performance, results and impact in relation to the main sustainability topics relating to the 2021 financial year. This document represents the Sustainability Report of the companies belonging to Stevanato Group and its subsidiaries (hereinafter also referred to as the “Company”, “Stevanato”, the “Stevanato Group”, the “Group” or “SG”). The scope of the economic data is the same as the 2021 Consolidated Finan- cial Statement of Stevanato Group. The scope of social and environmental data comprises the companies belonging to Stevanato Group as of December 31, 2021, consolidated on a line-by-line basis within the Group Consolidated Financial Statement. Note that some Group companies, which are not productive or operational, have not been included in the EHS aspect due to limitation of scope (see relevant footnotes). This Report, which is going to be published annually, was prepared mainly with reference to the “Global Reporting Initiative (GRI) Sustainability Reporting Standards”. For the specific GRI Standards 303 (Water and water discharges) and GRI 403 (Occupational health and safety), the most recent 2018 versions have been adopted, while for the specific GRI Standard 306 (Waste), the most recent 2020 version has been used. VII |
Sustainability Report—2021 The GRI Standards used in this report create a common language between the organization and its internal and external stakeholders so that the environmental, social and economic impacts can be communicated and understood. The following GRI disclosures have been referenced within this document using a “GRI-Referenced” approach: 102-1, 102-2, 102-3, 102-4, 102-5, 102-6, 102-7, 102-8, 102-9, 102-10, 102-11, 102-12, 102-13, 102-14, 102-16, 102-18, 102-40, 102-41, 102-42, 102-43, 102-44, 102-45, 102-46, 102-47, 102-48, 102-49, 102-50, 102-51, 102-52, 102-53, 102-54, 102-55, 102-56, 103- 1, 103-2, 103-3, 201-1, 204-1, 205-3, 206-1, 302-1, 303-1, 303-2, 303-3, 303-4, 305-1, 305-2, 306-1, 306-2, 306-3, 307-1, 401-1, 401-2, 403-1, 403-2, 403-3, 403-4, 403-5, 403-6, 403-7, 403-9, 405-1, 406-1, 413-2, 416-2. For more details, please see the table “GRI Content Index” in the appendix. The contents of the Report were selected based on the results of a materiality analysis carried out in 2020, which identified the material topics for the Group and its stakeholders published within this document as described in Chapter 2. The materiality analysis included the identification of possible ESG (Environmental, Social and Governance) topics relevant to the Group, the prioritization of the topics identified, and their approval by SG’s management. Note that the results of the materiality analysis process were examined and approved by the Board of Director at the meeting held on February 18, 2021. In line with the reporting guidelines, the sustainability information presentation reflects the principle of materiality. In regards to the reporting process, a global working group of approximately one hundred individuals was established from across the Group. The working group was coordinated and supported in its endeavors to determine the most significant information per material topic, select the appropriate indicators, collect and validate the narrative, and define the management approach and pertinent data. Specifically, the information included herein was taken both from the Group’s IT system and from the sustainability reporting package (data collection sheets and narrative collection forms). Plant managers across the Group’s local entities were also asked to identify the most important locally-based projects and initiatives, which were described as required. In order to properly manage the reporting process, a Sustainability Reporting Procedure was set up. It defined and illustrated how to prepare the Group’s Sustainability Report in accordance with the Sustainability Reporting Guidelines issued by the Global Reporting Initiative (GRI). This procedure also included timing, tools, roles and responsibilities of the functions and individuals. To ensure responsiveness and proper application of the procedures, the reporting process was extensively discussed and agreed upon by the working group. The information presented in this report refers solely to 2021 and includes a comparison with the previous year or past where possible. The information collected and reported is based on measurable data. In addition, in order to correctly present the Group’s performance and help to ensure data reliability, the use of estimates has been limited as much as possible. If they are provided, they have been made using the best methods available and are properly identified. The statement presents both positive and negative aspects equally with a comment on the results when appropriate. This report was approved by the Board of Directors of Stevanato Group S.p.A. on April 11, 2022. This document was submitted to a compliance opinion (“limited assurance engagement” according to the criteria indicated by the ISAE 3000 Revised standard) by Deloitte & Touche S.p.A., which expresses, in a separate report, a certificate of compliance with the GRI Standards. The audit was carried out in accordance with the procedures indicated in the “Independent Auditors’ Report”, included in this document. For further information and suggestions regarding Stevanato Group Sustainability Report, please contact: su-stainability@stevanatogroup.com. VIII |
Stevanato Group1
Sustainability Report—2021 1.1 Highlights Stevanato Group 10 |
Sustainability Report—2021 OVER 70YEARS OF HISTORY: FROM A GLASS MANUFACTURER TO A GLOBAL PROVIDER 16 PRODUCTION AND COMMERCIAL SITES IN 9 DIFFERENT COUNTRIES MORE THAN 700CUSTOMERS € 218 MM OF ADJ. EBITDA IN 2021 140 HIGHLY SKILLED PROFESSIONALS #1st IN PEN CARTRIDGES MORE THAN 100 +10% EMPLOYEE INCREASE IN 2021 65% OF RECYCLED WASTE 4,646 EMPLOYEES WORLDWIDE OVER 70 COUNTRIES SERVED € 844 MM OF REVENUE IN 2021 3.5% OF REVENUE INVESTED IN R&D #1st IN SG EZ-fill® PRE-STERILIZED VIALS #2nd IN PRE-FILLABLE SYRINGES THOUSAND HOURS OF TRAINING IN 2021 20% FEMALE DIRECTORS AND MANAGERS 8 DIFFERENT ISO CERTIFICATIONS Stevanato Group 11 |
Sustainability Report—2021 1.2 Story and evolution Stevanato Group, an Italian multinational company, is a leading global supplier of drug containment, delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. OWNERSHIP AS OF 31.12.2021 78,03% Stevanato 11,17% Holding S.r.l. Stevanato Group S.p.A. (Market shares) 10,43% Stevanato Group S.p.A. (Treasury shares) 0,37% Shares Owned by Directors and Officers Stevanato Group 12 |
Sustainability Report—2021 Headquartered in Piombino Dese (Padua, Italy), Stevanato Group is a joint stock company with a total of € 21.698.480 in paid-up capital. The majority shareholder is Stevanato Holding S.r.l. with 78.03% of shares owned, followed by Stevanato Group S.p.A. with 10.43% of shares held in treasury, other shareholders hold 11.17% of share capital and, lastly, a group of directors and officers with 0.37% of shares owned. In 1949, Giovanni Stevanato founded Soffieria Stella, a specialty glass manufacturer in Zelarino, near Venice. Soffieria Stella, the precursor to Steva-nato Group, operated until 1959 when Stevanato Group was established in Piombino Dese (Padua). Over the last 70 years, Stevanato has evolved from an Italian glassware manufacturer to a leading global provider of integrated solutions for the healthcare industry. Stevanato Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Reduced time Reduced supply Reduced total Consistent to market chain risk cost of ownership quality Unique combination of integrated capabilities to address customer needs across the pharmaceutical value chain Drug containment solutions Highly Customized and Pre-Sterilized Containment Solutions (SG EZ-fill®) through Ompi brand Drug Delivery Systems Proprietary Devices and CMO/CDMO Business Technologies & Manufacturing Equipment Sub & Final Assembly, Automation, & Packaging Solutions, Visual Inspection, Glass Converting Analytical Services & Regulatory Support (incl. TECs) Analytical Testing & Regulatory Support Systems Processes Services The Group’s priority is to provide flexible solutions that preserve the integrity of pharmaceutical products and enable its customers to deliver safe and effective treatments to patients while reducing time to market, total cost of ownership (i.e., logistics, drug product waste, storage and personnel costs) and supply chain risk. Steva-nato Group achieves this by developing products in close collaboration with its customers and leveraging its scientific research capabilities, technical expertise and engineering and manufacturing excellence to meet their quality requirements. Stevanato Group 13 |
Sustainability Report—2021 Stevanato Group solutions are highly integrated with the development, production and commercialization processes of customers. In addition to manufacturing drug containment and delivery solutions, Stevanato provides a full set of services across all stages of drug development, from pre-clinical to clinical and commercialization. The Group also engineers machinery and equipment for the production of drug containment and delivery systems that can be integrated into both its customers’ and its own manufacturing processes. The Group’s involvement at each stage of a drug’s life cycle, together with the breadth of Stevanato’s offerings, enables it to serve as a one-stop-shop for customers, which gives Stevanato Group a significant competitive advantage. The chart below illustrates the Group’s presence across the pharmaceutical value chain. Stevanato Group operates across the healthcare industry and serves some of its fastest-growing segments, including biologics, biosimilars, vaccines and molecular diagnostics. The Group is embedded in the drug production and delivery supply chain and well-positioned to benefit from secular trends within its targeted focus areas, such as increases in demand resulting from pharmaceutical innovation, acceleration and expansion of vaccination programs, growth of biologics/biosimilars, self-administration of medicines, aging demographics, increasing complexities in health conditions and co-morbidities, and evolving quality standards and regulation. Stevanato Group 14 |
Sustainability Report—2021 STEVANATO GROUP’S ROLE ALONG THE PHARMA VALUE CHAIN Drug Discovery API Manufacturing Drug Formulation Development Device & Container Concept Definition and Design Manufacturing of Pharma Machinery and Equipment Finished Product Device & Container Development and Manufacturing Fill & Finish Automatic Inspection Assembly Packaging Serialization Marketing & Distribution Stevanato Presence Stevanato Group 15 |
Sustainability Report—2021 Stevanato Group estimates that the to¬tal addressable market, based on the current overview, exceeds $13 billion in terms of revenue generated by all market participants in 2021, and con¬sists of biopharmaceutical injectables and in-vitro diagnostic products. Within each of these markets, Stevanato ope¬rates in some of the fastest-growing segments, including pre-filiable syrin¬ges, presterilized vials and cartridges, drug delivery systems, molecular dia¬gnostics and assembly equipment. Stevanato Group believes there are opportunities to further expand the addressable markets, including by tar¬geting (i) complementary containment solutions, (ii) additional delivery sy¬stems, (iii) complementary engineering solutions, and (iv) aftersales support and services. Stevanato Group categorizes the ad-dressable market by direct markets and end markets. Direct markets are comprised of products and product categories in which Stevanato directly participates, such as drug containment systems. The Group’s end markets in-clude broader sectors in which Steva¬nato sees demand for its products and services, such as vaccines and biologies. DIRECT MARKETS Business Segment Engineering Drug Drug In-Vitro Direct Market ContainmentDeliveryDiagnostic Engineering SolutionsSystemsSolutions KEY END MARKETS Market Segment Biopharmaceutical Injectables In-Vitro Diagnostics Molecular Other Diagnostics Diagnostics Stevanato Group operates in two segments: Biopharmaceutical and Diagnostic Solutions, which includes all the pro-ducts, processes and services deve-loped and provided for the contain-ment and delivery of pharmaceutica and biotechnology drugs and rea-gents, as well as the production of diagnostic consumables; and • Engineering, which includes all of the equipment and techno¬logies developed and provided to support the end-to-end phar¬maceutical, biotechnology and diagnostic manufacturing proces¬ses (assembly, visual inspection, packaging and serialization and glass converting). Overview of our business segments: it ED Stevanato Group 16 |
Sustainability Report—2021 Biopharmaceutical and Diagnostic Solutions Segment Drug Containment Solutions Platforms for Platforms for syringers vials Platforms for Integrated cartridges syringe safety systems Drug Delivery Systems Auto- Pen Injectors Injectors Wearable Dry Powder Drug Delivery Inhalers Devices IVD Solutions Point-of-lab Point-of-Care Consumables Consumables Handheld Devices Analytical Services • Primary Container • Compatibility and Functionality with Drug Product • Container Closure Integrity • Medical Devices/ Combination Products • Developmental (non-GMP) Fill & Finish services • Consultancy (regulatory, compilance support, test method development and transfer) Offering Proprietary “High-Value Solutions” Across Business Lines Over the past decades, Stevanato’s growth has been driven by cutting-edge developments in new containment and delivery solutions as well as strategic acquisitions. In 2005, the Group began its international expansion with the acquisition of Medical Glass, a Slovakia-based primary packaging manufacturing company. Subsequently, in 2007 and 2013, Stevanato acquired an Italian company, Optrel, and a Danish company, Inno-scan, which specialize in the production of inspection machines. These acquisitions marked its entry into the techno- logy and equipment manufacturing business. In 2016, Stevanato furthered its expansion through the acquisition of: (i) Balda, a company specialized in developing and manufacturing plastic diagnostic consumables, drug delivery systems and medical components; (ii) SVM, a company specialized in the production of high-tech machines and systems for assembly, packaging and serialization of pharmaceutical products; and (iii) Medirio, a start-up developing patents and other intellectual property for the wearable injectors business. Stevanato Group 17 |
Sustainability Report—2021 Engineering Segment Assembly • Sub-assembly and final assembly for drug delivery devices • Highly automated modular platforms Visual Inspection • Semi-automatic and automatic inspection machines • Diversifield portfolio • Artificial Intelligence Platform for AVI Packaging & Serialization • Single point of contact for packaging processes • Range of formats, reproducible settings • Traceability with serialization Glass Converting • Fully automated high-speed precision glass converting lines • Extensive dimensional and cosmetic inline controls After-Sales • Advanced after-sales services • Global service based on technical expertise and interactive tools Highly automated and advanced equipment for both in-house use and sale to customers Stevanato Group 18 |
Sustainability Report—2021 2021 Initial Public Offering and First Day of Public Trading on NYSE Initiated construction of new U.S. Facility in Indiana to increase manufacturing capabilities Initiated expansion of Headquarters in Piombino Dese to increase the production of high-value products 2017 Opened third greenfield plant in Sete Lagoas (BR) 2016 Plastic injection molding competences are added (Balda), in addition to Assembly & Packaging (SVM) 2007 Acquisitions of inspection competences (Optrel) 2007 Ompi starts SG EZ-fill® production 1993 Acquisition of lfamatic (drug containment solutions) 1949 Giovanni Stevanato founds Soffieria Stella: the foundation of Stevanato Group 2020 Opened U.S. TEC center in Boston 2019 New building in Piombino Dese increased syringe capacity 2020 SG Alina® pen injector licensing agreement Reusable wearable device for pain management agreement 2019 Integrated Safety System Launch Launch of SG Alba®, the solution for protein-based biologics 2013 Innoscan acquistion (high-speed inspection) 2012 Opened second greenfield plant in Zhangjiagang (CH) 2008 Opened firstgreenfield plant in Monterrey (MX) 2005 Acquisitions of Medical Glass in Bratislava (SK) 1971 Spami, specialized in glass converting systems, is established Organic Inorganic R&D Stevanato Group 19 |
Sustainability Report—2021 In parallel with Stevanato’s acquisition strategy, the Group regularly reviews its operations in the context of its organic growth plan. As a result of these ongoing assessments, Stevanato Group has expanded its offering through new departments, new laboratories, new offices and new plants. In 2019, Stevana-to opened a new building in Piombino Dese (Italy) to increase its syringe production capacity, and since 2008, the Group has opened three greenfield sites in (i) Monterrey, Mexico in 2008; (ii) Zhangjiagang, China in 2012; and (iii) Sete Lagoas, Brazil in 2017. In 2021, the Group announced plans to expand its global market position in high-value solutions by investing in additional capacity in the U.S. and China to meet the growing demands of the expanding pharmaceutical, biotech-nology and vaccine markets. The site in Fishers, Indiana, USA, will enable the Group to better serve its North America pharmaceutical customers with the production of pre-sterilized EZ-fill® syringes and vials. The capacity expansion for EZ-fill® products in Zhangjiagang, China, also has a strong focus on biologics and vaccines in addition to focusing on solutions for the engineering segment. Another capacity expansion is planned in Italy where it will generate new jobs. The Group will follow best practices to improve both environmental and societal impacts using the latest in technology and sustainable solutions. Finally, in 2021 Stevanato Group finalized the consolidation of its plastic component operations in the Balda, Ontario site. The expansion of the On-tario plant was carefully implemented, minimizing impact on the staff and customers’ production schedules, and will greatly improve its level of service, reduce time to market, and simplify supply chain and customer interfaces. This rich history of organic growth and strategic acquisitions has allowed Ste-vanato Group to create a comprehensive portfolio of integrated products, capabilities, technologies and services for the pharmaceutical and heal-thcare industries. The main company brands are: • Ompi – Drug Containment Solutions: with more than 70 years of experience, Ompi is specialized in the production of glass primary packaging for pharmaceutical use and collaborates with pharma companies to continually raise its quality standards and develop customized solutions. • Balda – IVD and Drug Delivery Systems Solutions: founded in 1908, Balda specializes in high-precision plastic injection molding for pharmaceutical and healthcare applications including diagnostic consumables, dispensing devices and medical components. Balda offers both contract manufacturing and development services. • Lab/TEC – Analytical Services: born in 2015, SG Lab Analytics holds a leading edge in scientific and technological expertise. It offers a wide range of analytical services related to glass primary packaging with a focus on analytical chemistry, material properties, and physical and mechanical performance. Inaugurated in Boston, USA, in 2020 the Technology Excellence Center (TEC) provides biopharma companies with integrated analytical services and effective project management to support their drug development activities from early phase to commercialization and lifecycle management. • Spami – Glass Converting Equipment: Since 1971, Spami has been the technological leader in designing and assembling automated lines for the transformation of glass tubing into containers for pharmaceutical use. It continuously upgrades its technologies, addressing the real needs of glass tubing packaging manufacturers, offering higher quality, stability, output speed and facility of use. Stevanato Group 20 |
Sustainability Report—2021 • Optrel – Visual Inspection Equipment: since it was founded in 1983 in Vicenza, Italy, Optrel has been developing advanced inspection technologies for pharmaceutical products. The company focuses on the inspection machine market for the pharmaceutical industry, including parenteral drugs, injectables and solid dosage inspection using medium-speed automatic, semiauto-matic and manual equipment, supporting pharma companies from the lab to commercialization • Innoscan – Visual Inspection Equipment: founded in 1988, the company is a Danish technology leader in the development, production and marketing of complex, high-speed inspection machines for difficult-to-inspect pharmaceutical injectables. It is specialized in the field of automatic equipment designed to cater to pharma companies’ needs for high-volume production and holds a significant track-record in the delivery of machines optimized to inspect insulin for diabetes treatment. SVM – Assembly & Packaging Equipment: founded in 1974 in Denmark, SVM is specialized in the design and construction of high-technology machines and systems for assembly, secondary packaging and serialization for pharmaceutical and combination products. The company develops specialized machines from the conceptual phase to production. Stevanato Group 21 |
Sustainability Report—2021 The combination of multinational a truly global company spread across dif-brands has transformed the Group into ferent countries and continents: 9 production plants for manufacturing and assembly of pharmaceutical and healthcare products across the world: • Drug containment solutions: • Italy – Piombino Dese (PD), Latina (LT); • Slovakia – Bratislava; • Mexico – Monterrey; • Brazil – Sete Lagoas; • China – Zhangjjagang; • IVD and Drug Delivery Systems Solutions: • Germany – Bad Oeynhausen; • USA – Ontario (CA), Oceanside (CA)1. 5 plants for the engineering and production of technologies and manufacturing equipment: • Glass Converting: • Italy – Piombino Dese (PD), Bologna; • Visual Inspection: • Italy – Piombino Dese (PD); • Denmark – Brabrand; • Assembly & Packaging: • Italy – Piombino Dese (PD), Bologna; • Denmark – Silkeborg. 2 sites for analytical services: • Italy – Piombino Dese (PD); • USA – Boston (MA). 2 commercial offices: • Japan – Nagoya; • USA – Newton (PA). 2 sites under construction: • USA – Fishers (IN); • China – Zhangjjagang. The manufacturing facilities in Mexico, China, Brazil and the hub under construction in the US all represent gre-enfield operations built by the Group. Facilities in Slovakia, Germany, Den-mark and the United States (the plant dedicated to IVD and DDS Solutions) were acquired in strategic transactions over the past 15 years. Our global presence, together with proprietary, standardized manufacturing systems and processes, allow the Group to provide consistent product and services standards to its customers in approximately 70 countries around the world. 1. Balda Precision Inc., Production metal components. Stevanato Group 22 |
Sustainability Report—2021 STEVANATO GROUP TODAY Global footprint with investments in attractive markets to fuel growth 9 Sites For drug containment/diagnostic and device development & manufacturing 1 2 3 4 5 6 7 8 9 US | CA US | CA Mexico Brazil Germany Slovakia Italy Italy China Oceanside Ontario Monterrey Sete Lagoas Oeynhausen Bad Bratislava Piombino Dese Latina Zhangjiagang Container/Device Devices & Diagnostics Devices & Diagnostics Drug Containment Drug Containment Devices & Diagnostics Drug Containment Drug Containment Drug Containment Characterization Manufacturing Manufacturing Solutions Solutions Manufacturing Solutions Solutions Solutions Solutions 10 11 5 6 16 14 7 1 19 18 8 2 12 9 3 13 17 15 4 10 11 12 13 14 15 16 17 Denmark Denmark Italy Italy US | MA Italy US | IN China Brabrand Silkeborg Piombino Dese Bologna Boston Piombino Fishers Zhangjiagang Dese Glass Converting, Glass Converting, Visual Inspection Visual Inspection Container/Device Container/Device Visual lnspection and Visual lnspection and ® ® Assembly/Packaging Assembly/Packaging Characterization Characterization New EZ-fill plant New EZ-fill plant Assembly/ Packaging Assembly/ Packaging Solutions Solutions Solutions Solutions Solutions Solutions 5 Sites For technologies & automated equipment (Engineering) 2 Sites For analytical services 2 Sites Investments underway for capacity expansion for EZ-fill®/ Engineering Source: SG Internal Data 18 19 US | PA Japan Analytical and Newtown Nagoya Plant testing services Commercial Office Commercial Office Office R&D 2 Sites Stevanato Group 23 |
Sustainability Report—2021 1.3 Mission, Vision and Values Stevanato Group’s Vision, Mission and Values provide a framework to guide the company’s pursuit of business goals with an ethical and transparent mindset and focus on fostering innovation. Stevanato Group 24 |
Sustainability Report—2021 MISSION The Group is committed to creating systems, processes and services that enhance the integrity of medicines. It strives to be the best, objective-focused partner in the research and delivery of innovative solutions to support the success of its customers. The continual innovation and pioneering of new trends in pharmaceutical glass packaging ensures the production of the world’s most advanced solutions year after year, enhancing the level of product integrity guaranteed to patients and always seeking to exceed customer expectations. Geographical Product Focus on customer Operational Quality portfolio and patient excellence Merges and Social Innovation Financial Research and acquisition development VISION & VALUES At the heart of Stevanato Group’s vision is the desire to drive technological innovations that combine pharmaceutical glass products and processes into systems, which then enhance the integrity of parenteral drugs in a way that is far superior to anything that has been achieved before. Stevanato Group’s vision is based on five fundamental values, each one closely connected to the other in order to guarantee synergistic collaboration and leadership rooted in excellence. Employees within the Group are particularly dedicated to being ethical and accountable in their day-to-day actions and are driven to deliver results. Listen and Trust and respect Be Deliver Be ethical communicate with everyone accountable results always transparency and honesty Stevanato Group 25 |
Sustainability Report—2021 GUIDING PRINCIPLES Guiding Principles provide practical direction on how to be more effective in living the company Values every day. They help Stevanato Group’s people to work as an aligned, integrated team in pursuit of the mutual goal of building value for the Group, with a focus on customer needs, best product development, and efficiency. Being humble, competent and ready to aim for excellence are the principles that have characterized Stevanato Group, helping it to become the corporation it is today. The adoption of the Guiding Principles leads the Group towards achieving its Mission and creates systems, processes and services that guarantee the integrity of medicines. Will to win Competence, Consistency well, have a Don’t be Humility experience and execution and big goal standard preparation decision making Stevanato Group 26 |
Sustainability Report—2021 1.4 The company structure and main corporate functions The organizational chart below shows the composition of the Group including its parent company, Stevanato S.p.A., and subsidiaries. For more detailed information on the Group structure, please refer to the Consolidated Financial Statements as of De-cember 31, 2021. The Group corporate structure as of December 31, 2021, was the following: Stevanato Group 27 |
Sustainability Report—2021 Stevanato Group S.p.A. 100% 100% 51% 100% Stevanato Group Nuova Ompi Ompi Of Spami S.r.l. International S.r.l. Japan Co., Ltd. (Italy) a.s (Slovakia) (Italy) (Japan) 100% 100% 30.8% 69.2% 100% 100% Balda, Stevanato Ompi SVM N. A. S. de N. A. S. de lnnoscan A/S Medical GmbH Aulomatilc: A/S (Denmark). (Germany) RL de CV RL de CV (Denmark) (Mexico) (Mexico) 100% 79.0% 21.0% 99.74% 100% Ompi do Brasil Ompi Ompi ind. E Com de Medical Pharmaceutical of America lnc. Embalagens Glass a.s. Packing (USA) Farmaceticas (Slovakia) Technology Ltda (Brasil) Co. Ltd. (China) 100% 100% 100% Balda C. Balda Meridio SA Holding Brewer lnc. Precision Inc. (Switzerland) (USA) (USA) Biopharmaceutical and Diagnostic Solutions Engineering Stevanato Group 28 |
Sustainability Report—2021 In terms of significant changes to the organizational structure, as of February 22, 2021, Franco Moro has replaced Franco Stevanato as Chief Executive Officer of Stevanato Group, and is responsible for overseeing the execution of business development plans to grow and enhance the company’s end-to-end offering for pharmaceutical and diagnostics companies. Franco Moro previously held key Officer positions within Stevanato Group and has significant experience in international manufacturing and pharmaceutical industries. After this re-organization, Franco Steva-nato is the new Executive Chairman of the Board of Directors, overseeing long-term business strategy, acquisitions, expansion into global markets, and relations with the Board of Directors. Marco Stevanato remains the Vice-Chairman and Sergio Stevanato has been appointed Chairman of the Board Emeritus. Stevanato Group is proud of its heritage. The family’s close ties to the business have been fundamental in allowing the company to expand. It has been able to develop naturally while always understanding the ever-increasing complexity of doing business. As the Group has grown, a structured and skilled management team with international roots has been put into place. Stevanato Group has adopted a corporate governance that sets the rules for the appropriate management of the Group, separating ownership from the operating activities. The Group is managed by the Board of Directors, which meets at least four times per year to make key decisions on reserved topics. The Group is led by an experienced, highly motivated, diverse Board, leading to more objectivity and independence, and an executive team with a proven track record of operational excellence. The Group believes that this has significantly benefitted its strategy building and execution capability, helping it to consistently achieve results by anticipating market trends and staying ahead of the competition. Stevanato Group intends to continue with this approach. As of December 31, 2021, the Board of Directors was composed as follows: Board of Directors at 12.31.2021 Role Stevanato Sergio Chairman of the Board Emeritus Stevanato Franco Executive Chairman Stevanato Marco Vice-Chairman Moro Franco Chief Executive Officer Nicoletti Fabiano Independent Director Spinazzi Alvise Director Bonanni Fabrizio Independent Director Buttignon Fabio Independent Director Balachandran Madhavan Independent Director Morel Jr. Donald Eugene Independent Director Paola Vezzaro Independent Director William Federici Independent Director Stevanato Group 29 |
Sustainability Report—2021 In regards to the Board of Directors composition, it is important to note that seven members are independent directors. Diversity of Board of Directors as of 12.31.2021 No. of Directors 12 Executive 2 Non-executive 10 Women 1 Men 11 < 30 years 0 30-50 years 3 > 50 years 9 BOARD OF DIRECTORS COMPOSITION BY GENDER AND AGE RANGE IN % [GRI 405-1] AS OF 12.31.2021 92% Male 8% Female 75% >50 years 25% 30-50 years The Italian Civil Code provides for three alternative corporate governance systems: (i) the traditional model (comprising a Board of Directors and a board of statutory auditors), (ii) the two-tier board system (comprising a management board and a supervisory board), or (iii) the one-tier board system (comprising a Board of Directors and an audit committee). Stevanato Group 30 |
Sustainability Report—2021 In May 2021, Stevanato Group S.p.A. adopted the one-tier corporate governance system which provides for a Board of Directors and an Audit Committee. The Audit Committee consists of Wil-liam Federici, Fabio Buttignon and Fa-brizio Bonanni. Mr. Federici serves as the chairman of the Audit Committee. The Board of Directors determined that all members of the Audit Committee must meet the requirements for financial literacy under the applicable rules and regulations of the SEC and the NYSE corporate governance rules. The Audit Committee is compliant with applicable rules and regulations of the SEC and NYSE corporate governance rules as well as Italian Law requirements with respect to its composition, expertise requisites, functioning and independence. The Audit Committee is responsible for, among other things, assisting the board in the oversight of: • the accounting and financial reporting practices of the Company as well as the integrity of the financial statements; • the adequacy of the Company’s organizational structure, internal control system, and administrative and accounting systems; • the Company’s risk assessment and risk management processes to ensure such processes are effective; • the supervision of compliance with legal and regulatory requirements including, as required by the rules and regulations of the SEC, the preparation of the Audit Committee report to be included in the Company’s annual proxy statement; • the independence and qualifications of the Company’s registered public accounting firm. The Audit Committee meets in a manner that the Audit Committee may deem fit at least once every ninety calendar days. Periodically, the Audit Committee also meets with the independent auditor and members of management. A more detailed analysis of the governance structure indicates there are also four committees that cooperate with the Board of Directors on day-to-day matters. The members of the different committees described in this document share the same term of office with the Board of Directors and provide opinions and suggestions, without prejudice to the Board’s competence and decision-making responsibility. Below is the main composition and activities of the four Stevanato Group committees. Stevanato Group 31 |
Sustainability Report—2021 The Nomination and Corporate Governance Committee is responsible for, among other things: Members Activities 4 members from the Board of • reviewing the structure, size and composition (including the skills, knowledge, Directors experience and diversity) of the Board of Directors; • identifying and appointing independent Board of Directors’ candidates to fill independent Board vacancies as and when these arise; • keeping under review the leadership needs of the organization, both executive and non-executive, with a view to ensuring the continuing ability of the organization to compete effectively in the marketplace; • constantly reviewing corporate governance rules and practices and ensuring that corporate governance codes that apply to the Company are observed; • formulating succession plans. The Business & Strategy Committee is responsible for, among other things: 8 members from the Board of • periodically reviewing and making recommendations on medium and long-term Directors strategies and strategic plans to be pursued; • reviewing the annual business plan, budget and capital structure of the Group before onward submission to the Board for approval; • meeting with management periodically to monitor the Company’s progress against its strategic goals and to discuss, review and recommend to the Board any such matters or issues which relate to the strategic planning of the Group; • ensuring the Board of Directors is regularly appraised of the Company’s progress with respect to implementation of any approved strategy. The Compensation Committee is responsible for, among other things: 3 members from the Board of • analyzing, discussing and making recommendations to the Board of Directors Directors on remuneration policies for directors and senior management and reviewing their appropriateness; • within the terms of the agreed policy and in consultation with the Board chairman, determining the total individual remuneration package of each Executive Director; • assessing, reviewing and recommending for approval by the Board, the CEO’s annual remuneration package and performance objectives based on the evaluation of the CEO’s performance; • reviewing and approving any significant changes to the overall compensation program and incentive plans. The ESG Committee is responsible for, among other things: 3 members from the Board of • assisting the Company in setting ESG strategies, including by reviewing, chal-Directors lenging and overseeing the content and approach to strategy concerning ESG matters; • supervising compliance of ESG disclosure and ensuring a sustainability strategy is considered by the Board as part of the overall business strategy of the Group; • bringing to the attention of the Board of Directors emerging ESG matters, and reviewing, challenging and approving annual sustainability KPIs and related targets in line with the agreed sustainability strategy; • putting systems in place to monitor ESG Matters and reviewing compliance with material regulation and legislation on ESG/sustainability issues, and any public ESG/sustainability-related commitments voluntarily subscribed to by the Group. The main corporate and business areas represent a significant investment for Stevanato and are essential to Ste-vanato Group’s operations and strategy. The purpose of the Group is to conduct a lawful, ethical, profitable and sustainable business in order to create value over the long term as reported below in the company chart. Stevanato Group 32 |
Sustainability Report—2021 Executive Chairman F. Stevanato CEO F. Moro Group PPMO Investor & C-Suite Office Relations Internal CRS & Communication Compliance CFO HRO M. Dal Lago T. Coviello Legal and Sustainability Corporate Affairs Project Process & Procedures Treasury & Group Tax Group Planning Admin. Italian HR Corp Admin & SG Academy & Organization HR Corporate Financial Risks Management & Control Companies Personnel Mgm IT Change Mgmt CTO CBO COO P.Patri M. Stocchi F. Moro Group Patent Strg. Marketing Customer Quality Ops Infrastructure PPM Attorney and M&A Service & Compliance & Service Corp. Business Communication Supply Chain Development Prov. Dev. DDS Sales Business SG TEC PM & Proposal & IVD Solutions Analysis Product Dev. Regulatory & PM & Bus. Ops Glass Ops CTQS CCS Quality R&D Dev DDS & Ezfill Engineering Ops Plastic Group KAM Sales EMEA AMERICAS APAC After Sales Eng. Stevanato Group 33 |
Sustainability Report—2021 1.5 Ethics, integrity and compliance An essential factor for success, and an indispensable asset to the Company’s reputation, is the adoption of high ethical conduct standards. The Values and Guiding Principles followed by the Group are the building blocks of its Code of Ethics. The Code of Ethics defines the guidelines and criteria of conduct for all recipients, and aims to ensure compliance with regulations in force to prevent improper acts or behavior and to help protect the legitimate interests of customers, employees, shareholders, business and financial partners, communities and all the different stakeholder groups. The Code of Ethics has been disseminated in all of Steva-nato Group’s companies. Overall, the Code of Ethics has the function of promoting fairness and loyalty in the management of transactions and human relations, within and outside the Group, by those who work on behalf of the Group. The recipients of the Code of Ethics, who are directors, employees, collaborators, suppliers and all those who, in any way, operate on behalf of the Group, are obliged to observe and enforce the provisions contained in it, by adopting the right behavior designed to preserve the Group’s image and the integrity of its economic and human heritage. Stevanato Group 34 |
Sustainability Report—2021 The specific provisions contained in the Code of Ethics have been reported in specific internal policies and procedures that ensure compliance with the principles and guidelines of the Code of Ethics (e.g., anti-corruption, insider trading, related parties and anti-discrimination). In this regard, it should be noted that the Group also approved an anti-bribery and anti-corruption policy on July 2, 2021, and approved an anti-discrimination policy on December 17, 2021. For further details on these policies please refer to the investors section of the corporate website. Stevanato Group acts in compliance with intellectual, industrial and commercial property rights, as well as with international laws and regulations in order to protect such rights. In 2021, no cases of non-compliance with environmental laws and regulations were registered. Since April 2021, Stevanato Group has adopted a whistleblowing procedure to correctly manage the reporting of any violations and irregularities concerning the Code of Ethics related to Italian Legal Entities. In this context, Stevanato Group ensures that business is conducted in line with fairness, completeness and transparency of information and legitimacy, excluding any form of corruption or favoritism. Employees can report any violations or suspected violations to the Company through a dedicated email address: csr-complian-ce@stevanatogroup.com. The information transmitted is promptly checked and, once the Report has been verified, the case is submitted to the competent corporate department for the application of any disciplinary sanctions or for the activation of contractual termination mechanisms. This whistleblowing procedure is designed to ensure the confidentiality of the person reporting the issue and the information received, as well as its validity. Note that, no grievances as of December 31, 2021, have been sent to the relevant function inbox and, during 2021, no cases of incidents of corruption or human rights violations were recorded in the Group. In accordance with Italian law, Steva-nato Group has introduced an Organizational, Management and Control model for its Italian entities as per Legislative Decree no. 231/01. The management principles envisaged by the Organizational, Management and Control framework are aimed at preventing the commission of crimes by employees, or any other crimes connected to Stevanato Group that may involve the Group’s Italian companies. The Group is currently working to strengthen management systems within the foreign companies to ensure compliance with each local law, taking into consideration the provisions of the Model of Organization, Management and Control pursuant to Legislative Decree 231/01. The parent company, Stevanato Group S.p.A., has set up a Supervisory Body pursuant to Legislative Decree 231/01, responsible for monitoring compliance, operating and updating the Model. A communication channel has been set up at the e-mail address odv.steva-natogroup@stevanatogroup.com, which only members of the Supervisory Board may access to receive reports of any violations or suspected violations of the Model from internal and external subjects. Stevanato Group 35 |
Sustainability Report—2021 A FOCUS ON STEVANATO GROUP RISK MANAGEMENT Risk monitoring and management is an integral part of Stevanato Group’s business model. Risk exposure is managed through careful monitoring carried out by each employee. At the moment, Stevanato Group tackles ESG risks & opportunities in accordance with current legislation and regulations. The main relevant risk categories identified are: • business risks related to activities and critical aspects of the business; • risks related to the efficiency and effectiveness of business operating processes with impact on Group performance; • risks related to human resources management and the effectiveness of the organizational structure; • risks related to financial planning processes and financial reporting activities, management of financial and insurance instruments; • risks related to compliance with national and international laws, regulations and Group policies. As proof of the Group’s ongoing commitment to ethical conduct and integrity in its business, there were no reports and/or complaints received about non-compliance with laws or regula- tions, or legal action taken regarding anti-competitive behavior, anti-trust or monopoly violations either in or out of court in 2021. Stevanato Group 36 |
Stevanato Group and sustainability SG Stevanato Group 2
Sustainability Report—2021| 2.1 Approach to sustainability Stevanato Group aims to align its corporate culture and business operations with relevant Environmental Social and Governance (ESG) elements pursuing a sustainable corporate model. The Group is committed to embedding sustainability values into its policies and practices and to establishing a culture of integrity. SG believes that the challenge and opportunity is to continue growing and supporting its customers through regenerative business innovation, while making a positive impact for the benefit of all, in everything the Company does. The Group considers itself an interdependent and responsible member of the community it operates in and, as such, promotes initiatives and solutions that foster the health and wellbeing of society and the planet as a whole. As a key player in the pharmaceutical and healthcare market, Stevanato Group is focused on developing and strengthening its sustainability practices. As stated in its EHS policy, Stevanato Group aims to protect the environment, to operate under the principles of sustainability on a global level, and to integrate EHS management into all business processes, including the commitment to energy-saving programs and the optimization of natural resources consumption. In addition, Stevanato Group pursues the Life Cycle Perspective of selected products, packaging and processes as part of its corporate Circular Economy innovation program. As such, it strives to improve the environmental and societal impact of its business through the integration of principles such as: (i) Design out waste and pollution; (ii) Keep products and materials in use; (iii) Regenerate natural systems. These sustainable practices can help mitigate impact in areas such as climate- change, biodiversity loss, and pollution. Finally, Stevanato Group fosters Public-Private co-innovation through collaboration with Universities/ Joint Labs to advance education and awareness on such topics. Through a materiality assessment, the Group has identified the ESG issues most relevant to the organization and its stakeholders. The issues considered have a substantial impact on Stevanato Group’s environmental, social and economic performance, or may substantially influence stakeholders’ decisions. Therefore, as required by the Standards of the Global Reporting Initiative (GRI), Stevanato Group has defined and organized the contents of the Sustainability Report to provide disclosure on how the Group manages sustainability by assessing these material issues. Sustainability 38
2. “Core Team” refers to the head of main corporate functions. “C-suite” refers to the Chief executive-level managers within Stevanato Group. Sustainability Report—2021 The process conducted by the Group has been developed with reference to the main international standards. First, SG has identified the potentially relevant topics for the company and the main Group stakeholders through an analysis of the context in which the Group operates. The main sources were a benchmarking analysis of peers, online pharmaceutical and healthcare market research, the Sustainable Accounting Standards Board Materiality Map for the company sector, internal documents, policies and commitments, and published rating agency searches. Consequently, a set of 14 relevant sustainability topics were selected and identified. These topics, divided into five categories (environmental responsibility, people responsibility, social responsibility, economic and company responsibility, and clients/product responsibility), were assessed through stakeholder engagement workshops and a remote survey. The main steps followed by the Group are reported in the chart below. Identification of Relevant Topics Analysis of the context in which the Group operates, regarding the reference sector Definition of a list of relevant topics Internal Assessment External Assessment Assessment by Group management Assessment by and internal stakeholders external stakeholder Stevanato Group Materiality Matrix The assessment process involved both internal and external stakeholders in a Core Team and C-suite2 workshop. They were asked to evaluate the relevance of fourteen topics from the perspective of Stevanato Group employees and management. External stakeholders also filled out an online survey with a valuation scale from 1 (“not important”) to 5 (“highly important”), and each sustainability topic was evaluated based on its relevance for stakeholders. The feedback gathered confirmed the materiality of all 14 topics. The results of the analysis were examined and approved for the 2021 Sustainability Report by the Board of Directors at a meeting held on February 18, 2021. Sustainability 39 |
Sustainability Report—2021 1 2 3 4 5 Research & Business ethics, Human capital Product quality Occupational Development governance and management and and responsibility Health & Safety and Innovation compliance development 14 6 Economic Local performance communities and value engagement MATERIAL TOPIC creation FOR SUSTAINABILITY REPORT 2021 13 7 Responsible GHG supply chain & Emissions procurement 12 11 10 9 8 Water Human Employee Waste Energy management rights wellbeing management Consumption The materiality assessment allowed the Group to identify 14 topics across five areas: environmental responsibility, people responsibility, social responsibility, economic and company responsibility and clients/product responsibility. These are considered highly relevant for Stevanato Group, as illustrated in the materiality matrix below. Sustainability 40 |
Sustainability 41 | Sustainability Report—2021 STEVANATO GROUP MATERIALITY MATRIX 5,00 4,80 4,60 Occupationel Product quality and Health & Safety responsability 4,40 Business ethics, governance Research & Development Waste and compilance and Innovation management Economic 4,20 performance and Human Energy Human capital manage-value creation STAKEHOLDERS rights Consumption FOR 4,00 ment and development Employee 3,80 GHG wellbeing Emissions Responsible supply chain RELEVANCE 3,60 & procurement Water management 3,40 Local communities 3,20 engagement 3,00 3,00 3,50 4,00 4,50 5,00 RELEVANCE FOR THE GROUP Environmental Responsibility Economic and Company Responsibility People Responsibility Social Responsibility Clients/Product Responsibility The top of the materiality matrix shows, on one hand, two aspects to which Ste-vanato Group, in line with its business strategy, has always given primary attention: product quality and responsibility, and research & development and innovation. On the other hand, certain elements closely associated with human resources, such as occupational health & safety and human capital management and development, highlighted the importance of the Company’s policies towards people. In addition, the importance of social and economic topics such as business ethics, governance and compliance, economic performance and value creation, and responsible supply chain and procurement are clear. In terms of environmental responsibility, attention is mainly dedicated to the reduction of environmental impacts for products and processes along with the energy consumption and waste management. Once the Group had identified the 14 material topics, which are the subject of this Sustainability Report, they were linked to specific GRI KPI’s with focus on each sustainability area. The preparation of the Group’s 2021 Sustainability Report was based on a structured reporting practice formalized through the Sustainability Reporting Procedure. It defines and outlines how to prepare the Group’s Sustainability Report at the operational level, in accordance with the Sustainability Reporting Guidelines issued by the Global Reporting Initiative (GRI). As discussed and agreed upon, the procedure included timing, tools, roles and responsibilities of the functions and individuals part of the working group (about one hundred individuals across the Group), to ensure the engagement and proper application of such procedure by the working group, it was extensively presented, discussed and commonly agreed.
Sustainability Report—2021 1 Product quality and responsibility 2 Research & Development and Innovation 3 Occupational Health & Safety 4 Business ethics, governance and compliance 5 Human capital management and development 6 Economic performance and value creation 7 Economic performance and value creation 8 Energy Consumption 9 Waste management 10 Employee wellbeing 11 Human rights 12 Water management 13 GHG Emissions 14 Local communities’ engagement Sustainability 42 |
tical issues emerged from stakeholder engagement activities carried out by Group companies. The following figure provides an overview of Stevanato’s seven most relevant stakeholder categories based on an in-depth analysis of the reference sector (peers and customers) carried out during the materiality analysis. Stevanato Group adopts practices that encourage dialogue and involvement with all stakeholder categories. Engagement is considered an essential element of the Group’s sustainability strategy and is directly correlated with the Group’s medium and long-term success. The main channels of dialogue and interaction are summarized below. The methods and frequency of stakeholder involvement vary according to the issues and opportunities subject to discussion during the year. Employes Shareholders and Board of Directors Regulators and authority Universities and research centres Community and local authority Customers Suppliers Finally, it is important to note that the procedure requires correct and compliant GRI KPIs associated with the involved functions and is coordinated by the Process Owner (Chief Financial Officer) and the Deputy Process Owner (responsible for the duties delegated by the Process Owner), as per assignment by the Board of Directors. Stevanato Group has also aligned its material topics with 15 of the 17 Sustainable Development Goals (SDGs) defined by the action program of the 193 UN member Countries. Below is a table showing the connection between Stevanato material topics and UN Sustainable Development Goals (SDGs). The Group has adopted flexible and diversified practices to share present and future Group development strategies with its main stakeholders. No cri-
Sustainability Report—2021 Stakeholder Employees Suppliers Customers Community and local authority Universities and research centres Regulators and authorities Shareholders and Board of Directors Engagement and interaction flow • Projects and/or initiatives for company welfare • Company Intranet • Internal newsletter • Insertion schemes for new employees • Company meetings to discuss results and future objectives • Training programs • Round table discussions with unions • Regular meetings • Quality assessment audits/visits • Regular meetings • Surveys/market research • Continuous dialogue through communication channels (e.g., e-mail, telephone, social media, posts) • Company website • Participation at trade fairs • Projects to support social initiatives • Meetings with representatives of local institutions • Site visits • Partnerships with key universities and schools in Italy and abroad • Discussion meetings with representatives of institutions • Meetings organized throughout the year Sustainability 44 |
Sustainability Report—2021 2.2 Certifications and awards As part of SG’s continuous efforts to improve its processes, the Group aims to meet leading standards in the field, both in terms of industrial production and product sales, while minimizing the risks to the environment, health and safety in the workplace. This commitment is outlined in the following table, showing the Group’s compliance with the highest standards of certification. Sustainability 45 |
following awards and endorsements by trusted third parties demonstrates Stevanato Group’s credibility, opening doors to new business and contacts. Certification Description Company ISO 15378 Primary packaging material for medicine products—particular • Nuova Ompi (IT-PD) requirements for the application of ISO 9001:2015 with refe- • Nuova Ompi (IT-LT) rence to Good Manufacturing Practice (GMP) • Medical Glass • Ompi North America • Ompi of China • Ompi do Brasil • Balda (DE) ISO 13485 Medical devices—Quality management systems • Nuova Ompi (IT-PD) • Balda (DE) • Balda (US) • SG Lab (IT-PD) ISO 9001 Quality management systems • Nuova Ompi ( IT-PD) • Nuova Ompi (IT-LT) • Medical Glass • Ompi North America • Ompi of China • Ompi do Brasil • Balda (DE) • Balda (US) • Spami • SG Lab (IT-PD) ISO 45001 Occupational Health and Safety Management System • Nuova Ompi (IT-PD) • Nuova Ompi (IT-LT) • Medical Glass • Ompi North America • Ompi of China • Ompi do Brasil • Balda (DE) ISO 14001 Environmental management systems • Nuova Ompi (IT-PD) • Nuova Ompi (IT-LT) • Medical Glass • Ompi North America • Ompi of China • Ompi do Brasil • Balda (DE) ISO 50001 Energy management systems • Balda (DE) ISO 17665 Sterilization of health care products—Moist heat • Nuova Ompi (IT-PD) ISO 17025 General requirements for the competence of testing and cali- • SG Lab (IT-PD) bration laboratories Stevanato Group is proud of its success not only in the pharma business, but also in the areas of innovation and communication. Recognition via these
MOST IMPORTANT AWARDS ACHIEVED The Pharma Innovation Awards are a celebration of technologies contributing to advancements in risk reduction, product quality improvement and manufacturing efficiency. The prize awarded by Pharma Manufacturing acknowledges the investment pharmaceutical equipment vendors put into developing and improving their products. The award is a tribute to Stevanato Group’s ability to listen to the needs of the market and its customers, distinguishing itself as a leader in equipment and technology. In 2018, Pharma Manufacturing recognized that LDP (Low Delamination Propensity) Vials from Ompi (part of Stevanato Group), offered minimized delamination propensity, reducing the risk of drug product recalls. In 2021, Stevanato Group was recognized as a winner of Pharma Manufacturing’s Pharma Innovation Award for its Artificial Intelligence-ready (AI) Vision Robot Unit (VRU). A robotic human-like inspection unit, the VRU is a perfect match for the factory of the future, combining human-like flexibility with machine learning capabilities. In addition, SG Vision AI, Stevanato Group’s Artificial Intelligence-based platform for visual inspection machines, was nominated among the top technologies in the shortlist of Innovation Awards 2021 powered by “The Medicine Maker”. Contamination Lab, also present in the Veneto Region, is an open-innovation program that fosters entrepreneurial culture in young talent through the development of market-based innovative projects. In 2021, C_Lab hosted a competition in which 12 companies from different industries took part, including 230 candidates, 80 participants and 12 teams of talent. Stevanato Group supported a team as part of the corporate Circular Economy innovation program, where the purpose was to improve the environmental impact of glass-based End-Of-Life Drug Containment Solutions. The team won first prize in the competition for its achievement in identifying and creating upcycling concepts for the End Of Life of glass-based products. On August 19, 2021, the Slovak Chamber of Commerce and Industry awarded our Medical Glass plant in Slovakia for its contribution to economic development and business in the Slovak Republic. The award recognized how SG actively involves its stakeholders in the continuous improvement of processes focused on responsible development in the communities in which we operate. Launched in 1997 by Pharmapack, the Pharmapack Awards celebrate the latest innovations from packaging companies within the drug, medical device, health product and veterinary drug sectors. The Pharmapack Awards recognize innovations that have improved drug efficacy and user safety, or reduced environmental impact. In 2019, the cartridge-based wearable device designed by Stevanato Group won the prize for the Best Innovation in Drug Delivery Device.
Open Innovation is one of the pillars of the Smau company. The Innovation Awards are intended to be a recognition of companies and public bodies and aim to share and spread good practices. Stevanato Group received the award in 2019 for its “SYN Here” geo-mapping software designed by the I-Digital department. The intelligence platform mapped specific locations, internal/external spaces and objects in SG plants, building an interactive component into company information processes. By creating a virtual twin of the plant, the digital model helped shed light on critical infrastructure attributes such as compliance and safety issues.
2.3 Participation in organizations and associations Stevanato Group cooperates with an extensive network of trade associations and organizations, facilitating the exchange of ideas, knowledge and different points of view.
Founded in 1890, the Drug, Chemical & Associated Technologies Association, Inc. (DCAT) is a not-for-profit, corporate member-supported and volunteer-led global business development association for companies engaged in the Bio/Pharmaceutical manufacturing value chain. DCAT has been providing a life-long collegial community for its Member Companies and their representative for over 130 years. DCAT creates objective, expert-driven education programs and informational services, so its Member Companies can easily gain insight into industry market trends, best practices and the issues affecting the industry. The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients. The International Society for Pharmaceutical Engineering is the world’s largest not-for-profit association leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. ISPE is the global industry leader in connecting pharmaceutical knowledge to manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients. MassBio is an American not-for-profit organization founded in 1985 that represents and provides services and support for the #1 life sciences cluster in the world. Mas-sBio’s mission is to advance Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives. They represent the premier global life sciences and healthcare hub, with 1,400+ members dedicated to preventing, treating, and curing diseases through transformative science and technology that brings value and hope to patients. Founded in 1996, the Massachusetts Medical Device Industry Council (MassME-DIC) is the largest regional MedTech association in the United States with over 300 members. MassMEDIC is the primary source of advocacy, information and support to the region’s MedTech manufacturers, suppliers and associated non-profit groups. It advocates for sound public policy that supports innovation and fosters a community built on a shared purpose: saving and improving the lives of patients everywhere through medical technology.
The ICG (International Commission on Glass) is a non-profit international Society of national scientific and technical organizations with particular interest in glass science and technology. It was founded in 1933 and has grown to become the recognized worldwide organization in the field of glass with 37 current members, bringing together the world’s most respected universities, scientific institutions and companies in the glass industry. The aim of ICG is to promote and stimulate understanding and cooperation between glass experts in the fields of science and technology as well as art, history and education. The China National Pharmaceutical Packaging Association (CNPPA) is a national non-profit organization, formerly known as the National Pharmaceutical Packaging Technology Center. It was set up in Guangzhou in June 1980 and was officially renamed China National Pharmaceutical Packaging Association in November 1991 with the approval of the Ministry of Civil Affairs. The association has nearly 500 members.
Economic sustainability 3
Economic sustainability 3.1 Stakeholder value creation The creation and distribution of direct economic value demonstrates how Stevanato Group has created wealth for its stakeholders, as shown by the figures in the Direct economic value generated and distributed (EVG&D) chart below. Founded on an accrual basis, it includes the basic components from Profit and Loss (P&L) statements for the global operations in accordance with GRI Disclosure. Throughout Stevanato’s operational activities, the Group creates value for a wide variety of stakeholders, including: • Suppliers in terms of operating costs; • Personnel by considering employee wages and benefits as total payroll; • Lenders looking at financial charges; • Public administration with payments to governments such as taxes; • Communities including donations, sponsorships and collaboration.
Direct economic value generated and distributed3 (€/000) [GRI 201-1] 2021 2020 (A) Total Economic value generated by Stevanato Group 865,391 670,252 (B) Economic value distributed by Stevanato Group 675,906 535,874 Operating costs – Remuneration to suppliers 424,043 313,208 Remuneration to personnel 211,635 194,484 Remuneration to lenders 8,637 9,815 Remuneration of the public administration 31,404 17,682 Donations 188 686 (A-B) Economic value retained by Stevanato Group 189,485 134,378 Amortization & Depreciation 55,440 53,893 Loss on receivable 946 215 Provisions and reserves (1,169) 1,673 Net Profit 134,269 78,598 In 2021, the economic value distributed by Stevanato Group resulted in a total amount of more than 675 million €. The difference between value created and distributed is the economic value retained by Stevanato Group, which goes towards further developing Group business, and is equal to more than 189 million €. In 2021, Stevanato Group directly generated over 865 million € in economic value (+29% in respect to 670 million € in 2020), of which 98% is attributed to busi- ness activity revenue and the remaining 2% is divided in other income, net financial income, income from participation and exchange rate differences. ECONOMIC VALUE DISTRIBUTED TO STAKEHOLDERS’ CATEGORIES IN PERCENTAGE IN 2021 Total economic value distributed by the Group 675,906 million € 62,74% Suppliers 31,31% Personnel 4,65% Public Administration 1,28% Lenders 0,03% Donations 3. Over the course of 2021, shareholders’ remuneration was covered by a withdrawal from the extraordinary reserve, thus not affecting the distribution of the economic value generated in 2021. Specifically, during 2021 dividends amounting to 11.2 million € were distributed to shareholders through the use of the extraordinary reserve.
revenues are reported in both segments and include a detailed breakdown of high-value solutions and other containment and delivery solutions. The figure shows the strong double-digit growth in all business sectors of the Group operational activities, confirming the commitment and efforts of all Group employees. The high-value solutions are complex products, processes and services for which the Group owns the intellectual property rights and has a strong proprietary know-how. 3.2 Key financial results During 2021, the Group continued working actively to support pharma companies in the fight against the Covid-19 pandemic. As a result, it experienced a growth in demand for its high-value solutions as well as other containment and delivery solutions, making 2021 a remarkable year for Stevanato Group with an increase in total revenue of more than 180 million € compared to 2020. The Group demonstrated strong resilience and effective capacity-building in response to the demand, overcoming the difficult challenges of the global situation. Overall, 2021’s increase in revenue, together with the investments in production capacity, provided a solid foundation for further growth in 2022 in both of Stevanato’s business segments, as analyzed below. Stevanato Group’s business segment revenue can be divided into Biophar-maceutical and Diagnostic Solutions and Engineering. In the table below,
Revenue in millions € 2021 2020 Delta Delta % Biopharmaceutical and Diagnostic Solutions 694.0 564.9 129.1 22.9% High-value solutions 207.8 146.3 61.5 42.0% Other containment and delivery solutions 486.2 418.6 67.6 16.2% Engineering 149.9 97.1 52.8 54.3% Total Revenue of The Group 843.9 662.0 181.9 27.5% ECONOMIC VALUE DISTRIBUTED TO STAKEHOLDERS’ CATEGORIES IN PERCENTAGE IN 2021 Revenue in millions € 17,76% Engineering 82,24% Biopharmaceutical and Diagnostic Solutions 70,06% Other containment and 29,94% delivery solutions High-value solutions
In 2021, Stevanato Group generated approximately 82% of total sales from the Biopharmaceutical and Diagnostic Solutions segment (85% in 2020) and approximately 18% from the Engineering segment (15% in 2020). The increase in Group revenue by 27.5% between 2020 and 2021 was driven by a growth in sales of “high-value” solutions in our Biopharmaceutical and Diagnostic Solutions segment and strong sales from our Engineering segment. Revenue generated in the Biopharma-ceutical and Diagnostic Solutions segment increased by 129.1 million € (or 22.9%), mainly due to the growth in high-value solutions (with an increase of 42.0% compared to 2020) and a general increase in other containment and delivery solutions (increase of 16.2%). Revenue growth of 54.3% in the Engineering segment was driven by an increase in sales in all business lines of the segment (glass converting, vi- sual inspection machinery, assembly platforms and secondary packaging machinery) as well as from after-sales business. Considering the global presence of the Group, the total revenue can be divided into four different geographical areas: EMEA (Europe, Middle East and Africa), APAC (Asia Pacific), North America and South America. Revenue shows an increase in all the geographic markets with the highest growth in the APAC market (+75.4%). Revenue increased by 18.3% in North America, by 17.8 % in South America, and by 23.9% in Europe, the Group’s traditional market. From these results, it is possible to confirm the Group’s capacity to strengthen its presence in almost all geographical regions, enter new markets, extend existing business relationships, and launch new solutions to consolidate positioning in markets with excellent growth prospects. Revenue in millions € 2021 2020 Delta Delta % EMEA 493.5 398.1 95.3 23.9% APAC 117.7 67.1 50.6 75.4% North America 207.0 174.9 32.0 18.3% South America 25.7 21.9 3.9 17.8% Total Revenue 843.9 662.0 181.9 27.5%
REVENUE BY GEOGRAPHICAL LOCATION (MILLION €) 2020 2021 600 493,5 500 398,1 400 300 207 200 174,9 117,7 100 67,1 21,9 25,7 0 EMEA APAC NORTH AMERICA SOUTH AMERICA The results achieved in 2021 are significant and a testimony to the level of excellence offered by Stevanato products and services, as well as the highest standards of professionalism demonstrated by all of the Group’s internal stakeholders.
STEVANATO GROUP HAS RECENTLY CONFIRMED ITS COMMITMENT TO THE FIGHT AGAINST CORONAVIRUS Stevanato Group has been in the vaccine business for decades, serving as a partner for the distribution of diverse vaccines worldwide. In 2020, the global COVID-19 pandemic caused both governments and private organizations to implement numerous measures seeking to contain the spread of the virus. These measures impacted, and are expected to continue impacting, the Group’s business and operations in several ways. Initially, unfavorable short-term impacts of COVID-19 on production and operational capabilities mainly included: (i) a temporary decrease in the sales of certain non-COVID-19 products as a result of traditional healthcare procedures being postponed and the diversion of our production capacity to support the rollout of the COVID 19 vaccine worldwide; (ii) labor absenteeism; (iii) disruptions to production lines; (iv) delays in, and increased costs of, logistics. However, COVID-19 also provided an uplift to the Group’s business with an acceleration of revenue from the sale of syringes and vials for vaccination programs globally. Stevanato Group has been supplying: (i) glass vials and syringes to approximately 90% of currently 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. Going forward, the Group expects demand for syringes, vials and related products and services to remain elevated as the COVID-19 vaccine and treatment programs continue to roll-out globally, and as customers contemplate the transition from multi-dose formats to single-dose formats. In addition, the Group expects continued tailwinds as epidemic preparedness, including the ongoing global COVID-19 vaccine rollout, booster shot distribution and new vaccination programs, remain a priority for governments. Longer-term, there remains uncertainty around the magnitude of the impact of COVID-19 and the demand for our solutions. Many scientists predict that COVID-19 will eventually transition to an endemic state. While timing of this transition is difficult to predict, experts believe that the transition may likely occur over the next twelve to twenty-four months. This may result in a continued need and relatively stable demand for the Group’s products and services related to COVID-19, which would be integrated into the standard vaccine business in the coming years.
Research, development, innovation and product responsibility 4
4.1 Stevanato Group products, technologies and services Stevanato Group is a leading provider of mission-critical containment, delivery and diagnostic solutions for the pharmaceutical, biotechnology and life sciences industries. The figure below provides a breakdown of the Group’s segments, as well as the business lines included within each segment. Stevanato’s two main business segments (Biopharmaceuti-cal and Diagnostic, and Engineering), combined with its global presence, allow it to sell products and provide services in over 70 countries worldwide mainly through business to business marketing channels and selected distributors.
STEVANATO GROUP’S OFFERING Biopharmaceutical and Segments Engineering Diagnostic Solutions Drug Delivery Visual Drug Containment Solutions Assembly Systems lnspection SG EZ-Fill® Business PFS Vials Cartridges IVD Solutions Lines Packaging & Glass Seriaization Converting Bulk Analytical Services lntegrated Solutions Systems Processes Services ACROSS THE FULL DRUG DEVELOPMENT LIFE CYCLE Development Delivery Pre-Clinical Phase I Phase Il Phase IIl Commercial Phase IV Stevanato refers to premium products in the Biopharmaceutical and Diagnostic Solutions segment as its “high- value” solutions. “High-value” solutions are fully owned, internally-developed products, processes and services for which the Group holds intellectual property rights or has strong proprietary know-how, and that are characterized by technological and procedural complexity and high performance. The “high-value” solutions deliver significant benefits to customers in terms of per- formance, time to market and reduced total cost of ownership. Among key “high-value” solutions is the EZ-fill® line of ready-to-fill injectable products, which can be customized to clients’ needs. Finally, Stevanato Group’s cutting-edge integrated systems, processes and services reduce customer lead times, total cost of ownership (TCO), and supply chain risk while providing real value to customers as well as improving patient treatment and safety.
Reduced time Reduced supply Reduced total Consistent to market chain risk cost of ownership quality Unique combination of integrated capabilities to address customer needs across the pharmaceutical value chain Drug containment Drug Delivery Technologies & Analytical Services solutions Systems Manufacturing & Regulatory Equipment Support (incl. TECs) Highly Customized Proprietary Devices and and Pre-Sterilized CMO/CDMO Business Sub & Final Assembly, Analytical Testing & Containment Solutions Automation & Packaging Regulatory Support (SG EZ-fill®) through Solutions, Visual Ompi brand Inspection, Glass Converting Systems Processes Services Research
4.1.1 BIOPHARMACEUTICAL AND DIAGNOSTIC SOLUTIONS Stevanato Group relies on more than 70 years of experience in the production of advanced glass containment solutions for the pharmaceutical and healthcare industries. The Group has evolved from a glassware producer to a full-solution provider, offering integrated capabilities and services along the pharma supply chain. Drug containment solutions SG has a vast range of commercially available drug containment solutions geared towards specific biopharmaceu-tical requirements. Today, the Group is the market leader in manufacturing both pre-sterilized glass vials and glass cartridges for insulin pen injectors, and the world’s second-largest manufacturer of pre-fillable syringes. VALUE CHAIN: ROLES & RESPONSIBILITIES Traditional and Bulk Contain- Container Washing Sterilization Filling ment Manufacturing Solutions DRUG CONTAINMENT PHARMA COMPANY INDUSTRY Containers Container Washing Sterilization Filling Manufacturing DRUG CONTAINMENT INDUSTRY PHARMA COMPANY Ready-to-Use Vials, Cartridges, Syringes Cost Savings: Simplified Reduction of Reduction of costs and Lower Validation Upstream issues associated with CapEx and Regulatory Operations lower quality solutions With traditional or bulk containment solutions, Pharma companies bear the burden of washing, sterilizing and filling containers before distributing Key Benefits REDUCE TCO i.e., logistics, drug product waste, storage and personnel cost INCREASE FLEXIBILITY INCREASE QUALITY REDUCE TIME TO MARKET REDUCE COMPLEXITY
Sustainability Report—2021 When it comes to ready-to-fill products, no solution matches Stevanato Group’s EZ-fill®. It’s a fully integrated, pre-sterilized containment platform for aseptic manufacturing, whose proven advantages have turned its processing technology into an industry standard for other players in the market, reducing complexity thanks to its great processability and pre-verified systems. Available in both nested and tray configurations, EZ-fill® solutions meet the flexibility requirements necessary to accommodate small or large batch production. Acting as a pre-sterilized customizable solution, it helps pharma companies maximize their efficiency by reducing total costs of ownership and time to market. Finally, by minimizing glass-to-glass contact, it improves the integrity of the drug product and ensures patients’ safety. In the following image, the added value of SG EZ-fill® for customers is illustrated. Thanks to its extensive knowledge of containment solutions, Stevanato Group can work together with biophar-ma companies and device manufacturers in the selection of the most appropriate packaging components, providing fully-integrated systems that enhance drug quality, safety and efficacy, as well as operational efficiency and patients’ health. The Group’s portfolio is highly diversified and includes Pre-Fillable Syringes, Vials, Cartridges and Ampoules. Within this portfolio, Stevanato Group provides customers with four main performance levels: FINA®—LDP – NEXA® – ALBA®—offering an array of quality and performance solutions. Below, a summary overview of the four main performance levels: FINA® Is a drug containment solution with a robust process validated for high volume and characterized by high-quality consistency. It is the customizable solution for injectables. LDP (low delamination propensity) vials are innovative borosilicate glass vials that significantly reduce the risk of corrosion and delamination. NEXA® is the next level of quality, specifically designed for high-value sensitive injectables. It is characterized by superior cosmetic quality and improved mechanical resistance thanks to its proprietary highly-automated process and application in No Metal To Glass (NMTG) and No Glass To Glass (NGTG) critical unit operations. ALBA® containers are the breakthrough solution for biologics. They are internally treated with an innovative coating and offer unparalleled performance in reducing ultralow content a) silicone oil droplets, b) any potential product-related substance such as an extractable compound.
HIGH VALUE SOLUTIONS Optimized Drug Containment Solutions designed around drug product key attributes APPLICATION AREAS VALUE PROPOSITION Protein-based drugs lnternally treated with an innovative coating Alba® (Biologics) reducing to ultralow content a) silicon oil droplets, b) any potential product relateci substance such an extractable cormpound. Superior cosmetic quality and improved Nexa® High-value drugs mechanical resistance thanks to proprietary highly automated process expertise around NMTG and NGTG criticai unit operations. LDP Vaccines and Innovative borosilicate glass vials significantly diluents reducing any corrosion and delamination risk. ® Injectables A robust process validated for high volumes Fina and characterized by high-quality consistency and custormization. The portfolio includes the following categories: Syringe Platform Stevanato Group’s historical brand, Ompi, provides a wide range of washed, siliconized and pre-sterilized EZ-fill® syringe systems. As a system supplier, Stevanato Group works hand-in-hand with rubber manufacturers to supply best-in-class components for each intended use. The plunger rod and backstop (extended finger flange) are designed to provide the maximum compatibility with industry rubber components and safety devices. SG syringes come in Alba®, Nexa® and Fina® performance level. Cartridge Platform Ompi is currently the market leader in cartridge manufacturing. Stevanato Group’s portfolio of cartridges is supplied in different formats, suitable for both liquid and powder formulations thanks to by-pass and multi-bypass engineering. With these products, the Group strives to ensure dosing accuracy and superior glass resistance from external forces. Stevanato Group’s cartridges are available both with Nexa® and Fina® features. SG Nexa® 3x Cartridges have three times the mechanical resistance of a standard glass cartridge; Nexa® Plus Cartridges enhance mechanical resistance and improve cosmetic appearance; and SG Fina® Cartridges offer the maximum degree of customization in bulk format.
Vial Platform Stevanato Group produces glass vials in different sizes and capacities, in bulk or ready-to-fill configuration. With full control over geometry and surface chemistry, the vials can be tailored to meet the different needs of biopharmaceutical customers. The Group’s portfolio also includes special vial containment solutions such as micro-vials for respiratory and su- blingual applications. The performance levels inside this category are: SG Nexa®, which provides the highest level of quality, safety and technology even for the most demanding drugs and low delamination propensity vials (LDP) for aggressive compounds; and SG Fina®, which is highly customizable in terms of geometry, dimension, and tolerances. Ampoules To meet the needs of different pharmaceutical applications, Stevanato Group produces a variety of ampoules compliant with ISO 9187. The Group provides high-quality glass containers for pharmaceutical applications with a broad range of geometries and breakage systems. The production methods and logistical processes for ampoules are compliant with the strict terms and conditions of pharmaceutical and cosmetic markets to ensure maximum adherence to the client’s quality processes. Drug Delivery Systems Over the past few years, Stevanato Group has strategically expanded its drug delivery systems team and broadened its offering to include capabilities and services as an integrated solutions provider. The company is now well-positioned to help its pharmaceutical partners launch drug products to market in a delivery device that suits the needs of patients. Stevanato Group focuses on two main areas with regard to drug delivery systems: Contract Manufacturing and Proprietary and Licensed devices. Through Contract Manufacturing, Stevanato Group provides customers with scalable manufacturing solutions for their drug delivery system programs. Customers can rely on: A complete CDMO or CMO offer, covering different stages of device development, up to the final product; High-quality production standards, thanks to an ISO 13485 certified Quality Management System and FDA inspected facilities; A worldwide presence, with manufacturing operations in Europe and the US and a global purchasing network. Stevanato Group’s Proprietary and Licensed devices include pen injectors, auto-injectors, wearables, and inhalers, as described in the table below.
Pen injectors Alina® is a variable- and fixed-dose disposable pen injector, based on Axis-D technology, exclusively licensed from pen injector device expert, Haselmeier. It is suitable for a broad range of therapeutic areas including diabetes & obesity. Auto-injectors Together with a trusted device partner, Stevanato Group is developing an innovative auto-injector solution that offers flexibility and speed-to-market for customers. The intuitive design is suitable for a broad range of therapeutic areas. Wearables Stevanato Group is developing a semi-reusable cartridge-based wearable device composed of two systems: a disposable pod and a reusable cradle. It is optimized for the administration of complex drug regimens from mid-high volume cartridges. Inhalers ICOcap® is an easy-to-use capsule-based dry powder inhaler licensed from inhalation specialist, Iconovo. It incorporates improved handling with equivalent performance-to-market products that are used to treat asthma and COPD. IVD Solutions At Balda, Stevanato Group experts are specialists in multi-component injection molding and automated system assembly. As a one-stop solution provider and manufacturer, the Group can cover all parts of the process, from product development to delivery of the final product, packaged and sterilized as needed. With Balda’s over 110 years of company history, Stevanato Group has gained unique knowledge of large-scale manufacturing of plastic components as well as complex assembly. As a leading producer, the Group combines the highest quality standards and economies of scale for large volumes and high product complexity. Stevanato Group plastic solutions are available in all three market areas: pharmaceutical, with intelligent plastic products and solutions based on extensive product development capabilities; medical, with the development and manufacture of medical plastic solutions with high functionality; and diagnostic, as point-of-care consumables and modern handheld devices. Analytical services As a branch of Research and Development, the analytical testing facilities focus on investigating the physical-chemical properties of primary packaging materials and components, and studying the interactions between Drug Containment Solutions and drugs. Stevanato Group relies on a multi-disciplinary team of highly-skilled professionals including scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience cover a range of specialized areas including Drug Containment Solutions and drug-delivery devices.
These services can be divided in: • Primary Container Compatibility and Functionality with Drug Product A series of characterization techniques that aims 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. • Container Closure Integrity Methodologies and techniques that challenge the sealing integri- ty of a container closure system to ensure the correct compatibility of materials and storage conditions. • Medical Devices/Combination Products Extensive testing to ensure the robustness of product functionality. • Developmental (non-GMP) Fill & Finish Service Small, flexible Fill & Finish equipment to perform preliminary work on drug product, process, or container optimization.
4.1.2 ENGINEERING Stevanato Group can count on a vast portfolio of technologies and manufacturing equipment to best serve its customers. First, Stevanato Group is specialized in glass converting, producing fully-automated, high-speed, precision glass tube converting lines through its brand, Spami. The Group can provide accurate processing of ampoules, vials, cartridges and syringes throughout the development process, and rigorous product inspection via state-of-the-art camera control systems. The manufacturing lines are certified and validated to process high quality type 1 glass all over the world. In addition, the Company provides an accurate after-sales service and a 360° support and consultancy, designing customers’ plant layouts for the production of bulk and ready-to-use pharmaceutical primary packaging. Secondly, Stevanato Group provides flexible inspection solutions at any stage of the product journey, from lab development to high-volume production. Through Optrel and InnoScan brands, the Group provides 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. The inspection machines can be divided into manual, semi-automatic and automatic equipment. Every feature is specific to the customer’s needs, with optimal synchronization of high-performance CMOS cameras, illumination and con- tainer rotation that enable highly efficient, multi-inspection of each primary container. Regarding this aspect, the Group has launched Stevanato Group Vision AI – a secure, cloud-based platform featuring Deep Learning models that increase the detection rate while minimizing the false rejection rate (see Chapter 4.2). Finally, the Group is equipped to offer device assembly and packaging equipment. Stevanato Group designs and manufactures flexible stand-alone or turnkey integrated systems to address and support customers’ requirements from the early stage up to commercialization. It delivers both precision assembly of a wide variety of medical devices, including pen injectors, auto-injectors, nasal sprays, inhalers, wearables, cartooning machines, packaging machinery and palletizing modules, and integrates equipment compliant with serialization and tamper-evident requirements. SG’s engineering leadership Master Plan aims to structure and guide the operational transformation of the engineering division of SG, defining a detailed road map to achieve success and consistent execution. The approach includes tangible milestones that will help track the business’ success. In addition, the approach is based on the competence, experience and preparation of the entire engineering team which is committed to exceeding the standards.
4.2 R&D and Innovation Research and development investment is a fundamental component of Stevanato Group’s growth and continued success. The company invested approximately 29.6 million € in 2021 (3.5% of revenue) compared to 12.2 million €. The research and development team comprises more than 140 highly skilled and specialized employees operating in Italy, Germany and the United States. R&D also represents a dimension of Stevanato Group’s vision, allowing it to evolve from a packaging component and automated equipment supplier to a leading provider of mission-critical drug containment, delivery and diagnostic solutions for the pharmaceutical, biotechnology and life sciences industries. The Group believes that customers trust the company because of its technical expertise and ability to design the best possible process to meet their requirements and the specifications necessary to effectively contain and deliver their drugs. Thanks to numerous investments in internal engineering capabilities, Stevanato Group is the owner of the most critical processes behind its manufactured products and is able to respond faster to customers’ needs for new or customized products. SG’s engineering capabilities also allow it to scale up production rapidly when required, thereby reducing the lead time for the commercialization of drugs. Investment in innovative products and technologies will continue to be a fundamental component of growth and success going forward, allowing the Group to capture incremental pipeline opportunities and drive attractive growth. Being involved in the customer’s drug development process at an early stage allow Stevanato Group’s R&D department to deliver science-based innovation through various services, including: • Clinical, laboratory and registration services with its laboratory and Technology Excellence Center, such as the one opened in Boston, Massa-chusetts in 2020. • High-quality product development, including in-depth risk analysis, to ensure a standardized project execution process. • Definition of new proof-of-concept with process, automation and robotics in the device assembly, testing and inspection phases. • Advanced technical customer support benefiting from experts in the field of materials science (such as glass, plastics, polymers, coating, rubbers and proteins), chemical science, mechanical engineering and medical devices. • Generation of technical and regulatory documentation fully compliant with global regulations such as those of the US Food and Drug Administration, China Food and Drug Administration and European Medicine Agency.
Drug Containment Solutions Developing solutions to maintain the stability, potency and purity of biopharma customers’ products prior to administration Drug Delivery Systems Focusing on DDS patient-centricity, sustainability and digitalization Process Excellence & Digitalization Continuously innovating the Group manufacturing processes in order to deliver superior quality, reducing waste and risk of drug shortages From a company perspective, the R&D department is divided into two divisions in line with Stevanato’s business segments: Biopharmaceuti-cal and Diagnostic Solutions, and Engineering. The two R&D divisions cooperate in perfect synergy in terms of maximizing value creation and accomplishing cross-functional projects. The mutual strategy of Stevanato Group’s R&D department is based on three fundamental pillars that focus and align the R&D team with the Company’s business growth: These three pillars are the guidelines of the Group’s R&D divisions: each R&D project is designed to contribute and support one or more of these pillars. 4.2.1 R&D FOR DRUG CONTAINMENT SOLUTIONS (DCS) The R&D team of the Biopharmaceuti-cal and Diagnostic Solutions segment is responsible for the development of many important Stevanato Group products and features, including the Drug Containment Solutions (DCS) portfolio. Regarding the first pillar, the DCS team is continuously developing syringes, vials and cartridges with the lowest particle generation, reduced or even no extractable release, and a metal-free option. In addition, the team is responsible for the improvement of deep freeze/dead volume properties of Stevanato solutions to refine the Vaccine and Gene Therapies application. To deliver superior quality Process Excellence & Digitalization, the Drug Containment So- lutions team is working on different assignments, among which, the development of a unique identification and serialization of individual containers, the integration of Artificial Intelligence to improve visual inspection, and the use of virtual prototypes that accelerate development of inspection and assembly. Finally, the DCS team projects also contribute to the development of Drug Delivery Systems patient-centricity, sustainability and digitalization, especially by providing the best primary packaging fully compatible with the devices under development. The main innovations included in the Drug containment solutions portfolio are: ALBA® Platform ALBA® is a sterile glass container platform including vials, and syringes with equivalent chemical and mechanical characteristics. All the ALBA® products have an internal lubricant layer which is cross-linked with the surface of the glass. The advantage given by this innovative platform is in limiting the quantity of silicone that is then released by the primary container, thereby improving both the quality and safety of the final product. Furthermore, the superior stability of the lubricant layer ensures no failures with self-administration injection related to auto injector applications, allowing for improved compliance with therapies. ALBA® involves several different internal and external companies with competences that range from design and testing to manufacturing. In 2021, its main activities were focused on assessing alternative grades of silicone as coating materials, thus obtaining an even more improved and reproducible product.
Integrated Safety System (ISS) The Integrated Safety System is an advanced, fully passive shield that prevents needle-stick injuries. ISS Integrated Safety System aims to offer a pre-assembled system ensuring passive needle protection after the injection of medicinal products for use in both hospital and household environments. It benefits not only the end-user thanks to its simple user experience and its intuitive application, but also the pharma-company with a reduced Total Cost of Ownership (TCO). It is an active project that involves more than twenty different internal and external companies which represent the full spectrum of expertise, from Safety System design development to industrial production. In 2021, the first commercial product based on our ISS system was approved by Regulatory Authorities and launched on the market. Primary Container Traceability This project permits the traceability of the container in every part of the manufacturing process. Every container can be marked with a unique serial number identifier and traced with a 2D barcode-reading machine. Primary Container Traceability enables the manufacturers to improve the drug life cycle by facilitating the tracking of potential issues within each process stage, preventing product mix-ups, permitting segregation in the event of a process issue, improving patient safety and maintaining ownership of the product’s identity even if the packaging/label has been damaged. Feasibility studies of the concept have been completed, allowing next steps to be taken in project development. In addition, Stevanato Group began looking into sustainability measures as part of its corporate Circular Economy innovation program. In particular, projects were mobilized to identify alternative materials and processes that would provide more sustainable sterilization techniques while maintaining the overall performance of materials post-sterilization cycle. The possibility of identifying the best material to be used across different products and sterilization conditions would give the Group a significant advantage in terms of simplifying and improving its long-term supply chain. SG is also actively collaborating with the scientific community and universities to advance its scientific insight into the Group’s current and prospective product line, as well as to provide its customers with the latest know-how on specific products. In certain research areas, including chemical-physical and morphological characterization of glass surfaces and drug interactions, we cooperate with universities such as Ca’ Fo-scari University (Venice, Italy), Federico II University (Naples, Italy), the National University of Ireland Mynooth (Ireland), and the University of Trento (Italy). 4.2.2 R&D ON DRUG DELIVERY SYSTEMS (DDS) In addition to the activities related to Drug Containment Solutions, a fundamental responsibility of Biopharma-ceutical and Diagnostic Solutions R&D is the development and expansion of Stevanato Group’s Drug Delivery Sy- stems (DDS) portfolio. This includes developing innovative delivery solutions that are focused on usability, safety, performance and manufacturability. The main projects on which the department is working are the following:
Alina® is a disposable, multi-dose pen injector platform for subcutaneous administration of injectable therapy. The platform is available in variable and fixed-dose versions compatible with established therapeutic regimens as well as innovative drug therapies related to diabetes care. The project involves multiple SG sites and functions and an international design and development team. An Auto-injector Platform is critical to the growth strategy of Stevanato Group’s integrated offering. This is supported by the ongoing market demand for auto-injector solutions. The R&D team continues to assess various auto-injector technologies, including both non-emergency use and emergency-use devices, while considering its environmental footprint as a key determinant of product suitability. Stevanato Group’s Wearable Product is designed for subcutaneous delivery of non-opioid anesthetics. The device enables controlled self-administration of therapy while reducing unnecessary hospital stays. The re-usable cradle component extends the lifespan of the product to multiple-u-ses and reduces product waste for a more sustainable device solution. This is the first of many steps in SG’s corporate Circular Economy innovation program. The overall concept of this wearable product can be extended to a platform capable of large volume delivery from different cartridges. ICOcap® is a capsule-based dry-powder inhaler for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and other respiratory-related diseases. It has similar performance to established inhalers on the market while offering improved handling features. The project involves multiple SG sites and functions and an international design and development team. 4.2.3 R&D ON ENGINEERING To advance R&D in the Engineering segment, the Group has invested in the latest equipment and expanded its lines and services to improve production and best serve its customers in four main product areas: Glass tube Converting, Visual Inspection, Assembly and Packaging. The Engineering department aims to achieve high performance and to understand internal and external expectations in order to clearly guide product development in the following directions: • High performance: line and equipment capable of achieving superior operating performance in the long term (OEE, Overall Equipment Effectiveness) whilst being cost effective and reducing the TCO (Total Cost of Ownership). • Quality and reliability: completion of the portfolio range based on modular architecture with the main target being a stable platform able to minimize planned, and avoid unplanned, downtime.
• Smart and connected equipment and lines: development of smart solutions by building machine intelligence into equipment via features like prediction, aided guidance and self-adjustment. Machines and lines are connected in a cyber-secure way to the cloud where big data technology can generate valuable information through advanced data analytics. The Deep Learning models embedded in the visual inspection solutions provide customers with an efficient system to assist them in significantly reducing the FRR (False Rejection Rate) and increasing the DR (Detection Rate). The Engineering quality control systems are designed to ensure that the manufacturing processes, including those of pharma customers and contracted manufacturing companies, comply with Generic Good Practice (GxP) standards based on the Good Automated Manufacturing Practice (GAMP) guidelines issued by the International Society for Pharmaceutical Engineering (ISPE). Each individual piece of machinery/equipment is developed and manufactured as a project and ad-hoc project management tools are utilized to manage every stage and minimize risk. Similarly to the Biopharmaceutical and Diagnostic Solutions R&D division, the Engineering division contributes to the three R&D pillars, in particular, to Process Excellence & Digitalization. Below are the main projects under Engineering R&D essential to promoting innovation and increasing Stevanato Group’s competitiveness and market share. Smart Factories – the Group has designed its production plants to be highly interconnected with the objective of: • Performance monitoring thanks to an automatic real-time data acquisition system that continuously controls the performance of equipment and lines. The system is equipped with a simple and intuitive user interface on fixed and portable devices, and is fully integrated with the Human-Machine Interface (HMI) equipment at all levels, from shop floor to corporate offices. • Improvement in solving capabilities with equipment that, in case of a problem, offers step-by-step guidance via accelerated Root Cause Analysis (RCA). After the analysis, the equipment guides the operator through the problem resolution process and stores all the pertinent
Sustainability Report—2021 information in a Big Data repository in order to improve the next RCA. • Improvement in predicting capabilities through the constant analysis and evaluation of data and operating parameters in machines and lines, helping to anticipate future downtime. • Automatic adjustment via equipment capable of setting optimal ranges for glass formation without the need of operator expertise. Also maintains long-term high-quality production while minimizing energy consumption. • Video Remote Assistance with real-time video support from a remote technician able to assist the on-site operator dealing with a machine operation problem. • Artificial Intelligence applied to Visual Inspection – Stevanato Group has started using artificial intelligence (AI) in visual inspection to address the problem of false rejects. AI enables the system to correlate the actual image of the product under inspection with a vast library of similar images of accepted and rejected products, thereby identifying the likelihood of it belonging to one of the categories. The phar-ma industry has been actively studying this technology over the past two years and Stevanato Group is among the forerunners, with the expectation of increasing its market share in the future. • With standard visual technology, operators use classical parameters of measurement, using their own experience and taking samples from production. “False rejects” are the inevitable trade-off of having access to a limited set of samples. Sometimes good products are rejected out of extreme caution. Research 76 |
Digital Twin the device is a virtual replica of a machine or line with examples of application on both Assembly and Visual Inspection. The customer can review its performance and interact virtually with the equipment before going into production. By experiencing the machine in advance, the customer can anticipate possible problems and reduce the production time needed once a decision is made. The digital twin can also be used both as a promotional tool and as a substitute for a possible test phase. Vision Robot Unit the Visual Robot Unit represents a new product within the product portfolio of Stevanato Group’s Pharma Vision area. It consists of a new type of automatized production machine that allows for flexibility during manual inspection along with the replicability and stability given by automatic equipment. It aims to address two main market needs: the demand for improved inspection performance and an extremely flexible unit to satisfy low-volume markets. The objective is to allow the Group to increase its position within emerging markets determined by low-production output per minute and high value of the product to be inspected. New SW and HW Platform for Inspection Equipment4 SG heavily invested in a new SW platform in 2021 aiming to improve performance and increase customer satisfaction. The platform merges know-how from both InnoScan and Optrel brands, whose combined resources have advanced overall efficiency and reduced timelines for the final customer. Moreover, the new SW platform leverages a series of new inspection tools which can improve the final DR (Detection Rate) and FRR (False Rejection Rate). Lines development improvements SG is developing new lines with the purpose of reducing capital expenditures and industrial costs, increasing productivity and improving in-line quality control. Such projects also involve syringe systems production. 4. CVT, CVT Sy and CVT Core Research 77 |
Sustainability Report—2021 Assembly | CollectQX data collection tool: CollectQX was developed in cooperation with a pharmaceutical company to create the best solution for data analysis, easy interface and future implementation of Artificial Intelligence (AI). The focus was to overcome boundaries of known data collection tools and create complete data transparency by connecting all the necessary in- formation. The unique tool is useful for the Group during running-in as well as for customer operations, maintenance and data analytics (please see the image below to better understand the project scope). The Engineering R&D projects noted above involved more than 30 highly-skilled employees. Batch Recipe Quality checks/-data Machine ID Product ID Workposition ID All Parameter Serialization ID Timestamp(s) All connected to each single Datapoint 4.2.4 ANALYTICAL SERVICES Another important branch in R&D for Ste-vanato Group is Lab Analytics. Its goal is to investigate and analyze chemical-physical phenomena and study the interactions between containers and drugs. In 2012, SG Lab started out as a laboratory staffed by a small group of young scientists, whose ranks soon began to grow. Today, SG Lab has a staff of more than 15 people including researchers, scientists, engineers, laboratory technicians and people in charge of ISO 17025 and, starting in 2021, ISO 13485 quality-systems management. The team can rely on members trained in the fields of chemistry, engineering, physics and pharmaceutical sciences who are able to examine and define each aspect of a drug product. Their knowledge ranges from add-on components to the performance of glass primary containers and how they interact with the drug. They also have a series of skills acquired and developed in the study and analysis of drug-container closure system and delivery devices. Staff training and development has always been a fundamental part of Stevanato Group’s agenda. The Group continues to invest in modern analytical instruments and in the acquisition of new skills, both internally and through external collaboration with universities and analytical excellence centers. Its personnel can rely on a solid knowledge base and a technical-scientific approach, enabling it to tackle future challenges with confidence. Research 78
Sustainability Report—2021 US TEC AT THE HEART OF THE BIOTECH COMMUNITY, BRINGING VALUE TO STEVANATO GROUP’S LABORATORY SERVICES To respond to the growing demand in the US biologics market for integrated analytical offerings and project management services, in September 2020 Stevanato Group established a Boston-based laboratory and Technology Excellence Center (TEC). US TEC can be considered an additional R&D and investigational testing facility. Its services can help determine new ways of improving product quality or identify the cause of any current quality issues. The laboratory is modelled after the SG Laboratories (with the same QMS system) and provides a full-service approach to support biopharma companies along their drug development journey, from the early phase to commercialization and lifecycle management. Leveraging the Group’s extensive knowledge in materials science of glass, plastics and rubber, US TEC supports one of the most critical decisions for biopharma industry players: how to select the optimum glass container. Making the right choice during the early-stage of product development ensures two-fold compatibility: Drug and Container Closure System as well as Container Closure System integration into Drug Delivery Systems. Since R&D represents a key driver for Stevanato Group’s growth, the US TEC advises on materials science, chemistry and engineering performance. Located in the cradle of the biotech region, US TEC easily integrates into the product development team and the value chain of local customers. In addition to supporting Stevanato Group’s existing large company partners, US TEC offers an opportunity for new, smaller to mid-sized companies to collaborate with the Group’s wide offering. The long-term objective of US TEC is providing a continuum of representation from container to device management. Research 79 |
Sustainability Report—2021 4.3 Product quality and responsibility As a commitment to the production of high-quality products, Stevanato has adopted a Group Quality Policy which aims to collaborate with its customers throughout the life cycle of their products from concept development to commercialization and post-sales support. The policy reflects SG’s dedication to delivering high quality products, advanced technologies and services that fulfill and anticipate its customers’ needs while ensuring end-user safety. To ensure product quality, it is important to note the following ISO certifications: • ISO 15378 on primary packaging material for medicine products – the certification is effective for Nuova Ompi (Padua and Latina), Medical Glass, Ompi North Ameri-ca, Ompi of China, Ompi do Brasil and Balda Germany. • ISO 13485 medical devices quality management systems – the certification is effective for Nuova Ompi (Padua), Balda Germany and Balda USA, and SG Lab Analytics. • ISO 9001 quality management systems – the certification is effective for Nuova Ompi (Padua and Latina), Medical Glass, Ompi North America, Ompi of China, Ompi do Brasil, Bal-da Germany, Balda USA, Spami and SG Lab Analytics. • ISO 17025 on general requirements of competence of testing and calibration laboratories, effective for SG Lab Analytics. Research 80
Sustainability Report—2021 Everyone in Stevanato Group, from senior management to individual employees, is accountable and strives to ensure the continuous improvement and effectiveness of Stevanato Group Quality Management System and Steva-nato Group Quality Policy. FOCUS ON QUALITY Among all its Drug Containment Solutions plants worldwide, the Group provides the same quality of product. The main advantage of this feature is that it best supports business continuity for SG customers: by producing the exact same product worldwide, with documented corporate audits, the company is able to manage risk mitigation and offer production flexibility. To reach the same level of quality across all SG sites, the Group ensures continuous alignment among its plants through product experts in Operational Excellence and Quality that support each site in case of issues, creating a portfolio of knowledge that is continuously shared among the sites. Regular trainings and discussions within the quality department allow all sites to stay up-to-date in both product quality and quality compliance, and keep abreast of industry trends in order to meet the highest regulatory and quality compliance standards. In general, the impact of product quality and responsibility is directly related to Stevanato Group’s activities. In fact, the primary goal for everyone involved in the production process is linked with Stevanato Group’s mission to create systems that enhance the integrity of parenteral medicines, ensuring maximum quality of the primary packaging. For example, pharmaceutical containers are integral to the pharmaceutical product itself, therefore their quality affects patient safety. In this regard, all employees are accountable for following Stevanato Group Quality Management System in order to maximize the quality and integrity of its products. Drug containment, diagnostic and delivery solutions are often borne out of years of collaboration with customers to develop the optimal manner of containing a drug product and delivering it to the patient community. The customized solutions provided vary depending on the characteristics and chemical composition of the pharmaceutical products, logistics needs (for example, ease of transport and shelf-life), factors such as the patient community to which the drug product is primarily addressed (including, potentially, its geographic location) and specific regulatory requirements. The containment and delivery solution provided is an integral part of the drug product itself and is included as part of the regulatory filings required to approve drug product marketing and commercialization. The quality and dependability of drug containment and delivery solutions is critical to obtaining commercialization and marketing approval from regulatory agencies. As a result, it is often the case that drug product containment and delivery solution cannot be changed without amending the regulatory filings that have been specifically approved by the relevant regulatory agency. During 2021, there were no incidents of non-compliance with regulations and/ or voluntary codes concerning the health and safety impacts of products and services within the reporting period. Research 81
Sustainability Report—2021 SG STEPS PROGRAM: FOCUS Customer Satisfaction Process digitalization & Quality Mindset PQ ET FI PM AM EQS SA Education & Progressive Focused Planned Autonomous Efficiency Safety Training Quality Improvement Maintenance Maintenance Quest System 5S PCS Performance Control System SG Steps Program leads the way to a World Class Operations Management (WCOM) transformation. The program centers on a common operating model for all the various processes at each of the manufacturing locations and involves staff working in operations and supporting functions. SG Steps is a rigorous system built on Stevanato Groups’ business and industrial capabilities to address the demands of pharmaceutical customers with the same quality level worldwide. It is developed and validated according to the best practices in the pharmaceutical and industrial sectors. SG Steps embodies Stevanato Group’s ambition to become the best-in-class in the reference field, adopting automation, digitalization and quality as main drivers. It covers all the high value-added processes, empowering each employee with the ideal degree of choice and autonomy, providing greater accountability and ownership in their work. SG Steps Program has three phases, starting from the identification of safety priorities and the creation of a shared plan for continuous improvement –Foundation Phase – up to the implementation of safety standards and the achievement of behavior-driven safety culture – Advanced Phase. The final Mastery Phase integrates safety with new product and process development. To implement the SG Steps Program, the Group follows two baselines – Performance Control System and the 5S methodology – and seven pillars – Safety, Focus Improvement, Efficiency Quest System, Autonomous Maintenance, Planned Maintenance, Education and Training and Progressive Quality. With focus on the last pillar, Stevana-to Group accompanies its customers through the life cycle of their products, setting up a self-sustaining standardized system that delivers the highest possible quality, anticipating their needs and ensuring end-user safety. Research 82 |
Attention to human capital 5
Sustainability Report—2021 5.1 Stevanato Group’s human resources5 In order to meet the demands of a constantly evolving market and accompany Stevanato Group’s evolution and mission, the HR Department’s main strategic objective is to build the best team possible to sustain the company’s growth. An efficient team is an asset to the organization and can boost performance and success by tapping into their unique strengths. The mutual growth of the Group and the team creates a solid foundation on which the company can thrive. This objective has also been confirmed through the materiality analysis that brought to light the importance of Human capital management and development and Employee wellbeing as material topics according to both the Group’s and stakeholders’ perspectives. In detail, the HR strategy is focused on: • Hosting training courses in order to develop technical, managerial and organizational skills for employees’ continuous improvement. • Promoting talent attraction in the context in which the Group operates. • Advancing inclusion policies, diversity management plans and equal opportunities, including equal pay for equal roles. • Setting up tools for assessing employee performance to help individual employees in their personal growth path. • Implementation of welfare programs to support both the employee’s working and private life. • Preparing initiatives in favor of work flexibility (working hours, smart working, etc.) and encouraging initiatives to support employees’ spending capacity. • Supporting physical and mental health plans for employees. 5. All data reported in this chapter is extracted directly from a computer system (Zucchetti database) and is related to all group entities except for Medirio SA, Ompi of Japan Co., Ltd. Human capital 84
Sustainability Report—2021 The Group is guided by legislation and international principles and is committed to maintaining a climate of trust and respect which promotes inclusion and team spirit. The Code of Ethics sets out the ethical principles and conduct standards that the Group has identified and which all stakeholders shall respect. Within the daily activities, all stakeholders shall respect the Guidelines which represent the Group’s pillars of business, among which: legality, fairness, anti-discrimination, professionalism, transparency, market abuse prevention, diligence and commitment in daily work execution, corruption prevention, privacy, health and safety, integrity, sustainability and environmental safety. In particular, the Group’s commitment to diversity, equal opportunities and non-discrimination is significantly expressed in the Code of Ethics. As a multinational organization, the Group manages people of different nationalities, genders and cultures who work together day-by-day in a climate of mutual respect. The objective is to promote an inclusive approach to encourage creativity and innovation, contributing to the development of multicultural human capital with different backgrounds and characteristics. A positive work climate at all Group facilities is ensured through dialogue and the sharing of opinions and ideas, which is why the Group offers the possibility of membership in trade unions and the right to collective bargaining, always in compliance with respect for human rights and diversity. Ste-vanato Group adheres to work hours in line with regulations and ensures that its employees’ needs are taken care of (e.g., sick leave, etc.). GRI 405-1: number of employees by professional category and gender % Employee category as of December 31, 2021 as of December 31, 2020 Male Female Total Male Female Total Director 92.3% 7.7% 1.1% 100.0% 0.0% 1.0% Manager 75.6% 24.4% 2.7% 75.0% 25.0% 2.6% White collar 62.3% 37.7% 23.5% 62,1% 37.9% 22.4% Blue collar 53.9% 46.1% 72.7% 52.1% 47.9% 74.0% Total 56.9% 43.1% 100.0% 55.4% 44.6% 100.0% As of December 31, 2021, Stevanato Group had 4,646 employees. The most numerous categories were Blue Collar with 3,377 people, followed by White Collar with 1090, Managers with 127 and Directors with 52. The number of total employees increases to 4,783 (+137) if external collaborators are included. It is important to remember that the Group considers only temporary agency workers and interns as external collaborators. The number of employees by percentage, reported in the tables below, provides useful insight into the scale of impact created by Stevanato’s business on a labor level. In addition, the breakdown by gender enables an understanding of gender representation across the organization, in which male components represent 56.9% (2,642) of the total, whereas females represent 43.1% (2,004). Focusing on each professional category, the Blue collars were composed of 53.9% male employees (1,819) and 46.1% of females (1,558), whereas the White collars were divided into 62.3% of male components (679) and 37.7% of females (411). The Manager category was composed of 75.6% males (96) and by 24.4% of females (31), and lastly, the Directors category was composed of 92.3% males (48) and 7.7% females (4). In the long term, the Group intends to balance this gender-gap in respect to managerial positions. Human capital 85
Sustainability Report—2021 • Stevanato Group is committed to ensuring fair treatment in terms of compensation and benefits as well as in opportunities and career development, regardless of gender, age, ethnicity, disability, sexual orientation, religion, or any other traits. • One of the ambitions of the Group is to foster a culture that values diversity, enhancing it in all the locations in which the Group operates, and promoting staff well-being through globally competitive compensation and welfare programs. • Stevanato Group confirms this commitment with the inclusion of specific targets in diversity through top management’s 2022 Short-Term In- centive goal card, whose progress is regularly monitored. The Group recognizes that gender diversity is a recognized prerequisite for building an equitable, effective and successful organization. The Group aims to build the best team to support the execution of its strategy, and for this reason, it has been decided that Gender Diversity will be among the primary objectives of the coming years. The Group will invest in a strategic development plan which aims to achieve an adequate mix of diverse individual skills, competences, cultures, personal attitudes and strengths. The issue of diversity is also consistent with the company’s Corporate Values and Guiding Principles. GRI 405-1: Number of employees by professional category and age category % Employee category as of December 31, 2021 as of December 31, 2020 <30 30-50 >50 <30 30-50 >50 Total Total years years years years years years Director 0% 59.6% 40.4% 1.1% 0.0% 62.8% 37.2% 1.0% Manager 0.8% 67.7% 31.5% 2.7% 0.9% 70.5% 28.8% 2.6% White collar 24.7% 63.0% 12.3% 23.5% 25.5% 61.6% 13.0% 22.4% Blue collar 25.6% 59.6% 14.7% 72.7% 25.9% 59.6% 14.5% 74.0% Total 24.4% 60.7% 14.9% 100.0% 24.9% 60.4% 14.8% 100.0 Considering the total number of employees by age category, it is important to note that the predominant category was composed of employees between the ages of 30 and 50 years with an overall percentage of 60.7% (2.818), followed by people below 30 years old with a percentage of 24.4% (1.135), and finally, people over 50 years old with a percentage of 14.9% (693). Deepening the analysis into the professional category by age range, the Blue Collars were composed of 25.6% under 30 years old (865), 59.6% between 30 and 50 years old (2,014), and 14.7% over 50 years old (498). The White Collars were divided into similar percentages: 24.7% of people under 30 years old (263), 63.0% between 30 and 50 years old (687), and 12.3% over 50 years old (134). The Manager and Director categories were formed similarly: the first was divided into 0.8% (1) under 30 years old, 67.7% (86) between 30 and 50, and 31.5% (40) over 50; the second category was composed of 59.6% (31) of people between 30 and 50 years old and 40.4% (21) over 50 years old. Human capital 86 |
Sustainability Report—2021 GRI 401-1: Incoming employees by age group and gender (n° and %) in 2021 Incoming employees as of December 31, 2021 by age Men % Women % Total % <30 years old 296 11.2% 212 10.6% 508 10.9% 30 – 50 years old 332 12.6% 226 11.3% 558 12.0% >50 years old 63 2.4% 44 2.2% 107 2.3% Total 691 26.2% 482 24.1% 1,173 25.2% GRI 401-1: Incoming employees by age group and gender (n° and %) in 2020 Incoming employees as of December 31, 2020 by age Men % Women % Total % <30 years old 218 9.3% 206 10.9% 424 10.0% 30 – 50 years old 283 12.1% 171 9.1% 454 10.7% >50 years old 37 1.6% 25 1.3% 62 1.5% Total 538 23.0% 402 21.3% 940 22.2% Stevanato Group has continued staff development plans in 2021 to support the company’s growth program. In 2021, new hires included 1,173 people, of which almost 41% were women. The Group hiring rate was around 25.2% and the new hires included 508 people in the under 30 age group, 558 in the intermediate age group (30-50), while the remaining 107 were over 50 years old. In general, the search in the production area focuses on candidates with a technical and mechanical degree, while for staff positions a three-year degree or master’s degree in Engineering or Biotechnology is required, followed by Mathematics, Chemistry and Economics. The before-mentioned company growth program is part of a broader integrated human resources development plan supporting Stevanato Group’s Vision and business plan. This HR development plan is divided into a series of project activities that cover all areas of Human Resources, including analysis of process efficiency; talent development, career planning and job rotation based on evaluation of performance and potential; targeted training plans and paths for the development of “soft” and “technical” skills through a Stevanato Group Academy; and finally, a Welfare system for Group companies. Human capital 87
Sustainability Report—2021 GRI 401-1: Incoming employees by gender and region (n° and %) in 2021 Incoming employees by region as of December 31, 2021 Italy Rest of EU Extra EU Total Men 353 148 190 691 % 13.4% 5.6% 7.2% 26.2% Women 204 75 203 482 % 10.2% 3.7% 10.1% 24.1% Total 557 223 393 1173 % 12.0% 4.8% 8.5% 25.2% GRI 401-1: Incoming employees by gender and region (n° and %) in 2020 Incoming employees by region as of December 31, 2020 Italy Rest of EU Extra EU Total Men 209 164 165 538 % 8.9% 7.0% 7.0% 23.0% Women 100 71 231 402 % 5.3% 3.8% 12.3% 21.3% Total 309 235 396 940 % 7.3% 5.6% 9.4% 22.2% A geographical breakdown of new hires shows that 557 people were hired in Italy, 223 in the rest of the European Union and 393 outside the European Union. From a more general perspective, it is important to note that employee hiring and turnover percentages have been cal- culated based on the total number of employees (by age group, gender and geographical area) employed at the end of the reporting period. It is important to highlight that the high rate of hiring is mainly due to the use of employment contracts in the production departments which allows the company to respond dynamically to customer orders. Human capital 88 |
Sustainability Report—2021 GRI 401-1: Outgoing employees by age group and gender (n° and %) in 2021 Outgoing employees as of December 31, 2021 by age Men % Women % Total % <30 years old 138 5.2% 142 7.1% 280 6.0% 30 – 50 years old 185 7.0% 167 8.3% 352 7.6% >50 years old 68 2.6% 58 2.9% 126 2.7% Total 391 14.8% 367 18.3% 758 16.3% GRI 401-1: Outgoing employees by age group and gender (n° and %) in 2020 Outgoing employees as of December 31, 2020 by age Men % Women % Total % <30 years old 101 4.3% 92 4.9% 193 4.6% 30 – 50 years old 146 6.2% 132 7.0% 278 6.6% >50 years old 42 1.8% 13 0.7% 55 1.3% Total 289 12.3% 237 12.6% 526 12.4% GRI 401-1: Outgoing employees by gender and region (n° and %) in 2021 Outgoing employees by region as of December 31, 2021 Italy Rest of EU Extra EU Total Men 129 97 165 391 % 4.9% 3.7% 6.2% 14.8% Women 97 54 216 367 % 4.8% 2.7% 10.8% 18.3% Total 226 151 381 758 % 4.9% 3.3% 8.2% 16.3% GRI 401-1: Outgoing employees by gender and region (n° and %) in 2020 Outgoing employees by region as of December 31, 2020 Italy Rest of EU Extra EU Total Men 95 79 115 289 % 4.1% 3.4% 4.9% 12.3% Women 56 38 143 237 % 3.0% 2.0% 7.6% 12.6% Total 151 117 258 526 % 3.6% 2.8% 6.1% 12.4% Human capital 89 |
Sustainability Report—2021 In 2021, 758 employees left the Group. The exit rate was around 16.3% and included 280 in the under 30 age group, 352 in the intermediate group (30-50), while the remaining 126 were over 50. A geographical breakdown of the turnover shows that 226 employees left the company from subsidiaries based in Italy, 151 from the rest of European Union and 381 outside the European Union. GRI 102-8: Number of employees by type of job Employment contract as of December 31, 2021 as of December 31, 2020 Men Women Total Men Women Total Italy 1,348 1,006 2,354 1,123 898 2,021 Permanent 1098 867 1,965 938 810 1,748 Temporary 250 139 389 185 88 273 Rest of EU 665 390 1,055 616 365 981 Permanent 603 363 966 571 343 914 Temporary 62 27 89 45 22 67 Extra EU 629 608 1,237 603 622 1,225 Permanent 555 564 1,119 517 563 1,080 Temporary 74 44 118 86 59 145 Total 2,642 2,004 4,646 2,342 1,885 4,227 Stevanato Group is committed to enhancing the professional contribution of each of its employees and to building lasting relationships based on the values of loyalty, mutual trust and collaboration. The majority of employe- es in the Group are employed with permanent contracts (87% of total Group employees). Note that the contract type of each employee is based on the definitions of specific national laws of the country in which the resource is based. Human capital 90 |
Sustainability Report—2021 GRI 102-8: Number of employees by type of job Full-time / Part-time as of December 31, 2021 as of December 31, 2020 Men Women Total Men Women Total Full-time 2,622 1,893 4,515 2,317 1,772 4,089 Part-time 20 111 131 25 113 138 Percentage of Part-time 0.8% 5.5% 2.8% 1.1% 6.0% 3.3% Total 2,642 2,004 4,646 2,342 1,885 4,227 Stevanato Group pays special attention to the necessities of its employees, supporting working conditions and flexible hours to those who need it. The total percentage of employees working part-time is 2.8% (131). Of the total headcount of female employees, 5.5% have part-time status as of De-cember 31, 2021. Depending on the countries in which the Group operates and their various regulations, working relations are regulated by national or corporate collective labor agreements or existing legislation. At present, 75% of the Group’s employees are covered by collective labor agreements. Human capital 91 |
Sustainability Report—2021 5.2 Employee management and development Stevanato Group is focused on providing a work environment that is free from physical, verbal and sexual harassment, where all employees are respected and have the opportunity to reach their potential and contribute to the success of the company. The Group respects the right to freedom of association and all applicable laws relating to the minimum age of employment. With a worldwide presence, Stevanato Group employs more than 4,600 people who share its commitment towards customer satisfaction and patient well-being. Joining SG means becoming part of a group of highly dedicated people who are committed to developing innovative solutions to complex problems for its customers across the pharmaceutical industry. Departments, positions and opportunities are related to: • Corporate Functions with a focus on Finance, Administration and Control, Human Resources and Supply Chain; • Marketing & Sales as part of the Group’s commercial team; • R&D with a dedicated team of engineers and scientific experts; • Engineering with a focus on experts in Technologies; • Operations & Quality for the development of high-quality products for the pharmaceutical market. Human capital 92 |
Sustainability Report—2021 In order to correctly manage human resources, and in consideration of the location of all group companies, Steva-nato Group has structured a human resources management system that combines a number of systems and processes to ensure the easy management of human resources, business processes and data. With this, the Group can combine several fundamental HR functions, such as storing employee data, managing payroll, recruitment, benefits administration, time and attendance, employee performance management, and competency tracking. Stevanato Group’s remuneration policy is designed to reward fairly, following the guiding principle of meri-tocracy. This is ensured by constant monitoring of the total compensation provided by the markets and by aligning to its professional model which takes all positions into account: tech- nical, professional and managerial. The remuneration policy pays individuals based on qualitative measures, such as pre-defined steps connected to their performance in line with the Group’s values, and on quantitative measures such as the achievement of specific KPIs. In 2020, Stevanato launched a new Performance Development Process (PDP) based on the Group Mission and Vision. There are two categories of PDP in Ste-vanato Group: • Managerial SG PDP: evaluated on a competency model made up of 12 competencies and 5 Guiding Principles • Professional SG PDP: evaluated on a competency model made up of 6 competencies and verification of the employee’s Consistency with SG Guiding Principles Human capital 93 |
Sustainability Report—2021 MANAGERIAL SG PDP COMPETENCY MODEL • Complex problem management • Change management Flexibility- Proactivy—Creativity/Innovation Cognitive Area • Focus on efficiency • Effective communication • Resilience and ability to controI and manage stress • Teamwork with peers Relational Area Agreement, lnfluence and Persuasion—Conflict management—Interfunctionality Operative Area • Focus on results • Customer orientation and listening to needs • Economic sensitivity • Organization & planning • Leadership Delegation—lnvolvement & Motivation—People Development • Decision making & accountability Managerial Area • Will to Win Well, Have a Big Goal • Don’t be Standard • Competence, Experience and Preaparation • Consistency, Execution and Decision making Guiding Principles • Humility PROFESSIONAL SG PDP COMPETENCY MODEL • Flexibility & Proactivity Cognitive Area • Effective communication & Emotional Intelligence • Ability to control and manage stress Relational Area • Teamwork Conflict management-lnterfunctionality • Focus on results & Organization Energy—Passion and Optimism—Organization Operative Area • Ownership Managerial Area • Consistency with SG Guiding Principles Guiding Principles Human capital 94 |
Sustainability Report—2021 THE PERFORMANCE DEVELOPMENT PROCESS Defining what it can be expected from people and how they can contribute to the achievement of SG’s goals. The Fuel purposes are setting specific, measurable, achievable, reliable and timely objectives (following SMART guidelines) in Performance line with role related needs and business needs; providing individuals with a clear vision of the expectations related to their role in line with company objectives and priorities and finally fostering the creation of a culture oriented toward Setting Goal responsible people development. Seeing, reinforcing and supporting the orts made by individuals in the pursuit of those same objectives throughout the year, modifying priorities and resources according to the upcoming changes. The purposes are providing the employee and manager the opportunity to conduct an open and honest communication based on facts, which will facilitate improvement, development and growth. Discussion Mid-year See Performance It is about seeing, reinforcing and supporting the orts made by individuals in pursuit of those same objectives throughout the year by gathering input from those who work closely with the individual and/or might provide relevant feedback. The purposes are broadening the scope of Performance Evaluation by involving directly additional managers and/or peers into the Evaluation process to gather significant information that improves the overall Feedback Evaluation; increasing objectivity of the Performance Evaluation and finally involving key stakeholders that might provide relevant Feedback Collection feedback on the individual’s performance. Recognizing, assessing and evaluating the individual performance observed throughout the year. The purposes are recognizing the performance of the year; evaluating the Employee based on actual behaviors and results instead of relying on assumptions, thus reducing the subjectivity and rating the objectives set at the beginning of the year and Performance the relative Competency Model. Recognize Evaluation Performance Discussing the Performance Evaluation with the individual through an open and transparent dialogue. The purposes are providing an opportunity to foster motivation and engagement by providing feedback on yearly performance and setting expectations for next months and finally providing a formal occasion to reinforce positive behaviors and correct Feedback Session ineective ones. Another key aspect contributing to the professional development of employees is training provided by the Group. Stevanato Group considers ongoing employee training an essential part of the company philosophy. The development of specialized skills and abilities not only maintains the Group’s competitive advantage, but also ensures that its customers receive technical solutions in line with their needs both in terms of quality and innovation. To this end, a few years ago Stevanato Group created a specific function called “SG Academy” which manages and coordinates training activities at the Corporate Level. In 2020, SG Academy became “SG Academy & Change Management”, a reference function for the launch of projects aimed at supporting critical phases of change. SG Academy designs and launches training initiatives ranging from technical workshops to “Soft Skills” development sessions. The Academy promotes a “One Group” approach encouraging knowledge acquisition and the adoption of the Group’s Values and Guiding Principles. Training is a fundamental process which starts at the very beginning of an employee’s professional career. In addition, EHS training is provided during the probation period and repeated with the frequency and manner prescribed by law. Based at the Group headquarters, SG Academy is responsible for monitoring global training activities and managing and designing corporate training. Furthermore, the department conducts an annual assessment of training needs and requirements in order to define a training plan for the year which strongly correlates with Budget guidelines and constraints. At the local level, the process is directly coordinated by the Local HR Manager in alignment with SG Academy. The training needs assessment process is directly managed Human capital 95 |
Sustainability Report—2021 by SG Academy and relies on different sources, such as: individual meetings with Managers to discuss the specific needs of collaborators; analysis of Performance Evaluation results to identify the priorities to be addressed; alignment with HR Development and HR Business Partners to follow up on the most critical areas of improvement and to support the implementation of specific development plans. Locally, the HR Manager identifies specific needs based on feedback from local Managers and shares them with the SG Academy. The implementation of the Local Training Plan is directly managed by the Local HR Manager in constant coordination with the SG Academy team. As mentioned before, the assessment of training needs provides a framework for the annual Training Plan, which includes both Corporate and Local initiatives. In particular, the Academy foresees three main areas: • Soft Skills Academy: this area is dedicated to the development of soft skills for Stevanato Group employees. The training is based on a structured Catalog designed and launched by SG Academy, and is dedicated to the development of competencies considered fundamental by the Company and directly linked to the Performance Development Process. Professional Academies: the main objectives of this area include fostering knowledge-sharing within the company and developing specific cross-competencies. For example, a “Finance for non-Finance” training module, which teaches financial skills to people who work in other areas. The courses are structured with particular attention to the level of prior knowledge, which is measured through a specific initial test, and to the type of target population, creating both basic modules and more specific advanced modules. Local Education: this area is dedicated to the locally-managed training programs such as language training and technical-specific initiatives dedicated to a restricted population or individual resource. Human capital 96 |
Sustainability Report—2021 Across the Group companies, training is delivered in different ways including classroom lessons, on-the-job training, video lessons and distance education like virtual classrooms. On-the-job training is done in the workplace/workstation while the employee is performing the actual job. During 2021, the Group provided 14,393 hours of employee training related to EHS and mandatory by law, and 46,472 hours of training on the Quality Management System in compliance with ISO 15378, which is explained in detail in the sub-chapter below. The Group’s remaining training activities classified as “not mandatory” amount to a total of 46,924 hours and include training in induction, soft skills, linguistic skills, technical skills, change management initiatives and job instructions. In total, SG provided 107,789 hours of training during 2021. The Group is working to further structure data collection for trainings and attendance reports in order to meet GRI Standards in the coming years. Quality Training Company training also underlines the importance of Quality for all Stevanato Group departments. Each employee is made aware of the Quality Policy and relevant Quality Objectives related to the Quality Management System, including the benefits of improved performance as well as the implications of non-conformity with the requirements. In compliance with ISO Standards and the principles of Good Manufacturing Practices, Quality training is regularly provided and mapped for all employees. In relation to Good Manufacturing Practices, the training includes the risk of contamination and cross-contamination, potential hazards to the end-user and/or patient and the impact of any deviations from specified procedures, processes or specifications on product quality or to the end-user. Particular attention is dedicated to the training of personnel involved with the manufacturing of sterile components. In addition, specific training in micro-biological and particulate contamination and the potential risk of contamination to the patient is provided to select employees. Change Management Change Management is the application of a structured process and set of tools for leading the people-side of change in order to achieve a desired outcome. “SG Academy & Change Management” has become the point of reference for the launch of programs promoting important phases of transformation. In particular, these initiatives aim to support change in terms of Mindset and leverage the involvement of people. The Change Management programs are different and range from supporting the transition of important organizational changes to guiding important evolutions, such as digitization. Initiatives conducted in in 2021 included the Group Change Management Program, the CTO Integration Journey and the One Engineering Program. All of these initiatives were aimed at fostering Customer Centricity and integration, and supporting SG in becoming a “Best in Class” provider of integrated solutions. Other Corporate Initiatives As part of SG’s “One Group” approach, the Academy and HR Team focus on initiatives that contribute to the sharing of knowledge and the adoption of the Company Values and Guiding Principles. Initiatives range from the definition and launch of dedicated Programs (such as a Mentorship Program), to the creation and release of specific tools that integrate the Group’s Values and Guiding Principles into daily work life. Stevanato Group believes that its Values and Guiding Principles are strongly connected with Business Objectives and, as such, are key to reaching SG’s ambitious Goals. Human capital 97 |
Sustainability Report—2021 Stevanato Group Welfare In regards to company welfare and employee well-being, Stevanato Group is currently implementing a global corporate welfare system in all its plants worldwide. From the end of 2020 and onwards, Stevanato Group has expanded the welfare plan at its facilities in Piombino Dese, adding further support measures and devoting special attention to employees in difficult situations, including issues caused by the pandemic. The agreement was designed in collaboration with the facility’s Trade Union and covers several interesting points. First, in the event of periods of absence that exceed those provided by law due to a serious and ongoing illness requiring life-saving treatment, the employee will retain his/her job until recovery. Additionally, permits have also been granted to take care of disabled minor children, and days of absence and flexible hours have been increased for the care of ill children up to 12 years of age. The agreement also provides assistance to families and two new benefits have been activated: • Fragility Bonus: in order to support employees with disabled children, an individual budget of 1,000 Euro has been assigned to select employees. This bonus increases to 3,000 Euro for employees that have disabled children under 4 years of age. • Birth Bonus: an individual budget of 500 Euro has been assigned to those employees that gave birth to a child during 2021. Finally, in support of new mothers, maternity leave has been extended up to 18 months after the birth of their child. Stevanato Group provides support and helps new mothers return to the wor-kplace with ad hoc designed paths. Employees of each facility are eligible for health benefits provided by the company or the government. In particular, in the Balda, USA facilities and Ompi of Brazil, all employees are eligible for health care benefits for which Stevanato Group pays a certain percentage and the employees pay their own share depending on the type of plan they choose. In addition, Balda Precision has provided an additional 24 hours of sick time to support employees during the Covid pandemic. Medical Glass provides additional pension insurance to all employees, whereby the amount of the allowance depends on the length of employment according to agreements with the Trade Union. Regarding the services offered to employees, no distinction is made in relation to contract type (part-time/ full-time) but benefits vary according to geographic area and applicable regulations. In Ompi North America all employees have: • Dining service during their shift (subsidized); • Transportation for operative staff; • Food vouchers; • Life insurance to protect workers’ families; • School support to promote education for children of employees. Partnerships with training institutes and universities Stevanato Group is strongly committed to discovering and cultivating employees of the future. To this end, it forges close collaborations with schools and universities to establish school-work alternation and internship opportunities. The Group regards these esteemed partnerships as a pivotal element of its sustainability strategy, as it directly improves students’ career prospects and their placement in the labor market. Human capital 98 |
Sustainability Report—2021 Over the years, Stevanato Group has initiated various collaborations with schools and universities in the areas where the company’s plants are located. Locally-based partnerships are the best way to promote the company and attract talent. In this context, Stevanato Group has specifically launched a Graduate Program for new graduates. The 18-month program includes two job rotations within two main functions that are based on the graduate’s educational background: Sales & Marketing, R&D and Operations. A tutor is assigned to the resource and supports their development within Stevanato Group through job training and classes aimed at developing soft skills. At the end of the period, the resource is assigned a role that best matches the evaluation results .. Human capital 99 |
Human capital 99 | 5.3 Occupational Health & Safety For Stevanato Group, health and safety work conditions include prevention of physical and mental harm and promotion of employee health. All business activities are carried out in line with the occupational health and safety regulations in force, as well as the requirements of the Code of Ethics and the Group’s EHS Policy and Guidelines. Analysis and Risk Assessment are regularly performed to detect the presence of any hazards in the workplace, to identify and assess risks, and to engage employees in the development, implementation and performance evaluation of occupational health and safety management systems. In accordance with the EHS policy, Stevanato Group aims to ensure the health and safety of its employees, customers, users, suppliers, partners and visitors. The EHS Policy statement has been issued by the Corporate CEO and will be reissued as necessary and communicated to all individuals and stakeholders during audits or working visits. It has also been published in targeted communication areas and on the corporate website. The core of Stevanato’s EHS Policy regards Top Management’s EHS philosophy, commitment and expectations, thus providing a visible guide for the entire organization. In line with this policy and in compliance with applicable legal requirements in terms of health and safety, Stevanato encourages its entire organization and stakeholders to act according to the highest standards. Doing so helps anticipate risks and identify preventive actions that contribute to the reduction of possible injuries or occupational illnesses. Human capital 100 |
Sustainability Report—2021 In order to reinforce health and safety standards for its employees and group stakeholders, Stevanato has developed and documented a system for managing various aspects of health, safety and environmental impact according to the international and Ita-lian reference standards, as follows: • EHS Policy and documented EHS objectives; • Specific EHS Management System Corporate Policies; • Reference standard procedures for the adequate management of EHS processes; • Further documents and practices necessary to ensure effective planning, operation and process control. As per above, the majority of Stevanato Group companies are certified to ISO 45001:2018 Standards with an Occupational Health and Safety Management System. Ompi of Ompi Ompi Medical Ompi of Ompi do Balda North (PD-IT) (LT-IT) Glass China Brasil Germany America ISO 45001ï,~ï,~ï,~ï,~ï,~ï,~ï,~ Certified SQS SQS SQS SQS SQS SQS TUV by At the Group level, health and safety is managed and supervised by the headquarters’ EHS Group Director, whereas at the local plant level, the area is led by the site EHS Coordinators in charge of ensuring the local implementation of Group H&S policies, procedures, initiatives and programs. Their responsibilities also include coordinating the EHS performance data, preparing formal reports, and ensuring the site’s compliance with relevant applicable standards as well as legal local requirements. Glass DCS division (Drug Containment Solutions) and Balda Germany have implemented a Safety (SA) Pillar developed by the Top Management and chaired by the Plant Manager. The Pillar’s purpose is to oversee, coordinate and monitor the progress of SA action plans, providing appropriate technical staffing and methodology for defining roles and responsibilities at each level of the organization. In addition, the SA Pillar monitors the adequate coverage of financial, human and technological resources to ensure the implemen- tation of health and safety initiatives. SA Pillar meets monthly, and the site EHS Coordinator, in accordance with the Plant Manager, defines topics in relation to the health and safety management approach. Following the EHS Stevanato management system procedures, each operating entity establishes and implements a documented training program that enables employees to acquire the appropriate EHS skills and knowledge to perform their job function. Moreover, Stevanato Group provides education and specific training on EHS topics to all employees based on legislative requirements. Education and training are provided in formal sessions as outlined in the EHS annual training plan, as well as through weekly safety meetings and incident investigations. The EHS Committee reviews and updates the EHS annual training plan on a regular basis, at least quarterly, in order to monitor progress of the plan implementation. During 2021, training activities on EHS topics totaled 14,393 hours. Human capital 101 |
Sustainability Report—2021 Participation and consultation in the development, implementation and evaluation of the occupational health and safety management system for all employees and their representatives is through: • their involvement and prior consultation regarding the identification of hazards, risk assessment, control measures, preventive measures and accident analysis; • their involvement in the development and revision of EHS policies, objectives and goals; • periodical meetings held in accordance with the frequency and method of the local legislation. Every day, before starting work or a new job, employees inspect their work stations to identify potential risks. Each hazardous condition is reported to the organization via specific reporting formats called TAG. Follow-up activities and corrective-action tracing are addressed by the Improvement Team on Safety which is led by department Supervisors. Supervisors and Shift Leaders must issue a monthly safety inspection of their responsibility areas by reporting non-conformities on specific checklists. The checklists cite risks, potential hazards, observable unsafe acts and compliance issues, which are reported and examined periodically by Local Top Management. Incidents are reported, reviewed and investigated to a level commensurate with the actual or potential consequence of the occurrence. In case of incidents with no serious consequences, a formal investigation is led by the department leader and supported by the site EHS Coordinator. When the severity of the consequences requires leadership to verify the accuracy of the investigation, Top Management is involved. Corrective actions are taken in order to avoid the repetition of the same accident. The site SA Pillar Team reviews inspections and corrective actions monthly to verify their consistency and ensure the completion of the corrective actions. All injuries with prognosis days are reviewed by HQ EHS dept. for leadership’s involvement and confirm the consistency of corrective actions, in addition to sharing lessons learned and best practices at the corporate level. Following significant health injuries, the HR department, along with the local EHS Coordinator, supports the injured person’s return to work through a re-entry program. Human capital 102 |
Sustainability Report—2021 The program may include medical examination by the company doctor, temporary assignment to a less difficult task and a recovery plan for the previous job role. In relation to fatality and serious injury management, the Stevanato Group Fatality & Serious Injury Review Board, chaired by a representative of the Chairman and CEO, and composed by several executive employees both at the Group and local level, reviews: • all employee workplace fatalities and serious injuries occurring within the operative unit; • work-related fatalities suffered by contractor personnel working directly for Stevanato Group at a Group facility or job site; • other safety-related incidents (e.g., “serious near misses”). To facilitate the reporting of occurrences by employees to line management, the SA Pillar team has implemented a TAG communication system which is clearly posted in working areas or specific departments. This system collects reports concerning unsafe acts, unsafe behaviors and near misses. At least once a week, the department Improvement Team led by supervisors, and composed of a representative of other supporting functions, analyzes events reported in order to identify root causes and assess opportunities for improvement or corrective actions. The occurrences are reported via an Improvement Plan Actions List, which is reviewed and analyzed to ensure that corrective and preventive actions are applied. Based on the analysis of risks pertaining to various tasks, the company medical service visits the workplace periodically and prescribes a medical protocol for the residual risks, which is cyclically reviewed. In some Group entities6, employees have access to additional healthcare insurance that includes agreements with third-party private medical clinics. In fact, as part of SG’s corporate welfare program, employees have supplementary health coverage (reimbursement of expenses + various free services). Furthermore, in compliance with legislative requirements, all Stevanato Group companies provide periodic mandatory medical visits carried out by an assigned doctor who assesses employee health and job suitability. Stevanato Group companies organize initiatives aimed at promoting health through diverse medical care services that are free-of-charge. Some health promotion campaigns have been carried out locally in order to promote awareness and good practice, including flu vaccination campaigns, cardiovascular disease prevention campaigns and breast cancer prevention campaigns. The table below shows the main health promotion initiatives carried out in 2021 around the world. 6. The companies are: Nuova Ompi, Spami, Balda Medical, Balda USA, Innoscan, SVM, Ompi do Brasil, Ompi Pharmaceutical Packing Technology and Stevanato Group NAS. Human capital 103 |
Sustainability Report—2021 What Where When Event description Safety Day Mexico April 2021 An in-depth focus on Safety issues for all employees World Breast Cancer Mexico October 19, 2021 To raise breast cancer prevention awareness Day Celebration and promote a healthy lifestyle Visual health Mexico August 2021 To promote vision examinations and health campaign advice for sight conservation EHS Month event Mexico April 2021 To raise awareness on EHS topics through testimonials, games, challenges, yoga and emergency simulations 5K Race Mexico September 2021 To promote fun and healthy competition among employees (200 employees participated with their families) Emotional Wellness Mexico January-December To promote psycho-emotional health program 2021 Safety & Brazil August 16-20, 2021 Awareness activities to promote Health, Safety Environmental week and Environment standards (SIPATMA) COVID-19 Mexico September/October COVID vaccination promotion Vaccination 2021 Campaign COVID-19 China 2021 COVID vaccination promotion Vaccination Campaign Seasonal Flu Italy November 2021 Flu vaccination campaign for all employees Vaccination Campaign National Safety Brazil May 2021 Traffic accident awareness campaign Traffic Campaign Yellow September Brazil September 2021 Event focused on suicide-prevention through mental health care Pink October Brazil October 2021 Initiative to discuss prevention, diagnosis and treatment of breast cancer Defibrillator training Slovakia October/November First-aid course focused on interventions in course 2021 cases of cardiac arrest Blue November Brazil November 2021 Event to raise awareness on medical issues affecting men, mainly prostate cancer COVID-19 Germany June 2021 COVID vaccination promotion Vaccination Campaign COVID tests Slovakia October/December On-site COVID testing Mexico 2021 Germany Human capital 104 |
Sustainability Report—2021 Stevanato Group’s approach to preventing or mitigating occupational health and safety impacts, which are directly linked to its operations, products and services, is connected to SG Steps Program. This allows the Group to lead a World Class Operations Management (WCOM) transformation that meets the demands of pharmaceutical customers with the same level of quality worldwide. The SG Steps Program is composed of seven pillars. The first one focuses on safety and is based on a “zero injuries” long-term safety policy promoting proper conduct at all levels in regards to the health and safety of workers. In 2021, there were 71 injuries at the group level: 70 cases consisted of work-related injuries and 1 was a high-consequence injury7. Therefore, the rate of high-consequence work-related injuries in 2021 was 0.14, and the rate of work-related injuries (excluding high-consequence injury) was 9.49. In 2021, no fatalities as a result of work-related injury occurred. The most frequent type of injuries reported included a slip, trip or fall to the ground while walking, and cuts caused when handling semi-finished glass products or using equipment. The main work-related hazards which can create a risk of injury are surfaces that become slippery in the presence of semi-finished glass products or lubricating oil from machines, or uneven footing such as raised platforms which can cause employees to trip or lose balance and fall. These hazards are identified through the accident investigation procedure and corrective actions are implemented in all areas of the plants in order to eliminate them. In the table below, the number of working hours is composed of ordinary hours plus overtime reported by the HR department’s time and attendance management software. The injury trend in 2021 increased approximately 10% compared to 2020. The increase was reported in the Glass (DCS) and Plastics (DDS, IVD) divisions. Major drivers of the increase include growth in the number of employees and activities reorganization. In regard to absence days due to prognosis, in 2021 Stevanato Group reported a significant reduction (-26% compared to 2020). GRI 403-9: Occupational Health & Safety Rates and Injuries8 Work related injuries 2021 2020 Number of recorded work-related injuries 70 63 Number of high-consequence work-related injuries (excluding fatalities) 1 -Number of fatalities as a result of work-related injury —Number of worked hours 7,376,860 7,278,992 Rate of recordable work-related injuries 9.49 8.69 Rate of high-consequence work-related injuries (excluding fatalities) 0.14—Rate of fatalities as a result of work-related injury —Rate of total injuries occurred at work 9.6 8.7 7. The high-consequence work-related injury had no correlation to job risk but was due to causes related to the employee’s health. 8. The scope of health and safety data includes employees only. The Group assesses the possibility of collecting data from external collaborators. Note that in 2021, one injury occurred to external workers (a cut to the hand with no permanent consequences, suffered by a contractor during maintenance intervention). Human capital 105 |
Sustainability Report—2021 IR—RATE OF RECORDABLE WORK-RELATED INJURIES 40 35 30 25 IR 20 13,9% 15 11,6% 8,7% 9,6% 10 5 0 2018 2019 2020 2021 Yearly number of Injuries + Restricted Duty Cases IR = x 1.000.000 Yearly Worked Hours COVID-19 Since the outbreak of the COVID-19 pandemic, Stevanato Group has been taking measures and monitoring the situation and its global impact on operations to preserve the safety and health of its employees and ensure business continuity for its customers. Stevanato is working to relocate orders among its plants and mitigating delays, whenever possible, and constantly updates its customers in regard. Its entire staff is committed to ensuring the usual responsiveness, even in this challenging context. In relation to the administrative staff, best practices in personal hygiene and conduct are regularly communicated and implemented to minimize the risk of contagion. For the office staff, Stevanato has extensively adopted remote working, ensuring a minimal office presence to the extent possible. In relation to logistics and global transportation, the Group is in constant contact with its customers to address specific delays due to transportation issues. The disruption of the pandemic on the three different business divisions of the Group are described as follows: Human capital 106
Sustainability Report—2021 Business segments Description Glass manufacturing In Italy, a critical part of the pharmaceutical and healthcare value chain, Stevanato Group activities activities have always been considered “essential business”. Therefore, the activities never stopped and are still operating without interruption in both its manufacturing plants located in Piombino Dese – Padua and Latina. At its plants in Slovakia, Brazil, Ompi N.A. and China, Stevanato is carrying out production seamlessly. The Group has replicated the preventive measures proven effective since the beginning of the pandemic and will keep them in place according to the local government guidelines, making adjustments based on the level of threat. In Mexico, the Government has decided to maintain social distancing, protective measures and suspension of all non-essential activities including transportation not related to essential needs. Therefore, operations are running on schedule, with no delays. Plastic injection Operations in Germany and the US are running on a regular schedule with no delays. molding activities Stevanato has ramped up the production of diagnostic test plates used globally for early COVID-19 detection. The safety precautions in injection molding plants in the US and Germany remain unaltered and include additional sanitation activities following the World Health Organization guidelines. Engineering activities In plants located in Italy and Denmark dedicated to the production of advanced glass processing, inspection, and assembly equipment for the pharmaceutical industry, the Group has continued its production activities. Stevanato has also intensified the usage of advanced remote assistance tools to support customers for FAT, SAT, and post-sales activities. There are no significant production or delivery delays. Human capital 107 |
Supply chain responsibility 6 Human capital 108
Sustainability Report—2021 6.1 Responsible supply chain & procurement In the definition of its supply chain and procurement practices, Stevanato Group’s supplier selection process and purchasing conditions are inspired by the values and criteria of competitiveness, objectivity, respectability, correctness, impartiality, fair pricing and quality. Procurement processes aim to achieve the maximum competitive advantage for the Group while ensuring fairness and impartiality towards every supplier in possession of the necessary prerequisites. The contractual relations with Stevana- to Group are subject to an initial asses- sment at the time of purchase and are regularly monitored. SG has specified analytical purchasing rules that establi- sh the contractual conditions, gover- ning the purchase of raw materials, se- mi-finished products or preparations and services. The Group’s supply chain is composed of more than five thousand suppliers. Focusing our analysis on suppliers with annual spending higher than 150.000 € (or equivalent in local currency), it is possible to note that more than 86% of the total expense applies to only 379 suppliers. These select suppliers represent just 8% of the total number (5,001). In particular, the top 10 Steva- nato Group suppliers account for 25% of the total procurement amount. Pharmaceutical quality & regulatory standards set specific requirements for products and services in the indu- stry. Stevanato Group works incessant- ly to meet such requirements. Supply chain 109 |
Supply chain 109 | Stevanato Group carries out specific audits in order to test the quality of supply products. The audits are defined by specific procedures designed by Stevanato Procurement functions. These procedures classify all suppliers under an “A-B-C-D” rating, according to the characteristics of the supplied materials or/and services. The A category includes the most important and fundamental resources for Group business operations. Therefore, they are subject to the strictest audit procedures including the analysis of a series of suitability requirements in relation to technological and production capacity, overall quality of processes and products, possession of quality certificates, and corporate and financial position. Under the D category, less important resources are included and more moderate audit procedures are carried out via a supplier questionnaire. Overall, the focus of Stevanato Group Procurement employees is to verify all quality aspects of its suppliers, including documentation management, production processes and relative control. Stevanato Group is also audited by its own corporate customers. CLOUD COMPUTING AND REMOTE ASSISTANCE Stevanato Group has strengthened its collaboration with Microsoft Italy through the use of new technologies designed to aid the pharmaceutical industry in overcoming challenges caused by the pandemic. Thanks to mixed reality, it is now possible to complete virtual audits of quality, health and safety systems, and conduct remote factory acceptance tests (FATs) on equipment. A Virtual Audit plan was launched using the Microsoft HoloLens2 holographic headset with integrated Dynamics Remote Assist. This allows technicians to show customers the installation and processes, including production and lab testing, remotely. It is also possible to perform a remote quality system audit to ascertain that the installation complies with required standards and customer needs. In addition, the HoloLens headset is capable of performing the Virtual FAT (Factory Acceptance Test) — the final pre-delivery inspection that assures the remotely connected customer that the equipment is functioning properly. While wearing the headset, a technician can demonstrate machine components, start it up and share documentation. Remote acceptance of equipment for the inspection of drugs and vaccines makes it possible to accelerate delivery to pharmaceutical companies, a factor that is critical in this period when the company has to manage large volumes on a short time frame. In 2021, Stevanato Group began requiring both new and existing suppliers to adhere to its Code of Conduct. Adherence ensures compliance with existing laws, loyalty, professional rigor and correctness as well as respect for the environment, human rights and workers’ rights. Any conduct that differs from these principles could result in the termination of the business relationship, or be a precluding factor for additional collaboration. Stevanato Group requires its suppliers and service providers (in terms of legal com- pliance) to comply with the statutory requirements of the applicable legal system and with the recognized international standards of ethical conduct. In regards to respect for the basic human rights of employees, the Code is focused on the promotion of equal opportunities in terms of skin color, race, nationality, social background, possible disability, sexual orientation, political or religious conviction, sex or age, and finally, with respect to personal dignity, privacy and the rights of each individual. Supply chain 110 |
With regards to the prohibition of child labor, the Group is committed to ensuring that its suppliers recognize and respect the rights of children and comply with the Conventions 138 and 182 of the International Labor Organization (ILO) on the restriction of child labor. In terms of the safety of suppliers’ employees, the Code emphasizes the importance of taking responsibility for all staff, ensuring the best possible pre-cautionary measures against accidents and providing regular training on health and safety issues. Finally, the last part of the Code of Conduct is related to environmental protection. In this section, the Group requires all suppliers: to act in accordance with the applicable statutory and international standards regarding environmental protection, to avoid environmental pollution through constant improvements in environmental protection protocols, and to set up an environmental management system according to ISO 14001. Presently, SG is not forcing or measuring the sustainability developments of its suppliers connected to ESG aspects. However, it recognizes the importance of this matter and intends to improve its valuation, giving more weight to sustainability values. In fact, the Group’s priority objective is to make the supplier selection system more robust in order to carry out targeted audits that also take environmental and social aspects into account. Sustainability Report—2021 In this context, in 2021 Stevanato Group started a collaboration with EcoVadis, a provider of business sustainability ratings, intelligence and collaborative performance improvement tools for the global supply chain. With EcoVadis’ support, Steva-nato Group is mapping its supplier base by ESG topics with the goal of monitoring their environmental and social responsibility and pushing for corrective actions where needed. This sustainable sourcing project includes the integration of social, ethical and environmental performance factors in the supplier selection process. EcoVa-dis will analyze the first few hundred Stevanato Group suppliers and provide an independent rating on ESG aspects. The project aims to reduce possible ESG sourcing risks in developed and developing Countries as the Group considers the expansion of its supply chain. It will also help SG meet the growing expectations of its stakeholders by ensuring and overseeing its suppliers’ environmental, social and ethical practices. Stevanato Group’s goal was to reach a target of 100 rated suppliers, which it greatly exceeded with a total of 114 suppliers assessed. In 2021, EcoVadis rated approximately 42% of SG’s suppliers and an additional 9% of suppliers have accepted joining the project and are under review. Supply chain 111 |
Sustainability Report—2021 STATUS OF ECOVADIS RATING ANALYSIS €241.537.324 46,6% To do €46.814.483 9% On going Results of the assessment are fairly good with an overall score of 52 based on reviews of 114 suppliers, as shown in the table below. Stevanato Group €216.916.565 41,8% Rated €7.557.097 1,5% Declined has higher average scores across all four areas than the EcoVadis benchmark. In addition, 64% of suppliers have a score above 45. Supply chain 112 |
Sustainability Report—2021 SCORE DISTRIBUTION9 Scored Suppliers 114 50 40 30 CENT PER 20 10 0% 0 00–14 Overall Score ENV LAB 52.0 53.4 54.7 EcoVadis: 43.9 EcoVadis: 43.9 EcoVadis: 46.7 23% 25% 18% 11% 2% 15–24 25–34 35–44 45–54 55–64 To define the percentages of its procurement budget by major locations, Ste-vanato Group has analyzed the Group’s expenses by division, computing the data using accruals accounting. For each division, the total respective expenses on suppliers have been extracted, selecting the values of only the following companies in terms of business: • Biopharmaceutical and Diagnostic Solutions: Nuova Ompi and Balda Medical; • Engineering division: Spami and In-noscan. FBP SUP 49.0 45.0 EcoVadis: 41.9 EcoVadis: 36.3 11% 10% 0% 65–74 75–84 85–100 Then, the selected suppliers have been divided by location, taking into consideration their registered offices and proximity to the organization. In the Glass business division (ref. DCS), the company focused on Nuo-va Ompi in Italy for the scope of its analysis. In this division, the distribution of the procurement budget on Glass suppliers was almost entirely connected to the European Union (94%). This percentage increased by 1% between 2020 and 2021. 9. Data as of February 9, 2022. Rated company status is reflected as absolute. Supply chain 113 |
Sustainability Report—2021 DISTRIBUTION OF LOCAL PURCHASES BY GLASS DIVISION % 2021 2020 100 80 60 48 49% CENT % 46% PER 44% 40 20 7 6% % 0 LOCAL UE EXTRA UE In the Plastics business division (ref. DDS, IVD), the company used Balda Medical in Germany for the scope of its analysis. In this case, the suppliers are mainly located in Europe (87% of the total procurement turnover). The extra-UE purchases grew by 7 percentiles between 2020 and 2021 due to British and American consultancy services. The suppliers in Italy amount to 21 and constitute a negligible percentage. DISTRIBUTION OF LOCAL PURCHASES BY PLASTIC DIVISION % 2021 2020 100 80 61% 60% 60 CENT PER 40 26 34% % 20 13% 6% 0 LOCAL UE EXTRA UE Supply chain 114 |
Sustainability Report—2021 Finally, for the Engineering segment, the companies included in the scope of analysis were SPAMI and Innoscan. The majority of Spami’s expenses were connected to Italy with a value of 94%, followed by the rest of the UE with 5% and extra-UE with 1%. In terms of suppliers, the highest number is in Italy (644), followed by the UE (62) and Extra-UE (42). Innoscan’s expenses were mainly tied to Denmark with a value of 91%, followed by the rest of the UE with 8% and extra-UE with 1%. The majority of suppliers are in Denmark (253) followed by the UE (37) and Extra-UE (8). Merging the two companies’ data, the UE purchases represent 99% of the total expenditure. DISTRIBUTION OF LOCAL PURCHASES BY ENGINEERING 2021 DIVISION %—SPAMI 2020 100 94% 95% 80 60 CENT PER 40 20 5% 3% 1% 1% 0 LOCAL UE EXTRA UE Supply chain 115 |
Sustainability Report—2021 DISTRIBUTION OF LOCAL PURCHASES BY ENGINEERING 2021 DIVISION %—INNOSCAN 2020 100 91% 93% 80 60 CENT PER 40 20 8% 6% 1% 1% 0 LOCAL UE EXTRA UE Supply chain 116 |
Attention to the environment 7
Sustainability Report—2021 Stevanato Group relentlessly seeks to reduce the environmental impact of all its processes and products. Accordingly, the Group is committed to the ongoing pursuit of the latest sustainable solutions in its field. This commitment is reflected by the Group’s EHS policy, which strives to find the right balance between environmental impact and economic growth. Environmentally-friendly measures taken by SG include: optimization of energy use and efficiency; optimization of natural resource consumption; reduction of waste and emissions using the best available technologies; and the recovery of materials from its production activities. Environment 7.1 Stevanato Group’s commitment to the environment Furthermore, Stevanato is committed to complying with the applicable environmental legislation and regulations, adopting the necessary precautions and provisions for the prevention of environmental pollution, promoting awareness and responsibility among all employees, providing appropriate information and training programs, and making its environmental policy available to the public. Stevanato is committed to carrying out its activities responsibly and to protecting the environment as outlined in its EHS policy, which reflects the principles and values set out in the company’s Code of Ethics. In line with these policies, the Group has identified the following lines of strategic action: • Minimization of environmental impact through constant monitoring and mapping of energy consumption; promotion of policies, initiatives and actions designed to optimize energy efficiency through “green” technologies; and procuring energy from renewable sources. • Waste and Air emissions reduction through monitoring, preventing and reducing emissions of main pollutants into the atmosphere, mainly related to the company’s production processes; promoting waste management awareness, with particular reference to hazardous waste, in compliance with regulations; promoting and implementing methods and practices for the reduction of waste produced; focusing on recycling, recovery and reuse of production waste as part of corporate Circular Economy innovation program. 118 |
SHARING ENVIRONMENTAL RESULTS WITH STAKEHOLDERS As part of its commitment to ethics, the Group actively involves its stakeholders in the continuous improvement of processes to bring responsible development to the communities where it operates. The environmental performance has a direct and indirect impact on human health and on the environment. SG believes that promoting employee engagement and individual responsibility for environmental actions is an important part of its success. Therefore, it encourages employees to take an active part in the process by sharing information on environmental and sustainability issues. Stevanato communicates information about waste production, natural gas and energy consumption on its website for all stakeholders and provides an overview of data related to the environment on the intranet for employees. Sustainability Report—2021 Stevanato Group is compliant with ISO 14001 Environmental Management System in seven sites. The synergistic use of these ISO and specific GRI Standards regarding the environment makes it easier for the Group to lessen its environmental impact and creates a sustainability model that is measurable, promotable and comparable. In order to constantly monitor its environmental footprint, SG uses a centralized management system that identifies potential risks in advance, enacting preventive measures and attentive supervision. The environmental data presented refers to all the Group’s production sites. It does not include SG’s commercial companies, which are deemed immaterial, given the small number of employees and their non-engagement in production activities. Any other exceptions or limitations to the scope are specified below in each table. The Group is committed to exceeding customer expectations in its respect for the environment and sustainability. Particularly, the company defined an EHS Policy in 2018 and updated in 2021, aiming to ensure the health and safety of its employees, customers, end-users, suppliers, partners and visitors, as well as protect the environment. Stevanato Group operates its worldwide business under the principles of sustainability, putting health, safety and environmental management at the heart of its business processes. In particular, the Group implements sustainability measures in the following areas: • energy efficiency and renewable energy (e.g., trigeneration system, heat recovery, solar energy); • water management (ref. water recovery for second use / closed loop); • waste management (mainly reuse, recycling and Waste-To-Value practices for glass and plastics scraps). Stevanato has identified the possible environmental impact areas of its business thanks to the materiality analysis (see chapter 2.1 Approach to sustainability), which include energy consumption, GHG emissions, water management and waste management. The Group regularly monitors and manages these impact areas to ensure compliance with the ruling legal requirements of the countries where it operates. Finally, Stevanato Group monitors and ensures active compliance with laws, ethical standards, and national and international norms. As a confirmation of these commitments, in 2021 the Group received no significant fines or non-monetary sanctions for non-compliance with environmental laws and/or regulations. Environment 119 |
Electricity and natural gas remain the main energy sources used in production processes. Energy consumption is one of the main indicators of environmental impact stemming from the Group’s production facilities. The direct and indirect emissions of Italian and foreign production sites are monitored centrally via the regular analysis of primary energy consumption, such as natural gas for heating and electricity for buildings. Stevanato Group has introduced a number of initiatives focused on mitigating energy consumption. In 2021, the following activities were carried out in conjunction with foreign production sites, such as: Sustainability Report—2021 For several years, Stevanato Group has implemented careful and responsible management of its energy consumption. For companies in the Glass (DCS, Drug Containment Solutions) business, the main energy sources are natural gas and electricity, whereas for the Plastics (DDS, Drug Delivery Systems; IVD, In Vitro Diagnostic) Solutions and Engineering segment, the main energy vector is electricity. Additional consumption derives from diesel fuel both for heating in Ompi of Brazil and, in Ompi North America, from generator systems and transportation of the company’s logistic vehicles. Diesel fuel used for company transportation includes the Balda facilities in the USA and all Italian plants. To advance sustainable mobility, the Group began upgrading its company fleet to hybrid vehicles in 2021. Environment 7.2 Energy Consumption and GHG Emissions • Development of Energy Management services to monitor, control and optimize the efficiency of its electric utility grid at the DCS plant in Piombino Dese and in Germany at Balda Medical. • Use of alternative energy production systems: since 2020, the Group has utilized a leased trigeneration plant (simultaneous generation of electri- city and heating and cooling) fueled by natural gas at its headquarters in Piombino Dese (Italy), significantly reducing emissions. • Improvements in lighting systems: Stevanato Group has reduced ener- gy inefficiency with a notable in- vestment in LED technologies. This improvement has also significantly increased the average lifespan of its lighting systems. • Replacement of air systems: over the last three years, the Group has replaced compressed air pro- duction systems with higher efficien- cy systems in its plants. Stevanato Group monitors key parameters like pressure, flow, power and dew point and, once collected, analyzes the data to verify any issues. 120 |
GRI 302-1: Energy consumption within the organization10 Types of consumption Unit 2021 2020 From non-renewable sources GJ 1,269,296.4 1,136,592.8 From renewable sources GJ 93.6 246.9 Natural Gas GJ 858,299.9 755,469.7 Diesel GJ 6,895.4 6,336.2 Of which productive use (power generators) GJ 479.4 61.9 Of which transportation GJ 6,416.0 6,274.3 LPG GJ 9.9 8.6 Electricity bought and internally produced from photovoltaic GJ 404,184.7 375,025.2 Electricity bought GJ 404,091.2 374,778.3 From renewable sources GJ — From non-renewable sources GJ 404,091.2 374,778.3 Electricity from photovoltaic systems GJ 93.6 246.9 Of which self-consumed GJ 93.6 246.9 Of which sold to the grid GJ — Total energy consumption GJ 1,269,390.0 1,136,839.7 Sustainability Report—2021 • Installation of photovoltaic energy systems: installed at the Piombi-no Dese facility in 2020 (140kW) and in 2021 (160 kW). The Group installed the panels to reduce energy consumption from non-renewable energy sources. • Implementation of heat recovery systems from compressor refrigeration and glass molding plants, resulting in a significant reduction in energy usage at the Piombino Dese facility. • Implementation of inverters on some pump stations at the Piombino plant to optimize energy consumption. The following table reports the energy consumption of the organization and highlights how sustainability is of the utmost importance to the Group. ENERGY CONSUMPTION WITHIN THE ORGANIZATION [GRI 302-1] Regarding the above data, in 2021 the total energy consumption totaled approximately 1,269,390 GJ. Specifically, 68% of this value derives from the consumption of natural gas and 32% comes from electricity sources. Electricity sources can be divided between purchased electricity (99.98%) and self-produced electricity from photovoltaic systems. Finally, for the natural gas values, energy input includes the production of electricity from the tri-generation plant, whose electricity is all consumed internally. 10. Conversion factors for all fuels used are taken from DEFRA 2021. Environment 121 |
• Scope 1: direct emissions associated with sources owned or controlled by the Group, used as fuels for heating and operational needs ; • Scope 2: indirect emissions deriving from the consumption of electricity purchased by Stevanato. Sustainability Report—2021 An increase of 12% in energy consumption in 2021 compared with 2020 is mostly due to an increase in production volumes (+16%) in addition to the implementation of new production lines for EZ-fill® areas. There was a decrease in the self-production of electricity in 2021 due to the temporary downtime of the photovoltaic system. Below are the main types of emissions related to the above-mentioned energy sources. In particular, to report greenhouse gas emissions, Stevanato Group has joined the Greenhouse Gas (GHG) Protocol, which requires the distinction of emissions into categories or “Scope”: Specifically, in compliance with GRI Reporting Standards, emissions are calculated according to Location and Market methodologies, using appropriate emission factors. The Group places particular focus on GHG emissions with regards to compliance with local regulations. Specific interest is applied to air emission reductions as defined in the EHS Policy. Emissions are calculated by directly measuring the relevant energy source and the conversion into GHG in order to determine the value of the CO2 equivalent. Direct (Scope 1) GHG emissions include the CO2 emissions from the energy fuel consumption as reported in Disclosure GRI 302-1. Regarding direct emissions (Scope 1), Stevanato Group produced a total of 44,254 of tons of CO2e in 2021. The data provided considers CO2 emissions deriving mainly from the use of natural gas, diesel fuel and refrigerant gas. The following table shows the strong influence of natural gas in the direct greenhouse gas emissions (Scope 1), which accounts for 99% of the total value. The remaining percentage derives mainly from diesel fuel used for both heating and transportation, and refrigerant gas. The increase of 12% in Scope 1 emissions in 2021 compared with 2020 is mostly due to an increase in production volumes (+16%) in addition to diesel consumption in OMPI Do Brazil used for energy generators due to a shortage of electricity from its supplier. Environment 122 |
GRI 305-1: Direct greenhouse gas emissions (Scope 1)11 From non-renewable sources Unit 2021 2020 Natural Gas t CO2 eq. 43,684.6 38,561.6 LPG t CO2 eq. 0.6 0.5 Diesel t CO2 eq. 456.4 421.4 of which productive use (power generators) t CO2 eq. 34.2 4.4 of which transportation t CO2 eq. 422.2 417.0 Refrigerant Gas t CO2 eq. 112.9 392.0 Total direct emissions by GHG (Scope1) t CO2 eq. 44,254.1 39,375.5 Sustainability Report—2021 DIRECT GREENHOUSE GAS EMISSIONS (SCOPE 1) [GRI 305-1] An increase in Scope 2 emissions in In relation to indirect emissions (Scope using mostly grid-average emission 2021 compared with 2020 is mostly 2), the CO2 produced in 2021 amoun- factor data, whereas the market-based due to an increase in production ted to 36,103 tons of CO2e for the loca- method reflects emissions from electri-volumes (+16%) and capacity. tion-based method and to 45,513 tons city that an organization has purpose-of CO2e for the market-based method. fully chosen. Moreover, with Scope 2 –The location-based method reflects the market-based method was avoided 16% the average GHG emissions of grids a part of the electricity from renewable on which energy consumption occurs, sources as defined by GRI Standards. EMISSIONS CALCULATED ACCORDING TO THE ‘LOCATION-BASED’ METHOD GRI 305-2: Indirect greenhouse gas emissions (Scope 2)12 Unit 2021 2020 Electricity t CO2 eq. 36,103.5 33,537.3 Total indirect emissios (Scope 2) t CO2 eq. 36,103.5 33,537.3 EMISSIONS CALCULATED ACCORDING TO THE ‘GROSS MARKET-BASED’ METHOD GRI 305-2: Indirect greenhouse gas emissions (Scope 2)13 Unit 2021 2020 Electricity t CO2 eq. 45,513.0 41,930.2 Total indirect emissios (Scope 2) t CO2 eq. 45,513.0 41,930.2 To sum up, in 2021 the Group registered a value for total emissions (Scope 1 and Scope 2 Location-based) of 80,357 tons of CO2 (+10.2% compared to 72,912 tons of CO2 in 2020). 11. These figures have been calculated using DEFRA 2021 and DEFRA 2020 emissions factors according to the GHG Protocol methodology. The consolidation approach for the Group’s emissions is the operational control. Figures refer to CO2 equivalents when available. Data is presented without consideration of any offsetting instruments. 12. The conversion factors used are taken from Terna 2020. The emissions are expressed in tons of CO2; however, the percentage of methane and nitrous oxide has a negligible effect on total greenhouse gas emissions (CO2 equivalents), as can be seen in the technical literature of reference. 13. The conversion factors used are taken from European Residual Mix 2020:AIB 2021. The emissions are expressed in tons of CO2; however, the percentage of methane and nitrous oxide has a negligible effect on total greenhouse gas emissions (CO2 equivalents), as can be seen in the technical literature of reference. When missing an AIB emission factor, conversion factors are taken from Terna. Environment 123 |
Water management is a key aspect of Stevanato’s environmental approach and a significant topic noted by SG stakeholders in the materiality analysis in terms of: • Defining strategies to increase efficiency and reduce water use, especially for the Group’s production activities, including water reuse and recycling methods; • Implementing and monitoring effective measures for the correct management of industrial wa-stewater discharges, especially discharges containing dangerous substances, in full compliance with current regulations. Sustainability Report—2021 7.3 Water management The Drug Containment Solutions companies draw 74% of their water from local underground sources, with the remaining 26% coming from the public water supply. Water is used in the production process in the following operations: • as washer and sanitizer for semi-finished glass products for pharmaceutical companies; • as a carrier fluid in cooling systems; • cleaner for hygienic uses; • catering for company canteen. 124 |
Companies in the DDS, IVD and Engineering segments use water almost exclusively for hygiene, cleaning and catering purposes. The water used in these plants comes from public services. The companies related to Ompi, Medical Glass and Balda Medical are ISO 14001 certified and overall water usage is assessed according to the protocols dictated by the certification standards as part of environmental impact analyses. The data obtained is periodically reviewed for Group reporting and communication to local authorities, as well as for monitoring environmental performance. The significant amount of water withdrawn from public services and groundwater, which is discharged by the organization post-production, represents the main environmental impact. By progressively improving the quality of water discharged, promoting its reuse in the industrial environment, and reducing its withdrawal by optimizing processes, the organization can reduce its impact on the surrounding environment. On one hand, the quality of the water discharged by the Group’s plants, due to the processes carried out during normal operations, has little impact on external watercourses and treatment plants. On the other hand, the amount of water withdrawn by Stevanato and the quantity of its discharges can impact the ecosystem in numerous ways. Balda Medical, Germany The total amount of water withdrawal by public service (third parties) comes from La Weser, which is a river of Lower Saxony in north-west Germany. Sustainability Report—2021 Direct impacts on a catchment can have wider impacts on the quality of life in an area, including social and economic consequences for local communities. An important initiative started at the headquarters in February 2020 is the modification of the water distribution system in order to re-utilize the fluid coming from the semi-finished product sanitizing process (WFI – Water For Injection). After this initial process (WFI), the water is channeled for filtering and cooling so that it can then be reused. This new implementation at the Piombi-no Dese plant has helped reduce water withdrawal by 10,000 m3/year. After treatment, water coming from production processes is made suitable for irrigation/gardening at Ompi North America (4144 m3/year) and Ompi Do Brasil (3007 m3/year). Starting in 2020, water withdrawal at production sites has also been monitored to assess locally-based water stress. For the identification of water-stressed areas, the Water Resource Institute tool is utilized, providing a more comprehensive overview of the organization’s water use and water-related impacts, and possible measures to manage them. According to the Water Resource Institute Tool, the entities located in high and extremely high-water stressed areas are: Ompi North America, Mexico 12% of the total amount of water withdrawal is by public service (third parties) and comes from Río Bravo del Norte, which is one of the principal rivers (along with the Colorado River) in the south-western United States and northern Mexico. Balda Precision, Oceanside (CA) The total amount of water withdrawal by public service (third parties) comes from the Colorado River, Carlsbad’s desalination plant, the California Aqueduct system, and recycled water programs. Balda C. Brewer Ontario (CA) The total amounts of water withdrawal by public service (third parties) comes from Santa Ana River Lakes, which are located in the city of Anaheim, California. Environment 125 |
Companies in the DDS, IVD and Engineering segments use water almost exclusively for hygiene, cleaning and catering purposes. The water used in these plants comes from public services. The companies related to Ompi, Medical Glass and Balda Medical are ISO 14001 certified and overall water usage is assessed according to the protocols dictated by the certification standards as part of environmental impact analyses. The data obtained is periodically reviewed for Group reporting and communication to local authorities, as well as for monitoring environmental performance. The significant amount of water withdrawn from public services and groundwater, which is discharged by the organization post-production, represents the main environmental impact. By progressively improving the quality of water discharged, promoting its reuse in the industrial environment, and reducing its withdrawal by optimizing processes, the organization can reduce its impact on the surrounding environment. On one hand, the quality of the water discharged by the Group’s plants, due to the processes carried out during normal operations, has little impact on external watercourses and treatment plants. On the other hand, the amount of water withdrawn by Stevanato and the quantity of its discharges can impact the ecosystem in numerous ways. Balda Medical, Germany The total amount of water withdrawal by public service (third parties) comes from La Weser, which is a river of Lower Saxony in north-west Germany. Sustainability Report—2021 Direct impacts on a catchment can have wider impacts on the quality of life in an area, including social and economic consequences for local communities. An important initiative started at the headquarters in February 2020 is the modification of the water distribution system in order to re-utilize the fluid coming from the semi-finished product sanitizing process (WFI – Water For Injection). After this initial process (WFI), the water is channeled for filtering and cooling so that it can then be reused. This new implementation at the Piombi-no Dese plant has helped reduce water withdrawal by 10,000 m3/year. After treatment, water coming from production processes is made suitable for irrigation/gardening at Ompi North America (4144 m3/year) and Ompi Do Brasil (3007 m3/year). Starting in 2020, water withdrawal at production sites has also been monitored to assess locally-based water stress. For the identification of water-stressed areas, the Water Resource Institute tool is utilized, providing a more comprehensive overview of the organization’s water use and water-related impacts, and possible measures to manage them. According to the Water Resource Institute Tool, the entities located in high and extremely high-water stressed areas are: Ompi North America, Mexico 12% of the total amount of water withdrawal is by public service (third parties) and comes from Río Bravo del Norte, which is one of the principal rivers (along with the Colorado River) in the south-western United States and northern Mexico. Balda Precision, Oceanside (CA) The total amount of water withdrawal by public service (third parties) comes from the Colorado River, Carlsbad’s desalination plant, the California Aqueduct system, and recycled water programs. Balda C. Brewer Ontario (CA) The total amounts of water withdrawal by public service (third parties) comes from Santa Ana River Lakes, which are located in the city of Anaheim, California. Environment 125 |
Water withdrawal data is calculated based on the official figures reported in the water supplier’s documentation noting the amount of water withdrawn by public service. In order to accurately monitor the volume of water taken from underground sources, a specific water meter measurement has been installed. Regarding the water discharge, the effluents are monitored in accordance with a plan for regular and precise chemical analyses, regulated by a specific monitoring and control procedure for effluents by the operating unit. Generally, water effluents from the group’s offices and production sites are discharged into the public sewer system regulated by a specific contract, which also outlines the acceptable limits in compliance with legislation. Sustainability Report—2021 The data presented below is the result of measurements with suitable instruments for the plants in Italy and China. The latter carries out real-time monitoring of water discharges by means of instrumentation prepared in cooperation with local authorities. In the other facilities, the water discharged into the public sewer system is estimated (for the Sustainability Report). Overall, Ste-vanato Group’s plants manage water discharges in accordance with local guidelines and the requirements defined in their licenses. It is important to note that the characteristics of water discharges from production facilities, due to the type of processes in place (mainly sanitization), do not cause significant environmental impact. WATER DISCHARGE [GRI 303-4 2018] GRI 303-4 (2018): Water discharge As of December 31, 2021 As of December 31, 2020 Areas with Areas with All areas All areas water stress water stress Surface water (total) — —Groundwater (total) — —Seawater (total) — —Third party water (total) 163.9 25.1 178.7 35.1 Third party water delivered to Treatment Plant 7.7 1.4 34.6 18.3 (total) Total water discharge 171.6 26.5 213.3 53.4 of which freshwater ( 1,000 mg/L Total Dissolved Solids) of which other water 171.6 26.5 213.3 53.4 (>1,000 mg/L Total Dissolved Solids) The table above shows the total water discharge related to third-party water, of which more than 4% was delivered to treatment plants in other organizations. Regarding water stress, almost 15% of the total water discharge is located in areas classified by the Water Resource Institute Tool in high and extremely high-water stress. Balda Precision eliminates dirty water discharge by use of an evaporator; residual sludge is then processed as low-level hazardous waste. Environment 127 |
Sustainability Report—2021 WATER INITIATIVES IN MEXICO Ompi North America, Mexico, has designed an initiative called Brackish that consists of the desalination of underground water to be used in the production process. Once the facility has used the water, it proceeds to discharge it in order to replenish aquifers and rivers with fresh water. In exchange for the discharge of desalinated water, the local governmental authority offers a discount to Ompi on its water consumption bill. The project is in line with SG’s mission to raise awareness and encourage responsibility for the environment, which, if managed efficiently, also generates significant savings for the company. The Brackish project has saved more than 2,000 € and 4 megaliters of water withdrawals a year. Environment 128 |
Sustainability Report—2021 Stevanato Group pays special attention to waste production, respecting all the mandatory regulations in every country where it operates and always striving to minimize the total amount of waste. As defined in the EHS Policy, specific focus is applied to waste reduction, implementing the best available techniques and reporting results to stakeholders. 7.4 Waste management The waste produced by the Group’s companies derives from the production processes and comes mainly from warehousing (packaging materials), production (production and quality waste) and ancillary activities such as maintenance and office work. The plants dedicated to the production of glass primary packaging generate several types of waste, depending on the nature of manufacturing operations. In this area, Stevanato stresses the importance of circularity in its production process as per the corporate Circular Economy innovation program. The circular economy is a set of principles that aims to turn products at the end of their service life into resources for others, closing loops in industrial ecosystems, minimizing waste and following sustainable practices. The circular economy is a strategic lever in Environment 129 |
tackling resource scarcity, global warming and waste management, and is prominently reflected in the Stevanato EHS policy. In this context, Stevana-to Group implements Waste to Value practices for glass and plastics scraps, giving new purpose to material that would otherwise become trash. In addition, Balda recycles the in-process trays in a circular loop. Among its initiatives, the Group endeavors to reduce single-use plastics by providing simple alternatives. In several plants, Stevanato has already eliminated PET plastic bottle consumption, replacing 500 ml bottles with coolers and 20-liter jugs in the office areas. In addition, Stevanato is also committed to reducing food waste in company canteens. In Brazil it has started a zero-food waste initiative, whereas in Mexico, it has implemented a meticulous system to differentiate and properly manage food waste, following the local recycling regulations. Balda Precision recycles all of its metal scrap and filters as well as machining oil to keep hazardous waste to an absolute minimum. The waste management process involves collecting and storing waste in defined areas and specific containers according to the type of waste. The volumes managed are controlled by measuring the masses delivered to the disposal plants; the relevant data is stored in a specific database for each plant and shared at group level so that it can be monitored by the central EHS department. Waste for disposal is entrusted to third parties who operate in compliance with the relevant contractual or legal regulations. Data on waste production is provided regularly in order to assess performance and ensure regular reporting to public bodies. The data below is the result of measurements carried out with appropriate instruments at waste disposal companies. In fact, all waste generated at Stevanato Group plants is stored temporarily at the production sites and transported by Sustainability Report—2021 authorized suppliers to storage facilities for further management and disposal. At this moment, the company does not directly recycle the production waste back into the value chain at its sites, mainly because of the pharma requirements. However, SG has started to investigate such opportunities as part of its corporate Circular Economy innovation program. All Stevanato plants are committed to implementing material reuse policies such as recyclable containers for the transport of raw materials and semi-finished products. A review of processes is also carried out to optimize the raw material input and the reduction of waste materials. Furthermore, all the waste from facilities is collected, differentiated and, wherever possible, recycled (plastic, brass chips, aluminum, stainless steel). The waste generated by Stevanato Group consists mainly of: • Recyclable waste: glass, cardboard, plastic, wooden pallets, exhaust oil, colors and solvents, laboratory chemicals, batteries, accumulators, iron and fluorescent tubes; • Not-recyclable waste: Freon exhaust, garbage, toners, packaging containing residues of dangerous substances, absorbents, oil rags. Most of the waste listed above comes from activities related to Ste-vanato Group organizations in the Glass (DCS) division, which accounts for 91% of the total waste produced, the Plastics (DDS, IVD) division, which accounts for 7%, and the Engineering division (2%). Taking all products produced annually into account, Stevana-to Group produces more than 10,400 tons of industrial process waste. Hazardous waste accounts for 7% of the total volume of waste produced. The percentage of waste recycling and reuse in the different divisions is remarkable, varying from 65% in the Glass (DCS) division to 79% in the Plastics (DDS, IVD) division, and 79% in the Engineering division. Environment 130 |
Sustainability Report—2021 The table below reports the total weight of waste generated in metric tons with a breakdown between recyclable and not-recyclable waste by business division. Waste production increased (+19%) in 2021, mostly due to an increase in production volumes and refurbishment of some new facilities. WASTE GENERATED [GRI 306-3 2020] GRI 306-3 (2020): As of December 31, 2021 As of December 31, 2020 Waste generated Not Not Recyclable Total Recyclable Total Recyclable Recyclable Glass (DCS) Division 6,225.1 3,398.1 9,623.2 5,974.8 1,628.7 7,603.4 Plastics (DDS, IVD) Division 469.4 121.7 591.1 468.5 192.6 661.1 Engineering Division 152.3 38.5 190.8 118.5 13.3 131.8 Total 6,846.8 3,558.3 10,405.1 6,561.8 1,834.6 8,396.3 Environment 131 |
Sustainability Report—2021 WASTE BY TYPE AND DISPOSAL METHOD 65% Recycling & Reclamation 0% Reuse Information about waste disposal methods reveals the extent to which an organization has managed the balance between disposal options and environmental impacts. Most waste minimization strategies emphasize prioritizing options for reuse and 19% Land Disposal 15% Treatment 1% Inceneration recycling, and then recovery, over other disposal options to minimize ecological impacts. As shown in the above graph, the most important disposal method at Stevanato Group is the Recycling & Reclamation category with a percentage of 65%. Environment 132 |
The link with the territory 8
8.1 Local communities engagement Sustainability Report—2021 Stevanato Group has always been closely connected to the land and the communities where it operates. In Italy, where it has been established for 70 years, Stevanato Group has shown its commitment to the local territory over time, reconciling its industrial development with an improvement in the overall quality of life of people. International developments are much more recent, as such, the link with communities is being steadily built as the Group’s companies grow, as demonstrated by the charitable donations made in China and Denmark over the last few years. From this ongoing and meaningful commitment to local community, and a desire to fund lasting projects with greater social impact, the decision to establish the Stevanato Foundation was born. The Foundation was established on October 26, 2017, and as a legal entity by Decree of the Ve-neto Region as of January 16, 2018. The founders and members of the Board of Directors are Sergio Stevana-to (Chairman), Franco Stevanato and Marco Stevanato. The Stevanato family provided the initial assets while the Italian companies contribute annually to support the Foundation’s mission. The Foundation pursues the aims of social solidarity, philanthropy and charity exclusively, operating in the fields of social and social-health care, educa- tion and training, and scientific research. In particular, it focuses on supporting children and young people with serious illnesses, disabilities, or other issues that may affect their health and growth, as well as their families. It does so by promoting educational, recreational and sports activities for youth, fostering social inclusion, encouraging the dissemination of civic values, supporting initiatives that have an immediately beneficial effect on society, and backing medical research projects that study illnesses and diseases. The interventions of the Stevanato Foundation, in both assets and funds, were distributed over a two-year period to the groups indicated in the following graphs: Territory 134 |
Sustainability Report—2021 2020 – STEVANATO FOUNDATION DISTRIBUTION OF DONATIONS Children 76% Research 17 % Social help 7% 2021 – STEVANATO FOUNDATION DISTRIBUTION OF DONATIONS Research 64% Social 26 help % Children 10% Territory 135 |
Sustainability Report—2021 The main projects and initiatives sup- establishment are reported below: ported by the Foundation since its Since 2018, the Stevanato Foundation has taken over support for V.I.M.M., a pillar of excellence at the international level for research in the field of cell and molecular biology, from Stevanato Group. In particular, the Foundation supports research projects on childhood diseases. Continuing the collaboration started by Stevanato Group in 2018, the Stevanato Foundation launched a multi-year project called “The 3.0 classroom” which introduces innovative teaching methods and new technologies so students can reach their full potential. The students become the main protagonists of the learning process and develop their creativity by solving problems and designing projects with others. The ULSS6 at Villa del Conte in Italy’s Veneto region has been restructured to begin caring for autistic children. The Stevanato Foundation contributed to the renovation of the facility. The new center, called “Rio Bio”, will engage a team of specialists to follow 162 cases of autistic children up to the age of 18. Thanks to the structural renovation, the existing spaces have been converted into health care areas, laboratories and spaces for therapeutic and group activities. The Foundation donated a car to the Elderly Movement Center of Piombino Dese, making it possible to activate a service for the home delivery of meals for elderly people who are not self-sufficient. The meals are cooked by a local cooperative in collaboration with the Foundation and the local administration. The Foundation contributed to the renovation of the outdoor playground area at the nursery in Piombino Dese, creating safe accessibility conditions for children with disabilities. Project ROP: project designed to provide the Mestre’s Hospital with a RetCam for early diagnosis and treatment of retinopathy in premature infants. The main objectives were: 1. “In house” diagnosis at Mestre’s Hospital, reducing children’s suffering and the inconvenience of travelling to other hospitals for their families; 2. Service for other hospitals in the district; 3. Enhancement of telemedicine (online diagnosis and consultation); 4. Enabling “in house” surgical treatment with increased specialist skills; 5. Support for diagnostics of other pathologies other than retinopathy. Territory 136 |
70TH ANNIVERSARY OF STEVANATO GROUP In 2019, Stevanato Group reached a major milestone, celebrating its 70th anniversary. Both customers and employees were invited to the headquarters in Piombino Dese and production plants around the world with the aim of thanking stakeholders for their support throughout the Group’s history and recognizing their role in the company’s growth. Stevanato opened its doors to the families of employees through “open factory” visits and hosted a “Family Day” featuring fun activities and thematic workshops for adults and children in our plants all over the world. Sustainability Report—2021 In addition to these initiatives, the Foundation has contributed to the well-being of its local communities through several non-profit donations which helped fund: a minibus for disabled people, wheelchair youth basketball and the Giovanni Stevanato trophy, and a machine that monitors vital stats (blood pressure, heart rate, saturation, electrocardiogram) for ambulances through the Italian Red Cross. In 2019, a collaboration between the Foundation, the municipality of Piombino Dese and its nurseries, was initiated to assist families in difficulty, help with payments of unpaid fees, and facilitate the contact between families and social services in cases of special need. Finally, in 2020, during the most critical phases of the Covid-19 pandemic emergency, Stevanato Group provided much-needed supplies and economic support to health and hospital facilities in the provinces of Venice, Padua and Treviso. Territory 137 |
Product quality and GRI 416 Customer Stevanato Group customers Generated by the Group responsibility Health and Safety Research & Development Material topic not directly Stevanato Group Generated by the Group and Innovation related to a Topic-Specific Suppliers and commercial GRI Standard partners Occupational Health GRI 403 (2018) Occupational Stevanato Group employees Generated by the Group & Safety Health and Safety Business ethics, governance GRI 205 Anti-corruption Stevanato Group Generated by the Group and compliance GRI 206 Anti-competitive Behavior GRI 307 Environmental Compliance Human capital management GRI 102 General Disclosures Stevanato Group Generated by the Group and development GRI 401 Employment GRI 405 Diversity and Equal Opportunity Economic performance and GRI 201 Economic Stevanato Group Generated by the Group value creation Performance Responsible supply chain & GRI 102 General Disclosure Stevanato Group Suppliers and business Procurement GRI 204 Procurement suppliers and commercial partners Practices partners Energy Consumption GRI 302 Energy Stevanato Group Generated by the Group and connected with the Group’s activities Waste management GRI 306 (2020) Waste Stevanato Group Generated by the Group and connected with the Group’s activities Employee wellbeing GRI 401 Employment Stevanato Group Generated by the Group Human rights GRI 406 Non-discrimination Stevanato Group Generated by the Group Suppliers, commercial partners and employees Water management GRI 303 (2018) Water Stevanato Group Generated by the Group and Effluents and connected with the Group’s activities GHG Emissions GRI 305 Emissions Stevanato Group Generated by the Group and connected with the Group’s activities Local community GRI 413 Local Communities Stevanato Group Communities and engagement future generations Sustainability Report—2021 Topic Boundaries The following table shows the sustai- the “GRI Sustainability Reporting Stan-nability aspects considered material dards” in this document. for the Stevanato Group and related to Material topics identified Topic-specific reference by Stevanato Group GRI Standards Boundary of material aspects Where the imapacts Type of impact occurred Territory 138 |
GRI Standards Disclosure Page number/Note Omissions GRI 102: GENERAL DISCLOSURES 2016 Organizational Profile 102-1 Name of the organization P. 12-13 102-2 Activities, brands, products and services P. 12-23 102-3 Location of the headquarters P. 13; 23 102-4 Location of operations P. 23 102-5 Ownership and legal form P. 12-13 102-6 Markets served P. 16 102-7 Scale of the organization P. 11 102-8 Information on employees and other workers P. 90-91 102-9 Supply chain of the organization P. 109-116 102-10 Significant changes to the organization and its supply chain P. 19-20 102-11 Precautionary principle or approach P. 36 102-12 External Initiatives P. 42; 46 102-13 Membership of Association P. 49-51 Strategy 102-14 Statement from senior decision-maker P. iv-vi Ethics and Integrity 102-16 Values, principles, standards and norms of behavior P. 24-26, 34-35 Governance 102-18 Governance structure P. 27-33 Stakeholder Engagement 102-40 List of stakeholder groups engaged P. 43 102-41 Collective bargaining agreements P. 91 102-42 Basis for identifying and selecting stakeholders P. 38-40 102-43 Approach to stakeholder engagement P. 44 102-44 Key topics and concerns that have been raised through P. 43 stakeholder engagement Sustainability Report—2021 GRI Content Index The table below shows the performance indicators, in line with the “GRI Sustainability Reporting Standards” according to the “GRI referenced” approach. Each indicator is accompanied by a reference to the section of the Sustainability Report in which it can be found. Territory 139 |
Sustainability Report—2021 GRI Standards Disclosure Page number/Note Omissions Reporting Practice 102-45 Entities included in the consolidated financial statement P. vii 102-46 Defining report content and topic boundaries P. vii-viii, 138 102-47 List of material topics P. 40 102-48 Restatement of information This is the first Sustainability Report of Stevanato Group. 102-49 Significant changes in the list of material topics This is the first and topic boundaries Sustainability Report of Stevanato Group. 102-50 Reporting period P. vii 102-51 Date of most recent previous report This is the first Sustainability Report of Stevanato Group. 102-52 Reporting cycle P. vii 102-53 Contact point for questions regarding the report P. viii 102-54 Claims of reporting in accordance with the GRI Standards P. vii-viii 102-55 GRI content index P. 139-143 102-56 External assurance P. 144-146 ECONOMIC PERFORMANCE: TOPIC-SPECIFIC STANDARDS GRI 201 Economic performance 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 53-59; 138 and its Boundary 103-2 Management of the topic: The management approach P. 53-59 and its components 103-3 Management of the topic: Evaluation of the management approach P. 53-59 201-1 Direct economic value generated and distributed P. 54 GRI 204 Procurement practices 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 109-116; 138 and its Boundary 103-2 Management of the topic: The management approach P. 109-116 and its components 103-3 Management of the topic: Evaluation of the management approach P. 109-116 204-1 Proportion of spending on local suppliers P. 114-116 GRI 205 Anti-corruption 2016 103-1 Management of the topic: Explanation of the material topic P. 34-35; 38; 138 and its Boundary 103-2 Management of the topic: The management approach P. 34-35 and its components Territory 140 |
Sustainability Report—2021 GRI Standards Disclosure Page number/Note Omissions 103-3 Management of the topic: Evaluation of the management approach P. 34-35 205-3 Confirmed incidents of corruption and actions taken P. 35 GRI 206 Anti-competitive behavior 103-1 Management of the topic: Explanation of the material topic P. 34-35; 38; 138 and its Boundary 103-2 Management of the topic: The management approach P. 34-35 and its components 103-3 Management of the topic: Evaluation of the management approach P. 34-35 206-1 Legal actions for anti-competitive behavior, anti-trust, and P. 36 monopoly practices ENVIRONMENTAL PERFORMANCE: TOPIC-SPECIFIC STANDARDS GRI 302: Energy 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 120-122; 138 and its Boundary 103-2 Management of the topic: The management approach P. 120-122 and its components 103-3 Management of the topic: Evaluation of the management approach P. 120-122 302-1 Energy consumption within the organization P. 121 GRI 303 Water and effluents 2018 103-1 Management of the topic: Explanation of the material topic P. 38; 124-128; 138 and its Boundary 103-2 Management of the topic: The management approach P. 124-128 and its components 103-3 Management of the topic: Evaluation of the management approach P. 124-128 303-1 Interactions with water as a shared resource P. 124-129 303-2 Management of water discharge-related impacts P. 124-125; 127 303-3 Water withdrawal P. 126 303-4 Water discharge P. 127 GRI 305 Emissions 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 122-123; 138 and its Boundary 103-2 Management of the topic: The management approach P. 122-123 and its components 103-3 Management of the topic: Evaluation of the management approach P. 122-123 305-1 Direct (Scope 1) GHG emissions P. 123 305-2 Energy indirect (Scope 2) GHG emissions P. 123 Territory 141 |
Sustainability Report—2021 GRI Standards Disclosure Page number/Note Omissions GRI 306 Waste 2020 103-1 Management of the topic: Explanation of the material topic P. 38; 129-132; 138 and its Boundary 103-2 Management of the topic: The management approach P. 129-132 and its components 103-3 Management of the topic: Evaluation of the management approach P. 129-132 306-1 Waste generation and significant waste-related impacts P. 129-132 306-2 Management of significant waste-related impacts P. 129-132 306-3 Waste generated P. 131 GRI 307 Environmental Compliance 2016 103-1 Management of the topic: Explanation of the material topic P. 34-36; 38; 118-and its Boundary 119; 138 103-2 Management of the topic: The management approach P. 34-36; 118-119 and its components 103-3 Management of the topic: Evaluation of the management approach P. 34-36; 118-119 307-1 Non-compliance with environmental laws and regulations P. 35; 119 SOCIAL PERFORMANCE: TOPIC-SPECIFIC STANDARDS GRI 401 Employment 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 92-99; 138 and its Boundary 103-2 Management of the topic: The management approach P. 92-99 and its components 103-3 Management of the topic: Evaluation of the management approach P. 92-99 401-1 New employee hires and employee turnover P. 87-89 401-2 Benefits provided to full-time employees that are not provided to P. 98 temporary or part-time employees GRI 403 Occupational health and safety 2018 103-1 Management of the topic: Explanation of the material topic P. 38; 100-107; 138 and its Boundary 103-2 Management of the topic: The management approach P. 100-107 and its components 103-3 Management of the topic: Evaluation of the management approach P. 100-107 403-1 Occupational health and safety management system P. 100-107 403-2 Hazard identification, risk assessment, and incident investigation P. 102-105 403-3 Occupational health services P. 103-104 403-4 Worker participation, consultation, and communication on P. 102 occupational health and safety 403-5 Worker training on occupational health and safety P. 97; 101 403-6 Promotion of worker health P. 100 Territory 142 |
Sustainability Report—2021 GRI Standards Disclosure Page number/Note Omissions 403-7 Prevention and mitigation of occupational health and safety P. 100-101 impacts directly linked by business relationships 403-9 Work-related injuries P. 105-106 GRI 405 Diversity and equal opportunity 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 92-99; 138 and its Boundary 103-2 Management of the topic: The management approach P. 92-99 and its components 103-3 Management of the topic: Evaluation of the management approach P. 92-99 405-1 Diversity of governance bodies and employees P. 30; 85-86 GRI 406 Non-discrimination 2016 103-1 Management of the topic: Explanation of the material topic P. 34-36; 38; 138 and its Boundary 103-2 Management of the topic: The management approach P. 34-36 and its components 103-3 Management of the topic: Evaluation of the management approach P. 34-36 406-1 Incidents of discrimination and corrective actions taken P. 35 GRI 413: Local Communities 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 134-137; 138 and its Boundary 103-2 Management of the topic: The management approach P. 134-137 and its components 103-3 Management of the topic: Evaluation of the management approach P. 134-137 413-2 Operations with significant actual and potential negative impacts In 2021, no on local communities significant actual or potential negative impacts on local communities were registered GRI 416: Customer Health and Safety 2016 103-1 Management of the topic: Explanation of the material topic P. 38; 80-82; 138 and its Boundary 103-2 Management of the topic: The management approach P. 80-82 and its components 103-3 Management of the topic: Evaluation of the management approach P. 80-82 416-2 Incidents of non-compliance concerning the health and safety P. 81 impacts of products and services Research & Development and Innovation: topic not covered by the topic-specific Standards GRI 103-1 Management of the topic: Explanation of the material topic P. 38; 81-87; 138 and its Boundary 103-2 Management of the topic: The P. 81-87 management approach and its components 103-3 Management of the topic: P. 81-87 Evaluation of the management approach Territory 143 |
Deloitte &ToucheS.p.A. Via Fratelli Bandiera., 3 31100Treviso Italia Independent Audit Report Deloitte Tel: +39 0422 5875 Fax:+390422 587812 www.cleloitte.it INDEPENDENT AUDITOR’S REPORT ON THE SUSTAINABILITY REPORT To the Board of Directors of Stevanato Group S.p.A. We have carried out a limited assurance engagement on the sustainability report (“Sustainability Report”) of Stevanato Group and its subsidiaries (hereinafter also “Group”) as of December 31, 2021. Responsibility of the Directors for the Sustainability Report The Directors of Stevanato Group S.p.A. are responsible for the preparation of the Sustainability Report n accordance with the “Global Reporting Initiative Sustainability Reporting Standards” established by GRI—Global Reporting Initiative (“GRI Standards”), which they have identified as reporting framework as specified in the “Methodological Note” paragraph of the Sustainability Report. The Directors are also responsible, for such internal control as they determine is necessary to enable the preparation of the Sustainability Report that is free from material misstatement, whether due to fraud or error. The Directors are also responsible for the definition of the Group’s objectives in relation to the sustainability performance, for the identification of the stakeholders and the significant aspects to report. Auditor’s Independence and quality control We have complied with the independence and other ethical requirements of the Code Of Ethics for Professional Accountants issued bythe International Ethics Standards Board for Accountants, which is founded on fundamental principles of integrity, objectivity, professional competence and due care, confidentiality and professional behaviour. Our auditing firm applies International Standardon Quality Control 1 (ISQC Italia 1) and, accordingly, maintains a comprehensive system of quality control including documented policies and procedures regarding compliance with ethical requirements, professional standards and applicable legal and regulatory requirements. Auditor’s responsibility Our responsibility is to express our conclusion based on the procedures performed about the compliance of the Sustainability Report with the GRI Standards. We conducted our work in accordance with the criteria established in the “International Standard on Assurance Engagements ISAE 3000 (Revised) -Assurance Engagements Other than Audits or Reviews of Historical Financial Information/’ (hereinafter “ISAE 3000 Revised”), issued by the International Auditing and Assurance Standards Board (IAASB) for imited assurance engagements. The standard requires that we plan and perform the engagement to obtain limited assurance whether the Sustainability Report is free from material misstatement. Ancona Ban Bergamo Bologna Brescia Caglari Rrenze Genova Milano NapoJi Padcva Parma Roma Torino TreyisoUdineVerona SedeLegale:ViaTortona, 25—20144 Mitano | CapitaleSodale: Euro 10.328.220,00 i.v. Codice Fscale/RegistrodelleImpresedi MilanoMonza BrianzaLcdi n. 03049560166—REA n. MI-1720239 | Partita IVA: IT03049560166 II nomeDelcittesi nfenscea unao pie celle seguenti entta: Deloitte louche Tohmatsu United, unasodetairglesea responsabilita limitata [“DTTL”), le memberfirmaderenti alsuo network e leenfrta a esse correlate. DTTLeciascuna dellesue memberfirm sono entita giuridicamenteseparate e indipendenti tra loro. DTTL (denominate anche “Delocte Global”) non fomisce seivizi a clients.Si invitaaleggere rinforrratiua completa rebtwa alia descrizione deHa stajttura legaledi DelotteTojcheTohmatsu Limited e delle sue memberfirmall’indirizzo www.d a lo’tte.corrV a bout El Iteioirte &Toiiche SpA
Deloitte. 2 Therefore, the procedures performed in a limited assurance engagement are less than those performed in a reasonable assurance engagement in accordance with ISAE 3000 Revised, and, therefore, do not enable us to obtain assurance that we would become aware of all significant matters and events that might be identified in a reasonable assurance engagement. The procedures performed on the Sustainability Report are based on our professional judgement and included inquiries, primarily with Company personnel responsible for the preparation of information included in the Sustainability Report, analysis of documents, recalculations and other procedures aimed to obtain evidence as appropriate. Specifically, we carried out the following procedures: analysis of the process relating to the definition of material aspects disclosed in the Sustainability Report, with reference to the methods used for the identification and prioritization of material aspects for stakeholders and to the internal validation of the process results; comparison between the economic and financial data and information included in the paragraph titled “Key financial results” of the Sustainability Report with those included in the Group’s financial statements; understanding of the processes underlying the origination, recording and management of qualitative and quantitative material information included in the Sustainability Report. In particular, we carried out interviews and discussions with the management of Stevanato Group S.p.A. and with the personnel of Nuova Ompi S.r.l., Spami S.r.L, Balda Medical Gmbh and Ompi N.A.S. de RL de CV and we carried out limited documentary verifications in order to gather information about the processes and procedures which support the collection, aggregation, elaboration and transmittal of non-financial data and information to the department responsible for the preparation of the Sustainability Report. In addition, for material information, taking into consideration the Group’s activities and characteristics: at the Group’s level: with regards to qualitative information included in the Sustainability Report, we carried out interviews and gathered supporting documentation in order to verify its consistency with the available evidence; with regards to quantitative information, we carried out both analytical procedures and limited verifications in order to ensure, on a sample basis, the correct aggregation of data; for Nuova Ompi S.r.l. and Spami S.r.L, which we selected based on their activities and their contribution to the performance indicators at the consolidated level, we carried out remote meetings, during which we met the management and gathered supporting documentation with reference to the correct application of procedures and calculation methods used for the indicators. Territory ]_45
Deloitte 3 Conclusion Based on the work performed, nothing has come to our attention that causes us to believe that the Sustainability Report of Stevanato Group as of December 31, 2021 is not prepared, in all material aspects, in accordance with the GRI Standards as stated in the paragraph “Methodological note” of the Sustainability Report. Other aspects The data for the year ended December 31, 2020, presented for comparative purposes in the Sustainability Report, have not been subject to a limited or to a reasonable assurance engagement. DELOITTE & TOUCHES.p.A. \Barbara Moscardi Partner Treviso, Italy May 3, 2022
Headquarters Global footprint with operating units Via Molinella, 17 and commercial offices in 9 countries. 35017 Piombino Dese Padova, Italy Visit our website to contact us. stevanatogroup.com
Exhibit 99.3
STEVANATO GROUP S.P.A.
REPORT OF THE AUDIT COMMITTEE
TO THE SHAREHOLDERS
ON THE ACTIVITIES CARRIED OUT
IN THE FINANCIAL YEAR 2021
|
|
2 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
On May 28, 2021, following the approval of the current by-laws (the “By-Laws”), Stevanato Group S.p.A. (the “Company” or “Stevanato”) adopted the one-tier system of corporate governance pursuant to articles 2409-sexiesdecies and subsequent of the Italian Civil Code (the “Civil Code”), which provides for the Company’s direction and internal control activities to be carried out, respectively, by the Board of Directors and by the Audit Committee (Comitato per il controllo sulla gestione; the “Committee”) established within the Board of Directors.
According to the provisions of law, the Committee shall supervise the adequacy of the Company’s organizational structure, the internal control system and the administrative and accounting system, as well as its suitability to present fairly the Company’s management facts, and perform the additional tasks entrusted to it by the Board of Directors, with particular regard to the relations with the audit firm in charge of the statutory audit (the “Audit Firm”).
Pursuant to the By-Laws, and following the listing of the Company’s ordinary shares on the New York Stock Exchange (“NYSE” and the “Listing”), the Committee shall also exercise the role of the “Audit committee” pursuant to the US law and regulation and to the NYSE Listing Rules applicable to the Company.
In accordance with such provisions, on June 16, 2021, the Board of Directors adopted the Committee’s charter (the “Charter”), which provides that the Committee shall carry out, inter alia, the supervision and control of (i) business processes and procedures, with particular regard to the internal control and market information processes and to the risk management policies adopted by the Company; (ii) the financial information provided by the Company; and (iii) the activity and independence of the Audit Firm.
Special functions are also assigned to the Committee by the Charter and by the policy on transactions with related parties approved by the Board of Directors on July 2, 2021 (the “Related Parties Policy”), with regard to, inter alia, (i) the appointment and determination of the compensation to be granted to the Audit Firm, (ii) the design of the policy and procedures for employees’ reporting of objectionable facts (so-called “whistleblowing procedures”), and (iii) the approval of transactions to be entered into with related parties and of amendments to the Related Parties Policy.
This report – prepared in accordance with the Italian law and submitted to the Shareholders’ Meeting convened for June 1, 2022 – provides a brief description of the supervisory activities carried out by the Committee in the period from May 28, 2021 (date of appointment of the current members of the Committee), and December 31, 2021 (2021 financial year ending date) (the “Report”).
*** *** ***
| 1. | COMPOSITION AND MEETINGS OF THE COMMITTEE. |
On May 28, 2021, the Board of Directors appointed as members of the Committee Mr. William Federici, Mr. Fabrizio Bonanni and Mr. Fabio Buttignon.
All the Committees’ members meet the requirements of independence set out in Article 2399 of the Civil Code, as well as the additional independence and financial competence requirements set out by the US and NYSE regulatory provisions applicable to the Company.
In such respect, the Board of Directors determined that Mr. William Federici and Mr. Fabio Buttignon are both “audit committee financial experts” as defined by the SEC rules and meet the financial experience requirement set forth by the NYSE Listing Rules. Moreover, in accordance with article 2409-octiesdecies, paragraph 3, of the Civil Code, Mr. Fabio Buttignon is a certified accountant and, therefore, is enrolled with the Italian Registry of Statutory Auditors established at the Ministry of Economy and Finance pursuant to Legislative Decree no. 39/2010.
On July 1, 2021, the Committee appointed Mr. William Federici as Chairman.
In 2021, four meetings of the Committee were held, attended by, in addition to the members of the Committee, the following persons: the Executive Chairman (Mr. Franco Stevanato), the Chief Executive Officer (Mr. Franco Moro), the Chief Financial Officer (Mr. Marco Dal Lago), the Group Planning and Control Director (Mr. Alessandro Gioga), the Legal Manager (Ms. Leila Petrelli), the Consolidation and Reporting Manager (Ms. Silvia Stella), the Process and Procedures Manager (Ms. Andrea Damian) the Senior Vice President Investor Relations (Ms. Lisa Miles), the HR Internal Communication Coordinator / AFC Project Manager (Ms. Elisabeth Marin), as well as the auditors responsible for the auditing of the Company’s financial statements as appointed by the Audit Firm EY S.p.A. (Mr. Maurizio Rubinato and Mr. Giuseppe Giovinazzi).
|
|
3 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
Below is attached a table with an indication of the number of meetings attended:
|
Partecipants
|
Number of meetings
|
Percentage of attendance
| ||
|
William Federici |
4 | 100% | ||
|
Fabrizio Bonanni |
4 | 100% | ||
|
Fabio Buttignon |
4 | 100% | ||
|
Executive Chairman |
2 | 50% | ||
|
CEO |
2 | 50% | ||
|
CFO |
3 | 75% | ||
|
Group Planning and Control Director |
2 | 50% | ||
|
Legal Manager |
4 | 100% | ||
|
Consolidation and Reporting Manager |
2 | 50% | ||
|
Process and Procedures Manager |
2 | 50% | ||
|
Investor Relations Senior Vice President |
3 | 75% | ||
|
HR Internal Communication Coordinator / AFC Project Manager |
1 | 25% | ||
|
EY S.p.A. |
2 | 50% | ||
The members of the Committee also took part in all the meetings of the Board of Directors (during the reporting period of this Report, equal to nine (9)), as well as in the meetings of the other Committees of which they are members, namely:
- Mr. William Federici at two (2) ESG Committee meetings and three (3) Business & Strategy Committee meetings; and
- Mr. Fabrizio Bonanni at two (2) meetings of the Nominating & Corporate Governance Committee and three (3) meetings of the Business & Strategy Committee.
| 2. | GENERAL OBSERVATIONS. |
The Committee obtained adequate information on the activities carried out by the Company, on the general economic performance and the foreseeable development of its operations, as well as on the financially most significant transactions carried out by the Company in the financial year 2021, including those carried out through companies directly or indirectly controlled (these companies, together with the Company, the “Group”), by (i) participating in the meetings of the Board of Directors, (ii) periodically meeting the Company’s executive directors, the Chief Financial Officer and the other managers mentioned in the previous paragraph, the Audit Firm and the external legal counsel, and (iii) examining the documentation submitted to, or specifically requested, by the Committee.
|
|
4 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
| 3. | SUPERVISORY ACTIVITIES ON THE ADEQUACY OF THE ORGANISATIONAL STRUCTURE OF THE COMPANY AND OF THE GROUP. |
In accordance with the provisions of article 2409-octiesdecies, paragraph 5, of the Civil Code, the Committee supervised, within its duties and responsibilities, the adequacy of the organizational structure of the Company.
Through a series of meetings with the Executive Chairman of the Company, the Chief Executive Officer, the Chief Financial Officer, the Group Planning and Control Director, the Legal Manager, the Consolidation and Reporting Manager and the Process and Procedure Manager, the Committee carried out an assessment of the organizational structure of the Company and the Group, paying particular attention to the adequacy and effective functionality of the various operational and control functions and to the adequacy of risk management mechanisms.
Following the recent growth of the Company and, in particular, the Listing process, the organizational structure of the Company and the Group underwent significant changes, the implementation of which the Committee has constantly monitored.
Among the most significant changes in the Group’s organizational structure implemented in the financial year 2021, we point out the following:
- the appointment of the Executive Chairman of the Board of Directors (Mr. F. Stevanato), responsible for the Group’s long-term business strategy, acquisitions and growth in global markets;
- the appointment of the Chief Executive Officer (Mr. F. Moro), in charge of overseeing the execution of business development plans in order to develop and increase the Group’s end-to-end offer to pharmaceutical and diagnostic companies;
- the appointment of the Vice President of Human Resources;
- the appointment of the Group PPMO and C- Suite Office Director - a new role within the Group, responsible for supporting the executives reporting directly to the Chief Executive Officer in the decision-making process in relation to projects considered as strategic for the growth of the Group having a high level of complexity;
- the appointment of the Senior Vice President Investor Relations (Ms. L. Miles) - a new role within the Group;
- the appointment of the Legal Manager - a new role within the Group.
As to the most significant changes in the Group’s organizational structure implemented in the financial year 2021, the following must be highlighted:
- the appointment of the Process and Procedure Manager - a new role within the Group, reporting directly to the CFO, implemented during the Listing process and responsible for carrying out the mapping of processes in the area of Administration Finance and Control (hereinafter referred to as “AFC”), according to the requirements set forth by the Sarbanes-Oxley Act (“SOX”);
- the appointment of the Sustainability Project Team Leader - new role within the Group, reporting directly to the CFO and responsible for managing the Group’s sustainability projects.
| 4. | SUPERVISORY ACTIVITIES ON THE ADEQUACY OF THE INTERNAL CONTROL AND RISK MANAGEMENT SYSTEM OF THE COMPANY AND THE GROUP. |
| 4.1. | SUPERVISION OF THE ADEQUACY OF THE INTERNAL CONTROL SYSTEM. |
Currently, the Company’s control structure consists of:
| • | controls operating at the group or subsidiary level, such as: definition of the delegated powers, the segregation of duties, formalization of internal policies relating to business processes and allocation to various employees of the access rights for the use of the information technology systems adopted in each Group company; |
|
|
5 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
| • | controls operating at the process level, such as: internal procedures, operating rules, authorization flows, reconciliations, management reviews, etc. This category includes controls concerning operational processes relating to the financial reporting and the financial statements closing process, as well as controls carried out by specific business functions. From time to time, these controls may be qualified as: |
- preventive, i.e. intended to prevent unintentional errors or fraud that could result in significant errors that would have a significant impact on financial reporting (material misstatement); or
- monitoring / investigative (detective), i.e. designed to verify that any errors or fraud have not occurred / have not been implemented; and
- manual, if personally executed by an operator; or
- automatic, if designed within the IT applications supporting business activities.
The Company’s internal control system comprises the following levels:
| • | First line of defense, which includes controls carried out by the process and controls owners (operational, business and staff functions) that within their day-by-day activities are responsible for executing the controls mitigating the risks identified within their processes and operational activities. Where possible, these controls are designed within the IT applications; |
| • | Second line of defense, which includes controls carried out by functions designated to managing risks, either to comply with applicable regulations or with internal policy and procedures, with the responsibilities of oversighting the execution and the proper functioning of the internal control system and properly informing the top management. These functions, among others, include CSR & Compliance, Process & Procedures, Legal & Corporate Affairs and Quality. |
Following the Listing, the Company has implemented the adoption of an internal control system over financial reporting compliant with the SOX provisions that will be applicable to the Company when certain conditions, set forth by the same legislation, are met.
In this regard, starting from September 2021, the Company, with the support of the consulting firm KPMG Advisory S.p.A., launched a project concerning the analysis and evaluation of the Group’s organizational structure and processes considered relevant for SOX purposes - especially, the business and IT processes – aimed at identifying the potential risks related to financial reporting and to assess the design of existing controls (the “SOX Project”). The implementation of the SOX Project has included the alignment with the Audit Firm in order to consider any guidelines or evidence resulting from the activity performed by the latter.
As a result of the first phase of the SOX Project, ended in March 2022, the Company identified the possible improvement areas and defined a “remediation plan” for proceeding with such improvements.
It is expected that an internal audit function is established within the Company’s organizational structure at an advanced stage of implementation of the SOX Project.
The Committee monitored the adequacy and effectiveness of the internal control system through periodic meetings and discussions with the Chief Executive Officer, the Chief Financial Officer, the Process & Procedures Manager, as well as the Audit Firm and the Management of AFC and Legal areas.
The verification and examination activities carried out by the Committee during 2021 did not reveal any material weaknesses in the structure of the internal control system.
During the reporting period of this Report, the Committee monitored the SOX Project and its state of implementation in order to evaluate, on the basis of the early results, any potential critical issues. The activities related to the SOX Project proceeded according to the plans.
|
|
6 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
The SOX Project subsequent phases, to be concluded by the end of 2022, will be aimed at completing the execution of the remediation plan and at evaluating the quality of the Company’s internal control system over the financial reporting, through periodic testing activities, both at the Group and subsidiary level, using sampling techniques consistent with the international best practices.
| 4.2. | SUPERVISORY ACTIVITIES ON THE ADEQUACY OF THE RISK MANAGEMENT SYSTEM. |
Currently, the Company has in place a formalized risk management process only with reference to the legal risks, as indicated in the following paragraph. The Company’s overall risk management and control system will be enhanced as a result of the completion of the SOX Project.
Pending the definition of a more structured risk management system within the framework of the SOX Project, the Committee has examined the most important operations carried out by the Group during the reporting period of this Report and assessed the risks associated with them and their management.
The Committee examined in particular:
| I. | the agreement reached between the Company and the Italian Tax Authority (Agenzia delle Entrate) in March 2021, relative to the so-called “Patent Box scheme” for the years 2016-2020; |
| II. | the start-up and development of the project concerning the construction of a new production facility in Fishers, Indiana, United States, for the production of pre-sterilized EZ-Fill® syringes and vials, scheduled for operation at the end of 2023 or early 2024, and the related co-investment agreement entered into with the Biomedical Advanced Research and Development Authority (BARDA); |
| III. | the acquisition, by the subsidiary Stevanato Group International A.S., on October 7, 2021, of the quota equal to 35% of the share capital of the Company’s subsidiary SVM Automatic A/S held by the minority shareholder M.L. 2016 Holding ApS; |
| IV. | the sale, by the subsidiary Stevanato Group International A.S., on October 22, 2021, of the shares held in the company Swissfillon AG; |
| V. | the acquisition, in December 2021, of a production plant located in Zhangjiagang, China, to be used for the expansion of the production capacity of pre-sterilized EZ-fill® vials and syringes, scheduled for operation in early 2024. |
| 4.3. | SUPERVISION OF THE PROCESSES OF VERIFYING THE COMPLIANCE OF THE ACTIVITIES OF THE COMPANY AND THE GROUP WITH THE APPLICABLE REGULATIONS. |
Compliance of the Company’s and the Group’s activities with the applicable regulations is ensured by the controls carried out by the CSR & Compliance, Process & Procedures, Legal & Corporate Affairs functions indicated in paragraph 4.1 above as well as by the Supervisory Body (Organismo di Vigilanza) established pursuant to Italian Legislative Decree no. 231/2001.
In particular, it must be highlighted that the Company has adopted an organizational and management model aimed at preventing the commission of offences that may involve a liability of the Company pursuant to Legislative Decree no. 231/2001 (the “Model 231”). The Model 231 consists of:
| - | a general section containing a description of: the contents of Legislative Decree no. 231/2001, the system of attribution of powers adopted by the Company, the communication and training plans in place in respect to Model 231, the sanctions provided in case of commission of offences relevant for Legislative Decree no. 231/2001, and the principles of operation of the Supervisory Body; |
| - | several special sections, one for each categories of offences relevant for Legislative Decree no. 231/01, containing a description of such offences, of the business processes which are to be considered “sensitive” in relation to the risk that offences relevant for Legislative Decree no. 231/2001 are committed, and the general principles of conduct in relation to individual offences; |
|
|
7 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
| - | two annexes containing a description of (i) the control protocols, provided for each “sensitive activity”, aimed at limiting the risk that offences relevant for Legislative Decree no. 231/2001 are committed, and (ii) the flow of information which must be provided to the Supervisory Body. |
The crime-risk assessment process defined by Model 231 considers, for each type of crime provided for by the aforementioned Legislative Decree no. 231/2001, the business processes (so-called “sensitive activities”) in which there is a risk of commission of such offences. For each process, identified the functions involved and among them the responsible one, an assessment of the crime-risk is carried out on the basis of criteria such as the probability and severity of the occurrence of the relevant offences and on the basis of the controls provided for the process considered. The identification and analysis of “sensitive activities” - which is carried out in event of substantial changes of both organizational and regulatory nature - implies the direct involvement of all managers and employees who, with reference to the specific process, have significant decision-making and management autonomy.
Model 231 also provides for a system of information flows and a planning of control activities allowing the Supervisory Body to promptly verify the state of effectiveness and implementation of Model 231 and the adequacy, over time, of the crime-risk assessment process.
In April 2021, Model 231 was updated, with reference the general section, to take into account the “whistleblowing” procedure set forth by the Company and, with regard to the special sections, to (i) insert the new area of risk relative to tax offences, (ii) adjust Model 231’s provisions to the latest regulatory changes in the field of offences against the public administration and (iii) take into account the new policies and procedures adopted by the Company with regard to offences in the fields of “health and safety at work” and “environment”.
With regard to further compliance control processes, it is pointed-out that, during 2021, the Company adopted the “Anti-Bribery”, “Insider trading” and “Global Sanctions and Export Controls” policies as well as an internal “whistleblowing” procedure, which sets forth the modalities by which the reports of alleged irregularities filed by employees becoming aware of such irregularities by reason of the functions performed must be managed by the Company.
In July 2021, the Company finalized a revision of the Group’s Code of Ethics, which was adapted to the standards required of companies listed on regulated markets, also taking into account the aforementioned policies.
| 5. | SUPERVISION OF THE ADMINISTRATIVE AND ACCOUNTING SYSTEM OF THE COMPANY AND OF THE GROUP - CONTROL OF THE COMPANY’S FINANCIAL INFORMATION. |
The Committee reviewed, and assessed, in reliance on external and internal experts, including the Audit Firm, and the management of Stevanato Group, the adequacy of, the financial information closing process and of the accounting-administrative system, and the reliability of the latter to fairly represent in all material respects the financial position and results of operations of Stevanato.
The Committee took also note of the opinions issued by the Company’s Chief Executive Officer and Chief Financial Officer with regard to the adequacy and effective application of the administrative and accounting procedures in the preparation of the financial statements and consolidated accounts for the financial year ended on December 31, 2021.
Moreover, the Committee reviewed the financial results for the second quarter of 2021 and the first half of 2021, the financial results for the third quarter of 2021, and the financial results for the fourth quarter of 2021 and entire financial year 2021, as well as the documentation relating to the publication of such results, including financial guidance. The documentation in question – prepared by the management and reviewed by the Audit Firm – was presented to the Committee by the Chief Financial Officer and the Consolidation and Reporting Manager. The Forms 6-K and 20-F filed with the SEC, consisting of the notes to the consolidated financial statements and the management discussion and analysis (MD&A), - respectively, reviewed or audited by the Audit Firm and reviewed by the legal advisor Skadden Arps, Slate, Meagher & Flom LLP - were also reviewed by the Committee.
|
|
8 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
The Committee reviewed also the press releases, commentary and presentations issued or made by the Senior Vice President Investor Relations and reviewed by the legal advisor Skadden Arps, Slate, Meagher & Flom LLP in order to assess their consistency with the Forms 6-K filed with the SEC.
Following their examination, also based on the on the controls carried out by, and on the discussions with, the Audit Firm, the external legal counsels, and the management of Stevanato, the Committee considered appropriate to recommend to the Board of Directors the approval of the results for (i) the second quarter of 2021 and the first half of 2021 (ii) the third quarter of 2021 and (iii) on the fourth quarter 2021 and the full year 2021, and of the Forms 6-K and 20-F respectively, as well as the related press releases prepared commentary and presentations.
| 6. | AUDIT ACTIVITIES AND INDEPENDENCE OF THE EXTERNAL AUDITOR. |
The Company, by resolution of the Shareholders’ Meeting on June 11, 2020, appointed EY S.p.A. as the auditor in charge of the statutory audit of the financial statement for the years 2020, 2021 and 2022. The appointment of the Audit Firm, pursuant to article 14 of Legislative Decree no. 39/2010, includes the auditing of the annual separate and consolidated financial statements, prepared in accordance with the International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB), to be carried out on the basis of the International Standards of Auditing (ISA Italia) issued by the International Auditing and Assurance Standards Board (IAASB), as well as the supervision on the compliance of the Company’s accounting practices with the relevant law provisions.
It is pointed of that, following the Listing, according to applicable US regulation, the Audit Firm is also required to audit the annual consolidated financial statements of Stevanato and to express an opinion on whether the consolidated financial statements present fairly, in all material respects, the financial position and the result of its operations, in conformity with IFRS, based on the auditing standards adopted by the Public Company Accounting Oversight Board (PCAOB).
In such respect, on October 25, 2021, the Audit Firm presented to Stevanato an offer to perform - in addition to the auditing services carried out under Italian law - the aforementioned auditing activities in relation to the annual consolidated financial statements for the financial year 2021 for an annual compensation estimated in Euro 380,000.00, to be added to the compensation paid as consideration for the auditing services carried out under Italian law.
As set forth by both the Italian Legislative Decree no. 39/2010 and the SEC and PCOAB provisions, and in compliance with the Audit Committee Charter, at the meeting of November 5, 2021, the Audit Committee examined and expressed a positive opinion on the offer presented by the Audit Firm for the financial year 2021, reserving to submit to the Shareholders’ Meeting that will be convened, inter alia, for the approval of the financial statements for the year 2021, a substantiated proposal to extend the appointment to the Audit Firm to the performance of the aforementioned audit activities and grant to the latter the additional compensation requested in consideration thereof.
It is pointed out that other Group’s companies appointed audit firms belonging to the network of EY S.p.A. as their statutory auditors. In the financial year 2021, the Company did not appoint the Audit Firm or companies belonging to its network for the provision of non-audit services, except for the appointment relating to the issuance of the statement confirming the compliance of the VAT declaration with the applicable tax provisions (which may be carried out exclusively by the Audit Firm being in charge of the statutory audit).
On March 3, 2022, the Audit Firm issued the required statement confirming its independence. The Committee took also note of the transparency report prepared by the Audit Firm on 29 October 2021 in relation to the financial period ended 30 June 2021, pursuant to the provisions of EU Regulation 537/2014 and Legislative Decree no. 39/2010.
In light of the appointments of the Audit Firm and of the companies belonging to its network made by the Group and of the independence confirmation statement issued by the Audit Firm, the Committee did not find any critical issue in respect to the independence of the latter.
The Committee examined the activities carried out by the Auditor Firm and, in particular, the methods and the auditing approach used for the different significant areas of the financial statements and the audit plan and discussed with the Audit Firm the issues related to business risks and all topics connected to the Listing process.
|
|
9 |
|
|
Stevanato Group S.p.A.
Report of the Audit Committee to the Shareholders On the Activities Carried Out in the Financial Year 2021 |
The Committee was also informed of the audit procedures carried out by the Audit Firm in relation to the accounting system and to the fair presentation of the accounting records, from which no findings or anomalies arose.
| 7. | OMISSIONS AND OBJECTIONABLE FACTS - OPINIONS ISSUED. |
During the reporting period of this Report, also based on the controls carried out by, and on the discussions with, the Audit Firm, the external legal counsels, and the management of Stevanato, the Committee found no violations of applicable laws or regulations, irregularities, omissions or other objectionable acts made by the Company, by other Group companies or their directors or employees to be reported to the shareholders’ meeting.
In the same period, the Committee was not notified or made aware, pursuant to article 2408 of the Civil Code or otherwise, of any complaints or reports from directors, shareholder, employees of the Company or the Group or third parties in relation to irregularities, omissions or other objectionable facts.
No opinion required under legal, regulatory or market regulations and/or the Charter was issued by the Committee during the financial year 2021.
| 8. | SUPERVISION OF RELATED PARTY TRANSACTIONS. |
In preparation for the Listing and with regard to the form F-1 to be filed with the SEC, the management performed an assessment to identify any potential parties related with the Group. The above-mentioned form - which include the Company’s identified related parties and of the significant transactions - was reviewed and verified by the Audit Firm and by the external legal counsel.
Moreover, during 2021, the Company’s management oversaw the transactions and the commercial relationships with third parties in order to detect any other potential related party. Such process was controlled also by the Audit Firm, to the extent required by its duties and responsibilities, to ensure the completeness of the monitoring activities performed by the management.
Information on the main related party transactions carried out in the financial year 2021, as well as a description of their characteristics and their effects on the financial position and results of Stevanato, were adequately disclosed and illustrated in the notes to the consolidated financial statements and to the financial statements of Stevanato for the financial year 2021 (as part of the note “Disclosure on transactions with related parties”), as well as in the report of the Directors for the same financial year.
During the reporting period of this Report, the Committee was not made aware of any further transactions with related parties, nor did it receive information in this regard from the Executive Directors, the CFO or other managers of the Company or the Group, or the Audit Firm.
| April 8, 2022 | On behalf of the Management Control Committee
The Chairman – William Federici | |
|
| ||
|
|
10 |
Exhibit 99.4
|
|
STEVANATO GROUP S.P.A.
NOMINATING AND CORPORATE
GOVERNANCE COMMITTEE’S REPORT
FOR 2021
|
1 |
|
|
|
|
2 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
Introduction
This Nominating and Corporate Governance Committee’s Report (hereinafter “the Report”) covers the period 1 January 2021 – 31 December 2021 and is voluntarily prepared according to the Nominating and Corporate Governance Committee’s Charter.
Corporate Governance recommendations and practices
As a “foreign private issuer,” as defined by the SEC, we are permitted to follow home country corporate governance practices instead of certain corporate governance practices required by NYSE applicable to U.S. domestic issuers.
If we cease to be a “foreign private issuer” under the NYSE rules and the Exchange Act, as applicable, we will take all action necessary to comply with applicable NYSE corporate governance rules.
Because we are a foreign private issuer, our directors and senior management are not subject to short-swing profit and insider trading reporting obligations under Section 16 of the Exchange Act. They will, however, be subject to the obligations to report changes in share ownership under Section 13 of the Exchange Act and related SEC rules.
The provisions of the Italian Civil Code regulating companies that are listed on a regulated market (società che fanno ricorso al mercato di capitale di rischio) apply to the Company. As described in more detail below, these rules differ in a number of ways from those applicable to U.S. domestic companies under NYSE listing standards, as set forth in the NYSE Listed Company Manual.
Board of Directors
In order to allow a better analysis about the management performance, additional economical and financial indicators are presented then those required by IFRS and by Local GAAP; these indicators have not considered as alternatives to those required by IFRS and by Local GAAP. In particular, the Non-GAAP Measures used in this report are:
Tracing of performance adjusted indicators to reported indicators
The Italian Civil Code provides for three alternative corporate governance systems: (i) the traditional model (comprising a board of directors and a board of statutory auditors), (ii) the two-tier board system (comprising a management board and a supervisory board) or (iii) the one-tier board system (comprising a board of directors and an audit committee).
In May 2021, we adopted the one-tier corporate governance system, which provides for a Board of Directors and an Audit Committee. The board of directors is appointed by the shareholders’ meeting and the Audit Committee is, in turn, appointed by the board of directors from among its members (as appointed by the shareholders’ meeting).
The board of directors is generally responsible for managing the affairs of the company. The Board may therefore undertake all transactions considered necessary, useful or appropriate in achieving the company’s corporate purpose except only for such actions as are reserved to the ordinary or extraordinary shareholders’ meeting by applicable law or the articles of association.
Within the limits prescribed by Italian Law, the Board may delegate its general powers to an executive committee and/or managing director to handle the day-to-day management consistent with the guidelines set by the board of directors.
|
|
3 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
The Chairman of the board of directors, any deputy chairman as well as any managing director are authorized to represent and bind the company in their capacity as legal representatives. The board of directors and any managing director may also delegate the power to carry out certain acts within the scope of their respective authority.
Our board of directors consists of 12 directors (including the members of the Audit Committee) and has been appointed by the ordinary shareholders’ meeting on May, 28, 2021 for a period of three fiscal years. Members of the board of directors who are also employees are entitled to applicable severance pay benefits (TFR) under Italian law. No other service contracts and/or agreements exist between members of the board of directors, us and/or our subsidiaries, providing for benefits and/or compensation to our directors upon termination of employment.
During 2021, the Board of Directors has been convened n. 17 times.
Foreign Private Issuer Status
As a foreign private issuer whose shares are listed on the NYSE, we have the option to follow certain Italian corporate governance practices rather than those of NYSE, except to the extent that such laws would be contrary to U.S. securities laws and provided that we disclose the practices we are not following and describe the home country practices we are following. We rely on this “foreign private issuer exemption” with respect to the following NYSE Corporate Governance Standards:
| ● | Section 303A of the NYSE Listed Company Manual, which requires that a majority of the board be independent (although all of the members of the audit committee must be independent under the Exchange Act); |
| ● | Section 303A.05 of the NYSE Listed Company Manual, which requires boards to have a compensation committee consisting entirely of independent directors; and |
| ● | Section 303A.03 of the NYSE Listed Company Manual, which requires an issuer to have regularly scheduled meetings at which only independent directors attend. |
Except as stated above, we comply with the rules generally applicable to U.S. domestic companies listed on NYSE. We may in the future decide to use other foreign private issuer exemptions with respect to some or all of the other NYSE listing requirements. Following our home country governance practices, as opposed to the requirements that would otherwise apply to a company listed on NYSE, may provide less protection than is accorded to investors under NYSE listing requirements applicable to domestic issuers.
Committees of the Board of Directors
On May 28, 2021, we established an Audit Committee while on June 16, 2021, we established a Compensation Committee, a Nominating and Corporate Governance Committee, a ESG Committee and a Business and Strategy Committee. Each of these committees are governed by a charter that is consistent with applicable Italian Law and SEC and NYSE corporate governance rules, and which is available on the Investors section of our website at https://www.stevanatogroup.com/en/ . The information contained on, or that can be accessed through, our website does not form part of the Report.
Audit Committee
Our Audit Committee consists of William Federici, Fabio Buttignon and Fabrizio Bonanni. Mr. Federici serves as the chairman of the Audit Committee. Our board determined that all members of our Audit Committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and the NYSE corporate governance rules.
|
|
4 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
Our board determined that Mr. Buttignon and Mr. Federici are both audit committee financial expert as defined by the SEC rules and have the requisite financial experience as defined by the NYSE corporate governance rules. Further, Mr. Buttignon is a certified accountant and, in such capacity, is enrolled with the Italian Registry of Statutory Auditors.
Our board determined that each member of our Audit Committee is “independent” as such term is defined under Italian Law, it being understood that a director cannot qualify as independent (and, therefore, cannot be an audit committee member) if any of the following applies: (i) being interdict, incapacitated, bankrupt, or convicted of an offense that implies the interdiction, even temporary, from public offices, or the inability to exercise managerial offices; (ii) being the spouse, relatives and relatives-in-law within the fourth degree of directors of the company, the directors themselves, the spouse, relatives and relatives-in-law within the fourth degree of directors of the companies controlled by the concerned company, of the companies that control it and of those subject to common control; and (iii) being linked to the company or to the companies controlled by it or to the companies that control it or to those subject to common control by an employment relationship or by an ongoing relationship of consultancy or paid work, or by other relationships of a financial nature that compromise their independence.
Our Audit Committee is compliant with applicable rules and regulations of the SEC and NYSE corporate governance rules as well as Italian Law requirements with respect to its composition, expertise requisites and functioning.
The Audit Committee is responsible for, among other things, assisting the board in the oversight of:
| ● | the accounting and financial reporting practices of the Company as well as the integrity of the financial statements; |
| ● | the adequacy of the Company’s organizational structure, internal control system, and administrative and accounting systems; |
| ● | the Company’s risk assessment and risk management processes to ensure such processes are effective; |
| ● | supervise compliance with legal and regulatory requirements including as required by the rules and regulations of the SEC, by preparing the report of the Audit Committee to be included in the Company’s annual proxy statement; |
| ● | the independence and qualifications of the Company’s registered public accounting firm. |
The Audit Committee meets regularly and in a manner that the Audit Committee may deem fit and, at least once every ninety calendar days. Periodically, the Audit Committee also meets with our independent auditor and members of our management.
During 2021, the Audit Committee has been convened n. 4 times.
Compensation Committee
Although not required under Italian law, on June 16, 2021, we established a compensation committee. This committee consists of Madhavan Balachandran (as chairman), Donald Eugene Morel Jr. and Paola Vezzaro.
The Compensation Committee is responsible for, among other things:
| ● | analyzing, discussing and making recommendations to the board of directors on remuneration policies for directors and senior management and review their appropriateness; |
| ● | within the terms of the agreed policy and in consultation with the board chairman determining the total individual remuneration package of each executive director; |
|
|
5 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
| ● | assessing, reviewing and recommending for approval by the board, the CEO’s annual remuneration package and performance objectives based on the evaluation of the CEO’s performance; |
| ● | reviewing and approving any significant changes to the overall compensation program and incentive plans. |
Pursuant to Italian Law, the shareholders’ meeting determines the base compensation of the members of the board of directors. After consultation with the Audit Committee, the board of directors may determine the compensation of executive officers, including the CEO. If the articles of association so provide, the shareholders’ meeting may determine an aggregate amount for the remuneration of all directors, including executive officers.
During 2021, the Compensation Committee has been convened n. 3 times.
Nominating and Corporate Governance Committee
Although not required under Italian law, on June 16, 2021, we established a Nominating and corporate governance committee. This committee consists of Franco Stevanato (as chairman), Madhavan Balachandran, Donald Eugene Morel Jr. and Fabrizio Bonanni.
The Nominating and Corporate Governance Committee is responsible for, among other things:
| ● | reviewing the structure, size and composition (including the skills, knowledge, experience and diversity) of the board of directors; |
| ● | identifying and appointing independent board of directors candidates to fill independent Board vacancies as and when these arise; |
| ● | keeping under review the leadership needs of the organization, both executive and non-executive, with a view to ensuring the continuing ability of the organization to compete effectively in the marketplace; |
| ● | constantly reviewing corporate governance rules and practices and ensuring that corporate governance codes that apply to the Company are observed; |
| ● | formulating succession plans. |
If, during the term of their office, one or more directors resign, the other directors must replace them by a resolution approved by the Audit Committee, provided that the majority of the board still comprises directors appointed by the company’s shareholders. The coopted directors remain in office until the next shareholders’ meeting. If at any time more than half of the members of the board of directors appointed by the shareholders’ meeting resign, the remaining members of the board of directors (or the audit committee if all the members of the board of directors have resigned or ceased to be directors) must promptly call an ordinary shareholders’ meeting to appoint the new directors and until such time as the new directors are appointed, the resigning directors remain in office.
During 2021, the Nominating and Corporate Governance Committee has been convened n. 2 times.
As mentioned above, the current Board of Directors was appointed in 2021 prior to the establishment of the Nominating and Corporate Governance Committee, which is also responsible for the report of the process used to make appointments to the Board of Directors and explain if external advice or open advertising has been used for such appointments. Such activity will be performed by the Nominating and Corporate Governance Committee from time to time, whenever appointments to the Board of Directors are concerned.
|
|
6 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
Business & Strategy Committee
On June 16, 2021, we established a Business and Strategy Committee. This committee consists of Donald Eugene Morel Jr. (as chairman), Sergio Stevanato, Franco Stevanato, Marco Stevanato, Madhavan Balachandran, Fabrizio Bonanni, Franco Moro and William Federici.
The Business and Strategy Committee is responsible for, among other things:
| ● | periodically reviewing and making recommendations on medium and long-term strategies and strategic plans to be pursued; |
| ● | reviewing the annual business plan, budget and capital structure of the Group before onward submission to the Board for approval; |
| ● | meeting with management periodically to monitor the Company’s progress against its strategic goals and to discuss, review and recommend to the Board any such matters or issues which relate to the strategic planning of the Group; |
| ● | ensuring the board of directors is regularly appraised of the Company’s progress with respect to implementation of any approved strategy. |
During 2021, the Business & Strategy Committee has been convened n. 3 times.
ESG Committee
On June 16, 2021, we established a ESG Committee. Our ESG Committee consists of Fabiano Nicoletti (as chairman), Paola Vezzaro and William Federici.
The ESG Committee is responsible for, among other things:
| ● | assisting the Company in setting ESG strategies, including by reviewing, challenging and overseeing the content of and approach to strategy concerning ESG matters; |
| ● | supervising compliance of ESG disclosure and ensuring a sustainability strategy is considered by the Board as part of the overall business strategy of the Group; |
| ● | bringing to the attention of the board of directors emerging ESG matters and reviewing, challenging and approving annual sustainability KPIs and related targets in line with the agreed sustainability strategy; |
| ● | putting systems in place to monitor ESG Matters and reviewing compliance with material regulation and legislation on ESG/sustainability issues, and any public ESG/sustainability-related commitments voluntarily subscribed to by the Group. |
During 2021, the ESG Committee has been convened n. 2 times.
|
|
7 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
Duties of Directors and Conflict of Interests
Under Italian law, the primary duty of directors is to carry out all activities as are necessary for the achievement of the corporate purpose in accordance with applicable law and the articles of association.
In particular, directors have a general duty to act with care, without self-interest and on a well-informed basis.
The applicable standard of conduct is determined, on a case-by-case basis, taking into account the characteristics of the corporation, the specific tasks and responsibilities conferred to the single directors, and the personal skills of the latter.
In addition, directors have numerous specific duties and obligations, such as, inter alia:—keeping the corporation’s books, records and other databases (including the shareholders’ register) in such a manner that the corporation’s rights and obligations may be ascertained from the interested parties at all times;—preparing the corporation’s annual accounts according with the applicable accounting principles and filing them with the Companies’ Register on time;—registering the corporation with the Companies’ Register and keeping the registered information up to date;—convening annually or when necessary or required by the shareholders the general meetings of the corporation; and—monitoring the own funds and financial position of the corporation and initiate the actions or procedures contemplated by the law in case of (i) losses entailing the reduction of the own funds of the corporation below the threshold of two thirds of the share capital or (ii) income, asset or financial unbalances having certain characteristics
The board of directors may delegate certain powers to one or more managing directors (amministratori delegati), determine the nature and scope of the powers delegated to each director and revoke such delegation at any time. The managing directors must report to the board of directors and the audit committee at least every 180 days on the company’s business and the main transactions carried out by the company or by its subsidiaries.
Directors having any interest in a proposed transaction must disclose such interest to the board of directors and to the audit committee, even if such interest is not (or is deemed not to be) in conflict with the interest of the company in the same transaction. The interested director is not required to abstain from voting on the resolution approving the transaction, but the resolution must state explicitly the reasons for, and the benefit to the company of, the approved transaction. In the event that these provisions are not complied with, or that the transaction would not have been approved but for the vote of the interested director, the resolution may be challenged by a director or by the audit committee if the approved transaction is (or is likely to be) prejudicial to the company. If the director carrying an interest in the transaction is the CEO and the transaction falls within his/her competence, he/she will in any case have to abstain from carrying out the transaction on behalf of the Company and will defer authority to the board of directors.
Terms of Directors and Officers
The board of directors is elected by the ordinary shareholders’ meeting of the Company, for the period established at the time of election but in any event for no more than three fiscal years. A director may be reappointed for successive terms.
The board of directors—may also appoint one or more general managers (direttori generali), who must report directly to the board of directors and confer powers for single acts or categories of acts to employees of the company or third-party representatives.
Under Italian law and pursuant to our articles of association, directors may be removed from office at any time by the shareholders’ meeting. A director that is removed without cause may have a claim for damages against the Company. Directors may resign at any time by written notice to the board of directors and to the chairman of the audit committee. The board of directors, subject to the approval of the audit committee, must appoint substitute directors to fill vacancies arising from removals or resignations to serve until the next ordinary shareholders’ meeting.
|
|
8 |
|
|
Stevanato Group S.p.A.
Nominating and Corporate Governance Committee’s Report for 2021 |
If at any time more than half of the members of the board of directors appointed by the shareholders’ meeting of the Company resign, the remaining members of the board of directors (or the audit committee if all the members of the board of directors have resigned or ceased to be directors) must promptly call an ordinary shareholders’ meeting to appoint the new directors and until such time as the new directors are appointed, the resigning directors remain in office.
|
|
9 |
Exhibit 99.5
STEVANATO GROUP S.P.A.
REPORT ON REMUNERATION POLICY
AND PRACTICES
|
|
|
|
2 |
|
|
Stevanato Group S.p.A.
Report on remuneration policy and practices |
Introduction
To attract and retain people fully committed to the vision and purpose of Stevanato Group and able to support the success of our customers, it is fundamental to pay appropriately and fairly, balancing the interests of shareholders and employees, as well as all other stakeholders.
Remuneration policies and practices contribute to the long-term interests of Stevanato Group (“Group”) and enable the Group to reward performance in line with the Mission, Vision and Values.
The Group’s ambition is to motivate and develop people of the highest caliber and potential, and to build the Best Team, creating added value and delivering the best result for the customer. In this perspective, the remuneration policy, through dedicated compensation and welfare programs, aims at fostering a culture that values diversity, innovation and excellence.
The object of this year’s report is to describe the framework and the approach that will drive the development of the compensation policy and practices of Stevanato Group as a listed company, from 2022 onwards. To this purpose, the Compensation Committee, established on June 16, 2021, is currently working, in close cooperation with Group management, on the development of a remuneration policy that will continuously evolve to ensure its adherence to market best practices, Group’s life cycle and strategic priorities.
From 2023, the Compensation Committee will be ready to share with Company’s shareholders the overall set-up of Group remuneration policy and practices. In particular, information will be provided that outlines how our remuneration program aligns with our guiding principles and will discuss the balance between fixed and variable compensation, key metrics included in our incentive programs, alignment of pay and performance and how our commitment to DE&I is supported in our short-term incentive program.
The Committee, in line with market best practices, has availed itself of the services of the external advisor Mercer, a global leader of HR consulting, with extensive experience in Executive Remuneration.
Approach to Remuneration Policy
The purpose of Stevanato Group’s Remuneration Policy is to support successful business performance through an engaged and motivated team, attracted to the organization by a consistent and differentiated employment offering delivered at an affordable and sustainable cost, in line with business goals and long-term company’s objectives.
Stevanato’s Remuneration Policy is based on the following key pillars:
|
|
3 |
|
|
Stevanato Group S.p.A.
Report on remuneration policy and practices |
Stevanato Group Remuneration Practices
The remuneration structure envisages an appropriate combination and balance of all the incentive levers and components (base salary, short term incentive plan, long term incentive plan, benefits), to design compensation packages consistent with different clusters of the population, roles and complexity of the positions.
Total remuneration packages are subject to periodical review to ensure internal consistency, as well as adequacy and competitiveness compared to the markets for positions of similar levels of responsibility and complexity.
Base Salary (Fixed Remuneration)
Base Salary is determined and allocated based on pre-defined criteria.
It reflects the role and the responsibilities assigned, taking into consideration skills, contribution and experience required for the position.
The overall amount and weight of Base Salary must be sufficient and appropriate to remunerate the role and is periodically reviewed with respect to a predefined reference market.
Variable Remuneration
The variable component of Stevanato’s remuneration framework consists of:
| ● | Short Term Incentive Plan |
| ● | Long Term Incentive Plan |
Short Term Incentive Plan is a cash-based plan that aims at motivating and rewarding the achievement of annual financial and non-financial objectives, within the framework of long-term sustainable performance.
Key performance indicators, foreseen in the annual bonus scheme, vary depending on organizational layer and responsibilities of the participants. There is a mix of financial metrics at Group level (such as revenues, ebitda or ebitda margin, net working capital, free cash flow) and non-financial metrics (such as strategic objectives linked to business plan priorities, ESG performance areas, and operating metrics in the areas of safety, quality, production, sales, customer satisfaction). It is expected that the heaviest weighting for senior executives will be on financial metrics.
Short Term Incentive Plan envisages a cap to the maximum award and pre-defined performance and payout curves.
Target bonus opportunity for eligible positions is defined according to the level of accountabilities, contribution to company results and consistent with practices of the reference market.
Long Term Incentive Plan aims at strengthening the link between variable compensation, company performance and shareholder return over a multi-year period. The current Plan is a Stock Grant Plan, subject to claw-back clause.
Stock Grant Plan provides for the right of the beneficiaries to be granted a pre-defined number of shares of the Company, free of any charges, that will be awarded at the end of the vesting period, subject to the achievement of specific financial performance objectives at Group level. Furthermore, at the end of the vesting period, the Plan provides for a lock-up period, during which beneficiaries shall maintain the shares awarded.
|
|
4 |
|
|
Stevanato Group S.p.A.
Report on remuneration policy and practices |
The Plan envisages pre-defined pay for performance curves and a cap to the maximum award that can be earned in terms of number of shares.
The number of shares individually granted at the beginning of the vesting period is defined according to the level of accountabilities and business impact of each eligible position and consistent with practices of the reference market.
Benefits
As an Employer of Choice, Stevanato provides comprehensive and competitive Employee Benefits (such as pension schemes, healthcare plans, company car) as part of the Total Rewards package. Benefits provide substantial guarantees for the well-being of staff during their active career, as well as their retirement.
Stevanato Group’s Commitment on Diversity, Equity & Inclusion (DE&I)
Stevanato Group is committed to ensure fair treatment in terms of compensation and benefits, as well as in terms of opportunities and career development, regardless of gender, age, ethnicity, disability, sexual orientation, religion, as well as any other traits.
One important ambition of the Group is to foster a culture that values DE&I in all the locations in which the Group operates, promoting staff well-being through dedicated compensation and welfare programs to be competitive globally.
Stevanato Group confirms this commitment also through the inclusion of specific targets on DE&I within the Short Term Incentive goal card of the top management and where progress is regularly monitored.
|
|
5 |
Exhibit 99.6
STEVANATO GROUP S.P.A.
ORDINARY AND EXTRAORDINARY
GENERAL MEETING OF SHAREHOLDERS
JUNE 1, 2022
Extraordinary Session
| 1. | Amendments to Articles 21.2 and 25.2 of Bylaws; related resolutions. |
Amended Bylaws
UNOFFICIAL ENGLISH TRANSLATION OF THE ARTICLES OF ASSOCIATION
This document is an English translation of a document in Italian language
BY-LAWS
TITLE I
DENOMINATION - REGISTERED OFFICE – CORPORATE PURPOSE – DURATION
Article 1
Denomination
| 1.1 | The Company is denominated “Stevanato Group Società per Azioni”, abbreviated to “Stevanato Group S.p.A.”. |
Article 2
Registered office
| 2.1 | The Company has its registered office in the Municipality of Piombino Dese (Pd). |
Article 3
Applicable Provisions
| 3.1 | The Company is subject to the provisions of the Italian Civil Code relating to joint stock companies and all other laws and regulations applicable to joint stock companies. |
| 3.2 | If the ordinary shares of the Company are traded on the New York Stock Exchange (“NYSE”), the provisions of the Italian Civil Code applicable to listed companies will also be applicable, pursuant to article 2325-bis of the Italian Civil Code. |
| 3.3 | If the ordinary shares of the Company are traded on a European regulated market, the provisions of legislative decree 58/1998 and the other laws relating to the same matter shall apply to the Company, notwithstanding anything to the contrary in these Articles. |
Article 4
Corporate purpose
| 4.1 | The corporate purpose of the Company is as follows and comprises: |
2
| i) | the undertaking, holding and management of shareholdings and interests of any kind, both directly and indirectly, in other companies and entities, including consortia, both under Italian and foreign law, whatever their purpose and object; in particular, the Company takes on, holds and manages shareholdings in companies operating in the fields of design, production and commerce of containers, packaging systems, drug delivery systems, automatic assembly systems and other goods and services predominantly (but not exclusively) for the pharmaceutical industry and other connected or related sectors; |
| ii) | the provision of administrative, financial, commercial and management services in general aimed at the management and strategic, technical and/or financial coordination or, in any event, provided in the interest of the subsidiaries companies and entities, including but not limited to: the coordination of the operational strategies, investment programs and development plans; the coordination of financial policy, centralized treasury operations and the granting of financing; the exercise of promotion and research activities; the use of technological assets, name and intellectual property rights; the administration and management of personnel, both for operational and disciplinary effects; |
| iii) | the study, creation, undertaking, licensing, registration, filing, management, purchase, and transfer of all types of rights relating to intangible assets of any kind, patents for industrial inventions, and for ornamental or utility models, trademarks and know-how; |
| iv) | the purchase, sale, possession and enjoyment of shares and bonds as well as other financial instruments, real rights and/or options in general on the same, whether issued and/or circulating in Italy or abroad; |
| v) | the purchase, construction, sale, exchange, personal management of civil and industrial, rustic and urban real estate. |
| The activities in paragraphs (i) and (ii) will not be exercised vis-à-vis the public, but will be aimed at a stable investment purpose. In particular, any activity of a fiduciary nature, collection of savings, credit exercise, placement on the market of financial instruments is excluded; all other activities reserved by law are also excluded. |
| Consequently, in a non-predominant and instrumental manner for the achievement of the Company’s corporate purpose, the Company may carry out all commercial, financial, industrial, securities and real estate operations; it may also grant sureties, endorsements, deposits and guarantees in general, including in favor of third parties. |
| 4.2 | The Company exercises and organizes its own activity with the objective of pursuing success and sustainable growth through the creation of long-term value for the benefit of shareholders, taking into account the interests of other stakeholders relevant to the Company. |
Article 5
Duration
| 5.1 | The duration of the Company is set until 31 (thirty-one) December 2100 (two thousand one-hundred). |
3
TITLE II
SHARE CAPITAL – SHARES
Article 6
Share capital
| 6.1 | The share capital of the Company is of Euro 21,698,480.00 and is divided into 295,540,036 shares, of which 34,103,005 ordinary shares and 261,437,031 special class “A” shares (the “Shares A” and, together with the ordinary shares, the “Shares”) all without par value. |
| 6.2 | The share capital can also be increased through contributions in kind or receivables and by issuing shares of different classes from the Shares, in compliance with the provisions of the law in force and of these Articles. |
| 6.3 | Pursuant to article 2443 of the Italian Civil Code, the extraordinary shareholders’ meeting can grant the Board of Directors the power to increase the share capital, in one or more occasions, up to a determined amount and for a maximum period of five years from the date of the resolution, as well as the power to issue bonds, including bonds convertible in shares, up to a determined amount and for a maximum period of five years from the date of the resolution. |
| 6.4 | If the ordinary shares of the Company are traded on the NYSE, the pre-emption rights of the shareholders on the newly issued ordinary shares can be excluded, pursuant to article 2441, paragraph 4, second sentence, of the Italian Civil Code, on a number of share of up to 10 (ten) percent of the existing share capital, provided that the issuing price matches the market value of the ordinary shares and this is confirmed in a report issued by a legal auditing company or an auditor. |
| 6.5 | The Company may also issue bonds and participatory and non-participatory financial instruments, convertible or non-convertible into shares, warrants and other financial instruments pursuant to the law and as provided in these Articles. |
Article 7
Shares – Shareholders’ register - Entitlement to exercise corporate rights
| 7.1 | The Shares are not represented by share certificates, pursuant to article 2346, paragraph 1, of the Italian Civil Code, and are not subject to the dematerialization regime pursuant to article 83-bis and following of the Italian Financial Act (Testo Unico della Finanza). Therefore, the entitlement to exercise corporate rights is subject to the provisions of article 2355, paragraph 1, of the Italian Civil Code, save as provided in these Articles. |
| 7.2 | The Company keeps, in compliance with applicable laws, the shareholders register, in paper form or in electronic form, in compliance with the provisions of article 2215-bis of the Italian Civil Code and the applicable laws and regulations (the “Shareholders’ Register”). |
| 7.3 | If the ordinary shares of the Company are traded on the NYSE, the ordinary shares are transferred on the basis of the documentation and/or the computer techniques commonly used in such market, provided that such documentation and techniques shall comply with the applicable provisions of Unites States law and the regulations of the NYSE. |
4
| 7.4 | If the ordinary shares of the Company are traded on the NYSE, the Board of Directors has the power to institute and hold a paper and/or electronic register, which methods and functions shall be compliant with United States law (the “US Register”), where to register the direct holders of the shares and the related share transfers, subsequently making a corresponding annotation in the Shareholders’ Register, also through a third-party provider authorized to provide transfer agency services in relation to financial instruments traded on the NYSE and supervised by the competent United States authorities (the “Transfer Agent & Registrar”). When and if the US register is instituted, as a result of trading of ordinary shares on the NYSE, recording the transfers of such shares in the US Register is a condition for the regularity and validity of the subsequent and corresponding registrations in the Shareholders’ Register, without prejudice to the legal nature and relevance of the latter pursuant to the Italian legislation. |
| 7.5 | If the ordinary shares of the Company are traded on the NYSE, the Board of Directors may also set up procedures for the identification of those who - as a result of the registration in the US Register of a single depositary of the ordinary shares designated by the company entrusted with the centralized management of the US Register in accordance with applicable laws (the “Holder of Record”) - indirectly hold the ordinary shares (the “Beneficial Owners”) and the right to indirectly exercise corporate rights pursuant to article 7.6(b) below. These procedures can be implemented also through third-party providers. |
| 7.6 | If the ordinary shares of the Company are traded on the NYSE, the entitlement to exercise corporate rights is governed as follows: |
| a) | all the entities registered as direct holders of the ordinary shares, and therefore registered in the US Register and in the Shareholders’ Register are entitled on their own by virtue of the aforementioned registration and can therefore exercise all corporate rights in the forms provided for by law and by these Articles of Association; |
| b) | all the Beneficial Owners who are not registered as direct owners of the shares in the US Register or in the Shareholders’ Register, not being entitled to the exercise the corporate rights in their own name, can exercise all corporate rights, including participation and voting in the shareholders’ meeting, (i) collectively, through the Holder of Record registered both in the US Register and in the Shareholders’ Register or a person specifically appointed by the Holder of Record, or (ii) individually, through the same Holder of Record or a person who was specifically appointed by, or received specific authorization and/or delegation from, the Holder of Record, in compliance with all applicable laws and regulations. |
No obligation to update the US Register and the Shareholders’ Register results from the exercise of corporate rights by the Beneficial Owners, in the name of the Holder of Record, either collectively or individually.
| 7.7 | The ordinary shares are registered, indivisible, freely transferrable and grant the holders equal rights. In particular, each ordinary share grants the right to one vote in the ordinary and extraordinary shareholders’ meetings of the Company and the other financial and administrative rights pertaining to shareholders pursuant to the law and these Articles. |
| 7.8 | The Class A Shares have the same characteristics and grant the same rights as the ordinary shares, save for the following: |
5
| a) | every Class A Share grants the right to 3 (three) votes pursuant to article 2351, paragraph 4, of the Italian Civil Code in the ordinary and extraordinary shareholders’ meetings of the Company; |
| b) | the Class A Shares convert automatically (without any resolutions of the extraordinary meeting of the holders of Class A Shares or the shareholders’ meeting) in ordinary shares, with the ratio of one ordinary share for each Class A Share, in the event of a transfer of such Class A Shares to anyone other than Sergio Stevanato (born in Venice on March 20, 1943), his descendants (collectively the “Stevanato Family”), any company or other entity controlled, even jointly, directly or indirectly, by one or more members of the Stevanato Family, or a trust (or, alternatively, by the related trustees) instituted by members of the Stevanato Family, provided that the beneficiaries are (or may be) one or more members of the Stevanato Family. “Control” has the meaning specified by article 2359, paragraphs 1 and 2 of the Italian Civil Code; |
| c) | the Class A Shares are convertible into ordinary shares at the ratio of one ordinary share for each Class A Share, in whole or in part and also in several instalments, upon request of the holder via notice to be sent to the Chairman of the Board of Directors of the Company, copying the Chairman of the Audit Committee, by registered mail, e-mail or any other means suitable to provide proof of receipt. |
| 7.9 | The Board of Directors acknowledges the occurrence of an event resulting in a conversion of Class A Shares in ordinary shares pursuant to article 7.8 letters (b) and (c) above (each, a “Conversion Event”) with a resolution passed in the first meeting following the occurrence of such Conversion Event or when known by at least one directors and, in any event, within 15 (fifteen) days of the occurrence of such Conversion Event or from when known by at least one director, with the majorities referred to in article 21.3 below. Failing the acknowledgment of the Board of Directors, the occurrence of a Conversion Event is acknowledged by the Audit Committee with a resolution passed with the majorities referred to in article 25.3 below within the following 15 (fifteen) days. Following the acknowledgment of the Conversion Event, the Chairman of the Board of Directors of the Company or, failing that, the Chairman of the Audit Committee shall without delay: (i) register the conversion of the shares in the Shareholders’ Register, with prior notice to the Transfer Agent & Registrar to allow the registration of the ordinary shares on the US Register referred to in article 7.4 above if necessary; (ii) make the necessary amendments to the Articles of Association, adjusting its content as a consequence of the different distribution of the share capital in the different classes of shares; (iii) deposit, in accordance with article 2436, paragraph 6 of the Italian Civil Code, the updated text of the Articles of Association in the companies’ register, completing any other formalities required by applicable law. |
| 7.10 | In no case can ordinary shares be converted in Shares A. |
| 7.11 | The Company can issue Class A Shares in connection with (a) a capital increase through new contributions in cash without exclusion or limitation of the pre-emption rights, (b) a capital increase without new contributions pursuant to article 2442 of the Italian Civil Code, and (c) a merger or demerger, in any event in combination with ordinary shares. |
| 7.12 | In connection with a rights offering carried out through the issue of ordinary shares only, the right to subscribe the newly issued ordinary shares will be recognized to all shareholders in proportion to the Shares – be they ordinary shares or Class A Shares – held by each of them at the time of the rights offering. |
| 7.13 | In connection with a capital increase to be carried out through the issue of ordinary shares and Shares A: (i) the percentage of new ordinary shares and new Class A Shares will have to be proportional to the percentage of existing ordinary shares and Class A Shares as of the date of the resolution approving the capital increase; and |
6
| (ii) the newly issued ordinary shares and Class A Shares must be offered for subscription to individual shareholders in proportion to the ordinary shares and Class A Shares held by them at the time of execution of the capital increase. If any newly issued Class A Shares are not subscribed by holders of Class A Shares by the end of the offering period, pursuant to article 2441, paragraph 2, of the Italian Civil Code, and be purchased by someone other than a holder of Class A Shares such shares will assume the nature of ordinary shares from the outset. |
| 7.14 | In connection with a merger or demerger in which the Company is a party, the holders of Class A Shares will have the right to receive, in exchange for or in addition to the Class A Shares held by them, shares having the same characteristics as the Shares A, within the limits of law and compatibility, unless otherwise resolved by the extraordinary shareholders’ meeting of the holders of the Shares A. |
Article 8
Withdrawal rights
| 8.1 | Shareholders have the right of withdrawal in the cases provided by mandatory provisions of law. |
| 8.2 | Shareholders who have not taken part in the approval of resolutions concerning the extension of the duration of the Company or the introduction or removal of restrictions on the circulation of Shares are not entitled to withdraw. |
| 8.3 | The right of withdrawal is exercised in accordance with article 2437-bis of the Italian Civil Code. In any event, in the cases referred to in article 2437, paragraph 1, of the Italian Civil Code, the withdrawal rights are validly exercise only if the Beneficial Owners that exercised such rights directly or through the Holder of the Record, according to article 7.6 above, prove that they did not contribute to the adoption of the resolutions giving rise to the right of withdrawal. |
| 8.4 | The liquidation value of the Shares is determined pursuant to article 2437-ter of the Italian Civil Code. If the ordinary shares of the Company are traded on the NYSE, the liquidation value of the ordinary shares is determined by reference to the arithmetic average of the closing prices in the six months that precede the publication of the notice of call of the shareholders’ meeting which resolutions triggered the withdrawal right. |
7
TITLE III
SHAREHOLDERS’ MEETING
Article 9
Shareholders’ meeting
| 9.1 | The shareholders’ meeting represents all the members and its resolutions, taken in compliance with the law and with the present Articles, are binding for all the members, even if dissenting or not attending. |
| 9.2 | The shareholders’ meeting is ordinary or extraordinary in accordance with the law. |
| 9.3 | If the ordinary shares of the Company are traded on the NYSE, any shareholders’ agreements have to be communicated to the Company and declared at the beginning of each shareholders’ meeting pursuant and for the purposes of article 2341-ter of the Italian Civil Code. |
Article 10
Notice
| 10.1 | The shareholders’ meeting is convened by the Board of Directors, also in a location other than the registered office, in Italy, in other countries of the European Union, in the United Kingdom or in the United States of America. |
| 10.2 | The Board of Directors shall convene the shareholders’ meeting without delay when so requested by a number of shareholders representing at least one tenth of the share capital or, if the ordinary shares of the Company are traded on the NYSE, one twentieth of the share capital pursuant to article 2367 of the Italian Civil Code. |
| 10.3 | The shareholders’ meeting, both ordinary and extraordinary, shall be held on first call and, if necessary, on second call, as well as possibly in calls subsequent to the second, even if the ordinary shares are traded on the NYSE, unless the Board of Directors establishes, with the notice of call, that the shareholders’ meeting is held in a single call. |
| 10.4 | The convocation of the shareholders’ meeting, both ordinary and extraordinary, is effected by means of a notice communicated to all the shareholders by means that guarantee proof of receipt at least 8 (eight) days before the date of the meeting. |
| 10.5 | If the ordinary shares of the Company are traded on the NYSE, the notice of the shareholders’ meeting, both ordinary and extraordinary, is carried out by notice to be published, in the manner specified below, at least 40 (forty) days prior to the date of the shareholders’ meeting. The notice of call is published: |
| a) | in English and Italian, on the website of the Company; |
8
| b) | in Italian, on the newspaper “Sole 24 Ore” or, in the event it is no longer published or there is an objective impediment, in the newspaper “Corriere della Sera”, or, finally, in the event it is no longer published or there is an objective impediment, on the Official Gazette of the Italian Republic. |
| 10.6 | The notice of call must contain: |
| a) | an indication of the place where the shareholders’ meeting is to be held, as well as any places connected to it by telematic means; |
| b) | indication of the date and time of the shareholders’ meeting convocation; |
| c) | the list of the items on the agenda; |
| d) | any other information required by law. |
as well as, if the ordinary shares of the Company are traded on the NYSE,
| e) | indication that the documentation required by applicable laws and regulations have been published on the Company’s website; |
| f) | the address of the website of the Company; |
| g) | indication of the date referred to in article 11.2 below, specifying that those who will become holders of Company’s Shares after that date will not have the right to attend and vote in the shareholders’ meeting. |
Article 11
Entitlement to attend and vote at the shareholders’ meeting - Voting proxies
| 11.1 | Entitlement to attend the shareholders’ meeting and exercise of voting rights is governed by article 7 above. |
| 11.2 | If the ordinary shares of the Company are traded on the NYSE, the entitlement to attend the shareholders’ meeting and exercise the right to vote in relation to the ordinary shares are vested in the entities that are registered both in the US Register and in the Shareholders’ Register as holders of these shares at the end of the accounting day (according to New York time zone) of the 25th (twenty-fifth) day prior to the date in which the shareholders’ meeting is called or, in the event that that day is not a trading day (according to the NYSE trading calendar), on the immediately preceding trading day (the “Record Date”). In this case, the entity entitled to attend and vote does not loose such entitlement if it has disposed of the shares after the Record Date. On the other hand, entities who are registered both in the US Register and in the Shareholders’ Register after the Record Date, but before the opening of the shareholders’ meeting, are considered, respectively, as absent from the shareholders’ meeting and not having participated to the adoption of the relevant resolutions for the purpose of challenging the shareholders’ meeting resolutions and the exercise of the right of withdrawal pursuant to articles 2377 and 2437 of the Italian Civil Code. However, the Beneficial Owners who were such at the Record Date and who are |
9
| registered in both the US Register and in the Shareholders’ Register between the Record Date and the opening date of the shareholders’ meeting will be able to challenge the resolution and exercise the right of withdrawal pursuant to articles 2377 and 2437 of the Italian Civil Code only by demonstrating that they did not participate to the adoption of the relevant resolutions. |
| 11.3 | Participation in the shareholders’ meeting may also take place by means of telecommunications, if provided for in the notice of call, in accordance with the procedures set out in the notice itself. |
| 11.4 | If the ordinary shares of the Company are traded on the NYSE, the right to vote may be exercised by correspondence or in electronic form, if provided by the notice of call, in accordance with the limits and the formalities established by the notice itself. |
| 11.5 | Those entitled to vote may be represented by proxy pursuant to article 2372 of the Italian Civil Code. Without prejudice to what is provided by article 7.6(b) above, if the ordinary shares of the Company are traded on the NYSE. |
Article 12
Chairman – Conduct of the shareholders’ meeting
| 12.1 | The shareholders’ meeting is chaired by the Chairman of the Board of Directors or, in case of absence or impediment, in order by a Vice-Chairman, by a Managing Director, if appointed, or, in case of absence or impediment of the latter, by another person designated by the shareholders’ meeting by majority vote of those present. |
| 12.2 | The Chairman of the shareholders’ meeting is assisted by a secretary, who may or may not be a shareholder, appointed by the shareholders’ meeting itself on proposal of the Chairman, with the vote of the majority of those present. In extraordinary shareholders’ meetings and, in any case, when the Chairman deems it appropriate, the functions of secretary are performed by a notary public. |
| 12.3 | The Chairman of the shareholders’ meeting ascertains the identity and the entitlement to attend and vote of those present, verifies that the shareholders’ meeting has been duly convened, regulates its proceedings, establishes the voting procedures in compliance with the law and ascertains the results of voting. |
| 12.4 | The conduct of the shareholders’ meeting may be governed by specific regulations, approved by resolution of the ordinary shareholders’ meeting. |
| 12.5 | Minutes of the shareholders’ meetings must be drawn up in accordance with the law. The minutes thus drawn up, signed by the Chairman of the meeting and by the secretary or notary public, must be transcribed in the book of meetings and resolutions of the shareholders’ meeting. |
10
Article 13
Powers, constitution and resolutions of the ordinary shareholders’ meeting
| 13.1 | The ordinary shareholders’ meeting is competent to resolve on all matters reserved to it by the law and by these Articles. |
| 13.2 | The ordinary shareholders’ meeting is validly constituted and resolves in first, second and subsequent calls or, if so established by the notice of call, in a sole call, with the majorities required by law. For the purposes of calculating the majorities, reference is made to the number of votes pertaining to the Shares and not to the number of Shares. |
Article 14
Powers, constitution and resolutions of the extraordinary shareholders’ meeting
| 14.1 | The extraordinary shareholders’ meeting is competent to pass resolutions on amendments to these Articles, on the appointment, substitution and powers of liquidators and on other matters reserved to it by law. |
| 14.2 | The extraordinary shareholders’ meeting is validly constituted and resolves in first, second and subsequent calls or, if so provided in the notice of call, in a sole call, with the majorities required by law. For the purposes of calculating the majorities, reference is made to the number of votes pertaining to the Shares and not to the number of Shares. |
TITLE IV
ADMINISTRATION AND AUDIT SYSTEM
Pursuant to article 2409-sexiesdecies and following of the Italian Civil Code, the Company adopts the one-tier system corporate governance, in which the functions of administration and audit are exercised respectively by the Board of Directors and the Audit Committee set up within the administrative body.
Article 15
Composition of the Board of Directors
| 15.1 | The Board of Directors is composed by a number of members ranging from a minimum of 9 (nine) and a maximum of 15 (fifteen). |
| 15.2 | The directors remain in office for a period not exceeding three financial years and their term of office expires on the date of the shareholders’ meeting convened to approve the financial statements for the last financial year of their office, without prejudice to the causes of termination and expiry provided for by law and by these Articles, and can be re-elected. |
| 15.3 | The directors must meet eligibility and integrity requirements pursuant to article 2382 of the Italian Civil Code and have the professionalism and skills to perform the tasks entrusted to them. |
11
| 15.4 | Without prejudice to the additional requirements envisaged for the directors who make up the Audit Committee by article 23 below, one third of the members of the Board of Directors, rounded up in the case of a fractional number, must possess the independence requirements set forth in article 2399 of the Italian Civil Code. |
Article 16
Appointment of the Board of Directors
| 16.1 | The directors are elected by the ordinary shareholders’ meeting, which also determines their number and term of office. |
| 16.2 | If the ordinary shares are traded on the NYSE, the directors will be elected on the basis of lists submitted by shareholders, in accordance with the following procedure. |
| 16.3 | The right to submit a list for the appointment of the Board of Directors is reserved to shareholders who hold, individually or jointly with other submitting shareholders, Shares representing at least 5 (five) percent of the total voting rights attached to the Shares issued by the Company. Each shareholder may only submit one list. The ownership of the number of Shares necessary for the presentation of the list is determined having regard to the entries on the Shareholders’ Register and the US Register on the date on which the lists are filed at the registered office, without prejudice to the provisions of article 7.6 above. |
| 16.4 | The lists are filed at the Company’s registered office, in accordance with the procedures indicated in the notice of call, at least 3 (three) days before the Record Date and are published by the Company in compliance with any applicable legal and regulatory provisions. |
| 16.5 | The lists indicate a number of director candidates ranging from 9 (nine) and 15 (fifteen). Director candidates must meet the eligibility and integrity requirements set out in article 15.3 above. Each list must also include: (a) at least one third of the director candidates, rounded up to the higher unit in case of a fractional number, who meet the independence requirements provided for in article 15.4 above; (b) at least 3 (three) director candidates who meet the independence and competence requirements provided for in articles 23.3 and 23.5 below; and (c) at least 1 (one) director candidate who meets the additional professionalism requirement provided for in paragraph 23.4 below. Each candidate may only stand for election in one list, under penalty of ineligibility. |
| 16.6 | The following must be attached to each list, under penalty of inadmissibility: (i) the curriculum vitae of each of the director candidates; (ii) the declarations with which each of the director candidates accepts his/her candidacy and certifies, under his/her own responsibility, that he/she possesses the eligibility and integrity requirements provided for in article 15.3 above, the independence requirements provided for in article 15.4 above, as well as the independence, professionalism and competence requirements provided for by articles 23.3, 23.4 and 23.5 below; (iii) an indication of the identity of the shareholders or Beneficial Owners who have submitted the lists and the percentage of the voting rights pertaining to the Shares held by them; (iv) any other or different statement, information and/or document required by the provisions of any applicable legislation. |
| 16.7 | Each shareholder may vote for only one list of candidates. The vote of each shareholder relates to the list and, therefore, to all the candidates indicated therein, without the possibility of variations, additions or exclusions. |
12
| 16.8 | The number of members of the Board of Directors is determined by the number of candidates indicated in the list that obtained the highest number of votes. |
| 16.9 | Upon completion of the voting process, the candidates on the list that obtained the highest number of votes will be elected. If more than one list has obtained the same number of votes, a new vote will be held during the same shareholders’ meeting; only the lists that reported the same number of votes shall take part in the vote. |
| 16.10 | If, at the end of the vote, one or more director candidates are elected directors who do not meet the eligibility and integrity requirements set out in article 15.3 above, such candidates will be excluded and, where necessary to ensure the correct composition of the Board of Directors pursuant to article 15 above, replaced pursuant to article 16.12 below. |
| 16.11 | If, at the end of the vote, no directors are elected who meet the independence requirements set out in article 15.4 above and/or the independence, professionalism and competence requirements set out in articles 23.3, 23.4 and 23.5 below at least in the minimum number indicated in the same articles, the candidates who do not comply with said requirements, who are indicated as last in the list from which they are taken, will be excluded and, where necessary to ensure the correct composition of the Board of Directors pursuant to the article 15 above and the Audit Committee pursuant to article 23 below, replaced pursuant to article 16.12 below. |
| 16.12 | In cases in which (a) no lists are submitted by the shareholders, (b) only one list is submitted and the same does not obtain the relative majority of votes, (c) the number of directors elected on the basis of the lists presented by the shareholders, also due to the exclusions determined pursuant to articles 16.10 and 16.11 above, is less than 9 (nine), (d) the entire Board of Directors does not have to be renewed or (e) it is not possible, for any reason, to appoint the Board of Directors according to the procedures provided for in article 16.2 and following, the directors will be appointed by the shareholders’ meeting without applying the list voting mechanism, without prejudice to the obligation to ensure the correct composition of the Board of Directors pursuant to the article 15 below and the Audit Committee pursuant to article 23 below. |
| 16.13 | Directors cease to hold office in the cases provided for by law and by these Articles. |
| 16.14 | If, during in the term of office, one or more directors cease to hold office, the Board of Directors shall replace them with directors who meet the eligibility and integrity requirements referred to in article 15.3 above and where necessary to ensure the correct composition of the Board of Directors pursuant to article 15 and of the Audit Committee pursuant to article 23 below, the independence requirements referred to in article 15.4 above and/or the independence, professionalism and skills requirements provided for in articles 23.3, 23.4, and 23.5 below. To that end, the provisions of article 2386, paragraph 1 of the Italian Civil Code shall apply, without prejudice to article 2386, paragraphs 2 and 3, of the Italian Civil Code in the event of termination of the majority of directors appointed by the shareholders’ meeting and the provisions of article 2409-octiesdecies, paragraph 4, of the Italian Civil Code and article 23.7 in relation to the substitution of the members of the Audit Committee. |
| 16.15 | If, following the loss by a director of the independence requirements referred to in article 15.4 above and/or the independence, professionalism and skills requirements set out in articles 23.3, 23.4 and 23.5 below, the Board of Directors and/or the Audit Committee are no longer correctly constituted pursuant to the previous article 15 and article 23 below, the director for whom the aforementioned requirements have ceased to apply shall cease to be a director and will be replaced pursuant to the article 16.14 above. |
13
Article 17
Powers of the Board of Directors - Chairman - Honorary Chairman - Delegated bodies
| 17.1 | The Board of Directors is vested with all the powers for the ordinary and extraordinary management of the Company, with the power to carry out all acts deemed appropriate to achieve the corporate purpose, excluding only those that the law and these Articles reserve to the shareholders’ meeting. |
| 17.2 | The Board of Directors is also responsible, pursuant to articles 2365, paragraph 2, and 2446, paragraph 3 of the Italian Civil Code, without prejudice to the competing powers of the extraordinary shareholders’ meeting resolutions concerning: (a) the merger and demerger of the Company in the cases provided for by articles 2505 and 2505-bis of the Italian Civil Code, (b) the transfer of the registered office within the Italian territory, (c) the establishment or closing of secondary offices, (d) the indication of the directors who are entitled to legally represent the Company, (e) the reduction of the share capital in the event of withdrawal of a shareholder, (f) the reduction of the share capital following losses of over one third of the capital, and (g) the adjustment of the Articles to regulatory provisions or as a result of a Conversion Event pursuant to paragraph 7.9 above. In such cases, article 2436 of the Italian Civil Code shall apply. |
| 17.3 | The Board of Directors elects the Chairman from among its members, unless the shareholders’ meeting does so, and may also appoint one or more Vice-Chairmen. |
| 17.4 | The Board of Directors may also assign the title of “Honorary Chairman” to a person of recognized prestige who has contributed to the affirmation and development of the Company. The office can also be assigned to subjects who are not members of the Board of Directors, has indefinite duration and can only be revoked for cause. If he/she is not also a director, the Honorary Chairman can attend meetings of the Board of Directors and the shareholders’ meetings to express non-binding opinions and opinions on the matters dealt with and may represent the Company on the basis of special powers of attorney. The Board of Directors determines any remuneration any other emolument and/or reimbursement of expenses due to the Honorary Chairman. |
| 17.5 | The Board of Directors may delegate part of its powers to an executive committee composed by some of its members or to one or more directors, determining their powers in compliance with the limitations of the law. To this end, the provisions of article 2381, paragraphs 3, 4 and 5, of the Italian Civil Code shall apply. |
| 17.6 | The Board of Directors and, if appointed, the executive committee and the Managing Directors, within the limits of their powers, may appoint, among the employees of the Company, general managers or proxies, as well as, also among third parties, special proxies or special attorneys, determining their duties and powers in compliance with the limitations of the law. |
Article 18
Company representation
| 18.1 | The legal representation of the Company is due to the Chairman of the Board, without limitations. |
| 18.2 | The representation of the Company is also the responsibility of the Managing Directors, if appointed, within the limits of the powers granted to them. |
14
| 18.3 | The representation of the Company is also vested in the General Manager, the proxies and the attorneys within the limits of the powers conferred on them by the deed of appointment. |
Article 19
Remuneration of the directors
| 19.1 | The shareholders’ meeting shall establish the remuneration due to the directors for their office as member of the Board of Directors, also in the form of insurance policies. Directors are also entitled to reimbursement of expenses incurred in the exercise of their duties. |
| 19.2 | The ordinary shareholders’ meeting may also determine an overall amount for the remuneration of all directors, including those holding particular offices, to be divided by the Board of Directors. |
| 19.3 | The Board of Directors may establish an additional remuneration for the directors vested with particular offices, which may consist of a fixed and a variable part, related to the achievement of certain objectives, or consist of the right to subscribe ordinary shares or other financial instruments of the Company at a predetermined price, including those to be issued in the future. |
| 19.4 | The shareholders’ meeting establishes the fixed remuneration of the Chairman and the members of the Audit Committee for the entire term of office. If the shareholders’ meeting fails to do so, the remuneration of the Chairman and the members of the Audit Committee is established by the Board of Directors. |
Article 20
Convening the Board of Directors
| 20.1 | The Board of Directors is convened and meets, even outside the registered office, in Italy or abroad, every time the Chairman deems it appropriate, or when requested by a Managing Director (if appointed) or by at least one third of its members. |
| 20.2 | The Board of Directors shall be convened by the Chairman or, if he/she is prevented from so doing, by a Vice Chairman or a Managing Director, if appointed, with a notice containing indication of the day, time and place of the meeting and the related agenda, as well as, in the cases set out in article 21.2 below, the arrangements for participation by audio or video conference. The notice of call is sent to each director by registered letter, e-mail or any other means capable of providing proof of receipt, at least three days in advance or, in urgent cases, the day before the date set for the meeting. |
| 20.3 | Even in the absence of formal convocation, the Board of Directors is deemed to be duly constituted if all the directors in office are present. |
15
Article 21
Meetings and resolutions of the Board of Directors
| 21.1 | The meetings of the Board of Directors are chaired by the Chairman, or, in the event of his absence or impediment, in order, by a Vice Chairman, if appointed, by a Managing Director, if appointed, or, in the event of the absence or impediment of the latter, by the person designated by the attending directors. |
| 21.2 | Pursuant to Article 2388, paragraph 1, of the Civil Code, participation to the meetings of the Board of Directors may also occur through means of distance communication, according to the provisions set out in the relevant convening notice, if any, and to the modalities agreed by the chairman of the meeting. In the convening notice, it may be provided that the relevant meeting of the Board of Directors is exclusively held by means of distance communication, without specifying a physical location for the meeting. |
| 21.3 | The presence of the majority of the Board of Directors and the favorable vote of the absolute majority of the directors present is required for the validity of the resolutions of the Board of Directors. In the event of a tie, the Chairman shall have a casting vote. |
| 21.4 | The Board of Directors may adopt a regulation containing the rules and procedures for its operation, also in order to ensure effective management of Board information. |
| 21.5 | Minutes of the meetings of the Board of Directors must be drawn up in accordance with the law. The minutes thus drawn up, signed by the Chairman of the meeting and by the secretary or notary public, must be transcribed in the book of meetings and resolutions of the Board of Directors. |
| 21.6 | The Managing Directors report to the Board of Directors, pursuant to article 2381, paragraph 5, of the Italian Civil Code, on the general performance of operations and on the outlook, as well as on the most significant transactions carried out by the Company and its subsidiaries at least every six months. |
| 21.7 | In relation to resolutions concerning transactions in which one or more directors have, on their own or on behalf of third parties, an interest, article 2391 of the Italian Civil Code applies. |
Article 22
Internal committees
| 22.1 | The Board of Directors may set up committees from among its members with investigative, consultative or propositional functions, establishing their purpose, composition and operating procedures. |
Article 23
Composition of the Audit Committee - Appointment, termination and replacement of members
| 23.1 | The Audit Committee is composed by 3 (three) members, appointed by the Board of Directors. |
| 23.2 | The members of the Audit Committee shall remain in office for three financial years and may be re-elected. |
16
| 23.3 | The members of the Audit Committee must meet the independence requirements set forth in article 15.3 above and, if the ordinary shares are traded on the NYSE, the additional requirements of independence required by United States law and regulation of the NYSE applicable to the Company from time to time. In any case, members of the executive committee, where appointed, and the directors who have been granted delegated powers or special offices and who in any event perform, even de facto, functions relating to the management of the Company, of companies that control it or are controlled by it, cannot be members of the Audit Committee. |
| 23.4 | At least one member of the Audit Committee must be chosen from among those enrolled in the register of legal auditors. |
| 23.5 | If the ordinary shares are traded on the NYSE, the members of the Audit Committee must also possess the financial expertise provided for by United States regulations applicable from time to time. |
| 23.6 | The Audit Committee elects a Chairman from among its members. |
| 23.7 | In the event of death, resignation, revocation or lapse of a member of the Audit Committee, the Board of Directors shall promptly replace him/her by selecting him/her from among the other directors who meet the independence, professionalism and skills requirements set forth in the articles 23.3, 23.4 and 23.5 above. If it is not possible to replace a member of the Board of Directors, the Board of Directors shall promptly take action in accordance with article 16.14 above. |
| 23.8 | If one or more members of the Audit Committee lose the requisites of independence, professionalism and skills referred to in articles 23.3, 23.4 and 23.5 above, they shall be removed from office. In this case, where possible, the Board of Directors will replace the removed members by selecting replacement candidates among the other directors possessing the aforementioned independence, professionalism and skills requirements. Otherwise, article 16.14 above will apply. |
Article 24
Functions and powers of the Audit Committee
| 24.1 | The Audit Committee (a) supervises the adequacy of the Company’s organizational structure, the internal control system and the administrative and accounting system, as well as its suitability to correctly represent management events, and (b) carries out the further tasks entrusted to it by the Board of Directors, with particular regard to maintaining relations with the person appointed to carry out the statutory audit of the accounts. |
| 24.2 | If the ordinary shares are traded on the NYSE, the Audit Committee also exercises the functions pertaining to the “Audit committee” pursuant to United States law applicable to the Company from time to time. |
| 24.3 | Articles 2404, paragraph 1, 3 and 4, 2405, paragraph 1, and 2408 of the Italian Civil Code shall apply to the Audit Committee, mutatis mutandis. |
17
Article 25
Meetings of the Audit Committee
| 25.1 | The Audit Committee meets at least every 90 (ninety) days. |
| 25.2 | The meetings of the Audit Committee may also be held by means of distance communication, pursuant to the provisions of paragraph 21.2 above. |
| 25.3 | The Audit Committee is duly constituted with the presence of the majority of its members and resolves by an absolute majority of those present. Any member who intends to disagree with the adoption of a resolution has the right to have the reasons for their dissent recorded in the minutes. |
| 25.4 | Minutes of the meetings of the Audit Committee must be taken. The minutes thus drawn up, signed by those present, must be transcribed in the book of meetings of the Audit Committee. |
Article 26
Legal audit of the accounts
| 26.1 | The legal auditing of the accounts shall be carried out by persons who meet the requirements provided by the laws and regulations in force. |
| 26.2 | The appointment of a legal auditor shall be made, on the basis of a reasoned proposal of the Audit Committee, by the ordinary shareholders’ meeting, which will also determine the fee for the entire duration of the appointment and any criteria for adjusting the fee during the term of office. |
| 26.3 | The term of office of the legal auditor has the duration of 3 (three) financial years, expiring on the date of the shareholders’ meeting called to approve the financial statements for the third year of the term of office. |
18
TITLE V
FINANCIAL STATEMENTS – PROFITS AND DIVIDENDS
Article 27
Financial statements
| 27.1 | The financial year ends on 31 December of each year. |
| 27.2 | If the ordinary shares are traded on the NYSE, the Board of Directors prepares the additional periodic financial reports envisaged by United States law and makes them available to the public in the forms and within the times indicated by such legislation. |
| 27.3 | The financial statements must be submitted to the ordinary shareholders’ meeting for approval of the shareholders within 180 (one-hundred and eighty) days from the end of each financial year pursuant to article 2364, paragraph 2, of the Italian Civil Code, as long as the Company is required to draw up the consolidated financial statements or, in any case, when special requirements relating to the structure and purpose of the Company so require. |
Article 28
Profits, dividends and other distributions
| 28.1 | The net profit reported in the duly approved financial statements, after deducing 5 (five) percent for the legal reserve, until this has reached one fifth of the share capital, shall be allocated to the shareholders by way of dividends or set aside as reserves, as resolved by the ordinary shareholders’ meeting. |
| 28.2 | If the legal requirements are met, the Board of Directors may, during the course of the financial year, approve the distribution of interim dividends to shareholders on the conditions and within the limits of article 2433-bis of the Italian Civil Code. |
| 28.3 | The ordinary or extraordinary shareholders’ meeting, depending on the competence, may at any time resolve to distribute to the shareholders the reserves resulting from the financial statements or formed by means of contributions by the shareholders, insofar as they are available according to applicable legislation, in cash or in kind, provided that the principle of equal treatment is ensured in every such case, as well as the assignment to the shareholders of shares, financial instruments or other rights vis-à-vis the Company. |
| 28.4 | The payment of dividends or interim dividends and the further distributions or allocations to shareholders is effected in accordance with the terms and procedures determined by the shareholders’ meeting or the Board of Directors according to competence. |
| 28.5 | If the ordinary shares are traded on the NYSE, the Board of Directors may set the date for the determination of the Beneficial Owners entitled to receive dividend payments, the other distributions or allotments due to the ordinary shares held by the Holder of Record. This date may be set at the same time as, before, or after, the date on which the resolution relating to the payment of dividends, to the distribution or assignment will be adopted by the shareholders’ meeting or by the Board of Directors. |
19
TITLE VI
DISSOLUTION AND LIQUIDATION - DISPUTES - FINAL PROVISIONS
Article 29
Dissolution and Liquidation
| 29.1 | The Company is dissolved in the cases provided for by law. |
| 29.2 | In any case of dissolution of the Company, the extraordinary shareholders’ meeting determines the liquidation procedure and appoints one or more liquidators, establishing their powers and remuneration, in accordance with article 2487 of the Italian Civil Code. |
Article 30
Disputes
| 30.1 | Any disputes that may arise between the shareholders, between the shareholders and the Company, the directors and/or the liquidators, between the Company and the directors and /or the liquidators, or between the directors and/or the liquidators, arising out of or in connection with these Articles and, in general, any other relationship relating to the life of the Company and which are not, by mandatory rules, referred to another judge, shall be subject to the exclusive jurisdiction of the commercial section of the Court in whose district the Company has its registered office. |
| 30.2 | Without prejudice to the provisions of article 30.1 above, the disputes to which the Company, the directors and/or liquidators, the shareholders or other entities who have acted in the interest and on behalf of the Company are part of and which derive from, or are inherent to the provisions of the United States Securities Act of 1933 and/or of the United States Exchange Act of 1934, as amended over time, and the related implementing provisions, are subject, as permitted by applicable law, to the exclusive jurisdiction of the United States District Court for the Southern District of New York. |
Article 31
Final Provisions
| 31.1 | Unless otherwise specified, any reference to applicable law contained in these Articles of Association must be considered as a reference to Italian law and, where applicable, to United States law and market regulation applicable to the Company due to the listing of its ordinary shares on the NYSE. |
20
Exhibit 99.7
Stevanato Group S.p.A.
Ordinary and Extraordinary Shareholders’ Meeting
on June 1, 2022
Item 4 of the Agenda - Additional remuneration of the External Auditor EY S.p.A. for the auditing of the consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, to be conducted in accordance with the standards of the Public Company Accounting Oversight Board (PCAOB); related resolutions.
Substantiated proposal of the Audit Committee
Dear Shareholders,
following the listing of the ordinary shares of Stevanato Group S.p.A. (“Stevanato” or the “Company”) on the New York Stock Exchange, Stevanato is required to appoint an external auditor to conduct an audit on the Company’s annual consolidated financial statements in accordance with the auditing standards set out by the Public Company Accounting Oversight Board (PCAOB) and to express an opinion on whether such statements are presented fairly and, in all material respects, in conformity with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB), which must be included in the Company’s annual report to be filed with the Security and Exchange Commission (SEC) on Form 20-F.
It must be highlighted that such auditing activity on the Company’s annual consolidated financial statements, as well as the opinion expressed in relation thereto, are different, respectively, from the audit conducted on the consolidated financial statements according to the Italian GAAP (ISA Italia) as issued by the International Auditing and Assurance Standards Board (IAASB), and from the opinion expressed based on such standards, pursuant to the Italian law provisions, by the Company’s current external auditor EY S.p.A., appointed by the shareholders at the meeting of June 11, 2020.
In such connection, on October 25, 2021, EY S.p.A. presented to Stevanato an offer to perform, in addition to the auditing services carried out under Italian law, the audit of the annual consolidated financial statements for the financial year ended on December 31, 2021, in accordance with the PCOAB standards and under the terms of the applicable SEC and PCOAB provisions, and express the relevant opinion, for an annual additional compensation estimated in Euro 380,000.00.
Additionally, on March 3, 2022, EY S.p.A. presented to the Company an offer to perform, in addition to the auditing services carried out under Italian law, the audit of the annual consolidated financial statements for the financial year ending on December 31, 2022, as well as the review of the quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and under the terms of the applicable SEC and PCOAB provisions, and express the relevant opinions, for an annual additional compensation estimated in Euro 635,000.00.
As set forth by both the Italian Legislative Decree no. 39/2010 and the SEC and PCOAB provisions, and in compliance with the Charter of Stevanato’s Audit Committee, at the meetings of November 5, 2021, and April 8, 2022, the Audit Committee expressed a positive opinion on the offers presented by EY S.p.A.
In particular, the Audit Committee considered it advisable that Stevanato accepts the offer by the current external auditor EY S.p.A. and extends the appointment of EY S.p.A. to perform also the aforementioned auditing services for the following reasons:
| - | it is appropriate that the audit of the consolidated financial statements of the Company is performed by the same external auditor for both Italian law and US regulations purposes, in order to avoid the redundancy of auditing activities and reviews on the same by the Audit Committee, along with the inefficiencies and expenses which would derive from the appointment of two different external auditors; |
| - | the additional remuneration requested by EY S.p.A. for the auditing of Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, as well as for the reviewing of the quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and pursuant to the applicable SEC and PCOAB provisions, as specified in the offers presented to the Company on October 25, 2021, and on March 3, 2022, is adequate in light of the complexity of the activity to be carried out and of the responsibilities to be assumed by the external auditor and in line with the market standards, based on the knowledge of the Audit Committee members. |
In consideration of the foregoing, pursuant to Article 13 of the Italian Legislative Decree no. 39/2010, as resolved at the Audit Committee’s meeting of April 8, 2022, we submit to you, in relation to item 4 of the agenda of the shareholders’ meeting convened on June 1, 2022, the proposal to:
| 1. | extend the appointment of the Company’s External Auditor EY S.p.A. to the performance, in addition to the auditing services carried out following the appointment resolved by the shareholders’ meeting of June 11, 2020, of the audit of Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, and for the financial year ending on December 31, 2022, as well as of the review of quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, in accordance with the PCOAB standards and under the terms of the applicable SEC and PCOAB provisions; and |
| 2. | grant to EY S.p.A., as consideration for the performance of the audit of Stevanato’s consolidated financial statements for the financial year ended on December 31, 2021, the additional annual compensation of Euro 380,000.00, as specified in the offer presented by EY S.p.A. on October 25, 2021, and, as consideration for the performance of the audit of Stevanato’s consolidated financial statements for the financial year ending on December 31, 2022, and of the review of quarterly consolidated financial statements as of March 31, June 30 and September 30, 2022, the additional estimated annual compensation of Euro 635,000.00, as specified in the offer presented by EY S.p.A. on March 3, 2022. |
* * *
Piombino Dese, April 8, 2022.
| The Chairman of the Audit Committee | ||
| William Federici | ||